Myovant Sciences Ltd. Common Shares

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

Thank you, operator. Good morning. And thanks for joining us today to review the financial results of Myovance third quarter of fiscal year 2021, and to discuss other corporate and business updates. Joining me for today's call are Dave Merrick, Myovance Chief Executive Officer, Yannick Mara, 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.myovant.com. Today, we will be referring to our third fiscal quarter, representing the three months ended December 31, 2021, as our third quarter, or Q3, throughout this presentation. During 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, MyOvent 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, MyOvent's Chief Executive Officer. Dave?

Thank you, Ryan, and good morning, everyone. Milevant continued to make significant progress with our U.S. launches of Orgovix and Mifembri during our third fiscal quarter of 2021. Milevant recorded $54.4 million of total revenue, including $29.3 million of net product revenue. Orgovix achieved net revenues of $24.4 million in its fourth quarter on the U.S. market, reflecting 40% sequential volume growth. compared to fiscal Q2, partially offset by a lower net selling price. Mifembri generated net revenue of $2.4 million, reflecting steadily increasing growth over each month of the fiscal third quarter. By December, Mifembri had captured 45 percent of new-to-brand prescription share among GnRH antagonists approved for uterine fibroids, more than double the 20 percent share that Mifembri held only three months prior. RIECO revenues from Gideon Richter, our international commercial partner for women's health, were $2.4 million, primarily reflecting revenues for product supply to Richter to support their European launches. Turning to business development and financial updates, we're currently engaged in a formal process to assess partnership opportunities for international rights to relugolix in oncology, focusing on potential partners with an established European commercial presence in urology or oncology. We remain on track towards our goal of reaching an agreement with a partner by the anticipated European Commission approval of relugolix for prostate cancer expected in the middle of this year. 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. Finally, we remain in a strong financial position to support Orgovix and MyFembri commercialization activities while seeking to expand our pipeline. As of December 31st, MyoVant had cash and committed financing of nearly $570 million. With the start of the new calendar year, I'd like to briefly discuss our goals and objectives for 2022. Building on the strong momentum we generated last year, we expect to drive Orgovix growth by increasing the depth and breadth of prescribing while increasing patient engagement. For Mifembri, we expect to accelerate uptake in uterine fibroids and pending FDA approval to launch Mifembri for endometriosis pain where there is also high unmet need for a large patient population searching for an effective treatment option. Significant prescriber overlap will enable us to execute an efficient launch for this new indication, if approved, by leveraging the same brand, the same dose, the same one pill once a day that is approved to treat uterine fibroids. In addition to executing commercially, we also need to build for tomorrow through pipeline expansion. We plan to advance Relugolix lifecycle opportunities, to advance MVT602 clinical development, and to announce an international partnership for Relugolix and oncology. And finally, we'll also continue to look externally for opportunities, primarily in urology, oncology, and women's health to add fuel to our clinical development engine and to complement our commercial capabilities. We're excited about the commercial momentum for Orgovix and the early launch progress for Mifembri. Together with our upcoming clinical and regulatory milestones, MyoVant remains 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.