Myovant Sciences Ltd. 10K 2021 V1

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number 001-37929 Myovant Sciences Ltd. (Exact name of registrant as specified in its charter) Bermuda 98-1343578 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Suite 1, 3rd Floor 11-12 St. James’s Square London SW1Y 4LB United Kingdom Not Applicable (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: +44 (207) 400 3351 Securities registered pursuant to Section 12(b) of the Act: Title of each Class Trading Symbol Name of each exchange on which registered Common Shares, $0.000017727 par value per share MYOV New York Stock Exchange Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” ”accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer � Smaller reporting company � Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (§ 15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No The aggregate market value of voting common shares held by non-affiliates of the registrant as of the end of the registrant’s most recently completed second fiscal quarter ended September 30, 2020 was approximately $559,121,548 based on the last reported sale price of the registrant’s common shares as reported on the New York Stock Exchange on September 30, 2020 of $14.05 per common share. Common shares held by our majority shareholder, Sumitovant Biopharma Ltd. and each officer and director have been excluded in that such persons, on such dates, may have been deemed to be affiliates. This determination of affiliate status is not a conclusive determination for other purposes. The number of the registrant’s common shares, $0.000017727 par value per share, outstanding on May 6, 2021, was 91,480,278. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement for the 2021 Annual General Meeting of Shareholders (the “2021 Proxy Statement”) to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein. 2 MYOVANT SCIENCES LTD. ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED MARCH 31, 2021 TABLE OF CONTENTS Page PART I. Item 1. Business 7 Item 1A. Risk Factors 34 Item 1B. Unresolved Staff Comments 69 Item 2. Properties 69 Item 3. Legal Proceedings 69 Item 4. Mine Safety Disclosures 69 PART II. Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 70 Item 6. Selected Financial Data 70 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 71 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 86 Item 8. Financial Statements and Supplementary Data 86 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 124 Item 9A. Controls and Procedures 124 Item 9B. Other Information 124 PART III. Item 10. Directors, Executive Officers and Corporate Governance 125 Item 11. Executive Compensation 125 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 125 Item 13. Certain Relationships and Related Transactions, and Director Independence 125 Item 14. Principal Accounting Fees and Services 125 PA RT I V. Item 15. Exhibits and Financial Statement Schedules 125 Item 16. Form 10-K Summary 129 Signatures 130 3 PART I. Information Relating to Forward-Looking Statements This Annual Report on Form 10-K (“Annual Report”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”). These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements appearing in several places throughout this Annual Report include, but are not limited to, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: • our and our collaboration partners’ ability to successfully plan for and commercialize ORGOVYX, as well as any other product candidates such as relugolix combination tablet, if approved; • the success and anticipated timing of our clinical studies for our product candidates; • the anticipated start dates, durations and completion dates of our ongoing and future nonclinical and clinical studies; • the anticipated designs of our future clinical studies; • the anticipated future regulatory submissions and the timing of, and our ability to obtain and maintain, regulatory approvals for our product candidates; • our ability to procure sufficient quantities of commercial relugolix drug substance and drug product from approved third party CMOs; • our ability to achieve commercial sales of any approved products, whether alone or in collaboration with others; • our ability to obtain and maintain reimbursement and coverage from government and private payers for our products if commercialized; • the rate and degree of market acceptance and clinical utility of any approved products; • our ability to initiate and continue relationships with third-party clinical research organizations and manufacturers and third-party logistics providers; • our ability to quickly and efficiently identify and develop new product candidates; • our ability to hire and retain our management and other key personnel; • our ability to obtain, maintain and enforce intellectual property rights for our products and product candidates; • our estimates regarding our results of operations, financial condition, liquidity, capital requirements, access to capital, prospects, growth and strategies; • our ability to continue to fund our operations with the cash, cash equivalents, and marketable securities currently on hand, including our expectations for how long these capital resources will enable us to fund our operations; • our expectations regarding potential future payments that we are eligible to receive from Richter under the Richter Development and Commercialization Agreement and Pfizer under the Pfizer Collaboration and License Agreement; • our ability to borrow under the Sumitomo Dainippon Pharma Loan Agreement; • third party collaboration partners’ abilities to perform their obligations under our agreements with them; • our ability to raise additional capital if needed, on terms acceptable to us; • industry trends; 4 • developments and projections relating to our competitors or our industry; • the success of competing drugs that are or may become available;

Load more