Achieved revenue of $78.7 million, driven by
approximately 18,400 clinical tests
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company focused on helping conquer cancer globally through use of
its proprietary blood tests, vast data sets and advanced analytics,
today reported financial results for the quarter ended March 31,
2021.
Recent Highlights
- Revenue of $78.7 million for the first quarter of 2021, an
increase of 17% over the corresponding period of 2020
- Reported 18,390 tests to clinical customers and 3,522 tests to
biopharmaceutical customers in the first quarter of 2021,
representing an increase of 21% and a decrease of 33%,
respectively, over the first quarter of 2020
- Successfully launched Guardant Reveal, the first blood-only
test with a 7-day turnaround time, for residual disease and
recurring monitoring in patients with early-stage colorectal cancer
and received positive early feedback from oncologists
- Received Advanced Diagnostic Laboratory Test (ADLT) status for
the Guardant360® CDx test to be reimbursed at a rate of $5,000
effective April 1, 2021, for all Medicare patients
- Study led by Massachusetts General Hospital Cancer Center and
published in Clinical Cancer Research demonstrated that Guardant
Reveal identifies patients most likely to recur with high clinical
accuracy
- Appointed Dr. Craig Eagle as Chief Medical Officer
“I am proud of our team for their continued hard work this
quarter. Despite continuing impacts of COVID, we achieved record
revenue and solid growth in our clinical business, and continued to
progress our product pipeline,” said Helmy Eltoukhy, PhD,
co-founder and CEO. “I am so excited about what is ahead for
Guardant and believe 2021 will be a pivotal year for us as we
expand our product portfolio and invest across our business to
build the foundations for complete cancer testing across the
continuum of care.”
First Quarter 2021 Financial Results
Revenue was $78.7 million for the three months ended March 31,
2021, a 17% increase from $67.5 million for the three months ended
March 31, 2020. Precision oncology revenue grew 6% driven
predominantly by an increase in clinical testing revenue which grew
31% over the prior year period. There were 18,390 clinical tests
and 3,522 biopharmaceutical tests performed during the first
quarter of 2021. Development services and other revenue increased
106% primarily related to the timing of project related milestones
for companion diagnostic development programs.
Gross profit, or total revenue less cost of precision oncology
testing and cost of development services and other, was $49.9
million for the first quarter of 2021, an increase of $2.9 million
from $47.0 million for the corresponding prior year period. Gross
margin, or gross profit divided by total revenue, was 63%, as
compared to 70% for the corresponding prior year period.
Operating expenses were $157.8 million for the first quarter of
2021, as compared to $81.9 million for the corresponding prior year
period, an increase of 93%. Non-GAAP operating expenses were $100.7
million for the first quarter of 2021, as compared to $65.9 million
for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common
stockholders was $109.7 million for the first quarter of 2021, as
compared to $27.7 million for the corresponding prior year period.
Net loss per share attributable to Guardant Health, Inc. common
stockholders was $1.09 for the first quarter of 2021, as compared
to $0.29 for the corresponding prior year period. Non-GAAP net loss
was $49.4 million for the first quarter of 2021, as compared to
$15.4 million for the corresponding prior year period. Non-GAAP net
loss per share was $0.49 for the first quarter of 2021, as compared
to $0.16 for the corresponding prior year period.
Adjusted EBITDA loss was $45.4 million for the first quarter of
2021, as compared to a $15.5 million loss for the corresponding
prior year period.
Cash, cash equivalents and marketable securities were $1.9
billion as of March 31, 2021.
2021 Guidance
Guardant Health now expects full year 2021 revenue to be in the
range of $360 million to $370 million, representing 26% to 29%
growth over full year 2020. Clinical volumes for 2021 are expected
to be greater than 90,000 tests, growing at least 42% over
2020.
Webcast Information
Guardant Health will host a conference call to discuss the first
quarter 2021 financial results after market close on Thursday, May
6, 2021 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 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 attributable to Guardant
Health, Inc., common stockholders, non-GAAP net loss per share
attributable to Guardant Health, Inc. common stockholders, basic
and diluted, and Adjusted EBITDA.
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; changes in estimated fair value
redeemable noncontrolling interest; contingent consideration;
acquisition related expenses, amortization of intangible assets,
and other non-recurring items.
Adjusted EBITDA is defined as net loss attributable to Guardant
Health, Inc. common stockholders adjusted for interest income;
interest expense; other income (expense), net, provision for
(benefit from) income taxes; depreciation; and amortization
expense; stock-based compensation expense and related employer
payroll tax payments; adjustments relating to non-controlling
interest and contingent consideration and, if applicable in a
reporting period, acquisition-related expenses and other
non-recurring items.
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 other items because we
believe that these income (expenses) do not reflect expected future
operating expenses. 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 helping conquer cancer globally through use of its proprietary
blood tests, vast data sets and advanced analytics. The Guardant
Health oncology platform leverages capabilities to drive commercial
adoption, improve patient clinical outcomes and lower healthcare
costs across all stages of the cancer care continuum. Guardant
Health has commercially launched liquid biopsy-based Guardant360®,
Guardant360 CDx, and GuardantOMNI® tests for advanced stage cancer
patients, and Guardant Reveal™ for early-stage cancer patients.
These tests fuel development of its LUNAR screening program, which
aims to address the needs of asymptomatic individuals eligible for
cancer screening.
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, 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, 2020 and in its other reports
filed with the Securities and Exchange Commission. 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 March
31,
2021
2020
Revenue:
Precision oncology testing
$
63,729
$
60,246
Development services and other
14,936
7,264
Total revenue
78,665
67,510
Costs and operating expenses:
Cost of precision oncology testing
23,590
18,191
Cost of development services and other
5,157
2,315
Research and development expense
55,508
37,016
Sales and marketing expense
34,338
25,115
General and administrative expense
67,935
19,785
Total costs and operating expenses
186,528
102,422
Loss from operations
(107,863)
(34,912)
Interest income
1,551
3,318
Interest expense
(646)
(12)
Other expense, net
(290)
(209)
Loss before provision for income taxes
(107,248)
(31,815)
Provision for (benefit from) income
taxes
110
14
Net loss
(107,358)
(31,829)
Adjustment of redeemable noncontrolling
interest
(2,300)
4,100
Net loss attributable to Guardant Health,
Inc. common stockholders
$
(109,658)
$
(27,729)
Net loss per share attributable to
Guardant Health, Inc. common stockholders, basic and diluted
$
(1.09)
$
(0.29)
Weighted-average shares used in computing
net loss per share attributable to Guardant Health, Inc. common
stockholders, basic and diluted
100,955
94,382
Guardant Health, Inc.
Condensed Consolidated Balance
Sheets (unaudited)
(in thousands, except share
and per share data)
March 31, 2021
December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents
$
869,372
$
832,977
Short-term marketable securities
1,071,078
961,903
Accounts receivable, net
48,039
53,299
Inventory
28,876
22,716
Prepaid expenses and other current assets,
net
15,679
17,466
Total current assets
2,033,044
1,888,361
Long-term marketable securities
—
246,597
Property and equipment, net
71,765
62,782
Right-of-use assets
205,671
37,343
Intangible assets, net
15,674
16,155
Goodwill
3,290
3,290
Other assets, net
17,297
17,253
Total Assets
$
2,346,741
$
2,271,781
LIABILITIES, REDEEMABLE NONCONTROLLING
INTEREST AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
22,318
$
7,340
Accrued compensation
37,180
28,280
Accrued expenses
27,643
22,639
Deferred revenue
8,360
8,550
Total current liabilities
95,501
66,809
Convertible senior notes, net
1,132,899
806,292
Long-term operating lease liabilities
210,244
41,565
Other long-term liabilities
1,651
1,520
Total Liabilities
1,440,295
916,186
Redeemable noncontrolling interest
59,400
57,100
Stockholders’ equity:
Common stock, par value of $0.00001 per
share; 350,000,000 shares authorized as of March 31, 2021 and
December 31, 2020; 101,085,653 and 100,213,985 shares issued and
outstanding as of March 31, 2021 and December 31, 2020,
respectively
1
1
Additional paid-in capital
1,557,954
1,902,389
Accumulated other comprehensive income
904
2,697
Accumulated deficit
(711,813)
(606,592)
Total Stockholders’ Equity
847,046
1,298,495
Total Liabilities, Redeemable
Noncontrolling Interest and Stockholders’ Equity
$
2,346,741
$
2,271,781
Guardant Health, Inc.
Reconciliation of Selected
GAAP Measures to Non-GAAP Measures
(unaudited)
(in thousands)
Three Months Ended March
31,
2021
2020
GAAP cost of precision oncology
testing
$
23,590
$
18,191
Amortization of intangible assets
(148)
—
Stock-based compensation expense and
related employer payroll tax payments
(799)
(322)
Non-GAAP cost of precision oncology
testing
$
22,643
$
17,869
GAAP research and development
expense
$
55,508
$
37,016
Stock-based compensation expense and
related employer payroll tax payments
(4,391)
(2,472)
Acquisition related expenses
—
(8,500)
Non-GAAP research and development
expense
$
51,117
$
26,044
GAAP sales and marketing
expense
$
34,338
$
25,115
Stock-based compensation expense and
related employer payroll tax payments
(2,934)
(1,930)
Non-GAAP sales and marketing
expense
$
31,404
$
23,185
GAAP general and administrative
expense
$
67,935
$
19,785
Amortization of intangible assets
(333)
(229)
Stock-based compensation expense and
related employer payroll tax payments
(49,375)
(1,911)
Change in fair value of contingent
consideration
—
190
Acquisition related expenses
—
(1,207)
Non-GAAP general and administrative
expense
$
18,227
$
16,628
GAAP loss from operations
$
(107,863)
$
(34,912)
Amortization of intangible assets
333
229
Stock-based compensation expense and
related employer payroll tax payments
56,700
6,313
Change in fair value of contingent
consideration
—
(190)
Acquisition related expenses
—
9,707
Non-GAAP loss from operations
$
(50,830)
$
(18,853)
GAAP net loss
$
(107,358)
$
(31,829)
Amortization of intangible assets
481
229
Stock-based compensation expense and
related employer payroll tax payments
57,499
6,635
Change in fair value of contingent
consideration
—
(190)
Acquisition related expenses
—
9,707
Non-GAAP net loss
$
(49,378)
$
(15,448)
GAAP net loss attributable to Guardant
Health, Inc. common stockholders
$
(109,658)
$
(27,729)
Amortization of intangible assets
481
229
Stock-based compensation expense and
related employer payroll tax payments
57,499
6,635
Change in fair value of contingent
consideration
—
(190)
Acquisition related expenses
—
9,707
Adjustments relating to non-controlling
interest
2,300
(4,100)
Non-GAAP net loss attributable to
Guardant Health, Inc. common stockholders
$
(49,378)
$
(15,448)
GAAP net loss per share attributable to
Guardant Health, Inc., common stockholders, basic and
diluted
$
(1.09)
$
(0.29)
Non-GAAP net loss per share
attributable to Guardant Health, Inc., common stockholders, basic
and diluted
$
(0.49)
$
(0.16)
Weighted-average shares used in
computing GAAP and Non-GAAP net loss per share, basic and
diluted
100,955
94,382
Guardant Health, Inc.
Reconciliation of GAAP Net
Loss Attributable to Guardant Health, Inc. Common Stockholders to
Adjusted EBITDA
(unaudited)
(in thousands)
Three Months Ended March
31,
2021
2020
GAAP net loss attributable to Guardant
Health, Inc. common stockholders
$
(109,658)
$
(27,729)
Interest income
(1,551)
(3,318)
Interest expense
646
12
Other expense, net
290
209
Provision for (benefit from) income
taxes
110
14
Depreciation and amortization
5,010
3,304
Stock-based compensation expense and
related employer payroll tax payments
57,499
6,635
Change in fair value of contingent
consideration
—
(190)
Acquisition related expenses
—
9,707
Adjustments relating to non-controlling
interest
2,300
(4,100)
Adjusted EBITDA
$
(45,354)
$
(15,456)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506006135/en/
Investor Contact: Carrie
Mendivil investors@guardanthealth.com
Media Contact: Anna Czene
press@guardanthealth.com
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