• Total Revenue: $203.5 million, up 21% year-over-year.
• Oncology Revenue: $150.6 million, up 20% year-over-year.
• Oncology Volume: Approximately 59,000 tests, up 25% year-over-year.
• Guardant360 ASP: Range of $3,000 to $3,100.
• Biopharma and Data Revenue: $45.4 million, up 21% year-over-year.
• Screening Revenue: $5.7 million from approximately 9,000 Shield tests.
• Licensing and Other Revenue: $1.9 million.
• Non-GAAP Gross Margin: 65%, up from 63% in the prior year.
• Non-GAAP Operating Expenses: $199.6 million, up 13% year-over-year.
• Adjusted EBITDA Loss: $58.5 million, an improvement of $2.6 million year-over-year.
• Free Cash Flow Burn: $67 million, impacted by timing of annual bonus payout.
• Cash and Equivalents: Approximately $804 million.
• Full Year 2025 Revenue Guidance: Increased to $880 million to $890 million.
• Shield Revenue Guidance: Raised to $40 million to $45 million.
• Non-GAAP Gross Margin Guidance: 62% to 63% for full year 2025.
• Non-GAAP Operating Expenses Guidance: $830 million to $840 million for full year 2025.
• Free Cash Flow Burn Guidance: $225 million to $235 million for full year 2025.

• Warning! GuruFocus has detected 7 Warning Signs with GH.

Release Date: April 30, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Guardant Health Inc (NASDAQ:GH) reported a strong start to the year with Q1 revenue growing 21% year-over-year to $203 million.
• The company achieved positive gross margins for both Reveal and Shield in Q1 2025, driven by significant cost reductions.
• Guardant360 ASP improved to the range of $3,000 to $3,100, supported by better Medicare Advantage and commercial reimbursement.
• The company announced a strategic collaboration with Pfizer, enhancing its long-term partnership and expanding its biopharma business.
• Shield received ADLT status, increasing the Medicare price from $920 to $1,495, which is expected to accelerate commercial infrastructure buildout.

Negative Points

• Despite the positive results, Guardant Health Inc (NASDAQ:GH) continues to report an adjusted EBITDA loss, with a $58.5 million loss for Q1 2025.
• Free cash flow burn increased to $67 million in Q1 2025, compared to $37 million in the prior year period, due to timing of bonus payouts.
• The company faces challenges in scaling its Shield business, with a significant portion of its cash burn related to screening efforts.
• There is uncertainty regarding the timing of guideline inclusion for Shield, which could impact commercial adoption and volume growth.
• The company is still in the early stages of deploying its sales force for Shield, with full productivity expected to take 12 to 18 months.

Q & A Highlights

Q: Helmy, you've had Guardant360 in the market for 11 years, and you're raising the oncology volume to over 25% growth. Can you rank-order the opportunities driving this acceleration? A: Helmy Eltoukhy, Co-CEO: We're seeing strong growth due to the Smart Liquid Biopsy upgrade, which has led to sequential growth for Guardant360. Reveal is also growing nicely, and we've made significant upgrades to our Tissue product. These factors, along with improvements in EMR integrations, are driving growth.

Q: Can you explain the components of the raised guidance for the screening business, particularly regarding Shield's ASP assumptions and Medicare mix? A: AmirAli Talasaz, Co-CEO: We're seeing improved productivity from our reps, and the VA contract provides access to millions of beneficiaries. Mike Bell, CFO, added that the ASP for Shield is expected to be around $800 for the rest of the year, with the ADLT status contributing to a $10 million increase in guidance.

Q: What are the ASP expectations for Guardant360 and TissueNext, and how is Reveal adoption progressing in the surveillance setting? A: Michael Bell, CFO: Guardant360 ASP is now in the range of $3,000 to $3,100, and TissueNext is around $1,700 to $1,800. Helmy Eltoukhy, Co-CEO, noted that Reveal is seeing accelerating growth, especially with the surveillance reimbursement, and is expected to continue as the fastest-growing product.

Q: Can you discuss the roadmap for Shield's multi-cancer early detection (MCED) and the steps needed for payer discussions? A: AmirAli Talasaz, Co-CEO: Shield is designed for multi-cancer detection, and we're generating additional data to support this. We're excited about the potential for Shield to be included in guidelines and are working on payer discussions to demonstrate its value.

Q: How do you expect the new tissue test to impact market share, and are there ASP implications for the new product? A: Helmy Eltoukhy, Co-CEO: We believe the new tissue test, which requires 40% less tissue, will significantly increase our market share. We plan to seek FDA approval and ADLT status, which could lead to higher pricing. We expect to capture a larger share of the tissue market over time.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.