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?