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    GRAL
    Earnings call· Jun 2026(Q2 FY26)

    GRAIL Q2 FY26 earnings call GRAL

    Aug 5, 2026 Source

    Executive summary

    GRAIL Q2 FY26 — Strong Galleri Volume Growth and FDA AdCom Anticipation

    GRAIL delivered strong Q2 FY26 results, driven by significant Galleri test volume and revenue growth, supported by a strategic financing and expanded sales force. The company is advancing towards anticipated FDA approval for Galleri in early 2027, with an advisory committee expected in the fall, despite competitive noise from unproven MCED tests. Management remains confident in its robust clinical data and differentiated methylation technology.

    Highlights

    5

    • Galleri test volume increased by 35% year-over-year to over 61,000 tests in Q2 FY26.

    • Total Galleri screening revenue grew 24% year-over-year to $42.6 million in Q2 FY26.

    • First half 2026 Galleri test revenue grew 30% year-over-year to over $80 million, with volume up 42% to over 117,000 tests.

    • Completed $110 million financing with Samsung in Q2 FY26, supporting international expansion.

    • Expanded sales and medical teams substantially complete by end of Q2 FY26, with positive initial feedback.

    Concerns

    3

    • Adjusted EBITDA loss increased by $11.9 million or 15% year-over-year to negative $90.3 million in Q2 FY26.

    • Primary endpoint of combined reduction of Stage III and IV cancers was not met in the NHS-Galleri trial.

    • Competition from "experimental MCEDs" causing customer confusion and operating with 3x to 5x higher false positive rates.

    Guidance & targets

    4
    CategoryTargetConfidence
    FDA Advisory Committee (AdCom)
    Expected in the fall
    high materiality
    High
    FDA Approval for Galleri
    Expected in the first part of 2027
    high materiality
    High
    Samsung Collaboration Progress
    More color as we move through the year
    medium materiality
    Medium
    Publication of PATHFINDER 2 and NHS-Galleri Study Results
    Hopeful of publication in the near future
    medium materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    Galleri Screening
    Screening revenue was up 24% as compared with the second quarter of 2025, with test volumes of more than 61,000, an increase of 35% over the second quarter of 2025.
    Test volume: >61,000Test volume growth YoY: 35%
    		$42.6 million24%——
    Development Services
    Total revenue for the second quarter consisted of $42.6 million of screening revenue and $2 million of development services revenue.
    		$2 million———

    Operational metrics

    20
    Total revenue growth
    26%YoY
    Q2 FY26

    Total revenue for the second quarter was $44.7 million, up $9.1 million or 26% as compared to the second quarter of 2025.

    Galleri test volume
    >117,000up 42% YoY
    H1 FY26

    For the first half of 2026, we saw Galleri test revenue growth of 30% year-over-year to more than $80 million and Galleri test volume growth of 42% to more than 117,000 tests.

    Galleri test revenue
    >$80 millionup 30% YoY
    H1 FY26

    For the first half of 2026, we saw Galleri test revenue growth of 30% year-over-year to more than $80 million and Galleri test volume growth of 42% to more than 117,000 tests.

    Adjusted gross profit
    $21.6 millionup 34% YoY
    Q2 FY26

    Non-GAAP adjusted gross profit for the second quarter was $21.6 million, an increase of $5.4 million or 34% as compared with the second quarter of 2025.

    Adjusted EBITDA
    negative $90.3 millionloss increased 15% YoY
    Q2 FY26

    Adjusted EBITDA for the second quarter was negative $90.3 million, an increase in adjusted EBITDA loss of $11.9 million or 15% as compared to the second quarter of 2025.

    Cash and investments balance
    $861.6 million
    Q2 FY26

    We ended the second quarter with a cash position of $861.6 million, which includes $110 million strategic investment by Samsung, which closed in June.

    Galleri false positive rate
    <0.5%3x to 6x fewer than other MCEDs
    current

    Galleri test performance is highly differentiated with a false positive rate of less than 0.5%, resulting in at least 3x to 6x fewer false positives than other MCED tests in development.

    Galleri positive predictive value
    50% to 60%
    current

    The Galleri test demonstrated very consistent performance with a false positive rate of less than 0.5% and positive predictive values ranging from 50% to 60%.

    Cancer detection rate increase (with Galleri)
    4x to 6.5xvs standard of care
    current

    Across both studies, adding Galleri to standard of care increased the cancer detection rate by 4x to 6.5x.

    Galleri detected cancers at Stages 1 & 2
    40% to 50%
    current

    Across these 2 studies, approximately 40% to 50% of the Galleri detected cancers were found at Stages 1 and 2.

    Galleri detected cancers at Stages 1-3
    ~70%
    current

    and approximately 70% were found at Stages 1 through 3.

    Standard of care screening detection rate
    ~14%
    current

    Today, standard of care screening finds only about 14% of cancers in the U.S.

    Standard of care screening detection rate
    ~6%
    current

    and about 6% of cancers in the U.K.

    Estimated cancer detection rate (with Galleri)
    50% or morevs standard of care
    current

    By adding Galleri, we estimate that those figures can increase to 50% or more.

    Cancer detection rate (with Galleri)
    60%
    current

    And indeed, in PATHFINDER 2, this number was 60%.

    NHS-Galleri Stage I and II cancers detected
    366more than 290 cancers detected at any stage by UK standard of care
    NHS-Galleri study

    Remarkably, in the NHS-Galleri study, Galleri detected 366 Stage I and II cancers, many more than the 290 cancers detected at any stage by the entirety of the U.K.'s standard of care screening program in the control arm.

    Illumina royalty rate
    7%
    Q4 FY26 onwards

    We disclosed in the financials, it's 7% to 9%, 7% royalty, I believe.

    New ordering providers
    ~1,000
    Q2 FY26

    and we added, again, about 1,000 new ordering providers in Q2.

    Self-pay volume percentage
    ~70%
    Q2 FY26

    Self-pay remains the majority of Galleri's volume, accounting for about 70% of sales.

    Average Selling Price (ASP) drivers
    —
    Q2 FY26

    the ASP decrease in second quarter '26 was the result of expansion of digital health volume and also lower employer pricing, which was planned.

    Deals & partnerships

    2
    Samsung C&T CorporationStrategic collaboration for commercialization of Galleri test$110 million

    Commercialize Galleri in South Korea, with potential to expand into Japan and Singapore.

    Priority HealthCollaboration to enable employer groups to add Galleri to existing screening coverage

    Priority Health is a nationally recognized nonprofit health plan.

    Risks & headwinds

    3
    Competition from "experimental MCEDs"Current

    Operating at 3x to 5x higher false positive rate

    Mitigation: Educating physicians on Galleri's robust clinical evidence and differentiated performance; anticipating market bifurcation post-FDA approval.

    NHS reform causing decision-making hiatusOngoing

    Enormous amount of uncertainty and organizational upheaval

    Mitigation: Engaging with leading clinicians who show overwhelming positivity about Galleri's results, hoping conversations translate into meaningful way forward.

    Decrease in Average Selling Price (ASP)Q2 FY26

    Not quantified, but stated as a factor partially offsetting adjusted gross profit.

    Mitigation: Planned result of expansion of digital health volume and lower employer pricing for strengthened partnerships.

    What to watch in Q3 FY26

    5

    FDA Advisory Committee (AdCom) timing

    Next quarter (fall)
    CurrentAnticipated in "fall"
    TargetSpecific timing announcement from FDA

    Why it matters

    Key step towards FDA approval, which is a major catalyst for market access and commercialization.

    We do expect the FDA to convene an advisory committee for Galleri in the fall. The FDA will announce specific timing of📎 an advisory committee.

    Q&A highlights

    6

    What will be the FDA's focus at the anticipated AdCom, and how is GRAIL preparing?

    GRAIL is preparing internally but does not yet know the specific focus or timing from the FDA. They anticipate an AdCom for groundbreaking technology.

    “So we are obviously getting ready and preparing internally. We don't know the nature of any of that information at this time, but we should -- obviously, we'll be informed about that as the time approaches.”

    asked by Subhalaxmi Nambi · answered by Joshua Ofman

    2 min read6 chapters

    Detailed Narrative

    01

    Clinical Validation and Differentiation

    GRAIL highlighted the unparalleled performance of Galleri, validated by interventional studies like PATHFINDER, PATHFINDER 2, and NHS-Galleri, which demonstrated a false positive rate of less than 0.5% and 3x to 6x fewer false positives than other MCED tests. The company emphasizes its proprietary methylation platform as superior for accuracy and localization, supported by a head-to-head genomic feature comparison study published in top-tier journals.

    02

    Regulatory Pathway and FDA Advisory Committee

    The premarket approval (PMA) application for Galleri was submitted to the FDA in early 2026, focusing on data from PATHFINDER 2 and NHS-Galleri. GRAIL anticipates an FDA advisory committee (AdCom) in the fall, viewing it as a standard process for groundbreaking technologies, with expected FDA approval in the first part of 2027. The company is confident in its submitted data package and iterative review process.

    03

    Commercial Expansion and Partnerships

    Galleri test volumes increased 35% year-over-year to over 61,000 tests in Q2 2026, driving $42.6 million in screening revenue. The company completed a $110 million financing with Samsung, initiating a strategic collaboration for commercialization in South Korea and potential expansion into other Asian markets. A new collaboration with Priority Health will expand Galleri coverage for employer groups, reaching over 1.4 million members in Michigan and nearby states.

    04

    Impact of Clinical Trial Results

    Despite the NHS-Galleri trial not meeting its primary endpoint for combined Stage III and IV cancer reduction, the study demonstrated strong performance, safety, and utility. Adding Galleri to standard of care increased cancer detection rates by 4x to 6.5x, with 40-50% of detected cancers found at Stages 1 and 2, and approximately 70% at Stages 1-3. In the NHS-Galleri study, 366 Stage I and II cancers were detected, exceeding the 290 cancers found by the UK's standard of care screening program.

    05

    Competitive Landscape and Market Bifurcation

    GRAIL critiques other MCED products for relying solely on observational case-control data, lacking interventional study validation, and having higher false positive rates (3x to 5x higher). Management expects FDA approval to create a market bifurcation, positioning Galleri as the gold standard against experimental, unproven tests, thereby clarifying market confusion.

    06

    Sales Force Expansion and Market Education

    Following positive clinical utility results from PATHFINDER 2 and NHS-Galleri, GRAIL expanded its field sales and medical teams, completing the expansion by the end of Q2 2026. These teams are now educating clinicians and employers on the trial results, receiving positive initial feedback, and are positioned to capitalize on anticipated FDA approval and drive Galleri adoption.

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