Myovant Sciences Announces Corporate Updates and Financial Results for Third Quarter Fiscal Year 2020

BASEL, Switzerland, Feb. 11, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the third quarter of fiscal year 2020.

“The FDA approval of ORGOVYX and the landmark collaboration with Pfizer represent pivotal catalysts that have advanced Myovant’s purpose of redefining care and its transformation into a commercial-stage company with compelling near-term opportunities in oncology and women’s health,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We are encouraged by the early launch progress for ORGOVYX and expect this momentum to continue to build with the Pfizer uro-oncology sales team recently joining the Myovant sales team in the field. ORGOVYX has the potential to become the new androgen deprivation therapy standard of care in advanced prostate cancer. Combined with relugolix combination tablet, if approved in uterine fibroids and endometriosis, these products are expected to drive significant revenue growth for Myovant in the years to come.”

Third Quarter Fiscal Year 2020 and Recent Corporate Updates

Pfizer Collaboration

ORGOVYX

Relugolix Combination Tablet

Uterine Fibroids

Endometriosis

CEO Appointment

COVID-19 Pandemic Environment

Expected Upcoming Milestones

Third Quarter Fiscal Year 2020 Financial Summary

Collaboration revenue in the three months ended December 31, 2020, was $1.4 million and represents partial amortization of the upfront payment received from Pfizer.

Research and development (R&D) expenses in the three months ended December 31, 2020, were $30.5 million compared to $48.9 million for the comparable prior year period. The decrease in R&D expenses reflects a reduction in clinical study costs as a result of the completion and continued wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, cost reimbursements from Pfizer for certain R&D expenses, and a reduction in share-based compensation expenses. This decrease was partially offset by an increase in personnel expenses, mainly driven by the continued expansion of Myovant’s medical affairs organization, in preparation for Myovant’s U.S. commercial launch of ORGOVYX for adult patients with advanced prostate cancer and the potential U.S. commercial launches of relugolix combination tablet for the women’s health indications, if approved.

Selling, general, and administrative (SG&A) expenses in the three months ended December 31, 2020, were $49.2 million compared to $29.1 million for the comparable prior year period. The increase was primarily due to higher expenses related to commercial readiness activities to support the ORGOVYX U.S. commercial launch and the potential U.S. commercial launches of relugolix combination tablet as well as higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, market access teams, and the oncology sales force. The increase in SG&A expenses was also driven by general overhead expenses to support Myovant’s organizational growth. These items were partially offset by lower share-based compensation expenses in the three months ended December 31, 2020, as the prior year period included incremental expense related to the accelerated vesting of certain equity awards as a result of the change in control of Myovant.

Interest expense was $2.6 million in the three months ended December 31, 2020, compared to $3.7 million in the comparable prior year period. The decrease in interest expense, despite higher outstanding loan balances, was driven by the significantly lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to Myovant’s previously outstanding debt obligations, which were repaid in December 2019.

Loss on extinguishment of debt in the three months 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 losses in the three months ended December 31, 2020.

Interest income in the three months ended December 31, 2020, was less than $0.1 million compared to $0.6 million for the comparable prior year period. The decrease was primarily due to decreases in interest rates and lower balances in cash equivalents and marketable securities during the current year period.

Other income, net in the three months ended December 31, 2020, was $5.9 million compared to $0.6 million for the comparable prior year period. This was primarily the result of a larger foreign currency exchange gain on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement during the three months ended December 31, 2020.

Net loss for the three months ended December 31, 2020, was $73.8 million compared to $85.6 million for the comparable prior year period. On a per common share basis, net loss was $0.82 and $0.96 for the three months ended December 31, 2020, and 2019, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and committed amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $832.1 million as of December 31, 2020, and consisted of $745.8 million of cash, cash equivalents, and marketable securities and $86.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, February 11, 2021, to discuss corporate updates and financial results for its third fiscal quarter ended December 31, 2020. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

The webcast will be archived on Myovant’s Investor Relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We have one FDA-approved medicine, ORGOVYX™ (relugolix), for adult patients with advanced prostate cancer. Our lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Myovant is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including the U.S., Japan, 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.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. 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 needs. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. For further information about Sumitovant, please visit https://www.sumitovant.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including: statements regarding Myovant’s aspiration to redefine care for women and for men; those statements in Mr. Marek’s quote; the expectation of Pfizer’s decision with respect to its exclusive option to acquire development and commercialization rights to relugolix in oncology outside of the Co-Promotion Territory; Myovant’s expectations regarding potential regulatory and sales milestones from Pfizer; Myovant’s expected timelines of coverage decisions by commercial and Medicare Part D payors; the expected timing and characterization of the results from Myovant’s ongoing clinical trials, including the planned SERENE study; the timing of Myovant’s regulatory submissions and anticipated regulatory review results; the statement that all of Myovant’s publicly announced milestones remaining on track; the statements regarding the effects of COVID-19 on Myovant’s operations; and those statements under the caption “Expected Upcoming Milestones.” 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. 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 to be filed on February 11, 2021, 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,Three Months Ended December 31,Nine Months Ended December 31,Nine Months Ended December 31,
 2020201920202019
Revenues:
Collaboration revenue1,3791,379
License and milestone revenue33,333
Total revenues1,37934,712
Operating expenses: 
Research and development (1)30,45348,927115,160150,847
Selling, general and administrative (1)49,24329,142103,38759,897
Total operating expenses79,69678,069218,547210,744
Loss from operations(78,317)(78,069)(183,835)(210,744)
Interest expense2,6093,6576,90811,238
Loss on extinguishment of debt4,8514,851
Interest income(32)(597)(16,178)(2,305)
Other income, net(5,891)(567)(16,178)(1,151)
Loss before income taxes(75,003)(85,413)(174,387)(223,377)
Income tax (benefit) expense(1,154)191(616)699
Net loss$(73,849)(85,604)(173,771)(224,076)
Net loss per common share — basic and diluted$(0.82)$(0.96)$(1.94)$(2.64)
Weighted average common shares outstanding — basic and diluted90,096,55788,893,57989,715,16084,750,114
  
(1) Includes the following share-based compensation expenses: 
Research and development$3,311$5,399$11,060$11,565
Selling, general and administrative$3,699$14,396$10,686$22,613

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

 December 31, 2020March 31, 2020
Assets  
Current assets:  
Cash and cash equivalents$713,523 $76,644
Marketable securities32,3242,997
Prepaid expenses and other current assets8,180 8,269
Total current assets754,02787,910
Property and equipment, net2,847 2,497
Operating lease right-of-use asset10,045 11,146
Other assets7,295 4,373
Total assets$774,214 $105,926
Liabilities and Shareholders’ Deficit  
Current liabilities:  
Accounts payable$12,357 $15,334
Interest payable (related party)15
Accrued expenses44,377 29,060
Deferred revenue100,56440,000
Cost share advance from collaboration partner92,415
Operating lease liability1,731 1,516
Amounts due to related parties628
Total current liabilities252,072 85,925
Deferred rent, non-current418,344
Cost share advance from collaboration partner, non-current46,424
Long-term operating lease liability9,669 10,996
Long-term debt, less current maturities (related party)313,700 113,700
Other4,6623,582
Total liabilities1,044,871 214,203
Total shareholders’ deficit(270,657) (108,277)
Total liabilities and shareholders’ deficit$774,214 $105,926

SOURCE: Myovant Sciences

Investor Contact:
Ryan Crowe
Vice President, Investor Relations
Myovant Sciences, Inc.
+1 (650) 781-9106
investors@myovant.com

Media Contact:
Albert Liao
Director, Corporate Communications
Myovant Sciences, Inc.
+1 (650) 410-3055
media@myovant.com

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