Lexicon Pharmaceuticals, Inc.

Good day and welcome to the Lexicon Pharmaceuticals second quarter 2024 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 on your telephone keypad. 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 questions, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Lisa DeFrancesco, Head, Investor Relations and Corporate Strategy. Please go ahead. Thank you, Betsy.

Good afternoon and welcome to the Lexicon Pharmaceuticals Second Quarter 2020-2024 Financial Results Conference Call. Joining me today are Dr. Mike Exson, Lexicon's new Chief Executive Officer and Director, Seth Wade, President and Chief Operating Officer, Tom Garner, Senior Vice President and Chief Commercial Officer, Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer, and Dr. Alan Main, Executive Vice President, Innovation and Chemical Sciences. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the second quarter of 2024, which is available on our website at www.lexpharma.com. and through our SEC filing. A webcast of this call, along with a slide presentation, is also 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. Relating to the safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of Inpepa, Synquista, LX9211, LX9851, and our other drug programs, as well as our business generally. These statements may include characterizations and projections relating to our commercial launch of Impefa and heart failure, as well as the clinical development, regulatory status, and market opportunity 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 that may cause our actual results to differ materially from those expressed or implied in such forward-looking statements, we refer you to our most recent annual report on Form 10-K and other SEC filings for detailed information describing such risks. I would now like to turn the call over to Mike Exson.

Thanks, Lisa, and good day, everyone. Thanks for joining us on the call. Before we begin our discussion on Lexicon's results for the second quarter of 2024, let me start by saying that even in my first few weeks here as CEO, I can already see what a tremendous opportunity we have to bring innovative new therapies to patients, transform the treatment landscape of multiple therapeutic areas, and indeed transform Lexicon as a company. Now, moving on to our accomplishments for the year, which are indeed incredibly significant. First of all, our in-pepper business continued to grow modestly. We saw progress across all areas of focus in this highly competitive market. Importantly, we also resubmitted our NDA for Zynqvista and have received a PDUFA goal date of December 20, 2024, setting us up for a potential commercial launch in this untapped market in early 2025. Furthermore, our phase three study for sotagliflozin in hypertrophic cardiomyopathy or HCM is underway, with sites already open and beginning to enroll patients. In addition, our phase 2B study for LX9211 in diabetic peripheral neuropathic pain, or DPNP, is on track to meet its timelines and its objectives, with top line data anticipated second quarter of 2025. And finally, our exciting novel drug candidate, LX9851, and oral therapy for obesity and weight management, which we believe has the potential to become an innovative next gen treatment in this large market is progressing into preclinical development. These are all really solid opportunities for Lexicon, not only for next year, but well beyond. So let's take a look at Sotagliflozin in particular. We see a significant opportunity for value and growth with this compound. across additional indications where Sotagliflozin's unique mechanism of action has potential for beneficial effect. Lexagon has taken a purposeful approach in each one of the areas that we're exploring. And as a result, we're now preparing for the next near-term opportunity to commercially launch Zynquista for glycemic control in adults with type 1 diabetes and chronic kidney disease, while working towards a longer-term goal of expanding Sotagliflozin into HCM. Now, in both of these areas, there are no SGLT therapies indicated, and we believe that the dual inhibition of SGLT1 and 2 offers unique advantages. These areas of unmet need are also highly concentrated in terms of treatment landscape, and they're very different from the competitive environment we're experiencing in heart failure, which currently is dominated by two larger players within a complex treatment and reimbursement environment. These are really very exciting near and long-term opportunities for Lexicon, and as we advance this pipeline of current and potential indications for Sotocliflozin, we'll continue to weigh and consider where this unique innovation can have the most impact for patients. Now, as we then go and look holistically at our pipeline, we see similar pipeline and appeal opportunities for our other candidates as well. We have the ability to potentially address unmet medical needs within large markets, with development opportunities beyond their initial indications, whether pursued by Lexicon alone or with a strategic partner. And so, I'm truly thrilled to have joined Lexicon at this pivotal time when we can focus on unlocking the significant value that these opportunities represent. So, with that overview, I'd like to now turn it over to Jeff Wade, President and COO, to discuss in detail the business and financial results. Over to you, Jeff.