Myovant Sciences Announces Corporate Updates and Financial Results for Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2021
- Fourth fiscal quarter 2020 total revenues of
$24.6 million; net product revenue from sales of ORGOVYX in the U.S.of $3.6 million
- FDA review of New Drug Application for relugolix combination tablet for uterine fibroids remains on track for a decision by
June 1, 2021target action date; U.S.launch expected in June 2021, if approved
- Remain on track to submit
U.S.regulatory filing for endometriosis in the second quarter of calendar year 2021 European Commissiondecision on uterine fibroids Marketing Authorization Application remains on track for mid-calendar year 2021; Gedeon Richterto launch and commercialize, if approved European Medicines Agencyvalidated Marketing Authorization Application for relugolix for the treatment of advanced prostate cancer
- Reported positive data for relugolix combination therapy from Phase 3 SPIRIT extension study in women with endometriosis and from Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids
- Company remains well-capitalized with cash, cash equivalents, marketable securities and committed funding of
$726.2 millionas of March 31, 2021
“The ORGOVYX launch is off to a strong start and its differentiated clinical profile has the potential to redefine care for men with advanced prostate cancer. ORGOVYX demand accelerated over the course of the quarter, reflecting our ongoing efforts to educate urologists and medical oncologists about ORGOVYX while improving access and reimbursement for patients. In partnership with Pfizer, we continue to execute on our long-term goal of establishing ORGOVYX as the new standard of care androgen deprivation therapy,” said
Fourth Fiscal Quarter 2020 and Recent Corporate Updates
- ORGOVYX was launched in the
U.S.and authorized specialty distribution channels were fully stocked in early January 2021. Fourth fiscal quarter 2020 net product revenues for ORGOVYX in the U.S.were $3.6 million.
- More than 800 treatment centers have prescribed ORGOVYX to over 2,000 patients, estimated through
April 30, 2021.
April 30, 2021, Myovantachieved 43% commercial coverage and 51% Medicare Part D coverage for ORGOVYX. Myovantcontinues to engage in coverage negotiations with key commercial and Medicare Part D payors and remains on track to achieve its goal of broad coverage at the end of calendar year 2021.
March 29, 2021, Myovantannounced that the European Medicines Agency(EMA) validated its Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirmed that the submission is sufficiently complete for the EMA to begin the review process.
Relugolix Combination Tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
- Uterine Fibroids
March 24, 2021, Myovantand Pfizer announced positive safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids. The study met its primary endpoint and all three key secondary endpoints. Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed.
January 26, 2021, Myovantand Pfizer announced that the Phase 3 SPIRIT long-term extension study in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the regulatory submission to the U.S. Food and Drug Administration(FDA) for relugolix combination tablet for the treatment of women with endometriosis, expected in the second quarter of calendar year 2021.
- Prevention of Pregnancy
April 12, 2021, Myovantand Pfizer announced that the first patient was dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet in healthy women ages 18-35 years who are at risk for pregnancy. The SERENE study is designed to enroll 900 sexually active, healthy women ages 18-35 years with presumed normal fertility. The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. Safety data will also be collected during the study. Results of the SERENE study could support a potential indication of pregnancy prevention for women treated with relugolix combination tablet, if approved.
January 4, 2021, Myovantannounced the appointment of David Marekas Chief Executive Officer of Myovant Sciences, Inc.Concurrent with this appointment, Mr. Marekwas also appointed Principal Executive Officer of Myovant Sciences Ltd.and a member of its Board of Directors.
April 5, 2021, Myovantannounced the appointment of Lauren Merendinoas Chief Commercial Officer of Myovant Sciences, Inc. Ms. Merendinois also a member of Myovant’s Executive Committee.
Expected Upcoming Milestones
- FDA decision for relugolix combination tablet for the treatment of uterine fibroids is expected by the
June 1, 2021target action date. If approved, Myovantand Pfizer expect to launch in the U.S.in June 2021. Upon FDA approval, Myovantwill receive a $100.0 millionregulatory milestone payment from Pfizer. U.S.regulatory submission to the FDA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in the second quarter of calendar year 2021.
- Pfizer’s decision regarding its exclusive option to acquire development and commercialization rights to relugolix in oncology outside of the
U.S.and Canada(excluding certain Asian markets) is expected in mid-calendar year 2021. If Pfizer exercises this option, Myovantwill receive a $50.0 millionpayment and will be eligible to receive double-digit royalties on net sales. European Commission(EC) decision on the uterine fibroids MAA is expected in mid-calendar year 2021. If approved, this launch will be executed by Gedeon Richter Plc. (Richter), Myovant’s commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europeand certain other international markets.
- MAA submission to the EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in calendar year 2021. Richter will be the MAA sponsor.
- EC decision on the advanced prostate cancer MAA is expected in calendar year 2022.
Fourth Fiscal Quarter and Fiscal Year Ended
Total revenues for the three months and year ended
- Product revenue, net from sales of ORGOVYX in the
U.S.for the three months and year ended March 31, 2021were $3.6 million.
- Collaboration revenue for the three months and year ended
March 31, 2021was $21.0 millionand $22.4 million, respectively, and represents partial amortization of the upfront payment received from Pfizer pursuant to the Pfizer Collaboration and License Agreement.
- License and milestone revenue for the year ended
March 31, 2021was $33.3 millionand represents the partial recognition of revenue associated with the $40.0 millionupfront payment and a $10.0 millionregulatory milestone payment received from Richter under the Richter Developmentand Commercialization Agreement.
Cost of product revenue for the three months and year ended
Collaboration expense to Pfizer for the three months and year ended
Research and development (R&D) expenses for the three months ended
Selling, general and administrative (SG&A) expenses for the three months ended
Interest expense was
There was no loss on extinguishment of debt for the year ended
Interest income for the three months ended
Foreign exchange loss (gain) 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 Dainippon 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. Relugolix monotherapy (120 mg) is FDA-approved as ORGOVYX™ for the treatment of adult patients with advanced prostate cancer and is under regulatory review in
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
Sumitovant is a global biopharmaceutical company with offices in
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; certain statements with respect to expectations of commercialization of ORGOVYX in Mr. Marek’s quote; Myovant’s expectations regarding status of its publicly announced milestones; Myovant’s expected timelines of coverage decisions by commercial and Medicare Part D payors; the timing of Myovant’s regulatory submissions, anticipated regulatory review results, and
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.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended
|Product revenue, net||$||3,630||$||—||$||3,630||$||—|
|License and milestone revenue||—||—||33,333||—|
|Operating costs and expenses:|
|Cost of product revenue||301||—||301||—|
|Collaboration expense to Pfizer||1,664||—||1,664||—|
|Research and development (1)||21,553||41,713||136,713||192,560|
|Selling, general and administrative (1)||78,036||22,430||181,423||82,327|
|Total operating costs and expenses||101,554||64,143||320,101||274,887|
|Loss from operations||(76,949||)||(64,143||)||(260,784||)||(274,887||)|
|Loss on extinguishment of debt||—||—||—||4,851|
|Foreign exchange loss (gain)||2||(470||)||(16,176||)||(1,621||)|
|Loss before income taxes||(80,411||)||(64,851||)||(254,798||)||(288,228||)|
|Income tax expense||952||62||336||761|
|Net loss per common share — basic and diluted||$||(0.89||)||$||(0.73||)||$||(2.83||)||$||(3.37||)|
|Weighted average common shares outstanding — basic and diluted||91,018,204||89,130,806||90,036,459||85,839,303|
(1) Includes the following share-based compensation expense:
|Research and development||$||2,989||$||2,959||$||14,049||$||14,524|
|Selling, general and administrative||28,941||3,114||39,627||25,727|
|Total share-based compensation expense||$||31,930||$||6,073||$||53,676||$||40,251|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|Cash and cash equivalents||$||674,493||$||76,644|
|Accounts receivable, net||3,570||—|
|Prepaid expenses and other current assets||13,536||8,269|
|Total current assets||704,645||87,910|
|Property and equipment, net||3,300||2,497|
|Operating lease right-of-use asset||9,655||11,146|
|Liabilities and Shareholders’ Deficit|
|Accrued expenses and other current liabilities||44,612||29,060|
|Share-based compensation liabilities||21,636||—|
|Amounts due to collaboration partner||1,954||—|
|Cost share advance from collaboration partner||92,415||—|
|Operating lease liability||1,807||1,516|
|Amounts due to related parties||543||15|
|Total current liabilities||281,340||85,925|
|Deferred revenue, non-current||397,369||—|
|Cost share advance from collaboration partner, non-current||29,447||—|
|Long-term operating lease liability||9,189||10,996|
|Long-term debt, less current maturities (related party)||358,700||113,700|
|Total shareholders’ deficit||(353,965||)||(108,277||)|
|Total liabilities and shareholders’ deficit||$||725,027||$||105,926|
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Source: Myovant Sciences, Inc.