Milestone Pharmaceuticals (MIST) Q1 2026 earnings summary

Executive summary

• CARDAMYST (etripamil) nasal spray launched in the U.S. in Q1 2026 as the first FDA-approved self-administered treatment for PSVT, with strong early adoption, broad prescriber engagement, and positive feedback from patients and providers.

• Achieved rapid commercial rollout, with CARDAMYST available in retail pharmacies within two months of FDA approval and active promotion beginning mid-February.

• Express Scripts national formulary coverage secured by March 31, expanding patient access to over 25% of commercially insured U.S. lives.

• Initiated phase III pivotal trial (ReVeRA-301) for etripamil in AFib-RVR, with first patient enrollment expected in H2 2026; global expansion progressing with EMA review in Europe and NDA accepted in China.

• Asset purchase agreement transferring Greater China rights for CARDAMYST to Everest Medicines in March 2026.

Financial highlights

• Ended Q1 2026 with $184.2 million in cash, cash equivalents, and short-term investments, up from $106 million at year-end 2025.

• Product revenue for Q1 2026 was $0.2 million, reflecting early-stage U.S. launch dynamics.

• Net loss for Q1 2026 was $26.1 million ($0.20 per share), compared to $20.8 million ($0.31 per share) in Q1 2025, driven by higher commercial expenses.

• Commercial expenses rose to $15.8 million from $10.4 million year-over-year, while R&D expenses decreased to $3.3 million from $5 million.

• Gross margin for Q1 2026 not representative of future periods due to zero-cost basis inventory at launch; cost of sales was $14K.

Outlook and guidance

• Cash runway expected to support operations and clinical programs into the second half of 2027, including Phase 3 AFib-RVR trial costs.

• Anticipates further acceleration in prescription volume as payer coverage expands and promotional efforts deepen.

• First patient enrollment in the ReVeRA-301 phase III AFib-RVR trial expected in H2 2026, with study completion targeted in approximately two years; European approval decision expected by H1 2027.

• Continued investment in CARDAMYST commercialization and AFib-RVR clinical development; anticipate ongoing operating losses as activities expand.