1 unchanged sentence
Evaluation of disclosure controls and procedures:
−Removed: We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of our disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e).
−Removed: Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of January 1, 2023 at a reasonable assurance level to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
+Added: We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of our disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the fiscal year.
+Added: Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of December 31, 2023 at a reasonable assurance level to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures.
Changes in internal control over financial reporting:
−Removed: As of January 1, 2023, management is in the process of integrating the internal controls of the acquired Ortho business into our existing operations as part of planned integration activities.
−Removed: There were no other changes in our internal control over financial reporting during the fiscal quarter ended January 1, 2023 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
+Added: There were no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2023 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s report on internal control over financial reporting:
5 unchanged sentences
Under the supervision and with the participation of our management, including our CEO and CFO, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework (2013) , issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: Based on our evaluation under the framework in Internal Control—Integrated Framework , our management concluded that our internal control over financial reporting was effective as of January 1, 2023.
−Removed: In accordance with SEC guidance, we have excluded from the scope of our assessment of internal control over financial reporting the operations and related assets of Ortho, which we acquired on May 27, 2022.
−Removed: At January 1, 2023 and for the period from acquisition through January 1, 2023, total assets and total revenues subject to Ortho’s internal control over financial reporting represented 22% and 36%, respectively, of our consolidated total assets and total revenues as of and for the fiscal year ended January 1, 2023.
−Removed: The effectiveness of our internal control over financial reporting as of January 1, 2023 has been audited by Ernst & Young LLP, our independent registered public accounting firm, as stated in their report, which is included in this Item 9A.
+Added: Based on our evaluation under the framework in Internal Control—Integrated Framework , our management concluded that our internal control over financial reporting was effective as of December 31, 2023.
+Added: The effectiveness of our internal control over financial reporting as of December 31, 2023 has been audited by Ernst & Young LLP, our independent registered public accounting firm, as stated in their report, which is included in this Item 9A.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
1 unchanged sentence
Opinion on Internal Control over Financial Reporting
−Removed: We have audited QuidelOrtho Corporation’s internal control over financial reporting as of January 1, 2023, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), (the COSO criteria).
−Removed: In our opinion, QuidelOrtho Corporation (the Company) maintained, in all material respects, effective internal control over financial reporting as of January 1, 2023, based on the COSO criteria.
−Removed: As indicated in the accompanying Management’s Report on Internal Control over Financial Reporting, management’s assessment of and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of Ortho which is included in the 2022 consolidated financial statements of the Company and constituted 22% of total assets as of January 1, 2023 and 36% of revenues for the year then ended.
−Removed: Our audit of internal control over financial reporting of the Company also did not include an evaluation of the internal control over financial reporting of Ortho.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of January 1, 2023 and January 2, 2022, the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows, for each of the three years in the period ended January 1, 2023, and the related notes and our report dated February 23, 2023 expressed an unqualified opinion thereon.
+Added: We have audited QuidelOrtho Corporation’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), (the COSO criteria).
+Added: In our opinion, QuidelOrtho Corporation (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and January 1, 2023, the related consolidated statements of (loss) income, comprehensive income, stockholders’ equity and cash flows, for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 29, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
18 unchanged sentences
Other Information
−Removed: Effective on February 22, 2023, the Board approved a change of the Company’s registered agent and registered office.
−Removed: The Company filed a Change of Registered Agent and/or Registered Office (the “Certificate of Change”) with the Secretary of State of the State of Delaware to change the Company’s registered agent to Registered Agent Solutions, Inc.
−Removed: and its registered office to 838 Walker Road, Suite 21-2, Dover, County of Kent, Delaware 19904.
−Removed: The Certificate of Change was approved by the Board in accordance with Delaware law and has the effect of amending Section 2 of the Company’s Charter.
−Removed: A copy of the Certificate of Change is attached as Exhibit 3.3 to this Annual Report and incorporated herein by reference.
+Added: (b) During the last fiscal quarter, no director or officer (as defined in Exchange Act Rule 16a-1(f)) adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
1 unchanged sentence
Directors, Executive Officers and Corporate Governance
−Removed: The information required by this item is incorporated herein by reference to our 2023 proxy statement to be filed with the SEC within 120 days of the year ended January 1, 2023 (the “2023 Proxy Statement”), including under the headings “Board of Directors and Corporate Governance,” “Information about our Executive Officers,” “Business Ethics and Compliance” and “Delinquent Section 16(a) Reports,” if applicable.
+Added: The information required by this item is incorporated herein by reference to our 2024 definitive proxy statement to be filed with the SEC within 120 days of the fiscal year ended December 31, 2023 (the “2024 Proxy Statement”), including under the headings “Proposal One - Election of Directors Proposal,” “Corporate Governance,” “Executive Officers” and “Delinquent Section 16(a) Reports.”
Executive Compensation
−Removed: The information required by this item is incorporated herein by reference to our 2023 Proxy Statement, including under the headings “Executive Compensation,” “Compensation Committee Interlocks and Insider Participation” and “Compensation Committee Report.”
+Added: The information required by this item is incorporated herein by reference to our 2024 Proxy Statement, including under the headings “Director Compensation,” “Executive Compensation,” “Compensation Committee Interlocks and Insider Participation” and “Compensation Committee Report.”
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The information required by this item is incorporated herein by reference to our 2023 Proxy Statement, including under the headings “Securities Available for Issuance under our Equity Compensation Plans” and “Security Ownership of Certain Beneficial Owners and Management.”
+Added: The information required by this item is incorporated herein by reference to our 2024 Proxy Statement, including under the headings “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” and “Securities Authorized for Issuance under Equity Compensation Plans.”
Certain Relationships and Related Transactions, and Director Independence
−Removed: The information required by this item is incorporated herein by reference to our 2023 Proxy Statement, including under the headings “Review and Approval of Related Party Transactions,” “Related Party Transactions” and “Director Independence.”
+Added: The information required by this item is incorporated herein by reference to our 2024 Proxy Statement, including under the headings “Director Independence,” “Review and Approval of Related Party Transactions” and “Related Party Transactions.”
Principal Accountant Fees and Services
−Removed: The information required by this item is incorporated herein by reference to our 2023 Proxy Statement, including under the heading “Independent Registered Public Accounting Firm.”
+Added: The information required by this item is incorporated herein by reference to our 2024 Proxy Statement, including under the headings “Independent Registered Public Accounting Firm” and “Policy on Audit Committee Pre-approval of Audit and Permissible Non-audit Services.”
Exhibits and Financial Statement Schedules
6 unchanged sentences
The Exhibit Index immediately following this Item 15 is filed as part of, and incorporated by reference into, this Annual Report.
−Removed: (c) Financial Statements required by Regulation S-X which are excluded from this Annual Report by Rule 14(a)-3(b).
+Added: (c) Financial Statements Required by Regulation S-X Which Are Excluded from the Annual Report by Exchange Act Rule 14(a)-3(b).
Not applicable.
4 unchanged sentences
(incorporated by reference to Annex A to the joint proxy statement/prospectus forming part of the Registration Statement on Form S-4 filed by Coronado Topco, Inc.
−Removed: with the SEC on January 31, 2022)
+Added: on January 31, 2022)
Amended and Restated Certificate of Incorporation of QuidelOrtho Corporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Form 8-K filed on May 27, 2022)
Amended and Restated Bylaws of QuidelOrtho Corporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Form 8-K filed on December 13, 2022)
−Removed: Certificate of Change of Registered Agent
+Added: Certificate of Change of Registered Agent (incorporated by reference to Exhibit 3.3 to the Registrant’s Form 10-K for the fiscal year ended January 1, 2023 filed on February 23, 2023)
Specimen Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
−Removed: Description of QuidelOrtho Corporation’s Securities Registered Pursuant to Section 12 of the Exchange Act of 1934
−Removed: Summary of Certain Compensation Arrangements for Executive Officers (incorporated by reference to the Registrant’s Form 8-K filed on June 6, 2022)
+Added: Description of QuidelOrtho Corporation’s Securities Registered Pursuant to Section 12 of the Exchange Act of 1934 (incorporated by reference to Exhibit 4.2 to the Registrant’s Form 10-K for the fiscal year ended January 1, 2023, filed on February 23, 2023)
Principal Stockholders Agreement, dated as of December 22, 2021, by and among Coronado Topco, Inc., Quidel Corporation, Ortho Clinical Diagnostics Holdings plc and the Initial Carlyle Stockholder (as defined therein) (incorporated by reference to Annex B to the joint proxy statement/prospectus forming part of the Registration Statement on Form S-4 filed by Coronado Topco, Inc.
−Removed: with the SEC on January 31, 2022)
+Added: on January 31, 2022)
Exhibit Number Description
11 unchanged sentences
Employment Agreement, dated January 16, 2009, between Quidel Corporation and Douglas C.
−Removed: Bryant (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by Quidel Corporation with the SEC on January 20, 2009)
+Added: Bryant (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by Quidel Corporation on January 20, 2009)
Employment Offer Letter, dated June 5, 2008, between Quidel Corporation and Robert J.
−Removed: Bujarski (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by Quidel Corporation with the SEC on June 6, 2008)
−Removed: Employment Offer Letter, dated April 24, 2014, between Quidel Corporation and Werner Kroll (incorporated by reference to Exhibit 10.1 to the Form 10-Q for the quarter ended June 30, 2014 filed by Quidel Corporation with the SEC on July 24, 2014)
−Removed: Enhanced Minimum Severance Letter, dated June 30, 2020, between Ortho-Clinical Diagnostics, Inc.
−Removed: and Joseph M.
−Removed: Busky (incorporated by reference to Exhibit 10.19 to the Form S-1 filed by Ortho Clinical Diagnostics Holdings plc with the SEC on January 4, 2021)
−Removed: Severance Letter Agreement with Michael Iskra, dated May 2021 (incorporated by reference to Exhibit 99.1 to the Form 8-K filed by Ortho Clinical Diagnostics Holdings plc with the SEC on May 25, 2021)
−Removed: Form of Retention/Loyalty Bonus Opportunity Agreement (incorporated by reference to Exhibit 99.1 to the Form 8-K filed by Ortho Clinical Diagnostics Holdings plc with the SEC on January 18, 2022)
−Removed: Amended and Restated Special Advisor Agreement, dated April 3, 2022, between Christopher Smith and QuidelOrtho Corporation (incorporated by reference to Exhibit 99.4 to the Form 8-K filed by Ortho Clinical Diagnostics Holdings plc with the SEC on April 7, 2022)
−Removed: Letter Agreement, dated April 3, 2022, between Ortho Clinical Diagnostics Holdings plc and Christopher Smith (incorporated by reference to Exhibit 99.3 to the Form 8-K filed by Ortho Clinical Diagnostics Holdings plc with the SEC on April 7, 2022)
−Removed: Form of Integration and Retention Bonus Letter (incorporated by reference to Exhibit 10.4 to the Form 8-K filed by Quidel Corporation with the SEC on February 4, 2022)
+Added: Bujarski (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by Quidel Corporation on June 6, 2008)
+Added: Form of Retention/Loyalty Bonus Opportunity Agreement (incorporated by reference to Exhibit 99.1 to the Form 8-K filed by Ortho Clinical Diagnostics Holdings plc on January 18, 2022)
+Added: Form of Integration and Retention Bonus Letter (incorporated by reference to Exhibit 10.4 to the Form 8-K filed by Quidel Corporation on February 4, 2022)
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.10 to the Registrant’s Form 8-K filed on May 27, 2022)
−Removed: Exhibit Number Description
−Removed: Form of Change in Control Agreement (incorporated by reference to Exhibit 10.11 to the Registrant’s Form 8-K filed on May 27, 2022)
−Removed: Individual Retirement Program for Werner Kroll (incorporated by reference to Exhibit 10.3 to the Form 8-K filed by Quidel Corporation with the SEC on February 4, 2020)
−Removed: Summers Ridge Lease (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by Quidel Corporation with the SEC on January 9, 2018)
+Added: Form of Severance and Change in Control Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed on December 1, 2023 )
+Added: Amended and Restated Individual Retirement Program for Werner Kroll, effective as of April 4, 2023 (incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended April 2, 2023 filed on May 4, 2023)
+Added: QuidelOrtho Board Deferred Compensation Plan
+Added: QuidelOrtho Employee Deferred Compensation Plan
+Added: Summers Ridge Lease (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by Quidel Corporation on January 9, 2018)
Master Agreement, dated as of July 24, 2021, by and among Quidel Corporation, Quidel Cardiovascular, Inc., and Beckman Coulter, Inc.
2 unchanged sentences
Consent of Independent Registered Public Accounting Firm
−Removed: Certification by Principal Executive Officer of QuidelOrtho Corporation pursuant to Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
−Removed: Certification by Principal Financial Officer of QuidelOrtho Corporation pursuant to Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
+Added: Exhibit Number Description
+Added: Certification by Principal Executive Officer of QuidelOrtho Corporation pursuant to Rules 13a-14 (a) and 15d-14 (a) , as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
+Added: Certification by Principal Financial Officer of QuidelOrtho Corporation pursuant to Rules 13a-14 (a) and 15d-14 (a) , as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certifications by Principal Executive Officer and Principal Financial Officer of QuidelOrtho Corporation pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: 101* The following financial statements from the Registrant’s Annual Report on Form 10-K for the year ended January 1, 2023, formatted in Inline XBRL:
−Removed: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Income, (iii) Consolidated Statements of Comprehensive Income, (iv) Consolidated Statements of Stockholders’ Equity, (v) Consolidated Statements of Cash Flows, and (vi) Notes to Consolidated Financial Statements, tagged as blocks of text and including detailed tags.
−Removed: 104 The cover page from the Registrant’s Annual Report on Form 10-K for the year ended January 1, 2023, formatted in Inline XBRL (included as Exhibit 101).
+Added: QuidelOrtho Clawback Policy
+Added: 101* The following financial statements from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2023, formatted in Inline XBRL:
+Added: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of (Loss) Income, (iii) Consolidated Statements of Comprehensive Income, (iv) Consolidated Statements of Stockholders’ Equity, (v) Consolidated Statements of Cash Flows, and (vi) Notes to Consolidated Financial Statements, tagged as blocks of text and including detailed tags.
+Added: 104 The cover page from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2023, formatted in Inline XBRL (included as Exhibit 101).
* Filed herewith.
3 unchanged sentences
Form 10-K Summary
−Removed: 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.
−Removed: Q UIDELORTHO C ORPORATION
−Removed: By /s/ D OUGLAS C.
+Added: Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized.
+Added: Q UIDEL O RTHO C ORPORATION
+Added: By /s/ M ICHAEL S.
February 29, 2024
−Removed: President and Chief Executive Officer
+Added: Interim Chief Executive Officer
(Principal Executive Officer)
1 unchanged sentence
Signature Title Date
−Removed: /s/ D OUGLAS C.
−Removed: Director, President and Chief Executive Officer
+Added: /s/ M ICHAEL S.
+Added: Interim Chief Executive Officer
(Principal Executive Officer) February 29, 2024
11 unchanged sentences
Mary Lake Polan
+Added: /s/ J AMES R.
Director February 29, 2024
−Removed: /s/ R OBERT R.
Director February 29, 2024
−Removed: /s/ C HRISTOPHER M.
+Added: /s/ R OBERT R.
Director February 29, 2024
−Removed: Christopher M.
/s/ M ATTHEW W.
5 unchanged sentences
Director February 29, 2024
−Removed: /s/ S TEPHEN H.
−Removed: Director February 23, 2023
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.