Raises 2024 Revenue Guidance to $274 to $282
Million
CareDx, Inc. (Nasdaq: CDNA) – today reported financial results
for the first quarter ended March 31, 2024.
First Quarter 2024 Highlights
- Reported first quarter revenue of $72.0 million.
- Revenue for Testing Services of $53.8 million, an increase of
15% as compared to the fourth quarter 2023.
- Grew testing services patients results for the third
consecutive quarter to approximately 42,000, an increase of 6% as
compared to the fourth quarter 2023.
- Over 30 oral presentations, posters and two symposia
highlighting CareDx’s scientific advancements in heart and lung
transplantation presented at the International Society for Heart
and Lung Transplantation (ISHLT).
- SHORE data presented at ISHLT demonstrated that HeartCare®
multimodal testing outperforms donor-derived cell-free DNA
(dd-cfDNA) testing alone in identifying allograft rejection.
- Expanded payer coverage by 14 million lives nationwide.
- Reported first quarter revenue of $9.6 million for Patient and
Digital Solutions and $8.6 million for Products, representing
year-over-year growth of 12% and 25%, respectively.
- Ended the quarter with cash, cash equivalents, and marketable
securities of approximately $216 million, with no debt.
“We set a new baseline in our Testing Services business in the
second half of 2023 and are back to delivering sequential growth. I
am pleased with the team’s strong performance across all businesses
this quarter,” said John W. Hanna, CareDx President and CEO.
“CareDx is the leader in transplant patient care and our dedication
to serving patients will continue to be our catalyst for
growth.”
First Quarter 2024 Financial Results
Revenue for the three months ended March 31, 2024, was $72.0
million, a decrease of 7% compared with $77.3 million for the first
quarter of 2023, and an increase of 10% compared with $65.6 million
in the fourth quarter of 2023. Testing Services revenue for the
first quarter 2024 was $53.8 million, a decrease of 13% compared
with $61.8 million in the same period in 2023, and an increase of
15% compared with $46.7 million in the fourth quarter of 2023.
Testing Services revenue benefited from continued revenue cycle
management initiatives including unpaid claims from test results
delivered in prior quarters. These efforts added approximately $3.7
million in revenue in the first quarter.
Total AlloSure® and AlloMap® patient results provided in the
first quarter 2024 were approximately 42,000, a decrease of 16% as
compared to the same quarter a year ago, and an increase of 6%
compared to the fourth quarter of 2023. Patient and Digital
Solutions revenue for the first quarter 2024 was $9.6 million,
compared to $8.6 million in the same period in 2023, an increase of
12%. Product revenue for the first quarter 2024 was $8.6 million,
compared to $6.9 million in the same period in 2023, an increase of
25%.
For the first quarter of 2024 net loss was $16.7 million,
compared to a net loss of $23.7 million in the first quarter of
2023. Basic and diluted net loss per share in the first quarter of
2024 was $0.32, compared to basic and diluted net loss per share of
$0.44 in the first quarter of 2023.
Non-GAAP net loss was $1.4 million in the first quarter of 2024,
compared to a non-GAAP net loss of $5.8 million in the first
quarter of 2023. Basic and diluted non-GAAP net loss per share was
$0.03 in the first quarter of 2024, compared to a basic and diluted
non-GAAP net loss per share of $0.11 in the first quarter of
2023.
Adjusted EBITDA for the first quarter of 2024 was a loss of $1.9
million, compared to an adjusted EBITDA loss of $6.4 million in the
first quarter of 2023, and $10.3 million adjusted EBITDA loss in
the fourth quarter of 2023.
CareDx delivered strong financial and operational performance in
the first quarter and is raising guidance for the full year 2024
revenue which is expected to be in the range of $274 million to
$282 million.
About CareDx – The Transplant Company
CareDx, Inc., headquartered in Brisbane, California, is a
leading precision medicine solutions company focused on the
discovery, development, and commercialization of clinically
differentiated, high-value healthcare solutions for transplant
patients and caregivers. CareDx offers testing services, products,
and digital healthcare solutions along the pre- and post-transplant
patient journey and is the leading provider of genomics-based
information for transplant patients. For more information, please
visit: www.CareDx.com.
Forward Looking Statements
This press release includes forward-looking statements,
including expectations regarding CareDx’s 2024 revenue, CareDx’s
focus in 2024 and CareDx’s proposed path to profitability. These
forward-looking statements are based upon information that is
currently available to CareDx and its current expectations, speak
only as of the date hereof, and are subject to numerous risks and
uncertainties, all of which are difficult to predict and many of
which are beyond our control, including general economic and market
factors, among others discussed in CareDx’s filings with the
Securities and Exchange Commission (the “SEC”), including, but not
limited to, the Annual Report on Form 10-K for the fiscal year
ended December 31, 2023 filed by CareDx with the SEC on February
28, 2024, the quarterly report on Form 10-Q for the quarter ended
March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and
other reports that CareDx has filed with the SEC. Any of these may
cause CareDx’s actual results, performance, or achievements to
differ materially and adversely from those anticipated or implied
by CareDx’s forward-looking statements. You are cautioned not to
place undue reliance on these forward-looking statements. CareDx
expressly disclaims any obligation, except as required by law, or
undertaking to update or revise any such forward-looking
statements, whether as a result of new information, future events
or otherwise.
Use of Non-GAAP Financial Measures
CareDx 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 testing services, non-GAAP cost of product, non-GAAP cost
of patient and digital solutions, non-GAAP research and development
expenses, non-GAAP sales and marketing expenses, non-GAAP general
and administrative expenses, non-GAAP other income, net, non-GAAP
income tax expense, non-GAAP gross profit, non-GAAP gross margin
(%), non-GAAP net loss, non-GAAP basic and diluted net loss per
share, adjusted EBITDA and non-GAAP operating expenses.
We define non-GAAP net loss and per share results as the GAAP
net loss and per share results excluding the impacts of stock-based
compensation; changes in estimated fair value of contingent
consideration; acquisition-related impairment charges and
amortization of purchased intangible assets and related tax
effects; costs involved with completing an acquisition; unrealized
loss on investments; restructuring charges and certain other
charges.
We define adjusted EBITDA as non-GAAP net loss before net
interest income, income tax (benefit) expense, depreciation and
other expense, net.
We are presenting these non-GAAP financial measures to assist
investors in assessing our operating results through the eyes of
management and because we believe that these measures provide an
additional tool for investors to use in comparing our core business
operating results over multiple periods. Management believes this
non-GAAP information is useful for investors, when considered in
conjunction with CareDx’s GAAP financial statements, because
management uses such information internally for its operating,
budgeting, and financial planning purposes. Non-GAAP information is
not prepared under a comprehensive set of accounting rules and
should only be used to supplement an understanding of CareDx’s
operating results as reported under GAAP. These non-GAAP financial
measures should not be considered in isolation from, or as a
substitute for, financial information prepared in accordance with
GAAP. These non-GAAP financial measures are not necessarily
comparable to similarly titled measures presented by other
companies. A reconciliation between GAAP and non-GAAP financial
information is provided immediately following the financial
tables.
CareDx, Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
(In thousands, except share and
per share data)
Three Months Ended March
31,
2024
2023
Revenue:
Testing services revenue
$
53,837
$
61,784
Product revenue
8,594
6,861
Patient and digital solutions revenue
9,618
8,617
Total revenue
72,049
77,262
Operating expenses:
Cost of testing services
13,632
15,296
Cost of product
5,344
4,066
Cost of patient and digital solutions
6,958
6,604
Research and development
18,711
24,357
Sales and marketing
19,830
23,231
General and administrative
26,911
28,032
Total operating expenses
91,386
101,586
Loss from operations
(19,337
)
(24,324
)
Other income:
Interest income, net
2,885
2,666
Change in estimated fair value of common
stock warrant liability
—
7
Other expense, net
(290
)
(1,974
)
Total other income
2,595
699
Loss before income taxes
(16,742
)
(23,625
)
Income tax benefit (expense)
83
(124
)
Net loss
$
(16,659
)
$
(23,749
)
Net loss per share:
Basic
$
(0.32
)
$
(0.44
)
Diluted
$
(0.32
)
$
(0.44
)
Weighted-average shares used to compute
net loss per share:
Basic
51,692,358
53,643,216
Diluted
51,692,358
53,643,216
CareDx, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
March 31, 2024
December 31, 2023
Assets
Current assets:
Cash and cash equivalents
$
93,299
$
82,197
Marketable securities
122,622
153,221
Accounts receivable
60,149
51,061
Inventory
20,130
19,471
Prepaid and other current assets
6,895
7,763
Total current assets
303,095
313,713
Property and equipment, net
34,411
35,246
Operating leases right-of-use assets
28,591
29,891
Intangible assets, net
43,330
45,701
Goodwill
40,336
40,336
Restricted cash
583
586
Other assets
2,060
1,353
Total assets
$
452,406
$
466,826
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
9,976
$
12,872
Accrued compensation
14,565
19,703
Accrued and other liabilities
45,670
45,497
Total current liabilities
70,211
78,072
Deferred tax liability
43
136
Deferred payments for intangible
assets
1,348
2,461
Operating lease liability, less current
portion
26,893
28,278
Other liabilities
97,686
96,551
Total liabilities
196,181
205,498
Commitments and contingencies
Stockholders’ equity:
Common stock
49
49
Additional paid-in capital
959,734
946,511
Accumulated other comprehensive loss
(8,108
)
(6,963
)
Accumulated deficit
(695,450
)
(678,269
)
Total stockholders’ equity
256,225
261,328
Total liabilities and stockholders’
equity
$
452,406
$
466,826
CareDx, Inc.
Reconciliation of GAAP to
Non-GAAP Financial Measures
(Unaudited)
(In thousands)
Three Months Ended March
31,
2024
2023
Cost of testing services
reconciliation:
GAAP cost of testing services
$
13,632
$
15,296
Stock-based compensation expense
(457
)
(479
)
Acquisition related-amortization of
purchased intangibles
(329
)
(329
)
Non-GAAP cost of testing services
$
12,846
$
14,488
Cost of product reconciliation:
GAAP cost of product
$
5,344
$
4,066
Stock-based compensation expense
(317
)
(360
)
Acquisition related-amortization of
purchased intangibles
(420
)
(418
)
Non-GAAP cost of product
$
4,607
$
3,288
Cost of patient and digital solutions
reconciliation:
GAAP cost of patient and digital
solutions
$
6,958
$
6,604
Stock-based compensation expense
(372
)
(402
)
Acquisition related-amortization of
purchased intangibles
(271
)
(248
)
Other income
5
—
Non-GAAP cost of patient and digital
solutions
$
6,320
$
5,954
Research and development expenses
reconciliation:
GAAP research and development expenses
$
18,711
$
24,357
Stock-based compensation expense
(1,760
)
(1,962
)
Other charges
(25
)
—
Non-GAAP research and development
expenses
$
16,926
$
22,395
Sales and marketing expenses
reconciliation:
GAAP sales and marketing expenses
$
19,830
$
23,231
Stock-based compensation expense
(3,044
)
(3,737
)
Acquisition related-amortization of
purchased intangibles
(633
)
(595
)
Other charges
(8
)
—
Non-GAAP sales and marketing expenses
$
16,145
$
18,899
General and administrative expenses
reconciliation:
GAAP general and administrative
expenses
$
26,911
$
28,032
Stock-based compensation expense
(7,394
)
(6,814
)
Change in estimated fair value of
contingent consideration
(319
)
(421
)
Acquisition related fees and expenses
(35
)
(284
)
Restructuring charges
—
(58
)
Other income
66
—
Non-GAAP general and administrative
expenses
$
19,229
$
20,455
Total other income (expense)
reconciliation:
GAAP other income, net
$
2,595
$
699
Unrealized loss on long-term marketable
equity securities
—
905
Asset impairments and write-downs
—
1,000
Other charges
—
20
Non-GAAP other income, net
$
2,595
$
2,624
Income tax benefit (expense)
reconciliation:
GAAP income tax benefit (expense)
$
83
$
(124
)
Tax effect related to amortization of
purchased intangibles
(102
)
(101
)
Non-GAAP income tax expense
$
(19
)
$
(225
)
CareDx, Inc.
GAAP and Non-GAAP Operating
Expenses
(Unaudited)
(In thousands)
Three Months Ended March
31,
2024
2023
GAAP operating expenses:
Research and development
$
18,711
$
24,357
Sales and marketing
19,830
23,231
General and administrative
26,911
28,032
Total GAAP operating expenses
$
65,452
$
75,620
Non-GAAP operating expenses:
Research and development
$
16,926
$
22,395
Sales and marketing
16,145
18,899
General and administrative
19,229
20,455
Total Non-GAAP operating expenses
$
52,300
$
61,749
CareDx, Inc.
Reconciliation of GAAP to
Non-GAAP Gross Profit and Gross Margin
(Unaudited)
(In thousands, except
percentages)
Three Months Ended March
31,
2024
2023
Total revenue
$
72,049
$
77,262
GAAP cost of sales
25,934
25,966
GAAP gross profit
46,115
51,296
Stock-based compensation expense
1,146
1,241
Other income
(5
)
—
Acquisition related-amortization of
purchased intangibles
1,020
995
Non-GAAP gross profit
$
48,276
$
53,532
Non-GAAP gross margin %
67
%
69
%
CareDx, Inc.
Reconciliation of GAAP to
Non-GAAP Financial Measures
(Unaudited)
(In thousands, except share and
per share data)
Three Months Ended March
31,
2024
2023
GAAP net loss
$
(16,659
)
$
(23,749
)
Stock-based compensation expense
13,344
13,754
Acquisition related-amortization of
purchased intangibles
1,653
1,590
Acquisition related fees and expenses
35
284
Change in estimated fair value of
contingent consideration
319
421
Other income and charges
(38
)
20
Tax effect related to amortization of
purchased intangibles
(102
)
(101
)
Asset impairments and write-downs
—
1,000
Unrealized loss on long-term marketable
equity securities
—
905
Restructuring charges
—
58
Non-GAAP net loss
$
(1,448
)
$
(5,818
)
GAAP basic and diluted net loss per
share
$
(0.32
)
$
(0.44
)
Non-GAAP basic net loss per share
$
(0.03
)
$
(0.11
)
Non-GAAP diluted net loss per share
$
(0.03
)
$
(0.11
)
Shares used in computing non-GAAP basic
net loss per share
51,692,358
53,643,216
Shares used in computing non-GAAP diluted
net loss per share
51,692,358
53,643,216
CareDx, Inc.
Reconciliation of Non-GAAP to
Adjusted EBITDA
(Unaudited)
(In thousands)
Three Months Ended March
31,
2024
2023
Non-GAAP net loss
$
(1,448
)
$
(5,818
)
Interest income
(2,885
)
(2,666
)
Income tax expense
19
225
Depreciation expense
2,168
1,808
Other expense, net
290
36
Adjusted EBITDA
(1,856
)
(6,415
)
Unrecognized AlloSure Kidney Medicare
claims
—
8,912
Adjusted EBITDA assuming recognition of
paused claims
$
(1,856
)
$
2,497
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version on businesswire.com: https://www.businesswire.com/news/home/20240509171418/en/
CareDx, Inc. Media Relations Anna Czene 818-731-2203
aczene@caredx.com
Investor Relations Greg Chodaczek investor@caredx.com
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