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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve material risks and uncertainties. This discussion should be read in conjunction with the section entitled “Future Uncertainties and Forward-Looking Statements” on page 4 and the “Risk Factors” starting on page 26 of this Annual Report. In addition, our discussion of QuidelOrtho’s financial condition

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and results of operations in this Item 7 should be read in conjunction with our Consolidated Financial Statements and the related Notes included elsewhere in this Annual Report.

Overview

Our vision is to advance diagnostics to power a healthier future. With our expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, we aim to support clarity for clinicians and patients to help create better health outcomes. Our global infrastructure and commercial reach support our customers across more than 140 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. We operate globally with manufacturing facilities in the U.S., U.K. and China and with sales centers, administrative offices and warehouses located throughout the world.

We manage our business geographically to better align with the market dynamics of the specific geographic regions in which we operate, with our reportable segments being North America, EMEA, China, JPAC and Latin America. We generate our revenue in the following business units: Labs, Transfusion Medicine (Immunohematology and Donor Screening product categories), Point of Care and Molecular Diagnostics. We also generate non-core revenue, including through our contract manufacturing business and certain business collaborations, which accounted for $112.9 million, $94.2 million and $125.0 million for fiscal years ended 2025, 2024 and 2023, respectively.

For fiscal year ended 2025, Total revenues decreased by 2% to $2,730.2 million as compared to the prior year. For fiscal year ended 2024, Total revenues decreased by 7% to $2,782.9 million as compared to the prior year. These decreases were primarily driven by variability of our U.S. respiratory products, mainly due to a decrease in COVID-19 revenues, partially offset by an increase in flu revenues. Currency exchange rates did not significantly impact our growth rate for fiscal year ended 2025. Currency exchange rates had an unfavorable impact of approximately 60 basis points on our growth rate for fiscal year ended 2024. Our revenues can be highly concentrated over a small number of products, including certain of our respiratory products. For fiscal years ended 2025, 2024 and 2023, revenues related to our respiratory products accounted for approximately 15%, 18% and 24% of our Total revenues, respectively. The respiratory products revenue included revenue related to COVID-19 of $80.2 million, $184.9 million and $409.1 million for fiscal years ended 2025, 2024 and 2023, respectively.

Wind-Down of U.S. Donor Screening Portfolio

In February 2024, we initiated a wind-down plan to transition out of the U.S. donor screening portfolio. Specifically, we are winding-down the VIP platform and microplate assays, which are only sold in the U.S. and have a lower growth and margin profile. This wind-down will not affect any donor screening portfolio outside of the U.S. While we wind-down this U.S. donor screening portfolio, we will continue to support our existing customers and honor our contractual commitments. The winding-down of the U.S. donor screening portfolio, as compared to the prior years, contributed to the decline in revenue with a margin lower than our overall margin. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 3. Revenue” for more information. The wind-down of our U.S. donor screening portfolio is expected to be substantially complete by the first half of 2026.

Restructuring and Other Charges

In the second quarter of 2025, we launched multi-year, enterprise-wide cost-reduction, strategic productivity and margin improvement initiatives (the “Optimization Plan”) that aim to (i) realign our costs with our long-term revenue expectations, (ii) drive operational efficiencies in manufacturing and distribution cost bases and (iii) support and align with our strategy to invest in key priorities. The cumulative pre-tax charges to be incurred by us to implement the Optimization Plan are expected to be approximately $100 million through 2027. The Optimization Plan is expected to deliver net cost savings of approximately $50 million to be achieved through 2027. The key initiatives of the Optimization Plan are:

•Rationalization and consolidation of facilities to reduce operational costs, improve processes, and optimize resource allocation;

•A structured approach to procurement to drive identified sourcing cost savings; and

•A distribution rationalization plan, mainly in EMEA, to streamline a complex corporate structure to reduce costs and improve efficiency.

We continue to monitor our operations for cost-reduction, strategic productivity and margin improvement opportunities to streamline our operations globally and identify additional cost savings. We may expand our cost-reduction, strategic productivity and margin improvement initiatives in the future, the costs of which could be material.

Additionally, in the second quarter of 2025, we announced a strategic refocusing of our Molecular Diagnostics business, including our plan to discontinue the development of the SAVANNA platform, which exit we expect to be substantially complete by the first half of 2027, and our intent to acquire LEX Diagnostics.

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Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 17. Restructuring, Integration and Other Charges” for further details regarding these actions.

Recent Macroeconomic Trends and Challenges

In April 2025, the U.S. announced tariffs on imports from most countries, including significant tariffs on imports from the U.K., Canada, Mexico and China, leading to increasing trade and political tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. In addition, the U.S. has announced potential new tariffs and related tariff actions affecting companies in the pharmaceutical and biotechnology industries, including a Section 232 national security investigation of imports of personal protective equipment, medical consumables, and medical equipment, including devices. These actions and the related rising political tensions could negatively impact global macroeconomic conditions and the stability of global financial markets. Currently, as a result of recently effected tariffs, we are incurring incremental costs of parts and materials that we use to produce products, as well as incremental costs to ship finished goods to customers. Although the Company plans to, and we have thus far, substantially offset such incremental costs through operating measures, including supply chain adjustments, current and future tariffs could have a material adverse effect on our business, financial condition and results of operations, including through increased supply chain costs. While trade negotiations are ongoing and certain bilateral trade deals have been announced, there remains substantial uncertainty about the duration of existing tariffs, tariff levels, implementation of announced tariffs or imposition of additional tariffs, the potential implications of the Section 232 investigations, litigation challenging tariffs and whether additional tariffs or retaliatory actions may be imposed, modified or suspended. We continue to closely monitor these events as they unfold and assess their potential impact on our operations to inform our response strategy.

Outlook

Our financial performance and results of operations will depend on future developments and other factors that are highly uncertain, continuously evolving and unpredictable, including the occurrence, spread, severity, duration and emergence of new variants of respiratory diseases, including flu, strep, RSV and COVID-19.

Demand for our respiratory products, which includes our COVID-19 products, declined in 2025 compared to 2024 due to the continued decreased occurrence, severity and duration of COVID-19 in an endemic environment. We expect overall demand for our non-respiratory and respiratory products to continue to fluctuate and pricing pressures on certain products to persist as a result of a number of factors, including increased supply, emergence and spread of new variants, and the demands of the respiratory season, which are variable and typically more prevalent during the fall and winter.

A recent research report was issued regarding the potential for the adoption of a dry chemistry VBP program in the Jiangxi province of China. At this time, we have no indication that such a program will be implemented or if our products would be included in such a program. Should this occur, we would seek to implement remediation efforts to offset potential costs. Based on current information, we believe that any potential business impact would likely be insignificant to our total annualized revenue.

Because our business environment is highly competitive, our long-term growth and profitability will depend in part on our ability to retain and grow our current customers and attract new customers through developing and delivering new and improved products and services that meet our customers’ needs and expectations, including with respect to product performance, product offerings, cost, automation and other work-flow efficiencies. We expect to continue to evaluate strategic opportunities to (i) expand our product lines and services, production capabilities, technologies and geographic footprint and address other business challenges and opportunities, and (ii) rationalize and consolidate facilities with the goal to improve our long-term results.

While we expect the revenues and financial results from our non-respiratory and respiratory products to be affected by the highly competitive environment and our respiratory products to be affected by the demands of the respiratory season, we intend to continue our focus on prudently managing our business and delivering improved financial results, while at the same time striving to introduce new products and services into the market.

Results of Operations

Comparison of fiscal years ended 2025, 2024 and 2023

Our fiscal year is the 52 or 53 weeks ending the Sunday closest to December 31. Fiscal years ended 2025, 2024 and 2023 were 52 weeks.

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Revenues

The following table compares Total revenues by business unit for fiscal years ended 2025, 2024 and 2023:

Fiscal Year Ended

(1) Certain reclassifications have been made to prior period amounts to conform to the current period presentation.

(2) As a result of the wind-down of the U.S. donor screening portfolio, the Transfusion Medicine business unit is shown in its two product categories: Immunohematology and Donor Screening.

For fiscal year ended 2025, Total revenues decreased to $2,730.2 million from $2,782.9 million for the prior year. Labs revenue increased 6% compared to the prior year, primarily due to growth in reagents, consumables and services, partially offset by a decline in instrument revenue. Immunohematology revenue increased 4% compared to the prior year, primarily due to reagent growth. Donor Screening revenue decreased 54% compared to the prior year, primarily due to the wind-down of the U.S. donor screening business. Point of Care revenue decreased 13% compared to the prior year, primarily due to decreases in sales of QUICKVUE SARS and SOFIA SARS Antigen assays. Molecular Diagnostics revenue increased 10% compared to the prior year, driven by higher SAVANNA revenue. Currency exchange rates did not significantly impact our growth rate for fiscal year ended 2025.

For fiscal year ended 2024, Total revenues decreased to $2,782.9 million from $2,997.8 million for the prior year. The increase in Labs revenue was primarily related to growth in reagents, consumables and services, partially offset by decreased COVID-19 and non-core revenue compared to the prior year. Immunohematology revenue increased 2% compared to the prior year, primarily due to reagent growth. Donor Screening revenue decreased 15% compared to the prior year, primarily due to the wind-down of the U.S. donor screening business. The Point of Care business unit contributed to revenue decline, driven by a decrease of $188.6 million in sales of QUICKVUE SARS Antigen assays, primarily due to a COVID-19 government award in the prior year, and a decrease of $5.8 million in sales of SOFIA SARS Antigen assays. Molecular Diagnostics sales decreased by $7.7 million, primarily driven by lower demand. Currency exchange rates had an unfavorable impact of approximately 60 basis points on our growth rate for fiscal year ended 2024.

Cost of Sales, Excluding Amortization of Intangible Assets

Cost of sales, excluding amortization of intangible assets, was $1,456.0 million, or 53.3% of Total revenues, for fiscal year ended 2025, compared to $1,496.4 million, or 53.8% of Total revenues, for fiscal year ended 2024. The decrease in cost of sales, excluding amortization of intangible assets as a percentage of revenue, was driven primarily by procurement-related cost-savings initiatives actioned in 2024.

Cost of sales, excluding amortization of intangible assets, was $1,496.4 million, or 53.8% of Total revenues, for fiscal year ended 2024, compared to $1,500.7 million, or 50.1% of Total revenues, for fiscal year ended 2023. The increase in cost of sales, excluding amortization of intangible assets as a percentage of revenue, was driven primarily by product mix, partially offset by a prior year COVID-19 government award, along with the corresponding inventory reserve release of $39 million.

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Operating Expenses

The following table summarizes operating expenses for fiscal years ended 2025, 2024 and 2023:

Fiscal Year Ended

Goodwill impairment charge 700.7 N/M 1,822.6 N/M — N/M

Asset impairment charge 9.7 N/M 56.9 N/M 4.5 N/M

* N/M - Not meaningful

Selling, Marketing and Administrative Expenses

Selling, marketing and administrative expenses for fiscal year ended 2025 decreased by $20.5 million, or 2.7%, to $746.3 million from $766.8 million for the prior year, primarily due to lower costs of outside services and lower compensation costs related to cost-savings initiatives actioned in 2024.

Selling, marketing and administrative expenses for fiscal year ended 2024 increased by $3.6 million, or 0.5%, to $766.8 million from $763.2 million for the prior year, primarily due to higher incentive-based employee compensation costs, partially offset by compensation costs related to cost-savings initiatives and lower advertising costs.

Research and Development Expense

Research and development expense for fiscal year ended 2025 decreased by $32.5 million, or 14.9%, to $186.2 million from $218.7 million for the prior year, primarily due to lower third-party material and outside service spend, compensation costs and clinical costs related to cost-savings initiatives actioned in 2024.

Research and development expense for fiscal year ended 2024 decreased by $26.3 million, or 10.7%, to $218.7 million from $245.0 million for the prior year, primarily due to lower employee compensation costs and costs of outside services.

Amortization of Intangible Assets

Amortization of intangible assets for fiscal years ended 2025, 2024 and 2023 was $189.2 million, $203.4 million and $204.8 million, respectively. The decrease in amortization expense in fiscal year ended 2025compared to fiscal year ended 2024 was primarily driven by intangible assets that became fully amortized by the end of 2024.

Restructuring, integration and other charges

Restructuring, integration and other charges were $263.6 million, $127.2 million and $113.4 million for fiscal years ended 2025, 2024 and 2023, respectively. The increase in costs in fiscal year ended 2025 compared to fiscal year ended 2024 was primarily driven by restructuring and other charges. The increase in costs in fiscal year ended 2024 compared to fiscal year ended 2023 was primarily due to integration charges related to employee compensation and consulting costs. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 17. Restructuring, Integration and Other Charges” for more information.

Goodwill Impairment Charge

During fiscal years ended 2025 and 2024, we recognized non-cash goodwill impairment charges of $700.7 million and $1.8 billion, respectively. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 8. Goodwill and Intangible Assets, Net” for more information.

Asset Impairment Charge

During fiscal years ended 2025 and 2024, we recognized impairment charges of $9.7 million and $56.9 million, respectively, related to the long-lived assets classified as assets held for sale. Refer to Part II, Item 8, “Financial Statements and

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Supplementary Data—Note 7. Assets Held for Sale” for more information. Asset impairment charge was $4.5 million for fiscal year ended 2023.

Other Operating Expenses

Other operating expenses were $97.7 million, $51.8 million and $27.1 million for fiscal years ended 2025, 2024 and 2023, respectively. The increase in costs in fiscal year ended 2025 compared to fiscal year ended 2024 was primarily related to (i) the contract termination cost of $65 million and (ii) the legal accrual in connection with the resolution of a contractual dispute, partially offset by (iii) a $20.0 million write off of the tax assessment refund in fiscal year ended 2024 and (iv) decline in profit sharing expense for our Joint Business. The increase in costs in fiscal year ended 2024 compared to fiscal year ended 2023 was primarily related to the $20.0 million write off of the tax assessment refund. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 3. Revenue” for information related to the contract termination cost and —Note 4. Segment and Geographic Information” for more information.

Non-operating Expenses

The following table summarizes non-operating expenses, net for fiscal years ended 2025, 2024 and 2023:

Fiscal Year Ended

Loss on extinguishment of debt 5.1 — — N/M N/M

* N/M - Not meaningful

Interest Expense, Net

Interest expense, net was $177.6 million, $163.5 million and $147.6 million for fiscal years ended 2025, 2024 and 2023, respectively. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 9. Borrowings” for more information.

Loss on Extinguishment of Debt

Loss on extinguishment of debt was $5.1 million for fiscal year ended 2025, and was related to the termination of the Prior Credit Agreement. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 9. Borrowings” for more information.

Other Expense, Net

Other expense, net was $5.8 million, $7.1 million and $20.6 million for fiscal years ended 2025, 2024 and 2023, respectively. The decrease in Other expense, net in fiscal year ended 2025 compared to fiscal year ended 2024 was primarily related to Prior Credit Agreement amendment fees in the prior year, partially offset by net foreign currency losses. The decrease in Other expense, net in fiscal year ended 2024 compared to fiscal year ended 2023 was primarily related to (i) a prior year release of tax reserves upon the settlement of certain U.S. federal tax matters, with an offsetting benefit recorded to income tax expense, and (ii) Prior Credit Agreement amendment fees, partially offset by loss on investments in the prior year. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 5. Income Taxes” for more information.

Income Taxes

For fiscal years ended 2025 and 2024, we recognized income tax expense of $24.1 million in relation to loss before taxes of $1,107.7 million and an income tax benefit of $79.5 million in relation to loss before taxes of $2,131.5 million, resulting in effective tax rates of (2.2)% and 3.7%, respectively. For fiscal years ended 2025 and 2024, the effective tax rate differed from the U.S. federal statutory rate primarily due to goodwill impairment charges that were nondeductible for tax purposes.

We recognized an income tax benefit of $79.5 million, resulting in an effective tax rate of 3.7% for fiscal year ended 2024, compared to an income tax benefit of $19.0 million, resulting in an effective tax rate of 65.3% for fiscal year ended 2023. For fiscal year ended 2023, the effective tax rate differed from the U.S. federal statutory rate, primarily due to a decrease in our pre-acquisition U.S. federal reserves for uncertain tax positions due to settlement of certain tax matters partially offset by net operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances and Global Intangible Low-Taxed Income.

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On July 4, 2025, the OBBBA was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. Our results for the fiscal year ended 2025 include the impacts of OBBBA on our Consolidated Financial Statements.

Segment Results

We operate under five geographically-based reportable segments: North America, EMEA, China, JPAC and Latin America. Beginning in the fourth quarter of 2025, we determined that the JPAC segment, previously included in “Other,” meets the quantitative thresholds for separate reporting under ASC 280. This determination was based on JPAC’s segment revenue exceeding 10% of the combined reported segment revenue. As Latin America is the only remaining immaterial operating segment, results are reported separately. This change in segment reporting did not have an impact on our previously reported Consolidated Financial Statements. Prior periods have been revised to align with the current period presentation.

The key indicators that we monitor are as follows:

•Total revenues — This measure is discussed in the section entitled “Results of Operations.”

•Adjusted EBITDA — Adjusted EBITDA by reportable segment is used by our management to measure and evaluate the internal operating performance of our reportable segments. It is also the basis for calculating certain management incentive compensation programs. We believe that this measurement is useful to investors as a way to analyze the underlying trends in our core business, including at the segment level, consistently across the periods presented and to evaluate performance under management incentive compensation programs. Adjusted EBITDA consists of Net loss before Interest expense, net, Provision for (benefit from) income taxes and depreciation and amortization and eliminates (i) certain non-operating income or expense items, and (ii) impacts of certain non-cash, unusual or other items that are included in Net loss and that we do not consider indicative of our ongoing operating performance. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 4. Segment and Geographic Information” for a reconciliation of Adjusted EBITDA by reportable segment to Loss before income taxes.

North America

Total revenues and Adjusted EBITDA for North America were as follows:

Fiscal Year Ended

Total revenues were $1,488.9 million for fiscal year ended 2025, compared to $1,619.8 million for fiscal year ended 2024. The decrease was primarily driven by decreases in sales of QUICKVUE and SOFIA SARS Antigen assays and the wind-down of the U.S. donor screening business, partially offset by an increase in Labs revenues.

Total revenues were $1,619.8 million for fiscal year ended 2024, compared to $1,877.1 million for fiscal year ended 2023. The decrease was primarily driven by (i) a decrease in Point of Care revenues, primarily due to a COVID-19 government award in the prior year, (ii) the wind-down of the U.S. donor screening business and (iii) the settlement award from a third party related to one of our collaboration agreements in the prior year.

Adjusted EBITDA was $807.0 million for fiscal year ended 2025, compared to $892.1 million for fiscal year ended 2024. The decrease was primarily driven by decreases in sales of QUICKVUE and SOFIA SARS Antigen assays and the wind-down of the U.S. donor screening business, partially offset by an increase in Labs revenues and lower operating expenses due to cost-savings initiatives.

Adjusted EBITDA was $892.1 million for fiscal year ended 2024, compared to $1,025.2 million for fiscal year ended 2023. The decrease was primarily driven by (i) a COVID-19 government award in the prior year, along with the corresponding inventory reserve release of $39 million, (ii) the wind-down of the U.S. donor screening business and (iii) the settlement award from a third party related to one of our collaboration agreements in the prior year, partially offset by a decrease in employee compensation costs and other operating expenses.

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EMEA

Total revenues and Adjusted EBITDA for EMEA were as follows:

Fiscal Year Ended

Total revenues were $360.7 million for fiscal year ended 2025, compared to $335.8 million for fiscal year ended 2024. The increase was primarily driven by increases in Immunohematology and Point of Care revenues.

Total revenues were $335.8 million for fiscal year ended 2024, compared to $327.3 million for fiscal year ended 2023. The increase was primarily driven by increases in Immunohematology and Point of Care revenues.

Adjusted EBITDA was $82.6 million for fiscal year ended 2025, compared to $46.5 million for fiscal year ended 2024. The increase was primarily driven by increases in Immunohematology and Point of Care revenues, product mix and lower distribution and selling costs and other operating expenses due to cost-savings initiatives.

Adjusted EBITDA was $46.5 million for fiscal year ended 2024, compared to $41.0 million for fiscal year ended 2023. The increase was primarily driven by increases in Immunohematology and Point of Care revenues.

China

Total revenues and Adjusted EBITDA for China were as follows:

Fiscal Year Ended

Total revenues were $334.7 million for fiscal year ended 2025, compared to $325.0 million for fiscal year ended 2024. The increase was primarily driven by an increase of 5% in Labs revenues, partially offset by decreases in Donor Screening and Immunohematology revenues.

Total revenueswere $325.0 million for fiscal year ended 2024, compared to $310.1 million for fiscal year ended 2023. The increase was primarily driven by an increase in Labs revenues, partially offset by a decrease in Point of Care revenues.

Adjusted EBITDA was $141.2 million for fiscal year ended 2025, compared to $130.5 million for fiscal year ended 2024. The increase was primarily driven by an increase in Labs revenues, partially offset by decreases in Donor Screening and Immunohematology revenues.

Adjusted EBITDA was $130.5 million for fiscal year ended 2024, compared to $127.2 million for fiscal year ended 2023. The increase was primarily driven by an increase in Labs revenues, partially offset by a decrease in Point of Care revenues and the impact from changes in product mix.

JPAC

Total revenues and Adjusted EBITDA for JPAC were as follows:

Fiscal Year Ended

Total revenues were $293.0 million for fiscal year ended 2025, compared to $279.4 million for fiscal year ended 2024. The increase was primarily driven by increases in Labs and Immunohematology revenues.

Total revenues were $279.4 million for fiscal year ended 2024, compared to $272.7 million for fiscal year ended 2023. The increase was primarily driven by an increase in Labs revenues, partially offset by a decrease in Immunohematology revenues.

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Adjusted EBITDA was $73.2 million for fiscal year ended 2025, compared to $69.9 million for fiscal year ended 2024. The increase was primarily driven by increases in Labs and Immunohematology revenues.

Adjusted EBITDA was $69.9 million for fiscal year ended 2024, compared to $58.5 million for fiscal year ended 2023. The increase was primarily driven by an increase in Labs revenues and a decrease in operating expenses, partially offset by a decrease in Immunohematology revenues.

Latin America

Total revenues and Adjusted EBITDA for Latin America were as follows:

Fiscal Year Ended

Total revenues were $252.9 million for fiscal year ended 2025, compared to $222.9 million for fiscal year ended 2024. The increase was primarily driven by an increase in Labs revenues.

Total revenues were $222.9 million for fiscal year ended 2024, compared to $210.6 million for fiscal year ended 2023. The increase was primarily driven by increases in Labs and Immunohematology revenues, partially offset by a decrease in Point of Care revenues.

Adjusted EBITDA was $78.4 million for fiscal year ended 2025, compared to $63.6 million for fiscal year ended 2024. The increase was primarily driven by an increase in Labs revenues, partially offset by an increase in operating expenses.

Adjusted EBITDA was $63.6 million for fiscal year ended 2024, compared to $56.8 million for fiscal year ended 2023. The increase was primarily driven by increases in Labs and Immunohematology revenues, partially offset by an increase in operating expenses and a decrease in Point of Care revenues.

Liquidity and Capital Resources

As of December 28, 2025 and December 29, 2024, our principal sources of liquidity consisted of the following:

Cash and cash equivalents $ 169.8 $ 98.3

Amount available to borrow under the Revolving Credit Facility $ 596.6 $ 589.0

Working capital including cash and cash equivalents, current $ 481.2 $ 220.1

As of December 28, 2025, we had $169.8 million in Cash and cash equivalents, a $71.5 million increase from December 29, 2024. Our cash requirements fluctuate as a result of numerous factors, including cash generated from operations, progress in R&D, capital expansion projects and acquisition, restructuring and business development activities. We believe our organizational structure allows us the necessary flexibility to move funds throughout our subsidiaries to meet our operational working capital needs.

Debt Capitalization

On August 21, 2025, we entered into the Credit Agreement by and among us, as borrower, Bank of America, and the other lenders and L/C issuers party thereto. Pursuant to the Credit Agreement, the Lenders provided us with (i) a $1.15 billion Term Loan A, (ii) a $100.0 million DDTL Term Loan A, (iii) a $1.45 billion Term Loan B and (iv) a $700.0 million Revolving Credit Facility. The Financing is guaranteed by certain of our material domestic subsidiaries and is secured by liens on substantially all of our assets and the Guarantors’ assets, excluding real property and certain other types of excluded assets. Loans under the Credit Agreement will bear interest at a rate equal to the Term SOFR, plus the Applicable Rate, or Base Rate, plus the Applicable Rate (each as defined in the Credit Agreement). On the Closing Date, we borrowed the entire amount of the Term Loan A and the Term Loan B, and the effective interest rates as of December 28, 2025 were 6.87% and 8.43%, respectively.

We used the proceeds of the Term Loan A and the Term Loan B, along with its cash on hand, to (i) repay the remaining $2.21 billion and $490.0 million owed under the previous term loan and previous revolving credit facility, respectively, under the Prior Credit Agreement, which was terminated upon such repayment, including principal, accrued interest and outstanding fees and (ii) pay the fees and expenses incurred in connection with the Financing.

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Availability under the Revolving Credit Facility, after deducting letters of credit of $23.4 million and $80.0 million borrowings outstanding, was $596.6 million as of December 28, 2025.

The Term Loans are subject to quarterly amortization at a quarterly rate of 1.25% and 0.25% of the aggregate initial principal amount of the Term A Loan and the Term B loan, respectively, as are set forth in the Credit Agreement. The Term Loan A Facilities and the Revolving Credit Facility will mature on August 21, 2030, and the Term Loan B will mature on August 21, 2032. The Company must prepay loans outstanding under the Credit Agreement in an amount equal to the Net Cash Proceeds (as defined in the Credit Agreement) from (i) certain property dispositions and (ii) the receipt of certain other amounts not in the ordinary course of business, such as certain insurance proceeds and condemnation awards, in each case, if not reinvested within a specified time period as contemplated in the Credit Agreement.

The Credit Agreement contains affirmative and negative covenants that are customary for credit agreements of this nature. The negative covenants include, among other matters, limitations on asset sales, mergers, indebtedness, liens, investments and transactions with affiliates. The Credit Agreement contains two financial covenants: (i) a maximum Consolidated Leverage Ratio (as defined in the Credit Agreement) as of the last day of each fiscal quarter of (a) 4.50 to 1.00 for each fiscal quarter in the first three years following the Closing Date and (b) 4.25 to 1.00 for each fiscal quarter thereafter; and (ii) a minimum Consolidated Interest Coverage Ratio (as defined in the Credit Agreement) of 3.00 to 1.00 as of the end of any fiscal quarter for the most recently completed four fiscal quarters. We were in compliance with the financial covenants as of December 28, 2025.

Receivables Purchase Agreement

On March 31, 2023, we entered into an amendment to our existing RPA, by and among Ortho-Clinical Diagnostics US FinanceCo I, LLC (“Ortho FinanceCo I”), as Seller, our wholly owned receivables financing subsidiary, Wells Fargo Bank, N.A., as administrative agent (the “Agent”), Ortho-Clinical Diagnostics, Inc., as the Master Servicer and as an Originator (“Ortho Inc.”), Quidel, as an Originator, and certain Purchasers. Under the RPA, as amended, Ortho FinanceCo I may sell receivables in amounts up to a $150.0 million limit, subject to certain conditions, including that, at any date of determination, the aggregate capital paid to Ortho FinanceCo I does not exceed a “capital coverage amount,” equal to an adjusted net receivables pool balance minus a required reserve. Ortho FinanceCo I has guaranteed the prompt payment of the sold receivables, and to secure the prompt payment and performance of such guaranteed obligations, Ortho FinanceCo I has granted a security interest to the Agent, for the benefit of the Purchasers, in all assets of Ortho FinanceCo I. Ortho Inc., in its capacity as Master Servicer under the RPA, is responsible for administering and collecting the receivables and has made customary representations, warranties, covenants and indemnities. We have also provided a performance guaranty for the benefit of Ortho FinanceCo I to cause the due and punctual performance by Ortho Inc. of its obligations as Master Servicer.

Capital Expenditures

Annual capital expenditures, including investments, net of proceeds from government assistance allocated to fixed assets, were approximately $182 million, $195 million and $196 million in fiscal years ended 2025, 2024 and 2023, respectively. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities and other facility-related activities.

Cash Flow Summary

Fiscal Year Ended

Net cash provided by operating activities $ 105.2 $ 83.0 $ 280.2

Net cash used for investing activities (192.7) (149.9) (187.6)

Net cash provided by (used for) financing activities 155.8 48.8 (265.8)

Effect of exchange rates on cash 3.0 (2.9) (1.2)

Fiscal Year EndedDecember 28, 2025

Cash provided by operating activities was $105.2 million for fiscal year ended 2025, and reflected a net loss of $1,131.8 million and non-cash adjustments of $1,362.8 million, primarily associated with a goodwill impairment charge, depreciation and amortization, asset write off related to restructuring, integration and other charges, and stock-based compensation expense, partially offset by $148.3 million and $117.5 million in cash outflows for inventories and accounts receivable, respectively.

Cash used for investing activities was $192.7 million for fiscal year ended 2025, and was primarily related to purchases of property, plant, equipment, investments and intangibles.

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Cash provided by financing activities was $155.8 million for fiscal year ended 2025, and was primarily related to proceeds from long-term borrowings, net of discount and debt issuance costs of $2,559.3 million, offset by payments on long-term borrowings of $2,289.2 million and net payments from the Revolving Credit Facility of $118.0 million.

Fiscal Year EndedDecember 29, 2024

Cash provided by operating activities was $83.0 million for fiscal year ended 2024, and reflected a net loss of $2,052.0 million and non-cash adjustments of $2,293.7 million, primarily associated with a goodwill impairment charge and change in deferred tax assets and liabilities, as well as depreciation and amortization, asset impairment charge and stock-based compensation expense. Cash provided by operating activities was also driven by $134.1 million of cash outflows for inventories.

Cash used for investing activities was $149.9 million for fiscal year ended 2024, and was primarily related to $195.1 million in purchases of property, plant, equipment, investments and intangibles, partially offset by $9.3 million in net proceeds from the sale of the McKellar, San Diego, CA facility. We also purchased $7.2 million and sold $63.1 million of marketable securities during fiscal year ended 2024.

Cash provided by financing activities was $48.8 million for fiscal year ended 2024, and was primarily related to net proceeds from the Revolving Credit Facility of $198.0 million, partially offset by payments on long-term borrowings of $143.0 million.

Fiscal Year EndedDecember 31, 2023

Cash provided by operating activities was $280.2 million for fiscal year ended 2023, and reflected a net loss of $10.1 million and non-cash adjustments of $485.2 million, primarily associated with depreciation and amortization, stock-based compensation expense, change in deferred tax assets and liabilities and accretion of interest on deferred consideration. In addition, we benefited from collections on accounts receivables, which contributed $160.0 million to Cash provided by operating activities, offset by other changes in working capital, including $211.6 million of cash outflows for inventories.

Cash used for investing activities was $187.6 million for fiscal year ended 2023, and was primarily related to $209.3 million in purchases of property, equipment, investments and intangibles and $13.5 million in proceeds from government assistance allocated to fixed assets. We also purchased $60.1 million and sold $78.3 million of marketable securities during fiscal year ended 2023.

Cash used for financing activities was $265.8 million for fiscal year ended 2023, and was primarily related to payments on long-term borrowings of $228.0 million, payments of deferred consideration of $30.3 million and payments of tax withholdings related to vesting of stock-based awards of $13.5 million.

Liquidity Outlook

Short-term Liquidity Outlook

Our primary source of liquidity, other than our holdings of Cash and cash equivalents, has been cash flows from operations. Cash generated from operations provides us with the financial flexibility we need to meet normal operating, investing and financing needs. We anticipate that our current Cash and cash equivalents, together with cash provided by operating activities and amounts available under our Revolving Credit Facility, will be sufficient to fund our near-term capital and operating needs for at least the next 12 months.

Normal operating needs include the planned costs to operate our business, including amounts required to fund working capital, R&D and capital expenditures. Our primary short-term needs for capital, which are subject to change, include expenditures related to:

•interest on and repayments of our long-term borrowings and lease obligations;

•acquisitions of property, equipment and other fixed assets in support of our manufacturing facility expansions;

•the continued advancement of R&D efforts;

•support of commercialization efforts related to our current and future products, including support of our direct sales force and field support resources; and

•potential strategic acquisitions and investments.

Due to the risks inherent in the product development process, we are unable to estimate with meaningful certainty the costs we will incur in the continued development of our product candidates for commercialization. Our R&D costs may be substantial as we move product candidates into preclinical and clinical trials and advance our existing product candidates into later stages of development.

The primary purposes of our capital expenditures are to invest in manufacturing capacity expansion, acquire certain of our instruments,acquire scientific equipment, purchase or develop IT and implement facility improvements. We plan to fund the capital expenditures with the cash on our balance sheet.

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We are focused on expanding the number of instruments placed in the field and solidifying long-term contractual relationships with customers. In order to achieve this goal, in certain jurisdictions where it is permitted, we have leveraged a reagent rental model that has been recognized as more attractive to certain customers. In this model, we lease, rather than sell, instruments to our customers. Over the term of the contract, the purchase price of the instrument is embedded in the price of the assays and reagents. Going forward, we intend to increase the number of reagent rental placements in developed markets, a strategy that we believe is beneficial to our commercial goals because it lowers our customers’ upfront capital costs and therefore allows purchasing decisions to be made at the lab manager level. For these same reasons, the reagent rental model also benefits our commercial strategy in emerging markets, where permitted by law. We believe that the shift in our sales strategy will grow our installed base, thereby increasing sales of higher-margin assays, reagents and other consumables over the life of the customer contracts and enhancing our recurring revenue and cash flows. During fiscal year ended 2025, we transferred $167.3 million of instrument inventories from Inventories to Property, plant and equipment, net, further increasing our investment in property, plant and equipment.

Long-term Liquidity Outlook

Our future capital requirements and the adequacy of our available funds to service any long-term debt outstanding and to fund working capital expenditures and business development efforts will depend on many factors, including:

•our ability to realize revenue growth from our new technologies and create innovative products in our markets;

•outstanding debt and covenant restrictions;

•our ability to leverage our operating expenses to realize operating profits with revenue growth;

•competing technological and market developments; and

•our entry into strategic collaborations with other companies or acquisitions of other companies or technologies to enhance or complement our product and service offerings.

Contractual Obligations and Off-Balance Sheet Arrangements

In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations relating to debt, income taxes, lease arrangements, purchase obligations and licensing arrangements are provided in Part II, Item 8, “Financial Statements and Supplementary Data—Note 9. Borrowings,” “—Note 5. Income Taxes,” “—Note 10. Leases” and “—Note 13. Commitments and Contingencies,” respectively.

We do not have any off-balance sheet arrangements that are material or reasonably likely to become material to our financial condition or results of operations.

Recent Accounting Pronouncements

Information about recent accounting pronouncements is included in Part II, Item 8, “Financial Statements and Supplementary Data—Note 1. Basis of Presentation and Summary of Significant Accounting Policies.”

Critical Accounting Estimates

Our discussion and analysis of our financial condition and results of operations are based on our Consolidated Financial Statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses. Our critical accounting estimates are those that significantly affect our financial condition and results of operations and require the most difficult, subjective or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates.

We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our Consolidated Financial Statements.

Allowance for Contractual Rebates

We record revenues primarily from product sales. These revenues are recorded net of rebates that are estimated at the time of sale, and are largely driven by various customer program offerings, including special pricing agreements and promotions. Rebates are calculated based on historical experience, estimated distributor inventory balances, contractual and statutory requirements and other relevant information, and are recorded as a reduction of sales. These rebates are presented as either an offset to trade accounts receivable or a liability based on forms of settlement. The allowance for contractual rebates involves estimating adjustments to revenue based on a high volume of data including inputs from third-party sources. In addition, the determination of such adjustments includes estimating rebate percentages which are dependent on estimated end-user sales mix

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and customer contractual terms, which vary across customers, the related balance of which was $28.7 million of our rebate reserves at December 28, 2025.

Goodwill and Intangible Assets

The useful lives of intangible assets with definite lives are based on the expected number of years the asset will generate revenue or otherwise be used by us and the related amortization is based on the straight-line method. Goodwill, which has an indefinite life, is not amortized but instead is tested at least annually for impairment, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include:

•the asset’s ability to continue to generate income from operations and positive cash flow in future periods;

•any volatility or significant decline in our stock price and market capitalization compared to our net book value;

•loss of legal ownership or title to an asset;

•significant changes in our strategic business objectives and utilization of our assets; and

•the impact of significant negative industry or economic trends.

If a change were to occur in any of the above-mentioned factors or estimates, the likelihood of a material change in our reported results would increase.

For goodwill, the entity has the option to first assess qualitative factors to determine whether it is necessary to perform the quantitative goodwill impairment test. The quantitative impairment test compares the fair value of a reporting unit with the carrying amount, including goodwill. If the fair value of a reporting unit exceeds its carrying amount, goodwill is considered not impaired; otherwise, goodwill is impaired and the loss is recorded.

As a result of the identification of indicators of impairment during the first quarter of 2024, we performed an interim impairment test that resulted in a non-cash goodwill impairment charge of $1.7 billion for the North America reporting unit. For our annual evaluation for impairment of goodwill as of September 30, 2024, we bypassed the qualitative assessment and proceeded directly to the quantitative goodwill impairment test for all reporting units. We concluded that the China and JPAC reporting units’ carrying values exceeded their respective estimated fair values. As a result, we recorded non-cash goodwill impairment charges of $17.3 million and $61.4 million in the fourth quarter of 2024 for the China and JPAC reporting units, respectively.

During the third quarter of 2025, the sustained decline in our stock price and market capitalization was a triggering event requiring an interim goodwill impairment assessment for all reporting units. Based on our interim goodwill impairment assessment in the third quarter of 2025, we concluded that the EMEA, China and Latin America reporting units’ carrying values exceeded their respective fair values. As a result, we recorded a non-cash goodwill impairment charge of $614.8 million, $68.1 million and $17.8 million in the third quarter of 2025 for the EMEA, China and Latin America reporting units, respectively, which represented a full impairment of the goodwill allocated to these reporting units.

This quantitative analysis required us to make estimates and assumptions in order to calculate the fair value of our reporting units. The quantitative goodwill assessment for all reporting units consisted of a fair value calculation that combines an income approach, using a discounted cash flow method, and a market approach, using the guideline public company method. The quantitative goodwill impairment assessment requires the application of a number of significant assumptions, including estimates of future revenue growth rates, EBITDA margins, discount rates and market multiples. The projected future revenue growth rates and EBITDA margins, and the resulting projected cash flows are based on historical experience and internal annual operating plans reviewed by management, extrapolated over the forecast period. Discount rates are determined using a weighted average cost of capital adjusted for risk factors specific to the reporting units. Market multiples are based on the guideline public company method using comparable publicly traded company multiples of revenue and EBITDA for a group of benchmark companies.

We believe the assumptions that were used in the quantitative goodwill impairment assessment are reasonable and consistent with assumptions that would be used by other marketplace participants.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 8. Goodwill and Intangible Assets, Net” for more information on the goodwill impairment recognized in 2024 and 2025.

Income Taxes

Significant judgment is required in determining our provision for income taxes, current tax assets and liabilities, deferred tax assets and liabilities, and our future taxable income, both as a whole and in various tax jurisdictions, for purposes of assessing our ability to realize future benefit from our deferred tax assets. A valuation allowance may be established to reduce our deferred tax assets to the amount that is considered more likely than not to be realized through the generation of future taxable income and other tax planning opportunities. As of December 28, 2025, we had a valuation allowance of $249.8 million, which

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represents the portion of our deferred tax assets that management believes is not more likely than not to be realized. We will continue to assess the need for a valuation allowance on our deferred tax assets by evaluating both positive and negative evidence that may exist.

We recognize liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained during an audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While we believe that we have appropriate support for the positions taken on our tax returns, we regularly assess the potential outcome of examinations by tax authorities in determining the adequacy of our provision for income taxes. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 5. Income Taxes” for more information on income taxes.

Inventory Valuations

We periodically review inventory for both potential obsolescence and potential declines in anticipated selling prices. In this review, we make assumptions about the future demand for and market value of the inventory and based on these assumptions estimate the amount of any obsolete, unmarketable, slow moving or overvalued inventory. We write down the value of our inventories by an amount equal to the difference between the cost of the inventory and the net realizable value. If actual market conditions are less favorable than those projected by management at the time of the assessment, however, additional inventory write-downs may be required, which could reduce our earnings.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Our business and financial results are affected by fluctuations in world financial markets, including interest rates and currency exchange rates. We manage these risks through normal operating and financing activities and, when deemed appropriate, through the use of derivative financial instruments. We have policies governing our use of derivative instruments, and we do not enter into financial instruments for trading or speculative purposes.

Interest Rate Risk

We are subject to interest rate risk in connection with our long-term debt. Our principal interest exposure relates to outstanding amounts under our Credit Agreement. Assuming facilities under the Credit Agreement are fully drawn, each one-eighth percentage point increase or decrease in the applicable interest rates would correspondingly change our interest expense on our outstanding borrowings under the Credit Agreement by approximately $4.1 million per year before considering the impact of derivative instruments.

We have interest rate swap contracts with a total notional value of $1.6 billion to hedge future interest rate exposures on variable rate debt, including the Revolving Credit Facility and Term Loans.

Foreign Currency Exchange Risk

We are exposed to foreign currency exchange risk by virtue of our international operations. These risks include the translation of local currency balances of foreign subsidiaries, transaction gains and losses associated with intercompany balances with foreign subsidiaries and transactions denominated in currencies other than the functional currency of the local jurisdiction. We derived approximately 47% of our Total revenues for the fiscal year ended December 28, 2025, from operations outside the U.S. For translation of operations in non-U.S. Dollar currencies, the local currency of most entities is the functional currency.

We have entered into foreign currency forward contracts to manage our exposures on foreign currency denominated firm commitments and forecasted foreign currency denominated intercompany and third-party transactions. We had forward contracts outstanding with a total notional amount of $1.9 billion as of December 28, 2025, with maturity dates through December 2026.

A sensitivity to changes in the value of the U.S. dollar on foreign currency denominated derivatives and investments indicated that if the U.S. dollar uniformly weakened by 10% against all currency exposures of the Company at December 28, 2025, Loss before income taxes would have increased by approximately $8.1 million in fiscal year ended 2025. Because the Company was in a net short (payable) position relative to its major foreign currencies after consideration of forward contracts, a uniform weakening of the U.S. dollar will yield the largest overall potential net loss in earnings due to exchange. This measurement assumes that a change in one foreign currency relative to the U.S. dollar would not affect other foreign currencies relative to the U.S. dollar. Although not predictive in nature, the Company believes that a 10% threshold reflects reasonably possible near-term changes in the Company’s major foreign currency exposures relative to the U.S. dollar.

The Company also uses forward exchange contracts to hedge a portion of its net investment in foreign operations against movements in exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation.

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Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 14. Derivative Instruments and Hedging Activities” for additional information related to such forward contracts.

Credit Risk

The use of derivative instruments exposes us to credit risk if the counterparty fails to perform when the fair value of a derivative instrument contract is positive. If the counterparty fails to perform, collateral is not required by any party whether derivatives are in an asset or liability position. We have a policy of diversifying derivatives with counterparties to mitigate the overall risk of counterparty defaults.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 14. Derivative Instruments and Hedging Activities” for additional information.

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Item 8. Financial Statements and Supplementary Data

Index of Consolidated Financial Statements and Schedule

Consolidated Balance Sheets 73

Consolidated Statements of Loss 74

Consolidated Statements of Comprehensive (Loss) Income 75

Consolidated Statements of Stockholders’ Equity 76

Consolidated Statements of Cash Flows 77

Notes to Consolidated Financial Statements 79

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and the Board of Directors

QuidelOrtho Corporation:

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheet of QuidelOrtho Corporation and subsidiaries (the Company) as of December 28, 2025, the related consolidated statements of loss, comprehensive (loss) income, stockholders’ equity, and cash flows for the year ended December 28, 2025, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 28, 2025, and the results of its operations and its cash flows for the year ended December 28, 2025, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 28, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February 18, 2026 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements 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 the consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Allowance for contractual rebates

As discussed in Notes 1 and 6 to the consolidated financial statements, the Company records revenues from product sales net of contractual rebates that are estimated at the time of sale. As of December 28, 2025, the Company recognized an allowance for contractual rebates of $28.7 million for certain rebates which are dependent on estimated rebate percentages that vary based on end-user sales mix.

We identified the evaluation of the allowance for contractual rebates as a critical audit matter. Evaluating the allowance for contractual rebates required challenging auditor judgment because the estimated rebate percentages are dependent on forecasted end-user sales mix and customer contractual terms.

The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls over the Company’s rebate allowance process, including controls related to the assessment of the estimated rebate percentages. To determine historical rebate percentages, we evaluated historical rebate payments based on historical end-user sales mix. We developed an independent expectation of the allowance for contractual rebates using a combination of the historical rebate percentages, Company internal data, executed contracts, and third-party data and compared our estimate to the amount recorded by the Company.

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Goodwill impairment assessment

As discussed in Notes 1 and 8 to the consolidated financial statements, the Company evaluates goodwill at the reporting unit level for impairment on an annual basis on the first day of the fourth quarter of the fiscal year, or whenever events or changes in circumstances occur that indicate that the fair value of a reporting unit is below its carrying amount. In performing its interim goodwill impairment assessment, reporting unit fair values were estimated by management using a weighting of the discounted cash flow method and guideline public company method. During the year ended December 28, 2025, the Company recognized a goodwill impairment charge of $700.7 million for the Europe, Middle East, and Africa (EMEA), China, and Latin America reporting units, which represented a full impairment of the goodwill allocated to these reporting units.

We identified the evaluation of the fair value of the EMEA, China, and Latin America reporting units used in its goodwill impairment assessment as a critical audit matter. Subjective auditor judgment was required to evaluate the discount rates, projected future revenue growth rates, and EBITDA margins used in the Company’s estimate of the fair value of its reporting units. Changes in the discount rates, projected future revenue growth rates, and EBITDA margins would have had a significant impact on the fair value of the reporting units. Additionally, the evaluation of the discount rates required the involvement of professionals with specialized skills and knowledge.

The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls over the Company’s goodwill impairment assessment process. This included controls related to the Company’s selection of discount rates, projected future revenue growth rates, and EBITDA margins. To evaluate the projected future revenue growth rates and EBITDA margins used in the estimate, we assessed the historical accuracy of the forecasted financial results by comparing historical forecasts to actual results. We also compared the projected future revenue growth rates and EBITDA margins to ranges that were developed using publicly available market data for comparable entities. In addition, we involved valuation professionals with specialized skills and knowledge, who assisted in evaluating the discount rates used by management by comparing them to a range of independently developed discount rates using publicly available market data for comparable companies.

/s/ KPMG LLP

We have served as the Company’s auditor since 2025.

Short Hills, New Jersey

February 18, 2026

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and the Board of Directors of QuidelOrtho Corporation

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheet of QuidelOrtho Corporation (the Company) as of December 29, 2024, the related consolidated statements of loss, comprehensive (loss) income, stockholders’ equity and cash flows for each of the two years in the period ended December 29, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 29, 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 29, 2024, in conformity with U.S. generally accepted accounting principles.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. 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 audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ernst & Young LLP

We served as the Company's auditor from 2002 to 2025.

San Diego, California

February 27, 2025

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QUIDELORTHO CORPORATION

CONSOLIDATED BALANCE SHEETS

(In millions, except par value)

ASSETS

Current assets:

Cash and cash equivalents $ 169.8 $ 98.3

Prepaid expenses and other current assets 250.5 262.4

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accrued payroll and related expenses 120.3 116.9

Income tax payable 11.5 5.4

Current portion of borrowings 178.3 341.8

Deferred tax liabilities 90.0 76.5

Commitments and contingencies (Note 13)

Stockholders’ equity:

Accumulated other comprehensive loss (15.4) (36.2)

Total liabilities and stockholders’ equity $ 5,769.3 $ 6,423.6

See accompanying notes.

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QUIDELORTHO CORPORATION

CONSOLIDATED STATEMENTS OF LOSS

(In millions, except per share data)

Fiscal Year Ended

Cost of sales, excluding amortization of intangibles 1,456.0 1,496.4 1,500.7

Restructuring, integration and other charges 263.6 127.2 113.4

Asset impairment charge 9.7 56.9 4.5

Loss on extinguishment of debt 5.1 — —

Provision for (benefit from) income taxes 24.1 (79.5) (19.0)

Weighted-average shares outstanding - basic 67.8 67.2 66.8

Weighted-average shares outstanding - diluted 67.8 67.2 66.8

See accompanying notes.

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QUIDELORTHO CORPORATION

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(In millions)

Fiscal Year Ended

Other comprehensive income (loss)

Changes in cumulative translation adjustment, net of tax 61.9 (38.4) 50.4

Changes in unrealized gains from investments, net of tax — — 0.5

Changes in unrealized (losses) gains from cash flow hedges, net of tax:

Net unrealized (losses) gains on derivative instruments (31.3) 52.1 12.6

See accompanying notes.

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QUIDELORTHO CORPORATION

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In millions)

Shares Par

Issuance of common stock under equity compensation plans 0.6 0.1 13.5 — — 13.6

Stock-based compensation expense — — 50.9 — — 50.9

Repurchases of common stock (0.1) — (7.2) — — (7.2)

Other comprehensive income, net of tax — — — 37.6 — 37.6

Issuance of common stock under equity compensation plans 0.7 — 5.4 — — 5.4

Stock-based compensation expense — — 41.0 — — 41.0

Other comprehensive loss, net of tax — — — (6.2) — (6.2)

Issuance of common stock under equity compensation plans 0.8 — 6.9 — — 6.9

Stock-based compensation expense — — 45.5 — — 45.5

Other comprehensive income, net of tax — — — 20.8 — 20.8

See accompanying notes.

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QUIDELORTHO CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In millions)

Fiscal Year Ended

OPERATING ACTIVITIES:

Asset impairment charge 9.7 56.9 4.5

Stock-based compensation expense 45.9 42.1 51.6

Change in deferred tax assets and liabilities 6.3 (99.3) (11.6)

Payment of accreted interest on contingent and deferred consideration — — (9.7)

Loss on extinguishment of debt 5.1 — —

Asset write off related to tax assessment refund — 20.0 —

Other non-cash, net 0.9 (2.0) (6.8)

Changes in assets and liabilities:

Prepaid expenses and other current and non-current assets (34.6) (9.5) (26.9)

Accrued payroll and related expenses 0.9 35.0 (53.9)

Other current and non-current liabilities 92.0 (22.6) (5.9)

Net cash provided by operating activities 105.2 83.0 280.2

INVESTING ACTIVITIES

Proceeds from held for sale asset, net of costs to sell — 9.3 —

Proceeds from government assistance allocated to fixed assets 6.5 — 13.5

Purchases of marketable securities — (7.2) (60.1)

Proceeds from sale of marketable securities — 63.1 78.3

Net cash used for investing activities (192.7) (149.9) (187.6)

FINANCING ACTIVITIES

Proceeds from issuance of common stock 6.1 5.0 11.6

Short-term borrowings, net 3.0 (1.6) 1.6

Revolving credit facility, net (118.0) 198.0 —

Repurchases of common stock — — (7.2)

Principal payments of deferred consideration — — (30.3)

Net cash provided by (used for) financing activities 155.8 48.8 (265.8)

Effect of exchange rates on cash 3.0 (2.9) (1.2)

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Fiscal Year Ended

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

Cash paid during the period for interest $ 172.4 $ 177.5 $ 150.0

Cash (received) paid for income taxes during the period $ (25.4) $ 41.6 $ 86.6

See accompanying notes.

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QuidelOrtho Corporation

Notes to Consolidated Financial Statements

Note 1. Basis of Presentation and Summary of Significant Accounting Policies

Organization and Business

The Company’s vision is to advance diagnostics to power a healthier future. With its expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, the Company aims to support clarity for clinicians and patients to help create better health outcomes. The Company’s global infrastructure and commercial reach support its customers across more than 140 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. The Company operates globally with manufacturing facilities in the U.S., U.K. and China and with sales centers, administrative offices and warehouses located throughout the world.

Basis of Presentation

The accompanying Consolidated Financial Statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.” and such principles, “U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for annual financial information.

Accounting Periods

The Company follows the concept of a fiscal year that ends on the Sunday nearest to the end of the month of December, and fiscal quarters that end on the Sunday nearest to the end of the months of March, June and September. For fiscal years ended 2025, 2024 and 2023, the Company’s fiscal years ended on December 28, 2025, December 29, 2024 and December 31, 2023, respectively. Fiscal years ended 2025, 2024 and 2023 were 52 weeks.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The estimates and underlying assumptions can impact all elements of the financial statements, including, but not limited to, accounting for deductions from revenues (e.g. rebates, returns, sales allowances and discounts), receivable and inventory valuations, fixed asset valuations, useful lives, recoverability of goodwill and tangible and intangible assets, the fair value of assets acquired and liabilities assumed in a business combination and related purchase price allocation, long-term employee benefit obligations, income taxes, environmental matters, litigation and allocations of costs. Estimates are based on historical experience, complex judgments, facts and circumstances available at the time and various other assumptions that are believed to be reasonable under the circumstances but are inherently uncertain and unpredictable. Actual results could differ from those estimates.

Consolidation

The Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.

Cash and Cash Equivalents

The Company considers cash equivalents to be highly liquid investments with a maturity at the date of purchase of three months or less. They are carried at cost plus accrued interest, which approximates fair value because of the short-term maturity of these instruments. Cash equivalents include money market funds and debt securities of high quality institutions. Cash balances may exceed government insured limits in certain jurisdictions.

Restricted Cash

Restricted cash primarily consists of funds reserved for legal requirements. Restricted cash balances are included in Other assets in the Consolidated Balance Sheets.

Accounts Receivable, Allowance for Credit Losses and Concentration of Credit Risk

The Company sells its products directly to physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other POC settings, blood banks and donor centers, as well as to individual, non-professional OTC customers, and other distributors in the U.S. and internationally (refer to “—Note 3. Revenue”). The Company periodically assesses the financial strength of these customers and establishes reserves for anticipated losses when necessary, which historically have not been material. The Company establishes a reserve based on historical losses, the age of receivables, customer mix and credit policies, current economic conditions in customers’ country or

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industry, and expectations associated with reasonable and supportable forecasts, and specific allowances for large or risky accounts. Amounts later determined to be uncollectible are charged or written off against this allowance. The balance of accounts receivable is net of reserves of $97.1 million and $99.6 million at December 28, 2025 and December 29, 2024, respectively.

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash equivalents, marketable securities and trade accounts receivable.

Credit losses are identified when cash flows received are not expected to be sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in operating results, with the amount of loss relating to other factors recorded in AOCI.

The Company performs credit evaluations of its customers’ financial condition and limits the amount of credit extended when deemed necessary, but generally requires no collateral. Credit quality is monitored regularly by reviewing credit history. The Company believes that the concentration of credit risk in its trade accounts receivables is moderated by its credit evaluation process, relatively short collection terms, the high level of credit worthiness of its customers, and letters of credit issued on the Company’s behalf. Potential credit losses are limited to the gross value of accounts receivable.

Inventories

Inventories are stated at the lower of cost (first-in, first-out) or net realizable value. The Company reviews the components of its inventory periodically for excess, obsolete and impaired inventory and records a reduction to the carrying value when identified.

Property, Plant and Equipment

Property, plant and equipment are recorded at cost and depreciated over the estimated useful lives of the assets using the straight-line method as follows:

Asset type Useful life

Building and building improvements 7-47 years

Machinery and equipment 3-7 years

Customer leased instruments 3-8 years

Computer software 3-5 years

Amortization of leasehold improvements is computed on the straight-line method over the shorter of the lease term or the estimated useful lives of the related assets.

When assets are surrendered, retired, sold or otherwise disposed of, their gross carrying values and related accumulated depreciation are removed from the accounts and included in determining gain or loss on such disposals. Maintenance and repairs are expensed as incurred; major replacements and improvements that extend the useful life are capitalized.

Assets Held for Sale

The following criteria are considered before concluding assets are classified as held for sale: (i) management’s commitment to a plan to sell, (ii) availability for immediate sale in its present condition, (iii) initiation of an active program to identify a buyer, (iv) probability of a completed sale within one year, (v) actively marketed for sale at a reasonable price in relation to its current fair value, and (vi) likelihood of significant changes to the plan will be made or that the plan will be withdrawn. If all of the criteria are met as of the balance sheet date, the net assets are presented separately in the balance sheet as held for sale at the lower of its carrying amount or fair value less costs to sell and is no longer depreciated or amortized while classified as held for sale. The Company assesses the fair value of a long-lived asset less any costs to sell at each reporting period and until the asset is no longer classified as held for sale.

Goodwill

Goodwill represents the excess of purchase price over the fair values of underlying net assets acquired in an acquisition. The Company assesses goodwill for impairment at the reporting unit level on an annual basis, or whenever events or changes in circumstances occur that indicate that the fair value of a reporting unit is below its carrying amount. The Company’s annual impairment assessment date is the first day of the fourth quarter of the fiscal year.

The CODM reviews the Company’s performance and allocates resources based on five operating segments: North America, EMEA, China, JPAC and Latin America, all of which are reportable segments. Each of these five operating segments is considered a reporting unit for the purpose of allocating goodwill and performing the annual goodwill recoverability assessment.

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When testing goodwill for impairment, the Company first has an option to assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not (more than 50%) that impairment exists. Such qualitative factors may include the following: macroeconomic conditions, industry and market considerations, cost factors, overall financial performance, and other relevant entity-specific events. In the event the qualitative assessment indicates that an impairment is more likely than not, the Company would be required to perform a quantitative impairment test. Under the quantitative goodwill impairment test, the evaluation of impairment involves comparing the current fair value of each reporting unit to its carrying value, including goodwill. The Company estimates the fair value of its reporting units by using forecasts of discounted future cash flows and peer market multiples. If the fair value of a reporting unit is less than its carrying value, impairment will be recognized in the amount by which the carrying value exceeds the fair value.

As a result of the identification of indicators of impairment during the third quarter of 2025, the Company performed an interim impairment test that resulted in non-cash goodwill impairment charges of $614.8 million, $68.1 million and $17.8 million for the EMEA, China and Latin America reporting units, respectively. There was no annual impairment test performed as there was no goodwill remaining on the balance sheet subsequent to the impairment.

As a result of the identification of indicators of impairment during the first quarter of 2024, the Company performed an interim impairment test that resulted in a non-cash goodwill impairment charge of $1.7 billion for the North America reporting unit. For the annual impairment test as of the beginning of the fiscal fourth quarter of 2024, the Company bypassed the qualitative assessment and proceeded directly to the quantitative goodwill impairment test for all reporting units. The Company concluded that the China and JPAC reporting units’ goodwill were impaired. As a result, the Company recorded non-cash goodwill impairment charges of $17.3 million and $61.4 million in the fourth quarter of 2024 for the China and JPAC reporting units, respectively. Refer to “—Note 8. Goodwill and Intangible Assets, Net” for further information.

Intangible Assets

Intangible assets are recorded at cost and amortized on a straight-line basis over their estimated useful lives, except for indefinite-lived intangibles such as goodwill. Software development costs associated with software to be leased or otherwise marketed are expensed as incurred until technological feasibility has been established. After technological feasibility is established, software development costs are capitalized and amortized on a straight-line basis over the estimated product life.

Long-lived Assets

The process of evaluating the potential impairment of long-lived assets, such as property, plant and equipment and intangible assets, is subjective and requires judgment. The Company reviews long-lived assets for impairment when events or changes in circumstances indicate the carrying value of an asset may not be recoverable. If these circumstances exist, recoverability of assets to be held and used is measured by a comparison of the carrying value of an asset group to future undiscounted net cash flows expected to be generated by the asset group. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets.

Revenue Recognition

The Company records revenues primarily from product sales. These revenues are recorded net of rebates and other discounts. These rebates and discounts are estimated at the time of sale, and are largely driven by various customer program offerings, including special pricing agreements, promotions and other volume-based incentives. Rebates and discounts are calculated based on historical experience, estimated discounting levels and estimated distributor inventory balances and recorded as a reduction of sales with offsets to accounts receivable and other current liabilities, respectively.

Transaction price for a contract represents the amount to which the Company is entitled in exchange for providing goods and services to the customer. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Revenue is recognized when control of the products is transferred to the customers in an amount that reflects the consideration the Company expects to receive from the customers in exchange for those products and services. This process involves identifying the contract with a customer, determining the performance obligations in the contract and the contract price, allocating the contract price to the distinct performance obligations in the contract and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. A performance obligation is considered to be satisfied once the control of a product is transferred to the customer or the service is provided to the customer, meaning the customer has the ability to use and obtain the benefit of the goods or service.

The Company generates a portion of its revenue from sales of the QUICKVUE At-Home OTC COVID-19 tests to retail customers. The Company estimates the transaction price for revenue from sales to retail customers based on historical experience and current trends to evaluate when uncertainties related to right of return provisions are resolved. Amounts received or receivable that are expected to be returned are recognized as a refund liability, which is included in Other current liabilities. The refund liability is estimated utilizing historical sale and return rates over the period during which customers have

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a right of return, taking into account available information on competitive products and contract changes. The refund liability is remeasured at each reporting period to reflect changes in assumptions about expected returns.

A portion of product sales includes revenues for diagnostic kits, which are utilized on leased instrument systems under the Company’s “reagent rental” program. The reagent rental program provides customers the right to use the instruments at no separate cost to the customer in consideration for a multi-year agreement to purchase annual minimum amounts of consumables. When an instrument is placed with a customer under a reagent rental agreement, the Company retains title to the equipment and it remains capitalized on the Company’s Consolidated Balance Sheets as Property, plant and equipment, net. The instrument is depreciated on a straight-line basis over the lesser of the lease term or life of the instrument. Depreciation expense is recorded in cost of sales included in the Consolidated Statements of Loss. Instrument and consumables under the reagent rental agreements are deemed two distinct performance obligations. Though the instrument and consumables do not have any use to customers without one another, they are not highly interdependent because they do not significantly affect each other. The Company would be able to fulfill its promise to transfer the instrument even if its customers did not purchase any consumables and the Company would be able to fulfill its promise to provide the consumables even if customers acquired instruments separately. The contract price is allocated between these two performance obligations based on the relative standalone selling prices. The instrument is considered an operating lease. Variable lease revenue and fixed lease revenue represented approximately 5% and 1%, respectively, of the Company’s Total revenues for fiscal year ended 2025. Variable lease revenue and fixed lease revenue represented approximately 6% and 1%, respectively, of the Company’s Total revenues for fiscal year ended 2024. Variable lease revenue and fixed lease revenue represented approximately 4% and 1%, respectively, of the Company’s Total revenues for fiscal year ended 2023.

Government Assistance

The Company has a previously established agreement between Ortho and BARDA, a division of HHS, which provides funding for Ortho to build manufacturing space and production support equipment to increase COVID-19 assay production capacity, as well as to build a manufacturing facility to produce certain analyzers needed to support COVID-19 testing. Amounts received from BARDA under this grant are recorded as a reduction to the carrying value of the related assets. A portion of the grant is for purposes of reimbursement of certain general and administrative expenses related to the project, which are not capitalized as part of the equipment constructed in connection with the project and are recorded as a reduction to the related expense. The Company received $13.5 million during fiscal year ended 2023, which was recorded as a reduction to the carrying value of the related assets. No funding was received during fiscal years ended 2025 and 2024.

During fiscal year ended 2025, the Company received $6.5 million for the extension of the Pencoed, Wales facility, which is deferred in Other current liabilities and recognized as a reduction to depreciation expense of the fixed asset once in service.

Research and Development Costs

R&D costs are charged to operations as incurred. Upfront and milestone payments made to third parties in connection with R&D collaborations are expensed as incurred up to the point of regulatory approval. Payments made to third parties at or subsequent to regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in other intangibles, net of accumulated amortization.

The Company enters into collaborative arrangements to develop and commercialize intellectual property. These arrangements typically involve two (or more) parties who are active participants in the collaboration and are exposed to significant risks and rewards dependent on the commercial success of the activities. These collaborations usually involve various activities by one or more parties, including R&D, marketing and selling and distribution. Often, these collaborations require upfront, milestone and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development. Amounts due from collaborative partners related to development activities are generally reflected as a reduction of R&D expense because the performance of contract development services is not central to the Company’s operations.

Product Shipment Costs

Product shipment costs are included in Selling, marketing and administrative expense in the accompanying Consolidated Statements of Loss. Shipping and handling costs were $134.3 million, $125.4 million and $124.1 million for fiscal years ended 2025, 2024 and 2023, respectively.

Advertising Costs

Advertising costs are expensed as incurred and included in Selling, marketing and administrative expense in the accompanying Consolidated Statements of Loss. Advertising costs were $8.9 million, $6.2 million and $15.1 million for fiscal years ended 2025, 2024 and 2023, respectively.

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Income Taxes

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized. The Company’s policy is to recognize the interest expense and penalties related to income tax matters as a component of the income tax provision.

The Company does not intend to permanently reinvest earnings of foreign subsidiaries at this time. Accordingly, the Company provides for income taxes and foreign withholding taxes, where applicable, on undistributed earnings. Any repatriation of undistributed earnings would be done at little or no tax cost.

Fair Value of Financial Instruments

The Company uses the fair value hierarchy established in ASC Topic 820, Fair Value Measurements and Disclosures, which requires that the valuation of assets and liabilities subject to fair value measurements be classified and disclosed by the Company in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

The carrying amounts of cash and cash equivalents, accounts receivables, accounts payable and accrued liabilities approximate their fair values due to their short-term nature.

Stock-based Compensation

Stock-based compensation, comprised of (i) stock options and (ii) RSUs, which include time-based RSUs, performance-based RSUs and restricted stock awards, to employees and non-employee directors, is measured at fair value on the grant date. Compensation expense is recognized over the requisite service period, which is generally the vesting period, and includes an estimate of the awards that will be forfeited, and an estimate of the level of performance the Company will achieve for performance-based awards.

Leases

Lease liabilities represent the obligation to make lease payments and ROU assets represent the right to use the underlying asset during the lease term. Lease liabilities and ROU assets are recognized at the commencement date of the lease based on the present value of lease payments over the lease term at the commencement date. When the implicit rate is unknown, an incremental borrowing rate based on the information available at the commencement date is used in determining the present value of the lease payments. Options to extend or terminate the lease are included in the determination of the lease term when it is reasonably certain that the Company will exercise such options.

For certain classes of assets, the Company accounts for lease and non-lease components as a single lease component. Variable lease payments, including those related to changes in the consumer price index, are recognized in the period in which the obligation for those payments is incurred and are not included in the measurement of the ROU assets or lease liabilities. Short-term leases are excluded from the calculation of the ROU assets and lease liabilities.

Operating leases are included in ROU assets, operating lease liabilities and operating lease liabilities non-current in the Consolidated Balance Sheets.

Comprehensive (Loss) Income

Comprehensive (loss) income includes unrealized gains and losses that are related to cumulative translation adjustments; unrealized gains and losses on marketable securities; changes in unamortized pension and post-employment actuarial gains and losses; and changes in the fair value of derivatives that are designated and qualify as cash flow hedging instruments excluded from the Consolidated Statements of Loss.

Acquisitions

In a business combination, the assets acquired and liabilities assumed are recorded based on the estimated fair values at the date of acquisition, including intangible assets, IPR&D and contingent payments. Any excess of the purchase price over the estimated fair values of net assets acquired is recorded as goodwill. Business acquisition costs are expensed when incurred.

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If the Company determines the assets acquired do not meet the definition of a business, the transaction will be accounted for as an acquisition of assets rather than a business combination and no goodwill is recorded. In an asset acquisition, acquired IPR&D with no alternative future use is charged to expense and contingent consideration is not recognized at the acquisition date.

Defined Benefit Plans and Other Post-Employment Benefits

The Company has defined benefit plans in certain countries and a retiree healthcare reimbursement plan for certain U.S. employees. Defined benefit plans specify an amount of pension benefit that an employee will receive on retirement, usually dependent on factors such as age, years of service and compensation. The net obligation with respect to defined benefit plans is calculated separately for each plan by estimating the amount of the future benefits that employees have earned in return for their service in the current and prior periods. These benefits are then discounted to determine the present value of the obligations and are then adjusted for the impact of any unamortized prior service costs. The net obligation is then determined with reference to the fair value of the plan assets (if any). The discount rate used is the yield on bonds that are denominated in the currency in which the benefits will be paid and that have maturity dates approximating the terms of the obligations. The calculations are performed by qualified actuaries using the projected unit credit method.

Recent Accounting Pronouncements

Recently Adopted Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to improve its income tax disclosure requirements. Under the guidance, entities must annually (i) disclose specific categories in the rate reconciliation and (ii) provide additional information for reconciling items that meet a quantitative threshold. This ASU was adopted in the fourth quarter of 2025 and is being applied prospectively (refer to “—Note 5. Income Taxes”). The adoption of this ASU did not impact the Company’s results of operations, cash flows or financial condition.

Recently Issued Accounting Standards Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure, in the notes to the financial statements, of specified information about certain costs and expenses. This ASU is effective for public entities for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. Other than the respective disclosures, this ASU is not expected to have an impact on the Company’s Consolidated Financial Statements.

In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides entities with a practical expedient to assume that current conditions as of the balance sheet date do not change for the remaining life of the asset when developing forecasts for estimating expected credit losses. The amendments in this ASU are effective for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those annual reporting periods. The Company is currently evaluating this guidance and does not expect this ASU to have a material impact on its Consolidated Financial Statements.

In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. Under the guidance, an entity is required to start capitalizing software costs when both of the following occur: (i) management has authorized and committed to funding the software project, and (ii) it is probable that the project will be completed and the software will be used to perform the function intended. The amendments in this ASU are effective for annual reporting periods beginning after December 15, 2027 and interim reporting periods within those annual reporting periods. The Company is currently evaluating this guidance and does not expect this ASU to have a material impact on its Consolidated Financial Statements.

In November 2025, the FASB issued ASU 2025-09, Derivatives and Hedging (Topic 815): Hedge Accounting Improvements, which includes amendments to more closely align hedge accounting with the economics of the entity’s risk management activities. The amendments in this ASU are effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods within those annual reporting periods. The Company is currently evaluating this guidance and does not expect this ASU to have a material impact on its Consolidated Financial Statements.

In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which establishes the accounting and presentation for government grants received by business entities. The amendments in this ASU are effective for annual reporting periods beginning after December 15, 2028 and interim reporting periods within those annual reporting periods. The Company is currently evaluating this guidance and does not expect this ASU to have a material impact on its Consolidated Financial Statements.

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, to improve the navigability of interim disclosure requirements and provide clarity on when that guidance is applicable. The amendments

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include (i) a comprehensive list of required interim disclosures and (ii) a disclosure principle that requires entities to disclose material events since the end of the last annual reporting period. The amendments in this ASU are effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Other than the respective disclosures, this ASU is not expected to have an impact on the Company’s Consolidated Financial Statements.

In December 2025, the FASB issued ASU 2025-12, Codification Improvements. The amendments in this ASU represent changes to the Codification that (i) clarify, (ii) correct errors, or (iii) make minor improvements, and make the Codification easier to understand and apply. The amendments in this ASU are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. This ASU is not expected to have an impact on the Company’s Consolidated Financial Statements.

Note 2. Computation of Earnings Per Share

Basic EPS is computed by dividing Net loss by the weighted-average number of shares of common stock outstanding. Diluted EPS is computed based on the sum of the weighted-average number of shares of common stock and potentially dilutive shares of common stock outstanding during the period. Potentially dilutive shares of common stock consist of shares issuable from stock options and unvested RSUs. Potentially dilutive shares of common stock from outstanding stock options and unvested RSUs are determined using the average share price for each period under the treasury stock method.

The following table presents the calculation of the weighted-average shares used in computing basic and diluted EPS in the respective periods:

Fiscal Year Ended

Basic weighted-average shares of common stock outstanding 67.8 67.2 66.8

Dilutive potential shares issuable from stock options and RSUs (1) — — —

Diluted weighted-average shares of common stock outstanding 67.8 67.2 66.8

(1) In fiscal years ended 2025, 2024 and 2023, all potential shares of common stock issuable for stock options and RSUs were excluded from the dilutive calculations above because the effect of including them would have been anti-dilutive. The dilutive effect of potential shares of common stock issuable for stock options and RSUs on the weighted-average number of shares of common stock outstanding would have been as follows:

Fiscal Year Ended

Basic weighted-average shares of common stock outstanding 67.8 67.2 66.8

Dilutive potential shares issuable from stock options and RSUs 0.2 0.2 0.5

Diluted weighted-average shares of common stock outstanding 68.0 67.4 67.3

Stock options and RSUs where the combined exercise price and unrecognized stock-based compensation was greater than the average market price for the Company’s common stock were not included in the computations of diluted weighted-average shares because the effect would have been anti-dilutive under the treasury stock method. These stock options and RSUs represented 1.6 million, 1.8 million and 1.6 million shares of common stock for fiscal years ended 2025, 2024 and 2023, respectively.

Note 3. Revenue

Contract Balances

Timing of revenue recognition may differ from timing of invoicing to customers. The Company records an asset when revenue is recognized prior to invoicing a customer (a “contract asset”). Contract assets are included within Prepaid expenses and other current assets in the Company’s Consolidated Balance Sheets and are transferred to accounts receivable when the right to payment becomes unconditional.

The contract asset balance consisted of contractual arrangements with certain customers under which the Company invoices the customers based on reportable results generated by its reagents; however, control of the goods transfers to the customers upon shipment or delivery of the products, as determined under the terms of the contract. Using the expected value method, the Company estimates the number of reagents that will generate a reportable result. The Company records the revenue upon shipment and an associated contract asset, and relieves the contract asset upon completion of the invoicing. The balance of the

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contract asset related to these arrangements was $34.7 million and $32.5 million as of December 28, 2025 and December 29, 2024, respectively.

The Company reviews contract assets for expected credit losses resulting from the collectability of customer accounts. Expected losses are established based on historical losses, customer mix and credit policies, current economic conditions in customers’ country or industry, and expectations associated with reasonable and supportable forecasts. No credit losses related to contract assets were recognized during fiscal years ended 2025 and 2024.

The Company recognizes a contract liability when a customer pays an invoice prior to the Company transferring control of the goods or services (“contract liabilities”). The Company’s contract liabilities consist of deferred revenue primarily related to customer service contracts. The Company classifies deferred revenue as current or non-current based on the timing of the transfer of control or performance of the service. The balance of the Company’s current deferred revenue was $37.8 million and $33.5 million as of December 28, 2025 and December 29, 2024, respectively, and was included in Other current liabilities in the Consolidated Balance Sheets. The Company has one arrangement with a customer where the revenue is expected to be recognized beyond one year. The balance of the deferred revenue included in long-term liabilities was $16.9 million and $17.3 million as of December 28, 2025 and December 29, 2024, respectively, and was included in Other liabilities in the Consolidated Balance Sheets. The amount of deferred revenue as of December 29, 2024 that was recorded in Total revenues during fiscal year ended 2025 was $30.0 million. The amount of deferred revenue as of December 31, 2023 that was recorded in Total revenues during fiscal year ended 2024 was $34.0 million.

Joint Business with Grifols

The Company has the Joint Business between Ortho and Grifols, under which Ortho and Grifols agreed to pursue a collaboration relating to Ortho’s Hepatitis and HIV diagnostics business. The governance of the Joint Business is shared through a supervisory board made up of equal representation by Ortho and Grifols, which is responsible for all significant decisions relating to the Joint Business that are not exclusively assigned to either Ortho or Grifols, as defined in the Joint Business agreement. The Company’s portion of the pre-tax net profit shared under the Joint Business was $30.9 million, $29.5 million and $47.3 million during fiscal years ended 2025, 2024 and 2023, respectively. These amounts included the Company’s portion of the pre-tax net profit of $10.7 million, $21.1 million and $21.4 million during fiscal years ended 2025, 2024 and 2023, respectively, on sales transactions with third parties where the Company is the principal. The Company recognized revenues, cost of sales, excluding amortization of intangibles, and operating expenses, on a gross basis on these sales transactions in their respective lines in the Consolidated Statements of Loss. The Company’s portion of the pre-tax net profit also included revenue from collaboration and royalty agreements of $20.2 million, $8.4 million and $26.0 million during fiscal years ended 2025, 2024 and 2023, respectively, which is presented on a net basis within Total revenues.

In December 2025, the Company and Grifols initiated discussions to terminate the Joint Business arrangement prior to its scheduled expiration date in 2039. Accordingly, the Company recorded a charge of $65.0 million payable to Grifols over a three-year period in Other operating expenses in the Consolidated Financial Statements for fiscal year ended 2025 to reflect the mutually agreed terms in principle. While the Company continues to engage in discussions with Grifols and additional information may become available as discussions progress, it is reasonably possible that the ultimate resolution of the termination may differ from the estimated amount accrued, and such an amount could be material to the Consolidated Financial Statements.

Disaggregation of Revenue

The following table summarizes Total revenues by business unit:

Fiscal Year Ended

(1) Certain reclassifications have been made to prior period amounts to conform to the current period presentation.

(2) As a result of the wind-down of the U.S. donor screening portfolio, the Transfusion Medicine business unit is shown in its two product categories: Immunohematology and Donor Screening.

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Concentration of Revenue and Credit Risk

For both fiscal years ended 2025 and 2024, one customer represented 11% of Total revenues in the North America segment. For fiscal year ended 2023, no customer individually accounted for more than 10% of Total revenues.

Revenue related to the Company’s respiratory products accounted for approximately 15%, 18% and 24% of Total revenues for fiscal years ended 2025, 2024 and 2023, respectively.

As of December 28, 2025, no customers had a balance due in excess of 10% of Accounts receivable, net. As of December 29, 2024, customers with a balance due in excess of 10% of Accounts receivable, net totaled $33.7 million.

Note 4. Segment and Geographic Information

The Company operates under five geographically-based reportable segments: North America, EMEA, China, JPAC and Latin America. Although all five segments are engaged in the marketing, distribution and sale of diagnostic instruments and assays for hospitals, retailers, distributors, laboratories and/or blood and plasma centers worldwide, each region is managed separately to better align with the market dynamics of the specific geographic region.

Beginning in the fourth quarter of 2025, the Company determined that the JPAC segment, previously included in “Other,” meets the quantitative thresholds for separate reporting under ASC 280. This determination was based on JPAC’s segment revenue exceeding 10% of the combined reported segment revenue. As Latin America is the only remaining immaterial operating segment, results are reported separately. This change in segment reporting did not have an impact on the Company’s previously reported Consolidated Financial Statements. Prior periods have been revised to align with the current period presentation.

The following table presents the results of operations of the Company’s reportable segments for fiscal years ended 2025, 2024 and 2023:

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Fiscal Year Ended 2025

(In millions) North America EMEA China JPAC Latin America Total

Less (1):

Reconciliation of segment Adjusted EBITDA

Depreciation and amortization (442.0)

Interest expense, net (177.6)

Restructuring, integration and other charges (263.6)

Goodwill impairment charge (700.7)

Asset impairment charge (9.7)

Loss on extinguishment of debt (5.1)

Contract termination cost (3) (65.0)

Amortization of deferred cloud computing implementation costs (27.0)

Legal accrual (4) (9.4)

EU medical device regulation transition costs (5) (0.7)

Gain on investments 2.5

Other adjustments (6.4)

Loss before income taxes $ (1,107.7)

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Fiscal Year Ended 2024

(In millions) North America EMEA China JPAC Latin America Total

Less (1):

Reconciliation of segment Adjusted EBITDA

Depreciation and amortization (453.4)

Interest expense, net (163.5)

Restructuring, integration and other charges (127.2)

Goodwill impairment charge (1,822.6)

Asset impairment charge (56.9)

Asset write off (6) (20.0)

Amortization of deferred cloud computing implementation costs (14.7)

Employee compensation charges (5.6)

Prior Credit Agreement amendment fees (4.0)

EU medical device regulation transition costs (5) (2.0)

Loss on disposal (7) (1.2)

Gain on investments 0.7

Other adjustments (4.0)

Loss before income taxes $ (2,131.5)

89

Fiscal Year Ended 2023

(In millions) North America EMEA China JPAC Latin America Total

Less (1):

Reconciliation of segment Adjusted EBITDA

Depreciation and amortization (457.2)

Interest expense, net (147.6)

Restructuring, integration and other charges (113.4)

Asset impairment charge (4.5)

Tax indemnification expense (12.6)

Amortization of deferred cloud computing implementation costs (9.2)

Loss on investments (3.6)

EU medical device regulation transition costs (5) (2.5)

Other adjustments (1.7)

Loss before income taxes $ (29.1)

(1) The significant expense categories and amounts align with the segment-level information that is regularly provided to the CODM.

(2) Primarily consists of costs related to executive and staff functions, including certain finance, human resources, manufacturing and IT functions, which benefit the Company as a whole. These costs are primarily related to the general management of these functions on a corporate level and the design and development of programs, policies and procedures that are then implemented in the individual segments, with each segment bearing its own cost of implementation. The Company’s corporate function also includes debt and stock-based compensation associated with all employee stock-based awards.

(3) Refer to “—Note 3. Revenue” for additional information.

(4) Represents reserves accrued in connection with the resolution of a contractual dispute. Refer to “—Note 13. Commitments and Contingencies” for additional information.

(5) Represents incremental consulting costs and R&D manufacturing site costs to align compliance of the Company’s existing, on-market products that were previously registered under the European In Vitro Diagnostics Directive regulatory framework with the requirements under the EU’s In Vitro Diagnostic Regulation, which generally apply from May 2022 onwards.

(6) Represents the write off of the tax assessment refund related to the Luxembourg net wealth tax, as the weight of available evidence indicated that it is not more likely than not that the position will be sustained during the pendency of an appeal.

(7) Represents loss on disposal from the sale of the McKellar, San Diego, CA facility.

The Company’s President and CEO is the Company’s CODM. The CODM reviews the segment adjusted EBITDA results against the forecast to assess segment performance and determine how to allocate resources. The CODM does not review and is not provided capital expenditures, total depreciation and amortization or assets by segment, and therefore this information has been excluded as it does not comprise part of management’s key performance metrics.

90

The following presents long-lived assets (excluding intangible assets) and total net revenue by geographic territory:

Long-lived Assets as of Total Revenues for Fiscal Year Ended

Note 5. Income Taxes

Significant components of the provision for income taxes were as follows:

Fiscal Year Ended

Current:

Total current provision (benefit) 24.0 25.9 (14.5)

Deferred:

Provision for (benefit from) income taxes $ 24.1 $ (79.5) $ (19.0)

The Company’s income before income taxes was subject to taxes in the following jurisdictions for the following periods:

Fiscal Year Ended

91

Significant components of the Company’s deferred tax assets and deferred tax liabilities as of December 28, 2025 and December 29, 2024 are shown below:

Deferred tax assets:

Allowance for returns and discounts 42.7 38.4

Stock-based compensation 7.8 9.7

Tax loss, interest expense and credit carryforwards 487.1 468.7

Research & development expenses 68.1 95.7

Employee related obligations 14.9 13.2

Other, net 48.4 —

Valuation allowance for deferred tax assets (249.8) (142.4)

Total deferred tax assets, net of valuation allowance 485.2 544.2

Deferred tax liabilities:

Right-of-use assets (35.2) (38.9)

Property, plant and equipment (83.5) (107.5)

Other, net — (5.7)

Total deferred tax liabilities (574.9) (620.7)