QuidelOrtho Corp
For the period ended Jun 28, 2026. Filed Aug 7, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 28, 2026 · Filed Aug 7, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-29; filed 2026-05-06.
0001906324-26-000024
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-28; filed 2026-08-07.
0001906324-26-000033
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 129 previous paragraphs and 141 current paragraphs.
77 unchanged; 39 reworded; 22 added; 12 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (22)
Current report
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 report
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 report
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.
Current report
Other Expense, Net
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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 report
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.
Current report
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 report
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.
Current report
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 report
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.
Current report
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.
Current report
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.
Current report
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 report
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.
Current report
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.
Current report
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 report
Six Months Ended June 28, 2026
Current report
Six Months Ended June 29, 2025
Removed paragraphs (12)
Previous report
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.
Previous report
(1) Certain reclassifications have been made to prior period amounts to conform to the current period presentation.
Previous report
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.
Previous report
Other (Income) Expense, Net
Previous report
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. The increase was primarily driven by an increase in Immunohematology revenues.
Previous report
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. The increase was primarily driven by an increase in Immunohematology revenues.
Previous report
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. 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.
Previous report
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. 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.
Previous report
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. The increase was primarily driven by an increase in Labs revenues.
Previous report
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. The increase was primarily driven by an increase in Labs revenues.
Previous report
Three Months Ended March 29, 2026
Previous report
Three Months Ended March 30, 2025
Reworded paragraphs (39)
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; 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 Re…
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, 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.
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 $24.7 million and $33.4 million for the three months ended March 29, 2026 and March 30, 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 $54.4 million and $59.8 million for the six months ended June 28, 2026 and June 29, 2025, respectively.
Previous wording
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. 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. 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.
Current 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.
Previous wording
In February 2024, we initiated a wind-down plan to transition out of the U.S. donor screening portfolio. Specifically, we are winding-down the ORTHO VERSEIA Integrated Processor platform and microplate assays, which are only sold in the U.S. and have a lower growth and margin profile. This wind-down will not affect any donor screening portfolio outside of the U.S. While we wind-down this U.S. donor screening portfolio, we will continue to support our existing customers and honor our contractual commitments. The winding-down of the U.S. donor screening portfolio, as compared to the prior year periods, contributed to the decline in revenue with a margin lower than our overall margin. Refer to Item 1, “Financial Statements—Note 3. Revenue” for more information. The wind-down of our U.S. donor screening portfolio is expected to be substantially complete by mid-year 2026.
Current wording
In February 2024, we initiated a wind-down plan to transition out of the U.S. donor screening portfolio. Specifically, we are winding-down the ORTHO VERSEIA Integrated Processor platform and microplate assays, which are only sold in the U.S. and have a lower growth and margin profile. This wind-down will not affect any donor screening portfolio outside of the U.S. While we wind-down this U.S. donor screening portfolio, we will continue to support our existing customers and honor our contractual commitments. The winding-down of the U.S. donor screening portfolio, as compared to the prior year periods, contributed to the decline in revenue with a margin lower than our overall margin. Refer to Item 1, “Financial Statements—Note 4. Revenue” for more information. We have substantially completed the wind-down of our U.S. donor screening portfolio as of June 28, 2026.
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 $20.4 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 $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:
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 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. 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 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 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.
Previous wording
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.
Current 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.
Previous wording
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.
Current wording
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. Based on current information, we believe that any business impact will not be material to our total annualized revenue.
Previous wording
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.
Current 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.
Previous wording
Because our business environment is highly competitive, our long-term growth and profitability will depend in part on our ability to retain and grow our current customers and attract new customers through developing and delivering new and improved products and services that meet our customers’ needs and expectations, including with respect to product performance, product offerings, cost, automation and other work-flow efficiencies. We expect to continue to evaluate strategic opportunities to (i) expand our product lines and services, production capabilities, technologies and geographic footprint and address other business challenges and opportunities, and (ii) rationalize and consolidate facilities with the goal of improving our long-term results. In April 2026, we completed the acquisition of LEX Diagnostics, which expanded our molecular diagnostics portfolio and marked a milestone in our plans to accelerate growth in point-of-care molecular diagnostics. Refer to Item 1, “Financial Statements—Note 13. Subsequent Event” for more information.
Current wording
Because our business environment is highly competitive, our long-term growth and profitability will depend in part on our ability to retain and grow our current customers and attract new customers through developing and delivering new and improved products and services that meet our customers’ needs and expectations, including with respect to product performance, product offerings, cost, automation and other work-flow efficiencies. We expect to continue to evaluate strategic opportunities to (i) expand our product lines and services, production capabilities, technologies and geographic footprint and address other business challenges and opportunities, and (ii) rationalize and consolidate facilities with the goal of improving our long-term results. In April 2026, we completed the acquisition of LEX Diagnostics, which expanded our molecular diagnostics portfolio and marked a milestone in our plans to accelerate growth in point-of-care molecular diagnostics. Refer to Item 1, “Financial Statements—Note 3. Acquisition” for more information.
Previous wording
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.
Current wording
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, COVID-19, and RSV seasons.
Previous wording
The following table compares Total revenues by business unit for the three months ended March 29, 2026 and March 30, 2025:
Current wording
The following table compares Total revenues by business unit for the three and six months ended June 28, 2026 and June 29, 2025:
Previous wording
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. Immunohematology revenue increased 8% compared to the prior year period, primarily due to reagent growth. Donor Screening revenue decreased 39% compared to the prior year period, primarily due to the wind-down of the U.S. donor screening business. Point of Care revenue decreased 34% 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.
Current 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.
Previous wording
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.
Current 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.
Previous wording
The following table summarizes operating expenses for the three months ended March 29, 2026 and March 30, 2025:
Current wording
The following table summarizes operating expenses for the three and six months ended June 28, 2026 and June 29, 2025:
Previous wording
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.
Current 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.
Previous wording
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.
Current 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.
Previous wording
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. Refer to Item 1, “Financial Statements—Note 12. Restructuring, Integration and Other Charges” for more information.
Current 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.
Previous wording
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. Refer to Item 1, “Financial Statements—Note 3. Revenue” for more information.
Current 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.
Previous wording
Interest expense, net was $51.1 million and $40.0 million for the three months ended March 29, 2026 and March 30, 2025, respectively. Refer to Item 1, “Financial Statements—Note 7. Borrowings” for more information.
Current 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.
Previous wording
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.
Current 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.
Previous wording
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. 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 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.
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 three months ended March 29, 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 six months ended June 28, 2026 include the impacts of OBBBA on our Consolidated Financial Statements.
Previous wording
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.
Current 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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current 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.
Previous wording
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. 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 $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.
Previous wording
As of March 29, 2026, we had $140.4 million in Cash and cash equivalents, a $29.4 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 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.
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 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.
Current 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.
Previous wording
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
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
Capital expenditures, including investments, were $34.0 million for the three months ended March 29, 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 $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.
Previous wording
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.
Current 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.
Previous wording
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.
Current 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.
Previous wording
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.
Current 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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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 28, 2026.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
(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.