GRAIL Hits 36% Test Growth, Misses Key Trial Endpoint

Date of Call: Feb 19, 2026

Financials Results

• Revenue: Q4: $43.6M, up 14% YOY. Full year: $147.2M, up 17% YOY.
• Gross Margin: Non-GAAP adjusted gross profit up 29% YOY in Q4 and 27% for full year. Long-term target of 50-60% at scale.

Guidance:

• Reiterated guidance for 2026: Galleri sales growth of 22% to 32%.
• Cash burn for full year 2026 expected to be no more than $300M.
• Cash runway extends into 2030.

Business Commentary:

Commercial Growth and Market Performance:

• GRAIL, Inc. reported U.S. Galleri test volume growth of 36% to more than 185,000 tests and U.S. Galleri revenue growth of 26% for 2025.
• The growth was driven by an increase in the prescriber base, which expanded by 30%, and the company's strategy of leaning into price elasticity with discounting programs to expand access.

Clinical Trial Results and FDA Submission:

• The NHS-Galleri trial showed a greater than 20% reduction in Stage IV diagnoses for the second and third rounds of screening, and a fourfold increase in cancer detection rate compared to standard of care.
• These results, along with strong safety profiles, were used to support the completion of the PMA submission to the FDA, marking a critical step towards broader availability and Medicare coverage pathway.

Financial Performance and Cash Position:

• GRAIL's revenue for Q4 2025 was $43.6 million, up 14% from Q4 2024, with screening revenue up 34%.
• The company ended the quarter with a strong cash position of $904.4 million, which includes proceeds from equity placements, supporting continued commercial momentum and expansion plans.

Expansion and Strategic Initiatives:

• GRAIL announced an expansion of its field sales and medical team to drive commercial momentum, reflecting confidence in continued growth.
• The company is focused on expanding partnerships with digital health companies and health systems to increase access to Galleri, supported by recent legislative developments like the Medicare Multi-Cancer Early Detection Screening Coverage Act.

Sentiment Analysis:

Overall Tone: Positive

• Strong commercial growth highlighted: U.S. test volume grew 36%, revenue up 26%. PMA submission completed with FDA, critical milestone. New federal law provides Medicare coverage pathway. Positive trial results observed: >20% reduction in Stage IV cancers, fourfold higher cancer detection rate. 'We are in a strong financial position with more than $900 million in cash.'

Q&A:

• Question from Subhalaxmi Nambi (Guggenheim Securities): Can you confirm that you don't expect the FDA approval decision to be impacted by the miss of the stage shift endpoint?
  Response: FDA focus is on clinical performance and safety data from submitted studies, not the NHS-Galleri trial's final results.

• Question from Kyle Mikson (Canaccord Genuity): How does the results impact strategy to expand Galleri to other countries?
  Response: Strong clinical benefits (Stage IV reduction, fourfold detection rate) will support international discussions; no negative impact on rollout plans.

• Question from Douglas Schenkel (Wolfe Research): Is the probability of FDA approval unchanged as a result of the NHS-Galleri readout?
  Response: FDA is focused on clinical validation and safety; the submitted data set is robust, and approvability is not impacted by the missed primary endpoint.

• Question from Catherine Ramsey (Robert W. Baird): Is extending the NHS trial follow-up by 6-12 months already agreed with NHS, and what is the goal?
  Response: Not yet discussed in detail, but no obstacles expected; goal is to mature control arm data for better comparison and understand longer-term effects.

• Question from Daniel Brennan (TD Cowen): How would Medicare evaluate clinical utility for coverage given the NHS trial results?
  Response: Medicare will conduct a national coverage analysis; GRAIL will submit a robust package including Stage IV reduction and detection rate data, along with real-world evidence.

Contradiction Point 1

FDA Approval Timeline and Strategy

It directly impacts expectations regarding the timeline for product availability and market entry, which are critical for investor confidence and strategic planning.

Subhalaxmi Nambi (Guggenheim Securities, LLC)? - Subhalaxmi Nambi (Guggenheim Securities, LLC)

2025Q4: The REACH study is properly powered to assess this effect, and the company is optimistic about observing a reduction in Stage IV cancer rates. - [Joshua Ofman](President), [Robert Ragusa](CEO)

Will missing the stage shift endpoint impact FDA approval or affect the Medicare REACH study? - Subhalaxmi Nambi (Guggenheim)

20251113-2025 Q3: The timeline has been tightened due to increased confidence from project progress. It reflects a narrower range of expected completion, moving from 'first half' to the more specific 'Q1.' - [Robert Ragusa](CEO)

Contradiction Point 2

International Regulatory Engagement Timing

It reflects inconsistencies in the strategy and timing for international market expansion, affecting global business plans and investor perceptions.

Can you summarize the key points from the recent earnings call? - Kyle Mikson (Canaccord Genuity Corp.)

2025Q4: The company has not yet started discussions with the NHS in the U.K.; those will likely wait for the full results presentation at ASCO. - [Harpal Kumar](Chief Scientific Officer & President International), [Robert Ragusa](CEO)

How do the results impact your strategy to expand Galleri internationally, and what's driving the sales force expansion despite the missed endpoint? - Kyle Mikson (Canaccord)

20251113-2025 Q3: The digital health channel is recognized as important for broad access, but will not diminish the focus on the PMA route. - [Robert Ragusa](CEO)

Contradiction Point 3

FDA Approval Process and Timeline

It presents conflicting statements on the review timeline and required data for FDA decision, creating uncertainty around regulatory approval and product launch.

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2025Q4: The FDA's review will focus on the clinical performance and safety data submitted in the PMA... The final NHS-Galleri results... are not expected to impact the FDA's review of the submitted data. - [Robert Ragusa](CEO) and [Joshua Ofman](President)

Can you confirm the FDA approval decision isn't impacted by missing the stage shift endpoint, and is there any impact on the Medicare REACH study? - Yuko Oku (Morgan Stanley)

2025Q2: The PMA submission is planned for the first half of 2026, with FDA approval expected after about a 1-year review process (including an advisory board), potentially mid-2027. - [Robert Ragusa](CEO) and [Andrew Partridge](Chief Commercial Officer)

Contradiction Point 4

PMA Submission Requirements and Clinical Utility Data

It involves inconsistent characterization of what data are needed for FDA approval versus for payers, which can lead to confusion and differing expectations from stakeholders.

Could you please provide more context or clarify the question? - Douglas Schenkel (Wolfe Research, LLC)

2025Q4: The FDA's focus is on clinical performance and safety data from PATHFINDER 2 and NHS-Galleri... The robust Stage IV reduction and fourfold cancer detection rate are compelling but not part of the current submission. - [Joshua Ofman](President), [Harpal Kumar](CSO), and [Robert Ragusa](CEO)

Has the probability of FDA approval changed, are there examples of diagnostics being reimbursed after missing primary endpoints, and what caused the shortfall in the primary endpoint? - Subhalaxmi T. Nambi (Guggenheim Securities, LLC)

2025Q2: The FDA focuses on *clinical validation* (performance in intended population) for PMA approval, not clinical utility (benefits/harms). Clinical utility data (like from the NHS Galleri study) are more for payer discussions. - [Joshua Ofman](President)

Contradiction Point 5

International Regulatory Strategy and NHS Engagement

It indicates a contradiction on the primary strategy for international expansion and timing of key discussions, influencing global market entry plans.

What are Kyle Mikson's key questions for Canaccord Genuity Corp.'s earnings call? - Kyle Mikson (Canaccord Genuity Corp.)

2025Q4: The results provide a strong data set to support international regulatory submissions... The company has not yet started discussions with the NHS in the U.K.; those will likely wait for the full results presentation at ASCO. - [Robert Ragusa](CEO) and [Harpal Kumar](CSO)

How do the results affect your strategy for data generation, rollout in other countries, and next steps in the U.K.? - Colleen Wohlrab Babington (Wolfe Research, LLC)

2025Q2: The positive results from the NHS Galleri study... are expected to be a strong 'calling card' to turn conversations into meaningful opportunities. The study's size and the NHS's reputation will provide a substantial growth opportunity. - [Robert Ragusa](CEO) and [Harpal Kumar](President of International Business & BioPharma)