Lexicon Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Pipeline progress: Pilavapadin showed positive Phase II results in neuropathic pain, with post-hoc analyses supporting Phase III readiness. Sotagliflozin's Phase III SONATA study in HCM had over 130 sites active. INPEFA has a virtual sales support system in the U.S. for growth. - Partnerships: Working with Viatris on SOTA for heart failure, Novo Nordisk on LX9851, and ongoing discussions for pilavapadin. - Zynquista: Engaged with FDA, submitted additional data, expecting feedback by year-end and potential resubmission in 2026. - Operational efficiency: Reduced operating expenses and implemented innovative ways to drive business forward.

For the third quarter of 2025, total revenue was $14.2 million. Licensing revenue from the agreement with Novo Nordisk was $13.2 million, and net product revenue from INPEFA was $1 million. Research and development expenses were $18.8 million, selling, general and administrative expenses were $7.6 million, and the net loss was $12.8 million. Cash, short-term investments, and restricted cash ended the quarter at $145 million.

• Maintaining full-year 2025 operating expense guidance between $105 million and $115 million, with R&D between $70 million and $75 million and SG&A between $35 million and $40 million. - Planning for pilavapadin's end of Phase II meeting by year-end, sotagliflozin data presentations at upcoming meetings, Zynquista potential resubmission in 2026, and LX9851's IND filing by Novo Nordisk.

Various risks may cause actual results to differ materially from forward-looking statements, with detailed risks referred to in recent annual report on Form 10-K and SEC filings.

Q: For Zynquista in type 1 diabetes, details on regulatory feedback and resubmission type?

A: Craig Granowitz said they're using STENO trial data to address FDA's concern on DKA, expecting a 6-month review clock for resubmission.

Q: How do third-party IST studies for SOTA in HCM and HFpEF give conviction in SONATA study?

A: Michael Exton said there's overlap between HFpEF and HCM, and data from these studies supports sotagliflozin's potential across diverse populations.

Q: Regarding pilavapadin partnership, how soon and type of deal?

A: Michael Exton said they'll continue engagements post-end of Phase II meeting in early 2026, with diverse partners and optionality in deals.