Myovant Sciences Ltd. (MYOV) stock prices were up by 3.33% as of the market closing on May 21st, 2021, bringing the price per share up to USD$22.98 at the end of the trading day.
Launch of ORGVYX
ORGOVYX saw its launch in the United States commencing in early January of the fiscal year 2021, with authorized specialty distribution channels being fully restocked concurrently. Net product revenues generated from ORGGOVYX in the U.S. were reported at USD$3.6 million for the fourth quarter of the fiscal year 2020. As of April 30th 2021, more than 2000 patients had been prescribed ORGOVYX by over 800 various treatment centers.
April 30th, 2021 saw the company having achieved commercial coverage of 43%, as well as 51% Medicare Part D coverage for ORGOVYX. MYOV continuously seeks to engage with key commercial and Medicare Part D payors to negotiate coverage, in the interests of its goal of broad coverage by the end of the calendar year 2021.
MAA Validation by EMA
The company announced on March 29th, 2021 that the European Medicines Agency (EMA) had validated a previously submitted Marketing Authorization Application (MAA). The MAA was for MYOV’s flagship relugolixin regard to the treatment of advanced prostate cancer. The validation of the MAA consolidated the sufficient completion of the submission for the EMA to initiate the review process.
Strategic Partnership with Pfizer
March 24th, 2021 had seen MYOV and Pfizer collaboratively announce the positive safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids. The resounding success of the study was made apparent with the meeting of its primary endpoint, as well as all of its three key secondary endpoints. Furthermore, the incidence of adverse events over an addition year of treatment was consistent with prior observations, with no new safety signals being observed.
Revenues reported for the three-month period ended March 31st, 2021 were USD$24.6 million, while USD$59.3 million were reported for the fiscal year ended the same date. As the company’s initial reportings, there were no recorded revenues reported in the prior year periods. Of these totals, Product revenue accounted for USD$3.6 million for both the three months and the year ended March 31st, 2021. Collaboration revenue amounted to USD$21 million and USD$22.4 million for the three months and the year ended March 31st, 2021, respectively.
Future Outlook for MYOV
With the company indicating a promising end to the fiscal year 2020, it is poised to capitalize on the fiscal year 2021. With increasing coverage and strategic partnerships, MYOV is hopeful for the increased coverage and proliferation of relugolix and its other pipeline candidates. Current and potential investors are hopeful that MYOV will be able to leverage the resources at its disposal to usher in significant and sustained increases in shareholder value.