What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-07 compared with 2026-05-06 · 136 added, 104 removed, 226 unchanged (52% of the section changed)

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changes in reimbursement rates for our products, including reimbursement rate reductions proposed by the China National Health Security Administration;

disruptions and challenges related to the ongoing conflicts in the Middle East;

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, global trade relations and other tariff-related developments, 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.

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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 $24.7 million and $33.4 million for the three months ended March 29, 2026 and March 30, 2025, respectively.

For the three months ended March 29, 2026, Total revenues decreased by 11% to $619.8 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 $54.4 million and $59.8 million for the six months ended June 28, 2026 and June 29, 2025, respectively.

For the six months ended June 28, 2026, Total revenues decreased by 4% to $1,250.7 million as compared to the same period in the prior year.

This decrease was primarily driven by (i) variability of our U.S.

respiratory products, mainly due to decreases in flu and COVID-19 revenues, and (ii) the termination of our Joint Business arrangement.

Currency exchange rates had a favorable impact of 210 basis points on our growth rate for the three months ended March 29, 2026.

respiratory products, mainly due to decreases in flu and COVID-19 revenues, (ii) the termination of our Joint Business arrangement and (iii) evolving market dynamics in China.

Currency exchange rates had a favorable impact of approximately 160 basis points on our growth rate for the six months ended June 28, 2026.

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

For the three months ended March 29, 2026 and March 30, 2025, revenues related to our respiratory products accounted for 11% and 17% of our Total revenues, respectively.

For the six months ended June 28, 2026 and June 29, 2025, revenues related to our respiratory products accounted for 9% and 13% of our Total revenues, respectively.

Wind-Down of U.S.

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Revenue” for more information.

The wind-down of our U.S.

donor screening portfolio is expected to be substantially complete by mid-year 2026.

We have substantially completed the wind-down of our U.S.

donor screening portfolio as of June 28, 2026.

Restructuring and Other Charges

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were struck down by the Supreme Court in February 2026, the U.S.

has announced separate potential new tariffs and related tariff actions affecting companies in the pharmaceutical and biotechnology industries, including a Section 232 national security investigation initiated in September 2025 that could result in future tariffs on imports of personal protective equipment, medical consumables, and medical equipment, including devices.

Additionally, in February 2026, following the Supreme Court ruling, the U.S.

implemented a 10% ad valorem tariff on imports into the U.S.

for 150 days under Section 122 of the Trade Act of 1974.

has announced separate new tariffs and related tariff actions affecting companies in the pharmaceutical and biotechnology industries, including a Section 232 national security investigation initiated in September 2025 that could result in future tariffs on imports of personal protective equipment, medical consumables, and medical equipment, including devices.

In July 2026, the U.S.

imposed new wide-ranging tariffs on goods from most U.S.

trading partners for alleged failures to halt imports of goods produced with forced labor, invoking Section 301 of the Trade Act of 1974.

These and other potential tariff actions as well as the related rising political tensions could negatively impact global macroeconomic conditions and the stability of global financial markets.

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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, uncertainty around the availability, timing and amount of any potential tariff refunds, and whether additional tariffs or retaliatory actions may be imposed, modified or suspended.

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 and Section 301 investigations, litigation challenging tariffs, uncertainty around the availability, timing and amount of any potential tariff refunds, 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.

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.

During the first quarter of 2026, we experienced lower demand for our influenza products, which was primarily driven by a weaker respiratory season, with influenza-like illness visits down by approximately 30% compared to the first quarter of 2025, as reported by the Centers for Disease Control and Prevention, April 3, 2026.

We expect overall demand for our non-respiratory and respiratory products to continue to fluctuate and pricing pressures on certain products to persist as a result of a number of factors, including increased supply, emergence and spread of new variants, and the demands of the respiratory season, which are variable and typically more prevalent during the fall and winter.

A weaker respiratory season contributed to lower demand for flu and COVID-19 testing during the first six months of 2026, and we believe this trend may continue through the second half of 2026.

In January 2026, the Jiangxi, China provincial Health Security Administration announced its plan to pilot a Volume-Based Procurement program on dry chemistry test strips.

At this time, we have no indication that such a program will be implemented or if our products would be included in such a program.

Should this occur, we would seek to implement remediation efforts to offset potential costs.

Based on current information, we believe that any potential business impact would not likely be material to our total annualized revenue.

In March 2026, the China National Health Security Administration (“NHSA”) issued draft IVD pricing guidelines and completed a public comment period on March 25, 2026.

The updated guidelines have not yet been published.

We believe that uncertainty regarding the China NHSA pricing guidelines contributed to lower purchase volumes in our Labs business in China during the first quarter of 2026.

Until China issues final guidelines and there is greater clarity on the scope, applicability, and timing of pricing changes, we are not able to assess potential business impact.

In addition, during the first quarter of 2026, we experienced delays in certain EMEA orders due to the ongoing conflicts in the Middle East.

At this time, we are unable to assess potential business impact if the ongoing conflicts in the Middle East continue for a prolonged period.

Based on current information, we believe that any business impact will not be material to our total annualized revenue.

In March 2026, the China National Health Security Administration (“NHSA”) issued initial draft IVD pricing guidelines.

Subsequent to the end of our second quarter of 2026, the NHSA issued a second draft of its guidelines.

We believe that uncertainty regarding the China NHSA pricing guidelines contributed to lower purchase volumes in our Labs business in China during the first six months of 2026, and that evolving market dynamics may continue to pressure our business in China.

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.

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Refer to Item 1, “Financial Statements—Note 3.

Subsequent Event” for more information.

Acquisition” for more information.

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

Revenues from our respiratory products are subject to, and significantly affected by, the seasonal demands of the cold, flu and RSV seasons, which are typically more prevalent during the fall and winter.

Historically, revenues from our influenza products have varied from year to year based, in large part, on the severity, length and timing of the onset of the cold, flu and RSV seasons.

In addition, the SARS-CoV-2 virus is expected to have similar seasonal demands and impacts on our revenues.

Historically, revenues from our influenza products have varied from year to year based, in large part, on the severity, length and timing of the onset of the cold, flu, COVID-19, and RSV seasons.

Results of Operations

The following table compares Total revenues by business unit for the three months ended March 29, 2026 and March 30, 2025:

Three Months Ended

(Dollars in millions) March 29, 2026 March 30, 2025 (1)

The following table compares Total revenues by business unit for the three and six months ended June 28, 2026 and June 29, 2025:

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change

Labs $ 382.9 $ 369.7 4 % $ 736.0 $ 742.7 (1) %

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Total revenues $ 630.9 $ 613.9 3 % $ 1,250.7 $ 1,306.7 (4) %

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

(1) As a result of the wind-down of the U.S.

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Immunohematology and Donor Screening.

For the three months ended March 29, 2026, Total revenues decreased to $619.8 million from $692.8 million for the same period in the prior year.

Labs revenue decreased 5% compared to the prior year period, primarily due to the termination of our Joint Business arrangement, which contributed to a $13.3 million decrease, and slower distributor sales related to pending changes to IVD pricing guidelines in China, partially offset by an increase in reagents, consumables and services in other regions.

For the three months ended June 28, 2026, Total revenues increased to $630.9 million from $613.9 million for the same period in the prior year.

Labs revenue increased 4% compared to the prior year period.

The overall increase in Labs revenue was partially offset by slower distributor sales related to pending changes to IVD pricing guidelines in China.

Immunohematology revenue increased slightly compared to the prior year period.

Donor Screening revenue decreased 70% compared to the prior year period, primarily due to the wind-down of the U.S.

donor screening business.

Point of Care revenue increased 16% compared to the prior year period, primarily due to increases in respiratory product revenue.

Molecular Diagnostics revenue decreased 71% compared to the prior year period, primarily due to a decrease in SOLANA revenue.

Currency exchange rates had a favorable impact of 90 basis points on our growth rate for the three months ended June 28, 2026.

For the six months ended June 28, 2026, Total revenues decreased to $1,250.7 million from $1,306.7 million for the same period in the prior year.

Labs revenue decreased 1% compared to the prior year period, primarily due to (i) the termination of our Joint Business arrangement, which contributed to a $15.2 million decrease, and (ii) slower distributor sales related to pending changes to IVD pricing guidelines in China, partially offset by an (iii) overall increase in Labs revenue.

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

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Point of Care revenue decreased 16% compared to the prior year period, primarily due to decreases in sales of SOFIA SARS and QUICKVUE SARS Antigen assays.

Molecular Diagnostics revenue increased 3% compared to the prior year period.

Currency exchange rates had a favorable impact of 210 basis points on our growth rate for the three months ended March 29, 2026.

Molecular Diagnostics revenue decreased 29% compared to the prior year period, primarily due to a decrease in SOLANA revenue.

Currency exchange rates had a favorable impact of approximately 160 basis points on our growth rate for the six months ended June 28, 2026.

Cost of Sales, Excluding Amortization of Intangible Assets

Cost of sales, excluding amortization of intangible assets, increased to $356.0 million, or 57.4% of Total revenues, for the three months ended March 29, 2026, compared to $349.5 million, or 50.4% of Total revenues, for the three months ended March 30, 2025.

The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by employee compensation costs.

Cost of sales, excluding amortization of intangible assets, increased to $358.0 million, or 56.7% of Total revenues, for the three months ended June 28, 2026, compared to $339.0 million, or 55.2% of Total revenues, for the three months ended June 29, 2025.

The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by higher depreciation, manufacturing costs and freight charges.

Cost of sales, excluding amortization of intangible assets, increased to $714.0 million, or 57.1% of Total revenues, for the six months ended June 28, 2026, compared to $688.5 million, or 52.7% of Total revenues, for the six months ended June 29, 2025.

The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by unfavorable product mix, higher depreciation, employee compensation costs and freight charges.

Operating Expenses

The following table summarizes operating expenses for the three months ended March 29, 2026 and March 30, 2025:

Three Months Ended

(Dollars in millions) March 29, 2026 % of

Total Revenues March 30, 2025 % of

The following table summarizes operating expenses for the three and six months ended June 28, 2026 and June 29, 2025:

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 % of

Total Revenues June 29, 2025 % of

Total Revenues June 28, 2026 % of

Total Revenues June 29, 2025 % of

Total Revenues

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Selling, Marketing and Administrative Expenses

Selling, marketing and administrative expenses for the three months ended March 29, 2026 increased by $12.3 million, or 6.6%, to $199.3 million from $187.0 million for the same period in the prior year, primarily due to higher employee compensation costs, including severance, and an increase of $3.3 million in cloud computing amortization.

Selling, marketing and administrative expenses for the three months ended June 28, 2026 increased by $11.7 million, or 6.6%, to $189.7 million from $178.0 million for the same period in the prior year, primarily due to higher distribution costs, higher employee compensation costs, including severance, and an increase of $2.8 million in cloud computing amortization.

Selling, marketing and administrative expenses for the six months ended June 28, 2026 increased by $24.0 million, or 6.6%, to $389.0 million from $365.0 million for the same period in the prior year, primarily due to higher employee compensation costs, including severance, and an increase of $6.1 million in cloud computing amortization.

Research and Development Expense

Research and development expense for the three months ended March 29, 2026 decreased by $8.3 million, or 15.6%, to $44.9 million from $53.2 million for the same period in the prior year, primarily due to lower third-party material and clinical costs, partially offset by higher costs of outside services.

Research and development expense for the three months ended June 28, 2026 increased by $3.0 million, or 6.6%, to $48.7 million from $45.7 million for the same period in the prior year, primarily due to higher costs of outside services, partially offset by lower third-party material and clinical costs.

Research and development expense for the six months ended June 28, 2026 decreased by $5.3 million, or 5.4%, to $93.6 million from $98.9 million for the same period in the prior year, primarily due to lower third-party material and clinical costs, partially offset by higher costs of outside services.

Amortization of Intangible Assets

Amortization of intangible assets was $46.8 million and $48.0 million for the three months ended March 29, 2026 and March 30, 2025, respectively.

Amortization of intangible assets was $49.0 million and $95.8 million for the three and six months ended June 28, 2026, respectively, and $47.9 million and $95.9 million for the three and six months ended June 29, 2025, respectively.

Restructuring, integration and other charges

Restructuring, integration and other charges were $4.4 million and $16.1 million for the three months ended March 29, 2026 and March 30, 2025, respectively.

Restructuring, integration and other charges were $6.5 million and $10.9 million for the three and six months ended June 28, 2026, respectively, and $178.9 million and $195.0 million for the three and six months ended June 29, 2025, respectively.

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

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Other Operating Expenses

Other operating expenses were $0.2 million and $6.4 million for the three months ended March 29, 2026 and March 30, 2025, respectively.

The decrease was primarily driven by the termination of our Joint Business arrangement.

Other operating expenses were $0.8 million and $1.0 million for the three and six months ended June 28, 2026, respectively, and $5.1 million and $11.5 million for the three and six months ended June 29, 2025, respectively.

The decreases were primarily driven by the termination of our Joint Business arrangement.

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

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Interest Expense, Net

Interest expense, net was $51.1 million and $40.0 million for the three months ended March 29, 2026 and March 30, 2025, respectively.

Interest expense, net was $54.7 million and $105.8 million for the three and six months ended June 28, 2026, respectively, and $40.5 million and $80.5 million for the three and six months ended June 29, 2025, respectively.

Refer to Item 1, “Financial Statements—Note 9.

Borrowings” for more information.

Other (Income) Expense, Net

Other income, net was $3.4 million for the three months ended March 29, 2026 compared to Other expense, net of $1.4 million for the three months ended March 30, 2025.

The increase was primarily related to net foreign currency gains for the three months ended March 29, 2026.

For the three months ended March 29, 2026, we recognized a provision for income taxes of $12.3 million in relation to loss before income taxes of $79.5 million, resulting in a negative effective tax rate of 15.5%.

For the three months ended March 30, 2025, we recognized a provision for income taxes of $3.9 million in relation to loss before income taxes of $8.8 million, resulting in a negative effective tax rate of 44.3%.

For the three months ended March 29, 2026, 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 and Global Intangible Low-Taxed Income.

For the three months ended March 30, 2025, the effective tax rate differed from the U.S.

Other Expense, Net

Other expense, net was $4.7 million and $1.3 million for the three and six months ended June 28, 2026, respectively, compared to $8.4 million and $9.8 million for the three and six months ended June 29, 2025, respectively.

The decreases were related to net foreign currency gains, partially offset by a loss on investments for the three and six months ended June 28, 2026.

For the three months ended June 28, 2026, we recognized a provision for income taxes of $11.7 million in relation to loss before income taxes of $81.2 million, resulting in a negative effective tax rate of 14.4%.

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 28, 2026 and 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 28, 2026, we recognized a provision for income taxes of $24.0 million in relation to loss before income taxes of $160.7 million, resulting in a negative effective tax rate of 14.9%.

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 28, 2026 and 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.

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.

Our results for the three months ended March 29, 2026 include the impacts of OBBBA on our Consolidated Financial Statements.

Our results for the six months ended June 28, 2026 include the impacts of OBBBA on our Consolidated Financial Statements.

Segment Results

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

Three Months Ended

(Dollars in millions) March 29, 2026 March 30, 2025 % Change

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change

Total revenues $ 327.4 $ 310.7 5 % $ 656.3 $ 717.4 (9) %

Adjusted EBITDA $ 169.6 $ 159.7 6 % $ 339.0 $ 394.0 (14) %

Total revenues were $328.9 million for the three months ended March 29, 2026, compared to $406.7 million for the three months ended March 30, 2025.

The decrease was primarily driven by (i) decreases in sales of SOFIA SARS and QUICKVUE SARS Antigen assays and (ii) a decrease in Labs revenues, primarily due to the termination of our Joint Business arrangement.

Adjusted EBITDA was $169.4 million for the three months ended March 29, 2026, compared to $234.3 million for the three months ended March 30, 2025.

The decrease was primarily driven by decreases in revenues.

Total revenues were $327.4 million for the three months ended June 28, 2026, compared to $310.7 million for the three months ended June 29, 2025.

The increase was primarily driven by increases in Labs and Point of Care revenues, partially offset by the wind-down of the U.S.

donor screening business.

Total revenues were $656.3 million for the six months ended June 28, 2026, compared to $717.4 million for the six months ended June 29, 2025.

The decrease was primarily driven by (i) decreases in sales of SOFIA SARS and QUICKVUE SARS Antigen assays, (ii) a decrease in Labs revenues, primarily due to the termination of our Joint Business arrangement and (iii) the wind-down of the U.S.

donor screening business.

Adjusted EBITDA was $169.6 million for the three months ended June 28, 2026, compared to $159.7 million for the three months ended June 29, 2025.

The increase was primarily driven by increases in Labs and Point of Care revenues, partially offset by the wind-down of the U.S.

donor screening business, and higher service and distribution costs.

Adjusted EBITDA was $339.0 million for the six months ended June 28, 2026, compared to $394.0 million for the six months ended June 29, 2025.

The decrease was primarily driven by decreases in revenues, and higher service and distribution costs.

Total revenues and Adjusted EBITDA for EMEA were as follows:

Three Months Ended

(Dollars in millions) March 29, 2026 March 30, 2025 % Change

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change

Total revenues $ 91.2 $ 87.3 4 % $ 183.7 $ 176.2 4 %

Adjusted EBITDA $ 22.1 $ 18.3 21 % $ 42.2 $ 34.8 21 %

Total revenues were $92.5 million for the three months ended March 29, 2026, compared to $88.9 million for the three months ended March 30, 2025.

Total revenues were $91.2 million for the three months ended June 28, 2026, compared to $87.3 million for the three months ended June 29, 2025.

The increase was primarily driven by an increase in Immunohematology revenues.

Adjusted EBITDA was $20.1 million for the three months ended March 29, 2026, compared to $16.5 million for the three months ended March 30, 2025.

Total revenues were $183.7 million for the six months ended June 28, 2026, compared to $176.2 million for the six months ended June 29, 2025.

The increase was primarily driven by an increase in Immunohematology revenues.

Adjusted EBITDA was $22.1 million for the three months ended June 28, 2026, compared to $18.3 million for the three months ended June 29, 2025.

The increase was primarily driven by an increase in Immunohematology revenues and cost savings initiatives, partially offset by higher distribution costs.

Adjusted EBITDA was $42.2 million for the six months ended June 28, 2026, compared to $34.8 million for the six months ended June 29, 2025.

The increase was primarily driven by an increase in Immunohematology revenues and cost savings initiatives, partially offset by higher distribution costs.

Total revenues and Adjusted EBITDA for China were as follows:

Three Months Ended

(Dollars in millions) March 29, 2026 March 30, 2025 % Change

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change

Total revenues $ 67.8 $ 83.4 (19) % $ 131.3 $ 158.4 (17) %

Adjusted EBITDA $ 30.3 $ 42.1 (28) % $ 50.8 $ 71.4 (29) %

Total revenues were $63.5 million for the three months ended March 29, 2026, compared to $75.0 million for the three months ended March 30, 2025.

Total revenues were $67.8 million for the three months ended June 28, 2026, compared to $83.4 million for the three months ended June 29, 2025.

The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to pending changes to IVD pricing guidelines in China and a decrease in Immunohematology revenues.

Total revenues were $131.3 million for the six months ended June 28, 2026, compared to $158.4 million for the six months ended June 29, 2025.

The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to pending changes to IVD pricing guidelines in China.

Adjusted EBITDA was $20.5 million for the three months ended March 29, 2026, compared to $29.3 million for the three months ended March 30, 2025.

Adjusted EBITDA was $30.3 million for the three months ended June 28, 2026, compared to $42.1 million for the three months ended June 29, 2025.

Adjusted EBITDA was $50.8 million for the six months ended June 28, 2026, compared to $71.4 million for the six months ended June 29, 2025.

The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to pending changes to IVD pricing guidelines in China.

Total revenues and Adjusted EBITDA for JPAC were as follows:

Three Months Ended

(Dollars in millions) March 29, 2026 March 30, 2025 % Change

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change

Total revenues $ 74.3 $ 72.2 3 % $ 144.3 $ 140.3 3 %

Adjusted EBITDA $ 18.3 $ 19.2 (5) % $ 34.8 $ 36.8 (5) %

Total revenues were $70.0 million for the three months ended March 29, 2026, compared to $68.1 million for the three months ended March 30, 2025.

Total revenues were $74.3 million for the three months ended June 28, 2026, compared to $72.2 million for the three months ended June 29, 2025.

The increase was primarily driven by an increase in Labs revenues.

Adjusted EBITDA was $16.5 million for the three months ended March 29, 2026, compared to $17.6 million for the three months ended March 30, 2025.

The decrease was primarily driven by higher service costs, partially offset by an increase in Labs revenues.

Total revenues were $144.3 million for the six months ended June 28, 2026, compared to $140.3 million for the six months ended June 29, 2025.

The increase was primarily driven by an increase in Labs revenues.

Adjusted EBITDA was $18.3 million for the three months ended June 28, 2026, compared to $19.2 million for the three months ended June 29, 2025.

The decrease was primarily driven by the impact of product mix and higher service costs, partially offset by an increase in Labs revenues.

Adjusted EBITDA was $34.8 million for the six months ended June 28, 2026, compared to $36.8 million for the six months ended June 29, 2025.

The decrease was primarily driven by the impact of product mix and higher service costs, partially offset by an increase in Labs revenues.

Latin America

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

Three Months Ended

(Dollars in millions) March 29, 2026 March 30, 2025 % Change

Three Months Ended Six Months Ended

(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change

Total revenues $ 70.2 $ 60.3 16 % $ 135.1 $ 114.4 18 %

Adjusted EBITDA $ 19.7 $ 18.7 5 % $ 35.5 $ 30.7 16 %

Total revenues were $64.9 million for the three months ended March 29, 2026, compared to $54.1 million for the three months ended March 30, 2025.

Total revenues were $70.2 million for the three months ended June 28, 2026, compared to $60.3 million for the three months ended June 29, 2025.

The increase was primarily driven by an increase in Labs revenues.

Adjusted EBITDA was $15.8 million for the three months ended March 29, 2026, compared to $12.0 million for the three months ended March 30, 2025.

Total revenues were $135.1 million for the six months ended June 28, 2026, compared to $114.4 million for the six months ended June 29, 2025.

The increase was primarily driven by an increase in Labs revenues.

Adjusted EBITDA was $19.7 million for the three months ended June 28, 2026, compared to $18.7 million for the three months ended June 29, 2025.

The increase was primarily driven by an increase in Labs revenues, partially offset by higher operating expenses.

Adjusted EBITDA was $35.5 million for the six months ended June 28, 2026, compared to $30.7 million for the six months ended June 29, 2025.

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

Liquidity and Capital Resources

As of March 29, 2026 and December 28, 2025, our principal sources of liquidity consisted of the following:

(In millions) March 29, 2026 December 28, 2025

As of June 28, 2026 and December 28, 2025, our principal sources of liquidity consisted of the following:

(In millions) June 28, 2026 December 28, 2025

Cash and cash equivalents $ 123.4 $ 169.8

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Working capital including cash and cash equivalents $ 383.2 $ 481.2

As of March 29, 2026, we had $140.4 million in Cash and cash equivalents, a $29.4 million decrease from December 28, 2025.

As of June 28, 2026, we had $123.4 million in Cash and cash equivalents, a $46.4 million decrease from December 28, 2025.

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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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).

The effective interest rates as of March 29, 2026 were 6.87% and 8.43%, respectively.

The weighted average effective interest rate on aggregate Term Loans, net of interest rate swaps, as of March 29, 2026 was 6.91%.

Availability under the Revolving Credit Facility, after deducting letters of credit of $23.6 million and $130.0 million borrowings outstanding, was $546.4 million as of March 29, 2026.

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 effective interest rates for the Term Loan A Facilities and Term Loan B as of June 28, 2026 were 6.86% and 8.43%, respectively.

The weighted average effective interest rate on aggregate Term Loans, net of interest rate swaps, as of June 28, 2026 was 6.97%.

Availability under the Revolving Credit Facility, after deducting letters of credit of $23.5 million and $250.0 million borrowings outstanding, was $426.5 million as of June 28, 2026.

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 Loan A Facilities and the Term Loan B, 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.

On April 9, 2026, we signed a committed loan notice with Bank of America, N.A., as administrative agent, requesting for borrowing under the DDTL Term Loan A.

On April 13, 2026, we borrowed $100.0 million comprised of Term SOFR loan to fund the acquisition of LEX Diagnostics and for general corporate purposes.

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.

In April 2026, we borrowed $100.0 million under the DDTL Term Loan A, comprised of a Term SOFR loan to fund the acquisition of LEX Diagnostics and for general corporate purposes.

The Credit Agreement contains affirmative and negative covenants that are customary for credit agreements of this nature.

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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 March 29, 2026.

We were in compliance with the financial covenants as of June 28, 2026.

Capital Expenditures

Capital expenditures, including investments, were $34.0 million for the three months ended March 29, 2026.

Capital expenditures, including investments, were $59.5 million for the six months ended June 28, 2026.

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

Cash Flow Summary

Three Months Ended

(In millions) March 29, 2026 March 30, 2025

Six Months Ended

(In millions) June 28, 2026 June 29, 2025

Net cash (used for) provided by operating activities $ (143.6) $ 18.8

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Net (decrease) increase in cash, cash equivalents and restricted cash $ (46.4) $ 53.2

Three Months Ended March 29, 2026

Cash used for operating activities was $33.0 million for the three months ended March 29, 2026 and reflected a net loss of $91.8 million, non-cash adjustments of $126.7 million, primarily associated with depreciation and amortization and stock-based compensation expense, and changes in working capital, including cash outflows of $72.6 million for inventories, partially offset by cash inflows of $54.0 million from collections on accounts receivables.

Cash used for investing activities of $34.0 million for the three months ended March 29, 2026 was related to purchases of property, plant, equipment, investments and intangibles.

Cash provided by financing activities was $37.6 million for the three months ended March 29, 2026 and was primarily related to net proceeds from the Revolving Credit Facility of $50.0 million, partially offset by net payments on long-term borrowings of $9.8 million.

Three Months Ended March 30, 2025

Cash provided by operating activities was $65.6 million for the three months ended March 30, 2025 and reflected a net loss of $12.7 million and non-cash adjustments of $123.7 million, primarily associated with depreciation and amortization and stock-based compensation expense, partially offset by $53.1 million in cash outflows for inventories.

Cash used for investing activities of $56.2 million for the three months ended March 30, 2025 was related to purchases of property, plant, equipment, investments and intangibles.

Cash provided by financing activities was $17.6 million for the three months ended March 30, 2025 and was primarily related to net proceeds from the Revolving Credit Facility of $52.0 million, partially offset by payments on long-term borrowings of $36.0 million.

Six Months Ended June 28, 2026

Cash used for operating activities was $143.6 million for the six months ended June 28, 2026 and reflected a net loss of $184.7 million, non-cash adjustments of $268.7 million, primarily associated with depreciation and amortization and stock-based compensation expense, and changes in working capital, including cash outflows of $123.3 million for inventories, partially offset by cash inflows of $62.9 million from collections on accounts receivables.

Cash used for investing activities was $141.3 million for the six months ended June 28, 2026 and was primarily related to the LEX Diagnostics acquisition of $96.8 million and purchases of property, plant, equipment, investments and intangibles of $59.5 million.

Cash provided by financing activities was $238.2 million for the six months ended June 28, 2026 and was primarily related to net proceeds from the Revolving Credit Facility of $170.0 million and long-term borrowings of $70.6 million.

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.

Liquidity Outlook

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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 three months ended March 29, 2026.

There have been no significant changes to our critical accounting policies and estimates during the six months ended June 28, 2026.

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