What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-06 · 163 added, 122 removed, 202 unchanged (59% of the section changed)

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failure to exercise the option to acquire or complete the proposed acquisition of LEX Diagnostics on the anticipated timeline, or at all, including risks and uncertainties related to LEX Diagnostics’ ability to secure FDA clearance and satisfy other customary closing conditions and provisions;

inability to realize the anticipated benefits of acquisitions, discontinuances of certain business operations (such as the Savanna Exit) or the Optimization Plan on our anticipated timelines, or at all;

inability to realize the anticipated benefits of acquisitions, debt refinancings, discontinuances of certain business operations (such as the Savanna Exit) or the Optimization Plan on our anticipated timelines, or at all;

delays in the development of or failures or delays in the receipt of approvals for new or enhanced products;

and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting our business generally, including those arising from the effects of announced or future or amended tariffs, trade policies and global trade relations, as well as those discussed under Part II, Item 1A, “Risk Factors” of this Quarterly Report and Part I, Item 1A, “Risk Factors” of our Annual Report.

and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting our business generally, including those arising from the effects of announced or future or amended tariffs, trade policies, investigations and global trade relations, as well as those discussed under Part II, Item 1A, “Risk Factors” of this Quarterly Report and Part I, Item 1A, “Risk Factors” of our Annual Report.

Investors should not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature.

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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 $59.8 million and $51.0 million for the six months ended June 29, 2025 and June 30, 2024, respectively.

For the six months ended June 29, 2025, Total revenues decreased by 3% to $1,306.7 million as compared to the same period in the prior year.

We also generate non-core revenue, including through our contract manufacturing business and certain business collaborations, which accounted for $25.8 million and $85.6 million for the three and nine months ended

September 28, 2025, respectively, and $24.0 million and $75.0 million for the three and nine months ended September 29, 2024, respectively.

For the nine months ended September 28, 2025, Total revenues decreased by 3% to $2,006.6 million as compared to the same period in the prior year.

This decrease was 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 had an unfavorable impact of 70 basis points on our growth rate.

Currency exchange rates did not significantly impact our growth rate for the nine months ended September 28, 2025.

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

For the six months ended June 29, 2025 and June 30, 2024, revenues related to our respiratory products accounted for 13% and 14% of our Total revenues, respectively.

The respiratory product revenue included $32.9 million and $69.1 million revenue related to COVID-19 for the six months ended June 29, 2025 and June 30, 2024, respectively.

For the nine months ended September 28, 2025 and September 29, 2024, revenues related to our respiratory products accounted for 14% and 17% of our Total revenues, respectively.

The respiratory product revenue included revenue related to COVID-19 of $26.9 million and $59.8 million for the three and nine months ended September 28, 2025, respectively, and $72.3 million and $141.4 million for the three and nine months ended September 29, 2024, respectively.

Planned Wind-Down of U.S.

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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 pretax charges to be incurred by us to implement the Optimization Plan are expected to be approximately $100 million through 2027.

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.

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In April 2025, the U.S.

announced tariffs on imports from most countries, including significant tariffs on imports from U.K., Canada, Mexico and China, leading to increasing trade and political tensions.

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.

These actions and the related rising political tensions could negatively impact global macroeconomic conditions and the stability of global financial markets, which 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 or pauses in tariffs, tariff levels and whether additional tariffs or retaliatory actions may be imposed, modified or suspended.

In addition, in recent months, 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.

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Results of Operations

The following table compares Total revenues by business unit for the three and six months ended June 29, 2025 and June 30, 2024:

Three Months Ended Six Months Ended

(Dollars in millions) June 29, 2025 June 30, 2024 % Change June 29, 2025 June 30, 2024 % Change

The following table compares Total revenues by business unit for the three and nine months ended September 28, 2025 and September 29, 2024:

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 September 29, 2024 % Change September 28, 2025 September 29, 2024 % Change

Labs $ 373.8 $ 356.0 5 % $ 1,116.5 $ 1,067.3 5 %

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Total revenues $ 699.9 $ 727.1 (4) % $ 2,006.6 $ 2,075.1 (3) %

(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:

(1) 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.

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

For the three months ended June 29, 2025, Total revenues decreased to $613.9 million from $637.0 million for the same period in the prior year.

For the three months ended September 28, 2025, Total revenues decreased to $699.9 million from $727.1 million for the same period in the prior year.

Labs revenue increased 5% compared to the prior year period, primarily due to growth in reagents, consumables and services, partially offset by a decline in instrument revenue.

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donor screening business.

Point of Care revenue decreased 21% compared to the prior year period, primarily due to decreases in sales of QuickVue and Sofia SARS Antigen assays.

Molecular Diagnostics revenue increased slightly compared to the prior year period.

Currency exchange rates did not significantly impact our growth rate for the three months ended June 29, 2025.

For the six months ended June 29, 2025, Total revenues decreased to $1,306.7 million from $1,348.0 million for the same period in the prior year.

Point of Care revenue decreased 20%

compared to the prior year period, primarily due to decreases in sales of QuickVue and Sofia SARS Antigen assays.

Molecular Diagnostics revenue decreased slightly compared to the prior year period.

Currency exchange rates had a favorable impact of approximately 90 basis points on our growth rate for the three months ended September 28, 2025.

For the nine months ended September 28, 2025, Total revenues decreased to $2,006.6 million from $2,075.1 million for the same period in the prior year.

Labs revenue increased 5% compared to the prior year period, primarily due to growth in reagents, consumables and services, partially offset by a decline in instrument revenue.

Immunohematology revenue increased 3%

compared to the prior year period, primarily due to reagent growth.

Immunohematology revenue increased 4% compared to the prior year period, primarily due to reagent growth.

Donor Screening revenue decreased 57% compared to the prior year period, primarily due to the wind-down of the U.S.

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Molecular Diagnostics revenue increased 5% compared to the prior year period, driven by higher Savanna revenue.

Currency exchange rates had an unfavorable impact of 70 basis points on our growth rate for the six months ended June 29, 2025.

Currency exchange rates did not significantly impact our growth rate for the nine months ended September 28, 2025.

Cost of Sales, Excluding Amortization of Intangible Assets

Cost of sales, excluding amortization of intangible assets, decreased to $339.0 million, or 55.2% of Total revenues, for the three months ended June 29, 2025, compared to $361.0 million, or 56.7% of Total revenues, for the three months ended June 30, 2024.

Cost of sales, excluding amortization of intangible assets, decreased to $364.3 million, or 52.1% of Total revenues, for the three months ended September 28, 2025, compared to $374.8 million, or 51.5% of Total revenues, for the three months ended September 29, 2024.

The decrease in cost of sales, excluding amortization of intangible assets, was driven primarily by procurement-related cost-savings initiatives actioned in 2024.

Cost of sales, excluding amortization of intangible assets, decreased to $688.5 million, or 52.7% of Total revenues, for the six months ended June 29, 2025, compared to $739.9 million, or 54.9% of Total revenues, for the six months ended June 30, 2024.

Cost of sales, excluding amortization of intangible assets, decreased to $1,052.8 million, or 52.5% of Total revenues, for the nine months ended September 28, 2025, compared to $1,114.7 million, or 53.7% of Total revenues, for the nine months ended September 29, 2024.

The decrease in cost of sales, excluding amortization of intangible assets, was driven primarily by procurement-related cost-savings initiatives actioned in 2024.

Operating Expenses

The following table summarizes operating expenses for the three and six months ended June 29, 2025 and June 30, 2024:

Three Months Ended Six Months Ended

(Dollars in millions) June 29, 2025 % of

Total Revenues June 30, 2024 % of

Total Revenues June 29, 2025 % of

Total Revenues June 30, 2024 % of

The following table summarizes operating expenses for the three and nine months ended September 28, 2025 and September 29, 2024:

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 % of

Total Revenues September 29, 2024 % of

Total Revenues September 28, 2025 % of

Total Revenues September 29, 2024 % of

Total Revenues

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Selling, Marketing and Administrative Expenses

Selling, marketing and administrative expenses for the three months ended June 29, 2025 decreased by $10.2 million, or 5.4%, to $178.0 million from $188.2 million for the same period in the prior year, primarily due to lower compensation costs related to cost-savings initiatives actioned in 2024 and lower outside services.

Selling, marketing and administrative expenses for the six months ended June 29, 2025 decreased by $27.9 million, or 7.1%, to $365.0 million from $392.9 million for the same period in the prior year, primarily due to lower compensation costs related to cost-savings initiatives actioned in 2024 and lower outside services.

Selling, marketing and administrative expenses for the three months ended September 28, 2025 increased by $0.5 million, or 0.3%, to $186.9 million from $186.4 million for the same period in the prior year.

Selling, marketing and administrative expenses for the nine months ended September 28, 2025 decreased by $27.4 million, or 4.7%, to $551.9 million from $579.3 million for the same period in the prior year, primarily due to lower compensation costs related to cost-savings initiatives actioned in 2024 and lower outside services.

Research and Development Expense

Research and development expense for the three months ended June 29, 2025 decreased by $10.6 million, or 18.8%, to $45.7 million from $56.3 million for the same period in the prior year, primarily due to cost-savings initiatives actioned in 2024.

Research and development expense for the six months ended June 29, 2025 decreased by $16.6 million, or 14.4%, to $98.9 million from $115.5 million for the same period in the prior year, primarily due to lower clinical supplies and compensation costs related to cost-savings initiatives actioned in 2024.

Research and development expense for the three months ended September 28, 2025 decreased by $14.4 million, or 25.8%, to $41.5 million from $55.9 million for the same period in the prior year, primarily due to lower clinical costs.

Research and development expense for the nine months ended September 28, 2025 decreased by $31.0 million, or 18.1%, to $140.4 million from $171.4 million for the same period in the prior year, primarily due to lower clinical costs and compensation costs related to cost-savings initiatives actioned in 2024.

Amortization of Intangible Assets

Amortization of intangible assets was $47.9 million and $95.9 million for the three and six months ended June 29, 2025, respectively, and $51.9 million and $103.6 million for the three and six months ended June 30, 2024, respectively.

Amortization of intangible assets was $47.7 million and $143.6 million for the three and nine months ended September 28, 2025, respectively, and $51.9 million and $155.5 million for the three and nine months ended September 29, 2024, respectively.

The decreases were 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 $178.9 million and $195.0 million for the three and six months ended June 29, 2025, respectively, and $30.9 million and $53.5 million for the three and six months ended June 30, 2024, respectively.

The increases were primarily driven by restructuring and other charges related to the (i) implementation of cost-reduction, strategic productivity and margin improvement initiatives under the Optimization Plan and (ii) the Savanna Exit, partially offset by a decrease in integration-related charges.

Restructuring, integration and other charges were $39.6 million and $234.6 million for the three and nine months ended September 28, 2025, respectively, and $36.8 million and $90.3 million for the three and nine months ended September 29, 2024, respectively.

Refer to Item 1, “Financial Statements—Note 14.

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Goodwill Impairment Charge

We recognized a non-cash goodwill impairment charge of $1.7 billion for the six months ended June 30, 2024.

During the three months ended September 28, 2025, we recognized a non-cash goodwill impairment charge of $700.7 million for our reporting units.

Refer to Item 1, “Financial Statements—Note 7.

Goodwill and Intangible Assets, Net” for more information.

We recognized a non-cash goodwill impairment charge of $1.7 billion for the nine months ended September 29, 2024.

Asset Impairment Charge

We recognized an impairment charge of $56.9 million related to the long-lived assets classified as assets held for sale for each of the three and six months ended June 30, 2024.

We recognized an impairment charge of $9.7 million as a result of the latest fair value assessment for the three and nine months ended September 28, 2025, and $56.9 million for the nine months ended September 29, 2024, related to the long-lived assets classified as assets held for sale.

Other Operating Expenses

Other operating expenses were $5.1 million and $11.5 million for the three and six months ended June 29, 2025, respectively, and $9.3 million and $17.3 million for the three and six months ended June 30, 2024, respectively.

Other operating expenses were primarily related to the profit share expense for our Joint Business.

Other operating expenses were $14.3 million and $25.8 million for the three and nine months ended September 28, 2025, respectively, and $6.3 million and $23.6 million for the three and nine months ended September 29, 2024, respectively.

The increases were primarily driven by the legal accrual, partially offset by decreases related to profit sharing for our Joint Business.

Refer to Item 1, “Financial Statements—Note 4.

Segment and Geographic Information” and “—Note 10.

Commitments and Contingencies” for more information on the legal accrual.

Non-operating Expenses

The following table summarizes non-operating expenses, net for the three and nine months ended September 28, 2025 and September 29, 2024:

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 September 29, 2024 % Change September 28, 2025 September 29, 2024 % Change

Interest expense, net $ 46.1 $ 42.9 7.5 % $ 126.6 $ 122.9 3.0 %

Interest expense, net was $40.5 million and $80.5 million for the three and six months ended June 29, 2025, respectively, and $41.0 million and $80.0 million for the three and six months ended June 30, 2024, respectively.

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

Other expense, net 0.9 0.9 — % 10.7 7.2 48.6 %

* N/M - Not meaningful

Interest Expense, Net

Interest expense, net was $46.1 million and $126.6 million for the three and nine months ended September 28, 2025, respectively, and $42.9 million and $122.9 million for the three and nine months ended September 29, 2024, respectively.

Refer to Item 1, “Financial Statements—Note 8.

Borrowings” for more information.

Loss on Extinguishment of Debt

Loss on extinguishment of debt was $5.1 million for the three and nine months ended September 28, 2025, and was related to the termination of the Prior Credit Agreement.

Refer to Item 1, “Financial Statements—Note 8.

Borrowings” for more information.

Other Expense, Net

Other expense, net was $8.4 million and $9.8 million for the three and six months ended June 29, 2025, respectively, and $4.4 million and $6.3 million for the three and six months ended June 30, 2024, respectively.

The increases from the prior year periods were primarily related to net foreign currency losses, partially offset by Credit Agreement amendment fees in the prior year periods.

For the three months ended June 29, 2025, we recognized a provision for income taxes of $25.8 million in relation to loss before income taxes of $229.6 million, resulting in a negative effective tax rate of 11.2%.

For the three months ended June 30, 2024, we recognized an income tax benefit of $15.2 million in relation to loss before income taxes of $162.9 million, resulting in an effective tax rate of 9.3%.

For the three months ended June 29, 2025, the effective tax rate differed from the U.S.

federal statutory rate primarily due to the impacts of operating losses in certain subsidiaries not benefited due to the establishment of valuation allowances.

For the three months ended June 30, 2024, the effective tax rate differed from the U.S.

federal statutory rate primarily due to Subpart F income and the Base Erosion and Anti-Abuse Tax liability.

For the six months ended June 29, 2025, we recognized a provision for income taxes of $29.7 million in relation to loss before income taxes of $238.4 million, resulting in a negative effective tax rate of 12.5%.

For the six months ended June 30, 2024, we recognized an income tax benefit of $108.1 million in relation to loss before income taxes of $1,961.8 million, resulting in an effective tax rate of 5.5%.

For the six months ended June 29, 2025, the effective tax rate differed from the U.S.

federal statutory rate primarily due to the impacts of operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances.

For the six months ended June 30, 2024, the effective tax rate differed from the U.S.

Other expense, net was $0.9 million and $10.7 million for the three and nine months ended September 28, 2025, respectively, and $0.9 million and $7.2 million for the three and nine months ended September 29, 2024, respectively.

The increase for the nine months ended September 28, 2025 was primarily related to net foreign currency losses, partially offset by Prior Credit Agreement amendment fees in the prior year period.

For the three months ended September 28, 2025, we recognized an income tax benefit of $23.9 million in relation to loss before income taxes of $756.9 million, resulting in an effective tax rate of 3.2%.

For the three months ended September 29, 2024, we recognized an income tax benefit of $8.9 million in relation to loss before income taxes of $28.8 million, resulting in an effective tax rate of 30.9%.

For the three months ended September 28, 2025, 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 the three months ended September 29, 2024, the effective tax rate differed from the U.S.

federal statutory rate primarily due to the utilization of net operating losses previously not benefited due to valuation allowances.

For the nine months ended September 28, 2025, we recognized a provision for income taxes of $5.8 million in relation to loss before income taxes of $995.3 million, resulting in a negative effective tax rate of 0.6%.

For the nine months ended September 29, 2024, we recognized an income tax benefit of $117.0 million in relation to loss before income taxes of $1,990.6 million, resulting in an effective tax rate of 5.9%.

For the nine months ended September 28, 2025, the effective tax rate differed from the U.S.

federal statutory rate primarily due to goodwill impairment charges that were nondeductible for tax purposes and the impacts of operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances.

For the nine months ended September 29, 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.

On July 4, 2025, the OBBBA was enacted in the U.S.

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The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.

We are in the process of evaluating the impacts on our Consolidated Financial Statements.

Our results for the nine months ended September 28, 2025 include the impacts of OBBBA on our Consolidated Financial Statements.

Segment Results

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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.

Adjusted EBITDA consists of Net loss 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 and that we do not consider indicative of our ongoing operating performance.

Refer to Item 1, “Financial Statements—Note 4.

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

Three Months Ended Six Months Ended

(Dollars in millions) June 29, 2025 June 30, 2024 % Change June 29, 2025 June 30, 2024 % Change

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 September 29, 2024 % Change September 28, 2025 September 29, 2024 % Change

Total revenues $ 381.4 $ 436.2 (13) % $ 1,098.8 $ 1,220.2 (10) %

Adjusted EBITDA $ 210.8 $ 248.0 (15) % $ 604.8 $ 670.2 (10) %

Total revenues were $310.7 million for the three months ended June 29, 2025, compared to $350.1 million for the three months ended June 30, 2024.

The decrease was primarily driven by the wind-down of the U.S.

donor screening business and decreases in sales of QuickVue and Sofia SARS Antigen assays, partially offset by an increase in Labs revenues.

Total revenues were $717.4 million for the six months ended June 29, 2025, compared to $784.0 million for the six months ended June 30, 2024.

The decrease was primarily driven by the wind-down of the U.S.

donor screening business and decreases in sales of QuickVue and Sofia SARS Antigen assays, partially offset by an increase in Labs revenues.

Adjusted EBITDA was $159.7 million for the three months ended June 29, 2025, compared to $185.6 million for the three months ended June 30, 2024.

The decrease was primarily driven by decreases in revenue due to the wind-down of the U.S.

donor screening business and decreases in sales of QuickVue and Sofia SARS Antigen assays, partially offset by lower operating expenses due to cost-savings initiatives and an increase in Labs revenues.

Adjusted EBITDA was $394.0 million for the six months ended June 29, 2025, compared to $422.2 million for the six months ended June 30, 2024.

The decrease was primarily driven by decreases in revenue due to the wind-down of the U.S.

Total revenues were $381.4 million for the three months ended September 28, 2025, compared to $436.2 million for the three months ended September 29, 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.

Total revenues were $1,098.8 million for the nine months ended September 28, 2025, compared to $1,220.2 million for the nine months ended September 29, 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.

Adjusted EBITDA was $210.8 million for the three months ended September 28, 2025, compared to $248.0 million for the three months ended September 29, 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.

Adjusted EBITDA was $604.8 million for the nine months ended September 28, 2025, compared to $670.2 million for the nine months ended September 29, 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.

Total revenues and Adjusted EBITDA for EMEA were as follows:

Three Months Ended Six Months Ended

(Dollars in millions) June 29, 2025 June 30, 2024 % Change June 29, 2025 June 30, 2024 % Change

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 September 29, 2024 % Change September 28, 2025 September 29, 2024 % Change

Total revenues $ 91.8 $ 84.0 9 % $ 268.0 $ 249.9 7 %

Adjusted EBITDA $ 24.4 $ 12.9 89 % $ 59.2 $ 36.6 62 %

Total revenues were $87.3 million for the three months ended June 29, 2025, compared to $81.1 million for the three months ended June 30, 2024, primarily driven by increases in revenues across all business units.

Total revenues were $176.2 million for the six months ended June 29, 2025, compared to $165.9 million for the six months ended June 30, 2024, primarily driven by increases in Immunohematology and Point of Care revenues.

Adjusted EBITDA was $18.3 million for the three months ended June 29, 2025, compared to $12.1 million for the three months ended June 30, 2024.

The increase was primarily driven by increases in revenues, lower distribution costs and other operating expenses due to cost-savings initiatives.

Adjusted EBITDA was $34.8 million for the six months ended June 29, 2025, compared to $23.7 million for the six months ended June 30, 2024, primarily driven by increases in revenues, lower distribution costs and other operating expenses due to cost-savings initiatives.

Total revenues were $91.8 million for the three months ended September 28, 2025, compared to $84.0 million for the three months ended September 29, 2024, primarily driven by an increase in Immunohematology revenues.

Total revenues were $268.0 million for the nine months ended September 28, 2025, compared to $249.9 million for the nine months ended September 29, 2024, primarily driven by increases in Immunohematology and Point of Care revenues.

Adjusted EBITDA was $24.4 million for the three months ended September 28, 2025, compared to $12.9 million for the three months ended September 29, 2024.

The increase was primarily driven by an increase in revenues, product mix and lower operating expenses.

Adjusted EBITDA was $59.2 million for the nine months ended September 28, 2025, compared to $36.6 million for the nine months ended September 29, 2024, primarily driven by increases in revenues and lower distribution costs and other operating expenses due to cost-savings initiatives.

Total revenues and Adjusted EBITDA for China were as follows:

Three Months Ended Six Months Ended

(Dollars in millions) June 29, 2025 June 30, 2024 % Change June 29, 2025 June 30, 2024 % Change

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 September 29, 2024 % Change September 28, 2025 September 29, 2024 % Change

Total revenues $ 84.6 $ 80.4 5 % $ 243.0 $ 238.1 2 %

Adjusted EBITDA $ 36.8 $ 36.8 — % $ 108.2 $ 98.6 10 %

Total revenues were $83.4 million for the three months ended June 29, 2025, compared to $81.6 million for the three months ended June 30, 2024, driven by an increase of 9% in Labs revenues, partially offset by decreases in revenues of other business units.

Total revenues were $158.4 million for the six months ended June 29, 2025, compared to $157.7 million for the six months ended June 30, 2024, driven by an increase of 5% in Labs revenues, partially offset by a decrease in Point of Care revenues.

Adjusted EBITDA was $42.1 million for the three months ended June 29, 2025, compared to $35.7 million for the three months ended June 30, 2024.

The increase was primarily driven by the impact from changes in product mix and higher Labs revenues.

Adjusted EBITDA was $71.4 million for the six months ended June 29, 2025, compared to $61.8 million for the six months ended June 30, 2024.

The increase was primarily driven by the impact from changes in product mix and higher Labs revenues.

Total revenues were $84.6 million for the three months ended September 28, 2025, compared to $80.4 million for the three months ended September 29, 2024, driven by an increase of 7% in Labs revenues.

Total revenues were $243.0 million for the nine months ended September 28, 2025, compared to $238.1 million for the nine months ended September 29, 2024, driven by an increase of 6% in Labs revenues, partially offset by a decrease in Point of Care revenues.

Adjusted EBITDA was $36.8 million for both the three months ended September 28, 2025 and September 29, 2024, primarily driven by higher Labs revenues offset by the impact from changes in product mix.

Adjusted EBITDA was $108.2 million for the nine months ended September 28, 2025, compared to $98.6 million for the nine months ended September 29, 2024.

The increase was primarily driven by higher Labs revenues and the impact from changes in product mix.

Total revenues and Adjusted EBITDA for Other were as follows:

Three Months Ended Six Months Ended

(Dollars in millions) June 29, 2025 June 30, 2024 % Change June 29, 2025 June 30, 2024 % Change

Three Months Ended Nine Months Ended

(Dollars in millions) September 28, 2025 September 29, 2024 % Change September 28, 2025 September 29, 2024 % Change

Total revenues $ 142.1 $ 126.5 12 % $ 396.8 $ 366.9 8 %

Adjusted EBITDA $ 44.2 $ 32.4 36 % $ 111.7 $ 97.9 14 %

Total revenues were $132.5 million for the three months ended June 29, 2025, compared to $124.2 million for the three months ended June 30, 2024, primarily driven by increases in Labs and Immunohematology revenues.

Total revenues were $254.7 million for the six months ended June 29, 2025, compared to $240.4 million for the six months ended June 30, 2024, primarily driven by an increase in Labs revenues.

Adjusted EBITDA was $37.9 million for the three months ended June 29, 2025, compared to $34.0 million for the three months ended June 30, 2024.

The increase was primarily driven by increases in Labs and Immunohematology revenues and lower operating expenses, partially offset by the impact from changes in product mix.

Adjusted EBITDA was $67.5 million for the six months ended June 29, 2025, compared to $65.5 million for the six months ended June 30, 2024, primarily driven by an increase in Labs revenues, partially offset by the impact from changes in product mix.

Total revenues were $142.1 million for the three months ended September 28, 2025, compared to $126.5 million for the three months ended September 29, 2024, primarily driven by an increase in Labs revenues.

Total revenues were $396.8 million for the nine months ended September 28, 2025, compared to $366.9 million for the nine months ended September 29, 2024, primarily driven by an increase in Labs revenues.

Adjusted EBITDA was $44.2 million for the three months ended September 28, 2025, compared to $32.4 million for the three months ended September 29, 2024.

The increase was primarily driven by an increase in Labs revenues and the impact from changes in product mix.

Adjusted EBITDA was $111.7 million for the nine months ended September 28, 2025, compared to $97.9 million for the nine months ended September 29, 2024, primarily driven by an increase in Labs revenues and the impact from changes in product mix.

Liquidity and Capital Resources

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

(In millions) June 29, 2025 December 29, 2024

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

(In millions) September 28, 2025 December 29, 2024

Cash and cash equivalents $ 98.1 $ 98.3

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Working capital including cash and cash equivalents $ 598.8 $ 220.1

As of June 29, 2025, we had $151.7 million in Cash and cash equivalents, a $53.4 million increase from December 29, 2024.

As of September 28, 2025, we had $98.1 million in Cash and cash equivalents, a $0.2 million decrease 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.

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Debt Capitalization

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

Availability under the Revolving Credit Facility, after deducting letters of credit of $12.7 million and $390.0 million borrowings outstanding, was $397.3 million as of June 29, 2025.

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 June 29, 2025.

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 September 28, 2025 were 6.86% 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 $2,213.9 million 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.

Availability under the Revolving Credit Facility, after deducting letters of credit of $12.8 million and $100.0 million borrowings outstanding, were $587.2 million as of September 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 September 28, 2025.

Capital Expenditures

Capital expenditures, including investments, were $87.2 million for the six months ended June 29, 2025.

Capital expenditures, including investments, were $136.4 million for the nine months ended September 28, 2025.

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

Cash Flow Summary

Six Months Ended

(In millions) June 29, 2025 June 30, 2024

Net cash provided by (used for) operating activities $ 18.8 $ (98.6)

Nine Months Ended

(In millions) September 28, 2025 September 29, 2024

Net cash (used for) provided by operating activities $ (26.7) $ 19.3

Net cash used for investing activities (143.1) (112.0)

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Effect of exchange rates on cash 2.5 (0.5)

Net increase (decrease) in cash, cash equivalents and restricted cash $ 53.2 $ (12.0)

Six Months Ended June 29, 2025

Cash provided by operating activities was $18.8 million for the six months ended June 29, 2025 and reflected a net loss of $268.1 million and non-cash adjustments of $407.0 million, primarily associated with depreciation and amortization, asset write off related to restructuring, integration and other charges, and stock-based compensation expense, partially offset by $102.6 million in cash outflows for inventories.

Cash used for investing activities of $89.2 million for the six months ended June 29, 2025 was primarily related to purchases of property, plant, equipment, investments and intangibles.

Cash provided by financing activities was $120.9 million for the six months ended June 29, 2025 and was primarily related to net proceeds from the Revolving Credit Facility of $192.0 million, partially offset by payments on long-term borrowings of $72.0 million.

Six Months Ended June 30, 2024

Cash used for operating activities was $98.6 million for the six months ended June 30, 2024 and reflected a net loss of $1,853.7 million and non-cash adjustments of $1,971.1 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.

We benefited from collections on accounts receivables, which contributed cash inflows of $24.2 million, offset by other changes in working capital, including $95.2 million cash outflows for inventories.

Cash used for investing activities was $55.5 million for the six months ended June 30, 2024 and was primarily related to $101.4 million in purchases of property, plant, equipment, investments and intangibles.

Net (decrease) increase in cash, cash equivalents and restricted cash $ (0.4) $ 24.5

Nine Months Ended September 28, 2025

Cash used for operating activities was $26.7 million for the nine months ended September 28, 2025 and reflected a net loss of $1,001.1 million and non-cash adjustments of $1,229.3 million, primarily associated with a goodwill impairment charge, depreciation and amortization, stock-based compensation expense, and asset write off related to restructuring, integration and other charges, partially offset by $141.7 million in cash outflows for inventories.

Cash used for investing activities of $143.1 million for the nine months ended September 28, 2025 was primarily related to purchases of property, plant, equipment, investments and intangibles.

Cash provided by financing activities was $166.9 million for the nine months ended September 28, 2025 and was primarily related to proceeds from long-term borrowings, net of discount and debt issuance costs of $2,546.2 million, offset by payments on long-term borrowings of $2,287.6 million and net payments from the Revolving Credit Facility of $98.0 million.

Nine Months Ended September 29, 2024

Cash provided by operating activities was $19.3 million for the nine months ended September 29, 2024 and reflected a net loss of $1,873.6 million and non-cash adjustments of $2,099.8 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 $110.9 million cash outflows for inventories.

Cash used for investing activities was $112.0 million for the nine months ended September 29, 2024 and was primarily related to $147.9 million in purchases of property, plant, equipment, investments and intangibles.

We also sold $63.1 million of marketable securities.

Cash provided by financing activities was $144.0 million for the six months ended June 30, 2024 and was primarily related to net proceeds from the Revolving Credit Facility of $253.0 million, partially offset by payments on long-term borrowings of $103.7 million.

Cash provided by financing activities was $117.7 million for the nine months ended September 29, 2024 and was primarily related to net proceeds from the Revolving Credit Facility of $230.0 million, partially offset by payments on long-term borrowings of $107.0 million.

Liquidity Outlook

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Recent Accounting Pronouncements

There have been no accounting pronouncements issued or adopted during the six months ended June 29, 2025 that are expected to have a material impact on the Company’s financial statements.

Information about recent accounting pronouncements is included in Item 1, “Financial Statements—Note 1.

Summary of Significant Accounting Policies.”

Critical Accounting Estimates

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A comprehensive discussion of our critical accounting estimates is included in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report.

There have been no significant changes to our critical accounting policies and estimates during the six months ended June 29, 2025.

Other than the following, there have been no significant changes to our critical accounting policies and estimates during the nine months ended September 28, 2025:

Goodwill Impairment

During the third quarter of 2025, we concluded that 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 unit’s 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.

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.

Quantitative and Qualitative Disclosures About Market Risk

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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-Q

Item 2. Management’s Discussion and Analysis