Lexicon Pharmaceuticals, Inc. Q4 FY2025 earnings call

Mike Exton highlighted progress in 2025 and early 2026. Lexicon has three late-stage programs: Sotocliflozin in cardiometabolic, LX9851 in obesity (licensed to Novo Nordisk), and Pilavapidin in chronic pain. Sonata HCM phase three trial enrolling well, expected to complete enrollment mid-2026. FDA feedback on Zinclista for type 1 diabetes supports NDA resubmission in 2026. Partnership strategy ongoing. Craig Granowitz detailed Sotocliflozin's mechanism, Sonata HCM trial progress, Zinclista's potential, LX9851's milestone, and Pilavapidin's phase three readiness. Scott Chianti provided financial updates on revenues, expenses, and cash position.

Total revenues were $5.5 million for the fourth quarter and $49.8 million for the full year 2025. Revenues for the fourth quarter included $4.3 million licensing revenue from the Novo Nordisk Agreement and $1.1 million net sales of IMPEFA. Year-ended revenues included $45 million licensing revenue from Novo Nordisk and $4.6 million net sales of IMPEFA. R&D expenses for Q4 2025 were $11.3 million vs $26.7 million in 2024; full-year 2025 R&D was $61.1 million vs $84.5 million in 2024. SG&A expenses for Q4 2025 were $8.8 million vs $32.3 million in 2024; full-year 2025 SG&A was $37.3 million vs $143.1 million in 2024. Net loss for Q4 2025 was $15.5 million vs $33.8 million in 2024; full-year 2025 net loss was $50.3 million vs $200.4 million in 2024.

Expect total operating expenses 2026 between $100 - $110 million, R&D between $63 - $68 million, SG&A between $37 - $42 million. Sonata HCM phase three trial expected to complete enrollment mid-2026. Zinclista NDA resubmission planned in 2026 with potential approval later that year. LX9851 had $10 million milestone in Feb 2026 with potential for $20 million more in 2026.

Various risks may cause actual results to differ from forward-looking statements, including those related to clinical development, regulatory status, market opportunity, commercial performance, growth, discovery/development of drug candidates, strategic alliances, and intellectual property. Refer to recent annual report on Form 10-K and other SEC filings for detailed risk information.

Q: How much patient worth of data does Open Label IST Stenum 1 study have on TKA safety right now for you to be able to guide to a potential approval in 2026? And then what are the exact timelines from submission to approval that you're expecting. Is this going to be a Class 1 or Class 2 resubmission here?

A: Matt was told they're expecting a six-month review, submission this year and approval before end of 2026. Craig added details on the study's enrollment and criteria.

Q: I've got a question on the partnerships for the pain program. So you had the end of phase two meeting. Could you just talk about how much the results from that meeting have accelerated the partnering discussions since then, and is there a clearer line of sight to transacting something this year?

A: Mike said the meeting allowed conversations to be more specific and provided confidence, with ongoing partnering discussions.

Q: Hey, guys. Good morning. Thanks for taking the question. So Mike, I know the intent for Pilavapidin is moving forward with an expected partner, but I want to ask the question this way. So based on the larger coffers that you have now and how things are rapidly progressing with the data and your FDA discussions, are you looking towards any sort of flexibility or optionality with regard to even starting the study on your own prior to getting a partner?

A: Mike said they're focused on near-term cardiometabolic opportunities and not investing in Pilavapidin phase three trial yet.

Q: Hi, this is Shannon on . Congrats on the progress and thanks for taking our question. Could you just help us understand your visibility and confidence for getting the additional 50% enrollment for Sonata by mid-2026? And then also, is there a cadence of that enrollment? Is that the same in both cohorts for NHCM and OHCM?

A: Craig said enrollment is on target, with steep part of S curve, and enrollment in both cohorts with more for non-obstructive HCM.

Q: Hi. This is Michael. I'm for Rowana Ruiz at Learing Partners. Thank you for taking our question. I have a question about phase three design of a pilavapidin program. Previously, you mentioned several measures to mitigate the placebo response that you saw previously. Are you able to comment on what the enrollment criteria changes will look like for phase three? Like for instance, will you require like minimum pain score threshold, things like that?

A: Michael was told about changes like expanding enrollment, considering renal impairment, adjusting neuropathy duration, and training patients on pain score measures.