Milestone Pharmaceuticals (MIST) investor relations material

Product pipeline and regulatory update

• Lead asset etripamil (Cardamist), a nasal spray calcium channel blocker, is under FDA review for SVT with a decision expected by mid-December.

• Completed phase 2 for atrial fibrillation; phase 3 to start after SVT launch.

• Addressed FDA's concerns on nitrosamine impurities through additional studies and meetings, resubmitting data per new guidance.

• Management is optimistic about approval following comprehensive agency interactions.

Commercial launch strategy and market opportunity

• Targeting a 2 million patient market, with half as potential candidates, and projecting over $500 million in opportunity.

• Launch will focus on cardiologists, leveraging familiarity with calcium channel blockers and a motivated patient base.

• Initial deployment of 50-60 sales reps, prioritizing commercial insurance coverage for faster uptake.

• Retail pharmacy distribution and wholesaler partnerships will ensure broad access.

Patient access, pricing, and payer engagement

• Strategy centers on affordable, broad access, with commercial co-pays targeted at $30-$50 and Medicare at $50-$80.

• Net sales price expected between $500-$1,000 per prescription in the launch year, with minimal rebates due to lack of competition.

• Assistance programs and copay mitigation will support early adoption and ensure prescriptions are filled.

• Payers are receptive due to the drug's potential to offset emergency department and hospitalization costs.