Is there a risk the AdCom pushes into next year due to FDA leadership changes? Will CMS wait for FDA approval before defining NCD criteria?

GRAIL cannot comment on FDA's ability to find experts or potential delays. They assume CMS will only undertake coverage analysis for FDA-approved products. “We do know that CMS' coverage authority is only for FDA-approved products. So our assumption has been that they would only undertake a national coverage analysis upon an FDA approval.”

How is competition impacting Galleri's pricing (ASP decrease)? Will USPSTF discuss MCEDs soon given market noise?

ASP decrease was planned due to digital health expansion and lower employer pricing for strengthened partnerships. Competition causes customer confusion due to unproven experimental MCEDs, which GRAIL addresses with its robust data. USPSTF discussion of MCEDs is unlikely before FDA approval. “Yes. I think the -- first of all, the ASP decrease in second quarter '26 was the result of expansion of digital health volume and also lower employer pricing, which was planned.”

Why was the sales force expansion pulled forward, and was the AdCom scenario known when sizing it? Will the AdCom make it easier or harder for incremental MCED tests?

Sales force expansion was pulled forward due to strong NHS-Galleri and PATHFINDER 2 data, completed by Q2 FY26, to be ready for FDA approval. The AdCom is specific to Galleri's data package and will set the approval bar for future MCEDs, not directly impacting their pathway. “Yes, we pulled forward the sales force expansion really on the back of the NHS-Galleri and PATHFINDER 2 data that we announced earlier in the year. given how excited we were with both sets of that data.”

GRAL

GRAIL (GRAL) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 5, 2026

Source: earnings call transcript

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

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

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

Category	Target	Timeline	Confidence
FDA Advisory Committee (AdCom)	Expected in the fall high materiality	Fall	High
FDA Approval for Galleri	Expected in the first part of 2027 high materiality	H1 2027 · FY27	High
Samsung Collaboration Progress	More color as we move through the year medium materiality	Rest of FY26	Medium
Publication of PATHFINDER 2 and NHS-Galleri Study Results	Hopeful of publication in the near future medium materiality	Near future	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
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 million	24%	—	—
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	—	—	—

Deals & partnerships

Samsung C&T Corporation Strategic collaboration for commercialization of Galleri test $110 million

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

Priority Health Collaboration to enable employer groups to add Galleri to existing screening coverage

Priority Health is a nationally recognized nonprofit health plan.

Risks & headwinds

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 hiatus Ongoing

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

FDA Advisory Committee (AdCom) timing

Next quarter (fall)

Current Anticipated in "fall"

Target Specific 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.

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

Q&A highlights

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 read 6 chapters

Detailed narrative

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.

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.

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.

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.

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.

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.

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