Quidelortho Corporation

08/07/2026 | Press release | Distributed by Public on 08/07/2026 04:01

Quarterly Report for Quarter Ending June 28, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations
In this Quarterly Report, all references to "we," "our" and "us" refer to QuidelOrtho Corporation and its subsidiaries.
Future Uncertainties and Forward-Looking Statements
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 not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. All forward-looking statements are based on information currently available to us and speak only as of the date of this Quarterly Report. We undertake no obligation to update any of the forward-looking information or time-sensitive information included in this Quarterly Report, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.
Information Available on Our Website
This Quarterly Report and each of our other periodic and current reports, including any amendments thereto, are available, free of charge, on our website, www.quidelortho.com, as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC. From time to time, we may use our website as a channel of distribution of material information related to the Company. Financial and other material information regarding the Company is routinely posted on and accessible at https://ir.quidelortho.com/. The information contained on or connected to our website is not deemed to be incorporated by reference into this Quarterly Report or filed with or furnished to the SEC and should not be considered part of this Quarterly Report.
Overview
Our vision is to advance diagnostics to power a healthier future. With our expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, we aim to support clarity for clinicians and patients to help create better health outcomes. Our global infrastructure and commercial reach support our customers across more than 140 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. We operate globally with manufacturing facilities in the U.S., U.K. and China and with sales centers, administrative offices and warehouses located throughout the world.
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.
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.
Wind-Down of U.S. Donor Screening Portfolio
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.
Restructuring and Other Charges
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:
•Rationalization and consolidation of facilities to reduce operational costs, improve processes, and optimize resource allocation;
•A structured approach to procurement to drive identified sourcing cost savings; and
•A distribution rationalization plan, mainly in EMEA, to streamline a complex corporate structure to reduce costs and improve efficiency.
We continue to monitor our operations for cost-reduction, strategic productivity and margin improvement opportunities to streamline our operations globally and identify additional cost savings. We may expand our cost-reduction, strategic productivity and margin improvement initiatives in the future, the costs of which could be material.
Additionally, in the second quarter of 2025, we announced a strategic refocusing of our Molecular Diagnostics business, including our plan to discontinue the development of the SAVANNA platform, which exit we expect to be substantially complete by the first half of 2027.
Refer to Item 1, "Financial Statements-Note 14. Restructuring, Integration and Other Charges" for further details regarding these actions.
Recent Macroeconomic Trends and Challenges
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.
Outlook
Our financial performance and results of operations will depend on future developments and other factors that are highly uncertain, continuously evolving and unpredictable, including the occurrence, spread, severity, duration and emergence of new variants of respiratory diseases, including flu, strep, RSV and COVID-19.
We expect overall demand for our non-respiratory and respiratory products to continue to fluctuate and pricing pressures on certain products to persist as a result of a number of factors, including increased supply, emergence and spread of new variants, and the demands of the respiratory season, which are variable and typically more prevalent during the fall and winter. A weaker respiratory season contributed to lower demand for flu and COVID-19 testing during the first six months of 2026, and we believe this trend may continue through the second half of 2026.
In January 2026, the Jiangxi, China provincial Health Security Administration announced its plan to pilot a Volume-Based Procurement program on dry chemistry test strips. Based on current information, we believe that any business impact will not be material to our total annualized revenue.
In March 2026, the China National Health Security Administration ("NHSA") issued initial draft IVD pricing guidelines. Subsequent to the end of our second quarter of 2026, the NHSA issued a second draft of its guidelines. We believe that uncertainty regarding the China NHSA pricing guidelines contributed to lower purchase volumes in our Labs business in China during the first six months of 2026, and that evolving market dynamics may continue to pressure our business in China.
Because our business environment is highly competitive, our long-term growth and profitability will depend in part on our ability to retain and grow our current customers and attract new customers through developing and delivering new and improved products and services that meet our customers' needs and expectations, including with respect to product performance, product offerings, cost, automation and other work-flow efficiencies. 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.
While we expect the revenues and financial results from our non-respiratory and respiratory products to be affected by the highly competitive environment and our respiratory products to be affected by the demands of the respiratory season, we intend to continue our focus on prudently managing our business and delivering improved financial results, while at the same time striving to introduce new products and services into the market.
Seasonality
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.
Results of Operations
Revenues
The following table compares Total revenues by business unit for the three and six months ended June 28, 2026 and June 29, 2025:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change
Labs $ 382.9 $ 369.7 4 % $ 736.0 $ 742.7 (1) %
Immunohematology (1)
134.2 132.3 1 % 272.5 260.8 4 %
Donor Screening (1)
4.0 13.3 (70) % 11.8 26.1 (55) %
Point of Care 108.2 93.0 16 % 221.0 263.9 (16) %
Molecular Diagnostics 1.6 5.6 (71) % 9.4 13.2 (29) %
Total revenues $ 630.9 $ 613.9 3 % $ 1,250.7 $ 1,306.7 (4) %
(1) As a result of the wind-down of the U.S. donor screening portfolio, the Transfusion Medicine business unit is shown in its two product categories: Immunohematology and Donor Screening.
For the three months ended June 28, 2026, Total revenues increased to $630.9 million from $613.9 million for the same period in the prior year. Labs revenue increased 4% compared to the prior year period. The overall increase in Labs revenue was partially offset by slower distributor sales related to pending changes to IVD pricing guidelines in China. Immunohematology revenue increased slightly compared to the prior year period. Donor Screening revenue decreased 70% compared to the prior year period, primarily due to the wind-down of the U.S. donor screening business. Point of Care revenue increased 16% compared to the prior year period, primarily due to increases in respiratory product revenue. Molecular Diagnostics revenue decreased 71% compared to the prior year period, primarily due to a decrease in SOLANA revenue. Currency exchange rates had a favorable impact of 90 basis points on our growth rate for the three months ended June 28, 2026.
For the six months ended June 28, 2026, Total revenues decreased to $1,250.7 million from $1,306.7 million for the same period in the prior year. Labs revenue decreased 1% compared to the prior year period, primarily due to (i) the termination of our Joint Business arrangement, which contributed to a $15.2 million decrease, and (ii) slower distributor sales related to pending changes to IVD pricing guidelines in China, partially offset by an (iii) overall increase in Labs revenue. Immunohematology revenue increased 4% compared to the prior year period, primarily due to reagent growth. 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.
Cost of Sales, Excluding Amortization of Intangible Assets
Cost of sales, excluding amortization of intangible assets, increased to $358.0 million, or 56.7% of Total revenues, for the three months ended June 28, 2026, compared to $339.0 million, or 55.2% of Total revenues, for the three months ended June 29, 2025. The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by higher depreciation, manufacturing costs and freight charges.
Cost of sales, excluding amortization of intangible assets, increased to $714.0 million, or 57.1% of Total revenues, for the six months ended June 28, 2026, compared to $688.5 million, or 52.7% of Total revenues, for the six months ended June 29, 2025. The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by unfavorable product mix, higher depreciation, employee compensation costs and freight charges.
Operating Expenses
The following table summarizes operating expenses for the three and six months ended June 28, 2026 and June 29, 2025:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 % of
Total Revenues 		June 29, 2025 % of
Total Revenues 		June 28, 2026 % of
Total Revenues 		June 29, 2025 % of
Total Revenues
Selling, marketing and administrative $ 189.7 30.1 % $ 178.0 29.0 % $ 389.0 31.1 % $ 365.0 27.9 %
Research and development 48.7 7.7 % 45.7 7.4 % 93.6 7.5 % 98.9 7.6 %
Amortization of intangible assets 49.0 7.8 % 47.9 7.8 % 95.8 7.7 % 95.9 7.3 %
Restructuring, integration and other charges 6.5 1.0 % 178.9 29.1 % 10.9 0.9 % 195.0 14.9 %
Other operating expenses 0.8 0.1 % 5.1 0.8 % 1.0 0.1 % 11.5 0.9 %
Selling, Marketing and Administrative Expenses
Selling, marketing and administrative expenses for the three months ended June 28, 2026 increased by $11.7 million, or 6.6%, to $189.7 million from $178.0 million for the same period in the prior year, primarily due to higher distribution costs, higher employee compensation costs, including severance, and an increase of $2.8 million in cloud computing amortization.
Selling, marketing and administrative expenses for the six months ended June 28, 2026 increased by $24.0 million, or 6.6%, to $389.0 million from $365.0 million for the same period in the prior year, primarily due to higher employee compensation costs, including severance, and an increase of $6.1 million in cloud computing amortization.
Research and Development Expense
Research and development expense for the three months ended June 28, 2026 increased by $3.0 million, or 6.6%, to $48.7 million from $45.7 million for the same period in the prior year, primarily due to higher costs of outside services, partially offset by lower third-party material and clinical costs.
Research and development expense for the six months ended June 28, 2026 decreased by $5.3 million, or 5.4%, to $93.6 million from $98.9 million for the same period in the prior year, primarily due to lower third-party material and clinical costs, partially offset by higher costs of outside services.
Amortization of Intangible Assets
Amortization of intangible assets was $49.0 million and $95.8 million for the three and six months ended June 28, 2026, respectively, and $47.9 million and $95.9 million for the three and six months ended June 29, 2025, respectively.
Restructuring, integration and other charges
Restructuring, integration and other charges were $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.
Other Operating Expenses
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.
Non-operating Expenses
Interest Expense, Net
Interest expense, net was $54.7 million and $105.8 million for the three and six months ended June 28, 2026, respectively, and $40.5 million and $80.5 million for the three and six months ended June 29, 2025, respectively. Refer to Item 1, "Financial Statements-Note 9. Borrowings" for more information.
Other Expense, Net
Other expense, net was $4.7 million and $1.3 million for the three and six months ended June 28, 2026, respectively, compared to $8.4 million and $9.8 million for the three and six months ended June 29, 2025, respectively. The decreases were related to net foreign currency gains, partially offset by a loss on investments for the three and six months ended June 28, 2026.
Income Taxes
For the three months ended June 28, 2026, we recognized a provision for income taxes of $11.7 million in relation to loss before income taxes of $81.2 million, resulting in a negative effective tax rate of 14.4%. For the three months ended June 29, 2025, we recognized a provision for income taxes of $25.8 million in relation to loss before income taxes of $229.6 million, resulting in a negative effective tax rate of 11.2%. For the three months ended June 28, 2026 and June 29, 2025, the effective tax rate differed from the U.S. federal statutory rate primarily due to the impacts of operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances.
For the six months ended June 28, 2026, we recognized a provision for income taxes of $24.0 million in relation to loss before income taxes of $160.7 million, resulting in a negative effective tax rate of 14.9%. For the six months ended June 29, 2025, we recognized a provision for income taxes of $29.7 million in relation to loss before income taxes of $238.4 million, resulting in a negative effective tax rate of 12.5%. For the six months ended June 28, 2026 and June 29, 2025, the effective tax rate differed
from the U.S. federal statutory rate primarily due to the impacts of operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances.
On July 4, 2025, the OBBBA was enacted in the U.S. 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.
Segment Results
We operate under five geographically-based reportable segments: North America, EMEA, China, JPAC and Latin America. Beginning in the fourth quarter of 2025, we determined that the JPAC segment, previously included in "Other," meets the quantitative thresholds for separate reporting under ASC 280. This determination was based on JPAC's segment revenue exceeding 10% of the combined reported segment revenue. As Latin America is the only remaining immaterial operating segment, results are reported separately. This change in segment reporting did not have an impact on our previously reported Consolidated Financial Statements. Prior periods have been revised to align with the current period presentation.
The key indicators that we monitor are as follows:
•Total revenues - This measure is discussed in the section entitled "Results of Operations."
•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.
North America
Total revenues and Adjusted EBITDA for North America were as follows:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change
Total revenues $ 327.4 $ 310.7 5 % $ 656.3 $ 717.4 (9) %
Adjusted EBITDA $ 169.6 $ 159.7 6 % $ 339.0 $ 394.0 (14) %
Total revenues were $327.4 million for the three months ended June 28, 2026, compared to $310.7 million for the three months ended June 29, 2025. The increase was primarily driven by increases in Labs and Point of Care revenues, partially offset by the wind-down of the U.S. donor screening business.
Total revenues were $656.3 million for the six months ended June 28, 2026, compared to $717.4 million for the six months ended June 29, 2025. The decrease was primarily driven by (i) decreases in sales of SOFIA SARS and QUICKVUE SARS Antigen assays, (ii) a decrease in Labs revenues, primarily due to the termination of our Joint Business arrangement and (iii) the wind-down of the U.S. donor screening business.
Adjusted EBITDA was $169.6 million for the three months ended June 28, 2026, compared to $159.7 million for the three months ended June 29, 2025. The increase was primarily driven by increases in Labs and Point of Care revenues, partially offset by the wind-down of the U.S. donor screening business, and higher service and distribution costs.
Adjusted EBITDA was $339.0 million for the six months ended June 28, 2026, compared to $394.0 million for the six months ended June 29, 2025. The decrease was primarily driven by decreases in revenues, and higher service and distribution costs.
EMEA
Total revenues and Adjusted EBITDA for EMEA were as follows:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change
Total revenues $ 91.2 $ 87.3 4 % $ 183.7 $ 176.2 4 %
Adjusted EBITDA $ 22.1 $ 18.3 21 % $ 42.2 $ 34.8 21 %
Total revenues were $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.
Total revenues were $183.7 million for the six months ended June 28, 2026, compared to $176.2 million for the six months ended June 29, 2025. The increase was primarily driven by an increase in Immunohematology revenues.
Adjusted EBITDA was $22.1 million for the three months ended June 28, 2026, compared to $18.3 million for the three months ended June 29, 2025. The increase was primarily driven by an increase in Immunohematology revenues and cost savings initiatives, partially offset by higher distribution costs.
Adjusted EBITDA was $42.2 million for the six months ended June 28, 2026, compared to $34.8 million for the six months ended June 29, 2025. The increase was primarily driven by an increase in Immunohematology revenues and cost savings initiatives, partially offset by higher distribution costs.
China
Total revenues and Adjusted EBITDA for China were as follows:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change
Total revenues $ 67.8 $ 83.4 (19) % $ 131.3 $ 158.4 (17) %
Adjusted EBITDA $ 30.3 $ 42.1 (28) % $ 50.8 $ 71.4 (29) %
Total revenues were $67.8 million for the three months ended June 28, 2026, compared to $83.4 million for the three months ended June 29, 2025. The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to pending changes to IVD pricing guidelines in China and a decrease in Immunohematology revenues.
Total revenues were $131.3 million for the six months ended June 28, 2026, compared to $158.4 million for the six months ended June 29, 2025. The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to pending changes to IVD pricing guidelines in China.
Adjusted EBITDA was $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.
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.
JPAC
Total revenues and Adjusted EBITDA for JPAC were as follows:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change
Total revenues $ 74.3 $ 72.2 3 % $ 144.3 $ 140.3 3 %
Adjusted EBITDA $ 18.3 $ 19.2 (5) % $ 34.8 $ 36.8 (5) %
Total revenues were $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.
Total revenues were $144.3 million for the six months ended June 28, 2026, compared to $140.3 million for the six months ended June 29, 2025. The increase was primarily driven by an increase in Labs revenues.
Adjusted EBITDA was $18.3 million for the three months ended June 28, 2026, compared to $19.2 million for the three months ended June 29, 2025. The decrease was primarily driven by the impact of product mix and higher service costs, partially offset by an increase in Labs revenues.
Adjusted EBITDA was $34.8 million for the six months ended June 28, 2026, compared to $36.8 million for the six months ended June 29, 2025. The decrease was primarily driven by the impact of product mix and higher service costs, partially offset by an increase in Labs revenues.
Latin America
Total revenues and Adjusted EBITDA for Latin America were as follows:
Three Months Ended Six Months Ended
(Dollars in millions) June 28, 2026 June 29, 2025 % Change June 28, 2026 June 29, 2025 % Change
Total revenues $ 70.2 $ 60.3 16 % $ 135.1 $ 114.4 18 %
Adjusted EBITDA $ 19.7 $ 18.7 5 % $ 35.5 $ 30.7 16 %
Total revenues were $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.
Total revenues were $135.1 million for the six months ended June 28, 2026, compared to $114.4 million for the six months ended June 29, 2025. The increase was primarily driven by an increase in Labs revenues.
Adjusted EBITDA was $19.7 million for the three months ended June 28, 2026, compared to $18.7 million for the three months ended June 29, 2025. The increase was primarily driven by an increase in Labs revenues, partially offset by higher operating expenses.
Adjusted EBITDA was $35.5 million for the six months ended June 28, 2026, compared to $30.7 million for the six months ended June 29, 2025. The increase was primarily driven by an increase in Labs revenues and the impact from changes in product mix, partially offset by higher operating expenses.
Liquidity and Capital Resources
As of June 28, 2026 and December 28, 2025, our principal sources of liquidity consisted of the following:
(In millions) June 28, 2026 December 28, 2025
Cash and cash equivalents $ 123.4 $ 169.8
Amount available to borrow under the Revolving Credit Facility $ 426.5 $ 596.6
Working capital including cash and cash equivalents $ 383.2 $ 481.2
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.
Debt Capitalization
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.
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.
In April 2026, we borrowed $100.0 million under the DDTL Term Loan A, comprised of a Term SOFR loan to fund the acquisition of LEX Diagnostics and for general corporate purposes.
The Credit Agreement contains affirmative and negative covenants that are customary for credit agreements of this nature. 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.
Capital Expenditures
Capital expenditures, including investments, were $59.5 million for the six months ended June 28, 2026. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities and other facility-related activities.
Cash Flow Summary
Six Months Ended
(In millions) June 28, 2026 June 29, 2025
Net cash (used for) provided by operating activities $ (143.6) $ 18.8
Net cash used for investing activities (141.3) (89.2)
Net cash provided by financing activities 238.2 120.9
Effect of exchange rates on cash 0.3 2.7
Net (decrease) increase in cash, cash equivalents and restricted cash $ (46.4) $ 53.2
Six Months Ended June 28, 2026
Cash used for operating activities was $143.6 million for the six months ended June 28, 2026 and reflected a net loss of $184.7 million, non-cash adjustments of $268.7 million, primarily associated with depreciation and amortization and stock-based compensation expense, and changes in working capital, including cash outflows of $123.3 million for inventories, partially offset by cash inflows of $62.9 million from collections on accounts receivables.
Cash used for investing activities was $141.3 million for the six months ended June 28, 2026 and was primarily related to the LEX Diagnostics acquisition of $96.8 million and purchases of property, plant, equipment, investments and intangibles of $59.5 million.
Cash provided by financing activities was $238.2 million for the six months ended June 28, 2026 and was primarily related to net proceeds from the Revolving Credit Facility of $170.0 million and long-term borrowings of $70.6 million.
Six Months Ended June 29, 2025
Cash provided by operating activities was $18.8 million for the six months ended June 29, 2025 and reflected a net loss of $268.1 million and non-cash adjustments of $407.0 million, primarily associated with depreciation and amortization, asset write off related to restructuring, integration and other charges, and stock-based compensation expense, partially offset by $102.6 million in cash outflows for inventories.
Cash used for investing activities of $89.2 million for the six months ended June 29, 2025 was primarily related to purchases of property, plant, equipment, investments and intangibles.
Cash provided by financing activities was $120.9 million for the six months ended June 29, 2025 and was primarily related to net proceeds from the Revolving Credit Facility of $192.0 million, partially offset by payments on long-term borrowings of $72.0 million.
Liquidity Outlook
Short-term Liquidity Outlook
Our primary source of liquidity, other than our holdings of Cash and cash equivalents, has been cash flows from operations. Cash generated from operations provides us with the financial flexibility we need to meet normal operating, investing and financing needs. We anticipate that our current Cash and cash equivalents, together with cash provided by operating activities and amounts available under our Revolving Credit Facility, will be sufficient to fund our near-term capital and operating needs for at least the next 12 months.
Normal operating needs include the planned costs to operate our business, including amounts required to fund working capital, R&D and capital expenditures. Our primary short-term needs for capital, which are subject to change, include expenditures related to:
•interest on and repayments of our long-term borrowings and lease obligations;
•acquisitions of property, equipment and other fixed assets in support of our manufacturing footprint;
•the continued advancement of R&D efforts;
•support of commercialization efforts related to our current and future products, including support of our direct sales force and field support resources; and
•potential strategic acquisitions and investments.
Due to the risks inherent in the product development process, we are unable to estimate with meaningful certainty the costs we will incur in the continued development of our product candidates for commercialization. Our R&D costs may be substantial as we move product candidates into preclinical and clinical trials and advance our existing product candidates into later stages of development.
The primary purposes of our capital expenditures are to invest in our manufacturing footprint, acquire certain of our instruments, acquire scientific equipment, purchase or develop IT and implement facility improvements. We plan to fund the capital expenditures with the cash on our balance sheet.
We are focused on expanding the number of instruments placed in the field and solidifying long-term contractual relationships with customers. In order to achieve this goal, in certain jurisdictions where it is permitted, we have leveraged a reagent rental model that has been recognized as more attractive to certain customers. In this model, we lease, rather than sell, instruments to our customers. Over the term of the contract, the purchase price of the instrument is embedded in the price of the assays and reagents. Going forward, we intend to increase the number of reagent rental placements in developed markets, a strategy that we believe is beneficial to our commercial goals because it lowers our customers' upfront capital costs and therefore allows purchasing decisions to be made at the lab manager level. For these same reasons, the reagent rental model also benefits our commercial strategy in emerging markets, where permitted by law. We believe that the shift in our sales strategy will grow our installed base, thereby increasing sales of higher-margin assays, reagents and other consumables over the life of the customer contracts and enhancing our recurring revenue and cash flows.
Long-term Liquidity Outlook
Our future capital requirements and the adequacy of our available funds to service any long-term debt outstanding and to fund working capital expenditures and business development efforts will depend on many factors, including:
•our ability to realize revenue growth from our new technologies and create innovative products in our markets;
•outstanding debt and covenant restrictions;
•our ability to leverage our operating expenses to realize operating profits with revenue growth;
•competing technological and market developments; and
•our entry into strategic collaborations with other companies or acquisitions of other companies or technologies to enhance or complement our product and service offerings.
Recent Accounting Pronouncements
Information about recent accounting pronouncements is included in Item 1, "Financial Statements-Note 1. Basis of Presentation and Summary of Significant Accounting Policies."
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations are based on our Consolidated Financial Statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires the use
of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses. Our critical accounting estimates are those that significantly affect our financial condition and results of operations and require the most difficult, subjective or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates.
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.
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