Key Financial Highlights for Q3 2024:
- Revenue: $191.5 million, up 34% year-over-year from $143.0 million in Q3 2023.
- Clinical and Biopharma Tests: 53,100 clinical tests (excluding Shield) and 10,500 biopharma tests, reflecting 21% and 40% growth, respectively, from Q3 2023.
- Guardant360 ASP: Over $3,000.
- Revenue Guidance Raised: Full-year 2024 revenue guidance now in the range of $720 million to $725 million, up 28% to 29% from 2023.
- Free Cash Flow: Improved to $(55) million, compared to $(80) million in Q3 2023.
- Revised Free Cash Flow Guidance: Now expected to be $(265) million to $(275) million for the full year, an improvement of $70 million to $80 million compared to 2023.
Recent Operating Highlights:
- Shield IVD Launch: Successful commercial debut with strong physician and patient reception.
- Medicare Pricing: Shield received a Medicare reimbursement rate of $920, effective August 1, 2024.
- CMS Policy Update: Medicare beneficiaries now have no cost-sharing for follow-up colonoscopies after a blood-based screening test.
- TissueNext Pricing: Medicare pricing for TissueNext will increase from $3,100 to $3,500, effective January 1, 2025.
- International Expansion: Entered a laboratory partnership with Policlinico Gemelli in Italy to serve advanced cancer patients.
CEO Comments:
“We had another record quarter, driven by significant reimbursement tailwinds for Guardant360 and strong volume growth,” said Helmy Eltoukhy, co-founder and co-CEO. “With this momentum, we’re raising our revenue guidance for the third time this year and improving our free cash flow outlook for 2024. The upgrade of Guardant360 LDT to Smart Liquid Biopsy has already contributed to broader account adoption and we expect this to drive further growth in our therapy selection business.”
“We’re thrilled with the positive reception to Shield since its commercial launch following FDA approval,” said AmirAli Talasaz, co-founder and co-CEO. “The $920 Medicare price for Shield underscores its potential as an important new class of colorectal cancer screening, and we’re excited to scale it into one of the most impactful products in diagnostics.”
Third Quarter 2024 Financial Results:
- Revenue: $191.5 million, a 34% increase from Q3 2023. Precision oncology revenue grew by 35% to $180.6 million, driven by increases in clinical and biopharma tests.
- Gross Profit: $117.0 million, up from $85.4 million in Q3 2023. Gross margin was 61%, slightly up from 60% last year. Precision oncology gross margin improved to 63% from 60%.
- Non-GAAP Gross Profit: $121.1 million, up 39% year-over-year. Non-GAAP gross margin was 63%, compared to 61% in Q3 2023.
- Operating Expenses: $234.3 million, compared to $199.0 million in Q3 2023. Non-GAAP operating expenses were $187.3 million, up from $177.3 million last year.
- Net Loss: $107.8 million, or $(0.88) per share, compared to a net loss of $86.1 million, or $(0.73) per share, in Q3 2023. The increase in net loss was primarily due to a $18.3 million rise in unrealized and realized losses related to Guardant’s investment in Lunit, Inc.
- Non-GAAP Net Loss: $55.0 million, or $(0.45) per share, improving from $79.2 million, or $(0.67) per share, in Q3 2023.
- Adjusted EBITDA Loss: $56.2 million, an improvement from a loss of $79.7 million in Q3 2023.
- Free Cash Flow: $(55.3) million, improving from $(80.2) million in Q3 2023. Cash, cash equivalents, and marketable securities were $1.0 billion as of September 30, 2024.
2024 Full-Year Guidance:
- Revenue: Guardant Health now expects 2024 revenue to range from $720 million to $725 million, reflecting growth of 28% to 29% compared to 2023. This is an increase from the previous range of $690 million to $700 million.
- Non-GAAP Gross Margin (excluding screening): Expected to be between 61% and 63%.
- Operating Expenses: Estimated to be in the range of $720 million to $730 million, flat to a 1% decrease compared to 2023.
- Free Cash Flow: Projected to be $(265) million to $(275) million, a year-over-year improvement of $70 million to $80 million.
Guardant Health continues to build momentum across its product portfolio and remains focused on its mission to transform cancer care through precision oncology and innovative diagnostic solutions.
