Snapshot
Guardant Health, Inc. reported $265M of revenue in Q3 2025, up 38.5% year over year, with diluted EPS of $-0.74 and an operating margin of -37.3%.
- Revenue
- $265M
- YoY growth
- +38.5%
- Diluted EPS
- $-0.74
- Operating margin
- -37.3%
What management said
- •Starting on slide three, Q3 was an exceptional quarter for Guardant Health, with broad-based growth across our business.
- •Technology volumes grew 40% as year-over-year volume growth continued to accelerate, driven by Guardant360 Liquid, Guardant360 Tissue, and Reveal.
- •Our biopharma business grew nicely year over year with positive CDx momentum, and screening volume accelerated with a sequential increase of 8,000 Shield tests.
- •Importantly, screening has started to generate meaningful revenue, tracking at an annual run rate of approximately $100 million, roughly one year into the commercial launch of the FDA-approved product.
- •Overall, we are very pleased with our performance this quarter, delivering 39% year-over-year revenue growth and crossing over $1 billion in annualized revenue for the first time.
- •Excluding screening, we reached a major milestone, with the rest of the business becoming cash flow positive one quarter earlier than expected.
- •Now turning to top-line performance in slide four, Q3 revenue grew 39% year over year to $265 million, with strong performance again across our oncology, screening, and biopharma and data businesses.
- •Taking a closer look at our oncology business on slide five, oncology revenue increased 31% to $184 million, and oncology volumes increased 40% year over year to approximately 74,000 tests in the third quarter.
- •In addition to Guardant360 Liquid, Guardant360 Tissue and Reveal volumes also experience strong year-over-year growth.
- •Looking more closely at some of the recent highlights within our oncology business on slide nine, Guardant360 volume grew exceptionally, with more than 30% year-over-year growth.
- •Turning to slide 10 to take a closer look at our Reveal data pipeline.
- •Turning now to slide 11, I'm proud of the progress we have made over the last few years in both driving demand and revenue growth across our portfolio.
What went well
- •Q3 revenue grew 39% year over year to $265.2 million, with the company crossing over $1 billion in annualized revenue for the first time.
- •Technology volumes grew 40% year over year, driven by Guardant360 Liquid (fifth consecutive quarter of accelerating growth, up more than 30%), Guardant360 Tissue, and Reveal.
- •Excluding screening, the rest of the business became free cash flow positive one quarter earlier than expected, and is expected to remain so in Q4 and full year 2026 and beyond.
- •Screening began generating meaningful revenue at an annual run rate of approximately $100 million, with $24.1 million of Shield revenue from about 24,000 tests and a sequential increase of 8,000 Shield tests.
- •Non-GAAP gross margin improved to 66% from 63% a year ago, driven by Reveal COGS falling from over $1,000 to under $500 per test and Shield gross margin improving to 55% from negative levels at launch.
- •The company surpassed 1 million cumulative clinical patients tested and submitted its PMA application to the FDA for Guardant360 Liquid.
What went wrong
- •The company is effectively getting paid more or less zero for its tranche of commercial-payer Shield patients, with commercial reimbursement still needing time to ramp.
- •Out-of-period oncology revenue recognized in Q3 was approximately $5 million, down from $12 million in the prior year period.
- •The government shutdown paused some ADLT status discussions for Reveal.
Guidance changes
| Metric | Period | Previous | Current | Change |
|---|---|---|---|---|
| Full year 2025 total revenue | FY2025 | midpoint $47.5M lower (prior range) | $965M-$970M (~31% growth) | Raised for the third time this year |
| Oncology revenue growth | FY2025 | ~20% | ~25% | Raised |
| Total oncology test volume growth | FY2025 | >27% | >30% | Raised |
| Shield revenue | FY2025 | $55M-$60M | $71M-$73M | Raised |
| Shield test volume | FY2025 | 68,000-73,000 tests | 80,000-82,000 tests | Raised |
| Biopharma and data revenue growth | FY2025 | mid-teens | mid-teens | Unchanged (on track) |
| Non-GAAP gross margin | FY2025 | 63%-64% | 64%-65% | Raised |
| Non-GAAP operating expenses | FY2025 | — | $865M-$875M (14%-16% increase vs 2024) | — |
| Free cash flow burn | FY2025 | — | $225M-$235M (improvement from $275M in 2024) | Reaffirmed |
| Company-wide cash flow breakeven | By end of 2027 | — | Committed to breakeven by end of 2027 | Reaffirmed |
Performance breakdown
| Metric | YoY change | Reason |
|---|---|---|
| Total revenue | +39% to $265.2M | Strong performance across oncology, biopharma and data, and screening businesses. |
| Oncology revenue | +31% to $184.4M | Another quarter of accelerated test volume growth, with approximately 74,000 oncology tests (+40%). |
| Guardant360 Liquid volume | +more than 30% | Expanding clinical utility enabled by smart apps launched over the past year; fifth consecutive quarter of accelerating growth. |
| Biopharma and data revenue | +18% to $54.7M | Continued strong performance including milestone revenue from two companion diagnostic approvals achieved during the quarter. |
| Screening (Shield) revenue | $24.1M from 24,000 tests | ASP of approximately $880, above expectations, reflecting continued focus on Medicare-covered patients, plus ~$3M out-of-period revenue from better-than-expected Medicare Advantage reimbursement. |
| Non-GAAP gross margin | 66% vs 63% | Significant reduction in Reveal COGS (from over $1,000 to under $500 per test) and strong progress in Shield gross margin. |
| Adjusted EBITDA loss | $45.5M loss, improved $10.7M from $56.2M loss | Operating leverage despite continued investment in screening commercial infrastructure. |
| Free cash flow burn | $45.8M, improved $9.5M | Disciplined cash management; core business excluding screening turned free cash flow positive. |
Earnings call themes & trends
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Shield commercial infrastructure scale-up | Original plan | Accelerated build-out beyond original plan, plus partnerships with Quest Diagnostics (650,000 clinician/hospital accounts, available Q1 2026) and Path Group (250+ health systems across 25 states) | expanding |
| Smart apps platform on Guardant360 Liquid | Introduced July last year | 15 smart apps launched to date with dozens more in development across Liquid, Tissue, and Reveal | expanding |
| Reveal MRD franchise | CRC surveillance Medicare coverage achieved early this year | Submitted dossiers for breast surveillance and IO therapy monitoring; planning chemo and CDK4/6 submissions; introducing Reveal Ultra tumor-informed assay | expanding |
| Shield Multicancer Detection (MCD) | Investor day data (9,251 individuals, 99% specificity, 41% PPV) | Now available nationwide through clinical data collection initiative, expected to reach hundreds of thousands of participants | expanding |
| Companion diagnostic (CDx) momentum | — | Two additional CDx approvals in Q3 (Guardant360 CDx for ESR1 breast cancer; Japan approval for HER2 NSCLC), reaching 23 total CDx approvals | expanding |
| American Cancer Society guideline inclusion for Shield | — | Research team appears nearly done; company optimistic about near-future inclusion but not counting on it in guidance | pending |
| Tests per patient / longitudinal testing | One test per patient per lifetime | Estimated at maturation 4-5 tests per patient per year (more than 10x current market) | growing |
Q&A summary
Can you walk through Shield ASP dynamics exiting the year and the phasing as ADLT pricing rolls off, given the walk-down toward $700 by 2028?
ASP reflects the Medicare $1,495 ADLT rate (also paid by Medicare Advantage), with majority of volume skewed to Medicare/Medicare Advantage and effectively zero from commercial patients. The company is confident in maintaining the $1,495 rate for at least the next two years. The main fluctuation through 2028 will be a higher proportion of commercial patients, which takes time to establish reimbursement.
Is American Cancer Society guideline inclusion realistic by year-end, how long until it translates to getting paid, and could reimbursement expand beyond the initial ~10 states toward ~20?
The ACS research team appears nearly done and management remains confident and optimistic about near-future inclusion, though it is not in this year's guide. Inclusion should improve appeal success rates initially and eventually broaden coverage and contracting. Florida Medicaid patients now have access via a consortium, and management cited positive dialogue with the administration on cancer screening.
How should we think about 2026 Shield growth and early MCD attach rates, and what is driving Guardant360 Liquid's 30%+ growth a decade after launch?
It is too early to comment on 2026 Shield growth, but management is confident in the long-term outlook shared at investor day. On Guardant360, growth reflects that it is an application platform (not a single test); smart apps multiply clinical utility, and the company sees it as still very early innings.
Is a late-2027 FDA submission for Shield MCD a reasonable expectation?
It is too early to set a specific timeline. The company just began accessing the clinical data needed and must monitor how quickly it can build evidence, potentially across hundreds of thousands of patients, before commenting on FDA approval timing.
What progress is being made on driving tests-per-patient higher for Reveal, and what catalysts should we watch?
After getting the surveillance reimbursement indication, the company turned on capabilities to pull in subsequent test orders and is seeing return on that investment. Tests per patient have risen nicely, with longitudinal testing (Serena 6/ESR1, upcoming therapy monitoring, MRD recurrence monitoring) expected to pay dividends across the blood-based portfolio.
Is the ~8,000 sequential Shield increase a reasonable near-term run rate, and is Reveal Ultra commercially launched with CMS timing?
The guide midpoint implies another ~8,000 sequential Shield increase in Q4; the company won't get ahead of itself and will discuss 2026 later, citing catalysts like Quest/Path Group, guideline inclusion, and commercial team build-out. On Reveal Ultra, the tumor-informed assay shows strong data with sensitivity expected below what exists in the field, but launch timing is being kept close to the chest.