Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of its disclosure controls and procedures, as such terms are defined in Rules 13a-15(b) and 15d-15(e) promulgated under the Exchange Act, as of December 31, 2020. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Based on such evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2020, our disclosure controls and procedures were effective at the reasonable assurance level and are effective to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the Exchange Act, is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely discussion regarding required disclosure.
Management’s Annual Report on Internal Control over Financial Reporting
Management, including our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control system was designed to provide reasonable assurance to our management and board of directors regarding the preparation and fair presentation of published consolidated financial statements in accordance with accounting principles generally accepted in the United States.
Management assessed the effectiveness of the Company's internal control over financial reporting as of December 31, 2020. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in the 2013 Internal Control-Integrated Framework. Based on our assessment, management has concluded the Company maintained effective internal control over financial reporting as of December 31, 2020.
Attestation Report of the Independent Registered Public Accounting Firm
The effectiveness of our internal control over financial reporting as of December 31, 2020 has been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their report, which appears herein.
Changes in Internal Control over Financial Reporting
None.
ITEM 9B. OTHER INFORMATION
None.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is incorporated by reference from the information contained in our Definitive Proxy Statement to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020 in connection with the Annual Meeting of Stockholders to be held in 2021, or the 2021 Proxy Statement. To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information required by this Item 10.
We have adopted a Code of Business Conduct and Ethics that applies to all of our officers and employees (including our principal executive officer, principal financial officer, principal accounting officer or controller and other employees who perform financial or accounting functions), agents and representatives, including our independent directors and consultants, who are not employees of ours, with regard to their CareDx-related activities. Our Company’s Code of Business Conduct and Ethics is available on its website at www.caredx.com under the heading “Compliance” under the section titled “Company”. We will post on this section of our website any amendment to our Code of Business Conduct and Ethics, as well as any waivers of our Code of Business Conduct and Ethics that are required to be disclosed by the rules of the SEC or The Nasdaq Stock Market LLC.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference from the information contained in the 2021 Proxy Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information required by this Item 11.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is incorporated by reference to from the information contained in the 2021 Proxy Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. To the extent that we do not file our 2021 Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information required by this Item 12.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated by reference to from the information contained in our 2021 Proxy Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information required by this Item 13.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item is incorporated by reference from the information contained in the 2021 Proxy Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information required by this Item 14.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1) Financial Statements:
Our Financial Statements are listed in the “Index to Consolidated Financial Statements” of CareDx, Inc. Part II, Item 8 of this Annual Report on Form 10-K.
(a)(2) Financial Statement Schedules
All financial statement schedules have been omitted because they are not required, not applicable, or the required information is included in the consolidated financial statements or notes thereto included in this Annual Report on Form 10-K.
(a)(3) Exhibits
The following exhibits are incorporated by reference or are filed with this report, in each case as indicated therein (numbered in accordance with Item 601 of Regulation S-K).
Exhibit
Number
Incorporated by Reference
Description Form File No. Exhibit Filing Date
3.1 Amended and Restated Certificate of Incorporation of the Registrant.
10-Q 001-36536 3.1 8/28/2014
3.2 Amended and Restated Bylaws of the Registrant.
10-Q 001-36536 3.4 8/28/2014
4.1 Form of Registrant’s common stock certificate.
10-K 001-36536 4.1 3/31/2015
4.2# 2014 Equity Incentive Plan and forms of agreements, as amended.
8-K 001-36536 10.1 6/26/2018
4.3# Form of Option Agreement under the 2014 Equity Incentive Plan for New Options.
SC TO-I 005-88252 99(d)(3) 10/12/2017
4.4# 2014 Employee Stock Purchase Plan and forms of agreements thereunder.
S-8 333-197493 4.5 7/18/2014
4.5# 2016 Inducement Equity Incentive Plan.
S-8 333-211538 4.1 5/23/2016
4.6 Form of Warrant.
8-K 001-36536 10.3 4/14/2016
4.7# 2019 Inducement Equity Incentive Plan.
8-K 001-36536 10.1 9/4/2019
4.8* Description of Securities of CareDx, Inc.
10.1# Executive Chair Agreement, dated October 29, 2020, by and between the Registrant and Peter K. Maag, Ph.D.
8-K 001-36536 10.2 10/29/2020
10.2# Offer Letter, dated October 18, 2011, by and between the Registrant and Michael D. Goldberg.
10-K 001-36536 10.15 3/31/2015
10.3# Offer Letter, dated April 8, 2014, by and between the Registrant and George Bickerstaff, III.
10-K 001-36536 10.14 3/31/2015
10.4# Offer Letter, between the Registrant and Sasha King, dated October 20, 2017.
10-K 001-36536 10.6 3/22/2018
10.5# Offer Letter, dated November 13, 2018, between the Registrant and Reginald Seeto, MBBS.
8-K 001-36536 10.1 11/26/2018
10.6# Form of Change of Control and Severance Agreement between the Registrant and each of its executive officers.
S-1 333-196494 10.11 6/3/2014
10.7# Amendment to Change of Control and Severance Agreement, dated October 29, 2020, by and between CareDx, Inc. and Reginald Seeto, MBBS.
8-K 001-36536 10.1 10/29/2020
10.8# Form of Indemnification Agreement between the Registrant and each of its directors and executive officers.
S-1 333-196494 10.1 6/3/2014
10.9# Executive Incentive Compensation Plan.
10-K 001-36536 10.19 3/31/2015
10.10# Outside Director Compensation Policy.
10.11 Lease, dated April 27, 2006, as amended on November 10, 2010, by and between the Registrant and BMR-Bayshore Boulevard LLC, for office and laboratory space located at 3260 Bayshore Boulevard, Brisbane, California 94005.
S-1 333-196494 10.12 6/3/2014
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Exhibit
Number
Incorporated by Reference
Description Form File No. Exhibit Filing Date
10.12+ Second Amendment to Lease, dated January 2, 2020, by and between the Registrant and BMR-Bayshore Boulevard LP (formerly known as BMR-Bayshore Boulevard LLC), for office and laboratory space located at 3260 Bayshore Boulevard, Brisbane, California 94005.
10-Q 001-36536 10.1 4/30/2020
10.13+ Consent to Sub-Sublease Agreement, dated as of October 30, 2019, by and among AP3-SF2 CT South, LLC, SuccessFactors, Inc., Medeor Therapeutics, Inc. and CareDx, Inc. for office space located at One Tower Place, 9th Floor, South San Francisco, California 94080.
10-Q 001-36536 10.2 4/30/2020
10.14† Amended and Restated Exclusive Agreement, dated January 27, 2014, by and between the Board of Trustees of the Leland Stanford Junior University and ImmuMetrix, Inc.
S-1/A 333-196494 10.17 7/15/2014
10.15 Sales Agreement, dated August 31, 2018 by and between the Registrant and Jeffries LLC.
S-3 333-227168 1.2 8/31/2018
10.16† License and Commercialization Agreement, dated May 4, 2018, between the Registrant and Illumina, Inc.
10-Q/A 001-36536 10.3 10/9/2018
21.1* Subsidiaries of the Registrant.
23.1* Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
24.1* Power of Attorney (see page 115 of this Annual Report on Form 10-K).
31.1* Principal Executive Officer’s Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2* Principal Financial Officer’s Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1** Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002).
101.INS* Inline XBRL Instance Document
101.SCH* Inline XBRL Taxonomy Extension Schema
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase
101.LAB* Inline XBRL Taxonomy Extension Label Linkbase
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase
104 Cover Page Interactive Data File, formatted in Inline XBRL
_____________________
† Confidential treatment has been granted with respect to certain portions of this Exhibit. Omitted portions have been filed separately with the SEC.
+ Non-material schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant hereby undertakes to furnish supplementally copies of any of the omitted schedules and exhibits upon request by the SEC.
# Indicates management contract or compensatory plan or arrangement.
* Filed herewith.
** Furnished herewith.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CAREDX, INC.
By: /s/ Reginald Seeto, MBBS
Reginald Seeto, MBBS
President and Chief Executive Officer
Date: February 24, 2021
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Reginald Seeto and Marcel Konrad, and each of them, his true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons, on behalf of the registrant on the dates and the capacities indicated.
Signature Title Date
/s/ REGINALD SEETO, MBBS President, Chief Executive Officer and Director
(Principal Executive Officer)
February 24, 2021
Reginald Seeto, MBBS
/s/ MARCEL KONRAD Interim Chief Financial Officer
(Principal Financial and Accounting Officer)
February 24, 2021
Marcel Konrad
/s/ PETER MAAG, PH.D. Executive Chair and Director February 24, 2021
Peter Maag, Ph.D.
/s/ GEORGE W. BICKERSTAFF, III Director February 24, 2021
George W. Bickerstaff, III
/s/ FRED E. COHEN Director February 24, 2021
Fred E. Cohen
/s/ GRACE COLÓN Director February 24, 2021
Grace Colón
/s/ CHRISTINE M. COURNOYER Director February 24, 2021
Christine M. Cournoyer
/s/ MICHAEL D. GOLDBERG Director February 24, 2021
Michael D. Goldberg
/s/ RALPH SNYDERMAN Director February 24, 2021
Ralph Snyderman
/s/ WILLIAM HAGSTROM Director February 24, 2021
William Hagstrom
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