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- **Pipeline Momentum**: Pilobafidin phase 2 data support phase 3 readiness; LX9851 IND filing imminent; Sonata HCM trial on track. 
- **Financial Strength**: Q3 2025 revenue up 700% YoY; operating expenses reduced by 78% since 2024. 
- **Strategic Focus**: Transitioning to R&D-driven model with disciplined capital allocation; exploring innovative commercial strategies. 
- **Regulatory Catalysts**: FDA feedback on Zingquista expected Q4; sotagliflozin presentations at AHA and HCM Society highlight broad cardiometabolic potential.

**【CEO Opening Remarks】**
- Lexicon achieved significant progress in 2025, including advancing pilobafidin toward phase 3, submitting an IND for LX9851, and accelerating recruitment in the Sonata HCM trial. 
- The company repositioned as an R&D-focused organization, reducing operating expenses by $39.1 million year-over-year while maintaining investment in high-value programs. 
- Empefa is transitioning from a break-even business to a growth driver in 2026, supported by a virtual sales system. 
- Legislative momentum in chronic pain management, including the Relief of Chronic Pain Act, aligns with pilobafidin's potential as a non-opioid alternative.

**【CMO Pipeline Update】**
- **Pilobafidin**: Phase 2 data showed a 2-point reduction in ADPS with 10mg dose, robust tolerability, and no cardiac signals. An end-of-phase 2 meeting with FDA is scheduled for late 2025. 
- **LX9851**: IND-enabling studies completed; Novo Nordisk may trigger $30M milestones upon IND filing. 
- **Sotagliflozin**: Sonata HCM trial (n=250 per subgroup) achieved 130+ site activations across 20 countries. Upcoming AHA and HCM Society presentations will highlight sotagliflozin's impact on cardiac remodeling and HFpEF. 
- **Zingquista**: FDA feedback expected by end-2025; potential resubmission in 2026 based on Steno trial DKA data.

**【CFO Financial Summary】**
- Q3 2025 revenue: $14.2M (vs. $1.8M in 2024), driven by $13.2M from Novo Nordisk agreement. 
- R&D expenses: $18.8M (down 27% YoY); SG&A: $7.6M (down 81% YoY). 
- Net loss: $12.8M; cash balance: $145M. 
- Full-year 2025 guidance: $105-115M operating expenses, with R&D at $70-75M.

**【Q&A Highlights】**
- **Zingquista Regulatory Path**: FDA expects written feedback by end-2025; potential 6-month review clock for resubmission. 
- **Pilobafidin Partnerships**: Discussions ongoing with high-quality partners; end-of-phase 2 meeting will inform partnership strategy. 
- **Sotagliflozin Positioning**: Targeted as first-line therapy for HCM due to ease of use and lack of REMS; differentiated from CMIs with broad cardiometabolic profile. 
- **Commercial Strategy**: Exploring virtual, hybrid, or co-promotion models for Zingquista; leveraging patient advocacy networks for market access.

Lexicon Pharmaceuticals, Inc. (LXRX) Q3 2025 Earnings Call Transcript

Revenue

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LXRX

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