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39f3d5ca0531a8df8f63b3e2c0241073
Hi, I just have two questions to you. Number one is kind of a high-level question. Based on the performance generally over the last decade, 15 years over, I kind of went back and looked at different periods of time and seeing what happened to book value in various situations. It used to be that if interest rates were g...
Sure. I appreciate your comments. I'll take your second question first. In terms of estimating book value, we certainly put out several communications during this period of time and we always want to have as much high-quality information available to the shareholders as we can. In fact, on one of our press releases, wh...
intermediate
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B
c2b4c28db19929c9572eb01b7f590e1a
I apologize, I missed the very beginning of the call. So if this has been discussed, just let me know. My global question is how do you see any of these going forward? You sold obviously more non-agencies than agencies. Do you want to become a pure agency fund like you were in the old days or restore the balance now th...
Well, there's obviously a considerable amount of uncertainty still as to what the economic impact on residential mortgage credit over the next six to 12 months maybe. That said, our belief is given the current market values for the non-agency securities we hold, and the fact that, as Brett mentioned, we are in a relati...
intermediate
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B
15d5dd27d648b35d6467b2000915ee72
You're kind of on hold is what you're saying in right now?
We're on hold until we see either, a, prices improved substantially, in which case, we might look to sell securities or if prices continue to stay at these levels, if we see some improvement in our ability to get some financing. The yields on these securities are in high-single digits, which is very attractive, but isn...
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A
c44b42cfec1b3d3b127d4a5fd01c7c44
So as you were saying earlier, obviously prepayments have been pretty high. Where do you -- and at some point, you want to stop paying down repo theoretically over time as your leverage gets lower. Where are incremental investments going at this point in time?
Well, as we had viewed that given the stabilization in the non-agency market, but still, obviously, a good deal of volatility potentially, and the record low interest rates we saw during the first quarter, that really this period of time, April, May, June was going to be the period where agency prepayments were going t...
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A
89f30f8c80656604a8e5134eebc5ae00
But that's fine, but when you get to the point that you would [Indecipherable], but assuming this situation, where do you see the opportunities, I guess, if I'm not being clear, I'm sorry.
Right now the opportunity is in the Agency MBS market would be driving potential levered ROEs in sort of the low teens where we're holding our Non-Agency MBS would be in the high teens. So right now when we get to that point, we're looking to deploy additional capital, we have to evaluate whether the potential risk in ...
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A
d9750b142c1f187b73cbb93fa91b670f
Got you and my other question is a little different. Given how much you've shrunk, and I'm assuming your expense ratio hasn't shrunk as much. What do you think your expense ratio is including the outside manager because you pay them as a percentage of your total equity? And how does that compare to your peers at this p...
Right. Well, two things there, Howard. First, I apologize, I do not have a good estimate of a pro forma G&A expense. What I will point out is that when you look at the two major expenses that are not depreciation in the first quarter, you have $1.5 million of management fee and a $1.1 million of other G&A expenses. The...
intermediate
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B
14bbac9ca010767d7abb5a4593fcb1d6
But stockholder equity is probably overstated, given -- if you took -- based on what you just said because you're not taking to kind of mark-to-market losses. I assume the equity is included to mark-to-market losses would be substantially lower. Is that not correct?
Well, again, we had some unrealized gains heading into this quarter. So in general, I wish I had the answer for you, Howard, and I'm happy to work on it and look it up for you. But in general, it has tracked fairly closely. There have not been significant discrepancies between that. We don't have -- we have not had lar...
intermediate
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B
09958f2bc88b01fac9948c7f98a9df26
And my last question would be, in light of these other things that we just talked about, have you or would you consider a sale at some point to a larger competitor to get the benefits of consolidation?
I think as I said in the comments and this is maybe more related to the -- well, I think it's in the same vein, the idea that currently -- I mean, as do many of the mortgage REITs now, but Anworth has dealt with this in the past as well. When you're trading at a significant discount to book, you're small, you don't hav...
intermediate
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B
db5519bed3481bf18d7a8f6616f1c2bc
So just from us, how do the MORNINGSKY results and Phase 2 hospitalized study results and form your thinking about the dose and formulation of AT-527 moving forward? Is it still likely that you will continue to pursue a revised formulation with a potential protease inhibitor combination? And then also, why wait for inp...
OK, so that's many questions. But let's do one at a time. Janet, if you like to start. I may make some comment on the formulation. Why don't you start on the clinical questions related. Yeah, so thank you very much. So firstly, in regards to the MORNINGSKY dose, we're very confident that the 550-milligram BID dose of...
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A
5be2df2a53edf2c32b17235532978a91
Great. And then just looking toward the upcoming data presentations, can we expect variant sequencing data and potentially any additional subgroup analyses in these year outs?
Yes. You can expect both variant sequencing and some subgroup analyses, yes.
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A
faaaec57a1e780abbdb446ba111350d2
I want to ask further about the potential combination, because you just mentioned you're going to do some PK/PD study. I want to ask, any other -- I mean, color you can give us about what are the potential partners you're going to collaborate?
Well, just first of all, we are evaluating ourself some external potential in-licensing as well as internal efforts on the PI. So we are very happy to collaborate with any interested party. But ultimately, our preference would be to have our own PI, either through external in-licensing or internal effort.
intermediate
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1e8738f4d8f0798404ec1f8cc6245c88
Hi, guys. Thanks for taking my question. I want to start by saying congratulations on the strength of the data on hospitalization. I guess in the same breath, I'm also a little confused on a few things. Number one, had Roche seen this data at the time they terminated the collaboration? And number two...
Very good question, Umer. Roche ended the partnership prior to the MORNINGSKY results.
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B
a80eada666eaab272ce1036e829eabdd
This was prior to? OK, great. And then also, JP, can you speak to the pace of recruitment in the trial? Because it doesn't seem as robust as we were seeing in the Pfizer and Merck studies. And also if you don't mind...
Yeah, it's a very good question, Umer. I'll let Janet to answer the difficult question. I answered the easy one. Go ahead, Janet. Roche was responsible for the Phase 3 trial, leadership and operational execution. And the recruitment was disappointing. There seems to have been some operational issues there. Sites are s...
intermediate
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B
230162112dce3d8b2f488582ea3d830e
OK. And I guess the third one is, in the seronegative population, how did the primary endpoint look in the seronegative population? As well as, as you think about this new trial that you're starting up, can you -- do you think you guys can wrap it up before the EUA is gone? I think that's a real question.
So we're going to present the subanalyses at a scientific meeting later in the year. So I'm afraid I'm going to leave you on the edge of your seat with regard to that one. And I don't know about the EUA and how long that's likely to be around. So we'll have to see, but we hope to go as fast as we can.
intermediate
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B
79c4026ccd4efa7feaeaaaba56986fb4
Hi. This is John on for Tim. Thanks so much for taking our question, and congrats on the new data. So I was just wondering, given the availability of other oral antivirals, how you're thinking and looking at how feasible it will be to enroll a Phase 3 study even with supply constraints out there? And what strategies ar...
So we're cognizant of the landscape. And I think as Jean-Pierre mentioned, here the White House is indicating that they're anticipating perhaps up to 100 million infections this coming fall and winter. And certainly, the virus seems to show no evidence of going away. So we think there are going to be plenty of patients...
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B
3f085c27c9e88270a1e780a4d8be035c
OK. Great. And maybe just one follow-up. So given the strength of the data today, do you think you have more leverage to go, potentially seek an external partner for a combination study?
Well, as I said, John, we welcome any potential interest. But it's clear that we will favor internal PI. We are evaluating actually several external opportunities as we speak. And some more advanced than others. And also, we have some interesting data from the internal efforts that definitely we share with the street ...
intermediate
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B
0fb0962ca8c617d8cf8ce987186ed2f1
Hi. Good morning. This is Nik Gasic on for Roanna. Thanks for taking our questions. I guess, I'll start with COVID-19. You talked a bit about design considerations for upcoming trials. I'm just curious, is assessing hospitalizations and deaths still a feasible endpoint at this stage given the evolving landscape? And w...
So unfortunately, yes, we believe that hospitalization and death are still endpoints I think, as you know, there's been a varied uptake of the vaccines. And of course, there are some patients who in spite of being vaccinated don't generate an adequate immune response. So in particular, the high-risk groups of patients ...
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A
78a3cd445b1a4b033e2e7e06b92dba2f
Got it. And just on dengue with 752, could you discuss your rationale for challenging patients with the dengue virus after they received 752 as opposed to waiting like a certain period of time to administer the treatment? And maybe just how many days after they've received 752, are patients being challenged?
So the patients are challenged within 24 hours of being given 752. But I think the purpose really of the study is more of a pre-exposure -- a prophylaxis study, not a pre-exposure, just a prophylaxis study, which I think is a very good way of demonstrating the activity of the drug in that patient population. It's chall...
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A
2cf9f037e734e8bd0f4fd8cdf84c7a25
Got it. And then just one more for me on dengue, this time for the proof of concept. Are you planning to roll higher-risk patients with comorbidities in this trial? What -- like what's the therapeutic window like for an antiviral like 752? And maybe what are you hoping to learn from this trial? Like what magnitude of v...
So I think and what we hope to see is that patients who are treated early are able to avoid developing a cytokine storm, which is what happens at dengue fever. And I think, obviously, the change in the viral load depends to some extent on where you start. But we hope to see that we are able to reduce viral loads to clo...
intermediate
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B
990803acf85960c6075dc4a8cddce404
This is actually Jon. I figured I'd hop on and ask as well. I was going to ask another follow-up about dengue actually. And I'm thinking about the next steps in development there. What -- of the two trials you're running, what are the key endpoints for advancement for this program? And do you think it's going to be ea...
So I think, I mean, I think what we want to be able to show is that we have a well-tolerated and efficacious drug, which is able to drop viral loads to the point where we obtain as clinically meaningful benefits for patients. And we think we should be able to see that at least get a glimpse of what that should look lik...
intermediate
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B
7ce01b1d56778d339ca321b09605984e
First question is just checking to see if you can provide perspective into pricing and reimbursement pressure with COVID-19 testing saturation and increased competition? I guess, how should we think about reimbursement for the PCR testing going forward?
So we continued to see kind of mid level -- mid-60s overall reimbursement for PCR. I think our view is that it's going to continue to be stable during the first quarter. Despite some of the changes that have been enacted under Medicare, I think were -- our overall pricing and reimbursement should remain at those levels...
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A
b173f72ed14a63d3122181d24da03ec4
Also wondering how you think about conversion of COVID-19 testing costs and personnel back to what the new base business will be as COVID-19 testing demand retreats over time? How are you guys thinking about that?
You know, I think the -- I don't want to confuse or the PCR testing long-term with what's happening on the rapid point-of-care side. So there is still a fairly large amount of interest and contractual relationships being established between multiple different industries relative to their desire to continue to test, whe...
intermediate
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B
ab08cfb87052a8580233da85a0106948
So you talked a little bit about the Stage 5 CKD study and that you're going through the data. Can you just talk a little bit more about what you plan on reporting as far as the number of patients and some of the data measures that you plan on reporting as well?
Hey, Maury, this is Charlie Bishop. Yes. The study that we just completed is an early Phase 2 study. It's Phase 2a. It involves a total of 44 subjects. So we'll be reporting on a three-to-one randomization active to placebo. And the design of the study was basically to look at three things: one is RAYALDEE tolerated we...
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A
a28207b519c8d68350d6552e6b0b3b9e
Maybe last follow-up is just if the COVID-19 RAYALDEE results could be reported at the same time? Or can you provide any more granularity on the time -- when we might see data from both these studies?
Well, I wish my crystal ball were really great because I can't tell you how the pandemic is going to go. But as long as infection rates stay high, we expect that enrollment will be good. You should keep in mind that we've designed the ongoing COVID-19 study not to take all comers. It is a study in outpatients, but most...
fully_evasive
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C
86c323560dce8a1935ae153329016f3a
I just had a question on kind of the margin progression throughout 2021. I know there are a lot of moving parts with, I guess, what presumably could be a margin tailwind from improving base business volumes offset maybe by a headwind from potentially lower COVID testing volumes as the vaccine rollout continues. Could y...
So I'll try to address them and, Jon, please weigh in as well. So I think the margin evolution, what you saw in the third and fourth quarter are pretty consistent. I think as COVID testing volumes continue to move, as Jon highlighted, into the point-of-care, I think those will stay and remain healthy. The PCR margins f...
intermediate
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B
0c76f54c7a48ce5c3d5ed3f0e39a9fa8
Did you say that the $38.7 million Claros written-down, where was that recognized?
No, that was last year, in last September.
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A
20eb4612e7d4cfe840b35ae822f2456d
And then looking at Somatrogon, can you tell us a little bit about what prep work is being done both on the regulatory side. Do you anticipate that there would be a panel? And then also in -- over at Pfizer with respect to commercial readiness?
Well, we don't expect the panel, but the work is -- we're responding and Pfizer is responding on a real-time basis to various inquiries. There are inspections going on, some of them, including down here in Miami. So that's pretty ordinary course at this point as we go through the process. Yeah. So Pfizer has got the pr...
intermediate
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B
d80e3f270be594f743b7e079a7feaaa9
The first question I have is that in terms of your guidance, 4.2 million to 4.8 million tests -- PCR tests in the first quarter, do you guys have any thoughts in terms of the trends for the serological tests in -- for 2021, especially as more people getting vaccine?
Yeah. So it's still a -- I don't know. We have a very large capacity to do several hundreds of thousands of antibody testing if need be. We have at least two different platforms we're running the antibody testing on which are both quantitative at this point and moving away from the qualitative [Inaudible] which was the...
intermediate
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B
abaa1b1e2f63670bea89dacf0fef4331
One more question is on the COVID-19 RAYALDEE studies. You mentioned there's only selective patient that is relevant. Could you give us some sense of what portion of the COVID patient, the hospitalized patient would be more suitable for treated by RAYALDEE?
Hi, Yale. What we're using for a primary efficacy endpoint in the ongoing study is a patient-reported outcome tool that's been validated for viral infections and we require patients to have a score on that tool that's above a certain level in order to get into the study. And what that does is, it enables the time cours...
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A
ea98bcf766e59c929d0a4919ed2709ae
Recently, the World Health Organization has released the guidance to laboratories stating that they should reduce the cycle count in PCR test which could lead to a lower number of new COVID-19 cases detected. So what's your opinion on that and what's your current practice?
Yeah. So, you know, we -- we run at least four platforms now, different manufacturers. One of them, in particular, well, there's really two. You know, we -- if requested, we'll report out the CT value, the cycle time values. I don't -- we're not in the position to determine what that should or should be relative to the...
intermediate
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B
39b14b89d68faaad79f636c7f5c64e8b
Your guidance on RAYALDEE for Q1 is just -- was it simply below Q1 '20, that was essentially the guidance in RAYALDEE?
That's right. That's right, Mike. So it's included in the total number, but I didn't break it out separately.
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A
e86f3bb6a4b2e27d5b34c9dcfaf271ee
As you think about COVID-19 PCR test, serology tests over time, I mean three years from now, is this still a -- I suspect it will be much reduced, but is it still a meaningful part of BRL revenue? Or do vaccinations sort of then take such hold and regularity for people that it's not anywhere near materiality three, fou...
Yeah. So that's the uh, -- that's a multibillion-dollar question, right? Nobody has any idea how this will evolve or morph over the next one to two years. We -- you now, I think everybody hopes that this all goes away. Now having said that, right now all the variants are being treated by the -- or at least mostly, depe...
intermediate
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B
f29659d93921b13675412006f9e8252b
August, you mentioned the RFP decline in January. I think you said 25%. Just curious, are you seeing any other signs of client hesitancy such as lengthening decision cycles or slower trial start-ups, anything like that?
No. We really haven't seen any other signs. There's always -- it's difficult to pick out a metric like that and measure it over a short period of time. But I don't really think there's been a sign of real lack of funding or more difficulty. Look, in our client base, that's always an issue, getting funding, and it alway...
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A
cf73832471064dedc5fec738b9f0e3d0
We've been hearing more commentary out of the FDA and CMS lately that there's -- they want more patient diversity in clinical trials. I'm curious if you are cognizant of that. Does that seem like a notable change? And does that have any implications on how you're going to approach new business?
Yes. No, it is an important factor in site selection and trying to get a diverse and representative sample of patients in trials. A very important issue. Generally, that is discussed with the client very early. They kind of have ideas on what sort of breakout they would like. Generally, it's not something that's strati...
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8f5c2f293a2b90872faa4828bdfc7499
You mentioned wages is the other concern. Are you changing your tactics about how you're going to get in front of this, for example, where you're recruiting or maybe the level of experience that you're going after?
No, I think it's business as usual. Our wage levels are inflating, particularly at the entry level quite a bit. But I think our recruitment strategies remain intact.
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cbd7b76f344338bf3e5fbb617ec3d190
I just wanted to maybe hear a little bit more on the inflation topic. I mean, you probably saw the producer price index out this morning, looks like up 10% year over year. I mean, these are some big inflation numbers. So I know on the -- or on the margin, are contracts changing? Like if you do a three- to five-year con...
OK. So I think your question is about how pricing changes in our different contracts? No. I think -- so a quick answer to that is no. We have the same structure to our contracts. The wage rates that are used in building the contract are fixed at time of bid. We do put wage inflation assumptions into the contracts. And ...
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A
1586ab3e2ef41d978b61b56670dc8328
My sense -- I mean, correct me if I'm wrong, you guys have fairly good pricing power in the past. So I guess what I'm hearing from you is you're not doing anything radically changing in terms of escalators in your contracts, but you might do so in the future, and you might -- you feel like you probably could be able to...
Yes, I think that's fair. And I think we can change our pricing for go-forward bids, which is, of course, the dynamic you're negotiating with a client. But it's difficult to address existing contracts that have a fixed reimbursement rate.
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8491780d1a44debebd6a3226d2bfe489
Got you. And maybe my follow-up question would be similar on the inflationary topic. You guys are holding a lot of cash on your balance sheet, which is good. And you -- obviously, you've done super well generating cash flow. Can you just maybe elaborate on your thoughts deploying that cash? Maybe just update us on any ...
Yes. Don, this is Kevin. Just in relation to our capital allocation strategy, we're going to be consistent with where we've been for a while now, and that we'll continue to invest in the organic growth of the business, whether it's infrastructure or people or what have you, the No.2 pillar for us, the primary pillar ou...
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A
92de820d3519893af3538e350d8f1c2e
Hi, good afternoon, gentlemen. Thanks for taking my call. Little newer to the story I've been working with Bill, but just curious on the revenue guidance that you gave low double-digit revenue growth for this fiscal '21. Is there any chance you give a little bit of granularity to maybe where some segments are going to ...
Yeah. So thanks, Gerry. Welcome to -- as I appreciate ROTH for years. So yeah, I guess across our businesses, I think we see the business units, OHP, Envance, AgriCenter, Australia and Brazil, and, of course, bolstered by Agrinos as well, so we see upside certainly there. I think we're also seeing a pretty healthy incr...
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B
67f662c12b081f9cacac070a4769a6e9
Got it. And I -- question about SIMPAS, and I apologize -- of course, this is the right environment or, but after seeing the video and reading about it, I mean the video also put into a little bit better perspective. But I just couldn't help, but notice at the end is it powered by Trimble, which I understand how that c...
Right. So with SmartBox, we did all of the sales ourself. We inherited that from DuPont back in 2000. We have sold as many as 1,200 systems in a given year. But we -- it's direct sales to the farmers. With SIMPAS, we have aligned ourselves with Trimble. So Trimble's dealers will be handling the distribution of it. And ...
direct
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A
c5c3e9850529cebf553ae3a400160da3
Perfect. Got it. And then final question coming up. This question has come up quite a bit and just -- I'm actually getting appliances across the board. Inflationary pressures, are you seeing anything? Do you have ability to manage that, if such arise? I mean, I do see freight in the presentation, and I know that's been...
Yeah. Hi, this is Bob. Yeah, we're keeping an eye on that. We're not that -- in our own portfolio, we're not that oil dependent. We have our own factories. We've had inventories in place as David described. So I think in the short term, for our own portfolio, not too much. In other parts of the world where we buy from ...
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cfa09eef9180a87ee3c06b2c17b0d0a1
Hey, good afternoon. Apologies, I joined this call late owing to some other obligations I had. But -- so I may have -- I missed most of your formal commentary. But I did have a question about the industry, and curious if you're seeing any effects in your business. But there was a one major agchem company talked about d...
I would say within regards to the United States, certainly, I think there was better expectations in '19 and '20 that occurred, and there was a lot of inventory of products that were brought over from China to try to beat the duties. And so with the market is not strong, I think there has been some lagging inventories ...
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B
8ca911e9ff639149fab895fbdb86567e
So, and then some of your -- in certain product lines you compete with alternative sources out of Europe, and the euro has been relatively strong, call it, I don't know, in the last seven months. So -- is that -- has that affected that or just the overall a more favorable environment with stronger commodity prices, is ...
Well, I've certainly seen chemical companies, not specifically in the ag side, but signaling price increases. And particularly, a company over in Germany that they encompassed really -- it seems like every day, I'm seeing them announcing new price increases, which certainly is favorable. But with oil going up, we do ha...
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B
d67de90bf17e661951af6917a184f2f7
Okay. And then I know you've guys have diversified away from corn judiciously, and you have some growth innovation platforms that are starting to get traction. That's great. But there -- you still have this core franchise of soil-applied insecticides that it could benefit in this environment. And I'm just curious if th...
Yeah. I mean there are -- I mean, it seems like kind of each day we see whether it's nematodes or corn rootworm, nutrition, particularly focus toward the corn and soybean market. So there's certainly a lot of awareness out there more than I've seen really since 2013. So we've got nice potential upside certainly in corn...
intermediate
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B
0a4aba612a724c69b6a3c44e91b09c62
Hey, so the follow-up was -- so let's just say, a year from now we're looking back at 2021, so relative to the setup that you guys envision currently what sort of, I don't know, Top 2 or 3 things, positive or negative, you think that could be a positive surprise as the 2020 -- [Indecipherable] for 2021. We're all tryin...
Well, as we, from the top side, I think I mentioned, we're looking at -- I think our impact in Dibrom, normalcy in corn and Folex and Bidrin. Our continued supply line for bromacil looks good now. But there is always the chance that we do get interruptions in starting up our PCNB facility. We've had different transmitt...
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261e67ed9a41013d4b29104f0793a916
Yeah. Thanks. Hi, guys. So now that you've taken the second price increase, I know it's kind of a, what-have-you-done-for-me-lately question, but how should we think about the final two price increases that you still have left? And probably just as important, what happens after the six-year period of this contract?
OK. Thanks for that question, Sterling. For those of you on the call who may not be familiar with the structure referred to in the question, let me just briefly cover that, if I might. So every six-year period, we are allowed for price increases in the back four years that we are in the first six-year period, which beg...
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A
1518592f715ef7991a1080f9555e3cd5
Yeah, it is helpful. I appreciate that. And then, within the context of the initial guide you're giving here for '22 for the domain name growth of the 2.5% to 4.5%, I think there's a lot of us that have watched the data year-to-date and granted we're just in the very beginning. But any comments you can give? Do you fee...
Yeah. Sure. Sure. Thanks, Jim. Yeah, Sterling, this is George. So I would just remind you and others on the call that we do have some seasonality as it relates to certain holidays and how they fall in the calendar. This year, in Q1, for example, the Chinese New Year is about two weeks earlier, started on February 1. L...
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3b3d8001777aa45eb21b421ce846a790
Makes sense. And then, very last one on .web. If all goes well with ICANN board, is it your anticipation that you would be in the market selling .web domains in '22?
Yeah. Well, so first of all, the process that I mentioned that was directed by ICANN's board, that is a process that's been held up for many years during litigation, which the panel has now basically shut down for the second time and directed ICANN to move with this process. So we're pleased to see ICANN doing it. That...
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a5ffda5f213602f8452e712ab7ee3b62
Great. Thanks, guys. Good afternoon. Sterling asked a lot of good questions. I'll just follow up on his. So just I'll start with .web since, Jim, that's where you left off. You did mention in your prepared remarks that you're going to be monitoring the process at ICANN. I just wanted to understand what's the vehicle fo...
OK. Well, I can't speak for Afilias. I can only tell you that the result of their last application was sanctions and a use of the word frivolous in the panel's answer to their application in reiterating their earlier finding, which is to direct ICANN to proceed. In terms of how we monitor that, most of these actions th...
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c98ef94d459ccfa9ca196dc014b5f3f9
Got it. OK. That's helpful, Jim. And then, George, just a couple quick ones for you. Just on the operating margin guide for '22, assuming, and I think you guys have, in the past, never included things in guides that weren't set. So assuming that guide does not include .web and assuming you got .web, there would be some...
Yeah. Rob, to the extent that when .web comes to us and clearly, we've got our plan and our launch in place, we'll clearly provide updated guidance to the extent that those expenses and/or revenue are going to impact the current year.
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bbf96f6a4276fcc2b9c39e1415f880e9
Got it. OK. Helpful. And then, just lastly, just you mentioned some of the kind of vagaries around global domain trends in Chinese New Year, of course. And just was wondering for about any sort of geographic color. And again, a follow-up on Sterling's question just about kind of what you're seeing here early in the yea...
Yeah. Sure, Rob. So as we mentioned in our prepared remarks, we had a solid year of growth in the domain name base. It was up 5% year over year. And in 2021, we saw the gains in the base, primarily from our U.S., EMEA and our Asia Pacific registrars. When you look at new units or gross adds, as Jim mentioned, we gener...
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1984869433a33c9d1bd93d48323863e1
A question on the COMET sub-studies. Are these purely hypothesis generating, or is it possible that results can be incorporated into the NDA submission?
The COMET trial will be incorporated into the NDA submission. It is our long-term safety study. And then, the sub-studies of the COMET trial, which are measuring efficacy in these different patient populations, those data, we would also expect to be included in the NDA filing.
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3c07750dc91a869d51489fbe75c33492
Regarding the mechanics of how you are going to enroll the patients into the sub-studies, will you be enrolling additional patients into the COMET Phase 3 long-term safety study to enroll in one of these three studies -- sub-studies, or will you be selecting from those already enrolled in the long-term safety COMET Pha...
There will be enough subjects being enrolled in total because, as we disclosed, the number of subjects enrolled in the COMET study is above 800 patients. So, there certainly are enough subjects in that sub-study. So, the sub-studies are prospectively defined patient groups, and also efficacy data is being collected in ...
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d3e230a20d772e38cde572a64b9b14be
Regarding your Phase 2 MERIT study, which is a randomized withdrawal study, are you aware -- it's very interesting that you're taking this approach, which tends to have lower placebo effect, are you aware of any antidepressants approved on a randomized withdrawal study design?
Yes. The -- I mean, if you look at the FDA's [Indecipherable] data package, so one of the studies that work was a randomized withdrawal study design.
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A
77b37f1ea896bce063628a78d6307e2e
These sub-studies that you have coming out of the COMET trial, did that come from some FDA guidance from your pre-NDA meeting or is that sort of your own plan of building out more robust data package?
So I'll let Cedric speak to that. But, yeah, just to answer the first part of your question, that did not come from FDA guidance, and this is really us wanting to make sure that there is as much information as possible available to clinicians, given the new mechanism of action of the drug and we wanted to study it in a...
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9dca9ffe5b93c0357e10aef6c62e4a00
Could you maybe explain a little bit clinically what the differences between TRD and unresponsive MDD? Is that something that physicians will easily recognize, and how do we think about that in terms of treatment paradigm?
Yes. So, they are well recognized clinical populations. So, for unresponsive MDD, you're talking about a patient population who -- like the patients who continue to have depressive symptomatology despite treatment with one antidepressant. And then, for the treatment-resistant depression population, that is also widely ...
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A
00116ce53ab792736d7b6594516a66e8
Is there anything you can tell us about the MOVEMENT trial regarding persistence of patients on AXS-07?
So, with regards to the MOVEMENT study, we've had great patient retention, I think, better than expected. And obviously when we provide the results of that trial, we'll give you more details.
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3153b6ba22857378fe91bed81571cdfd
If you could provide a little more color in terms of what your thoughts -- current thoughts are in terms of the Phase 3 program in narcolepsy. You mentioned starting two trials. Do you expect to start, I guess, two studies simultaneously later this year?
Thank you, Matt, for the question. That is the plan. So, right now, we're planning to launch our Phase 3 program, and we'd like to do that in parallel as much as possible. We do anticipate that two Phase 3 studies would be needed. And by launching them in parallel or as close to in parallel as possible, that should acc...
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A
dbef1956e65f07dd0fb3b7d76b273c5b
Going back to the sub-studies, the COMET sub-studies, and the MERIT study, do you expect the results -- the efficacy results from those four studies to be included potentially in the label AXS-05 is approved for MDD?
So, to be clear, these studies are not studies that are being conducted to support specific labeling. However, the data will be included in our FDA package. And what's important too about what we're doing is the indication that we're filing the NDA for its MDD, which is very broad and the data that's been generated in ...
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865ae0f33937a7e51a167331e70251ea
Just firstly on MERIT again, just wondering what your definition of treatment response in that trial would be prior to randomization to the withdrawal portion of the study. I'm assuming it's a 50% improvement from baseline on the MADRS, but correct me if I'm wrong there, and what treatment time period would that be?
So, thanks, Myles, for the question. I'll lead off and see if Cedric has anything else that he'd like to add. So, in order to be randomized in the MERIT study, so patients have to have not a specific reduction, but they have to be in remission. So these are patients who we met, and so which is a very stringent definiti...
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e9365e19ff48b2376a3f1823db2da6fe
You mentioned in parallel the esketamine approval package, this is starting to look a lot like that SPRAVATO one. So just curious as to whether somewhere future down the track you're going to be running a study in the elderly. I ask it because of a pretty benign safety profile that you saw in the ADVANCE-1 study of Alz...
So, certainly one of the benefits of the ADVANCE trial in addition to demonstrating efficacy in Alzheimer's disease agitation is that it did provide us a very clear sense of the safety profile of AXS-05 in the elderly. So that's really helpful to us in thinking about additional potential future indications. And while t...
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c5aca7b408fc231988a2d7228039cd61
Just in terms of the patient population you're enrolling in MERIT, none of those have come from COMET, yes, these are newly treated patients, which MERIT -- it's not like you're trying to define remission out of COMET and then use those patients to be randomized into the withdrawal period of MERIT. These are two comple...
So they are two completely separate trials. But as you can imagine, in the COMET study, we have a lot of patients who are de novo, some of whom have TRD. And we would look to certainly leverage the recruitment effort as much as possible. So patients from COMET who may have TRD would definitely be included. And that's o...
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A
9e022d959d920a247fdce5095d91883d
Very quickly on esreboxetine. I was wondering if you could comment on what some scenarios might be regarding the scope of clinical development if the FDA might ask you to recapitulate a study or studies that have already been done or if there might be the possibility of you are having to look at completely different ki...
So, thank you, Ram, for the question. So, with regards to AXS-14, as you know, and as you pointed out, we do have positive results from two controlled trials, one of them is the Phase 3 trial, one of them is the Phase 2 trial. And so, the simple studies were conducted. We don't believe that the endpoints have changed m...
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4729ddc4b4dfef811fb82dcd7b04a215
On the COMET-SI trial, can you comment on whether this trial would, if positive, have any direct implications for the specific utilization of AXS-05 in suicidal depression, and if that's potentially specific indication that we could see included on the label? And if that's the case, would the COMET-SI study be sufficie...
So, thank you, Ram, for the question. So, the COMET-SI trial is hypothesis generating. And the reason why it's important is, one of the features of AXS-05 that we have seen is its rapid onset of action. So we've seen statistically significant separation from placebo as early as week one, and also at week two. As a remi...
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b15e7a3717955cceb1e4f2a97523f4a7
It was my understanding from going through the press release that the COMET-TRD and MERIT studies would be effectively the additional basis for supporting a filing in TRD and that COMET-AU would not expressly be taken into consideration in terms of the supporting evidence for AXS-05 in the TRD indication. Can you just ...
So, the studies -- these studies are to provide information that we think will be clinically relevant and useful for patients as well as physicians as we launch the product. And the data from these trials will certainly be included in our NDA filing. Just to be clear at the indication that we are filing for is MDD more...
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ec1215c8697975424429633ca14a2226
I have two questions or two topics. One is on DraftKings. Can you give us a little bit more color on the economics, timing of impact? And is it exclusive, meaning can you do other sports betting deals? And can they do other radio deals? And then just one on podcasting. With more players coming into the market, there's ...
Let me start with the second one, and I'll let Rich hit the first one on DraftKings. I think on podcasting, I think you saw, Jessica, in the numbers here that if you look at Podtrac, we're actually increasing our lead over the other podcast publishers. And if you look at the revenue, I think it's on Slide 8. If you loo...
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42d55c945e826e6a91506c6dec20f745
Maybe first just to talk about what you're seeing in the ad market, Bob, I think you're the first advertising company this quarter to say that what's going on in supply chain isn't really impacting the business. And I know you had AudioCon in Las Vegas recently. So maybe you can just talk about what you think is going ...
Sure. Well, look, I think certainly, there are some people that are being affected by it, but there are some people that are doing better at the same time, so it's sort of give and takes. But I think we also see is anytime somebody -- and what we're hearing is anytime somebody's got a temporary supply problem, but they...
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e444577751071ca1463f100eaa1902c8
Yes. And then maybe expanding on that, could you talk about what SmartAudio is running as a percentage of Multiplatform sales and maybe where you see that going over the next year or 2?
Well, we haven't given out the number, but obviously, we think that is going to continue to increase. We've built out the whole SmartAudio platform so that our broadcast radio can be bought and sold like digital can be built around the cohorts. And with the Triton marketplace, which we announced, which we're going to l...
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df9f175e6870a04974cfa1c036eae062
And maybe last one, kind of a housekeeping one. As we think about next year, any major changes on either cash interest, cash tax or capex we should be mindful of?
Well, we're going to see capital expenditures go down. I think we said this quarter, we spent approximately $50 million of capital expenditures, an increase from the mid-30s last year, and the major increase in that is due to our real estate, in terms of our downsizing of our real estate, just getting more efficient in...
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883c802870dc75a84a5c85ca8fb6830e
Just first one, we've talked about this 4x leverage target for a while, and you look to be getting there in the next quarter or two as long as -- at least on a forward-looking basis. I guess once you're there, talk about the priorities for free cash flow between paying a dividend, buying back shares, how you weigh that...
Well, I'm not -- this won't surprise you and really appreciate the question, but I'm not going to comment on anything specifically including your comment on when we're going to get to -- including your comment on when we're going to get to 4x. Again, all we've said is our target is to get to 4x leverage, and I think ev...
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c1c30a4faf454e8921df4009242ea922
Got you. I want to turn to another topic. Just the DraftKings deal here that you announced. Obviously, sports betting being such a big opportunity here for radio advertisers. I mean do you see either at the local or national level, maybe the calculation changing for how aggressive do you get in terms of going after the...
We're actually pretty aggressive. And actually, we have quite a number of major teams carried on our radio stations play-by-play. We have a number of big sports talk radio stations. We have a -- even have some specific sports betting stations, The Gambler is the name of them, where we run them. And then we are doing th...
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61d1f742ee81d15b5255acad61dbd674
So I wanted to drill into Rasmussen. It looks like nursing continues to grow high single-digits, but could you provide a bit of color on the pressures we're seeing on the non-nursing side and or the health sciences programs that are being less impacted than the other non-nursing like business[Phonetic]?
Hi, Jasper, it's Angie Selden. Thanks for the question. Let's talk a little bit about Rasmussen non-nursing. First, as I mentioned in the script, there has been a deliberate focus on investing in marketing to generate leads for nursing, given both the momentum and the shortage in the number of nurses in the public mark...
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832a1c77b06f8518f1b1a1a5e5c854d5
Selling expense came in a bit higher than we were expecting. Could you give any color on how your marketing yield has trended and are you seeing more competition there than normal?
Yeah. So Jasper, we are seeing successes. Harry Wilkins and his team have been working on the internal metrics related to conversions and retentions -- retention. So as we see improvements there at APUS, we see additional opportunities to invest. And then of course in the nursing businesses, Hondros and Rasmussen given...
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e4116da27fd813b5f609c59496f6906d
And then last question for me on Rasmussen and Hondros, what's been the experience with reopening campuses? And then, how much of that expense will be say is can party[Phonetic] in the third quarter results versus incremental costs you see coming back in the fourth quarter or over 2020, '22[Phonetic]?
I'll start, and then Rick I'll ask you throw some[Phonetic] details. We are -- we have been and continue to be fully open at Hondros and at Rasmussen. And the cost profile that you're seeing in the financials today will continue to be the cost profile in the coming quarters. Yeah, absolutely. And I would also add that...
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1b666a25bd59a3fb56f201131aa2f122
I wanted to shift the focus back to nursing. And some of the other companies in this space talked this quarter about the difference between some of the post-licensure programs and the pre-licensure programs specifically that they were seeing pressure on post-licensure enrollment as nurses decided to continue working be...
Yeah. Hi, Jeff. In our case, the vast, vast majority, upwards of 95% of the nursing enrollment across Rasmussen and Hondros is pre-licensure. And so, we haven't really experienced sort of that bifurcation of enrollment trends because the proposed licensure is relatively small component of our total nursing enrollment. ...
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bb3da59ac7eb5c855590a99c8d21e2c5
A few times, you talked about some changes in student behavioral trends. It doesn't sound like you're really seeing it on the nursing side, but it sounds like you're seeing it on the non-nursing side across your various programs. What changed over the past few[phonetic] months? This wasn't something that you discussed ...
Well, what I can share with you is that we are continuing to see increasing enrollment momentum in our returning students at APUS. In fact, we had one of our largest returning students single-day registrations in five years at APUS in the past several weeks. And we have worked tirelessly as we began discussing on the l...
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A
c0b8a067ac30ceb15cf429afc62b122f
Can we dig in a little bit into revisit the Army portal impact? I see the impact in the December quarter. Is this impact likely to persist through first calendar quarter? And any sort of remaining impact and if you could give more color on the percentage of the total Army enrollment that is being impacted, if you can u...
I'll start. I'm really pleased to say -- well, thanks, Raj, for the question. Great to speak with you. Rick and I had the privilege last week of speaking with the leadership team running ArmyIgnitED. We really believe that was a breakthrough because up until this point, we haven't had the opportunity to have a fulsome ...
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ecfd921bcef74828c756a7ffa10b57b0
So in terms of the registrations or enrollment of Army personnel year-on-year, where do we stand? Are we down 20%, down 5% and where -- and when do we expect to kind of come back to last year's levels?
Yeah. So it's really -- Raj, it's really stabilized. In the third quarter actual, I think the Army was down for the quarter roughly 3%. And so, you're really seeing a return to kind of the prior year normal. Right now, as you look at our guidance for the fourth quarter, Army is going to be flat to slightly up, right. S...
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68dc4ac67b5bcb7acb8fe804622eda4a
The LOC -- could you come back to the LOC on the Rasmussen with the amount again, and is there any impact as far as regulatory impact is concerned, or is it just it was what it was under the last ownership and now they will be assessed on the CDR under APEI and going forward, it should not be a problem, but you won't -...
Yeah. So Raj, you have it right. It's related to the composite score under the prior ownership, where Rasmussen fell just below the threshold of 1.5, prompting the Department of Ed to require them to post a letter of credit. The letter of credit is required to be posted at 105% of 10% of their Title IV disbursements. T...
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83a44b816f6d0e6706209164768484e7
With respect to Army Ignite, can you further expand on the progression of the portal since the last earnings call? It may also be helpful, if you could provide some details on the mix between exception to policy enrollments and tuition assistance approved enrollments and how that trended throughout the quarter? It soun...
Well, the portal officially went live on July 19. And in the early implementation period, there was a lot of learning that needed to go on with soldiers utilizing the system. And we were -- we play a role in helping soldiers learn how to use the new system. We have folks in the field that work with soldiers and ESOs. T...
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654a1860bbf2c6267bc8408746333301
And switching gears, I was wondering if you could provide some commentary on how cost per lead and conversion rates have trended during the quarter?
Matt, we don't actually provide that level of detail unfortunately, but thanks for the good questions.
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2247fbea6c6a2218283c37658c7e8fcb
Recently, you announced a partnership with California Community Colleges to help program [Indecipherable] pursue an online bachelor's degree through APUS. Any updates on that partnership and your expectations for it going forward.
We have a large number of California students that enroll in APUS degree programs today, largely affiliated with military bases in the State of California. And we believe that the two-plus-two partnership that we've created for many community colleges around the country would certainly make a lot of sense with the 115-...
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2bb18f0df07be62b7e94bd092dafc9b0
So first, I just wanted to sort of start off high level and just talk about how you're seeing the landscape for investment opportunities in M&A. Obviously, things are different from the plans that you had when you started the year. So I just wanted to see how you're assessing the landscape and which of your segments mi...
Yes, so I think -- well, I'll start in our investment segment. I think we're -- we have a really large cash balance down at our investment segment. And so as a result of some recently closed M&A transactions that have us on the lookout for potential new activist investments. And we're also finding some stuff at the inv...
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41e39be3683ab9e526487b4b884303c3
OK. And then on the automotive segment obviously, you pivoted pretty quickly and you were able to cut costs. But I'm just curious when the environment improves, will there be any onetime costs or just kind of any ramifications from what you've done in the past couple of months to limit costs? Just curious on how quickl...
Yeah, sure. I think -- I don't anticipate any material onetime costs in ramping back up. I think frankly, the unfortunate pandemic has really forced companies to operate on a more lean basis and increase productivity. And our management team at Icahn automotive group on both sides of the business, but particularly the ...
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1e226b4ebc54c191c5d042cb67f89eaa
OK, thanks. And then lastly for me, on the real estate segment. I think this is an area where a lot of people think there could be some more permanent evolutions resulting from the pandemic. So I'm just curious on what your thoughts are there and how you view your capacity in your commercial real estate portfolio.
Yeah. So I mean, our commercial real estate portfolio at this point is pretty small. Basically, we have -- the most material asset we have is a 30-story building in Atlanta. That is -- the tenant who has left, but their leases continues to pay until 2021. We are currently redesigning that -- that was a single-tenant bu...
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d61551915797e77a1f1fec5da57f9cd8
A couple of questions. Maybe for Patrick and Tom. Starting off on the local side. First, on political. Is there any way-obviously presidential is not huge for you guys as part of your footprint but is there any way to quantify the impact the Bloomberg is having and what kind of variability there is in terms of your pol...
Thanks, Dan. Good morning. I would say that on the political side, we booked $7 million in the first half of fiscal '20. And that's double the comparable quarter from '16. So I think things that shows the variability as positive. Bloomberg is certainly having an impact across most of our footprint. As you mentioned pre...
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dfd444d040f7f65e6bee23cf7e5189c1
And then on the national side, just -- Tom with the -- you talked about portfolio rationalization for a while now, you're obviously-I think it's-you probably pulled off maybe a point and a half a margin upside in the quarter. I'm just curious if you can kind of outlay sort of your thoughts on the delta here or at least...
Yeah, I think, Dan, I think it's a difficult question to kind of break out all the detail of the margin game, but it's a combination of a lot of different things right. So, there's some-actually there's some great mix changes on our digital business where we're starting to see that video investment kick in and video CP...
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d2286dc59c6e8979939ae24c8702fd4b
How should we phase that 30% renewal over the two quarters in the second half of '20?
The 30% is at AT&T, Kyle and that is going to be in the fourth quarter. I think it's in May. It is in May.
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1e29fae948b957f9302f951a883f8d15
OK. I'm hearing kind of growing excitement around the friction that's coming out of national core through some industry efforts. Is that -- is it possible that that piece of the business, which is kind of been a drag for several years now on core, that that could turn into growth going forward, and then I've got anothe...
Yeah. It could. If you look at the second quarter, our national advertising was up eight. So I think we're seeing positive pace for this quarter in national as well. So it's nice to see it come back. I'm not going to get the firm on it, but we're cautiously optimistic that it will continue. And we're currently pacing K...
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d456b7ed5c889c31cf8778d77fd6769c
Gotcha, Patrick. Well, I've got you. Kind of an updated contribution number for auto and maybe not necessarily like a pacing for three 3Q, but you can give me that if you like, but kind of a longer-term view maybe at 12 to 24-month view on your market?
Yeah, I mean, in second quarter, automotive was down eight. And I think that's the trend that we've seen for the last six or so quarters. We don't look for that to reverse anytime soon. If you look at automotive sales numbers, they've been about 17 million flat for the last three years. In Q3, it's a little bit better....
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b6933d1813053298b3d076384de74abc
Great. Moving on to the NMG piece of the business. I'm trying to reconcile the readership up 4% with the consumer down 10%. And I know we've talked a little bit in the past about some potential subscriber issues in the time base, maybe just help reconciling those two numbers and an update on the progress you're making ...
Yeah, so audience number, the syndicated audience number that's in the print world, it's called MRI. It's kind of like Nielsen television ratings. So that's a syndicated audience. They go out, they measure brands, they have a panel of people that they go out, and they ask if you're reading the readership, you have pass...
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4596ca5689556f7ada83bb2611adc5fb
Got it. Lastly on an NMG maybe just a quick update on where you are in terms of allocating the 50 million in strategic investments, any kind of early returns you're seeing there. And then thank you for the impressions and the revenue growth on video, could you size that for us and kind of squint and look into the futur...
Yeah. I think I know, the video example that I gave was, listen, a big part of what we said from the beginning was that we're going to be investing in video and more video content. And as I said, it's great to see, you know roughly 30% growth in the first half of the fiscal year. You want to make sure that you're doing...
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B
2d71bed7ae387d4a11971e93a0acd44b
Good morning, everyone. Thanks for taking the questions. Just a couple for me, first what is your leverage at quarter and if you could talk about forward-looking leverage given the political inflow we should see later this year?
Hey, Davis, it's Joe. Our leverage at the end of December I believe was around three and a half times. As we look to the end of the year at June 30th, we expect that to be down about three-two.
direct
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A
e5d5f7cbfcd6a1811e497ab2cd91bd52
And would you expect and -- you don't have to give a number, but would you expect that number to migrate lower I guess with political dollars for the calendar year 2020 as well?
Yes, for sure. The focus is continuing to pay down debt. And with political coming in and the first half of 2021 we'll continue to aggressively pay down debt. And, we will expect in 2021 with political, that would help the EBITDA side of the equation as well.
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A
cc4df0746f1583f004019294c760e0e1
Got it. OK. And then second question from me is, now that the time integration is largely through as you said. How do you think about visibility for that segment going forward? I know you've already talked a bit about a lot of the investments you're making in video but do you think the visibility piece will improve in ...
Well, I think as we work through these changes I mean, the first year we had a lot of these brands that we were treating as held-for-sale that have sold and that really affected the visibility, over the last year. Now with the portfolio changes again, which was part of the plan, that is affecting the visibility. As we ...
intermediate
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B
4822863f0857cce5a0cf8b7fffe742a0
Just want to start with your comments on the shutdown of the Malaysian facilities. Could you quantify the revenue impact that had in Q1?
Yes. We -- the team did an amazing job, Jaeson. We did have a significant enough impact from COVID that we ended up really halting operations for about 10 days in two of our facilities there. But the team, by working weekends and overtime, did a really quite amazing job in recovering in the quarter. So I would say, rea...
intermediate
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B
ce4cc0e74e1abb522cf3e6cb2aa57026
I know Q1 is always a bit different because of Chinese New Year. And obviously, the macro remains a bit fluid. But could you just discuss how order patterns and bookings trended in Q1.
I mean I think it was not all that different than what we've seen in prior quarters. Because like you said, there are some things that are different in Q1 as we started the New Year. We don't always experience a ton of seasonality. But I think as the quarter progressed, we certainly have seen customers come in and star...
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A
ca1c6553da8450e8677b0c1983f249df
So if you could just elaborate a little bit on the supply chain challenges you have, what kind of visibility do you have there for the rest of the quarter? And you also said it puts a little bit of limitations on any upside demand within the quarter. Is there any way you can navigate that in the coming quarters?
Yes. Anja, this is Roop. I'll maybe start with a couple of comments. I think to your last question, first, can we navigate it? I think we have the ability to navigate it. With that said, I mean, it is a constrained market. It's not just semiconductors. It really cuts across all commodities. But our teams are working ha...
intermediate
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B
a52d1f0807a59b3f23057c3169858edc
So, hopefully, since you're part of the solution, you will be prioritized in the line for components. But in terms of the visibility though for the quarter and the guidance, that supply -- the supply need is accounted for, right? So there's no risk to your guidance. It's just in case there is any upside demand would --...
Yes, that's what I was trying to reiterate was the fact that our guidance actually takes into account our line of sight to supply, barring anything that comes up unexpectedly. But we obviously do a lot of work to align what source of supply. We just -- the reason that we're sharing that -- demand is very strong, and we...
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A
83c13866d8c8e9735f73440be0bd21f1
And in terms of the end markets, you talked about the elective medical coming back. What do you see there? How is that trending?
Well, we kind of -- we've watched what others have said in the space, too. We have seen that our Medical kind of in the first half has been flatter. I mean, we had a lot of growth last year. But we do see signals of the elective surgery demand picking up. We also participate quite a bit in cardiac products and diagnost...
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A