Lexicon Pharmaceuticals (LXRX) investor relations material

Strategic focus and pipeline milestones

• Transitioned to a focused cardiometabolic strategy, emphasizing pipeline advancement and late-stage clinical programs.

• SONATA Phase III HCM trial enrollment to complete by mid-year, with data expected in Q1 next year.

• Preparing for FDA resubmission of sotagliflozin (Zynquista) for type 1 diabetes, leveraging new prospective data from the Steno study.

• Pilavapadin for diabetic neuropathic pain is phase III-ready, with no addiction potential recognized by the FDA.

• LX9851 obesity asset licensed to Novo Nordisk, with milestone payments received and further payments expected as clinical development progresses.

Clinical development and differentiation

• SGLT1/2 dual inhibition positions sotagliflozin uniquely in HCM, targeting cardiac energetics and offering potential first-line use, especially in non-obstructive disease.

• Demonstrated benefits in heart failure, including reductions in stroke and MI, not seen with SGLT2-only inhibitors.

• Phase III HCM trial powered for a five-point KCCQ difference, with success based on the overall population.

• FDA confirmed one phase III trial and KCCQ as sufficient for approval in HCM.

Commercialization and market strategy

• Considering self-commercialization for HCM, with pre-launch activities underway; partnerships likely for type 1 diabetes.

• Zynquista expected to launch at a retail-based price, while HCM pricing will be differentiated and potentially premium.

• U.S. market for type 1 diabetes estimated at 1 million patients, with Zynquista positioned as the only non-insulin glycemic agent.

• High unaided brand awareness for Zynquista anticipated to drive strong launch uptake.