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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): July 31, 2024
 
CAREDX, INC.
(Exact Name of Registrant as Specified in its Charter)
 
Delaware 001-36536 94-3316839
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
8000 Marina Boulevard, 4th Floor
Brisbane, California 94005
(Address of Principal Executive Offices) (Zip Code)
(415) 287-2300
Registrant’s telephone number, including area code
N/A
(Former Name, or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 
 Securities registered pursuant to Section 12(b) of the Exchange Act:
(Title of each class)(Trading Symbol)(Name of exchange on which registered)
Common Stock, $0.001 Par ValueCDNAThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02 Results of Operations and Financial Condition.
On July 31, 2024, CareDx, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. A copy of the earnings presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
The information in this Item 2.02, including the press release attached hereto as Exhibit 99.1 and the earnings presentation attached hereto as Exhibit 99.2, are intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 
99.2
104Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: July 31, 2024  
CAREDX, INC.

  By: /s/ Abhishek Jain
   Abhishek Jain
   Chief Financial Officer


Exhibit 99.1
imagea.jpg

CareDx Reports Second Quarter 2024 Results and Increases Revenue Guidance
BRISBANE, Calif., July 31, 2024, CareDx, Inc. (Nasdaq: CDNA) — today announced financial results for the second quarter ended June 30, 2024.
Second Quarter 2024 Financial Highlights
•Reported total revenue of $92.3 million, an increase of 31% year-over-year.
•Grew Testing Services volume to 43,700 tests, an increase of 17% year-over-year.
•Reported GAAP net loss of $1.4 million, non-GAAP net income of $13.6 million, and positive adjusted EBITDA of $12.9 million, a significant improvement from the second quarter 2023.
•Generated $18.9 million cash from operations. Ended the quarter with cash, cash equivalents, and marketable securities of approximately $228.9 million, with no debt.
•Raised 2024 guidance for annual revenue to $320 to $328 million and adjusted EBITDA to a gain of $9 to $15 million.
Business Highlights
•In the first half of 2024, expanded coverage by 27 million lives nationwide.
•Published SHORE study data demonstrating that HeartCare® outperforms dd-cfDNA alone in identifying allograft rejection.
•Nature Medicine publication validates CareDx AlloView™ AI-enabled risk prediction model and demonstrates AlloSure® Kidney detects subclinical rejection in stable patients.

“We are pleased to announce yet another strong quarter, marked by growth across all our businesses. The dedication and hard work of our team over the past year have been instrumental in our performance. As we approach the second half of the year, we remain focused on maintaining our growth rate,” said John W. Hanna, CareDx President and CEO.
Second Quarter 2024 Financial Results
Total revenue for the three months ended June 30, 2024, was $92.3 million, an increase of 31% compared to $70.3 million for the second quarter of 2023. Testing Services revenue for the second quarter 2024 was $70.9 million, an increase of 33% compared to $53.4 million for the second quarter of 2023. Testing Services revenue for the second quarter included $13.2 million for tests performed in prior periods. Patient and Digital Solutions revenue for the second quarter of 2024 was $10.7 million, an increase of 19% compared to $9.0 million for the second quarter 2023. Product revenue for the second quarter of 2024 was $10.6 million, an increase of 35% compared to $7.9 million for the second quarter 2023.
For the second quarter of 2024 net loss was $1.4 million compared to a net loss of $25.0 million in the second quarter of 2023. Basic and diluted net loss per share in the second quarter of 2024 was $0.03, compared to basic and diluted net loss per share of $0.46 in the second quarter of 2023.
Non-GAAP net income was $13.6 million in the second quarter of 2024, compared to a non-GAAP net loss of $9.9 million in the second quarter of 2023. Diluted non-GAAP net income per share was $0.25 in the second quarter of 2024, compared to a diluted non-GAAP net loss per share of $0.18 in the second quarter of 2023.
Adjusted EBITDA income for the second quarter of 2024 was $12.9 million, compared to an adjusted EBITDA loss of $10.4 million for the second quarter of 2023.



2024 Guidance
CareDx now expects full year 2024 revenue to be in the range of $320 million to $328 million, compared to the prior range of $274 million to $282 million. CareDx now expects full year 2024 non-GAAP gross margin to be in the range of 67% to 68%, compared to the prior range of 63% to 65%. CareDx now expects full year 2024 adjusted EBITDA gain to be in the range of $9 million to $15 million, compared to an adjusted EBITDA loss of $14 million to $24 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, non-GAAP gross margin and adjusted EBITDA, 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, the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 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 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 June 30,Six Months Ended June 30,
2024202320242023
Revenue:
Testing services revenue$70,918 $53,414 $124,755 $115,198 
Product revenue10,610 7,876 19,204 14,737 
Patient and digital solutions revenue10,746 9,011 20,364 17,628 
Total revenue92,274 70,301 164,323 147,563 
Operating expenses:
Cost of testing services14,308 15,324 27,940 30,620 
Cost of product6,245 3,926 11,589 7,992 
Cost of patient and digital solutions7,393 6,637 14,351 13,241 
Research and development19,678 20,233 38,389 44,590 
Sales and marketing21,002 21,630 40,832 44,861 
General and administrative27,678 29,327 54,589 57,359 
Restructuring costs68 848 68 848 
Total operating expenses96,372 97,925 187,758 199,511 
Loss from operations(4,098)(27,624)(23,435)(51,948)
Other income:
Interest income, net2,826 2,871 5,711 5,537 
    Change in estimated fair value of common stock warrant liability
— 3 — 10 
Other expense, net(100)(271)(390)(2,245)
Total other income2,726 2,603 5,321 3,302 
Loss before income taxes(1,372)(25,021)(18,114)(48,646)
Income tax (expense) benefit(22)68 61 (56)
Net loss$(1,394)$(24,953)$(18,053)$(48,702)
Net loss per share:
Basic$(0.03)$(0.46)$(0.35)$(0.91)
Diluted$(0.03)$(0.46)$(0.35)$(0.91)
Weighted-average shares used to compute net loss per share:
Basic52,195,620 53,846,260 51,943,989 53,745,299 
Diluted52,195,620 53,846,260 51,943,989 53,745,299 




CareDx, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
June 30, 2024December 31, 2023
Assets
Current assets:
Cash and cash equivalents$95,782 $82,197 
Marketable securities133,089 153,221 
Accounts receivable66,161 51,061 
Inventory19,234 19,471 
Prepaid and other current assets6,343 7,763 
Total current assets320,609 313,713 
Property and equipment, net34,202 35,246 
Operating leases right-of-use assets27,188 29,891 
Intangible assets, net41,896 45,701 
Goodwill40,336 40,336 
Restricted cash588 586 
Other assets1,958 1,353 
Total assets$466,777 $466,826 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable$5,874 $12,872 
Accrued compensation25,004 19,703 
Accrued and other liabilities47,453 45,497 
Total current liabilities78,331 78,072 
Deferred tax liability50 136 
Deferred payments for intangible assets1,620 2,461 
Operating lease liability, less current portion25,386 28,278 
Other liabilities96,721 96,551 
Total liabilities202,108 205,498 
Commitments and contingencies
Stockholders’ equity:
Common stock
50 49 
Additional paid-in capital969,427 946,511 
Accumulated other comprehensive loss(7,964)(6,963)
Accumulated deficit(696,844)(678,269)
Total stockholders’ equity264,669 261,328 
Total liabilities and stockholders’ equity$466,777 $466,826 




CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In thousands)
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Cost of testing services reconciliation:
GAAP cost of testing services$14,308 $15,324 $27,940 $30,620 
Stock-based compensation expense(357)(492)(814)(971)
Acquisition related-amortization of purchased intangibles(329)(329)(658)(658)
Non-GAAP cost of testing services$13,622 $14,503 $26,468 $28,991 
Cost of product reconciliation:
GAAP cost of product$6,298 $3,926 $11,642 $7,992 
Stock-based compensation expense(225)(274)(542)(634)
Acquisition related-amortization of purchased intangibles(411)(416)(831)(834)
Restructuring costs(53)— (53)— 
Non-GAAP cost of product$5,609 $3,236 $10,216 $6,524 
Cost of patient and digital solutions reconciliation:
GAAP cost of patient and digital solutions$7,393 $6,651 $14,351 $13,255 
Stock-based compensation expense(350)(367)(722)(769)
Acquisition related-amortization of purchased intangibles(238)(255)(509)(503)
Restructuring costs— (14)— (14)
Other income— — 5 — 
Non-GAAP cost of patient and digital solutions$6,805 $6,015 $13,125 $11,969 
Research and development expenses reconciliation:
GAAP research and development expenses$19,693 $20,478 $38,404 $44,835 
Stock-based compensation expense(1,628)(1,704)(3,388)(3,666)
Restructuring costs(15)(245)(15)(245)
Other charges— — (25)— 
Non-GAAP research and development expenses$18,050 $18,529 $34,976 $40,924 
Sales and marketing expenses reconciliation:
GAAP sales and marketing expenses$21,002 $22,178 $40,832 $45,409 
Stock-based compensation expense(2,927)(2,779)(5,971)(6,516)
Acquisition related-amortization of purchased intangibles(628)(606)(1,261)(1,201)
Restructuring costs— (548)— (548)
Other charges— — (8)— 
Non-GAAP sales and marketing expenses$17,447 $18,245 $33,592 $37,144 
General and administrative expenses reconciliation:
GAAP general and administrative expenses$27,678 $29,368 $54,589 $57,400 
Stock-based compensation expense(7,683)(7,084)(15,077)(13,898)
Change in estimated fair value of contingent consideration(210)(67)(529)(488)
Acquisition related fees and expenses(5)— (40)(284)
Restructuring costs and charges— (41)— (99)
Other (charges) income(44)— 22 — 
Non-GAAP general and administrative expenses$19,736 $22,176 $38,965 $42,631 
Total other income (expense) reconciliation:
GAAP other income, net$2,726 $2,603 $5,321 $3,302 
Unrealized (gain) loss on long-term marketable equity securities— (53)— 857 
Asset impairments and write-downs— — — 1,000 
Other charges— 7 — 28 
Non-GAAP other income, net$2,726 $2,557 $5,321 $5,187 
Income tax (expense) benefit reconciliation:
GAAP income tax (expense) benefit $(22)$68 $61 $(56)
Tax effect related to amortization of purchased intangibles(98)(100)(200)(201)
Non-GAAP income tax expense$(120)$(32)$(139)$(257)




CareDx, Inc.
GAAP and Non-GAAP Operating Expenses
(Unaudited)
(In thousands)

Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
GAAP operating expenses:
Research and development$19,693 $20,478 $38,404 $44,835 
Sales and marketing21,002 22,178 40,832 45,409 
General and administrative27,678 29,368 54,589 57,400 
Total GAAP operating expenses$68,373 $72,024 $133,825 $147,644 
Non-GAAP operating expenses:
Research and development$18,050 $18,529 $34,976 $40,924 
Sales and marketing17,447 18,245 33,592 37,144 
General and administrative19,736 22,176 38,965 42,631 
Total Non-GAAP operating expenses$55,233 $58,950 $107,533 $120,699 








































CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin
(Unaudited)
(In thousands, except percentages)

Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Total revenue$92,274 $70,301 $164,323 $147,563 
GAAP cost of sales27,999 25,901 53,933 51,867 
GAAP gross profit64,275 44,400 110,390 95,696 
Stock-based compensation expense932 1,133 2,078 2,374 
Other income— — (5)— 
Restructuring costs53 14 53 14 
Acquisition related-amortization of purchased intangibles978 1,000 1,998 1,995 
Non-GAAP gross profit$66,238 $46,547 $114,514 $100,079 
Non-GAAP gross margin %72 %66 %70 %68 %






CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In thousands, except share and per share data)
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
GAAP net loss$(1,394)$(24,953)$(18,053)$(48,702)
Stock-based compensation expense13,170 12,700 26,514 26,454 
Acquisition related-amortization of purchased intangibles1,606 1,606 3,259 3,196 
Change in estimated fair value of contingent consideration210 67 529 488 
Acquisition related fees and expenses5 — 40 284 
Other charges44 7 6 28 
Restructuring costs and charges68 848 68 906 
Tax effect related to amortization of purchased intangibles(98)(100)(200)(201)
Asset impairments and write-downs— — — 1,000 
Unrealized (gain) loss on long-term marketable equity securities— (53)— 857 
Non-GAAP net income (loss)$13,611 $(9,878)$12,163 $(15,690)
GAAP basic and diluted net loss per share$(0.03)$(0.46)$(0.35)$(0.91)
Non-GAAP basic net income (loss) per share$0.26 $(0.18)$0.23 $(0.29)
Non-GAAP diluted net income (loss) per share$0.25 $(0.18)$0.23 $(0.29)
Shares used in computing non-GAAP basic net income (loss) per share52,195,620 53,846,260 51,943,989 53,745,299 
Shares used in computing non-GAAP diluted net income (loss) per share54,333,731 53,846,260 53,669,762 53,745,299 






























CareDx, Inc.
Reconciliation of Non-GAAP to Adjusted EBITDA
(Unaudited)
(In thousands)
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Non-GAAP net income (loss)$13,611 $(9,878)$12,163 $(15,690)
Interest income(2,826)(2,871)(5,711)(5,537)
Income tax expense (benefit)121 68 139 (56)
Depreciation expense1,937 2,052 4,105 3,860 
Other expense, net
100 279 390 664 
Adjusted EBITDA$12,943 $(10,350)$11,086 $(16,759)






CareDx, Inc.

Media Relations
Anna Czene
818-731-2203
aczene@caredx.com

Investor Relations
Greg Chodaczek
investor@caredx.com

Patrick G, Kidney Transplant Recipient July 31, 2024 Q2 2024 Financial and Business Presentation

 
These slides and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this presentation, including statements regarding the future financial position of CareDx®, Inc. (together with its subsidiaries, “CareDx” or the “Company”), including financial targets and expectations, business strategy, and plans and objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "target," "contemplate," "predict," "expect," and the negative and plural forms of these words and similar expressions are intended to identify that CareDx has based these forward-looking statements on its own estimates and assumptions and its current expectations and projections about future events. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those contained in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (the "SEC") on February 28, 2024, the Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024, filed with the SEC on May 9, 2024 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024, to be filed with the SEC on or about July 31, 2024. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward- looking statements as predictions of future events. CareDx undertakes no obligation to update publicly or revise any forward-looking statements for any reason after the date of this presentation or to conform these statements to actual results or to changes in CareDx’s expectations. These slides and the accompanying oral presentation contain certain non-GAAP financial measures, which are provided to assist in an understanding of the business and performance of CareDx. These measures should always be considered only as a supplement to, and not as superior to, financial measures prepared in accordance with GAAP. Please refer to the Appendix included in these slides for a reconciliation of the non-GAAP financial measures included in these slides and the accompanying oral presentation to the most directly comparable financial measures prepared in accordance with GAAP. Further information regarding our non-GAAP financial measures can be found in our filings with the SEC. Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or undertakes any obligation to update such data after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of the Company. Safe Harbor Statement 2

 
Cash flow positive, adjusted EBITDA positive • Reported total revenue of $92.3 million, an increase of 31% year-over-year. • Grew Testing Services volume to 43,700 tests, an increase of 17% year-over-year. • Reported GAAP net loss of $1.4 million, non-GAAP net income of $13.6 million, and positive adjusted EBITDA of $12.9 million, a significant improvement from the second quarter 2023. • Generated $18.9 million in cash from operations. Ended the quarter with cash, cash equivalents, and marketable securities of approximately $228.9 million, with no debt. • Raised 2024 guidance for annual revenue to $320 to $328 million and adjusted EBITDA to a gain of $9 to $15 million. • In the first half of 2024, expanded coverage by 27 million lives nationwide. • Published SHORE study data demonstrating that HeartCare® outperforms dd-cfDNA alone in identifying allograft rejection.​ • Nature Medicine publication validates CareDx AlloView AI-enabled risk prediction model and demonstrates AlloSure® Kidney detects subclinical rejection in stable patients​. Q2 2024 Financial and Business Highlights Kristin J, Stem Cell and Double Lung Recipient 3

 
Business Highlights

 
1. Khush K, Hall S, Kao A, et al. Surveillance with Dual Non-invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. May 15, 2024. Most Extensive Prospective Study of its Kind Demonstrates Clinical Value of HeartCare Over dd-cfDNA Alone 5 Journal of Heart and Lung Transplantation: Key Findings Patients experienced excellent outcomes with fewer biopsies1 HeartCare outperforms dd-cfDNA alone in detecting rejection1 SHORE (Surveillance in HeartCare Outcomes Registry) Study Details Largest heart transplant study of its kind Observational, prospective study 67 transplant centers across the US Over 2,700 patients Encompasses over 11,000 patient visits Study end points: • Survival and graft function • Reduction in surveillance biopsies

 
HeartCare® Better Identifies Acute Cellular Rejection (ACR)1 Dual Positive HeartCare Results Associated with the Highest Incidence of ACR1 HeartCare Supports Patient Risk Stratification Strategies Test Results Paired with EMB-Proven Acute Cellular Rejection.1 1. Khush K, Hall S, Kao A, et al. Surveillance with Dual Non-invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. May 15, 2024. HeartCare Outperforms dd-cfDNA Testing Alone in Identifying Allograft Rejection 6 1.9% 4.3% Samples: N=6363 Comprehensive View of Graft Injury and Immune Quiescence Immune Activation/ Quiescence Graft Injury AlloMap Heart AlloSure Heart HeartCare AlloMap Heart Positive A llo Su re H ea rt Positive Negative 1.5% Negative 9.2%

 
HeartCare Patients Experienced Excellent Two-Year Outcomes with Fewer Biopsies Follow-up endomyocardial biopsy rate (EMB) following HeartCare results.1 • Follow-up EMBs are performed at lower rate following a dual negative HeartCare Results and highest rate following a dual positive HeartCare result. • The rate of biopsies performed in response to a single positive result is 56% lower than dual-positive HeartCare results 8.8% 14.2% 22.8% AlloSure Heart AlloMap Heart 35.4% • 95% Survival Rate • 97% Normal Graft Function Reduction in Biopsies Over Time 2017-20211 Outcomes 2 Years Post-Transplant1 -10% -40% 1 Year Post Transplant 2 Year Post Transplant 1. Khush K, Hall S, Kao A, et al. Surveillance with Dual Non-invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. May 15, 2024. 7

 
1. Aubert, O., Ursule-Dufait, C., Brousse, R., et al. Cell-Free DNA for the detection of kidney allograft rejection. Nat Med (2024). https://doi.org/10.1038/s41591-024-03087-3 Nature Medicine Publication Validates AlloView and Demonstrates Utility of AlloSure Kidney 8 Nature Medicine: Key Findings Validates AlloView AI-enabled risk prediction model Surveillance monitoring with AlloSure and AlloView improves detection of all types of allograft rejection AlloSure detected subclinical rejection in clinically stable patients AlloSure dd-cfDNA levels elevated prior to biopsy proven rejection and declined in response to treatment Paris Institute for Transplantation and Organ Regeneration Study Details Objective: Assess the role of AlloSure dd-cfDNA and an AI enabled risk prediction model, AlloView, that incorporates AlloSure to improve detection, characterization, and treatment of kidney transplant rejection. Largest kidney transplant study of its kind 14 transplant centers across the US and Belgium Over 2,882 patients Large-scale real-world study

 
Nature Medicine Study Shows AlloSure Kidney is Leading Indicator of Rejection AlloSure dd-cfDNA Levels Elevated Prior to Biopsy Proven Rejection and Declined in Response to Treatment1 AlloSure increase for patients prior to de novo biopsy proven rejection (n=89) Prior to Rejection Following Treatment AlloSure decrease for patients with successfully treated rejection (p<0.0001) (n=89) Monitoring with AlloSure Kidney Improves the Detection of All Types of Rejection1 Association with antibody- mediated rejection (n=192 rejections) Association with T-Cell-mediated rejection (n=51 rejections) In stable patients (n=80 rejections) <0.0001 <0.0001 <0.0001 PAdjusted Odds Ratio 1. Aubert, O., Ursule-Dufait, C., Brousse, R., et al. Cell-Free DNA for the detection of kidney allograft rejection. Nat Med (2024). https://doi.org/10.1038/s41591-024-03087-3 9 1.0 2.0 Biopsy 1 Biopsy 2 M e an A ll o Su re No rejection Rejection 1.6 0.77 Biopsy 1 Biopsy 2 M e an A ll o Su re Rejection No rejection -0.5 0 0.5 1 1.5 2 2.5 3 3.5

 
Financial Highlights

 
Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Achieved Fourth Consecutive Quarter of Testing Services Volume Growth Across All Organs 49.9k 37.5k 38.4k 39.9k 42.1k 43.7k +2% Year-Over-Year Growth in Q2 1 +4% +6% +4% +17% 1. Drop in Testing Services volume from Q1 2023 to Q2 2023 due to the impact of Billing Article introduced in March 2023. 11

 
Q2 2024 Adjusted Revenue Adjusted Testing Services Revenue Up Over 20% Year-Over-Year Driven by Strong Volume Growth Q2 2023 Adjusted Revenue $13.2 Reported Adjusted $70.9 $57.7 $5.6 Reported Adjusted $53.4 $47.8 $47.8 $57.7 Q2 2023 Q2 2024 Year-Over-Year Adjusted Revenue +21% in m ill io ns U SD Tests performed in prior periods1,2 Tests performed in prior periods1 1. Adjusted for revenue associated with tests performed in prior periods. 2. Includes $7.8M in Medicare revenue associated with AlloSure Kidney tests pertaining to Q1 2023 that the Company submitted in Q2 2023, as disclosed previously. 12

 
Strong Year-Over-Year Revenue Growth Across Other Businesses 13 $7.9 $10.6 Q2 2023 Q2 2024 Products +35% in m ill io ns U SD $9.0 $10.7 Q2 2023 Q2 2024 Patient and Digital Solutions +19% in m ill io ns U SD

 
-$10.4 -$16.0 in m ill io ns U SD Q2 2023 in m ill io ns U SD Q2 2024 1. Adjusted for revenue associated with tests performed in prior periods. 2. Includes $7.8M in Medicare revenue associated with AlloSure Kidney tests pertaining to Q1 2023 that the Company submitted in Q2 2023, as disclosed previously. Revenue Growth Drives Improved Adjusted EBITDA 14 $5.61,2 $12.9 -$0.3 $13.21 Reported Adjusted for tests performed in prior periods Reported Adjusted for tests performed in prior periods

 
Revenue Guidance of $324M at the Mid-Point 15 $13 $10 $15 $7 Prior Guidance May 2024 Tests performed in prior periods1 Testing Services Volume Products & Patient and Digital Solutions Revised Guidance2 $278M $324M in m ill io n s U S D Driven by Topline Growth Across Businesses 1. Revenue associated with tests performed in prior periods. 2. 2024 baseline revenue at ~$310M at the mid-point excluding the revenue associated with tests performed in periods prior to 2024. ASP Expansion

 
Revised 2024 Guidance 16 Guide Assumptions May 2024 July 2024 Total Revenue $274M – $282M Testing Services • Low double-digit growth for Testing Services based on annualized actual testing services revenue for the fourth quarter 2023 • Other previously reported assumptions remain unchanged1 Products • High single-digit growth year-over-year Patient and Digital Solutions • Mid single-digit growth year-over-year $320M – $328M Testing Services • Volume to grow high teens and revenue to grow in mid twenties year-over-year in second half of 2024 • Revenue to outpace volume growth driven by ASP expansion • No change to Medicare coverage Products • High teens growth year-over-year Patient and Digital Solutions • Low double-digit growth year-over-year Non-GAAP Gross Margin 63% – 65% Expected to be at the high end of the range Driven by improvement in Testing Services gross margin 67% – 68% Driven by continued improvement in Testing Services gross margin Adjusted EBITDA Gain (Losses) ($14M – $24M) Improved top-line and gross margin assumptions $9M – $15M Improved top-line and gross margin assumptions 1. No change in Medicare coverage. No incremental revenue assumed from new private payer coverage decisions or one-time benefits associated with collections.

 

 
Appendix 18

 
Reconciliation of Adjusted EBITDA Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 GAAP Net Loss (25.0) (23.5) (118.1) (16.7) (1.4) Stock-based compensation expense 12.7 12.7 10.0 13.3 13.2 Unrealized loss (gain) on investments (0.1) 0.3 - - - Realized gain on investments - - (1.5) - - Acquisition related amortization of purchased intangibles 1.6 1.6 1.7 1.7 1.6 Acquisition related fees and expenses - 0.3 0.1 0.0 0.0 Change in estimated fair value of contingent consideration 0.1 1.2 0.9 0.3 0.2 Restructuring 0.8 0.0 1.5 (0.0) 0.1 Litigation expense​ - - 96.3 - - Other charges (gain) 0.0 (2.1) - - 0.0 Tax effect related to amortization of purchased intangibles (0.1) (0.1) (0.1) (0.1) (0.1) Non–GAAP Net Income (Loss) (9.9) (9.6) (9.3) (1.4) 13.6 Interest income (2.9) (3.2) (3.2) (2.9) (2.8) Income tax expense (benefit) 0.1 (0.2) 0.3 0.0 0.1 Depreciation expense 2.1 2.0 2.0 2.2 1.9 Other expense (income), net 0.3 (0.0) (0.1) 0.3 0.1 Adjusted EBITDA (10.4) (10.9) (10.3) (1.9) 12.9 in millions USD 19

 
Reconciliation of Non-GAAP Gross Margin Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Revenue 70.3 67.2 65.6 72.0 92.3 GAAP Cost of Revenue 25.9 24.5 25.8 25.9 28.0 GAAP Gross Profit 44.4 42.7 39.8 46.1 64.3 GAAP Gross Margin % 63% 64% 61% 64% 70% Non-GAAP Expense: Stock-based compensation expense (1.1) (1.1) (0.9) (1.1) (0.9) Restructuring (0.0) 0.0 (0.2) 0.0 (0.0) Acquisition related amortization of purchased intangibles (1.0) (1.0) (1.0) (1.0) (1.0) Non-GAAP Cost of Revenue 23.8 22.4 23.7 23.8 26.1 Non-GAAP Gross Profit 46.5 44.8 41.9 48.3 66.2 Non-GAAP Gross Margin % 66% 67% 64% 67% 72% in millions USD (except %) 20

 
v3.24.2
Cover Page
Jul. 31, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Jul. 31, 2024
Entity Registrant Name CAREDX, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-36536
Entity Tax Identification Number 94-3316839
Entity Address, Address Line One 8000 Marina Boulevard, 4th Floor
Entity Address, City or Town Brisbane,
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94005
City Area Code 415
Local Phone Number 287-2300
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 Par Value
Trading Symbol CDNA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001217234
Amendment Flag false
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