Milestone Pharmaceuticals Inc. reported a net loss of $63.1 million for the fiscal year ending December 31, 2025, compared to a loss of $41.5 million in the previous year, marking an increase of 51.9%. The company generated $1.5 million in revenue from license agreements, a significant change from no revenue in 2024, attributed to the successful FDA approval of its product, CARDAMYST™ (etripamil) nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Total operating expenses rose by 51.3% to $63.7 million, driven primarily by a 157.2% increase in commercial expenses as the company prepared for the product launch.
In terms of operational developments, Milestone has focused on the commercialization of CARDAMYST, which became available in retail pharmacies in early 2026. The company anticipates engaging approximately 500,000 patients diagnosed with PSVT in 2026, supported by a sales team of around 60 representatives. Additionally, Milestone is pursuing further development of etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR), having completed a successful Phase 2 study and planning a Phase 3 trial. The company has also submitted a marketing authorization application to the European Medicines Agency for etripamil under the trade name TACHYMIST™.
Milestone's financial position remains robust, with cash and cash equivalents totaling $73.0 million and short-term investments of $32.9 million as of December 31, 2025. The company has an accumulated deficit of $430.6 million, reflecting its ongoing investment in research and development. The recent sale of a royalty interest in CARDAMYST for $75 million is expected to bolster its financial resources, allowing for continued investment in commercialization and further clinical trials.
Looking ahead, Milestone anticipates continued operating losses as it invests in the commercialization of CARDAMYST and the development of additional indications for etripamil. The company expects to incur significant expenses related to ongoing clinical trials and the expansion of its sales and marketing capabilities. Despite these challenges, Milestone believes its existing cash and investments will be sufficient to fund operations for at least the next 12 months, although it may seek additional funding through equity or debt financing to support its growth strategy.
About Milestone Pharmaceuticals Inc.
Milestone Pharmaceuticals develops innovative cardiovascular medicines, focusing on rapid-onset nasal spray treatments for arrhythmias like PSVT and AFib-RVR. Its flagship product, CARDAMYST (etripamil), aims to provide self-administered, fast-acting therapy for episodic heart rhythm disturbances. The company targets the U.S. and global markets, leveraging proprietary formulations, clinical data, and strategic partnerships to address unmet needs in acute cardiovascular care.
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