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Item 7. Management’s Discussion and Analysis

2025-02-27 compared with 2024-02-29 · 189 added, 185 removed, 224 unchanged (63% of the section changed)

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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 provide clarity to clinicians and patients to help create better health outcomes.

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 130 countries and territories with quality diagnostics, a broad test portfolio and market-leading service.

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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 and China.

Latin America, Japan and Asia Pacific are immaterial operating segments that are not considered reportable segments and are included in “Other.” We generate our revenue primarily in the following business units:

Labs, Transfusion Medicine, Point of Care and Molecular Diagnostics.

Latin America and JPAC (Japan and Asia Pacific) are immaterial operating segments that are not considered reportable segments and are included in “Other.” 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 $94.2 million, $125.0 million and $73.1 million for fiscal years ended 2024, 2023 and 2022, respectively.

On May 27, 2022, pursuant to the BCA, Quidel and Ortho consummated the Combinations and each of Quidel and Ortho became a wholly owned subsidiary of QuidelOrtho.

Our Consolidated Financial Statements for 2023 include a full year of Ortho operations.

For additional information about the Combinations, see Part II, Item 8, “Financial Statements and Supplementary Data—Note 2.

Our Consolidated Financial Statements for fiscal years ended 2024 and 2023 each include a full year of Ortho operations.

For additional information about the Combinations, refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 2.

Business Combination.”

For fiscal year 2023, Total revenues decreased by 8% to $2,997.8 million as compared to the prior year.

For fiscal year 2022 , Total revenues increased by 92% to $3,266.0 million as compared to the prior year.

Currency exchange rates had an unfavorable impact of 100 basis points and 300 basis points on our growth rate for fiscal years 2023 and 2022, respectively.

For fiscal year ended 2024, Total revenues decreased by 7% to $2,782.9 million as compared to the prior year.

For fiscal year ended 2023 , Total revenues decreased by 8% to $2,997.8 million as compared to the prior year.

These decreases were primarily driven by variability of our U.S.

respiratory products.

Currency exchange rates had an unfavorable impact of approximately 60 basis points and 100 basis points on our growth rates for fiscal years ended 2024 and 2023, respectively.

Our revenues can be highly concentrated over a small number of products, including certain of our respiratory products.

For fiscal years 2023, 2022 and 2021, revenues related to our respiratory products accounted for approximately 24%, 57% and 81% of our Total revenues, respectively, primarily driven by sales of our COVID-19 products .

For fiscal years ended 2024, 2023 and 2022, revenues related to our respiratory products accounted for approximately 18%, 24% and 57% of our Total revenues, respectively .

Planned Wind-Down of U.S.

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donor screening portfolio.

Specifically, we plan to wind-down only the VIP platform and microplate assays, which are only sold in the U.S., and have a lower growth and margin profile than other parts of our Transfusion Medicine business.

Specifically, we plan to wind-down only 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.

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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 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 4.

Revenue” for more information.

The wind-down of our U.S.

donor screening portfolio is expected to be substantially complete by the end of 2025.

Supply Chains

As a result of the COVID-19 pandemic and other macroeconomic and geopolitical conditions, including inflationary pressures, general economic slowdown or a recession, rising interest rates, foreign exchange rate volatility and changes in monetary policy, we have experienced shortages and delays in receiving certain raw materials and other components for our products and have experienced logistics and distribution challenges, as well as challenges in labor availability and rising labor costs, all of which have affected our ability to fulfill customer orders, including instrument placements, on a timely basis.

While we have made notable improvements in 2023, these supply, production, logistics, distribution and labor disruptions and challenges have impacted, and we expect will continue for some period of time to impact, our operations.

However, the significance and frequency of such impact have lessened during the fourth quarter of 2023.

We obtain raw materials from reputable outside suppliers and believe our business relationships with them are good.

Some of our raw materials are available from a limited number of sources.

During 2023 and 2022, we encountered some increasing pressures on raw material pricing, though they were less severe in fiscal year 2023 than in 2022.

To mitigate these supply chain challenges, we continue to (i) partner with suppliers to invest in additional capacity and raw material inventory, (ii) diversify our supply base, where possible, to minimize reliance on a single source of supply for key raw materials and components and (iii) create redundancy in our global supply chain.

While we encountered increasing pressures on raw material pricing during fiscal years ended 2023 and 2022, inflationary impacts during fiscal year ended 2024 lessened and returned closer to pre-COVID-19 pandemic levels.

To help mitigate these supply chain challenges, we (i) partner with suppliers to invest in additional capacity and raw material inventory, (ii) diversify our supply base, where possible, to minimize reliance on a single source of supply for key raw materials and components, (iii) create redundancy in our global supply chain and (iv) insource activity where it makes strategic and financial sense.

In addition, we routinely evaluate our supply chain for potential gaps and continue to take other steps intended to help address continuity.

In our distribution operations, we have been investing in and implementing automation capabilities to help improve accuracy and timeliness of customer shipments.

We continue to monitor these macroeconomic and geopolitical developments and the impact of such factors on our business.

We cannot currently predict the frequency, duration or scope of these supply, production, logistics, distribution and labor disruptions and challenges.

However, we proactively work with our suppliers, manufacturers, distributors, industry partners and government agencies to address these challenges in our efforts to meet the needs of our customers.

Despite our mitigation efforts, such disruptions and challenges have materially affected and could further materially affect our ability to timely manufacture and distribute our products and could unfavorably impact our results of operations depending on the nature and duration of such disruptions and challenges.

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, as well as ongoing supply, production and logistics challenges.

Demand for our respiratory products, which includes our COVID-19 products, declined in 2023 compared to 2022 due to the end of the U.S.

public health emergency regarding COVID-19 and the transition of COVID-19 from a pandemic to an endemic environment.

We expect demand for our 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 seasonal demands of the respiratory seasons, which are typically more prevalent during the fall and winter.

Demand for our respiratory products, which includes our COVID-19 products, declined in 2024 compared to 2023 due to the decreased occurrence and duration of COVID-19 in an endemic environment and a COVID-19 government award in 2023 that

did not occur in 2024.

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 seasonal demands of the respiratory season, which are typically more prevalent during the fall and winter.

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.

As a result, we expect to continue to maintain our emphasis on R&D investments for longer term growth, including for our next generation platforms and assays, as well as additional assays to be launched on our current platforms.

In addition, we expect to continue to evaluate strategic opportunities to expand our product lines and services, production capabilities, technologies and geographic footprint and address other business challenges and opportunities.

While we expect the revenues and financial results from our respiratory products to be affected by the seasonal demands of the respiratory seasons, 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.

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 seasonal 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

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Our fiscal year is the 52 or 53 weeks ending the Sunday closest to December 31.

Fiscal years 2023, 2022 and 2021 were 52 weeks.

The following table compares Total revenues by business unit for fiscal years 2023, 2022 and 2021:

Fiscal years ended 2024, 2023 and 2022 were 52 weeks.

The following table compares Total revenues by business unit for fiscal years ended 2024, 2023 and 2022:

Fiscal Year Ended

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Labs $ 1,426.7 $ 1,425.4 $ 820.2 — % 74 %

Transfusion Medicine 648.5 393.8 — 65 % N/M

Immunohematology (1)

522.6 512.4 296.8 2 % 73 %

Donor Screening (1)

115.5 136.1 97.0 (15) % 40 %

Point of Care 694.1 892.2 1,955.3 (22) % (54) %

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Total revenues $ 2,782.9 $ 2,997.8 $ 3,266.0 (7) % (8) %

* N/M - Not meaningful

For fiscal year 2023, Total revenues decreased to $2,997.8 million from $3,266.0 million for the prior year.

The increases in Labs and Transfusion Medicine revenues were primarily related to incremental revenues from the Combinations.

(1) For presentation purposes, as a result of the wind-down of the U.S.

donor screening portfolio, the previously reported Transfusion Medicine business unit is shown in its two product categories:

Immunohematology and Donor Screening.

Prior periods have been revised to align with the current period presentation.

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 period, primarily due to reagent growth.

Donor Screening revenue decreased 15% compared to the prior year period, 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 period, 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 the growth rate for fiscal year ended 2024.

For fiscal year ended 2023, Total revenues decreased to $2,997.8 million from $3,266.0 million for the prior year.

The increases in Labs, Immunohematology and Donor Screening revenues were primarily related to incremental revenues from the Combinations.

Additionally, the increase in Labs revenue included a $19.2 million settlement award from a third party related to one of our collaboration agreements.

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Molecular Diagnostics revenue decreased by $65.0 million, primarily driven by lower demand for the Lyra SARS Antigen assay due to the end of the public health emergency in the U.S.

Currency exchange rates had an unfavorable impact of approximately 100 basis points on the growth rate for fiscal year 2023.

For fiscal year 2022, Total revenues increased to $3,266.0 million from $1,698.6 million for the prior year.

The increases in Labs and Transfusion Medicine were primarily related to new revenues from the Combinations.

The Point of Care business unit contributed to revenue growth, primarily driven by an increase of $586.1 million in sales of QuickVue SARS Antigen assays, partially offset by lower sales of Sofia assays and $46.7 million lower BNP sales due to the transition of the BNP Business to Beckman.

The decrease in revenues related to the transition of the BNP Business did not materially impact our gross profit.

Molecular Diagnostics revenue decreased by $103.8 million, primarily driven by lower demand and pricing of the Lyra SARS Antigen assay.

Currency exchange rates had an unfavorable impact of approximately 300 basis points on the growth rate for fiscal year 2022.

Currency exchange rates had an unfavorable impact of approximately 100 basis points on the growth rate for fiscal year ended 2023.

Cost of Sales, Excluding Amortization of Intangible Assets

Cost of sales, excluding amortization of intangible assets, increased to $1,503.4 million, or 50.2% of Total revenues, for fiscal year 2023, compared to $1,330.0 million, or 40.7% of Total revenues, for fiscal year 2022.

The increase in cost of sales, excluding amortization of intangible assets as a percentage of revenue, was primarily driven by incremental revenues in the Labs and Transfusion Medicine business units as a result of the Combinations and a decrease in sales of respiratory products.

We also recorded $60.6 million of expense related to the unwind of the inventory fair value adjustment related to the Combinations during fiscal year 2022.

Cost of sales, excluding amortization of intangible assets, increased to $1,330.0 million, or 40.7% of Total revenues, for fiscal year 2022, compared to $420.3 million, or 24.7% of Total revenues, for fiscal year 2021.

The increase in cost of sales, excluding amortization of intangible assets, was primarily driven by a large increase in sales of QuickVue SARS Antigen assays in 2022, as well as new product sales in the Labs and Transfusion Medicine business units as a result of the Combinations.

We also recorded $60.6 million of expense related to the unwind of the inventory fair value adjustment related to the Combinations during fiscal year 2022.

There were also increases in supply chain and other indirect manufacturing costs, which were only partially offset by increased absorption driven by higher production volumes.

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 period COVID-19 government award, along with the corresponding inventory reserve release of $39 million.

Cost of sales, excluding amortization of intangible assets, increased to $1,500.7 million, or 50.1% of Total revenues, for fiscal year ended 2023, compared to $1,329.8 million, or 40.7% of Total revenues, for fiscal year ended 2022.

The increase in cost of sales, excluding amortization of intangible assets as a percentage of revenue, was primarily driven by incremental revenues in the Labs, Immunohematology and Donor Screening business units as a result of the Combinations and a decrease in sales of respiratory products.

We also recorded $60.6 million of expense related to the unwind of the inventory fair value adjustment related to the Combinations during fiscal year ended 2022.

Operating Expenses

The following table summarizes operating expenses for fiscal years 2023, 2022 and 2021:

The following table summarizes operating expenses for fiscal years ended 2024, 2023 and 2022:

Fiscal Year Ended

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Acquisition and integration costs 127.2 4.6 % 113.4 3.8 % 136.0 4.2 %

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

Asset impairment charge 56.9 N/M 4.5 N/M 2.8 N/M

Other operating expenses 51.8 1.9 % 27.1 0.9 % 12.3 0.4 %

* N/M - Not meaningful

Selling, Marketing and Administrative Expenses

Selling, marketing and administrative expenses for fiscal year 2023 increased by $142.2 million, or 22.9%, to $763.2 million from $621.0 million for the prior year, primarily due to the incremental impact of the Combinations, partially offset by freight expense due to lower sales and shipment volume and lower employee compensation costs.

Selling, marketing and administrative expenses for fiscal year 2022 increased by $381.4 million, or 159.2%, to $621.0 million from $239.6 million for the prior year, primarily driven by the Combinations which contributed $326.5 million in increased expense, freight expense due to higher sales volume and expedited shipping, product promotional spend associated with the QuickVue At-Home OTC COVID-19 test, professional fees and higher employee-related costs.

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.

Selling, marketing and administrative expenses for fiscal year ended 2023 increased by $142.2 million, or 22.9%, to $763.2 million from $621.0 million for the prior year, primarily due to the incremental impact of the Combinations, partially offset by freight expense due to lower sales and shipment volume and lower employee compensation costs.

Research and Development Expense

Research and development expense for fiscal year 2023 increased by $56.3 million, or 29.6%, to $246.8 million from $190.5 million for the prior year, primarily due to the incremental impact of the Combinations, as well as increased costs related to the development of Savanna, QuickVue OTC assays and Sofia products.

Research and development expense for fiscal year 2022 increased by $94.8 million, or 99.1%, to $190.5 million from $95.7 million for the prior year, primarily due to the Combinations which contributed $86.0 million in increased expense, as well as increased costs related to SARS, Sofia and Savanna projects, and increased costs related to compensation driven by increased headcount and clinical trials.

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.

Research and development expense for fiscal year ended 2023 increased by $57.1 million, or 30.4%, to $245.0 million from $187.9 million for the prior year, primarily due to the incremental impact of the Combinations, as well as increased costs related to the development of Savanna, QuickVue OTC assays and Sofia products.

Amortization of Intangible Assets

Amortization of intangible assets for fiscal years 2023, 2022 and 2021 was $204.8 million, $132.5 million and $27.4 million, respectively.

The increases in amortization expense in fiscal year 2023 compared to fiscal year 2022 and fiscal year 2022 compared to fiscal year 2021 were primarily due to the Combinations.

Amortization of intangible assets for fiscal years ended 2024, 2023 and 2022 was $203.4 million, $204.8 million and $132.5 million, respectively.

The increase in amortization expense in fiscal year ended 2023 compared to fiscal year ended 2022 was primarily due to the Combinations.

Acquisition and Integration Costs

Acquisition and integration costs were $113.4 million, $136.0 million and $9.6 million for fiscal years 2023, 2022 and 2021, respectively.

The decrease in costs in fiscal year 2023 compared to fiscal year 2022 was primarily due to acquisition costs attributable to the Combinations, partially offset by higher integration-related costs.

The increase in costs in fiscal year 2022 compared to fiscal year 2021 was primarily due to acquisition and integration-related costs attributable to the Combinations.

Costs for fiscal year 2021 were primarily related to the evaluation of new business development opportunities, including the Combinations.

Acquisition and integration costs were $127.2 million, $113.4 million and $136.0 million for fiscal years ended 2024, 2023 and 2022, respectively.

The increase in costs in fiscal year ended 2024 compared to fiscal year ended 2023 was primarily due to employee compensation related charges and consulting costs.

The decrease in costs in fiscal year ended 2023 compared to fiscal

year ended 2022 was primarily due to acquisition costs attributable to the Combinations, partially offset by higher integration-related costs.

Goodwill Impairment Charge

During fiscal year ended 2024, we recognized a non-cash goodwill impairment charge of $1.8 billion.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 9.

Goodwill and Intangible Assets, Net” for more information.

Asset Impairment Charge

During fiscal year ended 2024, we recognized an impairment charge of $56.9 million related to the long-lived assets classified as assets held for sale.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 8.

Assets Held for Sale” for more information.

Asset impairment charges were $4.5 million and $2.8 million for fiscal years ended 2023 and 2022, respectively.

Other Operating Expenses

Other operating expenses were $27.1 million and $12.3 million for fiscal years 2023 and 2022, respectively, which were primarily related to the profit share expense for our Joint Business with Grifols acquired in connection with the Combinations.

Other operating expenses were $51.8 million, $27.1 million and $12.3 million for fiscal years ended 2024, 2023 and 2022, respectively, which were primarily related to the profit share expense for our Joint Business with Grifols and, in fiscal year ended 2024, a $20.0 million write off of the tax assessment refund.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 5.

Segment and Geographic Information” for more information.

Non-operating Expenses

The following table summarizes non-operating expenses, net for fiscal years 2023, 2022 and 2021:

Fiscal Year Ended

(Dollars in millions) 2023 2022 2021 % Change

% Change 2022 vs.

Interest expense, net $ 147.6 $ 75.7 $ 5.8 95.0 % N/M

Loss on extinguishment of debt — 24.0 — (100.0) % N/M

Other expense (income), net 20.6 8.1 (0.1) 154.3 % N/M

* N/M - Not meaningful

Interest Expense, Net

Interest expense, net was $147.6 million, $75.7 million and $5.8 million for fiscal years 2023, 2022 and 2021, respectively.

The increases in interest expense, net in fiscal year 2023 compared to fiscal year 2022 and fiscal year 2022 compared to fiscal year 2021 were primarily related to the Term Loan under the Credit Agreement entered into in connection with the Combinations.

See Part II, Item 8, “Financial Statements and Supplementary Data—Note 8.

Borrowings” for more information related to our Term Loan.

Interest expense, net was $163.5 million, $147.6 million and $75.7 million for fiscal years ended 2024, 2023 and 2022, respectively.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 10.

Borrowings” for more information.

Loss on Extinguishment of Debt

Loss on extinguishment of debt was $24.0 million for fiscal year 2022, and was related to the satisfaction and discharge of the senior notes and termination of the former term loans and revolving credit facility of Ortho, which occurred in connection with the consummation of the Combinations.

Other Expense (Income), Net

Other expense (income), net was $20.6 million, $8.1 million and $(0.1) million for fiscal years 2023, 2022 and 2021, respectively.

The increase in Other expense (income), net in fiscal year 2023 compared to fiscal year 2022 was primarily related to (i) the release of tax reserves upon the settlement of certain U.S.

Loss on extinguishment of debt was $24.0 million for fiscal year ended 2022, and was related to the satisfaction and discharge of the senior notes and termination of the former term loans and revolving credit facility of Ortho, which occurred in connection with the consummation of the Combinations.

Other Expense, Net

Other expense, net was $7.1 million, $20.6 million and $8.1 million for fiscal years ended 2024, 2023 and 2022, respectively.

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) Credit Agreement amendment fees, partially offset by loss on investments in the prior year period.

The increase in Other expense, net in fiscal year ended 2023 compared to fiscal year ended 2022 was primarily related to (i) the 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) net foreign currency losses.

See Part II, Item 8, “Financial Statements and Supplementary Data—Note 6.

Income Taxes” for more information related to our indemnification assets.

The change in Other expense (income), net in fiscal year 2022 compared to fiscal year 2021 was primarily related to net foreign currency losses and loss on investment, partially offset by fair value gains in interest rate caps.

For fiscal years 2023 and 2022, we recognized income tax benefits of $19.0 million in relation to loss before taxes of $29.1 million and income tax provisions of $187.2 million in relation to income before taxes of $735.9 million, resulting in effective tax rates of 65.3% and 25.4%, respectively.

For fiscal year 2023, the effective tax rate differed from the U.S.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 6.

Income Taxes” for more information.

For fiscal years ended 2024 and 2023, we recognized income tax benefits of $79.5 million in relation to loss before taxes of $2,131.5 million and $19.0 million in relation to loss before taxes of $29.1 million, resulting in effective tax rates of 3.7% and 65.3%, respectively.

For fiscal year ended 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.

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 (“GILTI”).

For fiscal year 2022, the effective tax rate was primarily impacted by income taxes owed in certain U.S.

We recognized an income tax benefit of $19.0 million, resulting in an effective tax rate of 65.3% for fiscal year ended 2023, compared to an income tax provision of $187.2 million, resulting in an effective tax rate of 25.4% for fiscal year ended 2022.

For fiscal year ended 2022, the effective tax rate differed from the U.S.

federal statutory rate, primarily due to income taxes owed in certain U.S.

states, foreign income taxed at rates other than the applicable U.S.

rate, and the deduction for foreign derived intangible income (“FDII”).

We recognized an income tax provision of $187.2 million, resulting in an effective tax rate of 25.4% for fiscal year 2022.

This effective tax rate is comparable to the effective tax rate of 21.8% for fiscal year 2021.

The lower tax expense for fiscal year 2022 compared to the prior year was primarily due to a decrease in pre-tax profits and state taxes, foreign income taxed at rates other than the applicable U.S.

rate, and an increased deduction for FDII, partially offset by increases in non-deductible executive compensation, GILTI and acquisition-related costs.

The Company will treat any U.S.

tax on foreign earnings under GILTI as a current period expense when incurred.

rate, and the deduction for foreign derived intangible income.

Segment Results

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North America, EMEA and China.

Our operations in Latin America, Japan and Asia Pacific are immaterial operating segments that are not considered reportable segments and are included in “Other.”

Our operations in Latin America and JPAC (Japan and Asia Pacific) are immaterial operating segments that are not considered reportable segments and are included in “Other.” In the fourth quarter of 2024, we revised the internal allocation of certain global costs primarily between the North America segment and Corporate to better align costs that impact us as a whole.

Prior periods have been revised to align with the current period presentation.

The key indicators that we monitor are as follows:

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Adjusted EBITDA consists of Net (loss) income before Interest expense, net, (Benefit from) provision for 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) income and that we do not consider indicative of our ongoing operating performance.

See Part II, Item 8, “Financial Statements and Supplementary Data—Note 5.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 5.

Segment and Geographic Information” for a reconciliation of Adjusted EBITDA by reportable segment to (Loss) income before income taxes.

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Adjusted EBITDA $ 892.1 $ 1,025.2 $ 1,689.2 (13) % (39) %

Total revenues were $1,877.1 million for fiscal year 2023, compared to $2,536.5 million for fiscal year 2022.

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 revenue, primarily due to a COVID-19 government award in the prior year period, (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 period.

Total revenues wer e $1,877.1 million for fiscal year ended 2023, compared to $2,536.5 million for fiscal year ended 2022.

The decrease was primarily driven by lower demand for QuickVue and Sofia SARS Antigen assays, partially offset by incremental revenues of $433.8 million from the Combinations.

Total revenues wer e $2,536.5 million for fiscal year 2022, compared to $1,500.2 million for fiscal year 2021.

During fiscal year 2022, the impact of the Combinations contributed $607.3 million to Total revenues.

The remaining increase of $429.0 million was primarily driven by increased demand for QuickVue SARS Antigen assays and non-SARS related rapid tests, partially offset by a decrease in revenues for the Sofia SARS Antigen assay.

Adjusted EBITDA was $949.2 million for fiscal year 2023, compared to $1,614.6 million for fiscal year 2022.

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 period, 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 period, partially offset by a decrease in employee compensation costs and other operating expenses.

Adjusted EBITDA was $1,025.2 million for fiscal year ended 2023, compared to $1,689.2 million for fiscal year ended 2022.

The decrease was primarily driven by lower demand for QuickVue and Sofia SARS Antigen assays, partially offset by decreased distribution costs and approximately $160 million of incremental impact of the Combinations.

Adjusted EBITDA was $1,614.6 million for fiscal year 2022, compared to $1,028.5 million for fiscal year 2021.

During fiscal year 2022, the impact of the Combinations contributed $260.7 million to Adjusted EBITDA.

The remaining increase of $325.4 million was primarily driven by increased revenues, partially offset by increased distribution and selling costs.

Total revenues and Adjusted EBITDA for EMEA were as follows:

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Adjusted EBITDA $ 46.5 $ 41.0 $ 31.4 13 % 31 %

Total revenues were $327.3 million for fiscal year 2023, compared to $206.8 million for fiscal year 2022.

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.

Total revenues were $327.3 million for fiscal year ended 2023, compared to $206.8 million for fiscal year ended 2022.

The increase was primarily driven by incremental revenues of $110.1 million from the Combinations, partially offset by a decrease in Point of Care revenue.

Total revenues were $206.8 million for fiscal year 2022, compared to $69.6 million for fiscal year 2021.

The increase was primarily driven by the impact of the Combinations, which contributed $146.2 million to Total revenues, partially offset by lower Point of Care revenue due to lower BNP sales from the transition of the BNP Business to Beckman.

Adjusted EBITDA was $58.3 million for fiscal year 2023, compared to $31.7 million for fiscal year 2022.

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.

Adjusted EBITDA was $41.0 million for fiscal year ended 2023, compared to $31.4 million for fiscal year ended 2022.

The increase was primarily driven by incremental revenues from the Combinations, partially offset by lower Point of Care revenue and increased selling and distribution costs.

Adjusted EBITDA was $31.7 million for fiscal year 2022, compared to $28.1 million for fiscal year 2021.

The increase was primarily driven by the impact of the Combinations, which contributed approximately $18 million to Adjusted EBITDA, partially offset by lower revenues and increased selling costs.

Total revenues and Adjusted EBITDA for China were as follows:

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Adjusted EBITDA $ 130.5 $ 127.2 $ 99.4 3 % 28 %

Total revenues were $310.1 million for fiscal year 2023, compared to $220.0 million for fiscal year 2022.

Total revenues were $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 revenue, partially offset by a decrease in Point of Care revenue.

Total revenues were $310.1 million for fiscal year ended 2023, compared to $220.0 million for fiscal year ended 2022.

The increase was primarily driven by incremental revenues of $95.0 million from the Combinations, partially offset by lower Point of Care revenue, primarily related to decreased demand for QuickVue SARS Antigen assays.

Total revenues were $220.0 million for fiscal year 2022, compared to $58.0 million for fiscal year 2021.

The increase was primarily driven by the impact of the Combinations, which contributed $161.3 million to Total revenues.

Adjusted EBITDA was $129.1 million for fiscal year 2023, compared to $104.1 million for fiscal year 2022.

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 revenue, partially offset by a decrease in Point of Care revenue and the impact from changes in product mix.

Adjusted EBITDA was $127.2 million for fiscal year ended 2023, compared to $99.4 million for fiscal year ended 2022.

The increase was primarily driven by approximately $29 million of incremental impact of the Combinations, partially offset by lower Point of Care revenue and a shift in product mix.

Adjusted EBITDA was $104.1 million for fiscal year 2022, compared to $24.1 million for fiscal year 2021.

The increase was primarily driven by the impact of the Combinations of approximately $81 million.

Total revenues and Adjusted EBITDA for Other, which includes our Latin America, Japan and Asia Pacific operating segments, were as follows:

Total revenues and Adjusted EBITDA for Other were as follows:

Fiscal Year Ended

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Adjusted EBITDA $ 133.5 $ 115.3 $ 91.2 16 % 26 %

Total revenues w ere $483.3 million for fiscal year 2023, compared to $302.7 million for fiscal year 2022.

Total revenues w ere $502.3 million for fiscal year ended 2024, compared to $483.3 million for fiscal year ended 2023.

The increase was primarily driven by an increase in Labs revenue, partially offset by a decrease in Point of Care revenue.

Total revenues w ere $483.3 million for fiscal year ended 2023, compared to $302.7 million for fiscal year ended 2022.

The increase was primarily driven by incremental revenues of $177.1 million from the Combinations and higher Labs revenue, partially offset by lower Point of Care revenue.

Total revenues w ere $302.7 million for fiscal year 2022, compared to $70.8 million for fiscal year 2021.

The increase was primarily driven by the impact of the Combinations, which contributed $250.5 million to Total revenues, partially offset by lower Point of Care revenue, driven by lower demand for QuickVue SARS Antigen and Sofia assays.

Adjusted EBITDA was $116.3 million for fiscal year 2023, compared to $92.7 million for fiscal year 2022.

Adjusted EBITDA was $133.5 million for fiscal year ended 2024, compared to $115.3 million for fiscal year ended 2023.

The increase was primarily driven by an increase in Labs revenue and a decrease in operating expenses, partially offset by a decrease in Point of Care revenue.

Adjusted EBITDA was $115.3 million for fiscal year ended 2023, compared to $91.2 million for fiscal year ended 2022.

The increase was primarily driven by approximately $37 million of incremental impact of the Combinations, partially offset by lower Point of Care revenue.

Adjusted EBITDA was $92.7 million for fiscal year 2022, compared to $43.0 million for fiscal year 2021.

The increase was primarily driven by the impact of the Combinations, which contributed approximately $63 million to Adjusted EBITDA, partially offset by lower revenues.

Liquidity and Capital Resources

As of December 31, 2023 and January 1, 2023, the principal sources of liquidity consisted of the following:

As of December 29, 2024 and December 31, 2023, our principal sources of liquidity consisted of the following:

(Dollars in millions) December 29,

2023 January 1,

2024 December 31,

Cash and cash equivalents $ 98.3 $ 118.9

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Working capital including cash and cash equivalents and marketable securities, current $ 220.1 $ 476.7

As of December 31, 2023, we had $118.9 million in Cash and cash equivalents, a $174.0 million decrease from January 1, 2023.

As of December 29, 2024, we had $98.3 million in Cash and cash equivalents, a $20.6 million decrease from December 31, 2023.

Our cash requirements fluctuate as a result of numerous factors, including cash generated from operations, progress in R&D, capital expansion projects and acquisition 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

Our Credit Agreement consists of a $2,750.0 million Term Loan and an $800.0 million Revolving Credit Facility.

As of December 31, 2023 and January 1, 2023, there were no amounts outstanding under the Revolving Credit Facility.

As of December 31, 2023, letters of credit issued under the Revolving Credit Facility totaled $12.9 million, which reduced the available amount under the Revolving Credit Facility to $787.1 million.

The Term Loan and the Revolving Credit Facility will mature on May 27, 2027.

In fiscal year 2023, we made $226.7 million in payments on our Term Loan, including a voluntary prepayment of $20.0 million.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 8.

Borrowings” for further information.

On March 31, 2023, we entered into an amendment to our existing receivables purchase agreement (the “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 Corporation, as an Originator, and certain Purchasers.

Availability under the Revolving Credit Facility, after deducting letters of credit of $13.0 million and $198.0 million borrowings outstanding, was $589.0 million as of December 29, 2024.

On April 25, 2024, we entered into Amendment No.

2 to the Credit Agreement, by and among us, the lenders party thereto, and Bank of America, N.A., as administrative agent.

The amendment sets a maximum Consolidated Leverage Ratio (as defined in the Credit Agreement) for the applicable measurement period as of the last day of each fiscal quarter of (a) 4.50 to 1.00 on or prior to June 30, 2023, (b) 4.00 to 1.00 after June 30, 2023 and on or prior to June 30, 2024, (c) 4.25 to 1.00 after June 30, 2024 and on or prior to December 31, 2024, (d) 4.00 to 1.00 after December 31, 2024 and on or prior to June 30, 2025 and (e) 3.75 to 1.00 each fiscal quarter after June 30, 2025.

The Credit Agreement contains 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 29, 2024.

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 Corporation, 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.

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of its obligations as Master Servicer.

Our Stock Repurchase Program allows us to repurchase up to $300.0 million of our common stock through August 17, 2024.

The Stock Repurchase Program does not obligate us to acquire any specific number of shares.

Under the Stock Repurchase Program, shares of common stock may be repurchased using a variety of methods, including privately negotiated and/or open market transactions, including under plans complying with Rule 10b5-1 under the Exchange Act, as part of accelerated stock repurchases and other methods.

The timing, manner, price and amount of any repurchases are determined by us in our

discretion and depend on a variety of factors, including legal requirements, price and economic and market conditions.

For the fiscal year ended December 31, 2023, we repurchased 120,000 shares of outstanding common stock under the Stock Repurchase Program for approximately $7.2 million.

The repurchased shares were retired and returned to the status of authorized but unissued shares of our common stock.

As of December 31, 2023, we had approximately $218.4 million available under the Stock Repurchase Program.

Refer to Part II, Item 5, “Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities” for further information.

Our investment portfolio includes marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors.

Our investment policy establishes limits on the amount and time to maturity of investments with any institution.

The investment policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 13.

Fair Value Measurements.”

Stock Repurchases

On August 17, 2022, our Board authorized the Stock Repurchase Program, allowing us to repurchase up to $300.0 million of our common stock, which expired on August 17, 2024.

We did not repurchase any shares of our common stock during fiscal year ended 2024 through the expiration date.

For the fiscal year ended 2023, we repurchased 120,000 shares of outstanding common stock under the Stock Repurchase Program for approximately $7.2 million.

Capital Expenditures

Annual capital expenditures, net of proceeds from government assistance allocated to fixed assets, were approximately $196 million, $123 million and $256 million in fiscal years 2023, 2022 and 2021, respectively.

We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities and other facility-related activities.

Annual capital expenditures, including investments, net of proceeds from government assistance allocated to fixed assets, were approximately $195 million, $196 million and $123 million in fiscal years ended 2024, 2023 and 2022, respectively.

continue to make capital expenditures in connection with the expansion of our manufacturing capabilities and other facility-related activities.

Cash Flow Summary

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Net cash used for investing activities (149.9) (187.6) (1,644.2)

Net cash (used for) provided by financing activities (265.8) 252.0 (173.1)

Net cash provided by (used for) financing activities 48.8 (265.8) 252.0

Effect of exchange rates on cash (2.9) (1.2) (2.0)

Net (decrease) increase in cash, cash equivalents and restricted cash $ (174.4) $ (508.9) $ 312.9

Net decrease in cash, cash equivalents and restricted cash $ (21.0) $ (174.4) $ (508.9)

Fiscal Year Ended December 29, 2024

Cash provided by operating activities was $280.2 million for fiscal year 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 and accretion of interest on deferred consideration.

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, 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 Ended December 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 2023, and was primarily related to $209.3 million in purchases of property, equipment, investments and intangibles.

We also purchased $60.1 million and sold $78.3 million of marketable securities during fiscal year 2023.

Cash used for financing activities was $265.8 million for fiscal year 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.

Fiscal Year Ended January 1, 2023

Cash provided by operating activities was $885.3 million for fiscal year 2022, and reflected net income of $548.7 million and non-cash adjustments of $389.8 million, primarily associated with depreciation and amortization, stock-based compensation expense, deferred income taxes, loss on extinguishment of debt and the unwind of the inventory fair value step up initially recorded in connection with the Combinations.

In addition, we benefited from collections on accounts receivables, which contributed $150.2 million to Cash provided by operating activities, offset by net cash outflows related to inventories, prepaid and other current and non-current assets and liabilities as well as income taxes payable and other current and non-current liabilities.

Cash used for investing activities was $1,644.2 million for fiscal year 2022, and was primarily related to the Combinations.

We purchased $140.9 million of property, equipment, investments and intangibles and received $18.4 million of proceeds from government assistance allocated to fixed assets.

We also purchased $63.7 million and sold $53.4 million of marketable securities during fiscal year 2022.

See Part II, Item 8, “Financial Statements and Supplementary Data—Note 2.

Business Combination” for further discussion regarding the Combinations.

Cash provided by financing activities was $252.0 million for fiscal year 2022, and was primarily related to proceeds from long-term borrowings, net of debt issuance costs of $2,734.5 million, payments on long-term borrowings and extinguishment costs of $2,388.3 million, repurchases of common stock of $74.3 million and payments of $37.7 million for contingent and deferred consideration.

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.

Fiscal Year Ended January 1, 2023

Cash provided by operating activities was $805.9 million for fiscal year 2021, and reflected net income of $704.2 million and non-cash adjustments of $104.5 million, primarily associated with depreciation and amortization, stock-based compensation expense and accretion of interest on deferred consideration.

Partially offsetting these inflows was a net working capital use of cash of $30.7 million, primarily driven by an increase in product inventory associated with the increased demand due to the COVID-19 pandemic and a decrease in income taxes payable, partially offset by a decrease in accounts receivable.

Cash used for investing activities was $319.5 million for fiscal year 2021, and was primarily related to investments in manufacturing equipment, building improvements, Sofia, Solana and Triage instruments available for lease and scientific equipment, partially offset by government proceeds received to fund such investments.

Additionally, we purchased $67.4 million of available-for-sale securities and sold $3.8 million of our available-for-sale securities during 2021.

Cash used for financing activities was $173.1 million for fiscal year 2021, and was primarily related to repurchases of common stock of $103.5 million, payments of tax withholdings for vesting of stock-based awards of $37.1 million, and the payment of deferred and contingent consideration of $39.8 million, partially offset by proceeds of $7.6 million from the issuance of common stock under the ESPP (as defined in this Annual Report) and pursuant to stock option exercises.

Cash provided by operating activities was $885.3 million for fiscal year ended 2022, and reflected net income of $548.7 million and non-cash adjustments of $389.8 million, primarily associated with depreciation and amortization, stock-based compensation expense, change in deferred tax assets and liabilities, loss on extinguishment of debt and the unwind of the inventory fair value step up initially recorded in connection with the Combinations.

In addition, we benefited from collections on accounts receivables, which contributed $150.2 million to Cash provided by operating activities, offset by other changes in working capital, including $116.9 million of cash outflows for inventories.

Cash used for investing activities was $1,644.2 million for fiscal year ended 2022, and was primarily related to the Combinations.

We purchased $140.9 million of property, equipment, investments and intangibles and received $18.4 million in proceeds from government assistance allocated to fixed assets.

We also purchased $63.7 million and sold $53.4 million of marketable securities during 2022.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 2.

Stockholders’ Equity.”

Business Combination” for further discussion regarding the Combinations.

Cash provided by financing activities was $252.0 million for fiscal year ended 2022, and was primarily related to proceeds from long-term borrowings, net of debt issuance costs of $2,734.5 million, payments on long-term borrowings and extinguishment

costs of $2,388.3 million, repurchases of common stock of $74.3 million and payments of $37.7 million for contingent and deferred consideration.

Liquidity Outlook

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For these same reasons, the reagent rental model also benefits our commercial strategy in emerging markets.

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 2023, we transferred $154.6 million of instrument inventories from Inventories to Property, plant and equipment, net, further increasing our investment in property, plant and equipment.

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 2024, we transferred $148.9 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 successfully integrate the recently acquired Ortho business and realize cross-selling revenue synergies;

• our ability to successfully integrate the Ortho business and realize cross-selling revenue synergies;

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

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

In January 2023, we entered into a lease for warehouse space in the U.S.

that has not yet commenced, with total lease payments of approximately $36 million.

This lease is expected to commence during the first half of 2024 with a lease term of five years.

Contractual Obligations and Off-Balance Sheet Arrangements

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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 generally accepted accounting principles in the U.S.

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.

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

Reserve for Contractual Rebates

Allowance for Contractual Rebates

We record revenues primarily from product sales.

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In addition, the determination of such adjustments includes estimating rebate percentages which are dependent on estimated end-user sales mix and customer contractual terms, which vary across customers, the related balance of which was $39.8 million of our rebate reserves at December 29, 2024.

Our total rebate reserve was $75.6 million at December 31, 2023.

Goodwill and Intangible Assets

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otherwise, goodwill is impaired and the loss is recorded.

For our annual evaluation for impairment of goodwill as of October 2, 2023, we bypassed the qualitative assessment and proceeded directly to the quantitative goodwill impairment test for all reporting units.

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.

This quantitative analysis required us to make estimates and assumptions in order to calculate the fair value of our reporting units.

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Under the market approach, we estimated the fair value based on market multiples of our revenue and EBITDA.

In all instances, the estimated fair values of our reporting units exceeded their carrying values and consequently did not result in an impairment.

The excess of the estimated fair value over carrying value (expressed as a percentage of carrying value for the respective reporting unit) for our North America, EMEA, Latin America, Japan and Asia Pacific reporting units as of the testing date ranged from approximately 8% to 70%.

The excess of the estimated fair value over carrying value for our China reporting unit was approximately 170%.

To evaluate the sensitivity of the fair value calculations used in the goodwill impairment test, the Company applied a hypothetical 5% decrease to the fair values of each reporting unit and compared those hypothetical values to the reporting unit carrying values.

Based on this hypothetical 5% decrease, the excess of the estimated fair value over carrying value (expressed as a percentage of carrying value for the respective reporting unit) for each of our reporting units ranged from approximately 3% to approximately 160%.

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.

The estimated fair values of the EMEA and Latin America reporting units exceeded their respective carrying values and consequently did not result in an impairment.

The excess of the estimated fair value over carrying value (expressed as a percentage of carrying value for the respective reporting unit) was approximately 8% and 45%, respectively.

To evaluate the sensitivity of the fair value calculations used in the interim goodwill impairment test for the EMEA and Latin America reporting units, we applied a hypothetical 5% decrease to the fair value of each reporting unit and compared that hypothetical value to the reporting unit’s carrying value.

Based on this hypothetical 5% decrease, the excess of the estimated fair value over carrying value (expressed as a percentage of carrying value for the respective reporting unit) was approximately 3% and 37% for the EMEA and Latin America reporting units, respectively.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 9.

Goodwill and Intangible Assets, Net” for more information on the goodwill impairment recognized in 2024.

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.

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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.

See Part II, Item 8, “Financial Statements and Supplementary Data—Note 6.

Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 6.

Income Taxes” for more information on income taxes.

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Under the acquisition method of accounting, the cost of an acquired business is assigned to the tangible and identifiable intangible assets acquired and liabilities assumed on the basis of the estimated fair values at the date of acquisition.

approach and a market approach, such as the estimation of future cash flows of the acquired business and current selling prices of similar assets.

We assess fair value, which is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, using a variety of methods including, but not limited to, an income approach and a market approach, such as the estimation of future cash flows of the acquired business and current selling prices of similar assets.

These valuations require us to make estimates and assumptions, especially with respect to intangible assets.

Fair value of the assets acquired and liabilities assumed, including intangible assets, in-process research and development (“IPR&D”), and contingent payments, are measured based on the assumptions and estimations with regards to variable factors such as the amount and timing of future cash flows for the asset or liability being measured, appropriate risk-adjusted discount rates, nonperformance risk, or other factors that market participants would consider.

Fair value of the assets acquired and liabilities assumed, including intangible assets, IPR&D, and contingent payments, are measured based on the assumptions and estimations with regards to variable factors such as the amount and timing of future cash flows for the asset or liability being measured, appropriate risk-adjusted discount rates, nonperformance risk, or other factors that market participants would consider.

Upon acquisition, we determine the estimated economic lives of the acquired intangible assets for amortization purposes, which are based on the underlying expected cash flows of such assets.

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If the initial accounting for a business combination is incomplete by the end of a reporting period that falls within the measurement period, we report provisional amounts in our financial statements.

During the measurement period, we adjust the provisional amounts recognized at the acquisition date to reflect new information obtained about facts and circumstances that existed as of the acquisition date that, if known, would have affected the measurement of the amounts recognized as of that date.

During the measurement period, we adjust the

provisional amounts recognized at the acquisition date to reflect new information obtained about facts and circumstances that existed as of the acquisition date that, if known, would have affected the measurement of the amounts recognized as of that date.

We record these adjustments to the provisional amounts with a corresponding offset to goodwill.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis