Milestone Pharmaceuticals Reports Q4 and Full Year 2025 Results, Updates on CARDAMYST™ (etripamil) Nasal Spray Launch

Key Highlights

• FDA Approval of CARDAMYST™: CARDAMYST™ (etripamil) nasal spray approved by the FDA on December 12, 2025, marking the first new option in 30 years for over two million U.S. patients with paroxysmal supraventricular tachycardia (PSVT).
• Strong Initial Launch Execution: Nationwide commercial launch on track, with positive initial feedback from healthcare providers, patients, and payers. National sales force of 60 representatives fully deployed within eight weeks of approval.
• Robust Financial Position: Pro forma cash position of \$200 million (including \$106 million at year-end 2025 and proceeds from follow-on financing), supporting operations and commercialization runway into late 2027.
• Early Prescription Uptake and Reimbursement: Early prescription fills indicate underlying demand and success of reimbursement investments, even before broad payer coverage is established.
• European Expansion: Marketing Authorization Application (MAA) for etripamil accepted by the European Medicines Agency (EMA), with a decision expected in H1 2027 under the TACHYMIST™ brand.
• Pipeline Progress: Phase 3 program planned for etripamil in atrial fibrillation with rapid ventricular rate (AFib-RVR), leveraging PSVT approval for regulatory pathway.
• Recent Financing Activities: \$75 million payment received from RTW Royalty I DAC post-FDA approval. Additional \$19 million net proceeds raised through ATM sales and warrant exercises.
• Leadership Update: David Sandoval appointed as General Counsel and Chief Compliance Officer, bringing extensive experience in late-stage development, regulatory, and commercialization.
• Financial Results: Net loss of \$63.1 million for full year 2025 (\$0.75 per share), compared to \$41.5 million (\$0.67 per share) in 2024.

In-Depth Details and Investor-Relevant Information

Commercial Launch of CARDAMYST™

CARDAMYST™ (etripamil) nasal spray is a first-in-class, self-administered therapy for PSVT. The FDA approval allows patients to manage acute episodes rapidly outside of healthcare settings, significantly addressing a longstanding treatment gap. The product became available in U.S. retail pharmacies in late January 2026, and the promotional launch commenced in mid-February with a 60-strong sales force focusing on cardiologists, electrophysiologists, and advanced practice providers.

Early prescription data suggest strong initial demand. Most prescriptions to date are for new patients and come from targeted providers. Milestone anticipates reporting more detailed quarterly prescription metrics as data accumulates, which could be a leading indicator of future revenue growth.

International Expansion

The company’s MAA for etripamil in PSVT was accepted by the EMA. Branded as TACHYMIST™ in Europe, a regulatory decision is expected by the first half of 2027. This presents significant future revenue potential and diversification beyond the U.S. market.

Clinical and Regulatory Developments

• A new Phase 3 registrational program for AFib-RVR is planned, aiming to expand etripamil’s label. The company will pursue a supplemental New Drug Application (sNDA) pathway, leveraging data from both PSVT and the new study.
• At the upcoming American College of Cardiology (ACC) Scientific Session (March 30, New Orleans), Milestone will present new data on the minimal blood pressure effects of intranasal etripamil, further supporting its safety and self-administration profile. ACC will also serve as a major launch event to drive product awareness among prescribers.

Financial Position and Capital Market Activity

• Year-end 2025 cash, cash equivalents, and short-term investments were \$106 million, up from \$69.7 million at year-end 2024.
• Pro forma cash position is \$200 million, with recent financing activities including:
  • \$75 million royalty payment from RTW Royalty I DAC following FDA approval.
  • \$10.9 million from ATM sales (5.5 million shares) and \$8 million from Series A warrant exercises (5.7 million warrants).
• Management expects this cash runway to fund operations and the CARDAMYST launch into late 2027, reducing near-term dilution risk and supporting continued pipeline development.

Financial Performance

• Revenue for 2025 was \$1.5 million, driven by a milestone payment from Corxel Pharmaceuticals upon FDA approval of CARDAMYST.
• Operating expenses rose significantly in 2025, reflecting launch preparations:
  • R&D: \$18.1 million (up from \$14.4 million in 2024)
  • General & Administrative: \$17.3 million (up from \$16.7 million)
  • Commercial: \$28.3 million (up from \$11.0 million)
• Net loss for the year was \$63.1 million (\$0.75 per share), up from \$41.5 million (\$0.67 per share) in the prior year, primarily due to increased commercial spend.
• Share count increased to 106.2 million common shares at December 31, 2025 (from 53.4 million in 2024), reflecting fundraising activities.

Important Safety Information for CARDAMYST™

CARDAMYST™ is indicated for the conversion of acute symptomatic PSVT to sinus rhythm in adults. It is contraindicated in patients with certain cardiac conditions (e.g., moderate/severe heart failure, WPW syndrome, sick sinus syndrome without pacemaker, higher-degree AV block) and should be used with caution in those with a history of fainting or low blood pressure. Common side effects include nasal discomfort, congestion, runny nose, throat irritation, and nosebleed. Patients should sit or lie down when using the product due to the risk of dizziness or fainting.

What Should Investors and Shareholders Watch?

• CARDAMYST Launch Trajectory: Early prescription uptake, provider engagement, and payer coverage progress are critical metrics. Future quarterly updates on prescription and prescriber data will be closely monitored for signs of commercial traction.
• Cash Runway and Dilution: The current \$200 million cash position provides a substantial runway, but ongoing monitoring of burn rate and financing needs is warranted given the company’s operating losses.
• Regulatory Milestones: EMA approval decision (expected H1 2027) and the initiation/progress of Phase 3 AFib-RVR trial could serve as significant catalysts.
• Pipeline Expansion: Success in the AFib-RVR indication would open a much larger addressable market, driving further upside.
• Shareholder Dilution: The increase in share count due to ATM and warrant exercises should be considered in valuation models.

Conference Call Details

• Date: March 20, 2026, at 8:30am ET
• Dial-in: 1-877-407-0792 (US), 1-201-689-8263 (International), Conference ID: 13759195
• Webcast: Available on Milestone’s investor relations site

Conclusion

The FDA approval and commercial launch of CARDAMYST™ mark a pivotal inflection point for Milestone Pharmaceuticals, opening a new chapter as a commercial-stage company. With a significant cash runway, early signs of market acceptance, and a potentially expanding pipeline and geographic footprint, the company is positioned for transformational growth. However, investors should remain attentive to commercial execution, regulatory developments, and ongoing financial performance, all of which could materially impact share value.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research and consult with professional advisors before making any investment decisions. The information contained herein is based on company disclosures as of March 20, 2026, and may be subject to change. Past performance is not indicative of future results.

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