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Milestone Pharmaceuticals (MIST) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 12, 2026

Source: earnings call transcript

Executive summary

Milestone Pharmaceuticals Q2 FY26 — Cardamyst Launch Progress and AFib-RVR Phase 3 Initiation

Milestone Pharmaceuticals reported solid early progress for its Cardamyst launch in Q2 FY26, marked by growing prescriber breadth and significant expansion in commercial coverage post-quarter end. The company is leveraging its PSVT launch experience to advance its Phase 3 AFib-RVR program, aiming for label expansion. Management expects accelerated growth in the second half of the year as coverage improves and patient activation initiatives begin.

Highlights

4
  • Over 600 unique healthcare professionals wrote prescriptions for Cardamyst in Q2 FY26, bringing the H1 FY26 total to over 800 unique prescribers.

  • Total prescriptions for Cardamyst reached over 1,200 in Q2 FY26, totaling over 1,500 for H1 FY26.

  • Commercial formulary coverage for Cardamyst expanded to over 50% of commercially insured lives as of August 2026, up from 25% in Q2 FY26.

  • Initiated pivotal Phase 3 trial (ReVeRA-301) for etripamil in AFib-RVR, leveraging prior PSVT program experience.

Concerns

1
  • Net loss for Q2 FY26 increased to $28.6 million (21 cents per share) from $13 million (20 cents per share) in Q2 FY25, driven by increased SG&A for launch.

Guidance & targets

CategoryTargetConfidence
Cash, cash equivalents, and short-term investments runway
Into the second half of 2027
high materiality
High
EMA decision for etripamil in PSVT
Expected in the first half of 2027
medium materiality
High

Segment performance

SegmentRevenueYoYQoQMargin
Cardamyst
Cardamyst is the company's primary commercial product for PSVT. The launch is showing early positive indicators with growing prescriber breadth and increasing commercial coverage. The company expects accelerated growth in the second half of the year.
Unique prescribers Q2 FY26: 600Unique prescribers H1 FY26: >800Total prescriptions Q2 FY26: >1,200Total prescriptions H1 FY26: >1,500Patients receiving Cardamyst Q2 FY26: >1,000Patients receiving Cardamyst H1 FY26: >1,300Commercial formulary coverage Q2 FY26: 25%Commercial formulary coverage as of August 2026: >50%
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Deals & partnerships

Everest Medicines Regulatory engagement for etripamil in China

Everest Medicines is Milestone's partner responsible for engaging with Chinese regulators regarding the marketing application for etripamil in PSVT.

Risks & headwinds

Low initial commercial coverage for Cardamyst Q2 FY26

25% of commercially insured lives during Q2 FY26

Mitigation:Expanded to over 50% post-quarter end; strategy to make drug easy to get with copay mitigation and denial conversion.

Increased SG&A expenses due to Cardamyst launch Q2 FY26

$22.6 million in Q2 FY26 vs $8.9 million in Q2 FY25

Mitigation:Expected to drive accelerated growth in H2 FY26 as coverage improves and patient activation begins.

Patient misdiagnosis of AFib-RVR events in Phase 3 trial Ongoing during Phase 3 trial

PSVT program saw ~20% mischaracterization

Mitigation:Incorporated into study powering; will adjust tactics as study progresses in a blinded manner.

Reliance on patient-reported outcomes as pivotal secondary endpoint in AFib-RVR Phase 3 trial During Phase 3 trial

Secondary endpoint is pivotal for approval

Mitigation:Double down to ensure patient-reported outcome performs well and data is captured as if it was a primary.

What to watch in Q3 FY26

Cardamyst Commercial Coverage

next quarter
Current >50% of commercially insured lives
Target Continued growth towards critical mass

Why it matters

Critical for reducing denial conversion, improving gross-to-net revenue, and increasing physician willingness to prescribe broadly.

As of last week, approximately half of commercially insured lives are now covered... we remain optimistic about securing the last of the major PBMs and associated insurance providers, as well as pulling through additional plans who work with ESI and Optum Rx.

Find out whether MIST delivers this. Inve re-checks your case every morning.

Q&A highlights

What percentage of the 600 new Q2 prescribers were high-volume vs. one-time writers, and how is the mix between cardiologists, electrophysiologists, and nurse practitioners shifting?

Many Q2 writers were one-timers, but this is seen as a strength, indicating broad initial adoption. Electrophysiologists are prescribing more than expected. The company plans to increase call frequency for early adopters to drive depth of prescribing, while continuing to expand breadth.

“You know, we always expected EPs to treat these patients, but we didn't expect them to write as early and as broadly because, you know, let's face it, their job is to do ablations, right? And so we always expected some use, but we're seeing, I think, more than we even expected, which I think is an early sign of, you know, a good sign for the market where we've got the thought leaders that are getting experience and then going to be advocating for it.”

asked by Athena Chan · answered by Joseph Oliveto

2 min read 6 chapters

Detailed narrative

Cardamyst Launch Dynamics and Early Indicators

The commercial launch of Cardamyst, initiated in mid-February, is showing early positive indicators. The company observed a significant increase in unique prescribers, total prescriptions, and patients receiving the drug from Q1 to Q2. The strategy has focused on making the drug accessible, even with low initial commercial coverage, by utilizing copay mitigation and denial conversion programs.

Management noted that electrophysiologists are prescribing more broadly and earlier than expected, which is a positive sign for market adoption.

Market Access Progress and Strategy

Commercial formulary coverage for Cardamyst was approximately 25% of commercially insured lives during Q2 FY26. However, post-quarter end, this expanded significantly to over 50% of commercially insured lives, driven by decisions from major PBMs like UnitedHealthcare, Express Scripts, and Optum Rx.

This improved coverage is expected to reduce denial conversions and improve gross-to-net revenue, as well as encourage broader physician prescribing due to reduced access hurdles.

AFib-RVR Program Advancement

Milestone has initiated its pivotal Phase 3 trial, ReVeRA-301, for etripamil in atrial fibrillation with rapid ventricular rate (AFib-RVR). This program aims to address a substantially larger patient population (3-4 million addressable patients) compared to PSVT. The study design mirrors the successful PSVT program, utilizing self-administration at home and the same 70mg dose, with an efficient sNDA pathway for label expansion.

The company expects first patients to be enrolled shortly.

International Regulatory Progress

Beyond the US, Milestone is pursuing regulatory decisions for PSVT in Europe and China. The marketing application with the European Medicines Agency (EMA) is on track for a decision in the first half of 2027. For China, partner Everest Medicines is managing engagement with local regulators, indicating ongoing efforts to expand etripamil access globally.

Sales and Marketing Strategy Evolution

The company's sales efforts have established a broad prescriber base across electrophysiologists, clinical cardiologists, interventional cardiologists, and advanced practice providers. The strategy for the second half of the year involves continuing to grow this base while also focusing on driving greater depth of prescribing among early adopters.

Patient activation efforts, including an enhanced Cardamyst.com and targeted digital advertising, are being initiated now that commercial coverage has reached a critical mass, aiming to encourage patients to ask their healthcare providers about Cardamyst.

Financial Position and Launch Costs

As of June 30, 2026, Milestone reported cash, cash equivalents, and short-term investments of $170.6 million, which is projected to be sufficient to cover operating expenses and capital expenditures into the second half of 2027. The increase in Selling, General and Administrative (SG&A) expenses to $22.6 million in Q2 FY26 (from $8.9 million in Q2 FY25) reflects the costs associated with the Cardamyst launch, including additional personnel and professional costs.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.