Viatris (NasdaqGS:VTRS) 2025 Conference November 18, 2025 06:30 AM ET Company ParticipantsDoretta Mistras - CFOCorinne Le Goff - CCOScott Smith - CEOPhilippe Martin - Chief Research and Development OfficerConference Call ParticipantsDennis Ding - AnalystDennis DingHi, good morning. Welcome to the Jefferies London Healthcare Conference. My name is Dennis Ding, biotech and spec pharma research analyst here at Jefferies. I have the great pleasure of having Viatris up here. It seems like the entire team is up h ...

Core Insights - Lexicon Pharmaceuticals presented new clinical data on sotagliflozin at the AHA Annual Scientific Sessions 2025, highlighting its benefits for heart failure patients with preserved ejection fraction (HFpEF) [1][5] - The study demonstrated significant improvements in cardiac structure, function, quality of life, and functional capacity for HFpEF patients without diabetes [4][5] Study Details - The "SOTA P CARDIA" trial was a randomized, double-blind, placebo-controlled study directed by Dr. Juan J Badimon, focusing exclusively on HFpEF patients [2] - The study enrolled 88 diverse participants, with 70% being female, and compared the effects of sotagliflozin against a placebo over six months [3] Key Findings - Treatment with sotagliflozin resulted in statistically significant improvements in left ventricular mass, diastolic function, six-minute walk test capacity, and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores [4] - Although peak VO2 improvement was not statistically significant, there was a notable enhancement observed post-treatment [4] Broader Implications - The findings suggest that sotagliflozin may represent a new class of medication for HFpEF patients, particularly given its potential to reduce risks for major adverse cardiovascular events (MACE) and rehospitalization [6] - Approximately 6.7 million Americans suffer from heart failure, with over half having preserved ejection fraction, indicating a significant patient population that could benefit from sotagliflozin [5] About Sotagliflozin - Sotagliflozin is an oral inhibitor of SGLT2 and SGLT1, involved in glucose regulation, and has been studied in various patient populations, including those with heart failure, diabetes, and chronic kidney disease [7] - The drug is also under investigation for hypertrophic cardiomyopathy (HCM) [7] Company Overview - Lexicon Pharmaceuticals aims to pioneer transformative medicines through its Genome5000™ program, focusing on genomics and the discovery of therapeutic protein targets [8] - The company has a pipeline of drug candidates in various stages of development, targeting conditions such as neuropathic pain, HCM, obesity, and metabolism [9]

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 - Lexicon Pharmaceuticals presented a post-hoc analysis of sotagliflozin's efficacy among older adults at the ESC 2025 Congress, highlighting improvements in heart failure endpoints and major adverse cardiovascular events (MACE) [1][2][3] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program for genomics target discovery [8] Study Details - The analysis pooled data from two pivotal Phase 3 studies, SCORED and SOLOIST-WHF, involving nearly 12,000 participants, with approximately 70% aged 65 or older [2][4] - The primary endpoint was total cardiovascular death, hospitalization for heart failure, or urgent visits for heart failure, with additional endpoints including total MACE [2] Efficacy Results - Sotagliflozin reduced the primary endpoint rate compared to placebo: 8.5 vs 11.8 events per 100 person-years (HR: 0.72) overall, and 8.9 vs 12.4 events per 100 person-years (HR: 0.73) for those aged 65 and older [5] - Total MACE was similarly reduced with sotagliflozin: 5.7 vs 7.1 events per 100 person-years (HR: 0.80) overall, and 5.9 vs 7.4 events per 100 person-years (HR: 0.80) for those aged 65 and older [6] Future Research Directions - Future research may focus on the benefits of sotagliflozin in heart failure patients with preserved ejection fraction (HFpEF), a demographic that is generally older and includes more women [3]

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]

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]