0001217234FALSE00012172342023-11-082023-11-08

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 8, 2023
 
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 8, 2023, CareDx, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023. 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 8, 2023  
CAREDX, INC.

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


Exhibit 99.1
logoa.jpg

CareDx Reports Third Quarter 2023 Results
BRISBANE, Calif., November 8, 2023 -- CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers -- today reported financial results for the third quarter ended September 30, 2023.
Third Quarter 2023 Highlights
•Reported revenue of $67.2 million, an increase of 7% over the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue.
•Grew Testing Services patient results to 38,400, an increase of 2% compared to the second quarter of 2023.
•Achieved revenue of $9.9 million for Digital Solutions and $9.5 million for Products, representing year-over-year growth of 33% for both businesses.
•Achieved the fourth consecutive quarter of collections at over 100% of revenue for Testing Services; collected over $22 million in incremental cash in the past four quarters.
•Maintained a strong balance sheet, with $268.2 million in cash and cash equivalents, and marketable securities, with no debt.
•Received Medicare coverage for HeartCare™ and AlloSure® Lung.
•Raised revenue guidance to $274 to $278 million for the full year 2023.
•SEC has concluded its inquiry and does not intend to recommend an enforcement action against the Company.

“CareDx continues to be well-placed in the transplant market. We are pleased to see a baseline being set in the Testing Services business in Q3 as patient testing volumes appear to have stabilized,” said Alex Johnson, President of Patient and Testing Services and member of the Office of the CEO at CareDx. “We remain committed to bringing high impact innovation to the transplant clinic, while accelerating our path back to profitability.”
Third Quarter 2023 Financial Results
Revenue for the three months ended September 30, 2023, was $67.2 million, a decrease of 15% compared with $79.4 million in the third quarter of 2022, and an increase of 7% compared with $62.5 million in the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue. Testing services revenue for the quarter was $47.8 million, compared with $64.8 million in the same period in 2022.
Approximately 38,400 AlloSure® and AlloMap® patient results were provided in the quarter, representing a decrease of 18% as compared to the same quarter a year ago, and an increase of 2% compared to the second quarter of 2023.
For the third quarter of 2023, net loss was $23.5 million, compared to a net loss of $16.9 million in the same period of 2022. Basic and diluted net loss per share in the third quarter of 2023 was $0.43, compared to basic and diluted net loss per share of $0.32 in the third quarter of 2022.



Non-GAAP net loss was $9.6 million in the third quarter of 2023, compared to a non-GAAP net loss of $3.4 million in the third quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.18 in the third quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.06 in the third quarter of 2022.
Adjusted EBITDA for the third quarter of 2023 was a loss of $10.9 million, compared to an adjusted EBITDA loss of $2.5 million in the third quarter of 2022.
Cash and cash equivalents and marketable securities were $268.2 million as of September 30, 2023.
2023 Guidance
For the full year 2023, CareDx expects revenue to be in the range of $274 to $278 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 statements regarding CareDx’s 2023 revenue expectations and the company’s path towards growth. All statements other than statements of historical fact contained in this press release, including statements regarding the future financial position of CareDx, including financial expectations, 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 filed by CareDx with the SEC on May 10, 2023, the quarterly report on Form 10-Q for the quarter ended June 30, 2023 filed by CareDx with the SEC on August 8, 2023, and the quarterly report on Form 10-Q for the quarter ended September 30, 2023 to be filed by CareDx with the SEC on or about November 8, 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 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 loss, non-GAAP basic and diluted net loss per share, adjusted EBITDA, normalized revenue after adjustment of Impacted March Tests (As defined below¹), normalized revenue for testing services after adjustment of Impacted March Tests, normalized non-GAAP gross margin for testing services after adjustment of Impacted March Tests, and normalized EBITDA after adjustment of Impacted March Tests.
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.
¹ Impacted March Tests represent $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue.



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,
2023202220232022
Revenue:
Testing services revenue$47,784 $64,751 $162,982 $198,330 
Product revenue9,536 7,194 24,273 20,696 
Patient and digital solutions revenue9,872 7,414 27,500 20,383 
Total revenue67,192 79,359 214,755 239,409 
Operating expenses:
Cost of testing services13,217 17,771 43,837 53,629 
Cost of product4,750 4,736 12,742 13,022 
Cost of patient and digital solutions6,566 5,794 19,807 16,071 
Research and development19,000 22,306 63,590 66,818 
Sales and marketing18,474 22,261 63,335 72,359 
General and administrative33,968 23,830 91,327 75,621 
Restructuring costs— — 848 — 
Total operating expenses95,975 96,698 295,486 297,520 
Loss from operations(28,783)(17,339)(80,731)(58,111)
Other income (expense):
Interest income, net3,171 1,225 8,708 1,892 
    Change in estimated fair value of common stock warrant liability
— 14 10 89 
Other income (expense), net2,047 (572)(198)(1,948)
Total other income5,218 667 8,520 33 
Loss before income taxes(23,565)(16,672)(72,211)(58,078)
Income tax benefit (expense) 80 (267)24 (206)
Net loss$(23,485)$(16,939)$(72,187)$(58,284)
Net loss per share:
Basic$(0.43)$(0.32)$(1.34)$(1.09)
Diluted$(0.43)$(0.32)$(1.34)$(1.09)
Weighted-average shares used to compute net loss per share:
Basic54,178,759 53,489,418 53,891,374 53,253,210 
Diluted54,178,759 53,489,418 53,891,374 53,253,210 




CareDx, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
September 30, 2023December 31, 2022
Assets
Current assets:
Cash and cash equivalents$75,980 $89,921 
Marketable securities192,204 203,168 
Accounts receivable51,694 66,312 
Inventory17,978 19,232 
Prepaid and other current assets7,310 9,216 
Total current assets345,166 387,849 
Property and equipment, net35,355 35,529 
Operating leases right-of-use assets30,973 34,689 
Intangible assets, net46,455 43,051 
Goodwill40,208 37,523 
Restricted cash582 522 
Other assets2,441 3,828 
Total assets$501,180 $542,991 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable$8,972 $9,942 
Accrued compensation16,664 16,902 
Accrued and other liabilities47,038 49,131 
Total current liabilities72,674 75,975 
Deferred tax liability140 — 
Common stock warrant liability— 32 
Deferred payments for intangible assets4,735 2,418 
Operating lease liability, less current portion29,252 33,406 
Other liabilities245 249 
Total liabilities107,046 112,080 
Commitments and contingencies
Stockholders’ equity:
Common stock
52 52 
Additional paid-in capital936,954 898,806 
Accumulated other comprehensive loss(8,670)(7,503)
Accumulated deficit(534,202)(460,444)
Total stockholders’ equity394,134 430,911 
Total liabilities and stockholders’ equity$501,180 $542,991 




CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In thousands)
Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
Cost of testing services reconciliation:
GAAP cost of testing services$13,217 $17,771 $43,837 $53,629 
Stock-based compensation expense(496)(470)(1,467)(1,055)
Acquisition related-amortization of purchased intangibles(329)(329)(987)(987)
Non-GAAP cost of testing services$12,392 $16,972 $41,383 $51,587 
Cost of product reconciliation:
GAAP cost of product$4,750 $4,736 $12,742 $13,022 
Stock-based compensation expense(301)(321)(935)(851)
Acquisition related-amortization of purchased intangibles(408)(416)(1,242)(1,305)
Non-GAAP cost of product$4,041 $3,999 $10,565 $10,866 
Cost of patient and digital solutions reconciliation:
GAAP cost of patient and digital solutions$6,566 $5,794 $19,821 $16,071 
Stock-based compensation expense(297)(299)(1,066)(882)
Acquisition related-amortization of purchased intangibles(265)(236)(768)(709)
Restructuring costs— — (14)— 
Non-GAAP cost of patient and digital solutions$6,004 $5,259 $17,973 $14,480 
Research and development expenses reconciliation:
GAAP research and development expenses$19,000 $22,306 $63,835 $66,818 
Stock-based compensation expense(1,491)(2,058)(5,157)(6,571)
Asset impairments and write-downs— (340)— (340)
Restructuring costs— — (245)— 
Non-GAAP research and development expenses$17,509 $19,908 $58,433 $59,907 
Sales and marketing expenses reconciliation:
GAAP sales and marketing expenses$18,474 $22,261 $63,883 $72,359 
Stock-based compensation expense(3,041)(2,672)(9,557)(9,702)
Acquisition related-amortization of purchased intangibles(616)(553)(1,817)(1,702)
Restructuring costs— — (548)— 
Non-GAAP sales and marketing expenses$14,817 $19,036 $51,961 $60,955 
General and administrative expenses reconciliation:
GAAP general and administrative expenses$33,968 $23,830 $91,368 $75,621 
Stock-based compensation expense(7,045)(5,380)(20,943)(15,366)
Change in estimated fair value of contingent consideration(1,243)(266)(1,731)(830)
Acquisition related fees and expenses(253)(58)(537)(387)
Restructuring costs— — (41)— 
Other charges(6)— (64)— 
Non-GAAP general and administrative expenses$25,421 $18,126 $68,052 $59,038 
Total other income (expense) reconciliation:
GAAP other income, net$5,218 $667 $8,520 $33 
Unrealized loss (gain) on long-term marketable equity securities333 (271)1,190 215 
Asset impairments and write-downs— 500 1,000 500 
Other (income) charges(2,109)14 (2,081)32 
Non-GAAP other income, net$3,442 $910 $8,629 $780 
Income tax benefit (expense) reconciliation:
GAAP income tax benefit (expense)$80 $(267)$24 $(206)
Tax effect related to amortization of purchased intangibles(98)(101)(299)(321)
Non-GAAP income tax expense$(18)$(368)$(275)$(527)








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,
2023202220232022
Total revenue$67,192 $79,359 $214,755 $239,409 
GAAP cost of sales24,533 28,301 76,400 82,722 
GAAP gross profit42,659 51,058 138,355 156,687 
Stock-based compensation expense1,094 1,090 3,468 2,788 
Restructuring costs— — 14 — 
Acquisition related-amortization of purchased intangibles1,002 981 2,997 3,001 
Non-GAAP gross profit$44,755 $53,129 $144,834 $162,476 
Non-GAAP gross margin %67 %67 %67 %68 %



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,
2023202220232022
GAAP net loss$(23,485)$(16,939)$(72,187)$(58,284)
Stock-based compensation expense12,671 11,200 39,125 34,427 
Asset impairments and write-downs— 840 1,000 840 
Unrealized loss (gain) on long-term marketable equity securities333 (271)1,190 215 
Acquisition related-amortization of purchased intangibles1,618 1,534 4,814 4,702 
Acquisition related fees and expenses253 58 537 387 
Change in estimated fair value of contingent consideration1,243 266 1,731 830 
Restructuring costs and charges6 — 912 — 
Tax effect related to amortization of purchased intangibles(98)(101)(299)(321)
Other (gains) charges(2,109)15 (2,081)32 
Non-GAAP net loss$(9,568)$(3,398)$(25,258)$(17,172)
GAAP basic and diluted net loss per share$(0.43)$(0.32)$(1.34)$(1.09)
Non-GAAP basic net loss per share$(0.18)$(0.06)$(0.47)$(0.32)
Non-GAAP diluted net loss per share$(0.18)$(0.06)$(0.47)$(0.32)
Shares used in computing non-GAAP basic net loss per share54,178,759 53,489,418 53,891,374 53,253,210 
Shares used in computing non-GAAP diluted net loss per share54,178,759 53,489,418 53,891,374 53,253,210 
































CareDx, Inc.
Reconciliation of Non-GAAP to Adjusted EBITDA
(Unaudited)
(In thousands)
Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
Non-GAAP net loss$(9,568)$(3,398)$(25,258)$(17,172)
Interest income(3,171)(1,225)(8,708)(1,892)
Income tax (benefit) expense(214)368 275 527 
Depreciation expense2,044 1,465 5,904 3,567 
Other (income) expense, net(40)314 79 1,112 
Adjusted EBITDA$(10,949)$(2,476)$(27,708)$(13,858)




CareDx, Inc.
Reconciliation of GAAP Revenue to Normalized Revenue After Adjustment of Impacted March Tests
(Unaudited)
(In thousands)
Three Months Ended
June 30, 2023September 30, 2023
GAAP revenue
$70,301 $67,192 
AlloSure Kidney Medicare claims (Impacted March Tests)
(7,771)— 
Normalized revenue after adjustment of Impacted March Tests
$62,530 $67,192 




CareDx, Inc.
Reconciliation of GAAP Revenue for Testing Services to Normalized Revenue for Testing Services After Adjustment of Impacted March Tests and
Reconciliation of Non-GAAP Gross Margin (%) for Testing Services to Normalized Non-GAAP Gross Margin (%) for Testing Services After Adjustment of Impacted March Tests
(Unaudited)
(In thousands)
Three Months Ended
June 30, 2023September 30, 2023
GAAP revenue
$53,414 $47,784 
AlloSure Kidney Medicare claims (Impacted March Tests)
(7,771)— 
Normalized revenue for testing services after adjustment of Impacted March Tests
$45,643 $47,784 
Non-GAAP cost of testing services$14,503 $12,392 
Non-GAAP gross margin for testing services73 %74 %
AlloSure Kidney Medicare claims (Impacted March Tests)
5 %— %
Normalized non-GAAP gross margin for testing services (%) after adjustment of Impacted March Tests68 %74 %








CareDx, Inc.
Reconciliation of Adjusted EBITDA to Normalized EBITDA After Adjustment of Impacted March Tests
(Unaudited)
(In thousands)
Three Months Ended
June 30, 2023September 30, 2023
Adjusted EBITDA
$(10,350)$(10,949)
AlloSure Kidney Medicare claims (Impacted March Tests)
(7,771)— 
Normalized EBITDA after adjustment of Impacted March Tests
$(18,121)$(10,949)





CareDx, Inc.

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

Investor Relations
Greg Chodaczek
investor@caredx.com


v3.23.3
Cover Page
Nov. 08, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 08, 2023
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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