LEXICON PHARMACEUTICALS, INC. Q3 FY2024 earnings call

• Completed resubmission of ZYNQUISTA NDA for glycemic control in T1D and CKD, FDA advisory committee met on 10/31, PDUFA goal date 12/20.
• Continued focus promotion of INPEFA to targeted high prescribers, with strategic repositioning including 50% reduction in field force effective September.
• Phase 3 study for sotagliflozin in HCM underway, enrolling 500 patients with obstructive or non-obstructive HCM, primary endpoint KCCQ score change.
• Phase 2b study for LX9211 in DPNP completed enrollment screening earlier than anticipated, anticipating top-line data in Q1 2025.
• LX9851, oral therapy for obesity and cardiometabolic disorders, had preclinical data presented at Obesity Week showing weight loss benefits.
• Exclusive licensing agreement with Viatris for sotagliflozin outside US and Europe, including $25M upfront payment and potential milestones.

The main product segment discussed is INPEFA. Net sales for the third quarter of 2024 were $1.7 million, representing 8% quarter-on-quarter growth, with year-to-date revenue of $4.5 million. Filled TRx volumes across commercially insured and Medicare patients improved, with gross unit volume increasing by 26%, driven by increased depth of prescribing among growing base of repeat INPEFA prescribers.

• Anticipate PDUFA outcome for ZYNQUISTA in next few weeks with preparations for multiple scenarios.
• SONATA HCM Phase 3 study enrolling patients with targeted 500-patient enrollment.
• LX9211 Phase 2b study expected to report top-line data in Q1 2025.
• IND-enabling studies for LX9851 ongoing, with IND filing anticipated mid-2025.

• Risks related to forward-looking statements, including actual results differing from projections.
• Regulatory uncertainties for ZYNQUISTA, including advisory committee vote results and potential additional studies needed.
• Uncertainties in clinical development and commercialization of pipeline assets.

Q: After the AdCom, what's confidence in getting a skinnier label for ZYNQUISTA in 60-90 CKD subgroup?

A: Mike Exton states it's not a skinnier label, represents more eligible CKD patients, and will continue working with FDA on scenarios.

Q: For LX9211 pain program, any views on placebo-adjusted efficacy separation?

A: Craig Granowitz says analyzing on intent-to-treat basis, expecting potential enhancement of relative efficacy compared to placebo if data holds up.

Q: For HCM study with sotagliflozin, views on patient competition?

A: Craig Granowitz mentions favorable feedback on study protocol, expanding study sites, and on track with regulatory approvals for other countries.

Q: For LX9211 data, key benchmarks to look at?

A: Craig Granowitz notes looking at placebo-adjusted reduction in pain score and baseline to maximum reduction in pain score as key benchmarks.

Q: Thoughts on INPEFA trajectory and patient access?

A: Tom Garner says modest growth expected, refocused sales force pushing increased depth among writers, and ongoing engagement with payer community.