Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Myovant Sciences Ltd. (MYOV)
Q2 2021 Earnings Call
Oct 26, 2021, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good day, everyone, and welcome to Myovant Sciences' second quarter of fiscal year 2021 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 -- Vice President of Investor Relations

Thank you, operator. Good morning and thanks for joining us today to review the financial results of Myovant's second quarter of fiscal year 2021 and to discuss other corporate and business updates. Joining me for today's call are Dave Marek, Myovant's chief executive officer; Uneek Mehra, chief financial and business officer; Lauren Merendino, 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 fiscal second quarter, which ended on September 30, 2021 as our second quarter or Q2 throughout this presentation. During the course of 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.

10 stocks we like better than Myovant Sciences Ltd.
When our award-winning analyst team has a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.* 

They just revealed what they believe are the ten best stocks for investors to buy right now... and Myovant Sciences Ltd. wasn't one of them! That's right -- they think these 10 stocks are even better buys.

See the 10 stocks

*Stock Advisor returns as of October 20, 2021

A discussion of these risks can be found in our SEC disclosure documents. In addition, Myovant does not undertake any obligation to update any forward-looking statements made during this call. I'll now turn the call over to Dave Marek, Myovant's chief executive officer. Dave?

Dave Marek -- Chief Executive Officer

Thank you, Brian, and good morning, everyone. During our second fiscal quarter, Myovant continued to make significant progress with our U.S. launches of ORGOVYX and MYFEMBREE, in addition to achieving important clinical and regulatory milestones, which position Myovant for long-term success. Myovant recorded $77.9 million of total revenue in the quarter including $21.1 million of net product revenue.

ORGOVYX achieved net revenues of $18.7 million in its third quarter on the U.S. market, reflecting 78% sequential growth compared to fiscal Q1. In its first full quarter on the U.S. market, MYFEMBREE achieved net revenues of $0.6 million, primarily reflecting a continuation of initial inventory stocking.

From a launch execution standpoint, we've made meaningful early progress educating prescribers about our differentiated clinical profile, reaching initial patients, and establishing payer coverage, all of which are foundational to MYFEMBREE's long-term success. Moving to clinical and regulatory updates. So during Q2, the European Commission and the U.K.'s Medicines and Healthcare Products Agency approved RYEQO as the first and only long-term once-daily oral treatment for uterine fibroids. Gedeon Richter, our international partner for women's health, has since launched RYEQO in seven countries.

For MYFEMBREE, we were pleased that the FDA accepted our supplemental New Drug Application seeking approval for the management of moderate to severe pain associated with endometriosis. We expect that the decision from the FDA by the May 6, 2022, PDUFA date. An FDA approval for this indication would trigger a $100 million milestone payment from Pfizer while providing a meaningfully different therapeutic option for women with endometriosis. Last week Myovant and Pfizer presented clinical data for MYFEMBREE at the American Society for Reproductive Medicine 2021 Congress.

In addition to the results of the LIBERTY randomized withdrawal study and the SPIRIT studies in endometriosis, we also presented pooled, safety, and tolerability data from the SPIRIT and LIBERTY programs, which demonstrated a consistent profile across women with uterine fibroids and women with endometriosis, providing further support of our one brand, one pill, once-a-day approach to treating these conditions. Quality of life data for women in -- with endometriosis was also presented, which demonstrated that significantly reducing endometriosis pain was associated with improvements in daily functioning, emotional well-being, self-image, and sense of control. Finally, in August, the FDA lifted its partial clinical hold for the Phase III SERENE study of MYFEMBREE to evaluate prevention of pregnancy, and we're pleased to have recently dosed our first patients under the amended protocol. Upon notification of the partial clinical hold in May, we not only addressed the FDA's requirement for bone mineral density monitoring but worked closely with them to further optimize the design of the SERENE study to gain incremental safety and efficacy data in patient populations with the greatest potential to benefit from MYFEMBREE.

The primary analysis of the study, prevention of pregnancy, remains unchanged. But now SERENE will focus on only evaluating women with a confirmed diagnosis of uterine fibroids for endometriosis. BMD monitoring will occur during the treatment period as well as after discontinuation, which will augment the profile observed in the LIBERTY and SPIRIT programs. The enrollment target was increased to 1,020 patients, who are 18 years to 50 years of age and at risk of pregnancy, enhancing the power of the study.

SERENE is the first study of its kind in this class of medicines and a positive result could expand MYFEMBREE's prescribing information to include a prevention-of-pregnancy indication. This would further support clinical differentiation and bring meaningful additional benefit and convenience to women with uterine fibroids and endometriosis. And turning to business development and financial updates. Today, we announced that Pfizer declined to exercise its option for development and commercialization rights to RELUGOLIX in oncology in international markets.

Based on discussions with Pfizer, their decision was not related to clinical or anticipated regulatory considerations for RELUGOLIX in oncology, but rather was based on their assessment of their current strategic investment priorities in international markets. I would underscore that it has no impact on our collaboration in the U.S. and Canada that's particularly given the ORGOVYX and the MYFEMBREE launches are off to a great start in large part due to our collaborative efforts to date. Over the months leading up to Pfizer's decision, we received inquiries regarding this opportunity from multiple interested parties.

We are currently assessing these opportunities, focusing on potential partners with an established European commercial presence in urology or oncology. Our goal is to reach agreement with a partner by the anticipated European approval of RELUGOLIX for prostate cancer expected in mid-2022. 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 now be in a position to execute a launch shortly after regulatory approval. Regarding financial updates.

Last month, Myovant appointed Uneek Mehra to chief financial and business officer. Uneek leads Myovant's finance, alliance partnerships and business development functions and is a member of Myovant's Executive Committee reporting to me. For those of you who have not met Uneek, he brings extensive financial leadership expertise supporting multibillion-dollar commercial-stage businesses in addition to deep with experience and successfully growing and scaling emerging companies, and we are delighted to have Uneek on the Myovant team. We continue to be in a strong financial position to support the launches of ORGOVYX and MYFEMBREE while seeking to expand our pipeline.

As of September 30th, Myovant had cash and committed financing of over $650 million. We are encouraged by the commercial momentum for ORGOVYX and the early launch progress for MYFEMBREE. Together with our recent notable clinical and regulatory achievements, Myovant is 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.

Lauren Merendino -- Chief Commercial Officer

Thank you, Dave. Today, I'll provide an update on the progress we've made on the ORGOVYX and MYFEMBREE launches in the U.S. ORGOVYX adoption continues to build as we and Pfizer work toward establishing it as the new androgen-deprivation standard of care. Nine months into our launch, we have recorded nearly $33 million of net revenues and estimate that approximately 8,000 men have been treated with ORGOVYX.

In fiscal Q2, ORGOVYX generated $18.7 million of net product revenues, reflecting 78% sequential demand-driven growth compared to fiscal Q1. This continued momentum for ORGOVYX reflects increasing patient and clinician demand for its differentiated clinical profile as well that's expanding payer coverage. Monthly estimated cumulative patients on therapy, which includes both patients on free and commercial drug has continued to steadily increase month over month. Through September, we estimate that approximately 8,000 men have initiated ORGOVYX therapy for their advanced prostate cancer.

The share of free drug from our free trial, bridge, and patient assistance programs continues to represent approximately one-third of total ORGOVYX volume dispensed to date. Although our visibility into patient-level data is incomplete, we continue to estimate that approximately 60% of our patients that have initiated ORGOVYX were previously naive to ADT. Additionally, based on our same market research, we believe that ORGOVYX is being utilized to treat patients across the spectrum of advanced prostate cancer, reflecting our broad FDA label and the therapeutic appeal of the ORGOVYX clinical profile, regardless of disease setting. Since launch, we have been actively engaging with prescribers to drive ORGOVYX awareness and build recognition of its differentiated clinical profile.

In the first nine months of launch, Myovant and Pfizer have conducted sales calls with over 17,000 unique providers. These sales efforts are delivering results. As you can see from the chart on the left, we have steadily broadened the base of prescribers to approximately 1,500 treatment of centers through September, an increase of approximately 350 over the past three months and nearly doubling since April. These numbers include accounts that are dispensing or prescribing ORGOVYX.

The order rate in these treatment centers also continues to build with nearly 90% of practices reordering ORGOVYX at least once, up from 80% at the end of June. Our launch activities to date have intentionally focused on Tier 1 customers to maximize impact on prescribing and we have reached 92% of these high-priority target prescribers. From a treatment center standpoint, nearly three out of four Tier 1 urology practices with in-office dispensing capabilities have dispensed ORGOVYX while just over half of Tier 1 oncology IOD practices have dispensed ORGOVYX. We are proud to have achieved broad coverage for ORGOVYX in advance of our calendar year-end 2021 goal.

Through October 1st, we have achievement coverage for over 173 million total lives, an increase of 23 million lives since July 1st. Nearly all of these incremental covered lives were for commercial plans, where we improved from 63% coverage in July to 76% as of October. Looking ahead to 2022, we expect broad commercial and Part D coverage for ORGOVYX to continue. We are making tremendous progress across all areas of the ORGOVYX launch and have built great momentum in the prostate cancer community.

As we look forward, we will continue to engage with urologists and oncologists to expand breadth and depth of ORGOVYX prescribing. Improved commercial and Part D coverage as well as an increasing engagement directly with patients with expected drive prescribing momentum in coming quarters. Myovant and Pfizer remain committed to improving the lives of men battling advanced prostate cancer and over time steadily establishing ORGOVYX as the new standard-of-care ADT. I'd now like to discuss the early progress we've made on the MYFEMBREE launch.

The FDA approved MYFEMBREE in late May 2021, as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. MYFEMBREE has the potential to redefine care for these women because its clinical profile aligns with physicians' stated treatment goals. In the LIBERTY clinical program, MYFEMBREE demonstrated sustained and meaningful reduction in menstrual blood loss. The hot flush, a particularly bothersome side effect, occurred in less than 11% of MYFEMBREE patients, not meaningfully different than the approximately 7% of patients treated with placebo.

The average decline in lumbar spine bone mineral density at 12 months was under 1%. However, due to the risk of continued bone loss the duration of use in the FDA label is limited to 24 months. Finally, MYFEMBREE achieved all of this in one small pill taken just once a day. We launched MYFEMBREE with Pfizer in mid-June, with a comprehensive focus across providers, patients, and payers.

Together, we've made encouraging progress in these early days and believe we're on the right track toward laying the groundwork for long-term commercial success. We fully expect that it will take time to change behavior for the treatment of uterine fibroids. The Myovant and Pfizer sales teams have been very active within the first four months of the launch, educating providers on the clinical profile and the convenience of MYFEMBREE. We have also ramped up our starter program, which is designed to give providers a seamless initial prescribing experience.

Our patient support programs are designed to facilitate access to MYFEMBREE. These resources include benefits investigation, prior authorization and appeals support, starter and bridge programs, co-pay support for commercially insured patients, and patient assistance for qualifying uninsured patients. Overtime, we also expect to drive MYFEMBREE product awareness and through various channels with the goal of activating women with symptomatic uterine fibroids. Finally, with payers our goal is to establish broad coverage quickly within a year of our launch.

Let's review our progress across each of these areas. One key priority for our launch is provider education, which can have a significant impact on awareness. Since launch, the Myovant and Pfizer sales teams have conducted 62,000 calls, reaching 77% of our high and medium priority target prescribers. This activity has improved aided awareness among potential prescribers from approximately 30% pre-launch, to nearly 70% as of September.

Unaided awareness has also improved remarkably with more than one in four target prescribers now able to identify the MYFEMBREE brand. For high-and medium-docile target providers, where we have primarily focused our initial education efforts, unaided awareness has grown to approximately 40% in just three months. Through September 30th, approximately 600 women have initiated treatment with MYFEMBREE, which includes patients both on free and commercial drugs, but this does not include patients that may be using product samples. Another important leading indicator for MYFEMBREE treatment initiation is the number of patients actively enrolled in the MYFEMBREE patient support hub.

There are currently approximately 100 patients in our hub that are pursuing therapy but either requires assistance navigating coverage and reimbursement or seeking co-pay assistance, or are applying for our bridge program. While many of these patients are likely to initiate treatment on free drugs, we expect the MYFEMBREE treatment experience will be positive. And that most patients will convert to commercial volumes overtime once coverage and reimbursement improves. Finally, starter packs or product samples are an important part of early launch strategy.

We want providers to have a seamless initial treatment experience with MYFEMBREE when a woman presents with heavy menstrual bleeding from uterine fibroids. Since mid-July, we have distributed over 3,000 months of therapy via starters to over 2,200 gynecologists around the country. While we recognize these samples may depress new prescription volume and revenues in the near-term, we view product samples like a long-term investment in the brand and are confident that these samples will ultimately accelerate adoption by generating a positive initial treatment experience for providers and patients. From launch through the end of Q2, we recorded $1.7 million of net revenues, including approximately $600,000 in Q2.

As expected, we saw continuation of initial inventory stocking early in the quarter and began to see modest demand-driven reorders to replenish launch inventories beginning in September. We continue to anticipate gradual adoption over the next few quarters as we execute our launch plan and lay the foundation for long-term during commercial success. Obtaining payer coverage for MYFEMBREE is a critical launch priority. Given we anticipate that approximately 85% of patients that could be prescribed MYFEMBREE are commercially insured, our initial focus has been on securing coverage with large commercial pharmacy benefit managers.

We're off to a great start. As of October 8th, we have achieved coverage for MYFEMBREE for 61% of commercial lives. Negotiations are ongoing with additional commercial payers that have yet to make coverage decisions and we expect coverage to improve in the coming months. Payer negotiations are focused on maintaining prescriber choice and then minimizing out-of-pocket cost for patients.

MYFEMBREE addresses the needs of providers and patients with its clinical profile and convenient one pill once-a-day dosing. We are excited about the progress we have been able to make in these early days of launch and remain passionate about bringing this new and differentiated treatment option to women with uterine fibroids. I'll now turn the call over to Uneek to review our financial results. Uneek?

Uneek Mehra -- Chief Financial and Business Officer

Thank you, Lauren. I'm excited to be joining Myovant at this pivotal stage of growth for the company and to be supporting its critical mission of redefining care for women and for men. My comments today will focus on the highlights of our financial performance in the second fiscal quarter ending September 30, 2021. Please also refer to our press release and Form 10-Q issued earlier today for additional information.

Let's begin with revenue. Myovant recorded $77.9 million of total revenue for this quarter. Q2 net product revenue totaled $21.1 million. ORGOVYX net revenues were $18.7 million, reflecting strong sequential demand, partially offset by an expected decrease in net price due to a higher gross-to-net discount compared to Q1.

We expect the ORGOVYX gross-to-net discount will continue to increase in coming quarters, reflecting the impact of rebates for incremental covered lives before stabilizing in 2022 once commercial and Part D coverage has been fully implemented. MYFEMBREE net revenues were $0.6 million, primarily reflecting continuation of initial inventory stocking. Modest demand-driven reorders to replenish launch of inventories began in September 2021. New this quarter, we recorded $1.8 million of product revenues from Gedeon Richter, primarily from RYEQO product supply and to a lesser extent, royalties.

Moving forward, Myovant is entitled to receive peer royalties on net sales of RYEQO ranging from mid-teens to mid-20s percent. 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 MYFEMBREE for uterine fibroids. In future quarters, we will continue to amortize these milestones at these same amounts through the end of calendar year 2026 when the amortization period is scheduled to end. Finally, we also recorded $31.7 million of license and milestone revenue from Gedeon Richter, consisting of a $15 million regulatory milestone payment for the EC approval of RYEQO for uterine fibroids and $16.7 million related to some remaining portion of the upfront and initial milestone payments.

Moving on to other highlights of our income statement. Cost of product revenue for the quarter was $2.6 million and largely comprised of the royalty on net sales of RELUGOLIX payable to Takeda and to a lesser extent, expenses related to the cost of goods sold. Collaboration expense was $8.6 million, reflecting Pfizer's 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S. during Q2.

R&D expenses in the second quarter were $26.3 million, compared to $40.5 million for the comparable prior year period. The decrease in R&D expenses were mainly driven by cost share reimbursements from Pfizer as well as a reduction in clinical study costs. These decreases were partially offset primarily by higher expenses incurred by Myovant's medical affairs organization. SG&A expenses in the quarter were $58.8 million, compared to $31.3 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 ORGOVYX and MYFEMBREE, and higher personnel-related costs in connection with the hiring of Myovant's commercial operations, marketing and then market access teams, as well as the oncology and women's health sales forces. Myovant generated a net loss of $21.6 million, or $0.23 per share in the second quarter of 2021, compared to a net loss of $67.1 million or $0.75 per share in the prior-year quarter. Looking ahead R&D expenses for the remaining fiscal 2021 quarters are projected to be in line with Q2 actual spend.

SG&A expenses for the remaining fiscal 2021 quarters are expected to increase modestly from Q2 actual spend. We ended fiscal Q2 with total cash, marketable securities and committed financing of $657.3 million, comprised of $616 million of cash 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. Our cash position and potential future milestone payments coupled with the sharing of certain expenses with Pfizer and the anticipated increase in ORGOVYX and MYFEMBREE revenues puts Myovant in an excellent position to execute our commercial strategies while at the same time expanding our pipeline through our future RELUGOLIX life cycle programs and potential business development. With that, I'll turn it back over to Dave for some closing remarks.

Dave?

Dave Marek -- Chief Executive Officer

Thank you, Uneek and Lauren. We are excited about the launch momentum that we've been able to generate for ORGOVYX. There is increasing recognition by clinicians regarding its differentiated clinical profile, which is leading to steadily increasing adoption. Over the past few months, we were able to improve commercial payer coverage and are in a very strong position as we finish 2021 and move into 2022.

We have been encouraged by the early progress that we've made on the MYFEMBREE launch and look forward to continuing to build the foundation for successful commercialization through prescriber education, easing access with expanded payer coverage and engaging directly with patients. MYFEMBREE is a significant advance for the treatment of heavy menstrual bleeding associated with uterine fibroids and with time, we believe, will represent a significant commercial opportunity. The SERENE study resumed in August with this updated clinical protocol that will evaluate prevention of pregnancy while gaining incremental safety and efficacy data in patients with the greatest potential to benefit from MYFEMBREE therapy. We dosed our first patient last week, and look forward to advancing the study as quickly as possible.

In addition to continuing to execute on the ORGOVYX and MYFEMBREE launches, Myovant has several important upcoming clinical and regulatory milestones. By late 2021 or in Q1 2022, we plan to submit our randomized withdrawal study to the FDA, which will include two-year bone mineral density data. In Q1 2022, we expect to report two-year data for the SPIRIT long-term extension study for MYFEMBREE in women with endometriosis-associated pain. Additionally, we expect to receive an FDA decision on the MYFEMBREE endometriosis sNDA filing by its May 6th, PDUFA date.

Richter is expected to file for EU approval of RYEQO in endometriosis next year. And finally, we expect the European Commission's decision for our prostate cancer filing in mid-2022. We continue to operate from a position of financial strength, giving us the flexibility to sufficiently fund our U.S. product launches while expanding our pipeline through RELUGOLIX life cycle opportunities and potential business development.

I'm extremely proud of the passion and the work done by our Myovant team to enable us to deliver on our mission to positively impact the lives of so many men and women. Thank you for your attention and I'll turn it over to Ryan to begin the Q&A session.

Ryan Crowe -- Vice President of Investor Relations

Thank you, Dave. Operator, can we now please poll for questions?

Questions & Answers:


Operator

Thank you. [Operator instructions] Our first question comes from the line of Brian Skorney with Baird. Your line is now open.

Brian Skorney -- Baird -- Analyst

Hey, good morning, guys. Thanks for taking the question. I guess my first question is just to think about the EU opportunity with the approval potentially coming mid next year. Is there expectation that you would have a partner ahead of approval now or is there any inclination toward building any infrastructure to launch on your own in the EU?

Dave Marek -- Chief Executive Officer

Hey, good morning, Brian. Thank you for the question. We have multiple interested parties and our next step will be really to initiate a formal process, where we'll select who we believe would be the ideal partner. We currently are not building infrastructure for launching in Europe and we feel confident with the interest that we've receive that we intend to have a partner in place in time for the launch.

Brian Skorney -- Baird -- Analyst

Great. And then if I could just ask another question. I was hoping you could kind of contextualize the conversation that you're having with payers and PBMs around sort of the differences in those conversations between ORGOVYX and MYFEMBREE. It just seems like the only thing you -- one needs to do to convince of the value for ORGOVYX is just the oral to get coverage.

But how are payer discussions going with regards to the competitive dynamic with ORILISSA? I understand it's pretty early but are payers looking to negotiate any exclusivity here at all, or are payers -- would you expect they would generally reimburse both and is getting the endometriosis label critical to driving better coverage since ORILISSA currently has both indications?

Dave Marek -- Chief Executive Officer

Yes. Brian I'll let Lauren weigh in here. I would just say from a top line perspective, our philosophy is to work with payers to grant as much access to patients as available and then let the decision really reside from a clinical perspective with the clinicians themselves whether that's ORGOVYX or MYFEMBREE. But let me look -- turn it over to Lauren to address the question more specifically.

Lauren Merendino -- Chief Commercial Officer

Yes. Good morning, Brian. So from a payer discussion perspective, we really focus on seeking parity coverage for MYFEMBREE. As Dave mentioned, we believe it's important for physicians to have a choice and we believe when they have that choice that MYFEMBREE will likely be their choice.

So that's how our conversations have been going with payers. And some of those payers have asked us if we would be interested in an exclusive option. Obviously, that comes with greater discounts and then year over year creates a competitive environment of repeated discounts. So that has not been our strategy.

We really kept those conversations to parity discussions and that's what we've been successful in securing so far.

Brian Skorney -- Baird -- Analyst

Great. Thanks.

Juan Camilo Arjona -- Chief Medical Officer -- Analyst

Brian, one thing to add, this is Juan Camilo. I just want to clarify based on your question that for endometriosis ORILISSA, it's a different brand than for uterine fibroids, which is ORIAHNN. So all the conversations that Lauren just mentioned is about ORIAHNN in uterine fibroids. But we do believe that once we are able to -- if we get approval by the FDA having both indications in one single label will be to our advantage.

Operator

Our next question comes from the line of Phil Nadeau with Cowen. Your line is now open.

Phil Nadeau -- Cowen and Company -- Analyst

Good morning. Thanks for taking our questions and congrats on the progress. First on the excellent partnership, just to follow up on Brian's question, I know you mentioned during the prepared remarks that you hope to find a partner that has established infrastructure in urology or oncology. What other priorities do you have in finding that partnership? How much -- how do you weigh, for example, established infrastructure dynamics that will be offered to you?

Dave Marek -- Chief Executive Officer

Yes. Thank you, Phil. Look our intention is to ensure that ORGOVYX gets to the patients, who we believe are in great need in the European market. So we'll look for a partnership that has the breadth to enable to get ORGOVYX to the right patients.

And one of the things that's helpful is an established infrastructure in oncology or urology is already in place, rather than needing to build that from the ground up. And then, of course, we'll look at the financial terms that we think will be mutually beneficial and particularly will be beneficial to Myovant.

Phil Nadeau -- Cowen and Company -- Analyst

Perfect. And then just a couple of questions on the launches here in the U.S. On ORGOVYX, do you have any sense for the duration that men remain on therapy or is it still, too early in the launch to really understand how it's being used in the men specifically?

Dave Marek -- Chief Executive Officer

Yes. Phil, we just don't have enough data that we feel like we can kind of demand on one kind of duration of therapy.As I think we've described in other settings, we do have a variety of patients -- patient types that are being prescribed ORGOVYX but we haven't landed on a specific duration, given the tenure that we have on the market and the limited data that we have to view.

Phil Nadeau -- Cowen and Company -- Analyst

Great. And then last question. On the MYFEMBREE launch, your statistics on aided and unaided awareness of MYFEMBREE are interesting. Our own anecdotal checks suggest that the awareness of GnRH class, the oral GnRH class is actually relatively low given how long ORIAHNN and ORILISSA has been on the market.

What has your market research suggested about the awareness of the overall class the fact that oral GnRH antagonists are actually an option. Is that awareness where you would think it would be, or is it significantly lower given how long the class has been on the market?

Dave Marek -- Chief Executive Officer

Yes. I'll let Lauren, take that. Lauren?

Lauren Merendino -- Chief Commercial Officer

Yes. So from an awareness perspective we do see that awareness of the class is higher than MYFEMBREE alone. But to your point, I think the real competition here is not in-class competition. It is changing the mindset of physicians from their standard of care, which is OCs and surgery.

And many of them have been doing this since they started as GYNs and is deeply ingrained and so that's what we really need to break through. And so our intention beyond just speaking to MYFEMBREE is also to expand the understanding of the disease, the impact on patients, and how GnRH products can help patients beyond OCs and surgery.

Dave Marek -- Chief Executive Officer

Yes, and I think that one of the areas that we can really help is the joint field force efforts that we have. So not only do we have our field force, but now you add Pfizer's from the very initial stages. And then as Lauren has mentioned in other forums, the expectation that we will begin engaging patients at the appropriate time as well in a more fulsome way. So we believe that those are all areas that will increase the recognition of MYFEMBREE specifically.

And we think that that's really going to be a great step forward. And we've also seen a shift with the ACOG guidelines. And for that one, I'll turn it over to, Juan Camilo.

Juan Camilo Arjona -- Chief Medical Officer -- Analyst

Yes. Thanks, Dave. Yes then we're excited about the more recent update to the ACOG guidelines for the treatment of heavy menstrual bleeding in uterine fibroids where as Lauren, was pointing out the patient perspective is highlighted as something that physicians should consider in -- during decision-making and the patients should be offered all the options. And the new guideline also highlights the importance of the addition of GnRH antagonist as a treatment option and furthermore, it does not determine lines of therapy.

It removes contraceptives at the first line and encourages physicians to provide all the options to patients, so that joint decision-making can take place. So we think all that is changing the landscape in favor of oral therapies and we believe that the MYFEMBREE profile is going to be successful in that setting.

Phil Nadeau -- Cowen and Company -- Analyst

That's very helpful. Thanks for taking our questions.

Operator

Our next question comes from the line of Roanna Ruiz with SVB Leerink. Your line is open.

Roanna Ruiz -- SVB Leerink -- Analyst

Hi, thanks for taking the question. First for ORGOVYX, I was curious if you could give some detail on the ongoing prescribing trends between oncologists and urologists. And has the percent split between these prescribers changed at all since last quarter?

Dave Marek -- Chief Executive Officer

Lauren?

Lauren Merendino -- Chief Commercial Officer

Yes. Thank you for the question. So the ratio has not changed.So we continue to see about 60% of our ORGOVYX volume coming from urologists and roughly 40% from oncologists.

Roanna Ruiz -- SVB Leerink -- Analyst

OK. Great. And then for MYFEMBREE, I was curious if you could talk a bit about how physician uptake is progressing. I noticed you mentioned that there is some inventory stocking.

I was wondering how that's layering into the prescribing trends you're seeing. I know it's very early days. And maybe could you remind us how aggressive are you being with the free drug program at least at the outset.

Dave Marek -- Chief Executive Officer

Yes. Lauren?

Lauren Merendino -- Chief Commercial Officer

Yes, that's a great question. So I'll start with your last question first around free products. So as we mentioned first experience is really important in this market, and so we have invested in multiple programs to provide support to patients upfront. These include free drug programs and we also have launched a sample program.

So none of the free drug programs or the sample program will be included in any of the data that -- any of the prescription data that we see. And so that's an important point because we are the first to launch with samples in this class so that may result in some differences in being able to estimate the demand. However, we think that that short-term delay in starting commercial product is actually worth it in the long-term because it provides an opportunity for physicians to get experience with the product for patients to see the efficacy of the product and build confidence over time in MYFEMBREE overall.

Roanna Ruiz -- SVB Leerink -- Analyst

Got it. And the dynamics of inventory stocking as well?

Lauren Merendino -- Chief Commercial Officer

Yes. So we had initial inventory stocking in June and running into July, and that was as expected. It was the levels that we expected. And then, since then as we mentioned in our last call, they needed to burn through the inventory in the channel before starting to reorder and we've now started to see some reorders in September that are based on demand.

Roanna Ruiz -- SVB Leerink -- Analyst

Great. Thanks.

Lauren Merendino -- Chief Commercial Officer

Thank you.

Operator

Our next question comes from the line of Gavin Clark-Gartner with Evercore ISI. Your line is open.

Gavin Clark-Gartner -- Evercore ISI -- Analyst

Hey, thanks for taking the questions and congrats on a good quarter. So I had two. First roughly how was your SG&A split between prostate cancer and women's health today? And is that likely to change moving forward including with the endometriosis launch? And then secondly under the Pfizer partnership, do you have the ability to invest more or less heavily in either franchise specifically? And what would the decision process look like?

Dave Marek -- Chief Executive Officer

So I'll let Uneek take the SG&A split question and then we'll cover Pfizer.

Uneek Mehra -- Chief Financial and Business Officer

Yes. Thanks Gavin. I think on the SG&A split, right now it's too early for us in terms of both launches we need to fund appropriately. They're both at an exciting stage of the launch.

I mean cumulatively you've seen what we have spent. I mean we are in line with what we spent in Q1. We continue to hope -- we continue to make sure that both these brands are adequately funded from an SG&A perspective. And that right now the split actually also favors in terms of planning for endometriosis that potentially could come down the line.

Dave Marek -- Chief Executive Officer

Yes, and Gavin I think over time on the MYFEMBREE side, certainly we have mentioned before that we'll keep an eye on appropriate spend for consumer awareness and engagement but we'll do that in a very fiscally savvy way to ensure that we're leveraging digital technologies etc. in order to reach women. Regarding the Pfizer relationship, we have preset agreements on -- guard rails around spending. Should we decide that, we want to change those or reapportion those, we have every option to sit down with Pfizer and then make sure that we're putting the appropriate spend against both franchises.

As you know, we're both very interested in the success of both MYFEMBREE and ORGOVYX equally, so we'll make sure that we continue to keep those dialogues running with Pfizer. So both franchises are fully funded.

Gavin Clark-Gartner -- Evercore ISI -- Analyst

That's helpful. Thanks.

Dave Marek -- Chief Executive Officer

Thank you.

Operator

[Operator instructions] Our next question comes from the line of Madhu Kumar with Goldman Sachs. Your line is now open.

Madhu Kumar -- Goldman Sachs -- Analyst

Hey, everyone. Thanks for taking our questions. So kind of thinking about the business development aspect, what kind of business development opportunities are you looking for? And when do you think we'll have a sense of visibility on potential kind of in-licensing potentially of products that could be distinct from the RELUGOLIX franchise?

Dave Marek -- Chief Executive Officer

Sure. Thanks, Madhu. I'll let Uneek take that.

Uneek Mehra -- Chief Financial and Business Officer

Yeah. Thanks, Madhu. I think we are focused on business development opportunities related to Madhu adjacencies to our current therapeutic areas. So to give you a perspective, I think opportunities in women's health would be a natural fit that we would consider given our presence in prostate cancer as well as the potential life cycle opportunities for ORGOVYX.

Beyond prostate cancer, urology or oncology is also a potential area of interest for us. From a timing perspective, I think we are taking a very prudent and thoughtful approach to any potential future business development opportunity. And we are taking that as a holistic view in addition to the current life cycle opportunities we have with the RELUGOLIX franchise as well.

Madhu Kumar -- Goldman Sachs -- Analyst

OK. And following from that, are there any technologies you'd be particularly focused in in those types of indication spaces, or is it really more of a kind of best athlete kind of mentality where the best drug you can find independent of a modality or a technology approach?

Uneek Mehra -- Chief Financial and Business Officer

Yeah, look, it's a good one, Madhu. If you think about that, all technologies that help us enable our current offerings in the market or help us augment those, I think would be in our line of sight right now. I think, as you know, there are potentially -- the technology is changing pretty rapidly around so we have a very focused look into several of these technologies right now to help us improve our current offerings.

Madhu Kumar -- Goldman Sachs -- Analyst

Great. Thanks very much, everyone.

Operator

Our last question comes from the line of Eric Joseph with J.P. Morgan. Your line is now open.

Eric Joseph -- J.P. Morgan -- Analyst

Hi. Good morning. Thanks for taking my questions. Just a couple of commercial ones from us.

First on ORGOVYX, we're noticing that as volume demand grows you're maintaining a pretty steady rate of patients accessing free drug or getting access to drug via free drug programs at about a-third. I guess we talked about the proportion of patients on free supply that convert to paid for products and I guess, how long that takes? And do you have a sense of where that ratio might go into next year? And then just coming back to early trends of MYFEMBREE, just looking to hopefully get a breakdown of patients that are on paid-for versus free drug and similarly there, just curious to know expectations around the conversion rate of women on free supply converting to paid-for-products? Thanks.

Dave Marek -- Chief Executive Officer

Yes. Thank you for the questions, Eric. I'll let Lauren address those.

Lauren Merendino -- Chief Commercial Officer

Yes. Thank you, Eric. So from a free trial perspective on ORGOVYX, because of our distribution model, we don't have clarity into conversion. So as you know, many -- much of our drug is dispensed through in-office dispensing.

And so we only see bottles, we can't tie it to a patient and so we don't have data on rates of conversion or seed of conversion as a result.

Dave Marek -- Chief Executive Officer

Yes. And I also think relative to ORGOVYX, you mentioned the proportionality of free goods to paying that were about the same as what we saw last time through as well. And I think that's the kind of the gap between this -- new coverage we received and that coverage infiltrating into the minds of our prescribers. And so I think prescribers are still leaning into the free goods program as we're continuing to communicate these advances that we've made in coverage and that just happens with time.

We're making progress in getting the word out, so to speak, but that does take time. And then, the Lauren, I'll let you address the MYFEMBREE question as well.

Lauren Merendino -- Chief Commercial Officer

Yes. So from a MYFEMBREE perspective, the majority of patients are on commercial drug. However, we aren't able to estimate how many patients are on samples. We know how many samples we've distributed but we don't know how many samples have made it into the hands of patients.

But the patient numbers that we shared in the presentation include both commercial patients as well as those on our free drug programs through our hub.And so in that case, the majority of those patients are commercial. Did that answer --

Eric Joseph -- J.P. Morgan -- Analyst

OK. Are the free drug -- it does mostly. Yes. Are the free drug programs term-limited in any way? I know there's probably some supply available beyond just the starter packs for both products.

Are they, I guess, term-limited however in some part?

Lauren Merendino -- Chief Commercial Officer

You mean how long a patient can stay on the free program? Is that what your question is?

Eric Joseph -- J.P. Morgan -- Analyst

Correct.

Lauren Merendino -- Chief Commercial Officer

Yes. So each program has a slightly different duration but our bridge programs are -- so our bridge program is two months for government patients, which actually is not called a bridge program then.

Dave Marek -- Chief Executive Officer

Patient assistance program for the government.

Lauren Merendino -- Chief Commercial Officer

And then the -- well, the patient assistance program is the long-term program for uninsured patients, so that one does not have a duration limit. But we have two bridge programs one for commercial and one for government patients, and those are two to four months. And then our free trial program on ORGOVYX is up to four months.

Eric Joseph -- J.P. Morgan -- Analyst

OK. OK. Great. Thanks for taking the questions.

Lauren Merendino -- Chief Commercial Officer

Yes.

Operator

Thank you. There are no further questions. I will now turn the call back to Dave Marek for closing remarks.

Dave Marek -- Chief Executive Officer

Look, we are very encouraged by the progress that we made to both the ORGOVYX and MYFEMBREE launches, enabling our mission of redefining care for women and for men. Myovant remains well-positioned, both operationally and financially, to deliver strong commercial execution and to deliver sustainable long-term value. Thank you and I look forward to keeping you updated on our progress.

Operator

[Operator signoff]

Duration: 55 minutes

Call participants:

Ryan Crowe -- Vice President of Investor Relations

Dave Marek -- Chief Executive Officer

Lauren Merendino -- Chief Commercial Officer

Uneek Mehra -- Chief Financial and Business Officer

Brian Skorney -- Baird -- Analyst

Juan Camilo Arjona -- Chief Medical Officer -- Analyst

Phil Nadeau -- Cowen and Company -- Analyst

Roanna Ruiz -- SVB Leerink -- Analyst

Gavin Clark-Gartner -- Evercore ISI -- Analyst

Madhu Kumar -- Goldman Sachs -- Analyst

Eric Joseph -- J.P. Morgan -- Analyst

More MYOV analysis

All earnings call transcripts