QuidelOrtho Corp

Previous wording

This Quarterly Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. These statements are any statement contained herein that is not strictly historical, including, but not limited to, certain statements under Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” including under “Outlook” and “Liquidity Outlook,” and statements located elsewhere herein regarding our commercial and other strategic goals, our cost-savings and operational improvement initiatives, industry prospects, our expected results of operations or financial position, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words “may,” “will,” “could,” “would,” “should,” “might,” “expect,” “anticipate,” “believe,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” “continue,” “aim,” “strive,” “seek” or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of our management as of the date of this Quarterly Report and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for our non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions (such as the integration of LEX Diagnostics), strategic restructurings (such as the Optimization Plan), divestitures, spin-offs or discontinuances of certain business operations (such as the SAVANNA Exit), or debt financings, 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; failure of new products and services to be commercially viable or accepted; changes in reimbursement rates for our products, including reimbursement rate reductions proposed by the China National Health Security Administration; 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. Investors should …

Excerpt shortened here; the source contains the full paragraph.

Current wording

This Quarterly Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. These statements are any statement contained herein that is not strictly historical, including, but not limited to, certain statements under Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” including under “Outlook” and “Liquidity Outlook,” and statements located elsewhere herein regarding our commercial and other strategic goals, our cost-savings and operational improvement initiatives, including the expected results and anticipated benefits of the cost transformation and enterprise restructuring program and the timing and amount of related charges, industry prospects, our expected results of operations or financial position, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words “may,” “will,” “could,” “would,” “should,” “might,” “expect,” “anticipate,” “believe,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” “continue,” “aim,” “strive,” “seek” or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of our management as of the date of this Quarterly Report and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for our non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions (such as the integration of LEX Diagnostics), strategic restructurings (such as the Optimization Plan and the cost transformation and enterprise restructuring program), divestitures, spin-offs or discontinuances of certain business operations (such as the SAVANNA Exit), or debt financings, 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; failure of new products and services to be commercially viable or accepted; changes in reimbursement rates for our products, including reimbursement rate reductions by the China National Health Security Administration; 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…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

We manage our business geographically to better align with the market dynamics of the specific geographic regions in which we operate, with our reportable segments being North America, EMEA, China, JPAC and Latin America. We generate our revenue in the following business units: Labs, Transfusion Medicine (Immunohematology and Donor Screening product categories), Point of Care and Molecular Diagnostics. We also generate non-core revenue, including through our contract manufacturing business and certain business collaborations, which accounted for $54.4 million and $59.8 million for the six months ended June 28, 2026 and June 29, 2025, respectively.

Current wording

We manage our business geographically to better align with the market dynamics of the specific geographic regions in which we operate, with our reportable segments being North America, EMEA, China, JPAC and Latin America. We generate our revenue in the following business units: Labs, Transfusion Medicine (Immunohematology and Donor Screening product categories), Point of Care and Molecular Diagnostics. We also generate non-core revenue, including through our contract manufacturing business and certain business collaborations, which accounted for $79.5 million and $85.6 million for the nine months ended September 27, 2026 and September 28, 2025, respectively.

Previous wording

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, (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 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.

Current wording

For the nine months ended September 27, 2026, Total revenues decreased by 7% to $1,869.6 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, (ii) the termination of our Joint Business arrangement and (iii) evolving market dynamics in China. Currency exchange rates had a favorable impact of approximately 100 basis points on our growth rate for the nine months ended September 27, 2026. Our revenues can be highly concentrated over a small number of products, including certain of our respiratory products. For the nine months ended September 27, 2026 and September 28, 2025, revenues related to our respiratory products accounted for 10% and 14% of our Total revenues, respectively.

Previous wording

In the second quarter of 2025, we launched the Optimization Plan that aims to (i) realign our costs with our long-term revenue expectations, (ii) drive operational efficiencies in manufacturing and distribution cost bases and (iii) support and align with our strategy to invest in key priorities. The cumulative pre-tax charges to be incurred by us to implement the Optimization Plan are expected to be approximately $100 million through 2027, with charges of $28.1 million incurred to date. The Optimization Plan is expected to deliver net cost savings of approximately $50 million to be achieved through 2027. The key initiatives of the Optimization Plan are:

Current wording

In the second quarter of 2025, we launched the Optimization Plan that aims to (i) realign our costs with our long-term revenue expectations, (ii) drive operational efficiencies in manufacturing and distribution cost bases and (iii) support and align with our strategy to invest in key priorities. The cumulative pre-tax charges to be incurred by us to implement the Optimization Plan are expected to be approximately $100 million through 2027, with charges of $36.7 million incurred to date. The Optimization Plan is expected to deliver net cost savings of approximately $50 million to be achieved through 2027. The key initiatives of the Optimization Plan are:

Previous wording

In April 2025, the U.S. announced tariffs on imports from most countries, including significant tariffs on imports from the U.K., Canada, Mexico and China, leading to increasing political and trade tensions. In response to tariffs, certain countries have implemented retaliatory tariffs on U.S. goods. Although certain tariffs imposed by the U.S. were struck down by the Supreme Court in February 2026, the U.S. 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. 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 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.

Current wording

In April 2025, the U.S. announced tariffs on imports from most countries, including significant tariffs on imports from the U.K., Canada, Mexico and China, leading to increasing political and trade tensions. In response to tariffs, certain countries have implemented retaliatory tariffs on U.S. goods. Although certain tariffs imposed by the U.S. were struck down by the Supreme Court in February 2026, the U.S. 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. 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 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 investigation and Section 301 tariffs, 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.

Previous wording

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.

Current wording

We expect overall demand for our non-respiratory and respiratory products to continue to fluctuate as a result of a number of factors, including 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 nine months of 2026, and we believe this trend may continue through the end of 2026.

Previous wording

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.

Current wording

In March 2026, the China National Health Security Administration (“NHSA”) issued initial draft IVD pricing guidelines. In mid-August 2026, the NHSA finalized its nationwide IVD pricing guidelines. We believe that uncertainty regarding the China NHSA pricing changes and implementation timelines contributed to lower purchase volumes in our China business during the first nine months of 2026, and that evolving market dynamics may continue to pressure our business in China.

Previous wording

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

Current wording

The following table compares Total revenues by business unit for the three and nine months ended September 27, 2026 and September 28, 2025:

Previous wording

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.

Current wording

For the three months ended September 27, 2026, Total revenues decreased to $618.9 million from $699.9 million for the same period in the prior year. Labs revenue decreased 6% compared to the prior year period, primarily due to slower distributor sales related to changes to IVD pricing guidelines in China. Immunohematology revenue was flat compared to the prior year period. Donor Screening revenue decreased 88% compared to the prior year period, primarily due to the wind-down of the U.S. donor screening business. Point of Care revenue decreased 27% compared to the prior year period, primarily due to decreases in respiratory product revenue. Molecular Diagnostics revenue decreased 50% compared to the prior year period, primarily due to a decrease in SOLANA revenue. Currency exchange rates did not significantly impact our growth rate for the three months ended September 27, 2026.

Previous wording

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. Donor Screening revenue decreased 55% compared to the prior year period, primarily due to the wind-down of the U.S. donor screening business. 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 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.

Current wording

For the nine months ended September 27, 2026, Total revenues decreased to $1,869.6 million from $2,006.6 million for the same period in the prior year. Labs revenue decreased 2% compared to the prior year period, primarily due to (i) the termination of our Joint Business arrangement, which contributed to a $17.3 million decrease, and (ii) slower distributor sales related to changes to IVD pricing guidelines in China. Immunohematology revenue increased 3% compared to the prior year period, primarily due to reagent growth. Donor Screening revenue decreased 67% compared to the prior year period, primarily due to the wind-down of the U.S. donor screening business. Point of Care revenue decreased 21% compared to the prior year period, primarily due to decreases in sales of SOFIA SARS and QUICKVUE SARS Antigen assays. Molecular Diagnostics revenue decreased 34% compared to the prior year period, primarily due to a decrease in SOLANA revenue. Currency exchange rates had a favorable impact of approximately 100 basis points on our growth rate for the nine months ended September 27, 2026.

Previous wording

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.

Current wording

Cost of sales, excluding amortization of intangible assets, decreased to $329.3 million, or 53.2% of Total revenues, for the three months ended September 27, 2026, compared to $364.3 million, or 52.1% of Total revenues, for the three months ended September 28, 2025. The decrease in cost of sales, excluding amortization of intangible assets, was driven primarily by lower employee compensation costs, manufacturing costs and freight charges.

Previous wording

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.

Current wording

September 28, 2025. The decrease in cost of sales, excluding amortization of intangible assets, was driven primarily by lower employee compensation costs and freight charges, partially offset by unfavorable product mix and higher depreciation.

Previous wording

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

Current wording

The following table summarizes operating expenses for the three and nine months ended September 27, 2026 and September 28, 2025:

Previous wording

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.

Current wording

Selling, marketing and administrative expenses for the three months ended September 27, 2026 decreased by $4.2 million, or 2.2%, to $182.7 million from $186.9 million for the same period in the prior year, primarily due to lower employee compensation costs, including severance, partially offset by higher distribution costs and an increase of $1.2 million in cloud computing amortization.

Previous wording

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.

Current wording

Selling, marketing and administrative expenses for the nine months ended September 27, 2026 increased by $19.8 million, or 3.6%, to $571.7 million from $551.9 million for the same period in the prior year, primarily due to higher distribution costs and an increase of $7.3 million in cloud computing amortization.

Previous wording

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.

Current wording

Research and development expense for the three months ended September 27, 2026 increased by $1.0 million, or 2.4%, to $42.5 million from $41.5 million for the same period in the prior year, primarily due to higher costs of outside services, partially offset by lower employee compensation costs.

Previous wording

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.

Current wording

Research and development expense for the nine months ended September 27, 2026 decreased by $4.3 million, or 3.1%, to $136.1 million from $140.4 million for the same period in the prior year, primarily due to lower third-party material and clinical costs and lower employee compensation costs, partially offset by higher costs of outside services.

Previous wording

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. Restructuring, Integration and Other Charges” for more information.

Current wording

Restructuring, integration and other charges were $7.1 million and $18.0 million for the three and nine months ended September 27, 2026, respectively, and $39.6 million and $234.6 million for the three and nine months ended September 28, 2025, respectively. Refer to Item 1, “Financial Statements—Note 14. Restructuring, Integration and Other Charges” for more information.

Previous wording

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. Revenue” for more information.

Current wording

Other operating expenses were $1.5 million and $2.5 million for the three and nine months ended September 27, 2026, respectively, and $14.3 million and $25.8 million for the three and nine months ended September 28, 2025, respectively. The decreases were primarily driven by the legal accrual in the prior period and the termination of our Joint Business arrangement. Refer to Item 1, “Financial Statements—Note 4. Revenue” and “—Note 11. Commitments and Contingencies” for more information.

Previous wording

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.

Current wording

Interest expense, net was $55.4 million and $161.2 million for the three and nine months ended September 27, 2026, respectively, and $46.1 million and $126.6 million for the three and nine months ended September 28, 2025, respectively. Refer to Item 1, “Financial Statements—Note 9. Borrowings” for more information.

Previous wording

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.

Current wording

Other expense, net was $1.3 million for the nine months ended September 27, 2026, compared to $10.7 million for the nine months ended September 28, 2025. The decrease was related to net foreign currency gains, partially offset by a loss on investments for the nine months ended September 27, 2026. Other expense, net was $0.9 million for the three months ended September 28, 2025.

Previous wording

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.

Current wording

For the three months ended September 27, 2026, we recognized an income tax benefit of $9.1 million in relation to loss before income taxes of $62.9 million, resulting in an effective tax rate of 14.5%. 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 27, 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. 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.

Previous wording

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.

Current wording

For the nine months ended September 27, 2026, we recognized a provision for income taxes of $14.9 million in relation to loss before income taxes of $223.6 million, resulting in a negative effective tax rate of 6.7%. 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 27, 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. 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.

Previous wording

On July 4, 2025, the OBBBA was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. Our results for the six months ended June 28, 2026 include the impacts of OBBBA on our Consolidated Financial Statements.

Current wording

On July 4, 2025, the OBBBA was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. Our results for the nine months ended September 27, 2026 include the impacts of OBBBA on our Consolidated Financial Statements.

Previous wording

•Adjusted EBITDA — Adjusted EBITDA by reportable segment is used by our management to measure and evaluate the internal operating performance of our reportable segments. It is also the basis for calculating certain management incentive compensation programs. We believe that this measurement is useful to investors as a way to analyze the underlying trends in our core business, including at the segment level, consistently across the periods presented and to evaluate performance under management incentive compensation programs. Adjusted EBITDA consists of Net loss before Interest expense, net, Provision for 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 5. Segment and Geographic Information” for a reconciliation of Adjusted EBITDA by reportable segment to Loss before income taxes.

Current wording

•Adjusted EBITDA — Adjusted EBITDA by reportable segment is used by our management to measure and evaluate the internal operating performance of our reportable segments. It is also the basis for calculating certain management incentive compensation programs. We believe that this measurement is useful to investors as a way to analyze the underlying trends in our core business, including at the segment level, consistently across the periods presented and to evaluate performance under management incentive compensation programs. Adjusted EBITDA consists of Net loss before Interest expense, net, (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 5. Segment and Geographic Information” for a reconciliation of Adjusted EBITDA by reportable segment to Loss before income taxes.

Previous wording

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.

Current wording

Total revenues were $987.0 million for the nine months ended September 27, 2026, compared to $1,098.8 million for the nine months ended September 28, 2025. The decrease was primarily driven by (i) decreases in respiratory product revenues, (ii) the wind-down of the U.S. donor screening business and (iii) a decrease in Labs revenues, primarily due to the termination of our Joint Business arrangement.

Previous wording

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.

Current wording

Adjusted EBITDA was $59.9 million for the nine months ended September 27, 2026, compared to $59.2 million for the nine months ended September 28, 2025. The increase was primarily driven by an increase in Immunohematology revenues and cost-savings initiatives, partially offset by higher distribution costs and a decrease in Labs revenues.

Previous wording

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.

Current wording

Total revenues were $48.9 million for the three months ended September 27, 2026, compared to $84.6 million for the three months ended September 28, 2025. The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to changes to IVD pricing guidelines in China and a decrease in Immunohematology revenues.

Previous wording

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. 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.

Current wording

Total revenues were $180.2 million for the nine months ended September 27, 2026, compared to $243.0 million for the nine months ended September 28, 2025. The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to changes to IVD pricing guidelines in China and a decrease in Immunohematology revenues.

Previous wording

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.

Current wording

Adjusted EBITDA was $20.3 million for the three months ended September 27, 2026, compared to $20.5 million for the three months ended September 28, 2025. The decrease was primarily driven by the impact of product mix and lower revenues, partially offset by cost-savings initiatives.

Previous wording

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.

Current wording

Adjusted EBITDA was $55.1 million for the nine months ended September 27, 2026, compared to $57.3 million for the nine months ended September 28, 2025. The decrease was primarily driven by the impact of product mix and higher service costs, partially offset by an increase in Labs revenues and cost-savings initiatives.

Previous wording

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.

Current wording

Adjusted EBITDA was $23.2 million for the three months ended September 27, 2026, compared to $23.7 million for the three months ended September 28, 2025. The decrease was primarily driven by higher operating expenses, partially offset by increases in Labs and Immunohematology revenues.

Previous wording

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.

Current wording

Adjusted EBITDA was $58.7 million for the nine months ended September 27, 2026, compared to $54.4 million for the nine months ended September 28, 2025. The increase was primarily driven by increases in Labs and Immunohematology revenues and the impact from changes in product mix, partially offset by higher operating expenses.

Previous wording

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. We believe our organizational structure allows us the necessary flexibility to move funds throughout our subsidiaries to meet our operational working capital needs.

Current wording

As of September 27, 2026, we had $166.4 million in Cash and cash equivalents, a $3.4 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. We believe our organizational structure allows us the necessary flexibility to move funds throughout our subsidiaries to meet our operational working capital needs.

Previous wording

Our Credit Agreement consists of (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. 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 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.

Current wording

Availability under the Revolving Credit Facility, after deducting letters of credit of $18.0 million and $315.0 million borrowings outstanding, was $367.0 million as of September 27, 2026.

Previous wording

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 of the Credit Agreement 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 June 28, 2026.

Current wording

The Credit Agreement contains affirmative and negative covenants that are customary for credit agreements of this nature. The negative covenants include, among other things, limitations on asset sales, mergers, indebtedness, liens, investments, restricted payments, certain debt prepayments and transactions with affiliates. We were in compliance with the financial covenants as of September 27, 2026.

Previous wording

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.

Current wording

Capital expenditures, including investments, were $80.5 million for the nine months ended September 27, 2026. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities and other facility-related activities.

Previous wording

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.

Current wording

Cash used for operating activities was $124.0 million for the nine months ended September 27, 2026 and reflected a net loss of $238.5 million, non-cash adjustments of $423.7 million, primarily associated with depreciation and amortization and stock-based compensation expense, and changes in working capital, including cash outflows of $188.8 million for inventories, partially offset by cash inflows of $40.4 million from collections on accounts receivables.

Previous wording

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.

Current wording

Cash used for investing activities was $162.2 million for the nine months ended September 27, 2026 and was primarily related to the LEX Diagnostics acquisition of $98.4 million and purchases of property, plant, equipment, investments and intangibles of $80.5 million.

Previous wording

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.

Current wording

Cash provided by financing activities was $282.3 million for the nine months ended September 27, 2026 and was primarily related to net proceeds from the Revolving Credit Facility of $235.0 million and long-term borrowings, net of $49.7 million.