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Item 1. Business

2026-02-19 compared with 2025-02-27 · 195 added, 161 removed, 452 unchanged (44% of the section changed)

All references to “the Company,” “we,” “our” and “us” in this Annual Report refer to QuidelOrtho Corporation (“QuidelOrtho”) and its subsidiaries.

References to “fiscal year ended 2024,” “fiscal year ended 2023” and “fiscal year ended 2022” in this Annual Report refer to the Company’s fiscal years ended December 29, 2024, December 31, 2023 and January 1, 2023, respectively.

References to “fiscal year ended 2025,” “fiscal year ended 2024” and “fiscal year ended 2023” in this Annual Report refer to the Company’s fiscal years ended December 28, 2025, December 29, 2024 and December 31, 2023, respectively.

Refer to the Summary of Abbreviated Terms at the end of this Annual Report for definitions of terms used throughout this Annual Report.

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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.

and with sales centers, administrative offices and warehouses located throughout the world.

We currently sell our products directly to end users through a direct sales force and through a network of distributors, for professional use in 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, as well as for individual, non-professional, OTC use.

On May 27, 2022, pursuant to the BCA, Quidel and Ortho consummated the Combinations and each of Quidel and Ortho became a wholly owned subsidiary of QuidelOrtho.

For additional information about the Combinations, refer to Part II, Item 8, “Financial Statements and Supplementary Data—Note 2.

Business Combination.”

We manage our business geographically to better align with the market dynamics of the specific geographic regions in which we operate.

Effective January 1, 2024, Japan and Asia Pacific operating segments were combined into one operating segment:

North America, EMEA and China are the Company’s reportable segments;

Latin America and JPAC are immaterial operating segments that are not considered reportable segments and are included in “Other.” We generate our revenue in the following business units:

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 currently sell our products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other POC settings, blood banks and donor centers, as well as for individual, non-professional, OTC use.

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.

In February 2024, we initiated a plan to transition out of our U.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.

Information concerning revenues attributable to our reportable segments and business units is set forth in Part II, Item 8, “Financial Statements and Supplementary Data—Note 3.

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Segment and Geographic Information.”

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 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 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 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 3.

Revenue” for more information.

The wind-down of our U.S.

donor screening portfolio is expected to be substantially complete by the first half of 2026.

Business Units and Products

We provide diagnostic testing solutions under various brand names, including, among others, the following:

AdenoPlus ™ , BIOVUE ® , FreshCells ™ , InflammaDry ® , Lyra ® , MeterPro ® , MicroVue ™ , Ortho ® , Ortho Clinical Diagnostics ® , Ortho Connect ® , Ortho Optix ™ , Ortho Plus ® , ORTHO VISION ® , QuickVue ® , Quidel ® , QuidelOrtho ™ , QVue ™ , Savanna ® , Sofia ® , Solana ® , Thyretain ® , Triage ® , ValuMetrix ® , Virena ® and VITROS ® .

Solely for convenience, in some cases, the trademarks, service marks and trade names referred to in this Annual Report are listed without the applicable ® and ™ symbols, but we intend to enforce our rights to these trademarks, service marks and trade names.

We provide diagnostic testing solutions under various registered and unregistered brand names, including, among others, the following:

ADENOPLUS ™ , BIOVUE ™ , FRESHCELLS ™ , INFLAMMADRY ™ , LYRA ™ , METERPRO ™ , MICROVUE ™ , ORTHO ™ , Ortho Clinical Diagnostics ™ , ORTHO OPTIX ™ , ORTHO VERSEIA ™ , ORTHO VISION ™ , QUICKVUE ™ , QUIDEL ™ , QuidelOrtho ™ , QuidelOrtho AUTOMATION ROUTING ™ , QuidelOrtho PERFORMANCE MANAGER ™ , QuidelOrtho RESULTS MANAGER ™ , SAVANNA ™ , SOFIA ™ , SOLANA ™ , THYRETAIN ™ , TRIAGE ™ , VALUMETRIX ™ , VIRENA ™ and VITROS ™ .

Solely for convenience, in some cases, the trademarks, service marks and trade names referred to in this Annual Report are listed without the applicable ™ symbol, but we intend to enforce our rights to these trademarks, service marks and trade names.

Other trademarks, service marks and trade names appearing in this Annual Report are the property of their respective owners.

We generate product revenue in the following business units:

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• improved storage, with longer shelf life and less shelf space required;

• an eco-friendly design that eliminates water usage and reduces chemical waste and biohazards;

• a design that eliminates water usage and reduces chemical waste and biohazards;

• a comprehensive menu covering 24 therapeutic areas and approximately 90% of a typical laboratory’s testing needs

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• 96% first-pass yield on test results;

• designed to offer high reliability with a 98% up-time guarantee for e-connected U.S.

• designed to offer high reliability with a 98% up-time for e-connected U.S.

VITROS Results Management Advanced informatics software product designed for laboratories of all sizes.

It is focused on automating a number of repetitive manual tasks such as sample auto-validation, quality control management, moving averages, STAT sample management, sample archiving, and the development and deployment of advanced rules to help laboratories easily manage their patient populations

Focused on automating a number of repetitive manual tasks such as sample auto-validation, quality control management, moving averages, STAT sample management, sample archiving, and the development and deployment of advanced rules to help laboratories more easily manage their patient populations

VITROS Automation Solutions A flexible and scalable track-based system that combines VITROS analyzers with a number of robotic modules to help laboratories enhance their operations by reducing or eliminating repetitive and redundant laboratory tasks and the total number of human interventions required to complete typical laboratory testing

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SOLANA Simplified molecular testing platform using our proprietary isothermal helicase-dependent amplification technology that is easy to run and can process 12 patient samples at the same time

Savanna CE-marked, 510(k) approved, multiplex, real-time PCR platform, with customizable flexible syndromic panels that run up to 12 unique analytes from a single patient sample in less than 25 minutes

CE-marked, 510(k) approved, multiplex, real-time PCR platform, with customizable flexible syndromic panels that run up to 12 unique analytes from a single patient sample in less than 25 minutes

SAVANNA RVP4 assay offers simultaneous qualitative detection and differentiation of influenza A, influenza B, RSV, and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs

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Non-respiratory Clostridium Difficile (organism), HSV 1+2/VZV, Group Strep B, Trichomonas

(1) In the second quarter of 2025, we announced a plan to discontinue the development of the SAVANNA platform.

POINT OF CARE

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Rapid Immunoassay

Sofia and Sofia 2 Easy-to-use, rapid testing using lateral-flow technology and advanced fluorescent immunoassay (“FIA”) chemistry

SOFIA and SOFIA 2

Easy-to-use, rapid testing using lateral-flow technology and advanced fluorescent immunoassay (“FIA”) chemistry

Combines unique software and SOFIA FIA tests to yield automatic, objective results that are readily available on the instrument’s screen, in a hard-copy printout and in a transmissible electronic form that can network via a lab information system to hospital and medical center databases

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SOFIA 2 systems include additional benefits and features, such as enhanced optics for improved performance and speed, at a cost point that better addresses the lower-volume segment of the diagnostic testing market

QuickVue Broad portfolio of rapid, visually read, lateral flow immunoassay products to diagnose a wide variety of infectious diseases and medical conditions, including the QuickVue At-Home OTC COVID-19 test, a leading at-home COVID-19 product available through many retail and online outlets

InflammaDry and AdenoPlus Rapid, lateral-flow-based POC products for the detection of infectious and inflammatory diseases and conditions of the eye

QUICKVUE Broad portfolio of rapid, visually read, lateral flow immunoassay products to diagnose a wide variety of infectious diseases and medical conditions, including the QUICKVUE At-Home OTC COVID-19 test, a leading at-home COVID-19 product

INFLAMMADRY and ADENOPLUS

Rapid, lateral-flow-based POC products for the detection of infectious and inflammatory diseases and conditions of the eye

Cardiometabolic Immunoassay

Triage MeterPro Portable, rapid testing platform offering a comprehensive menu of tests for diagnosis of critical diseases and health conditions, as well as the detection of certain drugs of abuse

TRIAGE METERPRO

Portable, rapid testing platform offering a comprehensive menu of tests for diagnosis of critical diseases and health conditions, as well as the detection of certain drugs of abuse

Aids in the diagnosis, assessment and risk stratification of patients having critical care issues, including congestive heart failure, acute coronary syndromes and acute myocardial infarction, which may reduce hospital admissions and potentially improve clinical and economic outcomes

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ORTHO VISION Platform Flagship immunohematology analyzers that automate blood typing, antibody identification and crossmatching for patient and donor blood banks

Models include ORTHO VISION, ORTHO VISION Max, and next-generation ORTHO VISION Swift and ORTHO VISION Swift Max, which are designed to be faster, quieter and even more cyber-secure than previous generations

Ortho Workstation Semi-automated immunohematology benchtop analyzer for lower-volume blood centers or centers that need semi-automated testing

Models include ORTHO VISION and ORTHO VISION Max, and ORTHO VISION Swift and ORTHO VISION Swift Max, which are designed to be faster and quieter

ORTHO Workstation

Semi-automated immunohematology benchtop analyzer for lower-volume blood centers or centers that need semi-automated testing

ORTHO OPTIX Semi-automated testing platform used to read manual test results, designed with improved software and ability to integrate with laboratory information systems and offers improved workflow and 99% concordance with ORTHO VISION test results

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BIOVUE Cassettes Test consumables that utilize CAT for our immunohematology instruments sold outside of the U.S., designed to provide reliable test results and simplify test workflow

Ortho Sera Reagents Comprehensive immunohematology test menu that we believe covers more than 99% of most tested blood antigens regularly required for transfusion screening globally

ORTHO Sera Reagents

Comprehensive immunohematology test menu that we believe covers more than 99% of most tested blood antigens regularly required for transfusion screening globally

Donor Screening

VIP Automated pipetting and processing system that combines the ORTHO VERSEIA pipettor and ORTHO Summit Processor to enable end-to-end pipetting and processing for tests used for blood and plasma screening for infectious diseases

Automated pipetting and processing system that combines the ORTHO VERSEIA pipettor and ORTHO Summit Processor to enable end-to-end pipetting and processing for tests used for blood and plasma screening for infectious diseases

Donor Testing Serology Comprehensive set of infectious disease screens, including important tests for tropical diseases like Chagas that are critical for care in emerging markets

(2) In the first quarter of 2024, we initiated a plan to wind-down the VIP platform and microplate assays, which are

only sold in the U.S.

Global Services

In addition to the products we provide, our services are a critical element of how we deliver value to our customers.

As of December 29, 2024, we had approximately 1,100 service teammates globally.

As of December 28, 2025, we had approximately 1,200 service employees globally.

We employ highly trained service professionals, including laboratory specialists with advanced qualifications.

Our highly valued suite of solutions include:

• Guarantee 98% up-time to our e-connected U.S.

customers−High instrument reliability and a proactive maintenance program.

• E-CONNECTIVITY Remote Monitoring Software−More than 75% of our installed base of VITROS 5600, XT 7600 and ORTHO VISION platforms are e-connected, enabling remote monitoring and improved analyzer availability.

• E-CONNECTIVITY Remote Monitoring Software−More than 75% of our installed base of VITROS 5600, XT 7600 and ORTHO VISION platforms are e-connected, enabling 98% up-time for our e-connected U.S.

customers, high instrument reliability and proactive maintenance.

• VALUMETRIX−A highly valued consulting service proven to increase laboratory workflow, productivity and laboratory service levels utilizing lean principles and process excellence.

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This allows both parties to see the same thing at the same time and provide guided instruction leading to better and faster fix rates.

• Aquant AI−A field-based machine fed tool used to troubleshoot instrument issues with standardized solutions.

We also provide our Virena wireless cellular data management and surveillance system that operates as a cloud-based solution connecting Sofia and Solana instruments across a healthcare system and automatically transmitting de-identified test results to a secure database.

• Aquant AI−A field-based machine learning tool used to troubleshoot instrument issues with standardized solutions.

We also provide our VIRENA wireless cellular data management and surveillance system that operates as a cloud-based solution with the ability to connect SOFIA and SOLANA instruments across a healthcare system and automatically transmit de-identified test results to a secure database.

With VIRENA, a health system, POL, urgent care center or retail clinic has the ability to compile, analyze, map and generate reports of de-identified test results, improving operational efficiencies, quality and patient outcome initiatives.

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We strive to connect our instruments to healthcare providers, labs and policymakers through proprietary and third-party solutions, creating valuable data assets.

Our portfolio of workflow automation solutions, such as Ortho Connect, Ortho Plus and myVirena, help simplify the testing and instrument management process.

We are also actively developing other products designed to help personalize and elevate individual test results, such as the QVue companion mobile application for our COVID-19 at-home tests, potentially resulting in specific clinical insights or actions.

Our portfolio of informatics solutions includes the newly launched QuidelOrtho RESULTS MANAGER for clinical labs.

We plan to release multiple products within this portfolio in 2026, including QuidelOrtho RESULTS MANAGER IH for Transfusion Medicine, QuidelOrtho RESULTS MANAGER POC for Point of Care, QuidelOrtho AUTOMATION ROUTING Solution for our customers with total lab automation, a validation manager for various areas of the lab, and the QuidelOrtho PERFORMANCE MANAGER to create a unique, seamless informatics experience for customers.

Our Strategic Capabilities and Competitive Strengths

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There are several global companies with whom we compete, as well as regional and local companies focused on particular markets and/or technologies.

Some of our principal competitors include, among others, Abbott Laboratories, Roche, Thermo Fisher Scientific, Danaher, Siemens Healthineers, Diasorin, Bio-Rad, Hologic, Qiagen, Becton-Dickinson, bioMérieux and Revitty.

Some of our principal competitors include, among others, Abbott Laboratories, bioMérieux, Bio-Rad, Danaher, Diasorin, Hologic, Qiagen, Revvity, Roche, Siemens Healthineers, Thermo Fisher Scientific, Waters Corporation (acquired BD Diagnostics division) and Wermerson Immuncor.

Some of these competitors have substantially greater financial, marketing and other resources than we have.

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This disciplined focus on serving customers has resulted in, and we believe will continue to create, a business model that can deliver profitable growth and stockholder returns.

The competitive strengths that serve as our foundation of success today and can drive future growth include three key aspects, all of which benefit from our talented people and loyal customers:

The competitive strengths that serve as our foundation of success today and can drive future growth include five key aspects, all of which benefit from our talented people and loyal customers:

• Superior customer experience and brand loyalty.

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Our service program allows us to retain and grow our customer base by providing an industry-leading customer experience driven by quality of service, innovation and access to a diverse product portfolio.

We recently received the Excellence Services Label in our EMEA region.

This award is a global ISO-sponsored award recognizing outstanding customer experience.

QuidelOrtho is the first medical device company to receive this distinction.

• Strong commercial footprint.

We leverage our commercial team of more than 2,700 teammates in sales, service and marketing across more than 130 countries to facilitate successful delivery of innovative solutions to meet customer and patient needs across the healthcare continuum.

We leverage our commercial team of more than 2,500 employees in sales, service and marketing across more than 140 countries and territories to facilitate successful delivery of innovative solutions to meet customer and patient needs across the healthcare continuum.

• POC Leadership.

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Our SOFIA and TRIAGE platforms are trusted across urgent care clinics, physician offices and other decentralized settings.

• Manufacturing Scale and Supply Chain Resilience.

Many of our proprietary processes are vertically integrated to facilitate reliability and quality advantages.

We also have a wide geographic diversity of manufacturing sites as well as a track record of navigating supply chain disruptions and scale-ups.

• Robust R&D and Innovation Capabilities.

Our ability to innovate is supported by disciplined R&D processes, deep scientific expertise and a history of developing high-quality assay methodologies and testing platforms.

We continue to invest in menu expansion, new platform capabilities, software and connectivity solutions and advanced technologies, such as automation and digital integrations, through a strategic blend of organic and inorganic innovation.

Business Strategy

We are driven to transform diagnostics into action for more people in more places.

To achieve this, we serve a broad range of market segments across the healthcare continuum, from large centralized laboratories to physicians’ offices and other decentralized settings.

To achieve this, we serve a broad range of market segments across the healthcare continuum, from medium to large sized centralized laboratories to physicians’ offices and other decentralized settings.

While these care settings have traditionally been less integrated, the healthcare landscape continues to become more integrated.

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Our near-term priorities include:

• capturing market share in high-value profit pools where we hold a strong competitive position;

• increasing market share in high-value profit pools where we provide a strong competitive offering;

• building a culture focused on driving sales growth, profitability, cash flow and returns for stockholders;

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• developing and executing a comprehensive talent management strategy.

Longer term, we plan to continue to build and enhance our award-winning customer service, invest in platform capabilities and improve our assay menus.

Recognizing the complexity and speed of innovation in these areas, we will explore partnerships where we find strategic and financial alignment.

This approach allows us to mitigate risk, accelerate innovation and deliver solutions to market more efficiently.

Longer term, we plan to continue to build and enhance our award-winning customer service, invest in platform capabilities and enhance our assay menus.

Recognizing the complexity and speed of innovation in these areas, in addition to internal development, where it may be better or more timely in serving our customers, we plan to continue to explore collaborations where we find strategic and financial alignment.

This approach helps mitigate risk, accelerate innovation and deliver solutions to market more quickly.

Research and Development

We continue to focus our R&D efforts on the following areas:

• creation of new and improved products for use on our installed base, including new and improved assays and software;

• creation of new and improved products for use by our customers, including new and improved assays and software;

• support of important life-cycle-management efforts to maintain our current on-market portfolio of products;

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Key strengths of our team include new assay format development, new instrument systems development and the complex integration of the two.

In addition, in order to create new opportunities, manage costs and adapt to a rapidly changing industry, we are also exploring strategic partnerships as part of our R&D process.

R&D expenses were $218.7 million, $245.0 million and $187.9 million for fiscal years ended 2024, 2023 and 2022, respectively, which includes the impact of Ortho’s operations from the date of the Combinations.

We anticipate a continued appropriate investment of our financial resources to product and technology R&D for the foreseeable future, with increases and decreases as projects progress through the various development phases.

R&D expenses were $186.2 million, $218.7 million and $245.0 million for fiscal years ended 2025, 2024 and 2023, respectively.

We anticipate a continued investment of our financial resources to product and technology R&D for the foreseeable future, with increases and decreases as projects progress through the various development phases.

Sales, Marketing and Distribution

Our current business strategy is designed to serve the continuum of healthcare delivery needs globally, from POC clinicians located in doctor’s office practices, to moderately complex POLs, and to highly complex hospitals, laboratories and blood and plasma centers.

plasma centers.

Within the inherent operational diversity of these various segments, we focus on differentiating ourselves and enhancing our market leadership by specializing in the diagnosis and monitoring of select disease states, conditions and wellness categories.

Latin America and JPAC (Japan and Asia Pacific) are immaterial operating segments that are not considered reportable segments and are included in “Other.” 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.

Certain of our revenue is driven by a “razor/razor blade” business model.

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In China and the Asia Pacific region, which includes Japan and India, our employees support sales and marketing activities, primarily for the Point of Care, Labs and Transfusion Medicine business units.

In addition, we have created shared service centers in Shanghai, China and Hyderabad, India to support general and administrative, technical support and customer service functions.

In addition, we have created shared service centers in Shanghai, China, Hyderabad, India, and Singapore to support general and administrative, technical support and customer service functions.

In Latin America, our employees support sales and marketing activities in key countries, such as Brazil and Mexico.

Our global team strives to deliver best-in-class customer service and support by surrounding our customers with devoted and experienced professionals.

Our global team strives to deliver best-in-class customer service and support by surrounding our customers with dedicated and experienced professionals.

Our call center team and field application specialists serve as the first line of contact for our customers and are available to provide customer training and ongoing customer support.

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Our manufacturing operations benefit from our broad global footprint, scale and workforce capabilities.

We believe our plant capacity and available space are sufficient to accommodate growth, maintain quality and support continuity.

Our primary manufacturing facilities are located in Carlsbad, California, San Diego, California, Athens, Ohio, Raritan, New Jersey, Rochester, New York, Pompano Beach, Florida, and Pencoed, Wales.

We believe our plant capacity and available space are sufficient to accommodate current growth, maintain quality and support continuity.

Our primary manufacturing facilities are located in Carlsbad, California;

San Diego, California;

Athens, Ohio;

Raritan, New Jersey;

Rochester, New York;

Pompano Beach, Florida;

and Pencoed, Wales.

We also have a manufacturing facility in Changsha, China.

Our Carlsbad, California lateral flow manufacturing facility consists of laboratories devoted to tissue culture, cell culture, protein purification or immunochemistry, and production areas dedicated to manufacturing and assembly.

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Our Athens, Ohio facility consists of a variety of clean room and chemistry laboratories and customized reagent filling and packaging areas to support the manufacturing at the facility of all products under cGMPs.

This facility supports the manufacturing of our molecular nucleic acid amplification products, our living tissue cell culture and antibody-based products, as well as our enzyme linked immunosorbent assays (“ELISA”).

We use a wide variety of biological and chemical supplies in

our manufacturing processes.

We use a wide variety of biological and chemical supplies in our manufacturing processes.

We also utilize specialized equipment for the lyophilization of reagents, cell culture growth, protein purification and a variety of automation methods for dispensing of antibodies, reagents and solutions.

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Our Rochester, New York facility consists of three sites for slide manufacturing, fluid manufacturing and CNP microwell and equipment manufacturing.

The Rochester sites manufacture the slides, microwells and fluids used for clinical diagnostic assays run on our VITROS analyzers.

The Rochester sites manufacture slides, microwells and fluids used for clinical diagnostic assays run on our VITROS analyzers.

Manufacturing capabilities include formulation, lyophilization, filling, coating, slitting, custom featuring, assembly and packaging, all under cGMPs.

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Warehousing and shipping logistics with cold chain storage capability are handled at this facility with products transported to our distribution facilities for onward handling to end customers.

Our Changsha, China facility manufactures our VITROS analyzers for distribution to the China market.

The manufacturing process of the instruments includes assembly activities, adjustment, release testing and packaging.

The facility has Class 8 cleanrooms and Class 7 laboratories, as well as cold chain storage capabilities, and has obtained ISO 13485 certification.

We aim to conduct our manufacturing in compliance with QMS regulatory requirements of the U.S., Australia, Brazil, Canada, Japan, Europe, South Korea and certain other countries.

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Suppliers and Raw Materials

We obtain raw materials from reputable outside suppliers and believe our business relationships with them are good.

Some of our raw materials are available from a limited number of sources.

While we encountered increasing pressures on raw material pricing during fiscal years ended 2023 and 2022, inflationary impacts during fiscal year ended 2024 lessened and returned closer to pre-COVID-19 pandemic levels.

To help mitigate these supply chain challenges, we (i) partner with suppliers to invest in additional capacity and raw material inventory, (ii) diversify our supply base, where possible, to minimize reliance on a single source of supply for key raw materials and components, (iii) create redundancy in our global supply chain and (iv) insource activity where it makes strategic and financial sense.

In addition, we routinely evaluate our supply chain for potential gaps and continue to take other steps intended to help address continuity.

For more information related to our supply chain, refer to Part I, Item 1A, “Risk Factors—Risks Relating to Our Business, Strategy and Operations—Interruptions and delays in the supply of raw materials, components, equipment and other products and services could adversely affect our operations and financial results.”

We source raw materials from external suppliers who we believe are reputable and with whom we can maintain strong business relationships.

Some materials are available from a single or limited number of sources.

We work closely with our suppliers to facilitate supply chain continuity and resilience by (i) partnering with suppliers to invest in additional capacity and inventory,

(ii) diversifying our supply base, where feasible, to reduce reliance on a single source, (iii) building redundancy into our global supply chain and (iv) insourcing activities where strategically and financially advantageous.

We regularly evaluate our supply chain for potential gaps and take proactive steps to mitigate risks.

Additionally, changes in U.S.

trade policies have resulted in higher tariffs applicable to certain non-U.S.

suppliers, and we are actively managing these impacts.

For more information on our supply chain, refer to Part I, Item 1A, “Risk Factors—Risks Relating to Our Business, Strategy and Operations—Interruptions and delays in the supply of raw materials, components, equipment and other products and services could adversely affect our operations and financial results.”

Collaboration Arrangements

We have various collaboration arrangements, which provide us with the rights to develop, produce and market products using certain know-how, technology and patent rights maintained by our collaborative partners.

These arrangements are often entered

into in order to share risks and rewards related to a specific program or product.

Our collaborative arrangements include a number of ongoing relationships for test development, instrument development and automation track design and distribution.

The Company has an ongoing Joint Business between Ortho and Grifols, under which Ortho and Grifols agreed to pursue a collaboration relating to Ortho’s Hepatitis and HIV diagnostics business.

The arrangement is governed by the Grifols Agreement, which, among other things, provides for a profit sharing arrangement whereby, the profits we generate from our production and sale of Hepatitis and HIV diagnostics products are shared with Grifols, and the profits generated by Grifols from its sale of certain antigens and licensing of certain intellectual property rights are shared with us.

The Grifols Agreement also gives us the right to use such intellectual property.

These arrangements are often entered into in order to share risks and rewards related to a specific program or product.

Our collaboration arrangements include a number of relationships for test development, instrument development and automation track design and distribution.

The Company has the Joint Business between Ortho and Grifols, under which Ortho and Grifols agreed to pursue a collaboration relating to Ortho’s Hepatitis and HIV diagnostics business.

The arrangement is governed by the Grifols Agreement, which includes, among other things, a profit and expense sharing arrangement.

Under the Grifols Agreement, we share with Grifols the profits from our production and sale of Hepatitis and HIV diagnostics products, along with certain expenses related to the collaboration.

Correspondingly, Grifols shares profits with us from its sale of certain antigens and the licensing of certain intellectual property rights, along with certain related expenses.

The Grifols Agreement also entitles us to use such intellectual property rights.

The majority of the patents underlying these intellectual property rights have expired.

Grifols also supplies us with a portion of the antigens used in its production of these diagnostics products.

Today, the most significant benefit to us under the Grifols Agreement is the manufacture and sale by us of HIV and Hepatitis tests, which are solely performed by us.

During fiscal year ended 2024, the revenue associated with the use of this patented intellectual property was less than 1% of our total revenues and the expense associated with the antigens supplied to us by Grifols was 2% of our cost of goods sold.

The initial 50-year term of the Grifols Agreement will expire on December 31, 2039, at which time it will automatically renew for successive five-year periods unless either party has notified the other at least five years in advance of such date that it wishes to terminate the Grifols Agreement.

Notwithstanding the initial term, in Europe, the Grifols Agreement will terminate on a country-by-country basis upon the expiration of the last patent right with respect to such country, provided that either party has a right to extend the Grifols Agreement for successive one-year terms by giving the other party notice prior to the termination date.

To date, the parties have extended the Grifols Agreement for Europe on an annual basis.

The Grifols Agreement may also be terminated by the non-breaching party if there is a breach or default of the agreement which is not cured during a 60-day cure period.

Grifols also supplies us with a portion of the antigens used in our production of these diagnostics products.

During fiscal year ended 2025, the revenue associated with the use of this patented intellectual property was less than 1% of our total revenues and the expense associated with the antigens supplied to us by Grifols was less than 2% of our cost of goods sold.

The expiration date of the initial 50-year term of the Grifols Agreement is December 31, 2039.

In December 2025, we and Grifols initiated discussions to terminate the Joint Business arrangement prior to its scheduled expiration date in 2039.

Accordingly, we recorded a charge of $65 million payable to Grifols over a three-year period in Other operating expenses in the Consolidated Financial Statements for the fiscal year ended 2025 to reflect the mutually agreed terms in principle.

While we continue to engage in discussions with Grifols and additional information may become available as discussions progress, it is reasonably possible that the ultimate resolution of the termination may differ from the estimated amount accrued, and such an amount could be material to the Consolidated Financial Statements.

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

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

In addition, the SARS-CoV-2 virus may have similar seasonal demands and impacts on our revenues in the future.

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

Revenues related to our respiratory products accounted for approximately 15% of our Total revenues for the fiscal year ended 2025.

Government Regulations

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Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device, like performance standards, post-market surveillance, patient registries and FDA guidance documents.

Class III devices generally pose the highest risks, such as life sustaining, life supporting or some implantable devices, and are typically subject to premarket approval to ensure their safety and effectiveness.

Class III devices generally pose the highest risks, such as life sustaining, life supporting or some implantable devices, and are typically subject to

premarket approval to ensure their safety and effectiveness.

Our current products are generally Class I or II.

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A PMA application must be supported by valid scientific evidence to demonstrate the safety and effectiveness of the device, typically including the results of clinical investigations, bench tests and reference laboratory studies.

In addition, modifications or enhancements for existing products that could significantly affect their safety or effectiveness or constitute a

major change in the intended use of the device, will require new submissions to the FDA.

In addition, modifications or enhancements for existing products that could significantly affect their safety or effectiveness or constitute a major change in the intended use of the device, will require new submissions to the FDA.

Class III devices require approval of a PMA application evidencing safety and effectiveness of the device.

Data and content requirements for premarket submissions, including 510(k) notifications and PMAs, can change over time.

For example, beginning in March 2023, premarket submissions for “cyber devices” must contain certain information about device cybersecurity.

For example, premarket submissions for “cyber devices” must contain certain information about device cybersecurity.

“Cyber devices” encompass any device that:

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• a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with Good Clinical Practices;

• satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is to be produced to assess compliance with cGMPs and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with Good Clinical Practices;

• FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the U.S.

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The FDA may withdraw a marketing authorization if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical studies to assess new safety risks, or imposition of distribution restrictions or other restrictions.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with

regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical studies to assess new safety risks, or imposition of distribution restrictions or other restrictions.

Other potential consequences include, among other things:

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However, the transition periods might still be subject to change.

In 2025, the European Commission held a public consultation and a Call for Evidence on a possible targeted revision of the MDR and IVDR, which would aim to reduce administrative burden and enhance predictability and cost-efficiency.

No further details of a possible reform proposal are public and there is no information on next steps on the subsequent legislative process.

Complying with these regulations may require us to incur significant expenditures.

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For products marketed in Australia, registration is required with the Therapeutic Goods Administration.

IVD products in Brazil are regulated by the Agencia Nacional de Vigilancia Sanitaria.

IVD products in Brazil are regulated

by the Agencia Nacional de Vigilancia Sanitaria.

For our products marketed in Canada, Japan, Brazil, Australia and the U.S., the MDSAP is a single regulatory audit of our QMS that satisfies the requirements of all five of these jurisdictions.

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Specific health-care laws and regulations that we may be subject to include:

• the federal Physician Self-Referral Law, which prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, and prohibits the entity from presenting or causing to be presented claims to Medicare for those referred services;

individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal healthcare program such as Medicare and Medicaid.

• the federal Physician Self-Referral Law, which prohibits a physician from making referrals for certain designated health services payable by Medicare or Medicaid to an entity with which he or she (or an immediate family member) has a financial relationship, and prohibits the entity from presenting or causing to be presented claims for payment for those referred services;

• the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, where one purpose is to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal healthcare program such as Medicare and Medicaid.

government has interpreted this law broadly to apply to the marketing and sales activities of medical device manufacturers;

• the federal civil and criminal false claims laws, including the FCA, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false or fraudulent.

Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;

Moreover, the federal Anti-Kickback Statute provides that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;

• the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

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We are subject to privacy, data security and data protection laws and regulations in numerous jurisdictions, as well as customer-imposed requirements, as a result of having access to and processing confidential, personal and/or sensitive information in the course of our business.

Failure to comply with such laws, regulations and requirements could result in reputational damage, regulatory investigations and enforcement actions (including significant fines and orders to cease or change our processing of personal information), and civil claims (including class action litigation).

Specific privacy, data security and data protection laws that we and our customers may be subject to include:

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state privacy laws that govern the privacy and data security of personal information, including health information, in certain circumstances.

The California Consumer Privacy Act of 2018, as amended by the CCPA, creates individual privacy rights for California consumers and imposes privacy and data security obligations on certain entities that do business in California, including to provide specific disclosures in privacy notices, to provide rights to California residents in relation to their personal information, and to conduct audits for certain higher risk data processing.

For example, the California Consumer Privacy Act of 2018, as amended by the CCPA, creates individual privacy rights for California consumers and imposes privacy and data security obligations on certain entities that do business in California, including to provide specific disclosures in privacy notices, to provide rights to California residents in relation to their personal information, and to conduct audits for certain higher risk data processing.

It also created a new data protection agency, the California Privacy Protection Agency, which is granted full administrative power, authority, and jurisdiction to implement and enforce the CCPA, in addition to the California Attorney General’s existing enforcement authority.

Similar laws have gone into effect or passed in other states, though most state laws exempt entities that are subject to HIPAA, unlike the CCPA, which only has a data-level exemption.

Comprehensive privacy laws also have been proposed in other states and at the federal level, reflecting a trend toward more stringent

privacy legislation in the U.S.

Comprehensive privacy laws also have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the U.S.

Additionally, certain U.S.

state laws, such as California’s Confidentiality of Medical Information Act and Washington’s My Health My Data Act, govern the privacy and security of health-related information, specifically;

state laws, such as California’s Confidentiality of Medical Information Act, Nevada’s Consumer Health Data Privacy Law and Washington’s My Health My Data Act, govern the privacy and security of health-related information, specifically;

• the FTC and U.S.

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data protection regime consisting primarily of the U.K.

General Data Protection Regulation and the U.K.

Data Protection Act 2018, which govern the processing of personal data of persons in those jurisdictions, and could result in significant fines (up to the greater of €20 million / £17.5 million or 4% of total worldwide annual turnover of the preceding financial year), regulatory investigations, reputational damage, orders to cease or change our processing of personal data, enforcement notices or assessment notices (for a compulsory audit), civil claims including representative actions and other class action type litigation;

General Data Protection Regulation, the U.K.

Data Protection Act 2018 and the U.K.

Data Use and Access Act, which govern the processing of personal data of individuals in those jurisdictions.

Failure to comply with these regimes could result in fines up to the greater of €20 million / £17.5 million or 4% of total worldwide annual turnover of the preceding financial year;

• EU and U.K.

rules with respect to cross-border transfers of personal data out of the EEA and the U.K., respectively, which are in flux, including in light of a decision by the Court of Justice of the EU invalidating the EU-U.S.

Privacy Shield Framework, the European Commission’s publishing of revised SCCs in 2021, and the U.K.

IDTA and Addendum to the SCCs (the “Addendum”) that came into effect on March 21, 2022, which we must consider and apply, where applicable.

When relying on SCCs or the U.K.

IDTA and Addendum, the data exporters are also required to conduct a transfer risk assessment to verify if anything in the law and/or practices of the third country may impinge on the effectiveness of the SCCs or U.K.

IDTA and Addendum in the context of the transfer at stake and, if so, to identify and adopt supplementary measures.

rules with respect to cross-border transfers of personal data out of the EEA and the U.K., respectively, which are in flux, including in light of the European Commission’s publishing of revised SCCs in 2021, and the U.K.

ICO’s publishing of the IDTA and the Addendum to the SCCs (the “Addendum”) that both came into effect on March 21, 2022, which we must consider and apply, where applicable.

When relying on SCCs, the IDTA and/or the Addendum, the data exporters are also required to conduct a transfer risk assessment to verify if anything in the law and/or practices of the third country may impinge on the effectiveness of the SCCs, the IDTA and/or the Addendum in the context of the transfer at stake and, if so, to identify and adopt supplementary measures.

Where no supplementary measure is suitable, the data exporter shall avoid, suspend or terminate the transfer.

With regard to the transfer of data from the EEA to the U.S., on July 10, 2023, the European Commission adopted its adequacy decision for the EU-U.S.

Data Privacy Framework.

On the basis of the new adequacy decision, personal data can flow from the EEA to U.S.

With regard to the transfer of data from the EEA to the U.K., the European Commission has issued decisions to extend prior adequacy decisions permitting the free flow of personal data from the EU to the U.K.

until December 2031, by which time additional measures will have to be implemented to comply with the GDPR or transfers of personal data from the EEA to the U.K.

will become restricted.

With regard to the transfer of data from the EEA to the U.S., the European Commission adopted its adequacy decision for the EU-U.S.

Data Privacy Framework, permitting the free flow of personal data from the EEA to U.S.

companies participating in the framework.

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to the U.S., the U.K.

government has recently adopted an adequacy decision for the U.S., the U.K.-U.S.

Data Bridge, which came into effect on October 12, 2023.

The U.K.-U.S.

Data Bridge recognizes the U.S.

government has adopted its adequacy decision for the U.K.

Extension to the EU-U.S.

Data Privacy Framework and the U.K.-U.S.

Data Bridge, which recognizes the U.S.

as offering an adequate level of data protection where the transfer is to a U.S.

company participating in the EU-U.S.

company listed on the EU-U.S.

Data Privacy Framework and the U.K.

In light of these changing requirements, we could suffer additional costs, complaints, regulatory investigations or fines, and if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services and the geographic location or segregation of our relevant systems and operations, which could adversely affect our financial results, including because we rely on third parties in other countries;

If we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services and the geographic location or segregation of our relevant systems and operations, which could adversely affect our financial results, including because we rely on third parties in other countries;

• evolving privacy laws on cookies and e-marketing.

In the EU, regulators are increasingly focusing on compliance with requirements in the online behavioral advertising ecosystem, and current national laws that implement the ePrivacy Directive will be replaced by an EU regulation known as the ePrivacy Regulation.

While the text of the ePrivacy Regulation is still under development, European court decisions and regulators’ recent guidance are driving increased attention to cookies and tracking technologies.

In the U.S., the FTC and many state laws have increasingly focused on the collection and use of behavioral data, including geolocation and biometric information.

In the EU, while the text of the ePrivacy Regulation is still under development, European court decisions and regulators’ recent guidance are driving increased attention to cookies and tracking technologies.

In the U.K., the ePrivacy Directive was implemented in national law through the Privacy and Electronic Communications Regulations 2003 (“PECR”), and there is similar regulatory scrutiny by the ICO over use

of cookies and other tracking technologies.

In the U.S., the FTC and many state regulators have increasingly focused on the collection and use of geolocation and other behavioral data, and private litigants are alleging (including via class action litigation) violations of wiretapping and other laws in connection with the use of third-party cookies and tracking technology.

As regulators start to enforce a stricter approach, this could lead to substantial costs, require significant systems changes, limit the effectiveness of our marketing activities, divert the attention of our technology personnel, adversely affect our margins, increase costs and subject us to additional liabilities;

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◦ China’s PIPL, which is similar to the GDPR and also applies extraterritorially.

The PIPL provides the legality of personal information processing and the basic requirements of notice and consent, sets out data localization requirements for CIIOs and personal information processors who process personal information above a certain threshold prescribed by the relevant authorities, and provides a list of rules for transferring personal information

outside of China.

Failure to comply with PIPL can result in fines of up to RMB 50 million or 5% of the prior year’s total annual revenue for the personal information processor and/or a suspension of services or data processing activities, among other fines and criminal liabilities, including ones that can be placed on responsible personnel;

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These directives require that personal data is processed and managed with the utmost care, respecting the rights and dignity of individuals, and promote data security measures to protect against data breaches, cyber-attacks and unauthorized access to personal information;

• enacted or considered legislation similar to the above in other countries around the world, in which we do business, including Brazil’s General Data Protection Law ( Lei Geral de Proteção de Dados Pessoais ), Chile’s Personal Data Protection Law, Mexico’s Federal Law on Protection of Personal Data Held by Private Parties ( Ley Federal de Protección de Datos Personales en Posesión de los Particulares ) and Panama’s Personal Data Protection Law ( Ley sobre Protección de Datos Personales ), which impose requirements for processing personal data about persons in those jurisdictions;

• enacted or considered legislation similar to the above in other countries around the world, in which we do business, including Brazil’s General Data Protection Law ( Lei Geral de Proteção de Dados Pessoais ), Chile’s Personal Data Protection Law, Colombia’s General Regime for the Protection of Personal Data ( Ley 1581 de 2012 y Decreto 1377 de 2013 ), Mexico’s Federal Law on Protection of Personal Data Held by Private Parties ( Ley Federal de Protección de Datos Personales en Posesión de los Particulares ) and Panama’s Personal Data Protection Law ( Ley sobre Protección de Datos Personales ), which impose requirements for processing personal data about persons in those jurisdictions;

• self-regulatory standards that privacy advocacy groups, the technology industry and other industries have established or may establish and various new, additional or different self-regulatory standards that may place additional burdens on us.

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We are subject to various environmental, health and safety laws and regulations both within and outside the U.S., such as those related to safe working conditions and laboratory practices.

Like other companies in our industry, our manufacturing and research activities involve the purchase, storage, movement, use and disposal of substances regulated under environmental, health and safety laws, including those related to hazardous or potentially hazardous substances.

Like other companies in our industry, our manufacturing and

research activities involve the purchase, storage, movement, use and disposal of substances regulated under environmental, health and safety laws, including those related to hazardous or potentially hazardous substances.

Laws Governing Reimbursement Activities

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Under PAMA, the revised Medicare reimbursement rates were scheduled to apply to clinical diagnostic laboratory tests furnished on or after January 1, 2018.

The revised reimbursement methodology is expected to generally result in relatively lower reimbursement under Medicare for clinical diagnostic lab tests than has been historically available.

The revised reimbursement methodology generally results in relatively lower reimbursement under Medicare for clinical diagnostic lab tests than has been historically available;

• 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.

Other Laws and Regulations Governing Our Sales, Marketing and Shipping

We are subject to the FCPA, the U.K.

Bribery Act of 2010 (the “Bribery Act”), the Brazilian Anti-Bribery Act (also known as the Brazilian Clean Company Act) and various other similar anti-corruption and anti-bribery laws.

Bribery Act of 2010 (the “Bribery Act”), the Brazilian Anti-Bribery Act (also known as the Brazilian Clean Company Act), China’s Anti-Unfair Competition Law and Criminal Law regime and various other similar anti-corruption and anti-bribery laws.

These laws generally prohibit us and our intermediaries from, among other things, offering, promising or making payments to foreign government entities or officials for the purpose of obtaining or retaining business.

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and foreign laws relating to the import and export of finished goods, raw materials and supplies.

We also must comply with various export control and trade embargo laws, which may require licenses or other authorizations for transactions within some countries or with some counterparties.

Additionally, we are subject to laws and regulations and certain sustainability requirements applicable to our government contracts, and failure to address these laws and regulations, sustainability requirements, or to comply with government contracts could result in fines, debarment or exclusion from federal healthcare or global tender programs, or harm our business by a reduction in revenue associated with these customers.

Such laws and regulations include those relating to customs valuation and classification of products, and failure to accurately classify or value our products could result in penalties, interest, back duties, and delays in importing and exporting of products.

We also must comply with various export control and trade embargo laws, regulations, orders and sanctions, which may require licenses or other authorizations for transactions within some countries or with some counterparties.

Additionally, we are subject to laws and regulations and certain sustainability requirements applicable to our government contracts, and failure to meet the requirements of these laws and regulations or sustainability requirements, or to comply with government contracts, could result in fines, debarment or exclusion from federal healthcare or global tender programs, or harm our business by a reduction in revenue associated with these customers.

We are also subject to audits for compliance with the regulations governing government contracts.

A failure to comply with these regulations could result in suspension of these contracts, criminal, civil and administrative penalties or debarment.

A failure to comply with these regulations could result in suspension of these contracts, criminal, civil and administrative penalties, or exclusion or debarment from participation in government programs or contracting.

Intellectual Property

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In the aggregate, our intellectual property is of material importance in the operation of our business.

However, although we possess numerous patents, trade secrets and trademarks that are important to our business, we believe that no single patent, trade secret or trademark by itself is material to our business as a whole and we rely on a combination of patents, trademarks, copyrights, trade secrets and contractual restrictions to protect our products.

We actively pursue patents for technologies that are considered patentable.

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It has been our policy to file for patent protection in the U.S.

and other countries with significant markets for our products, such as Western European countries and Japan, if the economics are deemed to justify such filing and our patent counsel advises that relevant patent protection may be obtained.

and other select countries for our products, if the economics are deemed to justify such filing and our patent counsel advises that relevant patent protection may be obtained.

However, we are aware that the pursuit of patent protection can be expensive and time-consuming, and the ultimate outcome of patent litigation can be uncertain.

We are aware of certain patents issued to various developers of diagnostic products with potential applicability to our diagnostic technologies.

We have entered into agreements with third parties to license and use their intellectual property, when applicable to our products and services, although no one such license is material to our business as a whole.

In the future, we expect that we will require or desire additional licenses from other parties in order to refine our products further and to allow us to develop, manufacture and market commercially viable or superior products effectively.

In addition to existing patents, a large number of individuals and commercial enterprises seek patent protection for technologies, products and processes in fields in, or related to, our areas of product development.

We have entered into agreements with certain third parties to license and use their intellectual property, when applicable to our products and services, although no one such license is material to our business as a whole.

In the future, we expect that we may require or desire additional licenses from other parties in order to refine our products further and to allow us to develop, manufacture and market commercially viable or superior products effectively.

In addition to existing patents, a large number of individuals and commercial enterprises may seek patent protection for technologies, products and processes in fields in, or related to, our areas of product development.

To the extent such efforts are successful, we may be required to obtain licenses and pay royalties or other compensation (some of which may be significant) in order to pursue certain of our future product strategies.

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In addition, we have implemented certain security measures in our laboratories and offices to protect the confidential and proprietary nature of these technologies.

In addition to patent and trade secret protection, we have also registered or applied to register certain trademarks and service marks in the U.S.

and in foreign countries that are used in our business and in conjunction with the sale of our products.

In addition to patent and trade secret protection, we also use trademarks and service marks in our business and in conjunction with the sale of our products.

We have registered or applied to register certain of those trademarks and service marks in the U.S.

and in select foreign countries.

Our principal trademarks and the products they cover are discussed above in the section entitled “Business Units and Products.”

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and approximately 2,900 employees outside of the U.S.

We employ approximately 1,800 manufacturing employees and approximately 2,700 employees in commercial sales, service and regional marketing positions worldwide, including approximately 1,100 service teammates.

We employ approximately 2,100 manufacturing employees and approximately 2,500 employees in commercial sales, service and regional marketing positions worldwide, including approximately 1,200 service employees.

Approximately 16% of our associates globally are covered by a union, collective bargaining agreement or works council, including associates in Austria, Belgium, Brazil, France, Germany, Italy, Spain, Sweden and the U.K.

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Inclusion and Belonging

Our employees are one of our most important assets and set the foundation for our ability to achieve our strategic objectives, drive operational execution, deliver strong financial performance, advance innovation, and maintain our quality and compliance programs.

Our employees are one of our most important assets and they set the foundation for our ability to achieve our strategic objectives, drive operational execution, deliver strong financial performance, advance innovation, and maintain our quality and compliance programs.

The success and growth of our business depend in large part on our ability to attract, retain, develop and motivate a diverse population of talented and high-performing employees at all levels of our organization.

We strive to provide a positive work environment for all employees, consultants, contingent workers, vendors and customers.

One of the ways we accomplish this is by embracing a variety of diverse experiences and perspectives and being inclusive team players.

One of the ways we accomplish this is by embracing a variety of experiences and perspectives and being inclusive team players.

We are dedicated to fostering a culture that supports diverse talents, experiences and perspectives, and an environment of mutual respect, equity and collaboration that helps drive our business.

As a global organization, our unique perspectives, diverse experiences and collective strengths drive creative solutions, breakthrough innovation and highly productive teams.

As a global organization, our unique perspectives, diverse experiences and collective strengths contribute to driving creative solutions, breakthrough innovation and highly productive teams.

We are committed to maintaining an environment of equal employment opportunities for all job applicants and members of our team.

We fulfill this commitment through a variety of measures, including internal and external posting of job openings, hiring, training and promoting employees based on merit.

We prohibit discrimination that is unlawful by federal, state or local law.

In keeping with our core values, we are steadfast in taking action to provide equal employment opportunity in accordance with all applicable federal, state and local laws.

We achieve this commitment through a variety of measures, including internal and external posting of job openings, hiring, training and promoting employees based on merit.

We prohibit discrimination that is unlawful by federal, state or local law, and are steadfast in taking action to provide equal employment opportunity in accordance with all applicable federal, state and local laws.

In addition, we review Company programs, policies, procedures and activities with inclusion in mind.

We have established defined core behaviors based on the QuidelOrtho Way, which defines our core values as a company and our ways of working together.

These core behaviors include “bring your best,” which reflects each individual contributing to their highest potential, “embrace inclusion,” which reinforces the role each team member plays in creating an inclusive and positive work environment, and “commit to service,” which reflects our value of serving our customers and communities in the core of everything we do.

We plan to expand upon the foundation of these core behaviors by incorporating other inclusive behaviors and providing training to support all of our employees in being authentic in their self-expression and open to the self-expression of others.

We have established defined core behaviors, designed to help drive employee satisfaction and empower each employee to bring their best.

These core behaviors include:

“Thrive Together,” which reflects each individual contributing to their highest potential while working together with the intention to drive meaningful impact;

“Embrace Inclusion,” which reinforces the role each team member plays in creating an inclusive and positive work environment;

and “Commit to Service,” which reflects our value of serving our customers and communities at the core of everything we do.

These all drive back to our final core behavior – “Make it Happen.” We collaborate, prioritize and promote cross-functional alignment, embracing growth, learning and continuous improvement to strengthen our capacity to achieve excellence and win together.

Employee Benefits

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We also maintain health and safety programs conforming to best practices in the diagnostics industry.

We are focused on minimizing risk and protecting

our employees and communities by employing safe technologies and operating procedures and creating opportunities for employee engagement and input to drive continuous improvement, which in turn can minimize recordable incidents and improve safety across our organization.

We are focused on programs designed to minimize risk and protect our employees and communities by employing safe technologies and operating procedures and creating opportunities for employee engagement and input to drive continuous improvement, which in turn can minimize recordable incidents and improve safety across our organization.

We believe that all of our manufacturing and distribution facilities are operated in compliance with existing environmental requirements in all material respects, including the operating permits required thereunder.

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Although we do not currently expect outstanding remediation obligations to have a material impact on our financial position, the ultimate cost of remediation is subject to a number of variables and is difficult to accurately predict.

Corporate Philanthropy

We listen to our internal and external stakeholders and aim to translate their needs into innovative solutions, in the products we offer and in our corporate philanthropy work.

Our charitable giving programs operate under the Gift.

(G.I.V.E.) program.

Our charitable giving programs and activities in the U.S.

consist of the following:

• Matching gifts−We match charitable contributions made by active employees to qualifying non-profit organizations of up to $200 per employee annually.

• Volunteer incentive program−When an employee volunteers at a qualifying organization for a minimum of 20 hours in a calendar year, we donate $100 to that organization.

• General grant fund−We may donate up to $2,000 to a qualifying organization proposed by an employee.

• Community initiatives and philanthropic programs−We contribute to a variety of community initiatives and philanthropic programs, including research partnerships, blood drive sponsorships, scholarship and internship programs, as well as STEM and STEAM programs with educational institutions.

Sustainability Strategy

We are driven by a purpose to improve the quality of life for people all over the world through our diagnostic solutions – providing vital health information when and where it is needed most.

We champion an authentic culture of service, empowering every employee to do their best.

We strive to create innovative products that are efficient, trusted, accessible and environmentally responsible to support practitioners and provide better outcomes for patients.

Through our corporate actions in the areas of environmental sustainability, social responsibility, ethics, corporate and ESG-related governance, and supply chain responsibility, we seek to positively impact our communities and stakeholders while driving value for our stockholders.

We are driven to improve the quality of life for people all over the world through our diagnostic solutions – providing vital health information when and where it is needed most.

We champion an authentic culture of service, to empower every employee to do their best.

We strive to support practitioners and provide better outcomes for patients by creating innovative products that are efficient, trusted, accessible and environmentally responsible.

Through our corporate actions in the areas of environmental sustainability, ethics, corporate and sustainability governance, and supply chain responsibility, we seek to positively impact our communities and stakeholders while driving value for our stockholders.

Information Available on Our Website

This Annual 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.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business