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Guardant Health, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 6 raised, 1 narrowed, 2 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose 36% year over year: Total revenue was $361.0 million, with Oncology, Screening and Biopharma & Data cited as drivers of the increase. Source
  • Screening revenue up 180%: Screening revenue reached $67.6 million, from $24.1 million, driven primarily by Shield test volume growth. Source
  • Breast cancer companion diagnostic approved: FDA approval and European CE-marking for Guardant360 CDx as companion diagnostic for AstraZeneca's camizestrant, the first such FDA approval for longitudinal breast cancer testing. Source
  • Non-GAAP operating costs climbed: Non-GAAP operating expenses were $287.4 million, up from $228.9 million, reflecting commercial and marketing spend for Screening and Oncology. Source
  • Shield test volume more than tripled: Shield volume reached 83,000 tests, up from 24,000 a year earlier. Source
  • Oncology volume grew 58%: Oncology tests reached 117,000, up 58%, with management citing broad contributions across the portfolio. Source
  • Quarterly free cash flow burn narrowed: Free cash flow was negative $37.2 million, compared with negative $45.8 million a year earlier. Source

“Revenue grew 36% year over year as we continued to execute across Oncology, Screening, and Biopharma,”

Helmy Eltoukhy, co-founder and co-CEO

Guidance

AreaPeriodFigureAgainst last quarter
Total revenue Sourcefull year 2026$1.36 to $1.37 billion, representing growth of 38% to 40%Raised from $1.34 to $1.36 billion, representing growth of 36% to 38%
Oncology revenue growth Sourcefull year 2026approximately 30%Kept
Oncology test volume growth Sourcefull year 2026over 50%Raised from approximately 50%
Biopharma & Data revenue growth Sourcefull year 2026low double-digit rangeKept
Screening revenue Sourcefull year 2026$233 to $238 millionRaised from $218 to $230 million
Shield test volume Sourcefull year 2026285,000 to 290,000 testsRaised from 270,000 to 285,000 tests
Non-GAAP gross margin Sourcefull year 202665%Narrowed, low end up from 64% to 65%
Total non-GAAP operating expenses Sourcefull year 2026$1.105 to $1.125 billionRaised from $1.080 to $1.100 billion
Free cash flow burn Sourcefull year 2026$205 million to $220 millionRaised from $195 million to $205 million

What changed from last quarter

  • Guidance raised: Revenue range raised to $1.36 to $1.37 billion from $1.34 to $1.36 billion. Source
  • Guidance raised: Screening revenue and Shield volume ranges both raised from the prior guidance. Source
  • Guidance raised: Full-year non-GAAP gross margin now 65%, compared with a prior range of 64% to 65%. Source
  • Guidance raised: Non-GAAP operating expense range increased by $25 million at each end. Source
  • Guidance raised: Full-year free cash flow burn range increased to $205 million to $220 million. Source
  • Guidance kept: Biopharma & Data growth remains in the low double-digit range; Oncology revenue growth stays at about 30%. Source
  • New: FDA approval and CE-marking in Europe for Guardant360 CDx as companion diagnostic for camizestrant. Source
  • New: A premarket approval application for Guardant360 Tissue was submitted to the FDA. Source
  • New: Shield commercial coverage now above 80% of eligible lives, with additions including Carelon and EviCore. Source
  • New: Guardant Reveal Ultra launched with biopharma partners in the quarter. Source

Results and growth drivers

  • Revenue rose 36% year over year: Total revenue was $361.0 million, with Oncology, Screening and Biopharma & Data cited as drivers of the increase. Source
  • GAAP net loss rose year over year: GAAP net loss was $124.4 million, or $0.93 per share, against $92.7 million, or $0.74 per share, a year earlier. Source
  • Non-GAAP net loss per share fell: Non-GAAP net loss was $38.8 million, or $0.29 per share, compared with $48.3 million, or $0.39 per share, a year earlier. Source
  • Adjusted EBITDA loss narrowed: Adjusted EBITDA loss was $37.3 million, compared with a $45.5 million loss in the prior-year quarter. Source

Segments and revenue lines

  • Screening revenue up 180%: Screening revenue reached $67.6 million, from $24.1 million, driven primarily by Shield test volume growth. Source
  • Oncology revenue up 25%: Oncology revenue rose to $231.3 million from $184.4 million, driven primarily by test volume. Source
  • Biopharma and Data revenue grew 8%: Biopharma & Data revenue was $59.0 million, compared with $54.7 million a year earlier. Source
  • Licensing and other revenue increased: Licensing and other revenue was $3.1 million, compared with $2.0 million a year earlier. Source

“The FDA approval of Guardant360 CDx for longitudinal ESR1 testing is a major advance for breast cancer patients, ushering in a new paradigm of cancer treatment.”

Helmy Eltoukhy, co-founder and co-CEO

Products, approvals and coverage

  • Breast cancer companion diagnostic approved: FDA approval and European CE-marking for Guardant360 CDx as companion diagnostic for AstraZeneca's camizestrant, the first such FDA approval for longitudinal breast cancer testing. Source
  • INLURIYO companion diagnostic approved: FDA approved Guardant360 CDx as a companion diagnostic for INLURIYO with VERZENIO in ESR1-mutated breast cancer. Source
  • Guardant360 Tissue filed with FDA: A premarket approval application for Guardant360 Tissue was submitted to the FDA during the quarter. Source
  • Shield coverage above 80% of lives: Shield commercial coverage now exceeds 80% of eligible lives, with UnitedHealth Group, Carelon and EviCore among the additions. Source

Costs, margins and pricing

  • Non-GAAP gross margin rose to 67%: Non-GAAP gross margin was 67%, up from 66%; GAAP gross margin was 65% in both periods. Source
  • Non-GAAP operating costs climbed: Non-GAAP operating expenses were $287.4 million, up from $228.9 million, reflecting commercial and marketing spend for Screening and Oncology. Source
  • GAAP operating expenses rose further: GAAP operating expenses were $368.9 million, up from $270.6 million, with higher stock-based compensation also cited. Source

“Shield continued to build momentum in the third quarter, with volume more than tripling year over year to 83,000 tests,”

AmirAli Talasaz, co-founder and co-CEO

Demand and test volumes

  • Shield test volume more than tripled: Shield volume reached 83,000 tests, up from 24,000 a year earlier. Source
  • Oncology volume grew 58%: Oncology tests reached 117,000, up 58%, with management citing broad contributions across the portfolio. Source
  • Shield coverage near 100 million lives: Recent policy updates extended Shield coverage to approximately 100 million lives, according to management. Source

Cash and capital

  • Cash balance $1.1 billion: Cash, cash equivalents and restricted cash totaled $1.1 billion at September 30, 2026. Source
  • Quarterly free cash flow burn narrowed: Free cash flow was negative $37.2 million, compared with negative $45.8 million a year earlier. Source
  • Shares outstanding increased: Shares issued and outstanding were 134,719,874 at September 30, 2026, up from 130,635,301 at December 31, 2025. Source

Strategy and investment

  • Guardant360 role in therapy decisions: Management said the approval reinforces Guardant360's role in enabling earlier therapy decisions across the cancer care continuum. Source
  • Shield workflow fully implemented: Management said the lower-COGS, higher-throughput Shield workflow is now fully implemented, providing a foundation for future Shield demand. Source
  • Shield aims at routine screening: Management described these advances as expanding access to Shield and moving closer to routine blood-based cancer screening. Source

Coming up, as management said on 5 November 2026

  • Reveal Ultra clinical launch planned: Clinical launch of Guardant Reveal Ultra is planned for 2026, following the launch with biopharma partners. Source

Figures management reported

FigureReported
Oncology tests Source117,000, up 58%
Shield tests Source83,000, up 246%

Earlier plans management reported on

  • On track: Management said it remains on track for the clinical launch of Guardant Reveal Ultra in 2026. Source
  • Met: Management reported the lower-COGS, higher-throughput Shield workflow was deployed. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.