Lexicon Pharmaceuticals, Inc.

Good morning, good afternoon, and good evening. My name is Donna, and I will be your conference operator today. At this time, I would like to welcome everyone to the Lexicon Pharmaceuticals, Inc. First Quarter 2021 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. Thank you. I would now like to hand the conference over to your first speaker for today, Chas Schultz, Executive Director of Corporate Communication and Investor Relations. Thank you. Please go ahead, sir.

Thank you, Donna. Good afternoon and welcome to the Lexicon Pharmaceuticals First Quarter 2021 Financial Results Conference Call. Joining me today are Lynelle Coates, Lexicon's President and Chief Executive Officer, and Jeff Wade, Lexicon's Executive Vice President of Corporate and Administrative Affairs and Chief Financial Officer. Earlier today, Lexicon issued a press release announcing our financial results for the first quarter of 2021, 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 an update on our clinical programs, 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, and the therapeutic and commercial potential of LX9211, Sotocliflozin, and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of LX9211, Cetagliflozin, 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, 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 the timing and the results of clinical trials and preclinical studies of LX9211, Cetagliflozin, 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 research and development activities. For a list and a description of the risk 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 Linnell Coates.

Thank you, Chas. Good afternoon, everyone, and thank you for joining us on the call. We, of course, welcome the opportunity to provide you an update on the first quarter of 2021 and the remainder of the year. Patient enrollment is ongoing in our two Phase II clinical studies of LX9211 and neuropathic pain. We continue to navigate the challenges associated with patient enrollment given the current environment with the pandemic. To help mitigate those challenges, we have increased the number of clinical sites in our relief DPN1 study. We're keeping a close eye on enrollment and will continue to adjust the challenges as they arise to ensure we stay on target. Late last year, our soloists and scored phase three outcome studies of Sotica Flosin and heart failure both achieved their primary endpoints. Based on the strong results from these studies and our subsequent discussions with the FDA, we made the decision to move forward expeditiously with a new drug application for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure. On the next slide, there are a number of events to look forward to during the remainder of 2021. As mentioned, we are working hard to reach our goal to have both of our proof of concept studies for LX9211 readout by the end of the year. We're very enthused by what we have seen from LX9211 in our preclinical and phase one studies and are looking forward to obtaining these phase two results. We plan to share more about the data from these earlier LX9211 studies and upcoming publications. We're moving forward with an NDA filing for psoriasis and heart failure and expect to submit the NDA during the second half of the year. We're also looking to establish a strategic alliance for Sotica-Flozen in heart failure, and those business development discussions are ongoing in parallel with our NDA preparations. Lastly, I should note that there are more analysis ongoing from the SOLOIS and SCORT studies, which we expect to result in additional publications throughout the year. There will be a presentation on Sotica-Flozen at the upcoming American College of Cardiology on May 16th entitled Sotica Flosin Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in a Solus Worsening Heart Failure Trial. Stay tuned and I hope you get a chance to chime in to that meeting. On the type 1 diabetes front, we continue to believe that Sotica Flosin demonstrated a positive benefit risk profile in the largest phase 3 development program ever conducted in type 1 diabetes and that it has the potential to become an important new treatment option as an adjunct to insulin for type 1 diabetes patients. We requested an opportunity for an administrative hearing with the FDA on whether there are grounds for its previous denial of our NDA for type 1 diabetes. In March, the FDA issued a public notice of opportunity for hearing and there was a period for the submission of public comments which ended earlier this week. We were very encouraged to see that those public comments were overwhelmingly positive in their support for psoriasis and type 1 diabetes. Last week, we submitted a written response to the FDA's position and look forward to continuing these discussions with the FDA. I would like to pause now and invite Jeff to take us through the financial results for the first quarter and our financial guidance for 2021.