8-K

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): January 10, 2022

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-36536	94-3316839
(State or Other Jurisdiction<br><br>of Incorporation)	(Commission<br><br>File Number)	(IRS Employer<br><br>Identification No.)

1 Tower Place, 9th Floor

South San Francisco, California 94080

(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 Value	CDNA	The 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 January 10, 2022, CareDx, Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter and year ended December 31, 2021. 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	Press Release issued by CareDx, Inc., dated January 10, 2022.
104	Cover 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: January 10, 2022	CAREDX, INC.
	By:	/s/ Ankur Dhingra
		Ankur Dhingra
		Chief Financial Officer

Document

Exhibit 99.1

CareDx Reports Preliminary Revenue Results for Fourth

Quarter and Full Year 2021

Another Record Revenue Quarter Caps Off Strong Year

SOUTH SAN FRANCISCO, Calif., Jan. 10, 2022 -- 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 preliminary financial results for the fourth quarter and full year ended December 31, 2021.

Fourth Quarter Highlights

•Revenue expected to be between $78.6 million to $79.0 million, representing year-over-year growth of 34% to 35%

•Testing volume greater than 41,900, including approximately 700 tests for AlloSure® Lung

•Achieved CLIA validation of AlloMap® Kidney

•Acquired MedActionPlan and The Transplant Pharmacy

•Record testing volume and revenues despite lower sequential transplant procedure volumes

Full Year 2021 Highlights

•Revenue expected to be in the range of $295.7 million to $296.1 million, representing year-over-growth of 54%

Preliminary revenue for the three months ended December 31, 2021, is expected to be between $78.6 million and $79.0 million, an increase of approximately 34% to 35% compared with $58.6 million in the fourth quarter of 2020. Testing services revenue for the quarter is expected to be between $68.2 million to $68.6 million, compared with $50.3 million in the same period in 2020. Total AlloSure and AlloMap patient results provided in the quarter were greater than 41,900, which includes approximately 700 AlloSure Lung patient results. Product revenue in the three months ended December 31, 2021, is expected to be $7.7 million, compared to $5.9 million in the same period in 2020. Digital and other revenue in the fourth quarter of 2021 is expected to be $2.7 million, compared to $2.4 million in the same period in 2020. Digital revenues include approximately $0.3 million revenue contribution from newly acquired businesses, MedActionPlan and The Transplant Pharmacy.

Preliminary revenue for the full year ended December 31, 2021, is expected to be between $295.7 million and $296.1 million, an increase of approximately 54% compared with $192.2 million in 2020. Testing services revenue for the year ended December 31, 2021, is expected to be between $258.9 million to $259.3 million, compared with $163.6 million in 2020. Product

revenue for the full year 2021 is expected to be $26.8 million, compared to $19.3 million in 2020. Digital and other revenue for the full year 2021 is expected to be $10.0 million, compared to $9.3 million in 2020.

Preliminary cash, cash equivalents, and marketable securities were approximately $348.0 million as of December 31, 2021.

“2021 was a record year for CareDx – with greater than 50% revenue growth driven by AlloSure Kidney adoption and greater than 90% attachment rate in HeartCare,” said Reg Seeto, CEO and President of CareDx. “A strong foundation for long-term growth strategy has been laid over the last 12 months with the commercial launch of AlloSure Lung, AlloMap Kidney CLIA validation, demonstrated clinical utility of AlloSure with long term data, and 5 acquisitions connecting the patient journey.”

The preliminary financial information presented in this press release is based on CareDx’s current expectations and may be adjusted as a result of, among other things, the completion of customary annual audit procedures. CareDx will report fourth quarter and full year 2021 financial results and anticipates providing 2022 financial guidance on its February 2022 earnings call.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in South San Francisco, 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 fourth quarter and full year 2021 revenue, number of patient results, and cash, cash equivalents, and marketable securities as of December 31, 2021, achievement of its financial and operational goals, its prospects in 2022, and its anticipation to report 2021 financial results and provide 2022 financial guidance on its February 2022 earnings call. 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, including the completion of the audit of CareDx’s 2021 financial statements, general economic and market factors, and global economic and marketplace uncertainties related to the COVID-19 pandemic, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by CareDx with the SEC on February 24, 2021, the quarterly report on Form 10-Q for the first quarter of 2021 ended on March 31, 2021 filed by CareDx with the SEC on May 5, 2021, the quarterly report on Form 10-Q for the second quarter of 2021 ended on June 30, 2021 filed by CareDx with the SEC on July 29, 2021, the quarterly report on Form 10-Q for the third quarter of 2021 ended on September 30, 2021, filed by CareDx with the SEC on October 28, 2021, 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. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS: CareDx, Inc. Sasha King Chief Marketing Officer 415-287-2393 sking@CareDx.com

Investor Relations Ian Cooney (415) 722-4563 investor@CareDx.com