0001217234FALSE00012172342024-11-042024-11-04

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): November 4, 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 November 4, 2024, CareDx, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 2.02, including the press release attached hereto as Exhibit 99.1, is 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 
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: November 4, 2024  
CAREDX, INC.

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


Exhibit 99.1
logo.jpg

CareDx Reports Third Quarter 2024 Results and Raises Revenue Guidance
BRISBANE, Calif., November 4, 2024, 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,
2024202320242023
Revenue:
Testing services revenue$60,807 $47,784 $185,562 $162,982 
Product revenue10,212 9,536 29,416 24,273 
Patient and digital solutions revenue11,864 9,872 32,228 27,500 
Total revenue82,883 67,192 247,206 214,755 
Operating expenses:
Cost of testing services13,447 13,217 41,387 43,837 
Cost of product6,212 4,750 17,801 12,742 
Cost of patient and digital solutions7,913 6,566 22,264 19,807 
Research and development17,486 19,000 55,875 63,590 
Sales and marketing19,802 18,474 60,634 63,335 
General and administrative28,515 33,968 83,104 91,327 
Restructuring costs— — 68 848 
Total operating expenses93,375 95,975 281,133 295,486 
Loss from operations(10,492)(28,783)(33,927)(80,731)
Other income:
Interest income, net3,001 3,171 8,712 8,708 
    Change in estimated fair value of common stock warrant liability
— — — 10 
Other income (expense), net283 2,047 (107)(198)
Total other income3,284 5,218 8,605 8,520 
Loss before income taxes(7,208)(23,565)(25,322)(72,211)
Income tax (expense) benefit(200)80 (139)24 
Net loss$(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:
Basic52,903,338 54,178,759 52,266,106 53,891,374 
Diluted52,903,338 54,178,759 52,266,106 53,891,374 




CareDx, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
September 30, 2024December 31, 2023
Assets
Current assets:
Cash and cash equivalents$95,400 $82,197 
Marketable securities145,453 153,221 
Accounts receivable66,627 51,061 
Inventory19,263 19,471 
Prepaid and other current assets7,344 7,763 
Total current assets334,087 313,713 
Property and equipment, net34,015 35,246 
Operating leases right-of-use assets25,823 29,891 
Intangible assets, net40,361 45,701 
Goodwill40,336 40,336 
Restricted cash592 586 
Other assets1,771 1,353 
Total assets$476,985 $466,826 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable$6,239 $12,872 
Accrued compensation29,915 19,703 
Accrued and other liabilities45,286 45,497 
Total current liabilities81,440 78,072 
Deferred tax liability202 136 
Deferred payments for intangible assets1,310 2,461 
Operating lease liability, less current portion23,841 28,278 
Other liabilities96,946 96,551 
Total liabilities203,739 205,498 
Commitments and contingencies
Stockholders’ equity:
Common stock
50 49 
Additional paid-in capital984,627 946,511 
Accumulated other comprehensive loss(7,179)(6,963)
Accumulated deficit(704,252)(678,269)
Total stockholders’ equity273,246 261,328 
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,
2024202320242023
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,
2024202320242023
GAAP operating expenses:
Research and development$17,486 $19,000 $55,890 $63,835 
Sales and marketing19,802 18,474 60,634 63,883 
General and administrative28,515 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 marketing16,382 14,817 49,974 51,961 
General and administrative20,128 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,
2024202320242023
Total revenue$82,883 $67,192 $247,206 $214,755 
GAAP cost of sales27,572 24,533 81,505 76,400 
GAAP gross profit55,311 42,659 165,701 138,355 
Stock-based compensation expense978 1,094 3,056 3,468 
Other income— — (5)— 
Restructuring costs— — 53 14 
Acquisition related-amortization of purchased intangibles918 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,
2024202320242023
GAAP net loss$(7,408)$(23,485)$(25,461)$(72,187)
Stock-based compensation expense13,694 12,671 40,208 39,125 
Acquisition related-amortization of purchased intangibles1,552 1,618 4,811 4,814 
Change in estimated fair value of contingent consideration232 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 share52,903,338 54,178,759 52,266,106 53,891,374 
Shares used in computing non-GAAP diluted net income (loss) per share57,699,624 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,
2024202320242023
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 expense1,919 2,044 6,024 5,904 
Other (income) expense, net(283)(40)107 79 
Adjusted EBITDA$6,905 $(10,949)$17,991 $(27,708)






CareDx, Inc.

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

Investor Relations
Greg Chodaczek
investor@caredx.com

v3.24.3
Cover Page
Nov. 04, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 04, 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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