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26700.0 | 2016-01-19 00:00:00 UTC | 3 Slides That Perfectly Sum Up Where AbbVie Is Headed Next | ABBV | https://www.nasdaq.com/articles/3-slides-perfectly-sum-where-abbvie-headed-next-2016-01-19 | nan | nan | Image source: AbbVie.
AbbVie's three amigos
The three amigos of AbbVie's pipeline are (not surprisingly) Humira in immunology, Imbruvica in oncology, and Viekira Pak in virology. Combined, AbbVie sees sales of these three products hitting approximately $18 billion, $5 billion, and $3 billion, respectively, by 2020. Later in the presentation, Gonzalez estimated that 2020 sales forecasts for the company could hit roughly $37 billion. In short, these three products could account for $26 billion of AbbVie's estimated $37 billion in sales five years from now.
Image source: AbbVie.
An underappreciated pipeline
ABT-494 is a JAK-1 inhibitor currently being studied in phase 3 trials for rheumatoid arthritis. The drug met its primary endpoint in two mid-stage studies (BALANCE I and BALANCE II) as a once-daily formulation by delivering ARC20 response rates ranging from 56%-71% in moderate-to-severe RA patients who'd previously responded poorly to anti-TNF treatments, and ARC20 rates of 65%-82% in methotrexate inadequate response patients. Considering its ability to tackle tough-to-treat RA patients, ABT-494 is definitely worth watching.
Next up, AbbVie's CEO wants you to pay attention to venetoclax, a BCL2 inhibitor that's being tested as a monotherapy and in combination with Rituxan as a treatment for relapsed and refractory (R/R) chronic lymphocytic leukemia. At the American Society of Hematology's annual meeting in December, AbbVie presented data on venetoclax in combination with Rituxan for CLL (R/R) patients that demonstrated an overall response rate of 86% and a whopping complete response rate of 47%. This is a therapy that could have expansive label potential.
Lastly, AbbVie is working on a once-daily HCV regimen that'll be able to take on Gilead Sciences Harvoni and Sovaldi. Gilead's once-daily pills and efficacy of 90% or higher in many HCV genotypes makes unseating it very difficult. However, AbbVie believes it'll soon have a pan-genomic, once-daily formulation that could achieve 90%+ HCV clearance in as little as eight weeks. The plan would be to launch its next-generation HCV therapy in 2017.
Image source: AbbVie.
Catalysts to monitor
Finally, there's a lot going on with AbbVie in 2016 as it relates to regulatory submissions and data readouts.
It's obviously expected to be a big year for Imbruvica on both sides of the aisle. We could see Imbruvica handed a big expansion in first-line CLL, and there's the potential for data in mantle cell lymphoma, diffuse-large B-cell lymphoma (DLBCL), follicular lymphoma, and marginal zone lymphoma. Keep in mind that cancer trials are always event-driven, and it's very difficult to predict event timing when it comes to cancer.
We could also be looking at a strong year for venetoclax, which is looking for its first approval in CLL (R/R) for patients with 17p deletion, and it may also deliver mid-stage data in indolent non-Hodgkin lymphoma and DLBCL.
Image source: AbbVie.
Importantly, we could be looking at the beginning of a long stream of top-line data from AbbVie's late-stage studies involving its next-generation HCV product beginning in the second half of 2016. We're talking about six ongoing studies that will likely begin reading out data over many months, meaning we may not see the end of the data until the first-half of 2017. Pay close attention to efficacy rates as they relate to the eight-week treatment timeframe.
AbbVie: buy or run?
After listening to AbbVie's presentation, I admit I'm feeling more positive about its future. AbbVie has a fairly steady track record of growth, and it's done a good job of returning cash to shareholders via a 4.2% dividend yield.
That doesn't mean it isn't without possible shortcomings, including the entrance of biosimilars for Humira, its heavy reliance on Humira, which will hurt once generics do enter the marketplace, and uncertainties surrounding Viekira Pak's future and whether or not it'll be able to effectively compete with Gilead and other potential entrants.
I would suggest approaching AbbVie with modest long-term growth expectations. It does have core products that could sustain strong cash flow, but it'll have some questions to answer in the coming years.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article 3 Slides That Perfectly Sum Up Where AbbVie Is Headed Next originally appeared on Fool.com.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen nameTMFUltraLong, track every pick he makes under the screen nameTrackUltraLong, and check him out on Twitter, where he goes by the handle@TMFUltraLong.The Motley Fool owns shares of and recommends Gilead Sciences. It also recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Image source: AbbVie. Next up, AbbVie's CEO wants you to pay attention to venetoclax, a BCL2 inhibitor that's being tested as a monotherapy and in combination with Rituxan as a treatment for relapsed and refractory (R/R) chronic lymphocytic leukemia. AbbVie has a fairly steady track record of growth, and it's done a good job of returning cash to shareholders via a 4.2% dividend yield. | Image source: AbbVie. Combined, AbbVie sees sales of these three products hitting approximately $18 billion, $5 billion, and $3 billion, respectively, by 2020. At the American Society of Hematology's annual meeting in December, AbbVie presented data on venetoclax in combination with Rituxan for CLL (R/R) patients that demonstrated an overall response rate of 86% and a whopping complete response rate of 47%. | Image source: AbbVie. AbbVie's three amigos The three amigos of AbbVie's pipeline are (not surprisingly) Humira in immunology, Imbruvica in oncology, and Viekira Pak in virology. At the American Society of Hematology's annual meeting in December, AbbVie presented data on venetoclax in combination with Rituxan for CLL (R/R) patients that demonstrated an overall response rate of 86% and a whopping complete response rate of 47%. | Image source: AbbVie. In short, these three products could account for $26 billion of AbbVie's estimated $37 billion in sales five years from now. AbbVie's three amigos The three amigos of AbbVie's pipeline are (not surprisingly) Humira in immunology, Imbruvica in oncology, and Viekira Pak in virology. |
26701.0 | 2016-01-18 00:00:00 UTC | AbbVie (ABBV) Looks Good: Stock Adds 5.1% in Session | ABBV | https://www.nasdaq.com/articles/abbvie-abbv-looks-good%3A-stock-adds-5.1-in-session-2016-01-18 | nan | nan | AbbVie Inc.ABBV was a big mover last session, as the company saw its shares rise over 5% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This reverses the recent trend for the company as the stock is now down 7.7% since Dec 30, 2015.
Though the company has seen 1 positive revision in the past 30 days, the Zacks Consensus Estimate has remained unchanged over the same time frame. Friday's price action is encouraging though, so make sure to keep a close watch on this firm in the near future.
AbbVie currently has a Zacks Rank #3 (Hold) while its Earnings ESP is positive.
A better-ranked pharmaceutical stock is AstraZeneca PLC AZN , holding a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV was a big mover last session, as the company saw its shares rise over 5% on the day. AbbVie currently has a Zacks Rank #3 (Hold) while its Earnings ESP is positive. Is ABBV going up? | Click to get this free report ASTRAZENECA PLC (AZN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV was a big mover last session, as the company saw its shares rise over 5% on the day. AbbVie currently has a Zacks Rank #3 (Hold) while its Earnings ESP is positive. | Click to get this free report ASTRAZENECA PLC (AZN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV was a big mover last session, as the company saw its shares rise over 5% on the day. AbbVie currently has a Zacks Rank #3 (Hold) while its Earnings ESP is positive. | AbbVie Inc.ABBV was a big mover last session, as the company saw its shares rise over 5% on the day. Click to get this free report ASTRAZENECA PLC (AZN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie currently has a Zacks Rank #3 (Hold) while its Earnings ESP is positive. |
26702.0 | 2016-01-17 00:00:00 UTC | The Best Healthcare ETF of the Week | ABBV | https://www.nasdaq.com/articles/best-healthcare-etf-week-2016-01-17 | nan | nan | What's going on inside the Health Care Select Sector SPDR ETF that allowed it to hold up so well?
Cracking it open
The Health Care Select Sector SPDR ETF is one of the biggest and most-popular healthcare ETFs out there, as it currently manages more than $12 billion. This fund's goal is to track the performance of healthcare stocks within the S&P 500, weighted by market cap.
While this fund currently holds positions in 57 different companies, it is actually fairly concentrated. A look at this fund's top 10 holdings is telling:
Source: iShares.
As you can see, this ETF keeps the majority of its assets in the giants of the healthcare industry. In fact, its current weighted average market cap is north of $106 billion dollars.
What worked this week?
As you would expect during a rough week for the market, most of the fund's top holdings declined during the past week. However, a few companies managed to buck the trend and put up positive returns.
Pharma giant AbbVie was the clear winner this week, as its shares ended the week up more than 3%. Two news items appear to be responsible for the surge in its share price.
First, AbbVie announced that the FDA accepted its New Drug Application for venetoclax. AbbVie submitted the drug as a potential treatment for chronic lymphocytic leukemia in adults who have received at least one prior therapy, and they granted the application a priority review. That means that the FDA should have an answer in six months time, instead of the normal wait of 10 months.
While that news was good, shares really roared higher on a news item released later in the week. On Thursday, news broke that the U.S. Patent Office rejected Amgen's attempts to invalidate patents related to AbbVie's best-selling drug, Humira. Amgen is pushing to bring a biosimilar version of Humira to the market by 2017, and it was trying to use a legal process called Inter Partes Review to invalidate two patents of Humira's patents.
Amgen hoped that, by using this tactic, it would be able to bring its Humira competitor to market on time. The U.S. Patent Office did not even formally review the move, as it believed that Amgen didn't have any chance of success.
Given that AbbVie is expecting Humira to deliver more than $18 billion in revenue by 2020, news of a competitor taking a step back was good enough to lift its shares.
Worth a look
There's a lot to like about the Health Care Select Sector SPDR ETF, as it offers investors broad-based exposure to an industry that's likely to continue to rise for a dirt-cheap expense ratio of only 0.15%. Investors who are looking for a way to bulk up their exposure to the healthcare sector should consider giving this ETF a look.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article The Best Healthcare ETF of the Week originally appeared on Fool.com.
Brian Feroldi owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool owns shares of Medtronic. The Motley Fool recommends Johnson & Johnson and UnitedHealth Group. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie submitted the drug as a potential treatment for chronic lymphocytic leukemia in adults who have received at least one prior therapy, and they granted the application a priority review. Given that AbbVie is expecting Humira to deliver more than $18 billion in revenue by 2020, news of a competitor taking a step back was good enough to lift its shares. Pharma giant AbbVie was the clear winner this week, as its shares ended the week up more than 3%. | Pharma giant AbbVie was the clear winner this week, as its shares ended the week up more than 3%. First, AbbVie announced that the FDA accepted its New Drug Application for venetoclax. AbbVie submitted the drug as a potential treatment for chronic lymphocytic leukemia in adults who have received at least one prior therapy, and they granted the application a priority review. | Pharma giant AbbVie was the clear winner this week, as its shares ended the week up more than 3%. First, AbbVie announced that the FDA accepted its New Drug Application for venetoclax. AbbVie submitted the drug as a potential treatment for chronic lymphocytic leukemia in adults who have received at least one prior therapy, and they granted the application a priority review. | On Thursday, news broke that the U.S. Patent Office rejected Amgen's attempts to invalidate patents related to AbbVie's best-selling drug, Humira. Pharma giant AbbVie was the clear winner this week, as its shares ended the week up more than 3%. First, AbbVie announced that the FDA accepted its New Drug Application for venetoclax. |
26703.0 | 2016-01-16 00:00:00 UTC | AbbVie's Management Just Made Some Pretty Bold Predictions | ABBV | https://www.nasdaq.com/articles/abbvies-management-just-made-some-pretty-bold-predictions-2016-01-16 | nan | nan | J.P. Morgan hosted its annual healthcare conference this week, and in its presentation to investors, AbbVie issued projections for its top-selling Humira, cancer drugs, and for revenue in 2020 that ought to make investors stand up and take notice. Let's take a closer look at what management is thinking and what it may mean to investors.
Defending the moat
With $24 billion in annualized quarterly sales, AbbVie is unquestionably big, but it gets more than 60% of those sales from one drug, Humira, and that's a big problem because Humira's composition of matter patent expires in December.
That revenue run rate makes Humira the best-selling drug on the planet, but it also puts it in the crosshairs of competitors eager to develop a generic version, and that's made investors rightfully nervous about how the next couple of years might shake out for the company. As a result, AbbVie's shares fell 6.5% in 2015.
However, based on sales projections offered up by the company this week at J.P. Morgan's conference, investors might be wrong to worry about Humira's revenue run rate, at least for now. That's because AbbVie seems to believe that generic interlopers will be kept at bay by other patents covering Humira, including those related to the method of treatment for various indications. AbbVie thinks that those Humira patents will allow its sales to grow, rather than shrink, to $18 billion in 2020.
That's a bold prediction given that the companies developing Humira biosimilars are among the biggest and most successful biopharma companies in the world. Amgen and Merck & Co. , which is working with Samsung and Biogen on a Humira biosimilar, already have phase 3 trial data in hand showing their look-alikes work as well as Humira, and those companies have significant experience and resources available to them that could allow them to skirt Humira's remaining patents.
Expanding indications
If Humira's patents do hold up, then it will buy AbbVie time to boost demand for its recently acquired (and fast-growing) oncology drug, Imbruvica.
AbbVie forked over $21 billion last year to get its hands on Imbruvica and management thinks the drug's revenue can climb from its current $1.2 billion pace to $5 billion over the coming few years.
Meeting that sales target will require Imbruvica to succeed in a slate of ongoing trials that could expand its addressable market. Imbruvica's use as a monotherapy in the first-line treatment of chronic lymphocytic leukemia (CLL) and its use as a treatment for multiple myeloma, a multibillion dollar indication, are among some of the most intriguing studies under way.
Additionally, AbbVie plans to leverage Imbruvica's sales and marketing know-how to build up revenue for its other hematology drugs, too. Those drugs include venetoclax, a CLL therapy; elotozumab, a treatment for relapsing multiple myeloma; and duvelisib, a late clinical stage CLL and indolent non-Hodgkins lymphoma medicine. If it can do that, then AbbVie will become one of the biggest cancer drugmakers in the next five years.
Pressing on
AbbVie's presentation also shows that it's unwilling to cede the highly lucrative hepatitis C market to competitor Gilead Sciences .
Currently, AbbVie only markets one hepatitis C drug: Viekira Pak. Viekira Pak was launched last January to compete against Gilead Sciences' Harvoni in genotype 1 HCV patients and its sales exited the third quarter at a $1.9 billion annualized clip. That's far shy of Harvoni's annualized $13 billion pace.
The company, however, still thinks it might be able to knock Gilead Sciences off its pedestal.
Thanks to an exclusivity deal it cut with pharmacy benefit manager Express Scripts shortly after Viekira Pak's launch, AbbVie thinks Viekira Pak can haul in $3 billion in peak annual sales and AbbVie is advancing next-generation hepatitis C programs, including a pan-genotype therapy and a short-duration approach, that could add billions more to the top line.
Given that there are 3 million hepatitis C patients in the U.S. and 9 million hepatitis C patients in the EU, this indication should continue to support AbbVie's quarterly financial results in the coming years.
Tying it together
It's common for management to be bullish about their company's prospects, but it's far less common for management to go out on a limb and provide a sales forecast that stretches out years into the future.
In this case, AbbVie's management thinks that Humira and its other drugs will combine to haul in $37 billion in sales in 2020, leading to double-digit annual EPS growth over the next five years. That's a confidence-inspiring prediction and, personally, I think it could translate into a higher stock price this year.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article AbbVie's Management Just Made Some Pretty Bold Predictions originally appeared on Fool.com.
Todd Campbell owns shares of Gilead Sciences. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Express Scripts and Gilead Sciences. The Motley Fool recommends Biogen. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Expanding indications If Humira's patents do hold up, then it will buy AbbVie time to boost demand for its recently acquired (and fast-growing) oncology drug, Imbruvica. J.P. Morgan hosted its annual healthcare conference this week, and in its presentation to investors, AbbVie issued projections for its top-selling Humira, cancer drugs, and for revenue in 2020 that ought to make investors stand up and take notice. Defending the moat With $24 billion in annualized quarterly sales, AbbVie is unquestionably big, but it gets more than 60% of those sales from one drug, Humira, and that's a big problem because Humira's composition of matter patent expires in December. | J.P. Morgan hosted its annual healthcare conference this week, and in its presentation to investors, AbbVie issued projections for its top-selling Humira, cancer drugs, and for revenue in 2020 that ought to make investors stand up and take notice. Thanks to an exclusivity deal it cut with pharmacy benefit manager Express Scripts shortly after Viekira Pak's launch, AbbVie thinks Viekira Pak can haul in $3 billion in peak annual sales and AbbVie is advancing next-generation hepatitis C programs, including a pan-genotype therapy and a short-duration approach, that could add billions more to the top line. Defending the moat With $24 billion in annualized quarterly sales, AbbVie is unquestionably big, but it gets more than 60% of those sales from one drug, Humira, and that's a big problem because Humira's composition of matter patent expires in December. | Defending the moat With $24 billion in annualized quarterly sales, AbbVie is unquestionably big, but it gets more than 60% of those sales from one drug, Humira, and that's a big problem because Humira's composition of matter patent expires in December. AbbVie forked over $21 billion last year to get its hands on Imbruvica and management thinks the drug's revenue can climb from its current $1.2 billion pace to $5 billion over the coming few years. Thanks to an exclusivity deal it cut with pharmacy benefit manager Express Scripts shortly after Viekira Pak's launch, AbbVie thinks Viekira Pak can haul in $3 billion in peak annual sales and AbbVie is advancing next-generation hepatitis C programs, including a pan-genotype therapy and a short-duration approach, that could add billions more to the top line. | AbbVie forked over $21 billion last year to get its hands on Imbruvica and management thinks the drug's revenue can climb from its current $1.2 billion pace to $5 billion over the coming few years. J.P. Morgan hosted its annual healthcare conference this week, and in its presentation to investors, AbbVie issued projections for its top-selling Humira, cancer drugs, and for revenue in 2020 that ought to make investors stand up and take notice. Defending the moat With $24 billion in annualized quarterly sales, AbbVie is unquestionably big, but it gets more than 60% of those sales from one drug, Humira, and that's a big problem because Humira's composition of matter patent expires in December. |
26704.0 | 2016-01-15 00:00:00 UTC | Cancer treatment gets cheaper: Oncobiologics files for a $115 million IPO | ABBV | https://www.nasdaq.com/articles/cancer-treatment-gets-cheaper-oncobiologics-files-115-million-ipo-2016-01-15 | nan | nan | Oncobiologics, a late-stage biotech developing biosimilars of blockbuster drugs Avastin and Humira, filed on Friday with the SEC to raise up to $115 million in an initial public offering.
Oncobiologics is ready to begin Phase 3 trials for both Avastin and Humira. If approved, the biosimilars would offer a less-expensive version of Roche's Avastin and AbbVie's Humira. Avastin is among the world's top-selling cancer therapies.
The Cranbury, NJ-based company was founded in 2010 and plans to list on the Nasdaq under the symbol ONS. Oncobiologics filed confidentially on November 16, 2015. Jefferies and Barclays are the joint bookrunners on the deal. No pricing terms were disclosed.
The article Cancer treatment gets cheaper: Oncobiologics files for a $115 million IPO originally appeared on IPO investment manager Renaissance Capital's web site renaissancecapital.com.
Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital's research analysts and do not constitute an offer to buy or sell any security. Renaissance Capital, the Renaissance IPO ETF (symbol: IPO) or the Global IPO Fund (symbol: IPOSX) , may have investments in securities of companies mentioned.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | If approved, the biosimilars would offer a less-expensive version of Roche's Avastin and AbbVie's Humira. Oncobiologics, a late-stage biotech developing biosimilars of blockbuster drugs Avastin and Humira, filed on Friday with the SEC to raise up to $115 million in an initial public offering. Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital's research analysts and do not constitute an offer to buy or sell any security. | If approved, the biosimilars would offer a less-expensive version of Roche's Avastin and AbbVie's Humira. The article Cancer treatment gets cheaper: Oncobiologics files for a $115 million IPO originally appeared on IPO investment manager Renaissance Capital's web site renaissancecapital.com. Renaissance Capital, the Renaissance IPO ETF (symbol: IPO) or the Global IPO Fund (symbol: IPOSX) , may have investments in securities of companies mentioned. | If approved, the biosimilars would offer a less-expensive version of Roche's Avastin and AbbVie's Humira. Oncobiologics, a late-stage biotech developing biosimilars of blockbuster drugs Avastin and Humira, filed on Friday with the SEC to raise up to $115 million in an initial public offering. The article Cancer treatment gets cheaper: Oncobiologics files for a $115 million IPO originally appeared on IPO investment manager Renaissance Capital's web site renaissancecapital.com. | If approved, the biosimilars would offer a less-expensive version of Roche's Avastin and AbbVie's Humira. Oncobiologics, a late-stage biotech developing biosimilars of blockbuster drugs Avastin and Humira, filed on Friday with the SEC to raise up to $115 million in an initial public offering. Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital's research analysts and do not constitute an offer to buy or sell any security. |
26705.0 | 2016-01-14 00:00:00 UTC | Why Neurocrine Biosciences Inc.'s Stock Skyrocketed 147% Higher in 2015 | ABBV | https://www.nasdaq.com/articles/why-neurocrine-biosciences-incs-stock-skyrocketed-147-higher-2015-2016-01-14 | nan | nan | What: Shares of Neurocrine Biosciences , a biopharmaceutical company focused on treatments for neurological and endocrine-related diseases, more than doubled in value during 2015, according to data from S&P Capital IQ.
So what: The year was filled with positive developments that gave investors reason to cheer, including:
In February, Neurocrine Biosciences raised $250 million through a common stock offering, selling nearly 7 million shares for $36 each.
In September, Neurocrine Biosciences and partner AbbVie reported results from a phase 2b study testing the safety of elagolix in patients with heavy menstrual bleeding associated with uterine fibroids. The trial showed that elagolix met the study's primary endpoints, giving AbbVie enough confidence in the drug to initiate a phase 3 trial.
In October, it released positive results from its phase 3 study of NBI-98854 ability to treat tardive dyskinesia, a condition that causes involuntary movements of various extremities. It announced plans to file a New Drug Application with the FDA in 2016.
Also in October, Neurocrine Biosciences initiated a phase 2 study of NBI-98854 as a potential treatment for Tourette's syndrome.
In November, it added a new molecule to its pipeline, NBI-640756. The drug is being studied in patients with essential tremors, and the company has initiated a phase I safety and pharmacokinetics trial.
Now what: Given the stream of good news, it's easy to see why the market was bidding up shares of Neurocrine Biosciences all year. Neurocrine Biosciences also appears to be on sound financial footing and has previously estimated that it would end 2015 with more than $450 million in cash in its bank account. Even with an expected uptick in spending as it advances its pipeline, the company should have plenty of capital to keep things running for at least several years.
With a huge cash hoard, two different compounds in late-stage clinical trials, and a strong partnership in place with pharma giant AbbVie, I see plenty of reasons to remain bullish on Neurocrine Biosciences' stock.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Why Neurocrine Biosciences Inc.'s Stock Skyrocketed 147% Higher in 2015 originally appeared on Fool.com.
Brian Feroldi has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In September, Neurocrine Biosciences and partner AbbVie reported results from a phase 2b study testing the safety of elagolix in patients with heavy menstrual bleeding associated with uterine fibroids. With a huge cash hoard, two different compounds in late-stage clinical trials, and a strong partnership in place with pharma giant AbbVie, I see plenty of reasons to remain bullish on Neurocrine Biosciences' stock. The trial showed that elagolix met the study's primary endpoints, giving AbbVie enough confidence in the drug to initiate a phase 3 trial. | In September, Neurocrine Biosciences and partner AbbVie reported results from a phase 2b study testing the safety of elagolix in patients with heavy menstrual bleeding associated with uterine fibroids. The trial showed that elagolix met the study's primary endpoints, giving AbbVie enough confidence in the drug to initiate a phase 3 trial. With a huge cash hoard, two different compounds in late-stage clinical trials, and a strong partnership in place with pharma giant AbbVie, I see plenty of reasons to remain bullish on Neurocrine Biosciences' stock. | In September, Neurocrine Biosciences and partner AbbVie reported results from a phase 2b study testing the safety of elagolix in patients with heavy menstrual bleeding associated with uterine fibroids. With a huge cash hoard, two different compounds in late-stage clinical trials, and a strong partnership in place with pharma giant AbbVie, I see plenty of reasons to remain bullish on Neurocrine Biosciences' stock. The trial showed that elagolix met the study's primary endpoints, giving AbbVie enough confidence in the drug to initiate a phase 3 trial. | The trial showed that elagolix met the study's primary endpoints, giving AbbVie enough confidence in the drug to initiate a phase 3 trial. In September, Neurocrine Biosciences and partner AbbVie reported results from a phase 2b study testing the safety of elagolix in patients with heavy menstrual bleeding associated with uterine fibroids. With a huge cash hoard, two different compounds in late-stage clinical trials, and a strong partnership in place with pharma giant AbbVie, I see plenty of reasons to remain bullish on Neurocrine Biosciences' stock. |
26706.0 | 2016-01-14 00:00:00 UTC | The Zacks Analyst Blog Highlights: Baxalta, Juno, Horizon Pharma, AbbVie and Dynavax | ABBV | https://www.nasdaq.com/articles/the-zacks-analyst-blog-highlights%3A-baxalta-juno-horizon-pharma-abbvie-and-dynavax-2016-01 | nan | nan | For Immediate Release
Chicago, IL - January 14, 2016 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Baxalta ( BXLT ), Juno ( JUNO ), Horizon Pharma ( HZNP ), AbbVie ( ABBV ) and Dynavax ( DVAX ).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free .
Here are highlights from Wednesday's Analyst Blog:
Biotech Stock Roundup
Just a couple of weeks into the new year and a major deal has already been announced in the biotech sector, with Shire finally succeeding in its attempts to combine with Baxalta ( BXLT ).
While this was the big news last week, investor focus also remained on the J.P. Morgan Healthcare Conference where several companies presented preliminary results for 2015 and also provided their guidance for 2016. Many companies also provided pipeline updates at the conference.
Recap of the Week's Most Important Stories
1. Shire has finally succeeded in its efforts to acquire Baxalta. The companies will be combining under a deal worth approximately $32 billion. The deal, set to close in mid-16, will lead to the creation of a global leader in rare diseases (Read more: Shire To Acquire Baxalta for $32 Billion, Strengthen Portfolio ).
Another acquisition announcement was made earlier this week by Juno ( JUNO ) - the company acquired AbVitro, Inc., a privately held biotech company with a leading next-generation single cell sequencing platform that will strengthen Juno's capabilities to create best-in-class engineered T cells against a wide range of cancer targets (Read more: Juno Acquires AbVitro, Adds Single Cell Sequencing Platform ).
2. Many companies attended the ongoing J.P. Morgan Healthcare Conference where key updates were provided. A preliminary look at 2015 results, guidance for 2016 and pipeline updates were provided by companies like Celgene (Read more: Celgene Drops on Preliminary Results & 2016 Outlook ), Aegerion (Read more: Aegerion Provides Preliminary Sales View & Pipeline Updates ), Agios (Read more: Agios Provides Pipeline Updates and 2016 Strategy ), Vertex (Read more: Vertex Gives 2016 View, Orkambi View to Come Later ), Acorda (Read more: Acorda's Ampyra Ends 2015 on Strong Note, Pipeline in Focus ) and Orexigen (Read more: Orexigen Targets Profitability by 2018, Focus on Contrave ) among others.
Meanwhile, Horizon Pharma's ( HZNP ) shares were up with the company raising its sales outlook for 2016 reflecting the acquisition of Crealta Holdings, slated to close shortly.
3. AbbVie ( ABBV ) came up with quite a few pipeline updates this week. The company said that it has been granted priority review for its application to expand the label of its hepatitis C virus (HCV) treatment, Viekira Pak (Read more: AbbVie's Viekira Pak sNDA Accepted with Priority Review ). The company's NDA for its experimental leukemia treatment, venetoclax, has also been granted priority review.
Moreover, AbbVie announced that it has moved a couple of candidates into late-stage development - experimental rheumatoid arthritis treatment, ABT-494 (Read more: AbbVie Starts Phase III Program on ABT-494 for RA Treatment ) and its all-oral, once-daily, ribavirin-free investigational HCV regimen.
4. Dynavax's ( DVAX ) shares shot up on positive late-stage data on the company's investigational hepatitis B vaccine, HEPLISAV-B, which was found to fare better than Engerix-B, a currently marketed product. Dynavax intends to resubmit its BLA for HEPLISAV-B this quarter (Read more: Dynavax's Heplisav-B Tops GlaxoSmithKline's Engerix-B ).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Stocks recently featured in the blog include Baxalta ( BXLT ), Juno ( JUNO ), Horizon Pharma ( HZNP ), AbbVie ( ABBV ) and Dynavax ( DVAX ). AbbVie ( ABBV ) came up with quite a few pipeline updates this week. The company said that it has been granted priority review for its application to expand the label of its hepatitis C virus (HCV) treatment, Viekira Pak (Read more: AbbVie's Viekira Pak sNDA Accepted with Priority Review ). | Stocks recently featured in the blog include Baxalta ( BXLT ), Juno ( JUNO ), Horizon Pharma ( HZNP ), AbbVie ( ABBV ) and Dynavax ( DVAX ). Click to get this free report BAXALTA INC (BXLT): Free Stock Analysis Report JUNO THERAPEUTC (JUNO): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report DYNAVAX TECH CP (DVAX): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) came up with quite a few pipeline updates this week. | Click to get this free report BAXALTA INC (BXLT): Free Stock Analysis Report JUNO THERAPEUTC (JUNO): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report DYNAVAX TECH CP (DVAX): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks recently featured in the blog include Baxalta ( BXLT ), Juno ( JUNO ), Horizon Pharma ( HZNP ), AbbVie ( ABBV ) and Dynavax ( DVAX ). AbbVie ( ABBV ) came up with quite a few pipeline updates this week. | Stocks recently featured in the blog include Baxalta ( BXLT ), Juno ( JUNO ), Horizon Pharma ( HZNP ), AbbVie ( ABBV ) and Dynavax ( DVAX ). AbbVie ( ABBV ) came up with quite a few pipeline updates this week. The company said that it has been granted priority review for its application to expand the label of its hepatitis C virus (HCV) treatment, Viekira Pak (Read more: AbbVie's Viekira Pak sNDA Accepted with Priority Review ). |
26707.0 | 2016-01-14 00:00:00 UTC | Why Galapagos NV's Shares Bolted Higher in 2015 | ABBV | https://www.nasdaq.com/articles/why-galapagos-nvs-shares-bolted-higher-2015-2016-01-14 | nan | nan | What : Over the course of 2015, the Belgian biotech Galapagos NV reported that its lead experimental candidate, filgotinib, was making major strides in its clinical development as an oral treatment for both rheumatoid arthritis and Crohn's disease. Based on these promising results, Galapagos decided to perform an IPO on the Nasdaq to raise money, and investors were apparently more than happy to gobble up the biotech's shares. According to data provided by S&P Capital IQ , Galapagos' share price appreciated by more than 24% from the time of its IPO until the end of 2015.
So what : Galapagos is currently in the process of advancing filgotinib into a late-stage trial for rheumatoid arthritis, and it looks like the drug could also enter a pivotal-stage study for Crohn's disease before the end of 2016. .
Put simply, filgotinib is targeting some of the very same territory occupied by AbbVie 's Humira, one of the best-selling drugs in the world over the last couple of years. That's why AbbVie was previously interested in co-developing filgotinib with Galapagos -- until AbbVie decided to go with its own orally-administered experimental candidate, ABT-494, last September.
After AbbVie exited its partnership with Galapagos last year, Gilead Sciences decided to enter the picture by inking a roughly $2 billion agreement with Galapagos to develop filgotinib across a wide diversity of inflammatory conditions.
Now what : While Gilead is undoubtedly a force to be reckoned with when it comes to picking top-flight experimental-stage drugs, investors should bear in mind that inflammatory diseases in general are a hotbed of research activity in the pharma industry right now due to their enormous market sizes. Taken together, the rheumatoid arthritis and Crohn's disease drug markets already sport a $20 billion valuation, as just one example.
Strong clinical results for any experimental-stage inflammatory drug therefore may not be enough to achieve commercial success for what is quickly becoming a rather crowded market. That's why I'm willing to hold off on buying this mid-cap biotech for the moment.
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The article Why Galapagos NV's Shares Bolted Higher in 2015 originally appeared on Fool.com.
George Budwell has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Put simply, filgotinib is targeting some of the very same territory occupied by AbbVie 's Humira, one of the best-selling drugs in the world over the last couple of years. That's why AbbVie was previously interested in co-developing filgotinib with Galapagos -- until AbbVie decided to go with its own orally-administered experimental candidate, ABT-494, last September. After AbbVie exited its partnership with Galapagos last year, Gilead Sciences decided to enter the picture by inking a roughly $2 billion agreement with Galapagos to develop filgotinib across a wide diversity of inflammatory conditions. | After AbbVie exited its partnership with Galapagos last year, Gilead Sciences decided to enter the picture by inking a roughly $2 billion agreement with Galapagos to develop filgotinib across a wide diversity of inflammatory conditions. Put simply, filgotinib is targeting some of the very same territory occupied by AbbVie 's Humira, one of the best-selling drugs in the world over the last couple of years. That's why AbbVie was previously interested in co-developing filgotinib with Galapagos -- until AbbVie decided to go with its own orally-administered experimental candidate, ABT-494, last September. | After AbbVie exited its partnership with Galapagos last year, Gilead Sciences decided to enter the picture by inking a roughly $2 billion agreement with Galapagos to develop filgotinib across a wide diversity of inflammatory conditions. Put simply, filgotinib is targeting some of the very same territory occupied by AbbVie 's Humira, one of the best-selling drugs in the world over the last couple of years. That's why AbbVie was previously interested in co-developing filgotinib with Galapagos -- until AbbVie decided to go with its own orally-administered experimental candidate, ABT-494, last September. | After AbbVie exited its partnership with Galapagos last year, Gilead Sciences decided to enter the picture by inking a roughly $2 billion agreement with Galapagos to develop filgotinib across a wide diversity of inflammatory conditions. Put simply, filgotinib is targeting some of the very same territory occupied by AbbVie 's Humira, one of the best-selling drugs in the world over the last couple of years. That's why AbbVie was previously interested in co-developing filgotinib with Galapagos -- until AbbVie decided to go with its own orally-administered experimental candidate, ABT-494, last September. |
26708.0 | 2016-01-13 00:00:00 UTC | Lee Ainslie Gains From Liberty Global But Loses From Axiall | ABBV | https://www.nasdaq.com/articles/lee-ainslie-gains-liberty-global-loses-axiall-2016-01-13 | nan | nan | Lee Ainslie ( Trades , Portfolio ) had some big gains and big losses after selling some holdings in the third quarter. His biggest gains were 33% and 23% from Liberty Global PLC ( LBTYA ) and Acuity Brands Inc. ( AYI ) while his biggest losses were 33% and 30% from Axiall Corp. ( AXLL ) and Rackspace Hosting Inc. ( RAX ).
He also gained 8% from UnitedHealth Group Inc. ( UNH ) and AbbVie Inc. ( ABBV ) and lost 18% and 13% from Baidu Inc. (BIDU) and Diamond Resorts International Inc. (DRII).
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Ainslie founded Maverick Capital in 1993 with $38 million. Today the fund is worth $10 billion. Maverick has six industry sector heads, most of whom are more or less Ainslie's age.
Baidu Inc.
The position was established in Q4 2013, but it was sold out in Q4 2014. In the first quarter of 2015 the guru acquired a new position and in the second quarter reduced his stake by 27%. In the third quarter, Ainslie sold the shares and lost 18% on the investment. The deal had an impact of -2.42% on the portfolio.
The company has a market cap of $87.89 billion. It has a P/E of 31.92, a forward P/E ratio of 16.56, a P/B of 6.80 and a P/S of 6.44. GuruFocus has given the stock a financial strength rating of 9/10 and a profitability and growth rating of 7/10.
The company is a Chinese language Internet search provider. It provides a platform for businesses to reach customers and offers its products and services to users through Baidu.com free of charge.
Many investors like Andreas Halvorsen (Trades, Portfolio), Louis Moore Bacon (Trades, Portfolio), Robert Karr (Trades, Portfolio), George Soros (Trades, Portfolio) and Steven Cohen (Trades, Portfolio) closed their holdings in the third quarter.
Liberty Global PLC
It had a position in the portfolio since 2012, and the guru had been increasing and reducing his holding since. In the third quarter, Ainslie sold the shares and gained 33% on the investment. The deal had an impact of -0.84% on the portfolio.
The company has a market cap of $30.23 billion. It has a forward P/E ratio of 41.32, a P/B of 2.49 and a P/S of 1.73. GuruFocus has given the stock a financial strength rating of 7/10 and a profitability and growth rating of 4/10.
The company provides video, broadband Internet, fixed-line telephony and mobile services across 14 countries.
The stock lost its position in the portfolios of Pioneer Investments (Trades, Portfolio) and Caxton Associates (Trades, Portfolio).
Axiall Corp.
It was a new stock in the portfolio. The guru acquired a position in the second quarter of 2015, and in the third quarter, he sold the shares and lost 33% on the investment. The deal had an impact of -0.56% on the portfolio.
The company has a market cap of $822.26 billion. It has a forward P/E ratio of 9.72, a P/B of 0.50 and a P/S of 0.20. GuruFocus has given the stock a financial strength rating of 6/10 and a profitability and growth rating of 3/10.
The company is a manufacturer and marketer of chemicals and building products. It operates through three reportable segments: chlorovinyls, building products and aromatics.
RS Investment Management (Trades, Portfolio) is another fund that exited its position in the third quarter.
AbbVie Inc.
The guru first bought Abbvie in Q2 2014, but in Q4 2014 he exited his position. In the first quarter of 2015 he acquired a new position and reduced his holding by 8.56% in the second quarter. In the third quarter, Ainslie sold the shares and gained 8% on the investment.
The company has a market cap of $89.65 billion. It has a P/E of 32.45, a forward P/E ratio of 9.54, a P/B of 18.48 and a P/S of 4.08. GuruFocus has given the stock a financial strength rating of 7/10 and a profitability and growth rating of 6/10.
The company is a research-based biopharmaceutical company with a portfolio of proprietary products including a broad line of adult and pediatric pharmaceuticals.
Steven Cohen (Trades, Portfolio) and Louis Moore Bacon (Trades, Portfolio) are other investors who closed their holdings.
Acuity Brands Inc.
The stock was new in the portfolio. The guru acquired a position in the first quarter and reduced his stake by 9.15% in the second quarter. In the third quarter, he sold the shares and gained 23% on the investment.
The company has a market cap of $9.16 billion. It has a P/E of 38.01, a forward P/E ratio of 24.69, a P/B of 6.35 and a P/S of 3.25. GuruFocus has given the stock a financial strength rating of 9/10 and a profitability and growth rating of 6/10.
The company provides lighting solutions for commercial, institutional, industrial, infrastructure and residential applications throughout North America and selected international markets.
Ainslie was the only investor who closed his holding, but many investors like Mario Gabelli (Trades, Portfolio), Chuck Royce (Trades, Portfolio), Jim Simons (Trades, Portfolio), Pioneer Investments (Trades, Portfolio) and Ken Heebner (Trades, Portfolio) reduced their holdings.
UnitedHealth Group Inc.
The position was established in Q4 2012, but in Q4 2014 the guru sold his shares. In the first quarter of 2015 the guru acquired a new position and reduced his stake by 5.22% in the second quarter. In the third quarter, Ainslie sold the shares and gained 8% on the investment.
The company has a market cap of $107 billion. It has a P/E of 17.84, a forward P/E ratio of 12.95, a P/B of 3.21 and a P/S of 0.74. GuruFocus has given the stock a financial strength rating of 7/10 and a profitability and growth rating of 8/10.
The company is a health and well-being company. It helps people live healthier lives and makes health care affordable.
The stock lost its position in the portfolios of HOTCHKIS & WILEY and Louis Moore Bacon (Trades, Portfolio).
Diamond Resorts International Inc .
In the first quarter the guru acquired a new position and increased his stake by 12.20% in the second quarter. In the third quarter, he sold the shares and lost 13% on the investment.
The company has a market cap of $1.69 billion. It has a P/E of 14.71, a forward P/E ratio of 16.67, a P/B of 5.63 and a P/S of 1.98. GuruFocus has given the stock a financial strength rating of 4/10 and a profitability and growth rating of 6/10.
The company provides hospitality and vacation ownership services. It also manages seven multiresort trusts. The company operates the front desks, provides housekeeping, conducts maintenance and manages human resources services.
Paul Tudor Jones (Trades, Portfolio), Jim Simons (Trades, Portfolio) and Ron Baron increased their holdings while Lee Ainslie (Trades, Portfolio) exited his position.
Rackspace Hosting Inc.
The guru acquired a new position in the second quarter of 2015; in the third quarter, he sold the shares and lost 30% on the investment.
The company has a market cap of $2.72 billion. It has a P/E of 22.10, a forward P/E ratio of 20.79, a P/B of 2.62 and a P/S of 1.49. GuruFocus has given the stock a strong financial strength rating of 9/10 and a profitability and growth rating of 7/10.
The company, through its operating subsidiaries, is a provider of Cloud computing services, managing web-based IT systems for small and medium-sized businesses as well as large enterprises.
The stock lost its position in the portfolios of Joel Greenblatt (Trades, Portfolio), RS Investment Management (Trades, Portfolio) and Steven Cohen (Trades, Portfolio).
About GuruFocus: GuruFocus.com tracks the stocks picks and portfolio holdings of the world's best investors. This value investing site offers stock screeners and valuation tools. And publishes daily articles tracking the latest moves of the world's best investors. GuruFocus also provides promising stock ideas in 3 monthly newsletters sent to Premium Members .
This article first appeared on GuruFocus .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | He also gained 8% from UnitedHealth Group Inc. ( UNH ) and AbbVie Inc. ( ABBV ) and lost 18% and 13% from Baidu Inc. (BIDU) and Diamond Resorts International Inc. (DRII). AbbVie Inc. The guru first bought Abbvie in Q2 2014, but in Q4 2014 he exited his position. | He also gained 8% from UnitedHealth Group Inc. ( UNH ) and AbbVie Inc. ( ABBV ) and lost 18% and 13% from Baidu Inc. (BIDU) and Diamond Resorts International Inc. (DRII). AbbVie Inc. The guru first bought Abbvie in Q2 2014, but in Q4 2014 he exited his position. | He also gained 8% from UnitedHealth Group Inc. ( UNH ) and AbbVie Inc. ( ABBV ) and lost 18% and 13% from Baidu Inc. (BIDU) and Diamond Resorts International Inc. (DRII). AbbVie Inc. The guru first bought Abbvie in Q2 2014, but in Q4 2014 he exited his position. | He also gained 8% from UnitedHealth Group Inc. ( UNH ) and AbbVie Inc. ( ABBV ) and lost 18% and 13% from Baidu Inc. (BIDU) and Diamond Resorts International Inc. (DRII). AbbVie Inc. The guru first bought Abbvie in Q2 2014, but in Q4 2014 he exited his position. |
26709.0 | 2016-01-13 00:00:00 UTC | Gilead Sciences Takes 2 Steps Forward and 1 Step Back | ABBV | https://www.nasdaq.com/articles/gilead-sciences-takes-2-steps-forward-and-1-step-back-2016-01-13 | nan | nan | Image source: Gilead Sciences.
While most of us, myself included, were getting back into gear after the holidays, Gilead Sciences was busy racking up headlines. The hepatitis C leader received news from regulators that could strengthen its position in this space even further. The following day, it announced a clinical win with a blockbuster hepatitis B treatment that could also strengthen this franchise.
But not all of Gilead's headlines in the new year have been positive. The company's efforts to branch out into other liver-related indications took a turn for the worse when independent data monitors suggested that a trial with simtuzumab end early because of a lack of efficacy.
One pill to treat them all
It's difficult to overstate the success of Gilead's combination hepatitis C treatment, Harvoni. Approved by the FDA in October 2014, sales of the drug in the first three quarters of 2015 reached an astounding $10.5 billion. As impressive as those numbers are, during this period the drug had approval only for treatment of genotype 1 patients, a population that comprises roughly 75% of U.S. hepatitis C infections.
Image source: Gilead Sciences.
In November, the FDA expanded Harvoni's label to include genotypes 4, 5, and 6. However, these three genotypes make up a tiny sliver of the U.S. market. The additional genotypes prevail in several emerging markets, but genotyping in these regions is often lacking. This is why Gilead's pan-genotypic candidate, which would eliminate the need for genotyping, represents such an exciting opportunity.
During the trials supporting its pending application with the FDA, the combination of experimental velpatasvir and sofosbuvir -- the latter of which is the active ingredient in Sovaldi and half of Harvoni -- performed well enough across all six genotypes that genetic screening shouldn't be necessary. The FDA considers the improvement over existing options significant enough to give the application a priority review, which should shave about four months off the process.
Gilead expects a decision from the FDA by the end of June. If approved, this should be plenty of time to get out in front of its only significant competitor in the hepatitis C space, AbbVie . The Illinois company didn't even begin a phase 3 program for its pan-genotypic combo until last November.
Hepatitis B and HIV
A priority review wasn't the only good news to begin the year for Gilead. With all eyes on its hepatitis C programs, it's easy to forget Gilead has a strong presence in other types of infection. Hepatitis B and HIV treatment Viread won FDA approval way back in 2001, but it's still selling at a run rate of more than $1 billion per year.
On its own, the drug comprised 3.6% of third-quarter 2015 revenue, but it's also a component of HIV drugs Stribild, Complera, Atripla, and Truvada. Combined, these four treatments racked up sales $2.6 billion in the third quarter of 2015 alone, comprising 31% of total revenue for the period.
Image source: Wikimedia Commons.
However, Viread, or tenofovir disoproxil fumarate, is associated with kidney damage and decreasing bone mineral density. If that isn't bad enough, it goes off patent in 2018.
But a new formulation, tenofovir alafenamide, or TAF, is on the way. Although already approved as part of Gilead's new HIV combination therapy, Genvoya, regulators need to know that TAF alone is an improvement over Viread in hepatitis B patients.
The results of a head-to-head hepatitis B study pitting Viread against TAF are in. Even though TAF isn't much of an improvement in terms of efficacy, patients receiving it showed significantly improved signs of kidney function and less of a decrease in bone mineral density.
Gilead probably won't develop new versions of all its HIV treatments that contain Viread, but two HIV candidates containing TAF are awaiting regulatory decisions in the U.S. and EU, and a third is in phase 3.Going forward, TAF's improved safety profile should go a long way toward convincing end payers that Gilead's new HIV treatments are worth the expense as older options lose patent protection.
Two down, two to go
Gilead may be the market leader in hepatitis C and HIV, but shareholders would breathe a little easier if it diversified its revenue stream. In the third quarter, antivirals comprised nearly 94% of the company's total product sales. Simtuzumab was supposed to help in this respect, with trials in a handful of varied indications.
Things aren't going so well. In 2014, the antibody failed to significantly slow progression of pancreatic cancer compared with standard chemotherapy. More recently, independent data monitors informed Gilead that simtuzumab would miss the mark again, this time in idiopathic pulmonary fibrosis, a fatal disease characterized by scarring of the lungs. Gilead was fortunate in that it was able to terminate the trial midway through a phase 2 trial and not a larger, more expensive phase 3 study.
Despite two previous failures, it isn't time to give up hope for simtuzumab. Gilead will continue to study the drug in non-alcoholic steatohepatitis and primary sclerosing cholangitis. Both ongoing phase 2 trials include 96 weeks of treatment and observation. Like the terminated pulmonary fibrosis trial, independent data monitors have looked at the results part of the way through and decided that both trials should continue.
There's a long way to go, but an approval for either indication would probably push simtuzumab into blockbuster territory, giving Gilead's revenue stream some much-needed diversity.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Gilead Sciences Takes 2 Steps Forward and 1 Step Back originally appeared on Fool.com.
Cory Renauer has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | If approved, this should be plenty of time to get out in front of its only significant competitor in the hepatitis C space, AbbVie . The company's efforts to branch out into other liver-related indications took a turn for the worse when independent data monitors suggested that a trial with simtuzumab end early because of a lack of efficacy. During the trials supporting its pending application with the FDA, the combination of experimental velpatasvir and sofosbuvir -- the latter of which is the active ingredient in Sovaldi and half of Harvoni -- performed well enough across all six genotypes that genetic screening shouldn't be necessary. | If approved, this should be plenty of time to get out in front of its only significant competitor in the hepatitis C space, AbbVie . Even though TAF isn't much of an improvement in terms of efficacy, patients receiving it showed significantly improved signs of kidney function and less of a decrease in bone mineral density. More recently, independent data monitors informed Gilead that simtuzumab would miss the mark again, this time in idiopathic pulmonary fibrosis, a fatal disease characterized by scarring of the lungs. | If approved, this should be plenty of time to get out in front of its only significant competitor in the hepatitis C space, AbbVie . Hepatitis B and HIV A priority review wasn't the only good news to begin the year for Gilead. Although already approved as part of Gilead's new HIV combination therapy, Genvoya, regulators need to know that TAF alone is an improvement over Viread in hepatitis B patients. | If approved, this should be plenty of time to get out in front of its only significant competitor in the hepatitis C space, AbbVie . The Illinois company didn't even begin a phase 3 program for its pan-genotypic combo until last November. Hepatitis B and HIV A priority review wasn't the only good news to begin the year for Gilead. |
26710.0 | 2016-01-13 00:00:00 UTC | 3 Stocks with Better Dividends Than CVS Health Corporation | ABBV | https://www.nasdaq.com/articles/3-stocks-better-dividends-cvs-health-corporation-2016-01-13 | nan | nan | Image source: CVS Health.
CVS Health has been an income investor's dream. The company has been steadily raising its dividend payments for 20 years now, and those increases add up quickly. In the last 10 years alone, its dividend payment is up a huge 797%, and after its most recent dividend hike of 21%, its shares now offer investors a healthy 1.8% yield. Better yet, with numerous avenues for growth ahead of it, the odds look favorable that the company's dividend will continue to grow for years to come.
Despite all of these positives, CVS Health is not my favorite dividend-paying stock right now, so if you're considering buying its stock solely to get your hands on its dividend, here are three other healthcare companies you might want to consider instead.
1. Amgen
Biotech stocks might not come immediately to mind when thinking about ways to add income to your portfolio, but Amgen isn't just any old biotech. The company has grown into a blue-chip over the past few decades, and its current strong dividend yield mixed with a below-market valuation make it a compelling choice right now.
Amgen has long been a cash machine thanks to its best-selling drugs Enbrel and Neulasta. Although these drugs might finally be facing some competition from biosimilars , Amgen's huge pipeline should help it stave off any potential revenue declines. Two recent drug launches look particularly promising: Repatha, which is used to lower cholesterol levels, and Kyprolis, its multiple myeloma treatment. Each of these drugs holds blockbuster potential, and when mixed in with the expected revenue from its other products, it should have no problem keeping its revenue and profits moving in the right direction.
Amgen is expecting to generate around $10 in earnings per share in 2015. That means its stock is only trading at a meager 15 times trailing earnings, which I'd argue is a perfectly fair price for a company expected to grow its bottom line by nearly 10% over the next five years. Add to that a sustainable 2.7% dividend yield that is poised for fast growth, and I think this stock is a great choice for income investors.
2. AbbVie
Pharma giant AbbVie is getting no love from the markets these days. Shares have declined so much over the past few months that they are now trading for less than 11 times their 2016 earnings estimates. The decline in its share price mixed with a recent dividend increase of 12% has pushed up its yield to a tempting 4.1%.
Why the share price decline? The company has been hit hard by news that Veikira Pak & Technivie -- two of AbbVie's drugs that treat Hepatitis C -- received warning letters from the FDA on reports that some patients who used the drugs were having liver injuries. Add in the fact that the patent for AbbVie's best-selling immunology drug Humira is expiring later this year, and investors are feeling down about the company's prospects.
Despite all of this, I think there are reasons to be optimistic, especially at today's discounted share price. AbbVie counts more than 20 new products or indications in its pipeline that it believes hold the potential to hit nearly $30 billion in peak sales down the road. All told, the company believes its revenue will grow to $37 billion by 2020, compared to only $20 billion in 2014. When factoring in its plans to expand its margins, the company believes its earnings per share will grow on average by double digits each year from now until 2020.
If the company can deliver on those targets, shareholders who get in today will bank a strong dividend yield and the potential for nice share price appreciation.
3. Johnson & Johnson
When I think of the best of the best dividend stocks , Johnson & Johnson always comes to mind. The company is so big and so broadly diversified that it can generate steady cash flows even in the most challenging of economic environments.
The company pulls in sales from three major product categories: consumer, pharmaceuticals, and medical devices. While all three of these segments hold potential, its pharmaceutical business looks particular primed for future growth as it counts more than 10 potential blockbuster drugs in development, or in the early innings of their commercial life cycles. As these new drugs hit pharmacy shelves, the company's profits should continue to move higher, which should lead to slow and steady share price appreciation.
Johnson & Johnson has been a dividend investor's dream for decade as it has successfully increased its payout for 53 straight years. Shares are currently yielding 3.1%, and its trailing price-to-earnings ratio is under 19. Both of those numbers compare favorably to CVS Health's stock right now, which indicates this dividend all-star could be the smarter choice right now.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article 3 Stocks with Better Dividends Than CVS Health Corporation originally appeared on Fool.com.
Brian Feroldi has no position in any stocks mentioned. The Motley Fool recommends CVS Health and Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Pharma giant AbbVie is getting no love from the markets these days. The company has been hit hard by news that Veikira Pak & Technivie -- two of AbbVie's drugs that treat Hepatitis C -- received warning letters from the FDA on reports that some patients who used the drugs were having liver injuries. Add in the fact that the patent for AbbVie's best-selling immunology drug Humira is expiring later this year, and investors are feeling down about the company's prospects. | AbbVie Pharma giant AbbVie is getting no love from the markets these days. The company has been hit hard by news that Veikira Pak & Technivie -- two of AbbVie's drugs that treat Hepatitis C -- received warning letters from the FDA on reports that some patients who used the drugs were having liver injuries. Add in the fact that the patent for AbbVie's best-selling immunology drug Humira is expiring later this year, and investors are feeling down about the company's prospects. | AbbVie Pharma giant AbbVie is getting no love from the markets these days. The company has been hit hard by news that Veikira Pak & Technivie -- two of AbbVie's drugs that treat Hepatitis C -- received warning letters from the FDA on reports that some patients who used the drugs were having liver injuries. Add in the fact that the patent for AbbVie's best-selling immunology drug Humira is expiring later this year, and investors are feeling down about the company's prospects. | AbbVie Pharma giant AbbVie is getting no love from the markets these days. The company has been hit hard by news that Veikira Pak & Technivie -- two of AbbVie's drugs that treat Hepatitis C -- received warning letters from the FDA on reports that some patients who used the drugs were having liver injuries. Add in the fact that the patent for AbbVie's best-selling immunology drug Humira is expiring later this year, and investors are feeling down about the company's prospects. |
26711.0 | 2016-01-13 00:00:00 UTC | Roche's NDA for Lymphocytic Leukemia Drug Accepted by FDA | ABBV | https://www.nasdaq.com/articles/roches-nda-for-lymphocytic-leukemia-drug-accepted-by-fda-2016-01-13 | nan | nan | Roche Holding AGRHHBY announced that the FDA has accepted its New Drug Application (NDA) and granted Priority Review for pipeline candidate venetoclax for the treatment of patients suffering from chronic lymphocytic leukemia (CLL), who have received at least one prior therapy, including those with 17p deletion.
Roche is developing venetoclax in partnership with AbbVie, Inc. ABBV . We remind investors that the candidate was granted Breakthrough Therapy Designation by the FDA in Apr 2015 for the treatment of patients with previously treated (relapsed or refractory) CLL with 17p deletion.
Meanwhile, a Marketing Authorisation Application (MAA) has also been validated by the regulatory body in the EU, the European Medicines Agency (EMA).
Venetolax is currently being evaluated for the treatment of CLL in phase II and phase III studies. The candidate is also being evaluated in phase I and phase II studies for several other blood cancers, including indolent non-Hodgkin's lymphomaL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukaemia (AML) and multiple myeloma (MM).
Successful development and commercialization of venetolax will further strengthen Roche's hematology portfolio, which already boasts drugs like MabThera/Rituxan (rituximab) and Gazyva as well as a deep pipeline that includes an anti-PDL1 antibody (atezolizumab/MPDL3280A), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small-molecule antagonist of MDM2 (idasanutlin/RG7388) among others.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs.
The company recently received FDA approval for Alecensa for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).
Roche currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the health care sector include Novartis NVS and Sanofi SNY . Both stocks sport a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Roche is developing venetoclax in partnership with AbbVie, Inc. ABBV . Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Roche Holding AGRHHBY announced that the FDA has accepted its New Drug Application (NDA) and granted Priority Review for pipeline candidate venetoclax for the treatment of patients suffering from chronic lymphocytic leukemia (CLL), who have received at least one prior therapy, including those with 17p deletion. | Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Roche is developing venetoclax in partnership with AbbVie, Inc. ABBV . Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >> Want the latest recommendations from Zacks Investment Research? | Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Roche is developing venetoclax in partnership with AbbVie, Inc. ABBV . Roche Holding AGRHHBY announced that the FDA has accepted its New Drug Application (NDA) and granted Priority Review for pipeline candidate venetoclax for the treatment of patients suffering from chronic lymphocytic leukemia (CLL), who have received at least one prior therapy, including those with 17p deletion. | Roche is developing venetoclax in partnership with AbbVie, Inc. ABBV . Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Roche Holding AGRHHBY announced that the FDA has accepted its New Drug Application (NDA) and granted Priority Review for pipeline candidate venetoclax for the treatment of patients suffering from chronic lymphocytic leukemia (CLL), who have received at least one prior therapy, including those with 17p deletion. |
26712.0 | 2016-01-11 00:00:00 UTC | AbbVie Starts Phase III Program on ABT-494 for RA Treatment | ABBV | https://www.nasdaq.com/articles/abbvie-starts-phase-iii-program-on-abt-494-for-ra-treatment-2016-01-11 | nan | nan | AbbVie Inc.ABBV announced that it has initiated a phase III program on ABT-494 for the treatment of patients with rheumatoid arthritis (RA).
The program includes five phase III studies that will evaluate ABT-494 in adult patients with inadequate responses to conventional or biologic disease-modifying antirheumatic drugs (DMARDs), as well as methotrexate-naïve patients.
Currently, patient enrollment in the first two phase III studies has been initiated. The first study, SELECT-COMPARE, will evaluate ABT-494 in combination with methotrexate (MTX) in adults (n=1,500) with moderate-to-severely active RA who had an inadequate response to prior treatment with MTX. The study will include Humira as an active comparator.
The second study, SELECT-NEXT, will evaluate two doses of ABT-494 (once-daily use of 15 mg and 30 mg) in combination with conventional synthetic DMARDS on patients (n=600) who had an inadequate response or intolerance to conventional synthetic DMARDs.
The company also said that in early 2016, it will initiate the other three phase III studies, that will evaluate ABT-494 in patients with an inadequate response to biologics and patients who are MTX-naïve.
We remind investors that the RA market is highly crowded with drugs like Orencia, Kineret, Cimzia and Enbrel among others.
We note that AbbVie already has a strong presence in this market with its blockbuster drug, Humira. Apart from RA, Humira is approved in the U.S. for several indications like moderately-to-severely active polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderate-to-severe Crohn's disease, moderate-to-severe ulcerative colitis, ankylosing spondyloarthritis, pediatric Crohn's disease, and moderate-to-severe chronic plaque psoriasis. Humira recorded worldwide sales of $10.3 billion in the first nine months of 2015.
Meanwhile, ABT-494 is also being evaluated in a phase II study for the treatment of patients with Crohn's disease.
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Horizon Pharma plc HZNP , Anika Therapeutics Inc. ANIK and Ligand Pharmaceuticals Incorporated LGND , each sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV announced that it has initiated a phase III program on ABT-494 for the treatment of patients with rheumatoid arthritis (RA). We note that AbbVie already has a strong presence in this market with its blockbuster drug, Humira. AbbVie currently carries a Zacks Rank #3 (Hold). | Click to get this free report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that it has initiated a phase III program on ABT-494 for the treatment of patients with rheumatoid arthritis (RA). We note that AbbVie already has a strong presence in this market with its blockbuster drug, Humira. | Click to get this free report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that it has initiated a phase III program on ABT-494 for the treatment of patients with rheumatoid arthritis (RA). We note that AbbVie already has a strong presence in this market with its blockbuster drug, Humira. | Click to get this free report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that it has initiated a phase III program on ABT-494 for the treatment of patients with rheumatoid arthritis (RA). We note that AbbVie already has a strong presence in this market with its blockbuster drug, Humira. |
26713.0 | 2016-01-09 00:00:00 UTC | 3 Healthcare Stocks to Buy on Sale | ABBV | https://www.nasdaq.com/articles/3-healthcare-stocks-buy-sale-2016-01-09 | nan | nan | Source: Flickr user Elliott Brown.
Many of the best stocks in healthcare go on sale whenever the market retreats, and this time is no different. Obviously, no one knows when these stocks will stop falling, but each of them has top-tier products and bulletproof balance sheets that make them perfect to consider for long-term portfolios.
No. 1: Gilead Sciences
It's probably not too surprising to see Gilead Sciences listed here. The company's sales and profit have been on a tear since launching hepatitis C drugs in 2013 and 2014 that quickly became the standard of care.
Last quarter, Gilead Sciences' hepatitis C drug sales were running at an annualized clip of nearly $20 billion, so the company is flush with cash that it can use to boost its dividend (which is currently yielding a 1.7%), buy back shares, and invest in future growth.
Admittedly, Gilead Sciences will face its stiffest challenge yet in hepatitis C this year because the FDA could approve a competing HCV therapy from Merck & Co. . However, Gilead Sciences' sales barely seemed to notice the launch of AbbVie 's HCV drug, Viekira Pak, last year, and the FDA is also could make a decision on whether to approve Gilead Sciences' next-generation hepatitis C therapy this summer.
Assuming that the FDA green-lights Merck & Co.'s and Gilead Sciences' drugs, Gilead Sciences could solidify its standing as the dominant player in HCV because its drug is arguably more effective and safer to use than Merck & Co.'s. If doctors agree, then Merck & Co.'s drug could end up being a bigger threat to AbbVie than it is to Gilead Sciences.
Overall, Gilead Sciences' HIV and hepatitis sales should eclipse $30 billion this year, and since the company has a ton of cash, the potential for a shareholder friendly-dividend increases, and with an industry-low forward P/E ratio of 8, it ought to be on investors' radar; especially at these prices.
No. 2: Mylan, Inc .
One of healthcare's biggest emerging trends is the shift from expensive biologics to cheaper generic alternatives, known as biosimilars.
Historically, biologic drugs have been mostly immune to the threat of generic competition because they're created in living cells and therefore are harder to duplicate than traditional small-molecule drugs. However, recent healthcare reform has provided a pathway to approval for drugs that work similarly but aren't exact copies of biologics, and as a result biosimilars are positioned to capture billions of dollars in sales annually in the coming years.
Because Mylan is already a global leader in generic medicine, it has the infrastructure and know-how in place to be at the forefront of biosimilar development and commercialization. The company is collaborating on 12 different biosimilars, including six that are in development with Biocon and another six that are tied to its recently signed partnership with Momenta Pharmaceuticals . A variation of AbbVie's $12 billion-per-year arthritis drug Humira and Bristol-Myers Squibb' s billion-dollar blockbuster arthritis drug Orencia are among those Mylan is working on.
Given that Mylan is already hauling in $9 billion in annual revenue and its shares are relatively cheap (its forward P/E ratio is below 10), the significant revenue and profit growth tied to biosimilars makes this company one of my favorites to stash away for the future.
Source: Pfizer.
No. 3: Pfizer
Speaking of biosimilars, global pharmaceutical Goliath Pfizer1 made a big splash in biosimilars last year, when it acquired Hospira, a specialty-drug maker with a robust pipeline of biosimilars, for $17 billion. The acquisition catapulted Pfizer into a leadership role in biosimilars, giving it five biosimilars targeting billions of dollars in sales that could make it to market by 2020.
Hospira, however, wasn't the only needle-moving deal Pfizer announced last year that makes it an intriguing stock to buy low.
The company also surprised investors with a massive $160 billion proposed merger with Botox drugmaker Allergan .
If that merger closes, it will add $16 billion in annual sales to Pfizer's top line and potentially shave $2 billion per year from Pfizer's tax bill. That's because Pfizer is structuring the merger as if Allergan, which is based in tax-friendly Ireland, is acquiring it, rather than the other way around.
Pfizer could also reward investors in the coming years with bigger profits, because it cut its costs significantly. After losing patent protection on its $13 billion-per-year Lipitor in 2011, the company's spending on SG&A has dropped to less than $14 billion from more than $18.5 billion. That means Pfizer is leaner than its been in years, and that has industry watchers thinking the company's EPS will grow to $2.36 in 2016 from $2.18 in 2015.
If you're still unconvinced, then consider this final point: Pfizer is trading at just 13.1 times forward earnings per share and its shares are paying a healthy 3.7% dividend yield. With a reasonable valuation like that and a dividend yield that high, this could be the perfect time to pick up some shares.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article 3 Healthcare Stocks to Buy on Sale originally appeared on Fool.com.
Todd Campbell owns shares of Gilead Sciences and Mylan. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool recommends Momenta Pharmaceuticals and Mylan. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, Gilead Sciences' sales barely seemed to notice the launch of AbbVie 's HCV drug, Viekira Pak, last year, and the FDA is also could make a decision on whether to approve Gilead Sciences' next-generation hepatitis C therapy this summer. If doctors agree, then Merck & Co.'s drug could end up being a bigger threat to AbbVie than it is to Gilead Sciences. A variation of AbbVie's $12 billion-per-year arthritis drug Humira and Bristol-Myers Squibb' s billion-dollar blockbuster arthritis drug Orencia are among those Mylan is working on. | However, Gilead Sciences' sales barely seemed to notice the launch of AbbVie 's HCV drug, Viekira Pak, last year, and the FDA is also could make a decision on whether to approve Gilead Sciences' next-generation hepatitis C therapy this summer. If doctors agree, then Merck & Co.'s drug could end up being a bigger threat to AbbVie than it is to Gilead Sciences. A variation of AbbVie's $12 billion-per-year arthritis drug Humira and Bristol-Myers Squibb' s billion-dollar blockbuster arthritis drug Orencia are among those Mylan is working on. | However, Gilead Sciences' sales barely seemed to notice the launch of AbbVie 's HCV drug, Viekira Pak, last year, and the FDA is also could make a decision on whether to approve Gilead Sciences' next-generation hepatitis C therapy this summer. If doctors agree, then Merck & Co.'s drug could end up being a bigger threat to AbbVie than it is to Gilead Sciences. A variation of AbbVie's $12 billion-per-year arthritis drug Humira and Bristol-Myers Squibb' s billion-dollar blockbuster arthritis drug Orencia are among those Mylan is working on. | However, Gilead Sciences' sales barely seemed to notice the launch of AbbVie 's HCV drug, Viekira Pak, last year, and the FDA is also could make a decision on whether to approve Gilead Sciences' next-generation hepatitis C therapy this summer. If doctors agree, then Merck & Co.'s drug could end up being a bigger threat to AbbVie than it is to Gilead Sciences. A variation of AbbVie's $12 billion-per-year arthritis drug Humira and Bristol-Myers Squibb' s billion-dollar blockbuster arthritis drug Orencia are among those Mylan is working on. |
26714.0 | 2016-01-09 00:00:00 UTC | Why Halozyme Therapeutics Inc. Rose 76% in 2015 | ABBV | https://www.nasdaq.com/articles/why-halozyme-therapeutics-inc-rose-76-2015-2016-01-09 | nan | nan | Halozyme Therapeutics had a seemingly endless stream of good news for its investors in 2015, causing its shares to soar 76% higher during the year, according to data from S&P Capital IQ.
Halozyme had quite a few highlights this year:
A global collaboration and license agreement with AbbVie provided Halozyme with an initial $23 million payment and could be worth up to $130 million more if milestones are met. AbbVie also agreed to pay Halozyme royalties if products are ultimately commercialized.
A clinical collaboration agreement with Eisai , a Japanese pharmaceutical company, to study its drug eribulin mesylate in combination with Halozyme's investigational drug PEGPH20 as a potential treatment for first-line HER2-negative metastatic breast cancer.
The first clinical dosing of a patient in a phase 1 trial that combined Rivipansel, one of Pfizer 's experimental compounds, with Halozyme's Enhanze platform . Given that Pfizer is currently also running a phase 3 study testing Rivipansel as a potential treatment for individuals hospitalized with vaso-occlusive crisis of sickle cell disease, the odds look favorable that this combination will progress through the early clinical trials.
A global collaboration deal with Eli Lilly to develop new products that utilize Halozyme's Enhanze platform brought in an immediate $25 million in fresh capital, with the potential to earn up to $800 million more if milestones are met.
It also continues to show solid clinical progress with its lead compound, called PEGPH20, which is being tested in a variety of cancer indications at the moment. Analysts believe that, if all goes well, it could eventually produced peak sales of $1.5 billion for the drug, which is a huge number for a company that is currently valued below $2 billion.
2015 was a terrific year for Halozyme Therapeutics, and since the company continues to play well with others , I also continue to think it's a solid choice going forward for the speculative portion of your portfolio.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Why Halozyme Therapeutics Inc. Rose 76% in 2015 originally appeared on Fool.com.
Brian Feroldi has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Halozyme had quite a few highlights this year: A global collaboration and license agreement with AbbVie provided Halozyme with an initial $23 million payment and could be worth up to $130 million more if milestones are met. AbbVie also agreed to pay Halozyme royalties if products are ultimately commercialized. Halozyme Therapeutics had a seemingly endless stream of good news for its investors in 2015, causing its shares to soar 76% higher during the year, according to data from S&P Capital IQ. | Halozyme had quite a few highlights this year: A global collaboration and license agreement with AbbVie provided Halozyme with an initial $23 million payment and could be worth up to $130 million more if milestones are met. AbbVie also agreed to pay Halozyme royalties if products are ultimately commercialized. The first clinical dosing of a patient in a phase 1 trial that combined Rivipansel, one of Pfizer 's experimental compounds, with Halozyme's Enhanze platform . | Halozyme had quite a few highlights this year: A global collaboration and license agreement with AbbVie provided Halozyme with an initial $23 million payment and could be worth up to $130 million more if milestones are met. AbbVie also agreed to pay Halozyme royalties if products are ultimately commercialized. A clinical collaboration agreement with Eisai , a Japanese pharmaceutical company, to study its drug eribulin mesylate in combination with Halozyme's investigational drug PEGPH20 as a potential treatment for first-line HER2-negative metastatic breast cancer. | Halozyme had quite a few highlights this year: A global collaboration and license agreement with AbbVie provided Halozyme with an initial $23 million payment and could be worth up to $130 million more if milestones are met. AbbVie also agreed to pay Halozyme royalties if products are ultimately commercialized. Given that Pfizer is currently also running a phase 3 study testing Rivipansel as a potential treatment for individuals hospitalized with vaso-occlusive crisis of sickle cell disease, the odds look favorable that this combination will progress through the early clinical trials. |
26715.0 | 2016-01-08 00:00:00 UTC | AbbVie's Viekira Pak sNDA Accepted with Priority Review | ABBV | https://www.nasdaq.com/articles/abbvies-viekira-pak-snda-accepted-with-priority-review-2016-01-08 | nan | nan | AbbVie Inc.ABBV announced that the supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), to be used without ribavirin (RBV), has been accepted by the FDA with priority review.
The company is looking to get the products's label expanded for use without ribavirin, for the treatment of patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A).
The priority designation reduces the regulatory review period to 6 months from the standard period of 10 months.
We note that Viekira Pak is currently approved in the U.S., as a twice-daily formulation used with or without ribavirin for the treatment of adults with genotype 1 (GT1) chronic HCV infection, including people who have a certain type of cirrhosis (compensated). In the first nine months of 2015, the company recorded worldwide Viekira sales of $1.1 billion.
We remind investors that AbbVie is also looking to get a once-daily, fixed-dose formulation of Viekira approved for the treatment of patients with GT1 HCV. Early last month, the company announced that its regulatory application for the once-daily, fixed-dose formulation has been accepted by the FDA with a final decision expected in the second half of 2016.
According to the Centers for Disease Control and Prevention, it has been estimated that 2.7 million individuals in the U.S. are chronically infected with HCV. The press release further states that out of the total GT1 HCV infected patients in the U.S., approximately 77% and 23% are diagnosed with GT1a and GT1b, respectively.
We note that currently, Gilead Sciences Inc. GILD is the leader in HCV market with two approved drugs - Sovaldi and Harvoni. These drugs generated combined sales of $14.2 billion in the first nine months of 2015. Gilead continues to further strengthen its position in the HCV market. Earlier this week, the company announced that its marketing application for a once-daily, fixed-dose combination of Sovaldi, with velpatasvir has been granted priority review by the FDA for the treatment of genotype 1-6 chronic HCV infection. The company expects to receive a final decision from the agency by Jun 28, 2016.
AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Horizon Pharma plc HZNP and Ligand Pharmaceuticals Incorporated LGND , both sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV announced that the supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), to be used without ribavirin (RBV), has been accepted by the FDA with priority review. We remind investors that AbbVie is also looking to get a once-daily, fixed-dose formulation of Viekira approved for the treatment of patients with GT1 HCV. AbbVie currently carries a Zacks Rank #3 (Hold). | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that the supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), to be used without ribavirin (RBV), has been accepted by the FDA with priority review. We remind investors that AbbVie is also looking to get a once-daily, fixed-dose formulation of Viekira approved for the treatment of patients with GT1 HCV. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that the supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), to be used without ribavirin (RBV), has been accepted by the FDA with priority review. We remind investors that AbbVie is also looking to get a once-daily, fixed-dose formulation of Viekira approved for the treatment of patients with GT1 HCV. | We remind investors that AbbVie is also looking to get a once-daily, fixed-dose formulation of Viekira approved for the treatment of patients with GT1 HCV. AbbVie Inc.ABBV announced that the supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), to be used without ribavirin (RBV), has been accepted by the FDA with priority review. AbbVie currently carries a Zacks Rank #3 (Hold). |
26716.0 | 2016-01-08 00:00:00 UTC | The Zacks Analyst Blog Highlights: AbbVie, Amgen, Ligand Pharmaceuticals, Revance Therapeutics and Exelixis | ABBV | https://www.nasdaq.com/articles/the-zacks-analyst-blog-highlights%3A-abbvie-amgen-ligand-pharmaceuticals-revance | nan | nan | For Immediate Release
Chicago, IL - January 08, 2016 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include AbbVie ( ABBV ), Amgen ( AMGN ), Ligand Pharmaceuticals Inc. ( LGND ), Revance Therapeutics, Inc. ( RVNC ) and Exelixis, Inc. ( EXEL ).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free .
Here are highlights from Thursday's Analyst Blog:
5 Biotech Stocks That Doubled in 2015
It's been a roller-coaster ride for the biotech sector in 2015, with several stocks seeing major highs and lows as the year progressed. The year continued to see mergers and acquisitions (M&A) and licensing and collaboration deals being signed. Other highlights were the pricing controversy, stretched valuations and the usual pipeline updates.
Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ( ABBV )-Pharmacyclics among others. AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios.
Licensing agreements and deals including those with opt-in arrangements also picked up pace with immuno-oncology remaining a favorite area. Companies like Kite, Ionis, Achillion and Juno were pretty active on the collaboration front. Most of the deals are with big pharma and biotech companies and are focused on immuno-oncology as well as hepatitis C virus (HCV).
Meanwhile, the FDA approved 45 new molecular entities (NMEs) and biological products in 2015, up from 41 in 2014. Some of the important new product approvals in 2015 include Vertex's cystic fibrosis treatment, Orkambi, Amgen's ( AMGN ) PCSK9 inhibitor, Repatha, Regeneron/Sanofi's PCSK9 inhibitor Praluent, Gilead's Genvoya (HIV) and label expansions for products like Kyprolis.
But the sector had its share of hiccups with pricing concerns remaining a major issue - democratic presidential frontrunner Hillary Clinton's "price gouging" tweet triggered a slide in healthcare stocks in September.
2015 also marked the FDA approval and launch of the first biosimilar in the U.S. - Sandoz's Zarxio - a biosimilar of Amgen's Neupogen. The approval is a landmark decision and follows years of debate regarding the regulatory path for biosimilars. Unlike their pharma counterparts, biotech companies have not been exposed to generic competition in the U.S. But with the approval of Zarxio, the floodgates have opened.
However, despite these headwinds, the NASDAQ Biotechnology gained 10.5% in 2015.
A Look at 5 Biotech Stocks that Doubled in 2015
Here is a look at 5 biotech stocks that doubled in 2015 and should continue performing well this year.
First on our list is Ligand Pharmaceuticals Inc. ( LGND ). La Jolla, CA-based Ligand's business model is based on developing or acquiring assets which generate royalties, milestones or other passive revenues for the company.
This Zacks Rank #1 (Strong Buy) stock had a good run in 2015 with its share price soaring 101.8% during the year. The company has a strong track record with earnings surpassing expectations in each of the last three quarters and an average earnings surprise of 43.66% over the last four quarters. 2016 earnings estimates for the company have been increasing. The company recently announced its intention to acquire OMT, Inc. and raised its revenue outlook for 2016.
Ligand also has partnerships with several leading health care companies like Novartis, Amgen and Pfizer among others that provide the company with funds in the form of milestone and royalty payments.
Next on our list is Newark, CA-based Revance Therapeutics, Inc. ( RVNC ), a company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic indications.
Shares of this Zacks Rank #2 (Buy) stock were up 105% in 2015. The company's shares shot up in late Oct 2015 on positive 24-week data from a mid-stage study comparing injectable RT002 to the current market leader Botox Cosmetic 20U and a placebo control in treating glabellar lines.
Revance's earnings track record is also pretty good with the company surpassing expectations in the last three quarters with an average surprise of 4.74% over the last four quarters. 2016 estimates are also seeing some positive revisions.
Revance has quite a few catalysts lined up for 2016 with the company expected to present results from some studies this year.
Exelixis, Inc. ( EXEL ) is another stock that had an excellent 2015. The company, whose shares slumped almost 77% in 2014, more than made up for lost ground in 2015 with its shares gaining 241.8%.
The South San Francisco, CA-based company has two approved products in its portfolio - Cometriq (cabozantinib) and Cotellic. This Zacks Rank #3 (Hold) company is currently looking to get cabozantinib approved for additional indications and recently finished submitting a rolling NDA for an advanced renal cell cancer indication.
In Conclusion
High risk and high returns -- this is a term that is often associated with the biotech sector. Biotech drugs, which are developed through a biological process/system or by using living organisms, require a lot of investment. The drugs are complex in nature and take several years to develop. Companies which hit the bull's eye become overnight success stories with shares even doubling or tripling on positive news. However, negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
Strong pipelines, innovative treatments, impressive results, growing demand for drugs especially for rare-to-treat diseases, an aging population and increased health care spending should support growth in this sector. With the sector witnessing a lot of M&A and licensing activity, expectations are high that more such deals will follow. Catalysts remain in the form of regulatory events and pipeline updates.
On the flip side, the high cost of treatments, pricing controversies and the threat of biosimilars remain dampeners for this high risk-high return sector.
Irrespective of who wins the presidential race, drug pricing will remain a topic of discussion among policymakers, the media and the general public.
Want to find the best stocks for 2016? Find out more information about the market-crushing Zacks Top 10 list here >>>
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios. Stocks recently featured in the blog include AbbVie ( ABBV ), Amgen ( AMGN ), Ligand Pharmaceuticals Inc. ( LGND ), Revance Therapeutics, Inc. ( RVNC ) and Exelixis, Inc. ( EXEL ). Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ( ABBV )-Pharmacyclics among others. | Stocks recently featured in the blog include AbbVie ( ABBV ), Amgen ( AMGN ), Ligand Pharmaceuticals Inc. ( LGND ), Revance Therapeutics, Inc. ( RVNC ) and Exelixis, Inc. ( EXEL ). Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report REVANCE THERAP (RVNC): Free Stock Analysis Report EXELIXIS INC (EXEL): Free Stock Analysis Report To read this article on Zacks.com click here. Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ( ABBV )-Pharmacyclics among others. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report REVANCE THERAP (RVNC): Free Stock Analysis Report EXELIXIS INC (EXEL): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks recently featured in the blog include AbbVie ( ABBV ), Amgen ( AMGN ), Ligand Pharmaceuticals Inc. ( LGND ), Revance Therapeutics, Inc. ( RVNC ) and Exelixis, Inc. ( EXEL ). Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ( ABBV )-Pharmacyclics among others. | Stocks recently featured in the blog include AbbVie ( ABBV ), Amgen ( AMGN ), Ligand Pharmaceuticals Inc. ( LGND ), Revance Therapeutics, Inc. ( RVNC ) and Exelixis, Inc. ( EXEL ). Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ( ABBV )-Pharmacyclics among others. AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios. |
26717.0 | 2016-01-07 00:00:00 UTC | 5 Biotech Stocks That Doubled in 2015 | ABBV | https://www.nasdaq.com/articles/5-biotech-stocks-doubled-2015-2016-01-07 | nan | nan | It's been a roller-coaster ride for the biotech sector in 2015, with several stocks seeing major highs and lows as the year progressed. The year continued to see mergers and acquisitions (M&A) and licensing and collaboration deals being signed. Other highlights were the pricing controversy, stretched valuations and the usual pipeline updates.
Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ABBV -Pharmacyclics among others. AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios.
Licensing agreements and deals including those with opt-in arrangements also picked up pace with immuno-oncology remaining a favorite area. Companies like Kite, Ionis, Achillion and Juno were pretty active on the collaboration front. Most of the deals are with big pharma and biotech companies and are focused on immuno-oncology as well as hepatitis C virus (HCV).
Meanwhile, the FDA approved 45 new molecular entities (NMEs) and biological products in 2015, up from 41 in 2014. Some of the important new product approvals in 2015 include Vertex's cystic fibrosis treatment, Orkambi, Amgen's AMGN PCSK9 inhibitor, Repatha, Regeneron/Sanofi's PCSK9 inhibitor Praluent, Gilead's Genvoya (HIV) and label expansions for products like Kyprolis.
But the sector had its share of hiccups with pricing concerns remaining a major issue - democratic presidential frontrunner Hillary Clinton's "price gouging" tweet triggered a slide in healthcare stocks in September.
2015 also marked the FDA approval and launch of the first biosimilar in the U.S. - Sandoz's Zarxio - a biosimilar of Amgen's Neupogen. The approval is a landmark decision and follows years of debate regarding the regulatory path for biosimilars. Unlike their pharma counterparts, biotech companies have not been exposed to generic competition in the U.S. But with the approval of Zarxio, the floodgates have opened.
However, despite these headwinds, the NASDAQ Biotechnology gained 10.5% in 2015.
A Look at 5 Biotech Stocks that Doubled in 2015
Here is a look at 5 biotech stocks that doubled in 2015 and should continue performing well this year.
First on our list is Ligand Pharmaceuticals Inc. LGND . La Jolla, CA-based Ligand's business model is based on developing or acquiring assets which generate royalties, milestones or other passive revenues for the company.
This Zacks Rank #1 (Strong Buy) stock had a good run in 2015 with its share price soaring 101.8% during the year. The company has a strong track record with earnings surpassing expectations in each of the last three quarters and an average earnings surprise of 43.66% over the last four quarters. 2016 earnings estimates for the company have been increasing. The company recently announced its intention to acquire OMT, Inc. and raised its revenue outlook for 2016.
Ligand also has partnerships with several leading health care companies like Novartis, Amgen and Pfizer among others that provide the company with funds in the form of milestone and royalty payments.
Next on our list is Newark, CA-based Revance Therapeutics, Inc. RVNC , a company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic indications.
Shares of this Zacks Rank #2 (Buy) stock were up 105% in 2015. The company's shares shot up in late Oct 2015 on positive 24-week data from a mid-stage study comparing injectable RT002 to the current market leader Botox Cosmetic 20U and a placebo control in treating glabellar lines.
Revance's earnings track record is also pretty good with the company surpassing expectations in the last three quarters with an average surprise of 4.74% over the last four quarters. 2016 estimates are also seeing some positive revisions.
Revance has quite a few catalysts lined up for 2016 with the company expected to present results from some studies this year.
Exelixis, Inc. EXEL is another stock that had an excellent 2015. The company, whose shares slumped almost 77% in 2014, more than made up for lost ground in 2015 with its shares gaining 241.8%.
The South San Francisco, CA-based company has two approved products in its portfolio - Cometriq (cabozantinib) and Cotellic. This Zacks Rank #3 (Hold) company is currently looking to get cabozantinib approved for additional indications and recently finished submitting a rolling NDA for an advanced renal cell cancer indication.
Another company that saw its shares shoot up last year is Sarepta Therapeutics, Inc. SRPT . This Cambridge, MA-based company is currently seeking FDA approval for its experimental Duchenne muscular dystrophy treatment, eteplirsen. The company has an important regulatory event coming up later this month with an FDA advisory panel expected to review eteplirsen. This Zacks Rank #3 company's shares gained 158.2% in 2015.
Rounding off our list is Heron Therapeutics, Inc. HRTX , another Zacks Rank #3 stock. Heron's shares were up 167.8% in 2015 on positive pipeline updates. The company is currently awaiting a response from the FDA regarding the approval status of Sustol for the prevention of acute and delayed chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy or highly emetogenic chemotherapy regimens. The FDA action date is Jan 17.
In Conclusion
High risk and high returns -- this is a term that is often associated with the biotech sector. Biotech drugs, which are developed through a biological process/system or by using living organisms, require a lot of investment. The drugs are complex in nature and take several years to develop. Companies which hit the bull's eye become overnight success stories with shares even doubling or tripling on positive news. However, negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
Strong pipelines, innovative treatments, impressive results, growing demand for drugs especially for rare-to-treat diseases, an aging population and increased health care spending should support growth in this sector. With the sector witnessing a lot of M&A and licensing activity, expectations are high that more such deals will follow. Catalysts remain in the form of regulatory events and pipeline updates.
On the flip side, the high cost of treatments, pricing controversies and the threat of biosimilars remain dampeners for this high risk-high return sector.
Irrespective of who wins the presidential race, drug pricing will remain a topic of discussion among policymakers, the media and the general public.
Want to find the best stocks for 2016? Find out more information about the market-crushing Zacks Top 10 list here >>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
AMGEN INC (AMGN): Free Stock Analysis Report
EXELIXIS INC (EXEL): Free Stock Analysis Report
LIGAND PHARMA-B (LGND): Free Stock Analysis Report
ABBVIE INC (ABBV): Free Stock Analysis Report
SAREPTA THERAP (SRPT): Free Stock Analysis Report
HERON THERAPEUT (HRTX): Free Stock Analysis Report
REVANCE THERAP (RVNC): Free Stock Analysis Report
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Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios. Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ABBV -Pharmacyclics among others. Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report EXELIXIS INC (EXEL): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report SAREPTA THERAP (SRPT): Free Stock Analysis Report HERON THERAPEUT (HRTX): Free Stock Analysis Report REVANCE THERAP (RVNC): Free Stock Analysis Report To read this article on Zacks.com click here. | Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report EXELIXIS INC (EXEL): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report SAREPTA THERAP (SRPT): Free Stock Analysis Report HERON THERAPEUT (HRTX): Free Stock Analysis Report REVANCE THERAP (RVNC): Free Stock Analysis Report To read this article on Zacks.com click here. Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ABBV -Pharmacyclics among others. AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios. | Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report EXELIXIS INC (EXEL): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report SAREPTA THERAP (SRPT): Free Stock Analysis Report HERON THERAPEUT (HRTX): Free Stock Analysis Report REVANCE THERAP (RVNC): Free Stock Analysis Report To read this article on Zacks.com click here. Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ABBV -Pharmacyclics among others. AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios. | Some of the important acquisitions announced/completed in 2015 include those between Shire-NPS Pharmaceuticals, Alexion-Synageva and AbbVie ABBV -Pharmacyclics among others. AbbVie's hefty price tag of $21 billion for Pharmacyclics may have raised quite a few eyebrows but it goes to show that lofty valuations will not deter large companies from pursuing acquisitions to boost their pipelines and product portfolios. Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report EXELIXIS INC (EXEL): Free Stock Analysis Report LIGAND PHARMA-B (LGND): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report SAREPTA THERAP (SRPT): Free Stock Analysis Report HERON THERAPEUT (HRTX): Free Stock Analysis Report REVANCE THERAP (RVNC): Free Stock Analysis Report To read this article on Zacks.com click here. |
26718.0 | 2016-01-07 00:00:00 UTC | Commit To Buy AbbVie At $35, Earn 5.7% Using Options | ABBV | https://www.nasdaq.com/articles/commit-buy-abbvie-35-earn-57-using-options-2016-01-07 | nan | nan | Investors considering a purchase of AbbVie Inc. (Symbol: ABBV) stock, but tentative about paying the going market price of $57.36/share, might benefit from considering selling puts among the alternative strategies at their disposal. One interesting put contract in particular, is the January 2018 put at the $35 strike, which has a bid at the time of this writing of $2.00. Collecting that bid as the premium represents a 5.7% return against the $35 commitment, or a 2.8% annualized rate of return (at Stock Options Channel we call this the YieldBoost ).
Selling a put does not give an investor access to ABBV's upside potential the way owning shares would, because the put seller only ends up owning shares in the scenario where the contract is exercised. And the person on the other side of the contract would only benefit from exercising at the $35 strike if doing so produced a better outcome than selling at the going market price. ( Do options carry counterparty risk? This and six other common options myths debunked ). So unless AbbVie Inc. sees its shares fall 39% and the contract is exercised (resulting in a cost basis of $33.00 per share before broker commissions, subtracting the $2.00 from $35), the only upside to the put seller is from collecting that premium for the 2.8% annualized rate of return.
Below is a chart showing the trailing twelve month trading history for AbbVie Inc., and highlighting in green where the $35 strike is located relative to that history:
The chart above, and the stock's historical volatility, can be a helpful guide in combination with fundamental analysis to judge whether selling the January 2018 put at the $35 strike for the 2.8% annualized rate of return represents good reward for the risks. We calculate the trailing twelve month volatility for AbbVie Inc. (considering the last 253 trading day closing values as well as today's price of $57.36) to be 32%. For other put options contract ideas at the various different available expirations, visit the ABBV Stock Options page of StockOptionsChannel.com.
In mid-afternoon trading on Thursday, the put volume among S&P 500 components was 847,990 contracts, with call volume at 847,990, for a put:call ratio of 0.76 so far for the day, which is above normal compared to the long-term median put:call ratio of .65. In other words, if we look at the number of call buyers and then use the long-term median to project the number of put buyers we'd expect to see, we're actually seeing more put buyers than expected out there in options trading so far today. Find out which 15 call and put options traders are talking about today .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Investors considering a purchase of AbbVie Inc. (Symbol: ABBV) stock, but tentative about paying the going market price of $57.36/share, might benefit from considering selling puts among the alternative strategies at their disposal. Below is a chart showing the trailing twelve month trading history for AbbVie Inc., and highlighting in green where the $35 strike is located relative to that history: The chart above, and the stock's historical volatility, can be a helpful guide in combination with fundamental analysis to judge whether selling the January 2018 put at the $35 strike for the 2.8% annualized rate of return represents good reward for the risks. We calculate the trailing twelve month volatility for AbbVie Inc. (considering the last 253 trading day closing values as well as today's price of $57.36) to be 32%. | Below is a chart showing the trailing twelve month trading history for AbbVie Inc., and highlighting in green where the $35 strike is located relative to that history: The chart above, and the stock's historical volatility, can be a helpful guide in combination with fundamental analysis to judge whether selling the January 2018 put at the $35 strike for the 2.8% annualized rate of return represents good reward for the risks. We calculate the trailing twelve month volatility for AbbVie Inc. (considering the last 253 trading day closing values as well as today's price of $57.36) to be 32%. Investors considering a purchase of AbbVie Inc. (Symbol: ABBV) stock, but tentative about paying the going market price of $57.36/share, might benefit from considering selling puts among the alternative strategies at their disposal. | Below is a chart showing the trailing twelve month trading history for AbbVie Inc., and highlighting in green where the $35 strike is located relative to that history: The chart above, and the stock's historical volatility, can be a helpful guide in combination with fundamental analysis to judge whether selling the January 2018 put at the $35 strike for the 2.8% annualized rate of return represents good reward for the risks. Investors considering a purchase of AbbVie Inc. (Symbol: ABBV) stock, but tentative about paying the going market price of $57.36/share, might benefit from considering selling puts among the alternative strategies at their disposal. Selling a put does not give an investor access to ABBV's upside potential the way owning shares would, because the put seller only ends up owning shares in the scenario where the contract is exercised. | Investors considering a purchase of AbbVie Inc. (Symbol: ABBV) stock, but tentative about paying the going market price of $57.36/share, might benefit from considering selling puts among the alternative strategies at their disposal. Below is a chart showing the trailing twelve month trading history for AbbVie Inc., and highlighting in green where the $35 strike is located relative to that history: The chart above, and the stock's historical volatility, can be a helpful guide in combination with fundamental analysis to judge whether selling the January 2018 put at the $35 strike for the 2.8% annualized rate of return represents good reward for the risks. Selling a put does not give an investor access to ABBV's upside potential the way owning shares would, because the put seller only ends up owning shares in the scenario where the contract is exercised. |
26719.0 | 2016-01-06 00:00:00 UTC | Why AbbVie Inc Spent $21 Billion to Buy Pharmacyclics | ABBV | https://www.nasdaq.com/articles/why-abbvie-inc-spent-21-billion-buy-pharmacyclics-2016-01-06 | nan | nan | Chicago-based pharmaceutical company AbbVie made a huge move in its purchase of Pharmacyclics for an estimated $21 billion.
Pharmacyclics commanded a rich price largely because of its potential blockbuster cancer drug, Imbruvica. Owning this treatment could reduce AbbVie's dependence on its own star performer, rheumatoid arthritis drug Humira, which is facing patent expiration. Imbruvica, if moved into place as a first line drug treatment, could bring in an estimated $14 billion in annual sales for AbbVie in the very near future.
The full podcast can be accessed by clicking here . A full transcript follows the video.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
This podcast was recorded on Dec. 16, 2015.
Kristine Harjes: Speaking of AbbVie, they had a pretty big buyout too in March. That one was Pharmacyclics for $21 billion.
Todd Campbell: Yeah, Humira counts for 61% of AbbVie's sales. So with the pending patent expiration, despite their best efforts to use legal wrangling, and new formulations to try and delay the entrance of biosimilars ...
Harjes: And that has been a valiant effort on their part.
Campbell: Yeah and they'll continue to advance that. And who knows? Maybe they push back the entrance of these biosimilars by a few years by doing it. But it's delaying the inevitable. So they needed to go out and really get something that was going to be big and potentially transformative to make up for the sales that could be lost to Humira -- a drug that has $13 billion in annual sales. Not easy to fill.
However, they did go out, they spent $21 billion to buy Pharmacyclics earlier this year to get their hands on the blood cancer drug, leukemia especially, Imbruvica -- which is co-developed by Johnson & Johnson . And that drug has just been a gangbuster drug, incredibly successful, potentially going to get approval next year for use in the first line setting. And that has AbbVie thinking that, "Well, at least we can get peak sales out of that drug of 5 to $6 billion over time."
Harjes: Yeah, and that's especially impressive when you think about the fact that they only get to retain 50% of the profits. And so if you have management saying that they could bring in $7 billion in revenue just from this one drug, you're talking about that equating to a projection of peak sales of $14 billion.
Campbell: Yeah, these drugs, again biologics are, like Imbruvica, are the very expensive drugs. They carry $100,000-plus-a-year price tags. I think now some of those drugs, expensive drugs, arguably don't add a lot of value in as far as extending progression for survival, or overall survival. But in the case of Imbruvica, it really does. The trial that's backing up the application for approval in the first line setting in CLL, Chronic Lymphocytic Leukemia, that showed an 85% reduction in risk of death. So this is a very important drug, it's an expensive drug, and it certainly could generate significant revenue for the company. Whether or not it's enough to offset the risk to Humira, that still remains to be seen. But it's definitely one of the bigger deals of the year.
The article Why AbbVie Inc Spent $21 Billion to Buy Pharmacyclics originally appeared on Fool.com.
Kristine Harjes owns shares of Johnson & Johnson. Todd Campbell has no position in any stocks mentioned. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Chicago-based pharmaceutical company AbbVie made a huge move in its purchase of Pharmacyclics for an estimated $21 billion. Imbruvica, if moved into place as a first line drug treatment, could bring in an estimated $14 billion in annual sales for AbbVie in the very near future. Owning this treatment could reduce AbbVie's dependence on its own star performer, rheumatoid arthritis drug Humira, which is facing patent expiration. | Imbruvica, if moved into place as a first line drug treatment, could bring in an estimated $14 billion in annual sales for AbbVie in the very near future. Todd Campbell: Yeah, Humira counts for 61% of AbbVie's sales. Chicago-based pharmaceutical company AbbVie made a huge move in its purchase of Pharmacyclics for an estimated $21 billion. | Imbruvica, if moved into place as a first line drug treatment, could bring in an estimated $14 billion in annual sales for AbbVie in the very near future. Chicago-based pharmaceutical company AbbVie made a huge move in its purchase of Pharmacyclics for an estimated $21 billion. Owning this treatment could reduce AbbVie's dependence on its own star performer, rheumatoid arthritis drug Humira, which is facing patent expiration. | Todd Campbell: Yeah, Humira counts for 61% of AbbVie's sales. Chicago-based pharmaceutical company AbbVie made a huge move in its purchase of Pharmacyclics for an estimated $21 billion. Owning this treatment could reduce AbbVie's dependence on its own star performer, rheumatoid arthritis drug Humira, which is facing patent expiration. |
26720.0 | 2016-01-05 00:00:00 UTC | Gilead's (GILD) HCV Drug Gets Priority Review Status in U.S. | ABBV | https://www.nasdaq.com/articles/gileads-gild-hcv-drug-gets-priority-review-status-in-u.s.-2016-01-05 | nan | nan | Gilead Sciences, Inc.GILD announced that its marketing application for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi, with velpatasvir (an investigational pangenotypic NS5A inhibitor) has been granted priority review by the FDA. Gilead is looking to get the combination approved for the treatment of genotype 1-6 chronic HCV infection. The company expects to receive a final decision from the FDA by Jun 28, 2016.
Gilead has also submitted a regulatory application for Sovaldi/velpatasvir in the EU. If approved, the company expects to make the drug available in the EU in 2016. The fixed-dose combination enjoys Breakthrough Therapy status in the U.S. Note that Breakthrough Therapy status is granted to candidates that have the potential to offer major advancements in treatment over existing options.
However, Gilead's HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies like Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Harvoni also witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. In this scenario, a label expansion for Harvoni will be a major win for the company. It should boost the drug's sales.
Meanwhile, competition in the HCV market is intensifying as several companies like Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Gilead currently carries a Zacks Rank #3 (Hold). Baxalta Incorporated BXLT is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies like Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that its marketing application for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi, with velpatasvir (an investigational pangenotypic NS5A inhibitor) has been granted priority review by the FDA. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies like Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. The fixed-dose combination enjoys Breakthrough Therapy status in the U.S. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies like Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Gilead Sciences, Inc.GILD announced that its marketing application for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi, with velpatasvir (an investigational pangenotypic NS5A inhibitor) has been granted priority review by the FDA. | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies like Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that its marketing application for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi, with velpatasvir (an investigational pangenotypic NS5A inhibitor) has been granted priority review by the FDA. |
26721.0 | 2016-01-01 00:00:00 UTC | Will 2016 Be Johnson & Johnson's Best Year Yet? | ABBV | https://www.nasdaq.com/articles/will-2016-be-johnson-johnsons-best-year-yet-2016-01-01 | nan | nan | Imbruvica's allure is that it delivered exceptional response rate in chronic lymphocytic leukemia and mantle cell lymphoma patients. Patients with CLL witnessed a 78% reduction in risk of disease progression or death, and 66% of MCL patients saw their cancers shrink or disappear. Considering that CLL and MCL are diseases that can progress over years, there's a long-tail opportunity for Imbruvica to grow. In 2016, it could generate $1 billion or more for J&J; over the long run, J&J and AbbVie are expecting total sales of Imbruvica to top $5 billion annually.
Darzalex, a drug developed by J&J and Genmab , was also recently approved as a third-line and higher treatment for multiple myeloma. Amgen 's Kyprolis has been quite the success story in the limited third-line and higher indication for multiple myeloma, where peak annual sales potential lies around the $750 million mark. When the Food and Drug Administration approved Kyprolis, it did so after the drug delivered a 23% overall response rate in patients that progressed on a median of five prior therapies.
Here's where things are getting interesting for J&J and Amgen. Although Darzalex and Kyprolis have never faced off in a head-to-head study, and no concrete head-to-head comparisons can be made, Darzalex's approval by the FDA comes after a similar study involving patients who had progressed on a median of five prior therapies showed an overall response rate of 29%! It's possible this modestly higher response could translate into rapid uptake of Darzalex in 2016, helping J&J, and hurting Amgen.
Cardiovascular
Within J&J's cardiovascular franchise, it should be interesting to see if SGLT2 inhibitor Invokana, a drug that treats type 2 diabetes, can keep adding to its impressive sales growth in 2016. Through nine months in 2015, global Invokana sales -- known as Invokamet in overseas markets -- came in at $936 million. That's more than double the $385 million earned through the first nine months of 2015.
What makes SGLT2 inhibitors so intriguing is their mechanism of action and early success. Instead of working in the pancreas or liver, as prior generations of type 2 diabetes drugs have done, SGLT2 inhibitors like Invokana work in the kidneys to block glucose absorption. This, in turn, allows the patient to remove excess glucose through their urine.
Now for the best part: In addition to improved glycemic balance, SGLT2 inhibitors have shown a propensity to induce weight loss and lower systolic blood pressure in type 2 diabetics. This is a good thing, because a majority of diabetics tend to be overweight and/or have high blood pressure.
Competing SGLT2 inhibitor Jardiance, a drug developed by Eli Lilly and Boehringer Ingelheim, also demonstrated a superior reduction in risk of death in a long-term cardiovascular-outcomes study relative to the current standard of care, which is something that had never before been observed in a type 2 diabetes medicine. It's possible this study could be a boon for all SGLT2 inhibitors in 2016, especially with data from J&J's long-term CV-outcomes study due in 2017.
All systems go for J&J
Johnson & Johnson no longer delivers the rapid growth that shareholders were accustomed to in the 1990s and early 2000s, but it's developed into a well-rounded healthcare conglomerate that investors who are seeking a lower-risk investment and a healthy dividend can trust.
Looking ahead, it's likely that the same troubles J&J faced in 2015 will remain on the table in 2016. Discussion of prescription-drug reform, adverse currency translation, and medical-device weakness in the domestic market stemming from uncertainties surrounding the Affordable Care Act, are all reasons why J&J's upside momentum could be slowed. But growth in all three major segments -- consumer health, medical devices, and pharmaceuticals -- is expected in 2016. As such, I see plenty of reasons to consider adding Johnson & Johnson to your investment and/or retirement portfolio.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Will 2016 Be Johnson & Johnson's Best Year Yet? originally appeared on Fool.com.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen nameTMFUltraLong, track every pick he makes under the screen nameTrackUltraLong, and check him out on Twitter, where he goes by the handle@TMFUltraLong.The Motley Fool owns shares of and recommends Gilead Sciences. It also recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2016 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In 2016, it could generate $1 billion or more for J&J; over the long run, J&J and AbbVie are expecting total sales of Imbruvica to top $5 billion annually. Amgen 's Kyprolis has been quite the success story in the limited third-line and higher indication for multiple myeloma, where peak annual sales potential lies around the $750 million mark. Competing SGLT2 inhibitor Jardiance, a drug developed by Eli Lilly and Boehringer Ingelheim, also demonstrated a superior reduction in risk of death in a long-term cardiovascular-outcomes study relative to the current standard of care, which is something that had never before been observed in a type 2 diabetes medicine. | In 2016, it could generate $1 billion or more for J&J; over the long run, J&J and AbbVie are expecting total sales of Imbruvica to top $5 billion annually. Patients with CLL witnessed a 78% reduction in risk of disease progression or death, and 66% of MCL patients saw their cancers shrink or disappear. When the Food and Drug Administration approved Kyprolis, it did so after the drug delivered a 23% overall response rate in patients that progressed on a median of five prior therapies. | In 2016, it could generate $1 billion or more for J&J; over the long run, J&J and AbbVie are expecting total sales of Imbruvica to top $5 billion annually. Although Darzalex and Kyprolis have never faced off in a head-to-head study, and no concrete head-to-head comparisons can be made, Darzalex's approval by the FDA comes after a similar study involving patients who had progressed on a median of five prior therapies showed an overall response rate of 29%! Cardiovascular Within J&J's cardiovascular franchise, it should be interesting to see if SGLT2 inhibitor Invokana, a drug that treats type 2 diabetes, can keep adding to its impressive sales growth in 2016. | In 2016, it could generate $1 billion or more for J&J; over the long run, J&J and AbbVie are expecting total sales of Imbruvica to top $5 billion annually. Patients with CLL witnessed a 78% reduction in risk of disease progression or death, and 66% of MCL patients saw their cancers shrink or disappear. When the Food and Drug Administration approved Kyprolis, it did so after the drug delivered a 23% overall response rate in patients that progressed on a median of five prior therapies. |
26722.0 | 2015-12-31 00:00:00 UTC | NeuroDerm Begins Enrollment in Parkinson's Disease Study | ABBV | https://www.nasdaq.com/articles/neuroderm-begins-enrollment-in-parkinsons-disease-study-2015-12-31 | nan | nan | NeuroDerm Ltd.NDRM announced that it has commenced patient enrollment in a phase II study evaluating the subcutaneously delivered levodopa/carbidopa (LD/CD) solution, ND0612H, for the treatment of patients suffering from advanced Parkinson's disease. The company's shares were up 2.3% following the announcement.
The 28-day, multi-center, parallel-group, rater-blinded, randomized pilot study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of two dosing regimens of ND0612H and compare them to the baseline oral standard of care. In the study, a total of 36 advanced Parkinson's disease patients are expected to be enrolled.
We are encouraged by NeuroDerm's progress with ND0612H. Per information provided by the company in its press release, ND0612H can prove to be an effective alternative treatment for advanced Parkinson's disease patients who suffer from motor complications that cannot be adequately controlled with currently available treatments and might otherwise require surgical intervention that may be associated with serious adverse effects and death.
Meanwhile, NeuroDerm continues to progress in Europe with a head-to-head PK comparison study on ND0612H and AbbVie Inc.'s ABBV Duodopa. Data from the study should be out in the second quarter of 2016. In addition, the company intends to initiate a pivotal phase III efficacy study on ND0612L for the treatment of patients with moderate-to-severe Parkinson's disease as well as a long-term safety follow-up in the first half of 2016.
Apart from ND0612H and ND0612L, NeuroDerm is also developing ND0701, a subcutaneously delivered apomorphine formulation for the treatment of patients suffering from severe Parkinson's disease who do not respond well to LD/CD.
We note that several companies including Prothena Corporation plc PRTA are working to bring Parkinson's disease treatments to the market.
NeuroDerm is a Zacks Rank #2 (Buy) stock. Aerie Pharmaceuticals, Inc. AERI is another favorably ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Meanwhile, NeuroDerm continues to progress in Europe with a head-to-head PK comparison study on ND0612H and AbbVie Inc.'s ABBV Duodopa. Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report PROTHENA CP PLC (PRTA): Free Stock Analysis Report AERIE PHARMACT (AERI): Free Stock Analysis Report NEURODERM LTD (NDRM): Free Stock Analysis Report To read this article on Zacks.com click here. The 28-day, multi-center, parallel-group, rater-blinded, randomized pilot study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of two dosing regimens of ND0612H and compare them to the baseline oral standard of care. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report PROTHENA CP PLC (PRTA): Free Stock Analysis Report AERIE PHARMACT (AERI): Free Stock Analysis Report NEURODERM LTD (NDRM): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, NeuroDerm continues to progress in Europe with a head-to-head PK comparison study on ND0612H and AbbVie Inc.'s ABBV Duodopa. NeuroDerm Ltd.NDRM announced that it has commenced patient enrollment in a phase II study evaluating the subcutaneously delivered levodopa/carbidopa (LD/CD) solution, ND0612H, for the treatment of patients suffering from advanced Parkinson's disease. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report PROTHENA CP PLC (PRTA): Free Stock Analysis Report AERIE PHARMACT (AERI): Free Stock Analysis Report NEURODERM LTD (NDRM): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, NeuroDerm continues to progress in Europe with a head-to-head PK comparison study on ND0612H and AbbVie Inc.'s ABBV Duodopa. NeuroDerm Ltd.NDRM announced that it has commenced patient enrollment in a phase II study evaluating the subcutaneously delivered levodopa/carbidopa (LD/CD) solution, ND0612H, for the treatment of patients suffering from advanced Parkinson's disease. | Meanwhile, NeuroDerm continues to progress in Europe with a head-to-head PK comparison study on ND0612H and AbbVie Inc.'s ABBV Duodopa. Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report PROTHENA CP PLC (PRTA): Free Stock Analysis Report AERIE PHARMACT (AERI): Free Stock Analysis Report NEURODERM LTD (NDRM): Free Stock Analysis Report To read this article on Zacks.com click here. NeuroDerm Ltd.NDRM announced that it has commenced patient enrollment in a phase II study evaluating the subcutaneously delivered levodopa/carbidopa (LD/CD) solution, ND0612H, for the treatment of patients suffering from advanced Parkinson's disease. |
26723.0 | 2015-12-31 00:00:00 UTC | Can Gilead Sciences Score With AbbVie's Dropped Ball? | ABBV | https://www.nasdaq.com/articles/can-gilead-sciences-score-abbvies-dropped-ball-2015-12-31 | nan | nan | The good times quickly came to an end for Galapagos shareholders in September when AbbVie decided to further development of its own JAK inhibitor, ABT-494, rather than purchase rights to Galapagos' pill. The stock was subsequently hammered, only to soar once more after Gilead Sciences swooped in with an even better deal for filgotinib.
The $16 billion rheumatoid arthritis market is largely dominated by biologics that require injections, so an effective oral therapy should be well received. Another oral JAK inhibitor, Pfizer 's Xeljanz, has been available in the U.S. since 2012, but a second-line indication and several black box warnings -- the FDA's most severe -- on its label aren't helping sales much. When Pfizer last reported, the drug was selling at an annual run rate of $508 million.
Half-a-billion after a few years is nothing to sneeze at, but Xeljanz sales pale in comparison to injected biologics used to treat rheumatoid arthritis like Humira and Enbrel. After Galapagos' oral JAK inhibitor was passed over by AbbVie, it's surprising to see Gilead put down $300 million for a similar drug, until you look at how well it performed in trials.
Sewing up the second line
An impressive 26% and 25% of rheumatoid arthritis patients that didn't respond to standard first-line treatment, methotrexate, experienced a 70% reduction in disease activity when dosed for 24 weeks with 100 mg or 200 mg of filgotinib, respectively. It looks like filgotinib has Xeljanz beat. When combined with methotrexate, only 11% of patients -- with inadequate response to methotrexate alone -- taking the approved dosage of Pfizer's pill enjoyed the same reduction in disease activity.
Xeljanz and filgotinib weren't tested in a head-to-head trial, so any comparisons made here need to be taken with a grain of salt. Given the wide difference in efficacy, I'd say Galapagos' claim that filgotinib has best-in-class potential holds water.
Best-in-class, or just best?
In fact, filgotinib may even have top-selling biologic treatments beaten. In a study with Humira in rheumatoid arthritis patients exhibiting an inadequate response to methotrexate, 21% experienced a 70% reduction in disease activity.
Again, this wasn't a head-to-head study, so we can't make any concrete conclusions about which is more effective. However, it looks like filgotinib could eventually threaten injected biologics dominating the rheumatoid arthritis market.
Wait there's more
Rheumatoid arthritis is an important indication, but filgotinib is also scoring high marks in Crohn's disease. Earlier this month, the company released results from a phase 2 study in which 48% of patients treated with the experimental drug experienced clinical remission after 10 weeks.
Humira and other biologics enjoy a large share of this roughly $4 billion market as well. However, if orally delivered filgotinib continues to put up numbers like these, that could all change in Gilead's and Galapagos' favor.
Looking ahead
Gilead Sciences isn't prone to dealmaking just for the sake of looking busy. While many were expecting a larger acquisition, this deal could jump-start the company's lackluster anti-inflammatory franchise. Ahead of the deal, this basically consisted of one candidate in phase 2 for irritable bowel disease, GS-5745. Filgotinib isn't about to become another record-breaker like Gilead's mega-blockbuster Harvoni, but if it gets approved approved, reaching annual peak sales estimates of $3 billion will help reduce the company's dependence on sales of antivirals.
It's too early to be sure, but the biggest threat to filgotinib could come from AbbVie's ABT-494. On the day AbbVie announced it would drop Galapagos' JAK inhibitor, AbbVie announced phase 2 results from its own candidate. Rates of disease reduction were similar to those seen in filgotinib studies, although there was a minor issue. Generally, we like to see efficacy measurements rise in step with increasing dosages. Several lower dosage groups in AbbVie's study showed the highest rates of disease reduction in their respective studies.
This kink will probably work itself out in larger trials, but you'll want to keep a close eye on any data ABT-494 throws off in the year ahead. Given the $200 million upfront payment required to license filgotinib, about $1 billion in potential milestone payments, and double-digit royalties on potential sales, the economics surrounding ABT-494 are highly favorable for AbbVie. This means you can't draw conclusions about which JAK inhibitor had better undisclosed data, because AbbVie probably would have gone for its own candidate even if it were somewhat inferior.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article Can Gilead Sciences Score With AbbVie's Dropped Ball? originally appeared on Fool.com.
Cory Renauer has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | After Galapagos' oral JAK inhibitor was passed over by AbbVie, it's surprising to see Gilead put down $300 million for a similar drug, until you look at how well it performed in trials. The good times quickly came to an end for Galapagos shareholders in September when AbbVie decided to further development of its own JAK inhibitor, ABT-494, rather than purchase rights to Galapagos' pill. It's too early to be sure, but the biggest threat to filgotinib could come from AbbVie's ABT-494. | On the day AbbVie announced it would drop Galapagos' JAK inhibitor, AbbVie announced phase 2 results from its own candidate. The good times quickly came to an end for Galapagos shareholders in September when AbbVie decided to further development of its own JAK inhibitor, ABT-494, rather than purchase rights to Galapagos' pill. After Galapagos' oral JAK inhibitor was passed over by AbbVie, it's surprising to see Gilead put down $300 million for a similar drug, until you look at how well it performed in trials. | On the day AbbVie announced it would drop Galapagos' JAK inhibitor, AbbVie announced phase 2 results from its own candidate. The good times quickly came to an end for Galapagos shareholders in September when AbbVie decided to further development of its own JAK inhibitor, ABT-494, rather than purchase rights to Galapagos' pill. After Galapagos' oral JAK inhibitor was passed over by AbbVie, it's surprising to see Gilead put down $300 million for a similar drug, until you look at how well it performed in trials. | After Galapagos' oral JAK inhibitor was passed over by AbbVie, it's surprising to see Gilead put down $300 million for a similar drug, until you look at how well it performed in trials. On the day AbbVie announced it would drop Galapagos' JAK inhibitor, AbbVie announced phase 2 results from its own candidate. The good times quickly came to an end for Galapagos shareholders in September when AbbVie decided to further development of its own JAK inhibitor, ABT-494, rather than purchase rights to Galapagos' pill. |
26724.0 | 2015-12-29 00:00:00 UTC | Irony of Ironies: Gilead Sciences Is Licensing AbbVie's Rejected Drug | ABBV | https://www.nasdaq.com/articles/irony-ironies-gilead-sciences-licensing-abbvies-rejected-drug-2015-12-29 | nan | nan | If you've been tracking the Gilead Sciences / AbbVie Hepatitis C match-up during the last year, you've seen what a one-sided fight looks like. In HCV, Gilead's drugs Sovaldi and Harvoni are the undisputed leaders, with $10 billion plus in combined sales in 2014 and 2015. And Viekira Pak -- on track for less than $2 billion in 2015 -- is a distant third.
Harvoni and Sovaldi have significant advantages over Viekira Pak -- most notably better dosing and a superior side-effect profile -- and they highlight a cornerstone of Gilead's strategy. CFO Robin Washington put it best at the recent Nasdaq Investor Program by noting that: "It's important to us to have best-in-class molecules. We try to develop them in-house, but if there are opportunities external... we take advantage of those." (Quote courtesy of S&P Capital IQ .)
That's why it was so weird to learn that Gilead paid $725 million upfront to license a drug that AbbVie had previously rejected. It didn't seem to fit. After all, why would a company with such high standards pick up another company's proverbial trash?
It turns out, of course, that there's more to the story than meets the eye.
Breaking it down
The drug, by the way, is called filgotinib, and it's targeted at inflammatory diseases. Galapagos NV , filgotinib's developer, reported positive phase 2 data earlier this year for the drug in both rheumatoid arthritis and Crohn's disease. Galapagos and Gilead plan to begin phase 3 trials in 2016.
Peak sales estimates for the drug are impressive -- as high as $2 billion according to one analyst -- which then begs two questions:
Why would AbbVie ditch a drug with multi-billion dollar potential; and
Was this the right move for Gilead?
AbbVie's reasoning for ditching the drug in September looked sound at the time -- and to some extent still does. Filgotinib had some troubling data that it might be toxic to the testicles. Plus, AbbVie has its own competitor drug, ABT-494, which had recently reported positive data in a midstage trial. And because ABT-494 was wholly owned by AbbVie, there'd be no need to pay royalties on it, unlike for filgotinib (and some estimates are that royalties on filgotinib would have cost AbbVie $1 billion or more in total).
What AbbVie had with filgotinib was a drug with some concerning data that, even if successful, would cost AbbVie extra because of royalties. Contrast that with another its own drug for similar indications that had reported great data and would be more profitable. Pretty easy to see why AbbVie made the choice it did.
Enter Gilead
Then, Galapagos reported positive filgotinib phase 2 data in Crohn's disease earlier this month, and at least partially resolved concerns about the drug's potential toxicity. For Gilead Sciences, which hasn't been shy about admitting its interest in adding new drugs to its pipeline, this is a solid deal. A brief look over Gilead's history shows that the company prefers to pay extra for drugs that have already been de-risked instead of taking moonshots on lots of early-stage assets, and buying rights to filgotinib fits in nicely with that strategy.
The price isn't bad either -- the $725 million Gilead is paying upfront includes a $425 million equity investment in Galapagos, meaning that Gilead will own roughly 15% of Galapagos after the deal has closed. Gilead has also offered $1.35 billion in potential milestone payments to Galapagos, plus tiered royalties starting at 20%, and the option for Galapagos to co-promote filgotinib in certain European countries.
Without knowing all the details, it's impossible to precisely work the math for the deal. But getting the vast majority of a drug's potential sales for around one times peak sales estimates looks like a very good price for Gilead. (Biotech buyouts usually happen at two times or three times peak sales.) Owning around 15% of Galapagos is a nice kicker, as the company has plenty of potential upside with two drugs in phase 2/3, two in phase 1, and a number in preclinical.
Who wins?
There's no way to predict who will win when these drugs (and a variety of competitors) hopefully get to market. And it's hard to blame AbbVie for its decision to cut filgotinib loose. Based on the data available at the time -- and the fact that AbbVie had a competitor in development -- it makes sense for the company to save money and focus its resources on the more profitable opportunity.
As I think everyone learned in Hepatitis C and HIV, Gilead Sciences will exploit any opening in a disease area of interest to the company -- and now it's beefing up an otherwise mostly early- and mid-stage autoimmune pipeline. That's great news for Gilead investors as the company works to diversify from a heavy reliance on HIV and Hepatitis C.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Irony of Ironies: Gilead Sciences Is Licensing AbbVie's Rejected Drug originally appeared on Fool.com.
Michael Douglass owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | If you've been tracking the Gilead Sciences / AbbVie Hepatitis C match-up during the last year, you've seen what a one-sided fight looks like. That's why it was so weird to learn that Gilead paid $725 million upfront to license a drug that AbbVie had previously rejected. Peak sales estimates for the drug are impressive -- as high as $2 billion according to one analyst -- which then begs two questions: Why would AbbVie ditch a drug with multi-billion dollar potential; and Was this the right move for Gilead? | The article Irony of Ironies: Gilead Sciences Is Licensing AbbVie's Rejected Drug originally appeared on Fool.com. If you've been tracking the Gilead Sciences / AbbVie Hepatitis C match-up during the last year, you've seen what a one-sided fight looks like. That's why it was so weird to learn that Gilead paid $725 million upfront to license a drug that AbbVie had previously rejected. | Peak sales estimates for the drug are impressive -- as high as $2 billion according to one analyst -- which then begs two questions: Why would AbbVie ditch a drug with multi-billion dollar potential; and Was this the right move for Gilead? If you've been tracking the Gilead Sciences / AbbVie Hepatitis C match-up during the last year, you've seen what a one-sided fight looks like. That's why it was so weird to learn that Gilead paid $725 million upfront to license a drug that AbbVie had previously rejected. | What AbbVie had with filgotinib was a drug with some concerning data that, even if successful, would cost AbbVie extra because of royalties. If you've been tracking the Gilead Sciences / AbbVie Hepatitis C match-up during the last year, you've seen what a one-sided fight looks like. That's why it was so weird to learn that Gilead paid $725 million upfront to license a drug that AbbVie had previously rejected. |
26725.0 | 2015-12-29 00:00:00 UTC | Notable ETF Outflow Detected - IWB, AMGN, MA, ABBV | ABBV | https://www.nasdaq.com/articles/notable-etf-outflow-detected-iwb-amgn-ma-abbv-2015-12-29 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Russell 1000 ETF (Symbol: IWB) where we have detected an approximate $74.3 million dollar outflow -- that's a 0.5% decrease week over week (from 132,650,000 to 132,000,000). Among the largest underlying components of IWB, in trading today Amgen Inc (Symbol: AMGN) is up about 1.6%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is higher by about 1.5%. For a complete list of holdings, visit the IWB Holdings page » The chart below shows the one year price performance of IWB, versus its 200 day moving average:
Looking at the chart above, IWB's low point in its 52 week range is $93.25 per share, with $119.74 as the 52 week high point - that compares with a last trade of $115.05. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs experienced notable outflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of IWB, in trading today Amgen Inc (Symbol: AMGN) is up about 1.6%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is higher by about 1.5%. For a complete list of holdings, visit the IWB Holdings page » The chart below shows the one year price performance of IWB, versus its 200 day moving average: Looking at the chart above, IWB's low point in its 52 week range is $93.25 per share, with $119.74 as the 52 week high point - that compares with a last trade of $115.05. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. | Among the largest underlying components of IWB, in trading today Amgen Inc (Symbol: AMGN) is up about 1.6%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is higher by about 1.5%. For a complete list of holdings, visit the IWB Holdings page » The chart below shows the one year price performance of IWB, versus its 200 day moving average: Looking at the chart above, IWB's low point in its 52 week range is $93.25 per share, with $119.74 as the 52 week high point - that compares with a last trade of $115.05. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). | Among the largest underlying components of IWB, in trading today Amgen Inc (Symbol: AMGN) is up about 1.6%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is higher by about 1.5%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Russell 1000 ETF (Symbol: IWB) where we have detected an approximate $74.3 million dollar outflow -- that's a 0.5% decrease week over week (from 132,650,000 to 132,000,000). For a complete list of holdings, visit the IWB Holdings page » The chart below shows the one year price performance of IWB, versus its 200 day moving average: Looking at the chart above, IWB's low point in its 52 week range is $93.25 per share, with $119.74 as the 52 week high point - that compares with a last trade of $115.05. | Among the largest underlying components of IWB, in trading today Amgen Inc (Symbol: AMGN) is up about 1.6%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is higher by about 1.5%. For a complete list of holdings, visit the IWB Holdings page » The chart below shows the one year price performance of IWB, versus its 200 day moving average: Looking at the chart above, IWB's low point in its 52 week range is $93.25 per share, with $119.74 as the 52 week high point - that compares with a last trade of $115.05. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). |
26726.0 | 2015-12-26 00:00:00 UTC | Is AbbVie's Growth Story Falling to Pieces? | ABBV | https://www.nasdaq.com/articles/abbvies-growth-story-falling-pieces-2015-12-26 | nan | nan | AstraZeneca may have just struck a serious blow to AbbVie 's stated goal of producing industry-leading growth heading into 2020 and beyond. Specifically, the British drugmaker reportedly bought 55% of privately held Acerta Pharma for $4 billion, giving the company access to the experimental blood cancer drug acalabrutinib.
Based on this guidance, however, AbbVie seems confident that its plan to protect Humira from biosimilars will work out, with the company projecting $18 billion in sales for the drug by 2020. Imbruvica, on the other hand, is expected to generate more than $5 billion in revenue per year for the drugmaker within the next four years, putting it on track to become Humira's heir apparent.
But therein lies the problem. Although acalabrutinib is well behind Imbruvica in terms of its clinical development, Astra believes the drug can become a best-in-class treatment for a variety of blood disorders. In short, acalabrutinib may prove to be more effective and come with fewer side effects than Imbruvica, making it a serious threat to AbbVie's long-term guidance and plans to significantly diversify its revenue base beyond Humira.
Tying it all together
AbbVie went for broke when it paid $21 billion for Pharmacyclics. The sheer size of this deal substantially narrowed the company's ability to engage in further M&A activity in hopes of finding its next flagship product. And now with Astra pushing deeper into hematology, this costly buyout is starting to look like a major misstep by AbbVie. As such, I'm personally content to watch this top biopharma from the sidelines for now.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Is AbbVie's Growth Story Falling to Pieces? originally appeared on Fool.com.
George Budwell has no position in any stocks mentioned. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Based on this guidance, however, AbbVie seems confident that its plan to protect Humira from biosimilars will work out, with the company projecting $18 billion in sales for the drug by 2020. AstraZeneca may have just struck a serious blow to AbbVie 's stated goal of producing industry-leading growth heading into 2020 and beyond. In short, acalabrutinib may prove to be more effective and come with fewer side effects than Imbruvica, making it a serious threat to AbbVie's long-term guidance and plans to significantly diversify its revenue base beyond Humira. | The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. AstraZeneca may have just struck a serious blow to AbbVie 's stated goal of producing industry-leading growth heading into 2020 and beyond. Based on this guidance, however, AbbVie seems confident that its plan to protect Humira from biosimilars will work out, with the company projecting $18 billion in sales for the drug by 2020. | Based on this guidance, however, AbbVie seems confident that its plan to protect Humira from biosimilars will work out, with the company projecting $18 billion in sales for the drug by 2020. In short, acalabrutinib may prove to be more effective and come with fewer side effects than Imbruvica, making it a serious threat to AbbVie's long-term guidance and plans to significantly diversify its revenue base beyond Humira. AstraZeneca may have just struck a serious blow to AbbVie 's stated goal of producing industry-leading growth heading into 2020 and beyond. | In short, acalabrutinib may prove to be more effective and come with fewer side effects than Imbruvica, making it a serious threat to AbbVie's long-term guidance and plans to significantly diversify its revenue base beyond Humira. AstraZeneca may have just struck a serious blow to AbbVie 's stated goal of producing industry-leading growth heading into 2020 and beyond. Based on this guidance, however, AbbVie seems confident that its plan to protect Humira from biosimilars will work out, with the company projecting $18 billion in sales for the drug by 2020. |
26727.0 | 2015-12-24 00:00:00 UTC | The Zacks Analyst Blog Highlights: Actelion, Amgen, Gilead, AbbVie and BioMarin | ABBV | https://www.nasdaq.com/articles/the-zacks-analyst-blog-highlights%3A-actelion-amgen-gilead-abbvie-and-biomarin-2015-12-24 | nan | nan | For Immediate Release
Chicago, IL - December 24, 2015 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Actelion ( ALIOF ), Amgen ( AMGN ), Gilead ( GILD ), AbbVie ( ABBV ) and BioMarin ( BMRN ).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free .
Here are highlights from Wednesday's Analyst Blog:
Biotech Stock Roundup
Last week, it was all about Martin Shkreli who made headlines thanks to his arrest on fraud charges. The saga continued with Shkreli being released on bail and then being fired from the position of CEO of two companies.
Recap of the Week's Most Important Stories
Martin Shkreli found himself being removed from the position of CEO of two companies - Turing and KaloBios . Shkreli, who has been in the news mainly due to his price gouging tactics, was arrested last week not due to pricing issues but due to fraudulent practices committed during a 5-year period when he was also working as a hedge-fund manager.
Meanwhile, quite a few companies tasted success on the regulatory front. While Actelion ( ALIOF ) gained FDA approval for its pulmonary arterial hypertension treatment, Uptravi, Amgen ( AMGN ) got EU approval for its melanoma treatment, Imlygic. The approval of Uptravi boosts Actelion's PAH portfolio which includes drugs like Opsumit and Veletri. Actelion will position Uptravi as an option to delay disease progression once therapy has been started with a baseline treatment like Opsumit and well before the use of Veletri for the late-stage disease. Meanwhile, Imlygic is the first oncolytic immunotherapy to demonstrate therapeutic benefit in patients with metastatic melanoma in a phase III study.
Isis Pharmaceuticals has finally changed its name and will now be known as Ionis Pharmaceuticals, Inc. and will trade under the symbol IONS instead of ISIS. The company decided to change its name so that people associate them with life-saving medicines. The name change will ensure that Isis is no longer associated with global terrorism.
Gilead ( GILD ) has signed up with Galapagos for the development and commercialization of filgotinib, a JAK1-selective inhibitor for inflammatory disease indications in a deal which could see Gilead paying out at least $2.075 billion including an upfront payment of $725 million. Earlier this month, Galapagos had reported encouraging mid-stage data on filgotinib in patients with Crohn's disease. We note that the Gilead agreement comes around three months after AbbVie ( ABBV ) terminated its deal with Galapagos for filgotinib (Read more: Gilead Collaborates with Galapagos for Filgotinib ).
BioMarin ( BMRN ) will have to wait a bit longer before the FDA announces its decision regarding the approval status of the company's experimental Duchenne muscular dystrophy treatment, Kyndrisa. The FDA has informed the company that they are yet to complete their review process, which means a response will not be available by the FDA action date of Dec 27. The agency said that it expects to take action in early Jan 2016 (Read more: BioMarin's Kyndrisa Review Period Extended by FDA ).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Stocks recently featured in the blog include the Actelion ( ALIOF ), Amgen ( AMGN ), Gilead ( GILD ), AbbVie ( ABBV ) and BioMarin ( BMRN ). We note that the Gilead agreement comes around three months after AbbVie ( ABBV ) terminated its deal with Galapagos for filgotinib (Read more: Gilead Collaborates with Galapagos for Filgotinib ). Click to get this free report ACTELION LTD (ALIOF): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report To read this article on Zacks.com click here. | Stocks recently featured in the blog include the Actelion ( ALIOF ), Amgen ( AMGN ), Gilead ( GILD ), AbbVie ( ABBV ) and BioMarin ( BMRN ). Click to get this free report ACTELION LTD (ALIOF): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report To read this article on Zacks.com click here. We note that the Gilead agreement comes around three months after AbbVie ( ABBV ) terminated its deal with Galapagos for filgotinib (Read more: Gilead Collaborates with Galapagos for Filgotinib ). | Stocks recently featured in the blog include the Actelion ( ALIOF ), Amgen ( AMGN ), Gilead ( GILD ), AbbVie ( ABBV ) and BioMarin ( BMRN ). Click to get this free report ACTELION LTD (ALIOF): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report To read this article on Zacks.com click here. We note that the Gilead agreement comes around three months after AbbVie ( ABBV ) terminated its deal with Galapagos for filgotinib (Read more: Gilead Collaborates with Galapagos for Filgotinib ). | Stocks recently featured in the blog include the Actelion ( ALIOF ), Amgen ( AMGN ), Gilead ( GILD ), AbbVie ( ABBV ) and BioMarin ( BMRN ). We note that the Gilead agreement comes around three months after AbbVie ( ABBV ) terminated its deal with Galapagos for filgotinib (Read more: Gilead Collaborates with Galapagos for Filgotinib ). Click to get this free report ACTELION LTD (ALIOF): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report To read this article on Zacks.com click here. |
26728.0 | 2015-12-23 00:00:00 UTC | Top Growth Dividend Stocks to Buy in 2016 | ABBV | https://www.nasdaq.com/articles/top-growth-dividend-stocks-buy-2016-2015-12-23 | nan | nan | The case has been made many times that dividend stocks are one of the best methods for growing your wealth over the long term. For that investing style to work, though, you need to invest in dividend stocks that will have the ability to grow those payouts for years to come.
So to help you get started with your own dividend portfolio in 2016, we asked our own motley crew of contributors to highlight a dividend stock that has years of stable dividend growth ahead of it. Here's what they had to say:
Reliability is an important attribute for a dividend growth stock, and 3M has a long history of delivering higher dividends to investors. For 57 years, the Dow component has boosted its dividend payouts on an annual basis, overcoming changing economic conditions year after year to give shareholders their due. Most recently, 3M gave investors a nearly 20% dividend increase early this year, and the company routinely raises its payouts early in the year, which should give investors an additional raise within the next few months.
Some investors worry that 3M's growth could slow, especially given its recent guidance toward weaker results for the remainder of this year. Yet the company still thinks it will see earnings growth of 7% to 12% in 2016, and with a dividend payout ratio of just over 50%, 3M has plenty of room to give investors a generous increase in its quarterly distributions without putting its healthy balance sheet at risk. 3M is vulnerable to the same economic trends as other cyclical companies, but it has demonstrated for decades that it can overcome those obstacles and produce long-term growth both in earnings and in what it pays to shareholders in dividends.
If investors are looking for an intriguing stock that is both growing in general and growing its dividend consistently, Polaris Industries perfectly fits the bill. Polaris is one of the most-respected, well-known, and innovative brands within the powersports market, and its share of North American powersports sales has gone from the middle of the pack in 2009 to a dominating No. 1 position.
Image source: Polaris' November investor presentation.
Zeroing in on its growing dividend -- which is currently $0.53 per share quarterly, for a yield of roughly 2.3% -- Polaris' five-year dividend compound annual growth rate is more than 20%. The good news for investors is that Polaris' overall sales growth, as well as its dividend growth, should continue as the company continues to invest wisely in its future products and acquisitions. For proof of that, consider that Polaris' return on invested capital has checked in above 40% each of the last four years.
No matter how you look at it, Polaris appears to be well positioned to grow in the years ahead.
I only recently pounded the table on Disney as a great stock to buy in December. But keeping in mind that Disney typically aims to return at least 20% of the cash it generates to shareholders in the form of dividends and share repurchases, I feel Disney's promise is worth reiterating for investors as 2016 nears. And that's especially so with Star Wars: Episode VII -- The Force Awakens continuing to shatter box office records as I write this.
Episode VII promptly gathered gross ticket sales of $57 million in Thursday-night previews last week -- crushing the previous Thursday-night record of $43.5 million held by Harry Potter and the Deathly Hallows Part 2 -- and pulled in a staggering $248 million for the full opening weekend. For perspective, the highest December launch of all time previously belonged to The Hobbit: An Unexpected Journey at $84.6 million, which itself went on to collect a respectable $1.02 billion in sales worldwide by the end of its own box office run. And Disney already has four more Star Wars films slated for release through the end of 2019, including two offshoot films and Episodes VIII and IX , so let it suffice to say Disney's $4 billion acquisition of LucasFilm was as astute as it comes for its thriving Studio segment.
Speaking of which, Disney has an equally impressive schedule slated outside of the Star Wars franchise for 2016, including Marvel's Captain America: Civil War and Alice Through the Looking Glass in May, Pixar's Finding Dory in June, and Doctor Strange in November. That's also not to mention the near certainty that the success of these movies will collectively drive Disney's higher-margin consumer products segment to another record year in 2016.
At the same time, the wild card remains in Disney's core media networks business, which singlehandedly generated more than half of Disney's total operating profit last year. But as fellow Fool Rick Munarriz pointed out recently, media networks also remained Disney's only segment that failed to grow operating income at a double-digit percentage rate last fiscal year, growing instead at "just" 6%. Within that, arguably most concerning is the fact that ESPN continues to lose subscribers as the effect of cord-cutters becomes more evident with each passing year. Over the long term, however, I still think Disney's Media Networks are powerful enough and well-positioned enough to adapt to our changing media landscape, whether it means offering channels like ESPN a la carte directly to consumers or striking inclusion deals as it did earlier this year with DISH 's Sling TV.
In the meantime, however, there are plenty of catalysts in Disney's other businesses to offset these concerns. And I think investors who buy in 2016 with the intention of holding Disney for the long run will be happy they did.
Tyler Crowe
Considering how much the market has beaten down the energy sector and master limited partnerships lately, I can understand how some investors might be a little wary of getting involved in the sector. Despite the major declines in stock prices and the recent dividend cuts in the sector, one company that really stands out as a stable dividend grower is Magellan Midstream Partners .
One of the major advantages that Magellan has over so many other pipeline companies is that a majority of its operational profits come from the transport of refined petroleum products such as gasoline and diesel. These kinds of products don't see the fluctuations in supply and demand that crude oil and natural gas do, so volumes across its system are pretty consistent. Also, Magellan's pipeline network has the added advantage of being the exclusive supplier for many parts of the country, which means its tariffs are regulated by the Federal Energy Regulatory Commission.
What makes this company appealing compared to so many other master limited partnerships, though, is that its conservative management has positioned it to withstand downturns in the commodity cycle. It still generates more than enough cash to fund payouts to its investors as well as reinvest in the business.
I can't say for certain when the energy market will rebound, but Magellan Midstream Partners is one of the few in the space that actually is built for the ups and downs of the market. With a greater than 5% yield and a 14-year streak of increasing its payout, Magellan looks like a pretty compelling investment in 2016.
AbbVie is one of the few names in healthcare that offer both a healthy dividend yield (at around 4%) and particularly strong growth prospects in terms of their bottom and top lines going forward.
For investors new to this stock, the company's main value driver is its megablockbuster anti-inflammatory drug, Humira. Despite this drug coming off patent protection in the U.S. in 2016, management thinks Humira can still generate sales in excess of $18 billion by 2020.
Behind Humira, AbbVie's next most important product is its blood cancer drug, Imbruvica, which was acquired during a $21 billion buyout of Pharmacyclics earlier this year. Between them, AbbVie thinks these two key drugs can help drive double-digit adjusted earnings-per-share growth through 2020 and perhaps beyond. If true, this would put the drugmaker in elite company in the context of large-cap growth stocks that pay a dividend.
While there are some lingering concerns that AbbVie's projections for these two drugs are overly optimistic, the company does sport a well-diversified clinical pipeline that has the potential to produce 20 new drugs or indications over the next few years. Some of these experimental drug candidates, like ABT-199 -- which is currently in several ongoing clinical studies for a variety of blood-based disorders -- definitely have the potential to make up for any shortfalls on the revenue front, if Humira or Imbruvica fail to live up to expectations.
All told, AbbVie does come with some notable risks such as a highly leveraged balance sheet stemming from its recent M&A activity, along with Humira's looming patent expiration. However, the company's industry-leading growth potential, combined with the fact that it's a Dividend Aristocrat, are certainly good reasons to dig deeper.
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The article Top Growth Dividend Stocks to Buy in 2016 originally appeared on Fool.com.
Dan Caplinger owns shares of Walt Disney. Daniel Miller has no position in any stocks mentioned. George Budwell has no position in any stocks mentioned. Steve Symington has no position in any stocks mentioned. Tyler Crowe owns shares of Magellan Midstream Partners and Walt Disney. The Motley Fool owns shares of and recommends Polaris Industries and Walt Disney. The Motley Fool recommends Magellan Midstream Partners. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie is one of the few names in healthcare that offer both a healthy dividend yield (at around 4%) and particularly strong growth prospects in terms of their bottom and top lines going forward. Behind Humira, AbbVie's next most important product is its blood cancer drug, Imbruvica, which was acquired during a $21 billion buyout of Pharmacyclics earlier this year. Between them, AbbVie thinks these two key drugs can help drive double-digit adjusted earnings-per-share growth through 2020 and perhaps beyond. | AbbVie is one of the few names in healthcare that offer both a healthy dividend yield (at around 4%) and particularly strong growth prospects in terms of their bottom and top lines going forward. Behind Humira, AbbVie's next most important product is its blood cancer drug, Imbruvica, which was acquired during a $21 billion buyout of Pharmacyclics earlier this year. Between them, AbbVie thinks these two key drugs can help drive double-digit adjusted earnings-per-share growth through 2020 and perhaps beyond. | AbbVie is one of the few names in healthcare that offer both a healthy dividend yield (at around 4%) and particularly strong growth prospects in terms of their bottom and top lines going forward. Behind Humira, AbbVie's next most important product is its blood cancer drug, Imbruvica, which was acquired during a $21 billion buyout of Pharmacyclics earlier this year. Between them, AbbVie thinks these two key drugs can help drive double-digit adjusted earnings-per-share growth through 2020 and perhaps beyond. | AbbVie is one of the few names in healthcare that offer both a healthy dividend yield (at around 4%) and particularly strong growth prospects in terms of their bottom and top lines going forward. Behind Humira, AbbVie's next most important product is its blood cancer drug, Imbruvica, which was acquired during a $21 billion buyout of Pharmacyclics earlier this year. Between them, AbbVie thinks these two key drugs can help drive double-digit adjusted earnings-per-share growth through 2020 and perhaps beyond. |
26729.0 | 2015-12-23 00:00:00 UTC | 10 Undervalued Dividend Champions For 2016: Be Greedy When Others Are Fearful | ABBV | https://www.nasdaq.com/articles/10-undervalued-dividend-champions-2016-be-greedy-when-others-are-fearful-2015-12-23 | nan | nan | By Chuck Carnevale :
Introduction
Dividend Champions/Aristocrats are the go-to dividend-paying stocks for prudent investors desirous of a safe, predictable and growing stream of income on the common stock portion of their retirement portfolios. As most investors are aware, in order to be classified as a Dividend Champion/Aristocrat, a company must meet the stern test of consecutively increasing their dividend for 25 years or longer. Of all the dividend-paying stocks in the universe, only a select few make these prestigious lists.
However, the popularity of Dividend Champions/Aristocrats often presents a conundrum to value-oriented dividend growth investors. These best-of-breed dividend-paying stalwarts are rare to find at attractive or prudent valuations. Nevertheless, since I am a fervent believer that you make your money on the buy side, high quality and an impeccable dividend record are not enough for me.
Before I am willing to invest in any company, Dividend Champion/Aristocrat or not, the company must be available at a prudent and attractive valuation. Of the more than 50 Dividend Aristocrats, and more than 100 Dividend Champions, I only found 10 that I considered currently attractive based on valuation.
Price Is What You Pay - Value Is What You Get
In December 2010, I started a series of articles where I presented the principles of valuation. Since I believe that principles of valuation are timeless, I offer the following excerpts from that series in order to revisit some of the more important principles, benefits and aspects of investing at fair value.
In part 1 of that three-part series found here , I presented the important principle that distinguishes the difference between price and value:
The venerable investor Warren Buffett has a real knack of putting complex concepts and ideas into simple and easily understood terms. In my opinion, his quote, " Price is what you pay. Value is what you get " is one of the more profound and important statements he has ever uttered. If truly understood, these simple words represent perhaps some of the most important bits of investment wisdom that an investor could ever receive.
The concept of value represents the key to receiving the full benefit that these wise words provide. Knowing the price you pay is simple and straightforward. And, although many have an intuitive understanding of value, its deeper meaning is often only vaguely comprehended. Anyone who has truly made the effort to study Warren Buffett's investment philosophy understands that receiving value on the money he invests is of high importance to him.
So how do you know, when buying a stock, if you're getting value or not for your money? I contend that the answer lies in the amount of cash flow (earnings) that the business you purchase is capable of generating on your behalf. And regardless of how much cash flow the business can generate for you, its value to you will be greatly impacted by the price you pay to obtain it. If you pay too much, you get very little value, but if you pay too little then the value you receive is greatly increased.
Therefore, if value is what you're looking for, then it's important that your attention be placed on the potential cash flows that you're expecting to receive. Unfortunately, few investors possess the presence of mind to focus on this critical element. Instead, investor attention is more commonly and intensely placed on stock price and its movement. A rising stock price is usually considered to be good, and a falling stock price considered bad.
At this point, I would like to focus the reader on an important subtlety about valuation that I alluded to in the above excerpt. Notice that I discussed cash flows, but also made a reference to earnings. As I will illustrate later, earnings are an important valuation metric, because in the long run, earnings drive stock price, which is the source of capital appreciation. However, when investing in dividend paying stocks, cash flows are equally if not more important because they represent a company's ability to cover their dividends. Moreover, there are certain companies where the correlation between cash flow and stock price is more distinct than the correlation between earnings and stock price.
Dividend payout ratios are typically expressed as a percentage of earnings. However, they can also be expressed as a percentage of cash flows. Additionally, the reader should also recognize that a company's cash flow per share will normally be higher than its earnings per share when examining a high-quality company producing consistency with both metrics. Consequently, many best-of-breed dividend-paying stalwarts command a premium valuation based on earnings, but will appear more attractively valued based on cash flows. This important point will be elaborated on later in the article.
Nevertheless, in part 2 of the 3-part series, I wrote in 2010 found here , I discussed the utilization of the P/E ratio as a first step in the valuation process. In the following excerpt, I discussed the relevance of a P/E ratio of 15 as a reasonable first blush valuation level, its limitations, and I also again alluded to the notion that certain companies routinely command premium valuations above that benchmark level.
In part 3 of my series on the principles of valuation found here , I discussed the key, as well as the importance that valuation plays regarding the avoidance of making obvious mistakes.
10 Fairly Valued Dividend Aristocrats/Champions Based On Earnings
As I screened the list of Dividend Champions presented by fellow Seeking Alpha author David Fish and the Dividend Aristocrats compiled and presented by S&P Capital IQ, I was only able to come up with 10 names that I felt were fairly valued based on earnings. Part of this relates to normal premium valuation applied to these names discussed above, and part of this relates to the popularity of these dividend-paying stalwarts. To be clear, many of these premier dividend-paying companies are currently being valued far in excess of even the normal premium valuations they have commanded in the past.
What Are You Investing For?
Every individual investor does not have the same investment goals, needs or investment objectives. Some investors are concerned with beating the market, others are concerned with maximum safety over the highest return, and others are concerned with maximizing their income and the growth thereof. In addition to these objectives, there are numerous variations and combinations that each unique individual investor is concerned with. Consequently, I believe one of the most important questions that every investor - in common stocks especially - should ask and answer for themselves before investing is: what am I investing for?
This question may seem simplistic to some, but I consider it one of the most vitally important questions an investor should ask and answer. The reason I say this is because it speaks to the reality that there are trade-offs in investments. As a general rule, and there are always exceptions to every rule, higher yield often implies lower capital appreciation, and vice versa.
Therefore, if for example, your investment objective is maximum current yield, you must generally be willing to accept a lower rate of capital appreciation in order to achieve that goal. If that's not true, then it might also apply that you taking on significantly more risk than you should be or are comfortable with. Of course, the opposite also applies. If you are looking for maximum capital appreciation or total return, you will typically not find it with the highest yielding securities.
High total return is a function of growth, and growth hungry companies are typically starved for capital to fund that growth. Consequently, they tend to retain more earnings and pay out less to shareholders in the form of dividends. In contrast, a more mature company looking to simply establish or maintain moderate growth, might not have use for all of their capital (cash flow), and therefore, pay out more earnings in order to attract shareholders through higher yield.
With the above in mind, I have presented my 10 fairly valued Dividend Champion/Aristocrats in order of highest yield to lowest. Additionally, future total returns will also be functionally related to the level of valuation that a company can be purchased at. Lower valuations can lead to higher future returns generated by P/E expansion as a result of a reversion to the mean. Consequently, if valuation is low enough, which could also be the source of an above-average current yield, this can result in high or above-average future returns that can be accomplished even through investing in lower growth entities.
The following F.A.S.T. Graphs ™ portfolio review lists my top 10 attractively valued Dividend Champion/Aristocrats based on earnings for 2016. Following the portfolio review, I will present individual earnings and price correlated F.A.S.T. Graphs™ plus performance reports on each company. On the earnings and price correlated graph, focus on price relative to the orange earnings valuation reference line. On the performance reports, note that total cumulative income versus the S&P 500. When appropriate, I have utilized 20 calendar-year graphs. However, on AT&T ( T ) and AbbVie ( ABBV ) specifically, I have utilized shorter time frames as appropriate.
AT&T, Inc.
Emerson Electric Company ( EMR )
AbbVie Inc.
Wal-Mart Stores Inc. ( WMT )
Archer Daniels Midland Company ( ADM )
Target Corp. (TGT)
T. Rowe Price Group, Inc. (TROW)
Aflac Incorporated (AFL)
Pentair Inc. (PNR)
Franklin Resources, Inc. (BEN)
Bonus: 5 Stalwarts Fairly Valued Based On Cash Flows
These 5 bonus companies are quintessential examples of highly rated blue chips that often command a premium valuation based on earnings. However, since these examples are most appealing based on safety and dividend yield, I am offering valuation graphs based on price and cash flow. Of course, HCP (HCP) is a REIT, and therefore, appropriately valued based on funds from operations.
HCP, Inc.
Johnson & Johnson (JNJ)
3M Company (MMM)
PepsiCo, Inc. (PEP)
Procter & Gamble (PG)
Summary and Conclusions
I want to be clear that these are not necessarily my favorite or what I consider best-valued dividend growth stocks. Instead, these are specifically what I consider the best or most fairly and attractively valued Dividend Aristocrats or Dividend Champions. Each of these companies has increased their dividends for 25 consecutive years or longer. Therefore, they all fall into the elite group of dividend growth stocks with long histories and legacies of dividend growth.
Consequently, I offer these 10 Dividend Aristocrats and Champions, and the 5 bonus selections based on cash flow for consideration by those investors most concerned with safety and dividend growth. In other words, these are not necessarily companies that will produce above-average long-term total returns.
On the other hand, I believe each of these companies represent a high level of safety and the opportunity to produce above-average current dividend income and long-term dividend growth. Therefore, these suggestions are offered for those investors desirous of achieving the highest long-term total accumulated amounts of dividend income from safe blue chip dividend-paying stocks.
Disclosure: Long PEP, PG, AFL, T, EMR, ABBV, WMT, TGT, JNJ, HCP
Disclaimer: The opinions in this document are for informational and educational purposes only and should not be construed as a recommendation to buy or sell the stocks mentioned or to solicit transactions or clients. Past performance of the companies discussed may not continue and the companies may not achieve the earnings growth as predicted. The information in this document is believed to be accurate, but under no circumstances should a person act upon the information contained within. We do not recommend that anyone act upon any investment information without first consulting an investment advisor as to the suitability of such investments for his specific situation.
See also EZchip-Mellanox Deal: Most Difficult Phase Is Still Ahead on seekingalpha.com
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Disclosure: Long PEP, PG, AFL, T, EMR, ABBV, WMT, TGT, JNJ, HCP Disclaimer: The opinions in this document are for informational and educational purposes only and should not be construed as a recommendation to buy or sell the stocks mentioned or to solicit transactions or clients. However, on AT&T ( T ) and AbbVie ( ABBV ) specifically, I have utilized shorter time frames as appropriate. AT&T, Inc. Emerson Electric Company ( EMR ) AbbVie Inc. Wal-Mart Stores Inc. ( WMT ) Archer Daniels Midland Company ( ADM ) Target Corp. (TGT) T. Rowe Price Group, Inc. (TROW) Aflac Incorporated (AFL) Pentair Inc. (PNR) Franklin Resources, Inc. (BEN) Bonus: 5 Stalwarts Fairly Valued Based On Cash Flows These 5 bonus companies are quintessential examples of highly rated blue chips that often command a premium valuation based on earnings. | AT&T, Inc. Emerson Electric Company ( EMR ) AbbVie Inc. Wal-Mart Stores Inc. ( WMT ) Archer Daniels Midland Company ( ADM ) Target Corp. (TGT) T. Rowe Price Group, Inc. (TROW) Aflac Incorporated (AFL) Pentair Inc. (PNR) Franklin Resources, Inc. (BEN) Bonus: 5 Stalwarts Fairly Valued Based On Cash Flows These 5 bonus companies are quintessential examples of highly rated blue chips that often command a premium valuation based on earnings. Disclosure: Long PEP, PG, AFL, T, EMR, ABBV, WMT, TGT, JNJ, HCP Disclaimer: The opinions in this document are for informational and educational purposes only and should not be construed as a recommendation to buy or sell the stocks mentioned or to solicit transactions or clients. However, on AT&T ( T ) and AbbVie ( ABBV ) specifically, I have utilized shorter time frames as appropriate. | AT&T, Inc. Emerson Electric Company ( EMR ) AbbVie Inc. Wal-Mart Stores Inc. ( WMT ) Archer Daniels Midland Company ( ADM ) Target Corp. (TGT) T. Rowe Price Group, Inc. (TROW) Aflac Incorporated (AFL) Pentair Inc. (PNR) Franklin Resources, Inc. (BEN) Bonus: 5 Stalwarts Fairly Valued Based On Cash Flows These 5 bonus companies are quintessential examples of highly rated blue chips that often command a premium valuation based on earnings. However, on AT&T ( T ) and AbbVie ( ABBV ) specifically, I have utilized shorter time frames as appropriate. Disclosure: Long PEP, PG, AFL, T, EMR, ABBV, WMT, TGT, JNJ, HCP Disclaimer: The opinions in this document are for informational and educational purposes only and should not be construed as a recommendation to buy or sell the stocks mentioned or to solicit transactions or clients. | However, on AT&T ( T ) and AbbVie ( ABBV ) specifically, I have utilized shorter time frames as appropriate. AT&T, Inc. Emerson Electric Company ( EMR ) AbbVie Inc. Wal-Mart Stores Inc. ( WMT ) Archer Daniels Midland Company ( ADM ) Target Corp. (TGT) T. Rowe Price Group, Inc. (TROW) Aflac Incorporated (AFL) Pentair Inc. (PNR) Franklin Resources, Inc. (BEN) Bonus: 5 Stalwarts Fairly Valued Based On Cash Flows These 5 bonus companies are quintessential examples of highly rated blue chips that often command a premium valuation based on earnings. Disclosure: Long PEP, PG, AFL, T, EMR, ABBV, WMT, TGT, JNJ, HCP Disclaimer: The opinions in this document are for informational and educational purposes only and should not be construed as a recommendation to buy or sell the stocks mentioned or to solicit transactions or clients. |
26730.0 | 2015-12-22 00:00:00 UTC | Halozyme Inks Collaboration Deal with Eli Lilly for Enhanze | ABBV | https://www.nasdaq.com/articles/halozyme-inks-collaboration-deal-with-eli-lilly-for-enhanze-2015-12-22 | nan | nan | Halozyme Therapeutics, Inc.HALO announced that it has entered into a global collaboration and license agreement with Eli Lilly and Company LLY for the development and commercialization of therapies that will combine the latter's compounds with Halozyme's Enhanze platform.
Terms of the Deal
Per the terms of the agreement, Eli Lilly will pay Halozyme an initial payment of $25 million. Halozyme is also entitled to milestone payments of up to $160 million for each of up to five collaboration targets, valued at a maximum of $800 million, depending on the achievement of milestones. Additionally, Lilly will pay mid single-digit royalties to Halozyme if products under the collaboration are commercialized.
We note that Halozyme's proprietary drug delivery platform, Enhanze, is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). This enzyme temporarily degrades hyaluronan, a chain of natural sugars in the body, which in turn enables dispersion and absorption of injected therapeutic drugs. Hence, the collaboration will allow faster delivery of Eli Lilly's injectable drugs through subcutaneous delivery.
Halozyme gained a strong partner in Eli Lilly given the latter's impressive position in the healthcare sector. We note that Halozyme had inked a similar agreement with AbbVie ABBV in Jun 2015 for the development and commercialization of therapies by combining its Enhanze technology platform with AbbVie's proprietary compounds.
In the past, Halozyme has collaborated with several other large pharma companies for its Enhanze technology. These collaborations fetch revenues for the company in the form of milestone payments, license fees, reimbursements and royalties.
Halozyme carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Baxalta, Inc. BXLT , which currently sports a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We note that Halozyme had inked a similar agreement with AbbVie ABBV in Jun 2015 for the development and commercialization of therapies by combining its Enhanze technology platform with AbbVie's proprietary compounds. Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report HALOZYME THERA (HALO): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We note that Halozyme's proprietary drug delivery platform, Enhanze, is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). | We note that Halozyme had inked a similar agreement with AbbVie ABBV in Jun 2015 for the development and commercialization of therapies by combining its Enhanze technology platform with AbbVie's proprietary compounds. Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report HALOZYME THERA (HALO): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Halozyme Therapeutics, Inc.HALO announced that it has entered into a global collaboration and license agreement with Eli Lilly and Company LLY for the development and commercialization of therapies that will combine the latter's compounds with Halozyme's Enhanze platform. | Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report HALOZYME THERA (HALO): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We note that Halozyme had inked a similar agreement with AbbVie ABBV in Jun 2015 for the development and commercialization of therapies by combining its Enhanze technology platform with AbbVie's proprietary compounds. Halozyme Therapeutics, Inc.HALO announced that it has entered into a global collaboration and license agreement with Eli Lilly and Company LLY for the development and commercialization of therapies that will combine the latter's compounds with Halozyme's Enhanze platform. | We note that Halozyme had inked a similar agreement with AbbVie ABBV in Jun 2015 for the development and commercialization of therapies by combining its Enhanze technology platform with AbbVie's proprietary compounds. Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report HALOZYME THERA (HALO): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Halozyme Therapeutics, Inc.HALO announced that it has entered into a global collaboration and license agreement with Eli Lilly and Company LLY for the development and commercialization of therapies that will combine the latter's compounds with Halozyme's Enhanze platform. |
26731.0 | 2015-12-22 00:00:00 UTC | Is Merck & Co. About to Derail Gilead Sciences? | ABBV | https://www.nasdaq.com/articles/merck-co-about-derail-gilead-sciences-2015-12-22 | nan | nan | Image source: Merck & Co.
The FDA is expected to make a decision on whether to approve Merck & Co. two-drug, once-daily therapy for hepatitis C in January, and if the agency gives Merck & Co. the green light, then it could significantly impact Gilead Sciences ' market share in the most common variation of this disease.
Joining the fight
By delivering 90% plus functional cure rates, eliminating the reliance on side effect-laden prior treatments and reducing treatment duration to as little as eight weeks, Gilead Sciences' Harvoni and Sovaldi have reinvented hepatitis C treatment. As a result, Gilead Sciences' hepatitis C sales are running at an annualized pace of nearly $20 billion.
But Gilead Sciences' two drugs aren't the only recently approved medicines that are putting up big sales numbers. AbbVie 's Viekira Pak, a genotype 1 therapy with a more onerous dosing regimen than Gilead Sciences' drugs, posted sales of $469 million in Q3 and Bristol-Myers Squibb 's hepatitis C franchise delivered sales of $402 million last quarter, primarily thanks to sales in overseas markets, including Japan.
Stealing away market share
Although it's premature to guess what Merck & Co. would price its therapy, payers have made it clear that they're more than willing to offer up exclusivity on their drug formularies in exchange for big-time discounts.
Last January, Express Scripts , the nation's largest drug benefit manager, cut such a deal with AbbVie for the then recently approved Viekira Pak. That exclusivity deal is a big reason why sales of Viekira Pak, an arguably second-tier treatment choice, have been as strong as they've been this year.
If Merck & Co. decides to compete on price, then it could reduce Viekira Pak to a bit role in the indication, while also relegating Bristol-Myers Squibb's drugs even further into niche status. More importantly, a low price for Merck & Co.'s therapy could pose the most significant challenge to Gilead Sciences market share in the U.S. yet.
Image source: AbbVie.
Although Viekira Pak is effective, it relies on the co-administration of ribavirin, a previous generation drug that most doctors are shying away from. Additionally, Viekira Pak is a multi-drug, multi-tablet formula that requires multiple daily doses. That makes patient adherence tough. Add those drawbacks to recently reported safety concerns and it's not hard to see why Viekira Pak is a bit of an also-ran in the race against Harvoni in genotype 1 treatment.
Merck & Co.'s therapy, however, is better than Viekira Pak.
In trials, the once-daily, single-tablet medicine delivered 95% cure rates, including in co-infected HIV patients. Rates in previously treated patients who failed to respond to other therapies were also an impressive 94%. The drug's cure rate was as high as 100% in genotype 4 patients and better than 80% in genotype 6 patients. Grazoprevir/elbasvir also appears to be safe given that adverse events occurred about as frequently in the treatment arm as the placebo arm and few patients discontinued treatment because of them.
Looking ahead
The FDA is considering approval of Merck & Co.'s therapy for genotypes 1, 4, and 6, and there's no guarantee that the FDA will approve the drug, but the trial results appear to support a green light. If so, then Merck & Co's success in hepatitis C will depend on its ability to outcompete Gilead Sciences. Unfortunately for Merck & Co. investors, it's not clear to me that they'll be able to do that.
Gilead Sciences' Harvoni has an edge as the first-to-market alternative and an even bigger advantage as the only treatment approved for use for as little as eight weeks. About 45% of genotype 1 patients qualify for Harvoni's shorter, eight-week treatment duration and those patients aren't likely to embrace Merck & Co.'s 12-week regimen willingly.
Gilead Sciences may also be able to sidestep Merck & Co.'s threat if it can win FDA approval for its next-generation hepatitis C drug that combines Sovaldi with velpatasvir, an improved NS5A inhibitor.
In October, Gilead Sciences filed for FDA approval of this therapy for use in all six genotypes of the disease after it put up an impressive average 98% cure rate in trials, and if it's approved next June, when the FDA is slated to make its decision, then it could remove the need for genotype testing. Because only one patient dropped out of this drug's trials, its safety is arguably as good, if not better than, Merck & Co.'s and for that reason, it could be the biggest reason why a Merck & Co. approval may not be as damaging next year to Gilead Sciences as it may seem.
The next billion-dollar iSecret
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The article Is Merck & Co. About to Derail Gilead Sciences? originally appeared on Fool.com.
Todd Campbell owns shares of Gilead Sciences. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Express Scripts and Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie 's Viekira Pak, a genotype 1 therapy with a more onerous dosing regimen than Gilead Sciences' drugs, posted sales of $469 million in Q3 and Bristol-Myers Squibb 's hepatitis C franchise delivered sales of $402 million last quarter, primarily thanks to sales in overseas markets, including Japan. Last January, Express Scripts , the nation's largest drug benefit manager, cut such a deal with AbbVie for the then recently approved Viekira Pak. Image source: AbbVie. | AbbVie 's Viekira Pak, a genotype 1 therapy with a more onerous dosing regimen than Gilead Sciences' drugs, posted sales of $469 million in Q3 and Bristol-Myers Squibb 's hepatitis C franchise delivered sales of $402 million last quarter, primarily thanks to sales in overseas markets, including Japan. Last January, Express Scripts , the nation's largest drug benefit manager, cut such a deal with AbbVie for the then recently approved Viekira Pak. Image source: AbbVie. | AbbVie 's Viekira Pak, a genotype 1 therapy with a more onerous dosing regimen than Gilead Sciences' drugs, posted sales of $469 million in Q3 and Bristol-Myers Squibb 's hepatitis C franchise delivered sales of $402 million last quarter, primarily thanks to sales in overseas markets, including Japan. Last January, Express Scripts , the nation's largest drug benefit manager, cut such a deal with AbbVie for the then recently approved Viekira Pak. Image source: AbbVie. | AbbVie 's Viekira Pak, a genotype 1 therapy with a more onerous dosing regimen than Gilead Sciences' drugs, posted sales of $469 million in Q3 and Bristol-Myers Squibb 's hepatitis C franchise delivered sales of $402 million last quarter, primarily thanks to sales in overseas markets, including Japan. Last January, Express Scripts , the nation's largest drug benefit manager, cut such a deal with AbbVie for the then recently approved Viekira Pak. Image source: AbbVie. |
26732.0 | 2015-12-22 00:00:00 UTC | Baxalta/Momenta's Humira Biosimilar Meets Trial Objective | ABBV | https://www.nasdaq.com/articles/baxalta-momentas-humira-biosimilar-meets-trial-objective-2015-12-22 | nan | nan | Baxalta Inc.BXLT and Momenta Pharmaceuticals, Inc . MNTA announced that their biosimilar candidate M923 has met the primary endpoint in a pharmacokinetic study.
Baxalta initiated the trial in Feb 2015. The primary objective of the randomized (n=324), double-blind, three-arm, parallel group, single-dose study was to evaluate the pharmacokinetics of M923 in comparison to AbbVie's ABBV blockbuster drug, Humira (adalimumab). The study also evaluated the safety, tolerability and immunogenicity of single doses of M923 given by injection. The safety profile and immunogenicity were found comparable to the reference product.
We note that the companies have collaborated to develop and commercialize M923. Humira is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis among others. The two companies expect this trial to support an approval of their biosimilar in both the U.S. and the EU.
Meanwhile, Baxalta initiated a randomized, double-blind, active-control, multi-center, global trial on M923 in Oct 2015 on patients suffering from chronic plaque psoriasis. The trial will compare the safety, efficacy and immunogenicity of M923 with Humira in chronic plaque psoriasis. Baxalta plans to submit the first regulatory application for marketing approval for M923 in 2017 and targets a commercial launch in 2018, assuming a potential approval.
Baxalta is also developing a biosimilar version of Amgen's AMGN Enbrel for the treatment of rheumatoid arthritis and psoriasis. The candidate is currently in phase III.
A potential approval would be a big boost for both the companies as Humira generated sales of $10.3 billion in the first nine months of 2015. However, competition is stiff in the biosimilar space.
We remind investors that last month, Amgen announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of Humira. The application is Amgen's first BLA submitted under the 351(k) biosimilar pathway.
While Baxalta sports a Zacks Rank #1 (Strong Buy), Momenta is a Zacks Rank #3 (Hold) stock.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The primary objective of the randomized (n=324), double-blind, three-arm, parallel group, single-dose study was to evaluate the pharmacokinetics of M923 in comparison to AbbVie's ABBV blockbuster drug, Humira (adalimumab). Click to get this free report MOMENTA PHARMA (MNTA): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, Baxalta initiated a randomized, double-blind, active-control, multi-center, global trial on M923 in Oct 2015 on patients suffering from chronic plaque psoriasis. | Click to get this free report MOMENTA PHARMA (MNTA): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. The primary objective of the randomized (n=324), double-blind, three-arm, parallel group, single-dose study was to evaluate the pharmacokinetics of M923 in comparison to AbbVie's ABBV blockbuster drug, Humira (adalimumab). Baxalta is also developing a biosimilar version of Amgen's AMGN Enbrel for the treatment of rheumatoid arthritis and psoriasis. | Click to get this free report MOMENTA PHARMA (MNTA): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. The primary objective of the randomized (n=324), double-blind, three-arm, parallel group, single-dose study was to evaluate the pharmacokinetics of M923 in comparison to AbbVie's ABBV blockbuster drug, Humira (adalimumab). Baxalta is also developing a biosimilar version of Amgen's AMGN Enbrel for the treatment of rheumatoid arthritis and psoriasis. | The primary objective of the randomized (n=324), double-blind, three-arm, parallel group, single-dose study was to evaluate the pharmacokinetics of M923 in comparison to AbbVie's ABBV blockbuster drug, Humira (adalimumab). Click to get this free report MOMENTA PHARMA (MNTA): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Baxalta initiated the trial in Feb 2015. |
26733.0 | 2015-12-21 00:00:00 UTC | iShares S&P 100 ETF Experiences Big Inflow | ABBV | https://www.nasdaq.com/articles/ishares-sp-100-etf-experiences-big-inflow-2015-12-21 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares S&P 100 ETF (Symbol: OEF) where we have detected an approximate $99.1 million dollar inflow -- that's a 2.2% increase week over week in outstanding units (from 49,750,000 to 50,850,000). Among the largest underlying components of OEF, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.5%, Celgene Corp. (Symbol: CELG) is up about 0.7%, and Starbucks Corp. (Symbol: SBUX) is up by about 0.9%. For a complete list of holdings, visit the OEF Holdings page » The chart below shows the one year price performance of OEF, versus its 200 day moving average:
Looking at the chart above, OEF's low point in its 52 week range is $71.52 per share, with $94.97 as the 52 week high point - that compares with a last trade of $90.71. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs had notable inflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of OEF, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.5%, Celgene Corp. (Symbol: CELG) is up about 0.7%, and Starbucks Corp. (Symbol: SBUX) is up by about 0.9%. For a complete list of holdings, visit the OEF Holdings page » The chart below shows the one year price performance of OEF, versus its 200 day moving average: Looking at the chart above, OEF's low point in its 52 week range is $71.52 per share, with $94.97 as the 52 week high point - that compares with a last trade of $90.71. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. | Among the largest underlying components of OEF, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.5%, Celgene Corp. (Symbol: CELG) is up about 0.7%, and Starbucks Corp. (Symbol: SBUX) is up by about 0.9%. For a complete list of holdings, visit the OEF Holdings page » The chart below shows the one year price performance of OEF, versus its 200 day moving average: Looking at the chart above, OEF's low point in its 52 week range is $71.52 per share, with $94.97 as the 52 week high point - that compares with a last trade of $90.71. Click here to find out which 9 other ETFs had notable inflows » The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of OEF, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.5%, Celgene Corp. (Symbol: CELG) is up about 0.7%, and Starbucks Corp. (Symbol: SBUX) is up by about 0.9%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares S&P 100 ETF (Symbol: OEF) where we have detected an approximate $99.1 million dollar inflow -- that's a 2.2% increase week over week in outstanding units (from 49,750,000 to 50,850,000). For a complete list of holdings, visit the OEF Holdings page » The chart below shows the one year price performance of OEF, versus its 200 day moving average: Looking at the chart above, OEF's low point in its 52 week range is $71.52 per share, with $94.97 as the 52 week high point - that compares with a last trade of $90.71. | Among the largest underlying components of OEF, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.5%, Celgene Corp. (Symbol: CELG) is up about 0.7%, and Starbucks Corp. (Symbol: SBUX) is up by about 0.9%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares S&P 100 ETF (Symbol: OEF) where we have detected an approximate $99.1 million dollar inflow -- that's a 2.2% increase week over week in outstanding units (from 49,750,000 to 50,850,000). For a complete list of holdings, visit the OEF Holdings page » The chart below shows the one year price performance of OEF, versus its 200 day moving average: Looking at the chart above, OEF's low point in its 52 week range is $71.52 per share, with $94.97 as the 52 week high point - that compares with a last trade of $90.71. |
26734.0 | 2015-12-21 00:00:00 UTC | Did AbbVie Blow $21 Billion Buying Pharmacyclics? | ABBV | https://www.nasdaq.com/articles/did-abbvie-blow-21-billion-buying-pharmacyclics-2015-12-21 | nan | nan | Image source: AbbVie.
Facing the loss of patent protection on its top-selling drug, AbbVie forked over $21 billion earlier this year to buy Pharmacyclics and its blood cancer drug Imbruvica. Imbruvica's sales are surging, but late-stage trials are under way for a next-generation therapy that targets cancer in the same way as Imbruvica that may be better.
Image source: AbbVie.
Revolutionizing treatment
Imbruvica, a BTK inhibitor that targets a signaling molecule that is responsible for B-cell cancer cell survival and that was co-developed by Johnson & Johnson , is reshaping how doctors treat mantle cell lymphoma, Waldenstrom's macroglobinemia, and chronic lymphocytic leukemia (CLL).
Mantle cell lymphoma and Waldenstrom's aren't common, but there are 15,720 cases of CLL diagnosed in the U.S. every year and that makes that indication most interesting to investors.
Historically, CLL patients have been treated with chemotherapy and/or Rituxan therapy, but chemotherapy is highly toxic and it can cause life-threatening side effects that make it far from an ideal treatment. Fortunately, following robust efficacy in trials studying Imbruvica's use in recurring CLL, doctors have increasingly been turning to its use and away from these other agents.
That shift in treatment may accelerate too as Imbruvica recently aced a late stage study evaluating its use in newly diagnosed CLL patients. In that trial, Imbruvica monotherapy reduced a patient's risk of death by 84% when compared to the chemotherapy chlorambucil.
Based on those results, AbbVie and Johnson & Johnson filed an application for approval in newly diagnosed CLL patients in September and if the FDA approves Imbruvica in that indication, then industry watchers estimate the widespread use of Imbruvica could turn this drug into a multibillion-per-year megablockbuster.
Emerging competitor
In order to deliver on industry watcher's lofty sales projections, Imbruvica may have to fend off competition from acalabrutinib, a drug that works similarly to Imbruvica and that is being developed by the privately held Acerta.
Like Imbruvica, acalabrutinib targets BTK to disrupt disease progression, but acalabrutinib could have a distinct advantage over Imbruvica because it more specifically targets BTK.
Despite Imbruvica's efficacy, the drug has been shown to impact non-BTK targets, such as EGFR, and it's thought that Imbruvica's off-target activity is why some patients suffer adverse events, including atrial fibrillation, that leads them to discontinue therapy. Off-target activity may also lead to cancer mutation, such as Richter's transformation, that results in the cancer's progression. Because acalabrutinib more precisely targets BTK, it may not suffer those drawbacks. Additionally, acalabrutinib has a shorter half life than Imbruvica, which may allow for twice-daily dosing that could reduce a patient developing resistance to it. That could prove to be another important advantage versus Imbruvica.
Recently, Acerta reported clinical-stage data for acalabrutinib in 60 CLL patients that appears to support the idea that this drug works better than Imbruvica.
Specifically, 95% of relapsed CLL patients who have received at least one prior therapy responded to acalabrutinib, including 100% of hard-to-treat patients who have the 17p13.1 deletion variation of the cancer. Moreover, there were no cases of Richter's transformation in the trial, and only one patient saw their disease progress in the 16-month evaluation period.
Additionally, acalabrutinib's safety profile appears to be best-in-class. Most adverse events were grade 1 or 2 and resolved over time. Only 2% of patients suffered grade 3 or grade 4 diarrhea, which is about half the percentage that has been observed in Imbruvica's trials. Also, no cases of atrial fibrillation or hemorrhage, another Imbruvica safety risk, were reported.
Source: AstraZeneca plc
Looking ahead
Given Acerta's trial results, it's not surprising that AstraZeneca plc is spending $4 billion to buy a 55% stake in the company. That deal, which was announced last week, includes $2.5 billion upfront to Acerta, plus another $1.5 billion conditional payment that will be paid upon regulatory approval of acalabrutinib or by the end of 2018, whichever comes first.
has confirmed it's in talks to acquire it in a deal that could be valued at $5 billion or more.
However, before AbbVie investors panic too much, they should remember that Acerta's trials are ongoing, and that its trial only included a small number of people, so it's far from certain that acalabrutinib's results will hold up in larger, later-stage trials.
Nevertheless, strong efficacy and a potentially better safety profile could make this a big threat to AbbVie and Johnson & Johnson's Imbruvica, and that means investors should keep tabs on Acerta's ongoing trials, including a phase 3 trial in which acalabrutinib is being studied head to head against Imbruvica in 17p deletion CLL patients. That trial has an estimated primary completion date of June 2018, so it may be a while before investors find out how acalabrutinib really stacks up to Imbruvica in these patients.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article Did AbbVie Blow $21 Billion Buying Pharmacyclics? originally appeared on Fool.com.
Todd Campbell owns shares of Celgene. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Celgene. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days .We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Image source: AbbVie. Facing the loss of patent protection on its top-selling drug, AbbVie forked over $21 billion earlier this year to buy Pharmacyclics and its blood cancer drug Imbruvica. Based on those results, AbbVie and Johnson & Johnson filed an application for approval in newly diagnosed CLL patients in September and if the FDA approves Imbruvica in that indication, then industry watchers estimate the widespread use of Imbruvica could turn this drug into a multibillion-per-year megablockbuster. | Image source: AbbVie. Nevertheless, strong efficacy and a potentially better safety profile could make this a big threat to AbbVie and Johnson & Johnson's Imbruvica, and that means investors should keep tabs on Acerta's ongoing trials, including a phase 3 trial in which acalabrutinib is being studied head to head against Imbruvica in 17p deletion CLL patients. Facing the loss of patent protection on its top-selling drug, AbbVie forked over $21 billion earlier this year to buy Pharmacyclics and its blood cancer drug Imbruvica. | Image source: AbbVie. Based on those results, AbbVie and Johnson & Johnson filed an application for approval in newly diagnosed CLL patients in September and if the FDA approves Imbruvica in that indication, then industry watchers estimate the widespread use of Imbruvica could turn this drug into a multibillion-per-year megablockbuster. Nevertheless, strong efficacy and a potentially better safety profile could make this a big threat to AbbVie and Johnson & Johnson's Imbruvica, and that means investors should keep tabs on Acerta's ongoing trials, including a phase 3 trial in which acalabrutinib is being studied head to head against Imbruvica in 17p deletion CLL patients. | Image source: AbbVie. Nevertheless, strong efficacy and a potentially better safety profile could make this a big threat to AbbVie and Johnson & Johnson's Imbruvica, and that means investors should keep tabs on Acerta's ongoing trials, including a phase 3 trial in which acalabrutinib is being studied head to head against Imbruvica in 17p deletion CLL patients. The article Did AbbVie Blow $21 Billion Buying Pharmacyclics? |
26735.0 | 2015-12-20 00:00:00 UTC | 5 Can't-Miss Drug Approvals of 2015 | ABBV | https://www.nasdaq.com/articles/5-cant-miss-drug-approvals-2015-2015-12-20 | nan | nan | Image source: Flickr user stockmonkeys.com.
The Food and Drug Administration has approved 40 new medicines in 2015, but not all of them will be investor-worthy. To find those that might deserve investor attention, I scoured the list for drugs that I think are game-changing in their indication and that could also be top sellers for drug developers. Read on to see which newly approved medications I think have the best shot at moving the needle in 2016 and beyond.
No. 1: Praluent and Repatha
Sanofi and Regeneron Praluent and Amgen 's Repatha are PCSK9 inhibitors that boost the liver's ability to clear bad cholesterol from the bloodstream by limiting PCSK9's ability to break down bad cholesterol receptors.
Because these drugs work in an entirely new way to reduce cholesterol levels, they could revolutionize how doctors try to prevent heart disease.
Currently, the most common approach is to prescribe statins, which lower cholesterol production in the liver. Tens of millions of patients are treated with statins every year, but many people still fail to hit their cholesterol targets. Because of that, doctors may turn to prescribing Praluent and Repatha alongside statins to address stubborn high cholesterol. In trials, adding these drugs to statin therapy lowered bad cholesterol by about 60%.
For now, Praluent and Repatha are only approved for use in patients with specific genetic predispositions to high cholesterol levels or patients who have already suffered a major cardiac event, but studies are underway that could prove that these drugs lower the risk of heart disease, and if they do, then their use could expand to include millions of additional patients.
Since the addressable patient population is big and these drugs clock in with annual prices of roughly $14,000, they could add billions of dollars tor Sanofi, Regeneron, and Amgen's top line in the coming years.
Image source: AstraZeneca plc.
No. 2: Tagrisso
When AstraZeneca plc secured approval for its novel lung cancer drug Tagrisso, it was thought that Clovis Oncology would soon challenge it for market share in EGFR patients with the T790 mutation.
However, Clovis Oncology's recent revelation that efficacy for its drug rociletinib may be lower than previously thought could mean that Tagrisso will dominate the indication.
If so, then the market opportunity for Tagrisso could exceed $1 billion per year because 10%-15% of non-small cell lung cancer patients are EGFR positive and the majority of EGFR positive patients who see their disease return have the T790 mutation that makes them resistant to other therapies.
Since 59% of patients responded to Tagrisso therapy in phase 2 trials and the five-year survival rate for lung cancer is a disappointing 22%, Tagrisso could offer hope to thousands of patients and, in the process, become a top seller for AstraZeneca.
No. 3: Empliciti
Multiple myeloma treatments like the corticosteroid dexamethasone and Celgene Corp. 's Revlimid have boosted five year survival rates for patients to 46.6%. That's a solid improvement over the 26.6% rate in 1975, but there's still a big need for new therapies such as Bristol-Myers Squibb and AbbVie 's Empliciti.
Empliciti is approved for use alongside Revlimid and dexamethasone and patients receiving the three drug combination in trials had progression free survival of 19.4 months versus 14.9 months for Revlimid and dexamethasone alone.
Because of its efficacy and the fact that roughly 27,000 new cases of multiple myeloma are diagnosed in the U.S. every year, Empliciti could be a blockbuster because Celgene's Revlimid, which costs $14,000 per month, is on pace to bring in at least $5.6 billion this year and Empliciti, which costs $10,000 per month, is approved for use alongside it.
Investors should remember, however, that any U.S. profits from Empliciti will be split between these two companies, with Bristol-Myers Squibb getting 70% and AbbVie getting 30%.
No. 4: Entresto
The FDA surprised industry watchers by approving Novartis Entresto six weeks ahead of schedule and that early approval is a good indication of just how important this drug could be for patients suffering from chronic heart failure.
Entresto is the next generation of Novartis' Diovan, a hypertension drug that has lost patent protection, but that had peak sales of about $6 billion per year.
In trials, Entresto reduced the risk of cardiovascular death by 20% versus the commonly used ACE inhibitor enalapril, and the company thinks that efficacy will lead to Entresto eventually hauling in $5 billion in peak annual sales.
That's a pretty aggressive target, but considering that the addressable patient population could be as high as 5 million people in the U.S. alone and Entresto's priced at about $4,500 per year, it would only require about 20% of patients being prescribed Entresto to hit Novartis' goal.
Of course, Novartis needs to overcome payer roadblocks that are reducing script volume, including national drug code (NDC) blocks, which can lower volume in the first six to 12 months of a drug launch, for that to happen.
No. 5: Zarxio
Novartis' Sandoz unit has been selling generic alternatives to blockbuster biologics in Europe for years, but it's only recently gotten a FDA go-ahead to begin selling them in America.
The FDA approved Novartis' Zarxio, a biosimilar to Amgen 's billion-dollar white-blood cell boosting drug, Neupogen, earlier this year and while this drug isn't expected to capture much more than 30% market share early on, the importance of Zarxio's approval to the industry can't be overstated.
Biologics, which are made in living organisms, are impossible to copy identically and in the past, that has kept generic versions of them on the sidelines. However, healthcare reform established a pathway for drugs that work similarly, but aren't an exact match, to reach the market and this year's approval of Zarxio paves the way for future approvals of other biologics.
When you consider that biologics with annual sales of $67 billion will lose patent protection over the next five years, you begin to understand just how important this approval really is to the industry.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article 5 Can't-Miss Drug Approvals of 2015 originally appeared on Fool.com.
Todd Campbell owns shares of Celgene. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Celgene. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | That's a solid improvement over the 26.6% rate in 1975, but there's still a big need for new therapies such as Bristol-Myers Squibb and AbbVie 's Empliciti. Investors should remember, however, that any U.S. profits from Empliciti will be split between these two companies, with Bristol-Myers Squibb getting 70% and AbbVie getting 30%. Since the addressable patient population is big and these drugs clock in with annual prices of roughly $14,000, they could add billions of dollars tor Sanofi, Regeneron, and Amgen's top line in the coming years. | That's a solid improvement over the 26.6% rate in 1975, but there's still a big need for new therapies such as Bristol-Myers Squibb and AbbVie 's Empliciti. Investors should remember, however, that any U.S. profits from Empliciti will be split between these two companies, with Bristol-Myers Squibb getting 70% and AbbVie getting 30%. 1: Praluent and Repatha Sanofi and Regeneron Praluent and Amgen 's Repatha are PCSK9 inhibitors that boost the liver's ability to clear bad cholesterol from the bloodstream by limiting PCSK9's ability to break down bad cholesterol receptors. | That's a solid improvement over the 26.6% rate in 1975, but there's still a big need for new therapies such as Bristol-Myers Squibb and AbbVie 's Empliciti. Investors should remember, however, that any U.S. profits from Empliciti will be split between these two companies, with Bristol-Myers Squibb getting 70% and AbbVie getting 30%. For now, Praluent and Repatha are only approved for use in patients with specific genetic predispositions to high cholesterol levels or patients who have already suffered a major cardiac event, but studies are underway that could prove that these drugs lower the risk of heart disease, and if they do, then their use could expand to include millions of additional patients. | That's a solid improvement over the 26.6% rate in 1975, but there's still a big need for new therapies such as Bristol-Myers Squibb and AbbVie 's Empliciti. Investors should remember, however, that any U.S. profits from Empliciti will be split between these two companies, with Bristol-Myers Squibb getting 70% and AbbVie getting 30%. Since 59% of patients responded to Tagrisso therapy in phase 2 trials and the five-year survival rate for lung cancer is a disappointing 22%, Tagrisso could offer hope to thousands of patients and, in the process, become a top seller for AstraZeneca. |
26736.0 | 2015-12-18 00:00:00 UTC | Gilead (GILD) Collaborates with Galapagos for Filgotinib | ABBV | https://www.nasdaq.com/articles/gilead-gild-collaborates-with-galapagos-for-filgotinib-2015-12-18 | nan | nan | Gilead Sciences, Inc.GILD announced that it has entered into a worldwide agreement with Galapagos NV GLPG for the development and commercialization of the JAK1-selective inhibitor, filgotinib, for inflammatory disease indications including rheumatoid arthritis (RA).
The companies plan to initiate phase III studies evaluating the candidate for RA and Crohn's disease in 2016.
Terms of the Agreement
Under the terms of the agreement, Gilead will make an upfront payment of $725 million, comprising license fees of $300 million and equity investment of $425 million (by subscribing for shares at a price of €58 per share, which represents a premium of 20% as compared to the average share price over the last month). After the issuance of shares, Gilead will own approximately 15% of the outstanding share capital of Galapagos.
Galapagos will fund 20% of global development activities and has the option to co-promote filgotinib in the UK, Germany, France, Italy, Spain, Belgium, the Netherlands and Luxembourg. Gilead will undertake the responsibility for manufacturing, and worldwide marketing and sales activities. Gilead will also make milestone payments up to $1.35 billion and tiered royalties starting at 20%, except co-promotion territories where profits will be shared equally.
The transaction is a huge win for Galapagos, which had received a setback in September when AbbVie ABBV decided not to exercise its right to in-license filgotinib from Galapagos and terminated its agreement with the company for the development of filgotinib.
Meanwhile, Gilead has a history of boosting its portfolio and pipeline by entering into licensing and acquisition agreements. In fact, the blockbuster hepatitis C virus (HCV) infection therapy, Sovaldi, was added to Gilead's portfolio through the Pharmasset acquisition in 2012. In May 2015, Gilead acquired privately held Danish company, EpiTherapeutics ApS, for $65 million, thereby gaining access to the latter's library of first-in-class, selective small molecule inhibitors of epigenetic regulation of gene transcription, in particular, histone demethylases. Earlier this year, the company acquired privately held biotechnology company, Phenex, to develop treatments for liver diseases, including nonalcoholic steatohepatitis. Thus, we hope to see more of such acquisitions by Gilead in the near term.
Gilead carries a Zacks Rank #2 (Buy). Achillion Pharmaceuticals, Inc. ACHN is another well-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The transaction is a huge win for Galapagos, which had received a setback in September when AbbVie ABBV decided not to exercise its right to in-license filgotinib from Galapagos and terminated its agreement with the company for the development of filgotinib. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ACHILLION PHARM (ACHN): Free Stock Analysis Report GALAPAGOS -ADR (GLPG): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that it has entered into a worldwide agreement with Galapagos NV GLPG for the development and commercialization of the JAK1-selective inhibitor, filgotinib, for inflammatory disease indications including rheumatoid arthritis (RA). | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ACHILLION PHARM (ACHN): Free Stock Analysis Report GALAPAGOS -ADR (GLPG): Free Stock Analysis Report To read this article on Zacks.com click here. The transaction is a huge win for Galapagos, which had received a setback in September when AbbVie ABBV decided not to exercise its right to in-license filgotinib from Galapagos and terminated its agreement with the company for the development of filgotinib. Terms of the Agreement Under the terms of the agreement, Gilead will make an upfront payment of $725 million, comprising license fees of $300 million and equity investment of $425 million (by subscribing for shares at a price of €58 per share, which represents a premium of 20% as compared to the average share price over the last month). | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ACHILLION PHARM (ACHN): Free Stock Analysis Report GALAPAGOS -ADR (GLPG): Free Stock Analysis Report To read this article on Zacks.com click here. The transaction is a huge win for Galapagos, which had received a setback in September when AbbVie ABBV decided not to exercise its right to in-license filgotinib from Galapagos and terminated its agreement with the company for the development of filgotinib. Gilead Sciences, Inc.GILD announced that it has entered into a worldwide agreement with Galapagos NV GLPG for the development and commercialization of the JAK1-selective inhibitor, filgotinib, for inflammatory disease indications including rheumatoid arthritis (RA). | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ACHILLION PHARM (ACHN): Free Stock Analysis Report GALAPAGOS -ADR (GLPG): Free Stock Analysis Report To read this article on Zacks.com click here. The transaction is a huge win for Galapagos, which had received a setback in September when AbbVie ABBV decided not to exercise its right to in-license filgotinib from Galapagos and terminated its agreement with the company for the development of filgotinib. Gilead Sciences, Inc.GILD announced that it has entered into a worldwide agreement with Galapagos NV GLPG for the development and commercialization of the JAK1-selective inhibitor, filgotinib, for inflammatory disease indications including rheumatoid arthritis (RA). |
26737.0 | 2015-12-17 00:00:00 UTC | The 6 Best Dividend Stocks to Buy in 2016 | ABBV | https://www.nasdaq.com/articles/6-best-dividend-stocks-buy-2016-2015-12-17 | nan | nan | By Dan Burrows, InvestorPlace Feature Writer
When price gains are hard to come by, it’s absolutely critical to have some of the best dividend stocks among your holdings. Indeed, the market is currently down more than 2%, but the dividend yield on the S&P 500 essentially offsets that loss to produce a breakeven total return.
The point is that you can’t count on price appreciation alone to drive upside. That’s especially true when market strategists expect 2016 to look much like what we’ve seen this year.
However, if you own some of the market’s best dividend stocks, at least you’re assured of getting at least something for your money.
True, plenty of dividend stocks are sitting on negative total returns because price losses more than erased the benefit of dividends, but that also means yields are more attractive. That means the best dividend stocks will disproportionately juice returns if (well … when) the market turns up.
And if a stock has a history of regular dividend hikes, so much the better. Stick around long enough, and regular raises will lead dividend winners to develop eye-popping yields on an original cost basis.
PLUS: The 7 Best ETFs to Buy for 2016
With low oil prices, a strong dollar and higher interest rates poised to weigh on the broader market next year, it’s time to look for the best dividend stocks to buy for 2016.
Here are six names that investors can trust to carry positive total returns next year:
AbbVie Inc (ABBV)
ABBV Dividend Yield: 4.1%
In addition to a dividend yield of more than 4%, AbbVie Inc (ABBV) looks ready to bounce back after a rough 2015.
AbbVie is off more than 15% for the year-to-date, largely because investors fear ABBV overpaid when it acquired Pharmacyclics earlier this year for $21 billion.
That’s short-sighted.
AbbVie is overly dependent on its Humira blockbuster drug treating arthritis, psoriasis and other ailments. The addition of Pharmacyclics solves that problem. At its peak, the company’s Imbruvica cancer drug should generate annual revenue of $7 billion after ABBV splits the take with Johnson & Johnson (JNJ).
Analysts at Jeffries named ABBV as their top pick globally thanks in part to the company’s strong pipeline and earnings per share growth. Indeed, Wall Street anticipates EPS rising 17% next year, which makes it among the best dividend stocks to buy if you want the potential for capital appreciation as well.
AT&T Inc. (T)
T Dividend Yield: 5.6%
In good times and bad, AT&T Inc. (T) is a dividend champion. No other mega-cap stock can rival the combination of a whopping yield and dependability.
AT&T has hiked its dividend for 31 consecutive years — with a 32nd hike likely later this month — and the telecommunications giant could also be a difference maker if the market puts up another year of lackluster returns.
Few stocks are as good at playing defense when the broader market is struggling. AT&T is essentially half as volatile as the S&P 500, and greater volatility is one thing most forecasters expect in 2016.
Lastly, AT&T generated a positive total return this year and should build on it next year.
After all, value stocks typically outperform growth stocks in a rising rate environment.
Ford Motor Company (F)
F Dividend Yield: 4.4%
Anyone holding Ford Motor Company (F) stock had a frustrating 2015. The car company had impressive results as the new-vehicle market continued to boom, but F stock was down 13% by mid-December.
Happily, the sour sentiment should lift in 2016 as the company picks up market share and delivers enviable growth in EPS.
Ford is enjoying record results in North America, but a bigger catalyst could come from overseas. The European segment is starting to get frisky and looks poised to swing profitability. That should allay some concerns about the potential impact of rate hikes on domestic sales.
Wall Street expects Ford to generate EPS growth of 18% next year, yet shares go for just 7 times forward earnings. That has Ford stock looking like one of the best dividend stocks to buy now if you’re interested in sheer value, too.
General Motors Company (GM)
GM Dividend Yield: 4.2%
Ford isn’t the only generous dividend stock among vehicle manufacturers. General Motors Company (GM) boasts a yield of more than 4% and has price upside to boot.
Everyone knows that the U.S. vehicle market is cruising along, but GM is also seeing strength overseas. The economic slowdown in China had been bad news for virtually all multinationals, but not General Motors. Heck, it’s tallying record sales and solid profits in the Middle Kingdom.
It also helps greatly that GM’s costs for faulty ignition switches are in the rear-view mirror. That removes headline risk and sets the company up for easy comparisons.
With next year’s EPS forecast to rise 13% on a price-to-earnings ratio of well less than 7, you can bet value investors will kick the tires on GM too.
The Coca-Cola Co (KO)
KO Dividend Yield: 3.1%
The upcoming year promises to offer an inflection point for The Coca-Cola Co (KO) after several years of slack growth.
Analysts figure that margins will improve this year because of flagging price pressure, but the big boost to profitability will come from deep cost cuts.
Indeed, KO is heading to the first anniversary of massive restructuring intended to squeeze $3 billion out of its cost base. The company intends to plow the saving into marketing in a bid to slow the decline is sales of fizzy drinks.
The beverage maker expects sales to go back to a mid-single-digit range after falling as low as 3% over the last few years.
The market’s outlook is brightening, too. Shares are up 10% over the past three months.
McDonald’s Corporation (MCD)
MCD Dividend Yield: 3.1%
McDonald’s Corporation (MCD) had a fantastic 2015, and yet the dividend yield still offers more than 3% for new money. Besides, even after rising nearly 25% YTD, MCD is just getting started.
MCD struggled for three long years, squeezed by competition from so-called fast casual chains like Chipotle Mexican Grill (CMG), Panera Bread (PNRA) and Shake Shack (SHAK).
And then MCD came up with a recipe for a turnaround. Among the welcome changes, the hamburger chain curbed the use of antibiotics in its chicken, relaunched the Egg McMuffin using butter rather than margarine, and added a buttermilk crispy-chicken sandwich to the menu.
Add in the benefit of all-day breakfast, and you can bet on MCD delivering accelerating top line growth next year, and putting it among 2016’s best dividend stocks to buy.
As of this writing, Dan Burrows did not hold a position in any of the aforementioned securities.
This article was originally published on InvestorPlace Media.
Plus:
7 Best Cheap Stocks to Buy for 2016
3 Dow Jones Stocks to Take to the Grave
2 Oil Stocks That Suddenly Look GREAT – EPD & PXD
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Here are six names that investors can trust to carry positive total returns next year: AbbVie Inc (ABBV) ABBV Dividend Yield: 4.1% In addition to a dividend yield of more than 4%, AbbVie Inc (ABBV) looks ready to bounce back after a rough 2015. AbbVie is off more than 15% for the year-to-date, largely because investors fear ABBV overpaid when it acquired Pharmacyclics earlier this year for $21 billion. AbbVie is overly dependent on its Humira blockbuster drug treating arthritis, psoriasis and other ailments. | Here are six names that investors can trust to carry positive total returns next year: AbbVie Inc (ABBV) ABBV Dividend Yield: 4.1% In addition to a dividend yield of more than 4%, AbbVie Inc (ABBV) looks ready to bounce back after a rough 2015. AbbVie is off more than 15% for the year-to-date, largely because investors fear ABBV overpaid when it acquired Pharmacyclics earlier this year for $21 billion. AbbVie is overly dependent on its Humira blockbuster drug treating arthritis, psoriasis and other ailments. | Here are six names that investors can trust to carry positive total returns next year: AbbVie Inc (ABBV) ABBV Dividend Yield: 4.1% In addition to a dividend yield of more than 4%, AbbVie Inc (ABBV) looks ready to bounce back after a rough 2015. AbbVie is off more than 15% for the year-to-date, largely because investors fear ABBV overpaid when it acquired Pharmacyclics earlier this year for $21 billion. AbbVie is overly dependent on its Humira blockbuster drug treating arthritis, psoriasis and other ailments. | Here are six names that investors can trust to carry positive total returns next year: AbbVie Inc (ABBV) ABBV Dividend Yield: 4.1% In addition to a dividend yield of more than 4%, AbbVie Inc (ABBV) looks ready to bounce back after a rough 2015. AbbVie is off more than 15% for the year-to-date, largely because investors fear ABBV overpaid when it acquired Pharmacyclics earlier this year for $21 billion. AbbVie is overly dependent on its Humira blockbuster drug treating arthritis, psoriasis and other ailments. |
26738.0 | 2015-12-17 00:00:00 UTC | 3 Value Stocks Near 52-Week Lows Worth Buying | ABBV | https://www.nasdaq.com/articles/3-value-stocks-near-52-week-lows-worth-buying-2015-12-17 | nan | nan | Image source: Pixabay.
While many companies' shares are rising past their fair values now, others are trading at potentially bargain prices. The difficulty with bargain shopping, though, is that you may be understandably hesitant to buy stocks wallowing at 52-week lows. In an effort to separate the rebound candidates from the laggards, it makes sense to start by determining whether the market has overreacted to a company's bad news.
Here's a look at three fallen angels trading near their 52-week lows that could be worth buying.
A rare value stock
Ireland-based rare disease drug giant Shire has had quite the topsy-turvy past two years. Last year, Illinois-based AbbVie agreed to purchase it for a whopping $55 billion, but wound up walking away from the deal following changes to U.S. laws governing tax inversions. The breakup fee from AbbVie netted Shire a handsome $1.6 billion windfall profit.
More recently, Shire has taken heat for some of its high-priced drugs, which in some instances cost upwards of $300,000 per year. Some members of Congress have been attempting to move that body to act on what they view as overpricing of drugs, and it's always possible that prescription drug reforms and monthly consumer spending caps could crush drug developers' profits.
Image source: Centers for Disease Control and Prevention.
However, I see things differently and would suggest value investors dig into the Shire story a bit deeper. They'll find a company with solid pricing power that could potentially bring a dozen or so new rare disease therapies to market by 2020. Keep in mind, this is all dependent on the success of its pipeline products in clinical trials. On an EPS basis alone, Shire is forecast to grow from the $10.60 reported in 2014 to north of $17 by 2018, with revenue growth of roughly 45% over that same time span.
There's also the potential that Shire could be acquired, or could go back on the offensive itself. In August, Shire bid $30 billion for Baxalta , a rare disease drugmaker focused on hematology and immunology indications. Baxalta rejected the initial offer, suggesting that it undervalued the company, but Shire is expected to make another run at Baxalta with a higher offer that's inclusive of a cash component this time around. Bloomberg estimates that the combined company could put as many as 30 new drugs on pharmacy shelves over a five-year period.
Exciting things are happening at Shire, and I believe this a value stock you'll want to consider owning.
Gas up your portfolio
The energy sector has been a major source of frustration for investors over the past year, but being selective may have its perks. Specifically, I'd point to midstream provider ONEOK which is responsible for natural gas pipelines, storage, processing and transportation, as well as natural gas liquids storage and distribution.
As you might have guessed by now, weaker natural gas prices are crushing the shares of any company that has even the faintest ties to the sector, including ONEOK. Exposure to weakening NGL pricing isn't helping either. ONEOK's NGL segment is where it generates the majority of its operating income, so investors are concerned about the distributor.
Image source: ONEOK.
But a lot of these concerns might be overblown. Despite NGL pricing weakness, volume growth of NGLs gathered and fractionated increased during the third quarter compared to the previous year, with NGLs transported on gathering lines rising by roughly 49%.
Furthermore, ONEOK's natural gas pipeline and storage business isn't really worrisome, even with natural gas prices falling. Pipelines are more dependent on demand for natural gas than on natural gas prices, and natural gas producers haven't done much of anything to reduce production. With the expectation that, as a cleaner burning fuel, natural gas will see its demand grow over time, it's a fairly safe bet that pipeline and storage infrastructure plays like ONEOK will benefit. Considering that many of ONEOK's contracts are locked in for multiple years, there's not much concern for the overall health of its natural gas segment.
By as early as 2017, Wall Street projects that ONEOK could generate earnings per share of more than $2, which, based on its current price, would work out to a very forward P/E of 10. The company is also expected to generate between $4 per share and $6 per share in annual cash flow, which should be more than enough to cover its quarterly $0.615 per share dividend. While dividend growth in the near-term may not be a priority, its 11% yield looks like an ample reward for investors in the interim.
Drive to be successful
Lastly, if you want a value stock near a 52-week low that you should consider pressing the pedal to the metal on, look no further than Dana Holding , a manufacturing of driveline, sealing and thermal-management technologies for the passenger, commercial, and off-highway equipment markets.
Dana's Spicer LMS Aluminum Wheel Hub System. Image source: Dana Holding.
What's wrong recently? Dana whiffed on Wall Street's EPS projections in two straight quarters, and its results are being hammered by negative foreign currency translation and the divestiture of its operations in Venezuela, which prevents an true apples-to-apples comparison of its performance to previous years. Additionally, supply restraint issues in North America and weaker South American truck production hurt its business in the third quarter.
Now for the good news. First, currency issues and divestments can be removed from the equation. These aren't items that are reflective of Dana's ongoing operations. If we do so, we see a company that grew year-over-year sales by 6%, or $69 million, in the third quarter. Also, the company says it has dealt with its supply constraints from the third quarter already, which should lead to it growing its North American market share in subsequent quarters. The passenger vehicle market in the U.S. has been pacing in excess of 18 million units for the past three months, implying there's still room for growth for auto component suppliers like Dana.
The company has also done a good job of returning money to shareholders. Its dividend of 1.7% may not be much to look at, but the company has also repurchased roughly 63 million shares of stock for a total of $1.33 billion.
Looking ahead, Wall Street isn't expecting a lot of growth from Dana in the near-term. However, it's trading at less than eight times its forward profit projections, and could easily generate in excess of $3 per share in cash flow next year. This reward-versus-risk profile would appear to suggest more upside than downside potential, and those are odds that value investors typically appreciate.
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The article 3 Value Stocks Near 52-Week Lows Worth Buying originally appeared on Fool.com.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen nameTMFUltraLong, track every pick he makes under the screen nameTrackUltraLong, and check him out on Twitter, where he goes by the handle@TMFUltraLong.The Motley Fool owns shares of and recommends Oneok. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Last year, Illinois-based AbbVie agreed to purchase it for a whopping $55 billion, but wound up walking away from the deal following changes to U.S. laws governing tax inversions. The breakup fee from AbbVie netted Shire a handsome $1.6 billion windfall profit. With the expectation that, as a cleaner burning fuel, natural gas will see its demand grow over time, it's a fairly safe bet that pipeline and storage infrastructure plays like ONEOK will benefit. | Last year, Illinois-based AbbVie agreed to purchase it for a whopping $55 billion, but wound up walking away from the deal following changes to U.S. laws governing tax inversions. The breakup fee from AbbVie netted Shire a handsome $1.6 billion windfall profit. Furthermore, ONEOK's natural gas pipeline and storage business isn't really worrisome, even with natural gas prices falling. | Last year, Illinois-based AbbVie agreed to purchase it for a whopping $55 billion, but wound up walking away from the deal following changes to U.S. laws governing tax inversions. The breakup fee from AbbVie netted Shire a handsome $1.6 billion windfall profit. Furthermore, ONEOK's natural gas pipeline and storage business isn't really worrisome, even with natural gas prices falling. | Last year, Illinois-based AbbVie agreed to purchase it for a whopping $55 billion, but wound up walking away from the deal following changes to U.S. laws governing tax inversions. The breakup fee from AbbVie netted Shire a handsome $1.6 billion windfall profit. While many companies' shares are rising past their fair values now, others are trading at potentially bargain prices. |
26739.0 | 2015-12-16 00:00:00 UTC | Is There Any Value Left in Healthcare? This Top Investing Firm Seems to Think Not | ABBV | https://www.nasdaq.com/articles/there-any-value-left-healthcare-top-investing-firm-seems-think-not-2015-12-16 | nan | nan | This extreme level of volatility among healthcare stocks has been due in part to the changing ownership profile across the sector. Many major investing firms, for instance, have decided to reduce their exposure to biopharmaceutical companies since the middle of the year as a result of the emerging political debate over branded-drug prices within the United States.
Perhaps most telling is that more conservative, value-based money-management firms have shied away from the sector almost entirely of late. According to the recently filed 13Fs, for example, Quantum Capital Management, a value-based firm designed for high-net-worth individuals and businesses, owned only a single healthcare-related stock in the third quarter of 2015, namely Computer Programs & Systems .
Even more intriguing is that Computer Programs & Systems isn't really a healthcare company per se . Instead, the company's primary business focuses on the logistics of clinical and financial management forrural and community hospitals in the United States, showing that it's essentially a technology company working in the healthcare-services industry.
Quantum's interest in this small-cap stock therefore probably lies in the 2010 Affordable Care Act's stated goal of lowering healthcare costs whenever possible. So we're not exactly talking about a speculative biopharma working on a potential cure for HIV or cancer.
Why is Wall Street losing its appetite for biopharma?
There are probably two good reasons for this more risk-averse attitude that's starting to take hold on Wall Street right now. First, there is the serious concern that the U.S. presidential election next year could lead to sweeping reforms regarding how manufacturers price their new medicines.
After all, Express Scripts , a top opinion leader among pharmacy benefits mangers, has repeatedly called for innovative pricing schemes to hem in the cost of newer medicines, and the company's efforts have started to make inroads toward this goal. Express Scripts, for example, was able to dramatically lower the cost of next-generation hepatitis C drugs by pitting AbbVie 's Viekira Pak against Gilead Science ' Sovaldi.
Source: AbbVie.
Although Express Scripts got the ball rolling on this front, Democratic front-runners Hillary Clinton and Bernie Sanders have both seemed eager to carry the ball across the finish line, so to speak. The days of heady 90% gross margins among drug manufacturers therefore might be coming to an end.
The second less-talked-about problem is that many drug companies have put the health of their balance sheets at risk to pursue a growth-by-acquisition strategy.
As it stands now, the average debt-to-equity ratio among drug manufacturers sits at 64.8%, according to S&P Capital IQ. This worrisome level of debt becomes even more concerning when singling out the top dogs in the pharma industry.
AbbVie, for instance, sports a 660% debt-to-equity ratio, and Gilead isn't doing much better at 123%. Worse still, AbbVie and Gilead have both indicated that they would be open to further M&A activity in the near term if the right opportunity presents itself, implying that they may leverage up further still in the quest to keep their top lines pushing higher.
All told, the danger that the industry could see its average gross margin take a major hit soon, combined with sky-high amounts of leverage across the pharma landscape, is probably scaring off some money managers such as Quantum Capital Management.
Should average investors move to the sidelines?
If you're a heavy biotech or healthcare investor like me, you may want to mull over these issues carefully in the coming months. I've started to rotate out of individual stocks and into less risky, broader industry-focused funds such as IBB and XBI because of these headwinds. Keeping with this risk-off strategy, I'm also thinking of hedging my remaining long positions in healthcare using options.
Overall, I think the time of unabashed bullishness for biotech and healthcare stocks is in its twilight, and caution is advised moving forward.
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The article Is There Any Value Left in Healthcare? This Top Investing Firm Seems to Think Not originally appeared on Fool.com.
George Budwell owns shares of iShares NASDAQ Biotechnology Index (ETF). The Motley Fool owns shares of and recommends Express Scripts and Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Express Scripts, for example, was able to dramatically lower the cost of next-generation hepatitis C drugs by pitting AbbVie 's Viekira Pak against Gilead Science ' Sovaldi. Source: AbbVie. AbbVie, for instance, sports a 660% debt-to-equity ratio, and Gilead isn't doing much better at 123%. | Express Scripts, for example, was able to dramatically lower the cost of next-generation hepatitis C drugs by pitting AbbVie 's Viekira Pak against Gilead Science ' Sovaldi. Source: AbbVie. AbbVie, for instance, sports a 660% debt-to-equity ratio, and Gilead isn't doing much better at 123%. | Express Scripts, for example, was able to dramatically lower the cost of next-generation hepatitis C drugs by pitting AbbVie 's Viekira Pak against Gilead Science ' Sovaldi. Source: AbbVie. AbbVie, for instance, sports a 660% debt-to-equity ratio, and Gilead isn't doing much better at 123%. | Express Scripts, for example, was able to dramatically lower the cost of next-generation hepatitis C drugs by pitting AbbVie 's Viekira Pak against Gilead Science ' Sovaldi. Source: AbbVie. AbbVie, for instance, sports a 660% debt-to-equity ratio, and Gilead isn't doing much better at 123%. |
26740.0 | 2015-12-14 00:00:00 UTC | Can AbbVie's New Cancer Drugs Offset Humira Losses? | ABBV | https://www.nasdaq.com/articles/can-abbvies-new-cancer-drugs-offset-humira-losses-2015-12-14 | nan | nan | Image source: Johnson & Johnson.
Since splitting from Abbott Laboratories to begin 2013, AbbVie has provided its investors with solid returns well in excess of the benchmark S&P 500 . However, past performance is little consolation going forward. AbbVie's most important drug, Humira, is responsible for more than 61% of the company's total revenue -- and it's about to get crushed by biosimilar competition. Humira may be the world's best-selling drug for now, but investors would love to see the company become less dependent on its most successful asset before it's too late.
A big part of AbbVie's strategy for reducing dependence on its flagship anti-inflammatory drug is building a world-class oncology portfolio. Its stable of cancer therapies took a giant step forward this spring, when the company purchased Pharmacyclics along with its rising-star therapy, Imbruvica, for $20.8 billion in cash and equity.
Since completing the acquisition of Pharmacyclics in May, the company has just one full quarter of sales info for Imbruvica, which is partnered with Johnson & Johnson . What a quarter it was. With $304 million in net revenue, it is now the company's third biggest seller behind Viekira Pak, with $469 million in quarterly sales, and Humira, with $3.65 billion.
At a recent scientific conference, AbbVie laid out reasons to believe Imbruvica and experimental therapy venetoclax could eventually command a leading share of the $24 billion market for beta-cell malignancies. Let's look at the latest data to see if the company's invigorated oncology pipeline can offset impending Humira losses.
Expanding Imbruvica
By AbbVie's calculations, Imbruvica could deliver $7 billion to the company's top line at its peak. The drug is already approved as a second line of attack for chronic lymphocytic leukemia patients who have progressed after their first therapy.
Sales of therapies for this relatively common form of leukemia reached $1.7 billion last year, and being first in line for newly diagnosed patients would help Imbruvica command a larger share. To support an application for an expansion to first-line CLL, the company has compared it with chlorambucil -- a standard chemotherapy used in the first-line setting -- in newly diagnosed patients over 65 who hadn't been treated with anything yet.
Image source: AbbVie
Imbruvica wiped the floor with chlorambucil. It reduced the risk of disease progression or death by at least 84% compared with the old standard of care. In fact, it may have reduced that risk even further, but a median hadn't been reached at the time of the presentation.
Further cementing Imbruvica pills' advantage over the old standard, adverse events leading to discontinuations were 155% more frequent in the chlorambucil arm.
An application to expand Imbruvica's label has already been submitted to the FDA. If approved, use of Imbruvica in the first-line setting could provide a sales boost in the first half of next year.
Something different
Venetoclax, which is being developed in partnership with Roche , is a promising inhibitor of B-cell lymphoma-2, a protein that prevents beta-cells from dying off when they're supposed to. Surprisingly, it is the only drug that acts on this pathway in serious developmental stages.
Don't let the lack of interest in this target put you off. It is surprisingly effective in a genetic subset of CLL patients known to have poor prognoses, those with a 17p deletion. The biomarker is present in just 3% to 10% of initial CLL diagnoses, but the subset represents 30% to 50% of advanced CLL patients.
It seems venetoclax could be a new option for this large but difficult-to-treat population. In a phase 2 study with 107 patients who had failed a median of two prior therapies, a surprising 85 showed a response. At 12 months, the disease of 72% of patients' on venetoclax hadn't progressed, and more than 20% of responders lacked leukemic cells in their bloodstream.
Maybe too good
These exciting results from the phase 2 venetoclax trial are supporting a new drug application currently in the hands of FDA regulators. If anything can derail this exciting new therapy, it could be its tendency to be a little too effective.
Tumor lysis syndrome is a common issue in a variety of cancers. It occurs when too many cells -- hopefully those of a recently destroyed tumor -- burst, releasing their contents into the bloodstream. Although no clinical tumor lysis syndrome events occurred, laboratory tumor lysis syndrome (the less serious of the two) was reported in five of the patients.
Although it looks like Imbruvica and venetoclax have a great deal of potential in CLL, fully dominating this $1.7 billion market won't be enough to offset potential losses to Humira competition in the years ahead. Luckily, Imbruvica is a part of 13 phase 3 studies in a wide range of indications, and venetoclax isn't far behind.
Last year, the industry recorded combined lymphoma and multiple myeloma therapy sales of about $13.2 billion. During the next several quarters, investors will want to look for data that supports further expansion into this territory. Given how well AbbVie's new cancer therapies are performing in leukemia, I expect the good news to keep rolling in.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Can AbbVie's New Cancer Drugs Offset Humira Losses? originally appeared on Fool.com.
Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | A big part of AbbVie's strategy for reducing dependence on its flagship anti-inflammatory drug is building a world-class oncology portfolio. At a recent scientific conference, AbbVie laid out reasons to believe Imbruvica and experimental therapy venetoclax could eventually command a leading share of the $24 billion market for beta-cell malignancies. Since splitting from Abbott Laboratories to begin 2013, AbbVie has provided its investors with solid returns well in excess of the benchmark S&P 500 . | The article Can AbbVie's New Cancer Drugs Offset Humira Losses? Since splitting from Abbott Laboratories to begin 2013, AbbVie has provided its investors with solid returns well in excess of the benchmark S&P 500 . AbbVie's most important drug, Humira, is responsible for more than 61% of the company's total revenue -- and it's about to get crushed by biosimilar competition. | Since splitting from Abbott Laboratories to begin 2013, AbbVie has provided its investors with solid returns well in excess of the benchmark S&P 500 . AbbVie's most important drug, Humira, is responsible for more than 61% of the company's total revenue -- and it's about to get crushed by biosimilar competition. A big part of AbbVie's strategy for reducing dependence on its flagship anti-inflammatory drug is building a world-class oncology portfolio. | Since splitting from Abbott Laboratories to begin 2013, AbbVie has provided its investors with solid returns well in excess of the benchmark S&P 500 . AbbVie's most important drug, Humira, is responsible for more than 61% of the company's total revenue -- and it's about to get crushed by biosimilar competition. A big part of AbbVie's strategy for reducing dependence on its flagship anti-inflammatory drug is building a world-class oncology portfolio. |
26741.0 | 2015-12-13 00:00:00 UTC | Top FDA Drug Approvals in 2015: Multiple Myeloma | ABBV | https://www.nasdaq.com/articles/top-fda-drug-approvals-2015-multiple-myeloma-2015-12-13 | nan | nan | Developed by Bristol-Myers Squibb and AbbVie Empliciti is the new kid on the cancer treatment block. It works in conjunction with existing drug therapies to more effectively treat multiple myeloma.
In this video segment, The Motley Fool's Kristine Harjes and Todd Campbell walk through some of the results of the clinical trials, and process how Empliciti could take on an integral role in standard drug therapy for multiple myeloma in the near future.
A full transcript follows the video.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
This podcast was recorded on Dec. 2, 2015.
Kristine Harjes: So our last drug that we wanted to talk about today is called Empliciti, and it is developed by Bristol-Myers and AbbVie, and that was just approved a few days ago -- Nov. 30.
Todd Campbell: Yeah, you know, Empliciti is important because, again, if you look at indication: Is there a need? There is. Empliciti treats multiple myeloma, and it's been approved for use alongside two very commonly used therapies for multiple myeloma -- Dexamethasone and Revlimid. And because it's being approved as an adjunct therapy, and it is being approved as adjunct therapy to these widely used drugs, there's a very good chance in my view that it becomes part of the standard of care in the second, and definitely in the third-line treatment for patients.
And since we're talking about 28,000 or so, I think, patients, or 26,000 patients that get diagnosed with multiple myeloma every year, a lot of whom who won't respond, will have to get retreated. I think that this, again, is going to be a very important drug because it put up very solid efficacy during trials.
Harjes: Yeah, this is a really devastating disease. About 11,000 people die from it every year. And so to get drugs that work better and better is a fantastic thing. And it's a huge market too. I mean the multiple myeloma market is expected to rise in value from $8.9 billion in 2014 to just over $22 billion by 2023.
Revlimid is a huge part of that. That's a Celgene drug. Sales should top about $5.6 billion this year, and you're going to see Revlimid continue to be used, especially because Empliciti is being used alongside it. Just to dig into a couple of the numbers from the trials: 78.5% of patients taking the Empliciti combination therapy, meaning alongside Dexa and Revlimid, saw complete or partial tumor shrinkage which was better than the 65.5% reported in just the Dexa and Revlimid arm. So clearly this is a statistically significant improvement.
Campbell: Yeah, and you've got almost a 5-month advantage in progression-free survival as well by adding that third drug to this cocktail. Revlimid is the most widely used in second-line therapy. It won approvals for first-line therapy early this year. It's getting more widely used there. Theoretically, there could be label-expansion opportunities that would move this combination into the first-line therapy. There could be use of it off-label in the first line. We don't know how that's going to shake out.
But as you mentioned, it's a huge marketplace. I mean, you've got Revlimid at $5.6 billion in sales. You've got Velcade, which is also another widely used drug in the first and second line of treating this disease. That's a $3 billion a year drug. You've got Pomalyst, which is a third-line drug also made by Celgene. That's selling at a billion-dollar pace a year. It's really hard for me to look at the numbers for progression-free survival and tumor shrinkage and not think that doctors are going to want to use this standard-of-care. And then of course, it just comes down to what we talked about before, which is, will payers pay for it?
Harjes: Indeed. Yeah, I mean this is not a cheap drug. It's going to be $10,000 a month as compared to Revlimid's $14,000 and Velcade's $9,000. And it's a "me too." You're using it alongside the current therapies, so it's just making things even more expensive.
Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S., it looks like Bristol is going to pay AbbVie a royalty. So this is definitely more of a needle-mover for Bristol than for AbbVie.
The article Top FDA Drug Approvals in 2015: Multiple Myeloma originally appeared on Fool.com.
Kristine Harjes has no position in any stocks mentioned. Todd Campbell owns shares of Celgene. The Motley Fool owns shares of and recommends Celgene. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Kristine Harjes: So our last drug that we wanted to talk about today is called Empliciti, and it is developed by Bristol-Myers and AbbVie, and that was just approved a few days ago -- Nov. 30. Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Developed by Bristol-Myers Squibb and AbbVie Empliciti is the new kid on the cancer treatment block. | Developed by Bristol-Myers Squibb and AbbVie Empliciti is the new kid on the cancer treatment block. Kristine Harjes: So our last drug that we wanted to talk about today is called Empliciti, and it is developed by Bristol-Myers and AbbVie, and that was just approved a few days ago -- Nov. 30. Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. | Developed by Bristol-Myers Squibb and AbbVie Empliciti is the new kid on the cancer treatment block. Kristine Harjes: So our last drug that we wanted to talk about today is called Empliciti, and it is developed by Bristol-Myers and AbbVie, and that was just approved a few days ago -- Nov. 30. Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. | Kristine Harjes: So our last drug that we wanted to talk about today is called Empliciti, and it is developed by Bristol-Myers and AbbVie, and that was just approved a few days ago -- Nov. 30. Developed by Bristol-Myers Squibb and AbbVie Empliciti is the new kid on the cancer treatment block. Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. |
26742.0 | 2015-12-11 00:00:00 UTC | Pre-Market Most Active for Dec 11, 2015 : TVIX, BBL, XIV, QQQ, DOW, ABBV, SUNE, DD, AAPL, BAC, EBAY, CTXS | ABBV | https://www.nasdaq.com/articles/pre-market-most-active-dec-11-2015-tvix-bbl-xiv-qqq-dow-abbv-sune-dd-aapl-bac-ebay-ctxs | nan | nan | The NASDAQ 100 Pre-Market Indicator is down -21.56 to 4,621.49. The total Pre-Market volume is currently 7,421,698 shares traded.
The following are the most active stocks for the pre-market session :
Daily 2X VIX ST ETN Velocityshares ( TVIX ) is +0.64 at $7.37, with 950,826 shares traded. This represents a 38.79% increase from its 52 Week Low.
BHP Billiton plc ( BBL ) is -0.79 at $21.68, with 877,181 shares traded. BBL's current last sale is 67.56% of the target price of $32.09.
Daily Inverse VIX ST ETN Velocityshares ( XIV ) is -1.32 at $25.80, with 831,502 shares traded. This represents a 21.07% increase from its 52 Week Low.
PowerShares QQQ Trust, Series 1 ( QQQ ) is -0.94 at $112.46, with 545,788 shares traded. This represents a 32.71% increase from its 52 Week Low.
Dow Chemical Company (The) ( DOW ) is -1.93 at $52.98, with 542,553 shares traded. DOW's current last sale is 98.11% of the target price of $54.
AbbVie Inc. ( ABBV ) is unchanged at $55.78, with 517,451 shares traded. As reported by Zacks, the current mean recommendation for ABBV is in the "buy range".
SunEdison, Inc. ( SUNE ) is +0.28 at $4.37, with 492,624 shares traded. SUNE's current last sale is 39.73% of the target price of $11.
E.I. du Pont de Nemours and Company ( DD ) is -4.3 at $70.25, with 425,694 shares traded. DD's current last sale is 108.08% of the target price of $65.
Apple Inc. ( AAPL ) is -0.94 at $115.23, with 369,034 shares traded. As reported by Zacks, the current mean recommendation for AAPL is in the "buy range".
Bank of America Corporation ( BAC ) is -0.14 at $17.06, with 357,506 shares traded. As reported by Zacks, the current mean recommendation for BAC is in the "buy range".
eBay Inc. ( EBAY ) is unchanged at $28.57, with 236,060 shares traded. EBAY's current last sale is 98.52% of the target price of $29.
Citrix Systems, Inc. ( CTXS ) is unchanged at $76.84, with 178,200 shares traded. Over the last four weeks they have had 4 up revisions for the earnings forecast, for the fiscal quarter ending Jun 2016. The consensus EPS forecast is $0.91. CTXS's current last sale is 90.4% of the target price of $85.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) is unchanged at $55.78, with 517,451 shares traded. As reported by Zacks, the current mean recommendation for ABBV is in the "buy range". The following are the most active stocks for the pre-market session : Daily 2X VIX ST ETN Velocityshares ( TVIX ) is +0.64 at $7.37, with 950,826 shares traded. | AbbVie Inc. ( ABBV ) is unchanged at $55.78, with 517,451 shares traded. As reported by Zacks, the current mean recommendation for ABBV is in the "buy range". The following are the most active stocks for the pre-market session : Daily 2X VIX ST ETN Velocityshares ( TVIX ) is +0.64 at $7.37, with 950,826 shares traded. | AbbVie Inc. ( ABBV ) is unchanged at $55.78, with 517,451 shares traded. As reported by Zacks, the current mean recommendation for ABBV is in the "buy range". This represents a 38.79% increase from its 52 Week Low. | AbbVie Inc. ( ABBV ) is unchanged at $55.78, with 517,451 shares traded. As reported by Zacks, the current mean recommendation for ABBV is in the "buy range". The NASDAQ 100 Pre-Market Indicator is down -21.56 to 4,621.49. |
26743.0 | 2015-12-10 00:00:00 UTC | What's in Store for VeriFone Systems (PAY) in Q4 Earnings? | ABBV | https://www.nasdaq.com/articles/whats-in-store-for-verifone-systems-pay-in-q4-earnings-2015-12-10 | nan | nan | VeriFone Systems, Inc.PAY is set to report fourth quarter and fiscal 2015 results on Dec 14, after the market closes. Last quarter, the company posted a negative earnings surprise of 2.56%. However, it has delivered positive surprises in three of the trailing four quarters, translating to an average positive surprise of 10.33%.
Let's see how things are shaping up for this announcement.
Factors to Consider
VeriFone seems well-positioned to gain from the ongoing demand shift toward EMV and NFC capable terminals. Furthermore, the company is benefiting from the presence of tech giants like Apple AAPL , Alphabet's GOOGL Google and Samsung in the mobile payments industry.
Additionally, the company is also focused on increasing its operational efficiency by taking a number of cost-cutting and streamlining measures. This has increased margins over the past few quarters.
The third quarter had been an important one for the company as it initiated its buyback program and also announced plans to acquire two new companies- InterCard AG, a leading Payment as a Service provider and Curb, specializing in the car-for-hire electronic hailing (e-hail), payment and media business.
Nonetheless, VeriFone faces significant competition from a number of local providers in the domestic, international as well as emerging markets such as China and India. At the same time, we believe VeriFone's highly leveraged balance sheet can limit its developmental activities.
VeriFone expects non-GAAP earnings per share in the fourth quarter to be in the range of 47-48 cents. Management had narrowed the fiscal 2015 earnings per share guidance, but at the same time mitigated a lot of investor concern by dismissing the anticipated "cliff" for EMV revenues in North America. Instead, it projects revenues to grow 3% in 2016 and expects the momentum to continue on account of sizeable greenfield opportunities.
Earnings Whispers?
Our proven model does not conclusively show that VeriFone will beat earnings estimates this quarter. This is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1, 2 or 3 for this to happen. That is not the case here as you will see below.
Zacks ESP: VeriFone has an Earnings ESP of 0.00%. This is because both the Most Accurate Estimate and the Zacks Consensus Estimate are pegged at 40 cents.
Zacks Rank: VeriFone's Zacks Rank #3 (Hold) when combined with a 0.00% ESP makes surprise prediction difficult.
We caution against stocks with a Zacks Rank #4 and 5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revisions momentum.
Stock to Consider
Here is another stock which you may want to consider as our model shows that it has the right combination of elements to post an earnings beat in its upcoming release:
The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Stock to Consider Here is another stock which you may want to consider as our model shows that it has the right combination of elements to post an earnings beat in its upcoming release: The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Click to get this free report VERIFONE SYSTMS (PAY): Free Stock Analysis Report APPLE INC (AAPL): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ALPHABET INC-A (GOOGL): Free Stock Analysis Report To read this article on Zacks.com click here. VeriFone Systems, Inc.PAY is set to report fourth quarter and fiscal 2015 results on Dec 14, after the market closes. | Click to get this free report VERIFONE SYSTMS (PAY): Free Stock Analysis Report APPLE INC (AAPL): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ALPHABET INC-A (GOOGL): Free Stock Analysis Report To read this article on Zacks.com click here. Stock to Consider Here is another stock which you may want to consider as our model shows that it has the right combination of elements to post an earnings beat in its upcoming release: The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Furthermore, the company is benefiting from the presence of tech giants like Apple AAPL , Alphabet's GOOGL Google and Samsung in the mobile payments industry. | Stock to Consider Here is another stock which you may want to consider as our model shows that it has the right combination of elements to post an earnings beat in its upcoming release: The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Click to get this free report VERIFONE SYSTMS (PAY): Free Stock Analysis Report APPLE INC (AAPL): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ALPHABET INC-A (GOOGL): Free Stock Analysis Report To read this article on Zacks.com click here. We caution against stocks with a Zacks Rank #4 and 5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revisions momentum. | Stock to Consider Here is another stock which you may want to consider as our model shows that it has the right combination of elements to post an earnings beat in its upcoming release: The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Click to get this free report VERIFONE SYSTMS (PAY): Free Stock Analysis Report APPLE INC (AAPL): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ALPHABET INC-A (GOOGL): Free Stock Analysis Report To read this article on Zacks.com click here. VeriFone expects non-GAAP earnings per share in the fourth quarter to be in the range of 47-48 cents. |
26744.0 | 2015-12-10 00:00:00 UTC | Will This Study Finally Catapult Gilead Sciences Into a Cancer Powerhouse? | ABBV | https://www.nasdaq.com/articles/will-study-finally-catapult-gilead-sciences-cancer-powerhouse-2015-12-10 | nan | nan | Source: Gilead Sciences
Gilead Sciences is best known for its top-selling HIV and hepatitis C drugs, but the FDA approval of Zydelig in 2014 means the company is also trying to build up its chops in cancer treatment.
So far, Zydelig has been a bit of a commercial dud, but recently reported data could change that situation if it causes Zydelig to capture a larger share of the market for recurring or relapsing chronic lymphocytic leukemia, or CLL.
Source: Gilead Sciences
Expanding access
Currently, Zydelig is only approved to treat relapsing/recurring CLL in patients who would be dosed with Rituxan alone. That's a pretty small addressable market, because Rituxan is often dosed in that setting alongside Teva Pharmaceuticals ' chemotherapy, Treanda.
As a result, Zydelig sales totaled just $36 million in the third quarter and only $92 million through the first nine months of 2015. That pales in comparison with AbbVie and Johnson & Johnson 's Imbruvica, a drug that won FDA approval for CLL around the same time as Zydelig but that can be used in more patients than Zydelig. In the third quarter, sales of Imbruvica were $304 million.
However, Gilead Sciences recently reported that combining Zydelig with Rituxan and Treanda significantly improved progression-free survival.
Specifically, the triplet therapy delayed disease progression for a median 23.1 months, versus 11.1 months for Rituxan and Treanda alone.
Gilead Sciences also reports that using the three drugs together reduces disease progression by 50% more than Rituxan and Treanda in patients harboring the tough-to-treat 17p or TP53 genetic mutations.
Overall survival -- the holy grail of cancer-drug development -- also improved when Zydelig was added to Rituxan and Treanda. In patients treated with all three drugs, there was a 45% reduction in risk of death versus the Rituxan and Treanda arm of the study, and the overall response rate to the therapy was 68% for the Zydelig cohort and 45% for the control arm.
Following those results, Gilead Sciences expects to ask the FDA early next year to expand Zydelig's label to include its use with Rituxan and Treanda.
Marketplace uncertainty
Although Gilead Sciences plans to file for supplementary approval of Zydelig for use with Rituxan and Treanda soon, it's not clear how widely used this triplet could become.
Since Rituxan is a billion-dollar blockbuster drug and Treanda's sales top $200 million per quarter, Zydelig may be in a position to see its sales jump significantly, but that will depend a great deal on how the market for Imbruvica shapes up.
Imbruvica is already approved for use in patients who have been treated at least once previously, and earlier this year, AbbVie offered up results from a trial exploring the use of Imbruvica with Rituxan and Treanda, too.
In that trial, adding Imbruvica to Rituxan and Treanda reduced the risk of disease progression or death by 80%, and the overall response rate to Imbruvica was 82.7%, versus a 67.8% overall response rate for Rituxan and Treanda therapy.
In addition to the fact that Imbruvica may have comparable or better efficacy in this triplet, Imbruvica may have safety and dosing advantage as well. That's because Zydelig has a black-box warning of liver toxicity that Imbruvica doesn't have on its label, and Imbruvica is taken once daily while Zydelig is taken twice daily.
Looking ahead
Zydelig and Imbruvica's trial progress suggest that chemotherapy is going to play an increasingly smaller role in treating CLL.
Studies are evaluating Zydelig in previously untreated patients and earlier this month, AbbVie announced that using Imbruvica in previously untreated patients significantly outperformed chemotherapy, the current standard of care in the first-line setting. In its trial, the risk of disease progression or death on Imbruvica fell by 84% versus chemotherapy, and 98% of Imbruvica patients were alive at the two-year mark, versus 85% of chemotherapy patients.
Those results may indicate that Imbruvica will soon displace chemotherapy in the first-line setting, and if so, it could open up the second-line market to a Zydelig containing combination therapy. That would certainly help boost Zydelig's sales, so investors will want to keep tabs on both of these drugs.
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The article Will This Study Finally Catapult Gilead Sciences Into a Cancer Powerhouse? originally appeared on Fool.com.
Todd Campbell owns shares of Gilead Sciences. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool recommends Johnson & Johnson and Teva Pharmaceutical Industries. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | That pales in comparison with AbbVie and Johnson & Johnson 's Imbruvica, a drug that won FDA approval for CLL around the same time as Zydelig but that can be used in more patients than Zydelig. Imbruvica is already approved for use in patients who have been treated at least once previously, and earlier this year, AbbVie offered up results from a trial exploring the use of Imbruvica with Rituxan and Treanda, too. Studies are evaluating Zydelig in previously untreated patients and earlier this month, AbbVie announced that using Imbruvica in previously untreated patients significantly outperformed chemotherapy, the current standard of care in the first-line setting. | Studies are evaluating Zydelig in previously untreated patients and earlier this month, AbbVie announced that using Imbruvica in previously untreated patients significantly outperformed chemotherapy, the current standard of care in the first-line setting. That pales in comparison with AbbVie and Johnson & Johnson 's Imbruvica, a drug that won FDA approval for CLL around the same time as Zydelig but that can be used in more patients than Zydelig. Imbruvica is already approved for use in patients who have been treated at least once previously, and earlier this year, AbbVie offered up results from a trial exploring the use of Imbruvica with Rituxan and Treanda, too. | That pales in comparison with AbbVie and Johnson & Johnson 's Imbruvica, a drug that won FDA approval for CLL around the same time as Zydelig but that can be used in more patients than Zydelig. Imbruvica is already approved for use in patients who have been treated at least once previously, and earlier this year, AbbVie offered up results from a trial exploring the use of Imbruvica with Rituxan and Treanda, too. Studies are evaluating Zydelig in previously untreated patients and earlier this month, AbbVie announced that using Imbruvica in previously untreated patients significantly outperformed chemotherapy, the current standard of care in the first-line setting. | That pales in comparison with AbbVie and Johnson & Johnson 's Imbruvica, a drug that won FDA approval for CLL around the same time as Zydelig but that can be used in more patients than Zydelig. Imbruvica is already approved for use in patients who have been treated at least once previously, and earlier this year, AbbVie offered up results from a trial exploring the use of Imbruvica with Rituxan and Treanda, too. Studies are evaluating Zydelig in previously untreated patients and earlier this month, AbbVie announced that using Imbruvica in previously untreated patients significantly outperformed chemotherapy, the current standard of care in the first-line setting. |
26745.0 | 2015-12-10 00:00:00 UTC | Gilead Reveals Encouraging Data on Leukemia Drug Zydelig | ABBV | https://www.nasdaq.com/articles/gilead-reveals-encouraging-data-on-leukemia-drug-zydelig-2015-12-10 | nan | nan | Gilead Sciences, Inc.GILD announced positive data from a prespecified interim analysis of a phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients.
In the study, a 67% reduction in the risk of disease progression or death (progression-free survival) was observed in patients receiving Zydelig in addition to Treanda (bendamustine) and Rituxan (rituximab) compared to those receiving only Treanda and Rituxan. Additionally, the Zydelig arm met all secondary endpoints, including overall survival.
We remind investors that earlier this year, the phase III study was unblinded early based on a recommendation from an independent Data Monitoring Committee.
We note that Zydelig is already approved in the U.S. in combination with Rituxan for patients with relapsed CLL for whom Rituxan alone would be considered appropriate therapy due to comorbidities. Zydelig is also approved as a monotherapy for treating patients with relapsed follicular B-cell non-Hodgkin lymphoma and small lymphocytic lymphoma in patients who have received at least two previous systemic therapies. For the first nine months of 2015, Zydelig generated revenues of $92 million. Label expansion of the product could further boost sales.
However, several companies are looking for similar label expansions for their leukemia drugs. We remind investors that last month, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Data from the study confirmed Imbruvica's ability to attain enhanced effectiveness when added to the Treanda/Rituxan combination for the treatment of relapsed or refractory patients with CLL or small lymphocytic lymphoma.
Gilead carries a Zacks Rank #2 (Buy). A couple of other favorably ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and Baxalta Incorporated BXLT . Both companies sport a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that last month, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that earlier this year, the phase III study was unblinded early based on a recommendation from an independent Data Monitoring Committee. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that last month, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Gilead Sciences, Inc.GILD announced positive data from a prespecified interim analysis of a phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that last month, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Gilead Sciences, Inc.GILD announced positive data from a prespecified interim analysis of a phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that last month, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Gilead Sciences, Inc.GILD announced positive data from a prespecified interim analysis of a phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients. |
26746.0 | 2015-12-09 00:00:00 UTC | iShares Russell 3000 ETF Experiences Big Outflow | ABBV | https://www.nasdaq.com/articles/ishares-russell-3000-etf-experiences-big-outflow-2015-12-09 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Russell 3000 ETF (Symbol: IWV) where we have detected an approximate $73.8 million dollar outflow -- that's a 1.2% decrease week over week (from 51,050,000 to 50,450,000). Among the largest underlying components of IWV, in trading today Citigroup Inc (Symbol: C) is up about 0.1%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.4%. For a complete list of holdings, visit the IWV Holdings page » The chart below shows the one year price performance of IWV, versus its 200 day moving average:
Looking at the chart above, IWV's low point in its 52 week range is $100.00 per share, with $127.97 as the 52 week high point - that compares with a last trade of $122.78. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs experienced notable outflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of IWV, in trading today Citigroup Inc (Symbol: C) is up about 0.1%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.4%. For a complete list of holdings, visit the IWV Holdings page » The chart below shows the one year price performance of IWV, versus its 200 day moving average: Looking at the chart above, IWV's low point in its 52 week range is $100.00 per share, with $127.97 as the 52 week high point - that compares with a last trade of $122.78. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. | Among the largest underlying components of IWV, in trading today Citigroup Inc (Symbol: C) is up about 0.1%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.4%. For a complete list of holdings, visit the IWV Holdings page » The chart below shows the one year price performance of IWV, versus its 200 day moving average: Looking at the chart above, IWV's low point in its 52 week range is $100.00 per share, with $127.97 as the 52 week high point - that compares with a last trade of $122.78. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). | Among the largest underlying components of IWV, in trading today Citigroup Inc (Symbol: C) is up about 0.1%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.4%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Russell 3000 ETF (Symbol: IWV) where we have detected an approximate $73.8 million dollar outflow -- that's a 1.2% decrease week over week (from 51,050,000 to 50,450,000). For a complete list of holdings, visit the IWV Holdings page » The chart below shows the one year price performance of IWV, versus its 200 day moving average: Looking at the chart above, IWV's low point in its 52 week range is $100.00 per share, with $127.97 as the 52 week high point - that compares with a last trade of $122.78. | Among the largest underlying components of IWV, in trading today Citigroup Inc (Symbol: C) is up about 0.1%, MasterCard Inc (Symbol: MA) is up about 1.4%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.4%. For a complete list of holdings, visit the IWV Holdings page » The chart below shows the one year price performance of IWV, versus its 200 day moving average: Looking at the chart above, IWV's low point in its 52 week range is $100.00 per share, with $127.97 as the 52 week high point - that compares with a last trade of $122.78. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). |
26747.0 | 2015-12-08 00:00:00 UTC | Here's Why Galapagos NV's Shares Are Soaring Today | ABBV | https://www.nasdaq.com/articles/heres-why-galapagos-nvs-shares-are-soaring-today-2015-12-08 | nan | nan | What : Shares of the Belgian-based drugmaker Galapagos NV gained over 17% today on heavy volume following a positive clinical update for the company's experimental JAK1 inhibitor, filgotinib, indicated for moderate to severe Crohn's disease. In a midstage study, filgotinib generated a 48% clinical remission rate, which was statistically significant when compared to patients taking a placebo, according to a 10-week interim analysis of the data. The company noted that the drug has also been generally well-tolerated in the study so far.
So what : Last September, AbbVie returned all rights to filgotinib to Galapagos after the company decided to develop its own JAK1 inhibitor, ABT-494, instead. AbbVie's decision was reportedly based on the belief that ABT-494 is more effective and has a cleaner safety profile than filgotinib. As many investors thought AbbVie was going to go with filgotinib -- or perhaps develop both compounds simultaneously -- Galapagos' shares ended up taking a beating following this news, losing around a third of their value in a single day. Therefore, this positive clinical development for filgotinib would seem to provide at least some comfort for Galapagos' weary shareholders that were hoping the company would fetch a high-dollar buyout from its former partner.
Now what : Per the press release, Galapagos intends on advancing filgotinib into a pivotal late-stage study as soon as possible. Before investors get too excited, though, it's important to understand that there are several other experimental treatments in ongoing trials for Crohn's disease, including ABT-494. Thus, filgotinib will need to be able to differentiate itself from currently available therapies -- and any forthcoming competitors -- in this increasingly crowded space to be a major value driver for Galapagos going forward. That's why I'm willing to watch this small-cap biotech safely from the sidelines for the moment.
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The article Here's Why Galapagos NV's Shares Are Soaring Today originally appeared on Fool.com.
George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | As many investors thought AbbVie was going to go with filgotinib -- or perhaps develop both compounds simultaneously -- Galapagos' shares ended up taking a beating following this news, losing around a third of their value in a single day. So what : Last September, AbbVie returned all rights to filgotinib to Galapagos after the company decided to develop its own JAK1 inhibitor, ABT-494, instead. AbbVie's decision was reportedly based on the belief that ABT-494 is more effective and has a cleaner safety profile than filgotinib. | The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. So what : Last September, AbbVie returned all rights to filgotinib to Galapagos after the company decided to develop its own JAK1 inhibitor, ABT-494, instead. AbbVie's decision was reportedly based on the belief that ABT-494 is more effective and has a cleaner safety profile than filgotinib. | As many investors thought AbbVie was going to go with filgotinib -- or perhaps develop both compounds simultaneously -- Galapagos' shares ended up taking a beating following this news, losing around a third of their value in a single day. So what : Last September, AbbVie returned all rights to filgotinib to Galapagos after the company decided to develop its own JAK1 inhibitor, ABT-494, instead. AbbVie's decision was reportedly based on the belief that ABT-494 is more effective and has a cleaner safety profile than filgotinib. | So what : Last September, AbbVie returned all rights to filgotinib to Galapagos after the company decided to develop its own JAK1 inhibitor, ABT-494, instead. AbbVie's decision was reportedly based on the belief that ABT-494 is more effective and has a cleaner safety profile than filgotinib. As many investors thought AbbVie was going to go with filgotinib -- or perhaps develop both compounds simultaneously -- Galapagos' shares ended up taking a beating following this news, losing around a third of their value in a single day. |
26748.0 | 2015-12-08 00:00:00 UTC | The Top 3 Drug Approvals of 2015 | ABBV | https://www.nasdaq.com/articles/top-3-drug-approvals-2015-2015-12-08 | nan | nan | Healthcare companies are constantly seeking new ways of treating chronic illnesses and thus increase the patient's life expectancy. During the year 2015 there have been significant advances particularly in the areas of cholesterol, lung cancer, and multiple myeloma. Join The Motley Fool's Kristine Harjes and Todd Campbell as they go through the top three drug approvals of 2015 and how they are assisting patients achieve long-awaited relief from their illnesses.
A full transcript follows the video.
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The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
This podcast was recorded on 12/2/2015.
Kristine Harjes: Top three drug approvals of 2015. This is Industry Focus. Welcome to Industry Focus everyone, Healthcare Edition. I'm your host Kristine Harjes. I've got Todd Campbell on Skype. Hi Todd!
Todd Campbell: Hi how are you? How was your turkey day?
Harjes: Great, I'm still full, still working through leftovers. That is quite literally what I will do as soon as we finish taping this show is go eat some more leftovers. How was yours?
Campbell: Fantastic.
Harjes: Did you have a good one?
Campbell: Yeah it was good. I think I'm done though. I could go another month without some turkey I think.
Harjes: Oh no way. That's my absolute favorite is Thanksgiving food. I'll eat it until it runs out.
So as I kicked the show off with, we are talking about top three drug approvals of 2015. But it's kind of hard to make the statement of top three. I mean that depends on how you measure it, right? So are we talking significance in the indication or biggest needle mover for the company? I mean you could say highest peak sales, biggest patient population. There are a million ways that you could probably answer, "Well what does top mean?"
So for now we're just going to call these some of our favorites. For those of you who follow the industry, let me pose a challenge to you. Go ahead and take a guess at what three drugs you think we're going to talk about. Go ahead and hit pause if you need to. Probably not if you're driving. Don't be playing with your phone while you're doing that. But I'll give you a hint. So two of the three drugs were recently approved -- talking like mid to late November here -- and the third is actually two drugs that make up a new class. If you can guess any of them correctly, honor system here and you want to brag a little bit, hit us up: IndustryFocus@Fool.com . We'd love to clap for you over here.
So meanwhile before we start digging in, I just want to put it out there that the Motley Fool is hiring interns for summer 2016. So our application is officially live. You can find it at Careers.Fool.com. We're hiring interns in international investing software and most exciting of all, editorial which of course is with us your Fool.com team. So I strongly encourage anyone interested to check it out. Mention how much you love our podcasts and maybe we'll see you here in Alexandria this summer.
Okay so let's kick it off. We'll start with the double trouble summer approval of two drugs marking a new class of cholesterol treatment. Todd?
Campbell: Boy I tell you, narrowing this list down to just a few that we talk about in the time that we have was tough because there are a lot of good drugs. I'm sure that when people were thinking of what drugs we would discuss, I'm sure a lot of people will be disappointed -- why didn't you pick my drug? But that being said, we had to make some judgment calls and the first one as you mentioned, that I think is a needle mover and a potential game changer is the approval of two brand-new cholesterol-busting drugs: Sanofi and Regeneron , one approval for their drug Praluent back in July and Amgen won an approval for their cholesterol-fighting drug a month later. And that drug is named Repatha.
Harjes: Right. And these two really just marked a whole new wave of how we look at cholesterol treatments. I mean people have been taking drugs called statins forever. I mean not actually forever, but for years. I mean 25 million or so Americans use statins. And meanwhile 76 million have, Americans have elevated bad cholesterol. So this is a huge, huge market and so to have two drugs that target this problem in a different way, could really be a game changer for a lot of people.
Campbell: Oh big time. You know, you've got 600,000 people a year dying from heart disease. It's a major issue. You've got as you mentioned 76 million people with elevated cholesterol levels. And while you know, these new drugs have not been proven to actually reduce or eliminate the risk of a heart attack, a stroke, or improve mortality for the condition, it's been generally thought that if you can lower cholesterol, then you will lower the risk of these events happening.
Harjes: Yeah.
Campbell: And I think that that's one of the reasons the statins have become so widely used. I mean this is, it's the most prescribed drug out there. And you know, as a result the cholesterol lowering statins were some of the best-selling drugs over the last 30 years. I think the first one came to the market in the 80s, by the mid-90s this was billion dollar category, in the 2000s Lipitor changed the entire paradigm of what people spend on drugs with the Lipitor that was bringing in $13 billion a year in sales.
I'm not saying that these drugs will get that level, but the ability to lower cholesterol by an additional 60% beyond what statins do, that's already pretty darn game-changing.
Harjes: Yeah it's really interesting when you dig into how exactly these drugs work. So they're called PCSK9 inhibitors by the way. That's the class name. So basically PCSK9 is a protein that destroys bad cholesterol receptors in the liver. So if you limit it, then you get more cholesterol being cleared from the bloodstream. And so this is a totally different mechanism than statins, which reduce cholesterol production.
So the thinking here is you use both of them and you're kind of coming at the issue from both sides of it. And it's worked really well so far in trials.
Campbell: Yeah, I mean lowering cholesterol again by 60% when used alongside maximum statin therapy could be, it's incredibly significant to make a difference for thousands and thousands of patients worldwide every year. There's some challenges obviously as far as pricing is concerned because these are not cheap drugs. And of course this affects millions of people. So figuring out how to pay for it, who should actually get the drugs, who shouldn't, all of that is going to have to be watched very closely over the course of the next year. But without a doubt this is a pretty important set of approvals.
Harjes: One thing to note is that this initial approval is limited to just patients that have suffered a cardiac event or who suffer from high cholesterol that's caused by genetic mutations. So when we talk about how big this market could be, it really depends pretty heavily on label expansion to more people. But that's a separate issue. But you mentioned the payer situation. That is something that I think is really important to talk about with every new drug that hits the market.
We got a really interesting email this past week from Caesar Poleram. Thank you for reaching out. He made some really interesting points about payer reimbursement. And he was talking specifically about the diabetes space and DexCom which we've covered previously on the show. But this is an issue that's relevant in every indication. I mean your drug could be the best in the world but if nobody will pay for it, it's not going to go very far.
So that's when you have to start looking at pricing for these drugs. I mean they're treatments that you will take for the rest of your life. It's not a one and done kind of thing. And so if you're looking at a list price of about $14,000 a year, that's huge when you put it across how big the market is and also that each of these people would be taking it year in and year out.
Campbell: Yeah even with limit the Express Scripts which is a pharmacy benefit manager that basically runs drug programs for other insurance companies and self-insured employers. They're putting in all sorts of different policies trying to reign in how many people are going to get access to this drug right away in a bid basically to try and temper how much money is going to have to be spent on these drugs over the course of the next year. But even with those discounts that it's getting and by requiring preauthorization, only limiting the use in certain patient populations, they still think that their clients are going to end up paying $750 million on these two drugs alone next year.
And Express Scripts while it's the biggest out there, only covers 8% of the population. So it's likely that these are going to be billion-dollar drugs in spite of all of these actions to try and reign in the use of them. It's something that is, like you said, the payer issue is an important issue and it's something that we have to spend some solid time as investors thinking about. Because it really could impact what the peak sales potential is for a drug if it's not getting used.
Harjes: Indeed, yeah. And that is where you have to keep an eye on your PBMs, your pharmacy benefits managers. So Express Scripts is paying for both of these drugs, both Praluent and Repatha. Interestingly though CVS , which is another major PBM other than just being the retail pharmacy that we all know of, they linked a deal with Amgen for Repatha which presumably carries a pretty heavy discount. I don't know exactly what that number is. I don't think it's a number that out there. But CVS claims that Repatha and Praluent are therapeutically equivalent; meaning that they're just as effective.
And so it came down to Amgen offering a bigger discount. So that will be an interesting space to monitor. I mean I totally understand why Express Scripts chose not to choose one over the other especially after what happened when they choose one Hepatitis C drive over another. And it turned out to be the worst option. But that's kind of a tangent story right there. But definitely worth noting that the payer landscape is something to keep an eye out for and to monitor exactly what's going to happen with this new class of cholesterol treatment.
Moving on, so our second drug that we wanted to talk about was just approved in mid-November, November 13 th . This is an AstraZeneca drug called Tagrisso.
Campbell: Tagrisso is an interesting and potentially very important drug because it does something, or it addresses something that hasn't been adequately addressed before. And that's a specific mutation that occurs in certain lung cancer patients that basically makes it so that current medicines that are available for them to use, no longer work.
So what specifically we're talking about is we're talking about lung cancer patients that have, that are EGFR positive. EGFR basically is involved in cell replication and survival. So by inhibiting EGFR, existing medications have done a pretty good job in slowing the pace of disease progression. However when that drug -- those drugs no longer work anymore, the prognosis gets much worse for patients and there are far fewer treatment options. And overwhelmingly the reason behind that disease progression is because of another mutation that ends up developing that becomes resistant to them. And that mutation is the T790m.
Harjes: Exactly, yeah. And as you mentioned the problem really is that patients will progress. I mean this drug is a tyrosine kinase inhibitor. So I'll just call it a TKI drug and this is a pretty relatively common kind of drug. But the problem again is this resistance.
So basically what we're seeing with Tagrisso is that it's targeting the exact mutation that is responsible for most cases of resistance. And in trials it shrank tumors in more than half of patients who had progressed on after other treatment with other of these TKIs. Medium response lasted over a year -- that's pretty durable, and you can tell that the FDA was also impressed. They approved the drug three months earlier than expected.
One of the things that I really kind of struggled with in researching this was figuring out just how many patients this could possibly affect. And when you start to dig into the numbers I just think it's, it makes it really clear just how difficult it is to put a specific number on a patient population pool -- which makes you want to take peak sales estimates with a grain of salt. But let's take a look at this for a quick minute. So bear with me here.
So the American Cancer Society estimates that about 221,000 new patients will be diagnosed with lung cancer in the coming year. 85% of those are non-small cell lung cancer. EGFR rates vary from country to country, but in the U.S. at least it's estimated to be around 10%. So multiply again by 10%, of those patients a majority progress. Again hard to pin down an exact number on that. But even if we just call it say 60%. So we multiply it by .6 and apparently the T790 mutation, the one that Tagrisso targets, is found in two thirds of these patients. So multiply that all together and you get like somewhere around 7500 or so patients in the U.S. every year.
Now any one of those numbers could be off by a little bit and throw the whole calculation off. And so I am by no means stating the 7500 definitively, but that's the thing is nobody has a definitive number out there. So I mean it's all you can do to try to dig in and extract one. But in the end it's pretty darn hard. And that's why you do see peak sales estimates all over the place. The one that I'm going to stick with is Astra's which is 3 billion in annual sales.
Campbell: Yeah. I think that investors, like you said, you need to take these things with a grain of salt. Studies have been done on peak sales estimates that show that the vast majority of those estimates are way off. So I think you kind of have to do your own diligence. Just recognize that OK, could this be an important drug? Doesn't it address a patient population that needs it? Is it priced at a point where people will be able to use it and pay for it? And when it comes to those kind of categories, I look at this drug, I say, yeah this could be a significant player. This could be a blockbuster drug because the 5-year survival rate is sadly for one patient still around 20%.
So there's a massive unmet need for new therapies that can attack and heal this disease. And even if we adjust your numbers by a little bit on either side, you're still talking about thousands of patients. So I think it's an important drug, it seems to work very well, it could become standard of care and if it does, then I think you're talking about a billion-dollar plus run rate.
Harjes: Yeah it goes without saying that these kind of developments are awesome for patients. And that is what matters most. It's just when you try to stand back as an investor and take a look at all the numbers, that's when it gets a little bit murkier.
One thing that did shine a little bit more of a light on the competitive landscape, so there's a competing, potentially competing drug that was being developed by a company called Clovis . And I think people were a little bit doubtful of AstraZeneca's estimate of 3 billion in annual sales for Tagrisso because of this Clovis drug which was supposed to be approved in March of 2016. But right after Tagrisso got its approval the FDA asked Clovis for basically more information about their drug. Which that doesn't sound too terrible, but it was quite a setback.
Basically the application that Clovis submitted had data that wasn't quite mature. So as time went on, not as many patients as expected went from unconfirmed to confirmed responses. So whereas it looked by all means in the immature data that Clovis had a drug that was about equivalent in efficacy to Astra's. Basically the response rate was cut in half when you actually started getting confirmed responses coming in. So at best approval's going to be delayed a couple of months for Clovis and at worst the FDA will reject it entirely since there's already a better drug arguably on the market for the same exact indication.
Clovis' stock for the record shed about 75% of its value just over the next couple days after that announcement. So really devastating news for shareholders in that company. But good news for Tagrisso.
Alright, so our last drug that we wanted to talk about today is called Empliciti and it is developed by Bristol-Myers and AbbVie and that was just approved a few days ago -- November 30 th .
Campbell: Yeah, you know Empliciti is important because again if you look at indication. Is there a need? There is. Empliciti treats multiple myeloma and it's been approved for use alongside two very commonly used therapies for multiple myeloma -- dexamethasone and Revlimid. And because it's being approved as an adjunct therapy, and it is being approved as adjunct therapy to these widely used drugs, there's a very good chance in my view that it becomes part of the standard of care in the second, and definitely in the third line treatment for patients.
And since we're talking about 28,000 or so, I think patients, or 26,000 patients that get diagnosed with multiple myeloma every year, a lot of whom who won't respond, will have to get retreated. I think that this again is going to be a very important drug because it put up very solid efficacy during trials.
Harjes: Yeah this is a really devastating disease. About 11,000 people die from it every year. And so to get drugs that work better and better is a fantastic thing. And it's a huge market too. I mean the multiple myeloma market is expected to rise in value from $8.9 billion in 2014 to just over $22 billion by 2023.
Revlimid is a huge part of that. That's a Celgene drug. Sales should top about $5.6 billion this year and you're going to see Revlimid continue to be used especially because Empliciti is being used alongside it. Just to dig into a couple of the numbers from the trials: 78-1/2% of patients taking the Empliciti combination therapy, meaning alongside Dexa and Revlimid, saw complete or partial tumor shrinkage which was better than the 65-1/2% reported in just the Dexa and Revlimid arm. So clearly this is a statistically significant improvement.
Campbell: Yeah and you've got almost a 5-month advantage in progression-free survival as well by adding that third drug to this cocktail. Revlimid is the most widely used in second-line therapy. It won approvals for first-line therapy early this year. It's getting more widely used there. Theoretically there could be label expansion opportunities that would move this combination into the first-line therapy. There could be use of it off label in the first line, we don't know how that's going to shake out.
But as you mentioned, it's a huge marketplace. I mean you've got Revlimid at $5.6 billion in sales, you've got Velcade which is also another widely used drug in the first and second-line of treating this disease. That's a $3 billion a year drug. You've got Pomalyst which is a third-line drug also made by Celgene. That's selling at a billion-dollar place a year. It's really hard for me to look at the numbers for progression-free survival and tumor shrinkage and not think that doctors are going to want to use this standard of care. And then of course it just comes down to what we talked about before which is will payers pay for it.
Harjes: Indeed. Yeah I mean this is not a cheap drug. It's going to be $10,000 a month versus as compared to Revlimid's $14,000 and Velcade's $9,000. And it's a "me too." You're using alongside the current therapies, so it's just making things even more expensive.
Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S. it looks like Bristol is going to pay AbbVie a royalty. So this is definitely more of the needle mover for Bristol than for AbbVie.
Campbell: Absolutely agree.
Harjes: Yeah. So as Todd mentioned earlier, we could extend this conversation to include so many more drugs. There are a ton that would make the cut. I mean this has been a truly tremendous year for innovation in the pharmaceutical and biotechnology sectors.
Of course 2015 isn't even over yet, there are some interesting PDUFA dates coming up just even before the end of the year. I know for one BioMarin has a December 27 th date for Drisapersen which is a treatment for Duchenne Muscular Dystrophy and this is a really heavily watched space with some fierce competition going on between BioMarin and Sarepta , but that's a story for another episode.
For now, thanks so much for listening in with us today and we'll be back next week. As always people in the program may have at interest in the stocks they talk about and the Motley Fool may have formal recommendations for or against, so don't buy or sell stocks based solely on what you hear.
The article The Top 3 Drug Approvals of 2015 originally appeared on Fool.com.
Kristine Harjes has no position in any stocks mentioned. Todd Campbell owns shares of Celgene. The Motley Fool owns shares of and recommends Celgene and Express Scripts. The Motley Fool recommends BioMarin Pharmaceutical and CVS Health. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Alright, so our last drug that we wanted to talk about today is called Empliciti and it is developed by Bristol-Myers and AbbVie and that was just approved a few days ago -- November 30 th . Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S. it looks like Bristol is going to pay AbbVie a royalty. | Alright, so our last drug that we wanted to talk about today is called Empliciti and it is developed by Bristol-Myers and AbbVie and that was just approved a few days ago -- November 30 th . Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S. it looks like Bristol is going to pay AbbVie a royalty. | Alright, so our last drug that we wanted to talk about today is called Empliciti and it is developed by Bristol-Myers and AbbVie and that was just approved a few days ago -- November 30 th . Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S. it looks like Bristol is going to pay AbbVie a royalty. | Alright, so our last drug that we wanted to talk about today is called Empliciti and it is developed by Bristol-Myers and AbbVie and that was just approved a few days ago -- November 30 th . Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S. it looks like Bristol is going to pay AbbVie a royalty. |
26749.0 | 2015-12-08 00:00:00 UTC | AbbVie Presents Data on Imbruvica and Venetoclax at ASH | ABBV | https://www.nasdaq.com/articles/abbvie-presents-data-on-imbruvica-and-venetoclax-at-ash-2015-12-08 | nan | nan | AbbVie Inc.ABBV presented encouraging results on Imbruvica and its experimental multiple myeloma candidate, venetoclax, at the annual meeting of the American Society of Hematology (ASH).
Presented Multiple Data on Imbruvica
AbbVie announced that results from the phase III study (RAY) showed Imbruvica significantly prolonged progression-free survival (the primary endpoint) and improved overall response rates (ORR) - a key secondary endpoint - in patients with relapsed or refractory mantle cell lymphoma (MCL) compared with Torisel (temsirolimus). Imbruvica resulted in a reduction in the risk of disease progression or death by 57% after a median follow-up of 20 months. Data was also published online in The Lancet .
The company also announced that data from a multicenter, open-label phase II study showed that Imbruvica plus Rituxan (rituximab) was found to be well tolerated and demonstrated an ORR of 82% in treatment-naive patients with follicular lymphoma (FL). The company also presented phase I dose-escalation data on Imbruvica in combination with Rituxan and Revlimid (lenalidomide) in treatment-naive FL patients.
Moreover, preliminary data from the ongoing dose-escalation phase I/IIb study showed that Imbruvica plus Kyprolis (carfilzomib) with or without dexamethasone resulted in an initial ORR of 62% in relapsed or refractory multiple myeloma patients. Overall, the combination was found to be well tolerated with no dose-limiting toxicities observed during the dose escalation phase.
Meanwhile, results from a head-to-head phase III study (RESONATE-2) in treatment-naive patients (aged 65 years and above) with chronic lymphocytic leukemia (CLL) showed that Imbruvica reduced the risk of progression or death by 84% with an estimated survival rate of 98% at 24 months when compared to Leukeran. The results were simultaneously published online in The New England Journal of Medicine .
We note that AbbVie has submitted a supplemental new drug application to the FDA for the use of Imbruvica in treatment-naïve patients with CLL.
Imbruvica is currently approved in the U.S. for the treatment of patients with MCL or CLL who have received at least one previous therapy and for CLL patients with del 17p. It is also approved for the treatment of patients with Waldenström's macroglobulinemia. We remind investors that Imbruvica was added to AbbVie's portfolio following the Pharmacyclics acquisition in May 2015. AbbVie has an agreement with Johnson & Johnson's JNJ Janssen Biotech for Imbruvica.
Venetoclax Hits Phase II Primary Endpoint
AbbVie announced results from a multicenter, open label phase II study conducted to evaluate the efficacy and safety of venetoclax monotherapy in relapsed/refractory CLL patients with 17p deletion. Data revealed that venetoclax monotherapy achieved the primary endpoint of the study with an ORR of 79.4% and 84.7% having sustained duration of response.
Data from the study have been submitted to the FDA and European Medicines Agency as part of a new drug application and a marketing authorization application, respectively, in patients with relapsed/refractory CLL. Moreover, AbbVie announced new data from a phase I study showing some patients with relapsed/refractory CLL when treated with venetoclax experienced a response, including complete responses. Data was published online in The New England Journal of Medicine .
We note that AbbVie has an agreement with Roche Holding AG RHHBY for venetoclax.
AbbVie is a Zacks Rank #3 (Hold) stock. Baxalta Incorporated BXLT is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV presented encouraging results on Imbruvica and its experimental multiple myeloma candidate, venetoclax, at the annual meeting of the American Society of Hematology (ASH). Presented Multiple Data on Imbruvica AbbVie announced that results from the phase III study (RAY) showed Imbruvica significantly prolonged progression-free survival (the primary endpoint) and improved overall response rates (ORR) - a key secondary endpoint - in patients with relapsed or refractory mantle cell lymphoma (MCL) compared with Torisel (temsirolimus). We note that AbbVie has submitted a supplemental new drug application to the FDA for the use of Imbruvica in treatment-naïve patients with CLL. | Presented Multiple Data on Imbruvica AbbVie announced that results from the phase III study (RAY) showed Imbruvica significantly prolonged progression-free survival (the primary endpoint) and improved overall response rates (ORR) - a key secondary endpoint - in patients with relapsed or refractory mantle cell lymphoma (MCL) compared with Torisel (temsirolimus). Venetoclax Hits Phase II Primary Endpoint AbbVie announced results from a multicenter, open label phase II study conducted to evaluate the efficacy and safety of venetoclax monotherapy in relapsed/refractory CLL patients with 17p deletion. Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. | Presented Multiple Data on Imbruvica AbbVie announced that results from the phase III study (RAY) showed Imbruvica significantly prolonged progression-free survival (the primary endpoint) and improved overall response rates (ORR) - a key secondary endpoint - in patients with relapsed or refractory mantle cell lymphoma (MCL) compared with Torisel (temsirolimus). Venetoclax Hits Phase II Primary Endpoint AbbVie announced results from a multicenter, open label phase II study conducted to evaluate the efficacy and safety of venetoclax monotherapy in relapsed/refractory CLL patients with 17p deletion. Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. | Presented Multiple Data on Imbruvica AbbVie announced that results from the phase III study (RAY) showed Imbruvica significantly prolonged progression-free survival (the primary endpoint) and improved overall response rates (ORR) - a key secondary endpoint - in patients with relapsed or refractory mantle cell lymphoma (MCL) compared with Torisel (temsirolimus). AbbVie is a Zacks Rank #3 (Hold) stock. Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. |
26750.0 | 2015-12-08 00:00:00 UTC | Roche & AbbVie Reveal Positive Data on Leukemia Drug | ABBV | https://www.nasdaq.com/articles/roche-abbvie-reveal-positive-data-on-leukemia-drug-2015-12-08 | nan | nan | RocheRHHBY announced positive data from a phase II study, M13-982, on its oncology candidate, venetoclax.
Roche is developing venetoclax with AbbVie ABBV for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion.
Results of the study showed that treatment with venetoclax resulted in a clinically meaningful reduction in the number of cancer cells. The study met its primary endpoint with an overall response rate of 79.4% as assessed by an independent review committee.
Data from the study were announced at the official press program of the 57th American Society of Hematology (ASH) Annual Meeting in Orlando.
Roche will also present data on venetoclax as a monotherapy or in combination with other drugs for CLL, non-Hodgkin's lymphoma, multiple myeloma and acute myeloid leukemia.
We remind investors that the FDA granted Breakthrough Therapy designation to venetoclax earlier in 2015 for the treatment of people with relapsed or refractory CLL harboring the 17p deletion. AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under Breakthrough Therapy designation. The company has also filed for an approval of the drug in Europe.
Meanwhile, results from a phase I study, M12-175, on venetoclax were published online in the New England Journal of Medicine.
Separately, Roche announced data from the CLL11 study on its leukemia drug, Gazyva. The study showed that Gazyva plus chlorambucil reduced the risk of disease worsening or death by more than half compared to Rituxan plus chlorambucil.
We remind investors that Gazyva was approved by the FDA for use in combination with chlorambucil in people with previously untreated chronic lymphocytic leukemia in 2013 under Breakthrough Therapy designation.
The drug was also approved by the European Commission in Jul 2014 under the brand name, Gazyvaro, for the treatment of patients with previously untreated CLL, who have co-existing medical conditions (comorbidities) that make them unsuitable for an intensive therapy (a full-dose fludarabine-based therapy).
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise, which includes drugs like Herceptin, Perjeta and Kadcyla.
Approval of new drugs for leukemia will further broaden its oncology portfolio and somewhat offset the loss of revenues resulting from the generic competition for Xeloda, Zelboraf and Pegasys.
Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include AstraZeneca PLC AZN and Eli Lilly and Co. LLY . While AstraZeneca sports a Zacks Rank #1 (Strong Buy), Eli Lilly has a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Roche is developing venetoclax with AbbVie ABBV for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion. AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under Breakthrough Therapy designation. Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. | Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Roche is developing venetoclax with AbbVie ABBV for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion. AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under Breakthrough Therapy designation. | Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Roche is developing venetoclax with AbbVie ABBV for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion. AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under Breakthrough Therapy designation. | Roche is developing venetoclax with AbbVie ABBV for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion. AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under Breakthrough Therapy designation. Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. |
26751.0 | 2015-12-07 00:00:00 UTC | Forget Altria, These Are the Best Dividend Stocks to Own | ABBV | https://www.nasdaq.com/articles/forget-altria-these-are-best-dividend-stocks-own-2015-12-07 | nan | nan | Though Altria Group operates in the challenging U.S. tobacco industry, thanks to cigarette volume remaining in secular decline, the company controls roughly 50% of the U.S. cigarette market and continues to dish out a dividend yield of nearly 4%. However, despite the challenging market, the company's addictive products provide the company with strong pricing power that should keep Altria's cigarette business lucrative in the near term.
If Altria isn't your style, three Foolish contributors offer strong dividend stocks that should have brighter futures than Altria.
Todd Campbell : Altria may have this company beat in terms of dividend yield, but in terms of long-term dividend potential, I don't think Altria can hold a candle to Microsoft .
Microsoft is reinventing itself as a giant in cloud-based services, and its Office-anywhere approach is solidifying its de facto standing as the dominant player in productivity software.
The company's Windows 10 rollout has gone about as smoothly as any launch in its history, and with 110 million installs and counting, it could be on more devices than any of its predecessors. That's great news given that Microsoft is showing a special knack for cross-platform integration.
Besides landing itself on increasingly more devices, Microsoft is also doing a solid job of tying together its services so that they naturally lead to sales growth. Integrating Cortana and Bing deeply in Windows 10 provides natural tailwinds for search revenue, and connecting Xbox to Windows 10 is an early move into un-connected gaming that frees players from a specific medium, such as the TV.
Add together all of the things Microsoft is doing right and the fact that the company is sitting on a dump truck full of dividend-friendly cash and you can see why I believe its current 2.67% dividend yield is competitive enough to warrant buying it instead of Altria.
Daniel Miller : AbbVie Inc has a dividend yield similar to Altria, currently sitting at about 3.8%, but its future seems much brighter. AbbVie has a trump card in the form of an immunology drug named Humira, which is going to drive very strong cash flows for the company despite its patent ending at the end of 2016. That cash flow will help fund research and development to fill the company's pipeline of future drug products.
A quick glance at AbbVie's near-term prospects is enough for investors to remain optimistic about the stock. The company expects to deliver top-tier revenue growth through 2020, with total company sales reaching roughly $37 billion in 2020, compared to nearly $20 billion in 2014.
Beyond that, the company has the potential to launch more than 20 new products or indications through 2020, some of which are expected to contribute in 2016. AbbVie believes its pipeline has the potential to achieve nominal revenues of nearly $30 billion by 2024 -- excluding new Humira and Imbruvica indications.
ABBV data by YCharts .
That all equates to AbbVie forecasting double-digit adjusted EPS growth on average through 2020. Currently, the stock trades at roughly 12 times forward earnings, and after upping its dividend by 12% last quarter, the company has a promising future in terms of growing its sales as well as its dividend.
Steve Symington : Altria may boast a solid 3.7% annual dividend yield, but I think Nike offers a much healthier combination of dividend growth and potential share price appreciation -- not to mention the stark contrast of Nike's exercise-centric products against those of the tobacco giant. Of course, past performance can't guarantee future results, but consider Nike's relative out performance for both metrics over the past five years:
NKE data by YCharts .
In October, Nike also indicated it has no intention of slowing down, announcing a new target to achieve $50 billion in annual revenue by the end of its 2020 fiscal year -- a more than 50% increase over this year's (fiscal 2016) expected revenue of $32.8 billion. At the same time, Nike aims to expand gross margin each year by 30 to 50 basis points, achieve average annual earnings-per-share growth in the mid-teen percentage range, grow free cash flow faster than net income, and achieve impressive returns on invested capital in the high-20% to low-30% range.
Altria bulls might also point to their company's recently authorized $1 billion share repurchase program (which it expects to complete by the end of next year) as a solid supplementary effort to return capital to shareholders. But keeping in mind both companies have nearly identical market capitalizations (at around $113 million), and Nike's float is significantly smaller (with shares worth $89.3 billion vs. Altria's $112.8 billion), Nike repurchased 5.5 million shares of its own stock for $588 million last quarter alone , leaving roughly $1.5 billion remaining under what was originally an $8 billion authorization set be exhausted by the end of this fiscal year. In addition, when Nike boosted its quarterly dividend by 14% two weeks ago, its board of directors approved an even more ambitious four-year, $12 billion repurchase authorization to commence when the current program completes.
In the end, despite its comparatively modest dividend yield at roughly 1%, I'm convinced Nike offers dividend investors the better chance to achieve superior absolute returns.
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The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article Forget Altria, These Are the Best Dividend Stocks to Own originally appeared on Fool.com.
Daniel Miller has no position in any stocks mentioned. Steve Symington has no position in any stocks mentioned. Todd Campbell has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Nike. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Daniel Miller : AbbVie Inc has a dividend yield similar to Altria, currently sitting at about 3.8%, but its future seems much brighter. AbbVie has a trump card in the form of an immunology drug named Humira, which is going to drive very strong cash flows for the company despite its patent ending at the end of 2016. A quick glance at AbbVie's near-term prospects is enough for investors to remain optimistic about the stock. | Daniel Miller : AbbVie Inc has a dividend yield similar to Altria, currently sitting at about 3.8%, but its future seems much brighter. AbbVie has a trump card in the form of an immunology drug named Humira, which is going to drive very strong cash flows for the company despite its patent ending at the end of 2016. A quick glance at AbbVie's near-term prospects is enough for investors to remain optimistic about the stock. | Daniel Miller : AbbVie Inc has a dividend yield similar to Altria, currently sitting at about 3.8%, but its future seems much brighter. AbbVie has a trump card in the form of an immunology drug named Humira, which is going to drive very strong cash flows for the company despite its patent ending at the end of 2016. A quick glance at AbbVie's near-term prospects is enough for investors to remain optimistic about the stock. | Daniel Miller : AbbVie Inc has a dividend yield similar to Altria, currently sitting at about 3.8%, but its future seems much brighter. AbbVie has a trump card in the form of an immunology drug named Humira, which is going to drive very strong cash flows for the company despite its patent ending at the end of 2016. A quick glance at AbbVie's near-term prospects is enough for investors to remain optimistic about the stock. |
26752.0 | 2015-12-07 00:00:00 UTC | The 3 Most Important Drugs in Gilead Sciences' Pipeline | ABBV | https://www.nasdaq.com/articles/3-most-important-drugs-gilead-sciences-pipeline-2015-12-07 | nan | nan | Image source: Centers for Disease Control and Prevention.
Although blue-chip biotech stock Gilead Sciences has had a bit of an up and down year, it's still sitting on a year-to-date gain of nearly 10%.
The catalyst behind Gilead's ongoing strength has been its hepatitis C franchise, headlined by Sovaldi and Harvoni, the company's once-daily HCV pills. These drugs have made an incredible difference in the lives of HCV patients, with cure rates typically above 90%, and relatively minimal side effects compared to the flu-like symptoms, anemia, and rashes which often accompanied the previous standard of care.
Through the end of the third quarter, Harvoni, which treats genotype 1, the most common form of HCV, had generated $10.52 billion in global sales, including $8.38 billion in the United States. Sovaldi, which is generally regulated to genotypes other than type 1, has generated $3.73 billion in global sales through Q3. Combined, that's $14.25 billion in HCV sales through three quarters, and an extrapolated $19 billion in estimated full-year sales from its franchise. Year-to-date, HCV sales make up 60% of Gilead's total product sales.
Image source: AbbVie.
These numbers are even more impressive considering that AbbVie 's Viekira Pak, the lone approved competitor to Harvoni in genotype 1, generated just $469 million in global sales during the third quarter and has sold only $1.09 billion through the first three quarters of 2015. AbbVie's sales are nothing to sneeze at, but Gilead's HCV dominance is night-and-day next to AbbVie and Viekira Pak.
Even better news for investors is that Harvoni and Sovaldi still have an exceptionally long patent shelf life, and there are approximately 180 million people worldwide with HCV based on estimates from the World Health Organization. Translation: Gilead's HCV franchise looks to be in good shape for a long time to come.
The most important drugs in Gilead Sciences' pipeline
However, Wall Street and investors are also forward-looking, and they'd like to see Gilead diversify or improve upon existing therapies. With that in mind, we'll briefly take a look at three pipeline products within Gilead's pipeline that could arguably be deemed its most important.
Simtuzumab
One of the most exciting developing drugs in Gilead Sciences' pipeline is simtuzumab, a monoclonal antibody designed to inhibit the lysyl oxidase-like-2, or LOXL2, enzyme. LOXL2 is believed to play an important role in tumor metastasis, as well as in the advancement of fibrotic diseases.
Simtuzumab is being tested in a variety of indications, and the initial results have been mixed. Once thought to be an intriguing candidate to fight treatment-naïve advanced pancreatic cancer, simtuzumab, in combination with Gemzar, failed to provide a statistically significant improvement in progression-free survival compared to the control group. This indication was eventually scrapped.
Image source: Centers for Disease Control and Prevention.
What should have your attention is simtuzumab as a treatment for nonalcoholic steatohepatitis, or NASH. It's estimated that NASH could affect anywhere from 2% to 5% of the U.S. population, and if left untreated it can lead to scarring of the liver known as fibrosis, which can lead to liver complications, liver cancer, or even death. The market for a drug that could halt liver fibrosis, or potentially reverse it, would be enormous.
In December 2012, Gilead announced that a phase 1 dosing of simtuzumab in 10 patents with liver disease demonstrated reductions in AST and ALT levels with no serious adverse events reported or discontinuations. Phase 1 studies focus almost entirely on safety, and on this merit simtuzumab cleared the bar.
The real test is upcoming in 2016 when Gilead is expected to report top-line data on its 96-week phase 2 study in NASH patients. If the data is truly phenomenal, Gilead may be able to file for an accelerated approval of simtuzumab. If approved, simtuzumab would appear to have an easy pathway to blockbuster status with no other NASH products currently on the market.
Zydelig (idelalisib)
Next up is Zydelig, known scientifically as idelalisib, a burgeoning oncology drug in Gilead's product portfolio and pipeline that's already approved to treat three types of blood cancers: relapsed chronic lymphocytic leukemia, small lymphocytic leukemia, and relapsed follicular B-cell non-Hodgkin lymphoma. Gilead received these three approvals in July 2014, and through the first three quarters of 2015 Zydelig has generated $92 million in sales.
What everyone should be watching are Zydelig's label expansion opportunities, as well as its ability to improve upon its existing indications.
Image source: Gilead Sciences.
Just a few weeks prior Gilead announced that the independent data monitoring committee overseeing a phase 3 study of Zydelig in combination with Treanda and Rituxan recommended it be unblinded early due to superior efficacy. Median progression-free survival for the trio was 23.1 months compared to just 11.1 months for the Treanda/Rituxan combination. Although approved in relapsed CLL already, Zydelig was only previously approved in combination with Rituxan. This PFS-thumping improvement over the control group should turn some heads and drum up Zydelig's use in relapsed CLL patients assuming it gains expanded approval from the Food and Drug Administration.
Other possible indications that could fuel Zydelig's growth include frontline CLL, relapsed refractory indolent non-Hodgkin lymphoma (iNHL), and frontline iNHL. Individually, none of these indications is going to result in blockbuster sales. However, if Zydelig can gain additional approvals into iNHL and frontline CLL, it very well could become a blockbuster drug with sales in excess of $1 billion annually.
It's important for Gilead to establish revenue outside of HCV, and Zydelig could be a decisive step in that direction.
Sovaldi + velpatasvir combo
Lastly, even though it's been said that Gilead needs to potentially lessen its reliance on HCV products within its portfolio, it's hard to ignore the efficacy of the Sovaldi/velpatasvir combination in the four ASTRAL studies that Gilead reported on in September.
Image source: Centers for Disease Control and Prevention.
This cocktail therapy is designed to treat all six genotypes of HCV, marking it the first pan-genomic HCV drug that could make it to market. Although Harvoni is pretty much engrained as the go-to drug of physicians and consumers for genotype 1, Gilead's newest cocktail drug could secure it as the dominant force in genotypes 2 through 6.
Of the 1,035 tested patients of all genotypes, just 20 failed to show virologic clearance of HCV, with seven of those 20 simply failing to report for trial follow-up. With respect to genotype, not a single patient with HCV genotype 2, 4, 5 and 6 demonstrated a relapse in the ASTRAL studies. Furthermore, sustained virologic response improved in the ASTRAL studies for genotype 2 and 3 patients to between 80% and 99%. The FISSION, POSITRON, and FUSION trials from 2013 with Sovaldi plus ribavirin yielded SVR rates ranging between 50% and 78%.
Gilead's new cocktail has all the makings of a dominant blockbuster in genotypes 2 through 6 and could be very difficult to unseat for the foreseeable future if it's approved by the FDA.
Does Gilead's pipeline make it a buy?
Even though Gilead's product portfolio is heavily reliant on Harvoni and Sovaldi, and competition within the hepatitis C is expected to grow in the coming years, I'd opine that Gilead remains a cash cow in the biotech sector that long-term investors should seriously consider owning.
Gilead has an impressive enough pipeline that it can grow its top- and bottom-line organically, but also boasts enough cash flow from its HCV dominance that acquisitions and partnerships are also a real possibility. Boasting a very low forward P/E, Gilead looks to have plenty of upside left in the tank.
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The article The 3 Most Important Drugs in Gilead Sciences' Pipeline originally appeared on Fool.com.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen nameTMFUltraLong, track every pick he makes under the screen nameTrackUltraLong, and check him out on Twitter, where he goes by the handle@TMFUltraLong.The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Image source: AbbVie. These numbers are even more impressive considering that AbbVie 's Viekira Pak, the lone approved competitor to Harvoni in genotype 1, generated just $469 million in global sales during the third quarter and has sold only $1.09 billion through the first three quarters of 2015. AbbVie's sales are nothing to sneeze at, but Gilead's HCV dominance is night-and-day next to AbbVie and Viekira Pak. | These numbers are even more impressive considering that AbbVie 's Viekira Pak, the lone approved competitor to Harvoni in genotype 1, generated just $469 million in global sales during the third quarter and has sold only $1.09 billion through the first three quarters of 2015. Image source: AbbVie. AbbVie's sales are nothing to sneeze at, but Gilead's HCV dominance is night-and-day next to AbbVie and Viekira Pak. | Image source: AbbVie. These numbers are even more impressive considering that AbbVie 's Viekira Pak, the lone approved competitor to Harvoni in genotype 1, generated just $469 million in global sales during the third quarter and has sold only $1.09 billion through the first three quarters of 2015. AbbVie's sales are nothing to sneeze at, but Gilead's HCV dominance is night-and-day next to AbbVie and Viekira Pak. | Image source: AbbVie. These numbers are even more impressive considering that AbbVie 's Viekira Pak, the lone approved competitor to Harvoni in genotype 1, generated just $469 million in global sales during the third quarter and has sold only $1.09 billion through the first three quarters of 2015. AbbVie's sales are nothing to sneeze at, but Gilead's HCV dominance is night-and-day next to AbbVie and Viekira Pak. |
26753.0 | 2015-12-07 00:00:00 UTC | Gilead's HCV Drug's Regulatory Application Validated in EU | ABBV | https://www.nasdaq.com/articles/gileads-hcv-drugs-regulatory-application-validated-in-eu-2015-12-07 | nan | nan | Gilead Sciences, Inc.GILD announced that its Marketing Authorisation Application (MAA) for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi with velpatasvir (an investigational pangenotypic NS5A inhibitor), has been fully validated and is now under assessment by the European Medicines Agency (EMA). The EMA has granted accelerated assessment to the MAA.
Gilead is looking to get the combination approved for the treatment of genotype 1-6 chronic HCV infection, including patients with compensated and decompensated cirrhosis. If approved, the company expects to make the drug available in the EU in 2016. Gilead has also submitted a regulatory application for Sovaldi/velpatasvir to the FDA. The fixed-dose combination enjoys Breakthrough Therapy status in the U.S. Note that Breakthrough Therapy status is granted to candidates that have the potential to offer major advances in treatment over existing options.
However, Gilead's HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Harvoni witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. In this scenario, a label expansion for Harvoni will be a major win for the company. It should boost the drug's sales.
Meanwhile, competition in the HCV market is intensifying as several companies like Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Gilead currently carries a Zacks Rank #2 (Buy). Baxalta Incorporated BXLT is another well-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that its Marketing Authorisation Application (MAA) for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi with velpatasvir (an investigational pangenotypic NS5A inhibitor), has been fully validated and is now under assessment by the European Medicines Agency (EMA). | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Gilead Sciences, Inc.GILD announced that its Marketing Authorisation Application (MAA) for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi with velpatasvir (an investigational pangenotypic NS5A inhibitor), has been fully validated and is now under assessment by the European Medicines Agency (EMA). | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak, among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that its Marketing Authorisation Application (MAA) for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi with velpatasvir (an investigational pangenotypic NS5A inhibitor), has been fully validated and is now under assessment by the European Medicines Agency (EMA). |
26754.0 | 2015-12-05 00:00:00 UTC | Why Halozyme Therapeutics Inc. Jumped 13% in November | ABBV | https://www.nasdaq.com/articles/why-halozyme-therapeutics-inc-jumped-13-november-2015-12-05 | nan | nan | What: Investors in human enzyme specialist Halozyme Therapeutics were treated to a prosperous November as the company's shares rose more than 13% during the month, according to data from S&P Capital IQ .
So what: As the chart above shows, the market put the company through a bit of a wild ride. Shares soared early in the month but then came crashing back down after reporting its third-quarter earnings results. Although the report was filled with good news -- sales jumped 42% over the year-ago period -- higher spending on progressing the company's big pipeline caused a higher-than-expected net loss for the period, which caused traders to sell . However, as the market had more time to digest the report, its shares gradually recovered and ultimately ended the month up.
Now what: Halozyme reached several milestones during the quarter that helped to trigger a slew of payments from its partners. It also managed to ink an exciting new deal with pharma giant AbbVie (NYSE: ABBV) during the quarter that looks especially promising. In it, Halozyme received a $23 million up-front payment from AbbVie for up to nine collaboration targets that will use Halozyme's Enhanze technology. One of those targets will be AbbVie's megablockbuster drug Humira. The companies believe that using Halozyme's technology could reduce the number of Humira injections that patients need to take. If all goes well, the deal could bring in a total of $130 million in milestone payments plus double-digit royalties of future sales.
Halozyme continues to fire on all cylinders. While the company is still losing money, its many partnerships should keep the milestone payments rolling in on a regular basis, ensuring funding for quite some time. For that reason, I continue to think that Halozyme is a solid choice for a speculative portion of your portfolio.
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The article Why Halozyme Therapeutics Inc. Jumped 13% in November originally appeared on Fool.com.
Brian Feroldi has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | It also managed to ink an exciting new deal with pharma giant AbbVie (NYSE: ABBV) during the quarter that looks especially promising. In it, Halozyme received a $23 million up-front payment from AbbVie for up to nine collaboration targets that will use Halozyme's Enhanze technology. One of those targets will be AbbVie's megablockbuster drug Humira. | The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. It also managed to ink an exciting new deal with pharma giant AbbVie (NYSE: ABBV) during the quarter that looks especially promising. In it, Halozyme received a $23 million up-front payment from AbbVie for up to nine collaboration targets that will use Halozyme's Enhanze technology. | In it, Halozyme received a $23 million up-front payment from AbbVie for up to nine collaboration targets that will use Halozyme's Enhanze technology. It also managed to ink an exciting new deal with pharma giant AbbVie (NYSE: ABBV) during the quarter that looks especially promising. One of those targets will be AbbVie's megablockbuster drug Humira. | In it, Halozyme received a $23 million up-front payment from AbbVie for up to nine collaboration targets that will use Halozyme's Enhanze technology. It also managed to ink an exciting new deal with pharma giant AbbVie (NYSE: ABBV) during the quarter that looks especially promising. One of those targets will be AbbVie's megablockbuster drug Humira. |
26755.0 | 2015-12-04 00:00:00 UTC | What Awaits GW Pharmaceuticals (GWPH) in Q4 Earnings? | ABBV | https://www.nasdaq.com/articles/what-awaits-gw-pharmaceuticals-gwph-in-q4-earnings-2015-12-04 | nan | nan | GW PharmaceuticalsGWPH is set to report fourth-quarter fiscal 2015 results on Dec 7, after the market closes. Last quarter, the company posted a negative earnings surprise of 23.08%. Let's see how things are shaping up for this announcement.
Factors at Play This Quarter
The company's key growth driver, Sativex, is approved outside the U.S. for the treatment of spasticity associated with multiple sclerosis. Sativex is currently being evaluated in a phase III study for the treatment of pain associated with cancer.
GW Pharma's pipeline includes interesting candidates like cannabidiol-based drug, Epidiolex. Epidiolex is currently in phase III development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. The company plans to initiate another phase III study on Epidiolex for the treatment of tuberous sclerosis complex. The company is preparing to submit a regulatory application for the candidate in 2016. Epidiolex has Fast Track designation in the U.S. for the treatment of Dravet syndrome, which should expedite the review process. Epidiolex also enjoys Orphan Drug designation in the U.S. for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. Investor focus is expected to remain on pipeline updates.
What Our Model Indicates
Our proven model does not conclusively show that GW Pharma is likely to beat estimates this quarter. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), #2 (Buy) or #3 (Hold) to likely post an earnings beat. That is not the case here as you will see below.
Zacks ESP: The Earnings ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is -5.80%. This is because the Most Accurate estimate is a loss of $1.46 while the Zacks Consensus Estimate stands at a loss of $1.38.
Zacks Rank: GW Pharma currently carries a Zacks Rank #1. Although the company's Zacks Rank #1 enhances the predictive power of the ESP, its negative ESP makes surprise prediction difficult.
We caution against stocks with a Zacks Rank #4 and #5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revisions.
Stocks That Warrant a Look
Here are a few health care stocks that you may want to consider, as our model shows that they have the right combination of elements to post an earnings beat.
The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3.
AmerisourceBergen Corporation ABC has an Earnings ESP of +0.8% and carries a Zacks Rank #2.
Bristol-Myers Squibb Company BMY has an Earnings ESP of +11.11% and carries a Zacks Rank #3.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Click to get this free report BRISTOL-MYERS (BMY): Free Stock Analysis Report AMERISOURCEBRGN (ABC): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report To read this article on Zacks.com click here. GW PharmaceuticalsGWPH is set to report fourth-quarter fiscal 2015 results on Dec 7, after the market closes. | Click to get this free report BRISTOL-MYERS (BMY): Free Stock Analysis Report AMERISOURCEBRGN (ABC): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report To read this article on Zacks.com click here. The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Zacks Rank: GW Pharma currently carries a Zacks Rank #1. | Click to get this free report BRISTOL-MYERS (BMY): Free Stock Analysis Report AMERISOURCEBRGN (ABC): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report To read this article on Zacks.com click here. The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Zacks ESP: The Earnings ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is -5.80%. | The Earnings ESP for AbbVie Inc. ABBV is +1.75% and it carries a Zacks Rank #3. Click to get this free report BRISTOL-MYERS (BMY): Free Stock Analysis Report AMERISOURCEBRGN (ABC): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report To read this article on Zacks.com click here. GW Pharma's pipeline includes interesting candidates like cannabidiol-based drug, Epidiolex. |
26756.0 | 2015-12-04 00:00:00 UTC | The 3 Most Important Drugs in Amgen's Pipeline | ABBV | https://www.nasdaq.com/articles/3-most-important-drugs-amgens-pipeline-2015-12-04 | nan | nan | Image source: Amgen via Flickr.
The original biotech blue-chip stock, Amgen , has had nothing short of a phenomenal year. Even though its share price is up a pedestrian 3% year to date, the trailing-12-month period has witnessed Amgen gaining six new approvals or expansions.
Beginning with the approval on Blincyto for a rare form of acute lymphoblastic leukemia in early Dec. 2014, Amgen has since delivered approvals for a number of new molecular entities, including Corlanor, Repatha, and Imlygic, an expanded label for multiple myeloma drug Kyprolis, and approval for the Onpro Kit to deliver Neulasta to patients undergoing chemotherapy.
The approvals are consistent with Amgen's announced plans to report data on 10 late-stage products between 2014 and 2016. What's truly been remarkable is that Amgen has been perfect in hitting its primary endpoints and gaining approval for its late-stage compounds. It's been a nice surprise for investors, and it could fuel years of sustainable growth for Amgen and its shareholders.
The most important drugs in Amgen's pipeline
But Amgen looks to be far from done when it comes to bringing lucrative products to market. Despite its deep pipeline, I would contend that the following three experimental therapies are currently its most important.
ABP 501
Interestingly enough, a "novel" medicine really isn't the most exciting developing drug in Amgen's pipeline. Instead, that distinction goes to ABP 501, one of Amgen's numerous biosimilar drugs in development. Biosimilars have similar active properties to innovator drugs that they're designed to compete with, but unlike a generic drug, they are not "copies" of an innovator drug. Biosimilars are still expected to command a healthy price tag, but they'll offer a discount likely ranging from 10% to as much as 50% from an innovator drug.
Image source: AbbVie.
ABP 501 is Amgen's biosimilar drug designed to compete with AbbVie 's anti-inflammatory drug Humira, which is currently the best-selling drug in the world and on pace for more than $13 billion in global sales in 2015. For AbbVie, Humira is expected to lose its patent exclusivity late in 2016, exposing the drug to multiple avenues of potential competition. Considering that Humira is roughly a $13 billion drug, the market for a biosimilar at a discounted price to Humira could become a blockbuster, even in a highly competitive therapeutic indication.
Just last week, Amgen announced that it had filed for U.S. approval of ABP 501 after it demonstrated comparable efficacy and safety to Humira in late-stage clinical studies for rheumatoid arthritis and plaque psoriasis. The irony here is the first biosimilar approved in the U.S. came earlier this year, and it was a biosimilar of Amgen's white blood cell-enhancing drug Neupogen.
Expect a lot of emphasis on Amgen's biosimilar franchise throughout the remainder of this decade and beyond, but look to ABP 501 to be the company's first step forward.
Omecamtiv mecarbil
When it comes to its new cardiovascular franchise, Amgen is breaking out of the box. For Big Pharma and blue-chip biotech companies, it's commonplace to focus on their strengths. For many, that equates to anywhere from one to six therapeutic indications. It's rare for bigger drug developers to deviate from their core indications because it usually means substantial marketing and launch costs, as well as a lot of established competition. Amgen, though, doesn't seem to care.
Image source: Centers for Disease Control and Prevention.
After bringing next-generation LDL-cholesterol-lowering injection Repatha to pharmacy shelves, as well as chronic heart failure drug Corlanor, Amgen and development partner Cytokinetics are looking for the trifecta with experimental cardiac myosin activator omecamtiv mecarbil. In layman's terms, omecamtiv mecarbil is designed to aid the heart's ability to contract, thus improving its ability to pump blood throughout the body.
In the midstage COSMIC-HF trial, which Amgen and Cytokinetics reported results from a little more than a month ago, omecamtiv mecarbil "showed statistically significant improvements in several measures of cardiac function, including systolic ejection time, stroke volume, and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization" in chronic heart failure patients. The trial wasn't modeled to assess cardiovascular outcomes, but from the perspective of safety and initial efficacy, everything is looking good.
If approved, omecamtiv mecarbil could generate north of $1 billion in peak annual sales.
Kyprolis
Finally, we're once again forced to sit on the edge of our seats to find out what happens next to multiple myeloma drug Kyprolis, which Amgen acquired when it purchased Onyx Pharmaceuticals.
Image source: Amgen.
Amgen shareholders had a bit of a scare last year after the company reported results from its two phase 3 trials, ASPIRE and FOCUS, designed to assess Kyprolis' efficacy and safety in a second-line setting. In ASPIRE, Kyprolis' progression-free survival improvement thumped the control group by a mile. However, in FOCUS Kyprolis didn't deliver a statistically significant survival benefit over the placebo. Nonetheless, Kyprolis was granted its label expansion to a second-line indication a few months prior.
What investors are going to want to monitor are two ongoing late-stage studies known as CLARION and ARROW. In CLARION, Kyprolis is being assessed in combination with melphalan and prednisone in newly diagnosed multiple myeloma patients compared to a control arm consisting of Velcade in combination with melphalan and prednisone. First-line multiple myeloma is where Celgene 's Revlimid makes a good chunk of its revenue, and moving into a possible first-line indication would be a major win for Kyprolis and Amgen.
ARROW is trial examining Kyprolis as a weekly dosing regimen for relapsed and refractory multiple myeloma patients.
If Kyprolis can somehow find additional label expansion opportunities from its current label of second-line and beyond, it could potentially see its sales double.
Time to buy Amgen?
Now that you have a good idea of what are arguably Amgen's most important developing drugs, you're probably curious as to whether you should be buying the stock. The answer really comes down to your investing strategy and your tolerance for risk. Biotech stocks, even those with established pipelines, tend to be more volatile than the stock market as a whole. Investors who are squeamish of short-term stock movements may not be suited to own Amgen stock.
However, Amgen does look poised for long-term success. Its new complement of approvals and its deep mid- and late-stage pipeline suggest that patent concerns won't be a huge issue due to improving product diversity. I would therefore encourage long-term investors to give Amgen a closer look.
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The article The 3 Most Important Drugs in Amgen's Pipeline originally appeared on Fool.com.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Image source: AbbVie. ABP 501 is Amgen's biosimilar drug designed to compete with AbbVie 's anti-inflammatory drug Humira, which is currently the best-selling drug in the world and on pace for more than $13 billion in global sales in 2015. For AbbVie, Humira is expected to lose its patent exclusivity late in 2016, exposing the drug to multiple avenues of potential competition. | ABP 501 is Amgen's biosimilar drug designed to compete with AbbVie 's anti-inflammatory drug Humira, which is currently the best-selling drug in the world and on pace for more than $13 billion in global sales in 2015. Image source: AbbVie. For AbbVie, Humira is expected to lose its patent exclusivity late in 2016, exposing the drug to multiple avenues of potential competition. | ABP 501 is Amgen's biosimilar drug designed to compete with AbbVie 's anti-inflammatory drug Humira, which is currently the best-selling drug in the world and on pace for more than $13 billion in global sales in 2015. Image source: AbbVie. For AbbVie, Humira is expected to lose its patent exclusivity late in 2016, exposing the drug to multiple avenues of potential competition. | Image source: AbbVie. ABP 501 is Amgen's biosimilar drug designed to compete with AbbVie 's anti-inflammatory drug Humira, which is currently the best-selling drug in the world and on pace for more than $13 billion in global sales in 2015. For AbbVie, Humira is expected to lose its patent exclusivity late in 2016, exposing the drug to multiple avenues of potential competition. |
26757.0 | 2015-12-03 00:00:00 UTC | The Zacks Analyst Blog Highlights: Repros Therapeutics, AbbVie, Amgen, XOMA and Gilead | ABBV | https://www.nasdaq.com/articles/the-zacks-analyst-blog-highlights%3A-repros-therapeutics-abbvie-amgen-xoma-and-gilead-2015 | nan | nan | For Immediate Release
Chicago, IL - December 03, 2015 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Repros Therapeutics ( RPRX ), AbbVie ( ABBV ), Amgen ( AMGN ), XOMA ( XOMA ) and Gilead ( GILD ).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free .
Here are highlights from Wednesday's Analyst Blog:
Biotech Stock Roundup
Repros Therapeutics ( RPRX ) suffered a setback with the FDA issuing a complete response letter (CRL) for the company's lead pipeline candidate. Meanwhile, AbbVie's ( ABBV ) oncology segment got a boost with the FDA approving its multiple myeloma drug.
Recap of the Week's Most Important Stories
1. It's back to the drawing board for Repros which received a CRL from the FDA for enclomiphene. Repros was looking to get enclomiphene approved for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.
But the FDA has made it clear that the design of the phase III studies on enclomiphene is no longer enough to show clinical benefit. The regulatory agency recommended that Repros should conduct an additional phase III study or studies to support approval in the target population. Other concerns raised by the FDA were about study entry criteria, titration and bioanalytical method validation in the phase III program.
While Repros shares were down more than 27%, the CRL does not really come as a surprise considering the FDA had cancelled an advisory panel meeting that was scheduled to take place in November.
2. AbbVie and partner Bristol-Myers Squibb gained FDA approval for their blood cancer treatment, Empliciti. Empliciti is currently under review in the EU where it received accelerated assessment. Multiple myeloma remains largely incurable with less than 50% of patients surviving for 5 years or more after diagnosis. (Read more: AbbVie/Bristol-Myers Multiple Myeloma Drug Gets FDA Nod ).
3. Biotech major Amgen ( AMGN ), which is currently facing biosimilar competition for one its key drugs in the U.S., is progressing in its own efforts to bring biosimilars to market. The company has filed a BLA for ABP 501, its biosimilar version of AbbVie's Humira (adalimumab). Amgen believes it is the first to submit a BLA for a Humira biosimilar.
At an analyst conference in Oct 2015, Amgen said that its biosimilars have the potential to generate revenues of more than $3 billion annually. Apart from Humira, Amgen is working on developing biosimilar versions of drugs like Avastin, Herceptin, Remicade, Rituxan and Erbitux (Read more: Amgen Seeks FDA Approval for First Biosimilar of Humira ).
4. XOMA ( XOMA ) has struck a deal with Novo Nordisk which could bring in up to $295 million (including an upfront payment of $5 million) and tiered royalties. In return, Novo Nordisk gets exclusive global rights to XOMA's XMetA program for the treatment of diabetes. Commercialization rights for rare disease indications remain with XOMA.
5. Results from an 18-month investigation into the pricing and marketing of Gilead's ( GILD ) blockbuster hepatitis C virus (HCV) drugs Sovaldi and Harvoni were released by Senate Finance Committee Ranking Member Ron Wyden, D-OR, and senior committee member Chuck Grassley, R-IA.
Based on information taken from internal company documents, interviews with health care experts, and data from Medicaid programs in 50 states and the District of Columbia, the investigation showed that Gilead's marketing strategy and final wholesale price of Sovaldi ($1,000 per pill or $84,000 for a single course of treatment; Harvoni was later introduced at $94,500) was based on revenue maximization.
The investigation indicated that encouraging broad, affordable access was not a key consideration in the process of setting the wholesale prices. The report also stated that Medicare spent more on Gilead HCV drugs in the first half of 2015 than in all of 2014. This report once again brings into focus concerns regarding the pricing of drugs.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Stocks recently featured in the blog include Repros Therapeutics ( RPRX ), AbbVie ( ABBV ), Amgen ( AMGN ), XOMA ( XOMA ) and Gilead ( GILD ). Meanwhile, AbbVie's ( ABBV ) oncology segment got a boost with the FDA approving its multiple myeloma drug. AbbVie and partner Bristol-Myers Squibb gained FDA approval for their blood cancer treatment, Empliciti. | Stocks recently featured in the blog include Repros Therapeutics ( RPRX ), AbbVie ( ABBV ), Amgen ( AMGN ), XOMA ( XOMA ) and Gilead ( GILD ). Click to get this free report REPROS THERAPEU (RPRX): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, AbbVie's ( ABBV ) oncology segment got a boost with the FDA approving its multiple myeloma drug. | Stocks recently featured in the blog include Repros Therapeutics ( RPRX ), AbbVie ( ABBV ), Amgen ( AMGN ), XOMA ( XOMA ) and Gilead ( GILD ). Click to get this free report REPROS THERAPEU (RPRX): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, AbbVie's ( ABBV ) oncology segment got a boost with the FDA approving its multiple myeloma drug. | Stocks recently featured in the blog include Repros Therapeutics ( RPRX ), AbbVie ( ABBV ), Amgen ( AMGN ), XOMA ( XOMA ) and Gilead ( GILD ). Meanwhile, AbbVie's ( ABBV ) oncology segment got a boost with the FDA approving its multiple myeloma drug. AbbVie and partner Bristol-Myers Squibb gained FDA approval for their blood cancer treatment, Empliciti. |
26758.0 | 2015-12-03 00:00:00 UTC | AbbVie's NDA for Once-Daily Viekira Pak Accepted by FDA | ABBV | https://www.nasdaq.com/articles/abbvies-nda-for-once-daily-viekira-pak-accepted-by-fda-2015-12-03 | nan | nan | AbbVie Inc.ABBV announced that its regulatory application for the once-daily, fixed-dose formulation of hepatitis C virus (HCV) infection drug, Viekira Pak, has been accepted by the FDA. The agency is expected to render a final decision in the second half of 2016.
The currently available twice-daily Viekira Pak was approved by the FDA late last year for the treatment of patients with chronic HCV genotype 1 infection, including those with cirrhosis, a type of advanced liver disease. The treatment can be used with or without ribavirin but is not recommended for use in patients whose liver is unable to function properly (decompensated cirrhosis). Once-daily Viekira Pak, if approved, could reduce the pill burden on patients and thus, increase patient compliance and convenience. Viekira recorded sales of $1.1 billion in the first nine months of 2015.
We remind investors that in October, Abbvie came under the spotlight after the FDA issued a warning related to Viekira Pak and another HCV drug, Technivie. The agency had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ).
Meanwhile, competition in the HCV market is intensifying. Gilead Sciences' GILD Sovaldi and Harvoni are already approved for the treatment of this disease, while several companies like Merck & Co. Inc. MRK are looking to bring their own HCV treatments to the market.
AbbVie currently carries a Zacks Rank #3 (Hold). Baxalta Incorporated BXLT and Gilead Sciences are a couple of better-ranked stock in the health care sector. While Baxalta sports Zacks Rank #1 (Strong Buy), Gilead has a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV announced that its regulatory application for the once-daily, fixed-dose formulation of hepatitis C virus (HCV) infection drug, Viekira Pak, has been accepted by the FDA. We remind investors that in October, Abbvie came under the spotlight after the FDA issued a warning related to Viekira Pak and another HCV drug, Technivie. The agency had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). | The agency had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that its regulatory application for the once-daily, fixed-dose formulation of hepatitis C virus (HCV) infection drug, Viekira Pak, has been accepted by the FDA. | The agency had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that its regulatory application for the once-daily, fixed-dose formulation of hepatitis C virus (HCV) infection drug, Viekira Pak, has been accepted by the FDA. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced that its regulatory application for the once-daily, fixed-dose formulation of hepatitis C virus (HCV) infection drug, Viekira Pak, has been accepted by the FDA. We remind investors that in October, Abbvie came under the spotlight after the FDA issued a warning related to Viekira Pak and another HCV drug, Technivie. |
26759.0 | 2015-12-02 00:00:00 UTC | Health Care Sector Update for 12/02/2015: ENTA, REPH, ACHC | ABBV | https://www.nasdaq.com/articles/health-care-sector-update-12022015-enta-reph-achc-2015-12-02 | nan | nan | Top Health-care stocks:
JNJ: flat
PFE: -0.1%
ABT: flat
MRK: flat
AMGN: flat
Health-care shares were mainly unchanged in pre-market trade Wednesday.
In health-care stocks news, Enanta Pharmaceuticals' ( ENTA ) partner AbbVie ( ABBV ) said that the Food and Drug Administration accepted its New Drug Application for VIEKIRA PAK, an all-oral, once-daily, fixed-dose treatment for patients with genotype I chronic hepatitis C virus infection.
Shares in Enanta were unchanged at $31.90 in recent pre-market trade, towards the lower end of the stock's 52-week trading range between $16.75 and $52.58.
Pharmaceutical company Recro Pharma ( REPH ) has named Stewart McCallum as its chief medical officer.
Shares in the company were flat at $9.29 in recent pre-market trade, also toward the lower end of the 52 week range between $2.36 and $18.30.
And Acadia Healthcare Company ( ACHC ), a provider of behavioral healthcare services, said Wednesday that it has acquired MMO Behavioral Health Systems.
Shares in the company were flat at $69.34 pre-bell, around the mid-point of the stock's 52 week trading range between $54.41 and $85.62.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
Copyright (C) 2016 MTNewswires.com. All rights reserved. Unauthorized reproduction is strictly prohibited.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In health-care stocks news, Enanta Pharmaceuticals' ( ENTA ) partner AbbVie ( ABBV ) said that the Food and Drug Administration accepted its New Drug Application for VIEKIRA PAK, an all-oral, once-daily, fixed-dose treatment for patients with genotype I chronic hepatitis C virus infection. Pharmaceutical company Recro Pharma ( REPH ) has named Stewart McCallum as its chief medical officer. Shares in the company were flat at $9.29 in recent pre-market trade, also toward the lower end of the 52 week range between $2.36 and $18.30. | In health-care stocks news, Enanta Pharmaceuticals' ( ENTA ) partner AbbVie ( ABBV ) said that the Food and Drug Administration accepted its New Drug Application for VIEKIRA PAK, an all-oral, once-daily, fixed-dose treatment for patients with genotype I chronic hepatitis C virus infection. ABT: flat MRK: flat AMGN: flat Health-care shares were mainly unchanged in pre-market trade Wednesday. Shares in Enanta were unchanged at $31.90 in recent pre-market trade, towards the lower end of the stock's 52-week trading range between $16.75 and $52.58. | In health-care stocks news, Enanta Pharmaceuticals' ( ENTA ) partner AbbVie ( ABBV ) said that the Food and Drug Administration accepted its New Drug Application for VIEKIRA PAK, an all-oral, once-daily, fixed-dose treatment for patients with genotype I chronic hepatitis C virus infection. ABT: flat MRK: flat AMGN: flat Health-care shares were mainly unchanged in pre-market trade Wednesday. Shares in Enanta were unchanged at $31.90 in recent pre-market trade, towards the lower end of the stock's 52-week trading range between $16.75 and $52.58. | In health-care stocks news, Enanta Pharmaceuticals' ( ENTA ) partner AbbVie ( ABBV ) said that the Food and Drug Administration accepted its New Drug Application for VIEKIRA PAK, an all-oral, once-daily, fixed-dose treatment for patients with genotype I chronic hepatitis C virus infection. ABT: flat MRK: flat AMGN: flat Health-care shares were mainly unchanged in pre-market trade Wednesday. Shares in the company were flat at $69.34 pre-bell, around the mid-point of the stock's 52 week trading range between $54.41 and $85.62. |
26760.0 | 2015-12-02 00:00:00 UTC | Gilead's High-Priced HCV Drugs in Focus on Senate Report | ABBV | https://www.nasdaq.com/articles/gileads-high-priced-hcv-drugs-in-focus-on-senate-report-2015-12-02 | nan | nan | Results of an 18-month investigation into the pricing and marketing of Gilead Sciences Inc. 's GILD hepatitis C virus (HCV) infection drug, Sovaldi, and its second-wave successor, Harvoni, were released by Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley.
The investigation concluded that Gilead had pursued a calculated marketing strategy and the final wholesale price of Sovaldi ($84,000 for a single course of treatment) was aimed to generate maximum revenue. Affordable access, on the other hand, was not a key consideration in the process of setting the wholesale prices. Materials reviewed under the investigation showed that Gilead considered a number of factors in determining a price for Sovaldi, including costs of the existing standard of care for HCV treatment and setting a high baseline for the next wave of HCV drugs like Harvoni, which was introduced at $94,500. The company has raked in $14.2 billion from sales of the two drugs in the first nine months of 2015.
Gilead is no stranger to the pricing controversy and has often been criticized for the pricing of its HCV treatments, Sovaldi and Harvoni. Last year, largest U.S. pharmacy benefit manager, Express Scripts ESRX dropped Gilead's HCV drugs for AbbVie's ABBV cheaper HCV treatment, Viekira Pak.
Gilead's HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from the year-ago figure owing to the availability of newer HCV therapies. Harvoni witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter.
Meanwhile, competition in the HCV market is intensifying as several companies including Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Gilead currently carries a Zacks Rank #2 (Buy). Express Scripts is another favorably ranked stock in the broader health care sector with the same rank as Gilead.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Last year, largest U.S. pharmacy benefit manager, Express Scripts ESRX dropped Gilead's HCV drugs for AbbVie's ABBV cheaper HCV treatment, Viekira Pak. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report EXPRESS SCRIPTS (ESRX): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Results of an 18-month investigation into the pricing and marketing of Gilead Sciences Inc. 's GILD hepatitis C virus (HCV) infection drug, Sovaldi, and its second-wave successor, Harvoni, were released by Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley. | Last year, largest U.S. pharmacy benefit manager, Express Scripts ESRX dropped Gilead's HCV drugs for AbbVie's ABBV cheaper HCV treatment, Viekira Pak. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report EXPRESS SCRIPTS (ESRX): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report EXPRESS SCRIPTS (ESRX): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Last year, largest U.S. pharmacy benefit manager, Express Scripts ESRX dropped Gilead's HCV drugs for AbbVie's ABBV cheaper HCV treatment, Viekira Pak. Results of an 18-month investigation into the pricing and marketing of Gilead Sciences Inc. 's GILD hepatitis C virus (HCV) infection drug, Sovaldi, and its second-wave successor, Harvoni, were released by Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley. | Last year, largest U.S. pharmacy benefit manager, Express Scripts ESRX dropped Gilead's HCV drugs for AbbVie's ABBV cheaper HCV treatment, Viekira Pak. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report EXPRESS SCRIPTS (ESRX): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead is no stranger to the pricing controversy and has often been criticized for the pricing of its HCV treatments, Sovaldi and Harvoni. |
26761.0 | 2015-12-01 00:00:00 UTC | Can Bristol-Myers Squibb And AbbVie's Empliciti Become a Top Seller? | ABBV | https://www.nasdaq.com/articles/can-bristol-myers-squibb-and-abbvies-empliciti-become-top-seller-2015-12-01 | nan | nan | Image source: Bristol-Myers Squibb.
The FDA has given Bristol-Myers Squibb and AbbVie 's multiple myeloma drug Empliciti a green light, and that could mean that the way doctors have traditionally treated recurring multiple myeloma is about to change. If so, then Empliciti could become a billion-dollar blockbuster.
Redefining care
Multiple myeloma occurs when abnormal plasma cells build up in the bone marrow and form tumors that can reduce the number of white and red blood cells that are produced in the bone marrow.
The cancer is diagnosed in 26,850 Americans every year and despite advances that are improving survival, there's still a significant need for new therapies because 11,240 people die from multiple myeloma every year.
Currently, newly diagnosed multiple myeloma patients are treated with dexamethasone or dexamethasone plus Celgene 's (NASDAQ: CELG) Revlimid, or a combination that includes Takeda 's Velcade, a proteasome inhibitor. However, because there's no cure for multiple myeloma, these and other medications -- including Celgene's Pomalyst -- are frequently used to help keep the disease from worsening.
The approval of these therapies has led to multiple myeloma five-year survival rates improving to 46.6% from 26.6% in 1975. Adding Bristol-Myers Squibb and AbbVie's Empliciti to second-line treatment may improve these survival rates further.
In trials, dosing Empliciti alongside dexamethasone and Revlimid in patients who have seen their disease return or fail to improve after first line therapy delayed disease progression by 19.4 months, which is far longer than the 14.9-month delay experienced by patients receiving only dexamethasone and Revlimid.
Additionally, 78.5% of patients taking the Empliciti combination therapy saw complete or partial tumor shrinkage and that was better than the 65.5% reported in the dexamethasone plus Revlimid arm of the study.
Image source: AbbVie.
A billion-dollar market
Celgene expects sales of Revlimid to top $5.6 billion this year, Velcade's sales totaled $2.9 billion last year, and sales of Pomalyst exited the third quarter at a billion-dollar annualized clip.
Those numbers suggest that Empliciti has blockbuster potential, too -- especially since Empliciti will cost roughly $10,000 per month , which is a little south of Revlimid's $14,000 monthly price tag but is north of Velcade's $9,000-per-month cost.
Looking forward
In the U.S., Bristol-Myers Squibb will get 70% of any profit on sales of Empliciti and AbbVie will get 30%. Outside the U.S., Bristol-Myers Squibb will pay AbbVie a royalty. As a result, Empliciti will move the needle more for Bristol-Myers Squibb than it does for AbbVie.
Ultimately, how much Empliciti contributes to each of these companies' top and bottom line will depend a lot on payers. Because each of these multiple myeloma drugs is pricey, payers may balk at using Empliciti in the second-line setting. Instead, they may try to convince doctors to use it as a third-line therapy and if so, then that would reduce its peak sales potential. For that reason, investors will want to keep an eye on Bristol-Myers Squibb's quarterly earnings releases in 2016 to see how quickly the drug's sales ramp.
The next billion-dollar iSecret
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The article Can Bristol-Myers Squibb And AbbVie's Empliciti Become a Top Seller? originally appeared on Fool.com.
Todd Campbell owns shares of Celgene. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Celgene. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The FDA has given Bristol-Myers Squibb and AbbVie 's multiple myeloma drug Empliciti a green light, and that could mean that the way doctors have traditionally treated recurring multiple myeloma is about to change. Adding Bristol-Myers Squibb and AbbVie's Empliciti to second-line treatment may improve these survival rates further. Image source: AbbVie. | The FDA has given Bristol-Myers Squibb and AbbVie 's multiple myeloma drug Empliciti a green light, and that could mean that the way doctors have traditionally treated recurring multiple myeloma is about to change. Adding Bristol-Myers Squibb and AbbVie's Empliciti to second-line treatment may improve these survival rates further. Image source: AbbVie. | The FDA has given Bristol-Myers Squibb and AbbVie 's multiple myeloma drug Empliciti a green light, and that could mean that the way doctors have traditionally treated recurring multiple myeloma is about to change. Adding Bristol-Myers Squibb and AbbVie's Empliciti to second-line treatment may improve these survival rates further. Image source: AbbVie. | The FDA has given Bristol-Myers Squibb and AbbVie 's multiple myeloma drug Empliciti a green light, and that could mean that the way doctors have traditionally treated recurring multiple myeloma is about to change. Looking forward In the U.S., Bristol-Myers Squibb will get 70% of any profit on sales of Empliciti and AbbVie will get 30%. Adding Bristol-Myers Squibb and AbbVie's Empliciti to second-line treatment may improve these survival rates further. |
26762.0 | 2015-12-01 00:00:00 UTC | AbbVie/Bristol-Myers Multiple Myeloma Drug Gets FDA Nod | ABBV | https://www.nasdaq.com/articles/abbvie-bristol-myers-multiple-myeloma-drug-gets-fda-nod-2015-12-01 | nan | nan | AbbVie Inc.ABBV and its partner Bristol-Myers Squibb Company BMY announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies.
This makes Empliciti the first and only immunostimulatory antibody to be approved for the treatment of multiple myeloma.
Empliciti is also under review in the EU as a combination therapy for the treatment of multiple myeloma patients who have received one or more prior therapies. It has been granted accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.
While AbbVie and Bristol-Myers are co-developing Empliciti, the latter will be solely responsible for commercial activities. Bristol-Myers plans to start shipping the drug in a couple of days.
We are encouraged by the FDA approval of Empliciti. Per information provided by Bristol-Myers in its press release, more than 114,200 new cases of multiple myeloma are diagnosed annually, resulting in more than 80,000 deaths globally. Moreover, it has been observed that the disease remains mostly incurable with less than half the patients surviving for five or more years after diagnosis.
We note that Johnson & Johnson's JNJ Darzalex (daratumumab) also gained FDA approval last month for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.
Among other approved drugs for the treatment of multiple myeloma are Kyprolis and Velcade.
Currently, both AbbVie and Bristol-Myers are Zacks Rank #3 (Hold) stocks. Achillion Pharmaceuticals, Inc. ACHN is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV and its partner Bristol-Myers Squibb Company BMY announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies. While AbbVie and Bristol-Myers are co-developing Empliciti, the latter will be solely responsible for commercial activities. Currently, both AbbVie and Bristol-Myers are Zacks Rank #3 (Hold) stocks. | Click to get this free report BRISTOL-MYERS (BMY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ACHILLION PHARM (ACHN): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV and its partner Bristol-Myers Squibb Company BMY announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies. While AbbVie and Bristol-Myers are co-developing Empliciti, the latter will be solely responsible for commercial activities. | AbbVie Inc.ABBV and its partner Bristol-Myers Squibb Company BMY announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies. Click to get this free report BRISTOL-MYERS (BMY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ACHILLION PHARM (ACHN): Free Stock Analysis Report To read this article on Zacks.com click here. While AbbVie and Bristol-Myers are co-developing Empliciti, the latter will be solely responsible for commercial activities. | AbbVie Inc.ABBV and its partner Bristol-Myers Squibb Company BMY announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies. Currently, both AbbVie and Bristol-Myers are Zacks Rank #3 (Hold) stocks. While AbbVie and Bristol-Myers are co-developing Empliciti, the latter will be solely responsible for commercial activities. |
26763.0 | 2015-11-30 00:00:00 UTC | Where Will Gilead Sciences Be in 10 Years? | ABBV | https://www.nasdaq.com/articles/where-will-gilead-sciences-be-10-years-2015-11-30 | nan | nan | Of course, investors who are interested in Gilead's stock today cannot simply rewind the clock to take advantage of its past success, so the only question that matters to them now is where this company's stock will be heading over the next 10 years. With that question in mind, we asked our team of Motley Fool contributors to share what they think Gilead Sciences' business will look like 10 years from now. Read below to see what they had to say.
Sean Williams: Where will Gilead Sciences be 10 years from now? Likely higher in terms of stock price, but the look of the company will more than likely be far different than what we see today.
At the moment, Gilead is highly reliant on its antiviral products, such as Harvoni and Sovaldi for hepatitis C, and Stribild as a treatment for patients with HIV. In the third quarter, global antiviral products accounted for $7.7 billion of Gilead's $8.21 billion in total revenue. For the time being this reliance fits Gilead's strategy just fine. There are an estimated 180 million people globally with HCV, per the World Health Organization, making it a disease with an abundant patient pool. It also doesn't hurt that no other HCV therapy on the market has matched Gilead in convenience and efficacy.
But the Gilead of 2025 is probably going to look a lot different. The Gilead is 2025 will likely still be a major player in treating hepatitis C, but there are probably going to be around a half-dozen additional entrants into the field. By 2025, Gilead may have garnered drug approvals for other common liver diseases, such as nonalcoholic steatohepatitis and hepatitis B. The increased competition in hepatitis C could wind up weighing on Gilead's luscious margins, but I highly doubt it'll make much of a dent in Gilead's overall profitability.
The biggest change I foresee is an expansion of Gilead's product portfolio into oncology and inflammation/respiratory. Zydelig (known scientifically as idelalisib) has demonstrated promise in certain types of leukemia, and JAK inhibitor momelotinib could prove successful in pancreatic cancer and myelofibrosis, a rare type of bone marrow cancer. Within its anti-inflammatory/respiratory pipeline you'll want to monitor GS-5745, which could have wide-ranging implications from rheumatoid arthritis to COPD.
I do believe Gilead's growth rate will slow over the next 10 years, but even with modest margin pressures would still expect its top- and bottom-line results to improve by 2025.
rian Feroldi : Ten years is a long enough time period for Gilead to navigate even its phase 1 clinical stage compounds through the regulatory approval process, so it makes sense to look there for clues about where this company is heading over the coming decade.
While Gilead has a number of drugs in early clinical trials that are designed to expand its leadership position in its core markets (HIV/AIDS and hepatitis C), Gilead has also been experimenting with drugs in a handful of other diseases as well. Gilead has built out an impressive number of drugs that could one day be used to treat diseases in the hematology, oncology, inflammation, respiratory, and cardiovascular spaces.
One particularly promising space for Gilead is rheumatoid arthritis treatment. The current leading treatment for this disease is AbbVie 's Humira. Humira was the world's best-selling drug last year, bringing in $3.6 billion last quarter alone. Although Humira is currently approved to treat far more than just rheumatoid arthritis, this indication clearly a huge market opportunity for Gilead to pursue. Keep an eye on Gilead's two phase 1 drugs in this therapeutic area.
Of course, all of Gilead's early-stage drug candidates still have years of development time ahead of them, and many of these compounds will likely fail before making their way to market. But since Gilead has such a long history of successfully bringing innovative new treatments to markets, I'd expect that at least one of these drugs will be a winner for the company a decade from now.
Cheryl Swanson : When I think of biotech juggernaut Gilead Sciences' 10-year future, a couple of things stand out. First, Gilead's growth rate is staggering. Last quarter, at the company level, Gilead was the largest contributor to earnings growth for the entire healthcare sector. In fact, if you exclude Gilead from sector earnings growth last quarter, the blended earnings growth rate for healthcare drops to 9.9% from 14.6%, according to FactSet.
As my colleagues have pointed out, this company's pipeline is top notch. But it's Gilead's expertise at making cunning acquisitions that I believe will continue to drive its long-term growth. Gilead's ability to identify, acquire, and commercialize drugs is in a class of its own. The company's first blockbuster was the drug Viread, bought from a European lab in 1991, which it transformed into one of the most widely-used components in HIV drugs. A string of astonishingly successful acquisitions followed, including small U.S. biotech Pharmasset, which Gilead scooped up for $11 billion in 2011. Within three years, due to a series of bold, high-risk trials, Gilead had brought Pharmasset's molecule sofosbuvir to market as the mega-blockbuster Sovaldi.
Gilead faces some challenges, and it may not be able to keep good news flowing quarterly in the near term. But consider that 10 years ago, in 2005, Gilead's fiscal-full-year revenue was a measly $2 billion. This year, it is forecasting revenue of $30 billion to $31 billion . Ten years from now? No guarantees, but I expect this biotech will still be blowing us out of the water.
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The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Where Will Gilead Sciences Be in 10 Years? originally appeared on Fool.com.
Brian Feroldi owns shares of Gilead Sciences. Cheryl Swanson has no position in any stocks mentioned. Sean Williams has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The current leading treatment for this disease is AbbVie 's Humira. I do believe Gilead's growth rate will slow over the next 10 years, but even with modest margin pressures would still expect its top- and bottom-line results to improve by 2025. rian Feroldi : Ten years is a long enough time period for Gilead to navigate even its phase 1 clinical stage compounds through the regulatory approval process, so it makes sense to look there for clues about where this company is heading over the coming decade. Gilead has built out an impressive number of drugs that could one day be used to treat diseases in the hematology, oncology, inflammation, respiratory, and cardiovascular spaces. | The current leading treatment for this disease is AbbVie 's Humira. In the third quarter, global antiviral products accounted for $7.7 billion of Gilead's $8.21 billion in total revenue. One particularly promising space for Gilead is rheumatoid arthritis treatment. | The current leading treatment for this disease is AbbVie 's Humira. Of course, investors who are interested in Gilead's stock today cannot simply rewind the clock to take advantage of its past success, so the only question that matters to them now is where this company's stock will be heading over the next 10 years. I do believe Gilead's growth rate will slow over the next 10 years, but even with modest margin pressures would still expect its top- and bottom-line results to improve by 2025. rian Feroldi : Ten years is a long enough time period for Gilead to navigate even its phase 1 clinical stage compounds through the regulatory approval process, so it makes sense to look there for clues about where this company is heading over the coming decade. | The current leading treatment for this disease is AbbVie 's Humira. With that question in mind, we asked our team of Motley Fool contributors to share what they think Gilead Sciences' business will look like 10 years from now. Likely higher in terms of stock price, but the look of the company will more than likely be far different than what we see today. |
26764.0 | 2015-11-28 00:00:00 UTC | Amgen Inc. Takes Aim at AbbVie Inc. | ABBV | https://www.nasdaq.com/articles/amgen-inc-takes-aim-abbvie-inc-2015-11-28 | nan | nan | Source: Amgen.
In preparation for a new era of generic competition, biotech companies are doubling down on research programs to protect their market share. In Amgen 's case, the company is also jumping into the generic biosimilars market to go after sales of their competitors.
Last week, Amgen submitted a biologics license application for its generic biosimilar to AbbVie Inc .'s best-selling drug, Humira. If that application leads to an approval, it could shift billions of dollars to Amgen from AbbVie.
What's at stake?
Humira is used to treat a variety of autoimmune diseases, including rheumatoid arthritis, which affects more than 1 million people in the United States alone. Because autoimmune diseases are common, and Humira is a complex biologic that commands a premium price of about $60,000 per year, the drug generates billions of dollars in sales for AbbVie every year, including $12.5 billion last year alone.
Source: AbbVie.
Brewing battle
Amgen's application follows its filing of two inter partes reviews (IPRs) this past summer challenging the validity of AbbVie patents that could blunt the threat of its biosimilar. The patents that Amgen is targeting were awarded last year and relate to new formulations of Humira that combine Humira with "well-known and commonly used liquid formulation components" to reduce dosing reactions.
A decision on whether to review AbbVie's patents is expected from the patent approval board by the end of 2015. If they eventually rescind the patents, it could tear down a key defense strategy that AbbVie is hoping will protect Humira's market share. If the patent board sides with AbbVie, then the company may be better positioned to leverage patents to transition traditional Humira patients to new Humira formulations offering patient benefits, such as less injection-site pain.
A similar strategy was successfully employed by Teva Pharmaceutical to protect its multi-billion dollar multiple sclerosis drug, Copaxone. Teva Pharmaceutical used litigation to delay the entry of Copaxone copycats, buying it time to convert roughly two-thirds of its Copaxone patients to a next-generation formulation that reduced the number of monthly injections. In the process, it's protecting billions of dollars in sales.
AbbVie is also developing new drugs for autoimmune diseases that may offer advantages to Humira, including the potential Humira successor, ABT-494. In Phase 2 trials, 82% of patients taking ABT-494 as a once-daily pill achieved a 20% or greater improvement in ACR criteria, or ACR20, and 71% of patients who fail on anti-TNF inhibiting drugs, such as Humira twice daily, achieved ACR20.
Following that mid-stage success, AbbVie plans to launch a phase 3 study by the end of 2015. If that upcoming study confirms the previous findings, AbbVie could have a new best-in-class treatment option available to patients that makes challenges to Humira less threatening.
Looking forward
AbbVie's efforts to protect Humira are critical because Humira represented 61% of AbbVie's sales in the third quarter. Amgen, however, isn't likely to give up easily; neither will other well-heeled competitors, including Novartis , which are also working on their own Humira biosimilars.
Since billions of dollars are at stake, and healthcare payers, including insurers, are desperate for low-cost alternatives to expensive biologics, AbbVie has its work cut out for it if it hopes to fend off biosimilars. Because the risk of biosimilars to the majority of AbbVie's sales is high in spite of its plans, investing in biosimilar drugmakers, rather than AbbVie, may be the better choice.
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The article Amgen Inc. Takes Aim at AbbVie Inc. originally appeared on Fool.com.
Todd Campbell has no position in any stocks mentioned. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool recommends Teva Pharmaceutical Industries. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Brewing battle Amgen's application follows its filing of two inter partes reviews (IPRs) this past summer challenging the validity of AbbVie patents that could blunt the threat of its biosimilar. If that upcoming study confirms the previous findings, AbbVie could have a new best-in-class treatment option available to patients that makes challenges to Humira less threatening. Since billions of dollars are at stake, and healthcare payers, including insurers, are desperate for low-cost alternatives to expensive biologics, AbbVie has its work cut out for it if it hopes to fend off biosimilars. | Because autoimmune diseases are common, and Humira is a complex biologic that commands a premium price of about $60,000 per year, the drug generates billions of dollars in sales for AbbVie every year, including $12.5 billion last year alone. If they eventually rescind the patents, it could tear down a key defense strategy that AbbVie is hoping will protect Humira's market share. If the patent board sides with AbbVie, then the company may be better positioned to leverage patents to transition traditional Humira patients to new Humira formulations offering patient benefits, such as less injection-site pain. | Because autoimmune diseases are common, and Humira is a complex biologic that commands a premium price of about $60,000 per year, the drug generates billions of dollars in sales for AbbVie every year, including $12.5 billion last year alone. If the patent board sides with AbbVie, then the company may be better positioned to leverage patents to transition traditional Humira patients to new Humira formulations offering patient benefits, such as less injection-site pain. Looking forward AbbVie's efforts to protect Humira are critical because Humira represented 61% of AbbVie's sales in the third quarter. | If the patent board sides with AbbVie, then the company may be better positioned to leverage patents to transition traditional Humira patients to new Humira formulations offering patient benefits, such as less injection-site pain. Last week, Amgen submitted a biologics license application for its generic biosimilar to AbbVie Inc . If that application leads to an approval, it could shift billions of dollars to Amgen from AbbVie. |
26765.0 | 2015-11-27 00:00:00 UTC | Amgen Seeks FDA Approval for First Biosimilar of Humira | ABBV | https://www.nasdaq.com/articles/amgen-seeks-fda-approval-for-first-biosimilar-of-humira-2015-11-27 | nan | nan | Amgen Inc.AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. The application is Amgen's first BLA submitted under the 351(k) biosimilar pathway. The company believes that it is the first to file a biosimilar application for Humira.
We note that Humira, an anti-TNF-α monoclonal antibody, is approved in many countries for the treatment of a wide range of inflammatory diseases. Humira delivered worldwide sales of $10.3 billion in the first nine months of 2015 and was one of the top-selling products in the U.S. in 2014.
Amgen currently has nine biosimilar candidates in its portfolio representing huge commercial opportunity - annual revenues of more than $3 billion. The company plans to launch its first biosimilar in 2017 followed by four others through 2019, subject to approval.
However, Amgen itself is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved biosimilar, was launched by Novartis AG's NVS generic arm, Sandoz, in September. Zarxio is the biosimilar version of Amgen's blockbuster drug, Neupogen. And it's not just Neupogen. Amgen is also likely to face biosimilar competition for a couple of key drugs in its portfolio - Neulasta and Enbrel. Sandoz announced that regulatory applications for the biosimilar versions of both Neulasta and Enbrel are currently under FDA review.
According to sources, the market for biosimilars can grow to $20 billion in 2020. Not surprisingly, competition in this space is intensifying with pharmaceutical and biotech companies racing to develop biosimilars.
Amgen is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Baxalta Incorporated BXLT , carrying a Zacks Rank #1 (Strong Buy). The company is also exploring the world of biosimilars.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Amgen Inc.AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. We note that Humira, an anti-TNF-α monoclonal antibody, is approved in many countries for the treatment of a wide range of inflammatory diseases. | Amgen Inc.AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Amgen Inc.AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. However, Amgen itself is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved biosimilar, was launched by Novartis AG's NVS generic arm, Sandoz, in September. | Amgen Inc.AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. Click to get this free report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Zarxio is the biosimilar version of Amgen's blockbuster drug, Neupogen. |
26766.0 | 2015-11-26 00:00:00 UTC | Gilead Sciences Grabs 4 Regulatory Wins -- but Does It Matter? | ABBV | https://www.nasdaq.com/articles/gilead-sciences-grabs-4-regulatory-wins-does-it-matter-2015-11-26 | nan | nan | Image source: Images_of_Money via Flickr Creative Commons.
Biotech blue-chip Gilead Sciences has been in the news a lot recently. The company is continuing to make clinical and regulatory progress on its huge pipeline, and with a few dozen clinical trials going on at any given time, it can be a bit of a challenge to keep up with the company's news flow. Since the start of October alone, Gilead has announced four regulatory wins. You wouldn't know it from only looking at the company's stock price, however, as shares have basically traded sideways over that time period.
Did investors miss something important? Let's dig in to the recent announcements to judge for ourselves.
A cardiovascular win
Most of the attention Gilead garners from investors relates to it dominant HIV and Hepatitis C businesses, so you might be surprised to learn that Gilead has a cardiovascular division. In fact, Gilead currently counts three different drugs on the market that treat cardiovascular diseases -- Letairis, Lexiscan, and Ranexa. While none of these medicines on their own is big enough to have much of an impact on Gilead's top or bottom lines, they still deserve some attention from investors. Combined, these drugs have produced nearly $1 billion in sales through the first nine months of the year.
GIlead's current best-selling cardiovascular drug, Letairis, just managed to nab an additional label expansion from the FDA. On October 2, the agency approved a new combination treatment option using Letairis and tadalafil for pulmonary arterial hypertension -- or PAH -- a condition characterized by high blood pressure in the lungs. In clinical studies, using Letairis and tadalafil together reduced the progression of PAH by almost 50% when compared to using either therapy alone.
Letairis isn't an enormously important drug for Gilead investors to concentrate on since it "only" generated $508 million in sales through the first nine months of the year, but a win is a win, and this label expansion should help the drug continue to grow.
A HIV/AIDS treatment win at home and across the pond
While revenue from its cardiovascular disease drugs is a relative drop in the bucket, revenue from Gilead's HIV/AIDS drugs is extremely important. These drugs have combined to generate roughly $8 billion in total sales since the start of the year.
With that in mind, investors should likely be cheering November 5th's FDA approval of Genvoya, Gilead's new single-tablet treatment for HIV-1.
Genvoya looks like it could be a big winner for Gilead. The drug showed improved renal and bone clinical outcomes compared to only using a TDF-based regimen, such as Gilead's Viread. That could prove to be a great clinical advantage since many patients with HIV also have low bone mineral density and renal impairment. In addition, Genvoya appears to be quite potent, as it showed similar clinical antiviral efficacy when compared to Viread at one tenth of the dosage level.
To add some more good news to this party, Gilead just announced that Genvoya also received marketing authorization in the European Union as well.
While the net impact on the company's financials is a bit tough to judge at this point -- Genvoya's success could end up simply stealing sales from its other HIV medicines -- it does show that Gilead continues to maintain its clinical edge in HIV. All told, Gilead should continue to dominate the HIV market.
A small Hepatitis C victory lap
Finally, Gilead announced on November 12 that the FDA has approved an expanded labeling for blockbuster HCV treatment Harvoni. Patients with Hepatitis C Genotypes 4, 5, and 6, as well as patients who are co-infected with HIV are now cleared to use Harvoni. In addition, Harvoni can also be used in combination with ribavirin in Genotype 1 patients who have cirrhosis.
Since Hepatitis C Genotype 4, 5, and 6 only represent a tiny fraction of the total U.S. Hepatitis C population, this approval is unlikely to greatly expand Harvoni's near-term sales. However, just like the Genvoya approval, it does show that Gilead continues to be one step ahead of competitors, which, in the Hepatitis C market, includes pharma giant AbbVie . Investors have been worried about AbbVie's entry into this market for some time, and that worry remains one of the reasons that Gilead's price-to-earnings ratio remains so low. However, Gilead continues to run circles around AbbVie in this market. AbbVie recently stumbled as it received a FDA warning letter related to both of its Hepatitis C drugs, sending shares lower . If nothing else, this approval should give investors confidence that Harvoni will continue to dominate.
Tying it all together
While each of these approvals helps to strengthen the company's market position, I don't think any of them are likely to have a meaningful impact on near-term financials. Harvoni and Sovaldi continue to be the near-term drivers of growth for Gilead, so seeing Harvoni get approved in Japan is a far bigger deal than any of these regulatory wins.
Still, wins come in all different shapes and sizes, and since each of these make the company incrementally stronger, I for one continue to feel bullish about Gilead's long-term potential.
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Brian Feroldi owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, just like the Genvoya approval, it does show that Gilead continues to be one step ahead of competitors, which, in the Hepatitis C market, includes pharma giant AbbVie . Investors have been worried about AbbVie's entry into this market for some time, and that worry remains one of the reasons that Gilead's price-to-earnings ratio remains so low. However, Gilead continues to run circles around AbbVie in this market. | However, just like the Genvoya approval, it does show that Gilead continues to be one step ahead of competitors, which, in the Hepatitis C market, includes pharma giant AbbVie . Investors have been worried about AbbVie's entry into this market for some time, and that worry remains one of the reasons that Gilead's price-to-earnings ratio remains so low. However, Gilead continues to run circles around AbbVie in this market. | However, just like the Genvoya approval, it does show that Gilead continues to be one step ahead of competitors, which, in the Hepatitis C market, includes pharma giant AbbVie . Investors have been worried about AbbVie's entry into this market for some time, and that worry remains one of the reasons that Gilead's price-to-earnings ratio remains so low. However, Gilead continues to run circles around AbbVie in this market. | However, Gilead continues to run circles around AbbVie in this market. However, just like the Genvoya approval, it does show that Gilead continues to be one step ahead of competitors, which, in the Hepatitis C market, includes pharma giant AbbVie . Investors have been worried about AbbVie's entry into this market for some time, and that worry remains one of the reasons that Gilead's price-to-earnings ratio remains so low. |
26767.0 | 2015-11-25 00:00:00 UTC | Can Pfizer Live Without Television? | ABBV | https://www.nasdaq.com/articles/can-pfizer-live-without-television-2015-11-25 | nan | nan | In a surprising change of position, the AMA recently adopted a new policy to promote prescription drug affordability. One bee in the association's bonnet is the impression prescription drug ads aimed at consumers are driving demand for expensive branded drugs when lower-cost alternatives exist.
Luckily for Pfizer, the AMA doesn't set prescription drug advertising policy. That role belongs to the U.S. Food and Drug Administration. While the regulator is vigilant in cases of off-label promotion, it has always been more concerned with safety than spending. In fact, the FDA states in no uncertain terms that such a ban is out of its hands, and would require an act of Congress. While such an act seems highly unlikely, now is a good time to examine just how dependent Pfizer has become on prescription drug advertising.
Coincidence?
With overall revenue falling steadily for years now, one bright spot for Pfizer has been at home, the only major market that allows DTC ads. In the third quarter, U.S. revenues rose 15% to $5.6 billion. International revenue grew 1% operationally, but unfavorable currency exchange led to a 13% loss.
Image source: Pfizer.
Pfizer attributed its domestic gain to the inclusion of revenue from the recent Hospira acquisition, as well as performance of key drugs such as Prevnar 13, Ibrance, Lyrica, Eliquis, Viagra, and Xeljanz. Four of these brands made the top 10 list of most advertised prescription drugs last year, and it looks like the ad spending floodgates are still open. With the exception of recently-launched breast cancer therapy Ibrance, Pfizer has aired thousands of TV ads for these drugs over the past 30 days.
While heavily promoted brands are probably responsible for a significant portion of U.S. sales growth, we can't attribute the international-to-domestic performance gap entirely to Pfizer's marketing practices. The most severe portion of the company's patent cliff has past, but loss of regulatory exclusivity in foreign markets has been somewhat lopsided lately. For example, Lyrica, the company's second largest source of revenue, is still on patent in the U.S., but lost exclusivity in major European markets last July.
Advertising vs. exclusivity
Also highlighting limitations of direct-to-consumer advertising is Celebrex. Last year Pfizer spent almost $119 million marketing the arthritis treatment in the U.S., and its worldwide sales reached $2.7 billion last year.
Celebrex lost exclusivity in Europe and the U.S. late last year, and prior advertising wasn't able to save it from falling off a patent cliff. When Pfizer last reported, third-quarter sales of the drug had plummeted 72% compared to the same period last year.
Stay calm
Over the past several years Pfizer has done a fine job of maintaining, even boosting profitability in the face of major patent losses. While I'm sure direct-to-consumer ads have been a part of the company's strategy, it's important to remember the U.S. is the only major market that allows direct-to-consumer advertising of prescription drugs.
While the U.S. is an extremely important market for any drugmaker, it's responsible for less than half of Pfizer's global revenue. An abrupt end of the practice might knock some points off Pfizer's top line, but I wouldn't consider it a major catastrophe.
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Cory Renauer has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Pfizer attributed its domestic gain to the inclusion of revenue from the recent Hospira acquisition, as well as performance of key drugs such as Prevnar 13, Ibrance, Lyrica, Eliquis, Viagra, and Xeljanz. While heavily promoted brands are probably responsible for a significant portion of U.S. sales growth, we can't attribute the international-to-domestic performance gap entirely to Pfizer's marketing practices. Just like newspaper publishers, telephone utilities, stockbrokers, record companies, bookstores, travel agencies, and big box retailers did when the Internet swept away their business models. | Luckily for Pfizer, the AMA doesn't set prescription drug advertising policy. While heavily promoted brands are probably responsible for a significant portion of U.S. sales growth, we can't attribute the international-to-domestic performance gap entirely to Pfizer's marketing practices. 3 Companies Poised to Explode When Cable Dies Cable is dying. | Luckily for Pfizer, the AMA doesn't set prescription drug advertising policy. With overall revenue falling steadily for years now, one bright spot for Pfizer has been at home, the only major market that allows DTC ads. While I'm sure direct-to-consumer ads have been a part of the company's strategy, it's important to remember the U.S. is the only major market that allows direct-to-consumer advertising of prescription drugs. | For example, Lyrica, the company's second largest source of revenue, is still on patent in the U.S., but lost exclusivity in major European markets last July. While I'm sure direct-to-consumer ads have been a part of the company's strategy, it's important to remember the U.S. is the only major market that allows direct-to-consumer advertising of prescription drugs. The Motley Fool has no position in any of the stocks mentioned. |
26768.0 | 2015-11-23 00:00:00 UTC | Can Merck & Co. Take Down Gilead Sciences? | ABBV | https://www.nasdaq.com/articles/can-merck-co-take-down-gilead-sciences-2015-11-23 | nan | nan | About a year ago, while we were still waiting for Viekira Pak from AbbVie to hit pharmacy shelves, many Gilead Sciences investors were worried the competitor would consume a hefty chunk of the overall hepatitis C market. Fast-forward to the present, and it seems those fears were overblown. Sales of Gilead's hepatitis C franchise -- Harvoni and Sovaldi -- are rolling in at an annualized run rate of $19.2 billion. Third-quarter sales of Viekira Pak suggest an annualized run rate of "just" $1.9 billion.
Image source: Merck & Co.
With Harvoni performing so well despite the entry of Viekira Pak, a combination hepatitis C treatment from Merck & Co. has elicited a relatively mild response. The FDA has been pouring over data from investigational elbasvir/grazoprevir for a few months now, and a decision is expected in by the end of January.
But should investors be more worried about the treat from Merck? Let's take a look at how Merck's once-daily tablet stacks up to Viekira Pak and Harvoni.
The latest data
On Nov. 6, Merck presented results of a clinical trial evaluating elbasvir and grazoprevir in patients with genotype 1, 4, or 6 who also inject drugs and are on an opioid agonist therapy such as methadone. A stunning 95% of patients treated for 12 weeks with the two drug combo achieved a sustained virologic response -- technical lingo that basically means they're cured.
Impressive cure rates on their own aren't enough to win over physicians, and Viekira Pak's main obstacle is an inferior safety profile as compared to Harvoni. We'll chalk up a few points for Merck's combo in this department. Of the 301 patients evaluated in the study -- of which 21 had cirrhosis and 7% were infected with HIV -- only two reported serious adverse events related to treatment.
Advantage... Merck
Sharing needles is perhaps the most common way hepatitis is transmitted, so it isn't surprising that AbbVie conducted a similar, albeit smaller study. In the phase 2 trial, Viekira Pak cured 37 of 38 patients.
Image source: Merck & Co.
That's impressive, but it's difficult to make an apples-to-apples comparison, here. It's important to bear in mind that in AbbVie's smaller study, none of the patients had cirrhosis or HIV, and all were infected with genotype 1. These patients also took ribavirin -- an antiviral with a host of serious known side effects -- along with the four-drug Viekira Pak combination.
Although AbbVie's multi-pill drug cocktail cured a slightly higher percentage of patients in the smaller study, no physician wants to give patients ribavirin if they can avoid it. After considering the size of Merck's study, and its success in a more challenging patient population with a well-tolerated, two-drug combo, I'm going to call this one in Merck's favor.
Looking further ahead
If approved, Merck's single-tablet combo will probably present a much bigger threat to Harvoni's share of the hepatitis C market than Viekira Pak. Whatever the case, most analysts agree that the next goal is shorter treatment durations effective across genotypes. Type 1 may be the most common, but globally, it represents less than half of all hepatitis C infections. A safe and effective pan-genotypic pill would be especially well received in emerging markets where genotyping patients isn't always an option.
A couple of months back, Gilead announced stunning results with its pan-genotypic combination of investigational NS5A inhibitor, velpatasvir, and sofosbuvir -- the last of which is Sovaldi's active ingredient. In a large phase 3 trial with genotypes 1 through 6, but excluding 3, treatment for 12 weeks led to a 99% cure rate. In a related trial, the same combo cured 95% of genotype 3 patients.
Merck is advancing its own pan-genotypic combination. As usual, making a direct comparison is unrealistic, but we do have some numbers to chew on. In a phase 2 trial, 240 patients were treated with grazoprevir, MK-3682, and either elbasvir or MK-8408.
Image source: Merck & Co.
Cure rates across treatment arms for genotypes 1 and 3 were 98% and 91%, respectively. Among genotype 2 patients, 15 of 16 treated with grazoprevir, the higher dose of MK-3682, and MK-8408 were cured, but other dosing regimens failed to produce an adequate response.
At this stage in their developments, both Merck and Gilead's pan-genotypic combinations appear equally safe. Higher cure rates seen with Gilead's 12-week regimen are a slight advantage, but that's not the only thing working in its favor.
First, the medical community has years of real-world experience with sofosbuvir in Sovaldi and half of Harvoni. That leaves just one unknown entity to deal with: velpatsvir. This is an advantage that will likely keep growing for quite some time. Gilead's pan-genotypic two-drug, single-tablet combo is already in the hands of the FDA, while Merck's potential competitor hasn't entered phase 3 yet.
Gilead investors will want to keep an eye on Merck's 8-week pan-genotypic regimen, and shouldn't let Viekira Pak's unflattering performance in its first quarters on the market lull it into complacency. Merck's emerging hepatitis C franchise is a far more serious threat, but it will be a long time before it's in any position to take down the leader in this space.
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The article Can Merck & Co. Take Down Gilead Sciences? originally appeared on Fool.com.
Cory Renauer has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | About a year ago, while we were still waiting for Viekira Pak from AbbVie to hit pharmacy shelves, many Gilead Sciences investors were worried the competitor would consume a hefty chunk of the overall hepatitis C market. Advantage... Merck Sharing needles is perhaps the most common way hepatitis is transmitted, so it isn't surprising that AbbVie conducted a similar, albeit smaller study. It's important to bear in mind that in AbbVie's smaller study, none of the patients had cirrhosis or HIV, and all were infected with genotype 1. | Although AbbVie's multi-pill drug cocktail cured a slightly higher percentage of patients in the smaller study, no physician wants to give patients ribavirin if they can avoid it. About a year ago, while we were still waiting for Viekira Pak from AbbVie to hit pharmacy shelves, many Gilead Sciences investors were worried the competitor would consume a hefty chunk of the overall hepatitis C market. Advantage... Merck Sharing needles is perhaps the most common way hepatitis is transmitted, so it isn't surprising that AbbVie conducted a similar, albeit smaller study. | About a year ago, while we were still waiting for Viekira Pak from AbbVie to hit pharmacy shelves, many Gilead Sciences investors were worried the competitor would consume a hefty chunk of the overall hepatitis C market. Advantage... Merck Sharing needles is perhaps the most common way hepatitis is transmitted, so it isn't surprising that AbbVie conducted a similar, albeit smaller study. It's important to bear in mind that in AbbVie's smaller study, none of the patients had cirrhosis or HIV, and all were infected with genotype 1. | About a year ago, while we were still waiting for Viekira Pak from AbbVie to hit pharmacy shelves, many Gilead Sciences investors were worried the competitor would consume a hefty chunk of the overall hepatitis C market. Advantage... Merck Sharing needles is perhaps the most common way hepatitis is transmitted, so it isn't surprising that AbbVie conducted a similar, albeit smaller study. It's important to bear in mind that in AbbVie's smaller study, none of the patients had cirrhosis or HIV, and all were infected with genotype 1. |
26769.0 | 2015-11-21 00:00:00 UTC | Gilead Sciences Inc. Has Plenty of Room to Run in Hepatitis C | ABBV | https://www.nasdaq.com/articles/gilead-sciences-inc-has-plenty-room-run-hepatitis-c-2015-11-21 | nan | nan | Gilead Sciences has had a massively successful run with its hepatitis C cures Sovaldi and Harvoni, and the more I look at the market size and the company's treatment strategy, the more I become convinced this business has plenty of room to run with hep C. Even though Gilead is treating a massive number of patients -- 600,000 total to date -- and making a massive amount of money -- $26.8 billion in two years -- it's only scratched the surface of the overall hepatitis C market, which is estimated to comprise 185 million people. And although the vast majority of those people live in places where treatment will be more difficult and also less profitable (like South America, Asia, and Africa -- Sovaldi sells for $900 in Egypt , for example, and $84,000 in the U.S.), there's still plenty of room to run in developed, profit-friendly markets.
Let's look at an example.
Europe for the long haul
Europe looks like a nice long-term opportunity for Gilead. Gilead's Vice President Paul Carter noted on the most recentearnings call "Looking ahead in Europe, we anticipate that our HCV revenues will be constrained by country-specific budgets rather than the number of patients in need of treatment." (This and other quotes courtesy of S&P Capital IQ .)
Put another way, countries will allocate some money each year to hepatitis C, and the remainder of potential patients will have to wait for future years. This means Gilead should be able to count on consistent revenue from Europe for years to come -- and indeed, Carter noted that Germany is already stabilizing, with Gilead "seeing a lower but more predictable and consistent level of patient starts."
Since the start of 2015, 80,000 Europeans have started on a Gilead hepatitis C drug, generating nearly $3 billion in revenue for the company. Add that 80,000 to the 32,000 hep C patient starts Gilead reported for Europe in 2014 and you see that Gilead has treated 112,000 people in Europe -- out of an estimated 9.3 million Europeans with the disease, according to Gilead's estimates.
Meanwhile, Austria and Sweden recently expanded approved use for Gilead drugs, and Poland and the Netherlands opened access for the first time during last quarter. Bottom line, Europe looks like a nice long-term market for Gilead, and with only 1.3% of the estimated infected population treated with Sovaldi/Harvoni thus far, it should deliver solid returns for a long time yet.
Curing the masses
Gilead estimates that the U.S. has roughly 4 million hepatitis C patients -- and Gilead has treated less than 10% of them so far (333,000). Gilead has only just begun selling Sovaldi (approved in March 2015) and Harvoni (approved in July 2015) in Japan, which has a patient population of about 1.1 million -- and last quarter earned $454 million from that market. And even though the rest of the world isn't as profit-friendly for Gilead, it's still brought in about $900 million since inception, with 156,000 people treated so far. Basically, Gilead has a big patient population it can pursue for years to come around the world -- and that's great news both for health advocates and for shareholders.
A potential fly in the ointment?
Of course, the key to this thesis is the belief that Gilead's drugs are and will remain best-in-class, and will able to continue vacuuming up a massive percentage of the market (currently, Gilead has roughly 90% market share in the United States). AbbVie 's competing treatment Viekira Pak has tanked so far, bringing in $467 million last quarter (compared to about $4.8 billion for Harvoni and Sovaldi). That's in large part because Viekira Pak requires four-to-six pills per day (depending on use of ribavirin with AbbVie's drug) compared to Sovaldi/Harvoni's one pill, although the FDA's recent warning about Viekira Pak probably doesn't help matters any .
But there's more to come and Gilead will undoubtedly eventually start bleeding market share. AbbVie anticipates that it will begin selling a new hepatitis C combo in 2017, which will be a once-daily pill that doesn't require ribavirin. Merck 's grazoprevir/elbasvir, which posted strong results in a series of phase 3 trials earlier last year (90%-plus cure rates) is scheduled for an FDA decision next January. Interestingly, Merck management has signaled that it doesn't plan to compete on price with Gilead -- indicating that the company may intend to price similarly to Harvoni (which runs a list price over $90,000). Merck also has a next-generation combination in trials, so there's something to watch longer term.
Of course, Gilead also has a next-generation combination in trials that should help shorten treatment duration to eight weeks (currently it's 12 weeks for most patients). Phase 2 data presented at the AASLD Liver Meeting in San Francisco earlier this week showed this new combination to be very effective at curing difficult-to-treat populations in eight weeks, although the data set is small and will be confirmed with larger phase 3 trials. And at the end of the day, since Merck has implied it doesn't plan to compete on price -- and since AbbVie's Viekira Pak appears to be the worse drug -- I don't see any reason for cash-conscious payers like the European countries to push their citizens toward a competitor, thereby preserving Gilead's first-mover advantage across the pond.
Competition's going to increase, but Gilead is ready for it.
Here's the real kicker
Even if I'm wrong -- even if Gilead gets hosed on market share at some point by somebody -- this is a big patient population with a need for the functional cures these companies are providing. This isn't a winner-takes-all game: This massive market can probably support more than one winner. With that in mind, I think the safe money's still on Gilead.
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The article Gilead Sciences Inc. Has Plenty of Room to Run in Hepatitis C originally appeared on Fool.com.
Michael Douglass owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie 's competing treatment Viekira Pak has tanked so far, bringing in $467 million last quarter (compared to about $4.8 billion for Harvoni and Sovaldi). That's in large part because Viekira Pak requires four-to-six pills per day (depending on use of ribavirin with AbbVie's drug) compared to Sovaldi/Harvoni's one pill, although the FDA's recent warning about Viekira Pak probably doesn't help matters any . AbbVie anticipates that it will begin selling a new hepatitis C combo in 2017, which will be a once-daily pill that doesn't require ribavirin. | AbbVie 's competing treatment Viekira Pak has tanked so far, bringing in $467 million last quarter (compared to about $4.8 billion for Harvoni and Sovaldi). That's in large part because Viekira Pak requires four-to-six pills per day (depending on use of ribavirin with AbbVie's drug) compared to Sovaldi/Harvoni's one pill, although the FDA's recent warning about Viekira Pak probably doesn't help matters any . And at the end of the day, since Merck has implied it doesn't plan to compete on price -- and since AbbVie's Viekira Pak appears to be the worse drug -- I don't see any reason for cash-conscious payers like the European countries to push their citizens toward a competitor, thereby preserving Gilead's first-mover advantage across the pond. | AbbVie 's competing treatment Viekira Pak has tanked so far, bringing in $467 million last quarter (compared to about $4.8 billion for Harvoni and Sovaldi). That's in large part because Viekira Pak requires four-to-six pills per day (depending on use of ribavirin with AbbVie's drug) compared to Sovaldi/Harvoni's one pill, although the FDA's recent warning about Viekira Pak probably doesn't help matters any . AbbVie anticipates that it will begin selling a new hepatitis C combo in 2017, which will be a once-daily pill that doesn't require ribavirin. | AbbVie 's competing treatment Viekira Pak has tanked so far, bringing in $467 million last quarter (compared to about $4.8 billion for Harvoni and Sovaldi). That's in large part because Viekira Pak requires four-to-six pills per day (depending on use of ribavirin with AbbVie's drug) compared to Sovaldi/Harvoni's one pill, although the FDA's recent warning about Viekira Pak probably doesn't help matters any . AbbVie anticipates that it will begin selling a new hepatitis C combo in 2017, which will be a once-daily pill that doesn't require ribavirin. |
26770.0 | 2015-11-20 00:00:00 UTC | Health Care Investor Larry Robbins Sells Drug Manufacturers, Buys Providers | ABBV | https://www.nasdaq.com/articles/health-care-investor-larry-robbins-sells-drug-manufacturers-buys-providers-2015-11-20 | nan | nan | Larry Robbins ( Trades , Portfolio ), founder of hedge fund Glenview Capital Management, rearranged his health care holdings rather than cut his exposure to the sector in the third quarter, amid sinking returns and before the release of an apologetic shareholder letter.
"The last 90 days have been exceedingly disappointing and frustrating. I've failed to protect your capital, and mine, from a significant drawdown, despite a flat market," Robbins wrote in an Oct. 26 letter to shareholders.
Glenview has roughly 51.6% of its public equity portfolio in stocks from the health care sector, which slid 11% for the quarter. The drop hurt the firm, which declined 13.5% year to date through Oct. 16, according to data from HSBC.
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As reasons for the drop, Robbins cited drug price hikes, the political climate, hedge fund repositioning and volatility in hospital earnings. A long-term investor, Robbins remained confident in the underlying fundamentals of his companies. His average holding period for his top three winners in 2013 was nine years, and for 2014 the average holding time for his top 20 winners was about three and a half years, he said in a talk at the Japan Society in February.
Robbins' bets on health care have served Glenview well in the past. In the first 10 months of 2013, his Glenview Capital Opportunity jumped 84.2%, which placed it as the best-performing hedge fund according to an annual Bloomberg Markets ranking. Since 2010, the sector has never made up less than a third of his portfolio.
"While there is merit to each of these concerns," he said of the problems plaguing health care stocks in his third quarter letter, "in aggregate we remain highly confident that these are transitory stock price factors that will self-correct because the underlying profit stability and growth, capital allocation, valuation and fundamental outlook all support meaningful equity price appreciation for the coming year and years."
His firm has already seen the beginning of a turnaround, as the S&P 500 Health Care Index rose almost 7% so far in the fourth quarter, placing it up 3.4% year to date.
The basis of much of Robbins' dealings in health care has been profiting from changes Obamacare spurred in the industry. Negative impacts rippled through the sector again today when the nation's largest health insurer, UnitedHealth Group Inc. ( NYSE:UNH ) announced today that it might cease participating in Obamacare plans, citing an inability to profit under the act's conditions.
In the third quarter, Robbins significantly reduced its holdings in drug manufacturers, selling 9% of its largest AbbVie Inc. ( ABBV ), 21% of Endo International PLC ( ENDP ), 23% of Allergan PLC ( AGN ) and 49% of Mylan NV ( MYL ).
Robbins also bought or significantly increased stocks of health care providers.
Brookdale Senior Living Inc. ( BKD )
Robbins' largest increase was to Brookdale Senior Living Inc., a 2.01% portfolio weight after he added 51.2% more shares in the third quarter when its share price averaged $30. Robbins owned 17,641,415 shares in total of the position, equal to 9.6% of shares outstanding, which he started in the second quarter of 2014 and increased in each subsequent quarter. He has a total estimated loss on the position of 31% at its Friday price of $22.61 per share.
Brookdale Senior Living operates senior living communities in 46 states, as well as outpatient therapy, home health, personalized health and hospice services. The company has a $4.2 billion market cap and its shares fell 38% year to date.
The company's reported revenue for the third quarter to $1.2 billion from $1.08 billion the previous year due to an acquisition and the addition of new units. It reported $68 million in net loss, from $37 million the previous year.
Brookdale had $70.4 million in cash at quarter end, down from $104 million at the end of 2014, and long-term debt of $716 million, down from $877.8 million at year end.
Brookdale also has a P/B ratio near a five-year low at 1.6 and P/S ratio near a three-year low at 0.85.
HealthSouth Corp. (HLS)
Robbins increased his HealthSouth holding by 52% to 6,819,080 shares at an average price of $44. His holding spans 1.3% of his portfolio and 7.5% of the company's outstanding shares. Robbins has boosted his share count for the past three quarters since starting the position and has a 20% loss approximately based on its $35.16 share price Friday.
HealthSouth is a large post-acute health care services and home-based patient care company. The $3.21 billion market cap company saw its shares decline almost 9% year to date.
For the third quarter, HealthSouth reported 30.4% higher revenues of $768.6 million, primarily from the acquisition of Encompass Home Health and Hospice and its inpatient rehabilitation hospitals. It posted net income of $51 million, up from $50 million.
HealthSouth ended the quarter with $801.6 million in cash, up from $66.7 at year end, and $2.8 billion in debt, up from $2.1 billion at year end.
The company has a P/E ratio of 19.2, P/B ratio of 5.07 and P/S ratio of 1.19, close to a two-year low.
Tenet Healthcare Corp. (THC)
Robbins owned 16.6% of Tenet Healthcare Corp. after increasing his holding by 11.5% in the third quarter. The 17,890,230 shares he held (including two more position increases in the fourth quarter) totaled 3% of his portfolio. Robbins started the position in the first quarter of 2012 and has an approximate 14% total gain on it at Friday's price of $31.33 per share, which is close to a two-year low.
Tenet Healthcare is a healthcare services company operating 87 hospitals, 20 short-stay surgical hospitals and hundreds of outpatient centers, along with nine facilities in the UK. The company has a $3.12 billion market cap and its stock price fell 38% year to date.
For the third quarter, Tenet reported %4.7 billion in net operating revenues, up from $4.2 billion. It posted $28 million in net income, up from $18 million. The company ended the quarter with cash of $450 million, up from $193 million at year end, and debt of $14.6 billion, up from $11.7 billion.
Tenet announced a $500 million share repurchase authorization due to volatility and increased cash resulting from divestitures. The company has a P/E of 235.5, P/B of 3.9 and P/S ratio of 0.18, near a five-year low.
In his smaller moves with health care providers, Robbins increased HCA Holdings Inc. by 6.5%, started a position in Kindred Healthcare Inc. (KND), left his Community Health Systems Inc. position unchanged and decreased his Universal Health Services position by less than 1%.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | ABBV 15-Year Financial Data The intrinsic value of ABBV Peter Lynch Chart of ABBV As reasons for the drop, Robbins cited drug price hikes, the political climate, hedge fund repositioning and volatility in hospital earnings. In the third quarter, Robbins significantly reduced its holdings in drug manufacturers, selling 9% of its largest AbbVie Inc. ( ABBV ), 21% of Endo International PLC ( ENDP ), 23% of Allergan PLC ( AGN ) and 49% of Mylan NV ( MYL ). Larry Robbins ( Trades , Portfolio ), founder of hedge fund Glenview Capital Management, rearranged his health care holdings rather than cut his exposure to the sector in the third quarter, amid sinking returns and before the release of an apologetic shareholder letter. | ABBV 15-Year Financial Data The intrinsic value of ABBV Peter Lynch Chart of ABBV As reasons for the drop, Robbins cited drug price hikes, the political climate, hedge fund repositioning and volatility in hospital earnings. In the third quarter, Robbins significantly reduced its holdings in drug manufacturers, selling 9% of its largest AbbVie Inc. ( ABBV ), 21% of Endo International PLC ( ENDP ), 23% of Allergan PLC ( AGN ) and 49% of Mylan NV ( MYL ). Larry Robbins ( Trades , Portfolio ), founder of hedge fund Glenview Capital Management, rearranged his health care holdings rather than cut his exposure to the sector in the third quarter, amid sinking returns and before the release of an apologetic shareholder letter. | ABBV 15-Year Financial Data The intrinsic value of ABBV Peter Lynch Chart of ABBV As reasons for the drop, Robbins cited drug price hikes, the political climate, hedge fund repositioning and volatility in hospital earnings. In the third quarter, Robbins significantly reduced its holdings in drug manufacturers, selling 9% of its largest AbbVie Inc. ( ABBV ), 21% of Endo International PLC ( ENDP ), 23% of Allergan PLC ( AGN ) and 49% of Mylan NV ( MYL ). "While there is merit to each of these concerns," he said of the problems plaguing health care stocks in his third quarter letter, "in aggregate we remain highly confident that these are transitory stock price factors that will self-correct because the underlying profit stability and growth, capital allocation, valuation and fundamental outlook all support meaningful equity price appreciation for the coming year and years." | ABBV 15-Year Financial Data The intrinsic value of ABBV Peter Lynch Chart of ABBV As reasons for the drop, Robbins cited drug price hikes, the political climate, hedge fund repositioning and volatility in hospital earnings. In the third quarter, Robbins significantly reduced its holdings in drug manufacturers, selling 9% of its largest AbbVie Inc. ( ABBV ), 21% of Endo International PLC ( ENDP ), 23% of Allergan PLC ( AGN ) and 49% of Mylan NV ( MYL ). HealthSouth Corp. (HLS) Robbins increased his HealthSouth holding by 52% to 6,819,080 shares at an average price of $44. |
26771.0 | 2015-11-19 00:00:00 UTC | Notable ETF Inflow Detected - VUG, GILD, MA, ABBV | ABBV | https://www.nasdaq.com/articles/notable-etf-inflow-detected-vug-gild-ma-abbv-2015-11-19 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Vanguard Growth ETF (Symbol: VUG) where we have detected an approximate $210.6 million dollar inflow -- that's a 1.0% increase week over week in outstanding units (from 189,259,651 to 191,186,829). Among the largest underlying components of VUG, in trading today Gilead Sciences, Inc. (Symbol: GILD) is off about 1.5%, MasterCard Inc (Symbol: MA) is down about 0.6%, and AbbVie Inc. (Symbol: ABBV) is lower by about 0.4%. For a complete list of holdings, visit the VUG Holdings page » The chart below shows the one year price performance of VUG, versus its 200 day moving average:
Looking at the chart above, VUG's low point in its 52 week range is $93.61 per share, with $111.92 as the 52 week high point - that compares with a last trade of $109.42. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs had notable inflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of VUG, in trading today Gilead Sciences, Inc. (Symbol: GILD) is off about 1.5%, MasterCard Inc (Symbol: MA) is down about 0.6%, and AbbVie Inc. (Symbol: ABBV) is lower by about 0.4%. For a complete list of holdings, visit the VUG Holdings page » The chart below shows the one year price performance of VUG, versus its 200 day moving average: Looking at the chart above, VUG's low point in its 52 week range is $93.61 per share, with $111.92 as the 52 week high point - that compares with a last trade of $109.42. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. | Among the largest underlying components of VUG, in trading today Gilead Sciences, Inc. (Symbol: GILD) is off about 1.5%, MasterCard Inc (Symbol: MA) is down about 0.6%, and AbbVie Inc. (Symbol: ABBV) is lower by about 0.4%. For a complete list of holdings, visit the VUG Holdings page » The chart below shows the one year price performance of VUG, versus its 200 day moving average: Looking at the chart above, VUG's low point in its 52 week range is $93.61 per share, with $111.92 as the 52 week high point - that compares with a last trade of $109.42. Click here to find out which 9 other ETFs had notable inflows » The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of VUG, in trading today Gilead Sciences, Inc. (Symbol: GILD) is off about 1.5%, MasterCard Inc (Symbol: MA) is down about 0.6%, and AbbVie Inc. (Symbol: ABBV) is lower by about 0.4%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Vanguard Growth ETF (Symbol: VUG) where we have detected an approximate $210.6 million dollar inflow -- that's a 1.0% increase week over week in outstanding units (from 189,259,651 to 191,186,829). For a complete list of holdings, visit the VUG Holdings page » The chart below shows the one year price performance of VUG, versus its 200 day moving average: Looking at the chart above, VUG's low point in its 52 week range is $93.61 per share, with $111.92 as the 52 week high point - that compares with a last trade of $109.42. | Among the largest underlying components of VUG, in trading today Gilead Sciences, Inc. (Symbol: GILD) is off about 1.5%, MasterCard Inc (Symbol: MA) is down about 0.6%, and AbbVie Inc. (Symbol: ABBV) is lower by about 0.4%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Vanguard Growth ETF (Symbol: VUG) where we have detected an approximate $210.6 million dollar inflow -- that's a 1.0% increase week over week in outstanding units (from 189,259,651 to 191,186,829). For a complete list of holdings, visit the VUG Holdings page » The chart below shows the one year price performance of VUG, versus its 200 day moving average: Looking at the chart above, VUG's low point in its 52 week range is $93.61 per share, with $111.92 as the 52 week high point - that compares with a last trade of $109.42. |
26772.0 | 2015-11-19 00:00:00 UTC | The Zacks Analyst Blog Highlights: Clovis Oncology, Gilead, AbbVie and Medicines Company | ABBV | https://www.nasdaq.com/articles/the-zacks-analyst-blog-highlights%3A-clovis-oncology-gilead-abbvie-and-medicines-company | nan | nan | For Immediate Release
Chicago, IL - November 19, 2015 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Clovis Oncology ( CLVS ), Gilead ( GILD ), AbbVie ( ABBV ) and Medicines Company ( MDCO ).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free .
Here are highlights from Wednesday's Analyst Blog:
Biotech Stock Roundup
With earnings season winding down, regulatory and pipeline updates from the biotech sector are back in focus. Clovis Oncology's ( CLVS ) shares plunged 70% as the company is possibly facing a delay in gaining FDA approval for its lead pipeline candidate. Meanwhile, companies like Gilead ( GILD ) and AbbVie ( ABBV ) provided pipeline and regulatory updates.
Recap of the Week's Most Important Stories
1. Clovis, which is focused on bringing cancer treatments to market, suffered a huge setback with the FDA asking the company to submit additional data on its lead pipeline candidate, rociletinib. Clovis is seeking both FDA and EMA approval for rociletinib for a non-small cell lung cancer indication.
The FDA was supposed to decide on the approval status of the candidate by Mar 30, 2016, but now that the agency is asking for additional information, there is low visibility as to when a response will be out (Read more: Clovis Crashes 70%, FDA Seeks More Data on Rociletinib ).
2. The Medicines Company ( MDCO ) got some good news with its petition for en banc review being granted. The company had filed the petition related to the decision of the U.S. Court of Appeals for the Federal Circuit invalidating the Orange Book patents covering Angiomax.
3. It's been a busy week for Gilead - the FDA approved the company's blockbuster hepatitis C virus (HCV) treatment, Harvoni for use in additional patient populations (Read more: Gilead's HCV Drug Harvoni's Label Expanded in U.S. ). Moreover, the company said that its late-stage study evaluating Zydelig plus standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early on the recommendation of an independent Data Monitoring Committee (Read more: Gilead's Leukemia Study Unblinded Early on Positive Data) .
4. AbbVie presented data on its investigational HCV regimen, ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor) from a couple of mid-stage studies at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The company also presented new data on its approved HCV treatment, Viekira Pak, from an ongoing late-stage study.
Meanwhile, AbbVie continues to progress with its efforts to expand Imbruvica's label. The company has submitted Imbruvica phase III combination data to the FDA (Read more: AbbVie Reports Encouraging Data on HCV Drug Viekira Pak ).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Stocks recently featured in the blog include the Clovis Oncology ( CLVS ), Gilead ( GILD ), AbbVie ( ABBV ) and Medicines Company ( MDCO ). Meanwhile, companies like Gilead ( GILD ) and AbbVie ( ABBV ) provided pipeline and regulatory updates. AbbVie presented data on its investigational HCV regimen, ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor) from a couple of mid-stage studies at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). | Stocks recently featured in the blog include the Clovis Oncology ( CLVS ), Gilead ( GILD ), AbbVie ( ABBV ) and Medicines Company ( MDCO ). Click to get this free report CLOVIS ONCOLOGY (CLVS): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report MEDICINES CO (MDCO): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, companies like Gilead ( GILD ) and AbbVie ( ABBV ) provided pipeline and regulatory updates. | Click to get this free report CLOVIS ONCOLOGY (CLVS): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report MEDICINES CO (MDCO): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks recently featured in the blog include the Clovis Oncology ( CLVS ), Gilead ( GILD ), AbbVie ( ABBV ) and Medicines Company ( MDCO ). Meanwhile, companies like Gilead ( GILD ) and AbbVie ( ABBV ) provided pipeline and regulatory updates. | Stocks recently featured in the blog include the Clovis Oncology ( CLVS ), Gilead ( GILD ), AbbVie ( ABBV ) and Medicines Company ( MDCO ). Meanwhile, companies like Gilead ( GILD ) and AbbVie ( ABBV ) provided pipeline and regulatory updates. AbbVie presented data on its investigational HCV regimen, ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor) from a couple of mid-stage studies at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). |
26773.0 | 2015-11-18 00:00:00 UTC | Infinity (INFI) Completes Enrollment in Phase III DUO Study | ABBV | https://www.nasdaq.com/articles/infinity-infi-completes-enrollment-in-phase-iii-duo-study-2015-11-18 | nan | nan | Infinity Pharmaceuticals, Inc. 's INFI shares gained 5.3% after the company announced that it has completed the targeted enrollment of 300 patients in the phase III DUO study on duvelisib.
The randomized, monotherapy study is evaluating the safety and efficacy of duvelisib in comparison with Novartis AG's NVS Arzerra (ofatumumab) for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Apart from the DUO study, duvelisib is being evaluated in the phase II DYNAMO study for the treatments of patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to Rituxan and to either chemotherapy or radioimmunotherapy: and in the phase III DYNAMO+R study in patients with previously treated follicular lymphoma (FL). Patient enrolment in the DYNAMO+R study is ongoing, while top-line data from the DYNAMO study in expected in the third quarter of 2016.
In addition, Infinity Pharma is enrolling patients in two studies on duvelisib including the phase Ib/II CONTEMPO study in treatment-naïve patients with FL and the phase Ib SYNCHRONY study for the treatment of CLL patients whose disease is refractory to or has relapsed while receiving a Bruton's tyrosine kinase (BTK) inhibitor.
Meanwhile, three additional studies on duvelisib are expected to be initiated in by year end. These include the phase III BRAVURA study in patients with relapsed iNHL, the phase II FRESCO study in patients with relapsed/refractory FL, and a study on the candidate in combination with AbbVie Inc.'s ABBV venetoclax.
We note that duvelisib has Fast Track designation in the U.S. for the treatment of patients with FL who have received at least two prior therapies and patient with CLL who have received at least one prior therapy.
Infinity Pharma plans to meet with the FDA to ascertain if BRAVURA can serve as a confirmatory study if DYNAMO supports accelerated approval.
We remind investors that in Sep 2014, Infinity Pharma had entered into a collaboration agreement with AbbVie for worldwide development and commercialization of duvelisib for cancer treatment. The candidate is being jointly developed by both companies.
An approved PI3K inhibitor in the market is Gilead Sciences Inc.'s GILD Zydelig.
Infinity Pharma carries a Zacks Rank #3 (Hold). Gilead is a better-ranked stock in the health care sector, carrying a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that in Sep 2014, Infinity Pharma had entered into a collaboration agreement with AbbVie for worldwide development and commercialization of duvelisib for cancer treatment. These include the phase III BRAVURA study in patients with relapsed iNHL, the phase II FRESCO study in patients with relapsed/refractory FL, and a study on the candidate in combination with AbbVie Inc.'s ABBV venetoclax. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report INFINITY PHARMA (INFI): Free Stock Analysis Report To read this article on Zacks.com click here. | These include the phase III BRAVURA study in patients with relapsed iNHL, the phase II FRESCO study in patients with relapsed/refractory FL, and a study on the candidate in combination with AbbVie Inc.'s ABBV venetoclax. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report INFINITY PHARMA (INFI): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that in Sep 2014, Infinity Pharma had entered into a collaboration agreement with AbbVie for worldwide development and commercialization of duvelisib for cancer treatment. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report INFINITY PHARMA (INFI): Free Stock Analysis Report To read this article on Zacks.com click here. These include the phase III BRAVURA study in patients with relapsed iNHL, the phase II FRESCO study in patients with relapsed/refractory FL, and a study on the candidate in combination with AbbVie Inc.'s ABBV venetoclax. We remind investors that in Sep 2014, Infinity Pharma had entered into a collaboration agreement with AbbVie for worldwide development and commercialization of duvelisib for cancer treatment. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report INFINITY PHARMA (INFI): Free Stock Analysis Report To read this article on Zacks.com click here. These include the phase III BRAVURA study in patients with relapsed iNHL, the phase II FRESCO study in patients with relapsed/refractory FL, and a study on the candidate in combination with AbbVie Inc.'s ABBV venetoclax. We remind investors that in Sep 2014, Infinity Pharma had entered into a collaboration agreement with AbbVie for worldwide development and commercialization of duvelisib for cancer treatment. |
26774.0 | 2015-11-17 00:00:00 UTC | Gilead's Leukemia Study Unblinded Early on Positive Data | ABBV | https://www.nasdaq.com/articles/gileads-leukemia-study-unblinded-early-on-positive-data-2015-11-17 | nan | nan | Gilead Sciences, Inc.GILD announced that the phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early based on an independent Data Monitoring Committee (DMC) recommendation.
The DMC recommendation followed a predefined interim analysis that indicated a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig in addition to Treanda (bendamustine) and Rituxan (rituximab) compared to those receiving only Treanda and Rituxan. The safety profile of Zydelig was in line with that observed in prior studies. Detailed data from this study will be presented at the annual meeting of the American Society of Hematology in December.
We note that Zydelig is already approved in the U.S. in combination with Rituxan for patients with relapsed CLL for whom Rituxan alone would be considered appropriate therapy due to comorbidities. Zydelig is also approved as monotherapy for treating patients with relapsed follicular B-cell non-Hodgkin lymphoma and small lymphocytic lymphoma in patients who have received at least two previous systemic therapies. For the first nine months of 2015, Zydelig generated revenues of $92 million. Label expansion of the product could further boost sales.
However, several companies are looking for similar label expansions for their leukemia drugs. We remind investors that earlier this week, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Data from the study confirm Imbruvica's ability to attain enhanced effectiveness when added to the Treanda/Rituxan combination for the treatment of relapsed or refractory patients with CLL or small lymphocytic lymphoma.
Gilead carries a Zacks Rank #2 (Buy). A couple of other favorably ranked stocks in the health care sector are GW Pharmaceuticals plc GWPH and Conatus Pharmaceuticals Inc. CNAT . While GW Pharma sports a Zacks Rank #1 (Strong Buy), Conatus holds a Zacks Rank #2.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that earlier this week, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report CONATUS PHARMA (CNAT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that the phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early based on an independent Data Monitoring Committee (DMC) recommendation. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report CONATUS PHARMA (CNAT): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that earlier this week, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Gilead Sciences, Inc.GILD announced that the phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early based on an independent Data Monitoring Committee (DMC) recommendation. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report CONATUS PHARMA (CNAT): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that earlier this week, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Gilead Sciences, Inc.GILD announced that the phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early based on an independent Data Monitoring Committee (DMC) recommendation. | We remind investors that earlier this week, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report GW PHARMA-ADR (GWPH): Free Stock Analysis Report CONATUS PHARMA (CNAT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced that the phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early based on an independent Data Monitoring Committee (DMC) recommendation. |
26775.0 | 2015-11-16 00:00:00 UTC | 3 High-Yield Dividend Stocks You Don't Have to Babysit | ABBV | https://www.nasdaq.com/articles/3-high-yield-dividend-stocks-you-dont-have-babysit-2015-11-16 | nan | nan | Image by Markgraf-Ave via Pixabay
With the S&P 500 once again in negative territory for the year, companies of all sizes have seen their share prices decline. When a stock that pays a strong dividend goes down, it has the happy effect of pushing its dividend yield even higher, which can create a nice buying opportunity for long-term investors who want to add income to their portfolio.
However, just because a stock's yield gets pushed higher doesn't mean that it's an automatic buy, as some equities that come with high yield also come with higher-than-average risk and hence require constant monitoring. In our never-ending quest to help investors demystify the markets, we asked three of our Motley Fool contributors to share their suggestions of high-yielding stocks that they think don't require constant attention. Read on to see which stocks they think fit that description to a T.
George Budwell : Pfizer is one of my favorite names among high-yield dividend stocks because the drugmaker has strong positive free-cash flows, a reasonable cash payout ratio, a solid balance sheet, and several exciting growth platforms.
With a current yield of 3.57%, Pfizer's dividend yield tops the healthcare sector's average of 2.47%, as well as the 3.26% average among major drug manufacturers. Even so, Pfizer's remarkable ability to generate positive free cash flow -- over $15 billion in over the last 12 months -- has kept its cash payout ratio within reason at 50%. That's significantly lower than many of Pfizer's big pharma peers, who are struggling to cope with the ongoing patent cliff.
Perhaps what's most reassuring, though, is the fact that Pfizer exited the third quarter of 2015 with over $20 billion in cash, cash equivalents, and short-term investments. As a result, Pfizer sports a fairly healthy balance sheet with a long-term debt-to-equity ratio of 58%. While that may sound sort of high, it's markedly lower than the sector average of 68%, according to data provided by S&P Capital IQ .
On a final note, Pfizer's quickly moving past its own problems with the patent cliff through the launch of several new products such as Prevnar 13, Ibrance, and Eliquis. Those three growth products, for example, helped to drive a 21% surge in sales within the company's innovative products business, on an operational basis, in the third quarter. As such, Pfizer's future appears to be on solid ground moving forward.
Todd Campbell : Finding high yielding dividend stocks that don't require a lot of investor attention can be tricky. Focus too much on high dividend yields and you might get stuck owning shares in a company whose business is risky. Alternatively, pick a company with a low dividend yield and your annual payout could be tiny.
In order to avoid falling into either of these two traps, investors have to strike a Goldilocks-like balance between risk and yield, and one company that appears to me to do that is Merck & Co .
Merck is one of the world's biggest drugmakers, with annual sales and profits last year of more than $42 billion and $11.9 billion, respectively. The company, however, has had some struggles due to patents expiring on its top-selling medicines, and that's why its dividend yield of 3.34% is a bit higher than some of its peers.
The good news, however, is that despite those patent expirations, Merck's quarterly dividend payment has still climbed. Launches of new drugs such as cancer treatment Keytruda, as well as a massive restructuring that's lopping off $2.5 billion in annual expenses, should give Merck enough insulation against future patent expirations to allow for additional dividend increases in the future.
Brian Feroldi : One high-yielding dividend stock that I like right now is pharma giant AbbVie . Although the company reported solid earnings, its stock has trailed the market by more than 8% since the start of the year, which could make right now a good time to pick up a few shares of this steady grower.
AbbVie recently released its long-term strategic plan and outlined its corporate objectives from now until 2020, and if the company can achieve those objectives, its future is certainly looking bright. AbbVie's management believes it should be able to grow total sales to $37 billion by 2020, which would be a solid increase from the roughly $22 billion it generated over the past 12 months.
AbbVie expects to achieve that growth largely on the backs of its blockbuster drugs Humira and Imbruvica, which the company believes will generate annual sales of $18 billion and $5 billion, respectively, by 2020. In addition, the company plans on launching north of 20 new products or expanding indications for current drugs over the next five years. The company believes that these new products and indications could deliver nearly $30 billion in peak sales combined.
AbbVie is looking to get more efficient as well; it has laid out plans to steadily improve its operating margin by 100 to 200 basis points each year, which would bring its operating margin to north of 50% by 2020. Between strong sales growth and a more efficient cost structure, AbbVie believes that it should be able to deliver double-digit EPS growth over that time period. Better yet, the company plans on passing a hefty amount of that cash back to its shareholders in the form of an ever-growing dividend.
AbbVie sees its 2016 adjusted EPS coming in between $4.90 and $5.10, which means that despite offering investors a plan for solid long-term growth, its shares are trading today for only 12 times forward earnings. Meanwhile, the company also offers investors a juicy 3.78% dividend yield that is nearly double the market average. That makes for a nice combination, which means that AbbVie is a high-yielding stock that also scores points on the "sleep well at night" factor.
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The article 3 High-Yield Dividend Stocks You Don't Have to Babysit originally appeared on Fool.com.
Brian Feroldi has no position in any stocks mentioned. George Budwell owns shares of AbbVie. Todd Campbell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie sees its 2016 adjusted EPS coming in between $4.90 and $5.10, which means that despite offering investors a plan for solid long-term growth, its shares are trading today for only 12 times forward earnings. Brian Feroldi : One high-yielding dividend stock that I like right now is pharma giant AbbVie . AbbVie recently released its long-term strategic plan and outlined its corporate objectives from now until 2020, and if the company can achieve those objectives, its future is certainly looking bright. | Brian Feroldi : One high-yielding dividend stock that I like right now is pharma giant AbbVie . AbbVie recently released its long-term strategic plan and outlined its corporate objectives from now until 2020, and if the company can achieve those objectives, its future is certainly looking bright. AbbVie's management believes it should be able to grow total sales to $37 billion by 2020, which would be a solid increase from the roughly $22 billion it generated over the past 12 months. | AbbVie expects to achieve that growth largely on the backs of its blockbuster drugs Humira and Imbruvica, which the company believes will generate annual sales of $18 billion and $5 billion, respectively, by 2020. Brian Feroldi : One high-yielding dividend stock that I like right now is pharma giant AbbVie . AbbVie recently released its long-term strategic plan and outlined its corporate objectives from now until 2020, and if the company can achieve those objectives, its future is certainly looking bright. | Brian Feroldi : One high-yielding dividend stock that I like right now is pharma giant AbbVie . AbbVie recently released its long-term strategic plan and outlined its corporate objectives from now until 2020, and if the company can achieve those objectives, its future is certainly looking bright. AbbVie's management believes it should be able to grow total sales to $37 billion by 2020, which would be a solid increase from the roughly $22 billion it generated over the past 12 months. |
26776.0 | 2015-11-16 00:00:00 UTC | AbbVie Reports Encouraging Data on HCV Drug Viekira Pak | ABBV | https://www.nasdaq.com/articles/abbvie-reports-encouraging-data-on-hcv-drug-viekira-pak-2015-11-16 | nan | nan | AbbVie Inc.ABBV announced encouraging new data from its ongoing phase IIIb TOPAZ-II study evaluating hepatitis C virus (HCV) infection drug, Viekira Pak. The single-arm, open-label, multicenter TOPAZ-II study is evaluating the safety and efficacy of 12 or 24 weeks of treatment with Viekira Pak, with or without ribavirin, in treatment-naïve or pegylated interferon and ribavirin treatment-experienced, adults with genotype 1 chronic HCV infection with or without compensated cirrhosis.
Preliminary data from the study revealed that Viekira Pak has effectively treated a diverse patient population with genotype 1 HCV, including those with compensated cirrhosis. Data show that 95% of patients in the TOPAZ-II study achieved sustained virologic response at 12 weeks post treatment after 12 or 24 weeks of treatment, which was a secondary endpoint of the study.
We remind investors that last month, Viekira Pak was in the spotlight after the FDA issued a warning related to Viekira Pak and another HCV drug, Technivie. The FDA had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ).
Meanwhile, competition in the HCV market is intensifying. Gilead Sciences' GILD Sovaldi and Harvoni are already approved for the treatment of this disease, while several companies like Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Meanwhile, AbbVie also announced submission of a supplemental New Drug Application to the FDA for labeling considerations based on the safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Data confirm Imbruvica's ability to attain enhanced effectiveness when added to the Treanda (bendamustine) and Rituxan (rituximab) combination for the treatment of relapsed or refractory patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
We remind investors that Imbruvica was added to AbbVie's portfolio following the company's Pharmacyclics acquisition in May 2015. The company has a development and commercialization agreement with Johnson & Johnson's JNJ Janssen Biotech, Inc. for Imbruvica.
AbbVie currently carries a Zacks Rank #3 (Hold). Gilead is a well-ranked stock in the health care sector, carrying a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV announced encouraging new data from its ongoing phase IIIb TOPAZ-II study evaluating hepatitis C virus (HCV) infection drug, Viekira Pak. Meanwhile, AbbVie also announced submission of a supplemental New Drug Application to the FDA for labeling considerations based on the safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. The FDA had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). | AbbVie Inc.ABBV announced encouraging new data from its ongoing phase IIIb TOPAZ-II study evaluating hepatitis C virus (HCV) infection drug, Viekira Pak. The FDA had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. | The FDA had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV announced encouraging new data from its ongoing phase IIIb TOPAZ-II study evaluating hepatitis C virus (HCV) infection drug, Viekira Pak. | AbbVie Inc.ABBV announced encouraging new data from its ongoing phase IIIb TOPAZ-II study evaluating hepatitis C virus (HCV) infection drug, Viekira Pak. The FDA had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Meanwhile, AbbVie also announced submission of a supplemental New Drug Application to the FDA for labeling considerations based on the safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. |
26777.0 | 2015-11-13 00:00:00 UTC | Hepatitis C Treatment in 2016: Will Gilead Sciences or AbbVie Win? | ABBV | https://www.nasdaq.com/articles/hepatitis-c-treatment-2016-will-gilead-sciences-or-abbvie-win-2015-11-13 | nan | nan | Gilead Sciences is a favorite healthcare stock for numerous Fools, and it's no surprise why. The recent stumble of AbbVie in its hepatitis C efforts has boosted the share price of Gilead, which has two key treatments that fight the illness.
Fools Kristine Harjes and Todd Campbell take a closer look at recent developments in the battle against hep C, and how these two companies in particular are likely to fare.
Listen to the full podcast by clicking here . A full transcript follows the video.
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Kristine Harjes: Hepatitis C has certainly been in the news a ton during 2015, and I think it's poised to be a big issue in 2016 as well. There are a handful of different companies that are working on improving treatment for hepatitis C, and in the most recent news, AbbVie, which makes a drug called Viekira Pak, and another one called Technivie, received news from the FDA that there was a safety alert going out that the FDA had received reports of liver failure and complications in patients taking these drugs that had already had scarring of the liver.
In reaction to this, AbbVie has said that a causal relationship between the treatments and the adverse effects hadn't actually been established, but the drugs couldn't be ruled out as a cause. Another result was that the label for the drugs is being updated to warrant against use in patients with more advanced liver scarring. This is 3%-5% of hepatitis C patients, just for context. I think people saw that news and they said, "AbbVie is not going to be a big player in hepatitis C anymore."
If they're potentially going to lose market share because of this, who do you think stands to be the big winner here? This is a no-brainer, for me at least, if you've listened to our show before. Todd?
Todd Campbell: Gilead Sciences.
Harjes: Woo!
Campbell: Not very surprising for longtime listeners, that's for sure. The news coming out of that -- AbbVie tried to downplay this on theirearnings conference call and I urge people to always dig into the transcripts of the conference calls, especially with top-selling, multibillion-dollar drugs to make sure there's nothing they could be aware that could shift the way market share looks. Certainly, as we go into 2016 a lot could theoretically happen that's going to shift shares around in hepatitis C.
AbbVie is one part of that, but it's an important part of it, because as we came into 2015, the big question on everyone's mind was, "How much market share can Viekera Pak steal away from Gilead Sciences' top selling drugs Sovaldi -- which launched in December of '13 -- and Harvoni, which launched in October of '14?" Those drugs have been massively successful. They're high-priced drugs, but they work very, very well, and as a result they've been used to treat hundreds of thousands of patients and they've generated out billions of dollars in revenue for Gilead Sciences.
Viekera Pak, over the first nine months of this year -- it won approval and launched in January -- has not reached the run rate that AbbVie had hoped and guided for coming out of 2014. AbbVie had hoped to see that drug putting up a run rate of about $3 billion per year. We're not quite there. In the third quarter it was about $469 million. You look at that and wonder why that's happening. It could be that there was some early insight into this problem with livers, as doctors were discussing with one another.
This revelation and addition to the label is not a deal-breaker for Viekera Pak, because it's still very successful in patients that don't suffer from liver disease already, but it certainly could mean fewer people are treated with it, especially since Sovaldi and Harvoni work so well. To some extent, the sales impact on AbbVie in 2016 may be offset by a recent approval in Japan, which is a major market for hepatitis C treatment.
I'm not willing to go out and say yet that the year-over-year sales will decline for Viekera Pak in 2016 because of this, because Japan should offset some of that downside risk, but it's definitely something to keep an eye on. I think most people should be re-evaluating their models on what they think Viekera Pak could do in the next 12 months.
Harjes: When you look at Gilead, you compare the numbers of Harvoni and Sovaldi, and they combine for $4.8 billion in sales during the third quarter. Todd quoted that Viekera Pak generated a revenue of $469 million in the third quarter. Half a billion dollars is not nothing, but it really pales in comparison to Gilead's numbers.
Gilead is claiming a 90% market share of hepatitis C patients. Clearly they're currently the dominating player, but is there anyone else other than AbbVie that's competing in this space and could stand to take down Gilead's dominance here?
Campbell: There are a couple. Bristol-Myers has a couple of drugs that are currently on the market. However, most of those sales -- again, we should downplay a $1 billion run rate -- but Bristol-Myers' drugs in third quarter for hepatitis C brought in about $400 million, down from $460 million the year before, because a lot of their sales in that space are coming out of Japan. In the past year, Gilead Sciences has won approval in Japan, and now AbbVie is winning approval in Japan.
So I think Bristol-Myers is going to become more of a vintage drug in this space, offering and selling more drugs in the niche category. I think the much bigger threat could come from Merck next year. People should be watching Merck very closely in January of next year, because that's when the FDA is set to make a decision on approving its hepatitis C drugs, and in trials those drugs, in my opinion, matched up best to what Gilead's Harvoni delivered in its own trials. Obviously, we know that Harvoni has been a massive success, so it will be very interesting to see how that plays out.
Harjes: Especially because the drugs are kind of similar in efficacy, and they're both one pill per day. To me the only advantage, or distinguishing factor, that I could see here between the offerings from Gilead and from Merck is that Harvoni can be dosed over eight weeks in more than 40% of genome type 1 patients, which is the biggest percentage of patients with hepatitis C, and Merck's drug is always going to be 12 weeks.
If you reduce duration, that's going to improve adherence, which is going to make your real-life efficacy better. I could see that being an advantage going to Gilead. Maybe if it ends up going the other way, it could be a pricing issue?
Campbell: Yeah. Merck's conference call was pretty firm in saying they're not going to fight on price for market share. That will be interesting to see how that plays out, too. Viekera Pak could be the one that stumbles.
Harjes: Yeah. One other thing I'll point out: Merck doesn't have any other hepatitis C drugs, all the way back until phase 1. To me, it doesn't look like they have this huge lineup of drug after innovative drug, to win away market share. Whereas you look at Gilead Sciences, and they're already developing their own next-generation hepatitis C therapy. To me, this really looks like somebody who is continuing to innovate and continuing to try and get better and better drugs.
The next hepatitis C therapy that they just submitted to the FDA for approval on Oct. 28 is a pan-genotype drug, which could theoretically eliminate the need for genotype testing to distinguish if you have genotype 1, or which particularly variety of the disease you have. I could see this being particularly helpful in emerging markets if they don't have the same healthcare infrastructure that we have here.
To eliminate the need for genotype testing could make this drug more accessible, and the data looks pretty good. In phase 3 it posted a 90% durable response after 12 weeks, and this was a trial across genotypes 1 through 6.
Campbell: Yeah, this may allow them to sidestep any threat from Merck as well. There's no question in my mind that Gilead Sciences is going to be the dominant player again in 2016 in syndication. Merck may pass AbbVie. Then in 2017, if you really want to look forward, it might get more interesting again, because that's when AbbVie's next-generation cocktail could hit the market.
That's also when other therapies from Johnson & Johnson , may start to make their way toward the FDA as well. We shouldn't discount Johnson & Johnson. They're just a little further back in their research. They've got some ongoing phase 2 stuff under way, which looks really intriguing and could help them in creating a shorter duration therapy for HCV. This is going to be a very interesting space to watch over the course of the next two years, still.
Harjes: As long-term investors, that's what we want to be looking at. Not just who the current market share winner is, but looking ahead at the pipelines and figuring out who will continue to win this space. I think one last piece of the puzzle that is worth touching on is the fact that you have a hepatitis C treatment. That means you're cured.
So are these drugs eliminating their own market? Do you think that this isn't going to be a huge space for drugmakers in a couple of years because we've already treated everyone?
Campbell: Even if you look at it and say Gilead is going to treat 350,000 people a year, maybe the other ones would get up to 500,000 people per year, the U.S. market should be able to handle that kind of pace until at least 2020, maybe 2021. Japan should be able to -- that market's still probably addressable into 2023, 2024. I'd say Europe goes even further than that, because they've got 9 million people who are suffering from this disease.
Then there's the emerging-market population, which some people estimate as high as 170 million people. So, yes, eventually the goal would be to have no one having hepatitis C because of these drugs. Does that mean this market disappears in the next two years? No. Five years? It starts to get a bit murky in some places, but I would say that you're still generating a lot of money that is a multibillion-dollar blockbuster indication for at least 10 years.
Harjes: I would agree with you there. There are so many people that are estimated to have this disease, and I think once the drugs are more prevalent, especially in developing areas, you're going to get a woodwork effect where even more people go and get tested and figure out that they have the disease. The hope there is that we have the best of the best drugs to treat them with.
The article Hepatitis C Treatment in 2016: Will Gilead Sciences or AbbVie Win? originally appeared on Fool.com.
Kristine Harjes owns shares of Gilead Sciences. Todd Campbell owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Viekera Pak, over the first nine months of this year -- it won approval and launched in January -- has not reached the run rate that AbbVie had hoped and guided for coming out of 2014. The recent stumble of AbbVie in its hepatitis C efforts has boosted the share price of Gilead, which has two key treatments that fight the illness. There are a handful of different companies that are working on improving treatment for hepatitis C, and in the most recent news, AbbVie, which makes a drug called Viekira Pak, and another one called Technivie, received news from the FDA that there was a safety alert going out that the FDA had received reports of liver failure and complications in patients taking these drugs that had already had scarring of the liver. | There are a handful of different companies that are working on improving treatment for hepatitis C, and in the most recent news, AbbVie, which makes a drug called Viekira Pak, and another one called Technivie, received news from the FDA that there was a safety alert going out that the FDA had received reports of liver failure and complications in patients taking these drugs that had already had scarring of the liver. Certainly, as we go into 2016 a lot could theoretically happen that's going to shift shares around in hepatitis C. AbbVie is one part of that, but it's an important part of it, because as we came into 2015, the big question on everyone's mind was, "How much market share can Viekera Pak steal away from Gilead Sciences' top selling drugs Sovaldi -- which launched in December of '13 -- and Harvoni, which launched in October of '14?" In the past year, Gilead Sciences has won approval in Japan, and now AbbVie is winning approval in Japan. | There are a handful of different companies that are working on improving treatment for hepatitis C, and in the most recent news, AbbVie, which makes a drug called Viekira Pak, and another one called Technivie, received news from the FDA that there was a safety alert going out that the FDA had received reports of liver failure and complications in patients taking these drugs that had already had scarring of the liver. Certainly, as we go into 2016 a lot could theoretically happen that's going to shift shares around in hepatitis C. AbbVie is one part of that, but it's an important part of it, because as we came into 2015, the big question on everyone's mind was, "How much market share can Viekera Pak steal away from Gilead Sciences' top selling drugs Sovaldi -- which launched in December of '13 -- and Harvoni, which launched in October of '14?" The recent stumble of AbbVie in its hepatitis C efforts has boosted the share price of Gilead, which has two key treatments that fight the illness. | The recent stumble of AbbVie in its hepatitis C efforts has boosted the share price of Gilead, which has two key treatments that fight the illness. There are a handful of different companies that are working on improving treatment for hepatitis C, and in the most recent news, AbbVie, which makes a drug called Viekira Pak, and another one called Technivie, received news from the FDA that there was a safety alert going out that the FDA had received reports of liver failure and complications in patients taking these drugs that had already had scarring of the liver. In reaction to this, AbbVie has said that a causal relationship between the treatments and the adverse effects hadn't actually been established, but the drugs couldn't be ruled out as a cause. |
26778.0 | 2015-11-13 00:00:00 UTC | Gilead's (GILD) HCV Drug Harvoni's Label Expanded in U.S. | ABBV | https://www.nasdaq.com/articles/gileads-gild-hcv-drug-harvonis-label-expanded-in-u.s.-2015-11-13 | nan | nan | Gilead Sciences, Inc.GILD announced a label expansion for its hepatitis C virus (HCV) infection drug, Harvoni, in the U.S. With the label expansion, Harvoni can now be used for the treatment of patients with chronic HCV genotypes 4, 5 and 6 infection and in patients co-infected with HIV. Additionally, Harvoni, in combination with ribavirin as a 12-week regimen, was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced genotype 1 patients with cirrhosis.
We remind investors that in the U.S., Harvoni is available for the treatment of chronic HCV genotype 1 infection in adults. We are encouraged by the label expansion of the drug. Harvoni is the key revenue driver at the company. However, Gilead's HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak among others. Harvoni witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. In this scenario, the label expansion of Harvoni is a major win for the company. It should boost the drug's sales.
Meanwhile, competition in the HCV market is intensifying as several companies like Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Gilead currently carries a Zacks Rank #2 (Buy). Baxalta Incorporated BXLT is another well-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Harvoni witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak among others. Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >> Want the latest recommendations from Zacks Investment Research? | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak among others. Gilead Sciences, Inc.GILD announced a label expansion for its hepatitis C virus (HCV) infection drug, Harvoni, in the U.S. With the label expansion, Harvoni can now be used for the treatment of patients with chronic HCV genotypes 4, 5 and 6 infection and in patients co-infected with HIV. | In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak among others. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report BAXALTA INC (BXLT): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc.GILD announced a label expansion for its hepatitis C virus (HCV) infection drug, Harvoni, in the U.S. With the label expansion, Harvoni can now be used for the treatment of patients with chronic HCV genotypes 4, 5 and 6 infection and in patients co-infected with HIV. |
26779.0 | 2015-11-11 00:00:00 UTC | Should Healthcare Dividend Hunters Target AbbVie or Johnson & Johnson? | ABBV | https://www.nasdaq.com/articles/should-healthcare-dividend-hunters-target-abbvie-or-johnson-johnson-2015-11-11 | nan | nan | For those seeking a steady source of income in the form of dividends, pharmaceutical heavyweight AbbVie and healthcare conglomerate Johnson & Johnson both have plenty to offer. Since its spinoff from parent company Abbott Laboratories at the start of 2013, AbbVie has handily outpaced the broad market. Johnson & Johnson's stock performance over the same period is less encouraging, but there isn't a company in healthcare that can beat its 53-year history of raising dividend payments.
Injunctive relief
Even ahead of the spinoff, analysts had been predicting doom and gloom for AbbVie once its blockbuster anti-inflammatory drug Humira faces biosimilar competition in the United States. At more than 60% of total revenue, there's a lot to be concerned about.
When the company reported third-quarter earnings, the headline numbers were encouraging, but what stoked the market was assurance from CEO Rick Gonzalez that an army of patent lawyers is prepared to secure Humira's future.
In the U.S., which generates more than 60% of Humira sales, AbbVie's main composition-of-matter patent expires at the end of next year. That's the bad news.
But AbbVie's legal department has been working around the clock since the spinoff. The company now claims a whopping 75 patents related to Humira. This list includes 16 that are indication specific, the first of which don't expire until 2022. During the third-quarter conference call, Gonzalez practically dared competitors to infringe on one, noting enormous potential damages given Humira's success, and a tendency for courts to issue preliminary injunctions in similar cases.
Confident in its ability to keep biosimilar competition at bay, the company is forecasting 2020 annual Humira sales above $18 billion. That's about 23% above the current run rate of $14.6 billion, and well over Wall Street's 2020 estimates of $13.3 billion.
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The article Should Healthcare Dividend Hunters Target AbbVie or Johnson & Johnson? originally appeared on Fool.com.
Cory Renauer owns shares of Abbott Laboratories and Johnson & Johnson. The Motley Fool owns shares of and recommends Express Scripts. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Injunctive relief Even ahead of the spinoff, analysts had been predicting doom and gloom for AbbVie once its blockbuster anti-inflammatory drug Humira faces biosimilar competition in the United States. For those seeking a steady source of income in the form of dividends, pharmaceutical heavyweight AbbVie and healthcare conglomerate Johnson & Johnson both have plenty to offer. Since its spinoff from parent company Abbott Laboratories at the start of 2013, AbbVie has handily outpaced the broad market. | For those seeking a steady source of income in the form of dividends, pharmaceutical heavyweight AbbVie and healthcare conglomerate Johnson & Johnson both have plenty to offer. Since its spinoff from parent company Abbott Laboratories at the start of 2013, AbbVie has handily outpaced the broad market. Injunctive relief Even ahead of the spinoff, analysts had been predicting doom and gloom for AbbVie once its blockbuster anti-inflammatory drug Humira faces biosimilar competition in the United States. | For those seeking a steady source of income in the form of dividends, pharmaceutical heavyweight AbbVie and healthcare conglomerate Johnson & Johnson both have plenty to offer. Since its spinoff from parent company Abbott Laboratories at the start of 2013, AbbVie has handily outpaced the broad market. Injunctive relief Even ahead of the spinoff, analysts had been predicting doom and gloom for AbbVie once its blockbuster anti-inflammatory drug Humira faces biosimilar competition in the United States. | For those seeking a steady source of income in the form of dividends, pharmaceutical heavyweight AbbVie and healthcare conglomerate Johnson & Johnson both have plenty to offer. Since its spinoff from parent company Abbott Laboratories at the start of 2013, AbbVie has handily outpaced the broad market. Injunctive relief Even ahead of the spinoff, analysts had been predicting doom and gloom for AbbVie once its blockbuster anti-inflammatory drug Humira faces biosimilar competition in the United States. |
26780.0 | 2015-11-09 00:00:00 UTC | Incyte Down on Data from Epacadostat Combination Study | ABBV | https://www.nasdaq.com/articles/incyte-down-on-data-from-epacadostat-combination-study-2015-11-09 | nan | nan | Incyte Corporation 's INCY shares plunged 14.2% on preliminary results from the ongoing dose-escalation and dose-expansion phase I/II study on epacadostat in combination with Merck & Co. Inc.'s MRK Keytruda. The results were presented at the annual meeting of the Society for Immunotherapy of Cancer.
Although results from the study showed that the overall response rate and disease control rate in patients were 53% and 74%, respectively, investors were disappointed as the company had reported better disease control rates earlier this month.
Incyte expects to initiate a phase III study on this combination in patients with advanced melanoma in 2016.
Meanwhile, Incyte and partner Eli Lilly and Company LLY announced detailed data from two pivotal phase III studies (RA-BEAM and RA-BEGIN) on baricitinib for the treatment of patients with moderate-to-severe active rheumatoid arthritis (RA).
Results from the RA-BEAM study, which evaluated baricitinib in comparison with AbbVie Inc.'s ABBV Humira, showed statistical superiority after 12 weeks, based on several critical measures of RA disease activity. Data also demonstrated improvements in all the seven components of the American College of Rheumatology (ACR) composite score, at 52 weeks, including a reduction in the number of tender and swollen joints, patients' pain and improving physical function.
Data from the RA-BEGIN study, revealed the superiority of baricitinib both as monotherapy and in combination with methotrexate, over methotrexate monotherapy in achieving clinical remission. Results demonstrated that both alone and in combination, the candidate led to improvements in all the ACR components from as early as week 1 and was maintained through 52 weeks. The combination also demonstrated a significant inhibition of progressive radiographic joint damage when compared to methotrexate monotherapy.
The companies plans to submit detailed data from the four pivotal phase III studies (RA-BEACON, RA-BUILD, RA-BEGIN and RA-BEAM) and the long-term extension study (RA-BEYOND) on baricitinib in scientific meetings and for publication in peer-reviewed journals in 2016.
According to the World Health Organization, more than 23 million people in the world suffer from RA. It has also been estimated that approximately 3 times as many women as men are affected by RA.
Incyte carries a Zacks Rank #3 (Hold). Eli Lilly is a better-ranked stock in the health care sector with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Results from the RA-BEAM study, which evaluated baricitinib in comparison with AbbVie Inc.'s ABBV Humira, showed statistical superiority after 12 weeks, based on several critical measures of RA disease activity. Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Incyte Corporation 's INCY shares plunged 14.2% on preliminary results from the ongoing dose-escalation and dose-expansion phase I/II study on epacadostat in combination with Merck & Co. Inc.'s MRK Keytruda. | Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Results from the RA-BEAM study, which evaluated baricitinib in comparison with AbbVie Inc.'s ABBV Humira, showed statistical superiority after 12 weeks, based on several critical measures of RA disease activity. Meanwhile, Incyte and partner Eli Lilly and Company LLY announced detailed data from two pivotal phase III studies (RA-BEAM and RA-BEGIN) on baricitinib for the treatment of patients with moderate-to-severe active rheumatoid arthritis (RA). | Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Results from the RA-BEAM study, which evaluated baricitinib in comparison with AbbVie Inc.'s ABBV Humira, showed statistical superiority after 12 weeks, based on several critical measures of RA disease activity. Meanwhile, Incyte and partner Eli Lilly and Company LLY announced detailed data from two pivotal phase III studies (RA-BEAM and RA-BEGIN) on baricitinib for the treatment of patients with moderate-to-severe active rheumatoid arthritis (RA). | Click to get this free report LILLY ELI & CO (LLY): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Results from the RA-BEAM study, which evaluated baricitinib in comparison with AbbVie Inc.'s ABBV Humira, showed statistical superiority after 12 weeks, based on several critical measures of RA disease activity. Meanwhile, Incyte and partner Eli Lilly and Company LLY announced detailed data from two pivotal phase III studies (RA-BEAM and RA-BEGIN) on baricitinib for the treatment of patients with moderate-to-severe active rheumatoid arthritis (RA). |
26781.0 | 2015-11-07 00:00:00 UTC | Is Celgene's Otezla Coming of Age? | ABBV | https://www.nasdaq.com/articles/celgenes-otezla-coming-age-2015-11-07 | nan | nan | Image source: Celgene Corporation.
Celgene Corp 's first foray into autoimmune disease, Otezla, notched FDA approval last year as a therapy for psoriasis, and its sales have been building steadily ever since, including an impressive 688% leap forward in the third quarter that may indicate it won't be long before Otezla delivers on pre-launch blockbuster expectations.
Transforming treatment
Globally, 125 million people suffer from psoriasis, an inflammatory disease of the skin caused by an uncontrolled immune system response.
Historically, patients suffering from psoriasis have been treated with steroid creams that can reduce itching, disease-modifying antirheumatic drugs (DMARD) that can decrease pain, and biologics, such as AbbVie 's mega multibillion-dollar per year blockbuster drug Humira.
Although creams, DMARDs, and biologics can be effective in controlling the symptoms of psoriasis, they don't work for everyone, and even when they do work, patients can suffer unwelcome side effects and, in the case of DMARDs and biologics, unsettling injection-based dosing and regular testing and monitoring.
In a bid to improve patient treatment and reduce patient burden, Celgene developed Otezla, an entirely new form of psoriasis treatment.
Unlike DMARDs and biologics, Otezla targets the release of cytokines from immune cells by inhibiting PDE4, an intracellular enzyme. Additionally, Otezla is taken orally, rather than applied via a cream or injected, and its label doesn't call for routine testing. Those advantages are likely welcome news to patients because a study published in JAMA Dermatology in 2013 (prior to Otezla's approval) found that 52% of psoriasis patients were dissatisfied with their treatment options.
Growing market share
Otezla's script volume has been growing more quickly than previously launched autoimmune drugs, including top-sellers Simponi and Stelara, both of which are manufactured by Johnson & Johnson and are approved to treat psoriasis symptoms.
Simponi is a once-monthly anti-TNF injection therapy that treats rheumatoid arthritis and psoriatic arthritis and has been on the market since 2009. Stelara is a monoclonal antibody that blocks the activity of two proteins that contribute to the overproduction of skin cells and inflammation; it won approval for use in psoriasis patients back in 2009.
Since Simponi and Stelara have been on the market for years, they may offer insight into how big the market opportunity may ultimately be for Otezla, especially in light of Otezla's faster script growth.
Last quarter, Johnson & Johnson reported that sales of Simponi grew 26.7% year over year to $380 million, giving it an annualized sales run rate of $1.5 billion. Meanwhile, Stelara sales grew 12.9% year over year to $613 million, giving it an annualized sales run rate of over $2.4 billion.
Based on Celgene's third-quarter Otezla sales and the company's recent launches of Otezla overseas, I don't think it's a stretch to believe that Otezla could one day be generating revenue at a similar pace.
In the third quarter, Otezla brought in $139 million in sales, and that was up 688% year over year and up 54% from the second quarter. That growth came primarily from rising script volume in the U.S., but new launches in Europe, including in Germany, are starting to kick in, too. International sales of Otezla totaled $10 million in the quarter.
Looking ahead
Celgene offered up long-term guidance to investors in January that includes projections for Otezla annual sales of between $1.5 billion and $2 billion in 2017. To deliver on that forecast, Celgene will need to continue growing market share in the U.S. while also successfully commercializing Otezla in other markets, such as Japan, where the company plans to file for Otezla's approval early next year.
Celgene could also see Otezla's sales benefit from growth tied to ongoing trials designed to expand its label and improve its standing with doctors. However, given that Otezla's script volume is already climbing sharply, I don't think Otezla needs those trials to succeed to become a billion-dollar blockbuster soon.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article Is Celgene's Otezla Coming of Age? originally appeared on Fool.com.
Todd Campbell owns shares of Celgene. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Celgene. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Historically, patients suffering from psoriasis have been treated with steroid creams that can reduce itching, disease-modifying antirheumatic drugs (DMARD) that can decrease pain, and biologics, such as AbbVie 's mega multibillion-dollar per year blockbuster drug Humira. Transforming treatment Globally, 125 million people suffer from psoriasis, an inflammatory disease of the skin caused by an uncontrolled immune system response. Stelara is a monoclonal antibody that blocks the activity of two proteins that contribute to the overproduction of skin cells and inflammation; it won approval for use in psoriasis patients back in 2009. | Historically, patients suffering from psoriasis have been treated with steroid creams that can reduce itching, disease-modifying antirheumatic drugs (DMARD) that can decrease pain, and biologics, such as AbbVie 's mega multibillion-dollar per year blockbuster drug Humira. Growing market share Otezla's script volume has been growing more quickly than previously launched autoimmune drugs, including top-sellers Simponi and Stelara, both of which are manufactured by Johnson & Johnson and are approved to treat psoriasis symptoms. Last quarter, Johnson & Johnson reported that sales of Simponi grew 26.7% year over year to $380 million, giving it an annualized sales run rate of $1.5 billion. | Historically, patients suffering from psoriasis have been treated with steroid creams that can reduce itching, disease-modifying antirheumatic drugs (DMARD) that can decrease pain, and biologics, such as AbbVie 's mega multibillion-dollar per year blockbuster drug Humira. Celgene Corp 's first foray into autoimmune disease, Otezla, notched FDA approval last year as a therapy for psoriasis, and its sales have been building steadily ever since, including an impressive 688% leap forward in the third quarter that may indicate it won't be long before Otezla delivers on pre-launch blockbuster expectations. Based on Celgene's third-quarter Otezla sales and the company's recent launches of Otezla overseas, I don't think it's a stretch to believe that Otezla could one day be generating revenue at a similar pace. | Historically, patients suffering from psoriasis have been treated with steroid creams that can reduce itching, disease-modifying antirheumatic drugs (DMARD) that can decrease pain, and biologics, such as AbbVie 's mega multibillion-dollar per year blockbuster drug Humira. In a bid to improve patient treatment and reduce patient burden, Celgene developed Otezla, an entirely new form of psoriasis treatment. Growing market share Otezla's script volume has been growing more quickly than previously launched autoimmune drugs, including top-sellers Simponi and Stelara, both of which are manufactured by Johnson & Johnson and are approved to treat psoriasis symptoms. |
26782.0 | 2015-11-05 00:00:00 UTC | First Trust Value Line Dividend Index Fund Experiences Big Outflow | ABBV | https://www.nasdaq.com/articles/first-trust-value-line-dividend-index-fund-experiences-big-outflow-2015-11-05 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust Value Line Dividend Index Fund (Symbol: FVD) where we have detected an approximate $113.6 million dollar outflow -- that's a 8.8% decrease week over week (from 52,637,986 to 47,987,986). Among the largest underlying components of FVD, in trading today AbbVie Inc. (Symbol: ABBV) is down about 2.8%, BOK Financial Corp. (Symbol: BOKF) is up about 1%, and L-3 Communications Holdings, Inc. (Symbol: LLL) is lower by about 0.4%. For a complete list of holdings, visit the FVD Holdings page » The chart below shows the one year price performance of FVD, versus its 200 day moving average:
Looking at the chart above, FVD's low point in its 52 week range is $14.85 per share, with $24.70 as the 52 week high point - that compares with a last trade of $24.36. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs experienced notable outflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of FVD, in trading today AbbVie Inc. (Symbol: ABBV) is down about 2.8%, BOK Financial Corp. (Symbol: BOKF) is up about 1%, and L-3 Communications Holdings, Inc. (Symbol: LLL) is lower by about 0.4%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust Value Line Dividend Index Fund (Symbol: FVD) where we have detected an approximate $113.6 million dollar outflow -- that's a 8.8% decrease week over week (from 52,637,986 to 47,987,986). These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. | Among the largest underlying components of FVD, in trading today AbbVie Inc. (Symbol: ABBV) is down about 2.8%, BOK Financial Corp. (Symbol: BOKF) is up about 1%, and L-3 Communications Holdings, Inc. (Symbol: LLL) is lower by about 0.4%. For a complete list of holdings, visit the FVD Holdings page » The chart below shows the one year price performance of FVD, versus its 200 day moving average: Looking at the chart above, FVD's low point in its 52 week range is $14.85 per share, with $24.70 as the 52 week high point - that compares with a last trade of $24.36. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). | Among the largest underlying components of FVD, in trading today AbbVie Inc. (Symbol: ABBV) is down about 2.8%, BOK Financial Corp. (Symbol: BOKF) is up about 1%, and L-3 Communications Holdings, Inc. (Symbol: LLL) is lower by about 0.4%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust Value Line Dividend Index Fund (Symbol: FVD) where we have detected an approximate $113.6 million dollar outflow -- that's a 8.8% decrease week over week (from 52,637,986 to 47,987,986). For a complete list of holdings, visit the FVD Holdings page » The chart below shows the one year price performance of FVD, versus its 200 day moving average: Looking at the chart above, FVD's low point in its 52 week range is $14.85 per share, with $24.70 as the 52 week high point - that compares with a last trade of $24.36. | Among the largest underlying components of FVD, in trading today AbbVie Inc. (Symbol: ABBV) is down about 2.8%, BOK Financial Corp. (Symbol: BOKF) is up about 1%, and L-3 Communications Holdings, Inc. (Symbol: LLL) is lower by about 0.4%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust Value Line Dividend Index Fund (Symbol: FVD) where we have detected an approximate $113.6 million dollar outflow -- that's a 8.8% decrease week over week (from 52,637,986 to 47,987,986). For a complete list of holdings, visit the FVD Holdings page » The chart below shows the one year price performance of FVD, versus its 200 day moving average: Looking at the chart above, FVD's low point in its 52 week range is $14.85 per share, with $24.70 as the 52 week high point - that compares with a last trade of $24.36. |
26783.0 | 2015-11-05 00:00:00 UTC | Gilead's Sovaldi in Focus on Bradyarrhythmia Concerns | ABBV | https://www.nasdaq.com/articles/gileads-sovaldi-in-focus-on-bradyarrhythmia-concerns-2015-11-05 | nan | nan | Concerns related to Gilead Sciences Inc .'s GILD Sovaldi have surfaced after a letter to the New England Journal of Medicine reported three cases of severe bradyarrhythmia during treatment with Sovaldi plus Daklinza, Olysio or ribavirin out of 415 patients treated in Hopital Cochin's hepatology and cardiology group in Paris last year.
Gilead clarified that the company had reported these three cases of bradyarrhythmia mentioned in the published letter to the FDA and the European Pharmacovigilance Risk Assessment Committee earlier this year.
We remind investors that Gilead's HCV drugs have already been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from the year-ago figure owing to the availability of newer HCV therapies. Another new HCV drug, Harvoni, witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. Meanwhile, Gilead is working on developing several Sovaldi-based regimens. In this scenario, if the product is found to be associated with a risk of severe bradyarrhythmia, it could prove to be a major setback for the company.
The report of potentially severe bradyarrhythmia being associated with Sovaldi came close on the heels of the FDA issuing a warning related to AbbVie Inc.'s ABBV HCV drugs, Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (read more: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ).
Meanwhile, competition in the HCV market is intensifying as several companies including Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Gilead currently carries a Zacks Rank #3 (Hold). Anika Therapeutics Inc. ANIK is a better-ranked stock in the health care sector. The stock sports a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The report of potentially severe bradyarrhythmia being associated with Sovaldi came close on the heels of the FDA issuing a warning related to AbbVie Inc.'s ABBV HCV drugs, Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (read more: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. | The report of potentially severe bradyarrhythmia being associated with Sovaldi came close on the heels of the FDA issuing a warning related to AbbVie Inc.'s ABBV HCV drugs, Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (read more: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. | The report of potentially severe bradyarrhythmia being associated with Sovaldi came close on the heels of the FDA issuing a warning related to AbbVie Inc.'s ABBV HCV drugs, Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (read more: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. | The report of potentially severe bradyarrhythmia being associated with Sovaldi came close on the heels of the FDA issuing a warning related to AbbVie Inc.'s ABBV HCV drugs, Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (read more: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ). Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. |
26784.0 | 2015-11-05 00:00:00 UTC | The Zacks Analyst Blog Highlights: AbbVie, Amgen, Dyax, Repros and Gilead | ABBV | https://www.nasdaq.com/articles/the-zacks-analyst-blog-highlights%3A-abbvie-amgen-dyax-repros-and-gilead-2015-11-05 | nan | nan | For Immediate Release
Chicago, IL - November 05, 2015 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the AbbVie ( ABBV ), Amgen ( AMGN ), DyaxCorp. ( DYAX ), Repros ( RPRX ) and Gilead ( GILD ).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free .
Here are highlights from Wednesday's Analyst Blog:
Biotech Stock Roundup
Several major biotech companies reported their third quarter results over the last week. While investors remained focused on earnings, the sector also saw an acquisition deal being announced as well some regulatory updates.
Recap of the Week's Most Important Stories
1. First a look at earnings results. It was a "beat and raise" quarter for AbbVie ( ABBV ) which continues to see strong sales from its flagship drug, Humira. The company reported that Humira's momentum has not been adversely impacted by the Remicade biosimilar. With approval for additional indications, Humira should continue growing (Read more: AbbVie Tops on 3Q Earnings & Revenues, Ups 2015 View ).
Vertex also posted a narrower-than-expected loss with revenues coming in well above expectations. Importantly, Kalydeco continued to improve and Vertex raised its Kalydeco sales outlook yet again. (Read more: Vertex Posts Narrower Q3 Loss, Ups Kalydeco View ) Amgen ( AMGN ) also reported a "beat and raise" quarter. (Read more: Amgen Ups 2015 Outlook with Q3 Earnings & Revenue Beat ) Meanwhile, Alexion's third-quarter results were mixed with the company missing on revenues but surpassing earnings estimates. (Read more: Alexion Beats on Earnings in Q3 but Misses on Revenues )
2. Dyax Corp.'s ( DYAX ) shares shot up on news that the company has entered into an acquisition agreement with Shire. Shire will be acquiring Dyax for about $5.9 billion plus a non-tradable contingent value right (CVR) worth $4.00 in cash representing an additional $646 million. (Read more: Shire to Buy Dyax for $5.9B Plus CVR, Boost HAE Portfolio )
3. Repros ( RPRX ) suffered a big setback with the FDA cancelling the advisory panel meeting for the company's enclomiphene product candidate. (Read more: Repros Hits 52-Week Low, FDA Delays Enclomiphene Meeting )
4. Gilead ( GILD ) continues to progress with its HCV portfolio with the company submitting an NDA for a once-daily fixed-dose combination of Sovaldi (a nucleotide analog polymerase inhibitor) and velpatasvir (VEL - a pan-genotypic NS5A inhibitor). The filing is for the treatment of chronic genotype 1-6 HCV infection. Approval would make this the first all-oral, pan-genotypic single-tablet regimen for chronic HCV infection.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | With approval for additional indications, Humira should continue growing (Read more: AbbVie Tops on 3Q Earnings & Revenues, Ups 2015 View ). Stocks recently featured in the blog include the AbbVie ( ABBV ), Amgen ( AMGN ), DyaxCorp. It was a "beat and raise" quarter for AbbVie ( ABBV ) which continues to see strong sales from its flagship drug, Humira. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report DYAX CORP (DYAX): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks recently featured in the blog include the AbbVie ( ABBV ), Amgen ( AMGN ), DyaxCorp. It was a "beat and raise" quarter for AbbVie ( ABBV ) which continues to see strong sales from its flagship drug, Humira. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report DYAX CORP (DYAX): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks recently featured in the blog include the AbbVie ( ABBV ), Amgen ( AMGN ), DyaxCorp. It was a "beat and raise" quarter for AbbVie ( ABBV ) which continues to see strong sales from its flagship drug, Humira. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report DYAX CORP (DYAX): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks recently featured in the blog include the AbbVie ( ABBV ), Amgen ( AMGN ), DyaxCorp. It was a "beat and raise" quarter for AbbVie ( ABBV ) which continues to see strong sales from its flagship drug, Humira. |
26785.0 | 2015-11-05 00:00:00 UTC | Does AbbVie's Viekira Pak Warning Land Express Scripts in the Penalty Box? | ABBV | https://www.nasdaq.com/articles/does-abbvies-viekira-pak-warning-land-express-scripts-penalty-box-2015-11-05 | nan | nan | Recently, the FDA slapped AbbVie 's hepatitis C virus franchise with a toxicity warning. The drug safety communication surprised few familiar with safety profiles of Viekira Pak and Technivie. Still, warning of serious liver injury risk in patients with underlying advanced liver disease after taking the drugs is bad news no matter how many expected it in the first place.
With Technivie's indication limited to HCV genotype 4 patients, Viekira Pak the major interferon-free combo therapy competing with the megablockbuster HCV franchise of Gilead Sciences . Competition in this space is fierce, as evidenced by Johnson & Johnson 's experience with Olysio. J&J recorded $2.3 billion in sales of Olysio last year. But, following the approval of Gilead's Harvoni last October, sales of Olysio have fallen off a cliff, reaching just $79 million in the most recent quarter. Going back a little further, Vertex Pharmaceuticals had a blockbuster in Incivek before Sovaldi's approval in December 2013. Vertex has since withdrawn Incivek from the U.S. market, putting its entire HCV program to rest.
In such a hypercompetitive market, every advantage is magnified, or at least it should be. Luckily for AbbVie investors, the company deftly worked out a sweetheart deal with America's largest pharmacy benefit manager, Express Scripts . It's the job of PBMs to create guidelines for healthcare providers that maximize benefits while reducing costs, typically by promoting the use of generics.
Three unknowns and two black boxes
Express Scripts inflamed the medical community when it excluded Harvoni from its formulary and insisted doctors prescribe Viekira Pak in its place despite Harvoni being arguably a better drug. At the top of physician complaints was lack of real-world data for three of the combination's four components.
The fourth component, ritonavir, is well understood, but that didn't help matters any. Marketed as Norvir, its label includes a black-box warning -- the FDA's most severe -- for "potentially serious and/or life-threatening adverse events".
Not only did Viekira Pak have more unknown compounds than Harvoni, but most patients also need to take it along with ribavirin. Marketed as Copegus by Roche , this side-effect laden drug also comes with black-box warnings for hemolytic anemia and embryocidal effects.
In clinical trials leading to Viekira Pak's approval, viral clearance rates of the three-compound regimen were impressive, and a little better with ribavirin added. In light of Harvoni's stellar viral clearance rates, the FDA had to insist on ribavirin's inclusion alongside Viekira Pak for the vast majority of patients.
However, following the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases of severe liver injury in patients taking one of these drugs have been submitted to the FDA. Of these, 10 patients experienced liver failure resulting in transplant or death. We can't know how many were reported elsewhere, and AbbVie quickly countered that some of the cases occurred in patients who shouldn't have been taking the drugs in the first place. However, AbbVie's investors were clearlyshaken by the news.
Going forward
Gilead's trifecta of safety, tolerability, and efficacy is an incredible achievement that doesn't need a safety warning to improve its position against Viekira Pak. That said, investors will want to keep an eye out for any admission of fault from Express Scripts, or at least a softening of its anti-Harvoni stance. The PBM will soon hold a meeting to review the news and changes to Viekira Pak's label, though the drug remains on the PBM's formulary for now. Gilead could find itself with a lot more potential patients depending on the outcome.
It would be impossible to state that some specific number of people ended up with severe liver injury because they were prevented from receiving Harvoni as a direct result of Express Scripts' formulary exclusion. One thing, however, is certain: The next time it or another PBM tries to exclude an expensive drug in favor of less expensive but unknown compounds, this safety warning will be remembered.
In my opinion, Express Scripts crossed a line by excluding Harvoni for a combination of three unknown compounds and two with black-box warnings. Let's hope the FDA safety warning will make it much harder to cut expensive drugs from formularies before alternatives have proven themselves in the real world.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Does AbbVie's Viekira Pak Warning Land Express Scripts in the Penalty Box? originally appeared on Fool.com.
Cory Renauer owns shares of Johnson & Johnson. The Motley Fool owns shares of and recommends Express Scripts and Gilead Sciences. The Motley Fool recommends Johnson & Johnson and Vertex Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Recently, the FDA slapped AbbVie 's hepatitis C virus franchise with a toxicity warning. Luckily for AbbVie investors, the company deftly worked out a sweetheart deal with America's largest pharmacy benefit manager, Express Scripts . We can't know how many were reported elsewhere, and AbbVie quickly countered that some of the cases occurred in patients who shouldn't have been taking the drugs in the first place. | Recently, the FDA slapped AbbVie 's hepatitis C virus franchise with a toxicity warning. Luckily for AbbVie investors, the company deftly worked out a sweetheart deal with America's largest pharmacy benefit manager, Express Scripts . We can't know how many were reported elsewhere, and AbbVie quickly countered that some of the cases occurred in patients who shouldn't have been taking the drugs in the first place. | Recently, the FDA slapped AbbVie 's hepatitis C virus franchise with a toxicity warning. Luckily for AbbVie investors, the company deftly worked out a sweetheart deal with America's largest pharmacy benefit manager, Express Scripts . We can't know how many were reported elsewhere, and AbbVie quickly countered that some of the cases occurred in patients who shouldn't have been taking the drugs in the first place. | However, AbbVie's investors were clearlyshaken by the news. Recently, the FDA slapped AbbVie 's hepatitis C virus franchise with a toxicity warning. Luckily for AbbVie investors, the company deftly worked out a sweetheart deal with America's largest pharmacy benefit manager, Express Scripts . |
26786.0 | 2015-11-03 00:00:00 UTC | Seattle Genetics, Inc. Earnings: Extending the Runway | ABBV | https://www.nasdaq.com/articles/seattle-genetics-inc-earnings-extending-runway-2015-11-03 | nan | nan | Seattle Genetics reported third-quarter earnings on Thursday. While the biotech does have one drug, Adcetris, on the market, sales aren't enough to offset the high research and development costs to expand Adcetris' label and develop the rest of its pipeline. However, Seattle Genetics isn't going to run out of money anytime soon.
Seattle Geneticsresults: The raw numbers
Source: Company press release.
What happened withSeattle Genetics this quarter?
Adcetris sales in the U.S. and Canada continue to climb, up 22.5% year over year.
The drug is also doing well elsewhere, where Takeda Pharmaceuticals sells Adcetris and Seattle Genetics collects a royalty.
In the quest to expand the Adcetris' label, increasing the potential market, Seattle Genetics completed enrolment in two different phase 3 trials and is testing the drug in combination with other drugs in earlier-stage trials.
The partnership with AbbVie , one of Seattle Genetics many partners, is going extremely well. The companies expanded their relationship to allow AbbVie access to additional technology developed by Seattle Genetics, and AbbVie started a phase 1 trial for a drug developed under the original partnership. Initiating the trial triggered a milestone payment to Seattle Genetics.
In September, Seattle Genetics raised over $525 million, which gives the company a nice nest egg to reach profitability.
What management had to say
"With AETHERA and that newer label, it takes a little bit of time to get to the high market penetration rates -- and we are doing a good job -- and there's expansion there, but it takes some time. We're not up to the level of market penetration that we are at the present time with our first two labels -- it's too quick to get there so that's still growing," said Chairman, President, and CEO Clay Siegall.
AETHERA was a clinical trial testing Adectris in patients with Hodgkin lymphoma at high risk of relapse or progression that have undergone an autologous stem cell transplant. The drug is used as a post-transplant consolidation, essentially betting that there might be cancer remaining after the transplant that Adcetris can kill. As Siegall points out, the launch there is going well, but Seattle Genetics still has a ways to go before it's capturing most of the patients in the new indication.
Eric Dobmeier, Seattle Genetics' chief operating officer highlighted the cash that Seattle Genetics has received from its partners that have licensed its antibody-drug candidate technology, "We received over $325 million under these collaborations with a potential for over $4 billion in milestones plus royalties under the deals." In addition to the cash on hand and profits from Adcetris sales and royalties, Seattle Genetics can use the additional milestone payments to extend its runway to profitability.
Looking forward
Management slightly raised 2015 guidance for sales of Adcetris in the U.S. and Canada to a range of $218 million to $223 million. That puts fourth-quarter estimate of at least $55 million, or about 19% higher than the year-ago quarter.
On the pipeline front, investors will get data this quarter from multiple clinical trials at the American Society of Hematology meeting. Abstracts will be released on November 5 with late-breakers released on Nov. 16. Then the full data will be presented at ASH in early December.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article Seattle Genetics, Inc. Earnings: Extending the Runway originally appeared on Fool.com.
Brian Orelli has no position in any stocks mentioned. The Motley Fool recommends Seattle Genetics. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The partnership with AbbVie , one of Seattle Genetics many partners, is going extremely well. The companies expanded their relationship to allow AbbVie access to additional technology developed by Seattle Genetics, and AbbVie started a phase 1 trial for a drug developed under the original partnership. We're not up to the level of market penetration that we are at the present time with our first two labels -- it's too quick to get there so that's still growing," said Chairman, President, and CEO Clay Siegall. | The companies expanded their relationship to allow AbbVie access to additional technology developed by Seattle Genetics, and AbbVie started a phase 1 trial for a drug developed under the original partnership. The partnership with AbbVie , one of Seattle Genetics many partners, is going extremely well. In addition to the cash on hand and profits from Adcetris sales and royalties, Seattle Genetics can use the additional milestone payments to extend its runway to profitability. | The companies expanded their relationship to allow AbbVie access to additional technology developed by Seattle Genetics, and AbbVie started a phase 1 trial for a drug developed under the original partnership. The partnership with AbbVie , one of Seattle Genetics many partners, is going extremely well. In the quest to expand the Adcetris' label, increasing the potential market, Seattle Genetics completed enrolment in two different phase 3 trials and is testing the drug in combination with other drugs in earlier-stage trials. | The partnership with AbbVie , one of Seattle Genetics many partners, is going extremely well. The companies expanded their relationship to allow AbbVie access to additional technology developed by Seattle Genetics, and AbbVie started a phase 1 trial for a drug developed under the original partnership. In the quest to expand the Adcetris' label, increasing the potential market, Seattle Genetics completed enrolment in two different phase 3 trials and is testing the drug in combination with other drugs in earlier-stage trials. |
26787.0 | 2015-11-02 00:00:00 UTC | ABBV Crosses Above Key Moving Average Level | ABBV | https://www.nasdaq.com/articles/abbv-crosses-above-key-moving-average-level-2015-11-02 | nan | nan | In trading on Monday, shares of AbbVie Inc. (Symbol: ABBV) crossed above their 200 day moving average of $62.64, changing hands as high as $63.22 per share. AbbVie Inc. shares are currently trading up about 5.8% on the day. The chart below shows the one year performance of ABBV shares, versus its 200 day moving average:
Looking at the chart above, ABBV's low point in its 52 week range is $45.45 per share, with $71.60 as the 52 week high point - that compares with a last trade of $62.99.
According to the ETF Finder at ETF Channel, ABBV makes up 9.12% of the First Trust US IPO Index Fund ETF (Symbol: FPX) which is trading up by about 1% on the day Monday.
Click here to find out which 9 other dividend stocks recently crossed above their 200 day moving average »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In trading on Monday, shares of AbbVie Inc. (Symbol: ABBV) crossed above their 200 day moving average of $62.64, changing hands as high as $63.22 per share. The chart below shows the one year performance of ABBV shares, versus its 200 day moving average: Looking at the chart above, ABBV's low point in its 52 week range is $45.45 per share, with $71.60 as the 52 week high point - that compares with a last trade of $62.99. AbbVie Inc. shares are currently trading up about 5.8% on the day. | In trading on Monday, shares of AbbVie Inc. (Symbol: ABBV) crossed above their 200 day moving average of $62.64, changing hands as high as $63.22 per share. The chart below shows the one year performance of ABBV shares, versus its 200 day moving average: Looking at the chart above, ABBV's low point in its 52 week range is $45.45 per share, with $71.60 as the 52 week high point - that compares with a last trade of $62.99. AbbVie Inc. shares are currently trading up about 5.8% on the day. | In trading on Monday, shares of AbbVie Inc. (Symbol: ABBV) crossed above their 200 day moving average of $62.64, changing hands as high as $63.22 per share. The chart below shows the one year performance of ABBV shares, versus its 200 day moving average: Looking at the chart above, ABBV's low point in its 52 week range is $45.45 per share, with $71.60 as the 52 week high point - that compares with a last trade of $62.99. AbbVie Inc. shares are currently trading up about 5.8% on the day. | In trading on Monday, shares of AbbVie Inc. (Symbol: ABBV) crossed above their 200 day moving average of $62.64, changing hands as high as $63.22 per share. AbbVie Inc. shares are currently trading up about 5.8% on the day. The chart below shows the one year performance of ABBV shares, versus its 200 day moving average: Looking at the chart above, ABBV's low point in its 52 week range is $45.45 per share, with $71.60 as the 52 week high point - that compares with a last trade of $62.99. |
26788.0 | 2015-11-02 00:00:00 UTC | Company News for November 02, 2015 | ABBV | https://www.nasdaq.com/articles/company-news-for-november-02-2015-2015-11-02 | nan | nan | • Shares of AbbVie Inc. ( ABBV ) climbed 10.1% after the company reported third quarter earnings per share of $1.13, beating the Zacks Consensus Estimate of $1.07
• Shares of Colgate-Palmolive Co. ( CL ) declined 4.2% after the company posted third quarter revenues of $3,999 million that missed the Zacks Consensus Estimate of $4,087 million
• Shares of LinkedIn Corporation ( LNKD ) surged 11% after the company reported third quarter loss per share of $0.06, narrower than the Zacks Consensus Estimate of a loss of $0.32
• Valeant Pharmaceuticals International, Inc.'s ( VRX ) shares tumbled 15.9% after the company announced that it will terminate ties with Philidor Rx Services
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | • Shares of AbbVie Inc. ( ABBV ) climbed 10.1% after the company reported third quarter earnings per share of $1.13, beating the Zacks Consensus Estimate of $1.07 • Shares of Colgate-Palmolive Co. ( CL ) declined 4.2% after the company posted third quarter revenues of $3,999 million that missed the Zacks Consensus Estimate of $4,087 million • Shares of LinkedIn Corporation ( LNKD ) surged 11% after the company reported third quarter loss per share of $0.06, narrower than the Zacks Consensus Estimate of a loss of $0.32 • Valeant Pharmaceuticals International, Inc.'s ( VRX ) shares tumbled 15.9% after the company announced that it will terminate ties with Philidor Rx Services Want the latest recommendations from Zacks Investment Research? Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report LINKEDIN CORP-A (LNKD): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. Today, you can download 7 Best Stocks for the Next 30 Days. | • Shares of AbbVie Inc. ( ABBV ) climbed 10.1% after the company reported third quarter earnings per share of $1.13, beating the Zacks Consensus Estimate of $1.07 • Shares of Colgate-Palmolive Co. ( CL ) declined 4.2% after the company posted third quarter revenues of $3,999 million that missed the Zacks Consensus Estimate of $4,087 million • Shares of LinkedIn Corporation ( LNKD ) surged 11% after the company reported third quarter loss per share of $0.06, narrower than the Zacks Consensus Estimate of a loss of $0.32 • Valeant Pharmaceuticals International, Inc.'s ( VRX ) shares tumbled 15.9% after the company announced that it will terminate ties with Philidor Rx Services Want the latest recommendations from Zacks Investment Research? Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report LINKEDIN CORP-A (LNKD): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | • Shares of AbbVie Inc. ( ABBV ) climbed 10.1% after the company reported third quarter earnings per share of $1.13, beating the Zacks Consensus Estimate of $1.07 • Shares of Colgate-Palmolive Co. ( CL ) declined 4.2% after the company posted third quarter revenues of $3,999 million that missed the Zacks Consensus Estimate of $4,087 million • Shares of LinkedIn Corporation ( LNKD ) surged 11% after the company reported third quarter loss per share of $0.06, narrower than the Zacks Consensus Estimate of a loss of $0.32 • Valeant Pharmaceuticals International, Inc.'s ( VRX ) shares tumbled 15.9% after the company announced that it will terminate ties with Philidor Rx Services Want the latest recommendations from Zacks Investment Research? Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report LINKEDIN CORP-A (LNKD): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | • Shares of AbbVie Inc. ( ABBV ) climbed 10.1% after the company reported third quarter earnings per share of $1.13, beating the Zacks Consensus Estimate of $1.07 • Shares of Colgate-Palmolive Co. ( CL ) declined 4.2% after the company posted third quarter revenues of $3,999 million that missed the Zacks Consensus Estimate of $4,087 million • Shares of LinkedIn Corporation ( LNKD ) surged 11% after the company reported third quarter loss per share of $0.06, narrower than the Zacks Consensus Estimate of a loss of $0.32 • Valeant Pharmaceuticals International, Inc.'s ( VRX ) shares tumbled 15.9% after the company announced that it will terminate ties with Philidor Rx Services Want the latest recommendations from Zacks Investment Research? Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report LINKEDIN CORP-A (LNKD): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. Today, you can download 7 Best Stocks for the Next 30 Days. |
26789.0 | 2015-11-01 00:00:00 UTC | 3 Drugs That Are About to Become Billion-Dollar Blockbusters in 2016 | ABBV | https://www.nasdaq.com/articles/3-drugs-are-about-become-billion-dollar-blockbusters-2016-2015-11-01 | nan | nan | Source: Bristol-Myers Squibb.
It's the hope of every drug developer to create a billion-dollar-per-year blockbuster therapy, but with 90% of drugs failing in clinical trials, few drug companies successfully do it. Bristol-Myers Squibb , Pfizer , and AbbVie , however, appear to have beaten those long odds, because each has a drug that's on pace to eclipse blockbuster status in the coming year.
Bristol-Myers Squibb: Opdivo
Bristol-Myers' immuno-oncology drug Opdivo, which costs about $12,500 per month, trounced industry watchers' estimates in the third quarter. Revenue from Opdivo clocked in at $305 million, and that was nicely higher than the $238 million that had been expected.
Opdivo's sales success stems from a massive R&D effort from Bristol-Myers to establish it as a go-to anti-cancer therapy that can be used both alone and in combination with other widely used drugs to make them work better.
So far, Opdivo has been approved for use as a monotherapy in the treatment of advanced melanoma and lung cancer and alongside another Bristol-Myers drug, Yervoy, in a specific genetic variation of metastatic melanoma.
More approvals are likely, too, because Bristol-Myers is conducting more than 50 studies across a variety of cancer indications. For example, Bristol-Myers recently reported that the FDA had awarded breakthrough therapy designation to Opdivo for use in kidney cancer.
Overall, Opdivo's potential to act as a building-block cancer therapy could clear the way for it to be a megamultibillion-dollar blockbuster, and as it stands today, the drug is on pace to surpass the billion-dollar sales mark in the coming year.
Pfizer : Ibrance
Ibrance is Pfizer's recently approved therapy for the treatment of breast cancer, and sales of the drug are outpacing projections. In the third quarter, Ibrance sales totaled $230 million, and while that isn't a billion-dollar run rate (yet), it's likely that Ibrance momentum will continue to boost its sales above that magic threshold soon.
According to Pfizer, 15,000 patients have been treated with Ibrance, which costs almost $10,000 per month, up from 9,000 patients in Q2 and 2,000 patients in Q1. Also, 4,000 doctors are now prescribing Ibrance, up from 3,000 doctors exiting the second quarter and 800 doctors in Q1, and as a result, Ibrance has already grabbed 27% of the market in first-line treatment.
Ibrance's commercial success isn't too surprising, given that the drug performed very well in trials (leading to an FDA approval roughly two months ahead of schedule) and because roughly 1 million of the 1.7 million people diagnosed with breast cancer in the U.S. every year possess the genetic markers Ibrance targets.
Since Ibrance is already approaching a billion-dollar run rate and with an EU approval is looming, it seems it's destined to become a blockbuster in 2016, too.
Source: AbbVie.
AbbVie: Imbruvica
When AbbVie acquired Pharmacyclics in a massive $21 billion deal earlier this year, it did so to get its hands on Imbruvica, a fast-growing drug that costs roughly $11,000 per month and is used to treat blood-related cancers, including chronic lymphocytic leukemia, or CLL, and Waldenstrom's macroglobulinemia.
Since winning approval last year for use in CLL patients, Imbruvica, which was co-developed by Johnson & Johnson , sales have taken off. In Q3, AbbVie reports that Imbruvica revenue jumped to $304 million, giving it a $1.2 billion annualized run rate. That revenue consists of $267 million in U.S. sales and $37 million tied to its profit-sharing agreement with J&J in other markets.
Imbruvica's script volume could continue to grow next year, especially since AbbVie has filed a supplemental application for approval in treatment-naive CLL patients. In trials, Imbruvica outperformed chemotherapy in these patients, suggesting that an approval could vault it from a leading second-line therapy into a leading first-line treatment. Overall, Pharmacyclics had previously estimated that Imbruvica's addressable patient population could expand from 40,000 in 2014 to 374,000 over time, and if that assessment is correct, then Imbruvica could become one of the top-selling oncology drugs on the market.
Tying it together
All three of these fast-growing medicines are cancer drugs, and each of these therapies has been priced at levels that make them among the industry's most expensive treatments. Recently, payer pushback on pricing has led many to wonder whether oncology companies are likely to take a hit on their top and bottom line, but while it's likely that some changes may occur in drug pricing, I'm not convinced that they'll derail the blockbuster potential of these drugs, because each is a game-changer in its ability to extend patient lives.
The next billion-dollar iSecret
The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .
The article 3 Drugs That Are About to Become Billion-Dollar Blockbusters in 2016 originally appeared on Fool.com.
Todd Campbell has no position in any stocks mentioned. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Bristol-Myers Squibb , Pfizer , and AbbVie , however, appear to have beaten those long odds, because each has a drug that's on pace to eclipse blockbuster status in the coming year. Source: AbbVie. AbbVie: Imbruvica When AbbVie acquired Pharmacyclics in a massive $21 billion deal earlier this year, it did so to get its hands on Imbruvica, a fast-growing drug that costs roughly $11,000 per month and is used to treat blood-related cancers, including chronic lymphocytic leukemia, or CLL, and Waldenstrom's macroglobulinemia. | In Q3, AbbVie reports that Imbruvica revenue jumped to $304 million, giving it a $1.2 billion annualized run rate. Bristol-Myers Squibb , Pfizer , and AbbVie , however, appear to have beaten those long odds, because each has a drug that's on pace to eclipse blockbuster status in the coming year. Source: AbbVie. | AbbVie: Imbruvica When AbbVie acquired Pharmacyclics in a massive $21 billion deal earlier this year, it did so to get its hands on Imbruvica, a fast-growing drug that costs roughly $11,000 per month and is used to treat blood-related cancers, including chronic lymphocytic leukemia, or CLL, and Waldenstrom's macroglobulinemia. Bristol-Myers Squibb , Pfizer , and AbbVie , however, appear to have beaten those long odds, because each has a drug that's on pace to eclipse blockbuster status in the coming year. Source: AbbVie. | Bristol-Myers Squibb , Pfizer , and AbbVie , however, appear to have beaten those long odds, because each has a drug that's on pace to eclipse blockbuster status in the coming year. Source: AbbVie. AbbVie: Imbruvica When AbbVie acquired Pharmacyclics in a massive $21 billion deal earlier this year, it did so to get its hands on Imbruvica, a fast-growing drug that costs roughly $11,000 per month and is used to treat blood-related cancers, including chronic lymphocytic leukemia, or CLL, and Waldenstrom's macroglobulinemia. |
26790.0 | 2015-10-31 00:00:00 UTC | Gilead Sciences Is Shrugging Off Its Competitors | ABBV | https://www.nasdaq.com/articles/gilead-sciences-shrugging-its-competitors-2015-10-31 | nan | nan | Image source: Gilead Sciences.
The fact that Gilead Sciences shares have toppled by 8% since July might have you thinking that competitors have the company on the ropes, but Gilead Sciences' third-quarter results show investors that simply isn't the case.
Holding off competitors
The biggest argument for avoiding Gilead Sciences had been that it's unlikely to maintain its dominance in hepatitis C treatment in the face of mounting competition, but following the introduction of AbbVie 's Viekira Pak this past January, that's exactly what Gilead Sciences has done.
Despite AbbVie's genotype 1 hepatitis C cocktail winning exclusivity on the nation's largest pharmacy benefit formulary, Viekira Pak's sales have barely put a dent in Gilead Sciences' top line.
Last quarter, AbbVie reported that Viekira Pak's sales totaled $469 million, and while that's certainly a healthy run rate, it pales in comparison to Gilead Sciences' Harvoni, which racked up $3.33 billion in revenue last quarter.
Moreover, sales of Viekira Pak, which is undeniably an important weapon against this disease, also trail Gilead Sciences' Sovaldi, which had revenue of $1.46 billion last quarter and aren't that much higher than Bristol-Myers Squibb 's two hepatitis C drugs, which posted combined sales of $402 million in Q3.
Although AbbVie and Bristol-Myers more recently approved drugs are selling at billion blockbuster rates, their impact has been more to expand the market for hepatitis C treatment than to cut into Gilead Sciences prescription volume. As evidence of this, Gilead Sciences has treated 190,000 hepatitis C patients in the U.S. during the first nine months of this year, and that's already far more than the 140,000 patients the company treated in the U.S. during all of 2014.
Gilead Sciences could still stumble if Merck & Co gets the go-ahead for its two-drug hepatitis C therapy on January 28; however, I think Merck's drug will prove to be a bigger threat to AbbVie than it is to Gilead Sciences.
Image source: AbbVie.
Merck's therapy and Gilead Sciences' Harvoni are both one-pill per day regimens with similar efficacy, and both drugs will be primarily used in genotype 1 patients, but while Merck's drug is dosed over 12 weeks, Harvoni can be dosed over eight weeks in more than 40% of type 1 patients, and that's an important advantage that could insulate Harvoni's market share.
Merck's drug is, however, an arguably better drug than AbbVie's Viekira Pak, which requires multiple pills per day, often with the co-administration of ribavirin. Additionally, Viekira Pak has recently been associated with causing additional liver damage in patients with pre-existing liver disease, and that could result in doctors being more willing to consider using Merck's drug instead.
Looking ahead
Gilead Sciences could be in a position to fend off competitors with its existing drugs, but it recently reported impressive phase 3 results for a next-generation hepatitis C drug that could really solidify Gilead Sciences' pole position in the indication.
During late-stage trials that included patients across the six genotypes, this new drug delivered 83% to 100% cure rates. Importantly, the drug's performance suggests it could become a pan-genotype therapy (even in patients with existing liver damage) that eventually eliminates the need for genotype testing -- something that would be helpful in emerging nations with a limited healthcare infrastructure.
Gilead Sciences is also conducting other studies that could shorten treatment duration for many patients, and in my opinion, it's these studies that could be the most important to Gilead Sciences' long-term success in the indication, because reducing treatment duration improves adherence, and if all other things are equal, then the shortest-duration therapy stands the best chance of winning over doctors and patients.
Regardless, the evidence from this year suggests that Gilead Sciences' efforts are allowing it to successfully maintain its leadership in hepatitis C, and absent a more competitive threat, it's hard to imagine Gilead Sciences' hepatitis C sales will be heading south anytime soon.
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The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early, in-the-know investors! To be one of them, just click here .
The article Gilead Sciences Is Shrugging Off Its Competitors originally appeared on Fool.com.
Todd Campbell owns shares of Gilead Sciences. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Despite AbbVie's genotype 1 hepatitis C cocktail winning exclusivity on the nation's largest pharmacy benefit formulary, Viekira Pak's sales have barely put a dent in Gilead Sciences' top line. Although AbbVie and Bristol-Myers more recently approved drugs are selling at billion blockbuster rates, their impact has been more to expand the market for hepatitis C treatment than to cut into Gilead Sciences prescription volume. Holding off competitors The biggest argument for avoiding Gilead Sciences had been that it's unlikely to maintain its dominance in hepatitis C treatment in the face of mounting competition, but following the introduction of AbbVie 's Viekira Pak this past January, that's exactly what Gilead Sciences has done. | Last quarter, AbbVie reported that Viekira Pak's sales totaled $469 million, and while that's certainly a healthy run rate, it pales in comparison to Gilead Sciences' Harvoni, which racked up $3.33 billion in revenue last quarter. Holding off competitors The biggest argument for avoiding Gilead Sciences had been that it's unlikely to maintain its dominance in hepatitis C treatment in the face of mounting competition, but following the introduction of AbbVie 's Viekira Pak this past January, that's exactly what Gilead Sciences has done. Despite AbbVie's genotype 1 hepatitis C cocktail winning exclusivity on the nation's largest pharmacy benefit formulary, Viekira Pak's sales have barely put a dent in Gilead Sciences' top line. | Gilead Sciences could still stumble if Merck & Co gets the go-ahead for its two-drug hepatitis C therapy on January 28; however, I think Merck's drug will prove to be a bigger threat to AbbVie than it is to Gilead Sciences. Holding off competitors The biggest argument for avoiding Gilead Sciences had been that it's unlikely to maintain its dominance in hepatitis C treatment in the face of mounting competition, but following the introduction of AbbVie 's Viekira Pak this past January, that's exactly what Gilead Sciences has done. Despite AbbVie's genotype 1 hepatitis C cocktail winning exclusivity on the nation's largest pharmacy benefit formulary, Viekira Pak's sales have barely put a dent in Gilead Sciences' top line. | Holding off competitors The biggest argument for avoiding Gilead Sciences had been that it's unlikely to maintain its dominance in hepatitis C treatment in the face of mounting competition, but following the introduction of AbbVie 's Viekira Pak this past January, that's exactly what Gilead Sciences has done. Despite AbbVie's genotype 1 hepatitis C cocktail winning exclusivity on the nation's largest pharmacy benefit formulary, Viekira Pak's sales have barely put a dent in Gilead Sciences' top line. Last quarter, AbbVie reported that Viekira Pak's sales totaled $469 million, and while that's certainly a healthy run rate, it pales in comparison to Gilead Sciences' Harvoni, which racked up $3.33 billion in revenue last quarter. |
26791.0 | 2015-10-30 00:00:00 UTC | AbbVie Tops on 3Q Earnings & Revenues, Ups 2015 View | ABBV | https://www.nasdaq.com/articles/abbvie-tops-3q-earnings-revenues-ups-2015-view-2015-10-30 | nan | nan | AbbVie Inc.ABBV reported third quarter 2015 earnings of $1.13 per share, up 27% from the year-ago quarter and surpassing the Zacks Consensus Estimate of $1.07.
Abbvie Inc. (ABBV) - Earnings Surprise | FindTheCompany
Revenues increased 18.4% to $5.944 billion in the third quarter of 2015, surpassing the Zacks Consensus Estimate of $5.894 billion.
The Quarter in Details
Key drug Humira recorded growth of 12.1% with revenues coming in at $3.6 billion. U.S. sales increased 30.4% ($2.3 billion) driven by growth across all three major market categories: rheumatology, dermatology and gastroenterology. Ex-U.S. sales declined 8.9% to $1.4 billion, impacted by negative currency movement (16%). Growing awareness, favorable clinical data, additional indications and expansion into new markets should help the product to continue contributing significantly to the top-line.
Other products that performed well include Lupron (up 2.4% to $201 million), and Creon (up 8.3% to $161 million). HCV product Viekira recorded sales of $469 million, up from $385 million in the second quarter of 2015.
AbbVie recorded Imbruvica U.S. sales of $267 million and $37 million of international profit sharing.
Meanwhile, products like AndroGel, Synagis, Synthroid and Kaletra (HIV) recorded a decline in revenues. While AndroGel 1% is facing generic competition, Kaletra was most likely impacted by negative market trends.
Ups 2015 View
AbbVie raised its earnings guidance to $4.26 - $4.28 per share (guidance provided with second quarter results: $4.10 - $4.30 per share). The Zacks Consensus Estimate of $4.25 is below the guidance range.
2016 Guidance In-Line With Expectations
The company also provided its earnings outlook for 2016 - AbbVie expects earnings of $4.90 - $5.10 per share in 2016. The Zacks Consensus Estimate of $4.97 is within this guidance range.
AbbVie also announced a 12% increase in 2016 dividend.
Forecasts Double-Digit EPS Growth Through 2020
AbbVie also said that it expects to deliver double-digit earnings growth on average through 2020 with revenues expected to reach $37 billion in 2020. While the company expects worldwide Humira sales of more than $18 billion in 2020, Imbruvica revenues are expected to be about $5 billion. Sales are also expected to be driven by more than 20 new products/label expansions. According to the company, its pipeline has the potential to deliver peak sales of about $30 billion.
Operating margin is expected to improve to more than 50% in 2020 (was 36.2% in 2014) including an average improvement of 100-200 bps every year. Expansion will be driven by ongoing cost savings initiatives, product mix and lower royalty expense associated with Humira in 2017 and 2018.
Our Take
AbbVie's third quarter results were strong with the company beating on the top- as well as bottom-line and raising its outlook for 2015. The company also provided its outlook for 2016 and long-term strategy. AbbVie is looking to reduce its dependence on Humira and the launch of Viekira is a step in this direction.
Moreover, the Pharmacyclics acquisition added Imbruvica to AbbVie's portfolio and diversified the company's revenue base. Imbruvica has multi-billion dollar potential and the company is exploring the potential to expand Imbruvica's label into solid tumors and autoimmune diseases.
AbbVie is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Bayer AG BAYRY , Pfizer, Inc. PFE and Eli Lilly and Company LLY . While Bayer is a Zacks Rank #1 (Strong Buy) stock, Pfizer and Lilly are Zacks Rank #2 (Buy) stocks.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc.ABBV reported third quarter 2015 earnings of $1.13 per share, up 27% from the year-ago quarter and surpassing the Zacks Consensus Estimate of $1.07. Abbvie Inc. (ABBV) - Earnings Surprise | FindTheCompany Revenues increased 18.4% to $5.944 billion in the third quarter of 2015, surpassing the Zacks Consensus Estimate of $5.894 billion. AbbVie recorded Imbruvica U.S. sales of $267 million and $37 million of international profit sharing. | Ups 2015 View AbbVie raised its earnings guidance to $4.26 - $4.28 per share (guidance provided with second quarter results: $4.10 - $4.30 per share). Click to get this free report BAYER A G -ADR (BAYRY): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV reported third quarter 2015 earnings of $1.13 per share, up 27% from the year-ago quarter and surpassing the Zacks Consensus Estimate of $1.07. | Abbvie Inc. (ABBV) - Earnings Surprise | FindTheCompany Revenues increased 18.4% to $5.944 billion in the third quarter of 2015, surpassing the Zacks Consensus Estimate of $5.894 billion. Click to get this free report BAYER A G -ADR (BAYRY): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc.ABBV reported third quarter 2015 earnings of $1.13 per share, up 27% from the year-ago quarter and surpassing the Zacks Consensus Estimate of $1.07. | Ups 2015 View AbbVie raised its earnings guidance to $4.26 - $4.28 per share (guidance provided with second quarter results: $4.10 - $4.30 per share). AbbVie Inc.ABBV reported third quarter 2015 earnings of $1.13 per share, up 27% from the year-ago quarter and surpassing the Zacks Consensus Estimate of $1.07. Abbvie Inc. (ABBV) - Earnings Surprise | FindTheCompany Revenues increased 18.4% to $5.944 billion in the third quarter of 2015, surpassing the Zacks Consensus Estimate of $5.894 billion. |
26792.0 | 2015-10-30 00:00:00 UTC | S&P 500 Movers: GNW, FSLR | ABBV | https://www.nasdaq.com/articles/sp-500-movers-gnw-fslr-2015-10-30 | nan | nan | In early trading on Friday, shares of First Solar ( FSLR ) topped the list of the day's best performing components of the S&P 500 index, trading up 10.3%. Year to date, First Solar registers a 26.1% gain.
And the worst performing S&P 500 component thus far on the day is Genworth Financial ( GNW ), trading down 10.4%. Genworth Financial is lower by about 45.0% looking at the year to date performance.
Two other components making moves today are KeyCorp ( KEY ), trading down 6.4%, and AbbVie ( ABBV ), trading up 9.1% on the day.
VIDEO: S&P 500 Movers: GNW, FSLR
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Two other components making moves today are KeyCorp ( KEY ), trading down 6.4%, and AbbVie ( ABBV ), trading up 9.1% on the day. And the worst performing S&P 500 component thus far on the day is Genworth Financial ( GNW ), trading down 10.4%. Genworth Financial is lower by about 45.0% looking at the year to date performance. | Two other components making moves today are KeyCorp ( KEY ), trading down 6.4%, and AbbVie ( ABBV ), trading up 9.1% on the day. And the worst performing S&P 500 component thus far on the day is Genworth Financial ( GNW ), trading down 10.4%. VIDEO: S&P 500 Movers: GNW, FSLR The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Two other components making moves today are KeyCorp ( KEY ), trading down 6.4%, and AbbVie ( ABBV ), trading up 9.1% on the day. In early trading on Friday, shares of First Solar ( FSLR ) topped the list of the day's best performing components of the S&P 500 index, trading up 10.3%. And the worst performing S&P 500 component thus far on the day is Genworth Financial ( GNW ), trading down 10.4%. | Two other components making moves today are KeyCorp ( KEY ), trading down 6.4%, and AbbVie ( ABBV ), trading up 9.1% on the day. And the worst performing S&P 500 component thus far on the day is Genworth Financial ( GNW ), trading down 10.4%. Genworth Financial is lower by about 45.0% looking at the year to date performance. |
26793.0 | 2015-10-30 00:00:00 UTC | Earnings Reaction History: AbbVie Inc., 40.0% Follow-Through Indicator, 2.1% Sensitive | ABBV | https://www.nasdaq.com/articles/earnings-reaction-history-abbvie-inc-400-follow-through-indicator-21-sensitive-2015-10-30 | nan | nan | Expected Earnings Release: 10/30/2015, Premarket
Avg. Extended-Hours Dollar Volume: $4,888,306
AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report in the upcoming extended-hours session. Given its history, traders can expect light trading in the issue immediately following its quarterly earnings announcement. Historical earnings event related premarket and after-hours trading activity in ABBV indicates that the price change in the extended hours is likely to be of limited value in forecasting additional price movement by the following regular session close.
Last 12 Qtrs Positive Only Price Reactions
Percent of time added to extended-hours gains: 37.5%
Average next regular session additional gain: 2.4%
Over the prior three fiscal years (12 quarters), when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 37.5% of the time (3 events) the stock posted additional gains in the following regular session by an average of 2.4%.
Last 12 Qtrs Negative Only Price Reactions
Percent of time added to extended-hours losses: 50%
Average next regular session additional loss: 0.3%
Over that same historical period, when shares of ABBV dropped in the extended-hours in reaction to its earnings announcement, history shows that 50.0% of the time (1 event) the stock dropped further, adding to the extended-hours losses by an average of 0.3% by the following regular session close.
Data provided by the MT Pro service at MTNewswires.com.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Last 12 Qtrs Positive Only Price Reactions Percent of time added to extended-hours gains: 37.5% Average next regular session additional gain: 2.4% Over the prior three fiscal years (12 quarters), when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 37.5% of the time (3 events) the stock posted additional gains in the following regular session by an average of 2.4%. Last 12 Qtrs Negative Only Price Reactions Percent of time added to extended-hours losses: 50% Average next regular session additional loss: 0.3% Over that same historical period, when shares of ABBV dropped in the extended-hours in reaction to its earnings announcement, history shows that 50.0% of the time (1 event) the stock dropped further, adding to the extended-hours losses by an average of 0.3% by the following regular session close. Extended-Hours Dollar Volume: $4,888,306 AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report in the upcoming extended-hours session. | Last 12 Qtrs Positive Only Price Reactions Percent of time added to extended-hours gains: 37.5% Average next regular session additional gain: 2.4% Over the prior three fiscal years (12 quarters), when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 37.5% of the time (3 events) the stock posted additional gains in the following regular session by an average of 2.4%. Last 12 Qtrs Negative Only Price Reactions Percent of time added to extended-hours losses: 50% Average next regular session additional loss: 0.3% Over that same historical period, when shares of ABBV dropped in the extended-hours in reaction to its earnings announcement, history shows that 50.0% of the time (1 event) the stock dropped further, adding to the extended-hours losses by an average of 0.3% by the following regular session close. Extended-Hours Dollar Volume: $4,888,306 AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report in the upcoming extended-hours session. | Last 12 Qtrs Positive Only Price Reactions Percent of time added to extended-hours gains: 37.5% Average next regular session additional gain: 2.4% Over the prior three fiscal years (12 quarters), when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 37.5% of the time (3 events) the stock posted additional gains in the following regular session by an average of 2.4%. Last 12 Qtrs Negative Only Price Reactions Percent of time added to extended-hours losses: 50% Average next regular session additional loss: 0.3% Over that same historical period, when shares of ABBV dropped in the extended-hours in reaction to its earnings announcement, history shows that 50.0% of the time (1 event) the stock dropped further, adding to the extended-hours losses by an average of 0.3% by the following regular session close. Extended-Hours Dollar Volume: $4,888,306 AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report in the upcoming extended-hours session. | Extended-Hours Dollar Volume: $4,888,306 AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report in the upcoming extended-hours session. Last 12 Qtrs Positive Only Price Reactions Percent of time added to extended-hours gains: 37.5% Average next regular session additional gain: 2.4% Over the prior three fiscal years (12 quarters), when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 37.5% of the time (3 events) the stock posted additional gains in the following regular session by an average of 2.4%. Historical earnings event related premarket and after-hours trading activity in ABBV indicates that the price change in the extended hours is likely to be of limited value in forecasting additional price movement by the following regular session close. |
26794.0 | 2015-10-30 00:00:00 UTC | Repros Hits 52-Week Low, FDA Delays Enclomiphene Meeting | ABBV | https://www.nasdaq.com/articles/repros-hits-52-week-low-fda-delays-enclomiphene-meeting-2015-10-30 | nan | nan | Repros Therapeutics Inc. 's RPRX shares touched a 52-week low of $1.85 on Oct 29 with the company announcing disappointing news that the FDA has cancelled a previously scheduled meeting with the Division of Bone, Reproductive and Urologic Products on Nov 3 to consider the company's new drug application for its enclomiphene product candidate (previously known as Androxal). Shares plunged 55.6% on the news.
Repros is looking to get enclomiphene approved in the U.S. for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A final response from the FDA regarding the approval status of the candidate was expected by Nov 30.
The FDA informed that certain concerns cropped up late in the review related to the bio-analytical method validation that could affect interpretability of certain pivotal study data.
Considering that Repros has no approved product in its portfolio at the moment with enclomiphene being the company's lead pipeline candidate, the cancellation of the advisory panel meeting comes as a disappointment for the company. Moreover, there is low visibility on the length of delay being faced by the candidate.
Meanwhile, currently prescribed treatments for testosterone deficiency include AbbVie Inc.'s ABBV AndroGel and Endo International plc's ENDP Testim among others.
We expect investor focus to remain on further updates from the company.
Repros is a Zacks Rank #4 (Sell) stock. A couple of better-ranked stocks in the health care sector are Endo and Actelion Ltd. ALIOF . While Actelion is a Zacks Rank #1 (Strong Buy) stock, Endo carries a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Meanwhile, currently prescribed treatments for testosterone deficiency include AbbVie Inc.'s ABBV AndroGel and Endo International plc's ENDP Testim among others. Click to get this free report REPROS THERAPEU (RPRX): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report ACTELION LTD (ALIOF): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Repros is looking to get enclomiphene approved in the U.S. for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. | Click to get this free report REPROS THERAPEU (RPRX): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report ACTELION LTD (ALIOF): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, currently prescribed treatments for testosterone deficiency include AbbVie Inc.'s ABBV AndroGel and Endo International plc's ENDP Testim among others. While Actelion is a Zacks Rank #1 (Strong Buy) stock, Endo carries a Zacks Rank #2 (Buy). | Click to get this free report REPROS THERAPEU (RPRX): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report ACTELION LTD (ALIOF): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, currently prescribed treatments for testosterone deficiency include AbbVie Inc.'s ABBV AndroGel and Endo International plc's ENDP Testim among others. Repros Therapeutics Inc. 's RPRX shares touched a 52-week low of $1.85 on Oct 29 with the company announcing disappointing news that the FDA has cancelled a previously scheduled meeting with the Division of Bone, Reproductive and Urologic Products on Nov 3 to consider the company's new drug application for its enclomiphene product candidate (previously known as Androxal). | Click to get this free report REPROS THERAPEU (RPRX): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report ACTELION LTD (ALIOF): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, currently prescribed treatments for testosterone deficiency include AbbVie Inc.'s ABBV AndroGel and Endo International plc's ENDP Testim among others. Considering that Repros has no approved product in its portfolio at the moment with enclomiphene being the company's lead pipeline candidate, the cancellation of the advisory panel meeting comes as a disappointment for the company. |
26795.0 | 2015-10-30 00:00:00 UTC | AbbVie (ABBV) Beats on 3Q Earnings & Revenues | ABBV | https://www.nasdaq.com/articles/abbvie-abbv-beats-on-3q-earnings-revenues-2015-10-30 | nan | nan | North Chicago, IL-based AbbVieABBV , which has been in the news thanks to its hepatitis C virus (HCV) treatment Viekira Pak as well as its acquisition of Pharmacyclics, is best known for its autoimmune disease drug, Humira.
Humira, the company's flagship product which is approved for a wide range of indications, is a major contributor to AbbVie's top line. While Humira will remain the key growth driver at AbbVie, the coming quarters will see investor focus remaining primarily on Viekira's performance. Key players in the HCV market include Gilead's Sovaldi and Harvoni.
Meanwhile, the Pharmacyclics acquisition has diversified AbbVie's product portfolio with the addition of Imbruvica.
ABBV has a pretty good earnings track record with the company delivering positive earnings surprises in the last four quarters with an average surprise of 8.15%. Estimate revisions, however, are mostly negative with analysts lowering their estimates for 2015 and 2016.
Currently, ABBV has a Zacks Rank #3 (Hold), but that could definitely change following the company's earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Earnings Beat : ABBV beat on third quarter earnings which came in at $1.13 per share while our consensus called for EPS of $1.07.
Revenues Beat : AbbVie posted revenues of $5.944 billion, surpassing consensus estimates of $5.894 billion.
Key Stats : Humira sales came in at $3.6 billion. Third-quarter Imbruvica sales in the U.S. were $304 million. Viekira sales were $469 million in the third quarter, up from $385 million in the second quarter.
Ups 2015 View : AbbVie raised its 2015 EPS guidance to $4.26 - $4.28. The Zacks Consensus Estimate is currently $4.25 per share.
Issues 2016 Outlook : AbbVie is guiding towards 2016 EPS of $4.90 to $5.10. The Zacks Consensus Estimate is currently $4.97 per share. The company is also forecasting double-digit EPS growth on average through 2020.
Check back later for our full write up on this ABBV earnings report.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | North Chicago, IL-based AbbVieABBV , which has been in the news thanks to its hepatitis C virus (HCV) treatment Viekira Pak as well as its acquisition of Pharmacyclics, is best known for its autoimmune disease drug, Humira. Humira, the company's flagship product which is approved for a wide range of indications, is a major contributor to AbbVie's top line. While Humira will remain the key growth driver at AbbVie, the coming quarters will see investor focus remaining primarily on Viekira's performance. | Revenues Beat : AbbVie posted revenues of $5.944 billion, surpassing consensus estimates of $5.894 billion. Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. North Chicago, IL-based AbbVieABBV , which has been in the news thanks to its hepatitis C virus (HCV) treatment Viekira Pak as well as its acquisition of Pharmacyclics, is best known for its autoimmune disease drug, Humira. | While Humira will remain the key growth driver at AbbVie, the coming quarters will see investor focus remaining primarily on Viekira's performance. We have highlighted some of the key stats from this just-revealed announcement below: Earnings Beat : ABBV beat on third quarter earnings which came in at $1.13 per share while our consensus called for EPS of $1.07. Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. | Meanwhile, the Pharmacyclics acquisition has diversified AbbVie's product portfolio with the addition of Imbruvica. Currently, ABBV has a Zacks Rank #3 (Hold), but that could definitely change following the company's earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below: Earnings Beat : ABBV beat on third quarter earnings which came in at $1.13 per share while our consensus called for EPS of $1.07. |
26796.0 | 2015-10-29 00:00:00 UTC | Another Strong Quarter for Gilead Sciences, Inc. | ABBV | https://www.nasdaq.com/articles/another-strong-quarter-gilead-sciences-inc-2015-10-29 | nan | nan | Image Source: Gilead Sciences
Gilead Sciences exceeded expectations when it reported financial results three months ago. Some big questions loomed large, though, as the biotech wrapped up its third quarter. Those questions centered on how well Gilead's hepatitis C drugs Harvoni and Sovaldi would perform in Europe and with potential payer headwinds. Gilead announced its third-quarter results after the market closed on Tuesday. Here are the highlights.
By the numbers
Total revenue for the third quarter came in at $8.3 billion. That's a nice 43% jump from the $6 billion reported in the third quarter of last year. It's a much smaller sequential increase, though, from the $8.2 billion posted in second quarter of 2015.
Gilead reported GAAP earnings of $4.6 billion, or $3.06 per diluted share. This reflected a whopping 70% year-over-year increase over the $2.7 billion, or $1.67 per diluted share, achieved in the third quarter of last year. On a non-GAAP basis, the biotech announced third-quarter earnings of $4.8 billion, or $3.22 per diluted share -- 60% higher than the $3.0 billion, or $1.84 per diluted share, posted in the prior-year period.
The company announced that it had $25.1 billion of cash, cash equivalents, and marketable securities as of the end of third quarter. At the end of the second quarter, Gilead had a cash stockpile of $14.7 billion. Issuance of $10 billion in senior unsecured notes in September made the big difference.
Gilead also bumped its full-year 2015 revenue guidance up to a range of $30 billion to $31 billion, from the $29 billion-to-$30 billion range previously provided.
Behind the numbers
Harvoni and Sovaldi combined for $4.8 billion in sales during third quarter -- 58% of Gilead's total revenue. However, that's a decrease from the second quarter and a sign that U.S. payers haven't loosened the purse strings yet as the biotech is hoping for. Even European sales dipped somewhat compared with last quarter. On a good note, though, sales outside the U.S. and Europe are growing for both drugs.
Within Gilead's HIV portfolio, Stribild experienced the fastest growth, climbing to $511 million in sales compared to $327 million in the prior-year period. Truvada continued as the biggest HIV moneymaker, with third-quarter sales of $903 million.
Gilead also saw some solid revenue growth from its non-antiviral drugs. Hypertension drug Letairis racked up sales of $181 million in third quarter -- a nearly 24% year-over-year increase. Sales for blood cancer drug Zydelig jumped to $36 million compared to $6 million in the third quarter of 2014.
Looking ahead
Gilead seems in good shape to benefit from safety concerns about AbbVie 's hep C treatment, Viekira Pak. A recent study found that Viekira Pak was more likely to trigger adverse side effects than either Harvoni or Sovaldi. AbbVie also had to update its labels last week to reflect a contraindication in patients with Child-Pugh B cirrhosis and recommend that physicians assess the potential for liver damage before prescribing.
Viekira Pak generated revenue of $385 million in the second quarter. That's only a fraction of the combined total for Harvoni and Sovaldi. However, should Gilead chip away at AbbVie's market share, it would improve Gilead's top and bottom lines in the fourth quarter and possibly into 2016.
Perhaps the biggest threat on the horizon for Gilead comes from Merck . The giant drugmaker submitted for FDA approval of its hep C combo in May. Merck's single pill combination of grazoprevir and elbasvir could hurt Sovaldi's sales, especially if Merck lowers its pricing significantly below what Gilead currently charges.
This possible challenge from Merck stands as one of the key reasons Gilead's valuation remains on the low end compared to most big biotechs. Investors should keep their eyes on the Merck threat, as well as the potential for major payers to relax reimbursement restrictions for the company's high-priced hep C drugs.
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The article Another Strong Quarter for Gilead Sciences, Inc. originally appeared on Fool.com.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie also had to update its labels last week to reflect a contraindication in patients with Child-Pugh B cirrhosis and recommend that physicians assess the potential for liver damage before prescribing. Looking ahead Gilead seems in good shape to benefit from safety concerns about AbbVie 's hep C treatment, Viekira Pak. However, should Gilead chip away at AbbVie's market share, it would improve Gilead's top and bottom lines in the fourth quarter and possibly into 2016. | Looking ahead Gilead seems in good shape to benefit from safety concerns about AbbVie 's hep C treatment, Viekira Pak. AbbVie also had to update its labels last week to reflect a contraindication in patients with Child-Pugh B cirrhosis and recommend that physicians assess the potential for liver damage before prescribing. However, should Gilead chip away at AbbVie's market share, it would improve Gilead's top and bottom lines in the fourth quarter and possibly into 2016. | However, should Gilead chip away at AbbVie's market share, it would improve Gilead's top and bottom lines in the fourth quarter and possibly into 2016. Looking ahead Gilead seems in good shape to benefit from safety concerns about AbbVie 's hep C treatment, Viekira Pak. AbbVie also had to update its labels last week to reflect a contraindication in patients with Child-Pugh B cirrhosis and recommend that physicians assess the potential for liver damage before prescribing. | Looking ahead Gilead seems in good shape to benefit from safety concerns about AbbVie 's hep C treatment, Viekira Pak. AbbVie also had to update its labels last week to reflect a contraindication in patients with Child-Pugh B cirrhosis and recommend that physicians assess the potential for liver damage before prescribing. However, should Gilead chip away at AbbVie's market share, it would improve Gilead's top and bottom lines in the fourth quarter and possibly into 2016. |
26797.0 | 2015-10-29 00:00:00 UTC | Will AbbVie (ABBV) Surprise on Earnings Again in Q3? | ABBV | https://www.nasdaq.com/articles/will-abbvie-abbv-surprise-earnings-again-q3-2015-10-29 | nan | nan | AbbVieABBV will be reporting third quarter 2015 earnings results on Oct 30 before the market opens.
AbbVie's performance has been pretty impressive with the company beating earnings expectations consistently. The average earnings surprise over the last four quarters is 8.15%.
Humira, Imbruvica and Viekira in Focus
Third quarter revenues are expected to grow in the low 20% range on an operational basis. Key drug, Humira, should remain the main growth driver in the third quarter - growing awareness, strong underlying demand, favorable clinical data, additional indications and market share gains should help the product to continue contributing significantly to the top-line.
Humira is expected to witness mid-teens growth on an operational basis in 2015. However, investors will be keen to know the impact of Remicade biosimilars on ex-U.S. sales of Humira.
We also expect investor focus to remain on the performance of hepatitis C virus (HCV) treatment, Viekira, especially considering that one of Gilead's GILD HCV treatments recorded a sequential decline in sales and the other a decline from the year-ago period.
A big question on the minds of investors will be the impact of the recent addition of liver injury warnings to the labels of AbbVie's HCV treatments. We note that on its recently heldearnings call pharmacy benefit manager Express Scripts ESRX said that the change in label will not impact the availability of Viekira Pak for patients for whom it is safe and effective or impact the PBM's utilization projections. Express Scripts also noted that there was no client disruption regarding Viekira Pak as a result of the FDA alert.
Another focus area will be the performance of Imbruvica which was added to AbbVie's portfolio following its May 2015 acquisition of Pharmacyclics. Imbruvica has multi-billion dollar potential and the company is exploring the potential to expand Imbruvica's label into solid tumors and autoimmune diseases.
AbbVie is positioning Imbruvica as a "pipeline in a molecule" -- the treatment is in more than 60 studies. AbbVie expects Imbruvica peak sales of more than $7 billion and sales of about $1 billion in 2015. Imbruvica is partnered with Johnson & Johnson JNJ , which recorded third quarter Imbruvica sales of $184 million.
Other products include Synagis, AndroGel and the lipid franchise. Synagis, which protects at-risk infants from severe respiratory disease, is a seasonal product with a major part of sales being recorded in the first and fourth quarters of the year. As a result, third quarter sales could be weak. Both AndroGel and lipid franchise sales should decline given the presence of generic competition. Negative market trends will impact HIV sales also.
Meanwhile, Duopa sales should ramp up eventually as physicians grow familiar with the product. Creon is expected to deliver double-digit sales growth in 2015 with the product capturing the vast majority of new prescription starts in the pancreatic enzyme market.
Currency movement will remain a headwind and is expected to impact third quarter sales by about 7%.
What Our Model Indicates
Our proven model does not conclusively show that AbbVie is likely to beat earnings. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank of #1, 2 or 3 for this to happen. That is not the case here, as you will see below.
Zacks ESP : Earnings Surprise Prediction or Earnings ESP , which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is 0.00%. Both the Most Accurate estimate and the Zacks Consensus Estimate for AbbVie are $1.07, at the higher end of the company's guidance range of $1.05 to $1.07 per share.
Zacks Rank #3 (Hold) : Note that stocks with Zacks Ranks of #1, #2 and #3 have a significantly higher chance of beating earnings. The sell-rated stocks (#4 and #5) should never be considered going into an earnings announcement.
The combination of AbbVie's Zacks Rank #3 and 0.00% ESP does not conclusively point to a positive surprise on Oct 30.
Stocks That Warrant a Look
Here is a health care stock that you may want to consider, as our model shows that it has the right combination of elements to post an earnings beat this quarter.
Sarepta Therapeutics, Inc. SRPT has an Earnings ESP of +10.08% and carries a Zacks Rank #3 (Buy). The company will reporting results on Nov 5.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVieABBV will be reporting third quarter 2015 earnings results on Oct 30 before the market opens. AbbVie's performance has been pretty impressive with the company beating earnings expectations consistently. A big question on the minds of investors will be the impact of the recent addition of liver injury warnings to the labels of AbbVie's HCV treatments. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report EXPRESS SCRIPTS (ESRX): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SAREPTA THERAP (SRPT): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVieABBV will be reporting third quarter 2015 earnings results on Oct 30 before the market opens. AbbVie's performance has been pretty impressive with the company beating earnings expectations consistently. | Click to get this free report ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report EXPRESS SCRIPTS (ESRX): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SAREPTA THERAP (SRPT): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVieABBV will be reporting third quarter 2015 earnings results on Oct 30 before the market opens. AbbVie's performance has been pretty impressive with the company beating earnings expectations consistently. | The combination of AbbVie's Zacks Rank #3 and 0.00% ESP does not conclusively point to a positive surprise on Oct 30. AbbVieABBV will be reporting third quarter 2015 earnings results on Oct 30 before the market opens. AbbVie's performance has been pretty impressive with the company beating earnings expectations consistently. |
26798.0 | 2015-10-29 00:00:00 UTC | Pre-Market Earnings Report for October 30, 2015 : XOM, CVX, CVS, ABBV, CL, PSX, IMO, AON, ETN, EXC, HCN, MYL | ABBV | https://www.nasdaq.com/articles/pre-market-earnings-report-october-30-2015-xom-cvx-cvs-abbv-cl-psx-imo-aon-etn-exc-hcn-myl | nan | nan | The following companies are expected to report earnings prior to market open on 10/30/2015. Visit our Earnings Calendar for a full list of expected earnings releases.
Exxon Mobil Corporation ( XOM ) is reporting for the quarter ending September 30, 2015. The oil company's consensus earnings per share forecast from the 10 analysts that follow the stock is $0.89. This value represents a 52.91% decrease compared to the same quarter last year. XOM missed the consensus earnings per share in the 2nd calendar quarter of 2015 by -9.91%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for XOM is 20.88 vs. an industry ratio of 14.20, implying that they will have a higher earnings growth than their competitors in the same industry.
Chevron Corporation ( CVX ) is reporting for the quarter ending September 30, 2015. The oil company's consensus earnings per share forecast from the 10 analysts that follow the stock is $0.79. This value represents a 73.22% decrease compared to the same quarter last year. CVX missed the consensus earnings per share in the 2nd calendar quarter of 2015 by -73.45%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for CVX is 28.24 vs. an industry ratio of 14.20, implying that they will have a higher earnings growth than their competitors in the same industry.
CVS Health Corporation ( CVS ) is reporting for the quarter ending September 30, 2015. The drug store company's consensus earnings per share forecast from the 21 analysts that follow the stock is $1.29. This value represents a 12.17% increase compared to the same quarter last year. In the past year CVS has met analyst expectations once and beat the expectations the other three quarters. Zacks Investment Research reports that the 2015 Price to Earnings ratio for CVS is 20.12 vs. an industry ratio of 22.20.
AbbVie Inc. ( ABBV ) is reporting for the quarter ending September 30, 2015. The large cap pharmaceutical company's consensus earnings per share forecast from the 9 analysts that follow the stock is $1.07. This value represents a 20.22% increase compared to the same quarter last year. In the past year ABBV has beat the expectations every quarter. The highest one was in the 2nd calendar quarter where they beat the consensus by 1.89%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for ABBV is 12.53 vs. an industry ratio of 4.90, implying that they will have a higher earnings growth than their competitors in the same industry.
Colgate-Palmolive Company ( CL ) is reporting for the quarter ending September 30, 2015. The cleaning company's consensus earnings per share forecast from the 12 analysts that follow the stock is $0.72. This value represents a 5.26% decrease compared to the same quarter last year. CL missed the consensus earnings per share in the 2nd calendar quarter of 2015 by -1.41%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for CL is 24.32 vs. an industry ratio of 20.40, implying that they will have a higher earnings growth than their competitors in the same industry.
Phillips 66 ( PSX ) is reporting for the quarter ending September 30, 2015. The oil refining company's consensus earnings per share forecast from the 8 analysts that follow the stock is $2.27. This value represents a 12.38% increase compared to the same quarter last year. In the past year PSX has beat the expectations every quarter. The highest one was in the 2nd calendar quarter where they beat the consensus by 1.1%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for PSX is 12.63 vs. an industry ratio of 9.90, implying that they will have a higher earnings growth than their competitors in the same industry.
Imperial Oil Limited ( IMO ) is reporting for the quarter ending September 30, 2015. The consensus earnings per share forecast from the 2 analysts that follow the stock is $0.44. IMO reported earnings of $0.98 per share for the same quarter a year ago; representing a a decrease of -55.10%. The "days to cover" for this stock exceeds 28 days.
Aon plc ( AON ) is reporting for the quarter ending September 30, 2015. The insurance brokers company's consensus earnings per share forecast from the 12 analysts that follow the stock is $1.23. This value represents a 4.65% decrease compared to the same quarter last year. In the past year AON has beat the expectations every quarter. The highest one was in the 2nd calendar quarter where they beat the consensus by 1.55%.
Eaton Corporation, PLC ( ETN ) is reporting for the quarter ending September 30, 2015. The machinery company's consensus earnings per share forecast from the 7 analysts that follow the stock is $0.97. This value represents a 24.81% decrease compared to the same quarter last year. In the past year ETN has beat the expectations every quarter. The highest one was in the 2nd calendar quarter where they beat the consensus by 1.75%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for ETN is 12.55 vs. an industry ratio of 9.90, implying that they will have a higher earnings growth than their competitors in the same industry.
Exelon Corporation ( EXC ) is reporting for the quarter ending September 30, 2015. The electric power utilities company's consensus earnings per share forecast from the 5 analysts that follow the stock is $0.71. This value represents a 8.97% decrease compared to the same quarter last year. EXC missed the consensus earnings per share in the 4th calendar quarter of 2014 by -5.88%. Zacks Investment Research reports that the 2015 Price to Earnings ratio for EXC is 11.56 vs. an industry ratio of 10.90, implying that they will have a higher earnings growth than their competitors in the same industry.
Welltower Inc. ( HCN ) is reporting for the quarter ending September 30, 2015. The reit company's consensus earnings per share forecast from the 10 analysts that follow the stock is $1.10. This value represents a 5.77% increase compared to the same quarter last year. In the past year HCN has met analyst expectations once and beat the expectations the other three quarters. Zacks Investment Research reports that the 2015 Price to Earnings ratio for HCN is 15.40 vs. an industry ratio of 13.00, implying that they will have a higher earnings growth than their competitors in the same industry.
Mylan N.V. ( MYL ) is reporting for the quarter ending September 30, 2015. The medical company's consensus earnings per share forecast from the 4 analysts that follow the stock is $1.37. This value represents a 18.10% increase compared to the same quarter last year. In the past year MYL has met analyst expectations once and beat the expectations the other three quarters. Zacks Investment Research reports that the 2015 Price to Earnings ratio for MYL is 10.71 vs. an industry ratio of 5.60, implying that they will have a higher earnings growth than their competitors in the same industry.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) is reporting for the quarter ending September 30, 2015. In the past year ABBV has beat the expectations every quarter. Zacks Investment Research reports that the 2015 Price to Earnings ratio for ABBV is 12.53 vs. an industry ratio of 4.90, implying that they will have a higher earnings growth than their competitors in the same industry. | Zacks Investment Research reports that the 2015 Price to Earnings ratio for ABBV is 12.53 vs. an industry ratio of 4.90, implying that they will have a higher earnings growth than their competitors in the same industry. AbbVie Inc. ( ABBV ) is reporting for the quarter ending September 30, 2015. In the past year ABBV has beat the expectations every quarter. | Zacks Investment Research reports that the 2015 Price to Earnings ratio for ABBV is 12.53 vs. an industry ratio of 4.90, implying that they will have a higher earnings growth than their competitors in the same industry. AbbVie Inc. ( ABBV ) is reporting for the quarter ending September 30, 2015. In the past year ABBV has beat the expectations every quarter. | In the past year ABBV has beat the expectations every quarter. AbbVie Inc. ( ABBV ) is reporting for the quarter ending September 30, 2015. Zacks Investment Research reports that the 2015 Price to Earnings ratio for ABBV is 12.53 vs. an industry ratio of 4.90, implying that they will have a higher earnings growth than their competitors in the same industry. |
26799.0 | 2015-10-28 00:00:00 UTC | Gilead (GILD) Beats on Q3 Earnings, HCV Drugs Lose Shine | ABBV | https://www.nasdaq.com/articles/gilead-gild-beats-on-q3-earnings-hcv-drugs-lose-shine-2015-10-28 | nan | nan | Gilead Sciences, Inc. 's GILD third-quarter earnings (including stock-based compensation expenses) of $3.19 per share surpassed the Zacks Consensus Estimate of $3.03. Moreover, the reported earnings were way above the year-ago figure of $1.79 per share.
Gilead Sciences Inc. (GILD) - Earnings Surprise | FindTheCompany
Total revenues of $8.3 billion were much above the year-ago figure of $6 billion. Quarterly revenues easily surpassed the Zacks Consensus Estimate of $8.1 billion.
Quarter in Detail
Product sales were up approximately 37.6% to $8.2 billion driven by the inclusion of sales of hepatitis C virus (HCV) drug, Harvoni (launched in the U.S. in Oct 2014).
Antiviral product sales for the quarter registered growth of 38.9% to $7.7 billion driven by Harvoni. Harvoni recorded revenues of $3.3 billion in the third quarter of 2015, down 7.6% sequentially. The company witnessed a gradual downward trend in demand from the retail market during the quarter. Another HCV drug, Sovaldi, registered sales of $1.5 billion, down 47.6% from the year-ago figure, owing to the availability of newer HCV therapies.
Other anti-viral products, such as HIV treatments Complera/Eviplera (up 9.1% to $360 million) and Stribild (up 56.3% to $511 million) performed well. Sales of older HIV drugs like Truvada (up 3% to $903 million) and Viread (up 8% to $297 million) were also impressive. However, Atripla sales declined 8.6% to $818 million. The company expects Atripla sales to continue declining.
Other products including Letairis, Ranexa and AmBisome recorded sales of $181 million (up 24%), $161 million (up 22%) and $88 million (down 10.2%), respectively. Newly launched Zydelig also performed well, recording revenues of $36 million, up 20% sequentially.
Research & development (R&D) expenses (including stock-based compensation expenses) climbed 20.9% to $757 million in the third quarter of 2015 due to increased investment in pipeline. Selling, general and administrative (SG&A) expenses (including stock-based compensation expenses) fell 4.7% to $900 million. SG&A expenses declined primarily due to a cumulative catch-up of the branded prescription drug fee recorded in the same period in 2014.
2015 Guidance Revised
Gilead upped its product sales guidance. The company now expects product sales in the range of $30-$31 billion (previous guidance: $29-$30 billion). The Zacks Consensus Estimate of $31.7 billion is slightly higher than the guidance range.
Adjusted product gross margin for 2015 is still expected in the range of 88-90%. The company reiterated its guidance for R&D expenses and SG&A expenses. R&D expenses (excluding stock-based compensation expenses and other special items) are projected in the range of $2.8-$3 billion. SG&A expenses are expected in the range of $3-$3.2 billion.
Meanwhile, the company declared its fourth-quarter dividend. Gilead has declared a quarterly cash dividend of 43 cents per share of common stock, to be paid on Dec 30, 2015, to all stockholders of record as of the close of business on the record date of Dec 16, 2015.
The company also repurchased shares worth $3.1 billion in the third quarter of 2015.
Our Take
Gilead posted strong third-quarter results with both earnings and revenues beating our expectations. We are nevertheless concerned about the slowdown in Harvoni sales and the gradual downward trend in demand from the retail market during the quarter. Pricing measures in the form of rebates and discounts could impact Harvoni sales further. The anticipated downtrend in Atripla sales due to newer HIV therapies is also concerning.
We note that several companies including AbbVie Inc. ABBV have launched their HCV treatments in the market. Additionally, other companies like Merck & Co. Inc. MRK are looking to bring their drugs to the market. Going forward, we expect investor focus to remain on Harvoni's performance. We also expect to see some merger & acquisition activities at the company.
Gilead currently carries a Zacks Rank #3 (Hold). Anika Therapeutics Inc. ANIK is a better-ranked stock in the health care sector. The stock holds a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We note that several companies including AbbVie Inc. ABBV have launched their HCV treatments in the market. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc. 's GILD third-quarter earnings (including stock-based compensation expenses) of $3.19 per share surpassed the Zacks Consensus Estimate of $3.03. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. We note that several companies including AbbVie Inc. ABBV have launched their HCV treatments in the market. Gilead Sciences, Inc. 's GILD third-quarter earnings (including stock-based compensation expenses) of $3.19 per share surpassed the Zacks Consensus Estimate of $3.03. | Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. We note that several companies including AbbVie Inc. ABBV have launched their HCV treatments in the market. Quarter in Detail Product sales were up approximately 37.6% to $8.2 billion driven by the inclusion of sales of hepatitis C virus (HCV) drug, Harvoni (launched in the U.S. in Oct 2014). | We note that several companies including AbbVie Inc. ABBV have launched their HCV treatments in the market. Click to get this free report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report ABBVIE INC (ABBV): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report To read this article on Zacks.com click here. Harvoni recorded revenues of $3.3 billion in the third quarter of 2015, down 7.6% sequentially. |
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