Milestone Pharmaceuticals (MIST) H.C. Wainwright 27th Annual Global Investment Conference summary

Product pipeline and regulatory update

• Lead asset etripamil (Cardamyst), a nasal spray calcium channel blocker, targets SVT with FDA approval expected by mid-December.

• Phase 2 completed for atrial fibrillation; phase 3 planned post-SVT launch.

• FDA's complete response letter focused on nitrosamine impurities; new data submitted after June meeting.

• Optimism expressed that regulatory requirements have been met following agency guidance.

Market opportunity and launch strategy

• SVT market estimated at 2 million patients, with half as potential candidates and a projected market exceeding $500 million.

• Cardiologists are primary prescribers; low barrier to adoption due to familiarity with drug class.

• Initial launch will use 50–60 reps, focusing on commercial insurance for faster coverage.

• Staged launch approach leverages retail pharmacy distribution and motivated patient base.

• Expansion planned for new indications and broader patient reach over time.

Patient access, pricing, and payer engagement

• Retail distribution and wholesaler partnerships ensure broad access; not limited to specialty pharmacy.

• Copay mitigation and pay-no-more-than programs will support affordability, especially early in launch.

• Pricing strategy aims for net sales price of $500–$1,000 per prescription, balancing access and payer requirements.

• Tier 2/3 formulary placement targeted, with commercial copays of $30–$50 and Medicare $50–$80.

• Emergency department cost offsets and payer engagement support favorable coverage.