ObsEva SA

And welcome to the Obzivo First Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance, please press star then zero on your touch-tone telephone. As a reminder, this call may be recorded. I would now like to introduce your host for today's conference, Katja Buehrer, Chief Strategy Officer for Azeva. Katja, you may begin.

Thank you, Operator, and hello, everyone. Thank you for participating in Azeva's first quarter 2022 earnings conference call. Members of the Azeva team joining me on the call today Brian O'Callaghan, our Chief Executive Officer, Brandy Howard, our Chief Clinical Officer, Will Brown, our Chief Financial Officer, and Clive Bertram, our Chief Commercial Officer. Following the prepared remarks, we will hold a question and answer session. A press release with our first quarter 2022 financial results was issued this morning and can be found on the investor relations section of the company's website. Before we begin, I would like to remind everyone that any remarks made on today's call that express a belief about future expectations, plans, prospects, or the company's future performance constitute forward-looking statements under the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to the company's management as of today and are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. For a discussion of some of the risks and factors that could affect the company's future results, please see the risk factors and other cautionary statements contained in the company's filings with the SEC, including those noted in the company's annual report on Form 20-S for the year end of December 31, 2021, and in our earnings press release issued today and now available on our website. Any statements made on this conference call speak only as of today's date, Tuesday, May 17, 2022, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date, except as required by law. As a reminder, this conference call is being recorded and will be available for audio replay on Obsiever's website. With that, I will now turn the call over to Brian O'Callaghan, Chief Executive Officer of Opsiva.

Thank you, Katja, and hello, everyone. We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update. 2022 is an exciting year for Opsiva as we eagerly anticipate approvals for Lindsay Gollick in both the US and EU, and then our transition to a commercial stage company. On the cusp of these key milestones, we wanted to share more details on what we see as the market opportunity for lindegolics for uterine fibroids, our commercial launch preparations, and how this program aligns with Opsiva's mission to bring much-needed innovation to the field of women's health. Our goal at Opsiva is to address the most challenging unmet needs facing women, and our lead program for the treatment of uterine fibroids is a prime example of the large, underserved indications that compromise female reproductive health. Throughout the US, almost 20 million women are affected by uterine fibroids, and at least a quarter of those experience symptoms such as heavy menstrual bleeding, pain, or prolonged periods, which can have a devastating impact on day-to-day life. The current standard of care has largely been off-label contraceptives and NSAIDs, with many women historically forced to choose between surgery or waiting for menopause for longer-term relief, which is unsatisfactory and creates a very large unmet need. GnRH antagonists are a relatively new class of drugs poised to revolutionize the treatment of uterine fibroids, and we think Linzagolic has the potential to lead the category. The Linzagolic program is currently before each of the European Commission and FDA for review, and if approved, will be the only approved oral GnRH antagonist to offer flexibility and choice for women suffering from uterine fibroids, including a non-hormonal dosing option to address the needs of women with uterine fibroids who cannot or do not want to take hormones. The last point bears repeating. We believe up to half of U.S. women suffering from uterine fibroids may have a contraindication to hormonal advect therapy. From our market research, we also know that many more women who aren't contraindicated would simply prefer not to use hormonal advect therapy if given the choice. Linzigolix has the potential to, for the first time in an approved product, offer choice and flexibility to women with uterine fibroids and the physicians who treat them. For women who can and want to take hormones, we have designed a dose that includes ADBAC therapy and has the potential to offer a best-in-class efficacy rate and tolerability profile, which, if approved, should position it strongly against other drugs in the class that target this patient segment. Importantly, for women with uterine fibroids who cannot, are at risk of, or simply do not want to take hormones, which, as I noted, may account for at least half the patient population, Linzagalix has the potential to be the first and only approved oral GnRH antagonist that does not exclude hormonal ad-back therapy. Accordingly, we think we have the potential to be either best in class or the first and only approved option in the main patient segments for this class of drugs, positioning Linzagalix strongly from a competitive perspective. Last month, the CHMP confirmed its positive opinion recommending approval of Linzagalix for uterine fibroids by the European Commission. If approved, this would be an historic moment for Aceva, representing our first approval and validation of the work we are doing to improve the reproductive health of women, which has far too long been overlooked and undervalued. We are actively working with our partner, Ceramex, on launch preparations in the EU. In parallel, preparations for the commercialization of linsegalics in the United States are advancing through our relationship with Synios Health as we approach our producer date of September 13th later this year. Together, these agreements are expected to maximize the market opportunity for lindegolics, and our Chief Commercial Officer, Clive Bertram, will speak in more detail on our commercial preparations momentarily. Turning to our second indication for lindegolics, here we are once again seeking to address a large unmet condition that severely impacts the quality of life of women who suffer from this disease. Endometriosis is an emotionally and physically painful condition that affects close to one in 10 women during their reproductive years, and there's a critical need for therapeutic options to address this chronic disorder. In January, we announced positive top-line results for our phase three Edelweiss trial in patients with moderate to severe endometriosis-associated pain. We hosted a call at the time to discuss the results in depth, and Brandy Howard, our chief clinical officer, will recap the highlights shortly. We were extremely pleased with the phase three results, which highlight the promising clinical profile of the lindegarlic 200 milligram once daily dose with ADVAC therapy for women with moderate to severe endometriosis associated pain and underscores the potential to be a leading GnRH antagonist option that balances safety and efficacy. We also believe the results from the 75 milligram without additional hormonal therapy are strong and therefore warrant further evaluation of a lower dose. Consistent with our commitments to addressing the individual treatment needs and preferences of all women, we intend to discuss next steps with regulators in the U.S. and the EU for this program. Beyond Lindsay Gullick's, our attractive pipeline also includes Iboviprins to address the significant unmet need of preterm labor. The future path of Iboviprins was established last July with our development and commercialization agreement with Organa. This collaboration, which includes tiered double-digit royalties and commercial sales, as well as up to $500 million in upfront and milestone payments, is an important validation of our ability to generate value. Although preterm birth rates are on the rise, with 1 in 10 babies born preterm in the U.S. each year, there are currently no approved therapies, nor other known compounds in development for acute treatment of preterm labor. We are working closely with Organon on the FDA submission of an investigational new drug application for Iverbifent, expected for this year to enable clinical development in the United States. Finally, we are continuing to advance the development of Melacivan to improve live birth rates in women undergoing in vitro fertilization via our partner Yuyan Bioscience Technology in China, which has the largest IVF population in the world. Our agreement with Yuyan also allows us to use these new clinical trial results should they support further developments in the United States and Europe. In parallel with the advancement of our promising pipeline, we continue to explore new indications partnerships, and other strategic opportunities that further our mission of advancing the field of women's health. There are many large unmet indications that compromise female health, together with undervalued assets in the sector. Just as biotech has come under strain in recent times, women's health companies, many with attractive assets and promising pipelines, have not been immune to market forces. We believe that current market conditions present opportunities within the sector, and that we are strongly positioned to be a catalyst for any roll-up, merger or acquisition, partnership, or licensing opportunities that may present as we look to enhance our value and fully realize the potential that exists within the sector. It is now my pleasure to introduce you to our new Chief Clinical Officer, Dr. Brandy Howard. Brandy is a recognized expert in women's health with demonstrated success leading women's health clinical development programs, medical affairs organizations, new product launches, and regulatory processes. She was most recently head of medical and clinical affairs at Evofem Biosciences, where she led the clinical program for the FDA approval of Phexxi, as well as the creation of the Medical Affairs Organization in support of the launch. And this market experience makes her the ideal person to take up SEVA into our next phase of growth. She will now provide an overview of our clinical and regulatory progress. Brandy?

Thanks, Brian. It's a pleasure to be speaking with you all today. I'm excited to be joining Opsiva at this pivotal time for the company as we work towards the approval of Lensagolic for uterine fibroids in Europe and the United States, potentially in the next six months. Both regulatory review processes are currently on track. In the EU, we received confirmation of CHMP's positive opinion in late April, and Lensagolic is now being reviewed by the European Commission. In the United States, we have a BDUFA target action date of September 13, 2022, and are where we'd expect to be in the regulatory review process at this time. As Brian noted, we believe what sets the Lens-A-Golic program apart is the potential to provide individualized treatment options to address the needs of all patients, including, for the first time in an approved product, those women who are contraindicated to at risk of, or prefer to avoid hormonal ad-back therapy. For this category of patients, we have a 100 milligram dose of Lentagolic without ad-back therapy, which delivered statistically significant and clinically meaningful results. For those women who can and want to take hormonal ad-back therapy, we have a 200 milligram once daily dose in combination with hormonal ad-back therapy. With what we believe to be best-in-class efficacy and a differentiated PKPB profile, including high bioavailability for reliable absorption, a half-life that allows for convenient once-daily dosing, no food effects, and strong safety data, including minimal bone mineral density changes, we are confident that, if approved, both dosing options could compete favorably in this class. At ACOG earlier this month, we were pleased to present four posters and an oral presentation from the Phase III Primrose studies of Lentagullix for uterine fibroids. The additional analyses and post-treatment data from the Primrose studies continue to underscore Lentagullix's clinical utility and differentiated profile and demonstrate its potential to balance safety, efficacy, and address the wide-ranging symptoms of uterine fibroids. We have a number of other congresses upcoming as we educate practitioners ahead of launch with Linda Golick's data to be featured in a poster presentation at the International Society of Gynecological Endocrinology World Congress and two oral presentations at the Society of Endometriosis and Uterine Disorders Congress in the coming months. Turning for a moment to our second indication for Linda Golick's endometriosis, We're very pleased with the results we reported for the phase three study early in the first quarter. For those who may not be familiar with endometriosis, it is a common chronic and progressive disease affecting approximately 180 million women worldwide. The most typical symptom is pain during menstruation, also known as dysmenorrhea. Patients may also experience non-menstrual pelvic pain, a number of other pain symptoms, and infertility. Endometriosis pain can be so severe and debilitating that it's frequently negatively impacting overall physical, mental, and social well-being. Consistent with uterine fibroids, our approach is to provide flexibility and choice for women when it comes to treatment of this condition by way of doses both with and without the use of hormonal add-back therapy. To highlight the key results of the trial, Lenzagolic's 200 milligrams with Advax therapy dose met both co-primary objectives of reduction in dysmenorrhea and non-menstrual pelvic pain at three months. There we also saw statistically significant and clinically meaningful improvements at six months in five ranked secondary endpoints. Dysmenorrhea, non-menstrual pelvic pain, dyskepsia, overall pelvic pain, and ability to do daily activities. The 75-milligram dose without ADVAC therapy likewise demonstrated a statistically significant reduction in dysmenorrhea and showed improvement but did not meet the co-primary objective of non-menstrual pelvic pain. Improvements were also observed at six months in the first five ranked secondary endpoints. While the 75 milligram dose did not meet the non-menstrual pelvic pain endpoint, the statistically significant and clinically meaningful responder rates versus placebo for dysmenorrhea at three months and the evidence of clinical activity and tolerability at six months are encouraging. Taken together, we believe these results support further development of lenzigolix in the endometriosis indication and we plan to discuss next steps with regulators, including exploration of a non-ADVAC therapy dose option, as we believe endometriosis remains a crucial unmet need in a large global patient population, and women deserve options and flexibility in their medical treatment. We announced additional efficacy results from the Phase III Edelweiss III trials, in March, which further build on the positive top-line results announced in January, including demonstration of rapid onset of treatment effects, impact on quality of life, and intentions for surgery. We also expect further Phase III data for the post-treatment follow-up mid-year and the data for the post-treatment follow-up for women who entered the extension, which is the majority of patients by early 2023. With that, I'll now hand the call over to Clive Bertram, our Chief Commercial Officer, to discuss launch preparations for lindegullix.

Thank you, Brandy. We believe lindegullix has the potential to change the treatment landscape and become the standard of care for women with uterine fibroids. As Brian noted, the unmet need is great. At least 5 million women in the U.S. with uterine fibroids experience symptoms. of which at least two million with heavy menstrual bleeding see treatment each year. The majority of these women fail first-line therapy, which is more often than not an oral contraceptive or an NSAID, and then tend to cycle through various therapies hoping for sustained relief. GnRH antagonists may offer a new gold standard treatment for uterine fibroids, and we believe lindegolics have the potential to not only lead the class in terms of efficacy and overall group profile, but also offer the first and only approved oral GnRH antagonist option to address the needs of women who can't, are at risk of, or would simply prefer not to take additional hormonal ad-hoc therapy. This is a key differentiator for Linzegolix, since as many as half the women with uterine fibroids may have a contraindication to hormonal ad-hoc therapy due to conditions such as uncontrolled hypertension, dyslipidemia, vascular disease, and obesity. Beyond this, our market research suggests an additional 20% of women with Euclid fibroids, if given the choice, would simply prefer not to use hormonal therapies, which are the only options among this class of drugs on the market currently. So, if approved, linzogonics would be the only approved dosing option without hormonal advect therapy to address what could become the largest patient population in this class. offering patients and physicians for the first time in an approved product personalized treatment options to address all patient segments. In fact, our market research suggests that even in the patients who are able and willing to take additional hormonal life-back therapy, many physicians will still consider initiating the lower 100 milligram non-hormonal dose as their first-line therapy. For the patients who can tolerate and are happy to take additional hormonal advect therapy, we believe Linda Golitz's profile with its efficacy, PKPD profile that gives truly once a day dosing, low food effect, and great bioavailability has the ability to compete and differentiate in the head-to-head choice with existing drugs in this patient population. Our goal with Linda Golitz is to provide for the first time in an approved product women and physicians with dosing options that address all patient needs. This approach is consistent with what OBGYNs are telling us are their most pressing requirements, namely a therapeutic that effectively reduces heavy mental bleeding and pain, is both safe and convenient to use, and importantly, can be used by the full spectrum of women with U3 fibroids, including those contraindicated against, at risk of, or who don't want to take additional hormonal advect therapies. Turning to our launch preparations, with the announcement of the Theramax licensing agreement, European commercial preparations are advancing, and we have a strong foundation to realize the commercial retention of the Linzagolitz program in Europe. Theramex is a proven global leader in women's health and has a track record of successful product launches, making it the ideal partner to maximize the opportunity for linsicolics in key international markets. They are one of the few pure women's health companies, and this program has strategic importance to them, considering the emerging importance of GnRH antagonists in the nutrient fiber treatment paradigm. Theramax's extensive women's health commercial infrastructure includes a dedicated sales force of more than 180 experienced representatives across Europe, Brazil, and Australia, alongside third-party distributors across approximately 60 countries in Europe, Middle East, Africa, Asia Pacific, and Latin America. With Theramax moving ahead on the European launch, it also allows us to focus our full attention on our U.S. launch strategies. In the U.S., preparations for commercialization of lindegolics are advancing through our relationship with Cineos Health as we approach our Purdue for Target action date of September 13, later this year. They have been involved in over 50 launches over the last five years, including 10 in women's health across an array of indications. And Cineos' clients span Big Pharma through to single product companies. The beauty of the CINEOS offering is that we will have access to the capabilities and experience of dedicated sales, marketing, medical affairs, and market access seasoned professionals with the flexibility to dial up or down our footprint as needed. Our CINEOS sales force will be fully dedicated to lindsay goelicks and comprised of experienced women's health sales representatives with established relationships in the sector. Our launch strategy comprehensively addresses the needs of providers, payers, and patients. For prescribers, we will position Linda Goldix, if approved, as providing the best efficacy across patient profiles and the only option to address the differing needs to all patient categories, including those women who can't, are at risk of, or don't want to take hormonal cutback therapy. We understand from our physician research that having optionality is something that physicians really do appreciate. Our focus here will be on education, and we have already been paving the way for prescribing knowledge on mentholics through our medical affairs strategy, especially at key congresses where we have been educating on the need for non-hormonal ad-hoc therapy options. Our focus will be on the highest prescribing HCPs and believe we can have a competitive share of audience here. We believe Lindsay-Garlic's potentially best-in-class profile and ability to provide choice and flexibility to this usually by-board patient population, currently not addressed by the available G&HR antagonists, are important differentiators for payers. And if approved, we expect to go on a broad support and coverage post-launch. In summary, we believe the Lindsay-Garlic's product profile, combining potentially best-in-class efficacy, and with the only dosing option to address the needs of patients who cannot, are at risk of, or simply don't want to take hormonal ad hoc therapy, alongside our commercial relationship, position this program to become a leading therapeutic in the class, if approved. And we look forward to updating you further on our Lord's preparation in the lead-up to anticipated approvals. I will now hand the call over to Will for a discussion on our financial results.

Thank you, Clive, and good day, everyone. For today's call, I will be providing a brief update on Obseva's first quarter 2022 financial and operating results. More comprehensive information can be found in our form 6K filed with the SEC today. Obseva ended Q1 2022 with approximately $58 million of cash on hand compared to $55 million at the end of 2021. The increase in our net cash is attributable to over $20 million of gross receipts during the current period, including $5.7 million of gross ATM receipts, $8.3 million in proceeds from our convertible debt agreement with JGB, a $5.7 million upfront payment related to our Whimsicolix licensing agreement with Theramex, offset by cash used for operating and investing activities. Turning to the income statement. Revenue in Q1 2022 was 2.2 million compared to 6,000 in Q1 2021. The change in revenue between periods was due to the partial recognition of the upfront payment associated with the aforementioned Theramex licensing agreement. We expect to recognize the remaining amount, or 2.5 million euros, once Lindsay Goelix is awarded marketing authorization by the European Commission. Research and development expenses were 5.6 million in Q1, 2022, compared to 15.5 million in the prior period. The decrease in R&D expense was primarily the result of the timing of clinical trial activities for Lensagolix. In the prior year period, the company was recognizing material clinical trial costs for both the endometriosis and the uterine fibroids phase three trials. During 2022, R&D costs primarily reflect endometriosis-related costs associated with the edelweiss trials, while the primrose trial costs associated with uterine fibroids are substantially complete. General and administrative expenses were $7.2 million in the first quarter of 2022 compared to $4.2 million in Q1 2021. The increased period-over-period is primarily attributable to commercial launch-related costs. Net loss for the three months ended March 31, 2022, was $11.8 million, or $0.14 net loss per share, compared to $20 million, or $0.29 net loss per share, for Q1 2021. The difference in net loss is primarily attributable to higher revenue and lower research and development expenses offset by higher general and administrative costs. In closing, the year ahead is expected to be transformational for Opsiva as we pursue our first approvals for Lensagolix and expect to transition to a commercial company. We believe Lensagolix has the potential to change the treatment paradigm for women with uterine fibroids, and we look forward to advancing our attractive pipeline as we further our mission of bringing novel therapies to market that improve women's health. We will now open the call to questions. Operator, will you please instruct the audience on Q&A procedure?

Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speaker phone, we ask that you please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. Today's first question comes from Ed Nash at Canaccord. Please go ahead.

Hi. Thanks, guys, for taking my call. Busy year this year for you guys. I wanted to ask just with regards to lenzagolix for endometriosis. I know that you're going to be getting additional data coming out and then as far out as to early 2023 for the post-treatment follow-up extension. Are you going to wait until you have that in hand before you have any discussions with the FDA on the next phase three trial or is that something you plan on doing this year?

Ed, thank you very much for the question. Great question. I'm going to hand you over to Brandy Howard, our chief clinical officer, to answer that one.

Thank you for the question. Yes, we will be in communication with the FDA before the end of the year.

Okay, great. And then can you just remind us, I don't know if the FDA came out, I can't remember if they openly came out and told you there would be no adcom, or is it just you're preparing for it but assuming there won't be one?

We've heard nothing from the FDA to imply that we should expect an adcom at this point.

Okay. And then my last question is, can you just remind us, just with regards to the uterine fibroid indication, and I guess maybe this is more of a Clive question, is should we be looking at the already approved GnRH antagonists out there to get an idea of what an initial Launch should look like or because of the fact that you offer the option of not having advec therapy Would we expect maybe a bit of a more steep trajectory an uptake?

Yeah, thanks, yeah, I think it's a great question I think for the class is still relatively early stages for the development, you know I think what we are seeing is each new entrant coming in is starting to grow the market as a whole and But I think you're correct in terms of the whole market, in terms of those current patients who are seeking treatment. At the moment, you know, from our work, we would suggest that the current oral genital antagonists are only addressing maybe half of the market because they can't address those patients who are contraindicated at risk or prefer to avoid hormonal therapy.

Got it. Thanks, guys.

And, ladies and gentlemen, our next question today comes from Nathan Weinstein with Aegis Capital. Let's go ahead.

Hey, good morning, Brian, and Abziva team. So thanks for taking my questions, and we really appreciate all the input on the call today. This first question is for Brian. Brian, could you talk about the hires you've made to build out your management team? Kind of what skills were you looking for during that process, and then how is the current management team situated to transition to a commercial stage company?

Sorry, Nathan, the last sentence, if you could repeat, you broke up just on that last bit.

Okay, the last part of the question was how you think of your management team as kind of suited to transition to the commercial stage.

Right, got it. Yeah, look, I think the last bit that we missed is almost the answer to the question, Nathan, but good question as it is. I think I was the start of the process. really 18 months ago when the board realized that this company was about to make the transition from being a late-stage clinical development company that was going into submissions and subsequently planning for success, becoming a commercialized company. So the transitions actually started at board level and then materialized at executive team level as well. So if you look at the board, for example, over the last 18 months since I arrived, we've brought in Anne Van Lent from the financial perspective where she brings a seasoned board member who has incredible experience at board level, dealing with investors, analysts, the street, and helping us make that transition from a company who was obviously planning for financing themselves for clinical trials to now planning for financing themselves for commercialization. Talking about going through that process, obviously it started with submissions. We also needed that level of seasoned experience from a regulatory perspective as well. So we brought in Katarina Edfeld at board level, who was a global head of regulatory for a large pharma company and brought that level of experience from both sides of the Atlantic, so dealing with the EMA as well as the FDA. And then finally, Stephanie Brown from a commercialization perspective, so that when planning and decision-making at board level, we had the areas of core competency that were required for the state and stage that the company is at now, at board level, as opposed to the boards that existed at the time that reflected a different time, which was a much earlier stage company. So all very amicably transitioned to a board that's now prepared for commercialization. So that then trickled down, of course, into the executive team, where they were, on top of transitioning, you know, from being a late-stage clinical stage company to a commercialized company, we also wanted to transition much of the executive team to the U.S., Where NASDAQ listed, commercialization potential is far greater in the U.S. than anywhere else. We raise more money in the U.S. than anywhere else, et cetera. So, I wanted to be much more front-facing with investors, investment banks, analysts, potential partners, et cetera, in the U.S., and therefore, much of the executive team now resides in the U.S., So we brought in a number of people, some who are not on this call today, to help us, first of all, migrate, as I said, the executive team or elements of it to the US, as well as prepare for commercialization. And in no particular order, I'm talking about people like Luigi Mauro, who brings core competency from a commercial readiness perspective. So about 18 months ago, again, we realized that, again, if we're planning for success, we needed to not just receive approvals, but be in a state of commercial readiness where we can actually supply products when and as needed in the market. So Luigi's been a tremendous addition to the team. Now, he's based here in Switzerland, where operations and headquarters still reside. Brandy Howard, who you've heard today already, brings clinical and commercialization experience that hasn't existed in the company until now to a core competency that obviously we need to acquire and acquire more of. So Brandy brings that commercialization perspective from a clinical, medical affairs, regulatory perspective. Clyde Bertram, who you've just heard from as well, Chief Commercial Officer, again, bringing that experience, that launch experience, and women's healthcare experience that was required and that we need to acquire more of. Katja Buehrer, one of the things that we're obviously trying to do better than we've ever done before and today hopefully is a reflection of it, is present and project ourselves to the street and all stakeholders more successfully than we ever have. We again needed to up our game in that regard and bring in more core competency and Katja as our Chief Strategy Officer has definitely helped us in that regard. And then finally, Will Brown. We obviously needed a CFO, a US-based CFO that was very NASDAQ experienced and everything he had done at his previous company, Altamune, suggested he'd be the perfect candidate for who we are now and who we want to be down the road. So Will was brought in, obviously, to help out on the financial front. So almost a complete... overhaul and many levels of leadership, of core competency at board level and executive team level also reflect the fact that we are planning for success, that we are about to be a commercialized company, and that we needed to be more physically present and front-facing in the U.S.

Wow, fantastic. Thank you, Brian.

That's really helpful and just an exciting team that you've assembled. We're looking forward to seeing what you can Accomplish with this new team put together maybe just one follow-up question for me And that's about the DN on each antagonist class and lindsay golex in particular obviously a number of advantages compared to older line medicines for the treatment of uterine fibroids Also our research has turned up that patients are very interested in having more options for their UF treatment So could you talk about you know what's the relative under? awareness of this attractive profile of the class and amongst HCPs and patients, and how much more room is there for education on the class overall?

Yeah, that's a great question, Nathan, and I'm going to turn you over to Clive initially, our Chief Commercial Officer, to talk about that, but Brandy may want to get in on this as well.

Yeah, thanks, Nathan. Again, a great question, and I think, and I totally agree with you, the differentiation is going to be key for us. In terms of overall education and awareness, I mean, we've been out there, you know, with our medical care strategies. So at Key Congress, over the last sort of 12 to 18 months in symposia, really trying to hammer home the message in terms of the unmet need for patients who, you know, again, are contraindicated at risk or if given the choice, you know, through shared decision-making, would prefer to avoid taking additional hormonal therapy. I think we're at the start of that journey. So I think there's good awareness among the KOLs. And we're starting to gain momentum and, again, put strategies in place and programs in place to cascade that message down to, I guess, to all the KOLs and the OBGYNs, you know, prescribing OBGYNs in the offices. But I think we know that that's a really critical success factor for us. And, again, we're putting – with Theramex in Europe and with Synios Health, you know, helping us with our launch in the U.S., we're putting those programs in place. to make sure that we achieve that and carry on that journey, you know, up to and through launch.

And Clive, I'll just add that I couldn't agree more as far as the desire for women to have more choices. I think with Linz and Golex, this really will be a great opportunity for women to have choices with and without ad-back therapy. But you're right, this is definitely a hot topic right now as far as educating HCPs on this concept, as Clive said, of shared decision-making and making sure that they understand that this should be a conversation to be had with the patient.

Okay, fantastic. Thank you, Clive, and thank you, Brandy.

Much appreciated on the color, and thanks again for taking my questions.

And, ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to Mr. O'Callaghan for any closing remarks.

Thank you. This is a pivotal year for Upceva, as we eagerly await our first approvals. We are confident that we have the right product profile and strategies in place to drive adoption of linsicolics if approved and redefine care for the millions of women who suffer from uterine fibroids. I look forward to driving this momentum forward while also staying apprised of opportunities to capitalize on the potential that exists within the sector and enhance our value. But I want to recognize the hard work and dedication of the Opsiva team and the support of our shareholders as we deliver on our mission to advance the field of women's health. With that being said, we look forward to updating you on our progress again next quarter.

Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.