Myovant Sciences Ltd.
Q4 2020 Earnings Call Transcript

Published:

  • Operator:
    Good day everyone and welcome to Myovant Sciences Fourth 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.
  • Ryan Crowe:
    Thank you, operator. Good morning and thank you for joining us today for a general business update and to review the financial results of Myovant's fourth 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; Lauren Merendino, Chief Commercial Officer; and Dr. Juan Camilo Arjona, Chief Medical Officer.
  • Dave Marek:
    Thank you, Ryan, and good morning everyone. Given our 2020 fiscal year ended on March 31, it's worthwhile to briefly reflect on Myovant’s 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 Myovant’s first ever FDA approval for ORGOVYX 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 ORGOVYX 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, Myovant generated $3.6 million of net product revenue for ORGOVYX 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 ORGOVYX at 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 a significant opportunity to improve the lives of women with uterine fibroids and fully unlock the potential of this market.
  • Lauren Merendino:
    Thank you, Dave. Today, I will provide an update on the early progress we've made on ORGOVYX launch and an overview of the upcoming potential U.S. launch a relugolix combination tablet in women with uterine fibroids. The ORGOVYX 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 ORGOVYX. 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 ORGOVYX. And it is from this foundation that we expect to build ORGOVYX 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 ORGOVYX aided awareness by 30 points since launch to 89%, nearly as high as branded leuprolide. For unaided awareness, we quadrupled our pre-launch benchmark, bringing ORGOVYX to 20% in April. This is impressive considering that leuprolide 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 ORGOVYX. Increased prescriber awareness is leading to ORGOVYX adoption and more men benefiting from this therapy. As you can see on the bar chart, the estimated number of men treated with ORGOVYX 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.
  • Frank Karbe:
    Thank you, Lauren. As Dave mentioned in his introductory remarks, Myovant’s fiscal year ends on March 31. Therefore, the financial results reported today cover both our fourth quarter and full-year results for fiscal year 2020. As usual, I will focus my comments on the highlights of our financial performance and refer you to our press release and Form 10-K issued earlier today for additional information. Before we get into the numbers, I want to highlight that there are a few new line items on our Q4 financial statements, reflecting our evolution to a commercial enterprise, as well as our collaboration with Pfizer. Let's begin with revenue. Myovant recorded 24.6 million of total revenue for the fourth quarter, composed of 3.6 million of net product revenues from U.S. sales of ORGOVYX and 21 million of collaboration revenue relating to the amortization of the upfront payment received from Pfizer. Collaboration revenue is expected to remain at 21 million in future quarters through the end of calendar year 2026 when the amortization period is scheduled to end. For the fiscal year, we recorded 59.3 million of total revenue, which in addition to the revenues recorded in fiscal Q4 included 33.3 million of license and milestone revenues, reflecting the partial recognition of upfront and milestone payments from our collaboration with Gideon Richter, as well as 1.4 million of collaboration revenue relating to the amortization of the upfront payment from Pfizer. Cost of product revenue, a new line item for both the quarter and year was 0.3 million and was largely comprised of the high single digit royalty on net sales of ORGOVYX payable to Takeda, as well as expense related to the cost of goods sold for ORGOVYX. Collaboration expense, also a new line item, for both the quarter and year was 1.7 million, reflecting Pfizer's 50% share of net profits from sales of ORGOVYX in the U.S. during Q4. R&D expenses in the quarter were 21.6 million, compared to 41.7 million for the comparable prior year period. For the year, R&D expenses were 136.7 million, compared to 192.6 million for the prior year. The decrease in R&D expenses in both periods, primarily reflects the completion and wind down of Myovant’s Phase 3 programs, as well as cost share reimbursements from Pfizer, partially offset primarily by increased expenses associated with a build-out of Myovant’s medical affairs organization to support the U.S. launch of ORGOVYX and the potential commercial launches of relugolix combination tablet for women's health. SG&A expenses in the quarter were 78 million, compared to 22.4 million for the comparable prior year period. For the year, SG&A expenses were 181.4 million, compared to 82.3 million for the prior year. The increase in both periods was primarily due to share based compensation charge of 25.7 million in Q4 related to our change in leadership, as well as increased spending on commercial activities to support the U.S. launcher of ORGOVYX and commercial readiness activities for the potential U.S. launches in women's health. Increased SG&A expense was also driven by hire personnel related costs, primarily related to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology Salesforce, and higher general overhead expenses to support Myovant’s organizational growth. Myovant generated a net loss of 81.4 million in the fourth quarter and 255.1 million for the year ended March 31, 2021. On a per share basis, net loss was $0.89 for the quarter and $2.83 for the year. Now looking ahead, we expect R&D expenses for fiscal year 2021 to be modestly lower than R&D expenses incurred in fiscal year 2020, largely due to our sharing of certain expenses with Pfizer. Overall, we expect declining spent on clinical programs that are winding down to be offset, primarily by incremental spend on new relugolix development programs, such as the Phase 3 SERENE study to potentially expand the commercial opportunity for the relugolix franchise. SG&A expense for fiscal year 2021 is expected to continue to increase significantly, compared to fiscal year 2020. This increase is expected to be driven by the full-year impact of oncology Salesforce, which was on boarded just prior to the approval of ORGOVYX, as well as the continued build-out of our commercial infrastructure and capabilities to support multiple product launches and commercialization activities, including of course, the hiring of our women's health Salesforce, which began in fiscal first quarter 2021. Let me wrap-up by commenting on our cash position. We ended fiscal year 2020 with 684.9 million of cash, cash equivalents, and marketable securities. And 41.3 million of capacity remaining under the low cost loan facility extended to us by Sumitomo Dainippon Pharma, our majority shareholder, resulting in total cash and committed funding of 726.2 million. There are several potential milestone payments in coming months that would further strengthen our liquidity position. Myovant could receive payments of up to 250 million under the Pfizer collaboration alone within the next 12 months, comprised of a 50 million payment, should Pfizer decide to exercise the international option for relugolix in oncology, as well as two regulatory milestone payments of 100 million each upon FDA approvals for relugolix combination tablet and uterine fibroids and endometriosis. Myovant is also eligible for milestone payment from Gideon Richter, based upon certain international regulatory submissions and approvals for relugolix combination tablet in women's health indication. Myovant has accomplished a lot this past year and we have a lot to look forward to. Our current cash position and significant potential milestone payments over the next year coupled with the sharing of certain expenses with Pfizer, as well as the anticipated increase in revenues driven by ORGOVYX and the potential launch of relugolix combination tablet puts Myovant in an excellent position to execute our commercial strategies, and at the same time, expand our pipeline through business development. With that, I'll turn the call back to Dave, for some closing remarks.
  • Dave Marek:
    Thank you, Frank and Lauren. We're very excited about the momentum we have generated in the first few months of the ORGOVYX launch and look forward to helping more men with advanced prostate cancer as we broaden our prescriber education efforts, continue to improve access and reimbursement and further engage patients. We're also making final preparations for a June launch of relugolix combination tablet in uterine fibroids, pending FDA approval by the June 1 PDUFA date. Our focus is squarely on the successful execution of these launches. And in collaboration with Pfizer to ensure that we are efficiently accelerating our efforts to bring these important therapeutic options to patients. We also have several other near term regulatory milestones. We expect the European Commission to make its decision on our uterine fibroids filing by mid-calendar year. We expect to submit our U.S. regulatory filing for endometriosis later this quarter and our European filing for endometriosis will be submitted in the second half of this calendar year. As Frank highlighted, we're approaching commercialization from a position of financial strength, which we expect to continue to build as we potentially achieve additional upcoming milestones. And our financial position gives us the flexibility to pursue pipeline expanding business development for attractive opportunities in women's health and oncology. I'm extremely proud of the passion and the work done by our Myovant team to enable us to be in this position to potentially redefine care and positively impact the lives of so many men and women. And we look forward to what's ahead. Thank you for your attention. And I'll turn it over to Ryan to begin the Q&A session.
  • Ryan Crowe:
    Thank you, Dave. Operator, can we now please poll for questions.
  • Operator:
    Our first question comes from the line of Jason Butler from JMP Securities. Your line is now open.
  • Unidentified Analyst:
    Hi, it’s in for Jason, thanks for taking our questions. I've had a couple on ORGOVYX, just where do you guys see the gross to net in general terms by the end of the year? It that in centers or with providers where you've experienced any pushback on ORGOVYX? Are you seeing a greater impact from the payers or is it more due to physician hesitancy to try something new or something else? And I have a follow up.
  • Dave Marek:
    Well, thanks for the question and thanks for joining us this morning. I think in terms of the gross to net we're not really providing guidance on the gross to net at this time. In terms of some of the barriers or hurdles that we're seeing in the clinics, I think as Lauren mentioned, they kind of fall into three buckets depending on the practice. You have, kind of the clinical, the financial considerations that they have in office dispensing and then how do they operationalize it. So, I think depending on the practice, they could be at different stages. As Lauren mentioned, we're helping them through each of those stages and we're making great progress. We are seeing as Lauren mentioned significant uptick from a payer perspective. So, while those are initial hurdles to getting patients on therapy, we've been able to successfully navigate many of those through our hub services. And we see that outlook really continuing to improve as we get more payers making decisions in the coming months. You got a follow up?
  • Unidentified Analyst:
    Okay, great. Yeah. And then on the – you mentioned, bolstering the pipeline, can you just remind us, kind of what stage of development candidates you're looking at and the target spaces that are going to stay in women's health and men's health or look outside of that? Thanks.
  • Dave Marek:
    Yeah, we haven't really limited specifically to what stage. Our clinical development capabilities really have proven themselves over the last few years as really being significantly effective. And when we look at therapeutic areas, we are clearly focused on women's health, prostate cancer, and then more broadly, oncology.
  • Unidentified Analyst:
    Great, thank you.
  • Dave Marek:
    Thank you.
  • Operator:
    Thank you. Our next comes from the line of Mohit Bansal with Citigroup. Your line is now open.
  • Mohit Bansal:
    Great, thanks for taking my questions up. Maybe a few questions, so if I look at the Slide number 10 and then the patient trend here, it seems like you're off to a good start with like 700 so patients added every month. So, first question is, are – the numbers you're showing are these gross patients or net patient? And number two, it seems like there is a little bit of, you know – from March to April, the additional number of patients are probably lower than they were before that. So, is it like, am I reading too much into it or is it like something that you would expect? So, thinking about it is, more like 500 or so patients per month? Is it a fair way of thinking about in coming year?
  • Dave Marek:
    Well, Mohit, thank you for the question this morning. I'll let Lauren respond to that. I think, you know, one of the considerations when we look at those numbers, we've certainly seen significant growth month-to-month over the patients that we've started. And just recall, early on, you know, the vast majority of patients that are coming in, of course are new starts. Over time, when we start to look at refills that will supplement, kind of the trends that we see in terms of our revenue growth. But let me turn it over to Lauren to add a little more color to that.
  • Lauren Merendino:
    Yeah, so the graph that you're looking at is cumulative patients, just to answer your question. And, as you can see, we're seeing significant growth in the last two months, steady growth throughout. But a lot of that is due to, as Dave mentioned earlier, removing some of those hurdles to utilizing our products. So, working with getting ORGOVYX in the e-prescribing systems, ensuring that our customers have the information they need to set up in-office dispensing, and then of course, making sure that physicians understand our clinical profile. So, through all of that, I think that that is driving the more recent acceleration that you're seeing in that graph.
  • Mohit Bansal:
    Very helpful. And welcome Lauren as well. Sorry, I didn’t say that before. Congrats on this new .
  • Lauren Merendino:
    Thank you.
  • Mohit Bansal:
    One other question, the 300,000 patients you are mentioning in the U.S. are these all new patients who start therapy every year or these are like, these are like some that are also included in that?
  • Dave Marek:
    Yeah, I'll let Lauren take that in terms of the types of patients that we're seeing initiating therapy. Lauren?
  • Lauren Merendino:
    Yeah. So, the 300,000 numbers that you mentioned, that is the total number of patients receiving ADT therapy each year. So, total being maintained. And then as far as what we're seeing is, you know, it's early days, and we have limited information based on our distribution model, since the majority of patients are receiving treatments through in-office dispensing, and the claims data is still immature at this point. But we are seeing a broad range of patients initiating ORGOVYX therapy, including both naive, as well as those transitioning from other ADT therapy, but we'll have more information as we get – as the data matures.
  • Mohit Bansal:
    Awesome. Thank you very much Lauren. Really appreciate it.
  • Lauren Merendino:
    Thank you.
  • Operator:
    Thank you. Our next question comes from a line of Eric Joseph from JP Morgan. Your line is now open.
  • Eric Joseph:
    Hi, good morning. Thanks for taking the questions. On the ORGOVYX side, just wondering what you're seeing in terms of repeats, or refill rates and also repeat describer rate. In terms of payer coverage or to what extent are you seeing payers require step out through or other ? Is there a meaningful difference between commercial payers versus Part D? And then just looking to the launch of relugolix combination to tablet, what do you see today in terms of product or brand awareness? And what are providers expecting or what are your expectations among providers in terms of how they will incorporate RCT into their practice? Thanks for taking the questions.
  • Dave Marek:
    Well, thank you, Eric. Let’s see if we can go through a few of those questions. I'll let Lauren talk about the awareness numbers that we're seeing in just a moment. I think when we look at your question regarding what we're seeing in terms of step edits, and commercial versus Part D, recall that our commercial coverage is, as we would expect is pacing a little ahead of Part D, we expect Part D decisions to be coming through the second half of the year, and really be in full force as we get to flipping into January of 2022. But we're very comfortable with the progress that we've made in terms of commercial coverage, overall, and what we are seeing is the coverage that is consistent with our package insert. So, it does not require a step through another therapy prior to initiating our therapy. And that's how the payers are looking at this. So, Lauren do you want to take the awareness numbers?
  • Lauren Merendino:
    Yeah, sure. Thank you for the question. So, we're quite proud of our awareness at this point. So, since launch, we've seen a significant increase. So, an increase of about 30 points in our aided awareness, bringing our awareness to 89%. And then for unaided, we're at about 20% in April, and that compares, well, when we look at branded , which is at about 39%, although it's been on the market for decades. So, we believe this demonstrates the effect of our marketing and sales efforts to date, but we're never satisfied and we’ll continue to spread awareness in the coming months.
  • Eric Joseph:
    I'm sorry, but thanks for that Lauren. I should have clarified, I meant combination, relugolix combination tablet awareness for uterine fibroids, just sort of were awareness is? I presume your comments are related to prostate cancer? Where does awareness ?
  • Lauren Merendino:
    Sorry, I thought you were still asking about ORGOVYX. I don't have the numbers in front of me for relugolix combination tablet awareness. But we can certainly circle back with you and provide them.
  • Eric Joseph:
    Okay. And just on refill rates, can you comment on how thus far, I know it's early days, but presumably you would have a maybe one or two months here to look at conversion from new starts and rebuilds, can you kind of ?
  • Dave Marek:
    Yeah, as a reminder, Eric, given the distribution network, we don't get the patient level data with the vast majority of our distribution channel going through specialty distributors and in office dispensing. So, we don't always capture what the nature of the prescription if it's for a new patient, or a, or if it's being refilled. So, we don't have a specific number in terms of the specific proportionality between a new RX and a refill RX.
  • Eric Joseph:
    Okay, got it. Alright, great. Thanks for taking the question.
  • Dave Marek:
    Yeah, thank you Eric.
  • Operator:
    Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your line is now open.
  • Paul Choi:
    Hi, thank you. Good morning team and congrats on all the progress. I just want to follow-up on Eric's prior question, particularly with regard to the commercial side. And can you maybe just comment on where in terms of cheering ORGOVYX has fallen so far on the commercial side for the most part, I recognize it's early days?
  • Dave Marek:
    So Lauren, do you want to talk about the commercial coverage?
  • Lauren Merendino:
    Yes. So, we're, you're right, it is early days, however, we are excited with the progress we've made so far. And as I mentioned, we have 43% of commercial patients currently have coverage. And we're also seeing about 51% of the Part D patients having coverage. As far as tearing, we are generally seeing coverage in alignment with RPI, and are satisfied with the coverage that we've seen to date.
  • Dave Marek:
    Yeah, I think where we have coverage is, not only have we been able to secure adequate coverage, but also I think one of the areas that we've been very pleased with is the, kind of the pre-P&T committee review coverage where we have, when patients go through our hub services, we're able to achieve coverage for two-thirds of those patients already. So, either with the payer coverage itself or with the pre-approval or pre-authorization of that. So, we're very pleased with where we are in terms of the initial coverage that we're seeing, and again, . So, there are no requirements for step-throughs. We also have the co-pay assistance programs for patients who are commercially insured as well. And we're seeing patients take advantage of that program.
  • Paul Choi:
    Okay. Thank you for that additional color. Then, as a follow up, I was wondering, you know, can you maybe just, sort of characterize what sort of median or typical patient who's on therapy now is, is this – does this tend to be a de novo patient, you know, or patients perhaps with cardiac risk issues? You know, as you highlighted that in your prior data, and it's, you know, it's in the label as well? So, is there any sort of preference or sort of, you know, average patient type that you can characterize so far?
  • Dave Marek:
    You know, I’ll let Lauren add some color to this, but I think we, you know, again, in the absence of the patient specific data, we're relying much on what we're hearing from the field and what physicians are telling us, and certainly it crosses the board. You can imagine that, you know, many patients that are naive to therapy are at that cusp of making a treatment decision. And so those patients are already, you know, making a determination of therapy. So, we skew probably a little more to some of those naive patients, simply because they're at a different point. And you know, in the initial point of their treatment journey. We are hearing a significant amount of transitioning of existing patients. And that's for a variety of reasons. As you can imagine, the oral versus injectable profile is something that's highly desirable for some physicians and some patients, and then with the increasing risk or focus on cardiovascular risk, we know that that is one of the areas that physicians are significantly aware of. And that certainly has been one of the motivating factors for some of the patients that we're hearing coming from the discussions with physician. So, that's how I would characterize it. Again, it's difficult to kind of put an average patient out there. But we're seeing that across the board, probably leaning a little more into naive patients than we are in patients transitioning at this point. Lauren, is there anything else you'd like to add?
  • Lauren Merendino:
    No, I think you covered it. You know, as the claims data matures, we hope to have more insight, but right now we're limited to what the field can tell us.
  • Paul Choi:
    Okay. Thanks, Dave. Thanks, Lauren for taking our questions.
  • Dave Marek:
    Sure.
  • Lauren Merendino:
    Thank you.
  • Operator:
    Thank you. Our next question comes from the line of Phil Nadeau from Cowen. Your line is now open.
  • Phil Nadeau:
    Good morning. Let me add my congratulations on the progress. First question on the $3.6 million in revenue, how much of that was in user demand versus channel fill?
  • Dave Marek:
    You know, I'll let Frank review the distribution of the revenues.
  • Frank Karbe:
    Hey Phil thanks for your question. So remember, we report revenue at the point of sale to our specialty distributors or specialty pharmacies. So, the net revenue that we reported with 3.6 million is revenue associated with products sold to those distribution channels. We have not seen any unusual ordering patterns throughout the quarter or towards the end of the quarter that would suggest that there was any channel stuffing going on.
  • Phil Nadeau:
    Do you have a sense of how much inventory is in the channel as the typical two to three weeks?
  • Dave Marek:
    Yeah. We don't have any reason to believe that it is more than that. And once we had the initial stocking, you know that we saw in January, we've seen the levels can gradually and continually increase, but there's no reason for us to believe that it would be anything other than what would be the normal inventory channel. Part of the reason why we don't have as much visibility is, we don't know what has moved from our specialty distributors that might be an in-office dispensing pharmacy. We would expect that to be low, but we have no visibility into what might be sitting on the shelves there. We wouldn't expect it to be significant. But that's why we have a little less visibility into that. But we're not seeing as Frank mentioned, any unusual buying patterns and no reason to expect it to be any different than as you mentioned, you know, in the order of three weeks.
  • Frank Karbe:
    Yeah. And I can add Phil, we are seeing regular re-orders from our distribution channels. So, there's sort of a regular pattern that has set in and what we are observing is, you know that reordering on a regular cadence, but the overall numbers, of course, are going up in-line with the increase in demand.
  • Phil Nadeau:
    That's very helpful. Second, a follow-up to Paul's question in terms of the patients who were using therapy, have you seen any trend early days? Have you seen any trend towards more intermittent dosing? Now that there's some oral option available. Is that something that physicians have indicated to you or any signs of it? Or is it is it simply too early in the launch to know?
  • Dave Marek:
    Well, I think, you know, when we're certainly getting patients of all, you know, kind of therapeutic intent. And so, we are hearing from the field that physicians are trying at across a different range of patients. And so that would certainly be in the mix. But I think the bulk of it would be other patients that are starting therapy as naive and maintaining continuity of therapy, or switching from other therapies and again, maintaining consistency that would be the vast majority of what we're hearing from the field.
  • Phil Nadeau:
    Got it. Okay, and then last question from us is, on the upcoming uterine fibroids launch, it seems like the launch from AbbVie's going slower than we and I think even AbbVie expected, what have you guys learned from their commercialization efforts? And there's stumbles in uterine fibroids that have better prepared you to launch into that market?
  • Dave Marek:
    Yeah. I think there are a few things. You know, first and foremost, I think it's really understanding the marketplace. And we've done a fair amount of research, as I'm sure you can imagine. And understanding what is it the market is looking for. And earlier, Lauren referenced that, you know, the three things that we're hearing consistently from particularly gynecologists, who are the vast majority of the prescriber audience here, what they're looking for are therapies that, first and foremost, take care of the symptoms. Second, therapies that are – have a tolerability and a safety profile that they're attracted to. And then third, specific for this therapeutic area in this audience, the idea of convenient straightforward dosing, skew is a little higher for this therapeutic area than many others that I've worked for. So that's really important, not only for the prescriber and what they're looking for, but what they believe their patients are looking for. So, when you look at our clinical data and how we align to those needs that the marketplace is telling us, we believe that we're really well-positioned to really address those priorities that physicians are telling us, particularly when you look at some of our tolerability data, whether that's hot flash and other areas. Certainly BMD is an area of focus for clinicians. And then finally, the simplicity of dosing, what physicians tell us is, they overwhelmingly prefer a once daily therapy. You know, it certainly is much more in-line with what this audience is accustomed to. So, from a clinical profile, that is one of the things that we think just getting out of the blocks that our clinical data really aligns well with the market, unmet needs. And then the other point that relates to simplicity and convenience is how you support both the practices and the patients with patient support services, and reimbursement support services, we fully expect that we'll have those services a very robust suite of offerings available at the time of launch. And we believe that our first experience with relugolix combination tablet, once approved, we think is going to be a very positive experience for clinicians and patients. And we think that's going to be something that's really going to help us in their early days.
  • Phil Nadeau:
    That's very helpful. Thanks for your perspectives.
  • Dave Marek:
    Sure.
  • Operator:
    Thank you. Our next question comes from the line of Brian Skorney from Baird. Your line is now open.
  • Brian Skorney:
    Hey, good morning, everyone. Thanks for taking my question. I have a question also on, sort of the patient numbers by month slide, Slide 10, just kind of back calculating it seems something that you guys have something on the order of maybe 2,700 by the end of – the quarter ending in March? Can you just help us understand sort of the free versus commercial dynamic here, I mean, it would seem that number of on a fully commercial basis would be like a 5.4 million in demand sales? So are, you know, in sort of the quarter composed about half and half of free versus commercial? And how do we kind of think about those free patients and do they get converted to commercial, and how do they sort of flow through to that? Thank you.
  • Dave Marek:
    Yeah, well, thank you for the question, Brian. You know, having the free goods program in place, to help physicians, kind of get off on the right start with patients to fulfill their treatment desire has really been beneficial. In the early days, we certainly have seen a number of physicians and patients take advantage of the free goods program, but also, because of the coverage we've been able to achieve early and the success that our hub has had in terms of seeking achieving coverage, then we haven't had to lean into that quite as much as we might have thought, initially. So, we're still seeing significant patient volumes coming through our hub. Again, about two out of three of those patients who are seeking coverage, were able to achieve coverage. We lose sight of them once we have helped to secure that coverage, to know what happens once they go back to the office. We don't have the tie-off to understand what happens once they – once we've achieved that coverage. So, I can't give you specific numbers there. But I think overall, if you were to look at our volume, as it relates to free goods, we're looking at about a third overall as what we've been seeing, and of course, that has migrated somewhat over time as more and more coverage comes online.
  • Brian Skorney:
    Okay, thanks. That's helpful.
  • Dave Marek:
    Great. Thank you, Brian.
  • Operator:
    Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to Dave Marek for closing remarks.
  • Dave Marek:
    Well, thank you, everyone. And as you can see, Myovant is off to a very exciting time with our evolution from a clinical stage company to now a clinical and commercial stage company. Clearly we're well-positioned both operationally and financially to really deliver strong commercial execution and build sustainable long-term value. 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’ fourth quarter of fiscal year 2020 earnings conference call. Thank you for participation. You may now disconnect.

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