On January 10, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported preliminary financial results for the third quarter of fiscal year 2021 (Press release, Myovant Sciences, JAN 10, 2022, View Source [SID1234598481]). The financial information presented in this press release may be adjusted at a later date following the completion of customary quarterly financial reviews and audit procedures.

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"Myovant delivered on its mission of redefining care for women and for men over the course of calendar-year 2021 as momentum for ORGOVYX and MYFEMBREE launches continued to build, positioning the company for long-term success. Our strong quarterly performance continues to give us the confidence that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "We believe we have set the stage for an important year in 2022 as we seek to drive significant revenue growth with continued ORGOVYX adoption and the potential launch of MYFEMBREE in endometriosis, pending FDA approval, while also expanding our pipeline by advancing relugolix lifecycle opportunities and pursuing business development."

Unaudited preliminary revenue results:

Total revenue for the three months ended December 31, 2021 is estimated to be in the range of $54.0-$55.0 million. There was $1.4 million of total revenue recorded in the three months ended December 31, 2020. Estimated total revenue consisted of the following:

Net product revenue is estimated to be in the range of $28.8-$29.8 million in fiscal third quarter 2021. There was no such revenue recorded in the comparable prior year period. Estimated net product revenue consists of the following:
ORGOVYX net product revenue is estimated to be in the range of $24.2-$24.6 million for fiscal third quarter 2021, reflecting 40% sequential volume growth compared to fiscal second quarter 2021, partially offset by a lower net price due to higher gross-to-net discounts. There were no material changes in channel inventory for ORGOVYX over the course of fiscal third quarter 2021.
MYFEMBREE net product revenue is estimated to be in the range of $2.3-$2.6 million for fiscal third quarter 2021. New-to-brand prescription (NBRx) share among GnRH antagonists FDA-approved for the treatment of uterine fibroids was 45% in December 2021 compared to 20% in September 2021, reflecting steadily increasing demand for the differentiated clinical profile of MYFEMBREE while growing the class. There were no material changes in channel inventory for MYFEMBREE over the course of fiscal third quarter 2021.
RYEQO net product revenue related to product supply and royalties from Gedeon Richter, Myovant’s commercialization partner for RYEQO in Europe and certain other international markets, is estimated to be in the range of $2.3-$2.6 million for fiscal third quarter 2021.
Pfizer collaboration revenue in fiscal third quarter 2021 was $25.2 million, reflecting the partial recognition of the upfront payment Myovant received from Pfizer in December 2020 and 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 in May 2021. Pfizer collaboration revenue for fiscal third quarter 2020 was $1.4 million and represents the partial amortization of the upfront payment received from Pfizer.
Unaudited capital resources:

Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled approximately $569.1 million as of December 31, 2021, and consisted of approximately $527.8 million of cash, cash equivalents, and marketable securities and $41.3 million of remaining available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Myovant to present at 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022

David Marek, Chief Executive Officer of Myovant Sciences, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:00 p.m. Eastern Time. A live webcast of the presentation can be accessed by visiting the investor relations page of Myovant’s website at investors.myovant.com. The webcast will be archived on Myovant’s Investor Relations website following the presentation.

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. ORGOVYX (relugolix 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix (120 mg) is also under regulatory review in Europe for men with advanced prostate cancer. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months, and by the European Commission and the Medicines and Healthcare products Regulatory Agency in July 2021 and August 2021, respectively, as RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted Myovant Sciences’ supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.