Collaborative Research and Development Agreements | 9. Collaborative Research and Development Agreements Bristol-Myers Squibb Company License and Collaboration Agreement On October 14, 2015, we entered into a license and collaboration agreement, or the cabiralizumab collaboration agreement, with Bristol-Myers Squibb Company, or BMS, pursuant to which we granted BMS exclusive global rights to develop and commercialize certain colony stimulating factor-1 receptor, or CSF1R, antibodies, including our monoclonal CSF1R inhibiting antibody that we refer to as cabiralizumab, and all modifications, derivatives, fragments, or variants of such antibodies, each of which we refer to as a licensed antibody. Under the terms of the cabiralizumab collaboration agreement, BMS is responsible, at its expense, for developing products containing licensed antibodies, each of which we refer to as a licensed product, under a development plan, subject to our option, at our own expense, to conduct certain studies, including registration-enabling studies to support approval of cabiralizumab in PVNS and in combination with our proprietary internal or in-licensed compounds, including in oncology. BMS is responsible for manufacturing and commercializing each licensed product and we will retain rights to a U.S. co-promotion option. This supersedes the clinical trial collaboration agreement we entered into with BMS in November 2014. We continue to conduct the current Phase 1a/1b clinical trial to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo ® Pursuant to the cabiralizumab collaboration agreement, BMS made an upfront payment of $350.0 million to us in December 2015. We applied ASC 605-25, Multiple-Deliverable Revenue Arrangements Additionally, we are eligible to receive up to $1.05 billion in development and regulatory milestone payments per anti-CSF1R product for oncology indications and up to $340 million in development and regulatory milestone payments per anti-CSF1R product for non-oncology indications, as well as royalties ranging from the high teens to the low twenties, such royalties to be enhanced in the U.S. in the event that we exercise our co-promotion option. 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 BMS do not meet the definition of a milestone under ASC 605-28, Milestone Method of Revenue Recognition Under the original clinical trial collaboration agreement, BMS paid us an upfront fee of $30.0 million in December 2014. Initially, the $30.0 million upfront fee was contingently refundable if certain change of control events occurred prior to a specified date. As such, the upfront fee was not considered to be fixed or determinable at that time and was recorded as deferred revenue as of December 31, 2014. Under the cabiralizumab collaboration agreement, the $30.0 million upfront fee under the original clinical trial collaboration is no longer contingently refundable. Therefore, upon the effectiveness of the cabiralizumab collaboration agreement, the upfront fee became fixed or determinable and we started recognizing revenue ratably, using a cumulative catch up method, over the estimated performance period ending in 2019. We will periodically evaluate the estimated performance period based on the progress made under the collaboration. During 2016 and 2015, we recognized $5.9 million and $6.4 million, respectively, of revenue relating to the upfront fee. For the years ended December 31, 2016 and 2015, we recognized $14.4 million and $359.9 million, respectively, of revenue under the cabiralizumab collaboration agreement. As of December 31, 2016 and 2015, we had deferred revenue relating to the collaboration of $17.7 million and $23.6 million, respectively. Immuno-Oncology Research Collaboration In March 2014, we entered into a research collaboration and license agreement, or the immuno-oncology research collaboration, with 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. Based on data arising from our initial screens, in January 2016, we amended the immuno-oncology research collaboration to add an additional checkpoint pathway to the research program, for a total of three undisclosed immune checkpoint pathways. 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. The initial research term under the immuno-oncology research collaboration expire in March 2017. In December 2016, BMS exercised its option to extend the research term for an additional year to March 2018. BMS has the option to extend the research term for one additional year. We applied ASC 605-25, Multiple-Deliverable Revenue Arrangements 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 ASC 605-28, 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 ASC 605-28 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 upfront payment. For the years ended December 31, 2016, 2015, and 2014, we recognized $7.7 million, $7.0 million and $6.0 million, respectively, of revenue under the immuno-oncology research collaboration. As of December 31, 2016 and 2015, we had deferred revenue relating to the immuno-oncology research collaboration of $10.6 million and $16.8 million, respectively. 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. GlaxoSmithKline LLC Respiratory Diseases Collaboration In April 2012, we entered into research collaboration and license agreement, or the respiratory diseases collaboration, with GlaxoSmithKline LLC, or 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 conducted six customized cell-based screens of our protein library under this agreement. Under the terms of the agreement, GSK paid us an upfront technology access payment of $7.5 million at the inception of the respiratory diseases collaboration We applied ASC 605-25, Multiple-Deliverable Revenue Arrangements Pursuant to the respiratory diseases collaboration, GSK exercised its option to expand the research plan to include two additional screening assays. We received $2.0 million in additional research funding for the two additional screening assays as of December 31, 2015. In January 2016, we amended our respiratory diseases collaboration to extend the research term by three months to July 2016 to allow additional validation of the protein targets we discovered and to increase the research funding by $0.7 million that GSK is obligated to pay us under our collaboration. Such funding was fully received as of December 31, 2016. 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 $124.3 million in potential target evaluation and selection fees and contingent payments with respect to each protein target for which GSK will have sole responsibility for the further development and commercialization of products that incorporate or target such protein target, or a track 1 target. GSK is also obligated to pay us tiered low- to mid-single digit royalties on global net sales for each product that incorporates or targets each such track 1 target. We are eligible to receive up to $193.8 million in potential target evaluation and selection fees and contingent payments with respect to each protein target 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 a phase 2 clinical trial, or a track 2 target. GSK is also obligated to pay us tiered high-single to low-double digit royalties on global net sales for each product that incorporates or targets each such track 2 target. In accordance with ASC 605-28, we determined that the remaining contingent payments under the respiratory diseases collaboration do not constitute milestone payments and we will not account for such payments under the milestone method of revenue recognition. In connection with our entry into the respiratory diseases collaboration, 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. In the years ended December 31, 2016, 2015 and 2014, we received $3.6 million, $3.9 million and $3.9 million, respectively, of research funding and milestones related to all research being performed under the respiratory diseases collaboration. Total revenue recognized under the respiratory diseases collaboration was $5.0 million, $7.3 million and $6.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we fully recognized the deferred revenue related to the respiratory diseases collaboration as we completed our obligation to provide research service. As of December 31, 2015, we had deferred revenue related to this agreement of $1.7 million. Additionally, GSK is obligated to reimburse us for certain specialized research and development costs associated with the screens under the respiratory diseases collaboration. The respiratory diseases collaboration 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, or the FP-1039 license, with Human Genome Sciences, Inc., or HGS, which was acquired by GSK in 2012. Pursuant to the FP-1039 license, we granted GSK an exclusive license to develop and commercialize our FP-1039 product and other FGFR1 fusion proteins in the United States, the European Union and Canada. We received an upfront license fee of $50.0 million from GSK in March 2011 in connection with our entry into the FP-1039 license. 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 the FP-1039 license. As of December 31, 2011, all deliverables under the FP-1039 license were fully delivered and we recognized the related $50.0 million of upfront license fee fully as revenue. In addition, GSK was obligated to pay us for the costs of all FP-1039 related research and development activities we elected to undertake on behalf of GSK. For the years ended December 31, 2016, 2015 and 2014, we recognized $21,000, $0.1 million and $0.1 million, respectively, in revenue from GSK related to development costs associated with FP-1039. In March 2016, GSK delivered to us a written notice of termination of the FP-1039 license. Pursuant to the terms of the FP-1039 license, termination of the FP-1039 license became effective on September 5, 2016, 180 days after GSK’s notice of termination. Pursuant to the terms of the FP-1039 license, we elected to have GSK complete the conduct of the Phase 1b clinical trial of FP-1039 that GSK is currently conducting, at GSK’s expense. Muscle Diseases Collaboration In July 2010, we entered into a research collaboration and license agreement, or the muscle diseases collaboration, with GSK, to identify potential drug targets and drug candidates to treat skeletal muscle diseases. Under the terms of the muscle diseases collaboration, 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. We fully recognized the deferred revenue related to this agreement in 2014 as we completed our obligation to provide research services. 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 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 ASC 605-28, 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 ASC 605-28, 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 muscle diseases collaboration do not meet the definition of a milestone under this standard because the achievement of these events is solely dependent on GSK’s performance. In connection with our entry into the muscle diseases collaboration, 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. We received the related selection fee of $0.3 million in 2013. In September 2013, we entered into an agreement with GSK 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 we have 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 the muscle diseases collaboration. 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 the muscle diseases collaboration was $3.4 million for the year ended December 31, 2014. 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 muscle diseases collaboration 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. UCB Fibrosis and CNS Collaboration In March 2013, we entered into a research collaboration and license agreement, or the fibrosis and CNS collaboration, with UCB Pharma, S.A., or UCB, to identify potential biologics targets and therapeutics in the areas of fibrosis-related immunologic diseases and central nervous system disorders. We applied ASC 605-25, Multiple-Deliverable Revenue Arrangements, to evaluate 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 agreement consideration in the same manner as the final deliverable of the research services. Under the terms of the fibrosis and CNS collaboration, UCB paid us an upfront payment of $6.0 million in March 2013. In addition, UCB agreed to pay us $6.6 million for a technology fee and $2.0 million for research funding. All of which was recorded as deferred revenue and being amortized over the initial five-year research period under the agreement. As of December 31, 2015, we fully collected on the technology fees and research funding under the fibrosis and CNS collaboration. 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 have offered to UCB in the collaboration. In accordance with ASC 605-28, we concluded that these fees under the agreement with UCB are substantive and should be accounted for under the milestone method of revenue recognition. During 2016 and 2015, we received $0.4 and $0.1 million in target evaluation and selection fees, respectively. In accordance with ASC 605-28, we determined that the remaining contingent payments under the agreement 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 ASC 605-28 because the achievement of these events solely depends on UCB’s performance. For the years ended December 31, 2016, 2015 and 2014, we recognized $3.5 million, $4.0 million and $3.2 million of revenue, respectively, under the fibrosis and CNS collaboration. As of December 31, 2016 and 2015, we have deferred revenue relating to this agreement of $3.7 million and $6.7 million, respectively. Additionally, UCB is obligated to reimburse us for certain specialized research and development costs associated with the screens under the agreement. Our initial research activities under this agreement were completed in 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. 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. bluebird bio, Inc. License Agreement In May 2015, we entered into an exclusive license agreement, or the bluebird license agreement, with bluebird bio, Inc., or bluebird, under which we licensed to bluebird human antibodies to an undisclosed cancer target to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using these antibodies. Under the bluebird license agreement, bluebird paid us a $1.5 million upfront fee in 2015. There are no other deliverables under the agreement other than the license grant. We recognized the $1.5 million upfront fee as revenue upon delivery of the license grant, which was completed in 2015. In January 2017, bluebird delivered to us written notice of termination of the license agreement. Pursuant to the terms of the license agreement, termination will become effective on May 17, 2017, which is 120 days after bluebird’s notice of termination. Following termination, bluebird will have no future payment obligations to us in connection with the license agreement. |