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): October 7, 2020

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

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:

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 October 7, 2020, CareDx, Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter ended September 30, 2020. 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.

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.

Document

Exhibit 99.1

CareDx Reports Preliminary Third Quarter 2020 Revenue

SOUTH SAN FRANCISCO, CA, October 7, 2020 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced preliminary unaudited revenue for the three months ended September 30, 2020.

Preliminary revenue for the three months ended September 30, 2020 is expected to be approximately $53.0 million, an increase of 57% compared with $33.8 million in the third quarter of 2019. Testing revenue for the quarter is expected to be approximately $45.2 million, compared with $28.2 million in the same period in 2019. Total AlloSure and AlloMap patient results provided in the quarter were approximately 21,800. Product revenue in the three months ended September 30, 2020 is expected to be $5.4 million, compared to $4.2 million in the same period in 2019. Digital & other revenue in the third quarter of 2020 is expected to be $2.4 million, compared to $1.4 million in the same period in 2019. The preliminary information presented in this press release is based on CareDx’s current expectations and may be adjusted as a result of, among other things, completion of customary quarterly review procedures.

"I am proud of the CareDx team for rising above the continued challenges of the pandemic and partnering with transplant centers to support transplant patients throughout these uncertain times,” said Peter Maag, Chairman and CEO of CareDx, Inc. “Our strong third quarter performance was driven by this dedication and our commitment to lead in advancing transplantation, underscored by our surveillance solutions, AlloSure and AlloMap.”

"We continue to invest in growth initiatives to position CareDx as the leader in transplantation and expand our pipeline, including most recently with patient care management and digital solutions,” said Reg Seeto, President and Chief Business Officer. “As a result of our strategic investments, we have been able to adapt more efficiently to meet the needs of individual transplant centers during this pandemic, and attract incredible talent to join the CareDx team.”

About CareDx

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 the Company's expectations of its unaudited revenue and total number of patient results for the three months ended September 30, 2020, achievement of our financial and operational goals and our prospects. 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 risks related to the completion of the customary quarterly financial statement review procedures; general economic and market factors; and specific risks related to global economic and marketplace uncertainties related to the COVID-19 pandemic, among others discussed in CareDx's filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2019 filed by CareDx with the SEC on February 28, 2020, and the periodic reports that CareDx subsequently files 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.

Investor Relations Contact

Greg Chodaczek

347-620-7010

investor@caredx.com