Milestone Pharmaceuticals Inc. Q2 FY2026 earnings call

Commercial Launch of Cardamist (PSVT Treatment)

• Cardamist launched commercially in mid-February 2026, making it the first FDA-approved self-administered at-home treatment for paroxysmal supraventricular tachycardia (PSVT). As of Q2 2026, the launch has built a strong early foundation:

  • Over 600 unique prescribers wrote Cardamist prescriptions in Q2 2026, up from ~200 in Q1, bringing total unique prescribers to over 800 across the first 4.5 months of commercial activity.
  • Total prescriptions hit 1,200 in Q2 2026, up from ~300 in Q1, for a total of over 1,500 in H1 2026. Over 1,000 patients received Cardamist in Q2, up from ~300 in Q1, for a total of over 1,300 patients in H1 2026.
  • Formulary coverage for commercially insured lives reached ~25% by the end of Q2, and expanded to over 50% in July-August 2026 following favorable formulary decisions from United Healthcare and other major insurers.
  • Early patient anecdotes confirm Cardamist successfully replaces emergency department visits for PSVT attacks, with positive feedback from both patients and providers.

• Commercial strategy update for H2 2026:

  • Shift from pure breadth of new prescriber acquisition to a dual focus on adding new prescribers and increasing depth of prescribing from existing early adopters.
  • Launch targeted patient activation initiatives (digital advertising, enhanced patient-focused Cardamist.com) now that 50% commercial coverage has been reached, to encourage patients to ask their providers about Cardamist, which correlates to high prescription approval rates.

Pipeline Progress

• The pivotal Phase III Rivera 301 trial for atripomil (Cardamist) in atrial fibrillation with rapid ventricular rate (AFib-RVR) has activated lead clinical sites, with first patient enrollment expected shortly.
  • AFib-RVR is a substantially larger market opportunity than PSVT, with an estimated 3-4 million addressable symptomatic patients in the U.S. The trial uses the same dose, self-administration protocol, and operational infrastructure as the successful PSVT Phase III program, lowering execution risk.
  • The regulatory pathway is a single-study supplemental new drug application (sNDA), an efficient route to label expansion.
• Global regulatory progress for PSVT: The EMA marketing application remains on track for a decision in H1 2027, and development in China is progressing via partner Everest Medicines.

Milestone Pharma operates only one commercial product segment at this time, its approved PSVT treatment Cardamist. For Q2 2026, Cardamist generated product revenue of $0.6 million, bringing total 2026 half-year product revenue to $0.8 million. There was no product revenue recorded in the same periods of 2025. Research and development (R&D) expense was $3.5 million in Q2 2026, down from $3.7 million in Q2 2025, and $6.8 million for the first half of 2026, down from $8.6 million in H1 2025, due to lower external drug development service costs. Selling, general, and administrative (SG&A) expense, which covers all commercial launch overhead for Cardamist, was $22.6 million in Q2 2026, up from $8.9 million in Q2 2025, and $43.3 million for H1 2026, up from $24.4 million in H1 2025, driven by additional personnel, professional, and launch-related operational costs. Net loss for Q2 2026 was $28.6 million (21 cents per share), compared to a $13 million net loss (20 cents per share) in Q2 2025. For H1 2026, net loss was $54.7 million (41 cents per share), compared to a $33.7 million net loss (51 cents per share) in H1 2025. As of June 30, 2026, the company held $170.6 million in cash, cash equivalents, and short-term investments, up from $106 million at December 31, 2025.

• Cash on hand as of June 30 2026 is expected to be sufficient to fund all operating expenses and capital expenditures into the second half of 2027. • Management expects accelerated Cardamist prescription and revenue growth in H2 2026, driven by expanded 50% commercial coverage, dual breadth/depth prescriber strategy, and newly launched patient activation initiatives. • Management expects to continue expanding commercial coverage to additional major PBMs and insurers after crossing the 50% of commercially insured lives threshold, and is bullish on further coverage gains in H2 2026. • First patient enrollment in the Phase III AFib-RVR trial is expected shortly, with updates provided as enrollment progresses. • EMA approval decision for PSVT is still expected in H1 2027, maintaining prior guidance timelines.

• Low commercial coverage through Q2 2026 required high levels of copay mitigation and denial conversion, which suppressed average selling prices for the quarter, though this is expected to improve as coverage expands. • For the AFib-RVR Phase III trial, two key risks differ from the prior PSVT program:

• A patient-reported secondary endpoint is pivotal to approval, which was not required for the original PSVT approval, adding execution uncertainty.
• Patient misdiagnosis of AFib-RVR events is expected to create a data dilution effect similar to what was seen in the PSVT program, though the company has adjusted trial powering to account for this risk. • Patient experience with Cardamist, which drives future prescribing, depends on patients experiencing a PSVT/AFib-RVR episode after receiving a prescription, which can delay the pace of adoption growth. • The timing of further formulary coverage decisions is controlled by payers, not Milestone Pharma, creating uncertainty around the pace of additional coverage gains.

Q: The analyst asks for a breakdown of 800 total unique prescribers, including the share of high-volume vs one-time prescribers and the specialty mix of prescribers, as well as how the mix is shifting during launch. / A: Management notes that most early prescribers are one-time writers, which they view as a positive early indicator of future growth, as half of the 10,000 high-value target providers have been reached so far, with 800 already prescribing. The prescriber base has a healthy mix of general/interventional cardiologists, advanced practice providers, and electrophysiologists (EPs). EP adoption has been stronger than expected, and EPs show a strong promotional response. Going forward, the strategy will combine continued breadth of new prescriber growth with increased frequency of outreach to existing prescribers to drive deeper prescribing volume.

Q: The analyst asks for commentary on pricing, gross-to-net discounts, and early indications of repeat patient use of Cardamist. / A: Management explains that low 25% commercial coverage in Q2 required high levels of copay mitigation and denial conversion, which significantly suppressed average selling prices for the quarter. As coverage expanded to 50% post-Q2, the share of prescriptions requiring mitigation will fall, and average selling prices will rise over time. Early data shows emerging repeat use across patients, with 1,500 total scripts for 1,300 total patients through H1, which aligns with expectations from clinical trials.

Q: The analyst asks how expanded 50% commercial coverage will impact prescriptions vs revenue, and what the key remaining risks are for the AFib-RVR Phase III trial. / A: Management states expanded coverage will improve both metrics: the biggest near-term impact is higher average selling prices from less denial conversion, but it will also drive higher prescription growth, as physicians are more willing to prescribe when coverage is reliable, reducing administrative friction. For the AFib trial, the key risks are that a pivotal patient-reported secondary endpoint (new to this program) must perform well, and that patient misdiagnosis of events can dilute trial data, though the trial has been powered to account for this effect.

Q: The analyst asks if prescribers are waiting for their own patient experience before broader adoption, and what the back-half 2026/2027 prescribing strategy will look like, and when the company will shift focus from breadth to depth of prescribing. / A: Management confirms it is common for cardiologists to wait for their own positive patient experience before expanding prescribing, which creates future upside as early positive experiences drive more adoption. Since patient events can be infrequent, this slightly slows near-term adoption. The strategy is already shifting to a dual focus: reps continue prospecting for new late-adopting targets, while increasing outreach frequency to existing early adopters to drive more consistent prescribing across their eligible patient population.

Q: The analyst asks what is driving the expected H2 2026 growth acceleration, what patient activation efforts entail, and how quickly commercial coverage will scale from 50%. / A: Management expects growth to come from the combined effect of expanded coverage, provider awareness building, and new targeted patient activation. Patient activation is not full DTC advertising: it is a targeted digital campaign that directs interested patients to the enhanced Cardamist.com website for education, copay resources, and encouragement to ask their provider about Cardamist, leveraging the high prescription approval rate when patients request the drug. Management is bullish on further coverage gains in H2 2026, though timing of decisions is controlled by payers.