Myovant Sciences Ltd. Common Shares

Good day, everyone, and welcome to Myovant Sciences' second fiscal quarter 2020 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Ryan Crowe, Vice President of Investor Relations at Myovant. Please go ahead.

Thank you, Operator. Good morning, and thanks for joining us today for a general business update and to review Myovant's second fiscal quarter 2020 financial results. Joining me for today's call are Dr. Lynn Seeley, Myovant's Chief Executive Officer and Frank Carba, President and Chief Financial Officer, Adele Golfo, Interim Chief Commercial Officer, and Dr. Juan Camilo Arjona, Chief Medical Officer. In addition to the press release issued earlier this morning, the slides that will be presented during today's webcast are available on our Investor Relations website, investors.myovant.com. During the course of this conference call, we'll be making forward-looking statements. These include plans and expectations with respect to our product candidates, strategies, opportunities and financials, all of which involve certain assumptions of risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A discussion of these risks can be found in our latest SEC disclosure documents. In addition, my event does not undertake an obligation to update any forward-looking statements made during this call. With that, I'll now turn the call over to Dr. Lynn Seeley, Myovant's Chief Executive Officer. Lynn?

Thank you, Ryan, and good morning, everyone. Today, we will review Myovant's progress to date, and more importantly, where we are headed as we approach our first commercial launches. At Myovant, we aspire to redefine care for women and for men through purpose-driven science, empowering medicine, and transformative advocacy. Our lead investigational drug candidate is Relugolix, a small molecule oral GnRH receptor antagonist, which is being evaluated as a one-pill, once-a-day treatment option for women with uterine fibroids or endometriosis and for men with advanced prostate cancer. We have developed two distinct formulations for Relugolix, which will be branded separately if approved. First, we have our Relugolix combination tablet for our women's health indications. we expect to have a single dose and one brand name for both uterine fibroids and for endometriosis. For men with advanced prostate cancer, we have a once-daily monotherapy tablet containing a higher dose of Raleigh-Gullick's. Since our founding in 2016, we have conducted five large multinational Phase III clinical trials, each of which has been robustly positive, forming the basis for three new drug applications. For relugolic combination therapy, we have conducted the Liberty and Spirit program. The Liberty program in women with uterine fibroids consists of two positive phase three six-month studies, a completed long-term extension study, and a one-year randomized withdrawal study, which is ongoing. The Spirit endometriosis program consists of two positive phase three studies and a long-term extension study, which is ongoing. We have also conducted a one-year prospective observational bone density study in untreated women with uterine fibroids and endometriosis. For men with advanced prostate cancer where you're developing relugolix monotherapy, we have successfully completed our Phase III HERO study designed for global regulatory filings. We have also a second therapeutic candidate under development for women with infertility. MBT-602 is a novel oligopeptide-keptin-1 receptor agonist that has completed Phase IIa clinical studies. 2020 has been a pivotal year for Myovant. In uterine fibroids, our NDA was accepted for review and given an FDA target action date of June 1, 2021. We also submitted our marketing authorization application to the European Medicines Agency in March 2020. Efficacy and safety data from our long-term extension study evaluating women with heavy menstrual bleeding and uterine fibroids were presented during a prize-winning oral presentation at the American Society for Reproductive Medicine meeting in October. In the study, 88% of women on velugolus combination therapy achieved the responder criteria for reduction in menstrual blood loss at one year, and on average, women experienced a 90% reduction in menstrual blood loss from baseline. Data from the Liberty Program, depicted in orange, demonstrated preservation of bone density in women treated with relugolix combination therapy over one year. Data from a natural history observational study consisting of 262 women with uterine fibroids is shown in green. Women in the natural history study were age-matched and enrolled concurrently at the same site as women enrolled in our Liberty Study, but did not receive GnRH treatment. This is the first longitudinal data set evaluating bone mineral density in premenopausal women with uterine fibroids. As you can see, changes in bone density over one year in women with uterine fibroids treated with Relugolix combination therapy are consistent with those of untreated women. We believe that Relugolix combination tablets, if approved, has the potential to be a best-in-class medical therapy for the millions of symptomatic women with uterine fibroids. We also presented the efficacy and safety data from our two positive Phase III spirit clinical studies in women with moderate to severe pain associated with endometriosis in October. This oral presentation was selected as the best clinical paper in endometriosis at the ASRM 2020 Annual Meetings. Data from the replicate phase three spirit studies evaluating women with moderate to severe endometriosis are presented in the orange columns of this slide. Approximately 75% of women responded to relugolib's combination with a clinically meaningful reduction in dysmenorrhea or pain during their period and also a significant reduction in dyspareunia or painful intercourse. A particularly important finding is dyspareunia is a very common and concerning symptom in women with endometriosis. These benefits were achieved with minimal tolerability issues, hot flashes, and bone density loss. Comparing data from different studies must always be done with caution, but especially in this case when different assessment measures were used. However, as you can see from the data in this slide, we believe relugolix combination therapy has an efficacy profile comparable to that of the high dose of elugolix, with a safety and tolerability profile more like that of the low dose of oligolics. We believe Religolic Combination Tablet, a one pill, once daily treatment for endometriosis, if approved, is poised to have a differentiated profile from other approved endometriosis treatments. Our NDA for advanced prostate cancer was granted priority review and has an FDA target action date of December 20th, 2020. The Phase III data from the Global HERO Study in Men with Advanced Prostate Cancer were presented at the American Society of Clinical Oncology meeting and simultaneously published in the New England Journal of Medicine earlier this year. On the business development front, we have also been quite active in 2020. In March, we entered into a license agreement with Gideon Richter to commercialize Religolix combination tablet for uterine fibroids and endometriosis and certain international markets, including Europe and Latin America. In August, we entered into a commercial collaboration agreement with Synodian Pharmaceuticals, a subsidiary of Sumitomo Dainipan Pharma, our majority shareholder, to support the planned U.S. commercialization of Raleigh Gullix, including logistics, trade, and retail distribution support, as well as contracting and other market access services. We also obtained an additional $200 million in low-interest, five-year-term loan commitment from Sumitomo Dynapon Pharma. With this latest commitment, Sumitomo Dynapon's total financing support for MyAvant has reached $600 million, providing us with the financial flexibility to appropriately resource our potential upcoming launches, but without rights to really Golex itself. In short, we have been busy in 2020, and the fact that we were able to achieve all of these milestones despite the challenges posed by the COVID-19 pandemic is truly a testament to the dedication of all of the MyoVan employees and our partners around the world. The progress we have made so far in 2020 has positioned the next 12 months to be a truly transformational period for MyoVan as we prepare for the potential launches of two products ultimately expected in three indications. For our uterine fibroids program, we look forward to the FDA Target Action Day of our NDA on June 1, 2021. We also anticipate a decision next year from the European Commission for a marketing authorization application. Finally, we expect to report top-line results from our randomized withdrawal study in Q1, 2021. For endometriosis, we plan to announce one-year results from our SPIRIT long-term extension study in the first quarter of 2021. The results of this study, in addition to the positive Phase III SPIRIT I and II studies, are expected to form the basis of regulatory filings in the U.S. and EU next year. Finally, we look forward to the FDA decision next month for relugolix and advanced prostate cancer, and if approved, launching in the U.S. in early 2021. We also expect to submit our MAA for advanced prostate cancer to the European Medicines Agency in the first half of 2021. As I think about the next 12 months, Strong commercial execution is clearly my advanced highest priority, and I couldn't be more pleased with the progress our commercial team has made towards this goal. Commercial execution starts with our potential launch of the prostate cancer indication in early 2021, an opportunity Adele will now discuss. Adele?