Lexicon Pharmaceuticals FY Conference Summary Company Overview - **Company**: Lexicon Pharmaceuticals (NasdaqGS:LXRX) - **Event**: 44th Annual JPMorgan Healthcare Conference - **Date**: January 15, 2026 Key Points Industry and Company Background - Lexicon Pharmaceuticals was founded 30 years ago with a focus on gene research, creating knockout mouse lines for 5,000 genes, identifying 200 genes of interest [2][3] - The company has conducted over 80 clinical trials, resulting in the approval of two medicines in the U.S., including INPEFA for heart failure and a novel approach for neuropathic pain [3][4] Product Pipeline and Therapeutic Areas - **Cardiometabolic Disease**: - INPEFA has been commercialized in the U.S. and is in phase three trials for hypertrophic cardiomyopathy (HCM) [5][9] - Zynquista is under regulatory discussions for type 1 diabetes [5][9] - LX9851 is a first-in-class non-incretin mechanism for obesity, currently licensed to Novo Nordisk [5][19] - **Pain Management**: - Pivapladin is a first-in-class AAK1 inhibitor for neuropathic pain, entering phase three trials in 2026 [6][18] - There is a significant unmet need in neuropathic pain, with approximately 9 million patients in the U.S. suffering from diabetic peripheral neuropathic pain (DPNP) [16][31] Clinical Trials and Regulatory Pathways - The SONATA trial for HCM is progressing well, with enrollment expected to conclude in the first half of 2026 [10][20] - The FDA has agreed on the parameters for resubmission of Zynquista, focusing on prospective data to assess the risk of diabetic ketoacidosis [27][28] - Pivapladin has shown significant placebo-adjusted improvements in pain scores, supporting its advancement into phase three trials [18][32] Market Opportunities - The cardiometabolic market is of high interest, particularly for HCM, which affects about 1 million people in the U.S. [11][25] - The DPNP market is characterized by a lack of effective treatments, creating a strong demand for new non-opioid options like Pivapladin [16][32] - The obesity treatment market is shifting towards oral medications, with a focus on improving tolerability and long-term adherence [33] Financial Position and Future Goals - Lexicon ended the previous year with approximately $125 million in cash, supporting operations into 2027 [20] - Goals for 2026 include advancing the late-stage pipeline, supporting partnerships with Novo Nordisk and Viatris, and maintaining financial discipline [20][36] Additional Insights - The company is focused on operational excellence and has implemented a virtual sales force for INPEFA to ensure continuous availability [8] - Legislative support for non-opioid pain treatments is growing, which may facilitate market access for Pivapladin [17][32] Conclusion Lexicon Pharmaceuticals is strategically positioned in the cardiometabolic and pain management sectors, with a robust pipeline and significant market opportunities. The company is focused on advancing its clinical trials and regulatory submissions while maintaining a strong financial position to support long-term growth.

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was reported at $14.2 million, a significant increase from $1.8 million in Q3 2024, primarily driven by $13.2 million in licensing revenue from Novo Nordisk [25] - Research and development expenses decreased to $18.8 million from $25.8 million in Q3 2024, reflecting lower external research expenses [26] - Selling, general, and administrative expenses decreased to $7.6 million from $39.6 million in 2024, due to strategic repositioning and reduced marketing efforts [26] - Net loss for Q3 2025 was $12.8 million, or $0.04 per share, compared to a net loss of $64.8 million, or $0.18 per share in Q3 2024 [26] - Cash, short-term investments, and restricted cash at the end of Q3 2025 totaled $145 million, down from $238 million as of December 31, 2024 [27] Business Line Data and Key Metrics Changes - Licensing revenue recognized from the agreement with Novo Nordisk totaled $40.7 million through September 30, 2025, with an additional $4.3 million expected in Q4 [25] - Net product revenue from sales of Empefa was $1 million for the quarter [25] Market Data and Key Metrics Changes - The company is actively engaging with the FDA regarding Zingquista, with expectations for written feedback by the end of the year, targeting a resubmission as early as possible in 2026 [12][31] - The partnership with Viatris for sotagliflozin is progressing, with plans for regulatory submissions in multiple international markets [31] Company Strategy and Development Direction - The company aims to progress pilobafidin to phase 3 trials, submit an IND for LX9851, and accelerate recruitment for the Sonata trial in hypertrophic cardiomyopathy [5][6] - Strategic partnerships are being pursued to maximize the value of R&D programs, with ongoing discussions for pilobafidin and LX9851 [10][11] - The focus remains on advancing the cardiometabolic disease pipeline, with a commitment to operational efficiency and targeted partnerships [6][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the legislative environment for chronic pain management, highlighting the introduction of the Relief of Chronic Pain Act and FDA guidance for non-opioid therapies [13][14] - The company is encouraged by the progress in its clinical programs and the potential for its assets to address significant unmet medical needs [29] Other Important Information - The company has completed IND enabling studies for LX9851 and anticipates milestone payments as it enters future phases of development [11] - The company is committed to maintaining a disciplined approach to capital allocation while advancing clinical programs [27] Q&A Session Summary Question: Regarding Zingquista and type 1 diabetes, what regulatory feedback are you seeking? - The company is leveraging ongoing trials to address FDA concerns and expects a six-month review clock for resubmission [34][36] Question: How do you expect non-HCM data to support the phase 3 Sonata study? - The overlap between HFpEF and HCM is significant, and data from ongoing studies will help build evidence for the efficacy of sotagliflozin [37][39] Question: What is the status of partnership opportunities in DPNP? - The company is re-engaging with potential partners and views the end-of-phase 2 meeting with the FDA as a critical milestone for discussions [43][44] Question: What is the commercial plan for Zingquista if it moves forward? - The company plans to explore various commercial models, including virtual sales support and potential partnerships, to maximize market access [56][58]