Myovant Sciences Ltd. Common Shares

Good day, everyone, and welcome to Myovant Sciences' third quarter of fiscal year 2020 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 for a general business update and to review the financial results of Myovant's third quarter of fiscal year 2020. Joining me for today's call are Dave Merrick, Myovant's Chief Executive Officer, Frank Carba, President and Chief Financial Officer, Adele Golfo, Interim Chief Commercial Officer, and Dr. Juan Camilo Arjona, Chief Medical Officer. In addition to the press release issued earlier this morning, 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 an 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. Since our last earnings report in November, I'm pleased to report that MyoVant has achieved four landmark milestones, an FDA approval, a collaboration agreement with Pfizer, positive data from a Phase III extension study, and a product launch. These are huge milestones that have helped transform us into a commercial stage company with compelling near-term opportunities in oncology and women's health. Before we review these milestones in more detail, let me first comment on the Orgovix launch. It's still early days, but I'm encouraged by the initial feedback we've heard from the field and the ordering trends we've seen after just five weeks. Through the end of last week, approximately 1,800 bottles of Orgovix have been shipped into our distribution channels, which include our specialty distributors, specialty pharmacies, and our free trial program. We will learn more about this inventory and how it's being dispensed to patients as we receive more patient and provider-level detail and data in the coming weeks. From a customer standpoint, I'm pleased that 10 of our top 20 highest priority accounts have placed at least one order for OrgoVix. And overall, of customers that have placed an order through the end of last week, 30% have already placed reorders. So in summary, great progress in the early days of the launch, but we're just getting started. In December last year, the FDA approved Orgovix, our oral relugolix monotherapy 120 milligram tablet for the treatment of adult patients with advanced prostate cancer. As the first and only approved oral gonadotropin-releasing hormone receptor antagonist, we believe Orgovix is poised to become the new androgen deprivation standard of care. And this is based on its differentiated clinical profile coupled with its patient-preferred oral formulation. And prostate cancer represents a substantial opportunity to improve or redefine care. It is the second most common type of cancer in men in the United States with approximately 3 million men living with this disease. And of those, approximately 300,000 patients are projected to receive androgen deprivation therapy or ADT this year alone. And of those patients, approximately 100,000 patients will initiate ADT this year and about 200,000 continuing ADT as part of their prostate cancer treatment journey. And due to advances in prostate cancer care and an aging population, the number of men with advanced prostate cancer in the U.S. is expected to grow by mid single digits annually in the coming years. Also, two out of three men with prostate cancer have cardiovascular risk factors and an estimated 30% of prostate cancer patients have diagnosed cardiovascular disease. So in fact, more men with prostate cancer die of cardiovascular disease than from prostate cancer itself. And it's well recognized that injectable LHRH agonists such as Luprolide, the current ADT standard of care, as well as certain other prostate cancer medicines may increase the risk of cardiovascular events. The approval of Orgovix now offers men with advanced prostate cancer rapid, profound, and sustained testosterone suppression. And this is without an initial surge in testosterone levels that can exacerbate clinical symptoms known as hormonal flare. And for men who receive time-limited treatment courses and who would benefit from a faster return to normal testosterone levels, Orgovix offers testosterone recovery within 90 days of treatment discontinuation for the majority of men. One of the clinical attributes providers have told us they find most compelling is that men treated with Orgovix in the Phase III HERO study had a lower incidence of major adverse cardiovascular events, including heart attacks, strokes, and death from any cause, compared to those receiving LHRH agonist injections. And finally, as a one pill, once a day therapy, Orgovix provides a convenient alternative for patients compared to the injectable options which require travel to the clinic or hospital for administration. So as you can imagine, this is particularly important for this population of patients with advanced prostate cancer during the ongoing COVID-19 pandemic. Now let's briefly review the MyoVant-Pfizer collaboration that was announced shortly after the Orgovix FDA approval. In December, MyoVan and Pfizer entered a broad collaboration agreement to jointly develop and commercialize Orgovix and Relugolix combination tablet in the U.S. and in Canada. Together, we believe we will maximize the benefit Relugolix can bring to patients across therapeutic areas and across markets. will evenly split Relugolix-associated profits and certain development and commercialization expenses in the U.S. and Canada. In exchange for these co-development and co-commercialization rights, MyoBand is eligible to receive up to $4.2 billion of net payments from Pfizer. Additionally, Pfizer obtained an exclusive option to develop and commercialize Relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries. So let me highlight more specifically the deal economics. We entered into this transaction because we believe it's good for patients, and it creates significant incremental value for Myoban. Adding Pfizer's capabilities to our own has the potential to significantly increase the value of the Relugolix franchise by accelerating product uptake and increasing overall peak revenue. The partnership will also allow us to maximize the clinical potential for Relugolix while reducing mildance cash burn through the sharing of certain expenses. The substantial deal economics dramatically strengthen our current financial condition and significantly improve mildance financial outlook. And this will now enable us to invest in our pipeline beyond Relugolix sooner than we previously planned. In addition to the $650 million upfront payment, Myobank could also receive additional payments of up to $250 million within the next 18 months. This could be composed of up to $200 million of regulatory milestones for FDA approvals in women's health, as well as a $50 million payment that would be triggered should Pfizer exercise its option to develop and commercialize rights to Relugolix in oncology outside the US and Canada. And this is a decision we anticipate Pfizer will make during the first half of this year. MyoVan is also eligible to receive up to $3.5 billion of tiered sales milestones equally split between Orgovix in oncology and Relugolix combination tablet in women's health based on annual net revenues for each product in the US and Canada. Myobant and Pfizer will also split 50-50 certain Relugolix associated development and commercialization expenses. This will enable us to reduce our anticipated cash burn compared to developing and commercializing Relugolix by ourselves. So, in summary, the significantly increased value of the Relugolix franchise that we anticipate from the collaboration coupled with the rich deal economics, is expected to more than offset the 50-50 profit split, resulting in greater overall value for MyoPAN. I'll now turn the call over to Juan Camilo to discuss the recent SPIRIT extension results and to share some exciting details on a near-term lifecycle opportunity, Relugolix Combination Tablet. Juan Camilo. Juan Camilo. Juan Camilo.