Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2020
- Co-primary endpoints and six key secondary endpoints met in Phase 3 SPIRIT 2 study in women with endometriosis, with results from the Phase 3 SPIRIT 1 study expected in the second quarter of calendar year 2020
- New Drug Application (NDA) submitted for relugolix monotherapy tablet for men with advanced prostate cancer, with castration resistance-free survival results expected in the third quarter of calendar year 2020
- Marketing Authorization Application for relugolix combination tablet for women with uterine fibroids submitted and currently under evaluation by the
- Strategic partnership with
“I am tremendously proud of the many accomplishments of the
Fourth Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Clinical Programs
March 2020, Myovantannounced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) 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 moderate to severe symptoms associated with uterine fibroids. The MAA submission has completed validation and is now under evaluation by the EMA. The MAA submission was supported by efficacy and safety data from the Phase 3 LIBERTY program which consisted of two multinational, replicate pivotal clinical studies, LIBERTY 1 and 2, as well as data from a long-term extension study of relugolix combination therapy. Myovantexpects to submit an NDA for relugolix combination tablet in uterine fibroids in May 2020.
April 2020, Myovantannounced that the Phase 3 SPIRIT 2 study evaluating the safety and efficacy of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) over 24 weeks in 623 women with endometriosis met its co-primary efficacy endpoints with a 75.2% response rate for dysmenorrhea (menstrual pain) and a 66.0% response rate for non-menstrual pelvic pain, while achieving six key secondary endpoints and demonstrating minimal bone mineral density loss. Myovantexpects to report top-line results from a replicate Phase 3 study, SPIRIT 1, in the second quarter of calendar year 2020.
April 2020, Myovant also announced that in an ovulation inhibition study relugolix combination therapy achieved 100% ovulation inhibition in 67 healthy women with no women ovulating during the 84-day treatment period, as evaluated by the Hoogland-Skouby assessment scale (score < 5). Furthermore, 100% of women resumed ovulation or menses upon discontinuation of treatment with an average time to ovulation of 23.5 days.
April 2020, Myovantannounced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix monotherapy tablet (120 mg) for the treatment of men with advanced prostate cancer. The NDA submission was supported by efficacy and safety data from the Phase 3 HERO study, a randomized pivotal study comparing relugolix monotherapy tablet versus leuprolide acetate. Myovantwill present new efficacy and cardiovascular safety data from the HERO study in an oral presentation at the American Society of Clinical Oncology(ASCO)’s ASCO20 Virtual Scientific Program on May 29, 2020. Myovantexpects to report additional data from the HERO study measuring castration resistance-free survival in approximately 430 men in the third quarter of calendar year 2020.
March 2020, Myovantand Gedeon Richter Plc. ( Richter), a major pharmaceutical company in Central Eastern Europe focused on women’s health, entered into an exclusive license agreement for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the agreement, Myovant received an upfront payment of $40 million and is eligible to receive up to $40 million in regulatory milestones (of which $10 millionwas received in April 2020) and $107.5 million in sales-related milestones, and tiered royalties on net sales following regulatory approval. Myovant retains all rights to relugolix combination tablet in the U.S. and Canada, as well as rights to relugolix in other therapeutic areas outside of women’s health.
COVID-19 Pandemic Environment
- To date the impact of the COVID-19 pandemic on Myovant’s ability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited and all of Myovant’s publicly 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’s activities,
Myovantmay experience more significant impacts on its business operations.
Fourth Fiscal Quarter and Full Fiscal Year 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended
General and administrative (G&A) expenses for the quarter ended
Interest expense for the quarters ended
Loss on extinguishment of debt for the year ended
Interest expense (related party) for the quarter and year ended
Interest income for the quarter and year ended
Net loss for the quarter ended
Capital resources: Cash, cash equivalents, marketable securities, and committed funding totaled
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer.
MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.
Sumitovant is a global biopharmaceutical company with offices in
About Sumitomo Dainippon Pharma
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies 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 Myovant Sciences’ aspiration to redefine care for women and for men; expectations to submit an NDA for relugolix combination tablet in uterine fibroids 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.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended
|Research and development (1)||$||41,713||$||59,019||$||192,560||$||222,607|
|General and administrative (1)||22,430||12,481||82,327||42,219|
|Total operating expenses||64,143||71,500||274,887||264,826|
|Loss on extinguishment of debt||—||—||4,851||—|
|Interest expense (related party)||1,425||—||1,441||—|
|Other (income) expense, net||(470||)||162||(1,621||)||309|
|Loss before income taxes||(64,851||)||(74,771||)||(288,228||)||(273,075||)|
|Income tax expense||62||243||761||476|
|Net loss per common share — basic and diluted||$||(0.73||)||$||(1.07||)||$||(3.37||)||$||(4.09||)|
|Weighted average common shares outstanding — basic and diluted||89,130,806||70,076,475||85,839,303||66,910,060|
(1) Includes the following share-based compensation expenses:
|Research and development (2)||$||2,959||$||1,914||$||14,524||$||7,161|
|General and administrative (3)||$||3,114||$||3,019||$||25,727||$||11,535|
(2) For the year ended
(3) For the year ended
Condensed Consolidated Balance Sheet
(Unaudited, in thousands)
|Cash and cash equivalents||$||76,644||$||156,074|
|Prepaid expenses and other current assets||8,269||10,194|
|Income tax receivable||—||524|
|Total current assets||87,910||166,792|
|Property and equipment, net||2,497||2,071|
|Operating lease right-of-use asset||11,146||—|
|Liabilities and Shareholders’ (Deficit) Equity|
|Interest payable (related party)||15||—|
|Operating lease liability||1,516||—|
|Current maturities of long-term debt||—||6,142|
|Total current liabilities||85,925||71,973|
|Deferred interest payable||—||2,273|
|Long-term operating lease liability||10,996||—|
|Long-term debt, less current maturities||—||93,240|
|Long-term debt, less current maturities (related party)||113,700||—|
|Total shareholders’ (deficit) equity||(108,277||)||4,334|
|Total liabilities and shareholders’ (deficit) equity||$||105,926||$||172,977|
President and Chief Financial Officer
Source: Myovant Sciences, Inc.