Myovant Sciences Ltd. Common Shares

Good day, everyone, and welcome to Myovant Sciences' second quarter of fiscal year 2021 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Ryan Crowe, Vice President of Investor Relations at Myovant. Please go ahead.

Thank you, Operator. Good morning, and thanks for joining us today to review the financial results of Myovant's second quarter of fiscal year 2021 earnings and to discuss other corporate and business updates. Joining me for today's call are Dave Merrick, MyOvent's Chief Executive Officer, Yannick Merra, Chief Financial and Business Officer, Lauren Marandino, Chief Commercial Officer, and Dr. Juan Camilo Arjona, Chief Medical Officer. In addition to the press release issued earlier today, the slides that will be presented during today's webcast are available on our investor relations website, investors.myovent.com. Today, we will be referring to our fiscal second quarter, which ended on September 30th, 2021, as our second quarter or Q2 throughout this presentation. During the course of this conference call, we will be making forward-looking statements. These include plans and expectations with respect to our products, 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 SEC disclosure documents. In addition, my event does not undertake any obligation to update any forward-looking statements made during this call. I'll now turn the call over to Dave Merrick, my event's chief executive officer. Dave?

Thank you, Ryan, and good morning, everyone. During our second fiscal quarter, MyoVent continued to make significant progress with our U.S. launches of Orgovix and Mifembri, in addition to achieving important clinical and regulatory milestones, which positioned MyoVent for long-term success. MyoVent recorded $77.9 million of total revenue in the quarter, including $21.1 million of net product revenue. Orgovix achieved net revenues of $18.7 million in its third quarter on the U.S. market, reflecting 78% sequential growth compared to fiscal Q1. In its first full quarter on the U.S. market, MyFembri achieved net revenues of $0.6 million, primarily reflecting a continuation of initial inventory stocking. From a launch execution standpoint, we've made meaningful early progress educating prescribers about our differentiated clinical profile, reaching initial patients, and establishing payer coverage, all of which are foundational to Mifembri's long-term success. Moving to clinical and regulatory updates, during Q2, the European Commission and the UK's Medicines and Healthcare Products Agency approved RIECHO as the first and only long-term once-daily oral treatment for uterine fibroids. Gideon Richter, our international partner for women's health, has since launched RIACO in seven countries. From Ifembri, we were pleased that the FDA accepted our supplemental new drug application seeking approval for the management of moderate to severe pain associated with endometriosis. We expect a decision from the FDA by the May 6, 2022 PDUFA date. An FDA approval for this indication would trigger a $100 million milestone payment from Pfizer while providing a meaningfully different therapeutic option for women with endometriosis. Last week, Myovan and Pfizer presented clinical data for Mifembri at the American Society for Reproductive Medicine 2021 Congress. In addition to the results of the Liberty Randomized Withdrawal Study and the SPIRIT studies in endometriosis, We also presented pooled safety and tolerability data from the Spirit and Liberty programs, which demonstrated a consistent profile across women with uterine fibroids and women with endometriosis, providing further support of our one brand, one pill, once a day approach to treating these conditions. Quality of life data in women with endometriosis was also presented. which demonstrated that significantly reducing endometriosis pain was associated with improvements in daily functioning, emotional well-being, self-image, and sense of control. Finally, in August, the FDA lifted its partial clinical hold for the Phase III serine study of Mifembri to evaluate prevention of pregnancy, and we're pleased to have recently dosed our first patients under the amended protocol. Upon notification of the partial clinical hold in May, we not only addressed the FDA's requirement for bone mineral density monitoring, but worked closely with them to further optimize the design of the serine study to gain incremental safety and efficacy data in patient populations with the greatest potential to benefit from myfembri. The primary analysis of the study, prevention of pregnancy, remains unchanged. but now Serene will focus on only evaluating women with a confirmed diagnosis of uterine fibroids or endometriosis. BMD monitoring will occur during the treatment period as well as after discontinuation, which will augment the profile observed in the Liberty and Spirit programs. The enrollment target was increased to 1,020 patients who are 18 to 50 years of age and at risk of pregnancy, enhancing the power of the studies. Serine is the first study of its kind in this class of medicines, and a positive result could expand Mifembri's prescribing information to include a prevention of pregnancy indication. This would further support clinical differentiation and bring meaningful additional benefit and convenience to women with uterine fibroids and endometriosis. Turning to business development and financial updates. Today we announced that Pfizer declined to exercise its option for development and commercialization rights to relugolics in oncology and international markets. Based on discussions with Pfizer, their decision was not related to clinical or anticipated regulatory considerations for relugolics in oncology, but rather was based on their assessment of their current strategic investment priorities in international markets. I would underscore that it has no impact on our collaboration in the U.S. and Canada, particularly given the Orgovix and the Mifembri launches are off to a great start, in large part due to our collaborative efforts to date. Over the months leading up to Pfizer's decision, we received inquiries regarding this opportunity from multiple interested parties. We are currently assessing these opportunities, focusing on potential partners with an established European commercial presence in urology or oncology. Our goal is to reach agreement with a partner by the anticipated European approval of Relugolix for prostate cancer, expected in mid-2022. In the meantime, we continue to work with the EMA through the ongoing review process and on other pre-launch activities related to pricing and reimbursement. So our chosen partner will be in a position to execute a launch shortly after regulatory approval. Regarding financial updates, last month, Myovant appointed Unique Mehra to Chief Financial and Business Officer. Unique leads Myovant's finance, alliance partnerships, and business development functions and is a member of Myovant's Executive Committee reporting to me. For those of you who have not met Unique, he brings extensive financial leadership expertise supporting multi-billion dollar commercial stage businesses in addition to deep experience successfully growing and scaling emerging companies. And we are delighted to have Unique on the MyoVant team. We continue to be in a strong financial position to support the launches of Orgovix and MyFembri while seeking to expand our pipeline. As of September 30th, MyoVent had cash and committed financing of over $650 million. We are encouraged by the commercial momentum for Orgovix and the early launch progress for MyFembri. Together with our recent notable clinical and regulatory achievements, MyoVent is well positioned for strong commercial execution and sustainable long-term growth. Now, for a more in-depth review of our commercial performance, I'll turn the call over to Lauren.