On June 7, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, or Myovant, reported corporate updates and reported financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2018 (Press release, Myovant Sciences, JUN 7, 2018, http://investors.myovant.com/news-releases/2018/06-07-2018-210515945 [SID1234527236]).
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"I am proud of the Myovant team and our fiscal 2017 clinical and corporate accomplishments. Our energy continues to be focused on completing patient enrollment for our ongoing global Phase 3 clinical development programs of relugolix for the treatment of heavy menstrual bleeding associated with uterine fibroids, endometriosis-associated pain and advanced prostate cancer," stated Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "With our recent capital raise and corporate progress, we believe we are well positioned to execute and advance our corporate mission."
Fourth Fiscal Quarter 2017 and Recent Business Highlights
On March 26, 2018, an additional $15.0 million of Myovant’s financing commitments from Hercules Capital, Inc., or Hercules, was funded prior to the March 31, 2018, term commitment termination date, resulting in $40.0 million total principal amount outstanding under the loan and security agreement.
On April 2, 2018, Myovant entered into a share purchase agreement with Roivant Sciences Ltd., or RSL, Myovant’s majority shareholder, pursuant to which Myovant issued and sold to RSL 1,110,015 common shares at a purchase price of $20.27 per common share in a private placement, or the Private Placement. Myovant received gross proceeds of $22.5 million at the closing of the Private Placement.
On April 2, 2018, Myovant also entered into a Sales Agreement with Cowen and Company, LLC, to sell common shares having an aggregate offering price of up to $100.0 million through an "at-the-market," or ATM, equity offering program. In the first quarter of fiscal 2018, Myovant issued and sold 2,767,129 common shares under this program at a weighted-average-price of $21.47 per common share for aggregate net proceeds of approximately $57.6 million, after deducting commissions.
On April 20, 2018, Myovant announced a partnership with PERIOD, Inc., a youth-led non-profit organization focused on menstrual equity, to elevate the conversation around period health, including an Ask Me About Periods campaign on college campuses around the country.
On May 30, 2018, Myovant entered into a Commercial Manufacturing and Supply Agreement with Takeda Pharmaceutical Company Ltd., or Takeda, pursuant to which Takeda will manufacture and supply Myovant with relugolix drug substance to support the commercial launch of relugolix, if marketing authorization is granted. Takeda has agreed to assist with the transfer of technology and manufacturing know-how to a second contract manufacturing organization of Myovant.
In May 2018, following the completion of a Phase 1 study, Myovant initiated a Phase 2a clinical trial in healthy female volunteers to characterize the dose response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile woman seeking pregnancy.
Fourth Fiscal Quarter and Full Fiscal Year 2017 Financial Summary
Research and development (R&D) expenses for the quarter ended March 31, 2018, were $40.1 million compared to $19.0 million for the comparable period in 2017. R&D expenses for the fiscal year ended March 31, 2018, were $116.8 million, compared to $43.5 million for the prior fiscal year. The increase for both the quarter and the year primarily reflects the progress of Myovant’s ongoing five Phase 3 clinical trials of relugolix, which were initiated in 2017, and additional personnel-related expenses as a result of an increased number of R&D employees.
General and administrative (G&A) expenses for the quarter ended March 31, 2018, were $7.3 million, compared to $3.9 million for the comparable period in 2017. G&A expenses for the fiscal year ended March 31, 2018, were $24.2 million, compared to $12.4 million for the prior fiscal year. The increase for both the quarter and the year primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.
Interest expense for the quarter and year ended March 31, 2018, was $1.1 million and $2.0 million, respectively, while there was no interest expense in the comparable prior year periods. Interest expense for both the quarter and the year consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P., or NovaQuest, and Hercules as well as the associated non-cash amortization of debt discount and issuance costs.
Net loss for the quarter ended March 31, 2018, was $48.3 million, compared to $21.7 million for the comparable period in 2017. Net loss for the fiscal year ended March 31, 2018, was $143.3 million, compared to $83.4 million for the prior fiscal year. On a per common share basis, net loss was $0.81 and $0.37 for the quarters ended March 31, 2018 and 2017, respectively, and $2.41 and $1.70 for the fiscal years ended March 31, 2018 and 2017, respectively. The increase in the net loss and net loss per common share for both the quarter and the year were driven primarily by the increase in costs associated with Myovant’s ongoing Phase 3 clinical trials, which were initiated in 2017, as well as increased personnel-related expenses. The net loss for the prior fiscal year of $83.4 million included $27.5 million of non-cash expense resulting from changes in the fair value of the Takeda warrant liability, which expired on April 30, 2017.
Capital resources: Cash and committed funding totaled $200.6 million at March 31, 2018, consisting of $108.6 million of cash and $92.0 million of remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. In the first quarter of fiscal year 2018, Myovant further strengthened its balance sheet, raising $22.5 million with the completion of the Private Placement of 1,110,015 common shares to RSL and raising net proceeds of approximately $57.6 million, after deducting commissions, from the issuance and sale of 2,767,129 common shares pursuant to its ATM program. Approximately $40.6 million of capacity remains available under the ATM program.
About Relugolix
Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist that has been evaluated in over 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones. In the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain and the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids, relugolix is undergoing evaluation with and without low-dose hormonal add-back therapy, the addition of which is expected to decrease potential relugolix side effects such as bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix alone in men with advanced prostate cancer.