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 13, 2020

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

1 Tower Place, South San Francisco, California 94080

(Address of Principal Executive Offices) (Zip Code)

(415) 287-2300

Registrant’s telephone number, including area code

3260 Bayshore Boulevard

Brisbane, California 94005

(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:

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 January 13, 2020, CareDx, Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter and year ended December 31, 2019. 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

CareDx Reports Preliminary Fourth Quarter and Full Year 2019 Results

SOUTH SAN FRANCISCO, Calif., January 13, 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 reported preliminary financial results for the fourth quarter and full year ended December 31, 2019.

Preliminary revenue for the three months ended December 31, 2019 is expected to be between $35.7 million and $36.0 million, an increase of 52% to 53% compared with $23.5 million in the fourth quarter of 2018. Testing revenue for the quarter is expected to be between $29.0 million to $29.3 million, compared with $18.9 million in the same period in 2018. Total AlloSure Kidney and AlloMap Heart patient results provided in the quarter were 14,055. Product revenue in the three months ended December 31, 2019 is expected to be $5.1 million, compared to $4.6 million in the same period in 2018. Digital & Other revenue in the fourth quarter of 2019 is expected to be $1.6 million, compared to $0.1 million in the same period in 2018.

Preliminary revenue for the full year ended December 31, 2019 is expected to be between $127.0 million and $127.3 million, an increase of approximately 66% compared with $76.6 million in 2018. Testing revenue for the year ended December 31, 2019 is expected to be between $104.4 million to $104.7 million, compared with $60.3 million in 2018. Product revenue for the full year 2019 is expected to be $18.3 million, compared to $15.7 million in 2018. Digital & Other revenue for the full year 2019 is expected to be $4.2 million, compared to $0.6 million in 2018.

Preliminary cash and cash equivalents were $38.2 million as of December 31, 2019.

“2019 was another record year for CareDx with 66% revenue growth. We are firmly positioned as the leading provider of genomics-based information in transplantation and have the momentum and capabilities to drive continued innovation and growth in 2019. We executed well against our transplant focused growth strategy, building on our strong platform by launching new and next generation technologies, and acquiring electronic medical records, quality tracking and transplant waitlist management capabilities,” said Peter Maag. “We look forward to another exciting year of strong growth as we continue to innovate and evolve novel solutions for the transplant community.”

LEGAL_US_W # 101639901.2

Effective January 1, 2020, the Board of Directors elected Peter Maag as Chairman of the Board. Dr. Maag will also continue his current role as Chief Executive Officer, a role he has held since 2012. Dr. Maag succeeds Chairman Michael Goldberg, who will continue on the Board and serve as its Lead Independent Director.

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 2019 financial results, and provide 2020 financial guidance on its February 2020 earnings call.

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 fourth quarter and full year 2019 revenue and cash and cash equivalents as of December 31, 2019, 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 completion of the audit of the Company’s 2019 financial statements, general economic and market factors, among others discussed in CareDx’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed by CareDx with the SEC on March 6, 2019 and the periodic reports that CareDx has subsequently 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.

Investor Relations Contact

Greg Chodaczek

646-924-1769

investor@caredx.com

LEGAL_US_W # 101639901.2