Lexicon Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. All participants will be in a 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 and then one using a touchtone telephone. To withdraw your questions, you may press star and two. Please also note that today's event is being recorded. And at this time, I'd like to turn the floor over to Terri Siragusa. Ma'am, please go ahead.

Thank you, Jamie. Good afternoon, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 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 first quarter of 2023, 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 Sotagliflozin LX9211 and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of Sotocliflozin, 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, LX9211, and our other drug candidates. 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 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 Lynelle Coates.

Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. First quarter of 2023 was another significant period for Lexicon. As we continue to advance in both of 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 LX9211 program for neuropathic pain, as many of you know, we reported on the results of two phase two proof of concept studies last year in diabetic peripheral neuropathic pain and post-hepatic neuralgia. Bolstered by these results, we have continued to move forward with development plans for late stage development and expect to have feedback from the FDA on these plans in the second quarter of this year. Turning to Sotica-Flozen, as shared in our last quarterly call, we had our late cycle review meeting with FDA in late February for NDA for the treatment of heart failure. The agency indicated that there were no substantial review issues and again confirm that it has no plans to hold an advisory committee meeting. So we believe everything remains on track for our PDUFA target date on May 27th. Now, since our last call, we also wanted to highlight the significant progress we have made across all functions of the company to be launch ready for PDUFA, including but not limited to very productive label discussions and negotiations with the FDA. Appropriate and pre-approval information exchanges with payers across national and regional accounts, government, and institutions. The recruitment of experienced cardiovascular sales professionals, of which the majority are already on board with the company. Presentations at two major medical meetings, including a feature presentation on the time to clinical benefit of Sotagliflozin, which Dr. Granowitz will speak further about shortly. And finally, we finalized, we're finalizing wholesaler and distribution agreements to be ready to ship product within the U.S. shortly following approval. We look forward to continuing to work with the FDA over the next few weeks and during the review period and are planning to commercially launch Sotocoflozin in the U.S. in the second quarter promptly following regulatory approval. I will now turn the call over to Jeff to review the Sotocoflozin program and to further review the status of our commercial launch preparations.