Collaboration and License Agreement | 4. Collaboration and License Agreement Sanofi (Aventis Inc.) In August 2014, the Company entered into the Collaboration Agreement with Aventis Inc., a wholly-owned subsidiary of Sanofi S.A., for the research, development and potential commercialization of pharmaceutical products for the treatment, prevention and diagnosis of hypertrophic and dilated cardiomyopathy, as well as potential additional indications. Pursuant to the Collaboration Agreement, in addition to potential future royalty payments, Sanofi agreed to provide up to $200.0 million in financial consideration to the Company consisting of the following components: 1. a $35.0 million upfront cash payment 2. a $10.0 million initial equity investment 3. a $25.0 million milestone-based contingent payment 4. up to an $85.0 million project continuation payment if Sanofi elects to extend the term of the research collaboration beyond December 31, 2016, as described below 5. up to $45.0 million in funding from Sanofi of approved in-kind research and clinical activities over a four-year period. The Company is also entitled to receive tiered royalties beginning in the mid-single digits to the mid-teens on net sales of certain hypertrophic cardiomyopathy (“HCM”) and dilated cardiomyopathy (“DCM”) finished products outside the United States and on net sales of certain DCM finished products in the United States. Sanofi is eligible to receive tiered royalties beginning in the mid-single digits to the low teens on the Company’s net sales of certain HCM finished products in the United States. In addition, under the terms of the Collaboration Agreement, Sanofi may reimburse the Company for a portion of the registration program costs for mavacamten. These registration costs will be reimbursed under the Registration Program Plan approved in October 2017. The Collaboration Agreement covers three main research programs, “HCM1” (or HCM-1 or mavacamten, formerly known as MYK-461), “HCM2” (or HCM-2) and “DCM1” (or DCM-1 or MYK-491). The Company is solely responsible for conducting research and development activities through early human efficacy studies, except for specified research activities to be conducted by Sanofi. The estimated completion of proof-of-concept phases are staggered, depending on the program. Thereafter, the Company will lead worldwide development and United States commercial activities for the mavacamten and HCM-2 programs, Sanofi will lead global development and commercial activities for DCM-1 and Sanofi will lead ex-United States development and commercial activities for the mavacamten and HCM-2 programs where it has ex-United States commercialization rights. Sanofi also has the option to co-promote in the U.S. for potential expanded cardiovascular diseases outside of the genetically targeted indications for the mavacamten and HCM-2 programs, with the Company having the option to co-promote the DCM-1 program in the United States. The Company accounted for the Collaboration Agreement by evaluating each of the financial components discussed above: 1. $35.0 million upfront payment. The Company received a non-refundable upfront payment and identified the following performance obligations at the inception of the Collaboration Agreement: (i) the transfer of intellectual property rights and know-how (license), (ii) the obligation to provide certain limited research and development services during the term of the license agreement and (iii) the obligation to participate on the development and commercialization committees. The Company applied the guidance under ASC 605-25, Multiple Element Arrangements, to account for this upfront payment. The Company evaluated the underlying goods and services delivered under the Collaboration Agreement and concluded that the performance obligations do not have standalone value, and accordingly accounted for the deliverables as one unit of accounting. The $35.0 million payment was recorded by the Company as deferred revenue on its consolidated balance sheet upon receipt, which the Company was recognizing as revenue on a straight-line basis over the expected term of research and development services through December 31, 2016 because there was not a more discernible pattern of performance in which the research and development services occurred. During the three months ended September 30, 2017 and 2016, the Company recognized zero and $3.6 million, respectively, and during the nine months ended September 30, 2017 and 2016, the Company recognized zero and $10.6 million of revenue, respectively, related to the $35.0 million upfront payment under the Collaboration Agreement. As of September 30, 2017 and December 31, 2016, the Company did not have any deferred revenue on its consolidated balance sheet related to this upfront payment. 2. $10.0 million upfront investment in Series A-1 redeemable convertible preferred stock. In August 2014, the Company entered into a Series A-1 redeemable convertible preferred stock purchase agreement with Sanofi. The Agreement was signed as a separate transaction from the Collaboration Agreement. Pursuant to the stock purchase agreement, the Company sold 6,666,667 shares of Series A-1 redeemable convertible preferred stock to Sanofi at $1.50 per share. The Company concluded that the $1.50 per share price represented the fair value of the redeemable convertible preferred stock issued. As of September 30, 2017, Sanofi owned 11.2% of the Company’s common stock. 3. $25.0 million milestone-based payment. The Company was eligible to receive a one-time, non-refundable, non-creditable payment of $25.0 million upon the submission of an investigational new drug application for any DCM-1 development candidate to the FDA or a comparable regulatory authority in Europe or another major market country for any DCM-1 product. The Company accounted for this milestone payment separately from the rest of the agreement. The Company has determined that the milestone was substantive as it was achieved based upon the Company’s past performance. The Company achieved this milestone in October 2016 and as a result, recognized the $25.0 million milestone payment from Sanofi as revenue during the year ended December 31, 2016. 4. Up to $85.0 million continuation payments. Under the Collaboration Agreement, Sanofi needed to determine by December 31, 2016 whether or not to continue the Collaboration Agreement. Under the terms of the Collaboration Agreement, if Sanofi so elected to continue the Collaboration Agreement, it would be obligated to pay: • a one-time, non-refundable, non-creditable cash payment of $45.0 million; and • an additional $40.0 million reduced by $5.0 million in connection with the purchase of the Company’s preferred stock, assuming the Company has not previously closed (i) either a Qualified IPO (at which time this obligation will terminate) or a private financing prior to a Qualified IPO and (ii) Sanofi has not previously purchased shares of the Company’s stock pursuant to such rights to purchase the Company’s capital stock in accordance with the terms of the Collaboration Agreement. The $40.0 million payment was reduced by $5.0 million to $35.0 million in connection with Sanofi’s subsequent purchase of shares of the Company’s Series B redeemable convertible preferred stock in April 2015, and the remaining obligation terminated in connection with the Company’s IPO in October 2015. Sanofi elected to continue the Collaboration Agreement in December 2016. The Company recorded a receivable and deferred revenue as of December 31, 2016 for the $45.0 million continuation payment, upon receipt of the election to continue, which the Company is recognizing on a straight-line basis over the expected term of research and development services through December 31, 2018 because there is no more discernable pattern of performance for which the R&D services occur. The payment was subsequently received in January 2017. In relation to this continuation payment, the Company recognized $5.6 million and $16.9 million as revenue during the three and nine months ended September 30, 2017, respectively, and had deferred revenue on its consolidated balance sheet of $28.1 million as of September 30, 2017. Sanofi also had a time-restricted right to purchase $40.0 million in shares of the Company’s redeemable convertible preferred stock at the discounted price, which would have satisfied the $40.0 million obligation to purchase shares of the Company’s capital stock in connection with the continuation decision. Sanofi’s option to purchase $40.0 million of additional shares of the Company’s redeemable convertible preferred stock at the discounted price expired upon the closing of the Series B redeemable convertible preferred stock financing in April 2015. The Company had determined that Sanofi’s right to purchase the redeemable convertible preferred stock at the discounted price, and the Company’s corresponding obligation to issue this additional redeemable convertible preferred stock, represented a freestanding financial instrument. The freestanding convertible preferred stock call option liability was initially recorded at its fair value of $0.7 million in 2014. The Company did not have a liability related to the redeemable convertible preferred stock call option on its consolidated balance sheet as of September 30, 2017 and December 31, 2016. 5. Up to $45.0 million in-kind research and collaboration activities. Sanofi can fund up to $45.0 million of pre-approved funding of research and collaboration activities. Since Sanofi will pay its vendors and personnel directly as per the Collaboration Agreement, the Company will not receive cash from Sanofi and therefore will not account for the funding of the in-kind services. |