On October 26, 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, reported financial results for the second quarter of fiscal year 2022 and provided other corporate updates (Press release, Myovant Sciences, OCT 26, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-corporate-updates-and-financial-5 [SID1234622418]).
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"With the recently announced merger agreement, we believe the expertise and resources of Sumitovant will best support Myovant and our employees, which will enable us to expand the impact of our differentiated therapies, accelerate clinical programs, and work to remove barriers to access quality care for the patients we serve," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. Mr. Marek added, "With the FDA approval for endometriosis, we are excited MYFEMBREE is now positioned to redefine care for more women as the first and only once daily oral GnRH antagonist treatment indicated for both uterine fibroids and endometriosis. In addition, ORGOVYX continues to gain momentum and is now the most prescribed GnRH antagonist for men with advanced prostate cancer."
Second Fiscal Quarter 2022 and Recent Corporate Updates
Corporate
On October 23, 2022, Myovant announced that it entered into a merger agreement with Sumitovant and Sumitomo under which Sumitovant has agreed to acquire the remaining shares of Myovant that Sumitovant does not currently hold. Subject to the terms and conditions set forth in the agreement, in the event the merger is consummated, holders of Myovant common shares will be entitled to receive $27.00 per share in cash.
ORGOVYX (relugolix 120 mg)
Second fiscal quarter 2022 net product revenues for ORGOVYX in the U.S. were $43.3 million, reflecting 20% sequential growth compared to the first fiscal quarter 2022. ORGOVYX commercial demand volume grew 20% quarter-over-quarter driven by accelerating new patient starts and continued expansion across all treatment settings.
Approximately 4,000 new patients started treatment with ORGOVYX in the second fiscal quarter of 2022, reaching approximately 22,000 cumulative patients since launch.
ORGOVYX is now the leading GnRH antagonist therapy for advanced prostate cancer with a 55% share based on months of therapy.
Since launching in January 2021, ORGOVYX drove a 133% volume increase of the GnRH antagonist market for products FDA-approved for the treatment of advanced prostate cancer.
In October 2022, Myovant’s commercialization partner, Accord Healthcare, Ltd. (Accord), launched ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe. Pursuant to the Accord License Agreement, the first commercial sale of ORGOVYX in Europe triggered a $5.0 million milestone payment due from Accord.
Myovant and Pfizer are initiating a new Phase 3 randomized open label clinical study, the REPLACE-CV study, to assess the risk of major adverse cardiovascular events (MACE) associated with ORGOVYX compared with leuprolide. The REPLACE-CV study design was agreed upon with the U.S. Food and Drug Administration (FDA). The study could further differentiate ORGOVYX by potentially adding additional data to the prescribing information concerning MACE events versus leuprolide, if approved by the FDA.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
Second fiscal quarter 2022 net product revenues for MYFEMBREE in the U.S. were $6.4 million, reflecting 60% sequential growth compared to first fiscal quarter 2022. MYFEMBREE commercial demand volume grew 40% quarter-over-quarter driven by strong growth in new patient starts and prescribers.
On August 5, 2022, the FDA approved MYFEMBREE for the management of moderate to severe pain associated with endometriosis, establishing it as the first and only once-daily oral GnRH treatment approved for both uterine fibroids and endometriosis. MYFEMBREE was launched in the U.S. for this indication by Myovant and Pfizer in August 2022. Pursuant to the terms of the Pfizer Collaboration and License Agreement, this approval triggered a $100.0 million regulatory milestone payment from Pfizer, which Myovant received in September 2022.
Approximately 3,200 new patients started treatment with MYFEMBREE in the second fiscal quarter 2022, resulting in 55% sequential quarterly growth in the number of patients treated since launch.
MYFEMBREE expanded its leadership in new-to-brand prescription (NBRx) and total prescription (TRx) share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids with 67% and 54% share in July 2022, respectively, prior to launching in endometriosis.
In the overall GnRH antagonist class for uterine fibroids and endometriosis, MYFEMBREE drove 23% TRx growth since its initial launch and reached 32% NBRx share in September 2022.
Significant progress has been made in the five weeks since MYFEMBREE’s endometriosis launch with over 22,000 health care professional (HCP) calls conducted, reaching 66% of high and medium target HCPs. As of October 1, 2022, 30% commercial coverage has been obtained, covering approximately 50 million lives.
In September 2022 and October 2022, Myovant and Pfizer completed New Drug Submissions to Health Canada seeking marketing approval in Canada for MYFEMBREE for heavy menstrual bleeding associated with uterine fibroids and MYFEMBREE for the treatment of endometriosis-associated pain, respectively.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
In September 2022, Myovant’s commercialization partner, Gedeon Richter Plc. (Richter) submitted a Type II variation application to the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) seeking approval for RYEQO for moderate to severe pain associated with endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.
In October 2022, Richter submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval for RYEQO for the treatment of moderate to severe pain associated with endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis. The acceptance of the Type II variation submission is pending validation by the EMA. Pursuant to the Richter Development and Commercialization Agreement, the acceptance of the Type II variation application by the EMA would trigger a $4.0 million milestone payment due from Richter.
Expected Upcoming Milestones
Myovant expects to submit a New Drug Submission to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer by the end of calendar year 2022.
Myovant expects the FDA decision for the MYFEMBREE supplemental New Drug Application (sNDA) proposing updates to MYFEMBREE’s U.S. Prescribing Information based on the safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years by the January 29, 2023 Prescription Drug User Fee Act goal date.
Myovant expects to submit an sNDA to the FDA for the SPIRIT 2-year long-term extension study for MYFEMBREE in women for the management of pain associated with endometriosis in the first half of calendar year 2023.
Second Fiscal Quarter 2022 Financial Summary
Total revenues for the three months ended September 30, 2022, and 2021 were $104.8 million and $77.9 million, respectively.
Product revenue, net for the three months ended September 30, 2022, and 2021 was $49.9 million and $21.1 million, respectively. Product revenue, net consisted primarily of the following:
Product revenue, net from sales of ORGOVYX in the U.S. for the three months ended September 30, 2022 was $43.3 million compared to $18.7 million for three months ended September 30, 2021.
Product revenue, net from sales of MYFEMBREE in the U.S. for the three months ended September 30, 2022 was $6.4 million compared to $0.6 million for the three months ended September 30, 2021.
Pfizer collaboration revenue for the three months ended September 30, 2022, and 2021 was $54.6 million and $25.2 million, respectively. Pfizer collaboration revenue for both the three months ended September 30, 2022 and 2021 consists of the partial recognition of the upfront payment Myovant received from Pfizer in December 2020 and of the $100.0 million regulatory milestone payment Myovant received from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids on May 26, 2021. Pfizer collaboration revenue for the three months ended September 30, 2022 also includes the partial recognition of the $100.0 million regulatory milestone payment Myovant received from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of moderate to severe pain associated with endometriosis on August 5, 2022.
Richter license and milestone revenue for the three months ended September 30, 2022 was $0.3 million compared to $31.7 million in the three months ended September 30, 2021. Richter license and milestone revenue for the three months ended September 30, 2021 included the recognition of $16.7 million of previously deferred revenue as a result of Myovant’s delivery of the remaining substantive relugolix combination tablet data packages to Richter pursuant to the Richter Development and Commercialization Agreement, and a $15.0 million regulatory milestone payment that was triggered upon the European Commission approval of RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Cost of product revenue for the three months ended September 30, 2022 was $4.9 million compared to $2.6 million for the three months ended September 30, 2021 related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. The increase in cost of product revenue in the three months ended September 30, 2022 was due to an increase in cost of goods sold and royalty expense payable to Takeda as a result of higher sales of ORGOVYX and MYFEMBREE in the U.S., as compared to the year ago period.
Collaboration expense to Pfizer for the three months ended September 30, 2022, was $22.4 million, compared to $8.6 million for the three months ended September 30, 2021, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S. The increase in collaboration expense to Pfizer in the three months ended September 30, 2022 was due to an increase in net profits generated from sales of ORGOVYX and MYFEMBREE in the U.S., as compared to the year ago period.
Selling, general and administrative (SG&A) expenses for the three months ended September 30, 2022, and 2021 were $84.3 million and $58.8 million, respectively. The increase in SG&A expenses primarily reflects higher expenses to support the ORGOVYX and MYFEMBREE commercialization activities in the U.S, including higher personnel-related costs and patient activation costs, particularly for MYFEMBREE.
Research and development (R&D) expenses for the three months ended September 30, 2022, and 2021 were $26.9 million and $26.3 million, respectively.
Interest expense for the three months ended September 30, 2022, and 2021 was $4.8 million and $3.5 million, respectively, and was primarily related to the Sumitomo Pharma Loan Agreement. Interest expense related to the Sumitomo Pharma Loan Agreement increased $1.9 million, as a result of an increase in 3-month LIBOR as compared to the year ago period.
Income tax expense (benefit) for the three months ended September 30, 2022, and 2021 was $8.1 million and $(0.1) million, respectively. Myovant’s tax expense currently relates principally to profits earned in the U.S. The increase in income tax expense was driven principally by the changed requirement under Internal Revenue Code Section 174, effective for years beginning after December 31, 2021, to capitalize and subsequently amortize R&D expenditures, pursuant to changes enacted in the Tax Cuts and Jobs Act of 2017. For periods beginning prior to December 31, 2021, R&D expenses were allowed to be expensed as incurred.
Net loss for the three months ended September 30, 2022 was $45.6 million compared to $21.6 million for the year ago period. On a per common share basis, net loss was $0.47 and $0.23 for the three months ended September 30, 2022 and 2021, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Pharma Loan Agreement totaled $412.6 million in the aggregate as of September 30, 2022, and consisted of $371.3 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Pharma Loan Agreement.
About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX (relugolix, 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer. In April and June 2022, respectively, the European Commission (EC) and the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) approved ORGOVYX (relugolix, 120 mg) as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced hormone-sensitive prostate cancer in Europe and the U.K. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral GnRH treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months; and in August 2022 as the first and only once-daily oral GnRH antagonist combination treatment for the management of moderate to severe pain associated with endometriosis, with a treatment duration of 24 months. In July 2021, the EC, and in August 2021, the U.K. MHRA, approved RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In June 2022, the FDA accepted to review Myovant’s supplemental New Drug Application (sNDA) for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of January 29, 2023 for this sNDA. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.