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    ALNY
    Earnings call· Jun 2026(Q2 FY26)

    ALNYLAM PHARMACEUTICALS Q2 FY26 earnings call ALNY

    Jul 30, 2026 Source

    Executive summary

    Alnylam Q2 FY26 — AMVUTRA Exceeds $1B Revenue, Guidance Revised

    Alnylam Pharmaceuticals delivered strong Q2 FY26 results, with AMVUTRA sales surpassing $1 billion for the first time, driven by robust first-line patient uptake. The company revised its full-year revenue guidance downwards due to a normalization of second-line demand for AMVUTRA, but expressed increased confidence in its long-term TTR leadership strategy, especially following competitive developments in the ATTR cardiomyopathy market. Management also highlighted ongoing pipeline progress and strategic AI collaborations.

    Highlights

    5

    • Total net product revenues reached approximately $1.2 billion, representing 74% growth versus Q2 last year.

    • AMVUTRA revenues exceeded $1 billion in a single quarter for the first time, achieving an annual run rate of over $4 billion.

    • Non-GAAP operating income more than tripled to $318 million compared to last year.

    • Cash, cash equivalents, and marketable securities increased to $3.3 billion from $2.9 billion as of year-end 2025.

    • First-line new patient starts for AMVUTRA now account for 80% of factory growth in the accelerating ATTR market.

    Concerns

    4

    • Total net product revenue guidance for FY26 was revised down to $4.7 billion-$5.1 billion, a $200 million reduction at the midpoint for TTR revenue.

    • TTR revenue guidance for FY26 was updated to $4.2 billion-$4.5 billion, reflecting a $200 million reduction from the original midpoint.

    • Second-line demand for AMVUTRA has normalized after an initial surge from pent-up demand in 2025.

    • The CARDIO-TTRansform study of eplontersen resulted in a negative outcome, raising investor questions about the competitive landscape.

    Guidance & targets

    4
    CategoryTargetConfidence
    Total Net Product Revenue
    $4.7 billion to $5.1 billion
    high materiality
    High
    TTR Revenue
    $4.2 billion to $4.5 billion
    high materiality
    High
    Collaboration and Royalty Revenues
    $575 million to $625 million
    medium materiality
    High
    Revenue CAGR
    25%
    high materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    TTR Franchise (Global)
    Reflecting the continued strength of the launch and robust execution of global teams. Driven by continued ATTR-CM uptake in Japan, U.K., and Germany, and strong polyneuropathy performance internationally, despite pricing headwinds.
    U.S. TTR revenue growth QoQ: 15%U.S. TTR revenue growth YoY: 114%Outside U.S. TTR revenue growth QoQ: 7%Outside U.S. TTR revenue growth YoY: 31%
    		$1.03 billion89%13%—
    Rare Disease Portfolio (ex-TTR)
    Continues to deliver meaningful impact for patients and consistent performance for the business.
    		$142 million11%——

    Operational metrics

    23
    Gross margin on product sales
    75%4% lower than Q2 last year
    Q2 FY26

    Decrease in margin primarily driven by increased royalties on AMVUTRA.

    Non-GAAP R&D expenses
    $377 millionincreased 38% compared to last year
    Q2 FY26

    Increase driven by pivotal studies and investment in programs for bleeding disorders, Huntington's disease, and CAA.

    Non-GAAP SG&A expenses
    $297 millionincreased 14% compared to last year
    Q2 FY26

    Increase driven by commercial launch investments.

    Non-GAAP operating income
    $318 millionmore than triple the amount achieved last year
    Q2 FY26

    Driven primarily by strong top-line results.

    Cash, cash equivalents and marketable securities
    $3.3 billioncompared with $2.9 billion as of year-end 2025
    Q2 FY26

    Primary driver of the increase year-to-date is strong operating performance.

    Collaboration revenue
    $47 million23% decrease compared with the same period last year
    Q2 FY26

    Impacted by various collaboration dynamics.

    Royalty revenue
    $72 millionincreased 79%
    Q2 FY26

    Strong growth driven by LEQVIO performance.

    AMVUTRA adherence
    exceed 90%
    Q2 FY26

    Reflects strong patient compliance with AMVUTRA treatment.

    AMVUTRA new prescribers
    over 1,700
    since launch

    Number of new prescribers added since the ATTR-CM launch.

    AMVUTRA first-line new patient starts
    80%
    Q2 FY26

    Proportion of new treatment initiations that are first-line starts for AMVUTRA.

    AMVUTRA market share among prescribers
    more than 50%
    Q2 FY26

    Among prescribers using AMVUTRA, it represents more than 50% of new patient starts, indicating strong physician preference.

    Untreated ATTR-CM patients
    80%
    current

    Estimated proportion of ATTR-CM patients who are still untreated, out of an estimated 200,000 total patients.

    TTR category growth
    around 40%
    year-over-year

    Overall growth rate of the TTR market, accelerated since AMVUTRA launch.

    Tafamidis U.S. loss of exclusivity
    2031
    anticipated

    Anticipated date for tafamidis U.S. generic entry.

    Nucresiran TTR knockdown
    over 95%
    expected

    Expected depth of TTR knockdown with nucresiran based on preliminary Phase I results.

    Vutrisiran median TTR knockdown
    91%
    steady state

    Median TTR knockdown observed with vutrisiran in polyneuropathy studies.

    Vutrisiran patients achieving 80% TTR knockdown
    82% to 84%
    steady state

    Proportion of vutrisiran-treated patients reaching the 80% deep knockdown threshold.

    Eplontersen median TTR knockdown
    84%
    steady state

    Median TTR knockdown reported for eplontersen.

    Eplontersen patients achieving 80% TTR knockdown
    about 67%
    steady state

    Estimated proportion of eplontersen-treated patients reaching the 80% deep knockdown threshold.

    Nucresiran patients achieving deep knockdown threshold
    over 99%
    expected

    Expected proportion of nucresiran-treated patients to surpass the deep knockdown threshold, based on modeling.

    HHT global patient population
    about 1.5 million
    current

    Estimated global patient population for hereditary hemorrhagic telangiectasia (HHT).

    HHT U.S. addressable patient population
    about 70,000
    current

    Estimated addressable patient population for HHT in the United States.

    ATTR patient population
    around 200,000
    current

    Estimated total patient population for ATTR in the U.S.

    Industry KPIs

    8
    MetricValueDetails
    Launch access metricsstrong
    Pipeline read out calendar4 key data readouts
    Product franchise net sales$1.03 billionUSD
    Regulatory approvals filingsAMVUTRA
    Therapeutic drug market sharemore than 50%%
    Prescription volume new starts80%%
    Clinical trial efficacy safety data41% reduction%
    Collaboration milestone royalty revenue$119 millionUSD

    Deals & partnerships

    3
    BenExclusive commercialization and distribution rights for AMVUTRA in Mainland China.

    Collaboration aims to advance awareness and support diagnosis of ATTR amyloidosis and bring AMVUTRA to underserved regions, subject to marketing authorization.

    InceptiveStrategic AI collaboration to expand the discovery of RNAi therapeutics.

    Part of a broader AI strategy to reshape how medicines are discovered and developed.

    Large health care system in CaliforniaCollaboration aimed at supporting early identification of ATTR cardiomyopathy in routine care.

    Builds on previously announced partnerships with Viz.ai and Komodo Health, focusing on disease identification in clinical practice.

    Risks & headwinds

    4
    Normalization of second-line AMVUTRA demandFY26

    $200 million reduction at midpoint of TTR guidance

    Mitigation: Focus on first-line new patient starts (80% of factory growth), expanding prescriber base, and driving overall category growth.

    Negative outcome of CARDIO-TTRansform study of eplontersenCurrent

    Study did not meet its primary endpoint

    Mitigation: Alnylam maintains conviction in TRITON-CM for nucresiran, citing distinct molecule attributes, study design, and team experience. Will review full data and adapt study plan if appropriate.

    Pricing headwinds for TTR revenues outside U.S.Q2 FY26 and ongoing

    Impacted Q2 FY26 growth outside U.S.

    Mitigation: Ongoing negotiations in various countries (e.g., Germany, Spain, Italy) to secure premium pricing; modest growth contribution expected in 2026 for Europe.

    Modest reduction in U.S. TTR net priceH2 FY26

    Modest quarter-to-quarter decreases

    Mitigation: Expected to continue for H2 FY26, still on track for mid-single-digit net price decrease year-over-year as guided.

    What to watch in Q3 FY26

    5

    AMVUTRA first-line new patient starts

    Next quarter
    Current80% of new treatment initiations
    TargetContinued robust growth

    Why it matters

    Indicates sustained market leadership and long-term growth potential in the largest opportunity segment.

    First-line new patient starts and now responsible for about 80% factory growth in this accelerating market.

    Q&A highlights

    8

    Given the revised guidance and previous 2030 CAGR target, how confident is management in maintaining growth, especially in the next 12-24 months, and meeting long-term goals?

    Management acknowledged the guidance cut but emphasized strong fundamentals, first-line momentum, and increased confidence due to competitive developments (eplontersen failure, tafamidis LOE). They stated that Q3 and Q4 growth needs to be consistent with Q2 to meet the revised FY26 midpoint. The 80% untreated market, strong first-line base, and expanding prescriber base support long-term confidence.

    “Clearly, we're not pleased to be lowering guidance, as Jeff said, we own it. But I think it's really important to emphasize that we believe that the fundamentals driving our opportunity a really strong, particularly market growth in our first-line momentum.”

    asked by Paul Matteis · answered by Yvonne Greenstreet

    2 min read6 chapters

    Detailed Narrative

    01

    AMVUTRA Commercial Performance & Strategy

    AMVUTRA achieved over $1 billion in revenue for the first time in Q2 FY26, driven by strong first-line patient uptake, which now accounts for 80% of new treatment initiations. The company is intensifying investments to expand its prescriber base and drive overall category growth, particularly in the untreated ATTR-CM patient population. Access remains broad with strong pull-through and adherence exceeding 90%.

    02

    Guidance Revision & Demand Dynamics

    Alnylam revised its full-year 2026 total net product revenue and TTR revenue guidance downwards by $200 million at the midpoint. This adjustment reflects a better understanding of demand dynamics, specifically the normalization of second-line AMVUTRA demand after an initial surge from pent-up demand in 2025. Despite the revision, the company maintains confidence in its long-term growth trajectory.

    03

    TRITON-CM Study & Competitive Landscape

    Despite the negative outcome of the CARDIO-TTRansform study for eplontersen, Alnylam maintains high confidence in its TRITON-CM Phase III study for nucresiran. This confidence is grounded in nucresiran's distinct RNAi mechanism, expected deep TTR knockdown (>95%), and the company's extensive experience in TTR drug development. The company plans to carefully review the eplontersen data to adapt its study plan if appropriate, noting that the eplontersen failure is likely attributable to molecule and study-specific issues.

    04

    Strategic AI Collaborations

    Alnylam announced new strategic AI collaborations, including with Inceptive to expand the discovery of RNAi therapeutics and with a large California healthcare system for early identification of ATTR cardiomyopathy in routine care. These partnerships build on existing initiatives with Viz.ai and Komodo Health, reflecting a long-term conviction that AI will fundamentally reshape medicine discovery, development, and delivery.

    05

    Pipeline Progress & Future Milestones

    The company is advancing a broad pipeline beyond TTR, initiating Phase II trials for ALN-6400 in Von Willebrand's disease and mivelsiran in Down Syndrome-associated Alzheimer's disease. Several key data readouts are anticipated in H2 2026, including initial Phase I results for ALN-HTT02 in Huntington's disease in October and ALN-2232 in obesity and weight management.

    06

    Alnylam 2030 Vision

    Alnylam's long-term strategy is anchored around three pillars: establishing global leadership in TTR, growing through sustainable innovation to deliver therapies that prevent, halt, or reverse disease, and scaling with discipline for durable, profitable growth. The company aims to become the leading science-driven, fully integrated global biopharmaceutical company and maximize the full potential of RNA therapeutics for patients.

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