Financial Performance - GRAIL incurred net losses of $125.7 million and $891.4 million for the three months ended September 30, 2024 and October 1, 2023, respectively, and $1.9 billion and $1.3 billion for the nine months ended September 30, 2024 and October 1, 2023, respectively[133]. - Adjusted EBITDA for the three months ended September 30, 2024 was $(108.2) million, compared to $(126.1) million for the same period in 2023[133]. - The company recorded a net loss of $891,448,000 for the three months ended September 30, 2024, compared to a net loss of $1,278,158,000 for the same period in 2023[170]. - Total revenue for the three months ended September 30, 2024, was $28,652,000, representing a 38% increase from $20,722,000 for the same period in 2023[172]. - Total revenue for the nine months ended September 30, 2024, was $87,343,000, representing a 39% increase from $62,779,000 for the same period in 2023[184]. - Adjusted EBITDA for the nine months ended September 30, 2024, was $(399.5) million, slightly improved from $(400.4) million for the same period in 2023[206]. - The company incurred net losses of $9.7 billion since the acquisition of GRAIL, which includes significant charges for impairment of goodwill and intangible assets[211]. Revenue and Sales - Screening revenue increased by $8,629,000, or 52%, primarily due to a 57% increase in Galleri sales volume, despite a 3% decrease in average selling price[172]. - Screening revenue increased by $24,732,000, or 47%, primarily due to a rise in Galleri sales volume, which was consistent in average selling price (ASP) period over period[184]. - The company recognizes revenue from cancer screening testing services at the point when test results are delivered to the ordering physician[223]. Restructuring and Cost Management - GRAIL's restructuring plan aims to reduce headcount by approximately 30%, including 350 full-time employees, which is expected to save about $120 million annually[140]. - The company expects to incur restructuring charges of approximately $19.0 million to $23.0 million through the fourth quarter of 2024[141]. - Sales and marketing expenses are expected to decrease immediately following the implementation of the Restructuring Plan and to continue decreasing as a percentage of revenue over the next three years[162]. - The company expects research and development expenses to decrease over the next three years as it reduces investment in product programs beyond Galleri[161]. Cash and Funding - As of September 30, 2024, the company's cash and cash equivalents totaled $853.6 million, following a cash contribution of $932.3 million from Illumina[210]. - The company received $1.2 billion in funding from Illumina during the nine months ended September 30, 2024, a significant increase from $378.0 million in the same period in 2023[217]. - Net cash used by operating activities for the nine months ended September 30, 2024, was $(483.7) million, compared to $(466.9) million for the same period in 2023[213]. - The company may need to raise additional financing in the future to fund operations, which could result in dilution for existing stockholders[212]. Research and Development - The company plans to continue investing in biopharmaceutical partnerships and leverage proprietary methylation technology in precision oncology applications[139]. - The company has invested heavily in clinical studies, including the NHS-Galleri Trial, which is expected to provide results in 2026 and could facilitate adoption in other single-payer systems globally[153]. - Research and development expenses rose by $19,393,000, or 8%, driven by increased laboratory supplies and compensation expenses[188]. - The company accrues for estimated costs of research and development activities based on the estimated amount of services provided, which are significant components of its R&D expenses[228]. Regulatory and Market Position - GRAIL's Galleri test is not yet approved by the U.S. Food and Drug Administration but is clinically validated based on studies involving over 21,000 participants[132]. - The company plans to complete a PMA submission with the FDA in the first half of 2026, which is subject to various risks and could take several years to obtain approval[148]. - The company is actively working with the FDA to determine the necessary data for PMA submission, which may change over time, complicating the approval process[148]. - Galleri is currently available as a laboratory developed test in the United States, with private reimbursement established from several self-insured employers and health plans, but lacks broader coverage from government healthcare programs like Medicare[148]. Goodwill and Impairment - The company recognized a goodwill impairment charge of $718,466,000 in the third quarter of 2023, which was not present in the current quarter[180]. - The company recorded a goodwill impairment charge of $888,900,000, reflecting a significant decrease in the fair value of GRAIL[192]. - Goodwill represents the costs in excess of the fair value of net assets of GRAIL acquired by Illumina in August 2021[232]. - The company tests goodwill and indefinite-lived intangible assets for impairment annually or more frequently if circumstances change[233]. International Expansion - The company is focused on international expansion, particularly in the United Kingdom, and is evaluating additional select geographies for future growth[149]. - The company aims to leverage its scalable infrastructure to meet increasing demand and improve margins over time[154].

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 | --- | --- | --- | |----------------------------------------------- ...

NEWS RELEASE Exhibit 99.1 GRAIL Reports Second Quarter 2024 Financial Results and Provides a Strategic Update Second Quarter Revenue Grew 43% Year-Over-Year to $32.0 Million Portfolio Prioritization and Corporate Restructure Extends Cash Runway into 2028 MENLO PARK, Calif. — Aug. 13, 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 second quarter 2024. Revenue in the second quarter was ...