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Collaboration and License Agreements
9 Months Ended
Sep. 30, 2017
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
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,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

BMS and Pfizer

 

$

1,038

 

 

$

1,798

 

 

$

3,824

 

 

$

4,785

 

Daiichi Sankyo

 

 

2,034

 

 

 

3,810

 

 

 

6,227

 

 

 

8,491

 

Bayer and Janssen

 

 

544

 

 

 

3,316

 

 

 

1,880

 

 

 

7,431

 

Bayer

 

 

212

 

 

 

398

 

 

 

812

 

 

 

1,052

 

Other

 

 

 

 

 

 

 

 

 

 

 

52

 

Total collaboration and license revenue

 

$

3,828

 

 

$

9,322

 

 

$

12,743

 

 

$

21,811

 

 

Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”)

In 2014, we entered into an agreement with BMS and Pfizer to study andexanet alfa as a reversal agent to apixaban in our Phase 3 studies. As of September 30, 2017, we have no further milestone payments eligible for achievement under this agreement and continue to recognize the non-contingent payments received on a straight-line basis over the period of performance, which is estimated to be through the third quarter of 2018. In the second quarter of 2017, we updated our estimated period of performance from the first quarter of 2018 to the third quarter of 2018 to reflect a modification to our clinical development and regulatory plans. The effect of this change in estimate was not significant. During the three and nine months ended September 30, 2017 and 2016, we recognized $0.4 million and $1.4 million, and $0.6 million and $1.6 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2017 was $9.8 million.  

In 2016, we entered into an agreement with BMS and Pfizer whereby they obtained exclusive rights to develop and commercialize andexanet alfa in Japan and we are responsible for certain research, development and manufacturing activities. As of September 30, 2017, we have milestone payments totaling up to $20.0 million that remain eligible for achievement upon certain regulatory events and up to $70.0 million which may be earned upon the achievement of specified annual net sales volumes in Japan in addition to royalties ranging from 5% to 15% on net sales of andexanet alfa in Japan. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the fourth quarter of 2020. In the second quarter of 2017, we updated our estimated period of performance from the first quarter of 2019 to the fourth quarter of 2020 to reflect a modification to our clinical development and regulatory plans. The effect of this change in estimate was not significant. During the three and nine months ended September 30, 2017 and 2016, we recognized $0.6 million and $2.4 million, and $1.2 million and $3.2 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2017 was $8.2 million.

Daiichi Sankyo, Inc. (“Daiichi Sankyo”)

In 2014, as amended in 2016, we entered into an agreement with Daiichi Sankyo to study andexanet alfa as a reversal agent to edoxaban. As of September 30, 2017, we have milestone payments totaling up to $12.5 million that remain eligible for achievement upon the occurrence of certain clinical events and patient enrollment targets.  We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the third quarter of 2018. The $8.0 million refundable portion of the upfront consideration is recorded as an obligation to collaborator and will be relieved as we make royalty payments or written off should we fail to commercialize andexanet alfa. During the three and nine months ended September 30, 2017 and 2016, we recognized $1.8 million and $5.4 million, and $3.4 million and $7.7 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2017 was $7.2 million.

In 2016 we entered into an agreement with Daiichi Sankyo associated with the pursuit of regulatory approval of andexanet alfa as a reversal agent to edoxaban in Japan. As of September 30, 2017, we have milestone payments totaling up to $10.0 million eligible for achievement upon initial and final regulatory approval of andexanet alfa as a reversal agent to edoxaban in Japan. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the fourth quarter of 2020. In the second quarter of 2017, we updated our estimated period of performance from the first quarter of 2019 to the fourth quarter of 2020 to reflect a modification to our clinical development and regulatory plans. The effect of this change in estimate was not significant. During the three and nine months ended September 30, 2017 and 2016, we recognized $0.2 million and $0.9 million, and $0.4 million and $0.8 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2017 was $2.9 million.  

Bayer Pharma, AG (“Bayer”) and Janssen Pharmaceuticals, Inc. (“Janssen”)

In 2014, we entered into an agreement with Bayer and Janssen to study andexanet alfa as a reversal agent to rivaroxaban in our Phase 3 studies. As of September 30, 2017, we have milestone payments totaling up to $5.0 million that remain eligible for achievement upon the occurrence of certain events associated with scaling up our manufacturing process. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the third quarter of 2018. In the second quarter of 2017 we updated our estimated period of performance from the first quarter of 2018 to the third quarter of 2018 to reflect a modification to our clinical development and regulatory plans. The effect of this change in estimate was not significant. During the three and nine months ended September 30, 2017 and 2016, we recognized $0.5 million and $1.9 million, and $3.3 million and $7.4 million in collaboration revenue, including milestone payments under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2017 was $2.2 million.

Bayer Pharma, AG (“Bayer”)

In 2016, we entered into an agreement with Bayer associated with the pursuit of regulatory approval of andexanet alfa as a reversal agent to rivaroxaban in Japan. As of September 30, 2017, the $10.0 million milestone payment associated with regulatory approval of andexanet alfa as a reversal agent to rivaroxaban in Japan remains eligible for achievement. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the fourth quarter of 2020. In the second quarter of 2017, we updated our estimated period of performance from the first quarter of 2019 to the fourth quarter of 2020 to reflect a modification to our clinical development and regulatory plans. The effect of this change in estimate was not significant. During the three and nine months ended September 30, 2017 and 2016, we recognized $0.2 million and $0.8 million, and $0.4 million and $1.1 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2017 was $2.7 million.