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906709_15_item7_p15_s0
906709_14_item7_p21_s1
Product sales increased during the year ended December 31, 2012 compared to the year ended December 31, 2011 as a result of increased product demand from a number of our collaboration partners.
Product sales decreased for the year ended December 31, 2014 compared to the year ended December 31, 2013 primarily as a result of decreased product demand from a number of our collaboration partners.
2
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[]
[ "decreased", "2013", "primarily", "decreased" ]
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906709_15_item7_p32_s6
906709_14_item7_p22_s6
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
2
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[]
[ "CIMZIA", "MIRCERA", "royalties", "remitted", "directly", "purchaser" ]
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906709_15_item7_p22_s4
906709_14_item7_p28_s2
Research and development expense increased during the year ended December 31, 2013 compared to the year ended December 31, 2012 primarily due to the etirinotecan pegol (NKTR-102) Phase 3 BEACON clinical study initiated in December 2011 as well as the NKTR-181 Phase 2 clinical study initiated in July 2012.
Research and development expense increased during the year ended December 31, 2013 compared to the year ended December 31, 2012 primarily due to the Phase 3 BEACON clinical study initiated in December 2011, the NKTR-181 Phase 2 clinical study initiated in July 2012 and the $11.3 million settlement charge recorded in 20...
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[]
[ "11.3", "million", "settlement", "charge", "recorded", "noted" ]
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906709_15_item7_p26_s11
906709_14_item7_p31_s11
We do not expect to have any significant future research and development costs associated with naloxegol or the naloxegol fixed-dose combination products as AstraZeneca is responsible for all further development and commercialization costs for these drug candidates.
We do not expect to have any significant future research and development costs associated with MOVANTIK or the MOVANTIK fixed-dose combination products as AstraZeneca is responsible for all further development and commercialization costs for these drug candidates.
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[ "MOVANTIK", "MOVANTIK" ]
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906709_15_item7_p28_s1
906709_14_item7_p33_s1
Furthermore, our strategy includes the potential of entering into collaborations with third parties to participate in the development and commercialization of some of our drug candidates such as those collaborations that we have already completed for naloxegol and Amikacin Inhale.
Furthermore, our strategy includes the potential of entering into collaborations with third parties to participate in the development and commercialization of some of our drug candidates such as those collaborations that we have already completed for MOVANTIK TM and Amikacin Inhale.
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[ "MOVANTIK", "TM" ]
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906709_15_item7_p17_s3
906709_14_item7_p37_s6
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
2
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[]
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906709_15_item7_p32_s8
906709_14_item7_p37_s8
There are a number of factors that could materially affect the estimated interest rate and we will assess this estimate on a periodic basis.
There are a number of factors that could materially affect the estimated interest rate, in particular, the amount and timing of royalty payments from future net sales of CIMZIA and MIRCERA , and we will assess this estimate on a periodic basis.
2
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906709_15_item7_p13_s0
906709_14_item7_p39_s2
The indebtedness includes $125.0 million in aggregate principal amount of 12.0% senior secured notes due July 15, 2017, but excludes our long-term liability relating to the sale of future royalties.
12.0% senior secured notes due July 15, 2017, but excludes our long-term liability relating to the sale of future royalties under the Purchase and Sale Agreement with RPI Finance Trust.
2
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[]
[ "Purchase", "Sale", "Agreement", "RPI", "Finance", "Trust" ]
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906709_15_item7_p12_s2
906709_14_item7_p39_s6
As of December 31, 2013, we estimated that we had at least twelve months of working capital to fund our current business plans.
Key Developments and Trends in Liquidity and Capital Resources As of December 31, 2014, we estimated that we had at least twelve months of working capital to fund our current business plans.
2
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906709_15_item7_p33_s9
906709_14_item7_p40_s3
Our current business plan is also subject to significant uncertainties and risks as a result of, among other factors, expenses being higher than anticipated, unplanned expenses, cash receipts being lower than anticipated, and the need to satisfy contingent liabilities, including litigation matters and indemnification o...
Our current business plan is also subject to significant uncertainties and risks as a result of, among other factors, the sales levels of products for which we are entitled to royalties such as MOVANTIK , clinical program outcomes, whether, when and on what terms we are able to enter into new collaboration transactions...
2
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906709_15_item7_p35_s2
906709_14_item7_p41_s1
We expect that cash flows used in operating activities, excluding upfront and milestone payments received, if any, will increase in 2014 as a result of increased spending on our proprietary research and development programs.
We expect that cash flows used in operating activities, excluding upfront and milestone payments received, if any, will increase in 2015 as a result of increased spending on our proprietary research and development programs, including the initiation of the Phase 3 clinical program for NKTR-181.
2
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906709_15_item7_p32_s5
906709_14_item7_p42_s3
Cash flows used in financing activities On February 24, 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA in exchange for $124.0 million.
On February 24, 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA in exchange for $124.0 million.
2
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[ "Cash", "flows", "used", "in", "financing", "activities", "On", "February", "24", ",", "2012", ",", "we", "sold", "all", "of", "our", "rights", "to", "receive", "future", "royalty", "payments", "on", "CIMZIA", "and", "MIRCERA", "in", "exchange", "for", "$"...
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[]
[]
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906709_15_item7_p36_s0
906709_14_item7_p42_s3
Cash flows used in financing activities On February 24, 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA in exchange for $124.0 million.
On February 24, 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA in exchange for $124.0 million.
2
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[ "Cash", "flows", "used", "in", "financing", "activities", "On", "February", "24", ",", "2012", ",", "we", "sold", "all", "of", "our", "rights", "to", "receive", "future", "royalty", "payments", "on", "CIMZIA", "and", "MIRCERA", "in", "exchange", "for", "$"...
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[]
[]
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906709_15_item7_p39_s3
906709_14_item7_p45_s4
The sublease is discussed in Note 6 of Item 8.
This is further discussed in Note 6 of Item 8.
2
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[ "The", "sublease", "is", "discussed", "in", "Note", "6", "of", "Item", "8", "." ]
[ "This", "is", "further", "discussed", "in", "Note", "6", "of", "Item", "8", "." ]
[]
[]
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906709_15_item7_p38_s2
906709_14_item7_p46_s3
This is further discussed in Note 6 of Item 8.
The sublease is discussed in Note 6 of Item 8.
2
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[]
[ "sublease" ]
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906709_15_item7_p17_s2
906709_14_item7_p62_s0
In February 2012, we sold all of our rights to receive future royalty payments from sales of the CIMZIA and MIRCERA drug products marketed by UCB and Roche, respectively.
In February 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA .
2
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[]
[]
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906709_15_item7_p57_s1
906709_14_item7_p63_s1
Such factors include, but are not limited to, changing standards of care, the introduction of competing products, manufacturing or other delays, biosimilar competition, intellectual property matters, adverse events that result in health authority imposed restrictions on the use of the drug products, and other events or...
Such factors include, but are not limited to, changing standards of care, the introduction of competing products, manufacturing or other delays, biosimilar competition, intellectual property matters, adverse events that result in health authority imposed restrictions on the use of the drug products, significant changes...
2
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[]
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906709_15_item7_p7_s1
906709_14_item7_p9_s1
The molecule has been designed to have a slow rate of entry into the brain, which is expected to reduce the attractiveness of the molecule as a target of abuse and reduce other serious central nervous system-related side effects, such as sedation and respiratory depression, which are commonly associated with standard o...
NKTR-181 has been designed to have a slow rate of entry into the brain, which is expected to reduce the attractiveness of the molecule as a target of abuse and reduce other serious central nervous system-related side effects, such as sedation and respiratory depression, which are commonly associated with standard opioi...
2
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[]
[ "NKTR-181" ]
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906709_16_item7_p37_s0
906709_15_item7_p12_s2
Key Developments and Trends in Liquidity and Capital Resources As of December 31, 2014, we estimated that we had at least twelve months of working capital to fund our current business plans.
As of December 31, 2015, we estimated that we had at least twelve months of working capital to f und our current business plans.
2
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[]
[ "f", "und" ]
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906709_16_item7_p34_s1
906709_15_item7_p17_s3
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
2
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[]
[ "CIMZIA", "MIRCERA", "royalties", "remitted", "directly", "purchaser" ]
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906709_16_item7_p16_s5
906709_15_item7_p17_s9
In addition, we recognized $8.0 million of milestones received in December 2014 related to positive results from Baxter s BAX 855 Phase 3 study.
In addition, in 2014, we recognized $8.0 million of milestones received in December 2014 related to positive results from Baxalta s ADYNOVATE TM Phase 3 study.
2
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[]
[ "Baxalta", "ADYNOVATE", "TM" ]
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906709_16_item7_p19_s0
906709_15_item7_p20_s0
The increase in revenue attributable to European countries for the year ended December 31, 2014 compared to the year ended December 31, 2013 is primarily attributable to increased milestone and royalty revenues from our existing European based collaboration partners, including the recognition of the $105.0 million mile...
The increase in revenue attributable to European countries for the year ended December 31, 2015 compared to the year ended December 31, 2014 is primarily attributable to increased milestone and other contingent payments from our existing European based collaboration partners, including the recognition of a total of $14...
2
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[]
[ "contingent", "total", "140.0", "connection", "commercial", "launches", "MOVANTIK", "TM" ]
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906709_16_item7_p19_s1
906709_15_item7_p20_s0
The increase in revenue attributable to European countries for the year ended December 31, 2014 compared to the year ended December 31, 2013 is primarily attributable to increased milestone and royalty revenues from our existing European based collaboration partners, including the recognition of the $105.0 million mile...
The increase in revenue attributable to European countries for the year ended December 31, 2014 compared to the year ended December 31, 2013 is also primarily attributable to increased milestone and other contingent payments from our existing European based collaboration partners, including the recognition of a total o...
2
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[]
[ "also", "contingent", "total", "connection", "FDA", "approval", "MOVANTIK", "TM" ]
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906709_16_item7_p21_s3
906709_15_item7_p22_s2
Research and development expense decreased during the year ended December 31, 2014 compared to the year ended December 31, 2013 primarily due to reduced activities on our ongoing Phase 3 BEACON study for etirinotecan pegol as the study progresses toward completion as well as the completion of our Phase 2 clinical study...
Research and development expense decreased during the year ended December 31, 2014 compared to the year ended December 31, 2013 primarily due to reduced activities on our Phase 3 BEACON study for NKTR-102 as the study progressed toward completion as well as the completion of our Phase 2 clinical study for NKTR-181 in t...
2
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[]
[ "NKTR-102", "progressed" ]
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906709_16_item7_p25_s3
906709_15_item7_p26_s5
We estimate that the total third party and direct material costs over the life of the BEACON study will be approximately $85.0 million, of which $72.7 million was incurred through the end of 2014.
We currently estimate that the total third party and direct material costs over the life of our NKTR-181 Phase 3 program will be approximately $130.0 million, of which $40.3 million was incurred through the end of 2015.
2
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[]
[ "currently", "NKTR-181", "Phase", "3", "program", "130.0", "40.3" ]
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906709_16_item7_p2_s3
906709_15_item7_p2_s3
MOVANTIK is an oral peripherally-acting opioid antagonist, for the treatment of opioid-induced constipation, or OIC, a side effect caused by chronic administration of prescription opioid pain medicines.
MOVANTIK TM is an oral peripherally-acting opioid antagonist, for the treatment of opioid-induced constipation, or OIC, a side effect caused by chronic administration of prescription opioid pain medicines.
2
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[]
[ "TM" ]
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906709_16_item7_p15_s5
906709_15_item7_p32_s6
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
2
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[]
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906709_16_item7_p11_s0
906709_15_item7_p33_s4
As of December 31, 2014, we estimated that we had at least twelve months of working capital to fund our current business plans.
Key Developments and Trends in Liquidity and Capital Resources As of December 31, 2015, we estimated that we had at least twelve months of working capital to fund our current business plans.
2
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[ "Key", "Developments", "Trends", "Liquidity", "Capital", "Resources" ]
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906709_16_item7_p37_s0
906709_15_item7_p33_s4
As of December 31, 2014, we estimated that we had at least twelve months of working capital to fund our current business plans.
As of December 31, 2015, we estimated that we had at least twelve months of working capital to f und our current business plans.
2
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[]
[ "f", "und" ]
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906709_16_item7_p43_s4
906709_15_item7_p38_s2
The sublease is discussed in Note 6 of Item 8.
This is further discussed in Note 6 of Item 8.
2
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[]
[]
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906709_16_item7_p42_s2
906709_15_item7_p39_s3
This is further discussed in Note 6 of Item 8.
The sublease is discussed in Note 6 of Item 8.
2
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[]
[ "sublease" ]
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906709_16_item7_p15_s4
906709_15_item7_p56_s0
In February 2012, we sold all of our rights to receive future royalty payments from sales of the CIMZIA and MIRCERA drug products marketed by UCB and Roche, respectively.
In February 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA .
2
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[]
[]
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906709_16_item7_p60_s0
906709_15_item7_p58_s0
In May 2014, the Financial Accounting Standards Board (FASB) issued guidance codified in ASC 606, Revenue Recognition Revenue from Contracts with Customers , which amends the guidance in former ASC 605, Revenue Recognition, and is effective for public companies for fiscal years beginning after December 15, 2016.
Recent Accounting Pronouncemen ts In May 2014, the Financial Accounting Standards Board (FASB) issued guidance codified in Accounting Standards Codification (ASC) 606, Revenue Recognition Revenue from Contracts with Customers , which amends the guidance in former ASC 605, Revenue Recognition , and is effective for publ...
2
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906709_16_item7_p5_s2
906709_15_item7_p8_s9
In this first efficacy study, we plan to enroll approximately 416 patients in an enriched enrollment randomized withdrawal design which will include a qualifying screening period, an open-label titration period where NKTR-181 is given to all patients, followed by a 12 week double-blind randomized period where subjects ...
In this study, we are randomizing patients with chronic low back pain in an enriched enrollment randomized withdrawal design which will include a qualifying screening period, an open-label titration period where NKTR-181 is given to all patients, followed by a 12 week double-blind randomized period where subjects will ...
2
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[]
[ "randomizing", "chronic", "low", "back", "pain" ]
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906709_16_item7_p3_s0
906709_15_item7_p9_s1
We have a collaboration with Baxter Healthcare (Baxter), to identify and develop PEGylated drug candidates with the objective of providing new long-acting therapies for hemophilia patients.
We have a collaboration with Baxalta to identify and develop PEGylated drug candidates with the objective of providing new long-acting therapies for hemophilia patients.
2
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[]
[ "Baxalta" ]
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906709_17_item7_p0_s3
906709_16_item7_p0_s0
We are a biopharmaceutical company developing a pipeline of drug candidates that utilize our PEGylation and advanced polymer conjugate technology platforms, which are designed to enable the development of new molecular entities that target known mechanisms of action.
These drug candidates utilize our advanced polymer conjugate technology platforms, which are designed to enable the development of new molecular entities that target known mechanisms of action.
2
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[]
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906709_17_item7_p2_s0
906709_16_item7_p10_s0
Historically, we have entered into a number of license and supply contracts under which we manufactured and supplied our proprietary PEGylation reagents on a fixed price or cost-plus basis.
Historically, we have entered into a number of license and supply contracts under which we manufactured and supplied our proprietary polymer reagents on a fixed price or cost-plus basis.
2
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[]
[ "polymer" ]
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906709_17_item7_p2_s1
906709_16_item7_p10_s1
Our current strategy is to manufacture and supply PEGylation reagents to support our proprietary drug candidates or our third-party collaborators where we have a strategic development and commercialization relationship or where we derive substantial economic benefit.
Our current strategy is to manufacture and supply polymer reagents to support our proprietary drug candidates or our third-party collaborators where we have a strategic development and commercialization relationship or where we derive substantial economic benefit.
2
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906709_17_item7_p7_s1
906709_16_item7_p15_s1
Royalty revenue received in cash increased for the year ended December 31, 2015 compared to the year ended December 31, 2014 due primarily to the launch of commercial sales by AstraZeneca of MOVANTIK TM in March 2015 and MOVENTIG in the EU in August 2015.
Royalty revenue received in cash increased for the years ended December 31, 2016 and 2015 compared to the years ended December 31, 2015 and 2014 due primarily to the commercial launch by AstraZeneca of MOVANTIK in the U.S. in March 2015 and MOVENTIG in the EU in August 2015 and the launch of ADYNOVATE by Baxalta in the...
2
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906709_17_item7_p27_s1
906709_16_item7_p15_s5
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
2
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906709_17_item7_p11_s0
906709_16_item7_p19_s0
The increase in revenue attributable to European countries for the year ended December 31, 2015 compared to the year ended December 31, 2014 is primarily attributable to increased milestone and other contingent payments from our existing European based collaboration partners, including the recognition of a total of $14...
The decrease in revenue attributable to European countries for the year ended December 31, 2016 compared to the year ended December 31, 2015 is primarily attributable to decreased milestone and other contingent payments from our existing European based collaboration partners, including the recognition in 2015 of a tota...
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906709_17_item7_p11_s0
906709_16_item7_p19_s1
The increase in revenue attributable to European countries for the year ended December 31, 2014 compared to the year ended December 31, 2013 is also primarily attributable to increased milestone and other contingent payments from our existing European based collaboration partners, including the recognition of a total o...
The decrease in revenue attributable to European countries for the year ended December 31, 2016 compared to the year ended December 31, 2015 is primarily attributable to decreased milestone and other contingent payments from our existing European based collaboration partners, including the recognition in 2015 of a tota...
2
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[]
[ "decrease", "decreased", "140.0", "commercial", "launches" ]
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906709_17_item7_p19_s9
906709_16_item7_p26_s0
Our discovery research organization is identifying new drug candidates by applying our PEGylation technology platform to a wide range of molecule classes, including small molecules and large proteins, peptides and antibodies, across multiple therapeutic areas.
Our discovery research organization is identifying new drug candidates by applying our polymer conjugation technology platform to a wide range of molecule classes, including small molecules and large proteins, peptides and antibodies, across multiple therapeutic areas.
2
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[ "polymer", "conjugation" ]
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906709_17_item7_p25_s1
906709_16_item7_p33_s0
Interest expense for the year ended December 31, 2014 decreased marginally as compared to the year ended December 31, 2013.
Interest expense for the year ended December 31, 2015 increased marginally compared to the year ended December 31, 2014.
2
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906709_17_item7_p7_s4
906709_16_item7_p34_s1
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
2
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[]
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906709_17_item7_p29_s8
906709_16_item7_p37_s4
In the future , we expect to receive royalties from commercial sales of products such as MOVANTIK TM and ADYNOVATE TM and potential substantial payments from future collaboration transactions if drug candidates in our pi peline achieve positive clinical or regulatory outcomes.
In the future, we expect to continue to receive increasing royalties from commercial sales of products such as MOVANTIK , MOVENTIG and ADYNOVATE as they continue to increase sales after their recent product launches and potential substantial payments from future collaboration transactions if drug candidates in our pipe...
2
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906709_17_item7_p30_s1
906709_16_item7_p38_s11
We expect that cash flows used in operating activities, excluding upfront, milestone and other contingent payments received, if any, will decrease in 2016 compared to 2015 primarily as a result of increased cash receipts from product sales and royalties.
We expect that cash flows used in operating activities, excluding upfront, milestone and other contingent payments received, if any, will increase in the full year of 2017 compared to 2016 primarily as a result of increased research and development expenses.
2
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906709_17_item7_p31_s2
906709_16_item7_p39_s0
Ca sh flows used in financing activities On October 5, 2015, we issued $250.0 million in aggregate principal amount of 7.75% senior secured notes due 2020 ( Notes ).
On October 5, 2015, we issued $250.0 million in aggregate principal amount of 7.75% senior secured notes due 2020.
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[]
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906709_17_item7_p25_s3
906709_16_item7_p39_s2
Interest is calculated based on actual days outstanding over a 360 day year.
Interest on the 7.75% senior secured notes is calculated based on actual days outstanding over a 360 day year.
2
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[]
[ "7.75", "senior", "secured", "notes" ]
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906709_17_item7_p34_s2
906709_16_item7_p43_s4
This is further discussed in Note 6 of Item 8.
The sublease is discussed in Note 6 of Item 8.
2
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[]
[ "sublease" ]
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906709_17_item7_p47_s0
906709_16_item7_p55_s0
Stock-Based Compensation We use the Black-Scholes option pricing model for each respective grant to determine the estimated fair value of stock options on the date of grant (grant date fair value) and common stock purchased under our Employee Stock Purchase Plan (ESPP).
Stock-Based Compensation We use the Black-Scholes option pricing model for each respective grant to determine the estimated fair value of stock options on the date of grant (grant date fair value).
2
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[]
[]
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906709_17_item7_p7_s3
906709_16_item7_p58_s0
In February 2012, we sold all of our rights to receive future royalty payments from sales of the CIMZIA and MIRCERA drug products marketed by UCB and Roche, respectively.
In February 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA .
2
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[]
[]
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906709_17_item7_p51_s2
906709_16_item7_p58_s3
Our estimate of the interest rate under the agreement is based on the amount of royalty payments to be received by RPI over the life of the arrangement and payments we are required to make to RPI under the agreement.
Our estimate of the interest rate under the agreement is based on the amount of royalty payments to be received by RPI over the life of the arrangem ent and payments we are required to make to RPI under the agreement.
2
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[]
[ "arrangem", "ent" ]
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906709_17_item7_p52_s3
906709_16_item7_p59_s3
If we had determined that the interest rate used in 2015 should have been one percentage point higher than our current estimate of 17%, the non-cash interest expense recognized in the year ended December 31, 2015 would have increased by $1.3 million.
If we had determined that the interest rate used in 2016 should have been one percentage point higher than our current estimate of 17%, the non-cash interest expense recognized in the year ended December 3 1, 2016 would have increased by $1.2 million.
2
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[]
[ "3", "1", "1.2" ]
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906709_17_item7_p0_s24
906709_16_item7_p9_s24
While the approved drugs and clinical development programs described above are key elements of our future success, we believe it is critically important that we continue to make substantial investments in our earlier-stage drug candidate pipeline.
For a discussion of these and some of the other risks and uncertainties affecting our business, see Item 1A "Risk Factors" of this Annual Report on Form 10-K. While the approved drugs and clinical development programs described above are key elements of our future success, we believe it is critically important that we ...
2
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906709_17_item7_p0_s26
906709_16_item7_p9_s26
We are also advancing several other drug candidates in preclinical development in the areas of cancer immunotherapy, pain and other therapeutic indications.
We are also advancing several other drug candidates in preclinical development in the areas of cancer immunotherapy, immunology, and other therapeutic indications.
2
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[]
[ "immunology" ]
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906709_18_item7_p23_s7
906709_17_item7_p13_s4
This increased margin is partially offset by a manufacturing arrangement with another partner that includes a fixed price which is less than the fully burdened manufacturing cost for the reagent and we expect this situation to continue with this partner in future years.
In particular, we have a manufacturing arrangement with a partner that includes a fixed price which is less than the fully burdened manufacturing cost for the reagent, and we expect this situation to continue with this partner in future years.
2
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[]
[ "particular" ]
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906709_18_item7_p24_s3
906709_17_item7_p14_s3
We currently expect product gross margin to decrease significantly in 2017 as compared to 2016 and gross margin may approximate breakeven in 2017 as a result of the anticipated decrease in product sales from our collaboration partner Ophthotech as described above.
We currently expect product gross margin to decrease in 2018 as compared to 2017 and gross margin may be negative in 2018 as a result of the anticipated decrease in product sales described above.
2
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[]
[ "negative" ]
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906709_18_item7_p26_s0
906709_17_item7_p15_s2
Research and development expense increased during the year ended December 31, 2016 compared to the year ended December 31, 2015 primarily due to costs incurred in our NKTR-214 clinical and NKTR-358 pre-clinical programs as well as increased headcount costs, partially offset by a decrease to our ONZEALD TM program costs...
expense increased during the year ended December 31, 2016 compared to the year ended December 31, 2015 p rimarily due to costs incurred in our NKTR-214 clinical and NKTR-358 pre-clinical programs as well as increased headcount costs, partially offset by a decrease in our ONZEALD TM program costs.
2
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[]
[ "p", "rimarily" ]
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906709_18_item7_p30_s6
906709_17_item7_p19_s3
The timing and amount of our future clinical investments in NKTR-214 and NKTR-358 will vary significantly based upon our evaluation of ongoing clinical results and the structure, timing, and scope of potential collaboration partnerships (if any) for these programs.
The timing and amount of our future clinical investments will vary significantly based upon our evaluation of ongoing clinical results and the structure, timing, and scope of potential collaboration partnerships (if any) for these programs.
2
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[]
[]
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906709_18_item7_p30_s7
906709_17_item7_p19_s4
If our NKTR-181 Phase 3 efficacy study results are positive, we plan to pursue a collaboration to secure a development and commercialization partner to fund further development for NKTR-181 through direct program funding, up-front payments, milestones, or a combination thereof.
We plan to file an NDA for NKTR-181 in the first half of 2018 and plan to pursue a collaboration to secure a development and commercialization partner to fund further development for NKTR-181 through direct program funding, up-front payments, milestones, or a combination thereof.
2
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[]
[ "file", "NDA", "first", "half", "2018" ]
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906709_18_item7_p31_s2
906709_17_item7_p20_s2
The cost and time required to complete clinical trials may vary significantly over the life of a clinical development program as a result of a variety of factors, including but not limited to:
The cost and time required to complete clinical trials may vary significantly over the life of a clinical development prog ram as a result of a variety of factors, including but not limited to:
2
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[]
[ "prog", "ram" ]
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906709_18_item7_p33_s0
906709_17_item7_p22_s0
Furthermore, our strategy includes the potential of entering into collaborations with third parties to participate in the development and commercialization of some of our drug candidates such as those collaborations that we have already completed for MOVANTIK and Amikacin Inhale.
Furthermore, our strategy includes the potential of entering into collaborations with third parties to participate in the development and commercialization of some of our drug candidates such as those collaborations that we have already completed for NKTR-214 and MOVANTIK .
2
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[ "NKTR-214" ]
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906709_18_item7_p18_s1
906709_17_item7_p27_s1
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
2
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906709_18_item7_p39_s8
906709_17_item7_p29_s8
In the future, we expect to continue to receive increasing royalties from commercial sales of products such as MOVANTIK , MOVENTIG and ADYNOVATE as they continue to increase sales after their recent product launches and potential substantial payments from future collaboration transactions if drug candidates in our pipe...
In the future, we expect to receive increasing royalties from commercial sales of products such as MOVANTIK , MOVENTIG and ADYNOVATE as they continue to increase sales.
2
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906709_18_item7_p40_s0
906709_17_item7_p29_s9
Our current business plan is also subject to significant uncertainties and risks as a result of, among other factors, the sales levels of products for which we are entitled to royalties such as MOVANTIK , MOVENTIG and ADYNOVATE , clinical program outcomes, whether, when and on what terms we are able to enter into new c...
ADYNOVATE , clinical program outcomes, whether, when and on what terms we are able to enter into new collaboration transactions, expenses being higher than anticipated, unplanned expenses, cash receipts being lower than anticipated, and th e need to satisfy contingent liabilities, including litigation matters and indem...
2
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906709_18_item7_p45_s1
906709_17_item7_p34_s2
The sublease is discussed in Note 6 of Item 8.
The lease is discussed in Note 6 of Item 8.
2
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[ "lease" ]
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906709_18_item7_p51_s1
906709_17_item7_p43_s4
Our original estimates are periodically evaluated to determine if circumstances have caused the estimates to change and if so, amortization of revenue is adjusted prospectively.
Our original estimates are periodi cally evaluated to determine if circumstances have caused the estimates to change and if so, amortization of revenue is adjusted prospectively.
2
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[ "periodi", "cally" ]
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906709_18_item7_p18_s0
906709_17_item7_p50_s0
In February 2012, we sold all of our rights to receive future royalty payments from sales of the CIMZIA and MIRCERA drug products marketed by UCB and Roche, respectively.
In February 2012, we sold all of our rights to receive future royalty payments on CIMZIA and MIRCERA .
2
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[]
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906709_18_item7_p58_s3
906709_17_item7_p51_s2
Our estimate of the interest rate under the agreement is based on the amount of royalty payments to be received by RPI over the life of the arrangem ent and payments we are required to make to RPI under the agreement.
Our estimate of the interest rate under the agreement is based on the amount of royalty payments to be received by RPI over the life of the arrangement and payments we are required to make to RPI under the agreement.
2
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906709_18_item7_p60_s3
906709_17_item7_p52_s3
If we had determined that the interest rate used in 2016 should have been one percentage point higher than our current estimate of 17%, the non-cash interest expense recognized in the year ended December 3 1, 2016 would have increased by $1.2 million.
If we had determined that the interest rate used in 2017 should have been one percentage point higher than our quarterly estimates during 2017, the non-cash interest expense recognized in the year ended December 31, 2017 and the Royalty Obligation balance as of December 31, 2017 would have increased by $1.1 million.
2
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906709_18_item7_p63_s0
906709_17_item7_p56_s0
In February 2016, the FASB issued guidance to amend a number of aspects of lease accounting, including requiring lessees to recognize almost all leases with a term greater than one year as a right-of-use asset and corresponding liability, measured at the present value of the lease payments.
In February 2016, the FASB issued guidance to amend a number of aspects of lease accounting, including requiring lessees to recognize almo st all leases with a term greater than one year as a right-of-use asset and corresponding liability, measured at the present value of the lease payments.
2
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906709_18_item7_p16_s6
906709_17_item7_p7_s2
We expect royalty revenue in 2017 will increase as compared to 2016 due to royalties we expect to receive from net sales of MOVANTIK , MOVENTIG and ADYNOVATE as a result of sales growth of these partnered products.
We expect royalty revenue in 2018 will increase as compared to 2017 due to royalties we expect to receive as a result of sales growth of these partnered products.
2
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[]
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906709_18_item7_p37_s1
906709_17_item7_p7_s4
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period.
As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as CIMZIA and MIRCERA royalties are remitted directly to the purchaser.
2
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[]
[ "CIMZIA", "MIRCERA", "royalties", "remitted", "directly", "purchaser" ]
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908259_12_item7_p61_s2
908259_11_item7_p113_s0
The table below summarizes the most significant components of our research and development expenses for the periods indicated, in thousands and as a percentage of total research and development expenses and provides the changes in these components and their percentages:
General and administrative expenses The table below summarizes the most significant components of our general and administrative expenses for the periods indicated, in thousands and as a percentage of total general and administrative expenses and provides the changes in these components and their percentages:
2
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908259_12_item7_p95_s3
908259_11_item7_p120_s0
The decrease in Investment income of $508,000 for fiscal 2009 from fiscal 2008 is primarily a result of a reduction in our average month end cash balance available for investment and lower average rate of return.
The decrease in Investment income of $93,000 for fiscal 2010 compared to fiscal 2009 is primarily a result of a reduction in our average month end cash balance available for investment during the respective periods.
2
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[]
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908259_12_item7_p96_s2
908259_11_item7_p127_s2
Net cash provided by financing activities for the year ended December 31, 2010 is primarily attributable to the net proceeds of our private placement of common stock and warrants completed in March 2010 and the sale of common stock under our at the market equity financing facility discussed below.
Net cash provided by financing activities for the year ended December 31, 2011 is primarily attributable to the net proceeds of the sale of common stock under our at the market equity financing facility discussed below.
2
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[]
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908259_12_item7_p97_s3
908259_11_item7_p140_s3
In the event such shareholder approval is obtained, the Series E Warrants issued at the initial closing shall be exchanged for the additional 457,544 shares of common stock.
Such shareholder approval was obtained on March 18, 2011, and the Series E Warrants issued at the initial closing were exchanged for the additional 457,544 shares of common stock.
2
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908259_12_item7_p30_s11
908259_11_item7_p154_s0
If we are unable to raise additional funds when needed, we will not be able to continue development of our product candidates or we will be required to delay, scale back or eliminate some or all of our development programs or cease operations.
If we are unable to access additional funds when needed, we may not be able to continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and other operations.
2
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[ "access", "may", "could" ]
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908259_12_item7_p30_s13
908259_11_item7_p155_s0
If we raise funds through collaborative or licensing arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize.
If we access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us.
2
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[]
[ "access" ]
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908259_12_item7_p3_s0
908259_11_item7_p1_s0
We are a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases.
We are a clinical-stage, biopharmaceutical company developing novel therapeutics primarily to treat cancer.
2
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[]
[ "primarily" ]
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908259_12_item7_p13_s1
908259_11_item7_p20_s2
Our data indicates that in addition to having potent vascular disrupting effects, OXi4503 is unique in that certain enzymes in the human body can help convert it to a form of chemical that has direct tumor cell killing effects.
We believe that OXi4503 is differentiated from other VDAs by its dual-action activity: in addition to having potent vascular disrupting effects, OXi4503 is unique in that certain enzymes in the human body can help convert it to a form of chemical that has direct tumor cell killing effects.
2
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[]
[ "believe", "differentiated", "VDAs", "dual", "action", "activity" ]
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908259_12_item7_p16_s0
908259_11_item7_p24_s0
The general direction of future development of OXi4503 solid tumors or hematologic indications will depend on the outcome of the analysis of both the solid tumor studies and the study in AML, as well as available financial resources and potential partnering activities.
The general direction of future development of OXi4503 for hematologic indications will depend on the outcome of the analysis of the study in AML, as well as available financial resources and potential partnering activities.
2
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[]
[]
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908259_12_item7_p17_s8
908259_11_item7_p35_s3
We currently have no material amount of licensing or other fee income.
We currently have no recurring material amount of licensing or other income.
2
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[ "We", "currently", "have", "no", "material", "amount", "of", "licensing", "or", "other", "fee", "income", "." ]
[ "We", "currently", "have", "no", "recurring", "material", "amount", "of", "licensing", "or", "other", "income", "." ]
[]
[ "recurring" ]
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908259_12_item7_p103_s13
908259_11_item7_p44_s2
If we are unable to access additional funds when needed, we may not be able to continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and other operations.
If we are unable to raise additional funds when needed, we will not be able to continue development of our product candidates or we will be required to delay, scale back or eliminate some or all of our development programs or cease operations.
2
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[]
[ "raise", "cease" ]
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908259_12_item7_p104_s0
908259_11_item7_p44_s4
If we access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us.
If we raise funds through collaborative or licensing arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize.
2
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908259_12_item7_p32_s0
908259_11_item7_p50_s0
Our management s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
Critical Accounting Policies and Significant Judgments and Estimates Our management s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
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908259_12_item7_p33_s0
908259_11_item7_p50_s1
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting perio...
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the re...
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908259_12_item7_p32_s1
908259_11_item7_p52_s0
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the re...
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting perio...
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908259_12_item7_p49_s0
908259_11_item7_p77_s0
A variable interest entity (VIE) is (1) an entity that has equity that is insufficient to permit the entity to finance its activities without additional subordinated financial support, or (2) an entity that has equity investors that cannot make significant decisions about the entity s operations or that do not absorb t...
Consolidation of Variable Interest Entity (VIE) A variable interest entity (VIE) is (1) an entity that has equity that is insufficient to permit the entity to finance its activities without additional subordinated financial support, or (2) an entity that has equity investors that cannot make significant decisions about...
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[ "Consolidation", "Variable", "Interest", "Entity" ]
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908259_12_item7_p61_s2
908259_11_item7_p89_s0
The table below summarizes the most significant components of our research and development expenses for the periods indicated, in thousands and as a percentage of total research and development expenses and provides the changes in these components and their percentages:
General and administrative expenses The table below summarizes the most significant components of our general and administrative expenses for the periods indicated, in thousands and as a percentage of total general and administrative expenses and provides the changes in these components and their percentages:
2
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908259_12_item7_p85_s1
908259_11_item7_p95_s0
The reduction in employee compensation and related expenses for the year ended December 31, 2010 compared to the same twelve month period of 2009 is due to a reduction in both our average full time equivalents of 16% and expenses in the 2009 period for administrative costs associated with the Symphony ViDA entity that ...
General and administrative expenses The table below summarizes the most significant components of our general and administrative expenses for the periods indicated, in thousands and as a percentage of total general and administrative expenses and provides the changes in these components and their percentages: The reduc...
2
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908259_13_item7_p27_s1
908259_12_item7_p102_s1
The agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty.
The LPC Purchase Agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty.
2
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[]
[ "LPC", "Purchase", "Agreement" ]
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908259_13_item7_p29_s5
908259_12_item7_p103_s0
In December 2011, we established a partnership agreement with Azanta Danmark A/S, or Azanta, to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis.
In December 2011, we established a distribution agreement with Azanta, which was expanded in August 2012, to provide access to ZYBRESTAT for the treatment of patients in certain specified territories with ATC on a compassionate use basis.
2
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[]
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908259_13_item7_p30_s1
908259_12_item7_p103_s10
However, this level of cash utilization does not provide for the initiation of any significant projects to further the development of our most advanced product candidates, primarily ZYBRESTAT in ATC.
However, this level of cash utilization does not allow for the initiation of any significant projects, including clinical trials, to further the development of our most advanced product candidates, primarily ZYBRESTAT.
2
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908259_13_item7_p5_s12
908259_12_item7_p103_s10
However, this level of cash utilization does not provide for the initiation of any significant projects to further the development of our most advanced product candidates, primarily ZYBRESTAT in ATC.
However, this level of cash utilization does not allow us to initiate any significant projects, including clinical trials, to further the development of our most advanced product candidates, primarily ZYBRESTAT.
2
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908259_13_item7_p5_s16
908259_12_item7_p103_s13
If we are unable to raise additional funds when needed, we will not be able to continue development of our product candidates or we will be required to delay, scale back or eliminate some or all of our development programs or cease operations.
If we are unable to access additional funds when needed, we may not be able to continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and other operations.
2
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[]
[ "access", "may", "could" ]
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908259_13_item7_p6_s0
908259_12_item7_p104_s0
If we raise funds through collaborative or licensing arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize.
If we access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us.
2
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908259_13_item7_p28_s0
908259_12_item7_p18_s0
On July 21, 2010, we entered into an at the market (ATM) equity offering sales agreement with McNicoll, Lewis Vlak LLC, (MLV), pursuant to which we may issue and sell shares of our common stock from time to time through MLV acting as our sales agent and underwriter.
On July 21, 2010, we entered into an at the market equity offering sales agreement, or ATM Agreement, with MLV Co. LLC, or MLV, pursuant to which we may issue and sell shares of our common stock from time to time through MLV who will act as our sales agent and underwriter.
2
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[]
[ "Agreement", "Co.", "act" ]
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908259_13_item7_p5_s7
908259_12_item7_p18_s0
On July 21, 2010, we entered into an at the market (ATM) equity offering sales agreement with McNicoll, Lewis Vlak LLC, (MLV), pursuant to which we may issue and sell shares of our common stock from time to time through MLV acting as our sales agent and underwriter.
We also have entered into an at the market equity offering sales agreement, or the ATM Agreement, with MLV Co. LLC, or MLV, pursuant to which we may issue and sell shares of common stock from time to time through MLV acting as our sales agent and underwriter.
2
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[ "also", "Agreement", "Co." ]
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