LEXICON PHARMACEUTICALS, INC.
LEXICON PHARMACEUTICALS, INC. Q1 FY2025 earnings call
May 13, 2025 · fiscal period ended 2025-03
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2025-05-13
Management highlights
• Announced exclusive license agreement with Novo Nordisk for LX9851, eligible for up to $75M upfront and near-term milestones, $45M received in April. • Pilavapadin Phase 2B study identified 10-milligram dose for Phase 3, with plans to engage FDA on Phase 3 design. • Sotagliflozin SONATA HCM study enrolling, EU and LATAM sites progressing. • Business development with Viatris for sotagliflozin, including $25M upfront and potential $200M milestones, Viatris advancing regulatory submissions. • Revised cost structure to be R&D-focused, improving balance sheet.
Segment performance
No specific product segment financial performance with absolute revenue and contribution % provided in the transcript.
Guidance
• Anticipate sharing full-progress data of pilavapadin in Q3 and end of Phase 2 meeting. • Collaborate with Novo Nordisk on LX9851 IND-enabling, Novo to submit IND. • SONATA HCM study sites expected operational by Q3. • Viatris to submit sotagliflozin regulatory filings in Canada shortly. • Plan to engage in regulatory process regarding sotagliflozin MACE data later this year. • Continue end-of-review process for ZYNQUISTA with FDA.
Risks
• Various risks may cause actual results to differ from forward-looking statements, refer to most recent Annual Report on Form 10-K and other SEC filings for detailed risk information.
Q&A highlights
Q: On the pain program, intended trial designs for pilavapadin, whether they're identical and need for third trial?
A: Plan is to run two parallel trials with similar design, not needing a third trial as there's a robust clinical signal with 10-milligram dose.
Q: Assuming end of Phase 2 goes well, when would pain data sets be and what peripheral studies needed?
A: Need to look at addiction liability animal studies, metabolism studies, long-term CARC studies, and preclinical trials.
Q: How are IND-enabling studies for LX9851 progressing?
A: IND-enabling studies are on track, Novo is engaged and will submit IND.
Q: Updates on SONATA study and non-obstructive HCM after ODYSSEY trial?
A: SONATA is powered on overall endpoint, designed with symptomatic disease criteria, and enrolling with no competing trials.
Q: On SONATA study design for non-obstructive HCM, inclusion-exclusion criteria?
A: Major criteria is symptomatic disease, aligning with diastolic dysfunction in HCM, and designed to include both obstructive and non-obstructive patients.
Q: On pilavapadin additional progress data, differential effect based on background therapy?
A: See benefit regardless of underlying DPNP medication, sample sizes too small to over-interpret.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | — | — | — | — |
| Revenue | — | — | — | — |
Transcript
May 13, 2025Full transcript unavailable for redistribution
The structured summary above covers the available call sections. Full transcript text is not included on this page.
Continue exploring
Prior quarters
This page presents the stored structured earnings-call summary and deterministic earnings calendar values. How this is generated. For informational purposes only; not investment advice.