GRAIL, Inc. (GRAL) Q4 2025 Earnings Call Transcript
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Overview
The earnings call summary presents a mixed outlook. While there is a positive emphasis on product development and strategic partnerships, the Q&A reveals concerns about trial results and FDA approval. The NHS-Galleri study's missed endpoint and lack of significant Stage III and IV cancer reduction are worrying. However, the company's optimism about future milestones and financial health, along with potential international expansion, balances the sentiment. The lack of market cap data limits the prediction's precision, but overall, the sentiment is neutral due to these mixed signals.
Key Financial Performance
U.S. Galleri test volume Grew 36% to more than 185,000 tests year-over-year. Growth driven by both breadth and depth of prescribing.
U.S. Galleri revenue Grew by 26% year-over-year to $136.8 million. Growth attributed to increased test volume and market expansion.
Prescriber base Increased by 30% year-over-year to approximately 17,000 providers. Growth driven by increased awareness and adoption.
Fourth quarter revenue $43.6 million, up 14% year-over-year. Screening revenue increased by 34% due to higher sales volume.
Full year total revenue $147.2 million, up 17% year-over-year. Screening revenue grew by 28%, while development services revenue decreased by 49%.
Net loss for the fourth quarter $99.2 million, an increase of 2% year-over-year. Loss impacted by operational costs and amortization of acquisition-related intangible assets.
Net loss for the full year $408.4 million, an improvement of 80% year-over-year. Improvement due to absence of prior year's goodwill and intangible asset impairment.
Non-GAAP adjusted gross profit for Q4 $23.1 million, up 29% year-over-year. Increase driven by revenue mix and efficiencies of scale.
Non-GAAP adjusted gross profit for the full year $73.6 million, up 27% year-over-year. Growth attributed to increased Galleri volume and operational efficiencies.
Adjusted EBITDA for Q4 Negative $71.8 million, an improvement of 15% year-over-year. Improvement due to operational efficiencies and revenue growth.
Adjusted EBITDA for the full year Negative $320.6 million, an improvement of 34% year-over-year. Improvement driven by cost management and increased revenue.
Cash position at year-end $904.4 million, bolstered by $436 million in equity proceeds. Strong cash position supports long-term growth.
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Operating Highlights
Galleri test: Achieved a 36% growth in U.S. test volume in 2025, with over 185,000 tests conducted. Revenue from U.S. Galleri grew by 26%, reaching $136.8 million. The test has been in the market for over 4 years, with nearly 0.5 million tests sold to date. The PMA submission to the FDA was completed, marking a critical step for broader availability.
Market expansion: Expanded prescriber base by 30% to approximately 17,000 providers. Partnerships with digital health companies and health systems are being expanded to increase access to Galleri. Medicare coverage pathway for FDA-approved multi-cancer early detection tests was established under new federal law.
Operational efficiencies: Non-GAAP adjusted gross profit for 2025 increased by 27% to $73.6 million, driven by revenue mix and scale efficiencies. Adjusted EBITDA improved by 34% to negative $320.6 million. Cash position at the end of 2025 was $904.4 million, with a cash runway extending into 2030.
Strategic shifts: Announced expansion of field sales and medical teams based on strong study results. Focused on increasing awareness of multi-cancer early detection and Galleri's differentiation. Planning to extend data collection for NHS-Galleri trial by 6-12 months for more mature data analysis.
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Risk or Challenges
NHS-Galleri trial results: The trial did not meet the primary endpoint of statistically significant reduction in combined Stage III and IV cancers, which could impact the perceived effectiveness of the Galleri test and its adoption.
Regulatory approval process: The PMA submission to the FDA is anticipated to take about 12 months for review, which could delay broader market access and Medicare coverage for the Galleri test.
Financial performance: Despite revenue growth, the company reported a net loss of $408.4 million for 2025, which could pose financial sustainability challenges.
Royalty payments to Illumina: Starting in 2027, the company will resume royalty payments to Illumina, which could impact gross margins and profitability.
Market adoption and competition: The company faces challenges in expanding awareness and adoption of the Galleri test, especially in a competitive market for cancer detection solutions.
Supply chain and operational costs: The company is obligated to pay royalties to Illumina and manage operational costs, which could affect long-term financial performance.
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Guidance & Outlook
Commercial Growth in 2026: GRAIL anticipates continued commercial growth in 2026, driven by new and expanding partnerships, including digital health opportunities and further integration into health systems. The company is focused on expanding awareness of multi-cancer early detection and Galleri's performance and capability differentiation.
FDA PMA Submission: GRAIL completed its PMA submission for Galleri to the FDA in January 2026. The company expects a 12-month review period, with the potential for FDA approval to expand access to Galleri.
Medicare Coverage Pathway: The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law, establishing a Medicare coverage pathway for FDA-approved multi-cancer early detection tests. This could significantly expand access to Galleri.
NHS-Galleri and PATHFINDER 2 Data Presentations: GRAIL plans to present full data from the NHS-Galleri and PATHFINDER 2 studies in mid-2026, which could further validate Galleri's clinical utility and drive adoption.
Revenue and Sales Growth Guidance for 2026: GRAIL reiterated its guidance for Galleri sales growth of 22% to 32% in 2026, supported by strong performance in the self-pay market and positive data readouts.
Cash Burn and Financial Position: The company expects cash burn for 2026 to be no more than $300 million and has a cash runway extending into 2030, positioning it well for growth and milestone achievements.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you confirm that you don't expect the FDA approval decision to be impacted by the miss of the stage shift endpoint?
A:The FDA will focus on the effectiveness and safety of the submission. The data from PATHFINDER 2 and the prevalent round of NHS-Galleri will be reviewed. There is no obvious correlation or impact between the NHS-Galleri study results and the FDA's view on the test.
Q:Is there any read-through from missing the NHS-Galleri stage shift endpoint to the Medicare REACH study, which has a primary endpoint of incidence rates of Stage IV cancers?
A:The primary endpoint of the REACH study is a Stage IV reduction, which was strongly observed in the NHS-Galleri trial. The study is properly powered, and the team is optimistic about observing the effect, but the study needs to read out.
Q:How do the results impact your strategy to expand Galleri to other countries in terms of data generation and rollout plans?
A:The strong reduction in Stage IV cancer, fourfold improvement in cancer detection rate, and reduction in emergency presentation are important for discussions with other countries. These results are expected to positively influence international approaches.
Q:What are the next steps in the U.K.? Have you had any discussions with them so far?
A:The team has not started conversations with the U.K. yet but anticipates that the NHS would want to see the full results before engaging in meaningful discussions. These results are expected to be presented at ASCO.
Q:If you're expanding the sales force despite not meeting the endpoint, what's the thought process behind that?
A:The reduction in Stage IV cancers and increased Stage I and II cancers are relevant to clinicians. Market research and customer feedback indicate that the NHS-Galleri results are compelling and meaningful, which supports expanding the provider sales force territories in the U.S.
Q:Is the probability of FDA approval unchanged as a result of the NHS-Galleri readout?
A:The probability of FDA approval is believed to be unchanged. The FDA focuses on clinical performance and safety, and the data submitted includes the PATHFINDER 2 study and the NHS-Galleri trial's performance period.
Q:Are there any examples where a diagnostic has been reimbursed after missing a primary endpoint?
A:It is rare for diagnostics to go through randomized controlled trials. The NHS-Galleri trial is a rigorous and large trial, and despite missing the primary endpoint, it demonstrated compelling clinical benefits, which could generate excitement in the clinical community.
Q:Has your analysis of NHS-Galleri results led to any explanation regarding why you came up short of the primary endpoint?
A:The data is still being analyzed. The primary endpoint combined Stage III and IV reduction, and while there was a Stage IV reduction, there was an increase in Stage II cancers. A longer follow-up period is expected to provide more insights.
Q:Is extending the trial follow-up by 6 to 12 months something you and NHS have already agreed on?
A:Discussions with NHS have not occurred yet, but no significant obstacles are anticipated. The goal is to allow the control arm data to mature for better comparison between study arms.
Q:What is your involvement in the NHS's application process for multi-cancer tests in primary care?
A:The team is applying to be part of the process and believes their data from the SYMPLIFY study is strong and encouraging in this context.
Q:How do you think Medicare would look at the NHS trial, and how would that impact the Medicare decision?
A:Medicare will evaluate a robust package of data, including registrational trials, NHS-Galleri results, real-world evidence, and the REACH study. There is no known bar for multi-cancer early detection tests, and the team believes the evidence will support coverage.
Q:Was there a decrease in Stage III and IV cancers collectively, and what was the level of that decrease?
A:There was no statistically significant reduction, but a favorable trend towards reduction over time was observed. Full results will be presented at ASCO.
Q:Why was the trial set up for 3 years instead of a longer follow-up period?
A:The trial was designed and powered with the best information available at the time. With hindsight, a longer follow-up period would have been better, and follow-up will now be extended.
Q:Can you go to the FDA to narrow or adjust your label to the 12 cancers you performed best in or an older subset?
A:The team believes they have a strong evidence package for their current intended use. Labeling will be negotiated with the FDA if clarification is sought. The 12 cancers represent two-thirds of all cancer mortality, but the Stage IV reduction is also true for all cancers.
Q:How does this impact your thoughts on a potential advisory committee meeting?
A:The FDA has already held an AdCom, and the team has addressed all issues in their submission. They believe another AdCom may not be necessary, but the decision lies with the FDA.
Q:How does the NHS-Galleri data impact USPSTF inclusion and guideline inclusion?
A:The first milestone is FDA approval, which is critical for payers and CMS coverage. USPSTF evaluation would come later and is seen as supplemental. The team believes FDA approval and robust evidence are most critical.
Q:Review of Unclear Management Responses
A:Management avoided directly answering questions about the collective decrease in Stage III and IV cancers, providing only a general statement about a favorable trend. They also did not provide a clear explanation for why the trial was initially set up for 3 years instead of a longer follow-up period, citing hindsight as the reason for extending the follow-up now.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Chief Scientific
ESMO
Harpal line
III IV
IV cancer
Illumina royalty
Medicare
NHS PATHFINDER
Officer President
Ofman
PMA application
Scientific Officer
Stage III
Stage IV
Stage cancer
benefit
cancer detection
cancer diagnosis
cancer mortality
cancer trial
cancer type
design
disease
equity
law
margin
momentum
payment
presentation ASCO
reduction Stage
reduction cancer
result NHS
result participant
revenue
sale
screening evidence
trend
trial result
validation
GRAL Transcript
GRAIL, Inc. (GRAL) Q4 2025 Earnings Call Transcript
Unknown2-19
The earnings call summary presents a mixed outlook. While there is a positive emphasis on product development and strategic partnerships, the Q&A reveals concerns about trial results and FDA approval. The NHS-Galleri study's missed endpoint and lack of significant Stage III and IV cancer reduction are worrying. However, the company's optimism about future milestones and financial health, along with potential international expansion, balances the sentiment. The lack of market cap data limits the prediction's precision, but overall, the sentiment is neutral due to these mixed signals.
GRAIL, Inc. (GRAL) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
GRAIL, Inc. (GRAL) Q3 2025 Earnings Call Transcript
Positive11-12
The earnings call reveals strong financial performance with a 69% increase in gross profit and a 14% rise in gross margin. The company has a robust cash position of $850 million, excluding a pending investment from Samsung. Despite some uncertainties, such as the impact of a $150 promotion, the company's strategic partnerships and growth in test volumes indicate a positive outlook. The updated FDA timeline and improved cost efficiencies further support a positive sentiment, suggesting a likely stock price increase over the next two weeks.
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Neutral9-9
GRAL Report
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