Milestone Pharmaceuticals (NASDAQ:MIST) executives highlighted the company’s transition to commercialization during a year-end 2025 update call, following the U.S. Food and Drug Administration’s December approval of CARDAMYST (etripamil nasal spray) for the conversion of paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm in adults.
Chief Executive Officer Joseph Oliveto described the approval as a “transformational event” and said the company is now focused on launching the product and building a commercial franchise. He said Milestone views the approval as a foundation for value creation, both through the U.S. launch and potential ex-U.S. opportunities.
Commercial launch: early prescription activity and access focus
According to management, the company moved quickly post-approval:
- Retail availability: CARDAMYST became available through retail pharmacies nationwide within about six weeks of FDA approval, with availability in late January.
- Promotional launch: Milestone began promotional efforts by mid-February.
- Sales force: The company hired, trained, and deployed a national sales force of approximately 60 representatives within about two months, with sales efforts targeting roughly 10,000 providers.
Muller said Milestone is targeting high-prescribing cardiologists, electrophysiologists, and advanced practice providers (APPs). He said the company estimates those 10,000 providers manage about half of the approximately 1 million PSVT patients expected to receive treatment for the condition in 2026.
In terms of early demand indicators, Muller said prescriptions are being written, wholesalers are ordering replenishment product, and patients are “walking out of pharmacies with CARDAMYST in hand,” which he said suggests retail distribution is functioning. He added that the sales force is delivering well over 1,000 engagements per week with targeted providers.
During the first month of promotion, management reported more than 150 prescriptions filled from more than 100 unique prescribers, with most filled prescriptions representing new patient starts and written by targeted providers. Muller cautioned that it is too early to comment on trends or durable patterns, particularly because the company does not yet have contracted coverage in place.
Reimbursement: denials, prior authorizations, and support services
Management emphasized that access and reimbursement will be critical near-term factors. Muller said Milestone’s early launch efforts were designed around three pillars: making CARDAMYST accessible and affordable for patients, making it easy to prescribe for providers, and limiting the need for payers to actively manage use.
In the Q&A, executives said early coverage denials and delays have often reflected insurer processes that effectively block coverage until plan review, requiring additional paperwork. Oliveto cited examples of documentation requests to confirm diagnosis and patient history, such as PSVT events and emergency room visits.
Oliveto also discussed the timing of reimbursement pull-through, noting that the company has only about four weeks of launch data. He said that once providers engage Milestone’s support systems, the company has seen prescriptions filled within days in some cases and within weeks in others, while a few prescriptions had not yet been filled as of the call.
Muller described the company’s patient assistance and reimbursement support platform, including benefits verification, reimbursement support, and copay assistance for eligible commercially insured patients whose plans cover CARDAMYST. He also described active work to support offices with prior authorization and medical exception paperwork, while the company continues payer engagement efforts. He said the “natural dampening” of prescription fills ahead of contracted coverage is within expectations based on pre-launch interactions with payers.
On the company’s contracting approach, Oliveto said Milestone’s strategy is to “drive to coverage” because lack of coverage dampens prescription fulfillment. He said the company is actively engaging payers, with a focus on commercial plans first while also working on Medicare, which he said has longer lead times. Oliveto reiterated prior expectations that Medicare coverage is more likely a 2027 achievement, while commercial coverage is expected to start in 2026, though he said timing is outside the company’s control.
Asked what favorable formulary positioning would look like, management said it is seeking relatively open access with standard requirements such as prior authorization consistent with the product’s label and attestation that the patient is being treated for PSVT. The company also expects potential quantity limits, particularly early in launch, which management said could help address payer questions about frequency of use. Management characterized the expected discounts as “standard pay-to-play.”
On patient mix, management said PSVT patients are roughly split, about 50% under age 65 and about 50% over 65.
Supply and patient feedback
Oliveto said Milestone is well prepared on supply, noting the company still has supply available from prior research and development efforts and has moved onto a routine cadence for future batches.
On early real-world feedback, Oliveto said it is too early to identify leading trends in what CARDAMYST may be replacing, describing initial prescribing as broad. He cited examples of patients receiving the product ahead of ablation and others who had been waiting for a new option. He also said the company is monitoring patient discussions and noted “excitement” among patients about having an on-hand option, even before use, given the uncertainty associated with PSVT episodes.
Regulatory update in Europe
Oliveto said Milestone filed a marketing authorization application in Europe in the fourth quarter of 2025 for etripamil nasal spray, which will be known as TACHYMIST in Europe. He said the European Medicines Agency accepted the application in January and that Milestone expects a review decision in the first half of 2027.
Financial results and liquidity update
Chief Financial Officer Amit Hasija reviewed financial results and recent financing activity. Milestone recognized $1.5 million in revenue in the fourth quarter and full year of 2025, which he said reflected amounts earned under a licensing collaboration agreement with Corxel following FDA approval in the U.S. There was no comparable revenue in 2024.
For expenses, Hasija reported:
- R&D expense (net of tax credits): $5.5 million in Q4 2025 versus $3.9 million in Q4 2024; $18.1 million for full-year 2025 versus $14.4 million in 2024, driven primarily by higher consulting and outside services costs, partially offset by lower personnel-related costs.
- G&A expense: $5.1 million in Q4 2025 versus $4.0 million in the prior-year quarter; $17.3 million for full-year 2025 versus $16.7 million in 2024, driven by higher outside services and personnel costs.
- Commercial expense: $8.2 million in Q4 2025 versus $4.4 million in Q4 2024; $28.3 million for full-year 2025 versus $11.0 million in 2024, reflecting added personnel, professional, and operational costs tied to launch preparation.
Net loss was $17.4 million, or $0.16 per share, in Q4 2025 compared to $12.4 million, or $0.19 per share, in Q4 2024. For the full year, net loss was $63.1 million, or $0.75 per share, compared to $41.5 million, or $0.67 per share, in 2024.
As of Dec. 31, 2025, Milestone had $106 million in cash, cash equivalents, and short-term investments. Hasija also detailed subsequent liquidity events: the company received $75 million on Jan. 12, 2026 from the sale of a royalty interest in CARDAMYST to RTW, raised approximately $10.9 million in net proceeds through its at-the-market program, and received $8 million in net proceeds from warrant exercises. On a pro forma basis, management estimated cash of approximately $200 million, which it said is expected to fund operations into late 2027.
Oliveto closed by calling the period “early days” for the launch and said Milestone plans to provide quarterly updates on launch progress going forward.
About Milestone Pharmaceuticals (NASDAQ:MIST)
Milestone Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on developing innovative therapies for respiratory diseases. The company’s research emphasizes both biologic and small-molecule approaches designed to improve mucociliary clearance, reduce airway inflammation and address chronic and refractory cough. Milestone’s pipeline targets key underserved conditions such as cystic fibrosis, primary ciliary dyskinesia and severe asthma.
Milestone’s lead product candidates are delivered through inhalation or systemic administration, reflecting the company’s commitment to optimizing therapeutic delivery directly to the lungs.
