Revenue growth of 34% driven by strong clinical
and biopharma volume and Guardant360 ASP tailwinds
Shield received favorable Medicare pricing of
$920
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today reported financial results for the quarter ended
September 30, 2024.
Third Quarter 2024 Financial Highlights
- Recorded revenue of $191.5 million for the third quarter of
2024, an increase of 34% over the third quarter of 2023
- Reported 53,100 clinical tests (excluding Shield) and 10,500
biopharma tests in the third quarter of 2024, representing
increases of 21% and 40%, respectively, over the third quarter of
2023
- Achieved Guardant360 ASP of over $3,000
- Raised 2024 annual guidance for revenue to a new range of $720
to $725 million, representing growth of 28% to 29%
- Improved free cash flow to $(55) million in the third quarter
of 2024, compared to $(80) million in the prior year
- Revised annual free cash flow guidance to $(265) to $(275)
million, an improvement of $70 to $80 million compared to 2023
Recent Operating Highlights
- Successfully launched Shield IVD with strong reception from
physicians and patients
- Received Medicare pricing of $920 for Shield effective August
1, 2024
- CMS finalized its policy to remove cost-sharing for a follow-on
colonoscopy after a blood-based screening test for Medicare
beneficiaries
- Announced Medicare pricing for TissueNext will increase from
$3,100 to $3,500 effective January 1, 2025
- Entered into laboratory partnership with Policlinico Gemelli in
Italy, a leading European oncology center, to test advanced cancer
patients locally
- Published data from SCRUM-Japan GOZILA study in Nature Medicine
showing patients receiving Guardant360 CDx guided treatment
survived twice as long
“We had another record quarter of revenue driven by significant
Guardant360 reimbursement tailwinds and volume growth,” said Helmy
Eltoukhy, co-founder and co-CEO. “With this momentum, we are
raising revenue guidance for the third time this year and improving
our free cash flow outlook for the full year. The upgrade of
Guardant360 LDT to Smart Liquid Biopsy has already contributed to
an increase in both breadth and depth of accounts, and we expect
this to be a strong growth driver for our therapy selection
business going forward.”
“Shield has received a very positive reception from physicians
and patients in the first few months of commercial launch following
FDA approval,” said AmirAli Talasaz, co-founder and co-CEO. “We
were very pleased to see Shield receive a Medicare price of $920,
which recognizes it as an important new class of CRC screening. We
look forward to continuing to execute our commercial scale-up as we
make Shield one of the most impactful products in the history of
diagnostics.”
Third Quarter 2024 Financial Results
Revenue was $191.5 million for the third quarter of 2024, a 34%
increase from $143.0 million for the corresponding prior year
period. Precision oncology revenue grew 35%, to $180.6 million for
the third quarter of 2024, from $133.4 million for the
corresponding prior year period, driven by an increase in the
volume of clinical tests (i.e., Guardant360, TissueNext, Response,
and Reveal tests) and biopharma tests, which grew 21% and 40%,
respectively, over the prior year period. The increase in precision
oncology revenue was also attributable to an increase in
reimbursement for our tests, due to an increase in Medicare
reimbursement for our Guardant360 LDT test to $5,000, effective
January 1, 2024; and an increase in both Medicare Advantage and
commercial payer reimbursement. Development services and other
revenue was $10.9 million for the third quarter of 2024, compared
to $9.6 million for the corresponding prior year period.
Gross profit, or total revenue less cost of precision oncology
testing and cost of development services and other, was $117.0
million for the third quarter of 2024, an increase of $31.6 million
from $85.4 million for the corresponding prior year period. Gross
margin, or gross profit divided by total revenue, was 61%, as
compared to 60% for the corresponding prior year period. Precision
oncology gross margin was 63% in the third quarter of 2024, as
compared to 60% in the prior year period. Development services and
other gross margin was 23% in the third quarter of 2024, as
compared to 59% in the prior year period.
Non-GAAP gross profit was $121.1 million for the third quarter
of 2024, an increase of $33.7 million, from $87.3 million for the
corresponding prior year period. Non-GAAP gross margin was 63% for
the third quarter of 2024, as compared to 61% for the corresponding
prior year period.
Non-GAAP gross profit excluding cost of screening was $124.0
million for the third quarter of 2024, an increase of $34.3
million, from $89.7 million for the corresponding prior year
period. Non-GAAP gross margin excluding cost of screening was 65%
for the third quarter of 2024, as compared to 63% for the
corresponding prior year period.
Operating expenses were $234.3 million for the third quarter of
2024, as compared to $199.0 million for the corresponding prior
year period. Non-GAAP operating expenses were $187.3 million for
the third quarter of 2024, as compared to $177.3 million for the
corresponding prior year period.
Net loss was $107.8 million for the third quarter of 2024, as
compared to $86.1 million for the corresponding prior year period.
Net loss per share was $0.88 for the third quarter of 2024, as
compared to $0.73 for the corresponding prior year period. The
year-over-year increase in net loss was primarily due to a $18.3
million increase in net unrealized and realized losses recorded for
our investment in Lunit, Inc.
Non-GAAP net loss was $55.0 million for the third quarter of
2024, as compared to $79.2 million for the corresponding prior year
period. Non-GAAP net loss per share was $0.45 for the third quarter
of 2024, as compared to $0.67 for the corresponding prior year
period.
Adjusted EBITDA loss was $56.2 million for the third quarter of
2024, as compared to a $79.7 million loss for the corresponding
prior year period.
Free cash flow for the third quarter of 2024 was $(55.3)
million, as compared to $(80.2) million for the corresponding prior
year period. Cash, cash equivalents, restricted cash and marketable
debt securities were $1.0 billion as of September 30, 2024.
2024 Guidance
Guardant Health now expects full year 2024 revenue to be in the
range of $720 to $725 million, representing growth of 28% to 29%
compared to full year 2023. This compares to the prior range of
$690 to $700 million, representing growth of 22% to 24%. Guardant
Health continues to expect full year 2024 non-GAAP gross margin
excluding screening to be in the range of 61% to 63% and total
non-GAAP operating expenses to be in the range of $720 to $730
million, representing a flat to 1% decrease compared to 2023.
Guardant Health now expects free cash flow to be in the range of
$(265) to $(275) million in 2024, representing an improvement of
$70 million to $80 million compared to 2023.
Webcast Information
Guardant Health will host a conference call to discuss the third
quarter 2024 financial results after market close on Wednesday,
November 6, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A
webcast of the conference call can be accessed at
http://investors.guardanthealth.com. The webcast will be archived
and available for replay for at least 90 days after the event.
Non-GAAP Measures
Guardant Health has presented in this release certain financial
information in accordance with U.S. Generally Accepted Accounting
Principles (GAAP) and also on a non-GAAP basis, including non-GAAP
cost of precision oncology testing, non-GAAP cost of development
services and other, non-GAAP cost of screening, non-GAAP gross
profit, non-GAAP gross profit excluding cost of screening, non-GAAP
research and development expense, non-GAAP sales and marketing
expense, non-GAAP general and administrative expense, non-GAAP loss
from operations, non-GAAP net loss, non-GAAP net loss per share,
basic and diluted, adjusted EBITDA, and free cash flow.
We define our non-GAAP measures as the applicable GAAP measure
adjusted for the impacts of stock-based compensation and related
employer payroll tax payments, contingent consideration,
amortization of intangible assets, unrealized and realized gains
and losses on marketable equity securities, impairment of
non-marketable equity securities and other related assets, and
other non-recurring items.
Adjusted EBITDA is defined as net loss adjusted for interest
income; interest expense; other income (expense), net; provision
for income taxes; depreciation and amortization expense;
stock-based compensation expense and related employer payroll tax
payments; contingent consideration; and other non-recurring items.
Free cash flow is defined as net cash used in operating activities
in the period less purchase of property and equipment in the
period.
We believe that the exclusion of certain income and expenses in
calculating these non-GAAP financial measures can provide a useful
measure for investors when comparing our period-to-period core
operating results, and when comparing those same results to that
published by our peers. We exclude certain items because we believe
that these income and expenses do not reflect expected future
operating performance. Additionally, certain items are inconsistent
in amounts and frequency, making it difficult to perform a
meaningful evaluation of our current or past operating performance.
We use these non-GAAP financial measures to evaluate ongoing
operations, for internal planning and forecasting purposes, and to
manage our business.
These non-GAAP financial measures are not intended to be
considered in isolation from, as substitute for, or as superior to,
the corresponding financial measures prepared in accordance with
GAAP. There are limitations inherent in non-GAAP financial measures
because they exclude charges and credits that are required to be
included in a GAAP presentation, and do not present the full
measure of our recorded costs against its revenue. In addition, our
definition of the non-GAAP financial measures may differ from
non-GAAP measures used by other companies.
About Guardant Health
Guardant Health is a leading precision oncology company focused
on guarding wellness and giving every person more time free from
cancer. Founded in 2012, Guardant is transforming patient care and
accelerating new cancer therapies by providing critical insights
into what drives disease through its advanced blood and tissue
tests, real-world data and AI analytics. Guardant tests help
improve outcomes across all stages of care, including screening to
find cancer early, monitoring for recurrence in early-stage cancer,
and treatment selection for patients with advanced cancer. For more
information, visit guardanthealth.com and follow the company on
LinkedIn, X (Twitter) and Facebook.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of federal securities laws, including statements
relating to Guardant Health’s future results, regulatory approval
for products or regarding the potential benefits and advantages of
Guardant Health’s platforms, assays and tests, which involve risks
and uncertainties that could cause Guardant Health’s actual results
to differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are
based on current expectations, forecasts and assumptions, and
actual outcomes and results could differ materially from these
statements due to a number of factors. These and additional risks
and uncertainties that could affect Guardant Health’s financial and
operating results and cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release include those discussed under the captions “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operation” and elsewhere in its Annual
Report on Form 10-K for the year ended December 31, 2023, and any
current and periodic reports filed with or furnished to the
Securities and Exchange Commission thereafter. The forward-looking
statements in this press release are based on information available
to Guardant Health as of the date hereof, and Guardant Health
disclaims any obligation to update any forward-looking statements
provided to reflect any change in its expectations or any change in
events, conditions, or circumstances on which any such statement is
based, except as required by law. These forward-looking statements
should not be relied upon as representing Guardant Health’s views
as of any date subsequent to the date of this press release.
Guardant Health, Inc.
Condensed Consolidated
Statements of Operations
(unaudited)
(in thousands, except per
share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Revenue:
Precision oncology testing
$
180,604
$
133,423
$
503,351
$
372,060
Development services and other
10,872
9,607
33,851
36,834
Total revenue
191,476
143,030
537,202
408,894
Costs and operating expenses:
Cost of precision oncology testing
66,095
53,648
191,116
148,111
Cost of development services and other
8,394
3,966
21,090
16,424
Research and development expense
87,306
93,851
254,210
277,338
Sales and marketing expense
97,880
68,934
260,172
216,100
General and administrative expense
49,129
36,174
128,243
118,135
Total costs and operating expenses
308,804
256,573
854,831
776,108
Loss from operations
(117,328
)
(113,543
)
(317,629
)
(367,214
)
Interest income
13,257
11,690
42,038
21,477
Interest expense
(646
)
(644
)
(1,936
)
(1,933
)
Other income (expense), net
(3,007
)
16,885
(47,272
)
56,490
Loss before provision for income taxes
(107,724
)
(85,612
)
(324,799
)
(291,180
)
Provision for income taxes
30
490
568
1,226
Net loss
$
(107,754
)
$
(86,102
)
$
(325,367
)
$
(292,406
)
Net loss per share, basic and diluted
$
(0.88
)
$
(0.73
)
$
(2.66
)
$
(2.66
)
Weighted-average shares used in computing
net loss per share, basic and diluted
123,051
117,736
122,406
109,791
Guardant Health, Inc.
Condensed Consolidated Balance
Sheets
(unaudited)
(in thousands, except share
and per share data)
September 30, 2024
December 31, 2023
ASSETS
Current assets:
Cash, cash equivalents and restricted
cash
$
688,368
$
1,133,537
Short-term marketable debt securities
310,701
35,097
Accounts receivable, net
88,465
88,783
Inventory, net
72,298
61,948
Prepaid expenses and other current assets,
net
66,883
27,741
Total current assets
1,226,715
1,347,106
Property and equipment, net
125,169
145,096
Right-of-use assets, net
144,964
157,616
Intangible assets, net
7,251
8,979
Goodwill
3,290
3,290
Other assets, net
31,338
124,334
Total Assets
$
1,538,727
$
1,786,421
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
15,473
$
51,741
Accrued compensation
80,647
72,736
Accrued expenses
71,671
63,475
Deferred revenue
29,554
17,965
Total current liabilities
197,345
205,917
Convertible senior notes, net
1,141,901
1,139,966
Long-term operating lease liabilities
170,131
185,848
Other long-term liabilities
89,446
96,006
Total Liabilities
1,598,823
1,627,737
Stockholders’ equity:
Common stock, par value of $0.00001 per
share; 350,000,000 shares authorized as of September 30, 2024 and
December 31, 2023; 123,158,418 and 121,629,861 shares issued and
outstanding as of September 30, 2024 and December 31, 2023,
respectively
1
1
Additional paid-in capital
2,410,416
2,304,220
Accumulated other comprehensive loss
(3,284
)
(3,675
)
Accumulated deficit
(2,467,229
)
(2,141,862
)
Total Stockholders’ (Deficit) Equity
(60,096
)
158,684
Total Liabilities and Stockholders’
(Deficit) Equity
$
1,538,727
$
1,786,421
Guardant Health, Inc.
Reconciliation of Selected
GAAP Measures to Non-GAAP Measures
(unaudited)
(in thousands, except per
share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
GAAP cost of precision oncology
testing
$
66,095
$
53,648
$
191,116
$
148,111
Amortization of intangible assets
(151
)
(151
)
(450
)
(448
)
Stock-based compensation expense and
related employer payroll tax payments
(1,505
)
(1,120
)
(4,092
)
(3,563
)
Non-GAAP cost of precision oncology
testing
$
64,439
$
52,377
$
186,574
$
144,100
GAAP cost of development services and
other
$
8,394
$
3,966
$
21,090
$
16,424
Amortization of intangible assets
—
(201
)
(267
)
(603
)
Stock-based compensation expense and
related employer payroll tax payments
(2,412
)
(437
)
(3,409
)
(1,391
)
Non-GAAP cost of development services
and other
$
5,982
$
3,328
$
17,414
$
14,430
GAAP gross profit
$
116,987
$
85,416
$
324,996
$
244,359
Amortization of intangible assets
151
352
717
1,051
Stock-based compensation expense and
related employer payroll tax payments
3,917
1,557
7,501
4,954
Non-GAAP gross profit
$
121,055
$
87,325
$
333,214
$
250,364
GAAP cost of screening
$
5,320
$
2,992
$
12,108
$
10,023
Amortization of intangible assets
—
(201
)
(267
)
(603
)
Stock-based compensation expense and
related employer payroll tax payments
(2,412
)
(437
)
(3,409
)
(1,391
)
Non-GAAP cost of screening
$
2,908
$
2,354
$
8,432
$
8,029
Non-GAAP gross profit excluding cost of
screening
$
123,963
$
89,679
$
341,646
$
258,393
GAAP research and development
expense
$
87,306
$
93,851
$
254,210
$
277,338
Stock-based compensation expense and
related employer payroll tax payments
(18,750
)
(8,611
)
(38,815
)
(25,877
)
Contingent consideration
(190
)
(531
)
(675
)
(1,632
)
Non-GAAP research and development
expense
$
68,366
$
84,709
$
214,720
$
249,829
GAAP sales and marketing
expense
$
97,880
$
68,934
$
260,172
$
216,100
Stock-based compensation expense and
related employer payroll tax payments
(13,287
)
(5,137
)
(27,874
)
(18,657
)
Non-GAAP sales and marketing
expense
$
84,593
$
63,797
$
232,298
$
197,443
GAAP general and administrative
expense
$
49,129
$
36,174
$
128,243
$
118,135
Amortization of intangible assets
(340
)
(339
)
(1,011
)
(1,006
)
Stock-based compensation expense and
related employer payroll tax payments
(14,068
)
(6,794
)
(30,891
)
(18,017
)
Contingent consideration
(340
)
(220
)
(760
)
(230
)
Non-GAAP general and administrative
expense
$
34,381
$
28,821
$
95,581
$
98,882
GAAP loss from operations
$
(117,328
)
$
(113,543
)
$
(317,629
)
$
(367,214
)
Amortization of intangible assets
491
691
1,728
2,057
Stock-based compensation expense and
related employer payroll tax payments
50,022
22,099
105,081
67,505
Contingent consideration
530
751
1,435
1,862
Non-GAAP loss from operations
$
(66,285
)
$
(90,002
)
$
(209,385
)
$
(295,790
)
GAAP net loss
$
(107,754
)
$
(86,102
)
$
(325,367
)
$
(292,406
)
Amortization of intangible assets
491
691
1,728
2,057
Stock-based compensation expense and
related employer payroll tax payments
50,022
22,099
105,081
67,505
Contingent consideration
530
751
1,435
1,862
Unrealized and realized losses (gains) on
marketable equity securities
1,686
(16,634
)
47,225
(84,513
)
Impairment of non-marketable equity
securities and other related assets
—
—
—
29,054
Non-GAAP net loss
$
(55,025
)
$
(79,195
)
$
(169,898
)
$
(276,441
)
GAAP net loss per share, basic and
diluted
$
(0.88
)
$
(0.73
)
$
(2.66
)
$
(2.66
)
Non-GAAP net loss per share, basic and
diluted
$
(0.45
)
$
(0.67
)
$
(1.39
)
$
(2.52
)
Weighted-average shares used in
computing GAAP and Non-GAAP net loss per share, basic and
diluted
123,051
117,736
122,406
109,791
Reconciliation of GAAP Net
Loss to Adjusted EBITDA
(unaudited)
(in thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
GAAP net loss
$
(107,754
)
$
(86,102
)
$
(325,367
)
$
(292,406
)
Interest income
(13,257
)
(11,690
)
(42,038
)
(21,477
)
Interest expense
646
644
1,936
1,933
Other expense (income), net
3,007
(16,885
)
47,272
(56,490
)
Provision for income taxes
30
490
568
1,226
Depreciation and amortization
10,598
11,037
31,933
32,013
Stock-based compensation expense and
related employer payroll tax payments
50,022
22,099
105,081
67,505
Contingent consideration
530
751
1,435
1,862
Adjusted EBITDA
$
(56,178
)
$
(79,656
)
$
(179,180
)
$
(265,834
)
Reconciliation of Free Cash
Flow to Net Cash Used in Operating Activities
(unaudited)
(in thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Net cash used in operating activities
$
(51,059
)
$
(77,791
)
$
(175,345
)
$
(246,247
)
Purchases of property and equipment
(4,199
)
(2,372
)
(16,210
)
(16,409
)
Free cash flow
$
(55,258
)
$
(80,163
)
$
(191,555
)
$
(262,656
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241106173129/en/
Investor Contact: Zarak
Khurshid investors@guardanthealth.com
Media Contact: Melissa
Marasco press@guardanthealth.com +1 650-647-3711
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