2Q24 Earnings Presentation ‹#› Forward-Looking Statements • This presentation, including any oral presentation accompanying it, contains "forward-looking statements," including statements about Lexicon's strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of INPEFA® (sotagliflozin), ZYNQUISTA™ (sotagliflozin ...

Financial Data and Key Metrics Changes - Net sales for Q2 2024 were $1.6 million, with $2.7 million for the first half of 2024, showing significant growth compared to minimal revenues in the same period of 2023 [25][26] - R&D expenses increased to $17.6 million from $14.5 million in Q2 2023, primarily due to higher external R&D expenses [25] - SG&A expenses rose to $39.2 million from $30 million in Q2 2023, reflecting investments in the commercial launch of INPEFA [26] - Net loss for Q2 2024 was $53.4 million, or $0.17 per share, compared to a net loss of $44.9 million, or $0.22 per share, in Q2 2023 [26] Business Line Data and Key Metrics Changes - INPEFA's net sales showed modest growth, with improvements in filled TRx and the number of new prescribers, achieving a payer coverage of 48% [12][13] - Zynquista's NDA was resubmitted, with a PDUFA goal date set for December 20, 2024, indicating potential for commercial launch in early 2025 [7][15] - The Phase 3 study for Sotagliflozin in hypertrophic cardiomyopathy (HCM) is underway, with patient enrollment already initiated [7][18] Market Data and Key Metrics Changes - The market for SGLT therapies in heart failure remains underpenetrated, with significant growth potential despite strong recommendations in treatment guidelines [14] - The expected market access environment for Zynquista in Type 1 diabetes is anticipated to be more favorable than in heart failure, with over 400,000 adults in the U.S. potentially eligible for treatment [16][17] Company Strategy and Development Direction - The company aims to transform treatment landscapes across multiple therapeutic areas, focusing on innovative therapies and addressing unmet medical needs [6][11] - The strategic focus includes leveraging existing commercial infrastructure for Zynquista, targeting a concentrated group of endocrinologists [35] - The company is evaluating its strategy and resources to optimize success across its programs, with a focus on large markets and unmet needs [28][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming opportunities, including the potential launch of Zynquista and the initiation of the SONATA Phase 3 study for HCM [27][29] - The company is optimistic about the unique advantages of its drug candidates, particularly in addressing unmet needs in various therapeutic areas [10][11] Other Important Information - The company has a strong cash position, ending the quarter with $310 million in cash and investments [25] - LX9211 is on track for top-line data in Q2 2025, with significant potential in neuropathic pain treatment [21][22] - LX9851 is progressing into preclinical development, targeting obesity and weight management with a unique mechanism [23][24] Q&A Session Summary Question: Updates on Zynquista and its launch trajectory - Management discussed the preparation for an advisory committee meeting and the focus on the risk-benefit profile for Zynquista, particularly in patients with chronic kidney disease [30][32] - The commercial strategy involves leveraging existing sales teams to target endocrinologists, with expectations of a more concentrated market compared to heart failure [35][36] Question: AdCom preparations and launch strength comparison - Management confirmed preparations for the AdCom will focus on risk-benefit discussions, with expectations for a stronger launch trajectory for Zynquista compared to INPEFA due to unmet needs in the Type 1 diabetes market [37][40] Question: HCM program evolution and timelines - The HCM program is expected to have final data towards the end of 2026 or early 2027, with a treatment duration shorter than typical due to prior successes in related indications [49][50] Question: Feedback from trial sites and execution standards - Positive feedback has been received from trial sites, with a focus on the ease of patient enrollment and execution of the SONATA trial [52][53] Question: Safety profile of LX9851 and its applicability - Management expressed confidence in the safety profile of LX9851, with ongoing studies to assess long-term effects and potential applicability in other metabolic conditions [66][70]

Lexicon Pharmaceuticals (LXRX) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.22 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 5.56%. A quarter ago, it was expected that this drugmaker would post a loss of $0.18 per share when it actually produced a loss of $0.20, delivering a surprise of -11.11%. Over the last four quarters, the company ...

Company Overview - Lexicon Pharmaceuticals, Inc. is a biopharmaceutical company focused on pioneering medicines that transform patients' lives through innovative drug discovery and development [3]. - The company has studied nearly 5,000 genes through its Genome5000™ program, identifying over 100 protein targets with significant therapeutic potential across various diseases [3]. Product Pipeline - Lexicon is commercially launching INPEFA® (sotagliflozin) in the United States and has a pipeline of promising drug candidates in discovery and clinical and preclinical development targeting neuropathic pain, diabetes, metabolism, and other indications [3]. Financial Information - Lexicon is set to release its second quarter 2024 financial results on August 1, 2024, after market close, followed by a conference call and live webcast to discuss the results and provide a business update [4].

Image Source: Zacks Investment Research An oral SGLT inhibitor, the commercial launch of Inpefa continues to progress across the country, driven by demand across the cardiology community and improving payer access. We remind investors that sotagliflozin was approved by the FDA last year to reduce the risk of death and hospitalization in adults with either heart failure or those with type II diabetes mellitus (T2D), CKD and other cardiovascular risk factors. The drug is being marketed under the name Inpefa. ...

Launch Preparations Actively Underway; Launch Planned for Early 2025 Lexicon Seeks Approval for Zynquista™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease THE WOODLANDS, Texas, July 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunc ...

Core Viewpoint - Lexicon Pharmaceuticals has appointed Mike Exton, Ph.D. as the new CEO, succeeding Lonnel Coats, who retired on July 7, 2024. Dr. Exton brings extensive experience from Novartis, particularly in cardiometabolic therapeutics [1][2][5]. Company Leadership Changes - Mike Exton has been appointed as CEO and director of Lexicon Pharmaceuticals, with a focus on executing near-term objectives to drive future value [1][2]. - Jeff Wade has been named president and chief operating officer, having previously served as president and chief financial officer since October 2021 [2]. Leadership Experience - Dr. Exton has a 14-year tenure at Novartis, where he led the commercialization of a leading heart failure drug and developed a strong cardiometabolic business [5]. - His background includes roles in research, development, commercialization, and strategic partnerships, enhancing Lexicon's management capabilities [5]. Company Overview - Lexicon Pharmaceuticals is dedicated to pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic protein targets [6]. - The company has launched INPEFA® (sotagliflozin) in the U.S. and has a pipeline of drug candidates in various stages of development for conditions such as neuropathic pain and diabetes [6].

Company Overview - Lexicon Pharmaceuticals has appointed Mike Exton, Ph.D. as the new chief executive officer, succeeding Lonnel Coats who retired on July 7, 2024 [7] - Dr. Exton has extensive experience in the pharmaceutical industry, including 14 years at Novartis, where he led the global cardiometabolic therapeutic area [8] - Lexicon is focused on pioneering medicines that transform patients' lives, with a unique genomics target discovery platform called Genome5000™ [9] Leadership Changes - Concurrent with Dr. Exton's appointment, Jeff Wade has been named president and chief operating officer, having previously served as Lexicon's president and chief financial officer since October 2021 [4] - The board of directors expressed confidence in Dr. Exton's leadership capabilities, highlighting his successful track record in commercialization and strategic partnerships [3] Product Pipeline and Strategy - Lexicon has commercially launched INPEFA® (sotagliflozin) in the United States and has a pipeline of promising drug candidates in various stages of development, including neuropathic pain and diabetes [9] - The company aims to achieve operational objectives and secure necessary regulatory approvals for its drug candidates, which include LX9211 and LX9851 [10]

Core Viewpoint - Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD) following feedback from the U.S. Food and Drug Administration (FDA) [1][3][10] Group 1: Regulatory Developments - The company anticipates a six-month review period from the FDA and a potential product launch in early 2025 [3] - The NDA for sotagliflozin was previously met with a complete response letter (CRL) from the FDA in 2019, and subsequent discussions led to the current resubmission [10] - The application remains in "filed" status at the FDA, with a formal communication expected within 30 days to establish the action date [10] Group 2: Company Insights - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic targets [7] - The company has successfully launched INPEFA® (sotagliflozin) in the U.S. and is developing additional drug candidates for various indications [7] - The CEO expressed confidence in the benefit/risk profile of sotagliflozin for patients with type 1 diabetes and CKD, emphasizing the importance of this therapy [6]

Company Anticipates Six Month Review and Potential Launch in Early 2025 "We are confident in the benefit/risk profile of sotagliflozin for people with type 1 diabetes and CKD, and our team has been resolute in identifying and pursuing a regulatory path forward," said Lonnel Coats, director and chief executive officer. "We are now one step closer to bringing this important potential therapy to market for the many people who suffer from type 1 diabetes and CKD, and who could benefit from an adjunct to insulin ...