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    MIST
    Earnings call· Jun 2026(Q2 FY26)

    Milestone Pharmaceuticals Q2 FY26 earnings call MIST

    Aug 12, 2026 Source

    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

    2
    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

    1
    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%
    		————

    Operational metrics

    19
    Cash, cash equivalents, and short-term investments
    $170.6 millionvs. $106 million at December 31, 2025
    June 30, 2026

    Financial position at quarter end.

    Product revenue
    $0.6 millionN/A
    Q2 FY26

    Product revenue for the three months ended June 30, 2026.

    Product revenue
    $0.8 millionN/A
    H1 FY26

    Product revenue for the six months ended June 30, 2026.

    Research and development expense net of tax credits
    $3.5 millionvs. $3.7 million for Q2 FY25
    Q2 FY26

    Decrease due to lower outside service costs related to drug development and research.

    Research and development expense net of tax credits
    $6.8 millionvs. $8.6 million for H1 FY25
    H1 FY26

    Decrease due to lower outside service costs related to drug development and research.

    Selling, general and administrative expense
    $22.6 millionvs. $8.9 million for Q2 FY25
    Q2 FY26

    Increase due to additional personnel costs, professional costs, and other operational expenses related to the launch of Cardamyst.

    Selling, general and administrative expense
    $43.3 millionvs. $24.4 million for H1 FY25
    H1 FY26

    Increase due to additional personnel costs, professional costs, and other operational expenses related to the launch of Cardamyst.

    Net loss
    $28.6 millionvs. $13 million for Q2 FY25
    Q2 FY26

    Net loss for the three months ended June 30, 2026.

    Net loss
    $13 millionN/A
    Q2 FY25

    Net loss for the three months ended June 30, 2025.

    Net loss
    $54.7 millionvs. $43.7 million for H1 FY25
    H1 FY26

    Net loss for the six months ended June 30, 2026.

    Net loss
    $43.7 millionN/A
    H1 FY25

    Net loss for the six months ended June 30, 2025.

    EPS
    21 centsvs. 20 cents per share for Q2 FY25
    Q2 FY26

    EPS for the three months ended June 30, 2026.

    EPS
    20 centsN/A
    Q2 FY25

    EPS for the three months ended June 30, 2025.

    EPS
    41 centsvs. 51 cents per share for H1 FY25
    H1 FY26

    EPS for the six months ended June 30, 2026.

    EPS
    51 centsN/A
    H1 FY25

    EPS for the six months ended June 30, 2025.

    Addressable population with burdensome symptomatic RVR
    3 to 4 million
    N/A

    Estimated addressable population for etripamil in AFib-RVR.

    Sales call universe
    26,000
    N/A

    Total number of targets for sales force outreach.

    Copay card out-of-pocket
    $25
    N/A

    Amount patients pay with the copay card.

    PSVT patient misdiagnosis rate in trials
    20%
    N/A

    Percentage of patients who mischaracterized their event in the PSVT program, relevant for AFib-RVR trial risk assessment.

    Industry KPIs

    4
    MetricValueDetails
    Prescription volume>1,200prescriptions
    Pipeline clinical milestonesPhase 3 trial initiated
    Regulatory approvals filingsEMA decision expected H1 2027; China engagement ongoing
    Price volume mix decomposition—

    Deals & partnerships

    1
    Everest MedicinesRegulatory 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

    4
    Low initial commercial coverage for CardamystQ2 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 launchQ2 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 trialOngoing 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 trialDuring 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

    4

    Cardamyst Commercial Coverage

    next quarter
    Current>50% of commercially insured lives
    TargetContinued 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.

    Q&A highlights

    6

    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 read6 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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.

    04

    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.

    05

    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.

    06

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.