Guardant Health Reports Third Quarter 2026 Financial Results and Increases 2026 Revenue Guidance

Original from: Guardant Health

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended September 30, 2026.

Third Quarter 2026 Financial Highlights

For the three-month period ended September 30, 2026, as compared to the same period of 2025:

- Reported total revenue of $361.0 million, an increase of 36%, driven by:

 · Oncology revenue of $231.3 million, an increase of 25%, and 117,000 oncology tests, an increase of 58%

 · Biopharma & Data revenue of $59.0 million, an increase of 8%

 · Screening revenue of $67.6 million, an increase of 180%, and 83,000 Shield tests, an increase of 246%

- Generated non-GAAP gross margin of 67%, compared to 66% for the third quarter of 2025

Recent Operating Highlights

- Received U.S. Food and Drug Administration (FDA) approval and CE-marking in Europe for Guardant360 CDx as a companion diagnostic for AstraZeneca’s ETCAMAH (camizestrant), the first FDA approval of a liquid biopsy companion diagnostic for longitudinal testing in breast cancer

- Received FDA approval for Guardant360 CDx as a companion diagnostic for INLURIYO (imlunestrant) in combination with VERZENIO (abemaciclib) for eligible patients with ESR1-mutated advanced or metastatic breast cancer

- Submitted a premarket approval (PMA) application to the FDA for Guardant360 Tissue

- Launched Guardant Reveal Ultra with biopharma partners and remain on track for clinical launch in 2026

- Expanded commercial coverage for Shield to more than 80% of eligible lives, with key additions including UnitedHealth Group, Carelon Healthcare Services, and EviCore

- Successfully deployed the new FDA-approved lower COGS, higher-throughput Shield workflow

“Revenue grew 36% year over year as we continued to execute across Oncology, Screening, and Biopharma,” said Helmy Eltoukhy, co-founder and co-CEO. “Oncology volume grew 58% with broad contributions across our portfolio. 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. It reinforces the role of Guardant360 in enabling earlier therapy decisions and strengthens our leadership across the cancer care continuum.”

“Shield continued to build momentum in the third quarter, with volume more than tripling year over year to 83,000 tests,” said AmirAli Talasaz, co-founder and co-CEO. “Commercial coverage continues to expand, with recent policy updates extending Shield coverage to approximately 100 million lives. With our lower COGS, higher-throughput workflow now fully implemented, we have a strong operational foundation to meet future Shield demand. Together, these advances expand access to Shield and move us closer to making blood-based cancer screening a routine part of preventive care.”

Third Quarter 2026 Financial Results

Revenue was $361.0 million for the third quarter of 2026, a 36% increase from $265.2 million for the corresponding prior year period. Oncology revenue grew 25% to $231.3 million for the third quarter of 2026, from $184.4 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume, which grew 58% over the prior year period. Screening revenue grew 180% to $67.6 million for the third quarter of 2026, from $24.1 million for the corresponding prior year period, driven primarily by an increase in Shield test volume, which grew to 83,000 tests in the third quarter of 2026, from 24,000 tests in the prior year period. Biopharma & Data revenue grew 8% to $59.0 million for the third quarter of 2026, from $54.7 million for the corresponding prior year period. Licensing and other revenue was $3.1 million for the third quarter of 2026, compared to $2.0 million for the corresponding prior year period.

Gross profit, or total revenue less cost of revenue, was $236.2 million for the third quarter of 2026, an increase of $64.5 million or 38%, from $171.6 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65% for the third quarter of 2026, as compared to 65% for the corresponding prior year period.

Non-GAAP gross profit was $240.2 million for the third quarter of 2026, an increase of $65.9 million or 38%, from $174.3 million for the corresponding prior year period. Non-GAAP gross margin was 67% for the third quarter of 2026, as compared to 66% for the corresponding prior year period.

Operating expenses were $368.9 million for the third quarter of 2026, as compared to $270.6 million for the corresponding prior year period. The year-over-year increase in operating expenses was primarily related to commercial infrastructure expansion and marketing activities to support Screening and Oncology growth and an increase in stock-based compensation. Non-GAAP operating expenses were $287.4 million for the third quarter of 2026, as compared to $228.9 million for the corresponding prior year period. The year-over-year increase in non-GAAP operating expenses was primarily related to commercial infrastructure expansion and marketing activities to support Screening and Oncology growth.

Net loss was $124.4 million for the third quarter of 2026, as compared to $92.7 million for the corresponding prior year period. Net loss per share was $0.93 for the third quarter of 2026, as compared to $0.74 for the corresponding prior year period.

Non-GAAP net loss was $38.8 million for the third quarter of 2026, as compared to $48.3 million for the corresponding prior year period. Non-GAAP net loss per share was $0.29 for the third quarter of 2026, as compared to $0.39 for the corresponding prior year period.

Adjusted EBITDA loss was $37.3 million for the third quarter of 2026, as compared to a $45.5 million loss for the corresponding prior year period.

Free cash flow for the third quarter of 2026 was $(37.2) million, as compared to $(45.8) million for the corresponding prior year period.

Cash, cash equivalents, and restricted cash were $1.1 billion as of September 30, 2026.

2026 Guidance

Guardant Health now expects full year 2026 revenue to be in the range of $1.36 to $1.37 billion, representing growth of 38% to 40% compared to full year 2025. This compares to the prior range of $1.34 to $1.36 billion, representing growth of 36% to 38%.

Within this revenue range:

- Oncology revenue is expected to grow approximately 30% and Oncology volume is now expected to grow over 50%.

- Biopharma & Data revenue growth is expected to be in the low double-digit range.

- Screening revenue is now expected to be in the range of $233 to $238 million, driven by Shield volume of 285,000 to 290,000 tests. This compares to the prior guidance of $218 to $230 million revenue and 270,000 to 285,000 tests.

Guardant Health now expects full year 2026 non-GAAP gross margin to be 65%, compared to prior guidance of 64% to 65%. The company expects total non-GAAP operating expenses to be in the range of $1.105 to $1.125 billion, an increase compared to the prior range of $1.080 to $1.100 billion. Guardant Health now expects full-year free cash flow burn of $205 million to $220 million, compared to the previous outlook of $195 million to $205 million.

Source: Guardant Health Reports Third Quarter 2026 Financial Results and Increases 2026 Revenue Guidance