CareDx Reports First Quarter 2023 Results
First Quarter 2023 Highlights
-
Delivered record number of patient test results for AlloMap® and AlloSure® of approximately 49,900 tests, growing year-over-year by
17% , and exceeding year-over-year market growth of10% .
-
Reported revenue of
$77.3 million 3% year-over year. This excludes approximately$8.9 million
Including the revenue associated with the Impacted March Tests, total revenue would have been
-
Achieved record revenues of
$8.6 million 39% year-over-year.
-
Reported GAAP net loss of
$23.7 million $5.8 million $6.4 million $2.5 million
-
Maintained strong balance sheet with
$285.9 million $0.7 million $21.5 million
-
Achieved cash collections at
110% of revenue for testing services, representing an approximate10% year-over-year increase, and demonstrating continued strong operational progress on this key initiative.
- Strong transplant ecosystem support in response to the Billing Article from leading professional societies, including the American Society of Transplantation, American Society of Transplant Surgeons, and the International Society for Heart and Lung Transplantation.
-
Leading patient groups, including the Transplant Life Foundation, Transplant Recipients International Organization (TRIO), Transplant Families, and the Heart Brothers Foundation announced in a press release the results of a survey from over 1,000 patients, as well as caregivers and family members that
95% of patients surveyed are concerned that a new Medicare Billing Article limits coverage of non-invasive post-transplant tests.
“The first quarter delivered strong operational execution against our 2022 strategic plan, reflected in our record testing services volumes, record patient and digital solutions revenue, and second consecutive quarter of testing services cash collections exceeding testing services revenue,” said Reg Seeto, CEO and President of CareDx. “That said, we are currently laser focused on the operational implementation of our plans to address the recent MolDX Billing Article changes. I am proud to see the transplant ecosystem coming together, including the professional and patient associations, and healthcare providers, to support transplant patients.”
First Quarter 2023 Financial Results
Revenue for the three months ended March 31, 2023 was
For the first quarter of 2023, net loss was
Non-GAAP net loss was
Adjusted EBITDA for the first quarter of 2023 was a loss of
Cash and cash equivalents and marketable securities were
2023 Guidance
CareDx is withdrawing 2023 revenue guidance at this time given a multitude of unknown variables related to the March and May 2023 Billing Article revisions. The Company will provide additional details during its Q1 2023 earnings call.
About CareDx – The Transplant Company
CareDx, Inc., headquartered in
Forward Looking Statements
This press release includes forward-looking statements with respect to expectations regarding CareDx’s upcoming milestones, vision, any revenue that the Company may or could have received related to the Impacted March Tests and its plans to provide additional detail regarding its 2023 revenue guidance. All statements other than statements of historical fact contained in this press release, including statements regarding the future financial position of CareDx, including financial targets, business strategy, and plans and objectives for future operations, are forward-looking statements. 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, and global economic and marketplace uncertainties, 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, 2022 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 to be filed by CareDx with the SEC on or about May 10, 2023, 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
CareDx, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
||||
Testing services revenue |
$ |
61,784 |
|
|
$ |
66,444 |
|
Product revenue |
|
6,861 |
|
|
|
6,788 |
|
Patient and digital solutions revenue |
|
8,617 |
|
|
|
6,184 |
|
Total revenue |
|
77,262 |
|
|
|
79,416 |
|
Operating expenses: |
|
|
|
||||
Cost of testing services |
|
15,296 |
|
|
|
17,628 |
|
Cost of product |
|
4,066 |
|
|
|
4,399 |
|
Cost of patient and digital solutions |
|
6,604 |
|
|
|
4,855 |
|
Research and development |
|
24,357 |
|
|
|
21,880 |
|
Sales and marketing |
|
23,231 |
|
|
|
23,148 |
|
General and administrative |
|
28,032 |
|
|
|
26,559 |
|
Total operating expenses |
|
101,586 |
|
|
|
98,469 |
|
Loss from operations |
|
(24,324 |
) |
|
|
(19,053 |
) |
Other income (expense): |
|
|
|
||||
Interest income, net |
|
2,666 |
|
|
|
189 |
|
Change in estimated fair value of common stock warrant liability |
|
7 |
|
|
|
27 |
|
Other expense, net |
|
(1,974 |
) |
|
|
(823 |
) |
Total other income (expense) |
|
699 |
|
|
|
(607 |
) |
Loss before income taxes |
|
(23,625 |
) |
|
|
(19,660 |
) |
Income tax (expense) benefit |
|
(124 |
) |
|
|
12 |
|
Net loss |
$ |
(23,749 |
) |
|
$ |
(19,648 |
) |
Net loss per share: |
|
|
|
||||
Basic |
$ |
(0.44 |
) |
|
$ |
(0.37 |
) |
Diluted |
$ |
(0.44 |
) |
|
$ |
(0.37 |
) |
Weighted-average shares used to compute net loss per share: |
|
|
|
||||
Basic |
|
53,643,216 |
|
|
|
53,015,459 |
|
Diluted |
|
53,643,216 |
|
|
|
53,015,459 |
|
CareDx, Inc. Condensed Consolidated Balance Sheets (Unaudited) (in thousands) |
|||||||
|
March 31, 2023 |
|
December 31, 2022 |
||||
Assets |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
74,660 |
|
|
$ |
89,921 |
|
Marketable securities |
|
211,279 |
|
|
|
203,168 |
|
Accounts receivable |
|
59,310 |
|
|
|
66,312 |
|
Inventory |
|
18,018 |
|
|
|
19,232 |
|
Prepaid and other current assets |
|
8,161 |
|
|
|
9,216 |
|
Total current assets |
|
371,428 |
|
|
|
387,849 |
|
Property and equipment, net |
|
35,506 |
|
|
|
35,529 |
|
Operating leases right-of-use assets |
|
33,431 |
|
|
|
34,689 |
|
Intangible assets, net |
|
45,637 |
|
|
|
43,051 |
|
Goodwill |
|
39,615 |
|
|
|
37,523 |
|
Restricted cash |
|
520 |
|
|
|
522 |
|
Other assets |
|
2,080 |
|
|
|
3,828 |
|
Total assets |
$ |
528,217 |
|
|
$ |
542,991 |
|
Liabilities and stockholders’ equity |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
12,861 |
|
|
$ |
9,942 |
|
Accrued compensation |
|
12,082 |
|
|
|
16,902 |
|
Accrued and other liabilities |
|
46,885 |
|
|
|
49,131 |
|
Total current liabilities |
|
71,828 |
|
|
|
75,975
|
|
Common stock warrant liability |
|
25 |
|
|
|
32 |
|
Deferred payments for intangible assets |
|
4,089 |
|
|
|
2,418 |
|
Operating lease liability, less current portion |
|
32,006 |
|
|
|
33,406 |
|
Other liabilities |
|
248 |
|
|
|
249 |
|
Total liabilities |
|
108,196 |
|
|
|
112,080 |
|
Commitments and contingencies |
|
|
|
||||
Stockholders’ equity: |
|
|
|
||||
Common stock |
|
52 |
|
|
|
52 |
|
Additional paid-in capital |
|
912,291 |
|
|
|
898,806 |
|
Accumulated other comprehensive loss |
|
(7,439 |
) |
|
|
(7,503 |
) |
Accumulated deficit |
|
(484,883 |
) |
|
|
(460,444 |
) |
Total stockholders’ equity |
|
420,021 |
|
|
|
430,911 |
|
Total liabilities and stockholders’ equity |
$ |
528,217 |
|
|
$ |
542,991 |
|
CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2023 |
|
|
|
2022 |
|
Cost of testing services reconciliation: |
|
|
|
||||
GAAP cost of testing services |
$ |
15,296 |
|
|
$ |
17,628 |
|
Stock-based compensation expense |
|
(479 |
) |
|
|
(19 |
) |
Acquisition related-amortization of purchased intangibles |
|
(329 |
) |
|
|
(329 |
) |
Non-GAAP cost of testing services |
$ |
14,488 |
|
|
$ |
17,280 |
|
Cost of product reconciliation: |
|
|
|
||||
GAAP cost of product |
$ |
4,066 |
|
|
$ |
4,399 |
|
Stock-based compensation expense |
|
(360 |
) |
|
|
(128 |
) |
Acquisition related-amortization of purchased intangibles |
|
(418 |
) |
|
|
(453 |
) |
Non-GAAP cost of product |
$ |
3,288 |
|
|
$ |
3,818 |
|
Cost of patient and digital solutions reconciliation: |
|
|
|
||||
GAAP cost of patient and digital solutions |
$ |
6,604 |
|
|
$ |
4,855 |
|
Stock-based compensation expense |
|
(402 |
) |
|
|
(192 |
) |
Acquisition related-amortization of purchased intangibles |
|
(248 |
) |
|
|
(236 |
) |
Non-GAAP cost of patient and digital solutions |
$ |
5,954 |
|
|
$ |
4,427 |
|
Research and development expenses reconciliation: |
|
|
|
||||
GAAP research and development expenses |
$ |
24,357 |
|
|
$ |
21,880 |
|
Stock-based compensation expense |
|
(1,962 |
) |
|
|
(2,190 |
) |
Non-GAAP research and development expenses |
$ |
22,395 |
|
|
$ |
19,690 |
|
Sales and marketing expenses reconciliation: |
|
|
|
||||
GAAP sales and marketing expenses |
$ |
23,231 |
|
|
$ |
23,148 |
|
Stock-based compensation expense |
|
(3,737 |
) |
|
|
(3,123 |
) |
Acquisition related-amortization of purchased intangibles |
|
(595 |
) |
|
|
(605 |
) |
Non-GAAP sales and marketing expenses |
$ |
18,899 |
|
|
$ |
19,420 |
|
General and administrative expenses reconciliation: |
|
|
|
||||
GAAP general and administrative expenses |
$ |
28,032 |
|
|
$ |
26,559 |
|
Stock-based compensation expense |
|
(6,814 |
) |
|
|
(4,982 |
) |
Change in estimated fair value of contingent consideration |
|
(421 |
) |
|
|
(64 |
) |
Restructuring charges |
|
(58 |
) |
|
|
— |
|
Acquisition related fees and expenses |
|
(284 |
) |
|
|
(143 |
) |
Non-GAAP general and administrative expenses |
$ |
20,455 |
|
|
$ |
21,370 |
|
Total other income (expense) reconciliation: |
|
|
|
||||
GAAP other income (expense), net |
$ |
699 |
|
|
$ |
(607 |
) |
Unrealized loss on long-term marketable equity securities |
|
905 |
|
|
|
507 |
|
Asset impairments and write-downs |
|
1,000 |
|
|
|
— |
|
Other charges |
|
20 |
|
|
|
28 |
|
Non-GAAP other income (expense), net |
$ |
2,624 |
|
|
$ |
(72 |
) |
Income tax (expense) benefit reconciliation: |
|
|
|
||||
GAAP income tax (expense) benefit |
$ |
(124 |
) |
|
$ |
12 |
|
Tax effect related to amortization of purchased intangibles |
|
(101 |
) |
|
|
(113 |
) |
Non-GAAP income tax expense |
$ |
(225 |
) |
|
$ |
(101 |
) |
CareDx, Inc. Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin (Unaudited) (In thousands, except percentages) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2023 |
|
|
|
2022 |
|
Total revenue |
$ |
77,262 |
|
|
$ |
79,416 |
|
GAAP cost of sales |
|
25,966 |
|
|
|
26,882 |
|
GAAP gross profit |
|
51,296 |
|
|
|
52,534 |
|
Stock-based compensation expense |
|
1,241 |
|
|
|
339 |
|
Acquisition related-amortization of purchased intangibles |
|
995 |
|
|
|
1,018 |
|
Non-GAAP gross profit |
$ |
53,532 |
|
|
$ |
53,891 |
|
Non-GAAP gross margin % |
|
69 |
% |
|
|
68 |
% |
CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data) |
|||||||
|
|
||||||
|
Three Months Ended March 31, |
||||||
|
|
2023 |
|
|
|
2022 |
|
GAAP net loss |
$ |
(23,749 |
) |
|
$ |
(19,648 |
) |
Stock-based compensation expense |
|
13,754 |
|
|
|
10,634 |
|
Asset impairments and write-downs |
|
1,000 |
|
|
|
— |
|
Unrealized loss on long-term marketable equity securities |
|
905 |
|
|
|
507 |
|
Acquisition related-amortization of purchased intangibles |
|
1,590 |
|
|
|
1,623 |
|
Acquisition related fees and expenses |
|
284 |
|
|
|
143 |
|
Change in estimated fair value of contingent consideration |
|
421 |
|
|
|
64 |
|
Restructuring charges |
|
58 |
|
|
|
— |
|
Tax effect related to amortization of purchased intangibles |
|
(101 |
) |
|
|
(113 |
) |
Other Charges |
|
20 |
|
|
|
28 |
|
Non-GAAP net loss |
$ |
(5,818 |
) |
|
$ |
(6,762 |
) |
|
|
|
|
||||
GAAP basic and diluted net loss per share |
$ |
(0.44 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
||||
Non-GAAP basic net loss per share |
$ |
(0.11 |
) |
|
$ |
(0.13 |
) |
Non-GAAP diluted net loss per share |
$ |
(0.11 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
||||
Shares used in computing non-GAAP basic net loss per share |
|
53,643,216 |
|
|
|
53,015,459 |
|
Shares used in computing non-GAAP diluted net loss per share |
|
53,643,216 |
|
|
|
53,015,459 |
|
CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA and Adjusted EBITDA Financial Measures Assuming Recognition of Paused Claims (Unaudited) (In thousands) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2023 |
|
|
|
2022 |
|
Non-GAAP net loss |
$ |
(5,818 |
) |
|
$ |
(6,762 |
) |
Interest income |
|
(2,666 |
) |
|
|
(189 |
) |
Income tax benefit |
|
225 |
|
|
|
101 |
|
Depreciation expense |
|
1,808 |
|
|
|
940 |
|
Other expense, net |
|
36 |
|
|
|
261 |
|
Adjusted EBITDA |
|
(6,415 |
) |
|
|
(5,649 |
) |
Unrecognized AlloSure Kidney Medicare claims |
|
8,912 |
|
|
|
— |
|
Adjusted EBITDA assuming recognition of paused claims |
$ |
2,497 |
|
|
$ |
(5,649 |
) |
CareDx, Inc. Reconciliation of GAAP Revenue to Adjusted Revenue (Unaudited) (In thousands) |
|||||
|
Three Months Ended March 31, 2023 |
||||
|
Testing Services |
|
Total Revenue |
||
GAAP revenue |
$ |
61,784 |
|
$ |
77,262 |
Unrecognized AlloSure Kidney Medicare claims |
|
8,912 |
|
|
8,912 |
Total adjusted revenue |
$ |
70,696 |
|
$ |
86,174 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230510005988/en/
CareDx, Inc.
Media Relations
Anna Czene
818-731-2203
aczene@caredx.com
Investor Relations
Greg Chodaczek
investor@caredx.com
Source: CareDx, Inc.
