Earnings summaries and quarterly performance for GRAIL.
Executive leadership at GRAIL.
Board of directors at GRAIL.
Research analysts who have asked questions during GRAIL earnings calls.
TS
Tejas Savant
Morgan Stanley
3 questions for GRAL
Also covers: ADPT, AKYA, AVTR +19 more
Douglas Schenkel
Wolfe Research, LLC
2 questions for GRAL
Also covers: A, AVTR, BRKR +21 more
KM
Kyle Mikson
Canaccord Genuity
2 questions for GRAL
Also covers: AKYA, BDSX, CSTL +12 more
Subbu Nambi
Guggenheim Securities
2 questions for GRAL
Also covers: BOLD, BRKR, CARS +16 more
AV
Alex Vukasin
Canaccord Genuity - Global Capital Markets
1 question for GRAL
Also covers: BDSX
CB
Colleen Babington
Wolfe Research, LLC
1 question for GRAL
Also covers: CARS, NTRA, TEM +1 more
Jon Petersen
Jefferies
1 question for GRAL
Also covers: CORZ, CUBE, DLR +11 more
SN
Subbu Nabi
Guggenheim Partners
1 question for GRAL
SN
Subhalaxmi Nambi
Guggenheim Securities
1 question for GRAL
Also covers: AKYA, BRKR, CSTL +15 more
Vijay Kumar
Evercore ISI
1 question for GRAL
Also covers: A, ABT, AVTR +21 more
YO
Yuko Oku
Morgan Stanley
1 question for GRAL
Also covers: ADPT, GH, MRVI +7 more
Recent press releases and 8-K filings for GRAL.
GRAIL, Inc. Reports Preliminary FY 2025 Results and Provides 2026 Guidance
GRAL
Earnings
Guidance Update
Revenue Acceleration/Inflection
- GRAIL, Inc. reported preliminary unaudited total revenue of $147-148 million for fiscal year 2025 and a cash position of $904 million as of December 31, 2025.
- The company provided 2026 guidance for total Galleri revenue growth of 22-32% and a cash burn of less than $300 million, projecting a cash runway into 2030.
- GRAIL achieved over 185,000 total Galleri test volume in 2025, representing 35% growth over 2024, and plans to complete its Pre-market Approval (PMA) submission in Q1 2026.
3 days ago
GRAIL Reports Strong 2025 Growth and Outlines 2026 Milestones
GRAL
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- GRAIL reported 2025 revenue between $147 million and $148 million, representing 17%-18% growth over 2024, with U.S. Galleri revenue up 25%-26% to between $136 million and $137 million.
- The company ended 2025 with a strong capital position of $904 million in cash after raising approximately $435 million in Q4 2025 and announcing a $110 million equity investment by Samsung expected to close in January 2026.
- For 2026, GRAIL expects total Galleri revenue to grow 22%-32% and cash burn to be less than $300 million, providing a cash runway into 2030.
- GRAIL plans to complete its PMA filing in Q1 2026 and present full data from the 140,000-person NHS-Galleri study and the 35,000-person PATHFINDER 2 study mid-year 2026.
- Commercial test volume for Galleri was over 185,000 tests in 2025, reflecting a 35% growth volume and an increase in the prescriber base of 30% to over 17,000 prescribers.
3 days ago
GRAL Updates on Financial Performance, 2026 Guidance, and Galleri Milestones
GRAL
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- GRAIL reported $147-148 million in total revenue for FY 2025, representing a 17-18% year-over-year growth, and a cash position of $904 million as of December 31, 2025.
- The company provided 2026 guidance for total Galleri revenue growth of 22-32% over $138-139 million in 2025, with cash burn expected to be less than $300 million, extending its cash runway into 2030.
- GRAIL plans to complete its modular PMA submission in Q1 2026 and present full data from the NHS-Galleri trial and PATHFINDER 2 study in mid-2026.
- The Galleri MCED test has been in market for over 4 years, with over 800,000 clinical and commercial tests completed to date, and over 475,000 commercial tests sold.
3 days ago
GRAIL Provides 2025 Financial Results and 2026 Outlook, Highlights Clinical and Commercial Progress
GRAL
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- GRAIL reported $147 million to $148 million in revenue for full year 2025, an 17%-18% growth over 2024, and projects total Galleri revenue growth of 22%-32% in 2026.
- The company ended 2025 with $904 million in cash, bolstered by approximately $435 million raised in Q4 2025 and an additional $110 million equity investment from Samsung expected in January 2026. Cash burn was reduced to approximately $274 million in 2025 and is guided to be less than $300 million in 2026, extending the cash runway into 2030.
- GRAIL expects to complete its modular PMA submission in Q1 2026 and will present full data from the 140,000-person NHS-Galleri randomized clinical trial and the 35,000-participant PATHFINDER 2 study in mid-2026.
- Commercial momentum for Galleri in 2025 included a 35% growth in volume, over 185,000 commercial tests sold, and a 30% increase in the prescriber base to over 17,000.
3 days ago
GRAIL Provides Updates on FDA Approval Timeline, Reimbursement Strategy, and Financial Outlook
GRAL
New Projects/Investments
Guidance Update
Product Launch
- GRAIL anticipates completing its modular PMA submission to the FDA for Galleri in Q1 2026, with an expected 12-month review period, potentially leading to approval in 2027.
- The company projects its current funding, including a recent $325 million PIPE and a potential $110 million from Samsung, will extend its cash runway into 2030, positioning it beyond anticipated broad U.S. reimbursement and NHS decisions.
- GRAIL's Galleri test demonstrated a 0.4% false positive rate and a 62% positive predictive value in Pathfinder 2, which are significantly better than competitors' tests, providing a key safety and performance advantage.
- GRAIL expects Medicare coverage for FDA-approved multi-cancer early detection (MCED) tests to begin phasing in by 2028, contingent on the passage of MCED legislation.
- The company's lab is capable of running one million samples today and can scale to 6-10 million samples, with adjusted gross margins reaching 55% in Q3 due to volume leverage, aiming for 50%-60% even at lower price points.
Dec 2, 2025, 8:00 PM
Grail Provides Updates on FDA Submission, Clinical Performance, and Financial Outlook
GRAL
Guidance Update
New Projects/Investments
Product Launch
- Grail anticipates completing its modular PMA submission to the FDA in Q1 2026, with an estimated 12-month review, potentially leading to reimbursement in 2027. This submission will be one of the largest diagnostic data submissions the FDA has ever seen, involving over 100,000 subjects.
- The Galleri test demonstrates a 0.4% false positive rate and a 62% positive predictive value, significantly outperforming competitors. It also increases the cancer detection rate by sevenfold when added to standard care screening and finds over half of cancers in stage one and two.
- Currently, 60% of Grail's business is self-pay, with 30%-40% reimbursed by enterprise channels. Broad reimbursement, including Medicare, is contingent on FDA approval and the passage of MCED legislation, with Medicare coverage potentially phasing in by 2028.
- Grail recently completed a $325 million PIPE and expects an additional $110 million if the Samsung deal closes, extending its cash runway into 2030. The company's adjusted gross margins increased to 55% in Q3 from 45% in the prior quarter due to volume, with a goal of 50%-60% even at lower ASPs.
- Grail has launched Galleri in Israel and Canada, and a strategic collaboration with Samsung is aimed at accelerating expansion into the Asian market.
Dec 2, 2025, 8:00 PM
GRAIL Updates on Regulatory Milestones, Financial Position, and Market Expansion
GRAL
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
- GRAIL anticipates completing its FDA PMA submission in Q1 2026, with a 12-month review period, potentially leading to approval around Q1 2027.
- Medicare coverage for the Galleri test is projected to begin approximately one year after FDA approval, contingent on MCED legislation passing, with provisions effective in 2028.
- The company recently raised $325 million via a PIPE and anticipates an additional $110 million from a Samsung partnership, extending its cash runway into 2030.
- Adjusted gross margins improved to 55% in Q3 from 45% in the prior quarter, with a target of 50%-60% even at lower price points, supported by a scalable lab capable of running 1 million samples today.
- Key international data from the 140,000-person NHS-Galleri study is expected in mid-2026, which is crucial for global market access.
Dec 2, 2025, 8:00 PM
GRAIL Provides Updates on FDA Submission, Clinical Data, and Reimbursement Pathway
GRAL
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
- GRAIL anticipates submitting its Galleri Multi Cancer Early Detection Test for FDA approval in Q1 2026, leveraging over 90,000 patient records from studies like Pathfinder 2 and the NHS-Galleri prevalent round.
- The company reported strong clinical performance from Pathfinder 2, demonstrating a 7-fold improvement in cancer detection rate when Galleri is added to standard of care screening, a 62% positive predictive value (PPV), and 90% cancer signal origin (CSO) accuracy.
- Key milestones for 2026 include the FDA submission in Q1 and the readout of the full NHS-Galleri study's clinical utility endpoint in mid-2026.
- Momentum is building for the MSAD bill in Congress, which could enable CMS reimbursement of approximately $500 per test starting in 2028 if passed.
- GRAIL has extended its financial runway into 2030, enhancing flexibility and de-risking future uncertainties, while also noting a repeat test rate of over 30% for Galleri.
Nov 18, 2025, 3:00 PM
GRAIL provides updates on FDA submission timeline, NHS-Galleri data, and extended financial runway
GRAL
Guidance Update
New Projects/Investments
Regulatory Update
- GRAIL plans to submit its PMA to the FDA in Q1 2026, narrowing the previous timeline. The company expresses high confidence due to a large data package, including over 90,000 patient records and strong performance metrics from Pathfinder 2, such as a 7-fold improvement in cancer detection rate when Galleri is added to standard care screening.
- The full NHS-Galleri study data, including its clinical utility endpoint (reduction in stage three and four cancers), is expected to read out in mid-2026. This data is crucial for NHS decisions and future US payer discussions, although the FDA submission will only include the prevalent round data.
- Momentum for the MSAD bill in Congress is strong, with bipartisan support, and if passed, it could lead to CMS coverage authority starting in 2028 with an estimated reimbursement of ~$500 per test.
- GRAIL has extended its financial runway into 2030, providing significant flexibility and de-risking the timing of FDA approval and CMS reimbursement.
- Commercial momentum is strong, with the repeat test rate for Galleri now over 30%, up from 20% earlier in the year, which is considered unprecedented for a non-reimbursed, non-FDA approved screening test.
Nov 18, 2025, 3:00 PM
GRAIL Narrows FDA Submission Timeline to Q1 2026 and Extends Financial Runway
GRAL
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- GRAIL plans to submit its Galleri Multi Cancer Early Detection Test for PMA approval to the FDA in the first quarter of 2026. The submission will include over 90,000 patient records, highlighting a seven-fold improvement in cancer detection rate and a 62% positive predictive value (PPV) from Pathfinder 2 data.
- The full NHS-Galleri study data, which will assess clinical utility, is anticipated to read out in mid-2026 and will be critical for both NHS decisions and US payer discussions.
- There is significant momentum for the MSAD bill in Congress, which could enable Medicare coverage authority by 2028 with an estimated reimbursement of $508 or $509 per test.
- GRAIL has extended its financial runway into 2030, enhancing flexibility and mitigating risks associated with regulatory and reimbursement timelines.
Nov 18, 2025, 3:00 PM
Quarterly earnings call transcripts for GRAIL.
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