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. (together with Aventis, Inc., “Sanofi”), 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; and 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. The Collaboration Agreement covers three main research programs, “HCM1” (“HCM-1” or “MYK-461”), “HCM2” (“HCM-2”) and “DCM1” (“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 MYK-461 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 MYK-461 and HCM-2 programs where it has ex-United States commercialization rights. Sanofi also has the option to co-promote in the United States for potential expanded cardiovascular diseases outside of the genetically targeted indications for the MYK-461 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 is recognizing as revenue on a straight-line basis over the expected term of research and development services through December 31, 2016 because there is not a more discernible pattern of performance in which the research and development services occur. During the three months ended September 30, 2016 and September 30, 2015, and the nine months ended September 30, 2016 and September 30, 2015, the Company recognized $3.6 million of revenue in both three-month periods and $10.6 million of revenue in both nine-month periods, respectively, under the Collaboration Agreement. As of September 30, 2016 and December 31, 2015, the Company had recorded deferred revenue on its consolidated balance sheet of $3.5 million and $14.2 million, respectively. 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 stock purchase 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. 3. $25.0 million milestone-based payment. The Company is 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 will account for this milestone payment separately from the rest of the agreement and recognize revenue upon achievement of the milestone. The Company had not achieved this milestone as of September 30, 2016. 4. Up to $85.0 million continuation payments. Under the Collaboration Agreement, Sanofi must determine by December 31, 2016 whether or not to continue the Collaboration Agreement. Sanofi agreed that if it so elects to continue the Collaboration Agreement, it will pay: • a one-time, non-refundable, non-creditable cash payment of $45.0 million • an additional $40.0 million in connection with the purchase of the Company’s preferred stock, assuming (i) the Company had not previously closed either a Qualified IPO (at which time this obligation would terminate) or a private financing prior to a Qualified IPO and (ii) Sanofi had 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 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 believes that the continuation payments have significant uncertainty and are outside the control of the Company because Sanofi has sole discretion to determine whether or not to continue, and will therefore account for these potential payments separate from the other deliverables in this agreement. The Company 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 recorded a decrease in the fair value of this liability of $0.3 million and $0.4 million in the consolidated statements of operations and comprehensive loss during the years ended December 31, 2015 and 2014, respectively. As of September 30, 2016, Sanofi had not provided the confirmation of continuation under the Collaboration Agreement. 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. |