Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Third Fiscal Quarter Ended December 31, 2019

BASEL, Switzerland, Feb. 10, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, today announced recent corporate updates and reported financial results for the third fiscal quarter ended December 31, 2019.

“The next six months promise to be an inflection point for Myovant as we expect to submit NDAs for prostate cancer and uterine fibroids in the U.S. and announce data from two Phase 3 studies in endometriosis,” said Lynn Seely, M.D., CEO of Myovant. “We are preparing to potentially bring two distinct one pill, once-a-day treatments to the many women and men who suffer from these common diseases. The low-interest loan facility from Sumitomo Dainippon Pharma strengthens our financial position and further supports this vision.”

Third Fiscal Quarter 2019 and Recent Business Highlights

Relugolix Phase 3 Clinical Programs

Corporate

Third Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended December 31, 2019, were $48.9 million compared to $58.4 million for the comparable prior year period. R&D expenses in both periods 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 study costs were partially offset by increases in other R&D expenses related predominantly to Myovant’s manufacturing activities in connection with preparations for Myovant’s anticipated commercial launches and regulatory submissions for relugolix combination tablet and relugolix monotherapy tablet in multiple indications and jurisdictions, as well as increases in personnel expenses, share-based compensation expense, and other R&D expenses.  For the quarter ended December 31, 2019, 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 the transaction between Roivant and Sumitomo Dainippon Pharma.

General and administrative (G&A) expenses for the quarter ended December 31, 2019, were $29.1 million compared to $10.7 million for the comparable prior year period. The increase primarily reflects a one-off increase in share-based compensation, as well as increases in personnel-related expenses, professional service fees, expenses related to commercial operations activities in advance of potential regulatory approvals of relugolix combination tablet and relugolix monotherapy tablet, other general overhead and administrative expenses to support Myovant’s headcount growth and expanding operations and the assumption of activities previously provided by Myovant’s former majority shareholder, Roivant. For the quarter ended December 31, 2019, G&A expenses include $14.4 million of share-based compensation, of which $10.2 million are related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant.

Interest expense for the quarter ended December 31, 2019, was $3.6 million compared to $1.6 million in the comparable prior year period. The increase for the quarter was primarily the result of higher outstanding debt balances under Myovant’s financing arrangements with NovaQuest and Hercules. On December 31, 2019, Myovant repaid all of its outstanding obligations to NovaQuest and Hercules.

Loss on extinguishment of debt for the quarter ended December 31, 2019, 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 comparable prior year period.

Interest income for the quarter ended December 31, 2019, was $0.6 million. There was no interest income for the quarter ended December 31, 2018. During the quarter ended December 31, 2019, a portion of Myovant’s cash was invested in a combination of money market funds, commercial paper, and short-term corporate bonds. There were no such investments during the comparable prior year period.

Net loss for the quarter ended December 31, 2019, was $85.6 million, compared to $70.6 million for the comparable prior year period. The increase in the net loss for the quarter was driven primarily by the increase in expenses outlined above. On a per common share basis, net loss was $0.96 and $1.04 for the quarters ended December 31, 2019, and 2018, respectively. The decrease in the net loss per common share for the quarter was due to an increase in the weighted-average common shares outstanding primarily as a result of Myovant’s underwritten public equity offering in June 2019.

Capital resources: Cash, cash equivalents, and marketable securities totaled $98.9 million as of December 31, 2019. As of December 31, 2019, Myovant had $286.3 million of available borrowing capacity under the loan facility from Sumitomo Dainippon Pharma. Additional funds may be drawn down by Myovant no more than once any calendar quarter, subject to certain terms and conditions, including consent of Myovant’s Board of Directors.

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 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 pain associated 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.

About Myovant Sciences 
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 Takeda Pharmaceutical Company Limited, granted the company an exclusive, worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive license to develop and commercialize MVT-602 in all countries worldwide. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma, is the majority shareholder of Myovant. For more information, please visit the company’s website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant’s promising pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant, please visit https://www.sumitovant.com.

About Sumitomo Dainippon Pharma
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.

Forward-Looking Statements
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’ aspirations to become the leading healthcare company focused on innovative treatments for women’s health and prostate cancer, Myovant Sciences’ plans and expected timing to submit regulatory filings for relugolix combination tablet and relugolix monotherapy tablet in the U.S. and Europe and Myovant’s plans to announce top-line results from ongoing clinical trials; and the potential for the LIBERTY open-label extension study data to positively impact the labeled duration of use. 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.  Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on November 12, 2019, and in Myovant Sciences’ future filings with the SEC, including without limitation, Myovant Sciences’ Quarterly Report on Form 10-Q expected to be filed with the SEC on or about February 10, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

MYOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)

 Three Months Ended December 31,Nine Months Ended December 31,
 2019201820192018
Operating expenses:  
Research and development (1)$48,927 $58,434 $150,847$163,588
General and administrative (1)29,142 10,68659,89729,738
Total operating expenses78,069 69,120 210,744193,326
Interest expense3,641 1,634 11,2224,831
Loss on extinguishment of debt4,851 —4,851
Interest expense (related party)16 —16
Interest income(597) — (2,305)
Other (income) expense, net(567) (121)(1,151)147
Loss before income taxes(85,413) (70,633)(223,377)(198,304)
Income tax expense191 —699233
Net loss$(85,604)$(70,633)$(224,076)$(198,537)
Net loss per common share — basic and diluted$(0.96)$(1.04)$(2.64)$(3.01)
Weighted average common shares outstanding — basic and diluted88,893,579 67,616,419 84,750,11465,873,779

(1) Includes the following share-based compensation expenses:

Research and development (2)$5,399$1,840$11,565$5,247
General and administrative (3)$14,396$2,954$22,613$8,516

(2) For the three and nine months ended December 31, 2019, includes approximately $1.8 million related to the accelerated vesting of certain equity awards as a result of a change in control of Myovant.

(3) For the three and nine months ended December 31, 2019, includes approximately $10.2 million related to the accelerated vesting of certain equity awards as a result of a change in control of Myovant.

MYOVANT SCIENCES LTD.
Condensed Consolidated Balance Sheet
(Unaudited, in thousands)

 December 31, 2019March 31, 2019
Assets  
Current assets:  
Cash and cash equivalents$83,073 $156,074
Marketable securities15,815 —
Prepaid expenses and other current assets12,086 10,194
Income tax receivable 524
Total current assets110,974 166,792
Property and equipment, net2,406 2,071
Operating lease right-of-use asset11,491 —
Other assets4,636 4,114
Total assets$129,507 $172,977
Liabilities and Shareholders’ (Deficit) Equity  
Current liabilities:  
Accounts payable$6,617 $11,019
Interest payable 1,077
Interest payable (related party)16 —
Accrued expenses45,214 53,735
Operating lease liability1,449 —
Current maturities of long-term debt 6,142
Total current liabilities53,296 71,973
Deferred rent 1,157
Deferred interest payable 2,273
Long-term operating lease liability11,399 —
Long-term debt, less current maturities 93,240
Long-term debt, less current maturities (related party)113,700 —
Total liabilities178,395 168,643
Total shareholders’ (deficit) equity(48,888) 4,334
Total liabilities and shareholders’ (deficit) equity$129,507 $172,977

Investor Contact:
Frank Karbe
President, Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com

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