QDEL 10-K & 10-Q changes, risk factors and insider trading

•failure to researchidentify and successfully develop new technologies, products and services and develop new markets;

•our inability to achieve anticipated market acceptance of our products;

•significant changes in the healthcare industry and related industries that we serve, including anstaffing effortconstraints and efforts to reduce costs;

•consolidation of our customer base andbase, the formation of group purchasing organizations and government-sponsored tendering processes;

•inability to realizesuccessfully theidentify anticipatedor benefitsconsummate ofstrategic acquisitions,transactions, divestituresstrategic restructurings or divestitures, spin-offs or discontinuances of certain business operationsoperations, or to realize the anticipated benefits;

•risks associated with our non-U.S. operations and international sales, including currency translation risks, the impact of possible new sanctions or tariffs, compliance with customs valuation and classification requirements, trade embargoes or trade wars and compliance with applicable trade measures;

•our inabilityinability, or that of our providers or third-party collaboration partners, to protect our information systems in our IT and product systems, and personal and confidential information, including from data corruption, cyber-attacks, security breaches or IT errors;

•our inability to obtain or maintain required clearances or approvals for our products, including approval requirements of the foreign countries in which we sell our products or EUAs on our respiratory products;

•inability to procure government contracts, including due to government-sponsored tendering requirements, lack of fundingfunding, and compliance and possible sanctionspenalties risks associated with contracts with government entities;

•our inability to generate cash flow sufficient to service our debt obligations;

•the outcomes of disputes and legal proceedings instituted against us;

•the volatility of the market price of our common stock; and

•risks associated with future sales of our common stock by us or our stockholders in the public market.market; and

Our diagnostic tests and services compete with similar products made by our competitors. We may not be able to supply customers with products and services that they deem superior or at competitive prices, and we may lose business to our competitors. There are a large number of multinational and regional competitors making investments in competing technologies, products and services, including several large pharmaceutical and diagnostics companies and diagnostic divisions of diversified healthcare companies and conglomerates. We also face competition from our distributors and retail customers as some have created, and others may decide to create, their own products and services to compete with ours. A number of our competitors have competitive advantages, such as substantially greater financial, managerial, technical, R&D, clinical, manufacturing,manufacturing and regulatory resources, capabilities and experience, and more established, larger and broader coverage in marketing, sales, distribution and service organizations and other resources than we have. Moreover, some competitors offer broader product lines and have greater name recognition than we have. Our operating results could be materially and adversely affected if:

•our competitors offer more competitive pricing or we fail to manufacture,manufacture or supply, in a cost-effective way, or at all, sufficient quantities of our products to meet customer demand.

In order to remain competitive and profitable, we must expend considerable resources to researchidentify and successfully develop new technologies, products and services and develop new markets, and there is no assurance our research efforts and our efforts to develop new technologies, products and services or markets will be successful or such technologies, products and services or markets will be commercially viable or accepted.

Our ability to retain customers, attract new customers, grow our business and enhance our brand depends on our success in developing and delivering products and services that meet our customers’ needs and expectations. We devote a significant amount of financial and other resources to researchingidentifying and developing new technologies, products, services and markets. The development, manufacture and sale of diagnostic products and services and new technologies require a significant investment of resources, such as capital, employee time, offices and R&D and manufacturing facilities, and development of new partners and channels. Furthermore, developing and manufacturing new products and services require us to anticipate customers’ and patients’ needs and emerging technology trends accurately. We have experienced, and may experience in the future, R&D, manufacturing, regulatory, marketing and other difficulties that could delay or prevent our introduction of new or enhanced products and services. The R&D process in the healthcare industry generally takes a significant amount of time from design stage to product launch. This process is conducted in various stages, and each stage presents the risk that we will not achieve our goals. In addition, innovations may not be accepted quickly in the marketplace, or at all, because of, among other things, entrenched patterns of clinical practice or uncertainty over third-party reimbursements. In the event of such failure, we may need to abandon a product or service in which we have invested substantial resources. For example, in June 2025, we announced plans to discontinue our SAVANNA platform development as a result of several factors, including the results of the SAVANNA RVP4X clinical trial.

The growth of our business and demand for our products and services are affected by changes in the health of the overall global economy and, in particular, of the healthcare industry. Demand for our products and services could change more dramatically than in previous years based on funding and reimbursement constraints and support levels from governments, universities, hospitals and the private industry, including laboratories. Our global business is adversely affected by decreases in the general level of economic activity, such as decreases in business and consumer spending, increases in unemployment rates, the inflationary environment,inflation, high interest rates, a recessionary environment, instability in financial institutions and budgeting constraints of governmental entities. Disruptions in the U.S., Europe, China or in other geographies, including as a result of the ongoing conflicts in Ukraine and the Middle East, or increasing regulation in emerging markets, such as China, could adversely affect our sales, profitability and/or liquidity.

A deterioration in financial markets, including due to instability in financial institutions, or reduction in confidence in major economies or other macroeconomic developments could affect businesses such as ours in a number of ways. A tightening of credit in financial markets could adversely affect the ability of our customers and suppliers to obtain financing for significant purchases and operations, could result in a decrease in or cancellation of orders for our products and services and could impact the ability of our customers to make payments. Similarly, a tightening of credit may adversely affect our supplier base, increase the potential for one or more of our suppliers to experience financial distress or bankruptcy, and could also impact our operations more directly, including any outstanding or contemplatedfuture credit facility or other borrowings. Our financial position, results of operations and cash flows could be materially adversely affected by difficult conditions and volatility in the capital, credit and commodities markets.

A significant percentage of our total revenues is generated from a limited number of our product families. InFor particular, revenues from theexample, sales of our respiratory products have represented a significant portion of our total revenues. Sales of our respiratory products accounted for approximately 18%15% of our total revenues for the year ended December 29,28, 2024.2025. Demand for our respiratory products has and may continue to fluctuate or decline as a result of a number of factors, including but not limited to the severity of the respiratory season, the emergenceoccurrence, spread, severity, duration and impactemergence of new variants orof resurgences,respiratory diseases, the effectiveness of vaccination efforts, and the increased market supply of respiratory products by our competitors. The gross margins derived from sales of our respiratory products are generally significantly higher than the gross margins from many of our other core products. AsFluctuations aor result,declines ifin the sales or revenues of our respiratory products fluctuate or decline for any reason,products, whether as a result of a mild respiratory season, market share loss or price pressure, obsolescence, regulatory matters,matters or any other reason, our operating results would becould materially and adversely affectedaffect onour aoperating disproportionate basis.results.

A significant portion of our revenues are from sales of products and services to distributors. Although we have many distributor relationships in the U.S. and globally, the market is dominated by a small number of these distributors and as a result, we rely on certain key distributors for the sales of some of our products. The loss or termination of our relationship with any of these key distributors could significantly disrupt our business unless suitable alternatives are timely found or lost sales to a distributor are taken up by anotherone distributoror more other distributors or in direct sales. Finding a suitable alternative to a lost or terminated distributor may pose challenges in our industry’s competitive environment, and anotherother suitable distributordistributors may not be found on satisfactory terms, if at all. For instance, some distributors already have exclusive arrangements with our competitors, and others do not have the same level of penetration into our target markets as our existing distributors. In addition, our efforts to distribute our products directly in some markets may be unsuccessful. The loss of any key distributor or an unsuccessful effort by us to directly distribute our products or transition direct markets to distribution could lead to reduced sales.

If total revenues from some of our significant customers were to decrease or not continue in any material amount in the future, or if we are not successful in growing our current or new customer relationships or timely transitioning our business to distribution or to direct sales, or from a lost or terminated distributor to one or more new distributors or to direct sales,distributors, our business, operating results and financial condition could be materially and adversely affected.

Unexpected increases in demand for our products or services or supply shortages could require us to incur additional costs to meet customer demand, or result in an inability to meet demand. These additional costs could involve purchasing or producing a safety stock of components or products, purchasing new machinery, obtaining additional labor resources or even acquiring or constructing new manufacturing facilities. Some supplies require significant ordering lead time and we may not be able to timely access sufficient supplies in the event of an unexpected increase in demand or supply shortage, or the cost of such supplies may be significantly greater. ThisIf available, this would increase our capital and other costs, which could adversely affect our earnings and cash resources. Additionally, our reliance on a small number of contract manufacturers and a large number of single and sole source suppliers makes us vulnerable to possible production capacity or other constraints of such suppliers or in their supply chain and reduced control over manufacturing, product availability, delivery schedules and costs.

In addition, due to regulatory requirements relating to the qualification of suppliers, we may not be able to establish additional or replacement sources on a timely basis or without excessivesubstantial cost. For example, stringent requirements of the FDA and other regulatory authorities regarding the manufacture of certain of our products may prevent us from quickly establishing additional or replacement sources for the raw materials, products, components or manufacturing services that we use, or from doing so without excessivesubstantial cost. Further, our suppliers may be subject to regulation or other actions by the FDA and other regulatory authorities that could hinder their ability to produce necessary raw materials, products and components. The implementation of these requirements has caused and will continue to cause increased costs to comply with these requirements and may inhibit our ability to source these materials.

If our current contract manufacturers, suppliers of raw materials and other third-party vendors are unable or unwilling to manufacture or supply our products or components or requirements for raw materials in required volumes and at required quality levels and costs or renew or continue existing terms under supply arrangements, we may be required to replace such manufacturers, suppliers and vendors and may be unable to do so in a timely or cost-effective manner, or at all. Any shortage in our supply of raw materials, equipment or components, or our inability to quickly and cost-effectively obtain alternative sources for this supply, could have a material adverse effect on our business, financial condition and operating results.

The global supply of some of our products depends on the uninterrupted efficient operation of our manufacturing facilities, and the continued performance of our contract manufacturers, suppliers of raw materials and other third-party vendors under our supply arrangements. Many of our manufacturing processes are complex and involve sensitive scientific processes involving the use of unique and often proprietary antibodies and other raw materials that cannot be replicated or acquired through alternative sources without undue delay or expense. Other processes present difficult technical challenges to obtain the manufacturing yields necessary to operate profitably. In addition, our manufacturing processes may require complex and specialized equipment, which can be expensive to maintain, repair or replace with required lead times of up to a year.year or more.

The manufacturing of certain of our products is concentrated in one or more of our manufacturing plants or those of our contract manufacturers, with no or limited alternate facilities. We have significant operations in California, near major earthquake faults and areas vulnerable to wildfire, which make us susceptible to earthquake and fire risk. We also have significant operations in Rochester, New York, Raritan, New Jersey, Pencoed, Wales, Pompano Beach, Florida, Athens, Ohio, and Athens,Changsha, Ohio.China. Severe weather, natural disasters, public health crises, fires, power shortages or outages, terrorism, political change or unrest, failure to follow specific internal protocols and procedures, equipment malfunction, environmental factors, damage to our equipment or one or more of our facilities, catastrophic events or other events outside of our control, or any other event that negatively impacts our manufacturing process, facilities, systems or equipment, or the process, facilities, systems or equipment of our contract manufacturers, suppliers or other third-party vendors on which we depend, could delay, reduce, suspend or terminate production of products or the release of new products, result in the delivery of inferior products or otherwise disruptcause significant disruption to our operations. In such circumstances, our revenue would decline and we could incur losses until such time as we or our contract manufacturersmanufacturers, suppliers or other third-party vendors are able to restore or rebuild our or their production processes or we are able to put in place alternative contract manufacturers, suppliers or third-party vendors. Similarly, any disruption or other operational challenges to one of our primary warehouse facilities could result in decreased revenue or increased costs given the challenge in finding suitable alternative facilities.

Our collaboration arrangements may not operate according to our business strategy and if we are unable to maintain our collaboration arrangementarrangements, partnersor failif tothese fulfillcollaboration theirarrangements obligations.are not successful, our results of operations could be materially adversely affected.

As part of our business, we are party to collaboration arrangements with other companies, including the Joint Business with Grifols,companies and we may enter into additional collaboration arrangements in the future. The nature of a collaboration arrangement requires us to share control over significant decisions with unaffiliated third parties. Since we maydo not exercise exclusive control over our current or future collaboration arrangements, we may not be able to require our collaboration arrangement partners to take actions that we believe are necessary to implement our business strategy. DisputesDifferences in views among collaboration arrangement partners may result in delayed decisions, failures to agree on major issues, or breaches or termination of our collaboration agreements. Additionally, disputes between us and our collaboration arrangement partners could also result in litigation,litigation or other legal proceedings, which can be expensive and time-consuming. Additionally, differences in views among collaboration arrangement partners may result in delayed decisions or failures to agree on major issues. If these differences or disputes cause our collaboration arrangements to be terminated or deviate from our business strategy, our results of operations could be materially adversely affected.

Leases, rather than sales, of instruments under our reagent rental model have the effect of reducing cash flows during the initial part of the applicable contract as we support those commercial transactions until we are able to recover our investment over the life of the contract. The use of upfront cash in connection with this model causes our cash flows to fluctuate from quarter to quarter and may have a negative effect on our financial condition.

We may not achieve anticipated market acceptance of our products by customers and this would have a negative effect on future sales.

We maintain customer relationships with numerous physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, leading universities, retail clinics, pharmacies, wellness screening centers, other POC settings, blood banks and donor centers, individual, non-professional OTC customers and other customers. We believe that sales of our products depend significantly on our customers’ confidence in, and recommendations of, our products. In addition, in a number of cases, our success depends on technicians’ acceptance and confidence in the effectiveness and ease-of-use of our products and services, including our new products. If we do not capture sales at the levels anticipated, our total revenues will not be at the levels that we expect and the costs we incur or have incurred may be disproportionate to our sales levels.

In order to achieve acceptance by healthcare professionals, we seek to educate the healthcare community as to the distinctive characteristics, perceived benefits, clinical efficacy and cost-effectiveness of our products and services compared to alternative products. Acceptance of our products also requires effective training of healthcare professionals in the proper use and application of our products. Failure to effectively educate and train our technician end-users, continue to develop relationships with leading healthcare professionals or achieve anticipated market acceptance from healthcare providers or other customers with respect to the use of our diagnostic products could result in lower acceptance or fewer recommendations of our products, which may adversely affect our sales and profitability.

The healthcare industry and related industries that we serve have undergone, and are in the process of undergoing, significant changes, including anstaffing effortconstraints and efforts to reduce costs, which could adversely affect our business, financial condition and results of operations.

Many of our customers, and the end-customers to whom our customers provide products, rely on private or government funding of and reimbursement for healthcare products and services and research activities. In the U.S., healthcare providers such as hospitals and physicians who purchase diagnostic products generally rely on third-party payors, principally private health insurance plans and federal Medicare and Medicaid, to reimburse all or part of the cost of the procedure, and these payors may reduce or modify reimbursement rates. For example, CMS implemented certain provisions of PAMA, which made substantial changes to the way in which clinical laboratory services are paid under Medicare. The revised reimbursement methodology under PAMA generally results in relatively lower reimbursement under Medicare for clinical diagnostic lab tests than has been historically available. Further, the OBBBA enacted changes to Medicaid eligibility, cost-sharing and financing that could result in relatively lower reimbursement due to decreased beneficiary enrollment and budgetary pressures. Such changes in the U.S., healthcare austerity measures in Europe and other potential global healthcare reform changes and government austerity measures may reduce the amount of government funding or reimbursement available to customers or end-customers of our products and services and/or the volume of medical procedures using our products and services. Third-party reimbursement and coverage may not be available or adequate in either the U.S. or foreign markets, current reimbursement amounts may be decreased in the future and future legislation, legislative amendments, regulation or reimbursement policies of third-party payors may reduce the demand for our products or adversely impact our ability to sell our products on a profitable basis.

Governmental and private healthcare providers and payors around the world are increasingly utilizing managed care for the delivery of healthcare services, forming group purchasing organizationsservices to improve their purchasing leverage and using competitive bid processes to procure healthcare products and services. Health insurance premiums, co-payments and deductibles have also generally increased in recent years. These increases may cause individuals to forgo health insurance, as well as medical attention. Further, healthcare staffing constraints may affect the prioritization of health care services.

SuchEach of these changes may cause participants in the healthcare industry to purchase fewer of our products and services, reduce the prices they are willing to pay for our products or services, reduce the amounts of reimbursement and funding available for our products or services from governmental agencies or third-party payors, reduce the volume of medical procedures that use our products and services and increase our compliance and other costs. Moreover, we believe the overall escalating cost of medical products and services has led to, and will continue to lead to, increased pressures on the healthcare industry, both foreign and domestic, to reduce the cost of products and services.

Consolidation among healthcare providers and the formation of buyinggroup groupspurchasing organizations and, with respect to our international operations, government-sponsored tendering processes, have put pressure on pricing and sales of our products, and in some instances, required payment of fees to group purchasing organizations or required us to provide lower pricing in the tendering or contracting process. Our success in these areas depends partly on our ability to enter into contracts with integrated health networks and group purchasing organizations. If we are unable to enter into contracts with these group purchasing organizations and integrated health networks on terms acceptable to us or if we fail to have our pricing terms accepted in the tendering or contracting process, our sales and results of operations may be adversely affected. Even if we are able to enter into these contracts or have our pricing terms accepted in the tendering or contracting process, they may be on terms that negatively affect our current or future profitability. For example, the Chinese government has started to expand its volume-based procurement (“VBP”) program to diagnostics at the provincial level, which aims to lower prices in exchange for high volume purchases. Some of our immunoassay products fall within the VBP scope in Anhui Province in China, and additional VBP programs can or may be expanded or adopted in China, which could result in other products falling within the scope of the programs, which could materially affect our revenues and margins in China. Furthermore, given the average industry contract length for our Orthoclinical instrumentslabs and transfusion medicine businesses is five to seven years, if we are unable to enter into a contract with a new customer or renew a given contract with an existing customer, it may be several years before we have an opportunity to acquire or reacquire, as applicable, such customer’s business, which may have a material adverse effect on our results of operations in the interim period.

We may engage in acquisitionsstrategic transactions, including acquisitions, investments, joint ventures, licensing arrangements and other strategic relationships, undertake strategic restructurings or divestituresdivest, spin-off or discontinue certain business operations, and may encounternot difficultiessuccessfully integrating acquired businesses with,identify or disposingconsummate ofthese divestedstrategic or discontinued businesses from, our current operationstransactions; therefore, we may not realize the anticipated benefits of these acquisitions,transactions, divestituresif or discontinuances.any.

We may seek to grow or diversify into priority growth areas through strategic acquisitions.transactions, such as acquisitions, investments, joint ventures, licensing arrangements or other strategic relationships. For example, in June 2025, we announced our intent to acquire LEX Diagnostics. However, we may not successfully identify appropriate acquisition targets or strategic relationships to pursue. Even if we identify appropriate acquisition targets or strategic relationships, we may not be able to obtain acceptable financing, consummate transactions or obtain agreements with favorable terms, if at all. Our due diligence reviews of our acquisition targets or potential strategic partners may not identify all of the material issues necessary to accurately estimate the cost or potential loss contingencies with respect to a particular transaction, including potential exposurelegal toor regulatory sanctionsexposure resulting from an acquisition target’s or potential strategic partner’s previous activities as well as potential vulnerability to cybersecurity risks. WeFurther, we may incur unanticipated costs or expenses, including post-closing asset impairment charges, expenses associated with eliminating duplicate facilities, litigation and other liabilities.liabilities, and strategic transactions may divert management’s attention and resources from our existing operations. We also may encounter difficulties in integrating acquisitions with our operations, applying our internal controls processes to these acquisitions, retaining key technical and management personnel, complying with regulatory requirements, or managing strategic investments.investments and partnerships. Furthermore, acquisitions may, at least in the near term, be dilutive and reduce our earnings and margins due to product, integration and transaction costs, financing expenses and the time required to realize anticipated synergies. Additionally, we may not achieve the benefits we anticipate when we first enter intofor a given strategic transaction in the amount or timeframe anticipated, if at all. Any of the foregoing could adversely affect our business and results of operations. In addition, accounting requirements relating to business combinations, including the requirement to expense certain acquisition costs as incurred, may cause us to experience greater earnings volatility and generally lower earnings during periods in which we acquire new businesses.

We may also make strategic divestitures or spin-off or discontinue certain business operations from time to time if certain of our businesses do not meet our strategic, growth or profitability objectives. For example, in February 2024, we initiated a plan to transition out of our U.SU.S. donor screening portfolio through the wind-down of the VIP platform and microplate assays, which are only sold in the U.S. and have a lower growth and margin profile. Additionally, in June 2025, we announced our plan to discontinue the development of the SAVANNA platform. Divestitures or spin-offs may result in continued financial involvement in the divested or spun-off businesses, such as through guarantees, indemnity obligations or other financial arrangements, following those transactions. Under these arrangements, nonperformance by those divested or spun-off businesses could result in financial obligations imposed upon us and could affect our future financial results. We may also need to provide transition services to the buyer or a spun-off entity for an extended period of time following the closing of the transaction, which may cause us to incur unanticipated costs and distraction. There can be no assurance that we will be able to complete any such divestiture or spin-off on terms favorable to us.us, or achieve the anticipated benefits. The divestituredivestiture, spin-off or discontinuance of certain businesses could result, individually or in the aggregate, in the recognition of material losses and a material adverse effect on our results of operations.

We have and are continuing to incorporate AI, including machine learning and independent algorithms, in certain of our internal operations and may incorporate AI into our products and services, which may enhance their operation and effectiveness internally and for our customers, suppliers,suppliers and consumers.patients. ThereAI development and deployment practices could subject us to competitive harm, reputational harm, increased cybersecurity risks, regulatory enforcement and legal liability. We also may face challenges relating to data provenance and consent, model bias and drift monitoring, governance over updates to adaptive algorithms, and transparency and post‑market monitoring expectations. Use of third‑party data or models could give rise to intellectual property or privacy claims. Emerging frameworks (including predetermined change control plans for AI or machine learning) may increase costs or delay adoption. If we fail to incorporate AI that meets our internal and customer needs, we may fail to recoup our investments, and our competitive position and reputation may be adversely impacted. Furthermore, there can be no assurance that we or our customers will realize the expected benefits from suchour implementation of AI. AI innovation presents risks and challenges that could impact our business. Our, or our vendors’, AI algorithms may be flawed. Our datasets or AI training algorithms may be insufficient or contain biased information. The use of AI may also create new cybersecurity vulnerabilities. Additionally, manyuse of AI technologies may expose us to an increased risk of regulatory enforcement and litigation. The legal and regulatory landscape surrounding AI and machine learning technologies is rapidly evolving and uncertain. Many countries and regions, including the EU,EU and various U.S. states, have enacted or proposed newlaws and evolving regulations related to the use of AI and machine learning technologies. TheMoreover, some AI features involve the processing of personal data and may be subject to laws and regulations related to privacy and data protection. These laws and regulations may impose onerous obligations on us and may require us to unexpectedly rework or reevaluate improvements to be compliant, which may result in the development of products that are subsequently unacceptable under new or revised regulatory frameworks. UseGiven the rapid rate of AIchange technologiesand maythe exposeoften usuncertain toscope, aninterpretation increasedand riskapplication of regulatorythese enforcementlaws and litigation.regulations, Moreover, some AI features involve the processing of personal data andwhich may be subjectin conflict across jurisdictions, we may not always be able to laws,anticipate policies,how courts and regulators will apply existing laws to AI, predict how new legal obligations,frameworks andwill codesaddress ofAI conductor relatedotherwise ensure compliance with these frameworks. Failure to privacyappropriately and data protection. AI development and deployment practices could subject usconform to competitivethis harm,evolving landscape may result in legal liability, regulatory enforcement,action increased cybersecurity risks,or reputational harm, and legal liability.harm.

We conduct our business on a global basis, as our products are sold internationally, with the majority of our international sales to our customers in our EMEA and China regions. Our international operations are subject to inherent macroeconomic, geopolitical and regulatory risks,risks and a range of diverse regulatory requirements, the occurrence of which, including those over which we have no control, or failure to comply with these regulatory requirements, could adversely impact our financial performance, cause interruptions in ouror suspensions of applicable international business operations, impede our international growth and operations, cause reputational harm, and subject us to civil or criminal fines and penalties, other remedial measures and legal expenses. These risks include, among others:

•compliance with complex foreign and U.S. laws and regulations that apply to our international operations, including regulations in the U.S., EUEU, China and other jurisdictions impacting the marketing of our products, U.S. laws on import/export limitations, data protection and cybersecurity, the FCPA, and foreign and local laws prohibiting bribery and corrupt payments to governmental officials, including anti-corruption laws in China;

•lost revenue as a result of macroeconomic developments, including the inflationary environmentenvironments and recessionary fears;

•U.S. or international sanction regimes, including current and future regulations and sanctions that could further limit the countries in which our products may be manufactured or sold,sold and the parties and financial institutions with which we can transact, increase the cost of conducting business in these countries, or restrict our access to, or increase the cost of obtaining, products from foreign sources;

•import and export duties, changes to import and export regulations, customs regulations and processes, including customs valuation and classification requirements, and restrictions on the transfer of funds, including currency controls;

The following discussion of our financial condition and results of operations contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve material risks and uncertainties. This discussion should be read in conjunction with the section entitled “Future Uncertainties and Forward-Looking Statements” on page 4 and the “Risk Factors” starting on page 2526 of this Annual Report. In addition, our discussion of QuidelOrtho’s financial condition and results of operation soperations in this Item 7 should be read in conjunction with our Consolidated Financial Statements and the related Notes included elsewhere in this Annual Report.

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 130140 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.S., U.K. and U.K.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, EMEAEMEA, China, JPAC and China. Latin America and JPAC (Japan and Asia Pacific) are immaterial operating segments that are not considered reportable segments and are included in “Other.”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 $94.2$112.9 million, $125.0$94.2 million and $73.1$125.0 million for fiscal years ended 2024,2025, 20232024 and 2022,2023, respectively.

For fiscal year ended 2025, Total revenues decreased by 2% to $2,730.2 million as compared to the prior year. For fiscal year ended 2024, Total revenues decreased by 7% to $2,782.9 million as compared to the prior year. For fiscal year ended 2023, Total revenues decreased by 8% to $2,997.8 million as compared to the prior year. These decreases were primarily driven by variability of our U.S. respiratory products.products, mainly due to a decrease in COVID-19 revenues, partially offset by an increase in flu revenues. Currency exchange rates did not significantly impact our growth rate for fiscal year ended 2025. Currency exchange rates had an unfavorable impact of approximately 60 basis points and 100 basis points on our growth ratesrate for fiscal yearsyear ended 2024 and 2023, respectively.2024. Our revenues can be highly concentrated over a small number of products, including certain of our respiratory products. For fiscal years ended 2024,2025, 20232024 and 2022,2023, revenues related to our respiratory products accounted for approximately 18%,15%, 24%18% and 57%24% of our Total revenues, respectively. The respiratory products revenue included revenue related to COVID-19 of $80.2 million, $184.9 million and $409.1 million for fiscal years ended 2025, 2024 and 2023, respectively.

Planned 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 planare to wind-down onlywinding-down the VIP 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 our goal is towe wind-down this U.S. donor screening portfolio, we will continue to support our existing customers and honor our contractual commitments. The winding downwinding-down of the U.S. donor screening portfolio, as compared to the prior years, contributed to the decline in revenue with a margin lower than our overall margin. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 4.3. Revenue” for more information. The wind-down of our U.S. donor screening portfolio is expected to be substantially complete by the endfirst half of 2025.2026.

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, as well as ongoing supply, production and logistics challenges.COVID-19.

Demand for our respiratory products, which includes our COVID-19 products, declined in 20242025 compared to 20232024 due to the continued decreased occurrenceoccurrence, severity and duration of COVID-19 in an endemic environment and a COVID-19 government award in 2023 that did not occur in 2024.environment. 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 seasonal demands of the respiratory season, which are variable and typically more prevalent during the fall and winter.

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 seasonal 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.

(12) For presentation purposes, asAs a result of the wind-down of the U.S. donor screening portfolio, the previously reported Transfusion Medicine business unit is shown in its two product categories: Immunohematology and Donor Screening. Prior periods have been revised to align with the current period presentation.

For fiscal year ended 2024,2025, Total revenues decreased to $2,782.9$2,730.2 million from $2,997.8$2,782.9 million for the prior year. The increase in Labs revenue wasincreased 6% compared to the prior year, primarily relateddue to growth in reagents, consumables and services, partially offset by decreaseda COVID-19decline andin non-coreinstrument revenue. Immunohematology revenue increased 4% compared to the prior year. Immunohematology revenue increased 2% compared to the prior year period,year, primarily due to reagent growth. Donor Screening revenue decreased 15%54% compared to the prior year period,year, primarily due to the wind-down of the U.S. donor screening business. The Point of Care businessrevenue unitdecreased contributed13% compared to revenuethe decline,prior drivenyear, byprimarily adue decreaseto of $188.6 milliondecreases in sales of QuickVueQUICKVUE SARS Antigen assays, primarily due to a COVID-19 government award in the prior year period, and a decrease of $5.8 million in sales of SofiaSOFIA SARS Antigen assays. Molecular Diagnostics salesrevenue decreasedincreased by10% $7.7compared million,to primarilythe prior year, driven by lowerhigher demand.SAVANNA revenue. Currency exchange rates haddid annot unfavorablesignificantly impact of approximately 60 basis points on theour growth rate for fiscal year ended 2024.2025.

For fiscal year ended 2023,2024, Total revenues decreased to $2,997.8$2,782.9 million from $3,266.0$2,997.8 million for the prior year. The increases in Labs, Immunohematology and Donor Screening revenues were primarily related to incremental revenues from the Combinations. Additionally, the increase in Labs revenue includedwas a $19.2 million settlement award from a third partyprimarily related to onegrowth in reagents, consumables and services, partially offset by decreased COVID-19 and non-core revenue compared to the prior year. Immunohematology revenue increased 2% compared to the prior year, primarily due to reagent growth. Donor Screening revenue decreased 15% compared to the prior year, primarily due to the wind-down of ourthe collaborationU.S. agreements.donor screening business. The Point of Care business unit contributed to revenue decline, driven by decreasesa decrease of $846.0$188.6 million in sales of QuickVueQUICKVUE SARS Antigen assaysassays, primarily due to a COVID-19 government award in the prior year, and $219.1a decrease of $5.8 million in sales of SofiaSOFIA SARS Antigen assays. Molecular Diagnostics revenuesales decreased by $65.0$7.7 million, primarily driven by lower demand for the Lyra SARS Antigen assay due to the end of the public health emergency in the U.S.demand. Currency exchange rates had an unfavorable impact of approximately 10060 basis points on theour growth rate for fiscal year ended 2023.2024.

Cost of sales, excluding amortization of intangible assets, increasedwas to $1,500.7$1,456.0 million, or 50.1%53.3% of Total revenues, for fiscal year ended 2023,2025, compared to $1,329.8$1,496.4 million, or 40.7%53.8% of Total revenues, for fiscal year ended 2022.2024. The increasedecrease in cost of sales, excluding amortization of intangible assets as a percentage of revenue, was driven primarily driven by incrementalprocurement-related revenuescost-savings initiatives actioned in the Labs, Immunohematology and Donor Screening business units as a result of the Combinations and a decrease in sales of respiratory products. We also recorded $60.6 million of expense related to the unwind of the inventory fair value adjustment related to the Combinations during fiscal year ended 2022.2024.

Amortization of intangible assets for fiscal years ended 2024,2025, 2024 and 2023 and 2022 was $203.4$189.2 million, $204.8$203.4 million and $132.5$204.8 million, respectively. The increasedecrease in amortization expense in fiscal year ended 20232025 compared to fiscal year ended 20222024 was primarily duedriven toby intangible assets that became fully amortized by the Combinations.end of 2024.

AcquisitionRestructuring, integration and integrationother costscharges were $127.2$263.6 million, $113.4$127.2 million and $136.0$113.4 million for fiscal years ended 2024,2025, 20232024 and 2022,2023, respectively. The increase in costs in fiscal year ended 2025 compared to fiscal year ended 2024 was primarily driven by restructuring and other charges. The increase in costs in fiscal year ended 2024 compared to fiscal year ended 2023 was primarily due to integration charges related to employee compensation related charges and consulting costs. The decrease in costs in fiscal year ended 2023 comparedRefer to fiscalPart yearII, endedItem 20228, was“Financial primarilyStatements dueand toSupplementary acquisitionData—Note costs17. attributableRestructuring, toIntegration theand Combinations,Other partiallyCharges” offsetfor bymore higher integration-related costs.information.

During fiscal yearyears ended 2025 and 2024, we recognized a non-cash goodwill impairment chargecharges of $700.7 million and $1.8 billion.billion, respectively. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 9.8. Goodwill and Intangible Assets, Net” for more information.

During fiscal yearyears ended 2025 and 2024, we recognized an impairment chargecharges of $9.7 million and $56.9 millionmillion, respectively, related to the long-lived assets classified as assets held for sale. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 8.7. Assets Held for Sale” for more information. Asset impairment chargescharge werewas $4.5 million and $2.8 million for fiscal yearsyear ended 2023 and 2022, respectively.2023.

Other operating expenses were $51.8$97.7 million, $27.1$51.8 million and $12.3$27.1 million for fiscal years ended 2024,2025, 20232024 and 2022,2023, respectively,respectively. whichThe wereincrease in costs in fiscal year ended 2025 compared to fiscal year ended 2024 was primarily related to (i) the contract termination cost of $65 million and (ii) the legal accrual in connection with the resolution of a contractual dispute, partially offset by (iii) a $20.0 million write off of the tax assessment refund in fiscal year ended 2024 and (iv) decline in profit sharesharing expense for our Joint BusinessBusiness. withThe Grifolsincrease and,in costs in fiscal year ended 2024,2024 acompared to fiscal year ended 2023 was primarily related to the $20.0 million write off of the tax assessment refund. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 5.3. Revenue” for information related to the contract termination cost and —Note 4. Segment and Geographic Information” for more information.

Loss on extinguishment of debt was $24.0$5.1 million for fiscal year ended 2022,2025, and was related to the satisfaction and discharge of the senior notes and termination of the formerPrior termCredit loansAgreement. Refer to Part II, Item 8, “Financial Statements and revolvingSupplementary creditData—Note facility9. ofBorrowings” Ortho,for whichmore occurred in connection with the consummation of the Combinations.information.

Other expense, net was $7.1$5.8 million, $20.6$7.1 million and $8.1$20.6 million for fiscal years ended 2024,2025, 20232024 and 2022,2023, respectively. The decrease in Other expense, net in fiscal year ended 2025 compared to fiscal year ended 2024 was primarily related to Prior Credit Agreement amendment fees in the prior year, partially offset by net foreign currency losses. The decrease in Other expense, net in fiscal year ended 2024 compared to fiscal year ended 2023 was primarily related to (i) a prior year release of tax reserves upon the settlement of certain U.S. federal tax matters, with an offsetting benefit recorded to income tax expense, and (ii) Prior Credit Agreement amendment fees, partially offset by loss on investments in the prior year period. The increase in Other expense, net in fiscal year ended 2023 compared to fiscal year ended 2022 was primarily related to (i) the release of tax reserves upon the settlement of certain U.S. federal tax matters, with an offsetting benefit recorded to income tax expense and (ii) net foreign currency losses.year. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 6.5. Income Taxes” for more information.

For fiscal years ended 20242025 and 2023,2024, we recognized income tax benefitsexpense of $24.1 million in relation to loss before taxes of $1,107.7 million and an income tax benefit of $79.5 million in relation to loss before taxes of $2,131.5 million and $19.0 million in relation to loss before taxes of $29.1 million, resulting in effective tax rates of 3.7%(2.2)% and 65.3%,3.7%, respectively. For fiscal yearyears ended 2025 and 2024, the effective tax rate differed from the U.S. federal statutory rate primarily due to goodwill impairment charges that were nondeductible for tax purposes. For fiscal year ended 2023, the effective tax rate differed from the U.S. federal statutory rate primarily due to a decrease in our pre-acquisition U.S. federal reserves for uncertain tax positions due to settlement of certain tax matters partially offset by net operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances and Global Intangible Low-Taxed Income.

We recognized an income tax benefit of $79.5 million, resulting in an effective tax rate of 3.7% for fiscal year ended 2024, compared to an income tax benefit of $19.0 million, resulting in an effective tax rate of 65.3% for fiscal year ended 2023, compared to an income tax provision of $187.2 million, resulting in an effective tax rate of 25.4% for fiscal year ended 2022.2023. For fiscal year ended 2022,2023, the effective tax rate differed from the U.S. federal statutory rate, primarily due to incomea taxesdecrease owedin our pre-acquisition U.S. federal reserves for uncertain tax positions due to settlement of certain tax matters partially offset by net operating losses in certain U.S.subsidiaries states,not foreignbeing incomebenefited taxeddue at rates other thanto the applicableestablishment U.S.of rate,valuation allowances and theGlobal deductionIntangible forLow-Taxed foreign derived intangible income.Income.

•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) income before Interest expense, net, Provision for (Benefitbenefit from) provision for income taxes and depreciation and amortization and eliminates (i) certain non-operating income or expense items, and (ii) impacts of certain non-cash, unusual or other items that are included in Net (loss) income and that we do not consider indicative of our ongoing operating performance. Refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 5.4. Segment and Geographic Information” for a reconciliation of Adjusted EBITDA by reportable segment to (Loss) income before income taxes.

Total revenues were $1,877.1$1,488.9 million for fiscal year ended 2023,2025, compared to $2,536.5$1,619.8 million for fiscal year ended 2022.2024. The decrease was primarily driven by lowerdecreases demandin forsales QuickVueof QUICKVUE and SofiaSOFIA SARS Antigen assays,assays and the wind-down of the U.S. donor screening business, partially offset by incrementalan revenuesincrease ofin $433.8Labs million from the Combinations.revenues.

AdjustedTotal EBITDArevenues waswere $892.1$1,619.8 million for fiscal year ended 2024, compared to $1,025.2$1,877.1 million for fiscal year ended 2023. The decrease was primarily driven by (i) a decrease in Point of Care revenues, primarily due to a COVID-19 government award in the prior year period, along with the corresponding inventory reserve release of $39 million,year, (ii) the wind-down of the U.S. donor screening business and (iii) the settlement award from a third party related to one of our collaboration agreements in the prior year period, partially offset by a decrease in employee compensation costs and other operating expenses.year.

Adjusted EBITDA was $1,025.2$807.0 million for fiscal year ended 2023,2025, compared to $1,689.2$892.1 million for fiscal year ended 2022.2024. The decrease was primarily driven by lowerdecreases demandin forsales QuickVueof QUICKVUE and SofiaSOFIA SARS Antigen assays,assays and the wind-down of the U.S. donor screening business, partially offset by decreasedan distributionincrease costsin Labs revenues and approximatelylower $160operating millionexpenses ofdue incrementalto impactcost-savings of the Combinations.initiatives.

TotalAdjusted revenuesEBITDA werewas $327.3$82.6 million for fiscal year ended 2023,2025, compared to $206.8$46.5 million for fiscal year ended 2022.2024. The increase was primarily driven by incremental revenues of $110.1 million from the Combinations, partially offset by a decreaseincreases in Immunohematology and Point of Care revenue.revenues, product mix and lower distribution and selling costs and other operating expenses due to cost-savings initiatives.

Total revenues were $334.7 million for fiscal year ended 2025, compared to $325.0 million for fiscal year ended 2024, compared to $310.1 million for fiscal year ended 2023.2024. The increase was primarily driven by an increase of 5% in Labs revenue,revenues, partially offset by a decreasedecreases in PointDonor ofScreening Careand revenue.Immunohematology revenues.

There has been no material change in our risk factors as previously disclosed in our Annual Report. For a detailed description of our risk factors, refer to Part I, Item IA,1A, “Risk Factors” of our Annual Report.

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 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.

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$54.4 million and $33.4$59.8 million for the threesix months ended MarchJune 29,28, 2026 and MarchJune 30,29, 2025, respectively.

For the threesix months ended MarchJune 29,28, 2026, Total revenues decreased by 11%4% to $619.8$1,250.7 million as compared to the same period in the prior year. This decrease was primarily driven by (i) variability of our U.S. respiratory products, mainly due to decreases in flu and COVID-19 revenues, and (ii) the termination of our Joint Business arrangement.arrangement and (iii) evolving market dynamics in China. Currency exchange rates had a favorable impact of 210approximately 160 basis points on our growth rate for the threesix months ended MarchJune 29,28, 2026. Our revenues can be highly concentrated over a small number of products, including certain of our respiratory products. For the threesix months ended MarchJune 29,28, 2026 and MarchJune 30,29, 2025, revenues related to our respiratory products accounted for 11%9% and 17%13% of our Total revenues, respectively.

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 3.4. Revenue” for more information. TheWe have substantially completed the wind-down of our U.S. donor screening portfolio isas expectedof toJune be substantially complete by mid-year28, 2026.

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 in FebruaryJuly 2026, following the Supreme Court ruling, the U.S. implementedimposed anew 10%wide-ranging ad valorem tarifftariffs on importsgoods intofrom themost U.S. trading partners for 150alleged daysfailures underto halt imports of goods produced with forced labor, invoking Section 122301 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.

During the first quarter of 2026, we experienced lower demand for our influenza products, which was primarily driven by a weaker respiratory season, with influenza-like illness visits down by approximately 30% compared to the first quarter of 2025, as reported by the Centers for Disease Control and Prevention, April 3, 2026. We expect overall demand for our non-respiratory and respiratory products to continue to fluctuate and pricing pressures on certain products to persist as a result of a number of factors, including increased supply, emergence and spread of new variants, and the demands of the respiratory season, which are variable and typically more prevalent during the fall and winter. A weaker respiratory season contributed to lower demand for flu and COVID-19 testing during the first six months of 2026, and we believe this trend may continue through the second half of 2026.

In January 2026, the Jiangxi, China provincial Health Security Administration announced its plan to pilot a Volume-Based Procurement program on dry chemistry test strips. At this time, we have no indication that such a program will be implemented or if our products would be included in such a program. Should this occur, we would seek to implement remediation efforts to offset potential costs. Based on current information, we believe that any potential business impact wouldwill not likely be material to our total annualized revenue.

In March 2026, the China National Health Security Administration (“NHSA”) issued initial draft IVD pricing guidelinesguidelines. andSubsequent completedto the end of our second quarter of 2026, the NHSA issued a publicsecond commentdraft periodof onits March 25, 2026. The updated guidelines have not yet been published.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 quartersix months of 2026. Until China issues final guidelines2026, and therethat isevolving greatermarket claritydynamics onmay the scope, applicability, and timing of pricing changes, we are not ablecontinue to assesspressure potentialour business impact.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 13.3. Subsequent EventAcquisition” for more information.

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, fluflu, COVID-19, and RSV seasons. In addition, the SARS-CoV-2 virus is expected to have similar seasonal demands and impacts on our revenues.

The following table compares Total revenues by business unit for the three and six months ended MarchJune 29,28, 2026 and MarchJune 30,29, 2025:

For the three months ended MarchJune 29,28, 2026, Total revenues decreasedincreased to $619.8$630.9 million from $692.8$613.9 million for the same period in the prior year. Labs revenue decreasedincreased 5%4% compared to the prior year period,period. primarilyThe dueoverall toincrease thein terminationLabs ofrevenue ourwas Jointpartially Businessoffset arrangement, which contributed to a $13.3 million decrease, andby 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.China. Immunohematology revenue increased 8%slightly compared to the prior year period, primarily due to reagent growth.period. Donor Screening revenue decreased 39%70% compared to the prior year period, primarily due to the wind-down of the U.S. donor screening business. Point of Care revenue decreasedincreased 34%16% compared to the prior year period, primarily due to decreasesincreases in salesrespiratory ofproduct SOFIA SARS and QUICKVUE SARS Antigen assays.revenue. Molecular Diagnostics revenue increaseddecreased 3%71% compared to the prior year period.period, primarily due to a decrease in SOLANA revenue. Currency exchange rates had a favorable impact of 21090 basis points on our growth rate for the three months ended MarchJune 29,28, 2026.

Cost of sales, excluding amortization of intangible assets, increased to $356.0$358.0 million, or 57.4%56.7% of Total revenues, for the three months ended MarchJune 29,28, 2026, compared to $349.5$339.0 million, or 50.4%55.2% of Total revenues, for the three months ended MarchJune 30,29, 2025. The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by employeehigher compensationdepreciation, costs.manufacturing costs and freight charges.

The following table summarizes operating expenses for the three and six months ended MarchJune 29,28, 2026 and MarchJune 30,29, 2025:

Selling, marketing and administrative expenses for the three months ended MarchJune 29,28, 2026 increased by $12.3$11.7 million, or 6.6%, to $199.3$189.7 million from $187.0$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 $3.3$2.8 million in cloud computing amortization.

Research and development expense for the three months ended MarchJune 29,28, 2026 decreasedincreased by $8.3$3.0 million, or 15.6%,6.6%, to $44.9$48.7 million from $53.2$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, partially offset by higher costs of outside services.costs.

Amortization of intangible assets was $46.8$49.0 million and $48.0$95.8 million for the three and six months ended MarchJune 29,28, 20262026, respectively, and March$47.9 30,million and $95.9 million for the three and six months ended June 29, 2025, respectively.

Restructuring, integration and other charges were $4.4$6.5 million and $16.1$10.9 million for the three and six months ended MarchJune 29,28, 20262026, respectively, and March$178.9 30,million and $195.0 million for the three and six months ended June 29, 2025, respectively. Refer to Item 1, “Financial Statements—Note 12.14. Restructuring, Integration and Other Charges” for more information.

Other operating expenses were $0.2$0.8 million and $6.4$1.0 million for the three and six months ended MarchJune 29,28, 20262026, respectively, and March$5.1 30,million and $11.5 million for the three and six months ended June 29, 2025, respectively. The decreasedecreases waswere primarily driven by the termination of our Joint Business arrangement. Refer to Item 1, “Financial Statements—Note 3.4. Revenue” for more information.

Interest expense, net was $51.1$54.7 million and $40.0$105.8 million for the three and six months ended MarchJune 29,28, 20262026, respectively, and March$40.5 30,million and $80.5 million for the three and six months ended June 29, 2025, respectively. Refer to Item 1, “Financial Statements—Note 7.9. Borrowings” for more information.

Other (Income) Expense, Net

Other income,expense, net was $3.4$4.7 million and $1.3 million for the three and six months ended MarchJune 29,28, 20262026, respectively, compared to Other$8.4 expense,million netand of $1.4$9.8 million for the three and six months ended MarchJune 30,29, 2025.2025, respectively. The increasedecreases was primarilywere related to net foreign currency gainsgains, partially offset by a loss on investments for the three and six months ended MarchJune 29,28, 2026.

For the three months ended MarchJune 29,28, 2026, we recognized a provision for income taxes of $12.3$11.7 million in relation to loss before income taxes of $79.5$81.2 million, resulting in a negative effective tax rate of 15.5%.14.4%. For the three months ended MarchJune 30,29, 2025, we recognized a provision for income taxes of $3.9$25.8 million in relation to loss before income taxes of $8.8$229.6 million, resulting in a negative effective tax rate of 44.3%.11.2%. For the three months ended MarchJune 29,28, 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 allowances2026 and GlobalJune Intangible Low-Taxed Income. For the three months ended March 30,29, 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 threesix months ended MarchJune 29,28, 2026 include the impacts of OBBBA on our Consolidated Financial Statements.

Total revenues were $328.9$327.4 million for the three months ended MarchJune 29,28, 2026, compared to $406.7$310.7 million for the three months ended MarchJune 30,29, 2025. The decreaseincrease was primarily driven by (i) decreases in sales of SOFIA SARS and QUICKVUE SARS Antigen assays and (ii) a decreaseincreases in Labs and Point of Care revenues, primarilypartially dueoffset toby the terminationwind-down of ourthe JointU.S. Businessdonor arrangement.screening business.

AdjustedTotal EBITDArevenues waswere $169.4$656.3 million for the threesix months ended MarchJune 29,28, 2026, compared to $234.3$717.4 million for the threesix months ended MarchJune 30,29, 2025. The decrease was primarily driven by (i) decreases in revenues.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.

Total revenues were $92.5$91.2 million for the three months ended MarchJune 29,28, 2026, compared to $88.9$87.3 million for the three months ended MarchJune 30,29, 2025. The increase was primarily driven by an increase in Immunohematology revenues.

AdjustedTotal EBITDArevenues waswere $20.1$183.7 million for the threesix months ended MarchJune 29,28, 2026, compared to $16.5$176.2 million for the threesix months ended MarchJune 30,29, 2025. The increase was primarily driven by an increase in Immunohematology revenues.

Total revenues were $63.5$67.8 million for the three months ended MarchJune 29,28, 2026, compared to $75.0$83.4 million for the three months ended MarchJune 30,29, 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.China and a decrease in Immunohematology revenues.

AdjustedTotal EBITDArevenues waswere $20.5$131.3 million for the threesix months ended MarchJune 29,28, 2026, compared to $29.3$158.4 million for the threesix months ended MarchJune 30,29, 2025. The decrease was primarily driven by a decrease in Labs revenues due to slower distributor sales related to pending changes to IVD pricing guidelines in China.

Total revenues were $70.0$74.3 million for the three months ended MarchJune 29,28, 2026, compared to $68.1$72.2 million for the three months ended MarchJune 30,29, 2025. The increase was primarily driven by an increase in Labs revenues.

AdjustedTotal EBITDArevenues waswere $16.5$144.3 million for the threesix months ended MarchJune 29,28, 2026, compared to $17.6$140.3 million for the threesix months ended MarchJune 30,29, 2025. The decreaseincrease was primarily driven by higher service costs, partially offset by an increase in Labs revenues.

Total revenues were $64.9$70.2 million for the three months ended MarchJune 29,28, 2026, compared to $54.1$60.3 million for the three months ended MarchJune 30,29, 2025. The increase was primarily driven by an increase in Labs revenues.

AdjustedTotal EBITDArevenues waswere $15.8$135.1 million for the threesix months ended MarchJune 29,28, 2026, compared to $12.0$114.4 million for the threesix months ended MarchJune 30,29, 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.revenues.

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

As of MarchJune 29,28, 2026, we had $140.4$123.4 million in Cash and cash equivalents, a $29.4$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.

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 MarchJune 29,28, 2026 were 6.87%6.86% and 8.43%, respectively. The weighted average effective interest rate on aggregate Term Loans, net of interest rate swaps, as of MarchJune 29,28, 2026 was 6.91%.6.97%. Availability under the Revolving Credit Facility, after deducting letters of credit of $23.6$23.5 million and $130.0$250.0 million borrowings outstanding, was $546.4$426.5 million as of MarchJune 29,28, 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 LoanFacilities and the Term BLoan 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.

OnIn April 9, 2026, we signedborrowed a$100.0 committed loan notice with Bank of America, N.A., as administrative agent, requesting for borrowingmillion under the DDTL Term Loan A. On April 13, 2026, we borrowed $100.0 millionA, 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 MarchJune 29,28, 2026.

Capital expenditures, including investments, were $34.0$59.5 million for the threesix months ended MarchJune 29,28, 2026. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities and other facility-related activities.

Cash used for operating activities was $33.0$143.6 million for the threesix months ended MarchJune 29,28, 2026 and reflected a net loss of $91.8$184.7 million, non-cash adjustments of $126.7$268.7 million, primarily associated with depreciation and amortization and stock-based compensation expense, and changes in working capital, including cash outflows of $72.6$123.3 million for inventories, partially offset by cash inflows of $54.0$62.9 million from collections on accounts receivables.

Cash used for investing activities ofwas $34.0$141.3 million for the threesix months ended MarchJune 29,28, 2026 and was primarily related to the LEX Diagnostics acquisition of $96.8 million and purchases of property, plant, equipment, investments and intangibles.intangibles of $59.5 million.