Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Second Fiscal Quarter Ended September 30, 2019
-Landmark Agreement with
-Myovant to report top-line data from Phase 3 HERO study in advanced prostate cancer by the end of calendar year 2019 and Phase 3 SPIRIT studies in endometriosis in the first and second quarters of calendar year 2020
-Myovant secured commitment from Roivant Sciences and
-Submission of New Drug Application (NDA) for uterine fibroids together with PRV now expected in
“Myovant continues to make great progress towards our milestones and is poised for a strong commercial launch of relugolix if approved, with two positive Phase 3 studies evaluating relugolix combination therapy in women with uterine fibroids and approximately
Second Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs
July 2019, Myovant announced positive top-line data from LIBERTY 2, the second of two Phase 3 studies evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids and heavy menstrual bleeding. Results from a separate bioequivalence study support submission to the FDAof a potential one tablet, once-daily dosing regimen of relugolix combination therapy. In addition, the 12-month safety data from the LIBERTY open-label extension study are expected in the first quarter of calendar year 2020.
- Roivant Sciences and
Sumitomo Dainippon Pharmahave committed to Myovant a priority review voucher (PRV) expected to become available in early December 2019. Myovant plans to use the PRV in conjunction with its NDA submission for a once-daily, relugolix combination tablet for the treatment of heavy menstrual bleeding and uterine fibroids, potentially decreasing the standard FDAreview time. Myovant has decided to defer its NDA submission for a once-daily, relugolix combination tablet for the treatment of heavy menstrual bleeding and uterine fibroids until April 2020, which would allow inclusion of the complete 12-month safety data from the LIBERTY open-label extension study, key data that may positively impact the labeled duration of use of the combination tablet. The terms regarding how the PRV will be transferred to Myovant will be determined in connection with the closing of the Roivant-Sumitomo Dainippon Pharma transaction. The transfer is expected to be a related-party transaction and will not involve the issuance of Myovant shares. Myovant still plans to submit a Marketing Authorisation Application (MAA) to the European Medicines Agencyin the first quarter of calendar year 2020.
July 2019, Myovant completed enrollment of an additional cohort of 139 men with metastatic prostate cancer in the Phase 3 HERO study in order to assess the secondary objective of demonstrating that relugolix can delay the time to progression of the lethal state of the disease, castration-resistant prostate cancer, as compared to leuprolide. Myovant expects the top-line data readout for the HERO study by the end of calendar year 2019, with results from this additional cohort, including the castration resistance-free survival endpoint, expected in the third quarter of calendar year 2020. Myovant also anticipates submitting its NDA for its once-daily, oral relugolix monotherapy tablet for men with advanced prostate cancer in the second quarter of calendar year 2020.
- In August and
October 2019, Myovant completed patient recruitment for the Phase 3 SPIRIT 2 and SPIRIT 1 studies, respectively, evaluating the safety and efficacy of relugolix combination therapy in women with pain associated with endometriosis. Myovant expects to report top-line results from SPIRIT 2 and SPIRIT 1 in the first and second quarters of calendar year 2020, respectively.
October 2019, Myovant entered into a landmark agreement with Sumitomo Dainippon Pharmato secure a $350 millionlow-interest, five-year term loan facility, with no payments due until the end of the term, and an Investors Rights Agreement, which is intended to provide safeguards to minority shareholders. The term loan facility and Investors Rights Agreement are expected to become effective in connection with the closing of Sumitomo Dainippon Pharma’s transaction with Roivant.
Second Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended September 30, 2019, were
General and administrative (G&A) expenses for the quarter ended September 30, 2019, were
Interest expense for the quarter ended September 30, 2019, was
Interest income for the quarter ended September 30, 2019, was
Net loss for the quarter ended September 30, 2019, was
Capital resources: Cash, cash equivalents, and marketable securities 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. Myovant Sciences is developing a relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with endometriosis-associated pain. Myovant is also evaluating relugolix monotherapy (120 mg once daily) in men with advanced 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.
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer. The company’s lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist. The company has three late-stage clinical programs for relugolix in uterine fibroids, endometriosis, and prostate cancer. The company is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, that has completed a Phase 2a study for the treatment of female infertility as part of assisted reproduction. Takeda Pharmaceuticals International AG, a subsidiary of
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 regarding Myovant Sciences’ aspirations to become the leading healthcare company focused on innovative treatments for women’s health and prostate cancer; the expected timing and terms of agreements with
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.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended September 30,||Six Months Ended September 30,|
|Research and development (1)||$||50,803||$||53,813||$||101,920||$||105,154|
|General and administrative (1)||16,603||10,310||30,755||19,052|
|Total operating expenses||67,406||64,123||132,675||124,206|
|Other expense (income), net||121||(21||)||(584||)||268|
|Loss before income taxes||(70,373||)||(65,682||)||(137,964||)||(127,671||)|
|Income tax expense||195||88||508||233|
|Net loss per common share — basic and diluted||$||(0.79||)||$||(0.99||)||$||(1.68||)||$||(1.97||)|
|Weighted average common shares outstanding — basic and diluted||88,798,398||66,666,876||82,667,061||64,997,698|
(1) Includes the following share-based compensation expenses:
|Research and development||$||3,618||$||1,846||$||6,166||$||3,407|
|General and administrative||$||4,313||$||2,879||$||8,217||$||5,562|
Condensed Consolidated Balance Sheet
(Unaudited, in thousands)
|September 30, 2019||March 31, 2019|
|Cash and cash equivalents||$||130,373||$||156,074|
|Prepaid expenses and other current assets||9,969||10,194|
|Income tax receivable||17||524|
|Total current assets||167,579||166,792|
|Property and equipment, net||2,288||2,071|
|Operating lease right-of-use asset||8,973||—|
|Liabilities and Shareholders’ Equity|
|Operating lease liability||853||—|
|Due to Roivant Sciences Ltd., Roivant Sciences, Inc., and Roivant Sciences GmbH||271||121|
|Current maturities of long-term debt||8,402||6,142|
|Total current liabilities||60,030||71,973|
|Deferred interest payable||5,323||2,273|
|Long-term operating lease liability||9,320||—|
|Long-term debt, less current maturities||92,075||93,240|
|Total shareholders’ equity||17,254||4,334|
|Total liabilities and shareholders’ equity||$||184,002||$||172,977|
Chief Financial Officer
SOURCE: Myovant Sciences
Source: Myovant Sciences, Inc.