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Sep 30
Milestone Pharmaceuticals Q3 2025 Earnings Report
Milestone Pharmaceuticals reported a wider net loss in Q3 2025 as operating expenses rose ahead of a potential CARDAMYST launch, with no revenue recorded during the quarter.
Key Takeaways
Milestone Pharmaceuticals saw its Q3 2025 net loss increase to $11.9 million amid rising commercial expenses as the company gears up for the potential launch of CARDAMYST. No revenue was generated during the quarter.
No revenue was reported in Q3 2025.
Net loss increased to $11.9 million compared to $9.4 million in Q3 2024.
Commercial expenses rose to $4.6 million due to launch preparations for CARDAMYST.
Cash and cash equivalents rose to $82.6 million following an equity offering and amended royalty agreement.
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
Milestone is preparing for a potential FDA approval of CARDAMYST in December 2025, with resources and infrastructure in place for a rapid commercial launch.
Positive Outlook
- PDUFA target date for CARDAMYST set for December 13, 2025.
- Promotional launch plans are in place for immediate rollout upon approval.
- Strengthened financial position through recent equity offering and royalty agreement.
- Clinical data presented supports efficacy and safety of etripamil.
- Phase 3 protocol for AFib-RVR program finalized with FDA discussions completed.
Challenges Ahead
- No revenue generated in Q3 2025.
- Net loss increased year-over-year.
- Commercial expenses surged due to pre-launch investments.
- Interest income decreased compared to Q3 2024.
- Dependent on FDA approval and regulatory outcomes to proceed with commercial plans.