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CareDx Inc

For the period ended Dec 31, 2023. Filed Feb 28, 2024.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Feb 28, 2024

CDNA$84.42+7.5%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

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Contents

Table of Contents

Item No.PageNo.
PART I5
Item 1. Business5
Item 1A. Risk Factors24
Item 1B. Unresolved Staff Comments63
Item 1C. Cybersecurity63
Item 2. Properties64
Item 3. Legal Proceedings64
Item 4. Mine Safety Disclosures64
PART II65
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities65
Item 6. [Reserved]66
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations67
Item 7A. Quantitative and Qualitative Disclosures About Market Risk84
Item 8. Financial Statements and Supplementary Data85
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure130
Item 9A. Controls and Procedures130
Item 9B. Other Information132
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections132
PART III133
Item 10. Directors, Executive Officers and Corporate Governance133
Item 11. Executive Compensation133
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters133
Item 13. Certain Relationships and Related Transactions, and Director Independence133
Item 14. Principal Accountant Fees and Services133
PART IV134
Item 15. Exhibits, Financial Statement Schedules134
Signatures138

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this Annual Report on Form 10-K other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “target,” “contemplate,” “predict,” “expect” and the negative and plural forms of these words and similar expressions are intended to identify forward-looking statements.

These forward-looking statements may include, but are not limited to, statements concerning the following:

our ability to generate revenue and increase the commercial success of our current and future testing services, products and patient and digital solutions;

our ability to obtain, maintain and expand reimbursement coverage from payers for our current and other future testing services, if any;

our plans and ability to continue updating our testing services, products and patient and digital solutions to maintain our leading position in transplantations;

the outcome or success of our clinical trial collaborations and registry studies;

the favorable review of our testing services and product offerings, and our future solutions, if any, in peer-reviewed publications;

our ability to obtain additional financing on terms favorable to us, or at all;

our anticipated cash needs and our anticipated uses of our funds, including our estimates regarding operating expenses and capital requirements;

anticipated trends and challenges in our business and the markets in which we operate;

our dependence on certain of our suppliers, service providers and other distribution partners;

disruptions to our business, including disruptions at our laboratories and manufacturing facilities;

our ability to retain key members of our management team;

our ability to make successful acquisitions or investments and to manage the integration of such acquisitions or investments;

our ability to expand internationally;

our compliance with federal, state and foreign regulatory requirements;

our ability to protect and enforce our intellectual property rights, our strategies regarding filing additional patent applications to strengthen our intellectual property rights, and our ability to defend against intellectual property claims that may be brought against us;

our ability to successfully assert, defend against or settle any litigation brought by or against us or other legal matters or disputes;

our ability to remediate the material weaknesses in our internal control over financial reporting as of December 31, 2023; and

our ability to comply with the requirements of being a public company.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled “Risk Factors” included in Part I, Item 1A and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially and adversely from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.

You should read this Annual Report on Form 10-K and the documents that we reference in this Annual Report on Form 10-K and have filed with the Securities and Exchange Commission, or the SEC, as exhibits to this Annual Report on Form 10-K with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. We qualify all forward-looking statements by these cautionary statements.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.