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spk02: Good day, everyone, and welcome to Myobot Science's third quarter of fiscal year 2021 earnings conference call. Today's call is being recorded at this time. I'd like to turn the call over to Ryan Crowe, Vice President of Investor Relations at Myobot. Please go ahead.
spk09: Thank you, operator. Good morning. And thanks for joining us today to review the financial results of Myovance third quarter of fiscal year 2021, and to discuss other corporate and business updates. Joining me for today's call are Dave Merrick, Myovance Chief Executive Officer, Yannick Mara, Chief Financial and Business 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. Today, we will be referring to our third fiscal quarter, representing the three months ended December 31, 2021, as our third quarter, or Q3, throughout this presentation. During this conference call, we will be making forward-looking statements. These include plans and expectations with respect to our products, product candidates, strategies, opportunities, and financials, all of which involve certain assumptions of risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A discussion of these risks can be found in our SEC disclosure documents. In addition, MyOvent does not undertake any obligation to update any forward-looking statements made during this call. I'll now turn the call over to Dave Merrick, MyOvent's Chief Executive Officer. Dave?
spk10: Thank you, Ryan, and good morning, everyone. Milevant continued to make significant progress with our U.S. launches of Orgovix and Mifembri during our third fiscal quarter of 2021. Milevant recorded $54.4 million of total revenue, including $29.3 million of net product revenue. Orgovix achieved net revenues of $24.4 million in its fourth quarter on the U.S. market, reflecting 40% sequential volume growth. compared to fiscal Q2, partially offset by a lower net selling price. Mifembri generated net revenue of $2.4 million, reflecting steadily increasing growth over each month of the fiscal third quarter. By December, Mifembri had captured 45 percent of new-to-brand prescription share among GnRH antagonists approved for uterine fibroids, more than double the 20 percent share that Mifembri held only three months prior. RIECO revenues from Gideon Richter, our international commercial partner for women's health, were $2.4 million, primarily reflecting revenues for product supply to Richter to support their European launches. Turning to business development and financial updates, we're currently engaged in a formal process to assess partnership opportunities for international rights to relugolix in oncology, focusing on potential partners with an established European commercial presence in urology or oncology. We remain on track towards our goal of reaching an agreement with a partner by the anticipated European Commission approval of relugolix for prostate cancer expected in the middle of this year. In the meantime, we continue to work with the EMA through the ongoing review process and on other pre-launch activities related to pricing and reimbursement, so our chosen partner will be in a position to execute a launch shortly after regulatory approval. Finally, we remain in a strong financial position to support Orgovix and MyFembri commercialization activities while seeking to expand our pipeline. As of December 31st, MyoVant had cash and committed financing of nearly $570 million. With the start of the new calendar year, I'd like to briefly discuss our goals and objectives for 2022. Building on the strong momentum we generated last year, we expect to drive Orgovix growth by increasing the depth and breadth of prescribing while increasing patient engagement. For Mifembri, we expect to accelerate uptake in uterine fibroids and pending FDA approval to launch Mifembri for endometriosis pain where there is also high unmet need for a large patient population searching for an effective treatment option. Significant prescriber overlap will enable us to execute an efficient launch for this new indication, if approved, by leveraging the same brand, the same dose, the same one pill once a day that is approved to treat uterine fibroids. In addition to executing commercially, we also need to build for tomorrow through pipeline expansion. We plan to advance Relugolix lifecycle opportunities, to advance MVT602 clinical development, and to announce an international partnership for Relugolix and oncology. And finally, we'll also continue to look externally for opportunities, primarily in urology, oncology, and women's health to add fuel to our clinical development engine and to complement our commercial capabilities. We're excited about the commercial momentum for Orgovix and the early launch progress for Mifembri. Together with our upcoming clinical and regulatory milestones, MyoVant remains well-positioned for strong commercial execution and sustainable long-term growth. Now for a more in-depth review of our commercial performance, I'll turn the call over to Lauren.
spk05: Thank you, Dave. Today I'll provide an update on the progress we've made on the Orgovix and Mifembri launches in the U.S. Orgovix momentum continues to build as we and Pfizer drive incremental adoption and ultimately work towards establishing Orgovix as an androgen deprivation standard of care. In our first year on the U.S. market, we recorded $57 million of net revenue and estimate that 11,000 men were treated with Orgovix. As Dave mentioned, Orgovix generated $24.4 million of net revenue in fiscal Q3, reflecting 40% sequential volume growth driven by growing patient and clinician demand for Orgovix and improving payer coverage. Estimated cumulative patients on therapy has continued to steadily increase month over month. Since the end of September, we estimate that at least 3,000 additional men were treated with Orgovix, bringing the total to 11,000 patients through December, including patients on free and commercial drugs, but excluding patients utilizing product samples. During November, we began distributing Orgovix samples while enrollment in the free trial program was discontinued at the end of the month. Therefore, unlike prior months, the estimated number of incremental patients treated in December did not include any new patients from the free trial program. In terms of patients taking Orgovix, market research continues to suggest that it is being utilized across the spectrum of advanced prostate cancer settings. We initiated the sample program to provide patients and physicians the opportunity to gain experience with Orgovix and to facilitate new patient starts at the point of care immediately upon treatment decision. Since November, we have distributed over 2,200 monthly samples to nearly 1,000 providers with high prescribing potential. We have received positive feedback from many providers regarding the additional convenience of having Orgovix at the ready for appropriate patients to trial. And for practices that do not allow samples, we have provided vouchers that enable patients to receive an initial month of Orgovix for free. Breath of prescribing has steadily increased since launch. Approximately 1,800 treatment centers have dispensed or prescribed Orgovix through December, an increase of approximately 300 from the end of September and nearly doubling since May. The reorder rate remains high at approximately 90%, which we believe demonstrates a very high satisfaction with the overall Orgovix treatment and prescribing experience. The mix of specialties prescribing Orgovix since launch remains at approximately 60% urologists and 40% oncologists. Approximately 75% of total commercial volume has been dispensed via the specialty distributor channel, which serves practices with in-office dispensing capabilities, including large group practices, hospitals, academic centers, and integrated delivery networks. We expect this channel to remain our primary source of business going forward. The remaining 25% of Orgovic's volume was distributed via specialty pharmacy channel, which generally serves practices that do not have in-office pharmacies. Coverage for Orgovix continues to improve with 190 million lives covered across commercial and Medicare Part D as of January 2022. Since October, we obtained coverage for an additional 17 million lives, bringing commercial coverage to 81% and Part D coverage to 99% of lives. Out-of-pocket costs for commercial patients, which we estimate are approximately 50% of Orgovix patients treated to date, can be reduced to as little as $10 per month with the use of a copay card. Nearly all of the remaining Orgovix patients to date are on Medicare Part D plans, with approximately half of these men eligible for either the lowest income subsidy or an employee group waiver plan, both of which significantly reduce patient out-of-pocket costs compared to the standard Part D beneficiary. For the remaining Part D patients not eligible for LIS or an employer plan, independent third-party patient support foundations may be able to provide financial assistance to offset their out-of-pocket costs. In closing for Orgovix, I'd like to highlight our tremendous opportunity to redefine care for so many more men with advanced prostate cancer. This year, of the 3 million men living with this deadly disease, approximately 300,000 are projected to receive androgen deprivation therapy, with approximately 100,000 initiating ADT for the first time. We are excited about the momentum we were able to generate in our first year of launch and the opportunity for substantial future growth that lies ahead. Now, turning to my fembrie. We are very pleased with the continued progress that we've made in the uterine fibroids launch. Since its May FDA approval and mid-June launch in the US, Mifembri has generated $4.1 million of net revenue, more than half of which we recorded in our most recent quarter. Approximately 1,400 women were treated with Mifembri through November, including patients on free or commercial drugs, but excluding patients utilizing samples. This is more than double the number of patients treated through the end of September and reflects the rapidly expanding pool of prescribers, which reached 800 through December. Also encouraging was the 45% new-to-brand prescription share that Mifembri captured in December among GnRH antagonist therapies FDA approved for uterine fibroids, up from 20% in September. Provider education has been a hallmark of our launch and continues to have significant impact on awareness. Since launch, the MyAvant and Pfizer sales team have conducted 134,000 calls, reaching 85% of our high and medium priority target prescribers. This activity has continued to drive awareness. Among potential prescribers, aided awareness has grown from approximately 30% pre-launch to nearly 90% as of December. Unaided awareness has also improved remarkably, with two in five target prescribers now able to identify the Mifembri brand. Increasing awareness has clearly had a favorable impact on the Mifembri launch trajectory, its prescriber base, and overall class growth. New-to-brand prescription share is a key leading indicator for future adoption, and we are proud that in the first six months of launch, Mifembri had already captured 45% share of this class. We believe this rapid shift in share reflects the simplicity, convenience, and desirable clinical profile of Mifembri, as well as the effectiveness of our sales and marketing efforts. The full potential of Mifembri can only be unlocked by growing the overall uterine fibroids market and the GnRH antagonist prescriber base. Providers are recognizing Mifembri's clinical profile, reflected by the rapidly increasing number of prescribers in every month since launch. Through December, approximately 800 providers have prescribed Mifembri at least once. The pool of prescribers has also expanded as nearly 60% are first-time GnRH antagonist prescribers for uterine fibroids. We have also seen class growth since the Mifembri launch. The four-week moving average of total GnRH antagonist prescriptions for uterine fibroids increased 81% from late June through December. demonstrating that this market can be expanded with the right treatment option. Obtaining high-quality commercial payer coverage for Mifembri has been a critical launch priority given approximately 85% of women who are candidates for Mifembri treatment are commercially insured. We have made extraordinary progress in the six months since our launch, achieving coverage for 148 million, or 83% of commercial lives. an improvement of nearly 40 million lives since October. Negotiations continue with other commercial payers that have yet to make a coverage determination, and we expect coverage to continue to expand in coming months. Just as important as having broad coverage is having high-quality coverage that supports prescriber choice while minimizing out-of-pocket costs for patients and other barriers to access. Of the commercial covered lives to date, 77% have prior authorization criteria that is at parity with Orion. And the out-of-pocket cost for commercial patients can be reduced to as little as $5 per month with the use of our copay card. Pending FDA approval by its May 6th PDUPA date, we expect to launch myfembri in endometriosis in May. Endometriosis impacts approximately 8 million women in the U.S., of which 6 million experience often debilitating symptoms like pelvic pain, pain during intercourse, and infertility, which can significantly impact quality of life. Approximately 1 million women with symptomatic endometriosis are failed by initial therapy, underscoring the high unmet need for this disease. We have a very clear and direct strategy for our endometriosis launch. Pending FDA approval, we intend to highlight the clinical profile and leverage the same one-dose, one-pill, once-a-day approach currently approved for uterine fibroids. Additionally, given the significant prescriber overlap between uterine fibroids and endometriosis, we plan to utilize the existing women's health sales forces and leverage prescriber's familiarity with myfembrys. Incumbent GnRH antagonists offer a confounding array of two brands, three doses, and multiple dosing intervals across uterine fibroids and endometriosis. Misembry, on the other hand, resembles the once-daily dosing for oral contraceptives, with which many women are already experienced, and is often the initial therapy prescribed by gynecologists to treat these diseases. We believe that these factors, combined with the accelerated payer coverage should help to support initial uptake in endometriosis if misembry is approved by the FDA for this indication. There are approximately 5 million women in the U.S. with symptomatic uterine fibroids who are seeking treatment, and 6 million women with symptomatic endometriosis. Of these women, approximately 4 million are failed by initial treatment for their disease. While we realize that changing entrenched prescriber behavior takes time, even capturing a small share of this 4 million patient market would result in a significant commercial opportunity for my family. We are off to a great start with a differentiated product that, with time, has the potential to change the treatment paradigm in uterine fibroids as well as in endometriosis, pending FDA approval. I'll now turn the call over to Munique to review our financial results.
spk00: Thank you, Lauren. My comments today will focus on the highlights of our financial performance in the third fiscal quarter ending December 31st, 2021. Please refer to our press release and form 10Q issued earlier today for additional information. Let's begin with revenue. Consistent with the preliminary revenue ranges we provided earlier this month, MyAvant recorded $54.4 million of total revenue for the quarter. Q3 net product revenue was $29.3 million. Orgovix net revenue was $24.4 million, reflecting 40% sequential volume growth partially offset by a decrease in net price due to a higher gross-to-net discount compared to Q2. The gross-to-net discount for Orgovix in fiscal third quarter was in the low 40%, and we expect it to remain in the low to mid 40% for the foreseeable future. For fiscal Q4 2021 specifically, we anticipate the impact of gross-to-net discounts for Orgovics to be in line with the impact from fiscal Q3. MyFemri net revenue was $2.4 million, reflecting steadily increasing demand for the differentiated clinical profile of MyFemri along with the class growth. We recorded $2.4 million of net product revenue from Gideon Richter, primarily reflecting revenues for product supply to support the European launches of VARIACO and, to a lesser extent, royalties. We also recorded $25.2 million of Pfizer collaboration revenue, consisting of $21 million related to the partial recognition of the upfront payment MyoVant received from Pfizer in December 2020 and $4.2 million related to the partial recognition of $100 million regulatory milestone payment triggered upon FDA approval of Mifembri for uterine fibroids. In future quarters, we will continue to amortize these milestones at the same amounts through the end of calendar year 2026 when the amortization period is scheduled to end. Moving on to other highlights of our income statement. Cost of product revenue for the quarter was $4.2 million and largely comprised of expenses related to the cost of goods sold as well as the royalty on net sales of Relogolix payable to Takeda. Collaboration expense was $12.1 million, reflecting Pfizer's 50% share of net profits from sales of Orgovix and Mifembri in the U.S. during Q3. R&D expenses in the third quarter were $25.7 million compared to $30.5 million for the comparable prior year period. The decrease in R&D expenses was mainly driven by a reduction in clinical study costs as well as higher cost sharing with Pfizer for certain R&D expenses. SG&A expenses in the third quarter were $72.1 million compared to $49.2 million for the comparable prior year period. The increase was primarily due to higher expenses related to commercial activities to support the U.S. launches of Orgovix and MyFemBree, including higher personnel-related costs in connection with the hiring of MyAvans commercial operations, marketing, and market access teams, as well as the oncology and women's health sales forces. My event generated a net loss of $63.4 million or 68 cents per share in the third quarter of 2021 compared to a net loss of $73.8 million or 82 cents per share in the prior year quarter. Looking ahead, R&D expenses for the fourth fiscal quarter 2021 are projected to be in line with Q3 actual spend. Subsequently, we expect fiscal year 2022 R&D expenses to increase as compared to projected fiscal year 2021, driven by spending on Relugolic's lifecycle opportunities, such as the Phase III serene study, as well as on post-marketing requirements as agreed upon with the FDA. SG&A expenses for fourth fiscal quarter 2021 are expected to decline modestly from Q3 actual spending, which included expenses for certain sales and marketing activities that were originally expected to be incurred in fiscal Q4. Subsequently, we expect SG&A expenses to be higher in fiscal year 2022 compared to projected fiscal year 2021 due to increased marketing and promotional expenses to support the ongoing commercialization of Orgovix and MyFamily in the U.S. We ended fiscal Q3 with total cash, marketable securities, and committed financing of $569.1 million, comprised of $527.8 million of cash and marketable securities, and $41.3 million of capacity remaining under the low-cost loan facility extended to us by Sumitomo, Dynip, and Pharma, our majority shareholders. Our cash position and potential future milestone payments, coupled with the sharing of certain Relogolix-related development and commercial expenses with Pfizer, as well as the anticipated increase in Orgovix and MyFamily revenue, puts MyAvant in an excellent position to execute our commercial strategies while at the same time expanding our pipeline. I will now turn it back over to Dave for some closing remarks. Dave?
spk10: Thank you, Yannick and Lauren. In closing, we believe Orgovix adoption will continue to build as breadth and depth of prescribing increases and as we step up patient activation efforts. After our first year on the market, we continue to believe that Orgovix is poised to become an ADT standard of care in advanced prostate cancer, representing a significant commercial opportunity over time. Mifembri has the potential to impact the lives of millions of women by transforming the treatment paradigm for uterine fibroids and, if approved by the FDA, for pain associated with endometriosis. Our recent launch progress in uterine fibroids has been encouraging as we've been able to rapidly gain new-to-brand prescription share while simultaneously growing the class and the prescriber base. We have plans to expand our pipeline this year by executing on Relugolix lifecycle opportunities, by advancing MVT602, and by pursuing business development, which all can be supported by our strong financial positions. In addition to executing commercially, in the coming months we expect to complete multiple regulatory filings, receive multiple regulatory decisions, read out important clinical data, and potentially initiate additional clinical studies, all of which will better position us for sustainable long-term growth. I'm confident in our ability to deliver on our mission of redefining care for those who depend on us for our differentiated medicines. and I look forward to this translating to long-term value creation for shareholders. Thank you for your attention, and I'll turn it over to Ryan to begin the Q&A session. Thank you, Dave.
spk09: Operator, can we now please poll for questions?
spk02: Ladies and gentlemen, as a reminder to ask a question, you will need to press star 1 on your telephones. And to withdraw your question, just press the pound key. Please stand by while we compile the Q&A roster. Our first question will come from the line of Rowana Reese from SVB Lyric. Your line is open.
spk04: Great, thanks. And morning, everybody. I have a question for our Govics. Perhaps, could you update us on the status of your efforts negotiating with large group purchase organizations and you know, removing disincentives for in-office dispensing. And do you expect these efforts to taper off anytime soon, or are you going to continue it through the year?
spk10: Yeah, thank you, Rowana. Lauren, would you like to take that?
spk05: Yes, sure. So, from a GPO perspective, we have contracts in place with key GPOs that enable the practices to purchase our product, purchase Orgovix through our specialty distribution channel. And so those contracts exist and are in place and are being utilized by our accounts today.
spk04: Okay, great. And so are there any other smaller accounts that might tag on, or is this relatively stable? It's relatively stable at this point. Great, thanks.
spk05: Thank you.
spk02: Offline of Eric Joseph from JP Morgan. Your line is open.
spk08: Hi, good morning. Thanks for taking the questions. First is on your potential European launch and potential partnering considerations. You talked a little bit about having started some of the initial pricing and reimbursement work in Germany. I'm curious to know whether a Milovent launch or land launch in Europe is one of the strategic alternatives that might happen here, and whether the relationship with Synovion offers any leverage in the European market.
spk10: Good morning, Eric. I'll let Unique address it. I believe you're referring to the European opportunity for Orgovic. Yorick, could you take that?
spk00: Yeah. Hey, good morning, Eric. At this point in time, we're not contemplating my event led launches in Europe. As we stated before, we are a formal processes underway right now to evaluate potential partners for Orgovix in ex-US markets. And we have considerable interest in the opportunity. As mentioned before, we're also seeking partners who have established commercial infrastructure in Europe, preferably in urology and oncology. And consistent with our previous remarks, we hope to have a partner in place ahead of the EU approval decision, which is expected sometime in the middle of this year.
spk08: And, okay, thanks for that. And just on the U.S. launch, you, at least at the conference, you highlighted the expectation of stabilized growth to net. Can you just talk a little bit about sort of how far out your current contracts reach? Any guidance as to how you'd be thinking about pricing methods for Govex in the outer years, 2024 and beyond?
spk10: Certainly, Unique, can you address the gross-to-net outlook?
spk00: Sure, Eric. We expect in the foreseeable future, which should be at least until the end of calendar year 2022, for our gross-to-net to be in the sort of low to mid 40%. Most of our contracts typically will go until that point in time. And then beyond the calendar year end 2022, there will be some sort of renegotiations that may likely happen. But our guidance right now is at least until the end of 2022, we expect to be in that range.
spk08: Okay, great. Thanks for taking the questions.
spk00: Thank you.
spk02: Our next question on the clock line, Phil Nadeau from Cali. You may begin.
spk01: Good morning. Congrats on the progress, and thanks for taking our questions. A few from us. So I guess first on the Orgovix launch in the U.S., you discussed a bit about the physicians who are prescribing the drug. What about the patients who are being the first to put on it? Any unifying characteristics among those patients? For example, do they have cardiovascular risk or anything else notable?
spk03: Yeah, Lawrence?
spk05: Yes, so when we do an analysis of our claims data, so keep in mind, due to our distribution model, we have limited data access. But with the data that we have, we're able to analyze the types of patients that are receiving Orgovix today. And we look at them grouped into three groups. So the localized, those with localized disease, those who have locally advanced disease, and those with metastatic disease. And what we see is that about half of Orgovix patients have localized disease, and so this means they're earlier in their disease course. And about 35% of patients are metastatic, so have more advanced disease. But this is a very similar patient distribution to Lupron, and also generally reflective of the size of these patient groups. So that's generally how we look at the patient subsets. We don't have access to data that allows us to assess cardiovascular risk. However, we do hear anecdotally from the field that that is a consideration for physicians as they make treatment decisions.
spk01: Perfect. That's very helpful. The second question on Orgovix and the EMA, have you received the day 120 questions? from the EMA and any notable issues raised?
spk10: If you have one, Camille, I'll let you address that. I know we typically don't discuss kind of the regulatory discussions, but maybe you could provide some context in terms of our feeling on the progress there.
spk03: Yeah, thank you, Dave, and hi, Phil. Yeah, as Dave pointed out, we usually don't provide that granularity However, I'll tell you, we remain on track for a mid-2020 decision, and if you do the math and knowing that the process is pretty standardly regulated in Europe, we are definitely past the day 120, and we are excited to see the next steps towards the final decision.
spk01: Perfect. Then one last regulatory question from us, if you're willing to answer it. In terms of the two-year BMD data that will be filed, any recent thoughts on the ability of that data to remove the limitation and duration of use from the U.S. label of Mifembri?
spk10: Yeah, Juan Camilo?
spk03: Yeah. Similarly, as we stated before, we are very excited about the data we saw from the randomized withdrawal study. We are pretty confident on our work. We believe that that data, together with the rest of the data from the Liberty Program, have shown the limited effect of Mifambri on DMD. So we are putting together a submission that should go as planned in the next few weeks into the FDA. However, we cannot predict how FDA will interpret this data and then what is the likelihood of that having an impact on the duration of treatment. So we are putting our best case forward with our assessment of the data, and we'll wait for their review.
spk01: Thanks for taking our questions, and congrats again on the progress.
spk10: Yeah, thanks, Phil. And just to add on to that last response, just remember the label is one area that physicians will look for those data. We also certainly expect that it will be available through publications and other means as well. Next question, please.
spk02: Our next question will come from Brian Swarney from Bayer. Your line is open. Hey, good morning.
spk07: Thank you for taking the question. I was hoping maybe you could discuss the intended submission of the Liberty randomized withdrawal study and how you think getting this added to the label could wind up impacting uptake and the ability to detail relative to Orion.
spk10: Yeah, well, let's, Juan Camilo, maybe again, let's just kind of touch on that regarding how you believe prescribers will, how important this data is to prescribers, regardless of where it ends up in the label or in the public. And then, Lorne, maybe just talk about what we hear from physicians in our promotional efforts. So, Juan Camilo, why don't we start with you?
spk03: Yeah, thanks, Dave. Yeah, as Dave pointed out, we will disseminate this data in multiple ways, right? The first one is we're providing or submitting to the FDA and we expect the data, at least some of the data, to be reflected in the label. As I mentioned before, if it affects the duration of treatment will be an FDA decision. In parallel with that, we are proceeding with presentations of the data in multiple scientific conferences, and we will move forward to also a publication of the data we consider very robust. In that way, physicians will have all the information that we believe will be useful to them to make their treatment decisions. And as a reminder, we are the only – my firm is the only GnRH antagonist that has run two-year trials that are now publicly available. And I think that adds another layer of confidence by prescribers on the profile of my family. Lauren?
spk10: Lauren, you're on mute.
spk05: Sorry. From a physician perspective, we continue to hear that physicians are focused on uterine fibroids as a long-term disease. And so they're looking for therapies that match their patients' needs, which we believe Mifembri offers a unique clinical profile for those patients. And so as more data becomes available, And once we have approval to use it promotionally, we'll, of course, do that. And payers will also have access to the data as soon as it's available and published.
spk10: And, Brian, one other addition. You know, when we think about the spirit data of the longer-term data, many times we focus on the BMD results. I know clinicians are very focused on that. But the other part that gets a little less airtime, is what happens when you discontinue Mifembri? And what we see is the symptomatology returns back very quickly for these women. And so I think that's a consideration as physicians look to make treatment decisions down the road and why the BMD data is important, but also what happens when you withdraw and then reinitiate Mifembri. Of course, the efficacy returns fairly rapidly. So that's another key part of that data set.
spk07: Thanks.
spk02: That's very helpful. Manu Kumar from Goldman Sachs. You may begin.
spk06: Hey, thanks for taking our question. So kind of following up on that last comment about the withdrawal studies, in kind of commercial practice, what kind of feedback are you getting on the idea of kind of this two-year – period of use being a limitation to uptake and that people don't want to have to go on to a therapy and then come off of it and have, like, their disease rebound? Like, how much of that is a barrier to that end, kind of following up on both Phil and Brian's questions? How much would a kind of removal of the limitation of use resolve that issue?
spk10: Juan Camilo, as a physician, I know you have faced these types of decisions. I'll let you talk about your perceptions of how physicians would view the Again, the long-term considerations for uterine fibroids.
spk03: Yeah. Thanks, Dave. And hi, Matthew. I think that there are multiple things that are considered by physicians that treat women with uterine fibroids. I think that one thing that's been very clear now that the vehicle guidelines have been updated is that what is very important is that for women to have multiple options for treatment. Until recently, the options were limited. Some of the medical treatment options had limited efficacy, like contraceptives or NSAIDs. And therefore, the addition of a gene or an antagonist adds in a layer of effective, now effective treatments that provide options for women. What we've heard from our market research is that that women in general would rather not have major surgery in the, the, the, the cornerstone of treatment of uterine fibroids with myomectomies and hysterectomies. So from a treating physician perspective, I think that that is the value that is the, the, the, my family brings to the table is, uh, another option that provides predictable efficacy and safety and, and, uh, and allow women to delay or prevent the need for surgery.
spk06: Okay, great. And one follow-up question for Unique. How should we think about you having a good color on fiscal 22 R&D and SG&A spend? How should we think about the growth of those relative to the growth from fiscal 20 to fiscal 21?
spk00: Yeah, thanks Madhu for the question. We'll be providing more color on the dimensionalization of that growth in our fiscal Q4 call in May as we sort of work through the end of this year as well as close out the activities for this year in our alliance with Pfizer. At that point, we'll be in a better position to give you the dimensionalization of that increase.
spk02: And our last question will come from the line of Gavin Clark-Gartner from Evacor ISI. Your line is open.
spk11: Hey, thanks for taking the questions. I just had a couple. First, HRSA and DOD recently issued guidance that states payers must cover FDA-approved contraceptives with no out-of-pocket costs. Once the serene indication is on the label, would this guidance likely apply to all myfembri patients?
spk10: Juan Camilo? Hello?
spk03: Yeah, Gavin, good morning. So first let me just say that we are very excited about our steering study. We believe that having a product that provides the treatment for uterine fibers and hopefully endometriosis if approved that also provides contraception would be very meaningful for prescribers and for patients. This is contraception is something that It's a consideration that is top of mind for women in this reproductive age that suffer from uterine fibrosis and endometriosis. And therefore, we believe that a successful serine study would be a critical differentiator for myfembrane. As she pointed out, the regulations or the rules require that at least one contraceptive of a specific class is covered at no cost for the patient. And that certainly has been a consideration, but we will wait until we have the data and then we will go through the process of assessing that to determine the full implication of that if applicable for myfembrane. But we remain very excited about the serine study and the value that it will bring for prescribers and for patients.
spk11: Yeah, got it. And there are also 3.5 billion in potential tiered sales milestones from Pfizer under the partnership. Can you share any more details on what the tier A or B sales thresholds are, what the milestone payments are, and when it's possible that any of these milestones could be reached?
spk10: Yeah, Unique, would you like to discuss the – I know we aren't providing specific numbers on the tiering, but maybe you could add some color there.
spk00: Yeah, thanks, Chris. We have not provided any details in terms of the tiers on these milestones. I think when you look at the 3.6 and typically billion and then spread it across generally available four or five tiers, you can probably estimate where those tiers are. And in regards to your second sort of follow-up as to when we would likely expect to achieve those tiers, I think still too early. given that our launches are just gaining traction on both MyFamily and OrgoVix. So at this point, it's a little early to sort of indicate when we would have that achievement of those tiers.
spk11: Yeah, got it. Thanks. And maybe one last one on OrgoVix. Are bigger urology and oncology practices adopting formal preferences for Orgovic's other GnRH agents? So it could be kind of listing it as a preferred agent in their EMR or e-prescribed system. Or alternatively, are they just including it in their system with parity access to the other agents and leaving the decision up to the prescribers? Thanks.
spk10: Yeah, thank you, Gavin. Lawrence?
spk05: So we don't have complete transparency into the EMR systems. We more receive feedback from our customers about, you know, their preferences and how they're utilizing OrgoVix. And it seems that for certain patient types, they do have a preference to start with OrgoVix. But it is an individualized treatment decision with each patient.
spk10: Okay. Operator, are there further questions?
spk02: Thank you. And I'm not showing any further questions at this time. I'll turn the call over to Dave for any closing remarks.
spk10: Well, thank you. As you can hear today, we're very encouraged by the progress that we've made on Orgovex and Microembrane. We're energized by the tremendous remaining commercial opportunity for both brands. We're also very well positioned to deliver a strong, commercial execution while building sustainable long-term value through pipeline expansion. So thank you, and I look forward to keeping you updated on our progress. Have a good day.
spk02: Ladies and gentlemen, this concludes my advanced sciences third fiscal quarter 2021 earnings conference call. Thank you for your participation. You may now disconnect. Everyone have a great day.
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