Galleri Revenue Grew 52% Year-Over-Year to $25.4 Million Commercial Galleri Sales Surpassed 250,000 Tests Since Launch Cash Balance of $853.6 Million Provides Runway Into 2028 MENLO PARK, Calif., Nov. 12, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the third quarter 2024. Revenue in the third quarter was $28.7 million, representing 38% growth year over year, and revenue f ...

NEWS RELEASE Exhibit 99.1 GRAIL Reports Third Quarter 2024 Financial Results Galleri Revenue Grew 52% Year-Over-Year to $25.4 Million Commercial Galleri Sales Surpassed 250,000 Tests Since Launch Cash Balance of $853.6 Million Provides Runway Into 2028 MENLO PARK, Calif. — Nov. 12, 2024 — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the third quarter 2024. Revenue in the third quarter was $28. ...

MENLO PARK, Calif., Nov. 4, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that company management will present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum in New York on Thursday, Nov. 21 at 11:00 a.m. ET. Live and replay webcasts may be accessed in the investor relations section of GRAIL's website at investors.grail.com. The webcast will be archived and available for r ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |----------------------------------------------- ...

[Financial & Business Highlights](index=1&type=section&id=Financial%20%26%20Business%20Highlights) GRAIL reported strong Q2 2024 revenue growth and significant clinical trial progress, despite a substantial net loss due to impairment charges [Q2 2024 Financial Performance](index=1&type=section&id=Q2%202024%20Financial%20Performance) GRAIL reported strong revenue growth of 43% year-over-year to $32.0 million for the second quarter of 2024, but recorded a significant net loss of $(1.59) billion primarily due to a $1.42 billion impairment charge Q2 2024 Financial Highlights (vs. Q2 2023) | Financial Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $32.0 million | $22.4 million | +43% | | **Gross Loss (GAAP)** | $(17.9) million | $(24.3) million | +26% improvement | | **Net Loss (GAAP)** | $(1.59) billion | $(193.0) million | +721% increase | | **Adjusted Gross Profit (Non-GAAP)** | $16.0 million | $9.6 million | +66% | | **Adjusted EBITDA (Non-GAAP)** | $(139.4) million | $(136.5) million | -2% | - The significant increase in net loss was primarily driven by a goodwill and intangible impairment charge of **$1.42 billion**[3](index=3&type=chunk) - As of June 30, 2024, cash and cash equivalents totaled **$958.8 million**[3](index=3&type=chunk) - This is the company's first quarterly report as an independent public company following its separation from Illumina on June 24, 2024, with over **215,000 Galleri® tests** sold as of June 30[2](index=2&type=chunk) [Recent Business Highlights](index=2&type=section&id=Recent%20Business%20Highlights) GRAIL has achieved significant milestones in its major clinical trials, including commencing enrollment for REACH and completing enrollment for PATHFINDER 2 and final visits for NHS-Galleri - Began enrollment in the REACH (Galleri-Medicare) study, which will enroll **50,000 individuals** from the Medicare population to provide clinical validation and utility data[4](index=4&type=chunk) - Completed enrollment of over **35,000 participants** in the registrational PATHFINDER 2 study, evaluating Galleri's safety and performance in individuals aged 50 and older[4](index=4&type=chunk) - Completed final study visits for the NHS-Galleri trial, a large-scale randomized controlled trial with over **140,000 participants** in the UK[4](index=4&type=chunk) [Strategic Update & Outlook](index=2&type=section&id=Strategic%20Update%20%26%20Outlook) GRAIL is implementing a corporate restructure to prioritize core MCED initiatives, reducing costs and extending its financial runway into 2028 [Portfolio Prioritization and Corporate Restructure](index=2&type=section&id=Portfolio%20Prioritization%20and%20Corporate%20Restructure) Following a portfolio review, GRAIL is implementing a corporate restructure to focus resources on its core multi-cancer early detection (MCED) priorities, particularly the Galleri test - The company is reducing overall spending to focus on core MCED priorities, including completing registrational studies and the premarket approval (PMA) application submission for Galleri[5](index=5&type=chunk) - Restructuring includes a reduction of approximately **30%** in existing headcount and planned hires for 2024[6](index=6&type=chunk) - Commercial operations will be refocused on the most productive provider territories, with streamlined investments in the enterprise business (employer and life insurance)[6](index=6&type=chunk) - Investment in biopharmaceutical partnerships will continue, leveraging GRAIL's methylation technology for precision oncology applications[6](index=6&type=chunk) [Financial Outlook](index=2&type=section&id=Financial%20Outlook) The strategic cost reductions are projected to significantly improve GRAIL's financial runway, extending it from the second half of 2026 into 2028 - The cost reduction measures are expected to extend the company's cash runway from **H2 2026 into 2028**[7](index=7&type=chunk) - The company anticipates reducing its cash burn to **$325 million** in 2025[7](index=7&type=chunk) - Expected savings in 2024 are **$27 million**, net of anticipated severance and benefits costs[7](index=7&type=chunk) [Financial Statements & Reconciliations](index=4&type=section&id=Financial%20Statements%20%26%20Reconciliations) This section provides detailed financial statements including balance sheets, income statements, cash flow statements, and reconciliations of GAAP to non-GAAP financial metrics [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2024, GRAIL's total assets were **$3.27 billion**, a decrease from **$3.91 billion** at the end of 2023, largely due to the complete impairment of goodwill Selected Balance Sheet Data (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $958,845 | $97,287 | | **Intangibles assets, net** | $2,086,056 | $2,687,223 | | **Goodwill** | $0 | $888,936 | | **Total assets** | $3,269,640 | $3,913,814 | | **Total liabilities** | $574,513 | $267,627 | | **Total stockholders' equity** | $2,695,127 | $3,646,187 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2024, GRAIL generated **$32.0 million** in total revenue, a 43% increase, but reported a net loss of **$(1.59) billion** primarily due to a **$1.42 billion** impairment charge Statement of Operations Summary - Three Months Ended (in thousands, except per share data) | Account | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Total revenue** | $31,970 | $22,414 | | **Goodwill and intangible impairment** | $1,420,936 | $0 | | **Loss from operations** | $(1,641,291) | $(204,367) | | **Net loss** | $(1,585,337) | $(193,044) | | **Net loss per share** | $(51.06) | $(6.22) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2024, net cash used in operating activities was **$(379.1) million**, with a net increase in cash of **$861.3 million** primarily from financing activities, ending with **$962.8 million** in cash Cash Flow Summary - Six Months Ended (in thousands) | Activity | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Net cash used by operating activities** | $(379,085) | $(309,391) | | **Net cash used by investing activities** | $(3,934) | $(5,923) | | **Net cash provided by financing activities** | $1,244,300 | $303,775 | | **Net increase (decrease) in cash** | $861,251 | $(11,282) | | **Cash, cash equivalents and restricted cash — end of period** | $962,763 | $234,846 | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) This section details the adjustments made to arrive at non-GAAP metrics, such as Adjusted Gross Profit and Adjusted EBITDA, by excluding specific non-cash or non-recurring expenses for comparable operational performance assessment - Adjusted Gross Profit is used by management to assess operational performance by excluding indirect costs, amortization, and stock-based compensation from the cost of revenue[16](index=16&type=chunk)[17](index=17&type=chunk) - Adjusted EBITDA is used to assess financial performance and for internal planning, providing a comparable overview by excluding items like capital structure, tax rates, and certain non-cash or non-recurring expenses[18](index=18&type=chunk)[19](index=19&type=chunk) [Reconciliation to Adjusted Gross Profit](index=9&type=section&id=Reconciliation%20to%20Adjusted%20Gross%20Profit) For Q2 2024, a GAAP gross loss of **$(17.9) million** was reconciled to a non-GAAP Adjusted Gross Profit of **$16.0 million**, representing a 66% increase from Q2 2023 Reconciliation to Adjusted Gross Profit - Three Months Ended (in thousands) | Line Item | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Gross loss (GAAP)** | $(17,912) | $(24,278) | | Amortization of intangible assets | $33,472 | $33,472 | | Stock-based compensation | $463 | $450 | | **Adjusted Gross Profit (Non-GAAP)** | **$16,023** | **$9,644** | [Reconciliation to Adjusted EBITDA](index=10&type=section&id=Reconciliation%20to%20Adjusted%20EBITDA) For Q2 2024, the GAAP net loss of **$(1.59) billion** was reconciled to a non-GAAP Adjusted EBITDA of **$(139.4) million**, with the largest adjustment being the exclusion of the **$1.42 billion** impairment charge Reconciliation to Adjusted EBITDA - Three Months Ended (in thousands) | Line Item | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Net loss (GAAP)** | $(1,585,337) | $(193,044) | | Goodwill and intangible impairment | $1,420,936 | $0 | | Benefit from income tax expense | $(53,144) | $(9,796) | | Amortization of intangible assets | $34,583 | $34,583 | | Stock-based compensation | $25,947 | $25,548 | | Other adjustments (Interest, D&A, etc.) | $17,624 | $6,162 | | **Adjusted EBITDA (Non-GAAP)** | **$(139,391)** | **$(136,545)** |