Lexicon Pharmaceuticals, Inc.

Good day and welcome to the Lexicon Pharmaceuticals Second Quarter 2023 Financial Results 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 a touch-tone phone, and to withdraw your question, please press star then two. Please note, this event is being recorded. I'd now like to turn the conference over to Kari Sturgeiser. Please go ahead.

Thank you, Cam. Good afternoon, and welcome to the Lexicon Pharmaceuticals Second 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'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 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, clinical development, regulatory status, and therapeutic and commercial potential of MPEFA, LX9211, and our other drug programs. These statements may also include characterizations of our commercial launch of MPEFA and heart failure, as well as the clinical development, regulatory status, and market opportunities for all of our drug programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, 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 commercial launch of MPEFA, our discussions with the FDA and other regulatory authorities regarding our drug programs, the timing and results of clinical trials and preclinical studies of our 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. 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. Second quarter of 2023 was an important and productive quarter for Lexicon with the achievement of a transformational milestone for the company and important advancements for our business. First, we received FDA approval of Impefa for the treatment of heart failure. Impefa was granted a broad label across the full range of left ventricular ejection fraction and for patients with and without diabetes. We have fully launched into the market with product made available and sales representatives deployed within 30 days of approval. Our ability to swiftly launch into market was a direct result of the significant investments we made over the last 12 months and the dedication across all of our teams to bring a new innovation into the heart failure market. Turning to LX9211. We have also announced this quarter our plans to move into late stage development in diabetic peripheral neuropathic pain with a clinical program that was designed to de-risk phase three based on FDA feedback and accelerate time to completion for a 2027 pilot. Neuropathic pain is a very large market opportunity, and we have aligned our development plan with the FDA feedback and are moving forward with a strategy that is designed to optimize development time and efficiency while increasing the likelihood of a successful path to regulatory approval. I will now turn the call over to Jeff to review additional key milestones from this quarter.