LEXICON PHARMACEUTICALS, INC. Q4 FY2024 earnings call

• Mike Exton discussed the PROGRESS Phase 2b study of pelabapentin in DPNP, noting top-line results with clear separation in ADPS from baseline, improved tolerability, and plans to advance the 10-milligram dose in pivotal trials.
• LX9851's IND enabling studies are ongoing, with animal model data showing weight reduction, food intake reduction, and mitigated weight regain post-GLP-1 analog discontinuation; on track for IND submission in 2025.
• Sotagliflozin's Phase 3 Sonata HCM study ongoing; ceased promotion of Impepper in US heart failure; licensing agreement with Beatrice for outside US/Europe; recent Lancet publication highlights sotagliflozin's MACE reduction.
• Scott Chianti provided financial updates on cash, expenses, and 2025 operating expense guidance.

Lexicon Pharmaceuticals ended 2024 with $238 million in cash, cash equivalents, and short-term investments, compared to $170 million in 2023. Fourth quarter revenue was $26.6 million, full year 2024 revenue was $31.1 million. Revenues for MPIFA were $1.7 million in Q4 2024 and $6 million for the full year. Research and development expenses in Q4 2024 increased to $26.7 million from $14.8 million in Q4 2023. Full year 2024 R&D expenses were $84.5 million vs $106 million in 2023. SG&A expenses in Q4 2024 were $32.3 million, comparable to $32.6 million in Q4 2023. Full year 2024 SG&A expenses were $143.1 million vs $114 million in 2023. Net loss in Q4 2024 was $33.8 million, full year 2024 net loss was $200.4 million.

• 2025 operating expenses expected in range of $135 million to $145 million, with R&D expenses $100 million to $105 million and SG&A expenses $35 million to $40 million.
• Upcoming catalysts for pillabapentin include disclosure of full PROGRESS dataset, end of phase two meeting with FDA, and data presentations at medical meetings.

• Forward-looking statements made, and various risks may cause actual results to differ materially from projections; refer to recent SEC filings for detailed risk information.

Q: Joseph Stringer asked about the LX9851 oral obesity asset, including whether it's for monotherapy or combo therapy, trial designs, and partnership clinical data needs.

A: Craig Granowitz answered that LX9851 is developed as monotherapy and combo therapy, phase one program has goals like weight loss and tolerability, and partnership would depend on generated clinical data.

Q: Hina asked about HCM enrollment progress, end of phase two meeting for pillabapentin, and IND filing steps for LX9851.

A: Mike Exton responded that HCM enrollment is on plan with timelines to final study results end 2026 and FDA filing Q1 2027; pillabapentin aims for end of phase two meeting in 2025 and phase three start; LX9851 has IND enabling studies ongoing with targets to complete.

Q: Joe Pantginis asked about key open questions for pillabapentin's FDA meeting and phase three.

A: Craig Granowitz mentioned secondary endpoints like sleep interruption, acetaminophen rescue protocol, and response regardless of underlying DPNP medication use as important.

Q: Andrew Tsai asked about FDA end of phase two meeting and phase three powering.

A: Mike Exton stated the trial could count as supportive pivotal, and phase three would be powered similarly to current trials with 0.6 placebo-adjusted drop expectation.

Q: Maizion asked about sotagliflozin partnership and Sonata baseline characteristics.

A: Mike Exton responded that ex-US/Europe is licensed to Beatrice, US commercialization planned, and Sonata has no limitations on background beta blocker or CMI therapy, including all patients with symptomatic HCM regardless of background meds.