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Co-Development and License Agreement | 9 Months Ended
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Sep. 30, 2017
Co Development And License Agreement Disclosure [Abstract] |
Co-Development and License Agreement | NOTE 6 — CO-DEVELOPMENT AND LICENSE AGREEMENT On February 13, 2014, the Company signed a co-development and license agreement (“the agreement”) with Janssen, which became effective upon completion of the Company’s initial public offering and the payment of a $22.0 million license fee. Under the agreement, Janssen, the licensor, granted the Company an exclusive license, with the right to sublicense, in the Minerva Territory, under (i) certain patent and patent applications to sell products containing any orexin 2 compound, controlled by the licensor and claimed in a licensor patent right as an active ingredient and (ii) seltrorexant for any use in humans. In addition, upon regulatory approval in the Minerva Territory (and earlier if certain default events occur), the Company will have rights to manufacture seltrorexant, also known as JNJ-42847922. The Company has granted to the licensor an exclusive license, with the right to sublicense, under all patent rights and know-how controlled by the Company related to seltrorexant to sell seltrorexant outside the Minerva Territory. In consideration of the licenses granted on July 7, 2014, the Company made a license fee payment of $22.0 million, which was included as a component of research and development expense in 2014. The original agreement contains certain provisions, which include the Company’s ability to opt-out of the agreement upon completion of certain milestones. If the Company elects to participate in the development program through to the potential commercial approval of seltorexant, the Company will pay a quarterly royalty percentage to the licensor in the high single digits on aggregate net sales for seltrorexant products sold by the Company, its affiliates and sublicensees in the Minerva Territory. The licensor will pay a quarterly royalty percentage to the Company in the high single digits on aggregate net sales for seltrorexant products sold by the licensor outside the Minerva Territory. In accordance with the development agreement, the Company will pay 40% of seltrorexant development costs related to the joint development of any seltrorexant products. The Company’s share of aggregate development costs shall not exceed (i) $5.0 million for the period beginning from the effective date of the license and ending following the completion of certain Phase 1b clinical trials and animal toxicology studies, and (ii) $24.0 million for the period beginning from the effective date of the license and ending following the completion of certain Phase 2 clinical trials. Janssen has a right to opt out at the end of certain development milestones, after which, Janssen will not have to fund further development of seltrorexant and the Minerva Territory will be expanded to also include all of North America. The Company would then owe Janssen a reduced royalty in the mid-single digits for all sales in the Minerva Territory. Janssen may also terminate the agreement for the Company’s material breach or certain insolvency events, including if the Company is unable to fund its portion of the development costs. The Company accounts for the co-development and license agreement as a joint risk-sharing collaboration in accordance with ASC 808, Collaboration Arrangements. Payments between the Company and the licensor with respect to each party’s share of seltrorexant development costs that have been incurred pursuant to the joint development plan are recorded within research and development expenses or general and administrative expenses, as applicable, in the accompanying consolidated statements of operations due to the joint risk-sharing nature of the activities. The Company has included zero million and $2.5 million in accrued collaborative expenses, as of September 30, 2017 and December 31, 2016, respectively, related to this agreement. In the nine months ended September 30, 2017 and 2016, the Company paid $2.5 million and zero, respectively, related to development activities under this agreement. On July 6, 2016, the Company and Janssen agreed that “Decision Point 2” had been reached as defined under the co-development agreement. As neither party has exercised their right to withdraw from the agreement, the Company has paid Janssen $3.5 million and have incurred direct expenses of $0.3 million related to development activities under the current phase of development. During the three months ended September 30, 2017 and 2016, the Company recorded an expense of $4.5 million and $3.5 million, respectively, for certain development activities in accordance with the terms of the co-development agreement. During the nine months ended September 30, 2017 and 2016, the Company recorded an expense of $11.2 million and $3.5 million, respectively, for certain development activities in accordance with the terms of the co-development agreement. The company has included zero and $2.5 million in accrued collaborative expenses as of September 30, 2017 and December 31, 2016, respectively, related to this agreement. In June 2017, the Company entered into the Amendment. The effectiveness of the Amendment was contingent upon approval of its terms by the European Commission and the closing of the acquisition of Actelion by affiliates of Janssen. These conditions were subsequently met, and the agreement became effective on August 29, 2017. Under the amended agreement, Janssen has waived its right to royalties on seltorexant insomnia sales in the European Union, Switzerland, Liechtenstein, Iceland and Norway (the “Minerva Territory”). The Company retains all of its rights to seltorexant, including commercialization of the molecule for the treatment of insomnia and as an as adjunctive therapy for MDD, which include an exclusive license in the Minerva Territory, with royalties payable by the Company to Janssen on seltorexant MDD sales. Royalties on sales outside of the Minerva Territory are payable by Janssen to the Company. Janssen made an upfront payment to the Company of $30 million upon the effectiveness of the Amendment and agreed to make a $20 million payment at the start of a Phase 3 insomnia trial for seltorexant and a $20 million payment when 50% of the patients are enrolled in this trial. Janssen further agreed to waive the remaining payments due from the Company until completion of the Phase 2 development of seltorexant. The $30 million payment and $11.2 million in previously accrued collaborative expenses, which were forgiven upon the effective date of the agreement, will be earned and recognized as revenue as the services are performed from the commencement of Phase 3 development to the completion of the development activities using the proportional performance method. The $30 million payment along with the $11.2 million in previously accrued collaborative expenses have been included under Deferred Revenue on the Company’s balance sheet at September 30, 2017. In connection with the Amendment, the Company repurchased all of the approximately 3.9 million shares of its common stock previously owned by Johnson & Johnson Innovation-JJDC Inc. at a per share price of $0.0001, for an aggregate purchase price of approximately $389. As a result of the Amendment, the Company assumed strategic control for the clinical development of seltorexant in insomnia under the Phase 2 development program, but has no further financial obligations until the Phase 2b development milestone is complete, which is expected to occur in the second half of 2019. Upon completion of this development milestone, referred to as “Decision Point 4”, Minerva has the right to opt-out of the agreement and collect a royalty on worldwide sales of seltorexant in the single digits with no further obligations to Janssen. If the Company elects to continue to Phase 3, the Company would be obligated to fund the clinical trials related to insomnia, and receive $40 million in milestone payments from Janssen, and would also be responsible for 40% of Janssen’s development costs in their Phase 3 MDD program.

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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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