On May 18, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2020 (Press release, Myovant Sciences, MAY 18, 2020, View Source [SID1234558234]).
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"I am tremendously proud of the many accomplishments of the Myovant team over the last year, with four positive Phase 3 studies, multiple regulatory submissions, and a strategic partnership with Gedeon Richter to accelerate the potential commercialization of relugolix combination tablet," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "We look forward to submitting our NDA in uterine fibroids this month and sharing the SPIRIT 1 results later this quarter, as we continue to realize our vision of redefining care for the millions of women and men with uterine fibroids, endometriosis, and prostate cancer."
Fourth Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Clinical Programs
In March 2020, Myovant announced 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. Myovant expects to submit an NDA for relugolix combination tablet in uterine fibroids in May 2020.
In April 2020, Myovant announced 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. Myovant expects to report top-line results from a replicate Phase 3 study, SPIRIT 1, in the second quarter of calendar year 2020.
In 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.
In April 2020, Myovant announced 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. Myovant will present new efficacy and cardiovascular safety data from the HERO study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program on May 29, 2020. Myovant expects 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.
Corporate
In March 2020, Myovant and 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 million was 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, Myovant may 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 March 31, 2020, were $41.7 million compared to $59.0 million for the comparable prior year period. R&D expenses for the fiscal year ended March 31, 2020, were $192.6 million, compared to $222.6 million for the prior fiscal year. R&D expenses for the periods presented primarily include expenses related to Myovant’s Phase 3 clinical programs, manufacturing expenses, as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses related to Myovant’s clinical programs have continued to decline, driven primarily by the wind down of Myovant’s Phase 3 studies. The decrease in relugolix Phase 3 study costs were partially offset by increases in other R&D expenses related predominantly to regulatory activities in connection with regulatory submissions for relugolix combination tablet and relugolix monotherapy tablet in multiple indications and jurisdictions and the build out of Myovant’s medical affairs organization in connection with preparations for Myovant’s anticipated commercial launches, as well as increases in personnel expenses, share-based compensation, and other R&D expenses. For the year ended March 31, 2020, R&D expenses include $1.8 million of share-based compensation related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant in connection with the closing of a transaction between Roivant and Sumitomo Dainippon Pharma.
General and administrative (G&A) expenses for the quarter ended March 31, 2020, were $22.4 million compared to $12.5 million for the comparable prior year period. G&A expenses for the fiscal year ended March 31, 2020, were $82.3 million, compared to $42.2 million for the prior fiscal year. The increase in G&A expenses for the quarter and the fiscal year ended March 31, 2020 were primarily due to increases in expenses related to commercial operations activities in advance of potential future regulatory approvals of relugolix combination tablet and relugolix monotherapy tablet, personnel-related expenses, and share-based compensation expenses, as well as professional services fees, and other general overhead, administrative and information technology expenses to support Myovant’s headcount growth and expanding operations. For the year ended March 31, 2020, G&A expenses include certain one-off increases as a result of the change in control in Myovant, namely $10.2 million in share-based compensation expense related to the accelerated vesting of certain equity awards as well as a $3.6 million capital tax accrual.
Interest expense for the quarters ended March 31, 2020 and 2019, was $0 and $3.9 million, respectively. On December 31, 2019, Myovant repaid all of its outstanding debt obligations to NovaQuest and Hercules and as a result there was no interest expense during the quarter ended March 31, 2020. For the year ended March 31, 2020, interest expense was $11.2 million, compared to $8.8 million for the comparable prior year period, reflecting higher outstanding debt balances with NovaQuest and Hercules until the debt repayment on December 31, 2019.
Loss on extinguishment of debt for the year ended March 31, 2020, was $4.9 million, which resulted from the early retirement of Myovant’s outstanding obligations to NovaQuest and Hercules. There were no such amounts in the other periods presented.
Interest expense (related party) for the quarter and year ended March 31, 2020, was $1.4 million in relation to Myovant’s outstanding debt of $113.7 million to Sumitomo Dainippon Pharma, which did not exist in the year ended March 31, 2019.
Interest income for the quarter and year ended March 31, 2020, was $0.2 million and $2.6 million, respectively. There was interest income of $0.8 million and $0.9 million for the quarter and year ended March 31, 2019, respectively.
Net loss for the quarter ended March 31, 2020, was $64.9 million, compared to $75.0 million for the comparable prior year period. Net loss for the fiscal year ended March 31, 2020, was $289.0 million, compared to $273.6 million for the prior fiscal year. On a per common share basis, net loss was $0.73 and $1.07 for the quarters ended March 31, 2020 and 2019, respectively, and $3.37 and $4.09 for the years ended March 31, 2020 and 2019, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and committed funding totaled $365.9 million as of March 31, 2020, and consisted of $79.6 million of cash, cash equivalents, and marketable securities and $286.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement. Additional funds may be drawn down by Myovant once per calendar quarter, subject to certain terms and conditions, including consent of Myovant’s Board of Directors. In April 2020, Myovant borrowed an additional $80.0 million under the Sumitomo Dainippon Pharma Loan Agreement. In April 2020, Myovant received a $10.0 million regulatory milestone payment from Richter.
About Relugolix
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 is developing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids and for women with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.
About MVT-602
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.