On October 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter ended September 30, 2025.
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Third Quarter 2025 Financial Highlights
For the three-month period ended September 30, 2025, as compared to the same period of 2024:
•Reported total revenue of $265.2 million, an increase of 39%, driven by:
◦Oncology revenue of $184.4 million, an increase of 31%, and approximately 74,000 oncology tests, an increase of 40%
◦Screening revenue of $24.1 million, and approximately 24,000 Shield screening tests, compared to $1.0 million in the prior year period
◦Biopharma & Data revenue of $54.7 million, an increase of 18%
•Generated non-GAAP gross margin of 66%, compared to 63% in the third quarter of 2024
Recent Operating Highlights
•Expanded Shield to include multi-cancer detection (MCD) and initiated a large-scale real-world data initiative for Shield MCD
•Announced strong real-world performance data for Shield MCD utilizing the InfinityAI learning engine
•Established strategic collaborations with Quest Diagnostics and PathGroup to further accelerate nationwide access to Shield
•Improved stage I performance in Shield V2 CRC screening test
•Established a partnership with American Cancer Society to expand cancer screening access and advance health equity
•Reached a major milestone with the submission of Guardant360 Liquid PMA application to FDA
•Submitted Reveal immuno-oncology monitoring data package to MolDx for Medicare reimbursement
•Received new Guardant360 companion diagnostic approvals for breast cancer and non-small cell lung cancer
"This was an exceptional quarter for Guardant with broad-based growth across our business," said Helmy Eltoukhy, co-founder and co-CEO. "Oncology volumes grew 40% year-over-year, driven by very strong performance across all products, including the fifth consecutive quarter of accelerating Guardant360 Liquid volume growth. Notably, this quarter we crossed over $1 billion in annualized revenue. This sets us up well to deliver on the long-term plan we presented at our Investor Day last month."
"We made incredible progress in Screening in the third quarter. It has been very rewarding to see Shield take off and hear story after story of patients positively impacted by this pioneering test. To support the growing demand, we have accelerated our commercial infrastructure build out and established strategic collaborations with Quest Diagnostics and PathGroup to help rapidly broaden access to Shield throughout the country," said AmirAli Talasaz, co-founder and co-CEO. "Beyond CRC screening, I’m pleased to share that we have now expanded Shield to include multi-cancer detection nationwide through our clinical data initiative, bringing this important innovation to a broader population."
Third Quarter 2025 Financial Results
Revenue was $265.2 million for the third quarter of 2025, a 39% increase from $191.5 million for the corresponding prior year period. Oncology revenue grew 31% to $184.4 million for the third quarter of 2025, from $141.2 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume (Guardant360 Liquid, Tissue, and Reveal), which grew 40% over the prior year period. Screening revenue was $24.1 million for the third quarter of 2025, primarily generated from approximately 24,000 Shield tests. Biopharma and Data revenue grew 18% to $54.7 million for the third quarter of 2025, from $46.5 million for the corresponding prior year period, driven primarily by the achievement of certain milestones of our service agreements. Licensing and other revenue was $2.0 million for the third quarter of 2025, compared to $2.7 million for the corresponding prior year period.
Gross profit, or total revenue less cost of revenue, was $171.6 million for the third quarter of 2025, an increase of $54.6 million from $117.0 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65%, as compared to 61% for the corresponding prior year period.
Non-GAAP gross profit was $174.3 million for the third quarter of 2025, an increase of $53.3 million or 44%, from $121.1 million for the corresponding prior year period. Non-GAAP gross margin was 66% for the third quarter of 2025, as compared to 63% for the corresponding prior year period.
Operating expenses were $270.6 million for the third quarter of 2025, as compared to $234.3 million for the corresponding prior year period. Non-GAAP operating expenses were $228.9 million for the third quarter of 2025, as compared to $187.3 million for the corresponding prior year period. The year-over-year increase in both operating expenses and non-GAAP operating expenses was primarily related to commercial team expansion and marketing activities to support the Shield product launch and existing product growth.
Net loss was $92.7 million for the third quarter of 2025, as compared to $107.8 million for the corresponding prior year period. Net loss per share was $0.74 for the third quarter of 2025, as compared to $0.88 for the corresponding prior year period.
Non-GAAP net loss was $48.3 million for the third quarter of 2025, as compared to $55.0 million for the corresponding prior year period. Non-GAAP net loss per share was $0.39 for the third quarter of 2025, as compared to $0.45 for the corresponding prior year period.
Adjusted EBITDA loss was $45.5 million for the third quarter of 2025, as compared to a $56.2 million loss for the corresponding prior year period.
Free cash flow for the third quarter of 2025 was $(45.8) million, as compared to $(55.3) million for the corresponding prior year period. Cash, cash equivalents, and restricted cash were $689.5 million as of September 30, 2025.
2025 Guidance
Guardant Health now expects full year 2025 revenue to be in the range of $965 to $970 million, representing growth of approximately 31% compared to full year 2024. This compares to the prior range of $915 to $925 million, representing annual growth of 24% to 25%.
Within this revenue range:
•Oncology revenue is now expected to grow approximately 25% year over year in 2025, compared to prior guidance of approximately 20% growth. Oncology volume is now expected to accelerate greater than 30% growth in 2025 compared to 20% growth in 2024.
•Screening revenue is now expected to be in the range of $71 to $73 million, driven by Shield volume of 80,000 to 82,000 tests. This compared to the prior range of $55 to $60 million and 68,000 to 73,000 tests.
•Biopharma & Data revenue growth is expected to continue to be in the mid-teens range.
Guardant Health now expects full year 2025 non-GAAP gross margin to be in the range of 64% to 65%, an improvement compared to prior expectations of 63% to 64%. Guardant Health now expects total non-GAAP operating expenses to be in the range of $865 to $875 million, an increase compared to the prior range of $840 to $850 million due to the continued investment in commercial team expansion and marketing activities to support the Shield product launch and existing product growth. Guardant Health continues to expect free cash flow burn to be in the range of $225 to $235 million, an improvement compared to $275 million for the full year 2024.
Webcast Information
Guardant Health will host a conference call to discuss the third quarter 2025 financial results after market close on Wednesday, October 29, 2025 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.
(Press release, Guardant Health, OCT 29, 2025, View Source [SID1234657103])