Myovant Sciences Announces Corporate Updates and Financial Results for Third Quarter of Fiscal Year 2020
- ORGOVYX™ (relugolix) approved by the
U.S. Food and Drug Administration(FDA) in December 2020as the first and only oral GnRH receptor antagonist for adult patients with advanced prostate cancer; ORGOVYX launched in the U.S.in early January 2021
- Announced collaboration with Pfizer in
December 2020to jointly develop and commercialize relugolix in oncology and relugolix combination tablet in women’s health in the U.S.and Canada
- Reported positive one-year efficacy and safety data from Phase 3 SPIRIT program for relugolix combination therapy in women with endometriosis-associated pain, including bone mineral density data
- 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; European Commissiondecision on uterine fibroids Marketing Authorization Application expected in mid-calendar year 2021
- Announced Phase 3 SERENE study to assess the contraceptive efficacy of relugolix combination tablet; study designed to support potential benefit of prevention of pregnancy for women taking relugolix combination tablet for the treatment of uterine fibroids and endometriosis, if approved for those indications
- Cash, cash equivalents, and marketable securities of
$745.8 millionas of December 31, 2020
“The FDA approval of ORGOVYX and the landmark collaboration with Pfizer represent pivotal catalysts that have advanced Myovant’s purpose of redefining care and its transformation into a commercial-stage company with compelling near-term opportunities in oncology and women’s health,” said
Third Quarter Fiscal Year 2020 and Recent Corporate Updates
December 2020, Myovantentered into a collaboration agreement with Pfizer under which Myovantand Pfizer will jointly develop and commercialize relugolix in oncology and women’s health and equally share profits and certain expenses, in the U.S.and Canada(the Co-Promotion Territory).
December 2020, Myovantreceived a $650.0 millionupfront payment and is eligible to receive additional regulatory and sales milestones, for total net payments of up to $4.2 billion. Myovantgranted Pfizer an exclusive option to acquire development and commercialization rights to relugolix in oncology outside of the Co-Promotion Territory (excluding certain Asian markets). If Pfizer exercises this option, Myovantwill receive an additional $50.0 millionpayment and will be eligible to receive double-digit royalties on net sales. Pfizer’s decision is expected in the first half of calendar year 2021.
December 18, 2020, the U.S.Food and Drug Administration (FDA) approved ORGOVYX for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral GnRH receptor antagonist for men with advanced prostate cancer.
- ORGOVYX was launched in the
U.S.and authorized specialty distribution channels were fully stocked in early January 2021.
- The ORGOVYX patient support program launched in early January, including access to free trial for new commercial and government insured patients and co-pay support for eligible commercial patients.
Myovantcompleted the hiring of its 100-person oncology sales force during December 2020. All sales professionals completed training and began actively promoting ORGOVYX to target prescribers in early January 2021.
- Pfizer’s uro-oncology sales force was trained in
January 2021and began actively promoting ORGOVYX to target prescribers in early February 2021. Myovantis engaging in coverage negotiations with key commercial and Medicare Part D payors, with some coverage anticipated by the middle of calendar year 2021 and broad coverage anticipated by the end of calendar year 2021.
Relugolix Combination Tablet
• Uterine Fibroids
October 2020, Myovantpresented the following data for relugolix combination therapy in women with uterine fibroids at the American Society for Reproductive Medicine(ASRM) 2020 Virtual Congress:
- One-year efficacy and safety data from the LIBERTY long-term extension study (Scientific Congress Prize Paper Session 1).
- A validated exposure-response model simulating long-term effects of relugolix combination therapy on bone mineral density at the lumbar spine.
- A poster describing the improvement of pain associated with uterine fibroids in the LIBERTY Phase 3 program (1st Place in
October 2020, data from the replicate Phase 3 SPIRIT 1 and SPIRIT 2 studies were presented at the ASRM 2020 Virtual Congressin an oral presentation named the Prize Paper by the Endometriosis Special Interest Group.
January 2021, Myovantand Pfizer announced positive one-year data from the SPIRIT extension study of once-daily relugolix combination therapy in women with endometriosis. 84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with stable bone mineral density after initial minimal 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.
- The results of the SPIRIT clinical program will support a New Drug Application (NDA) for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted to the FDA in the first half of calendar year 2021.
January 2021, Myovantannounced the appointment of David Marekas Chief Executive Officer of Myovant Sciences, Inc.Concurrent with this appointment, Mr. Marekwas also appointed as Principal Executive Officer of Myovant Sciences Ltd.and as a member of its Board of Directors.
COVID-19 Pandemic Environment
- Myovant’s priorities during the COVID-19 pandemic are protecting the health and safety of its employees and patients while continuing its mission to redefine care for women and for men. To date, the impact of the COVID-19 pandemic on Myovant’s ability to advance its clinical studies, regulatory activities, commercial launch activities for ORGOVYX, and preparations for the potential commercialization of relugolix combination tablet has been limited, and all of Myovant’s publicly announced milestones remain on track. At this time,
Myovantdoes not believe that the COVID-19 pandemic has disproportionately impacted it relative to other companies in Myovant’s industry and the medical community appears to be highly engaged with Myovant’s field team. To date, Myovanthas not experienced supply constraints, and believes it has procured sufficient quantities of relugolix drug substance to meet its U.S.ORGOVYX launch plans and U.S.launch plans for relugolix combination tablet, if approved. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant’s activities, Myovantmay experience more significant impacts on its business operations.
Expected Upcoming Milestones
- Data from the LIBERTY randomized withdrawal study, including efficacy and safety data of relugolix combination therapy in women with uterine fibroids for up to two years, is expected in the first quarter of calendar year 2021.
- Marketing Authorization Application (MAA) submission to the
European Medicines Agency(EMA) for relugolix monotherapy for advanced prostate cancer expected in the first quarter of calendar year 2021. Myovantand Pfizer plan to initiate in the first half of calendar year 2021 a Phase 3 open-label clinical study in the U.S.to assess the contraceptive efficacy of relugolix combination tablet. The SERENE study will enroll sexually active, healthy premenopausal women ages 18-35 years with presumed normal fertility. Women will receive once-daily relugolix combination tablet for 13 28-day cycles. The primary efficacy endpoint will be the Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. Positive data from the SERENE study would further differentiate relugolix combination tablet by potentially adding the benefit of prevention of pregnancy for women taking relugolix combination tablet for the treatment of uterine fibroids and endometriosis, if approved for these indications.
- FDA decision for relugolix combination tablet for the treatment of uterine fibroids expected by
June 1, 2021target action date.
- NDA submission to the FDA for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in the first half of calendar year 2021.
European Commissiondecision on the uterine fibroids MAA expected in mid-calendar year 2021. If approved, this launch will be executed by Gedeon 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 EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in calendar year 2021.
Gedeon Richterwill be the MAA sponsor.
Third Quarter Fiscal Year 2020 Financial Summary
Collaboration revenue in the three months ended
Research and development (R&D) expenses in the three months ended
Selling, general, and administrative (SG&A) expenses in the three months ended
Interest expense was
Loss on extinguishment of debt in the three months ended
Interest income in the three months ended
Other income, net in the three months ended
Net loss for the three months ended
Capital resources: Cash, cash equivalents, marketable securities, and committed amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled
As previously announced,
The webcast will be archived on Myovant’s Investor Relations website following the call.
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 (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) 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
Forward Looking Statements
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; those statements in Mr. Marek’s quote; the expectation of Pfizer’s decision with respect to its exclusive option to acquire development and commercialization rights to relugolix in oncology outside of the Co-Promotion Territory; Myovant’s expectations regarding potential regulatory and sales milestones from Pfizer; Myovant’s expected timelines of coverage decisions by commercial and Medicare Part D payors; the expected timing and characterization of the results from Myovant’s ongoing clinical trials, including the planned SERENE study; the timing of Myovant’s regulatory submissions and anticipated regulatory review results; the statement that all of Myovant’s publicly announced milestones remaining on track; the statements regarding the effects of COVID-19 on Myovant’s operations; and those statements under the caption “Expected Upcoming Milestones.” 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
||Nine Months Ended
|License and milestone revenue||—||—||33,333||—|
|Research and development (1)||30,453||48,927||115,160||150,847|
|Selling, general and administrative (1)||49,243||29,142||103,387||59,897|
|Total operating expenses||79,696||78,069||218,547||210,744|
|Loss from operations||(78,317||)||(78,069||)||(183,835||)||(210,744||)|
|Loss on extinguishment of debt||—||4,851||—||4,851|
|Other income, net||(5,891||)||(567||)||(16,178||)||(1,151||)|
|Loss before income taxes||(75,003||)||(85,413||)||(174,387||)||(223,377||)|
|Income tax (benefit) expense||(1,154||)||191||(616||)||699|
|Net loss per common share — basic and diluted||$||(0.82||)||$||(0.96||)||$||(1.94||)||$||(2.64||)|
|Weighted average common shares outstanding — basic and diluted||90,096,557||88,893,579||89,715,160||84,750,114|
|(1) Includes the following share-based compensation expenses:|
|Research and development||$||3,311||$||5,399||$||11,060||$||11,565|
|Selling, general and administrative||$||3,699||$||14,396||$||10,686||$||22,613|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|Cash and cash equivalents||$||713,523||$||76,644|
|Prepaid expenses and other current assets||8,180||8,269|
|Total current assets||754,027||87,910|
|Property and equipment, net||2,847||2,497|
|Operating lease right-of-use asset||10,045||11,146|
|Liabilities and Shareholders’ Deficit|
|Interest payable (related party)||—||15|
|Cost share advance from collaboration partner||92,415||—|
|Operating lease liability||1,731||1,516|
|Amounts due to related parties||628||—|
|Total current liabilities||252,072||85,925|
|Deferred rent, non-current||418,344||—|
|Cost share advance from collaboration partner, non-current||46,424||—|
|Long-term operating lease liability||9,669||10,996|
|Long-term debt, less current maturities (related party)||313,700||113,700|
|Total shareholders’ deficit||(270,657||)||(108,277||)|
|Total liabilities and shareholders’ deficit||$||774,214||$||105,926|
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Source: Myovant Sciences, Inc.