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]

UPDATE Q3 Earnings November 6, 2025 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 pilavapadin (LX9211), LX9851, sotagliflozin ...

Core Insights - Lexicon Pharmaceuticals has made significant progress in its R&D initiatives and operational strategies, positioning itself for a pivotal year in 2026 [3][4]. R&D and Pipeline Highlights - Pilavapadin (LX9211) is being developed for Diabetic Peripheral Neuropathic Pain (DPNP) and has shown a two-point reduction in average daily pain scores in a Phase 2b study [7]. - All IND-enabling studies for LX9851, a drug for obesity, have been completed and submitted to Novo Nordisk, with potential milestone payments of up to $1 billion [5][7]. - The SONATA-HCM Phase 3 study of sotagliflozin is on track for enrollment completion by 2026, with 130 sites initiated across 20 countries [14]. Financial Performance - Total revenues for Q3 2025 increased to $14.2 million from $1.8 million in Q3 2024, primarily driven by licensing revenue from Novo Nordisk [9]. - R&D expenses decreased to $18.8 million in Q3 2025 from $25.8 million in Q3 2024, reflecting lower external research costs [10]. - SG&A expenses significantly decreased to $7.6 million in Q3 2025 from $39.6 million in Q3 2024 due to strategic repositioning [11]. Net Loss and Cash Position - The net loss for Q3 2025 was $12.8 million, or $0.04 per share, a reduction from a net loss of $64.8 million, or $0.18 per share, in Q3 2024 [12]. - As of September 30, 2025, Lexicon had $145.0 million in cash and investments, down from $238.0 million at the end of 2024 [13].

Core Insights - The company has shifted focus back to being a pure R&D entity, emphasizing progress in its pipeline [1] Group 1: Pipeline Developments - The company has made significant advancements in its three main pipeline assets [1] - In Q1, the company licensed LX9851, a preclinical asset targeting obesity and related conditions, to Novo Nordisk under an exclusive worldwide license [1]

Lexicon Pharmaceuticals (LXRX) Conference Summary Company Overview - **Company**: Lexicon Pharmaceuticals (LXRX) - **Date of Conference**: September 03, 2025 - **Key Speakers**: Mike Exton (CEO), Craig Granowitz (CMO) Key Points and Arguments Company Evolution and Pipeline Focus - Lexicon Pharmaceuticals has shifted back to a pure R&D focus, emphasizing its pipeline development [4][5] - The company has made significant progress with three main assets in its pipeline [4] Licensing and Collaborations - In Q1 2025, Lexicon licensed LX9851, a preclinical asset for obesity, to Novo Nordisk, a leader in obesity treatment [4] Clinical Trials and Data - The PROGRESS Phase 2b study for pilovapitan, a non-opioid treatment for diabetic peripheral neuropathic pain, has shown promising results, with plans to move into Phase 3 trials in early 2026 [5][6] - The company is preparing for a busy September with multiple data rollouts at medical meetings [6] Heart Failure and HCM Programs - Lexicon continues to market sotagliflozin for heart failure under PEPFAR, maintaining sales levels from the previous year [6] - The SONARDA trial for hypertrophic cardiomyopathy (HCM) is progressing well, with full patient enrollment expected by 2026 [7] Data Analysis and Findings - A pooled analysis of over 12,000 patients in heart failure studies showed consistent responses across age groups, particularly in elderly patients [10] - The analysis indicated a 50% reduction in hospital readmissions and cardiovascular death at various time points, highlighting the efficacy of sotagliflozin compared to other SGLT inhibitors [12][14] Differentiation in Treatment - Lexicon's approach to treating HFpEF and non-obstructive HCM is unique, as sotagliflozin addresses underlying metabolic disorders in the myocardium [29] - The company aims to position sotagliflozin as the first-line treatment for both HFpEF and HCM, leveraging its efficacy and safety profile [35] Trial Design and Regulatory Engagement - The SONARDA trial is designed to include both obstructive and non-obstructive HCM patients, with a primary endpoint focused on symptom relief [40] - Lexicon is in discussions with the FDA to finalize the design for Phase 3 trials, aiming for a straightforward approval process based on previous Phase 2 data [62][66] Financial and Partnership Strategy - Lexicon plans to partner for the Phase 3 program, seeking a partner that is committed to long-term investment in the drug's development [78] - The company is exploring various partnership structures, aiming for a worldwide deal [79] Upcoming Events - The Arrowhead meeting in October will feature data presentations across Lexicon's Phase 2 programs, which are expected to inform the end of Phase 2 meeting with the FDA [81] Additional Important Insights - The analysis of the MAPLE trial indicated that beta blockers may cause harm, suggesting a potential shift in treatment paradigms for HCM [34] - The company is focused on simplifying trial designs to reduce variability and enhance the clarity of results [68] This summary encapsulates the key discussions and insights from the Lexicon Pharmaceuticals conference, highlighting the company's strategic focus on R&D, clinical advancements, and market positioning in the biopharmaceutical landscape.

Financial Data and Key Metrics Changes - For Q2 2025, Lexicon Pharmaceuticals reported revenues of $28.9 million, a significant increase from $1.6 million in Q2 2024, primarily driven by $27.5 million in licensing revenue from Novo Nordisk [24] - The net income for Q2 2025 was $3.3 million, or $0.01 per share, compared to a net loss of $53.4 million, or $0.17 per share, in the same period of 2024 [25] - Total operating expenses decreased by $31.9 million quarter over quarter, reflecting the company's strategic repositioning as an R&D-focused entity [27] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 decreased to $15.7 million from $17.6 million in Q2 2024, mainly due to lower external research expenses on the PROGRESS clinical trial [25] - Selling, general, and administrative expenses decreased to $9.4 million in Q2 2025 from $39.2 million in 2024, attributed to reduced marketing efforts for MPEFA [25] Market Data and Key Metrics Changes - The company is actively pursuing regulatory approvals for sotagliflozin in various international markets, including the UAE, Saudi Arabia, Canada, Australia, New Zealand, and several Southeast Asian countries [31] - The ongoing Phase III SONATA study for sotagliflozin is the only registrational trial currently evaluating treatment in both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [20] Company Strategy and Development Direction - Lexicon is focused on advancing its innovative portfolio of potential medicines, with a strategic pivot towards R&D that has taken shape in 2025 [6] - The company aims to maximize the potential of its drug candidates through partnerships, particularly with Novo Nordisk for LX9851 and Viatris for sotagliflozin [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of their R&D programs and the potential for pilavapitan to become a transformative therapy for patients with neuropathic pain [14] - The company anticipates presenting full progress data for pilavapitan in Q3 2025 and is preparing for an end-of-Phase II meeting [33] Other Important Information - The company ended Q2 2025 with $168 million in cash and short-term investments, down from $238 million at the end of 2024 [26] - Lexicon expects to recognize the remaining $17.5 million of licensing revenue from the Novo agreement in the second half of 2025 [26] Q&A Session Summary Question: Can you walk us through the SOTA CROSS trial and its design? - Management explained that the SOTA CROSS trial is designed to evaluate therapeutic options for non-obstructive HCM, with a crossover design allowing patients to serve as their own control [42] Question: How does the company plan to take advantage of the push for non-opioid pain medications? - Management highlighted their engagement with legislative efforts supporting non-opioid medications and expressed optimism about the potential for pilavapitan in this context [48] Question: What is Novo's plan for the Phase I study in obesity? - Management indicated that Novo is expected to vigorously pursue the Phase I program for LX9851, with a focus on oral and combination therapies [56] Question: How does the recent Vertex announcement impact confidence in the pain market? - Management expressed increased confidence in their own neuropathic pain program, citing successful Phase II results with pilavapitan [72] Question: Will an echo be required for patients if sotagliflozin is approved? - Management stated that while an echo will be part of the study protocol, it may not be a major impediment for patient suitability if approved [78]

Pipeline Progress - Pilavapadin 10 mg consistently delivered clinically meaningful pain reduction in Phase 2 trials[8] - Lexicon plans to present full Phase 2 results for Pilavapadin in September 2025 and partnership discussions are ongoing[5] - IND-enabling studies of LX9851 are on track to be completed in 2025[5] - Accelerated site initiations are underway for the Phase 3 SONATA-HCM study of sotagliflozin in HCM[5] Sotagliflozin in HCM - Approximately 1.1 million people in the U S have either obstructive or non-obstructive HCM[15] - 30% of HCM patients are diagnosed with oHCM and 70% are diagnosed with nHCM[16] - The SONATA-HCM Phase 3 study is evaluating sotagliflozin 400 mg versus placebo in 500 patients with oHCM and nHCM[22] - Enrollment in the SONATA-HCM Phase 3 study is accelerating, with all sites expected to be active by the end of Q3 2025[23] Financial Performance - Lexicon reported $28.9 million in total revenues for Q2 2025, including $1.3 million in net product revenues and $27.5 million in licensing revenue[30] - The $27.5 million in licensing revenue includes an upfront payment for the exclusive licensing agreement of LX9851 with Novo Nordisk[31] - Total operating expenses for 2025 are now expected to be between $105 million and $115 million[33]

Core Insights - Lexicon Pharmaceuticals is making significant progress in its R&D strategy, with ongoing partnership discussions for pilavapadin and IND-enabling studies for LX9851 on track for completion in 2025 [3][4][8] - The company reported a substantial increase in total revenues for Q2 2025, reaching $28.9 million, compared to $1.6 million in Q2 2024, primarily driven by licensing revenue from Novo Nordisk [11][21] - Lexicon's net income for Q2 2025 was $3.3 million, a notable improvement from a net loss of $53.4 million in the same period last year [14][21] Partnership and Product Development - Partnership discussions for pilavapadin are ongoing, with full Phase 2 data expected to be presented at an upcoming medical meeting [3][8] - LX9851, a novel oral candidate for obesity, is in preclinical development, with an exclusive licensing agreement with Novo Nordisk that includes an upfront payment of $45 million and potential milestone payments up to $1 billion [8][11] - The SONATA Phase 3 study for sotagliflozin in hypertrophic cardiomyopathy (HCM) is progressing well, with over 100 sites initiated across 20 countries [3][16] Financial Performance - Total revenues for Q2 2025 were $28.9 million, consisting of $27.5 million in licensing revenue and $1.3 million from INPEFA® sales [11][21] - Research and development expenses decreased to $15.7 million in Q2 2025 from $17.6 million in Q2 2024, reflecting optimized resource allocation [12][21] - Selling, general, and administrative expenses significantly decreased to $9.4 million in Q2 2025 from $39.2 million in Q2 2024 due to strategic repositioning [13][21] Cash Position and Investments - As of June 30, 2025, Lexicon had $139 million in cash and investments, down from $238 million at the end of 2024, primarily due to severance payments related to strategic changes [15][21] - The company also reported $29 million in restricted cash as of the same date [15][21] Pipeline and Future Outlook - Lexicon is focused on advancing its pipeline, with sotagliflozin being commercially available in the U.S. for heart failure as INPEFA® [7][19] - The company is also preparing for regulatory filings for sotagliflozin in various international markets, with submissions already made in the UAE and Saudi Arabia [16][19]

Pipeline Development - Pilavapadin (LX9211) Phase 2b PROGRESS study identified the 10 mg dose as the most clinically meaningful for DPNP[13], with post-hoc analysis showing statistically significant pain reduction compared to placebo (p = 0.04) in combined 10 mg dosing arms[16] - The PROGRESS study enrolled 496 patients[12], and the 10 mg dose had a completion rate of 87.8%[18], similar to the placebo group's 87.9%[18] - LX9851 IND-enabling studies are underway for obesity and related metabolic disorders[6], showing potential for weight loss maintenance after semaglutide discontinuation in preclinical studies[34] - SONATA-HCM Phase 3 trial is enrolling globally to evaluate sotagliflozin in both obstructive and non-obstructive HCM patients[21, 29] Sotagliflozin & INPEFA - Sotagliflozin has shown a 0.77 hazard ratio (95% CI 0.65-0.91, p=0.0020) for reduced major adverse cardiovascular events (MACE) in patients with T2D, CKD, and high CV risk[23] - Approximately 1.1 million people in the U.S. have HCM[26, 27], presenting a significant market opportunity for sotagliflozin[26] - Viatris is undertaking ex-US, ex-EU registration and regional development of sotagliflozin[21] Market Opportunity & Partnerships - Approximately 9 million U.S. patients have progressive DPNP[20], with 60% experiencing moderate-to-severe pain and low satisfaction with current treatments[20] - Lexicon entered an exclusive licensing agreement with Novo Nordisk for LX9851, receiving $75 million in upfront and near-term milestones, with potential for up to $1 billion in aggregate payments[40] - Lexicon entered an exclusive licensing agreement with Viatris for sotagliflozin outside the U.S. and Europe, receiving $25 million upfront, with potential for almost $200 million in milestone payments[40]

Business Highlights - Lexicon entered an exclusive worldwide licensing agreement with Novo Nordisk for LX9851[5, 21] - Pilavapadin (LX9211) PROGRESS readout identified a de-risked dose of 10mg to move into Phase 3 trials[5] - The company reduced debt and strengthened its financial position[5] - Pilavapadin 10 mg has consistently delivered clinically meaningful pain reduction[7] Market Opportunity - Approximately 9 million people in the U S living with diabetes suffer from DPNP[10] - It is projected that there will be 13 million DPNP patients in the U S by 2035[10] - Approximately 70% of patients with neuropathic pain do not achieve partial pain management[10] - Approximately 11 million people in the U S have either obstructive or non-obstructive HCM[14] Financial Overview - As of March 31, 2025, Lexicon had $1948 million in cash, cash equivalents, and short-term investments[26] - Total debt was $586 million as of March 31, 2025[26] - Total revenues for Q1 2025 were $13 million compared to $11 million in Q1 2024[26] - The company expects total 2025 operating expenses to be between $135 million and $145 million[29]