Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of disclosure controls and procedures: We have performed an evaluation under the supervision and with the participation of our management, including our CEO and 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. Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were not effective at a reasonable assurance level as of December 29, 2024 due to the material weaknesses described below in Management’s Report on Internal Control over Financial Reporting.
Management’s report on internal control over financial reporting: Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such terms are defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of management, including our CEO and CFO, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on our evaluation, our management concluded that our internal control over financial reporting was not effective as of December 29, 2024.
A “material weakness” is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statement will not be prevented or detected on a timely basis.
As of December 29, 2024, the Company identified material weaknesses relating to:
(1) Undue reliance on information generated from certain software solutions affecting net revenue without effectively designed controls to ensure that the information generated from these software solutions used by management in accounting for gross revenue, accounts receivable and in the estimation of accrued rebates, was complete and accurate. We also determined there were design deficiencies over certain management review controls including lack of evidence of review and failure to consider the completeness and accuracy of information used in the performance of those controls related to these same accounts.
(2) Insufficient controls over the evaluation of all available evidence, both positive and negative, to assess realizability of deferred tax assets.
The effectiveness of our internal control over financial reporting as of December 29, 2024 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report included herein, which contains an adverse opinion on the effectiveness of our internal control over financial reporting.
Remediation Plan: With respect to the material weaknesses above, management, under the oversight of the Audit Committee, is in the process of designing appropriate controls to address these material weaknesses. While we have taken steps to implement our remediation plan, the material weaknesses will not be considered remediated until the enhanced controls operate for a sufficient period of time and management has concluded, through testing, that the related controls are effective. The Company will monitor the effectiveness of its remediation plan and refine its remediation plan as appropriate.
Changes in internal control over financial reporting: There were no changes in our internal control over financial reporting during the fiscal quarter ended December 29, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, other than the remediation activities described herein.
During the period ended December 29, 2024, the Company identified an interim material weakness relating to the design and operating effectiveness of management’s review controls over certain key assumptions that were utilized to determine fair value of reporting units in the Company’s interim goodwill impairment assessment conducted in the first quarter of 2024. The Company enhanced the design and operation of certain management review controls operating over key assumptions, including projected financial information, by defining the precision by which the controls operate and retaining sufficient evidence of the review over key inputs and assumptions. In the fourth quarter of 2024, the Company conducted its annual goodwill impairment assessment for all reporting units and concluded that the interim material weakness was fully remediated as of December 29, 2024.
Prior to filing this Annual Report, we completed significant additional procedures for the year ended December 29, 2024. Based on these procedures, management believes that our Consolidated Financial Statements included in this Annual Report have been prepared in accordance with U.S. GAAP. Our CEO and CFO have certified, that based on their knowledge, the financial statements, and other financial information included in this Annual Report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Annual Report.
113
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of QuidelOrtho Corporation
Opinion on Internal Control over Financial Reporting
We have audited QuidelOrtho Corporation’s internal control over financial reporting as of December 29, 2024, 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). In our opinion, because of the effect of the material weaknesses described below on the achievement of the objectives of the control criteria, QuidelOrtho Corporation (the Company) has not maintained effective internal control over financial reporting as of December 29, 2024, based on the COSO criteria.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The following material weaknesses have been identified and included in management’s assessment.
The Company identified a material weakness related to revenue, accounts receivable and accrued rebates due to undue reliance on information generated from certain software solutions and design and operating deficiencies related to management review controls. The Company also identified a material weakness related to insufficient controls over the evaluation of all available evidence to assess realizability of deferred tax assets.
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 29, 2024 and December 31, 2023, the related consolidated statements of (loss) income, comprehensive (loss) income, stockholders‘ equity and cash flows for each of the three years in the period ended December 29, 2024 and the related notes. These material weaknesses were considered in determining the nature, timing and extent of audit tests applied in our audit of the 2024 consolidated financial statements, and this report does not affect our report dated February 27, 2025, which expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s report on internal control over financial reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
San Diego, California
February 27, 2025
114
Item 9B. Other Information
(a) On February 12, 2025, the Company furnished a Current Report on Form 8-K that attached a press release announcing unaudited financial results for its fourth quarter and full year ended December 29, 2024, and posted a supplemental earnings presentation setting forth such results on the investor relations portion of the Company’s website (collectively, the “Earnings Materials”). Subsequent to the date of furnishing the Earnings Materials, in connection with the audit of our Consolidated Financial Statements by our independent registered public accounting firm and the assessment of realizability of deferred tax assets, we identified certain tax adjustments impacting the fourth quarter and full year of 2024, resulting in an increase in Provision for income taxes and a decrease in deferred tax assets, as well as conforming changes to other measures related to these adjustments (the “Adjustments”). This Annual Report updates the following for the fourth quarter and full year ended December 29, 2024:
Consolidated Statements of Operations
(in millions, except per share data) Previously Reported in Earnings Release Adjustments Fourth Quarter Financial Results Previously Reported in Earnings Release Adjustments Full Year Financial Results
Provision for (benefit from) income taxes $ 12.5 $ 25.0 $ 37.5 $ (104.5) $ 25.0 $ (79.5)
Net (loss) income $ (153.4) $ (25.0) $ (178.4) $ (2,027.0) $ (25.0) $ (2,052.0)
Basic (loss) earnings per share $ (2.28) $ (0.37) $ (2.65) $ (30.16) $ (0.38) $ (30.54)
Diluted (loss) earnings per share $ (2.28) $ (0.37) $ (2.65) $ (30.16) $ (0.38) $ (30.54)
Condensed Consolidated Balance Sheets
(in millions) Previously Reported in Earnings Release Adjustments As of
December 29, 2024
Deferred tax assets $ 25.0 $ (25.0) $ —
Total assets $ 6,448.6 $ (25.0) $ 6,423.6
Total stockholders’ equity $ 3,009.5 $ (25.0) $ 2,984.5
Total liabilities and stockholders’ equity $ 6,448.6 $ (25.0) $ 6,423.6
We have also updated the corresponding earnings release and earnings presentation on the investor relations portion of our website at https://ir.quidelortho.com to reflect these Adjustments, including related updates to the (i) Reconciliation of Non-GAAP Financial Information – Adjusted Net Income table and (ii) Reconciliation of Non-GAAP Financial Information – Adjusted EBITDA table. The Adjustments have no impact on the Condensed Consolidated Statements of Cash Flows, Adjusted EBITDA, Adjusted Net Income and Adjusted Diluted EPS for the fourth quarter and full year ended December 29, 2024 that were initially set forth in the earnings release and earnings presentation on February 12, 2025.
(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.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
115
Part III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item is incorporated herein by reference to our 2025 definitive proxy statement to be filed with the SEC within 120 days of the fiscal year ended December 29, 2024 (the “2025 Proxy Statement”), including under the headings “Proposal One - Election of Directors Proposal,” “Corporate Governance,” “ Insider Trading Policy ,” “Executive Officers” and “Delinquent Section 16(a) Reports.”
Item 11. Executive Compensation
The information required by this item is incorporated herein by reference to our 2025 Proxy Statement, including under the headings “Director Compensation,” “Executive Compensation,” “Compensation Committee Interlocks and Insider Participation” and “Compensation Committee Report.”
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated herein by reference to our 2025 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.”
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated herein by reference to our 2025 Proxy Statement, including under the headings “Director Independence,” “Review and Approval of Related Party Transactions” and “Related Party Transactions.”
Item 14. Principal Accountant Fees and Services
The information required by this item is incorporated herein by reference to our 2025 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.”
116
Part IV
Item 15. Exhibits and Financial Statement Schedules
The following documents are filed as part of this Annual Report:
(a) (1) Financial Statements
The Consolidated Financial Statements required by this Item are submitted in Part II, Item 8 of this Annual Report.
(2) Financial Statement Schedules
Financial Statement Schedules have been omitted because of the absence of conditions under which they are required or because the required information is included in the Consolidated Financial Statements or the Notes thereto.
(3) Exhibits
See Item 15(b) below.
(b) Exhibits
The Exhibit Index immediately following this Item 15 is filed as part of, and incorporated by reference into, this Annual Report.
(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.
EXHIBIT INDEX
Exhibit Number Description
2.1+
Business Combination Agreement, dated as of December 22, 2021, by and among Quidel Corporation, Ortho Clinical Diagnostics Holdings plc, Coronado Topco, Inc., Orca Holdco, Inc., Laguna Merger Sub, Inc. and Orca Holdco 2, Inc. (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. on January 31, 2022)
3.1
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)
3.2
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)
3.3
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)
4.1
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)
4.2
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)
10. 1 +
Credit Agreement, dated May 27, 2022, by and among QuidelOrtho Corporation, each lender from time to time party thereto, each L/C Issuer (as defined therein), and Bank of America, N.A., as Administrative Agent and Swing Line Lender (incorporated by reference to Exhibit 10.2 to the Registrant’s Form 8-K filed on May 27, 2022)
117
Exhibit Number Description
10. 2
Increase Joinder No. 1, dated August 4, 2022, by and among QuidelOrtho Corporation, JPMorgan Chase Bank, N.A., as New Revolving Credit Lender, a Lender and a L/C Issuer, the Guarantors party thereto, and Bank of America, N.A., as the Administrative Agent (incorporated by reference to Exhibit 10.4 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10.3
Amendment No. 2 to the Credit Agreement, dated April 25, 2024, by and among QuidelOrtho Corporation, the lenders party thereto, and Bank of America, N.A., as Administrative Agent (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed on April 29, 2024)
10. 4 (1)
QuidelOrtho Corporation Amended and Restated 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Form 8-K filed on May 27, 2022)
10. 5 (1)
Form of Restricted Stock Unit Award Grant Notice (incorporated by reference to Exhibit 10.6 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10. 6 (1)
Form of Restricted Stock Unit Award Grant Notice (Performance-based) (incorporated by reference to Exhibit 10.7 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10. 7 (1)
Form of Restricted Stock Unit Award Grant Notice (Time-based) (incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10. 8 (1)
Form of Restricted Stock Unit Award Grant Notice (Deferred) (incorporated by reference to Exhibit 10.9 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10. 9 (1)
Form of Notice of Grant of Nonqualified Stock Options and Option Agreement (incorporated by reference to Exhibit 10.10 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10. 10 (1)
Form of Phantom Stock Unit Award Grant Notice (incorporated by reference to Exhibit 10.11 to the Registrant’s Form 10-Q for the quarter ended July 3, 2022 filed on August 5, 2022)
10. 11 (1)
QuidelOrtho Corporation Amended and Restated 1983 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Form 8-K filed on May 27, 2022)
10. 12 (1)
Employment Offer Letter, dated April 30, 2024, between QuidelOrtho Corporation and Brian J. Blaser (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed on May 7, 2024)
10.13(1)
Certain compensation arrangements between QuidelOrtho Corporation and Joseph M. Busky (incorporated by reference to Item 5.02 of the Registrant’s Form 8-K/A filed on February 29, 2024)
10.14(1)
Certain compensation arrangements between QuidelOrtho Corporation and Joseph M. Busky (incorporated by reference to Item 5.02 of the Registrant’s Form 8-K filed on November 18, 2024)
10.15(1)
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)
10. 1 6 (1)
Form of Integration and Retention Bonus Letter (incorporated by reference to Exhibit 10.4 to the Registrant ’ s Form 8-K filed on February 4, 2022)
10. 1 7 (1)
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.10 to the Registrant’s Form 8-K filed on May 27, 2022)
10. 1 8 (1) *
Form of Severance and Change in Control Agreement
10. 1 9 (1)
QuidelOrtho Board Deferred Compensation Plan ( incorporated by reference to Exhibit 10 .1 9 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2023 filed on February 29, 2024)
10. 20 (1)
QuidelOrtho Employee Deferred Compensation Plan (incorporated by reference to Exhibit 10 . 20 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2023 filed on February 29, 2024)
10.21(1)
Form of Retention Compensation Agreement for Joseph M. Busky (incorporated by reference to Exhibit 10.3 to the Registrant’s Form 10-Q for quarter ended June 30, 2024 filed on August 1, 2024)
10. 22
Summers Ridge Lease (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Form 8-K filed on January 9, 2018)
10. 2 3
Master Agreement, dated as of July 24, 2021, by and among Quidel Corporation, Quidel Cardiovascular, Inc., and Beckman Coulter, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Form 8-K filed on July 26, 2021)
118
Exhibit Number Description
19.1*
QuidelOrtho Insider Trading Compliance Policy
21.1*
Subsidiaries of QuidelOrtho Corporation
23.1*
Consent of Independent Registered Public Accounting Firm
31.1*
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
31.2*
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
32.1**
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
97.1 *
QuidelOrtho Clawback Policy
101* The following financial statements from the Registrant’s Annual Report on Form 10-K for the year ended December 29, 2024, formatted in Inline XBRL: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of (Loss) Income, (iii) Consolidated Statements of Comprehensive (Loss) 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
104 The cover page from the Registrant’s Annual Report on Form 10-K for the year ended December 29, 2024, formatted in Inline XBRL (included as Exhibit 101)
* Filed herewith.
** Furnished herewith.
(1) Indicates a management plan or compensatory plan or arrangement.
+ Certain identified information has been omitted by means of marking such information with asterisks in reliance on Items 601(b)(2)(ii) and 601(b)(10)(iv) of Regulation S-K, as applicable, because it is both (i) not material and (ii) the type that the Registrant treats as private or confidential.
Item 16. Form 10-K Summary
None.
SUMMARY OF ABBREVIATED TERMS
QuidelOrtho Corporation and its consolidated subsidiaries may be referred to as QuidelOrtho, the Company, we, our or us in this Annual Report, unless the context otherwise indicates. Throughout this Annual Report, we have used terms which are defined below:
ABO Accumulated benefit obligation
Annual Report Annual Report on Form 10-K for the fiscal year ended December 29, 2024
AOCI Accumulated other comprehensive loss
ASC Accounting Standards Codification
ASU Accounting Standards Update
Audit Committee Audit Committee of the Board
BARDA Biomedical Advanced Research and Development Authority
BCA Business Combination Agreement entered into as of December 22, 2021, by and among Quidel, Ortho, QuidelOrtho (formerly Coronado Topco, Inc.), Orca Holdco, Inc., Laguna Merger Sub, Inc., and Orca Holdco 2, Inc.
BLA Biologics License Application
Board Board of directors
CAT Column agglutination technology
CCPA California Privacy Rights Act of 2020
CEO Chief Executive Officer
119
CFO Chief Financial Officer
cGMPs Current good manufacturing practices
CIIOs Critical information infrastructure
CISO Chief Information Security Officer
CLIA The FDA’s Clinical Laboratory Improvement Amendment of 1988
CMS Centers for Medicare & Medicaid Services
CODM Chief Operating Decision Maker
Combinations Business combination consummated by Quidel and Ortho on May 27, 2022, pursuant to the BCA
Credit Agreement Credit agreement, dated May 27, 2022, by and among the Company, as borrower, Bank of America, N.A., as administrative agent and swing line lender, and the other lenders and
L/C issuers party thereto
CRL Complete Response Letter
EBITDA Earnings before interest, taxes, depreciation and amortization
EEA European Economic Area
EMEA Europe, the Middle East and Africa
EPS (Loss) earnings per share
ESG Environmental, social and governance
EU European Union
EU IVDR EU In Vitro Diagnostic Regulation (EU 2017/746)
EU MDR EU Medical Device Regulation (EU 2017/745)
EUA Emergency use authorization
Exchange Act Securities Exchange Act of 1934, as amended
FASB Financial Accounting Standards Board
FCA False Claims Act
FCPA U.S. Foreign Corrupt Practices Act
FDA U.S. Food and Drug Administration
FDCA U.S. Federal Food, Drug, and Cosmetic Act
Financing The Term Loan together with the Revolving Credit Facility
FTC Federal Trade Commission
GAAP Generally accepted accounting principles in the U.S.
GDPR General Data Protection Regulation 2016/679
Grifols Grifols Diagnostic Solutions, Inc.
Grifols Agreement Agreement governing the Company’s ongoing Joint Business between Ortho and Grifols, originally entered into in 1989 with a 50-year term, as amended
HHS U.S. Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
IND Investigational New Drug Application
IPR&D In-process research and development
ISO International Organization for Standardization
IT Information technology
IVD In vitro diagnostics
Joint Business Ongoing collaboration arrangement between Ortho and Grifols
JPAC Japan and Asia Pacific
MACRA The Medicare Access and CHIP Reauthorization Act of 2015
MDSAP Medical Device Single Audit Program
120
NMPA China’s National Medical Products Administration, formerly CFDA
NOL Net operating loss
OCI Other comprehensive (loss) income
Ortho Ortho Clinical Diagnostics Holdings plc
OTC Over-the-counter
PAMA Protecting Access to Medicare Act of 2014
PBO Projected benefit obligations
PCR Polymerase chain reaction
PHI Protected health information
PIPEDA Canada’s Personal Information Protection and Electronic Documents Act
PIPL China’s Personal Information Protection Law
PMA Premarket approval
POC Point-of-care
POL Physician office laboratory
PPACA The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act
QMS Quality Management System
QSR Quality System Regulation
Quidel Quidel Corporation
R&D Research and development
RPA Receivables purchase agreement, as amended on March 31, 2023, by and among Ortho-Clinical Diagnostics US FinanceCo I, LLC, as Seller, our wholly owned receivables financing subsidiary, Wells Fargo Bank, N.A., as administrative agent, Ortho-Clinical Diagnostics, Inc., as the Master Servicer and as an Originator, Quidel Corporation, as an Originator, and certain Purchasers
Revolving Credit Facility $800.0 million revolving credit facility under the Credit Agreement
ROU Right-of-use
RSUs Restricted stock units; includes time-based RSUs, performance-based RSUs and restricted stock awards
RSV Respiratory syncytial virus
SCCs Standard contractual clauses
SEC Securities and Exchange Commission
Securities Act Securities Act of 1933, as amended
SGC Security Governance Committee
SOFR Secured overnight financing rate
Stock Repurchase Program A stock repurchase program allowing the Company to repurchase up to $300.0 million of its common stock through August 17, 2024, which was authorized by our Board of Directors on August 17, 2022
Term Loan $2,750.0 million senior secured term loan facility under the Credit Agreement
U.K. United Kingdom
U.K. IDTA U.K. International Data Transfer Agreement
U.S. United States
USD United States dollar
VIP ORTHO VERSEIA ® Integrated Processor
121
SIGNATURES
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.
Q UIDEL O RTHO C ORPORATION
By /s/ B RIAN J. B LASER
Date: February 27, 2025
Brian J. Blaser
President and Chief Executive Officer
(Principal Executive Officer)
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 and in the capacities and on the dates indicated.
Signature Title Date
/s/ B RIAN J. B LASER
Chief Executive Officer
(Principal Executive Officer) February 27, 2025
Brian J. Blaser
/s/ J OSEPH M. B USKY
Chief Financial Officer
(Principal Financial and Accounting Officer) February 27, 2025
Joseph M. Busky
/s/ K ENNETH F. B UECHLER
Chairman of the Board February 27, 2025
Kenneth F. Buechler
/s/ J OHN R. C HIMINSKI
Director February 27, 2025
John R. Chiminski
/s/ E VELYN S. D ILSAVER
Director February 27, 2025
Evelyn S. Dilsaver
/s/ R ICHARD S. H UENNEKENS
Director February 27, 2025
Richard S. Huennekens
/s/ E DWARD L. M ICHAEL
Director February 27, 2025
Edward L. Michael
/s/ M ARY L AKE P OLAN
Director February 27, 2025
Mary Lake Polan
/s/ A NN D. R HOADS
Director February 27, 2025
Ann D. Rhoads
/s/ M ATTHEW W. S TROBECK
Director February 27, 2025
Matthew W. Strobeck
/s/ K ENNETH J. W IDDER
Director February 27, 2025
Kenneth J. Widder
/s/ J OSEPH D. W ILKINS J R .
Director February 27, 2025
Joseph D. Wilkins Jr.
122