What Management Said

Read the full Q4 2025 transcript ↗

2025 represents the first full year for Shield IVD, where very meaningful volume and revenue generation exceeds our expectations. We have significantly expanded the commercial team and established impactful strategic partnerships to meet the growing demand for a high-performing, blood-based screening option. Importantly, this execution has directly driven strong financial performance, both accelerating our top-line growth and strengthening our path to profitability. Turning to top-line performance on slide four, we delivered $281 million of revenue in the Q4, representing 39% year-over-year growth, and $982 million of revenue or 33% year-over-year growth for the full year.

This exceptional performance reflects continued broad-based growth across our oncology screening and biopharma and data businesses. Taking a closer look at our oncology business in slide five, oncology revenue increased 30% to $190 million, and oncology volumes grew 38% to approximately 79,000 tests in the Q4. Together, these drivers will continue to catalyze very strong growth in our oncology business. Reveal continues to be our fastest-growing product, reflecting growing demand for tissue-free MRD.

Turning to slide 9 to take a closer look at our Reveal data pipeline. Shifting gears to our biopharma and data business in slide 11, we delivered another year of strong performance, with revenue growing 18% year-over-year to $210 million in 2025. We are a leader in companion diagnostics, with 25 approvals to date across the U.S., Japan, and Europe, and a robust pipeline of ongoing CDx programs. We delivered $35 million of Shield testing revenue in Q4, driven by approximately 38,000 tests, which was a meaningful step-up compared to 24,000 tests in Q3.

What went well
  • Q4 revenue grew 39% year-over-year to $281.3 million, and full-year 2025 revenue grew 33% to $982.0 million, reflecting broad-based growth across oncology, biopharma and data, and screening.
  • Oncology revenue rose 30% to $189.9 million in Q4 with volumes up 38% to approximately 79,000 tests, and Guardant360 Liquid volumes grew nearly 30% supported by Smart app adoption.
  • Shield delivered $35 million in screening revenue in Q4 from about 38,000 tests, a step-up from 24,000 tests in Q3, with management calling it the most successful diagnostic launch in history outside of COVID testing.
  • Shield achieved 93% real-world adherence across the first 100,000 tests ordered, well above the 25%-71% range typical of other screening modalities.
  • Non-GAAP gross margin improved to 66% in Q4 (from 63% a year earlier), driven by Reveal cost per test falling under $500 and Shield gross margin reaching 52% from negative levels at launch.
  • The core business excluding screening generated positive free cash flow in both Q3 and Q4, and full-year free cash flow burn improved by $42 million to $233 million.
What went wrong
  • Biopharma and data Q4 revenue grew only 9% to $54.0 million, a slower rate than other segments, though described as in line with expectations.
  • Full-year non-GAAP operating expenses of $903.7 million came in modestly above guidance due to a higher 2025 bonus accrual and continued reinvestment of screening gross profit into sales and marketing.
  • Adjusted EBITDA remained a loss of $64.9 million in Q4 and $220.9 million for the full year, and the company does not expect company-wide cash flow breakeven until the end of 2027.
  • Shield ASP of approximately $850 reflects a focus on Medicare-covered patients, and management guided ASP lower in 2026 as growing demand from under-65 commercial patients shifts the payer mix.

Guidance Changes

MetricPeriodCurrent guidance
Total revenueFY2026$1.25B-$1.28B (27%-30% growth) (new)
Oncology revenue growthFY202625%-27%, with ~30% volume growth (new)
Screening revenueFY2026$162M-$174M on 210,000-225,000 tests (new)
Biopharma and data revenue growthFY2026low double-digit (new)
Non-GAAP gross marginFY202664%-65% (lower)
Non-GAAP operating expensesFY2026$1.03B-$1.05B (14%-16% growth) (higher)
Free cash flow burnFY2026$185M-$195M (improved)
Long-range revenue targetFY2028$2.2 billion (reaffirmed)

Performance Breakdown

MetricYoYNote
Q4 total revenue +39% to $281.3M Strong execution across oncology, biopharma and data, and screening.
Q4 oncology revenue +30% to $189.9M Continued strong volume growth driven by Smart app adoption on Guardant360 Liquid, the Guardant360 Tissue Smart Platform upgrade, and Reveal.
Q4 oncology volume +38% to ~79,000 tests Broad contribution across all oncology products, with Reveal the fastest-growing on CRC surveillance reimbursement and therapy monitoring uptake.
Q4 biopharma and data revenue +9% to $54.0M In line with expectations.
Q4 non-GAAP gross margin 66% vs 63% Reveal cost per test fell from over $1,000 in Q3 2024 to under $500, plus Shield gross margin improving to 52%.
Q4 adjusted EBITDA loss Improved to -$64.9M from -$78.4M Revenue growth and gross margin improvement outpacing expense growth.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Smart Platform driving oncology volumesTissue upgrade released Q2 202515 Smart applications developed on Guardant360 Liquid; tissue accelerating in second halfExpanding
Reveal therapy monitoring—Launched in Q4; bridges Guardant360 therapy selection to monitoring to retreatment; data packages submitted to MolDXExpanding
Shield commercial scale-up~300 reps at year-endQuest and PathGroup collaborations broadening national reach in 2026; ADLT rate of $1,495 secured through December 2027Expanding
Multi-cancer detection (MCD)MCD report introduced OctoberShield MCD report covers nine cancers plus CRC; new Medicare coverage pathway legislation passed but not a near-term driverEarly/expanding
Path to profitability—Core business ex-screening free cash flow positive in 2026; company-wide breakeven targeted end of 2027Improving
MetaSyte acquisition—Acquired in December for $59M upfront plus up to $90M contingent; complementary technology to enhance CRC screening and MCDNew

Q&A Summary

How should Reveal therapy monitoring be framed for both Reveal and Guardant360 volumes? (Dan Leonard, UBS)
Therapy monitoring works synergistically with Guardant360 by monitoring patients on therapies and bridging to the next Guardant360 test when they progress; with reimbursement wins for IO and chemo monitoring it could be an important growth driver over the next few years.
How should investors think about oncology growth across Guardant360 versus Reveal through 2026, given camizestrant and other drivers are not in the guide? (Puneet Souda, Leerink)
Management expects another strong year for Guardant360 at around at least 20% volume growth and Reveal to remain the fastest-growing product with acceleration from therapy monitoring; tissue is also expected to accelerate, helped by potential FDA approval pull-through.
What is the expected Shield-specific cash burn and the pacing of rep hiring in 2026? (Doug Schenkel, Wolfe Research)
About $220 million of the $233 million 2025 burn was screening; a similar ~$220 million screening burn is expected in 2026 as a year of investment, with 2027 as the inflection year, and incremental gross profit will be reinvested primarily into the sales force.
What ADLT pricing assumption is baked into the Guardant360 guide, and where is the most conservatism in the oncology outlook? (Tycho Peterson, Jefferies)
No Guardant360 ADLT pricing is baked into 2026; FDA submission is on track for the second half, potentially setting up a new rate in early 2027, and the 30% oncology volume growth guide is viewed as strong across the full portfolio.
What will differentiate Reveal Ultra and when can data be expected? (Daniel Markowitz, Evercore ISI)
Reveal Ultra is on track to launch this year and management believes its clinical sensitivity will be best in class and redefine the tumor-informed space, with more details to be shared later in the year.
Where is Shield demand coming from — care gap closure or share from colonoscopy, FIT, or Cologuard? (Luke Sergott, Barclays)
Demand comes from PCP physicians focused on the unscreened population, with about 90% of Shield-screened patients not having been screened in the prior five years; care gap programs are not yet a driver because Shield does not yet qualify for HEDIS quality scores.

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Q4 2025 call
Reported 2026-02-19 · figures from the Guardant Health, Inc. Q4 2025 earnings call.

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