ObsEva SA
Q1 2022 Earnings Call Transcript

Published: 17 May 2022

[Operator:]

Good day, ladies and gentlemen, and welcome to the ObsEva 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. 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.

[Katja Buhrer:]

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 of 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-F for the year end at December 31st, 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 17th, 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.

[Brian O’Callaghan:]

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 US and EU, and then our transition to a commercial stage company. On the cost of these key milestones, we wanted to share more details on what we see as the market opportunity for Linzagolix for uterine fibroids, our 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 at 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 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 NSAID, 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 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 fibroid, including a non-hormonal dosing option to address the needs of women with uterine fibroid who cannot or do not want to take hormones. The last point bears repeating, we believe up to half of US 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 contraindicated 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 fibroid and the physicians who treat them. For women who can and want to take hormone, we have designed the dose that include the 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 exclude 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 confirmed its positive opinion recommending approval of Linzagolix for uterine fibroids by the European Commission. If approved, this would be an 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 and 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 preparation 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’s 200 milligram one 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 the EU for this program. Beyond Linzagolix, our attractive pipeline also includes Ebopiprant to address the significant unmet need in pre-term 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 payment, is an important validation of our ability to generate value. Although pre-term birth rates are on the rise with 1 in 10 babies born pre-term in the U.S. each year, there are currently no approved therapies. There are other known compounds in development for acute treatment of pre-term labor. We are working closely with Organon on the FDA submission of an investigational new drug application for Ebopiprant’s 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 virtualization via our partner YuYuan Bioscience Technology in China, which has the largest IVF population in the world. Our agreements with YuYuan also allows us to use these new clinical trial results should they support further development 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 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. 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?

[Brandi Howard:]

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 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 Linzagolix is now being reviewed by the European Commission. In the United States we have a PDUFA target action date of September 13th, 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 PKPD 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 four 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 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 Linzagolix data to be featured in a poster presentation at the International Society for Gynecological Endocrinology World Congress, and two 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 its frequently negatively impacting overall physical, mental and social wellbeing. 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 milligrams with add-back 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 improvement at six months in five ranked secondary endpoints, dysmenorrhea, non-menstrual pelvic pain, dyspepsia, overall pelvic pain, and ability to do daily activities. The 75 milligram dose without add-back therapy likewise demonstrated a statistically significant reduction in dysmenorrhea and showed improvements 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 endpoint. 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 Linzagolix in the endometriosis indication, and we plan to discuss next steps with regulators, including exploration of a non add-back 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 3 EDELWEISS 3 trial in March, which further builds 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 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 preparation for Linzagolix.

[Clive Bertram:]

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 US with uterine fibroids experience symptoms, of which at least 2 million with heavy mental bleeding see treatments each year. The majority of these meaning 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 antagonists may offer a new gold standard treatment for uterine fibroids, and we believe linzagolix has a 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 simply prefer not to take additional hormonal add-back therapy. This is a key differentiator for linzagolix since as many as half the women with uterine fibroids may have a indication 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, 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 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 womenwith uterine fibroids, including those contra-indicated 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 retention of the Linzagolix 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 of the 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 antagonists 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 in 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 five years, including 10 in women's health across some 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 accessibility 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 different 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 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 voice here. We believe Linzagolix’s potentially best in class profile and ability to provide choice of flexibility to this uterine fibroid patient population currently not addressed by the available GnRH antagonists are important differentiators for 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 we're 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 in the lead up to anticipated approvals. I will now hand the call over to Will for the discussion on our financial results.

[Will Brown:]

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 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 EUR2.5 million 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 costs 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 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 increase period over period is primarily attributable to commercial launch related costs. Net loss for the three months ended March 31st, 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 approvals 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 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:]

Today's first question comes from Ed Nash of Canaccord.

[Ed Nash:]

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 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 3 trial, or is that something you plan on doing this year?

[Brian O’Callaghan:]

Hey, 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.

[Brandi Howard:]

Yes, we will be in communication with the FDA before the end of the year.

[Ed Nash:]

And then can you just remind, 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 in you're preparing for it, but assuming there won't be one?

[Brandi Howard:]

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

[Ed Nash:]

And then my last question is, can you just remind us just with regards to the uterine fibroid indication. And I guess maybe just as 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 an uptake?

[Clive Bertram:]

Yeah, I think -- it's a great question. I think for the class, it's still relatively early stages for the development, you know? But I think what we are seeing is 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 oral GnRH antagonists are only addressing, it may be half of the market because they can't address those patients who are contraindicated at risk or prefer to avoid hormonal therapy.

[Operator:]

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

[Nathan Weinstein:]

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?

[Brian O'Callaghan:]

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

[Nathan Weinstein:]

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

[Brian O'Callaghan:]

Right. Got it. Yeah. 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 at 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 it 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 VanLent 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 at our -- from a regulatory perspective as well. So we brought in Catarina Edfjäll 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 Atlantics, 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 staged that the company is at now at board level as opposed to 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's then trickled down 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 the 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 new -- 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 U.S. as well as prepare 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 product when and as needed in the market. So Luigi's been a tremendous addition to the team. Now, he's still -- he's based here in Switzerland where operations and 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 to a 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 healthcare experience that was required and that we need to require more of. Katja Bührer, 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 regards 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 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, you know, almost a complete overhaul and -- in many levels, of leadership and 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 US.

[Nathan Weinstein:]

Wow. Fantastic. Thank you, Brian. That's really helpful, and just an exciting team that you've assembled. So, you know, we're looking forward to seeing what you can accomplish with this new team put together. Maybe just one follow up question from 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 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 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?

[Brian O'Callaghan:]

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 Brandi may want to get in on this as well.

[Clive Bertram:]

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 with our medical affairs 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 gain contraindicated at risk or if given the choice, 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 OB/GYNs, you know, prescribing OB/GYNs in the offices. But I think we know that that's a really critical success factor for us. And again, we we're putting with Theramex in Europe and with Syneos Health, you know, helping us with our launch in the US, we're putting those programs in place to make sure that we achieve that and carry on that journey up to and through launch.

[Brandi Howard:]

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 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, it’s shared decision making and making sure that they understand that this should be a conversation to be had with the patients.

[Nathan Weinstein:]

Okay. Fantastic. Thank you, Clive. And thank you Brandy, much appreciated on the color. And thanks again for taking my questions.

[Operator:]

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.

[Brian O’Callaghan:]

Thank you. This is a pivotal year for ObsEva 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 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 exist 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.

[Operator:]

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.