Milestone Pharmaceuticals (MIST) Investor update summary

Regulatory and Launch Timeline

• CARDAMYST (etripamil nasal spray) is under FDA review with a PDUFA date of March 27, 2025, and a commercial launch guided for mid-2025, pending approval.

• $75M in royalty financing is secured, providing runway into mid-2026 post-approval, with payment expected upon approval.

• Post-approval, launch timing will be specified, focusing on logistics like drug distribution, sales force deployment, and patient support services.

• Approval will also enable advancement of the AFib RVR program, with first patient enrollment targeted for the first half of the year.

• Fully integrated leadership team in place to execute phased commercial launch.

Commercial Strategy and Market Opportunity

• The initial sales force will consist of about 60 reps across eight districts, targeting 10,000–12,000 high-value cardiology prescribers.

• The staged launch will prioritize commercial payers and expand to broader coverage and more prescribers in 2026–2027.

• Over 2 million Americans are diagnosed with PSVT, costing the healthcare system more than $5 billion annually.

• CARDAMYST is positioned as a first-in-class, on-demand therapy for PSVT, empowering patients with fast, reliable, self-administered relief.

• The drug is expected to be used 3–5 times per year per patient, with initial use lower in the launch year and increasing as adoption grows.

Payer Access, Pricing, and Patient Support

• Pricing will be set to keep Medicare co-pays below specialty tier, targeting a net price of $500–$1,000 per prescription.

• Payers are expected to implement some utilization management, such as prior authorization and quantity limits (e.g., 6–12 doses/year), but broad access is anticipated due to cost-offset potential.

• Payers recognize the value in reducing healthcare resource utilization and are not expected to impose onerous restrictions.

• Patient assistance programs and comprehensive support services will be available at launch, with 2–6% of patients expected to utilize assistance.

• Retail and mail-order distribution will ensure ease of access, and co-pay mitigation will be offered, especially in the first year.