Lexicon Pharmaceuticals, Inc.

Good afternoon and welcome to the Lexicon Pharmaceuticals fourth quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Carrie Siragusa. Please go ahead.

Thank you, Gary. Good afternoon, and welcome to the Lexicon Pharmaceuticals Fourth 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 Senior Vice President and Chief Medical Officer. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the fourth 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 in the 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 will be making forward-looking statements, including statements relating to the safety, efficacy, regulatory status, and therapeutic and commercial potential of Sotocoflozin, 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 in 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 that 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 Coats.

Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. Fourth quarter 2022 was another active period for both our lead programs, Sotagiflozin, our dual SGLT1 and 2 inhibitor that we're developing for heart failure, and LX9211, our AAK1 inhibitor, that we're developing for neuropathic pain. Starting with our LX9211 program for neuropathic pain, in June of last year, we had previously announced positive top line results from our phase two proof of concept study in diabetic peripheral neuropathic pain. The final data demonstrated further significant benefits in both burning pain and on pain interference with sleep. In December, we announced top line results from a second phase two proof of concept study of LX9211 in post-herpetic neuralgia. These results demonstrated clear evidence of effect, further supporting the advancement and another indication within neuropathic pain. These results showed a consistent and statistically significant reduction in average daily pain score, or ADPS, compared to placebo throughout the dosing period, but as we have shared, not reaching statistical significance on the primary endpoint measured at week six. One of the more exciting aspects of these results is the remarkable consistency seen across both Phase II studies, and we will share more today about the development plans already underway to move LX9211 forward to late-stage development. We continue to believe LX9211 represents an innovative approach to treating neuropathic pain and, if approved, could provide a significant opportunity to improve the treatment landscape for the benefit of patients. Now, turning the soda to flozin. I'm pleased to say we had our late cycle review meeting with the FDA earlier this week for our NDA for the treatment of heart failure. The agency indicated that there were no substantial review issues and again confirmed that it has no plans to hold an advisory committee meeting. Therefore, we believe everything remains on track for our PDUFA target date of May 27, 2023. We look forward to continue to work with the FDA throughout the remainder of the review period and are planning to commercially launch Sotocoflozin in the U.S. in the first half of this year, preparations for which are already underway. We continue to believe the unique data from our SOLUS worsening heart failure trial in patients recently hospitalized for heart failure may provide a point of clinical differentiation, enabling a strong entry into the heart failure market. As a reminder, this past November, new data from the Soloist Worsening Heart Failure Trial were presented at the American Heart Association Scientific Sessions, demonstrating Sotica flows and significant effects in reducing cardiovascular mortality and the risk of hospital readmissions at 30 and 90 days following discharge after an initial event. This was indeed a significant finding that we believe could provide tremendous benefits to patients, physicians, hospitals, and payers, and help differentiate Sotagiflozin within the current heart failure treatment paradigm. I'm going to turn the call now over to Jeff, who will review the Sotagiflozin program and the status of our commercial launch preparations.