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Significant Collaboration and Licensing Agreements | 9 Months Ended
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Sep. 30, 2019
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Significant Collaboration and Licensing Agreements | 2. Significant Collaboration and Licensing Agreements Voyager. We entered into a collaboration and license agreement with Voyager, a clinical-stage gene therapy company, which became effective in March 2019. The agreement is focused on the development and commercialization of four programs using Voyager’s proprietary gene therapy platform. The four programs consist of the VY-AADC program for Parkinson’s disease, the VY-FXN01 program for Friedreich’s ataxia and the rights to two programs to be determined by the parties in the future. In connection with the agreement, we paid Voyager $115.0 million upfront and purchased $50.0 million of Voyager’s common stock at $11.9625 per share, representing approximately 4.2 million shares. Pursuant to the terms of the agreement, Voyager may also be entitled to an additional $1.7 billion in development, regulatory and commercial milestone payments across the four programs, as well as royalties on net sales of any collaboration product. Pursuant to development plans agreed to by us and Voyager, unless Voyager exercises its co-development and co-commercialization rights as provided for in the agreement, we will be responsible for all development costs. Further, upon the occurrence of a specified event for each program, we will assume responsibility for the development, manufacturing, and commercialization activities of such program. We accounted for the transaction as an asset acquisition as the set of acquired assets did not constitute a business. Our equity investment in Voyager was recorded at a fair value of $54.7 million after considering Voyager’s stock price on the date of closing and certain lock-up and voting provisions applicable to the acquired shares. The remaining $113.1 million of the purchase price, which includes the applicable transaction costs, was expensed as in-process research and development (IPR&D) in the first quarter of 2019. In June 2019, we entered into an amendment to the collaboration and license agreement with Voyager. Under the terms of the amendment, we paid Voyager $5.0 million upfront to obtain rights outside the United States (U.S.) to the Friedreich’s ataxia program, VY-FXN01, in connection with the early return of those rights to Voyager pursuant to a restructuring of Voyager’s gene therapy relationship with Sanofi Genzyme. The upfront payment was expensed as IPR&D in the second quarter of 2019. We may terminate the collaboration and license agreement with Voyager upon 180 days written notice to Voyager prior to the first commercial sale of any collaboration product or upon 1 year after the date of notice if such notice is provided after the first commercial sale of any collaboration product. Unless terminated earlier, the agreement will continue in effect until the expiration of the last to expire royalty term with respect to any collaboration product or the last expiration or termination of any exercised co-development and co-commercialization rights by Voyager as provided for in the agreement. BIAL – Portela & Ca, S.A. In February 2017, we entered into an exclusive license agreement with BIAL – Portela & Ca, S.A. (BIAL) for the development and commercialization of opicapone for the treatment of human diseases and conditions, including as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in adult Parkinson's disease patients, in the U.S. and Canada. In connection with the agreement, we paid BIAL an upfront license fee of $30.0 million and agreed to make additional regulatory event-based milestone payments of up to $40.0 million, of which $20.0 million has been paid as of September 30, 2019, and up to an additional $75.0 million in commercial event-based milestone payments. In the second quarter of 2019, we submitted a new drug application (NDA) with the FDA for opicapone as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in adult Parkinson's disease patients. The NDA was accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 26, 2020. The FDA’s acceptance of the NDA triggered a milestone payment of $10.0 million, expensed as R&D in the second quarter of 2019 and pa id by us to BIAL in the third quarter of 201 9. Mitsubishi Tanabe Pharma Corporation. In March 2015, we entered into a collaboration and license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of INGREZZA® (valbenazine) for movement disorders in Japan and other select Asian markets. In connection with the agreement, MTPC made an upfront payment of $30.0 million and agreed to make an additional $85.0 million in development and regulatory event-based milestone payments, payments for the manufacture of pharmaceutical products and royalties on product sales in select territories in Asia. Since inception of the agreement, we have recognized revenue of $19.8 million associated with the delivery of a technology license and existing know-how and $15.0 million in development event-based milestone payments resulting from MTPC’s initiation of Phase II/III clinical trials of INGREZZA in TD in Asia. In accordance with our continuing performance obligations, at the inception of the agreement, $10.2 million of the $30.0 million upfront payment received was originally deferred in connection with our initiation of a clinical trial of valbenazine in Huntington’s chorea and will be recognized as revenue over the clinical trial period. In September 2019, we announced the initiation of the KINECT-HD study, a placebo-controlled Phase III study of valbenazine in adult Huntington’s disease (HD) patients with chorea. Under the terms of the agreement, any payment we receive is generally non-refundable. AbbVie. In June 2010, we entered into an exclusive worldwide collaboration with AbbVie to develop and commercialize elagolix and all next-generation gonadotropin-releasing factor antagonists for women’s and men’s health. In connection with the agreement, AbbVie made an upfront payment of $75.0 million and agreed to make additional development and regulatory event-based milestone payments of up to $480.0 million, of which $135.0 million has been earned as of September 30, 2019, and up to an additional $50.0 million in commercial event-based milestone payments. In the third quarter of 2019, AbbVie submitted an NDA with the FDA for the approval of elagolix in the treatment of uterine fibroids. The NDA was accepted by the FDA with a PDUFA target action date in the second quarter of 2020. The FDA’s acceptance of the NDA triggered a milestone payment of $20.0 million, recognized as revenue in the third quarter of 2019 and payable to us by AbbVie in the fourth quarter of 2019.

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