Grail, Inc.(GRAL) - 2025 Q1 - Quarterly Results

Financial Performance GRAIL reported $31.8 million in total revenue for Q1 2025, a 19% year-over-year increase, with net loss significantly improving to $106.2 million and adjusted EBITDA improving by 35% Key Financial Metrics | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenue | $31.8 million | $26.7 million | +19% | | Galleri Revenue | $29.1 million | $23.5 million | +24% | | U.S. Galleri Revenue | $28.7 million | - | +22% | | Net Loss | $(106.2) million | $(218.9) million | +51% Improvement | | Adjusted EBITDA | $(98.7) million | $(152.0) million | +35% Improvement | | Gross Loss | $(19.9) million | $(21.9) million | +9% Improvement | - The company's cash, cash equivalents, restricted cash, and short-term marketable securities totaled $677.9 million as of March 31, 2025, which is expected to provide a financial runway into 2028[1][4] - Over 37,000 Galleri tests were completed in the first quarter of 2025[3] Clinical and Business Updates GRAIL announced positive top-line results from the NHS-Galleri trial, showing a higher Positive Predictive Value (PPV) than the PATHFINDER study, alongside new partnerships and educational initiatives - Positive top-line results from the NHS-Galleri trial's prevalent screening round showed a substantially higher Positive Predictive Value (PPV) than the PATHFINDER study, with consistent Cancer Signal of Origin (CSO) accuracy (88%) and specificity (99.5%)[1][7] - Future data releases are planned, with registrational data from the PATHFINDER 2 study expected later in 2025 and final results from the three-year NHS-Galleri trial anticipated in mid-2026[8] - Recent business developments include: - Presentation of real-world data from 100,000 patients at AACR 2025, confirming Galleri's performance - A partnership with athenahealth to integrate Galleri test ordering into its EHR platform, reaching over 160,000 U.S. providers - Launch of the 'Generation Possible' educational campaign with actress Kate Walsh[9] Financial Statements The unaudited condensed consolidated financial statements detail the company's financial position and operational results, showing a decrease in total assets and liabilities, alongside a significant reduction in net loss Condensed Consolidated Balance Sheets As of March 31, 2025, GRAIL's total assets were $2.85 billion, with total liabilities decreasing to $433.9 million, and total stockholders' equity at $2.41 billion Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Item (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $133,895 | $214,234 | | Total current assets | $727,655 | $819,861 | | Total assets | $2,847,605 | $2,983,307 | | Total current liabilities | $74,977 | $76,925 | | Total liabilities | $433,937 | $479,902 | | Total stockholders' equity | $2,413,668 | $2,503,405 | Condensed Consolidated Statements of Operations For Q1 2025, GRAIL generated $31.8 million in total revenue, significantly reducing its loss from operations to $153.6 million and improving net loss to $106.2 million Condensed Consolidated Statements of Operations (in thousands) | Statement of Operations (in thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenue | $31,837 | $26,721 | | Total costs and operating expenses | $185,444 | $254,143 | | Loss from operations | $(153,607) | $(227,422) | | Net loss | $(106,213) | $(218,914) | | Net loss per share — Basic and Diluted | $(3.10) | $(7.05) | Reconciliation of GAAP to Non-GAAP Financial Measures GRAIL provides non-GAAP measures like Adjusted Gross Profit and Adjusted EBITDA to clarify operational performance, with Q1 2025 Adjusted Gross Profit at $14.3 million and Adjusted EBITDA at $(98.7) million Reconciliation to Adjusted Gross Profit (in thousands) | Reconciliation to Adjusted Gross Profit (in thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Gross loss (GAAP) | $(19,929) | $(21,909) | | Amortization of intangible assets | $33,472 | $33,472 | | Stock-based compensation | $762 | $481 | | Adjusted Gross Profit (Non-GAAP) | $14,305 | $12,044 | Reconciliation to Adjusted EBITDA (in thousands) | Reconciliation to Adjusted EBITDA (in thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss (GAAP) | $(106,213) | $(218,914) | | Adjustments (Interest, Tax, D&A, etc.) | $7,478 | $66,945 | | Adjusted EBITDA (Non-GAAP) | $(98,735) | $(151,969) | Forward-Looking Statements This section contains cautionary language regarding forward-looking statements, highlighting risks that actual results may differ materially from projections, particularly concerning clinical trial outcomes - The press release includes forward-looking statements concerning financial performance, clinical studies, and growth strategies, which are subject to risks and uncertainties[20] - A key risk highlighted is that final results from ongoing studies, such as the NHS-Galleri trial, may be inconsistent with interim results due to factors like the detection of prevalent late-stage cancers in the first screening round[21]