On July 27, 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 first quarter of fiscal year 2022 and provided other corporate updates (Press release, Myovant Sciences, JUL 27, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-corporate-updates-and-financial-4 [SID1234617011]).
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"We’re excited to start fiscal year 2022 with solid performance across both brands," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "ORGOVYX delivered double digit volume growth across treatment settings and MYFEMBREE is now the market leader in new and total prescriptions while continuing to grow the class." Mr. Marek added, "despite the challenging macro-economic environment, we remain well capitalized to build on our commercial momentum and advance our pipeline in women’s health and hormone-sensitive oncology."
First Fiscal Quarter 2022 and Recent Corporate Updates
ORGOVYX (relugolix 120 mg)
First fiscal quarter 2022 net product revenues for ORGOVYX in the U.S. were $36.0 million, reflecting 22% sequential growth compared to fourth fiscal quarter 2021. ORGOVYX commercial demand volume grew 26% quarter-over-quarter driven by broad adoption and strong growth across all treatment settings.
Approximately 3,500 new patients started treatment on ORGOVYX in the first fiscal quarter of 2022, reaching approximately 18,000 cumulative patients since launch.
A $50.0 million upfront payment was received from Accord Healthcare, Ltd. (Accord), pursuant to the exclusive license agreement Myovant entered into with Accord in May 2022 to commercialize ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe.
On April 29, 2022, the European Commission (EC), and on June 17, 2022, the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA), approved ORGOVYX as the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in the European Union (EU) and U.K., respectively. We expect our commercialization partner, Accord, to commence the launch of ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe in the second half of calendar year 2022.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
First fiscal quarter 2022 net product revenues for MYFEMBREE in the U.S. were $4.0 million.
MYFEMBREE maintains market leadership in new-to-brand prescription (NBRx) share among GnRH antagonist therapies approved by the U.S. Food and Drug Administration (FDA) for the treatment of uterine fibroids and is now the number one prescribed GnRH antagonist therapy for uterine fibroids with 51% total prescription (TRx) share in June 2022. Data provided by Symphony Health.
Approximately 2,400 new patients started treatment on MYFEMBREE in first fiscal quarter 2022, resulting in 71% sequential quarterly growth in the number of patients treated since launch.
MYFEMBREE continues to drive total prescription growth of the GnRH antagonist for uterine fibroids class, which has grown 180% since its launch in June 2021, with 61% of MYFEMBREE prescribers being first time prescribers of a GnRH antagonist FDA-approved for the treatment of uterine fibroids.
FDA provided labeling comments with respect to the MYFEMBREE sNDA for the management of moderate to severe pain associated with endometriosis. FDA’s decision is expected by the extended Prescription Drug User Fee Act (PDUFA) goal date of August 6, 2022. An approval would trigger a $100.0 million milestone payment from Pfizer. If approved by the PDUFA goal date, Myovant and Pfizer expect to launch MYFEMBREE in the U.S. for this indication in August 2022.
In June 2022, the FDA accepted for review an sNDA that proposes updates to MYFEMBREE’s U.S. Prescribing Information (USPI) based on 2-year safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids. The FDA set a target action date of January 29, 2023 for this sNDA.
In June 2022, Myovant and Pfizer announced that the results of the Phase 3 SPIRIT 1 and SPIRIT 2 studies of once-daily relugolix combination therapy (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women with endometriosis-associated pain were published in The Lancet.
Additional data from the SPIRIT 2-year extension study in women with endometriosis were presented at the European Society of Human Reproduction and Embryology (ESHRE) 2022 Annual Meeting in July 2022. The Society recognized the presentation as the best oral presentation of a clinical topic at the ESHRE 2022 Annual Meeting.
Expected Upcoming Milestones
Myovant expects the FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis by its extended PDUFA goal date of August 6, 2022. Approval would trigger a $100.0 million milestone payment from Pfizer. If approved by the PDUFA goal date, Myovant and Pfizer expect to launch MYFEMBREE in the U.S. for this indication in August 2022.
European Medicines Agency regulatory submission for RYEQO for the treatment of women with endometriosis-associated pain is expected in the second half of calendar year 2022. Gedeon Richter Plc. (Richter) will be the sponsor.
Myovant expects to submit New Drug Submissions to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer, MYFEMBREE for heavy menstrual bleeding associated with uterine fibroids, and MYFEMBREE for the treatment of endometriosis-associated pain in Canada in the second half of calendar year 2022.
Accord is expected to commence the launch of ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe in the second half of calendar year 2022.
Myovant expects the FDA decision for the MYFEMBREE sNDA proposing updates to MYFEMBREE’s USPI based on the safety and efficacy data from the Phase 3 LIBERTY RWS of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years by the January 29, 2023 PDUFA goal date.
First Fiscal Quarter 2022 Financial Summary
Total revenues for the three months ended June 30, 2022, and 2021 were $116.5 million and $41.1 million, respectively.
Product revenue, net for the three months ended June 30, 2022 and 2021 were $41.4 million and $11.6 million, respectively. Product revenue, net consisted of the following:
Product revenue, net from sales of ORGOVYX in the U.S. for the three months ended June 30, 2022 was $36.0 million compared to $10.5 million for the three months ended June 30, 2021.
Product revenue, net from sales of MYFEMBREE in the U.S. for the three months ended June 30, 2022 was $4.0 million compared to $1.1 million for the three months ended June 30, 2021. MYFEMBREE was launched in the U.S in June 2021.
Product revenue, net related to product supply to Richter for the three months ended June 30, 2022 was $1.1 million. Product revenue, net related to royalties on net sales of RYEQO in Richter’s Territory for the three months ended June 30, 2022 was $0.2 million. There were no such revenues in the year ago period.
Pfizer collaboration revenue for the three months ended June 30, 2022 and 2021 was $25.1 million and $29.5 million, respectively, reflecting the partial recognition of the upfront payment Myovant received from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021.
Accord license revenue for the three months ended June 30, 2022 was $50.0 million, reflecting the recognition of the upfront payment received from Accord in May 2022 pursuant to the Accord License Agreement. There was no Accord license revenue in the year ago period.
Cost of product revenue for the three months ended June 30, 2022 was $4.9 million, compared to $1.0 million for the three months ended June 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 June 30, 2022 was primarily 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 June 30, 2022, was $18.0 million, compared to $5.3 million for the three months ended June 30, 2021, 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. The increase in collaboration expense to Pfizer in the three months ended June 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 June 30, 2022, and 2021 were $79.0 million and $61.2 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, patient activation costs particularly for MYFEMBREE, as well as a banker fee associated with the Accord License Agreement.
Research and development (R&D) expenses for the three months ended June 30, 2022, and 2021 were $23.9 million and $30.9 million, respectively. The decrease in R&D expenses primarily reflects a reduction in clinical study costs due to the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies.
Interest expense for the three months ended June 30, 2022, and 2021 was $4.2 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 $0.7 million, as a result of an increase in 3-month LIBOR as compared to the year ago period. Interest expense includes $0.6 million of accretion of the financing component of the cost share advance from Pfizer for both the three months ended June 30, 2022, and 2021.
Income tax expense for the three months ended June 30, 2022, and 2021 was $8.2 million and $0.9 million, respectively. 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 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 June 30, 2022 was $21.2 million compared to $61.7 million for the year ago period. On a per common share basis, net loss was $0.22 and $0.67 for the three months ended June 30, 2022 and 2021, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Pharma Loan Agreement totaled $400.0 million as of June 30, 2022, and consisted of $358.7 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Pharma Loan Agreement.
Conference Call
As previously announced, Myovant will hold a webcast and conference call to discuss corporate updates and financial results for its first fiscal quarter, ended June 30, 2022. The webcast and conference call will be held at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time on July 27, 2022. Investors and the general public may access the live webcast: View Source The live webcast can also be accessed by visiting the investor relations page of Myovant’s website at: https://investors.myovant.com/. A replay of the webcast, along with the earnings press release and presentation materials, can be found on Myovant’s investor relations website for a period of one year.
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 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 treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. In July 2021, the European Commission, 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 September 2021, the FDA accepted to review Myovant’s supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. On May 6, 2022, Myovant and Pfizer announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for this sNDA to August 6, 2022. In June 2022, the FDA accepted to review Myovant’s 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 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.