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 11, 2021

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 January 11, 2021, CareDx, Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter and year ended December 31, 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 Fourth Quarter

and Full Year 2020 Results

SOUTH SAN FRANCISCO, Calif., January 11, 2021 (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, 2020.

Preliminary revenue for the three months ended December 31, 2020 is expected to be between $58.4 million and $58.6 million, an increase of approximately 63% compared with $35.8 million in the fourth quarter of 2019. Testing revenue for the quarter is expected to be between $50.0 million to $50.2 million, compared with $29.1 million in the same period in 2019. Total AlloSure and AlloMap patient results provided in the quarter were approximately 25,100, which includes approximately 1,100 AlloSure Heart patient results since CareDx received Medicare Reimbursement for AlloSure Heart. Product revenue in the three months ended December 31, 2020 is expected to be $5.9 million, compared to $5.1 million in the same period in 2019. Digital & other revenue in the fourth quarter of 2020 is expected to be $2.4 million, compared to $1.6 million in the same period in 2019.

Preliminary revenue for the full year ended December 31, 2020 is expected to be between $191.9 million and $192.1 million, an increase of approximately 51% compared with $127.1 million in 2019. Testing revenue for the year ended December 31, 2020 is expected to be between $163.3 million to $163.5 million, compared with $104.6 million in 2019. Product revenue for the full year 2020 is expected to be $19.3 million, compared to $18.3 million in 2019. Digital & other revenue for the full year 2020 is expected to be $9.3 million, compared to $4.2 million in 2019.

Preliminary cash, cash equivalents and marketable securities were approximately $224.7 million as of December 31, 2020.

“2020 was an outstanding year of growth for CareDx even with the underlying challenges brought upon by COVID-19. Our record fourth quarter results and 2020 revenue growth were driven by our team’s focus on putting patients first,” said Reg Seeto, CareDx President and Chief Executive Officer. “As we look to 2021, we will continue to execute on our winning formula and expand across the transplant 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 2020 financial results, and anticipates providing 2021 financial guidance on its February 2021 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 2020 revenue, number of patient results, and cash, cash equivalents and marketable securities as of December 31, 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 the completion of the audit of the Company’s 2020 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, 2019, filed by CareDx with the SEC on February 28, 2020, 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.

CONTACTS:

Investor Relations

Greg Chodaczek

347-620-7010

investor@caredx.com