Myovant Sciences Ltd. (NYSE:MYOV) is a biopharmaceutical company that has made significant strides in the oncology and women's health sectors. The company has executed multiple successful Phase 3 clinical trials, leading to the approval of three of its drug products by the U.S. Food and Drug Administration (FDA).
In the fiscal year ended March 31, 2024, Myovant reported annual revenue of $230,972,000, a decrease from the prior year. The company's annual net income was -$205,981,000, and its annual operating cash flow and free cash flow were -$268,559,000 and -$269,533,000, respectively.
Business Overview
Myovant was founded in 2016 and has since established itself as a leader in the development and commercialization of innovative therapies. The company's portfolio includes ORGOVYX® (relugolix 120 mg), which was approved by the FDA in December 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer. Additionally, MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved by the FDA in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids and in August 2022 for the management of moderate to severe pain associated with endometriosis, making it the first and only once-daily oral GnRH treatment approved for both indications.In the international markets, Myovant has also achieved significant milestones. In July 2021, the European Commission (EC) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as the first and only long-term, once-daily oral treatment in the European Union and the UK, respectively, for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Additionally, in April 2022, the EC and the MHRA approved ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe.
Myovant's pipeline also includes the investigational oligopeptide kisspeptin-1 receptor agonist, MVT-602, which has completed a Phase 2a study for the treatment of female infertility as part of assisted reproduction.
Financials
In the third quarter of fiscal year 2024, Myovant reported total revenues of $100,229,000, a significant increase from the $54,440,000 reported in the same period of the previous year. This growth was driven by strong product revenue, net, which reached $61,422,000, up from $29,268,000 in the prior-year quarter. The company also reported Pfizer collaboration revenue of $29,307,000, Accord license and milestone revenue of $5,000,000, and Richter license and milestone revenue of $4,000,000 during the quarter.The company's operating costs and expenses increased to $152,124,000 in the third quarter of fiscal year 2024, compared to $114,180,000 in the same period of the previous year. This increase was primarily due to higher selling, general, and administrative expenses, as well as increased research and development costs.
Myovant reported a net loss of $57,627,000, or $0.59 per common share, in the third quarter of fiscal year 2024, compared to a net loss of $63,445,000, or $0.68 per common share, in the prior-year quarter.
As of December 31, 2023, Myovant had cash, cash equivalents, and marketable securities of $274,400,000, which the company believes will be sufficient to fund its anticipated operating expenses and capital expenditure requirements for at least the next 12 months.
Operational Highlights
During the third quarter of fiscal year 2024, Myovant achieved several important operational milestones. The company and its collaboration partner, Pfizer, completed New Drug Submissions to Health Canada seeking marketing approval for MYFEMBREE for heavy menstrual bleeding associated with uterine fibroids, MYFEMBREE for the treatment of endometriosis-associated pain, and ORGOVYX for advanced prostate cancer.Additionally, the Type II variation application to the European Medicines Agency (EMA) filed by Myovant's commercialization partner, Richter, seeking approval for RYEQO for the treatment of moderate to severe pain associated with endometriosis was validated and accepted by the EMA. This triggered a $4,000,000 milestone payment to Myovant.
In the ex-U.S. markets, Myovant's commercialization partner, Accord, launched ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe. The first commercial sale of ORGOVYX in Europe triggered a $5,000,000 milestone payment to Myovant.
Risks and Challenges
Myovant faces several risks and challenges that could impact its future performance. The company operates in a highly competitive environment, with products that compete with established therapies and potential future competitors. Additionally, the company's success is dependent on the successful commercialization of its approved drug products, ORGOVYX and MYFEMBREE, as well as the development and regulatory approval of its product candidates.Myovant also relies on third-party manufacturers and suppliers, and any disruptions or issues with these partners could delay the company's ability to develop and commercialize its products. The company's financial performance is also subject to macroeconomic factors, such as changes in inflation, interest rates, and global supply chain constraints, which could impact its costs and operations.
Outlook
Despite the challenges, Myovant remains optimistic about its future prospects. The company is actively pursuing additional regulatory approvals for its drug products in new indications and markets, which could further expand its commercial opportunities.Myovant is also continuing to invest in the development of its product candidates, including the ongoing Phase 3 SERENE study evaluating MYFEMBREE for contraceptive efficacy and the Phase 3 REPLACE-CV study assessing the risk of major adverse cardiovascular events associated with ORGOVYX.
The company's strong cash position and the potential for additional milestone and royalty payments from its collaboration partners, such as Pfizer, Richter, and Accord, provide a solid foundation for Myovant to navigate the challenges and capitalize on the opportunities ahead.