GRAIL Reports Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

GRAIL (NASDAQ: GRAL) reported strong growth in Q4 and full year 2024, with total revenue increasing 26% to $38.3M in Q4 and 35% to $125.6M for the full year. Galleri® test sales exceeded 137,000 units in 2024, driving U.S. Galleri revenue up 45% year-over-year to $108.6M.

Q4 net loss was $97.1M, including $34.6M in Illumina acquisition-related amortization. Full-year net loss reached $2.0B, primarily due to $1.4B in goodwill and intangible assets impairment. The company ended 2024 with a strong cash position of $767M, extending runway into 2028.

Notable developments include TRICARE Health Insurance adding Galleri as a covered benefit for high-risk patients aged 50+ and a new integration with Quest Diagnostics' ordering system, enabling access through 7,400 patient points nationwide. GRAIL completed study visits for two registrational studies in July and plans to complete its modular PMA submission in H1 2026.

Positive

• Revenue growth: 26% YoY increase in Q4 to $38.3M, 35% YoY increase for full year to $125.6M
• Galleri test revenue up 45% YoY to $108.6M with over 137,000 tests sold in 2024
• Strong cash position of $767M extending runway into 2028
• TRICARE coverage expansion for Galleri test
• Quest Diagnostics integration providing access to 7,400 patient points

Negative

• Q4 net loss of $97.1M
• Full year net loss of $2.0B, including $1.4B goodwill impairment
• Gross loss of $78.0M for full year 2024
• Negative adjusted EBITDA of $(483.5)M for 2024

Insights

Financial Analyst

GRAIL's Q4 and FY2024 results demonstrate robust commercial execution while making strategic progress toward broader market adoption. The 45% year-over-year growth in Galleri revenue to $108.6M reflects strong market penetration, with over 137,000 tests sold in 2024. This growth trajectory is particularly impressive in the competitive diagnostics market.

The Quest Diagnostics integration represents a transformative opportunity, providing access to approximately 7,400 patient access points and over 500,000 healthcare providers. This dramatically reduces friction in test ordering and could accelerate adoption rates significantly. The TRICARE coverage decision for patients 50+ with elevated cancer risk adds another substantial market segment, potentially serving as a blueprint for broader insurance coverage.

Financial efficiency is improving, with Q4 adjusted EBITDA loss narrowing by 32% year-over-year to $(84.0M). The $766.8M cash position, extending runway into 2028, provides ample time to achieve key milestones, including the completion of registrational studies and planned modular PMA submission in H1 2026.

However, the $2.0B net loss, including $1.4B in goodwill and intangible assets impairment, reflects the significant costs of establishing market presence in the early detection space. The improving gross margins and operational efficiencies suggest a path to profitability, though significant scale is still needed.

The positive patient-reported outcomes published in Lancet Oncology, showing minimal distress and high satisfaction, support continued adoption and could influence both provider recommendations and payer coverage decisions. The completion of registrational study visits marks a important step toward potential FDA approval, which could catalyze broader commercial acceptance and payer coverage.

Sold More than 137,000 Galleri^® Tests in 2024, Growing U.S. Galleri Revenue 45% Year-Over-Year to $108.6 Million

Completed Study Visits for Two Registrational Studies in July to Support Modular PMA Submission for Galleri

On Track for Continued Commercial Growth in 2025 with TRICARE Coverage and Recent Announcement of Quest Integration

Moderated Cash Burn, Ending 2024 with a Cash Position of $767M, Extending Runway into 2028

MENLO PARK, Calif., Feb. 20, 2025 /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 fourth quarter and full year 2024 and provided business updates.

Fourth quarter revenue grew 26% year-over-year to $38.3 million, and Galleri revenue grew 39% year over year to $31.6 million. Net loss for the quarter was $97.1 million, which includes amortization of Illumina acquisition-related intangible items of $34.6 million. Gross loss was $16.0 million. Non-GAAP adjusted gross profit was $17.9 million and non-GAAP adjusted EBITDA was $(84.0) million.¹

For the full year, total revenue grew 35% year over year to $125.6 million, and Galleri revenue grew 45% year over year to $108.6 million. Net loss for the year was $2.0 billion, which includes goodwill and intangible assets impairment of $1.4 billion and amortization of Illumina acquisition-related intangible items of $138.3 million. Gross loss was $78.0 million. Non-GAAP adjusted gross profit was $57.8 million and non-GAAP adjusted EBITDA was $(483.5) million.¹

Additionally, TRICARE Health Insurance recently added GRAIL's Galleri multi-cancer early detection test as a covered benefit. The Galleri test will be covered for patients who are 50 years or older with an elevated risk for cancer. TRICARE is one of the largest health plans in the U.S. and serves active duty service members, National Guard and Reserve members, retirees and their families.

"2024 was a transformational year for GRAIL as we completed the separation from Illumina in June 2024, and completed study visits for our two registrational studies in July," said Bob Ragusa, Chief Executive Officer at GRAIL. "We executed a restructuring in the third and fourth quarters, and continue to focus on business efficiencies while also growing commercially. We plan to read out our registrational studies in 2025 and 2026 and complete our modular PMA submission in the first half of 2026."

______________________________

1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures.

For the three months ended December 31, 2024, as compared to the three months ended December 31, 2023, GRAIL reported:

• Revenue: Total revenue, comprised of screening and development services revenue, was $38.3 million, an increase of $7.9 million or 26%.
• Net loss: Net loss was $97.1 million, an improvement of $90.5 million or 48%.
• Gross loss: Gross loss was $16.0 million , an improvement of $2.7 million or 14%.
• Adjusted gross profit¹: Adjusted gross profit was $17.9 million, an increase of $2.6 million or 17%.
• Adjusted EBITDA¹: Adjusted EBITDA was $(84.0) million, an improvement of $39.4 million or 32%.

For the twelve months ended December 31, 2024, as compared to the twelve months ended December 31, 2023, GRAIL reported:

• Revenue: Total revenue, comprised of screening and development services revenue, was $125.6 million, an increase of $32.5 million or 35%.
• Net loss: Net loss was $2.0 billion, an increase of $561.3 million or 38%, primarily driven by goodwill and intangible asset impairment.
• Gross loss: Gross loss was $78.0 million, an improvement of $17.6 million or 18%.
• Adjusted gross profit¹: Adjusted gross profit was $57.8 million, an increase of $17.6 million or 44%.
• Adjusted EBITDA¹: Adjusted EBITDA was $(483.5) million, an improvement of $40.3 million or 8%.

Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $766.8 million as of December 31, 2024.

Additional business highlights include:

• Patient Reported Outcomes for GRAIL's Galleri Multi-Cancer Early Detection Blood Test Published in Lancet Oncology. Analysis of patient reported outcomes from PATHFINDER indicate minimal patient distress associated with multi-cancer early detection (MCED) testing, and high overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were "likely"/"very likely" to adhere to future guideline recommended screening tests as recommended by their healthcare provider.
• GRAIL and Quest Diagnostics Announced Availability of GRAIL's Galleri MCED Test Through the Quest Diagnostics Test Ordering System. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest's Quantum laboratory portal and more than 900 electronic health record systems. More than 500,000 providers used the Quest connectivity system last year. The integration will help streamline the process of ordering the Galleri test and increase availability by allowing patients access to the test at any of the approximately 7,400 patient access points nationwide. Patients can now go directly to Quest without needing to bring a Galleri test kit to the blood draw appointment.

Conference Call and Webcast
A webcast and conference call will be held today, February 20, 2025, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL's website at investors.grail.com.

A replay of the webcast will be available on GRAIL's website for 30 days.

About GRAIL
GRAIL, Inc. is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL's common stock is listed under the ticker symbol "GRAL" on the Nasdaq Stock Exchange.

For more information, visit grail.com.

About Galleri®
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.

For more information, visit galleri.com.

* Sensitivity in study participants with – Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).

Laboratory/Test Information
GRAIL's clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL's clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Non-GAAP Disclosure
In addition to our financial results, this press release also includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP"). Our non-GAAP financial disclosure includes Adjusted Gross Profit (Loss) and Adjusted EBITDA. We encourage investors to carefully consider our results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations.

• Adjusted Gross Profit/(Loss) is a key performance measure that our management uses to assess our operational performance, as it represents the results of revenues and direct costs, which are key components of our operations. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it reflects the gross profitability of our operations, and excludes the indirect costs associated with our sales and marketing, product development, general and administrative activities, and depreciation and amortization, and the impact of our financing methods and income taxes.
  
  We calculate Adjusted Gross Profit/(Loss) as gross profit/(loss) (as defined below) adjusted to exclude amortization of intangible assets and stock-based compensation allocated to cost of revenue. Adjusted Gross Profit/(Loss) should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other GAAP measures of income (loss) or profitability. The following table presents a reconciliation of gross loss, the most directly comparable financial measure calculated in accordance with GAAP, to Adjusted Gross Profit.
  
  
• Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it provides a comparable overview of our operations across historical periods. In addition, we believe that providing Adjusted EBITDA, together with a reconciliation of net income (loss) to Adjusted EBITDA, helps investors make comparisons between our company and other companies that may have different capital structures, different tax rates, different operational and ownership histories, and/or different forms of employee compensation.
  
  Adjusted EBITDA is used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period-to-period comparisons of net income or income from operations. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items, and may not be directly comparable to similarly titled metrics used by other companies.
  
  Adjusted EBITDA should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other U.S. GAAP measures of income (loss). Additionally, it is not intended to be a measure of free cash flow for management's discretionary use, as it does not consider certain cash requirements such as interest and tax payments. Further, our definition of Adjusted EBITDA may differ from similarly titled measures used by other companies and therefore may not be comparable among companies. The following table presents a reconciliation of net loss, the most directly comparable financial measure calculated in accordance with U.S. GAAP, to Adjusted EBITDA on a consolidated basis.

Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in tabular form below.

Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of our future financial performance, future tests or products, technology, clinical studies, regulatory compliance, potential market opportunity, anticipated growth strategies, restructuring costs, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, restructuring and stock-based compensation costs, impact of the restructuring on our operations and growth and anticipated trends in our business.

These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2024 (the "Form 10-K"). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.

Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.

GRAIL
Condensed Consolidated Balance Sheets
(in thousands, except for per share data)	December 31, 2024		December 31, 2023
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$                 214,234		$                    97,287
Short-term marketable securities	549,236		—
Accounts receivables, net	20,312		16,942
Supplies	18,632		21,695
Prepaid expenses and other current assets	17,447		20,141
Total current assets	819,861		156,065
Property and equipment, net	69,061		84,995
Operating lease right-of-use assets	66,373		84,386
Restricted cash	3,349		4,225
Intangibles assets, net	2,016,890		2,687,223
Goodwill	—		888,936
Other non-current assets	7,773		7,984
Total assets	$              2,983,307		$              3,913,814
Liabilities and stockholders'/member's (deficit) equity
Current liabilities:
Accounts payable	$                      4,844		$                    19,673
Accrued liabilities	57,241		73,806
Incentive plan liabilities	—		54,513
Operating lease liabilities, current portion	13,260		14,809
Other current liabilities	1,580		809
Total current liabilities	76,925		163,610
Operating lease liabilities, net of current portion	54,881		69,598
Deferred tax liabilities, net	345,860		32,921
Other non-current liabilities	2,236		1,498
Total liabilities	479,902		267,627
Stockholders'/member's equity:
Preferred stock, par value of $0.001 per share; 50,000,000 shares authorized, no shares issued and outstanding as of December 31, 2024 and December 31, 2023	—		—
Common stock $0.001 par value per share, 1,500,000,000 shares authorized, 33,893,409 shares issued and outstanding as of December 31, 2024, no shares authorized, issued and outstanding as of December 31, 2023	34		—
Additional paid-in capital	12,305,250		—
Member's equity	—		11,421,446
Accumulated other comprehensive income	1,451		1,066
Accumulated deficit	(9,803,330)		(7,776,325)
Total stockholders'/member's equity	2,503,405		3,646,187
Total liabilities and stockholders'/member's equity	2,983,307		3,913,814

 

GRAIL
Condensed Consolidated Statements of Operations
(Unaudited)
	Three Months Ended				Year Ended
(in thousands except for per share data)	December 31, 2024		December 31, 2023		December 31, 2024		December 31, 2023
Revenue:
Screening revenue	$            31,551		$            22,655		$         108,627		$            74,999
Development services revenue	6,701		7,671		16,968		18,106
Total revenue	38,252		30,326		125,595		93,105
Costs and operating expenses:
Cost of screening revenue (exclusive of amortization of intangible assets)	17,803		13,587		63,284		47,966
Cost of development services revenue	2,945		1,917		6,444		6,861
Cost of revenue — amortization of intangible assets	33,472		33,472		133,889		133,889
Research and development	48,328		84,086		322,380		338,745
Sales and marketing	30,525		39,123		153,958		162,292
General and administrative	42,117		52,734		213,862		200,268
Goodwill and intangible assets impairment	—		—		1,420,936		718,466
Total costs and operating expenses	175,190		224,919		2,314,753		1,608,487
Loss from operations	(136,938)		(194,593)		(2,189,158)		(1,515,382)
Other income (expense):
Interest income	9,366		1,351		26,733		7,954
Other expense (income), net	578		213		64		(208)
Total other income, net	9,944		1,564		26,797		7,746
Loss before income taxes	(126,994)		(193,029)		(2,162,361)		(1,507,636)
Benefit from income taxes	29,928		5,502		135,356		41,951
Net loss	$          (97,066)		$        (187,527)		$    (2,027,005)		$    (1,465,685)
Net loss per share — Basic and Diluted	$              (2.89)		$              (6.04)		$            (63.54)		$            (47.21)
Weighted average shares of common stock—basic and diluted	33,612,372		31,049,148		31,901,259		31,049,148

 

GRAIL
Condensed Consolidated Statements of Cash Flows
(Unaudited)
	Year Ended
(in thousands)	December 31, 2024		December 31, 2023
Net cash used by operating activities	$          (577,156)		$          (595,800)
Net cash used by investing activities	(551,011)		(12,887)
Net cash provided by financing activities	1,244,300		463,766
Effect of exchange rate changes on cash, cash equivalents, and restricted cash	(62)		305
Net increase (decrease) in cash, cash equivalents, and restricted cash	$            116,071		$          (144,616)
Cash, cash equivalents and restricted cash — beginning of period	$            101,512		$            246,128
Cash, cash equivalents and restricted cash — end of period	$            217,583		$            101,512

 

GRAIL
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
	Three Months Ended				Year Ended
(in thousands)	December 31, 2024		December 31, 2023		December 31, 2024		December 31, 2023
Gross loss (1)	$          (15,968)		$          (18,650)		$          (78,022)		$          (95,611)
Amortization of intangible assets	33,472		33,472		133,889		133,889
Stock-based compensation	432		522		1,954		1,970
Adjusted Gross Profit	$            17,936		$            15,344		$            57,821		$            40,248

___________
(1)	Gross profit/(loss) is calculated as total revenue less cost of revenue (exclusive of amortization of intangible assets), cost of revenue—related parties, and cost of revenue—amortization of intangible assets.

 

GRAIL
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
	Three Months Ended				Year Ended
(in thousands)	December 31, 2024		December 31, 2023		December 31, 2024		December 31, 2023
Net loss	$          (97,066)		$        (187,527)		$    (2,027,005)		$    (1,465,685)
Adjusted to exclude the following:
Interest income	(9,366)		(1,351)		(26,733)		(7,954)
Benefit from income tax expense	(29,928)		(5,502)		(135,356)		(41,951)
Amortization of intangible assets (1)	34,583		34,583		138,333		138,333
Depreciation	4,858		5,346		19,723		20,364
Goodwill and intangible assets impairment (2)	—		—		1,420,936		718,466
Illumina/GRAIL merger & divestiture legal and professional services costs(3)	—		6,122		22,158		17,320
Stock-based compensation (4)	13,582		24,852		86,084		97,235
Restructuring (5)	(694)		—		18,313		—
Adjusted EBITDA	$          (84,031)		$        (123,477)		$        (483,547)		$        (523,872)

___________
(1)	Represents amortization of intangible assets, including developed technology and trade names.
(2)	Reflects impairment of the goodwill and intangible assets recognized as a result of Illumina's acquisition of the Company in August 2021 ("the Acquisition").
(3)	Represents legal and professional services costs associated with the Acquisition and corresponding antitrust litigation, including compliance with the hold separate arrangements imposed by the European Commission, and legal and professional services costs associated with the divestiture.
(4)	Represents all stock-based compensation recognized on our standalone financial statements for the periods presented.
(5)	Represents employee severance, benefits, payroll taxes, and other costs associated with the Company's restructuring plan approved in August 2024.

 

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SOURCE GRAIL, Inc.

FAQ

What was GRAL's revenue growth in Q4 2024?

GRAL's total revenue grew 26% year-over-year to $38.3 million in Q4 2024, with Galleri revenue specifically growing 39% to $31.6 million.

How many Galleri tests did GRAL sell in 2024?

GRAL sold more than 137,000 Galleri tests in 2024, resulting in U.S. Galleri revenue growth of 45% year-over-year to $108.6 million.

What is GRAL's cash runway following Q4 2024 results?

GRAL ended 2024 with a cash position of $767 million, which extends their runway into 2028.

When will GRAL complete its modular PMA submission for Galleri?

GRAL plans to complete its modular PMA submission for Galleri in the first half of 2026.

What is the new TRICARE coverage for GRAL's Galleri test?

TRICARE Health Insurance now covers GRAL's Galleri test for patients who are 50 years or older with an elevated risk for cancer.