In This Article:
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Revenue: $31.8 million, up 19% compared to Q1 2024.
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Screening Revenue: $29.1 million, up 24% compared to Q1 2024.
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Development Service Revenue: $2.7 million.
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US Galleri Revenue: $28.7 million, up 22% compared to Q1 2024.
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Net Loss: $106.2 million, an improvement of 51% compared to Q1 2024.
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Non-GAAP Adjusted Gross Profit: $14.3 million, up 19% compared to Q1 2024.
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Cash Position: $677.9 million at the end of the quarter.
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Galleri Tests Sold: More than 37,000 tests in Q1 2025.
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Repeat Testing: More than 20% of Galleri volume is repeat testing.
Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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GRAIL Inc (NASDAQ:GRAL) reported a strong first quarter with revenue of $31.8 million, marking a 19% increase compared to the first quarter of 2024.
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The Galleri test demonstrated a specificity of 99.5%, equating to a low false positive rate of 0.5%, which is crucial for reducing unnecessary workups and costs.
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The NHS Galleri trial, the largest randomized control trial of any MCED test, showed encouraging top-line results from its first screening round.
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GRAIL Inc (NASDAQ:GRAL) has a substantial cash position of $677.9 million, with a cash runway extending into 2028, allowing them to achieve major planned clinical and regulatory milestones.
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The company has achieved Tricare coverage and has made Galleri more accessible through partnerships with Quest Diagnostics and Athena Health.
Negative Points
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GRAIL Inc (NASDAQ:GRAL) reported a net loss of $106.2 million for the quarter, despite an improvement of 51% compared to the first quarter of 2024.
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The company is facing competition from other upcoming MCED launches, which could impact their operational expenses and market position.
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There are concerns about the health economics of the Galleri test, particularly regarding the cost-effectiveness of annual testing at the current ASP levels.
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The NHS Galleri trial results are not expected until mid-2026, which delays potential commercialization decisions in the UK.
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Despite a strong cash position, there are concerns about the company's ability to fund operations through the period leading up to FDA approval and CMS reimbursement.
Q & A Highlights
Q: Can you quantify the short-term variable cost improvements from the new version of Galleri launched in December? A: Aaron Freidin, CFO: We launched the new version at the end of last year, and in the first quarter, we expect margins to improve as we increase scale and transition fully to the new version. Variable cost improvements will become more apparent over time.