CareDx Reports First Quarter 2024 Results
CareDx, Inc. (Nasdaq: CDNA) reported first quarter 2024 revenue of $72.0 million, with Testing Services revenue growing by 15% compared to the previous quarter. The company expanded payer coverage by 14 million lives, presented scientific advancements at ISHLT, and ended the quarter with approximately $216 million in cash and no debt. However, there was a 7% decrease in revenue compared to the first quarter of 2023, with a net loss of $16.7 million in the first quarter of 2024.
Testing Services revenue grew by 15% compared to the previous quarter, reaching $53.8 million.
Expanded payer coverage by 14 million lives nationwide.
Ended the quarter with approximately $216 million in cash, cash equivalents, and marketable securities, with no debt.
Raising 2024 revenue guidance to $274 to $282 million.
7% decrease in revenue compared to the first quarter of 2023, with revenue of $72.0 million.
Net loss of $16.7 million in the first quarter of 2024.
Decrease of 16% in total AlloSure® and AlloMap® patient results provided in the first quarter of 2024 compared to the same period a year ago.
Insights
Reviewing CareDx's Q1 2024 financial results reveals several key points of interest. The reported increase of 10% in sequential quarter revenue is a sign of resilience, especially given the broader decrease of 7% year-over-year. The significant growth in the Products sector, at 25% year-over-year, indicates a solid performance in a typically volatile market.
The company's strategy to expand payer coverage substantially could contribute to longer-term stability and increased market share. However, the reduction in total patient results year-over-year raises questions about market penetration and the competitive landscape. Investors should monitor how this metric evolves to assess the company's performance relative to market expectations.
While the non-GAAP net loss improvement suggests that the company is on a path to profitability, the still-present net loss indicates ongoing challenges in managing expenses relative to revenue. The upward revision of full-year revenue guidance, however, is a strong positive signal to investors, suggesting management's confidence in the company's growth trajectory.
CareDx operates in the complex and highly specialized field of transplant diagnostics, where technological advances like their AlloSure® and AlloMap® tests are closely watched. The mention of 30 oral presentations and symposia at a major industry event underscores the company's commitment to scientific leadership in its niche. The specific mention of HeartCare® outperforming other testing methods is noteworthy and could impact the company's competitive advantage.
The fact that the company has successfully expanded its payer coverage by 14 million lives is also significant. This expansion is likely to increase utilization of CareDx’s services and could lead to a more stable revenue stream from recurring testing cycles, which is critical in healthcare services.
However, despite such positive operational metrics, the overall decrease in patient result numbers compared to the same period last year could be indicative of market challenges or increased competition. Such trends need to be monitored to understand whether they represent a temporary fluctuation or a more systemic issue within the transplant diagnostics market.
Raises 2024 Revenue Guidance to
First Quarter 2024 Highlights
-
Reported first quarter revenue of
$72.0 million -
Revenue for Testing Services of
$53.8 million 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 $8.6 million 12% and25% , respectively. -
Ended the quarter with cash, cash equivalents, and marketable securities of approximately
$216 million
“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
Total AlloSure® and AlloMap® patient results provided in the first quarter 2024 were approximately 42,000, a decrease of
For the first quarter of 2024 net loss was
Non-GAAP net loss was
Adjusted EBITDA for the first quarter of 2024 was a loss of
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
About CareDx – The Transplant Company
CareDx, Inc., headquartered in
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
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 |
|
View source 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
Source: CareDx, Inc.
FAQ
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