Myovant Sciences Announces Financial Results for First Quarter of Fiscal Year 2021 and Corporate Updates
- First fiscal quarter 2021 total revenues of
$41.1 million; net product revenue from U.S.sales of ORGOVYX® of $10.5 millionand MYFEMBREE® of $1.1 million
- MYFEMBREE approved by the
U.S.FDA in May 2021as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids; FDA approval triggered a $100.0 millionmilestone payment from Pfizer received in July 2021
- RYEQO® approved by the
European Commissionin July 2021for the treatment of women with uterine fibroids; Gedeon Richterwill commercialize RYEQO in Europe; approval triggered a $15.0 millionmilestone payment from Gedeon Richter, expected to be received in second fiscal quarter 2021
- Supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis submitted to FDA in
- Timeline for Pfizer’s exclusive option to acquire development and commercialization rights to relugolix in oncology outside of
U.S.and Canadaextended through October 2021 Myovantremains well-capitalized with cash, cash equivalents, marketable securities, and committed funding of $611.1 millionas of June 30, 2021, excluding $115.0 millionof recently-triggered milestone payments
“I am pleased with the significant progress
First Fiscal Quarter 2021 and Recent Corporate Updates
ORGOVYX (relugolix 120 mg)
- First fiscal quarter 2021 net product revenues for ORGOVYX in the
U.S.were $10.5 million, driven by increased prescriber demand.
- Approximately 1,150 treatment centers have prescribed ORGOVYX to over 4,500 patients on free and commercial drug, estimated through
June 30, 2021. The number of estimated patients initiating ORGOVYX therapy has steadily increased in each successive month since launch.
- As of
July 1, 2021, Myovantachieved 63% commercial coverage and 78% Medicare Part D coverage for ORGOVYX. Myovantcontinues to engage in negotiations with payors yet to make 2021 coverage decisions and now expects to achieve broad coverage before its original calendar year-end 2021 goal.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
May 26, 2021, MYFEMBREE was approved by the U.S. Food and Drug Administration(FDA) as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids.
- The FDA approval of MYFEMBREE triggered a
$100.0 millionregulatory milestone payment from Pfizer, which Myovantreceived in July 2021(Myovant’s second fiscal quarter 2021).
mid-June 2021, Myovantand Pfizer launched MYFEMBREE in the U.S.First fiscal quarter 2021 net product revenues for MYFEMBREE in the U.S.were $1.1 million, reflecting initial inventory stocking by distributors upon MYFEMBREE product availability.
- As of
July 1, 2021, 37% of commercial lives were eligible for pre-review coverage for MYFEMBREE. Myovantcontinues to engage in coverage negotiations with key commercial payors and remains on track to achieve its goal of broad coverage within one year of launch.
July 6, 2021, Myovantsubmitted a supplemental New Drug Application (sNDA) to the FDA for once-daily MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In April and June 2020and January 2021, Myovantreported positive results from the two replicate Phase 3 SPIRIT studies and the SPIRIT long-term extension study.
June 15, 2021, the United States Patent and Trademark Office (USPTO) granted U.S.Patent. No. 11,033,551 to Myovant. This patent covers the unique and innovative method of treating patients for heavy menstrual bleeding associated with uterine fibroids with MYFEMBREE. This patent will expire in September of 2037 and is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). This patent term matches that of two methods patents ( U.S.Patent. Nos. 10,786,501 and 10,449,191) previously granted by the USPTO for ORGOVYX that cover methods of treating advanced prostate cancer with relugolix.
May 18, 2021, the FDA informed Myovantthat they placed a partial clinical hold on the Phase 3 SERENE study evaluating MYFEMBREE for the prevention of pregnancy, pending certain study protocol modifications. In July 2021, Myovantprovided to the FDA an amended study protocol for the SERENE study. Following Myovant’s discussions with the FDA, Myovantexpects the partial clinical hold to be lifted in August 2021.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
July 16, 2021, the European Commission(EC) approved RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO is the first and only long-term, once-daily oral treatment for uterine fibroids in Europeand has no limitation on its duration of use. The approval was based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study. The commercial launch of RYEQO is expected to begin in the second half of calendar year 2021 and will be executed by Gedeon Richter(Richter), Myovant’s commercialization partner for RYEQO in Europeand certain other international markets.
- The approval of RYEQO for the uterine fibroids indication by the EC triggered a
$15.0 millionregulatory milestone payment due from Richter, which Myovantexpects to receive and record as Richter license and milestone revenue in its second fiscal quarter of 2021. In addition to tiered milestones upon reaching certain net sales thresholds, Myovantis also eligible to receive tiered royalties on net sales.
July 2021, Myovantand Pfizer agreed to extend the timeline for Pfizer’s decision to exercise its exclusive option to develop and commercialize relugolix in oncology outside of the U.S.and Canada, excluding certain Asian countries (the “Pfizer Territory”), through the end of October 2021.
Expected Upcoming Milestones
- Pfizer’s decision regarding its exclusive option to acquire development and commercialization rights to relugolix in oncology in the Pfizer Territory is expected by the end of
October 2021. If Pfizer exercises this option, Myovant will receive a $50.0 million payment and will be eligible to receive double-digit royalties on net sales in the Pfizer Territory.
- Commercial launch of RYEQO in
Europeis expected to begin in the second half of calendar year 2021, to be executed by Richter.
- Marketing Authorization Application (MAA) submission to the
European Medicines Agency for RYEQOfor the treatment of women with endometriosis-associated pain is expected in the second half of calendar year 2021. Richter will be the MAA sponsor.
- FDA submission of the Phase 3 LIBERTY randomized withdrawal study results for MYFEMBREE in women with uterine fibroids is expected by the end of calendar year 2021.
- EC decision on the advanced prostate cancer MAA is expected in calendar year 2022.
First Fiscal Quarter 2021 Financial Summary
Total revenues for the three months ended
- Product revenue, net from sales of ORGOVYX and MYFEMBREE in the
U.S.for the three months ended June 30, 2021were $10.5 millionand $1.1 million, respectively. There were no such revenues recorded in the comparable prior year period.
- Pfizer collaboration revenue for the three months ended
June 30, 2021was $29.5 million, reflecting the partial recognition of the upfront payment Myovantreceived from Pfizer in December 2020and of the regulatory milestone payment that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids on May 26, 2021. There were no such revenues recorded in the comparable prior year period.
- Richter license and milestone revenue for the three months ended
June 30, 2020was $33.3 million, reflecting the partial recognition of the upfront payment Myovantreceived from Richter in March 2020and the regulatory milestone payment Myovantreceived from Richter in April 2020. There were no such revenues in the three months ended June 30, 2021.
Cost of product revenue for the three months ended
Collaboration expense to Pfizer for the three months ended
Research and development (R&D) expenses for the three months ended
Selling, general and administrative (SG&A) expenses for the three months ended
Interest expense was
Foreign exchange gain for the three months ended
Net loss for the three months ended
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled
As previously announced,
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. ORGOVYX® (relugolix 120 mg) was approved in the
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
Sumitovant is a global biopharmaceutical company with offices in
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; certain statements with respect to expectations of Myovant’s approved drug products in Mr. Marek’s quote; Myovant’s expectations of the commercialization of RYEQO by
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.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended
|Product revenue, net||$||11,554||$||—|
|Pfizer collaboration revenue||29,509||—|
|Richter license and milestone revenue||—||33,333|
|Operating costs and expenses:|
|Cost of product revenue||1,032||—|
|Collaboration expense to Pfizer||5,261||—|
|Research and development (1)||30,880||44,186|
|Selling, general and administrative (1)||61,212||22,828|
|Total operating costs and expenses||98,385||67,014|
|Loss from operations||(57,322||)||(33,681||)|
|Foreign exchange gain||—||(3,569||)|
|Loss before income taxes||(60,749||)||(32,188||)|
|Income tax expense||911||672|
|Net loss per common share — basic and diluted||$||(0.67||)||$||(0.37||)|
|Weighted average common shares outstanding — basic and diluted||91,637,151||89,300,210|
(1) Includes the following share-based compensation:
|Research and development||$||3,957||$||4,024|
|Selling, general and administrative||$||7,155||$||3,788|
Revenue components are as follows:
|Product revenue, net:|
|Total product revenue, net||11,554||—|
|Pfizer collaboration revenue:|
|Amortization of upfront payment||20,974||—|
|Amortization of regulatory milestone||8,535||—|
|Total Pfizer collaboration revenue||29,509||—|
|Richter license and milestone revenue||—||33,333|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|Cash and cash equivalents||$||484,960||$||674,493|
|Accounts receivable, net||10,608||3,570|
|Milestone receivable from Pfizer||100,000||—|
|Prepaid expenses and other current assets||17,569||13,536|
|Total current assets||702,135||704,645|
|Property and equipment, net||2,968||3,300|
|Operating lease right-of-use asset||9,252||9,655|
|Liabilities and Shareholders’ Deficit|
|Accrued expenses and other current liabilities||42,938||44,612|
|Share-based compensation liabilities||21,151||21,636|
|Amounts due to Pfizer||11,025||1,954|
|Cost share advance from Pfizer||104,178||92,415|
|Operating lease liability||1,886||1,807|
|Amounts due to related parties||39||543|
|Total current liabilities||307,570||281,340|
|Deferred revenue, non-current||451,193||397,369|
|Cost share advance from Pfizer, non-current||—||29,447|
|Long-term operating lease liability||8,685||9,189|
|Long-term debt, less current maturities (related party)||358,700||358,700|
|Total shareholders’ deficit||(399,626||)||(353,965||)|
|Total liabilities and shareholders’ deficit||$||727,770||$||725,027|
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Source: Myovant Sciences, Inc.