Core Insights - Lexicon Pharmaceuticals announced positive results from a post hoc analysis of sotagliflozin, indicating improved glycemic control in type 1 diabetes patients with normal and mildly reduced kidney function after one year [1][2] Group 1: Clinical Study Results - The post hoc analysis utilized pooled data from two 52-week, placebo-controlled trials, showing that both 200 mg and 400 mg doses of sotagliflozin significantly decreased HbA1c, body weight, systolic blood pressure, and total insulin use compared to placebo in patients with CKD Class 1 and 2 [2][3] - Improvements in efficacy measures were less pronounced in patients with CKD Class 3A, but sotagliflozin still reduced events of blood glucose ≤55 mg/dL across all kidney function categories [3] Group 2: Future Developments - Lexicon is on track to resubmit the New Drug Application (NDA) for ZYNQUISTA (sotagliflozin) in 2026, based on FDA feedback and additional clinical data from the STENO1 study [4] - The STENO1 study is an investigator-initiated study conducted by the Steno Diabetes Center in Denmark, focusing on sotagliflozin and other agents [4] Group 3: About Sotagliflozin - Sotagliflozin is an oral dual inhibitor of SGLT1 and SGLT2, responsible for glucose regulation, and has been studied in various patient populations, including approximately 20,000 patients across conditions like heart failure and chronic kidney disease [5] - The drug is also under investigation for hypertrophic cardiomyopathy (HCM) [5] Group 4: Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, with a pipeline in neuropathic pain, HCM, obesity, metabolic disorders, and other cardiometabolic indications [6]

Fourth Quarter and Full Year 2025 Earnings M a r c h 5 , 2026 Forward-Looking Statements 2 • 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 sotagliflozin, pi ...

Core Insights - Lexicon Pharmaceuticals has made significant progress in its pipeline and financial position, with key milestones achieved in 2025 and a strong start to 2026 [2][3] Financial Performance - Total revenues for Q4 2025 were $5.5 million, with annual revenues of $49.8 million, including $4.3 million from licensing revenue and $1.1 million from net sales of INPEFA [12] - The company reported a net loss of $15.5 million for Q4 2025, a reduction from a net loss of $33.8 million in Q4 2024, and a full-year net loss of $50.3 million compared to $200.4 million in 2024 [16] - Research and development expenses decreased to $11.3 million in Q4 2025 from $26.7 million in 2024, while full-year R&D expenses were $61.1 million, down from $84.5 million [14] - Selling, general and administrative expenses also saw a significant decrease, totaling $8.8 million in Q4 2025 compared to $32.3 million in Q4 2024, and $37.3 million for the full year versus $143.1 million in 2024 [15] Pipeline Developments - Sotagliflozin, an oral SGLT1 and SGLT2 inhibitor, has been studied in approximately 20,000 patients and is commercially available in the U.S. for heart failure as INPEFA [4] - The SONATA-HCM study, a pivotal Phase 3 trial for hypertrophic cardiomyopathy, has surpassed 50% enrollment with a target of 500 patients and is expected to complete enrollment by mid-2026 [8] - Lexicon is on track for a potential NDA resubmission for ZYNQUISTA in Type 1 Diabetes in 2026, contingent on meeting FDA requirements [8] Strategic Partnerships and Funding - The company strengthened its financial position with over $100 million in additional cash from a capital raise and a milestone payment from Novo Nordisk [3][19] - Lexicon has entered into a licensing agreement with Viatris for the commercialization of sotagliflozin outside the U.S. and Europe, with regulatory submissions planned for several markets in 2026 [7][9] Regulatory and Development Readiness - A successful End-of-Phase 2 meeting with the FDA for pilavapadin confirms its readiness for Phase 3 development, which will include placebo-controlled studies [17] - The company is actively engaged in partnership discussions to maximize the global potential of its investigational therapies [17]