Collaborative Research and Development Agreements | 12 Months Ended |
Dec. 31, 2014 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborative Research and Development Agreements | 9. Collaborative Research and Development Agreements GlaxoSmithKline |
Muscle Diseases Collaboration |
In July 2010, we entered into a research collaboration and license agreement, referred to as the muscle diseases collaboration with GlaxoSmithKline LLC, or GSK, to identify potential drug targets and drug candidates to treat skeletal muscle diseases. Under the terms of the agreement, we received an upfront technology access payment of $7.0 million in August 2010. The $7.0 million upfront technology access payment was recorded as deferred revenue, which we initially began recognizing over the initial three-year research period under the agreement. |
In May 2011, we amended the agreement to expand the research plan in scope and duration to include an additional cell-based screen and an in vivo screen using our RIPPS technology. Under the amendment, GSK agreed to provide an additional $6.3 million of research funding over a three-year research program term beginning on the date of the expansion. We received $0 million, $1.5 million and $4.2 million of research funding in the years ended December 31, 2014, 2013 and 2012, respectively, related to research we performed under the muscle diseases collaboration. Due to this amendment, in May 2011 we revised our estimate of our substantive performance period under this collaboration to extend through the end of this additional research term and began recognizing the remaining unamortized portion of the upfront payment over this revised period into May 2014. |
We were eligible to receive certain option and selection payments related to targets identified in the collaboration. We are also eligible to receive payments for the achievement of certain development activities and royalties on the sales of products related to targets GSK selected for exclusive development. |
We were eligible to receive up to $1.8 million of option and selection payments per target when GSK claimed and selected a target for further development. In accordance with ASU No. 2010-17, we concluded that these payments under the agreement with GSK were substantive and accounted for these milestones under the milestone method of revenue recognition. |
In accordance with ASU No. 2010-17, we determined that the remaining contingent payments under the agreement with GSK do not constitute milestone payments and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments under the agreement with GSK do not meet the definition of a milestone under ASU 2010-17 because the achievement of these events is solely dependent on GSK’s performance. Any revenue from these contingent payments would be subject to an allocation of arrangement consideration and would be recognized over any remaining period of performance obligations, if any, relating to this arrangement. If there are no remaining performance obligations under the arrangement at the time the contingent payment is triggered, the contingent payment would be recognized as revenue in full upon the triggering event. |
In connection with the agreement, GSK purchased 329,597 shares of our Series A-2 convertible preferred stock at a price of $22.76 per share, resulting in net cash proceeds to us of $7.5 million. We determined that the purchase price of $22.76 per share exceeded the estimated fair value of the Series A-2 convertible preferred stock by $3.0 million and, therefore, recorded the $3.0 million as revenue in the same manner as the upfront technology access payment. |
In December 2012, GSK selected a protein therapeutic target for further evaluation. The related selection fee of $0.3 million was received in 2013. In September 2013, we and GSK entered into an agreement to extend the evaluation period for this protein therapeutic target by approximately eight months. In connection with the extension of the evaluation period, GSK paid a $0.2 million extension fee, which had been fully recognized in revenue over the eight-month extension period in 2014. |
In October 2013, GSK exercised its right to reserve for further evaluation several protein therapeutic targets for muscle diseases that we discovered pursuant to this agreement with GSK. In connection with reserving these targets for further evaluation, GSK paid us a selection fee of $0.3 million in 2013. In September, 2014, GSK exercised its option to license an undisclosed muscle disease target that we identified. We granted GSK an exclusive, worldwide license to products containing or directed to the target. We received a payment of $1.5 million in connection with the option exercise |
Total revenue recognized under this arrangement was $3.4 million for the year ended December 31, 2014 and $5.8 million for the years ended December 31, 2013 and 2012. As of December 31, 2013, we had deferred revenue relating to this collaboration agreement of $1.9 million. As of December 31, 2014, the deferred revenue related to this agreement had been fully recognized as we completed our obligation to provide research services. |
The agreement will terminate upon the expiration of the royalty terms of any products that incorporate or target a protein exclusively licensed under the collaboration. In addition, GSK may terminate this agreement at any time with advance written notice, and either party may terminate this agreement with written notice for the other party’s material breach if such party fails to cure the breach or upon certain insolvency events. |
Respiratory Diseases Collaboration |
In April 2012, we entered into research collaboration and license agreement, referred to as the respiratory diseases collaboration, with GSK to identify new therapeutic approaches to treat refractory asthma and chronic obstructive pulmonary disease, or COPD, function with a particular focus on identifying novel protein therapeutics and antibody targets. We initially planned to conduct up to six customized cell-based screens of our protein library under this agreement. The four-year research term will end in April 2016. Under the terms of the agreement, GSK paid us an upfront technology access payment of $7.5 million in April 2012. |
We applied ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, in evaluating the appropriate accounting for this agreement. In accordance with this guidance, we concluded that the arrangement should be accounted for as a single unit of accounting and that the arrangement consideration should be recognized in the same manner as the final deliverable, which is the research service. The $7.5 million upfront technology access payment was recorded as deferred revenue and is being recognized over the initial four-year research period under the agreement. In addition, GSK agreed to pay us $10.5 million of research funding over the research program term. |
In April 2014, we amended the agreement with GSK. Pursuant to the original agreement, GSK has an option to elect to include additional screening assays under the research plan. The amendment allowed GSK to terminate any additional screening assay it elects under the research plan within six months of so electing, which termination right lapsed unexercised in October 2014. Concurrent with the amendment, GSK exercised its option and expanded the research plan to include two additional screening assays. In connection with GSK’s exercise of its option, we are entitled to receive up to $1.0 million in additional research funding in 16 equal quarterly payments for each additional screening assay, for a total of up to $2.0 million in additional research funding for both additional screening assays, of which we have received $1.0 million as of December 31, 2014. In the years ended December 31, 2014, 2013 and 2012, we received $3.9 million, $3.4 million and $1.3 million, respectively, of research funding related to all research being performed under the respiratory diseases collaboration. |
We are eligible to receive certain option and selection payments, payments for the achievement of certain development activities, and royalties on the sales of products related to targets GSK selects for exclusive development, if any. |
We are eligible to receive up to $1.8 million of option and selection payments for each target claimed and selected for further development. In addition, prior to the time GSK exercises its right to obtain an exclusive worldwide license to a protein target, we and GSK will discuss and agree on Track 1 Targets, for which GSK will have sole responsibility for the further development and commercialization of products that incorporate or target the protein targets, and Track 2 Targets, for which we will develop biologics that incorporate or target the protein targets through to clinical proof of mechanism in either a Phase 1 clinical trial or Phase 2 clinical trial. We and GSK will take into consideration each party’s available resources and capabilities at the time in deciding which protein targets will be Track 1 Targets or Track 2 Targets, but subject to each party’s general right to alternate in such selection, with GSK having the right to first select. For each Track 2 Target, we are eligible to receive a $4.0 million milestone payment upon initiation of the first GLP toxicology study, a $6.5 million milestone payment upon the initiation of Phase 1 clinical trial and a $11.0 million milestone payment upon the initiation of Phase 2 clinical trial. We are also eligible to receive a $14.0 million option exercise milestone if GSK exercises its option to develop a Track 2 Target prior to the initiation of Phase 2 clinical trial or a $23.0 million option exercise milestone if GSK exercises after the initiation of Phase 2 clinical trial for the Track 2 Targets. Substantive uncertainty exists at the inception of the agreement as to whether any of these milestones will be achieved because of the numerous variables that may affect our ability to identify targets that GSK would be interested in further evaluating or with respect to which GSK would develop products. In accordance with ASU No. 2010-17, we concluded that these milestones under the agreement with GSK are substantive and will be accounted for under the milestone method of revenue recognition. |
In accordance with ASU No. 2010-17, we determined that the remaining contingent payments under the agreement with GSK do not constitute milestone payments and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments under the agreement with GSK do not meet the definition of a milestone under ASU 2010-17 because the achievement of these events is solely dependent on GSK’s performance. Any revenue from these contingent payments would be subject to an allocation of arrangement consideration and would be recognized over any remaining period of performance obligations, if any, relating to this arrangement. If there are no remaining performance obligations under the arrangement at the time the contingent payment is triggered, the contingent payment would be recognized as revenue in full upon the triggering event. |
In connection with the agreement, GSK purchased 381,693 shares of our Series A-3 convertible preferred stock at a price of $26.20 per share, resulting in net cash proceeds to us of $10.0 million. We determined that the purchase price of $26.20 per share exceeded the estimated fair value of the Series A-3 convertible preferred stock by $3.1 million and, therefore, recorded the $3.1 million as deferred revenue to be recognized in the same manner as the upfront technology access payment. |
Total revenue recognized under this arrangement was $6.4 million, $5.6 million and $3.2 million for the years ended December 31, 2014, 2013 and 2012, respectively. As of December 31, 2014 and 2013, we had deferred revenue relating to this collaboration agreement of $4.3 million and $6.8 million, respectively. Additionally, GSK is obligated to reimburse us for certain specialized research and development costs associated with the screens under the agreement. As of December 31, 2014 and 2013, the receivable from GSK under the agreement related to such costs was $0.3 million and $0.1 million, respectively. |
The agreement will terminate upon the expiration of the royalty terms of any products that incorporate or target a protein exclusively licensed under the collaboration. In addition, GSK may terminate this agreement at any time with advance written notice, and either party may terminate this agreement with written notice for the other party’s material breach if such party fails to cure the breach or immediately in the case of failure to comply with certain anti-bribery and anti-corruption policies or upon certain insolvency events. |
FP-1039 License and Collaboration |
In March 2011, we entered into a license and collaboration agreement with Human Genome Sciences, Inc., which was acquired by GSK in 2012, and which we refer to as the FP-1039 license. Pursuant to the agreement we granted GSK an exclusive license to develop and commercialize our FP-1039 product and other FGFR1 fusion proteins for multiple cancers in the United States, the European Union and Canada. Under the terms of the agreement, GSK paid us an upfront license fee of $50.0 million. We received full payment of the $50.0 million upfront license fee in March 2011. The agreement also calls for tiered double-digit percentage royalty payments on net sales. GSK has exclusive rights to develop and commercialize FP-1039 for all indications in the United States, the European Union and Canada. We have an option to co-promote FP-1039 in the United States and retain development and commercialization rights in territories outside the United States, the European Union and Canada. |
We applied ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, in evaluating the appropriate accounting for this agreement. In accordance with this guidance, we identified the initial license, associated technology transfer and services for the conduct of the then-concluding FP-1039 Phase 1 clinical trial as substantive deliverables under this agreement. However, since all of the deliverables were fully delivered by December 31, 2011, the $50.0 million upfront license fee associated with the deliverables was entirely recognized as revenue in 2011. |
Additionally, GSK is obligated to reimburse us for all future research and development costs associated with FP-1039 incurred by us in the conduct of research and development activities on behalf of GSK. At the time we entered into the FP-1039 license, we agreed to perform services for the conduct of the then-concluding Phase 1 clinical trial. We also elected to conduct a Phase 2 clinical trial of FP-1039 in endometrial cancer for which we were reimbursed by GSK. The Phase 2 clinical trial was terminated in January 2012 and we are no longer conducting any activities with respect to this trial. Additionally, GSK is obligated to pay us for the costs of other FP-1039 related research and development activities we elect to undertake on behalf of GSK. Revenue from GSK related to these development costs associated with FP-1039 is recognized as we incur these costs. For the years ended December 31, 2014, 2013 and 2012, we recognized $0.1 million, $0.1 million and $0.9 million, respectively, in revenue from GSK related to development costs associated with FP-1039. |
GSK is obligated to pay us certain amounts contingent upon the achievement of pre-specified development, regulatory and commercial criteria, which could total approximately $435.0 million. We determined that these contingent payments will not be accounted for under the milestone method of revenue recognition as the events that trigger these payments under the agreement with GSK do not meet the definition of a milestone under ASU 2010-17 because the achievement of these milestones is solely dependent on GSK’s performance. Revenue from these contingent payments will be recognized if and when such payments become due, subject to satisfaction of all the criteria necessary to recognize revenue at that time, because we do not have any outstanding performance obligations under this arrangement. |
The agreement will terminate upon the expiration of the royalty terms of any products that result from the collaboration. In addition, GSK may terminate this agreement at any time with advance written notice, and either party may terminate this agreement for the other party’s material breach if such party fails to cure the breach or upon certain insolvency events. |
UCB Pharma S.A. |
In March 2013, we and UCB Pharma, S.A., or UCB, entered into a research collaboration and license agreement to identify potential biologics targets and therapeutics in the areas of fibrosis-related immunologic diseases and central nervous system disorders. We plan to conduct up to five customized cell-based and in vivo screens of our protein library under this agreement. We currently expect to complete our initial research activities under this agreement by March 2016. Upon the completion of those research activities, UCB has up to a two-year evaluation period during which we may be obligated to perform additional services at the request of UCB. |
We applied ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, in evaluating the appropriate accounting for this agreement. In accordance with this guidance, we concluded that we should account for the arrangement as a single unit of accounting and recognize the arrangement consideration in the same manner as the final deliverable, which is research service. |
Under the terms of the agreement, UCB paid us an upfront payment of $6.0 million in March 2013. In addition, UCB agreed to pay us a $6.6 million technology fee, of which we received $2.2 million in each of the years 2014 and 2013. The remaining $2.2 million technology access fee is due on the second anniversary of this agreement. UCB also agreed to pay us $2.0 million of research funding during the second and the third years of the research program term, of which we received $1.0 million in 2014. We recorded the $6.0 million upfront payment, $4.4 million technology access payment and $1.0 million of research funding as deferred revenue, which we will recognize over the initial five-year research period under the agreement. |
We are eligible to receive certain evaluation and selection fees and contingent payments with respect to each protein target that UCB elects to obtain an exclusive license, and royalties on the sales of products related to such targets, if any. |
We are eligible to receive up to $0.4 million of target evaluation and selection fees with respect to each target we offer to UCB in the collaboration. Substantive uncertainty exists at the inception of the agreement as to whether any of these fees will be received because of the numerous variables that may affect our ability to identify targets that UCB would be interested in further evaluating or with respect to which UCB would develop products. In accordance with ASU No. 2010-17, we concluded that these fees under the agreement with UCB are substantive and will be accounted for under the milestone method of revenue recognition. |
In accordance with ASU No. 2010-17, we determined that the remaining contingent payments under the agreement with UCB do not constitute milestone payments and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments under the agreement with UCB do not meet the definition of a milestone under ASU 2010-17 because the achievement of these events solely depends on UCB’s performance. Any revenue from these contingent payments would be subject to an allocation of arrangement consideration and would be recognized over any remaining period of performance obligations, if any, relating to this arrangement. If we have no remaining performance obligations under the arrangement at the time the contingent payment is triggered, we would recognize the contingent payment as revenue in full upon the triggering event. |
For the years ended December 31, 2014 and 2013, we recognized $3.2 million and $2.2 million of revenue, respectively, under this arrangement. As of December 31, 2014 and 2013, we have deferred revenue relating to this collaboration agreement of $6.5 million and $6.2 million, respectively. Additionally, UCB is obligated to reimburse us for certain specialized research and development costs associated with the screens under the agreement. As of December 31, 2014 and 2013, the receivable from UCB under the agreement related to such costs was $0.1 million and $0.2 million, respectively. |
The agreement will terminate upon the expiration of the royalty terms of any products that incorporate or target a protein exclusively licensed under the collaboration. In addition, UCB may terminate this agreement at any time with advance written notice, and either party may terminate the agreement with written notice for the other party’s material breach if such other party fails to timely cure the breach or upon certain insolvency events. |
Bristol-Myers Squibb Company |
Research Collaboration and License Agreement |
In March 2014, we entered into a research collaboration and license agreement, referred to as the immuno-oncology research collaboration, with Bristol-Myers Squibb Company, or BMS, to carry out a research program to (i) discover novel interacting proteins in two undisclosed immune checkpoint pathways, which we refer to as the checkpoint pathways, using our target discovery platform; (ii) further the understanding of target biology with respect to targets in these checkpoint pathways; and (iii) discover and pre-clinically develop compounds suitable for development for human therapeutic uses against targets in these checkpoint pathways. Under the immuno-oncology collaboration, we granted BMS an exclusive, worldwide license to research, develop and commercialize products directed towards certain targets in the checkpoint pathways. BMS will have an option to take exclusive licenses to additional targets we may identify in these checkpoint pathways during the course of the immuno-oncology research collaboration. |
We received an upfront payment of $20.0 million from BMS in April 2014 in connection with our entry into the immuno-oncology research collaboration and expect to receive $9.5 million in research funding over the course of the three-year research term based on the research activities currently planned under the research plan. BMS may extend the research term for two additional one-year periods on a year-by-year basis, during which extensions we would be obligated to perform additional services as agreed to with BMS and BMS would be obligated to pay us research funding with respect to such services. |
We applied the FASB Accounting Standards Update, or ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, in evaluating the appropriate accounting for the immuno-oncology collaboration. In accordance with this guidance, we concluded that we should account for the immuno-oncology research collaboration as a single unit of accounting because the intellectual property delivered to BMS was not considered to have stand-alone value and recognize the immuno-oncology research collaboration consideration in the same manner as the final deliverable, which is research service. The $20.0 million upfront payment was recorded as deferred revenue and is being recognized over the five-year research period under the collaboration. In addition, BMS agreed to pay us $9.5 million of research funding over the initial three-year research program term. We received $3.4 million of research funding in 2014 related to research we performed under the immuno-oncology research collaboration. |
We are eligible to receive certain contingent payments with respect to each target subject to the immuno-oncology research collaboration and royalties on sales of products related to such targets, if any. |
In accordance with ASU No. 2010-17, Milestone Method of Revenue Recognition, we determined that the remaining contingent payments under the immuno-oncology research collaboration do not constitute milestone payments and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments under the collaboration do not meet the definition of a milestone under ASU 2010-17 because the achievement of these events solely depends on BMS’s performance. Any revenue from these contingent payments would be subject to an allocation of arrangement consideration and would be recognized over any remaining period of performance obligations, if any, relating to the collaboration. If we have no remaining performance obligations under the immuno-oncology research collaboration at the time the contingent payment is triggered, we would recognize the contingent payment as revenue in full upon the triggering event. |
In connection with the immuno-oncology research collaboration, BMS purchased 994,352 shares of our common stock at a price per share of $21.16, for an aggregate purchase price of $21.0 million. We determined that the purchase price of $21.16 per share exceeded the fair value of our common stock by $2.4 million and, therefore, recorded the $2.4 million as deferred revenue to be recognized in the same manner as the $20.0 million up-front payment. |
For the year ended December 31, 2014, we recognized $6.0 million of revenue under the immuno-oncology research collaboration. As of December 31, 2014, we had deferred revenue relating to the immuno-oncology research collaboration of $19.7 million. |
The immuno-oncology research collaboration will terminate upon the expiration of all payment obligations under the collaboration. In addition, BMS may terminate the immuno-oncology research collaboration in its entirety or on a collaboration target-by-collaboration target basis at any time with advance written notice and either party may terminate the collaboration in its entirety or on a collaboration target-by-collaboration target basis with written notice for the other party’s material breach if such other party fails to timely cure the breach or immediately upon certain insolvency events. |
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Clinical Trial Collaboration Agreement |
In November 2014, we entered into a clinical trial collaboration agreement with BMS, referred to as the clinical trial collaboration, to evaluate the safety, tolerability and preliminary efficacy of combining our FPA008 antibody with BMS’s nivolumab antibody, which we refer to together as the combined therapy, as a potential treatment option for patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. |
Pursuant to the terms of the agreement, we are responsible for conducting the clinical phase 1a/1b study. In addition, either BMS or we may, by mutual agreement, expand the scope of the clinical trial collaboration to study additional tumor types using the combined therapy. |
Under the terms of the agreement, BMS paid us a one-time fee of $30.0 million in December 2014. If a change of control of FivePrime closes prior to the initial results date, defined as the earlier date that (i) certain dose escalation and pharmacodynamics conditions are met in the planned Phase 1a portion of the first clinical study of the combined therapy; or (ii) the first subject is dosed in the Phase 1b portion of the first clinical study of the combined therapy, then if, |
• | immediately prior to such change of control, the acquirer in such change of control (or any of its affiliates) owns or controls an anti-PD-1 or anti-PD-L1 antagonist that is then in clinical development for use in treating cancer or is then being commercialized for use in treating cancer; |
• | BMS is using commercially reasonable efforts in the performance and fulfillment of its activities under the clinical trial collaboration; |
• | the parties are developing or pursuing the development of the combined therapy under the clinical trial collaboration; and |
• | a change of control of BMS has not occurred, |
we would be obligated to pay to BMS the lesser of (x) $30.0 million or (y) 10% of the aggregate purchase price paid to us or our stockholders at the closing of such change of control (with any contingent consideration being risk-adjusted and discounted). |
We applied the ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, in evaluating the appropriate accounting for the clinical trial collaboration. In accordance with this guidance, we concluded that we should account for the clinical trial collaboration as a single unit of accounting because the delivered items did not have stand-alone value and recognize the clinical trial collaboration consideration in the same manner as the final deliverable, which is conducting the clinical phase 1a/1b study. The $30.0 million one-time fee is contingently refundable upon certain change of control events prior to the initial results date. The one-time fee was not considered to be fixed or determinable as of December 31. 2014 and was recorded as deferred revenue as of December 31, 2014. Once the one-time fee is considered fixed or determinable, we will start recognizing revenue ratably, using a cumulative catch up method, over the estimated performance period of approximately three years. We will periodically evaluate the estimated performance period based on the progress made under the collaboration. No revenue related to this collaboration has been recognized as of December 31, 2014. |
Unless earlier termination by either party, the clinical trial collaboration will continue until the date that is 90 days after the completion of all clinical trials under the agreement, the delivery of all study data by both parties and the completion of all obligations under the clinical trial collaboration. Either party may terminate the agreement with written notice (i) if the other party is in material breach and such breach has not been cured within the applicable cure period, (ii) if either party deems it necessary to protect the safety, health or welfare of the subjects enrolled in a clinical trial or (iii) 90 days following the commencement of a clinical hold. |