Myovant Sciences Ltd. (MYOV) 10K Annual Reports & 10Q SEC Filings

•Fiscal year 2021 total revenue of $231.0 million, including net product revenues of $94.3 million; fourth fiscal quarter 2021 total revenues of $57.6 million, including net product revenue of $32.4 million

•European Commission approval of ORGOVYX® as the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe in April 2022

•Announced exclusive license agreement with Accord Healthcare, Ltd. (Accord) to commercialize ORGOVYX in Europe; total deal value up to $140.5 million, inclusive of upfront payment of $50.0 million, plus tiered royalties

•Net product revenue from U.S. sales of ORGOVYX of $83.0 million in fiscal year 2021; fourth fiscal quarter 2021 net product revenues of $29.4 million with sequential quarterly demand volume growth of 18%

•Net product revenue from U.S. sales of MYFEMBREE® of $6.4 million in fiscal year 2021; fourth fiscal quarter 2021 net product revenues of $2.2 million; nearly doubling of MYFEMBREE demand volume quarter-over-quarter offset by gross-to-net seasonality

•ORGOVYX cumulative patients estimated at 14,500 through March 2022

•MYFEMBREE is now the number one prescribed FDA-approved gonadotropin-releasing hormone (GnRH) antagonist therapy for the treatment of uterine fibroids for new patients; 59% new-to-brand share in March 2022

•Prescription Drug User Fee Act (PDUFA) goal date for MYFEMBREE for the management of moderate to severe pain associated with endometriosis extended by FDA to August 6, 2022

•SPIRIT long-term extension study demonstrated consistent efficacy and safety profile of MYFEMBREE over two years in women with endometriosis-associated pain

•Myovant remains well-capitalized with cash, cash equivalents, and marketable securities of $434.2 million as of March 31, 2022

BASEL, Switzerland, May 10, 2022 -- Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, today announced financial results for the fourth fiscal quarter and fiscal year ended March 31, 2022 and provided other corporate updates.

“Fiscal year 2021 was a transformative year for Myovant as we expanded ORGOVYX utilization in the U.S. and successfully launched MYFEMBREE, finishing the year with another quarter of strong demand growth. Our recent approval of ORGOVYX in Europe and partnership with Accord, coupled with our prior approval of RYEQO, will enable more patients than ever to have access to these meaningful and differentiated medicines,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. Mr. Marek added, “Our strong commercial momentum, advancement of our lifecycle and business development strategies, and our financial strength position Myovant for another exciting year in fiscal year 2022.”

The following information was filed by Myovant Sciences Ltd. (MYOV) on Tuesday, May 10, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Myovant Sciences Ltd.'s 10-K Annual Report:

Other - Other Highlight
An accounting policy is considered to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact the consolidated financial statements.

Financial - Cash Flow Highlight
Until such time, if ever, as we can generate positive cash flows as a result of increased sales of ORGOVYX, MYFEMBREE, or any product candidate, we expect to fund our operations through a combination of cash, cash equivalents, and marketable securities currently on hand and amounts available to us under the Sumitomo Pharma Loan Agreement, subject to the consent of our board of directors, as well as potential payments we are eligible to receive from Pfizer, Richter, and Accord pursuant to the terms of our agreements with them.
Financial - Expense Highlight
Selling, General and Administrative Expenses SG&A expenses increased $77.9 million, to $259.4 million, in the year ended March 31, 2022 compared to $181.4 million in the year ago period, primarily due to higher costs related to commercial activities to support our U.S launches of ORGOVYX and MYFEMBREE.
Legal - Other Highlight
It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of raw materials and fuel, supplies, freight and labor, inflation, and fluctuations in currency exchange rates, all of which could impact our business, financial condition and results of operations.
Financial - Expense Highlight
The $11.2 million increase in our cost of product revenue for the year ended March 31, 2022 compared to the year ago period was due to an increase in cost of goods sold and royalty expense to Takeda as a result of higher sales of ORGOVYX during the year ended March 31, 2022, as well as sales of MYFEMBREE in the U.S., which began in the three months ended June 30, 2021, and sales of product supply to Richter that began in the three months ended September 30, 2021.
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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Myovant Sciences Ltd. provided additional information to their SEC Filing as exhibits

Exhibit 10.7: Material Contract

Exhibit 10.40: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: MYOV
CIK: 1679082
Form Type: 10-K Annual Report
Accession Number: 0001679082-22-000071
Submitted to the SEC: Wed May 11 2022 9:02:47 AM EST
Accepted by the SEC: Wed May 11 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations

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Myovant Sciences Ltd. (MYOV) SEC Filing 10-K Annual Report for the fiscal year ending Thursday, March 31, 2022

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