Myovant Sciences Ltd. Common Shares

Good day, everyone, and welcome to Myovant Sciences' first 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 Crow, 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 my event's first quarter of fiscal year 2021 and to discuss other corporate and business updates. Joining me for today's call are Dave Merrick, my event's Chief Executive Officer, Frank Carba, President and Chief Financial 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.myevent.com. Today we will be referring to our fiscal first quarter, which ended on June 30, 2021, as our first quarter, or Q1, 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. The discussion of these risks can be found in our SEC disclosure documents. In addition, MyAvant 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, MyAvant's Chief Executive Officer. Dave?

Thank you, Ryan, and good morning, everyone. Myovant's 2021 fiscal year is off to a strong start, marked by accelerating commercial momentum in the US and significant regulatory achievements that will enable us to bring our differentiated therapies to more and more patients. In our first quarter, Myovant recorded $41.1 million of total revenue, including $11.6 million of product revenue and $29.5 million of Pfizer collaboration revenue. During its second quarter on the market, Orgovix achieved revenues of $10.5 million, reflecting strong sequential growth quarter to quarter. This continued growth reflects increasing enthusiasm from clinicians regarding the differentiated clinical profile of Orgovix, as well as increased payer coverage. We're also pleased with the FDA approval and June launch of Mifembri. as the first and only once daily oral treatment for women with uterine fibroids. We achieved revenues of $1.1 million, reflecting initial inventory stocking by distributors. We and Pfizer conducted a simultaneous launch and remain excited to bring this differentiated profile to the millions of women battling uterine fibroids where high unmet need remains. From a regulatory standpoint, We've achieved several significant milestones over the past few months. In addition to the FDA approval of Mifembri, the European Commission also approved RIECHO, the European brand name for Relugolix combination tablet. The commercial launch of RIECHO is expected to begin in the second half of this calendar year and will be executed by Gideon Richter, Myovans commercialization partner for RIECHO in Europe. The approval of RIECHO is notable for a couple of reasons. Not only is it the first once-daily oral treatment for women with uterine fibroids approved in Europe, it's also the first treatment that does not have a limitation on duration of use. Recall that our European regulatory submission included two-year bone mineral density data from the Phase III Liberty randomized withdrawal study, whereas those data were not available at the time of our FDA submission. We do intend to submit the two-year BMD data to the FDA later this year for potential inclusion in the Mifembri label. Also for Mifembri, in early July, we submitted a supplemental NDA in the U.S. seeking approval for the management of moderate to severe pain associated with endometriosis. And finally, in response to the FDA partial clinical hold regarding the phase three serine study for Mifembri to evaluate the prevention of pregnancy, in July we provided the FDA with an amended study protocol where we're incorporating BMD monitoring as well as modifying the study population per their guidance to better support the prevention of pregnancy claim in women for whom Mifembri is indicated. Following further discussions with FDA, we expect a partial clinical hold to be lifted next month. Turning to business development and intellectual property updates, Milavant and Pfizer recently agreed to extend the timeline for Pfizer's decision regarding its option to acquire development and commercialization rights to relugolix and oncology in Europe and other international markets through the end of October. In June, we also took another step in protecting our intellectual property as we were issued a new methods of treatment patent, which could expand the exclusivity period for Mifembri and uterine fibroids. This patent joins two other methods patents previously granted for Orgovix for treating advanced prostate cancer, all of which are now listed in the FDA Orange Book with expirations in September of 2037. And finally, We continue to be in an excellent financial position with cash and committed financing of over $600 million as of June 30th, excluding $115 million of recently triggered regulatory milestone payments from Pfizer and Richter. We're excited about the opportunity that we have with Mifembri to redefine care for women with uterine fibroids, and we continue to be encouraged by the continued launch momentum for Orgovix. Now for a more in-depth review of our commercial performance, I'll turn the call over to Lauren. Lauren?