Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2013 |
Collaboration and License Agreements | ' |
7. Collaboration and License Agreements |
Summary of Collaboration Related Revenue |
We have recognized revenue from our collaboration and license agreements as follows (in thousands): |
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| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2013 | | | 2012 | | 2013 | | | 2012 | |
Novartis: | | | | | | | | | | | | | | |
Recognition of upfront license fee | $ | | — | | | $ | | | 738 | | $ | | | — | | | $ | | | 53,846 | |
Reimbursement of research and development expense | | — | | | | — | | | — | | | | 16,238 | |
Novartis total | | — | | | | 738 | | | — | | | | 70,084 | |
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BMS and Pfizer: | | | | | | | | | | | | | | |
Recognition of research and development services | | 772 | | | | — | | | 3,865 | | | | — | |
BMS and Pfizer total | | 772 | | | | — | | | 3,865 | | | | — | |
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Bayer and Janssen: | | | | | | | | | | | | | | |
Recognition of research and development services | | 1,028 | | | | — | | | 3,466 | | | | — | |
Bayer and Janssen total | | 1,028 | | | | — | | | 3,466 | | | | — | |
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Lee’s: | | | | | | | | | | | | | | |
Recognition of research and development services | | 78 | | | | — | | | 130 | | | | — | |
Lee’s total | | 78 | | | | — | | | 130 | | | | — | |
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Daiichi Sankyo: | | | | | | | | | | | | | | |
Recognition of research and development services | | 888 | | | | — | | | 1,013 | | | | — | |
Daiichi Sankyo total | | 888 | | | | — | | | 1,013 | | | | — | |
| | | | | | | | | | | | | | |
Total collaboration and license revenue | $ | | 2,766 | | | $ | | | 738 | | $ | | | 8,474 | | | $ | | | 70,084 | |
Novartis AG (“Novartis”) |
In February 2009, we entered into a license agreement with Novartis to develop and commercialize Elinogrel. We estimated the term of our obligation to participate in the Joint Steering Committee and Joint Development Committee (collectively, the “Committees”) to extend through December 31, 2018. In April 2012, we and Novartis agreed to a plan to return all rights to Elinogrel to Portola and to terminate the exclusive worldwide license agreement effective July 1, 2012. In connection with this plan, the expected term of our obligation to participate in the Committees changed from December 31, 2018 to July 1, 2012. The change in term of the obligation to participate in the Committees was accounted for as a change in accounting estimate on a prospective basis effective April 1, 2012. All remaining deferred revenue was recognized as revenue through July 2012, as no further performance obligations remained upon termination. As of the time of termination, no milestones had been achieved and no royalties had been triggered under our agreement with Novartis. |
Biogen Idec, Inc. (“Biogen Idec”) |
In October 2011, we entered into an exclusive, worldwide license and collaboration agreement with Biogen Idec, under which Portola and Biogen Idec were to jointly develop and commercialize selective, novel oral Syk inhibitors for the treatment of autoimmune and inflammatory diseases. |
In November 2012, we elected to exercise our option under our agreement with Biogen Idec to convert the agreement to a fully out-licensed agreement. After such election, we relinquished our right to share profits from sales of products related to PRT2607 and other selective Syk inhibitors, but are entitled to receive royalties from sales of these products by Biogen Idec. We no longer have the responsibility to fund the program under the agreement. The out-licensed agreement now provides for future payments to us of up to approximately $370.0 million based on the occurrence of certain development and regulatory events. As all contingent consideration payments are based solely on the performance of Biogen Idec, the milestone method of accounting will not be applied to such amounts. Biogen Idec has elected to assume all future development work for Syk inhibitors, including the major indications, such as allergic asthma. This agreement will continue in force until either party terminates the agreement pursuant to the agreement or until the expiration of Biogen Idec’s royalty obligations pursuant to the agreement. Biogen Idec may terminate the agreement without cause upon 120 days’ notice. In such event, we would regain all development rights and Biogen Idec would have no further payment obligations pursuant to the agreement. |
During the three and nine months ended September 30, 2013 and 2012, we recorded a reduction in research and development expense of $227,000 and $721,000, and $1.0 million and $5.9 million, respectively, owed by Biogen Idec to us under the cost-sharing terms of the agreement. |
Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) |
In October 2012, we entered into a three-way agreement with BMS and Pfizer to include subjects dosed with apixaban, their jointly owned product candidate, in one of our Phase 2 proof-of-concept studies of Andexanet alfa. We are responsible for the cost of conducting this clinical study. BMS and Pfizer will work closely with us on both development and regulatory aspects of Andexanet alfa in connection with our Phase 2 proof-of-concept studies to the extent such matters relate to apixaban. Pursuant to our agreement with BMS and Pfizer we are obligated to provide research and development services and participate on various committees. We originally estimated the period of performance of our obligations to extend through June 2013. In March 2013, we revised our estimated period of performance to be through July 2013. In June 2013, we revised our estimated period of performance to be through September 2013. In September 2013, we revised our estimated period of performance to be through October 2013. The effects of these changes in estimates were not significant. |
The total consideration under this agreement of $6.0 million is being recognized as revenue on a straight-line basis over the estimated performance period through October 2013. |
During the three and nine months ended September 30, 2013, we recognized $772,000 and $3.9 million in collaboration revenue, respectively. The deferred revenue balance as of September 30 2013 was $176,000. |
Lee’s Pharmaceutical (HK) Ltd (“Lee’s”) |
In January 2013, we entered into an agreement with Lee’s to jointly expand our Phase 3 APEX Study of Betrixaban into China. Under the terms of the agreement, Lee’s provided us with an upfront and non-refundable fee of $700,000 and will reimburse our costs in connection with the expansion of the APEX study into China. Lee’s will lead this study and the regulatory interactions with China’s State Food and Drug Administration. We granted Lee’s an exclusive option to negotiate for the exclusive commercial rights to Betrixaban in China, which may be exercised by Lee’s for 60 days after it receives the primary data analysis report from the Phase 3 APEX study. |
We identified the following deliverables under the agreement with Lee’s: 1) the granting of an exclusive option to negotiate for the exclusive commercial rights to Betrixaban in China, 2) the obligation to manufacture and supply product in support of the APEX study in China, 3) the obligation to participate in a joint working group, and 4) the delivery of the primary data analysis report from the APEX study. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value and therefore are accounted for as a single unit of accounting with the upfront fee recognized as revenue ratably over the estimated period of performance. Any reimbursements we may receive from Lee’s for the costs we incur in connection with this agreement are expected to be immaterial. |
During the three and nine months ended September 30, 2013, we recognized $78,000 and $130,000, respectively, of collaboration revenue. The deferred revenue balance as of September 30, 2013 was $570,000. |
Aciex Therapeutics, Inc. (“Aciex”) |
In February 2013, we entered into a license and collaboration agreement with Aciex pursuant to which we granted Aciex an exclusive license to co-develop and co-commercialize PRT2070 and certain related compounds for nonsystemic indications, such as the treatment and prevention of ophthalmological diseases by topical administration and allergic rhinitis by intranasal administration. Under the terms of this risk and cost sharing agreement, Portola and Aciex will each incur and report their own internal research and development costs. Further, third-party related development costs will be shared by Aciex and us 60% and 40%, respectively, until the end of the Phase 2 clinical study, and then equally afterwards. Also, we are entitled to receive either one-half of the profits, if any, generated by future sales of the products developed under the agreement, or royalty payments. Aciex has the primary responsibility for conducting the research and development 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. We can opt out of our obligation to share in the development costs at various points in time, the timing of which impacts future royalties we may receive based on product sales made by Aciex. All net costs we incur in connection with this agreement will be recognized as research and development expenses. We have not incurred any such costs during the three and nine months ended September 30, 2013 related to this agreement. |
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 Joint Collaboration Committee (“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 on the JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the revenue associated with these two deliverables. We have accounted for the research and development services and our participation on the JCC as a single unit of accounting as neither deliverable has standalone value and both obligations will be delivered throughout the estimated period of performance. We originally estimated the period of performance to be through November 2013. In June 2013, we revised our estimated period of performance to be through January 2014. In September 2013, we revised our estimated period of performance to be through March 2014. The effect of this change was not significant. The total consideration under this agreement is being recognized as revenue ratably over the estimated performance period through March 2014. |
During the three and nine months ended September 30, 2013, we recognized $1.0 million and $3.5 million in collaboration revenue, respectively. The deferred revenue balance as of September 30, 2013 was $1.5 million. |
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 will provide us with an upfront fee of $6.0 million, $3.0 million of which is subject to refund should Daiichi Sankyo decide to terminate the agreement. We are obligated to participate on 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 on the JCC. |
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We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the revenue associated with these two deliverables. We have accounted for the research and development services and our participation on the JCC as a single unit of accounting as neither deliverable has standalone value and both obligations will be delivered throughout the estimated period of performance through May 2014. The total non-contingent consideration under this agreement of $3.0 million is being recognized as |
revenue ratably over the estimated non-contingent performance period through May 2014. The contingent consideration under this agreement of $3.0 million will be recognized after the contingency is resolved over the remaining performance period, which is currently estimated to begin in May 2014 and conclude in October 2014. |
During the three and nine months ended September 30, 2013, we recognized $888,000 and $1.0 million, respectively, in collaboration revenue associated with the non-contingent element of the arrangement. The contingent element of the arrangement of $3.0 million and the unearned portion of the non-contingent element of the arrangement of $2.0 million was recorded as deferred revenue as of September 30, 2013. |