Collaboration and License Agreements | 5. Collaboration and License Agreements Summary of Collaboration-Related Revenue We have recognized revenue from our collaboration and license agreements as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 BMS and Pfizer $ 1,798 $ 388 $ 4,785 $ 1,152 Daiichi Sankyo 3,810 1,154 8,491 3,424 Bayer and Janssen 3,316 1,316 7,431 2,922 Bayer 398 — 1,052 — Lee’s Pharmaceutical — 54 52 158 Total collaboration and license revenue $ 9,322 $ 2,912 $ 21,811 $ 7,656 Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) In January 2014, we entered into a collaboration agreement with BMS and Pfizer to further study andexanet alfa as a reversal agent for their jointly owned FDA approved oral Factor Xa inhibitor, apixaban, through Phase 3 studies. We initiated Phase 3 studies in the first half of 2014. We are responsible for the cost of conducting this clinical study. Pursuant to our agreement with BMS and Pfizer we are obligated to provide research, development and regulatory approval services and participate in the Joint Collaboration Committee (“JCC”) We identified the following non-cancellable performance deliverables under the January 2014 agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate in the JCC. We considered the provisions of the multiple-elements arrangement guidance and determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout the estimated period of performance and will be accounted for as a single unit of accounting. The non-contingent upfront consideration under this agreement of $6.5 million is being recognized as collaboration revenue on a straight-line basis over the estimated period of performance. In the third quarter of 2014, we revised the remaining estimated period of performance from the first quarter of 2017 to the first quarter of 2018 to reflect a modification to our clinical development and regulatory plans. The contingent upfront consideration of $6.5 million will be recognized if and when the refundable nature of these amounts lapses based upon the achievement of specified regulatory and/or clinical events. The contingent milestone payments under the January 2014 agreement are not considered substantive because a portion may be refunded upon certain events. The non-contingent portion of the milestone payment will be recognized as collaboration revenue on a straight-line basis over the estimated period of performance, which is now through the first quarter of 2018. The contingent portion of the milestone payments will be recognized if and when the refundable nature of these amounts lapse based upon the achievement of specified regulatory and/or clinical events. During the three months ended September 30, 2016, we received no payments. During the nine months ended September 30, 2016, we received two contingent milestone payments totaling $3.5 million related to the achievement of two of these milestones. The non-contingent portion of these milestones is being recognized in collaboration revenue on a straight-line basis over the estimated remaining period of performance and the contingent portion of these milestones are included in deferred revenue, long term in the condensed consolidated balance sheet. One of the contingent payments totaling $3.0 million remained eligible for achievement as of September 30, 2016. During the three and nine months ended September 30, 2016 and 2015, we recognized $603,000 and $1.6 million and $388,000 and $1.2 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2016 was $11.8 million. In February 2016, we entered into a collaboration and license agreement with BMS and Pfizer whereby BMS and Pfizer obtained exclusive rights to develop and commercialize andexanet alfa in Japan. BMS and Pfizer are responsible for all development, regulatory and commercial activities in Japan and we will reimburse BMS and Pfizer for expenses they incur for research and development activities specific to Factor Xa inhibitors other than apixaban. Pursuant to this agreement, we are obligated to provide certain research and development activities outside of Japan, provide clinical drug supply and related manufacturing services and to participate on various committees in exchange for a non-refundable upfront fee of $15.0 million. We are also eligible to receive, contingent payments totaling up to $20.0 million which may be earned upon achievement of certain regulatory events and up to $70.0 million which may be earned upon achievement of specified annual net sales volumes in Japan. We are also entitled to receive royalties ranging from 5% to15% on net sales of andexanet alfa in Japan. We concluded that the January 2014 and February 2016 agreements should each be accounted for as standalone agreements. We identified the following non-cancellable performance deliverables under the February 2016 agreement: 1) grant of intellectual property license, 2) the obligation to provide research and development services, 3) the obligation to manufacture and provide clinical supply of andexanet alfa, and 4) the obligation to participate in various committees. The February 2016 agreement also contains an obligation to manufacture and provide commercial supply of andexanet alfa which we concluded was a contingent deliverable because andexanet alfa is not yet a commercially approved product and is currently subject to additional clinical studies prior to commercial approval in Japan. We considered the provisions of the multiple-elements arrangement guidance and determined that none of the deliverables have standalone value because of our required expertise associated with the manufacturing process of andexanet alfa and the interdependency of the remaining deliverables on the clinical supply of andexanet alfa. We evaluated the timing of delivery for each of the deliverables and concluded that our obligation to participate on the various committees would be the last delivered element under the arrangement and therefore would be the basis for revenue recognition for the combined unit of accounting. The total upfront consideration under this agreement is being recognized as collaboration revenue on a straight-line basis over the estimated performance period through the first quarter of 2019. We have determined that the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and payment terms within the agreement are commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of the milestone will be recognized in the period when the milestone is achieved and collectability is reasonably assured. As of September 30, 2016, no amounts had been recognized as collaboration revenue for any of these milestones and all the contingent payments remained eligible for achievement as of September 30, 2016. During the Daiichi Sankyo, Inc. (“Daiichi Sankyo”) In June 2013, we entered into an agreement with Daiichi Sankyo to include subjects dosed with edoxaban, their Factor Xa inhibitor product, in one of our Phase 2 proof-of-concept studies of andexanet alfa. We are responsible for the cost of conducting this clinical study. Under the terms of the agreement, Daiichi Sankyo provided us with an upfront fee of $6.0 million, $3.0 million of which was subject to refund if Daiichi Sankyo decided to terminate the agreement. We are obligated to participate in a JCC with Daiichi Sankyo to oversee the collaboration activities under the agreement. We identified the following performance deliverables under the agreement: 1) the obligation to provide research and development services, which includes supplying andexanet alfa and providing a final written report, and 2) the obligation to participate in the JCC. We considered the provisions of the multiple-element arrangement guidance and accounted for the research and development services and our participation in the JCC as a single unit of accounting. We originally estimated the non-contingent consideration under this agreement of $3.0 million would be recorded as collaboration revenue on a straight-line basis over the estimated non-contingent performance period through the second quarter of 2014. In December 2013, the JCC agreed to forego certain preclinical studies that were planned in the original study design at the inception of the agreement. As a result of this change, we updated our non-contingent performance period to be through the first quarter of 2014.The recognition of contingent consideration under this agreement of $3.0 million commenced upon resolution of the contingency in the first quarter of 2014 and was recognized as collaboration revenue through the fourth quarter of 2015. During the three and nine months ended September 30, 2015, we recognized $264,000 and $782,000, in collaboration revenue associated with the contingent and non-contingent elements of this arrangement. There was no deferred revenue balance under this agreement as of September 30, 2016. In July 2014, we entered into an agreement with Daiichi Sankyo to study the safety and efficacy of andexanet alfa as a reversal agent to their oral Factor Xa inhibitor, edoxaban, in our Phase 3 and Phase 4 studies. We are responsible for the cost of conducting these clinical studies. Pursuant to our agreement with Daiichi Sankyo we are obligated to provide research, development and regulatory services and to participate in a JCC in exchange for an upfront nonrefundable fee of $15.0 million, up to two contingent payments totaling $5.0 million which are payable upon the initiation of our Phase 3 study and achievement of certain events associated with scaling up our manufacturing process to support a commercial launch, and up to four payments totaling $20.0 million payable upon acceptance of filing and regulatory approval of andexanet alfa as a reversal agent to edoxaban by the FDA and European Medicines Agency (“EMA”). We identified the following non-cancellable performance deliverables under the agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate in the JCC. We considered the provisions of the multiple-element arrangement guidance and determined that none of the deliverables had standalone value, all of these obligations will be delivered throughout the estimated period of performance and will be accounted as a single unit of accounting. The total upfront consideration under this agreement is being recognized as collaboration revenue on a straight-line basis over the estimated performance period through the third quarter of 2018. We have determined all but one of the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and the payment terms within the agreement are commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved and collectability is reasonably assured. For the three and nine months ended September 30, 2016, we recognized $2.5 million and $5.0 million in collaboration revenue associated with achievement of milestones, respectively. Amounts for the contingent payment not considered to be a substantive milestone will be deferred when received and recognized as collaboration revenue on a straight-line basis over the remaining performance period. All remaining contingent payments remained eligible for achievement as of September 30, 2016. During the three and nine months ended September 30, 2016 and 2015, we recognized $3.4 million and $7.7 million and $890,000 and $2.6 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2016 was $7.1 million. In March 2016, we entered into an agreement with Daiichi Sankyo to perform an ethnic sensitivity study (“ESS-Study”) of Japanese ethnicity, perform any further studies requested by the Japanese regulatory authorities and to deliver services in connection with our collaboration agreement to commercialize andexanet alfa in Japan with BMS and Pfizer. Daiichi Sankyo will reimburse us for 33% of our costs and expenses incurred to conduct the ESS-Study and between 33% and 100% of costs and expenses we incur for other studies that involve edoxaban under the terms of the arrangement. Pursuant to our agreement with Daiichi Sankyo, we are obligated to provide research and development services, clinical drug supply and related manufacturing services, regulatory approval services and to participate in a JCC in exchange for an upfront nonrefundable fee of $5.0 million. We are eligible to receive, up to two contingent payments totaling $10.0 million payable upon the initial and final regulatory approval for andexanet alfa as a reversal agent to edoxaban in Japan. The $10.0 million contingent payments will be reduced to $7.0 million if the Japanese regulatory approval is attained based only upon the ESS-study results. We concluded that the July 2014 and March 2016 agreements should each be accounted for as standalone agreements. We identified the following non-cancellable performance deliverables under the March 2016 agreement: 1) the obligation to provide research and development services 2) the obligation to provide regulatory approval services, 3) the obligation to manufacture and provide clinical supply of andexanet alfa, and 4) the obligation to participate in the JCC. We considered the provisions of the multiple-element arrangement guidance and determined that none of the deliverables have standalone value and accordingly will be accounted for as a single unit of accounting. The total upfront consideration received under this agreement is being recognized as collaboration revenue on a straight-line basis over the estimated performance period associated with our participation in the JCC through the first quarter of 2019. We have determined that the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverable and payment term within the agreement are commensurate with our performance to achieve the milestones after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestones are achieved and collectability is reasonably assured. As of September 30, 2016, no amounts had been recognized as collaboration revenue for any of these milestones and the contingent payments remained eligible for achievement as of September 30, 2016. During the three and nine months ended September 30, 2016 we recognized $410,000 and $840,000 in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2016 was $4.2 million. Bayer Pharma, AG (“Bayer”) and Janssen Pharmaceuticals, Inc. (“Janssen”) In February 2013, we entered into a three-way agreement with Bayer and Janssen to include subjects dosed with rivaroxaban, their Factor Xa inhibitor product, in one of our Phase 2 proof-of-concept studies of andexanet alfa. We are responsible for the cost of conducting this clinical study. Under the terms of the agreement, Bayer and Janssen have each provided us with an upfront and non-refundable fee of $2.5 million, for an aggregate fee of $5.0 million. The agreement also provides for additional non-refundable payments to us from Bayer and Janssen of $250,000 each for an aggregate of $500,000 following the delivery of the final written study report of our Phase 2 proof-of-concept studies of andexanet alfa. Also, we are obligated to participate on a JCC with Bayer and Janssen to oversee the collaboration activities under the agreement. We identified the following performance deliverables under the agreement: 1) the obligation to provide research and development services, which includes supplying andexanet alfa and providing a final written report, and 2) the obligation to participate in a JCC. We considered the provisions of the multiple-element arrangement guidance and determined that that none of the deliverables had standalone value and therefore they were accounted for as a single unit of accounting. The total upfront consideration under this agreement was recognized as collaboration revenue on a straight-line basis over the estimated performance period through the fourth quarter of 2014 and $500,000 was recognized in the third quarter of 2015 following the delivery of the final written study report of our Phase 2 proof-of-concept studies of andexanet alfa. In January 2014, we entered into a three-way agreement with Bayer and Janssen to study the safety and efficacy of andexanet alfa as a reversal agent to their oral Factor Xa inhibitor, rivaroxaban, in our Phase 3 studies. We are responsible for the cost of conducting this clinical study. Pursuant to our agreement with Bayer and Janssen we are obligated to provide research, development and regulatory services and to participate in a JCC in exchange for an upfront nonrefundable fee of $10.0 million. We are also eligible to receive, up to three contingent payments totaling $7.0 million payable upon achievement of certain events associated with scaling up our manufacturing process to support a commercial launch, and up to three payments totaling $8.0 million payable upon initiation of our Phase 3 study and regulatory approval of andexanet alfa as a reversal agent to rivaroxaban by the FDA and EMA. We identified the following non-cancellable performance deliverables under the agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate in the JCC. We considered the provisions of the multiple-element arrangement guidance and determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout the estimated period of performance and accounted for as a single unit of accounting. The total upfront consideration under this agreement is being recognized as collaboration revenue on a straight-line basis over the estimated period of performance period. In the third quarter of 2014 we updated our estimated period of performance from the first quarter of 2017 to the first quarter of 2018 to reflect a modification to our clinical development and regulatory plans. We have determined all but one of the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and the payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved and collectability is reasonably assured. For the three and nine months ended September 30, 2016, we recognized $2.5 million and $5.0 million in collaboration revenue associated with achievement of a milestone, respectively. The contingent payment of $3.0 million, not considered to be a substantive milestone, was received in the third quarter of 2014 and is being recognized as collaboration revenue on a straight-line basis over the estimated performance period through the first quarter of 2018. All remaining contingent payments remained eligible for achievement as of September 30, 2016. During the three and nine months ended September 30, 2016 and 2015, we recognized $3.3 million and $7.4 million and $816,000 and $2.4 million in collaboration revenue including milestone payment under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2016 was $4.9 million. Bayer Pharma, AG (“Bayer”) In February 2016, we entered into an agreement with Bayer to perform an ESS-Study of Japanese ethnicity, perform any further studies requested by the Japanese regulatory authorities and to deliver services, in connection with our collaboration agreement to commercialize andexanet alfa in Japan with BMS and Pfizer. Bayer will reimburse us 33% of our costs and expenses incurred to conduct the ESS-Study and between 33% and 100% of costs and expenses we incur for other studies that involve rivaroxaban under the terms of the arrangement. Pursuant to our agreement with Bayer we are obligated to provide research and development services, provide clinical drug supply and related manufacturing services, provide regulatory approval services and to participate in a JCC in exchange for an upfront nonrefundable fee of $5.0 million. We are also eligible to receive, one contingent payment of $10.0 million which is payable upon the initial regulatory approval for andexanet alfa for rivaroxaban in Japan. The $10.0 million contingent payment will be reduced to $7.0 million if Japanese regulatory approval is attained based only upon the ESS-study results. We concluded that the January 2014 agreement with Bayer and Janssen and February 2016 agreement with Bayer should each be accounted for as standalone agreements. We identified the following non-cancellable performance deliverables under the February 2016 agreement: 1) the obligation to provide research and development services 2) the obligation to provide regulatory approval services, 3) the obligation to manufacture and provide clinical supply of andexanet alfa, and 4) the obligation to participate in the JCC. We considered the provisions of the multiple-element arrangement guidance and determined that none of the deliverables had standalone value, all of these obligations will be delivered throughout the estimated period of performance and accounted for as a single unit of accounting. The total upfront consideration under this agreement is being recognized as collaboration revenue on a straight-line basis over the estimated performance period through the first quarter of 2019. We have determined that the future contingent payment meets the definition of a milestone and that such milestone is substantive in that the consideration is reasonable relative to all of the deliverables and payment terms within the agreement are commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of the milestone will be recognized in the period when the milestone is achieved and collectability is reasonably assured. As of September 30, 2016, no amounts had been recognized as collaboration revenue for any of this milestone and the contingent payment remained eligible for achievement as of September 30, 2016. During the three and nine months ended September 30, 2016we recognized $398,000 and $1.1 million in collaboration revenue under this agreement. The deferred revenue balance under this agreement as of September 30, 2016 was $3.9 million. Ora, Inc. (“Ora”) In May 2015, we entered into a license and collaboration agreement with Ora pursuant to which we granted Ora an exclusive license to co-develop and co-commercialize one of our specific Syk inhibitors, PRT2761. Ora has the primary responsibility for conducting the research and development and regulatory activities under this agreement. We are obligated to provide assistance in accordance with the agreed- upon development plan as well as participate on various committees. Under the terms of this risk and cost sharing agreement, each party will incur its own share of development costs. Third-party related development costs will be shared by Ora and us at approximately 60% and 40%, respectively, until an End of Phase 2 meeting with the FDA, and equally thereafter. We are entitled to receive either 50% of the profits, if any, generated by future sales of the products developed under the agreement or royalty payments on such sales, should we opt out of the agreement. We may opt out of the agreement any time prior to 90 days after an End of Phase 2 meeting with the FDA. The timing of the exercise of our opt out rights would impact future royalties we would be entitled to receive from Ora. Each party may also buy out the rights and interests in the licensed compound by paying the greater of $6.0 million or two times the actual aggregate development cost incurred by both parties before or 90 days after an End of Phase 2 meeting with the FDA. All costs we incur in connection with this agreement will be recognized as research and development expenses. During the three and nine months ended September 30, 2016, we incurred $28,000 and $467,000 of costs related to this agreement, respectively. |