Myovant Sciences Ltd. Common Shares

Good day, everyone, and welcome to MyOVAN Science's first quarter of fiscal year 2022 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Yannick Meira, the financial and business officer at MyOVAN. Please go ahead.

Thank you, operator. Good afternoon, and thank you for joining us today to discuss MyOVAN's corporate updates and review the financial results of Mirovan's first quarter of fiscal year 2022. Joining me for today's call are Dane Merrick, Mirovan's Chief Executive Officer, Lauren Merendino, Chief Commercial Officer, and Dr. Juan Camilo Arjona, Chief Medical Officer. In addition to the press release issued earlier today, the slides presented during today's webcast will be available on our investor relations website investors.myovent.com after today's call. Today we will be referring to our first fiscal quarter representing the three months ended June 30th, 2022 as our first quarter or Q1 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, my event does not undertake any obligation to update any forward-looking statements made during this call. I will now turn the call over to Dave Merrick, MyoVans' Chief Executive Officer.

Dave? Thank you, Unique, and good afternoon, everyone. MyoVans' 2022 fiscal year is off to a strong start, marked by significant volume-driven growth for both Orgovix and Mifembri, and with regulatory advances that enable us to reach more patients with our differentiated medicine. In our first quarter, MyoVant recorded $116.5 million of total net revenues, including $41.4 million of net product revenue. We continue to reach more men with advanced prostate cancer through continued adoption of Orgovix across a broad range of patient types and treatment settings, resulting in quarterly sequential demand volume growth of 26%. With Mifembri, we continue to grow the GnRH antagonist class for the treatment of uterine fibroids, and we're proud that Mifembri is now the number one prescribed GnRH therapy with leadership in both new-to-brand and total prescription shares. Outside the U.S., Ryeco is now launched in 19 European countries, making it more widely available for women with uterine fibroids. And we've made great progress with our regulatory efforts. We are pleased to be in labeling discussions with the FDA with respect to our Mifembri SMDA for endometriosis-associated pain and expect a decision from the FDA by the PDUFA goal date of August 6th. We remain confident in the clinical profile of Mifembri and its potential to become a meaningfully differentiated therapeutic option for women with endometriosis. We'll continue to work closely with the FDA to support the advancement of our SNDA. In June, we announced that the FDA accepted for review our SNDA for Mifembri based on two-year safety and efficacy data from the Phase III Liberty randomized withdrawal study. These study results show the longer-term benefit Mifembri can potentially have on treating women's uterine fibroid symptoms. The FDA set a PDUFA goal date of January 29th, 2023. Moving to oncology, I'm excited to share that Orgovix is now approved in the United Kingdom as the first and only oral androgen deprivation therapy for adult patients with advanced hormone sensitive prostate cancer. This approval, coupled with the European Commission approval in April, will bring this meaningful therapy to more patients across Europe. Finally, our strategic partnerships continue to be a value driver for Myoban. This includes the $50 million upfront payment received from Accord in Q1 for its exclusive license agreement to commercialize Orgovix in Europe. And despite the challenging macroeconomic environment, we ended the quarter in a strong financial position with cash and committed financing of $400 million, enabling us to fully support Orgovix and Mifembri commercialization activities while also seeking to expand our pipeline. Now I'll turn the call over to Lauren for a more in-depth review of our commercial performance.