Item 1.02 Termination of a Material Definitive Agreement
On January 2, 2019, MyoKardia, Inc. (the “Company”) announced that effective as of December 31, 2018, the initial research term (the “Research Term”) under the Company’s License and Collaboration Agreement, dated August 1, 2014 (the “Collaboration Agreement”), with Aventis Inc., a wholly-owned subsidiary of Sanofi S.A. (“Sanofi”) expired, and the parties elected not to extend the Research Term. In addition, Sanofi provided the Company with notice of termination of the Collaboration Agreement with respect to theHCM-1 program pursuant to Section 12.2(a)(iii) thereof, effective 90 days after January 1, 2019 (the “Effective Date”), resulting in termination of the Collaboration Agreement in its entirety at that time. During the period leading up to the end of the Research Term, it was important for the Company to maintain 100 percent of the U.S. commercial rights for mavacamten as well as not giving additional rights in expanded indications. Sanofi subsequently provided the Company with notification of its decision to conclude the collaboration in conjunction with the end of the Research Term. Sanofi also cited broader portfolio prioritization needs.
The Collaboration Agreement covered three main research programs:HCM-1 (mavacamten andMYK-224) ,HCM-2, andDCM-1(MYK-491). Under the Collaboration Agreement, the Company retained rights to develop and commercialize mavacamten,MYK-224 andHCM-2 in the United States, as well asco-commercialization rights toMYK-491 in the United States, at the Company’s option. The Company granted to Sanofi: (i) worldwide rights to commercializeMYK-491; and (ii) regulatory and commercialization rights outside the United States for the two HCM programs. After the Effective Date, Sanofi will remain eligible to receive royalties associated with any potentialHCM-1 products that will range frommid-single tolow-double digits in the U.S. There is no royalty obligation to Sanofi for sales outside the U.S. There are no material early termination penalties that will be incurred by the Company.
For purposes of this Form8-K, the Company refers to Sanofi as theco-party to the Collaboration Agreement.
Item 7.01 Regulation FD Disclosure
On January 2, 2019, the Company issued a press release announcing the termination of the Collaboration Agreement (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 to this Current Report on Form8-K.
The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events
In connection with the termination of the Collaboration Agreement, the Company has updated its cash guidance. The Company anticipates that its current cash, cash equivalents and investments are sufficient to fund operations through the second half of 2020.
Forward-Looking Statements
Statements made by the Company in this Form8-K may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. The Company intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the Company’s expected cash runway, reflect the Company’s current views about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to the Company and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations, strategies and
