Myovant Sciences Announces Financial Results for First Quarter of Fiscal Year 2021 and Corporate Updates
BASEL, Switzerland, July 28, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the first quarter of fiscal year 2021.
“I am pleased with the significant progress Myovant has made toward delivering on our mission of redefining care for women and for men. MYFEMBREE was approved by the FDA in May for women with uterine fibroids and was launched by Myovant and Pfizer in mid-June. We are encouraged by our early progress and are excited to be bringing this important new treatment option to the millions of women suffering from the symptoms of uterine fibroids. In July, we submitted to the FDA a supplemental New Drug Application seeking to extend approval of MYFEMBREE to include women with endometriosis. Finally, RYEQO was approved in Europe as the first and only long-term, once-daily oral treatment for uterine fibroids. We look forward to RYEQO’s launch later this year, to be executed by Gedeon Richter,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc.
Mr. Marek added, “ORGOVYX launch momentum continued to accelerate in first fiscal quarter 2021 with net product revenues of $10.5 million, demonstrating substantial growth compared to the previous quarter. This performance reflects the overwhelmingly positive feedback we have received from patients and clinicians regarding the impact ORGOVYX has had on the advanced prostate cancer treatment experience. Providing patients and prescribers with an oral medication that is able to rapidly and profoundly reduce testosterone levels without an initial hormonal surge has positioned ORGOVYX to potentially become the new standard of care androgen deprivation therapy over time.”
First Fiscal Quarter 2021 and Recent Corporate Updates
ORGOVYX (relugolix 120 mg)
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
Expected Upcoming Milestones
First Fiscal Quarter 2021 Financial Summary
Total revenues for the three months ended June 30, 2021 and 2020 were $41.1 million and $33.3 million, respectively.
Cost of product revenue for the three months ended June 30, 2021 was $1.0 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such amounts recognized in the comparable prior year period.
Collaboration expense to Pfizer for the three months ended June 30, 2021, was $5.3 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such amounts recognized in the comparable prior year period.
Research and development (R&D) expenses for the three months ended June 30, 2021, were $30.9 million compared to $44.2 million for the comparable prior year period. The decrease in R&D expenses reflects cost share reimbursements from Pfizer for certain R&D expenses and a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies. The decrease also reflects lower regulatory expenses during the three months ended June 30, 2021, as the prior year period included submission fees for Myovant’s New Drug Applications for ORGOVYX for advanced prostate cancer and MYFEMBREE for the uterine fibroids indication. This decrease was partially offset by an increase in medical affairs personnel expenses to support the U.S. commercial launches of ORGOVYX and MYFEMBREE.
Selling, general and administrative (SG&A) expenses for the three months ended June 30, 2021, were $61.2 million compared to $22.8 million for the comparable prior year period. The increase was primarily due to higher expenses related to commercial activities to support the ORGOVYX and MYFEMBREE U.S. launches, higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces, and higher general overhead expenses to support Myovant’s organizational growth.
Interest expense was $3.5 million for the three months ended June 30, 2021, compared to $2.2 million for the comparable prior year period. The increase in interest expense was primarily driven by the higher balance under Myovant’s loan agreement with Sumitomo Dainippon Pharma (Sumitomo Dainippon Pharma Loan Agreement) and $0.6 million of accretion of the financing component of the cost share advance from Pfizer.
Foreign exchange gain for the three months ended June 30, 2020 was $3.6 million, primarily the result of the increase in Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement and the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.
Net loss for the three months ended June 30, 2021 was $61.7 million compared to $32.9 million for the comparable prior year period. On a per common share basis, net loss was $0.67 and $0.37 for the three months ended June 30, 2021 and 2020, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $611.1 million as of June 30, 2021, and consisted of $569.8 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement. Subsequent to the end of the quarter, Myovant received a $100.0 million milestone payment from Pfizer in July 2021 and expects to receive a $15.0 million milestone payment from Richter in second fiscal quarter 2021.
About Sumitomo Dainippon Pharma Co., Ltd.
About Sumitovant Biopharma Ltd.
Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. Myovant Sciences 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. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q to be filed on July 28, 2021, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.
MYOVANT SCIENCES LTD.
Revenue components are as follows:
MYOVANT SCIENCES LTD.
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