Milestone Pharmaceuticals (MIST) Q4 2025 earnings summary

Executive summary

• FDA approved CARDAMYST (etripamil) nasal spray for PSVT in December 2025, marking the first new acute PSVT therapy in 30 years and initiating a new commercial phase for over two million patients.

• CARDAMYST launched in the U.S. market within six weeks of approval, became broadly available in retail pharmacies in late January 2026, and promotional activities began mid-February 2026.

• Early launch feedback is positive, with over 150 prescriptions filled by more than 100 unique prescribers in the first month and strong engagement from targeted providers.

• EMA accepted the marketing application for TACHYMIST (etripamil) in Europe, with a decision expected in the first half of 2027.

• Leadership strengthened with the appointment of a new General Counsel and Chief Compliance Officer.

Financial highlights

• Reported $1.5 million in revenue for Q4 and full year 2025, reflecting milestone payments post-FDA approval; no revenue in 2024.

• R&D expenses rose to $5.5 million in Q4 2025 (from $3.9 million in Q4 2024) and $18.1 million for the year (from $14.4 million in 2024).

• Commercial expenses surged to $8.2 million in Q4 2025 and $28.3 million for the year, reflecting launch preparations.

• Net loss was $17.4 million ($0.16/share) for Q4 2025 and $63.1 million ($0.75/share) for the year, compared to $41.5 million ($0.67/share) in 2024.

• Year-end cash, cash equivalents, and short-term investments totaled $106 million, up from $69.7 million at year-end 2024.

Outlook and guidance

• Commercial coverage for CARDAMYST expected to expand in 2026, with Medicare coverage targeted for 2027.

• Anticipates prescription volume and payer coverage to increase, with more meaningful progress in the second half of 2026.

• Operating runway projected into late 2027, supported by a pro forma cash position of $200 million.

• Plans to report prescription and prescriber data in future quarters as commercial data matures.

• Phase 3 program for etripamil in AFib-RVR is planned, leveraging FDA guidance and prior PSVT data.