Myovant Sciences Announces Corporate Updates and Financial Results for First Fiscal Quarter 2022
- First fiscal quarter 2022 total revenue of
$116.5 million, including net product revenue of $41.4 million
- Net product revenue from
U.S.sales of ORGOVYX® of $36.0 millionin first fiscal quarter 2022, with sequential quarterly demand volume growth of 26% and cumulative patients estimated at 18,000 through June 2022
- Net product revenue from
U.S.sales of MYFEMBREE® of $4.0 millionin first fiscal quarter 2022, with sequential quarterly demand volume growth of 54%
- MYFEMBREE remains the number one prescribed FDA-approved gonadotropin-releasing hormone (GnRH) antagonist therapy for the treatment of uterine fibroids for new patients and is now the market leader in total prescriptions (TRx) with 51% TRx share in
- FDA provided labeling comments with respect to the MYFEMBREE supplemental New Drug Application (sNDA) for the management of moderate to severe pain associated with endometriosis; on track for a decision by its
August 6, 2022target action date
- FDA accepted sNDA proposing updates to MYFEMBREE’s
U.S.Prescribing Information based on 2-year data from the Phase 3 LIBERTY randomized withdrawal study; set target action date of January 29, 2023 Myovantremains well-capitalized with cash, cash equivalents, marketable securities, and committed financing of $400.0 millionas of June 30, 2022
“We’re excited to start fiscal year 2022 with solid performance across both brands,” said
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.
$50.0 millionupfront payment was received from Accord Healthcare, Ltd.(Accord), pursuant to the exclusive license agreement Myovantentered into with Accord in May 2022to commercialize ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe.
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 Europein 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 millionmilestone payment from Pfizer. If approved by the PDUFA goal date, Myovantand Pfizer expect to launch MYFEMBREE in the U.S.for this indication in August 2022.
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, 2023for this sNDA.
June 2022, Myovantand 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
Myovantexpects 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 millionmilestone payment from Pfizer. If approved by the PDUFA goal date, Myovantand Pfizer expect to launch MYFEMBREE in the U.S.for this indication in August 2022. European Medicines Agencyregulatory 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. Myovantexpects to submit New Drug Submissions to Health Canadaseeking 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 Canadain 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
Europein the second half of calendar year 2022. Myovantexpects 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, 2023PDUFA goal date.
First Fiscal Quarter 2022 Financial Summary
Total revenues for the three months ended
- Product revenue, net for the three months ended
June 30, 2022and 2021 were $41.4 millionand $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, 2022was $36.0 millioncompared to $10.5 millionfor 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, 2022was $4.0 millioncompared to $1.1 millionfor the three months ended June 30, 2021. MYFEMBREE was launched in the U.Sin June 2021.
- Product revenue, net related to product supply to Richter for the three months ended
June 30, 2022was $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, 2022was $0.2 million. There were no such revenues in the year ago period.
- Product revenue, net from sales of ORGOVYX in the
- Pfizer collaboration revenue for the three months ended
June 30, 2022and 2021 was $25.1 millionand $29.5 million, respectively, reflecting the partial recognition of the upfront payment Myovantreceived from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020and 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, 2022was $50.0 million, reflecting the recognition of the upfront payment received from Accord in May 2022pursuant 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
Collaboration expense to Pfizer for the three months ended
Selling, general and administrative (SG&A) expenses for the three months ended
Research and development (R&D) expenses for the three months ended
Interest expense for the three months ended
Income tax expense for the three months ended
Net loss for the three months ended
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Pharma Loan Agreement totaled
As previously announced,
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
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through its unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early through late-stage investigational assets for other serious conditions. Sumitovant, a wholly-owned subsidiary of Sumitomo Pharma, is also the majority-shareholder of
About Sumitomo Pharma Co., Ltd.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including: statements regarding Myovant’s aspiration to redefine care for women and for men; Myovant’s expectations of the success of commercialization of its approved drug products; statements with respect to Myovant’s expectations to remain well capitalized to build on its commercial momentum and advance its pipeline in women’s health and hormone-sensitive oncology in Mr. Marek’s quote; statements regarding the timing of Myovant’s regulatory submissions, anticipated regulatory review results, as well as Myovant’s and its collaboration and commercialization partners’ expected commercial launches of Myovant’s products, including, with no limitations, the timeline and potential outcome of the FDA’s review of the MYFEMBREE sNDA for the management of moderate to severe pain associated with endometriosis and if approved by the FDA, the potential milestone payment from Pfizer and the timing and expected launch of MYFEMBREE for this indication; the timeline and potential outcome of the FDA’s review of the MYFEMBREE sNDA proposing updates to MYFEMBREE’s USPI based on 2-year safety and efficacy data from the Phase 3 LIBERTY RWS of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids; the timeline and expectation of launching ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in
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 and the conflict in
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in thousands, except share and per share data)
|Three Months Ended
|Product revenue, net||$||41,351||$||11,554|
|Pfizer collaboration revenue||25,141||29,509|
|Accord license revenue||50,000||—|
|Operating costs and expenses:|
|Cost of product revenue(1)||4,915||1,032|
|Collaboration expense to Pfizer||18,016||5,261|
|Selling, general and administrative(1)||79,032||61,212|
|Research and development(1)||23,890||30,880|
|Total operating costs and expenses||125,853||98,385|
|Loss from operations||(9,361||)||(57,322||)|
|Loss before income taxes||(13,075||)||(60,749||)|
|Income tax expense||8,164||911|
|Net loss and comprehensive loss||$||(21,239||)||$||(61,660||)|
|Net loss per common share — basic and diluted||$||(0.22||)||$||(0.67||)|
|Weighted average common shares outstanding — basic and diluted||95,388,294||91,637,151|
(1)Includes the following share-based compensation:
|Selling, general and administrative||$||5,972||$||7,155|
|Research and development||3,666||3,957|
|Cost of product revenue||68||3|
|Total share-based compensation||$||9,706||$||11,115|
Revenue components are as follows:
|Product revenue, net:|
|Richter product supply and royalties||1,318||—|
|Total product revenue, net||41,351||11,554|
|Pfizer collaboration revenue:|
|Amortization of upfront payment||20,974||20,974|
|Amortization of regulatory milestone||4,167||8,535|
|Total Pfizer collaboration revenue||25,141||29,509|
|Accord license revenue||50,000||—|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|Cash and cash equivalents||$||325,535||$||406,704|
|Accounts receivable, net||29,648||23,296|
|Prepaid expenses and other current assets||18,750||22,498|
|Amount due from related party||458||580|
|Total current assets||426,829||488,145|
|Property and equipment, net||2,681||2,944|
|Operating lease right-of-use asset||7,501||7,961|
|Marketable securities, non-current||1,938||—|
|Liabilities and Shareholders’ Deficit|
|Accrued expenses and other current liabilities||65,688||68,594|
|Amounts due to Pfizer||39,244||32,563|
|Cost share advance from Pfizer||8,555||33,818|
|Operating lease liability||2,256||2,148|
|Amounts due to related parties||382||393|
|Total current liabilities||226,241||250,330|
|Deferred revenue, non-current||350,565||375,706|
|Long-term operating lease liability||6,431||7,041|
|Long-term debt, less current maturities (related party)||358,700||358,700|
|Total shareholders’ deficit||(483,524||)||(473,477||)|
|Total liabilities and shareholders’ deficit||$||460,130||$||520,011|
Chief Financial Officer
Vice President, Corporate Communications
Source: Myovant Sciences, Inc.