CareDx, Inc. (Nasdaq: CDNA) – today announced financial results
for the third quarter ended September 30, 2024.
Third Quarter 2024 Financial Highlights
- Total revenue of $82.9 million increased 23%
year-over-year
- Testing Services volume of 44,600 tests increased 16%
year-over-year
- GAAP net loss of $7.4 million, non-GAAP net income of $8.0
million, and positive adjusted EBITDA of $6.9 million, a
significant improvement from the third quarter 2023
- Cash flow from operations of $12.5 million. Cash, cash
equivalents, and marketable securities of $241 million, with no
debt
- Raised annual revenue guidance to $327 to $331 million and
adjusted EBITDA to a gain of $18 to $22 million
Business Highlights
- CMS reaffirmed longstanding Medicare coverage for AlloSure® and
AlloMap® Testing
- Surveillance testing mix in kidney began to increase in the
second half of September and continued through October
- Hired industry veterans Keith Kennedy, Chief Operating Officer;
Jessica Meng, Chief Commercial Officer; and Jing Huang, PhD, Chief
Data and AI Officer
- Announced the launch of the next generation of Assign software
for AlloSeq™ Tx HLA typing and enhancements to QTYPE® rapid typing
solution for deceased donor HLA typing
- DOJ concluded its investigation into CareDx with no finding of
wrongdoing
"CareDx had another strong quarter of topline growth and
achieved positive adjusted EBITDA for the second consecutive
quarter. We raised our annual guidance, and remain focused on
ending the year strong,” said John W. Hanna, CareDx President and
CEO.
Third Quarter 2024 Financial Results
Total revenue for the three months ended September 30, 2024, was
$82.9 million, an increase of 23% compared to $67.2 million for the
third quarter of 2023. Testing Services revenue for the third
quarter 2024 was $60.8 million, an increase of 27% compared to
$47.8 million for the third quarter of 2023. Testing Services
revenue included $1.2 million for tests performed in prior periods.
Patient and Digital Solutions revenue for the third quarter of 2024
was $11.9 million, an increase of 20% compared to $9.9 million for
the third quarter 2023. Product revenue for the third quarter of
2024 was $10.2 million, an increase of 7% compared to $9.5 million
for the third quarter 2023.
For the third quarter of 2024 net loss was $7.4 million compared
to a net loss of $23.5 million in the third quarter of 2023. Basic
and diluted net loss per share in the third quarter of 2024 was
$0.14, compared to basic and diluted net loss per share of $0.43 in
the third quarter of 2023.
Non-GAAP net income was $8.0 million in the third quarter of
2024, compared to a non-GAAP net loss of $9.6 million in the third
quarter of 2023. Diluted non-GAAP net income per share was $0.14 in
the third quarter of 2024, compared to a diluted non-GAAP net loss
per share of $0.18 in the third quarter of 2023.
Adjusted EBITDA income for the third quarter of 2024 was $6.9
million, compared to an adjusted EBITDA loss of $10.9 million for
the third quarter of 2023.
2024 Guidance
CareDx now expects full year 2024 revenue to be in the range of
$327 million to $331 million, compared to the prior guidance of
$320 million to $328 million. CareDx now expects full year 2024
non-GAAP gross margin to be approximately 69%, compared to the
prior range of 67% to 68%. CareDx now expects full year 2024
adjusted EBITDA gain to be in the range of $18 million to $22
million, compared to the prior guidance of an adjusted EBITDA gain
of $9 million to $15 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, and
non-GAAP gross margin and adjusted EBITDA. 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, the quarterly report
on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx
with the SEC on July 31, 2024, the quarterly report on Form 10-Q
for the quarter ended September 30, 2024 filed by CareDx with the
SEC on November 4, 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 income (loss), non-GAAP
basic and diluted net income (loss) per share, adjusted EBITDA and
non-GAAP operating expenses.
We define non-GAAP net income (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 income (loss) before
interest income, income tax expense (benefit), depreciation and
other (income) 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 September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Revenue:
Testing services revenue
$
60,807
$
47,784
$
185,562
$
162,982
Product revenue
10,212
9,536
29,416
24,273
Patient and digital solutions revenue
11,864
9,872
32,228
27,500
Total revenue
82,883
67,192
247,206
214,755
Operating expenses:
Cost of testing services
13,447
13,217
41,387
43,837
Cost of product
6,212
4,750
17,801
12,742
Cost of patient and digital solutions
7,913
6,566
22,264
19,807
Research and development
17,486
19,000
55,875
63,590
Sales and marketing
19,802
18,474
60,634
63,335
General and administrative
28,515
33,968
83,104
91,327
Restructuring costs
—
—
68
848
Total operating expenses
93,375
95,975
281,133
295,486
Loss from operations
(10,492
)
(28,783
)
(33,927
)
(80,731
)
Other income:
Interest income, net
3,001
3,171
8,712
8,708
Change in estimated fair value of common
stock warrant liability
—
—
—
10
Other income (expense), net
283
2,047
(107
)
(198
)
Total other income
3,284
5,218
8,605
8,520
Loss before income taxes
(7,208
)
(23,565
)
(25,322
)
(72,211
)
Income tax (expense) benefit
(200
)
80
(139
)
24
Net loss
$
(7,408
)
$
(23,485
)
$
(25,461
)
$
(72,187
)
Net loss per share:
Basic
$
(0.14
)
$
(0.43
)
$
(0.49
)
$
(1.34
)
Diluted
$
(0.14
)
$
(0.43
)
$
(0.49
)
$
(1.34
)
Weighted-average shares used to compute
net loss per share:
Basic
52,903,338
54,178,759
52,266,106
53,891,374
Diluted
52,903,338
54,178,759
52,266,106
53,891,374
CareDx, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
September 30, 2024
December 31, 2023
Assets
Current assets:
Cash and cash equivalents
$
95,400
$
82,197
Marketable securities
145,453
153,221
Accounts receivable
66,627
51,061
Inventory
19,263
19,471
Prepaid and other current assets
7,344
7,763
Total current assets
334,087
313,713
Property and equipment, net
34,015
35,246
Operating leases right-of-use assets
25,823
29,891
Intangible assets, net
40,361
45,701
Goodwill
40,336
40,336
Restricted cash
592
586
Other assets
1,771
1,353
Total assets
$
476,985
$
466,826
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
6,239
$
12,872
Accrued compensation
29,915
19,703
Accrued and other liabilities
45,286
45,497
Total current liabilities
81,440
78,072
Deferred tax liability
202
136
Deferred payments for intangible
assets
1,310
2,461
Operating lease liability, less current
portion
23,841
28,278
Other liabilities
96,946
96,551
Total liabilities
203,739
205,498
Commitments and contingencies
Stockholders’ equity:
Common stock
50
49
Additional paid-in capital
984,627
946,511
Accumulated other comprehensive loss
(7,179
)
(6,963
)
Accumulated deficit
(704,252
)
(678,269
)
Total stockholders’ equity
273,246
261,328
Total liabilities and stockholders’
equity
$
476,985
$
466,826
CareDx, Inc.
Reconciliation of GAAP to
Non-GAAP Financial Measures
(Unaudited)
(In thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Cost of testing services
reconciliation:
GAAP cost of testing services
$
13,447
$
13,217
$
41,387
$
43,837
Stock-based compensation expense
(418
)
(496
)
(1,232
)
(1,467
)
Acquisition related-amortization of
purchased intangibles
(329
)
(329
)
(987
)
(987
)
Non-GAAP cost of testing services
$
12,700
$
12,392
$
39,168
$
41,383
Cost of product reconciliation:
GAAP cost of product
$
6,212
$
4,750
$
17,854
$
12,742
Stock-based compensation expense
(234
)
(301
)
(776
)
(935
)
Acquisition related-amortization of
purchased intangibles
(419
)
(408
)
(1,250
)
(1,242
)
Restructuring costs
—
—
(53
)
—
Non-GAAP cost of product
$
5,559
$
4,041
$
15,775
$
10,565
Cost of patient and digital solutions
reconciliation:
GAAP cost of patient and digital
solutions
$
7,913
$
6,566
$
22,264
$
19,821
Stock-based compensation expense
(326
)
(297
)
(1,048
)
(1,066
)
Acquisition related-amortization of
purchased intangibles
(170
)
(265
)
(679
)
(768
)
Restructuring costs
—
—
—
(14
)
Other income
—
—
5
—
Non-GAAP cost of patient and digital
solutions
$
7,417
$
6,004
$
20,542
$
17,973
Research and development expenses
reconciliation:
GAAP research and development expenses
$
17,486
$
19,000
$
55,890
$
63,835
Stock-based compensation expense
(1,775
)
(1,491
)
(5,163
)
(5,157
)
Restructuring costs
—
—
(15
)
(245
)
Other charges
—
—
(25
)
—
Non-GAAP research and development
expenses
$
15,711
$
17,509
$
50,687
$
58,433
Sales and marketing expenses
reconciliation:
GAAP sales and marketing expenses
$
19,802
$
18,474
$
60,634
$
63,883
Stock-based compensation expense
(2,786
)
(3,041
)
(8,757
)
(9,557
)
Acquisition related-amortization of
purchased intangibles
(634
)
(616
)
(1,895
)
(1,817
)
Restructuring costs
—
—
—
(548
)
Other charges
—
—
(8
)
—
Non-GAAP sales and marketing expenses
$
16,382
$
14,817
$
49,974
$
51,961
General and administrative expenses
reconciliation:
GAAP general and administrative
expenses
$
28,515
$
33,968
$
83,104
$
91,368
Stock-based compensation expense
(8,155
)
(7,045
)
(23,232
)
(20,943
)
Change in estimated fair value of
contingent consideration
(232
)
(1,243
)
(761
)
(1,731
)
Acquisition related fees and expenses
—
(253
)
(40
)
(537
)
Restructuring costs and charges
—
—
—
(41
)
Other (charges) income
—
(6
)
22
(64
)
Non-GAAP general and administrative
expenses
$
20,128
$
25,421
$
59,093
$
68,052
Total other income (expense)
reconciliation:
GAAP other income, net
$
3,284
$
5,218
$
8,605
$
8,520
Unrealized gain on long-term marketable
equity securities
—
333
—
1,190
Asset impairments and write-downs
—
—
—
1,000
Other charges
—
(2,109
)
—
(2,081
)
Non-GAAP other income, net
$
3,284
$
3,442
$
8,605
$
8,629
Income tax (expense) benefit
reconciliation:
GAAP income tax (expense) benefit
$
(200
)
$
80
$
(139
)
$
24
Tax effect related to amortization of
purchased intangibles
(102
)
(98
)
(302
)
(299
)
Non-GAAP income tax expense
$
(302
)
$
(18
)
$
(441
)
$
(275
)
CareDx, Inc.
GAAP and Non-GAAP Operating
Expenses
(Unaudited)
(In thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
GAAP operating expenses:
Research and development
$
17,486
$
19,000
$
55,890
$
63,835
Sales and marketing
19,802
18,474
60,634
63,883
General and administrative
28,515
33,968
83,104
91,368
Total GAAP operating expenses
$
65,803
$
71,442
$
199,628
$
219,086
Non-GAAP operating expenses:
Research and development
$
15,711
$
17,509
$
50,687
$
58,433
Sales and marketing
16,382
14,817
49,974
51,961
General and administrative
20,128
25,421
59,093
68,052
Total Non-GAAP operating expenses
$
52,221
$
57,747
$
159,754
$
178,446
CareDx, Inc.
Reconciliation of GAAP to
Non-GAAP Gross Profit and Gross Margin
(Unaudited)
(In thousands, except
percentages)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Total revenue
$
82,883
$
67,192
$
247,206
$
214,755
GAAP cost of sales
27,572
24,533
81,505
76,400
GAAP gross profit
55,311
42,659
165,701
138,355
Stock-based compensation expense
978
1,094
3,056
3,468
Other income
—
—
(5
)
—
Restructuring costs
—
—
53
14
Acquisition related-amortization of
purchased intangibles
918
1,002
2,916
2,997
Non-GAAP gross profit
$
57,207
$
44,755
$
171,721
$
144,834
Non-GAAP gross margin %
69
%
67
%
69
%
67
%
CareDx, Inc.
Reconciliation of GAAP to
Non-GAAP Financial Measures
(Unaudited)
(In thousands, except share and
per share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
GAAP net loss
$
(7,408
)
$
(23,485
)
$
(25,461
)
$
(72,187
)
Stock-based compensation expense
13,694
12,671
40,208
39,125
Acquisition related-amortization of
purchased intangibles
1,552
1,618
4,811
4,814
Change in estimated fair value of
contingent consideration
232
1,243
761
1,731
Acquisition related fees and expenses
—
253
40
537
Other (gains) charges
—
(2,109
)
6
(2,081
)
Restructuring costs and charges
—
6
68
912
Tax effect related to amortization of
purchased intangibles
(102
)
(98
)
(302
)
(299
)
Asset impairments and write-downs
—
—
—
1,000
Unrealized loss on long-term marketable
equity securities
—
333
—
1,190
Non-GAAP net income (loss)
$
7,968
$
(9,568
)
$
20,131
$
(25,258
)
GAAP basic and diluted net loss per
share
$
(0.14
)
$
(0.43
)
$
(0.49
)
$
(1.34
)
Non-GAAP basic net income (loss) per
share
$
0.15
$
(0.18
)
$
0.39
$
(0.47
)
Non-GAAP diluted net income (loss) per
share
$
0.14
$
(0.18
)
$
0.36
$
(0.47
)
Shares used in computing non-GAAP basic
net income (loss) per share
52,903,338
54,178,759
52,266,106
53,891,374
Shares used in computing non-GAAP diluted
net income (loss) per share
57,699,624
54,178,759
55,609,263
53,891,374
CareDx, Inc.
Reconciliation of Non-GAAP to
Adjusted EBITDA
(Unaudited)
(In thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Non-GAAP net income (loss)
$
7,968
$
(9,568
)
$
20,131
$
(25,258
)
Interest income
(3,001
)
(3,171
)
(8,712
)
(8,708
)
Income tax expense (benefit)
302
(214
)
441
275
Depreciation expense
1,919
2,044
6,024
5,904
Other (income) expense, net
(283
)
(40
)
107
79
Adjusted EBITDA
$
6,905
$
(10,949
)
$
17,991
$
(27,708
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241104115097/en/
CareDx, Inc.
Media Relations Anna Czene 818-731-2203 aczene@caredx.com
Investor Relations Greg Chodaczek investor@caredx.com
Grafico Azioni CareDx (NASDAQ:CDNA)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni CareDx (NASDAQ:CDNA)
Storico
Da Gen 2024 a Gen 2025