Obseva SA (OBSV) 2022 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the ObsEva First Quarter 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this call may be recorded.

I would now like to introduce your host for today's conference, Katja Buhrer, Chief Strategy Officer for ObsEva. Katja, you may begin.

Thank you, operator, and hello, everyone. Thank you for participating in ObsEva's first quarter 2022 earnings conference call. Members of the ObsEva team joining me on the call today are Brian O'Callaghan, our Chief Executive Officer; Brandi 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 of 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-F for the year ended December 31, 2021, and in our earnings press release issued today are 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 ObsEva's website.

With that, I will now turn the call over to Brian O'Callaghan, Chief Executive Officer of ObsEva.

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 ObsEva as we eagerly anticipate approvals for linzagolix in both the U.S. and EU and then our transition to a commercial stage company.

And the cost of these key milestones, we wanted to share more details on what we see as the market opportunity for linzagolix for uterine fibroid or commercial launch preparations and how this program aligns with ObsEva's mission to bring much needed innovation to the field of women's health.

Our goal of ObsEva 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 U.S., almost 20 million women are affected by uterine fibroids and at least 1/4 of those experience symptoms such as heavy menstrual bleeding, pain of long 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 linzagolix has the potential to lead the category.

The linzagolix 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 hormone.

The last point bears repeating. We believe up to half of U.S. women suffering from uterine fibroids may have a contraindication to hormonal add-back therapy. From our market research, we also know that many more women who aren't contraindicators would simply prefer not to use hormonal add-back therapy if given the choice. Linzagolix 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 add-back 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, linzagolix has the potential to be the first and only approved oral GnRH antagonist that does not include hormonal add-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 linzagolix strongly from a competitive perspective. Last month, the CHMP confirms its positive opinion recommending approval of linzagolix for uterine fibroids by the European Commission.

If approved, this will be a historic moment for ObsEva, 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, Theramex, on launch preparations in the EU, in parallel preparations for the commercialization of linzagolix in the United States are advancing through our relationship with Syneos Health as we approach our PDUFA date of September 13, later this year.

Together these agreements are expected to maximize the market opportunity for linzagolix and our Chief Commercial Officer, Clive Bertram, will speak in more detail on our commercial preparations momentarily.

Turning to our second indication for linzagolix, 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 1 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 3 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 Brandi Howard, our Chief Clinical Officer, will recap the highlights shortly.

We were extremely pleased with the Phase 3 results, which highlight the promising clinical profile of the linzagolix 200 milligram once-daily dose with add-back 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 EU for this program.

Beyond linzagolix, our attractive pipeline also includes ebopiprant to address the significant unmet need in preterm labor. The future path of ebopiprant was established last July with our development and commercialization agreement with Organon. This collaboration, which includes tiered double-digit royalties on 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 therapy and there are 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 ebopiprant expected for this year to enable clinical development in the United States.

Finally, we are continuing to advance the development of nolasiban to improve live birth rates in women undergoing in vitro fertilization via our partner, YuYuan Bioscience Technology in China, which has the largest IVF population in the world. Our agreement with YuYuan 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 time, 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 rollup, 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. Brandi Howard. Brandi 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 ObsEva into our next phase of growth. She will now provide an overview of our clinical and regulatory progress. Brandi?

Thanks, Brian. It's a pleasure to be speaking with you all today. I'm excited to be joining ObsEva at this pivotal time for the company as we work towards the approval of linzagolix for uterine fibroids in Europe and the United States, potentially in the next 6 months. Both regulatory review processes are currently on track.

In the EU, we received confirmation of CHMP's positive opinion in late April, and linzagolix is now being reviewed by the European Commission. In the United States, we have a PDUFA 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 linzagolix 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 add-back therapy. For this category of patients, we have a 100-milligram dose of linzagolix without add-back therapy, which delivered statistically significant and clinically meaningful results.

For those women who can and want to take hormonal add-back therapy, we have a 200-milligram once-daily dose in combination with hormonal add-back therapy. With what we believe to be best-in-class efficacy and a differentiated PK/PD profile, including high bioavailability for reliable absorption, a half-life that allows for convenient once-daily dosing, no food effect 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 4 posters and an oral presentation from the Phase 3 PRIMROSE studies of linzagolix for uterine fibroids. The additional analyses and post-treatment data from the PRIMROSE studies continue to underscore linzagolix's clinical utility and differentiated profile and demonstrate a potential to balance safety, efficacy and address the wide-ranging symptoms of uterine fibroids.

We have a number of other conferences upcoming as we educate practitioners ahead of launch with linzagolix data to be featured in a poster presentation at the International Society of Gynecological Endocrinology, World Congress and 2 oral presentations at the Society of Endometriosis and Uterine Disorders Congress in the coming month.

Turning for a moment to our second indication for linzagolix, endometriosis, we're very pleased with the results we reported for the Phase 3 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, linzagolix 200 milligram with add-back therapy dose met both co-primary objectives of reduction in dysmenorrhea and non-menstrual pelvic pain at 3 months. There we also saw statistically significant and clinically meaningful improvement at 6 months in 5 range secondary endpoints; dysmenorrheal, non-menstrual pelvic pain, dyschezia, overall pelvic pain, inability to do daily activities.

The 75 milligram dose without add-back therapy likely 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 6 months in the first 5 ranked secondary endpoints. While the 75 milligram dose did not meet the non-menstrual pelvic pain endpoints, the statistically significant and clinically meaningful responder rates versus placebo for dysmenorrhea at 3 months and the evidence of clinical activity and tolerability at 6 months are encouraging.

Taken together, we believe these results support further development of linzagolix in the endometriosis indication, and we plan to discuss the next steps with regulators, including exploration of a non-add-back therapy dosed 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 3 EDELWEISS 3 trial in March, which further build on the positive top line results announced in January, including demonstration of rapid onset of treatment effect, impact on quality of life and intentions for surgery. We also expect further Phase 3 data for the post-treatment follow-up midyear and the data for the post-treatment follow-up for women who enter 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 preparation for linzagolix.

Thank you, Brandi. We believe linzagolix 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 2 million with heavy menstrual bleeding seek treatment each year.

The majority of these women failed 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 antagonist may offer a new gold standard treatment for uterine fibroids. And we believe linzagolix has the potential to not only lead the class in terms of efficacy and overall 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 add-back therapy.

This is a key differentiator for linzagolix since as many as half women with uterine fibroids may have a contraindication to hormonal add-back 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 uterine 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, linzagolix will be the only approved dosing option without hormonal add-back 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 add-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 add-back therapy, we believe linzagolix's profile with its efficacy, PK/PD profile that gives truly once a day dosing, no food effect and great bio-availability, has the ability to compete and differentiate in the head-to-head choice with existing drugs in this patient population. Our goal with linzagolix 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 OB/GYNs are telling us are their most pressing requirements, namely a therapeutic that effectively reduces heavy menstrual bleeding and pain, is both safe and convenient to use and importantly can be used by the full spectrum of women with uterine fibroids, including those contraindicated against, at risk of or who don't want to take additional hormonal add-back therapies.

Turning to our launch preparations. With the announcement of the Theramex licensing agreement, European commercial preparations are advancing and we have a strong foundation to realize the commercial potential of the linzagolix program in Europe. Theramex is a proven global leader in women's health and have a track record of successful product launches, making it the ideal partner to maximize the opportunity for linzagolix 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 antagonist in the uterine fibroid treatment paradigm. Theramex'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 Theramex moving ahead on the European launch, it also allows us to focus our full attention on our U.S. launch strategy. In the U.S., preparations for commercialization on linzagolix are advancing through our relationship with Syneos Health as we approach our PDUFA target action date of September 13, later this year.

They have been involved in over 50 launches over the last 5 years, including 10 in women's health across an array of indications. And Syneos' clients span big pharma through to single product companies. The beauty of the Syneos 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 Syneos sales force will be fully dedicated to linzagolix and comprise 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 linzagolix 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 add-back therapy.

We understand from our physician and 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 linzagolix to our medical affairs strategy, especially at key Congresses where we have been educating on the need for non-hormonal add-back therapy options.

Our focus will be on the highest prescribing HCPs and believe we can have a competitive share of bonds here. We believe linzagolix's potentially best-in-class profile and ability to provide choice and flexibility to this uterine fibroid patient population currently not addressed by the available GnRH antagonists are important differentiators to payers. And if approved, we expect to go on a broad support and privilege post launch.

In summary, we believe the linzagolix 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 add-back therapy alongside our commercial relationships, position this program to become a leading therapeutic in the class if approved. And we look forward to updating you further on our launch preparation and 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'll be providing a brief update on ObsEva's first quarter 2022 financial and operating results. More comprehensive information can be found in our Form 6-K 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 linzagolix 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 EUR 2.5 billion once linzagolix 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 linzagolix. In the prior year period, the company was recognizing material clinical trial cost for both the endometriosis and the uterine fibroids Phase 3 trials. During 2022, R&D costs primarily reflect endometriosis-related costs associated with the EDELWEISS trials, while the PRIMROSE trial cost 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 increase period-over-period is primarily attributable to commercial launch-related costs. Net loss for the 3 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 ObsEva as we pursue our first approval for linzagolix and expect to transition to a commercial company. We believe linzagolix 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 the market and improve women's health.

We will now open the call to questions. Operator, will you please instruct the audience on Q&A procedure.

(Operator Instructions) Today's first question comes from Ed Nash at Canaccord.

Busy year this year for you guys. I wanted to ask just with regards to linzagolix for endometriosis. I know that you're going to be getting additional data coming out and then as far out, is too 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 3 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 Brandi Howard, our Chief Clinical Officer, to answer that one.

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

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.

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, can we -- should we be looking at the already approved GnRH antagonist 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 add-back therapy, would we expect maybe a bit of a more steep trajectory in uptake?

Yes. Thanks, Ed. Yes, I think it's a great question. I think for the classes, it's still relatively early stages for the development. But I think what we are seeing is that each new entrant coming in is starting to grow the market as a whole. But I think you're correct, in terms of the whole market, in terms of those current patients that are seeking treatment at the moment, from our work, we would suggest that the current, all GnRH antagonists are only addressing may be half of the market because they can't address those patients who are contraindicated, at risk or prepared to avoided hormonal therapy.

And ladies and gentlemen, our next question today comes from Nathan Weinstein with Aegis Capital.

And I really appreciate all the insight on the call today. This first question is for Brian. Brian, could you talk about the hires you 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.

The last part of the question was how you think of your management team as kind of suited to transition to commercial stage?

Right. Got it. Yes, look, I think that the last bit that we missed is almost the answer to the question, Nathan, but good question as it is. I think, I guess, the start to 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 brought in Anne VanLent from the financial perspective where she brings a seasoned, a board member who has incredible experience at board level, dealing with investors, analysts, the streets 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 Catarina Edfjall 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 -- and planning and decision-making at board level, we had the areas of core competency that were required for the stages of the company that now at board level as opposed the board 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 trickledown, of course, into the executive team, where they were -- on top of transitioning 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 raised more money in the U.S. than anywhere else, et cetera. So 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 teams are elements often to the U.S. as well as prepared for commercialization. And in no particular order, I'm talking about people like Luigi Marro, 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 has been a tremendous addition to the team. Now he's still -- he is based here in Switzerland, where operations at headquarters still reside.

Brandi Howard, who you've heard today already, brings clinical and commercialization experience that hasn't existed in the company till now. So our core competency that obviously we need to acquire and acquire more of. So Brandi brings that commercialization perspective from a clinical, medical affairs, regulatory perspective. Clive Bertram, we've just heard from as well, Chief Commercial Officer, again, bringing that experience, that launch experience and women's health care experience that was required and that we need to acquire more of.

Katja Buhrer, 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 us is presents and project ourselves to the street and all stakeholders more successfully than we ever have. We again needed to offer a gain 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 U.S. based CFO that was very NASDAQ experienced and everything he has done in his previous company, Altimmune, 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 in many levels of leadership of core competency at board level and executive team level also reflects 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.

Well, fantastic. Thank you, Brian. That's really helpful and just an exciting team that you've assembled. So 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 GnRH antagonist class and linzagolix in particular, obviously, a number of advantages compared to older line medicines for the treatment of uterine fibroid? Also our research has turned up that patients are very interested in having more options for their UF treatment. So could you talk about what's the relative awareness of this attractive profile of the class amongst HCPs and patients? And how much more room is there for education on the class overall?

Yes, 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 Brandi may want to get in on this as well.

Yes. Thanks, Nathan. Again, 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 with our medical affair strategy. 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, again, contraindicated, at risk or if given the choice to share 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 the KOLs and the OB/GYNs, prescribing OB/GYNs 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 Syneos Health helping us with our launch in the U.S. with putting those programs in place to make sure that we achieve that and carry on that journey both 2 and 3 launch.

And Clive, I'll just add to that, I couldn't agree more as far as the desire for women to have more choices. I think with linzagolix, this really will be a great opportunity for women to have choices with and without add-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.

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 ObsEva as we eagerly await our first approval. We are confident that we have the right product profile and strategies in place to drive adoption of linzagolix, 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 ObsEva 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.