Milestone Pharmaceuticals Inc. Q4 FY2025 earnings call

• December 2025 saw the FDA approval of Cardamist, a trypamil nasal spray for paroxysmal supraventricular tachycardia. - The commercial team is executing the launch of Cardamist, aiming to bring it to patients and build a strong commercial franchise. - Plan to leverage FDA approval to seek marketing approvals in other parts of the world, with a marketing authorization application for Europe accepted in January 2026 and expected review decision in the first half of 2027. - Recently enhanced the leadership team with the addition of David Sandoval as General Counsel and Chief Compliance Officer.

In the fourth quarter of 2025, milestone revenue was $1.5 million, with no revenue comparables in 2024 for the full - year milestone revenue which was $1.5 million. R&D expense net of tax credits was $5.5 million in the fourth quarter of 2025 compared to $3.9 million in the fourth quarter of 2024, and for the full year, R&D expense was $18.1 million compared to $14.4 million in 2024. G&A expense was $5.1 million in the fourth quarter of 2025 compared to $4.0 million in the prior quarter, and for the full year, it was $17.3 million compared to $16.7 million in 2024. Commercial expense was $8.2 million in the fourth quarter of 2025 compared to $4.4 million in the fourth quarter of 2024, and for the full year, it was $28.3 million compared to $11 million in 2024. Net loss for the fourth quarter of 2025 was $17.4 million, or $0.16 per share, compared to $12.4 million, or $0.19 per share, in the fourth quarter of 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. As of December 31st, 2025, there was $106 million in cash, cash equivalents, and short - term investments. After additional funds from RTW royalty payment, at - the - market offering, and warrant exercises, the pro forma cash number was approximately $200 million.

• Expect prescription volume to increase and commercial coverage to expand over time, with more meaningful progress in the back half of the year. - The pro forma cash of approximately $200 million supports a successful launch of Cardamist and provides operating runway into late 2027.

• Forward - looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties are described in detail in the company's filings with the SEC, including the risk factor section of the earnings report on Form 10 - K for the year ended December 31, 2025.

Q: A couple questions on the cardamom launch. How has feedback been to date between the different prescribers that you're targeting, and where are you seeing the most adoption? And on coverage, what are the leading reasons for coverage denial?

A: With regard to prescribers, seeing a broad mix across cardiology, electrophysiology, and APPs. For coverage denial, it's a bit of a mix early on, with a lot of paperwork for confirmation like on whether the patient has PSVT, had events, visited the emergency department, etc.

Q: How long is it taking for reimbursement to kick in? And what is Milestone doing to kind of make sure patients get drug in that delay period? How does that work? Or are they getting drug and it's just they then have to kind of fight to get it paid for? And then secondly, when it comes to supply, What can you tell us about manufacturing supply and sort of how that side of the business is looking?

A: With regard to reimbursement, there is natural dampening with some scripts not filled yet, but have patient support system, copay assistance programs. On supply, well prepared with supply left over from R&D efforts and routine cadence for next batches.

Q: Given it is early, do you have any sense of, when COTOMIST is being prescribed currently, what it is replacing? Is it the pull in the pockets? Is it newly diagnosed patients? Just any color there would be helpful. And then maybe secondly, I'll just ask this with it because, you know, granted, I don't know how much data you have at this stage, but in terms of early real - world feedback, have you heard of any patients having an episode post having cardamom? And if that has happened, you know, has it worked as anticipated?

A: On what COTOMIST is replacing, it's broad with examples like patients getting it before an ablation or as routine course. On patients having an episode post - using cardamom, waiting to hear from patients but have social listening and support group.

Q: Could you talk a little bit more about what does good formulary positioning look like for cartomus and how much rebate pressure should we expect if you push for broader access? And then separately, what is the patient mix in terms of coverage, in terms of commercial versus Medicare?

A: Good formulary positioning includes prior off to label and attestation of patient being treated for PSVT, with expected quantity limits. Patient mix is roughly 50 - 50 between commercial and Medicare.