Lexicon Pharmaceuticals, Inc.

Good morning. My name is April, and I will be your conference operator today. At this time, I would like to welcome everyone to the Lexicon Pharmaceuticals, Inc., fourth 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 that 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 will now turn the call over to Chas Schultz. Please go ahead, sir.

Thank you, April. Good morning and welcome to the Lexicon Pharmaceuticals fourth quarter 2021 financial results conference call. Joining me today are Linnell 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 morning, Lexicon issued a press release announcing our financial results for the fourth 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 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, and the 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 Sotocoflozin, LX9211, and 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 the timing and outcome of our plan, NDA resubmission 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 improved products, the timing and results of clinical trials and preclinical studies of sotagliflozin, LX9211, and other drug candidates, our dependence upon strategic alliances and other third-party relationships, our ability to obtain patent protections for our discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our research, development, and commercialization 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 Lynelle Coates.

Thank you, Chas. Good morning, everyone, and thank you for joining us on the call. I would first like to discuss what is likely on the top of all of your minds, and that is our decision to voluntarily withdraw and resubmit our NDA for Soda Gafloza. This decision was necessary to ensure the completeness of our NDA submission. We recently identified a technical issue with our NDA submission, which was not related to the clinical results or the interpretation of the underlying clinical data. The company identifies supportive documents related to site monitoring visits that were inadvertently not included in the submission. We promptly notified the FDA about the issue and have been in discussions with the agency to correct the submission. Unfortunately, the issue was discovered near the end of our 60-day filing review period, which did not allow a sufficient amount of time for us to correct the submission and for the FDA to complete its filing review. After consultation with the FDA, we determined that the withdrawal of the NDA in a subsequent resubmission would be the most appropriate action to provide a complete submission for review. I would like to reiterate that this technical issue does not involve the substance or the analysis of the clinical results, and it does not impact the conclusions from our soloist nor scored phase three outcome studies. We plan to correct this issue and promptly resubmit the NDA by early second quarter. Now let me turn our attention to LX9211, which is a selective inhibitor of AAK1. Despite neuropathic pain affecting millions of people, there remains a high level unmet need for those suffering from the condition. The current therapies are limited by lack of efficacy, compounded by debilitating side effects, and in the case of opioids, risk of potential abuse and addiction. We believe LX9211 has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from neuropathic pain on a daily basis. We have made significant progress over the last few months in our two ongoing phase two proof of concept studies and expect top line results in the very near term. For relief VPN1, our study in diabetic peripheral neuropathic pain, I'm very pleased to report that we are completing recruitment this week. We expect to report top-line results by the end of Q2 2022. For relief PHN1, our study in post-herpetic neuralgia, which is a global study, we continue to enroll patients and expect to report top-line results in the third quarter of 2022. I would now like to invite Jeff to take us through the financial results for the fourth quarter of 2021. Thank you, Lonnell.