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Collaborative and Other Relationships | 6 Months Ended
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Jun. 30, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
Collaborative and Other Relationships | Collaborative and Other Relationships Bristol-Myers Squibb Company On April 13, 2017, we entered into an agreement to exclusively license BMS-986168, a Phase 2-ready experimental medicine with potential in Alzheimer’s disease (AD) and progressive supranuclear palsy (PSP), from Bristol-Myers Squibb Company (BMS). BMS-986168 is an antibody targeting tau, the protein that forms the deposits, or tangles, in the brain associated with AD and other neurodegenerative tauopathies such as PSP. PSP is a rare condition that affects movement, speech, vision and cognitive function. The transaction closed on June 1, 2017 and, in connection with the closing, we made an upfront payment to BMS of $300.0 million. Following the closing, we now refer to BMS-986168 as BIIB092. Under the agreement, we received worldwide rights to BIIB092 and are responsible for the full development and global commercialization of BIIB092 in AD and PSP. We may pay BMS up to $410.0 million in additional milestone payments, and potential royalties. We also assumed all remaining obligations to the former stockholders of iPierian, Inc. (iPierian) related to BMS’s acquisition of iPierian in 2014. In June 2017 we triggered a $60.0 million developmental milestone payable to the former stockholders of iPierian upon dosing of the first patient in the Phase 2 PSP study for BIIB092 and we may pay the former stockholders of iPierian up to $490.0 million in remaining milestone payments, and potential royalties. Both the $300.0 million upfront payment and the $60.0 million developmental milestone payment were recognized as research and development expense in our condensed consolidated statements of income for the three and six months ended June 30, 2017. AbbVie Inc. We have a collaboration agreement with AbbVie Inc. (AbbVie) aimed at advancing the development and commercialization of ZINBRYTA in MS, which was approved for the treatment of relapsing forms of MS in the U.S. in May 2016 and in the E.U. in July 2016. Under the agreement, we and AbbVie conduct ZINBRYTA co-promotion activities in the U.S., E.U. and Canadian territories (Collaboration Territory), where development and commercialization costs and profits are shared equally. Outside of the Collaboration Territory, we are solely responsible for development and commercialization of ZINBRYTA and will pay a tiered royalty to AbbVie as a percentage of net sales in the low to high teens. Co-promotion Profits and Losses In the U.S., AbbVie recognizes revenues on sales to third parties and we recognize our 50% share of the co-promotion profits or losses as a component of total revenues in our condensed consolidated statements of income. The collaboration began selling ZINBRYTA in the U.S. in the third quarter of 2016. During the three and six months ended June 30, 2017, we recognized a net reduction in revenue of $3.9 million and $9.8 million, respectively, to reflect our share of an overall net loss within the collaboration. In the E.U. and Canada, we recognize revenues on sales to third parties in product revenues, net in our condensed consolidated statements of income. We also record the related cost of revenues and sales and marketing expenses to their respective line items in our condensed consolidated statements of income as these costs are incurred. We reimburse AbbVie for their 50% share of the co-promotion profits or losses in the E.U. and Canada. This reimbursement is recognized in collaboration profit (loss) sharing in our condensed consolidated statements of income. We began to recognize product revenues on sales of ZINBRYTA in the E.U. in the third quarter of 2016. For the three and six months ended June 30, 2017, we recognized net expense of $1.3 million to reflect AbbVie's 50% sharing of the net collaboration profits in the E.U. and Canada. Ionis Pharmaceuticals, Inc. SPINRAZA (nusinersen) In January 2012 we entered into an exclusive worldwide option and collaboration agreement with Ionis Pharmaceuticals, Inc. (Ionis) under which both companies develop and commercialize the antisense investigational drug candidate, SPINRAZA, for the treatment of SMA. Under the terms of the agreement, during the third quarter of 2016, we exercised our option to develop and commercialize SPINRAZA and paid Ionis a $75.0 million license fee in connection with the option exercise. This amount was recognized as research and development expense in our condensed consolidated statements of income. In December 2016 SPINRAZA was approved by the FDA for the treatment of SMA in pediatric and adult patients in the U.S. triggering a $60.0 million milestone payment due to Ionis, which was capitalized in intangible assets, net in our condensed consolidated balance sheets. This amount was paid during the first quarter of 2017. In June 2017 SPINRAZA was approved by the European Commission for the treatment of SMA in pediatric and adult patients in the E.U. triggering a $50.0 million milestone payment due to Ionis, which was capitalized in intangible assets, net in our condensed consolidated balance sheets as of June 30, 2017. In July 2017 the Japanese Ministry of Health, Labor and Welfare approved SPINRAZA for the treatment of infantile SMA, triggering an additional $40.0 million milestone payment due to Ionis, which we will capitalize in intangible assets, net in our condensed consolidated balance sheets in the third quarter of 2017. For the three and six months ended June 30, 2017, we recognized revenues totaling $194.8 million and $241.2 million, respectively, on our sales of SPINRAZA in the U.S. and $8.1 million and $9.1 million, respectively, on our sales of SPINRAZA outside of the U.S. Pursuant to our agreement with Ionis, we make royalty payments to Ionis on annual worldwide net sales of SPINRAZA using a tiered royalty rate between 11% and 15%. Samsung Bioepis Joint Venture Agreement In February 2012 we entered into a joint venture agreement with Samsung Biologics, establishing an entity, Samsung Bioepis, to develop, manufacture and market biosimilar pharmaceuticals. As of June 30, 2017, our ownership interest was approximately 5%, which reflects the effect of additional equity financings in which we did not participate. We maintain an option to purchase additional stock in Samsung Bioepis that would allow us to increase our ownership percentage up to 49.9%. The exercise of this option is within our control. We recognize our share of the results of operations related to our investment in Samsung Bioepis one quarter in arrears when the results of the entity become available, which is reflected as equity in loss of investee, net of tax in our condensed consolidated statements of income. During 2015, as our share of losses exceeded the carrying value of our investment, we suspended recognizing additional losses and will continue to do so unless we commit to providing additional funding. Commercial Agreement We began to recognize revenue on sales of BENEPALI and FLIXABI in the E.U. in the first and third quarters of 2016, respectively. We reflect revenues on sales of BENEPALI and FLIXABI to third parties in product revenues, net in our condensed consolidated statements of income and record the related cost of revenues and sales and marketing expenses in our condensed consolidated statements of income to their respective line items when these costs are incurred. We share 50% of the profit or loss in accordance with the cost sharing provision of the commercial agreement with Samsung Bioepis. This profit share with Samsung Bioepis is recognized in collaboration profit (loss) sharing in our condensed consolidated statements of income. For the three and six months ended June 30, 2017, we recognized a net expense of $25.2 million and $46.0 million, respectively, to reflect Samsung Bioepis's 50% sharing of the net collaboration profits, as compared to net income of $5.6 million to reflect sharing of the net collaboration losses in both of the prior year comparative periods. Other Services Simultaneous with the formation of Samsung Bioepis, we also entered into a license agreement, a technical development services agreement and a manufacturing agreement with Samsung Bioepis. For the three and six months ended June 30, 2017, we recognized $12.7 million and $14.9 million, respectively, in connection with these services as a component of other revenues in our condensed consolidated statements of income, as compared to $14.2 million and $16.9 million, respectively, in the prior year comparative periods. For additional information related to these and our other significant collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2016 Form 10-K.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -URI http://asc.fasb.org/topic&trid=5833765 + Details
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