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.
