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Milestone Pharmaceuticals (MIST) investor relations material
Milestone Pharmaceuticals Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- CARDAMYST launches for PSVT with rapid uptake, robust support, and plans for AFib expansion.MIST
TD Cowen 46th Annual Health Care Conference3 Mar 2026 - FDA-approved CARDAMYST targets rapid PSVT relief, unlocking a $1B+ market opportunity.MIST
Corporate presentation3 Mar 2026 - Etripamil aims for broad SVT market access with retail launch, affordable pricing, and payer support.MIST
H.C. Wainwright 27th Annual Global Investment Conference31 Dec 2025 - Nasal spray nears FDA approval for PSVT, promising rapid relief and strong market impact.MIST
TD Cowen 45th Annual Healthcare Conference26 Dec 2025 - Up to $250M in securities may be offered to fund a novel self-administered arrhythmia therapy.MIST
Registration Filing16 Dec 2025 - FDA approved first self-administered nasal spray for PSVT, launching Q1 2026.MIST
FDA Announcement16 Dec 2025 - CARDAMYST aims to transform PSVT care with rapid, on-demand relief and strong commercial prospects.MIST
Company Presentation15 Dec 2025 - Shareholders will vote on director elections, auditor ratification, and key compensation matters.MIST
Proxy Filing2 Dec 2025 - Virtual meeting to elect directors, appoint auditor, and review governance and compensation.MIST
Proxy Filing2 Dec 2025
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