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Significant Collaboration and Licensing Agreements
 9 Months Ended
Sep. 30, 2021
Business Combinations [Abstract]  
Significant Collaboration and Licensing Agreements Significant Collaboration and Licensing Agreements
Takeda Pharmaceutical Company Limited, or Takeda. We entered into an exclusive license agreement with Takeda, which became effective in July 2020, to develop and commercialize certain compounds in Takeda’s early to mid-stage psychiatry pipeline. Specifically, Takeda granted us an exclusive license to (i) luvadaxistat (NBI-1065844/TAK-831) which we are studying in cognitive impairment associated with schizophrenia, (ii) NBI-1065845 (TAK-653) which we are studying in inadequate response to treatment in major depressive disorder, (iii) NBI-1065846 (TAK-041) which we are studying in anhedonia in depression and (iv) four non-clinical stage assets. Under the terms of the agreement, Takeda may be entitled to receive potential future payments of up to $1.9 billion upon the achievement of certain milestones associated with luvadaxistat and the four non-clinical stage assets, as well as receive royalties on the future net sales of such assets.
With respect to luvadaxistat, Takeda declined to opt-in to a profit-sharing arrangement and instead will be entitled to receive royalties on the future net sales of such asset (in lieu of equally sharing in the operating profits and losses).
With respect to NBI-1065845 and NBI-1065846, Takeda will retain the rights to opt-out of the profit-sharing arrangements pursuant to which Takeda would be entitled to receive royalties on the future net sales of such asset (in lieu of equally sharing in the operating profits and losses). Takeda may elect to exercise such opt-out rights immediately following the completion of the associated second Phase II clinical study or, under certain circumstances related to the development and commercialization activities to be performed by us, before the initiation of a Phase III clinical study for such asset. We and Takeda will equally share in the operating profits and losses associated with NBI-1065845 and NBI-1065846.
Idorsia Pharmaceuticals Ltd., or Idorsia. In May 2020, we entered a collaboration and licensing agreement with Idorsia to license the global rights to NBI-827104 (ACT-709478), a potent, selective, orally active and brain penetrating T-type calcium channel blocker, in clinical development for the treatment of a rare pediatric epilepsy. Under the terms of the agreement, Idorsia may be entitled to receive potential future payments of up to $1.7 billion upon the achievement of certain milestones as well as receive royalties on the future net sales of any collaboration product.
Xenon Pharmaceuticals Inc., or Xenon. In December 2019, we entered into a license and collaboration agreement with Xenon to identify, research, and develop sodium channel inhibitors, including clinical candidate NBI-921352 (XEN901) and three preclinical candidates. Under the terms of the agreement, Xenon may be entitled to receive potential future payments of up to $1.7 billion upon the achievement of certain milestones as well as receive royalties on the future net sales of any collaboration product.
In September 2021, we received approval of a clinical trial application, or CTA, submitted in the European Union for NBI-921352 for the treatment of focal-onset seizures in adults. In connection with the approval of the CTA for NBI-921352, we paid Xenon a regulatory milestone of $10.0 million, of which we expensed $4.5 million as research and development in the third quarter of 2021, and purchased 0.3 million shares of Xenon’s common stock (at $19.9755 per share) for $5.5 million. The purchased shares were recorded at a fair value of $4.6 million after considering Xenon’s stock price on the measurement date and certain transfer restrictions applicable to the shares. Further, we recorded a charge of $0.9 million to research and development to reflect the premium paid on our purchase of the shares on the measurement date.
Voyager Therapeutics, Inc., or Voyager. We entered into a collaboration and license agreement with Voyager, which became effective in March 2019, to develop and commercialize four programs using Voyager’s proprietary gene therapy platform. The four programs consist of the NBIb-1817 (VY-AADC) for Parkinson’s disease program, the Friedreich’s ataxia program and the rights to two undisclosed programs. In February 2021, we notified Voyager of our termination of the NBIb-1817 for Parkinson’s disease program, which became effective August 2, 2021. The termination does not apply to any other development program other than NBIb-1817 for Parkinson’s disease, and our collaboration and license agreement with Voyager will otherwise continue in effect. Under the terms of the agreement, Voyager may be entitled to receive potential future payments of up to $1.3 billion upon the achievement of certain milestones, as well as receive royalties on the future net sales of any collaboration product.
BIAL – Portela & Ca, S.A., or BIAL. In February 2017, we entered into an exclusive license agreement with BIAL to acquire the United States, or US, and Canada rights to ONGENTYS® (opicapone). Under the terms of the agreement, BIAL may be entitled to receive potential future payments of up to $75.0 million upon the achievement of certain milestones.
We launched ONGENTYS in the US in September 2020, after receiving FDA approval for ONGENTYS as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in adult Parkinson's disease patients in April 2020.
Mitsubishi Tanabe Pharma Corporation, or MTPC. In March 2015, we entered into a collaboration and license agreement with MTPC for the development and commercialization of INGREZZA® (valbenazine) for movement disorders in Japan and other select Asian markets. Under the terms of the agreement, we are entitled to receive royalties on the future worldwide net sales of any collaboration product in select territories in Asia and may also be entitled to receive potential future payments of up to $55.0 million upon the achievement of certain milestones.
In April 2021, MTPC submitted a marketing authorization application, or MAA, with the Ministry of Health and Welfare in Japan for valbenazine for the treatment of tardive dyskinesia. The MTPC submission of the MAA for valbenazine triggered a milestone payment of $15.0 million, which we recognized as milestone revenue in the second quarter of 2021.
We are currently conducting the KINECT-HD study, a placebo-controlled Phase III study of valbenazine in adult Huntington disease patients with chorea. In connection with our performance of the study, we recognized non-cash collaboration revenue of $0.9 million and $3.3 million, respectively, in the three and nine months ended September 30, 2021, and $0.5 million and $1.8 million, respectively, in the three and nine months ended September 30, 2020. As of September 30, 2021, $3.5 million of revenue is being deferred in connection with our continuing performance obligations under the collaboration and will be recognized as non-cash collaboration revenue over the remaining study period using an input method according to costs incurred to-date relative to estimated total costs associated with the study.
AbbVie Inc., or 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. Under the terms of the agreement, we are entitled to receive royalties on the future worldwide net sales of any collaboration product and may also be entitled to receive potential future payments of up to $366.0 million upon the achievement of certain milestones.
AbbVie launched ORILISSA® (elagolix tablets) in the US and Canada in August and November 2018, respectively. In June 2020, AbbVie launched ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) in the US. We receive royalties at tiered percentage rates on AbbVie net sales of elagolix. We recognized elagolix royalty revenue of $5.9 million and $16.3 million, respectively, in the three and nine months ended September 30, 2021, and $3.9 million and $13.4 million, respectively, in the three and nine months ended September 30, 2020.