Lexicon Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Lexicon Pharmaceuticals, Inc. second quarter 2022 earnings conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Today's call is being recorded Tuesday, August 2, 2022, And I would now like to turn the conference over to Mr. Mike Kelly. Please go ahead, sir.

Thank you, Michelle. Good afternoon, and welcome to the Lexicon Pharmaceuticals Second Quarter 2022 Financial Results Conference Call. Joining me today are Lynelle Coates, Lexicon's Chief Executive Officer, Jeff Wade, Lexicon's President and Chief Financial Officer, and Dr. Craig Granowitz, Lexicon's Senior Vice President and Chief Medical Officer. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the second quarter of 2022, which is available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call, along with a slide presentation, is available on our website. During this call, we will review the information provided, then release, provide a corporate update, and then use the remainder of our time to answer your questions. Before we begin, let me remind you that we'll be making forward-looking statements, including statements relating to the safety, efficacy, and therapeutic and commercial potential of Sotagliflozin, LX9211, and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of Sotagliflozin, LX9211, and our other drug candidates, and the regulatory status and market opportunity for those programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, launch and commercialization plans for any approved products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Various risks may cause our actual results to differ materially from those expressed or implied in such forward-looking statements. These risks include uncertainties related to our NDA for Sotagliflozin and heart failure, and our discussions with the FDA regarding Sotagliflozin relating to heart failure and type 1 diabetes, the success of our commercialization efforts with respect to any approved products, the timing and results of clinical trials, and preclinical studies of Sotagliflozin, LX9211, and our other drug candidates, our dependence upon strategic alliances and other third-party relationships, our ability to obtain patent protection for our discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our planned research, development, and commercialization activities. For a list and a description of the risks and uncertainties we face, please see the reports we have filed with the Securities and Exchange Commission. I would now like to turn the call over to Lynell Coates.

Thank you, Mike, and good afternoon, everyone, for joining the call. We go to the next slide. As expected, the second quarter of 2022 was a pivotal time for Lexicon with major milestones achieved for both our dual SGLT1 and 2 inhibitor, Sotagaflozin, for heart failure, and our AAK1 inhibitor, LX9211, for neuropathic pain. We resubmitted our new drug application for Sotagaflozin for the treatment of heart failure in May, and as we announced last week, The filing was accepted by the FDA with a standard review and an anticipated PDUFA target date in May 2023. Our regulatory interactions have given us confidence in seeking a broad label on heart failure, including patients with and without type 2 diabetes, expanding on the potential opportunity for psilocybin. Importantly, we believe the unique data from our SOLOIS WHF trial in recent and worsening heart failure may provide a point of differentiation and strong entry into the heart failure market, if approved. The overall heart failure market is already a very large multi-billion dollar market and is anticipated to further grow at nearly 20% per year for the most of this decade, driven primarily by the SGLT inhibitor class and newly adopted guidelines for heart failure in the U.S. We believe that our unique mechanism of action, clinical data, and a growing market offers an opportunity for Sotica Flozin to achieve blockbuster potential. We look forward to continuing to work with FDA throughout the review period, and if approved for marketing, we're planning to launch Sotica Flozin in the U.S. in the first half of next year. I'm pleased to speak about another major achievement this quarter. We announced positive top-line results for our Phase II proof-of-concept study of LX9211 in painful diabetic neuropathy. By achieving a primary endpoint of the study, we accomplished our ambitions, our ambitious goal of translating a new mechanism of action for the treatment of neuropathic pain from research and discovery to human clinical results. This represents the culmination of over 15 years of biological research, medicinal chemistry, and clinical science on a novel target that we, through our proprietary discovery platform, were the first to identify as a potential target for neuropathic pain. We have a second proof of concept study for LX9211 in post-hepatic neuralgia with top line results anticipated to read out before the end of this year. The large multi-billion dollar neuropathic pain market remains largely unsatisfied with today's treatments. An innovative approach with a novel compound such as LX9211 could provide a significant opportunity to change the neuropathic pain treatment landscape for the benefit of millions of patients. I will now turn the call over to Jeff to discuss our opportunity and strategy for psoriasis and heart failure. Jeff?