Myovant Sciences Announces Corporate Updates and Financial Results for First Quarter Fiscal Year 2020
- New Drug Application (NDA) for relugolix monotherapy tablet in advanced prostate cancer accepted for Priority Review by the FDA with target action date of
December 20, 2020
- NDA for relugolix combination tablet in uterine fibroids submitted in
USD 200 millionlow-interest, five-year term loan commitment from Sumitomo Dainippon Pharma and commercial collaboration agreement with Sunovion Pharmaceuticalsincreases financial flexibility and provides access to well-established commercial infrastructure
- Co-primary endpoints and seven key secondary endpoints achieved in second Phase 3 study in women with endometriosis
- Phase 3 data in advanced prostate cancer presented in oral presentation at the
American Society of Clinical Oncology(ASCO)’s ASCO20 Virtual Scientific Program with simultaneous publication in the New England Journal of Medicine
"I am very proud of the many recent accomplishments achieved by
First Quarter Fiscal Year 2020 and Recent Corporate Updates
Relugolix Phase 3 Clinical Programs
- Prostate cancer: In
June 2020, the U.S. Food and Drug Administration(FDA) accepted for Priority Review Myovant’s New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer, setting a target action date of December 20, 2020. In May 2020, efficacy and safety data from the Phase 3 HERO study of relugolix in men with advanced prostate cancer were simultaneously published in the New England Journal of Medicineand presented at the American Society of Clinical Oncology(ASCO)’s ASCO20 Virtual Scientific Program. In July 2020, these data were also presented in an oral presentation during the American Urological Association(AUA)’s 2020 Virtual Experience.
- Uterine fibroids: In
May 2020, Myovantsubmitted an NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids. In July 2020, Myovantpresented additional data from the Phase 3 LIBERTY program showing improvement in patient-reported outcomes and in hemoglobin levels in women with anemia, as well as detailed data from a separate ovulation inhibition study, at the European Society of Human Reproduction and Embryology (ESHRE)’s virtual 36th Annual Meeting.
- Endometriosis: In
April 2020, Myovantannounced that the SPIRIT 2 Phase 3 study evaluating the efficacy and safety of once-daily, oral relugolix combination therapy in women with pain associated with endometriosis met the co-primary efficacy endpoints with 75.2% and 66.0% of women achieving clinically-meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, respectively. In June 2020, Myovantannounced that the replicate SPIRIT 1 Phase 3 study also met the co-primary efficacy endpoints with 74.5% and 58.5% of women achieving clinically-meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, respectively. Relugolix was generally well-tolerated and resulted in minimal bone mineral density loss over 24 weeks in both studies.
August 5, 2020, Myovantannounced an additional USD 200 millionlow-interest, five-year term loan commitment from Sumitomo Dainippon Pharma, which, subject to the negotiation of a definitive agreement, will bring its total financing support for Myovantto USD 600 million, further bolstering Myovant’s cash and committed funding, and increasing Myovant’s financing flexibility as it prepares for multiple potential product launches.
August 5, 2020, Myovantalso announced that it entered into a three-year commercial collaboration agreement with Sunovion Pharmaceuticals Inc.(Sunovion). Under the agreement, Sunovion will provide third-party logistics, trade and retail distribution, contract operations, and market access account management services to Myovantand will become a non-exclusive distributor of relugolix for prostate cancer and the exclusive distributor of relugolix combination tablet for uterine fibroids and endometriosis in the U.S.
June 2020, Myovantpartnered with BlackDoctor.org, Evidation Health, and Movember to launch Forward Momentum, a cross-sector coalition working on innovative projects to increase diversity in research and develop new digital resources for men with prostate cancer.
COVID-19 Pandemic Environment
- Myovant’s priorities during the COVID-19 pandemic are protecting the health and safety of its employees while continuing its mission to redefine care for women and for men. To date the impact of the COVID-19 pandemic on
Myovant'sability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited and all of Myovant'spublicly announced milestones remain on track. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant'sactivities, Myovantmay experience more significant impacts on its business operations.
Expected Upcoming Milestones
- Castration-resistance free survival data for prostate cancer expected in the third quarter of calendar year 2020.
- Data from the uterine fibroids cohort in the prospective observational bone mineral density study expected in the third quarter of calendar year 2020.
- Relugolix monotherapy tablet for advanced prostate cancer target action date of
December 20, 2020.
- Data from the LIBERTY randomized withdrawal study expected in the first quarter of calendar year 2021.
- One-year efficacy and safety data from the SPIRIT extension study expected in the first quarter of calendar year 2021.
First Quarter Fiscal Year 2020 Financial Summary
License and milestone revenue in the three months ended
Research and development (R&D) expenses in the three months ended
General and administrative (G&A) expenses in the three months ended
Interest expense was
Interest income in the three months ended
Other income, net in the three months ended
Net loss for the quarter ended
Capital resources: Cash, cash equivalents, marketable securities, and committed funding from Sumitomo Dainippon Pharma totaled
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under development for women with uterine fibroids and for women with endometriosis. Relugolix monotherapy tablet (120 mg once daily) is under regulatory review in the
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under development for women with uterine fibroids and for women with endometriosis. Relugolix monotherapy tablet (120 mg once daily) is under regulatory review in the
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.
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. Forward-looking statements include all statements regarding Myovant Sciences’ intent, belief, or expectations regarding future events or results and can be identified by words such as "anticipate," "aspire," "believe," "can," "continue," "could," "estimate," "expect," "intend," "likely," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "to be," "will," "would," or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements and quotes regarding
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended
|License and milestone revenue||$||33,333||$||—|
|Research and development (1)||44,186||51,117|
|General and administrative (1)||22,828||14,152|
|Total operating expenses||67,014||65,269|
|Loss from operations||(33,681||)||(65,269||)|
|Interest expense (related party)||2,184||—|
|Other income, net||(3,569||)||(705||)|
|Loss before income taxes||(32,188||)||(67,591||)|
|Income tax expense||672||313|
|Net loss per common share — basic and diluted||$||(0.37||)||$||(0.89||)|
|Weighted average common shares outstanding — basic and diluted||89,300,210||76,468,347|
(1) Includes the following share-based compensation expenses:
|Research and development||$||4,024||$||2,548|
|General and administrative||$||3,788||$||3,904|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|Cash and cash equivalents||$||84,726||$||76,644|
|Prepaid expenses and other current assets||9,370||8,269|
|Total current assets||109,066||87,910|
|Property and equipment, net||2,453||2,497|
|Operating lease right-of-use asset||10,790||11,146|
|Liabilities and Shareholders' Deficit|
|Interest payable (related party)||24||15|
|Operating lease liability||1,585||1,516|
|Total current liabilities||52,584||85,925|
|Long-term operating lease liability||10,571||10,996|
|Long-term debt, less current maturities (related party)||193,700||113,700|
|Total shareholders' deficit||(134,610||)||(108,277||)|
|Total liabilities and shareholders' deficit||$||126,682||$||105,926|
President and Chief Financial Officer
Director, Corporate Communications
Source: Myovant Sciences, Inc.