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Despite regulatory and competitive risks, GRAIL's strong financial performance, reduced cash burn, and extended cash runway are positive indicators. Revenue growth and improved margins suggest operational efficiency. The Q&A session reveals optimism about cost improvements and market expansion. While management was vague on some cost details, the overall sentiment is positive, with a focus on achieving major milestones. The company's financial health and strategic focus on growth and efficiency are likely to lead to a positive stock price movement.
Revenue $31.8 million, up $5.1 million or 19% compared to Q1 2024. This increase is attributed to continued demand for the Galleri test, with more than 37,000 tests sold in the first quarter.
Screening Revenue $29.1 million, up 24% compared to Q1 2024. The growth in screening revenue is driven by a 22% increase in US Galleri revenue, which reached $28.7 million.
Net Loss $106.2 million, an improvement of 51% compared to Q1 2024. This improvement is due to reduced expenses, including amortization of intangible assets and stock-based compensation.
Non-GAAP Adjusted Gross Profit $14.3 million, an increase of $2.3 million or 19% compared to Q1 2024. This increase reflects the growth in revenue and improved cost management.
Cash Position $677.9 million. The company expects cash burn for the full year 2025 to be no more than $320 million, representing a decrease of more than 40% compared to 2024.
Galleri Test Sales: GRAIL sold more than 37,000 Galleri tests in Q1 2025, with over 325,000 tests prescribed since launch.
Enhanced Galleri Test: An enhanced version of the Galleri test was rolled out in Q4 2024, integrating automation to support volume and reduce costs.
Partnership with Athena Health: A new partnership with Athena Health was announced to streamline the Galleri test ordering process for over 160,000 US providers.
Commercial Launch in Israel: GRAIL has commercially launched in Israel in partnership with OncoTest, with initial test orders received.
Operational Efficiency: The enhanced Galleri test rollout includes significant automation to support volume at scale and reduce costs.
Cash Position: GRAIL ended Q1 2025 with a cash position of $677.9 million, with a projected cash burn of no more than $320 million for the year.
FDA Approval Plans: GRAIL plans to submit data for FDA premarket approval in the first half of 2026.
Educational Campaign: An educational campaign called Generation Possible was initiated to raise public awareness of multi-cancer early detection.
Regulatory Risks: GRAIL is pursuing FDA approval for Galleri, which involves significant regulatory scrutiny and uncertainty regarding the approval process.
Competitive Pressures: As the first mover in the multi-cancer early detection field, GRAIL faces competition from emerging technologies and companies that may develop similar or superior tests.
Supply Chain Challenges: While GRAIL does not expect major impacts from tariffs due to its US-based laboratory and suppliers, any disruptions in the supply chain could affect operations.
Economic Factors: The company is managing a significant net loss of $106.2 million, which could impact its financial stability and ability to fund future projects.
Market Adoption: Despite positive test results, the adoption of Galleri by healthcare providers and patients remains a challenge that could affect revenue growth.
Cash Burn: GRAIL expects a cash burn of no more than $320 million for 2025, which, while a decrease from 2024, still poses a risk to financial sustainability.
Galleri Test Sales: GRAIL sold more than 37,000 Galleri tests in Q1 2025, with over 325,000 tests prescribed since launch.
Partnerships: Announced a partnership with Athena Health to streamline Galleri test ordering for over 160,000 US providers.
International Expansion: Commercial launch in Israel in partnership with OncoTest.
Educational Campaign: Initiated 'Generation Possible' campaign to raise awareness of multi-cancer early detection.
Clinical Trials: Continued advancement of Galleri through key clinical and regulatory milestones, including the NHS Galleri trial.
Revenue Growth: Guided for US Galleri revenue growth of 20% to 30% for the full year 2025.
Cash Burn: Expected cash burn for 2025 to be no more than $320 million, a decrease of over 40% compared to 2024.
Cash Position: Ended Q1 2025 with a cash position of $677.9 million, extending cash runway into 2028.
Clinical Milestones: Expect interim data from PATHFINDER 2 study in late 2025 and completion of PMA submission to the FDA in the first half of 2026.
Cash Position: GRAIL ended the quarter with a cash position of $677.9 million.
Cash Burn Guidance: GRAIL expects cash burn for the full year 2025 to be no more than $320 million, representing a decrease of more than 40% compared to 2024.
Cash Runway: GRAIL's cash runway extends into 2028, enabling the achievement of major planned clinical and regulatory milestones.
The earnings call reveals strong financial performance with a 69% increase in gross profit and a 14% rise in gross margin. The company has a robust cash position of $850 million, excluding a pending investment from Samsung. Despite some uncertainties, such as the impact of a $150 promotion, the company's strategic partnerships and growth in test volumes indicate a positive outlook. The updated FDA timeline and improved cost efficiencies further support a positive sentiment, suggesting a likely stock price increase over the next two weeks.
The earnings call reveals strong financial metrics, including a significant improvement in net loss and cash burn guidance, alongside positive developments like the partnership with Athena Health and commercial launch in Israel. Despite some uncertainties in international plans and NHS Galleri study specifics, the overall sentiment remains positive due to the strategic focus on growth and cost management. The Q&A section reinforces this with management's confidence in revenue growth and operational efficiencies. Given these factors, a positive stock price movement of 2% to 8% is expected.
Despite regulatory and competitive risks, GRAIL's strong financial performance, reduced cash burn, and extended cash runway are positive indicators. Revenue growth and improved margins suggest operational efficiency. The Q&A session reveals optimism about cost improvements and market expansion. While management was vague on some cost details, the overall sentiment is positive, with a focus on achieving major milestones. The company's financial health and strategic focus on growth and efficiency are likely to lead to a positive stock price movement.
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