Myovant Sciences Ltd.
Q3 2020 Earnings Call Transcript

Published:

  • Operator:
    Good day, everyone and welcome to Myovant Sciences Third Fiscal Quarter 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.
  • Ryan Crowe:
    Thank you, Operator. Good morning and thanks for joining us today for a general business update and to review Myovant's third quarter of fiscal year 2020. Joining me for today's call are Dave Marek, Myovant's Chief Executive Officer; Frank Karbe, President and Chief Financial Officer; Adele Gulfo, Interim Chief Commercial Officer; and Dr. Juan Camilo Arjona, Chief Medical Officer.
  • Dave Marek:
    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 3 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 ORGOVYX 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 1800 bottles of ORGOVYX have been shipped into our distribution channels, which include our specialty distributors, specialty pharmacies, and our pre 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 ORGOVYX. 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 ORGOVYX, our oral relugolix monotherapy 120 milligram tablet for the treatment of adult patients with advanced prostate cancer. As a first and only approved oral gonadotropin-releasing hormone receptor antagonist, we believe ORGOVYX 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.
  • Juan Camilo Arjona:
    Thank you, Dave. Last month, we reported the 52-week results for the SPIRIT extension study in women with endometriosis. These results built on the positive 24-week data from the SPIRIT 1 and SPIRIT 2 Phase 3 trials were presented last year. SPIRIT 1 and SPIRIT 2 had identical designs and enrolled women with moderate to severe pain associated with endometriosis, surgically diagnosed in the last 10 years. Approximately 1250 women were enrolled across both studies and were randomized one to one to one into three groups to receive placebo for 24 weeks, relugolix combination therapy once daily for 24 weeks or relugolix monotherapy for 12 weeks, followed by 12 weeks of relugolix combination therapy. This last group allowed us to compare the safety of relugolix combination therapy with that of relugolix alone over the first 12 weeks of treatment. The two co-primary endpoints defined as a proportion of women with a clinically meaningful reduction in dysmenorrhea or menstrual pain, and a clinically meaningful reduction in non-menstrual pelvic pain, both assessed by a numerical rating scale, were analyzed after 24 weeks of treatment and compared the relugolix combination and placebo groups. Following the 24-week treatment period, patients were given the option to enroll in an extension study for up to 80 additional weeks with an initial analysis of efficacy and safety at week-52. Another analysis will be conducted at week-104 in about one year from now. A total of 802 women enrolled in the extension study, all of whom receive relugolix combination therapy regardless of their treatment assignments in SPIRIT 1 and SPIRIT 2. Let's first review the 24-week results of this SPIRIT studies. As you can see from the data in the orange columns over 24-week, relugolix combination therapy demonstrated significant and very consistent efficacy results in both SPIRIT studies with the responder rate for dysmenorrhea of about 75%, responder rate for non-menstrual pelvic pain of over 60% and improvement in dyspareunia or painful intercourse a key secondary endpoint. Women receiving relugolix combination therapy have minimal non clinically meaningful bone mineral density loss and a low incidence of hot flashes. Put these results in context, we present on the right side of the table the results from the elagolix monotherapy pivotal studies called ELARIS 1 and ELARIS 2. While these studies have all similar designs. Let me remind you that comparing data from different studies must always be done with caution.
  • Adele Gulfo:
    Thank you, Juan Camilo. It has certainly been an exciting first month of our promotional efforts. After our launch meeting just five weeks ago, we are already receiving tremendous prescriber interest and feedback, which leads us to believe that ORGOVYX has the potential to be everything we hoped. Our long term goal is to establish ORGOVYX as a standard of care androgen deprivation therapy for men with advanced prostate cancer. Executing on our launch priorities represents the first steps towards achieving this goal. Educating physicians, so they have confidence prescribing ORGOVYX. Establishing broad access by enabling seamless treatment starts and engaging patients to drive awareness are all foundational to our commercialization strategy. We've made significant progress across each of these priorities, which I'll now review in more detail. Due to the large percentage of in-office dispensing and specialty pharmacy distribution, we believe that achieving broad ORGOVYX adoption goes beyond clinical education to encompass office economics and operational considerations, including e-prescribing. I'm happy to say we're making significant strides across all three areas. The clinical component is being driven by our sales force who are initially targeting key prescribers and are equipped with materials and technology to perform this function virtually as well as in person. The economic component primarily impacts those practices with in-office dispensing capabilities. The vast majority of these practices now have access to our ORGOVYX contract, which was designed to ensure they are not economically disadvantaged when prescribing ORGOVYX. For those customers without dispensing capabilities, ORGOVYX is available through a specialty pharmacy network. And finally, we need to ensure that prescribing ORGOVYX is seamless. This includes supporting office e-prescribing systems, ensuring that practices and patients take advantage of reimbursement and financial support offers to the ORGOVYX support program. And where necessary that ORGOVYX is appropriately added to the clinical pathways to support prescribing. We are very pleased with our early efforts to reach prescribers. We have had over 10,000 total touch points with health care providers since launch. A high concentration of our meaningful interactions to date have been with Tier 1 or Tier 2 accounts, including academic centers, and large urology and oncology group practices that drive a significant share of ADT scripts. We were able to accomplish this in just five weeks and almost exclusively with Myovant's 100 person sales force. We are proud to have hired a highly experienced sales team in urology and oncology averaging eight years and many with local established relationships. Anecdotally, our representatives are seeing customer engagements, reaching over 30 minutes with tremendous enthusiasm for the clinical profile, particularly the compelling efficacy, the cardiovascular profile, and given the ongoing pandemic, ORGOVYX's oral formulation. We are pleased to report that the Pfizer sales team is now fully trained and joined us in the field last week, which should bolster the early momentum that we were able to generate. As mentioned previously, the vast majority of in-office dispensing practices have access to our contract pricing. And these early efforts are translating into ORGOVYX orders. In fact 10 out of our Top 20 highest priority accounts have already placed orders. And another encouraging sign, 30% of all accounts that have placed ORGOVYX orders have already reordered. In addition, half of our highest priority accounts have ORGOVYX in their e-prescribing system, which is great progress. We have already also made notable progress in establishing broad patient access to ORGOVYX. Our distribution channel was fully stocked within 72 hours of launch and our Patient Support Program, including the free trial program and copay support for commercial patients went live during the first week of launch. Regarding payer coverage, approximately 30% of commercial patients currently have access to reimbursement today via pre review coverage, and more may have access through the formulary exceptions process. Part D patients may also have access today via their formulary exceptions process. Our patient support services include support for prior authorization, and we have seen a good success rate with these requests so far. Engaged engagement with payers continues with initial commercial coverage decisions expected in the first half of 2021, which should support coverage for most commercial patients beginning in the second half of 2021. The path to broad Medicare Part D coverage starts with submitting our bids for the 2022 plan year, and we expect decisions by the May or June timeframe. Following these decisions, we do expect some Medicare Part D plans to offer access to ORGOVYX in 2021 with broad coverage anticipated no later than January 2022. Our strategy for engaging patients has three phases, two of which have already launched. The goal for our initial campaign is to drive early brand awareness with highly engaged patients. Let them know ORGOVYX is approved and available and drive them to talk to their doctor. In the second half of this year, after prescriber education milestones are met we will look to broaden our awareness efforts with the goal of increasing patient activation through targeted direct-to-consumer campaigns. Our efforts to drive patient adherence utilize three pronged approach. When a patient initiates ORGOVYX, nurse services are offered to each patient to coach them through the early days on therapy. A welcome kit with information on what a patient should expect after starting ORGOVYX, as well as a treatment planner to help the patient remain on track is also provided. As treatment continues, patients are sent monthly mailers that provide helpful information on ORGOVYX, and other content to maintain engagement and adherence. We are off to a great start regarding patient engagement. In the few weeks since launch, we've had over 37,000 total visits to our ORGOVYX's patient website, 83% of which were unique visitors with nearly one in five visitors downloading material. This is four times higher than our benchmarking data or other recent oncology product launches, and likely reflects just how engaged men with prostate cancer and their caretakers are and making decisions regarding their health. We are very pleased with the early progress we have made on all three of our launch priorities and look forward to keeping you updated in the future. I will now turn the call over to Frank to review our fiscal third quarter financial results. Frank?
  • Frank Karbe:
    Thank you, Adele. And good morning everyone. I will focus my comments on the highlights of our financial performance in the quarter and refer you to our press release and form 10-Q issued earlier today for additional information. Please remember that Myovant's fiscal year starts on April 1st. So the financial results for the quarter ended December 31, 2020 represent our third fiscal quarter of 2020. I will begin with revenue. We've recorded $1.4 million of collaboration revenue, which represents about one week's amortization of the upfront payment we see from Pfizer. Given the signing of the deal occurred in late December, the amortization period in fiscal Q3 was very short. Collaboration revenue related to the upfront payment will increase to $21 million in fiscal Q4 and is expected to remain constant each quarter thereafter, over the next six years. R&D expenses in the quarter was $30.5 million, compared to $48.9 million for the comparable prior year period. The decrease in R&D expenses primarily reflects the completion and continued wind down of Myovant's Phase 3 programs partially offset primarily by increased expenses associated with a build out of Myovant's medical affairs organization in preparation for the U.S. launch of ORGOVYX and the potential commercial launches of relugolix combination tablet for women's health. Our R&D expenses in the quarter also reflects a cost sharing reimbursement from Pfizer of $7.6 million for expenses associated with pre-launch commercial inventory. SG&A expenses in the quarter were $49.2 million, compared to $29.1 million for the comparable prior year period. The increase was primarily due to increased spending on commercial readiness activities to support the U.S. launch of ORGOVYX, personnel related costs, including the hiring of our oncology, sales force, and other general overhead expenses as we continue to prepare for the potential commercial launches of relugolix combination tablet in the women's health indications. Total operating expenses for the quarter was $79.7 million, of which approximately $7 million was stock-based compensation. We also incurred a $5.8 million gain on foreign currency during the quarter that was recorded in our other income line. Myovant generated a net loss of $73.8 million in the third quarter of 2020, compared to $85.6 million for the comparable prior year period. On a per share basis, our net loss was $0.82 in third quarter 2020 and $0.96 in the prior year period. Now looking ahead, we expect R&D expenses over the next several quarters to be at roughly similar levels to our fiscal Q3, 2020 R&D expense, excluding the $7.6 million of expense reimbursement from Pfizer. Declining spent on clinical programs that are winding down as well as our sharing of certain expenditures with Pfizer, are expect it to be offset by incremental spend on relugolix lifecycle management activities, such as the planned Phase 3 SERENE study. In upcoming quarters, where regulatory filing expenses are incurred, that could be modest deviations from this trend. SG&A expenses overall are expected to continue to increase from fiscal Q3 2020 levels as we continue to build out our commercial capabilities and support our commercialization activities. This increase is primarily driven by the hiring of our women's health sales force, which we now expect will be comprised of approximately 120 sales professionals, and it's expected to occur in fiscal Q1, 2021 as we approached the FDA uterine fibroid target action date of June 1, 2021. Additionally, our fiscal third quarter 2020 reflected only partial expenses of our prostate cancer sales force, because the hiring occurred gradually over the course of the quarter. Finally, please note that in fiscal Q4, 2020, we expect to record incremental non cash stock-based compensation expense of approximately $28 million due to the accelerated vesting and modification of our former CEOs equity awards upon her separation from the company. Let me wrap up by commenting on our cash position. We ended the quarter with $746 million of cash, cash equivalents and marketable securities on our balance sheet. This was bolstered by the $650 million upfront payment that was received from Pfizer in late December 2020. As of the end of fiscal Q3, there was approximately $86 million of capacity remaining under the low cost loan facility that Sumitomo Dainippon Pharma, our majority shareholder extended to us. An additional $200 million loan commitment that was extended to us by DSP in August 2020 also remains available to us until March 2021. Let me also remind you that there are several potential milestone payments anticipated in coming months that will further enhance our strong liquidity position. As Dave mentioned in his opening remarks, Myovant could receive additional payments of up to $250 million under the Pfizer collaboration alone 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 obtain development and commercialization rights to relugolix in oncology outside the U.S. and Canada. This is a decision we anticipate Pfizer will make during the first half of this year. So overall, Myovant is well capitalized to advance our commercial launches, and potentially expand our pipeline. Now with that, I'll turn it back to Dave for some closing remarks.
  • Dave Marek:
    Thank you, Frank, Adele, and Juan Camilo. In summary, this is an exciting time for Myovant. With the ongoing launch of ORGOVYX and the potential upcoming launch of relugolix combination tablet in the uterine fibroids indication around mid year. Our focus is squarely on successfully executing these launches and working with Pfizer to ensure we are efficiently bringing these important therapeutic options to patients in the U.S. And as Frank highlighted, we are approaching commercialization from a position of financial strength, which we expect to continue to build as we achieve additional upcoming milestones. One year SPIRIT results position relugolix combination tablet as a potential best-in-class therapy for women with endometriosis, and will support upcoming regulatory filings in the U.S. and the EU. I am extremely proud of all of the work done by the Myovant team to get us to this point. And I look forward to what's ahead. Thank you for your attention. And now I'll turn it back over to Ryan to begin the Q&A session.
  • Ryan Crowe:
    Thank you, Dave. Operator, can we now please poll for questions.
  • Operator:
    Now first question coming from the line of Jason Butler with JPM Securities. Your line is open.
  • Jason Butler:
    Hi. Thanks for taking the question and really appreciate all the details you ran through there. I guess just the first one on the commercial side. Can you speak to the types of patients that are being initiated on therapy first? A newly diagnosed versus having been through prior therapies, severity of disease, et cetera. And then just on the contraception program, can you just speak to -- I guess, just review for us the data you have in your Phase 3 trials, the completed Phase 3 trials and extension studies in terms of pregnancy frequency? And just any regulatory dialogue or precedent that you think is relevant here? Thanks.
  • Dave Marek:
    Sure. Thanks for joining us this morning, Jason. I really appreciate the questions. All cover the types of patients and I'll ask, Adele to weigh in. And then I'll turn it over to Juan Camilo for the contraception study. But just as a reminder, when we look at the types of patient, I just want to recall, I know many of you know this regarding our distribution channel. So while we are a retail product, we don't receive the same data that would be typical as an oral agent in the retail setting. Recall, we're in the specialty pharmacy distribution, and therefore the visibility we have as the product goes into our specialty distributors, and then ultimately to in-office dispensing, the visibility we have on patient level data is limited. So I just put that as a reminder, and I'll turn it over to Adele to add color on what we would expect to see in terms of the patient profile. Adele?
  • Adele Gulfo:
    Yes. Thanks. Thanks for that. And thanks for the question. What I will say, it is a bit early. We will still continue to gather information on our patients and have a bit more insights into that. But what I can tell you today is that our medical affairs team is actually engaging our providers on how we would go about transitioning patients who are on other therapies as well as initiating. So what that tells us is, we are hearing what we would expect to hear is that doctors are interested in starting patients on ORGOVYX who are either new to therapy, or who are experienced. So what I can tell you is that that's what we're seeing to date.
  • Dave Marek:
    And then, Juan Camilo, would you take the contraception question?
  • Juan Camilo Arjona:
    Yes, Dave. Thank you. So Jason, we're excited about their contraception study. And I heard two questions in your question. One is the any regulatory precedent and comment on the pregnancies in prior studies. I'll start with the second one. As we've mentioned in our prior presentations, we have seen a few pregnancies in our prior studies, mostly on the placebo patients, but a couple of patients receiving relugolix information therapy. In these studies, we were not set up for assessing prevention of pregnancy nor patients were instructed to take this drug as a means for prevention of pregnancy. Every patient in the studies was required to use non-hormonal methods of contraception. So these studies are not really set out for assessing the contraception efficacy of relugolix combination therapy. We have shown before our ovulation inhibition studies that demonstrated 100% of ovulation inhibition. And this is study specifically designed to assess the effect of relugolix combinations on ovulation. So we're very, very confident on that. And therefore, we decided to take the next step, which is to conduct a study that -- its a pretty standard design study. The way these studies look like when you're assessing contraception. So, we have decided to run that study to provide that information to patients and physicians.
  • Jason Butler:
    Great. That's helpful. Thanks.
  • Operator:
    And our next question coming from the Phil Nadeau with Cowen. Your line is open.
  • Phil Nadeau:
    Good morning. Congrats on the progress. And thanks for taking my question. First one on the commercialization efforts with Pfizer. Can you discuss how the resources you're getting from Pfizer and their sales force is coordinating with your own plans in the U.S.? Who takes what and how is that decided?
  • Dave Marek:
    Sure. I'll kick off and once again, I'll turn it over to Adele. I think, again, we view Pfizer as really the ideal partner not only for women's health eventually, but right out of the gates here with prostate cancer. And one of the areas that we really value from Pfizer is the long standing relationships they have with customers and their knowledge of the prostate cancer itself. But also the speed in which that they've moved to really activate around this launch, and that they were fully trained and in the field as early as just last week. So we're really heartened by the speed in which they've been able to be trained and get up to speed on the therapy, and then really start to contribute. So I'll turn it over to Adele to add her perspective as well.
  • Adele Gulfo:
    Yes. But I would ask you. So Dave has come online in the last week. And what we're hearing and, and actively monitoring is the very active collaboration at the ground level. So the reps are coordinating in terms of the calls that they're making on the prescribers. And also we are -- we're actively ensuring that they're working collaboratively as it relates to our most important accounts, because in addition to the sales representatives that we have from Pfizer. We also will have the opportunity to tap into their key account managers and the teams that they have that are covering these large group practices and those other accounts that are primarily the ones with in-office dispensing that we talked about.
  • Phil Nadeau:
    Great. That's very helpful. On the economics deal, how does it work free and post profitability? Is there a true-up every quarter on your expense lines on SG&A and R&D? Or will there be a separate reimbursement line where you record some of the reimbursement revenue, pre-profitability and then post-profitability will there be a collaboration profit sharing in your expense lines?
  • Dave Marek:
    So, I will -- there was a little feedback on the beginning of that. But I think, Frank, if you caught that question, I'll turn it over to you to clarify.
  • Frank Karbe:
    Yes. I think I caught it. Thank you, Phil. Let me maybe speak more broadly about how the Pfizer collaboration will be reflected in our financial statements. And there's maybe four points to make here. The first one is, remember that Myovant will record 100% of the net product revenue. So under our revenue section in the P&L going forward, there will be several captions, one of them will be net product revenue, that will show 100% of the net product revenue. There will also be a line that will be titled something along of collaboration revenue, which will be comprised of the amortization payments from the upfront payment and any potential milestone payments. And then under our cost of goods portion of the P&L, we will have a line item called collaboration expense. And that will reflect the gross profit share with Pfizer that will essentially be comprised of the net product revenue, minus cost of goods, and half of that is attributable to Pfizer. So let's see that on a separate line and called collaboration expense. And then thirdly, with regards to expense sharing, the allowable expenses that are subject to expense sharing will flow through the respective line items in R&D and in SG&A. And the way this will appear on our P&L is basically as a reduction in our expenses. So R&D and SG&A expenses will appear lower going forward than they would have been without the Pfizer collaboration.
  • Phil Nadeau:
    That is very helpful. Thank you. And then one last question from us is just on the -- it's a follow-up to the question on the pregnancy study. In terms of the Pearl Index, what needs to be achieved in order to support licenser ? Is there any regulatory precedents for what you have to show?
  • Dave Marek:
    Juan Camilo?
  • Juan Camilo Arjona:
    Yes. Thank you, Phil. As I mentioned before, this is a pretty traditional design, like any other contraception study. And it's based on regulatory guidance documents from the FDA and how this study should be designed. And the Pearl Index, it's pretty simple calculation is just the number of pregnancies that occur over 100-patient years of exposure. So we enroll patients that are otherwise believed to be fertile. And they agreed to use relugolix combination therapy as their only method for prevention of pregnancy. And then we collect the number of pregnancies and divided by the number of months that women were taking this medication. And that gives you Pearl Index.
  • Phil Nadeau:
    Right. But is there a specific hurdle that you have to reach? Like if the Pearl Index is over x, you can't get the label. But if it's below x, it might could be approved?
  • Dave Marek:
    Yes. We're not going to comment on that at this moment. I think that you just want to demonstrate the ability to prevent pregnancy. And we're pretty confident based on our ovulation inhibition data that we will get a Pearl Index that is pretty reassuring to physicians and patients.
  • Phil Nadeau:
    Got it. Thanks for taking my questions. And congrats again on progress.
  • Operator:
    An our next question coming from the line of Eric Joseph with JPMorgan. Your line is open.
  • Eric Joseph:
    Hi, good morning. Thanks for taking the question. I was just wondering if you could elaborate on how long of a free trial period is being offered to patients with ORGOVYX, particularly among government insured patients. I guess will physicians have sort of enough flexibility to write to Medicare patients until there's a formal party coverage decision? And then I have a follow up on the contraception study.
  • Dave Marek:
    Yes. Well, good morning, Eric. Regarding the free trial program, the free trial program is available to all patients. As I'm sure you know, that has an extension of up to two months. And then beyond that, we have a bridge program that's open to commercial patients in which that enables patients to stay on therapy while commercial coverage is being determined. So two months for the free trial, and then an extension for commercial patients on bridge. Regarding progress on what we're seeing in terms of Medicare coverage, I'll turn it over to Adele.
  • Adele Gulfo:
    The point that Dave made is the right one, is that the free trial program is offered to both commercial and Medicare patients. And what I can say about the Medicare patients is that they do have access to the formulary exceptional process. And we're seeing this actually happen. So we have the formulary exceptional process for those Medicare patients who are Medicare Part D patient. And I'll comment that we continue to have very good discussions with the Medicare Part D plans. And I'll remind you that by May, June timeframe of this year, we should have our decisions. And we do expect some plans will come online even in 2021. Of course the majority of coverage starts in January of 22. But we will expect to see some plans come online this year.
  • Eric Joseph:
    Okay. Got it. And I guess just trying to better understand the rationale, strategic rationale behind the contraception study with the combination tablet? Is it correct to read this as a desire to directly compete with OCTs and potentially forego the need to step through? Oral contraceptive use in the endometriosis segment. And then, if that's the case, have thoughts around pricing of the combination tablet changed as a means of maximizing the value proposition there? Thanks.
  • Dave Marek:
    Yes. Regarding pricing, I think we're not in a position to talk yet about pricing. But I ask Juan Camilo to talk about the strategic rationale.
  • Juan Camilo Arjona:
    Yes. Thank you, Dave. And thank you, Eric. So let me just clarify one thing, we're not going to compete with combining hormonal contraceptives in the overall population. What we heard loud and clear from patients and from their physicians is that we're talking about a pre-menopausal population for both indications; endometriosis and uterine fibroids. And in addition to wanting treatment for this condition, they want to manage their live and contraception is a component of that. So, as I mentioned in my remarks, what's available today in terms of GnRH antagonism treatment does not provide requires use of ovarian methods of contraception that quite honestly are not usually desirable by patients, nor consistently use. So we believe that having seen the data from our ovulation inhibition study with 100% of ovulation inhibition, we have an opportunity to provide a full prevention of pregnancy in addition to the treatment of symptoms of uterine fibroids or endometriosis if its approved for those patients that desire it. And we believe that would be highly differentiating from other drugs in the class.
  • Eric Joseph:
    That's helpful. Thank you.
  • Operator:
    And our next question coming from the line of Paul Choi with Goldman Sachs. Your line is open.
  • Paul Choi:
    Thank you. And good morning, everyone. Thanks for taking our questions. First, just on the Part D discussions. I was wondering if you could just clarify and elaborate a little bit. First, is there a possibility of temporary codes for 2021 versus the exception process? And then also, just to confirm you're seeking a permanent J code or something comparable to that for 2022?
  • Dave Marek:
    So Adele, I'll let you address the -- our expectations around Part D coverage.
  • Adele Gulfo:
    Yes. And I -- we can double check this. But in terms of codes, we're not pursuing any of that. We're going with the standard process. So I'm not quite sure that's relevant for us. We have been having very good discussions with the payers as I've said, both on the commercial and on the Medicare side. And we started this process end of last year and we're continuing it with coverage decisions made here and plans coming online thereafter.
  • Paul Choi:
    Okay. Thank you for that. Then, just with regard to Europe, can you maybe tell us where you are with regard to your own commercial infrastructure build? Specifically, I know you're considering and still waiting on the potential Pfizer opt in. But just where you are with respect to your commercial infrastructure development in Europe?
  • Dave Marek:
    Sure, Paul. I think when you look at the women's health in Europe, we've already established a collaboration with Gideon Richter. So we're very enthusiastic as we approach the potential commercial approval in uterine fibroids that we would hope would come around mid year. And so, Gideon Richter will be the lead commercial, or will lead the commercial efforts in women's health. Regarding prostate cancer, as we've mentioned, Pfizer has the first option or right of first refusal, so to speak of the prostate cancer. We expect that they will make that decision in the first half of this year in our negotiations in the collaboration, they were very enthusiastic about that opportunity. So we will await their decision as we get closer. Should they choose not to take that option. We did have and still do have other partners who are very interested in the prostate cancer opportunity in Europe. And so, we will have plenty of time to determine another partner that could potentially launch prostate cancer in Europe. We are not currently building out our European infrastructure to support those launches directly. We will do that through partnerships.
  • Paul Choi:
    Okay, great. Thanks for that clarification. And then just lastly, in terms of your physician tracks, and just sort of where the European practitioners broadly see relugolix fitting in terms of the ADT landscape for prostate cancer. Can you maybe just comments on what your early market research is suggesting where it could potentially fit in? Thank you very much.
  • Dave Marek:
    Thank you, Paul. I will ask Adele to comment on your question.
  • Adele Gulfo:
    Yes. Search in Europe, we haven't done an extensive amount, but how physicians prescribe and maybe Juan Camilo can just add. But we see patients with advanced prostate cancer and the incorporation of ADT in a similar manner. And just as we would expect in the U.S., we have our goal, because ORGOVYX becoming the new standard of care for ADT. We would hope to see that in Europe. But I'll ask Juan, if he wants to comment on prescribing, because it's pretty parallel.
  • Juan Camilo Arjona:
    Yes. Thank you, Adele. I think -- sorry. I think you're right. It's pretty parallel to the U.S. where agonist are the primary form of ADT use there. With the physicians that we've spoken in Europe. There is a high enthusiasm for the antagonists, being now available in a way that is -- well, not available, but this could potentially be available for oral route and they look forward to seeing it. So I don't think it's very different than what we see in to U.S.
  • Paul Choi:
    Thank you very much.
  • Dave Marek:
    Thank you, Paul.
  • Operator:
    And our next question coming from the line of Mohit Bansal with Citi. Your line is open.
  • Mohit Bansal:
    Great. Thanks for taking my question. And Congrats on the progress. Maybe a couple of questions. So one question on the cadence of revenue uptake going forward. It sounds like you're saying that, I mean, the to creating the awareness, and obviously, there is probably more towards the back half of the year as you get into some of those Medicare plans, and maybe more to come in 2022. Am I reading it right? And to that end, I mean, consensus seems to be assuming about $50 million in 2021 calendar year. Does this seem reasonable to you, considering all that?
  • Dave Marek:
    Well, I'm not sure I heard the entire question. There was a little break up there. But let me just speak to. We're not in a position to provide revenue guidance at this point. We need a few more quarters I think to get a sense of the trajectory that we are seeing. What we can say is that we are very pleased that we already have 30% of commercial plans that are providing coverage prior to their formulary decisions. And so, we feel very comfortable that that's a great statement in terms of how payers are viewing the therapeutic area and the role ORGOVYX can play. We anticipate that we will have more commercial decisions, not only this quarter, but leading into second quarters. So our ability to monetize the demand trajectory that we're seeing looks very promising. And then, as you mentioned, in terms of Part D plans, I think, Adele mentioned that we expect that some of those decisions will begin happening, we anticipate this year. But much of that coverage will actually take place at the beginning of next year. So that's when we would see more monetization of that patient volume will be more substantial as we get into the beginning of 2022. So I hope that provides clarity on what you're looking for there, Mohit.
  • Mohit Bansal:
    This is a very, very, very helpful. And maybe one big picture question. Now that cash is not an issue for you, plus, I mean, if Pfizer opt-in, you could have more cash coming in? How are you thinking about going beyond relugolix? And would that be something internal in terms of building your pipeline? And I'm quite intrigued by the R&D complemented , R&D would probably be stable for a few quarters. So just thinking about the future four to five years down the line, how you're thinking about using this cash, utilizing this cash to build a company for future?
  • Dave Marek:
    Yes. Well, I'll make some intro comments, and then I'll turn it over to Frank here. But I think from a big picture perspective, we have two large corporate priorities this year. The first is execution. We will execute on our launches. We will work diligently to make sure that we get our therapies in the hands of patients. And part of that execution is also our regulatory filings and seeing those through. But you've touched on the second large pillar of our strategy this year, which is really building a sustainable growth for us many years to come. And that has to do with really building out our pipeline. I think our organization has demonstrated that we are an outstanding clinical development organization. And we want to leverage those strengths, to really make sure that we are building our pipeline. So when we talk about the cash, the areas of focus will be first of all partnering with Pfizer on building out the relugolix franchise, because we see additional opportunities there in women's health and in cancer and oncology. And so that will be one of the key areas of priority. And we've already made significant progress with Pfizer and the discussions around the prioritization there. Second, in terms of building our pipeline, of course, we have MVT-602. And we are assessing what the different applications of that therapy could be. And we'll come back at a future date with kind of prioritization of how we see any potential development there. And then third is really the business development efforts. As you can imagine, we would stay closer to home in terms of our focus being women's health, as well as oncology. Those would be the areas of prioritization in building out our pipeline. So those would be kind of the strategic direction. And I'll turn it over to Frank, if you want to add any further color on how we might allocate that and making sure that we -- as we look at business development, we're really looking towards the right valuations.
  • Frank Karbe:
    Maybe just to highlight, again, the comment I made about so the directional guidance where we expect R&D expenses to go. As you said, we expect it to be constant over the next few quarters. Keep in mind, I mean, R&D expense overall has come down quite substantially, about $20 million from the same quarter a year ago. But we expect it now to be about constant because as Dave said, we have this proven development engine. And we want to keep that engine humming. And in the first instance, we are not doing this with some lifecycle management opportunities. You heard the first example of that with a SERENE study that we plan to initiate, and there are likely others to follow. And then beyond that, of course, we are now evaluating other opportunities to bring in assets that extend the Myovant's pipeline beyond the relugolix franchise.
  • Mohit Bansal:
    Very helpful. Thank you very much, Dave and Frank.
  • Operator:
    And our next question coming from the line of Ami Fadia with Leerink. Your line is open.
  • Ami Fadia:
    Hi. Good morning. Thank you for taking the question. Firstly, just on the commercial front, maybe a question for Adele. Can you talk about how you're in the Pfizer sales force is sort of coordinating on sort of splitting up the various territories, except for a new kind of talked about 10 -- sorry, 20 key accounts. Can you help us understand how much the Top 20 accounts that you're focusing on accounts for the total addressable markets here? And then secondly, I had a question on just sort of commercial coverage. What is your anticipation with regards to any type of prior authorization that may be required either on the commercial side or Medicare side in order to get relugolix?
  • Dave Marek:
    Adele?
  • Adele Gulfo:
    Just on the commercial coverage with prior authorizations, we are not seeing any issues in that when they're -- when -- if they plan requires a prior auth. It's usually just to ensure the patient is actually according to label. So it's been very administrative. To date, it's early days on that. But I just want to signal that we're not seeing any challenges as a relates to the offices who need any support with prior authorizations. We're in there, we're helping with them. And that's going extremely smoothly. As it relates to Pfizer, as I mentioned, there's great coordination. So the way to think about it is that our field representatives, our 100 field reps, as well as their 100 plus reps are working together, they're collaborating on the highest priority positions. These are the physicians that are our top decile. They're working most closely across those doctors. And as I said, we've had very good meaningful interactions with the top accounts. These are the high priority accounts. They could be academic centers or mostly the large urology group practices, oncology practices, multi specialty discipline, seasonal ones that are generating a large share of the prescriptions, mostly they have in office dispensing. And those are the accounts that we're really focused on. Some of them are volume, and some of them are about influence. It's a lot -- especially those large academic centers that I could rattle off to you. But those are the ones that you would know the big brand new ones that we're really focused on.
  • Ami Fadia:
    I guess my question, I guess my question. Sorry, I'm hearing some feedback here. But is that highly concentrated in terms of the market that the Top 20 are extremely influential or carry a fair amount of prescription volume?
  • Adele Gulfo:
    They are a combination of very influential, as well as they're the ones that are having a lot of volume flow through them.
  • Ami Fadia:
    Got it. Okay.
  • Dave Marek:
    Great. Thank you, Ami.
  • Operator:
    Thank you. And that's all the time we have for questions today. I would now like to turn the call back over to our speakers for closing remarks.
  • Dave Marek:
    Thank you, Olivia. Our journey to commercialization is just beginning. And it's built on a strong foundation from the efforts of last year. In addition, we now have more resources than ever to look towards product development and pipeline expansion. So 2021 is certain to be a very exciting year for Myovant. And I'm confident in our ability to deliver on our purpose of redefining care for patients. So thank you for joining us today. And I look forward to keeping you updated on our progress.
  • Operator:
    Ladies and gentlemen, this concludes Myovant Sciences' third quarter of fiscal year 2020 earnings conference call. Thank you for your participation. You may now disconnect.

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