Milestone Pharmaceuticals Inc.

What they do

Milestone Pharmaceuticals commercializes CARDAMYST (etripamil) nasal spray for paroxysmal supraventricular tachycardia (PSVT) in the U.S., with a sales team of about 60 representatives and a third-party logistics distribution network. The company is also developing etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) in a Phase 3 registrational trial. It continues to seek regulatory approval outside the U.S., including in Europe and China, and focuses on corporate development activities that could lead to strategic collaborations.

Revenue drivers

• CARDAMYST (etripamil) nasal spray for PSVT — Approved in December 2025 and launched in mid-February 2026; revenue has just started with $238,000 in Q1 2026 and $559,000 in Q2 2026. Early launch metrics include more than 1,500 scripts filled for more than 1,300 patients through June 30, 2026.
• Etripamil for AFib-RVR (development) — Phase 3 ReVeRA-301 trial is open and enrolling; no revenue yet. If approved, it would address a larger adjacent patient population.
• International partnerships — Marketing authorization application under review in Europe (decision expected H1 2027) and in China via partner Everest Medicines; potential future royalties or collaboration revenue.

Recent performance

In Q2 2026 (quarter ended June 30, 2026), the company reported revenue of $559,000, up from $0 in the same period a year earlier. It held $170.6 million in cash, equivalents, and short-term investments at June 30, 2026. The company reported a net loss of $63.1 million for 2025 and an accumulated deficit of $430.6 million as of December 31, 2025. Operating cash flow was negative $49.0 million in 2025. Management stated that the cash runway extends into H2 2027.

Strategy

Management is prioritizing three areas: commercialization of CARDAMYST for PSVT, development of etripamil for AFib-RVR, and corporate development for strategic collaborations. The launch focuses on expanding prescriber base – more than 800 unique prescribers by June 30, 2026 – and improving formulary coverage, which has grown from ~25% to ~50% of commercially insured lives. The AFib-RVR trial uses the same self-administered regimen, offering a clear path to a second indication. Management also highlighted efforts to raise awareness of PSVT burden and the new treatment option through peer-reviewed publications and conference presentations.

Risks

• Limited revenue and ongoing losses — The company has incurred net losses since inception, including a $63.1 million loss in 2025, and expects to continue incurring substantial losses until CARDAMYST revenue becomes sufficient.
• Launch execution risk — Commercial success depends on adoption by cardiologists and insurers; current script volume is still small (1,500+ scripts) and coverage is only about 50% of commercially insured lives.
• Regulatory reliance for international approvals — Approvals in Europe and China are pending, and delays or failures could limit market expansion.
• Clinical trial uncertainty — The Phase 3 AFib-RVR trial is early-stage; results may not support regulatory approval or commercial viability.

Outlook

Management expects the runway of $170.6 million in cash to fund operations into H2 2027. They anticipate continued prescription growth driven by improved insurance coverage and optimized sales and marketing strategies. The EU regulatory decision for etripamil is expected in H1 2027, and the company plans to enroll the first patient in the Phase 3 AFib-RVR trial in the near term.