Myovant Sciences Ltd. Common Shares

Thank you, Operator. Good morning, and thank you for joining us today for a general business update and to review the financial results of Myovans' fourth quarter of fiscal year 2020. Joining me for today's call are Dave Merrick, Myovans' 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.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 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. With that, I'll now turn the call over to Dave Merrick, my event's Chief Executive Officer. Dave?

Thank you, Ryan, and good morning, everyone. Given our 2020 fiscal year ended on March 31st, It's worthwhile to briefly reflect on MyoVans' significant accomplishments over the past year. From a clinical development perspective, results from two of our clinical programs were published in the New England Journal of Medicine, and we announced additional positive data in both uterine fibroids and endometriosis. From a regulatory perspective, we achieved MyoVans' first ever FDA approval. for Orgovix in advanced prostate cancer. We also filed for U.S. approval for uterine fibroids and EU approval for advanced prostate cancer. These impressive accomplishments were achieved while we built our commercial readiness with in-house capabilities and through partnerships. Most notably, we entered into a landmark collaboration across oncology and women's health with Pfizer, who has already contributed substantially to the successful launch of Orgovix and to our Women's Health launch readiness. Now let's turn to the most recent achievements and upcoming milestones. In addition to the $21 million of collaboration revenue recorded in the fiscal fourth quarter, MyoVan generated $3.6 million of net product revenue for Orgovix during its first three months on the U.S. market. In these early days, we have formed the beginnings of a foundation that we believe can support our long-term vision to establish Orgovix as the standard of care androgen deprivation therapy for men with advanced prostate cancer. We've also made notable progress preparing for our upcoming launch of Relugolix combination tablet pending FDA approval. With only a few weeks before our PDUFA date, we are on track for a June launch of this potential new treatment option for women with uterine fibroids. We and Pfizer are fully aligned on our commercialization approach and are excited about this significant opportunity to improve the lives of women with uterine fibroids and fully unlock the potential of this market. Last month, MyoVamp named Lauren Marandino as Chief Commercial Officer. Her experience building and leading top-performing commercial teams will be critical in delivering our medicines to patients. I would also like to sincerely thank Adele Gohol for serving as our Interim Chief Commercial Officer over the past year and for her continued support as a member of MyelVans Board of Directors. On the clinical development front, building on the milestones previously mentioned, we reported positive Phase III Liberty data from our randomized withdrawal study with first-in-class maintenance of bone mineral density through two years. We also dosed the first patient in the Phase III Serine study, which is designed to assess the potential of relugolic's combination tablet to prevent pregnancy and may complement our data from the Spirit and Liberty programs. We've also made meaningful progress in advancing towards regulatory approvals. We remain on track for an FDA decision by the June 1st PDUFA date for Relugolix combination tablet and uterine fibroids, and are also on track to submit our endometriosis filing to the FDA later this quarter. In the middle of this calendar year, we expect the European Commission's decision on our uterine fibroids filing in Europe. Following approval, Gideon Richter, our international partner for women's health, is expected to launch Relugolix combination tablet in Europe beginning in the second half of this calendar year. Lastly, on business development, we await Pfizer's decision regarding its option for international development and commercialization rights to Relugolix in oncology, excluding Canada and certain Asian countries, which we expect in the middle of this calendar year. We also continue to evaluate business development opportunities to broaden our pipeline with a focus primarily in women's health and oncology. Given the Relugolix pivotal studies are largely behind us, our proven development engine has capacity to take on and advance drug candidates that have demonstrated the potential for significant differentiation in either preclinical models or in clinical development. We approach this process from a position of financial strength. With $726 million of cash and committed financing, sufficient runway to not only fund our product launches, but also to expand our pipeline. In summary, we are encouraged by the early launch momentum of Orgovix. We're finalizing our preparations pending FDA approval to launch in uterine fibroids next month. We're progressing towards key regulatory milestones, particularly the planned submission of endometriosis to the FDA, and are well-positioned financially to execute our commercial strategy while expanding our pipeline. Now for a more in-depth review of our commercial performance, I will now turn the call over to our new Chief Commercial Officer, Lauren Marandino. Lauren?

Thank you, Dave. Today, I will provide an update on the early progress we've made on Orgovix launch and an overview of the upcoming potential U.S. launch of Relugolix combination tablet in women with uterine fibroids. The Orgovix launch is off to a strong start as we embark on redefining care for men with advanced prostate cancer. Our launch has been focused on three priorities, educating prescribers, establishing broad access, and engaging patients. As we and Pfizer have made progress executing these priorities, launch momentum has accelerated. In only a few short months, over 2,000 men are benefiting from Orgovix. That's over 2,000 men who have been able to treat their prostate cancer with androgen deprivation therapy without their lives being interrupted by injections, without the worry of a testosterone surge, and with the confidence that if they are able to discontinue therapy, their testosterone is likely to return more rapidly. In our launch quarter, we recorded $3.6 million of net revenues, demonstrating the early confidence physicians have in Orgovix. And it is from this foundation that we expect to build Orgovix into the standard of care ADT over time. Let's take a closer look at the progress we've made on our three priorities, starting with educating prescribers. We increased Orgovix aided awareness by 30 points since launch to 89%, nearly as high as branded Luperlide. For unaided awareness, we quadrupled our prelaunch benchmark, bringing Orgovix to 20% in April. This is impressive considering that Luperlai brands are at 39% despite being commercialized for decades. This is remarkable progress and reflects the effectiveness of our sales efforts and the differentiated profile of Orgovix. Increased prescriber awareness is leading to Orgovix adoption and more men benefiting from this therapy. As you can see on the bar chart, the estimated number of men treated with Orgovix has grown steadily month over month to over 2,000 by the end of April. But we are just beginning to penetrate this very large and growing market. We expect to build on this early progress and expand our impact to many more of the 300,000 men treated with ADT annually. Clinical, economic, and operational factors play a role in ADT treatment decisions. We have made progress enabling accounts in all three areas. The depth and breadth of our Salesforce interactions has grown significantly since launch. We have conducted over 20,000 meaningful interactions with providers, including reaching over two-thirds of our highest priority target prescribers. We anticipate that as COVID restrictions ease and in-person detailing resumes in all areas of the country, our Salesforce reach and effectiveness will only continue to increase. Our efforts thus far have resulted in a broad base of prescribers with over 800 treatment centers utilizing Orgovix through April, with 75% utilizing more than once. And we've made great progress in easing the process for prescribing. We have worked with major EMR companies to expedite adding Orgovix to their systems. As a result, all of our highest priority accounts have Orgovix available in their e-prescribing systems, and the majority of our target practices are also enabled for e-prescribing. Increasing prescriber confidence and reducing barriers to prescribing are essential to driving continued uptake, as is our second launch priority, establishing broad access. As of May 1st, we have coverage for Orgovix for 102 million total lives. On the commercial side, 43% of lives currently have coverage. Plans that cover approximately half of commercial lives are expected to make coverage decisions in the near term. Until these coverage decisions are made, patients on these plans may obtain reimbursement via the formulary exception process. On the Medicare Part D side, We have achieved coverage for Orgovix for 51% of lives. Plans that cover 49% of Part D lives are expected to make coverage decisions around mid-year, with some plans potentially implementing Orgovix coverage beginning as early as July of this year. We are pleased with the progress we've made with payers thus far, and coverage as of May 1st is in line with our expectations. We continue to engage in coverage negotiations with key commercial and Part D plans with decisions expected in coming months. Overall, we remain on track to achieve our goal of broad coverage by the end of this calendar year. Our third priority is engaging patients, which we have primarily done to date through digital channels, targeting patients seeking information regarding prostate cancer treatment options. We developed strong media partnerships with leading health publishers and made strategic investments in search so patients and their caregivers are aware that Orgovix is a potential new treatment option for them to discuss with their doctor. These efforts have successfully driven significant traffic to our branded patient website, Orgovix.com. There have now been over 152,000 visitors to the site, the vast majority of which were unique. This is notable because it's four times greater than other oncology launch benchmarks. As we move into the second half of 2021, we look forward to launching targeted, branded, and unbranded direct-to-consumer campaigns to broaden patient and caregiver awareness and to activate men to request Orgovix at their next visit to the clinic. So, as you can see, we've made tremendous progress across all areas of our launch, and built great momentum in the prostate cancer community. As we look forward with increasing physician engagement post-COVID, potentially expanded access in the second half of the year, and increasing patient activation through our DTC campaigns, we believe that the momentum will continue to build and Orgovix will make a difference in the lives of many more men battling advanced prostate cancer. I'd now like to pivot to the potential upcoming U.S. launch of Relugolix combination tablets in women with uterine fibroids. We expect a decision from FDA by our PDUFA date of June 1st, and if approved, we anticipate launching later that month. We believe Relugolix combination tablet has the potential to be a truly meaningful advance in women's health. and could become the standard of care treatment for women with uterine fibroids. The unmet need here is significant. Approximately 5 million women in the U.S. have sought treatment for symptoms of their uterine fibroids. Of these women, over 3 million are unable to control their most challenging symptoms due to the inadequacy of current treatment options. 85% of these women cycle through multiple therapies seeking relief. And even though two out of three women would prefer a medical option versus surgery, approximately 250,000 women a year in the U.S. make the difficult choice to undergo a hysterectomy for relief from their uterine fibroids. Myovant and Pfizer are united in our goal to provide women with an effective, well-tolerated, and convenient medical option that meets their needs and redefines the treatment of uterine fibroids. When speaking to OBGYNs, they have made it clear that what they need in a uterine fibroid therapy is threefold. First, it needs to effectively reduce the challenging symptoms. Second, it needs to have minimal side effects. And finally, it needs to be easy and convenient for them and patients. If approved, we believe that Relugolix combination tablet aligns with these treatment needs and is poised to become the standard of care therapy. Relugolix Combination Tablets formulation combines 40 milligrams of Relugolix with 1 milligram of estradiol and half a milligram of progestin. Our formulation, along with the Relugolix Half-Life, make our product candidate unique from other GnRH antagonists currently being marketed or those that are in development. The results of our Phase III Liberty studies demonstrated significant relief of heavy menstrual bleeding, patient's most bothersome symptom, with a safety and tolerability profile that was generally comparable to a placebo. Finally, as 90% of OBGYNs prefer, the dosing of Relugolix combination tablet is convenient, one pill once a day. Our launch strategy has a comprehensive focus across providers, payers, and patients, with the overarching goal of creating a positive first experience for all customers. For prescribers, we will position Relugolic's combination tablet, if approved, as an effective, convenient, and non-invasive option for patients with symptomatic uterine fibroids. Our goal with payers is to establish broad coverage quickly which we believe is possible given the strong value proposition for Relugolix combination tablets relative to other treatments. For patients, we hope to drive awareness of our product through various channels with the goal of activating women to seek treatment for their heavy menstrual bleeding. The majority of our women's health Salesforce has been onboarded and preliminary payer discussions are underway. We expect to have outstanding patient support programs and services available at launch, and are confident that we will deliver an excellent treatment experience for prescribers and patients from day one. We have the right strategies in place to accelerate adoption of Relugolix combination tablets, if approved, and change the treatment paradigm for women with uterine fibroids. Our passionate and experienced field team is working to complete final preparations for launch. We are eager to receive FDA approval, execute a differentiated launch, and improve the lives of many women who are suffering with uterine fibroids. I will now turn the call over to Frank to review our financial results.