What changed in this filing

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Item 1A. Risk Factors

2026-02-19 compared with 2025-02-27 · 243 added, 245 removed, 498 unchanged (49% of the section changed)

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• the highly competitive nature of our industry and market segments;

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

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

• adverse developments in global market, macroeconomic and geopolitical conditions;

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• fluctuations in our cash flows as a result of our reagent rental model;

• our inability to achieve market acceptance of our products;

• significant changes in the healthcare industry and related industries that we serve, including an effort to reduce costs;

• consolidation of our customer base and the formation of group purchasing organizations;

• inability to realize the anticipated benefits of acquisitions, divestitures or discontinuances of certain business operations;

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

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

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

• inability to successfully identify or consummate strategic transactions, strategic restructurings or divestitures, spin-offs or discontinuances of certain business operations, or to realize the anticipated benefits;

• legal and regulatory risks, reputational harm or other adverse business consequences as a result of implementing artificial intelligence (“AI”) and machine learning technologies;

• risks associated with our non-U.S.

operations and international sales, including currency translation risks, the impact of possible new sanctions or tariffs, trade embargoes or trade wars and compliance with applicable trade measures;

• failure to integrate successfully the businesses of Quidel and Ortho in the expected timeframe;

• continued incurrence of significant integration-related costs;

• our inability to protect our information systems and personal and confidential information, including from data corruption, cyber-attacks, security breaches or IT errors;

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 inability, 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;

• interruptions to our third-party IT service providers and/or the inability of our digital solutions to interoperate with certain operating systems;

• our inability to develop, obtain and protect our proprietary technology rights or defend against intellectual property infringement suits against us by third parties;

• the loss of EUAs on our respiratory products;

• 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;

• 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;

• our inability to adequately manage our clinical studies;

• failure to comply with applicable regulations by the FDA and other federal, state and foreign regulatory agencies, which may result in significant costs, the suspension or withdrawal of previously obtained regulatory approvals, product recalls, seizure of products or injunctions against the distribution of our products, operating restrictions and criminal prosecution;

• failure to comply with applicable regulations by the FDA and other federal, state and foreign regulatory agencies;

• disruptions at government agencies that prevent them from performing normal business functions or prevent new or modified products from being developed, cleared, approved or commercialized in a timely manner, or at all;

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

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

• liability claims and harm to our reputation resulting from claims that our products are defective or do not comply with applicable regulations;

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• risks related to our indebtedness;

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

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

• restrictions imposed under the agreements governing our indebtedness from time to time, which may limit our operating flexibility;

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• work stoppages, union negotiations, labor disputes and other matters associated with our labor force;

• identified material weaknesses in our internal controls;

• the outcomes of legal proceedings instituted against us;

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

• additional costs and new risks associated with sustainability matters, including evolving legal standards and regulations concerning such matters;

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

• failure to develop or maintain an effective system of internal controls.

The following is a more complete discussion of the risks facing our business that we have determined are currently material.

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• our competitors are able to obtain regulatory approvals for products or services or otherwise deliver competing products to market earlier than us;

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

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

Competitive and regulatory conditions in many markets in which we operate restrict our ability to fully recover through price increases, higher costs of acquired goods and services resulting from inflation, and other drivers of cost increases.

In addition, there has been a trend toward industry consolidation in our markets over the last few years.

there has been a trend toward industry consolidation in our markets over the last few years.

We may not be able to compete successfully in an increasingly consolidated industry.

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If we are unable to compete successfully in this highly competitive industry, it could have a material effect on our business, financial condition and results of operations.

In order to remain competitive and profitable, we must expend considerable resources to research 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.

In order to remain competitive and profitable, we must expend considerable resources to identify and successfully develop new technologies, products and services and develop new markets, and there is no assurance our efforts 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 researching 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 employee time, offices and R&D and manufacturing facilities, and development of new partners and channels.

We devote a significant amount of financial and other resources to identifying 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 may experience R&D, manufacturing, regulatory, marketing and other difficulties that could delay or prevent our introduction of new or enhanced products and services.

We have experienced, and may experience in the future, R&D, manufacturing, regulatory, marketing and other difficulties that 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.

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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.

We cannot be certain that:

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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, high interest rates, a recessionary environment, instability in financial institutions and budgeting constraints of governmental entities.

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, 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.

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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 contemplated credit facility or other borrowings.

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 future 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.

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A significant percentage of our total revenues is generated from a limited number of our product families.

In particular, revenues from the sales of our respiratory products have represented a significant portion of our total revenues.

Sales of our respiratory products accounted for approximately 18% of our total revenues for the year ended December 29, 2024.

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 emergence and impact of new variants or resurgences, the effectiveness of vaccination efforts, and the increased market supply of respiratory products by our competitors.

For example, sales of our respiratory products accounted for approximately 15% of our total revenues for the year ended December 28, 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 occurrence, spread, severity, duration and emergence of new variants of 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.

As a result, if sales or revenues of our respiratory products fluctuate or decline for any reason, whether as a result of a mild respiratory season, market share loss or price pressure, obsolescence, regulatory matters, or any other reason, our operating results would be materially and adversely affected on a disproportionate basis.

Fluctuations or declines in the sales or revenues of our respiratory products, whether as a result of a mild respiratory season, market share loss or price pressure, obsolescence, regulatory matters or any other reason, could materially and adversely affect our operating results.

A significant portion of our total revenues are from a relatively small number of customers, and if we fail to retain or expand our customer relationships or significant customers terminate or do not renew their contracts, our business, operating results and financial condition could be adversely affected.

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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 another distributor or in direct sales.

Finding a suitable alternative to a lost or terminated distributor may pose challenges in our industry’s competitive environment, and another suitable distributor may not be found on satisfactory terms, if at all.

Finding a suitable alternative to a lost or terminated distributor may pose challenges in our industry’s competitive environment, and other suitable distributors 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 could lead to reduced sales.

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.

In addition to distributors, we also have a number of direct customers who are significant.

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Moreover, customer consolidation could reduce the number of customers and may increase the risk of our dependence on a small number of customers.

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 from a lost or terminated distributor to one or more new distributors or to direct sales, our business, operating results and financial condition could be materially and adversely affected.

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, our business, operating results and financial condition could be materially and adversely affected.

Interruptions and delays in the supply of raw materials, components, equipment and other products and services could adversely affect our operations and financial results.

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We cannot predict the frequency, duration or scope of these supply, production, logistics, distribution and labor disruptions and challenges.

Unexpected increases in demand for our products or services or supply shortages could require us to incur additional costs to meet customer demand.

These 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.

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.

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.

While we proactively work with our suppliers, manufacturers, distributors, industry partners and government agencies to address these challenges in our efforts to meet the needs of our customers, such disruptions and challenges have materially affected and could further materially affect our ability to timely manufacture and distribute our products and have unfavorably impacted and could further unfavorably impact our results of operations.

If 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.

affected and could further materially affect our ability to timely manufacture and distribute our products and have unfavorably impacted and could further unfavorably impact our results of operations.

As a result, we have encountered, and may in the future encounter, significant customer backlogs of orders and inventory shipments.

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New or increased quotas, duties or tariffs, or threats or changes in policy with respect to such trade restrictions, may have a material adverse effect on our business, financial condition, results of operations or cash flows.

For example, in April 2025, the U.S.

announced tariffs on imports from most of our trading partners, including significant tariffs on imports from the U.K., Canada, Mexico and China, leading to increasing trade and political tensions.

In response to tariffs, other countries have implemented retaliatory tariffs on U.S.

In addition, the U.S.

has announced potential new tariffs and related tariff actions affecting companies in the pharmaceutical and biotechnology industries, including a Section 232 national security investigation of imports of personal protective equipment, medical consumables and medical equipment, including devices.

These actions and the related rising political tensions could negatively impact global macroeconomic conditions and the stability of global financial markets.

Currently, as a result of recently effected tariffs, we are incurring incremental costs of parts and materials that we use to produce products, as well as incremental costs to ship finished goods to customers.

Although the Company plans to, and we have thus far, substantially offset such incremental costs through operating measures, including supply chain adjustments, current and future tariffs could have a material adverse effect on our business, financial condition and results of operations, including through increased supply chain costs.

While trade negotiations are ongoing and certain bilateral trade deals have been announced, there remains substantial uncertainty about the duration of existing tariffs, tariff levels, implementation of announced tariffs or imposition of additional tariffs, the potential implications of the Section 232 investigations, litigation challenging tariffs and whether additional tariffs or retaliatory actions may be imposed, modified or suspended.

Future trade agreements could also provide our competitors with an advantage over us or increase our costs, either of which could have a material adverse effect on our business, financial condition, results of operations or cash flows.

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 excessive 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 excessive cost.

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 substantial 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 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.

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.

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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.

In addition, our manufacturing processes require complex and specialized equipment, which can be expensive to maintain, repair or replace with required lead times of up to a 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, and Athens, Ohio.

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 disrupt our operations.

In such circumstances, our revenue would decline and we could incur losses until such time as we or our contract manufacturers 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.

We also have significant operations in Rochester, New York, Raritan, New Jersey, Pencoed, Wales, Pompano Beach, Florida, Athens, Ohio, and Changsha, China.

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 cause 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 manufacturers, 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 if our collaboration arrangement partners fail to fulfill their obligations.

As part of our business, we are party to collaboration arrangements with other companies, including the Joint Business with Grifols, and we may enter into additional collaboration arrangements in the future.

Our collaboration arrangements may not operate according to our business strategy and if we are unable to maintain our collaboration arrangements, or if these collaboration arrangements 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 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 may 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.

Disputes between us and our collaboration arrangement partners could also result in litigation, 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 cause our collaboration arrangements to deviate from our business strategy, our results of operations could be materially adversely affected.

Since we do 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.

Differences 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 or other legal proceedings, which can be expensive and time-consuming.

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.

A decrease in the number of surgical procedures performed, and the resulting decrease in blood demand, could negatively impact our financial results.

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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 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 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.

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, 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.

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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 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 an effort to reduce costs, which could adversely affect our business, financial condition and results of operations.

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 staffing constraints 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.

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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 results in relatively lower reimbursement under Medicare for clinical diagnostic lab tests than has been historically available.

to customers or end-customers of our products and services and/or the volume of medical procedures using our products and services.

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 organizations to improve their purchasing leverage and using competitive bid processes to procure healthcare products and services.

Governmental and private healthcare providers and payors around the world are increasingly utilizing managed care for the delivery of healthcare services 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.

This behavior may reduce the demand for certain of our diagnostics products and services.

Such 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.

Further, healthcare staffing constraints may affect the prioritization of health care services.

Each 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.

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Consolidation of our customer base, the formation of group purchasing organizations and government-sponsored tendering processes could materially adversely affect our sales and results of operations.

Consolidation among healthcare providers and the formation of buying groups 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 process.

Consolidation among healthcare providers and the formation of group purchasing 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 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 process, they may be on terms that negatively affect our current or future profitability.

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.

Furthermore, given the average industry contract length for our Ortho instruments 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 acquisitions or divestitures or discontinue business operations, and may encounter difficulties integrating acquired businesses with, or disposing of divested or discontinued businesses from, our current operations;

therefore, we may not realize the anticipated benefits of these acquisitions, divestitures or discontinuances.

We may seek to grow through strategic acquisitions.

Our due diligence reviews of our acquisition targets 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 exposure to regulatory sanctions resulting from an acquisition target’s previous activities as well as potential vulnerability to cybersecurity risks.

We may incur unanticipated costs or expenses, including post-closing asset impairment charges, expenses associated with eliminating duplicate facilities, litigation and other liabilities.

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.

Additionally, we may not achieve the benefits we anticipate when we first enter into a transaction in the amount or timeframe anticipated, if at all.

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 clinical labs 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 strategic transactions, including acquisitions, investments, joint ventures, licensing arrangements and other strategic relationships, undertake strategic restructurings or divest, spin-off or discontinue certain business operations, and may not successfully identify or consummate these strategic transactions;

therefore, we may not realize the anticipated benefits of these transactions, if any.

We may seek to grow or diversify into priority growth areas through strategic 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 legal or regulatory exposure resulting from an acquisition target’s or potential strategic partner’s previous activities as well as potential vulnerability to cybersecurity risks.

Further, we may incur unanticipated costs or expenses, including post-closing asset impairment charges, expenses associated with eliminating duplicate facilities, litigation and other liabilities, and strategic transactions may divert management’s attention and resources from our existing operations.

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 for 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 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.S donor screening portfolio through the wind-down of the VIP platform and microplate assays, which are only sold in the U.S.

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.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.

Divestitures may result in continued financial involvement in the divested

businesses, such as through guarantees, indemnity obligations or other financial arrangements, following those transactions.

Under these arrangements, nonperformance by those divested businesses could result in financial obligations imposed upon us and could affect our future financial results.

There can be no assurance that we will be able to complete any such divestiture on terms favorable to us.

The divestiture 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.

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, or achieve the anticipated benefits.

The divestiture, 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 may also undertake initiatives to restructure or streamline our operations in order to achieve cost savings and improve operational efficiency.

For example, in the second quarter of 2025, we launched the Optimization Plan that aims to (i) realign our costs with our long-term revenue expectations, (ii) drive operational efficiencies in manufacturing and distribution cost bases and (iii) support and align with our strategy to invest in key priorities.

The cumulative pre-tax charges to be incurred by us to implement the Optimization Plan are expected to be approximately $100 million through 2027, and the Optimization Plan is expected to deliver net cost savings of approximately $50 million to be achieved through 2027.

However, the timing, magnitude and nature of costs associated with implementing a restructuring initiative and the resulting cost savings are uncertain.

We may incur costs beyond the amount contemplated when we first developed the initiative, and these increased costs may be substantial, which could adversely impact our results of operations for the periods in which those adjustments are made.

Additionally, there can be no assurance we will realize the intended benefits of a strategic restructuring on the expected timeline, or at all.

Failure to successfully execute the Optimization Plan or any other strategic restructuring on a timely basis, or the failure to realize the expected benefits of such strategic restructuring or mitigate associated risks and disruptions, may have a material adverse effect on our business, financial condition and results of operations.

We have been incorporating AI into our internal operations and may incorporate AI into our products and services.

Implementation of AI and machine learning technologies may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business.

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, and consumers.

There can be no assurance that we or our customers will realize the expected benefits from such implementation of AI.

AI innovation presents risks and challenges that could impact our business.

AI 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 our 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.

Additionally, many countries and regions, including the EU, have proposed new and evolving regulations related to the use of AI and machine learning technologies.

The regulations may impose onerous obligations 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.

Use of AI technologies may expose us to an increased risk of regulatory enforcement and litigation.

Moreover, some AI features involve the processing of personal data and may be subject to laws, policies, legal obligations, and codes of conduct related to privacy and data protection.

AI development and deployment practices could subject us to competitive harm, regulatory enforcement, increased cybersecurity risks, reputational harm, and legal liability.

The use of AI may also create new cybersecurity vulnerabilities.

Additionally, use 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 and various U.S.

states, have enacted or proposed laws and regulations related to the use of AI and machine learning technologies.

Moreover, 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 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.

Given the rapid rate of change and the often uncertain scope, interpretation and application of these laws and regulations, which may be in conflict across jurisdictions, we may not always be able to anticipate how courts and regulators will apply existing laws to AI, predict how new legal frameworks will address AI or otherwise ensure compliance with these frameworks.

Failure to appropriately conform to this evolving landscape may result in legal liability, regulatory action or reputational harm.

Risks Relating to Our International Operations

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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, which could adversely impact our financial performance, cause interruptions in our business operations, impede our international growth and subject us to civil or criminal penalties, other remedial measures and legal expenses.

Our international operations are subject to inherent macroeconomic, geopolitical and regulatory 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 or 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:

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• compliance with complex foreign and U.S.

laws and regulations that apply to our international operations, including regulations in the U.S., EU and other jurisdictions impacting the marketing of our products, U.S.

laws on import/export limitations, the FCPA, and local laws prohibiting corrupt payments to governmental officials, including anti-corruption laws in China;

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

laws and regulations that apply to our international operations, including regulations in the U.S., EU, China and other jurisdictions impacting the marketing of our products, 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 inflationary environments and recessionary fears;

• the imposition or threat of, or changes in policy regarding, trade barriers (such as sanctions, tariffs, quotas, preferential bidding, import restrictions or other barriers) by U.S.

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and foreign countries;

or international sanction regimes, including future regulations and sanctions that could further limit the countries in which our products may be manufactured or sold, increase the cost of conducting business in these countries, or restrict our access to, or increase the cost of obtaining, products from foreign sources;

or international sanction regimes, including current and future regulations and sanctions that limit the countries in which our products may be manufactured or 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;

• reduced or lack of protection for and enforcement of our intellectual property rights;

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• increased financial accounting and reporting burdens and complexities;

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

• 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;

• complex and potentially adverse tax consequences resulting from international tax laws;

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or other markets that are sold into other international markets at lower prices.

The occurrence of any of these or other factors over which we do not have control could lead to reduced revenue and profitability.

Currency translation risk and currency transaction risk may adversely affect our financial condition, results of operations and cash flows.

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Given the volatility of exchange rates, we may not be able to effectively manage our currency transaction and/or translation risks, and any volatility in currency exchange rates may have an adverse effect on our financial condition, results of operations and cash flows.

We have entered into hedging agreements to address certain of our currency risks and intend to utilize local currency funding of expansions when appropriate.

Risks Relating to Our Integration and Business Efficiency Efforts

The failure to integrate successfully the businesses of Quidel and Ortho would adversely affect our future business and financial performance.

As a result of the Combinations, we have been and continue to devote significant management and employee attention and resources to integrate the business practices and operations of Quidel and Ortho.

The integration process may disrupt our business and, if implemented ineffectively, could preclude realization of the full benefits we expect to result from the Combinations.

Any failure to meet the challenges involved in successfully integrating the operations of Quidel and Ortho or otherwise to realize the anticipated benefits of the Combinations could also seriously harm our results of operations.

In addition, the integration of Quidel and Ortho may result in material unanticipated problems, expenses and liabilities.

The difficulties of combining the operations of Quidel and Ortho, some of which we have already experienced, include, among others:

• managing a significantly larger company and expanded business operations and the associated increased costs and complexity;

• aligning and executing our strategy;

• inconsistencies in standards, controls, systems, procedures and policies;

• the possibility of faulty assumptions underlying expectations regarding the integration process and results;

• coordinating sales, distribution and marketing efforts;

• integrating IT, enterprise resource planning (“ERP”), customer relationship management and other systems, including the implementation of a new ERP system to integrate certain existing business, operational and financial processes,

which requires significant investment of capital and human resources and the reengineering of many business processes;

• managing tax costs or inefficiencies associated with integrating the operations of Quidel and Ortho;

• taking actions that may be required in connection with obtaining regulatory approvals.

Many of these factors are outside of our control and any one of them could subject us to increased costs, decreased revenues and diversion of management’s and employees’ time and energy, which could materially impact our business, financial condition and results of operations.

In addition, we are transitioning from integration efforts of the two independent businesses to focusing on business efficiencies of the combined company with the goal of creating a more efficient and agile company.

We may not realize the full benefits of the Combinations and our business efficiency initiatives, including the synergies, cost savings or sales or growth opportunities that we expect, or these benefits may take longer to realize than expected.

If we are unable to realize the anticipated benefits and synergies expected from the Combinations and our business efficiency initiatives within the anticipated timeframe, our business, financial condition and operating results may be adversely affected.

We will continue to incur significant integration-related costs in connection with the Combinations.

We have incurred and expect to continue to incur a number of non-recurring direct and indirect costs associated with the Combinations.

There are processes, policies, procedures, operations, technologies and systems that still must be integrated in connection with the Combinations and the integration of Quidel’s and Ortho’s businesses.

While we have assumed that a certain level of expenses would be incurred in connection with the Combinations and continue to assess the magnitude of these costs, there are many factors beyond our control that could affect the total amount or the timing of the integration and implementation expenses.

Although we expect that the strategic benefits of the Combinations will offset the integration and implementation expenses over time, this net benefit may not be achieved in the near term or at all.

We have entered into hedging agreements to address certain of our currency risks and intend to utilize local currency funding of expansions when appropriate, but these may not mitigate risks, fully or at all.

Risks Relating to Our IT Systems

Our ability to protect our information systems and personal and confidential information, including from data corruption, cyber-attacks, security breaches or IT errors, is critical to the success of our business.

We are highly dependent on IT networks and systems, including our office networks, operational environment, special purpose networks, systems and software used to provide our products and services, including operating our instruments and devices, and those networks and systems managed by vendors or third parties, to securely collect, process, transmit, disclose, share, use and store electronic information (including sensitive personal information and proprietary or confidential information) (collectively, “information systems”).

Our information systems may prove inadequate to our business needs and necessary upgrades may not be available or operate as designed, which could result in excessive costs or disruptions in portions of our business.

These risks may be heightened as we integrate the combined systems and operations of Quidel and Ortho.

Like any large corporation, from time to time the information systems on which we rely, including those controlled and managed by third parties, are subject to computer viruses, malicious software, attacks by hackers and other forms of cyber intrusions or unauthorized access, any of which can create system disruptions, shutdowns or unauthorized disclosure of personal or confidential information, all of which can be timely and costly to remediate.

In addition, a security breach that impacts personal information could require us to comply with breach notification requirements under applicable data privacy and security laws, result in litigation or regulatory action, or otherwise subject us to liability under those laws.

Our ability, 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, is critical to the success of our business.

We are highly dependent on IT networks and systems, including our office networks, operational environment, special purpose networks, systems and software used in or to provide our products and services, including operating our instruments, automation systems and other devices, whether internally developed or by third parties and collaboration partners, and those networks and systems managed by vendors or third parties, including cloud/SaaS platforms supporting connected instruments, to securely collect, process, transmit, disclose, share, use and store electronic information (including sensitive personal information and proprietary or confidential information) (collectively, “information systems”).

Our information systems may prove inadequate to meet our business needs and necessary upgrades may not be available or operate as designed, which could result in excessive costs or disruptions in portions of our business.

Additionally, device cyber requirements and post-market vulnerability management expectations may affect our products’ time-to-market, product updates and costs.

Like any large corporation, from time to time the information systems on which we rely, including those controlled, developed and managed by third parties, are subject to computer viruses, malicious software, attacks by hackers, ransomware, supply-chain compromises, credential theft and attacks targeting our enterprise and manufacturing environments, product vulnerabilities, security breaches and other forms of cyber intrusions or unauthorized access, any of which can create system disruptions, shutdowns or unauthorized disclosure of personal or confidential information, all of which can take time and be costly to remediate, affect our ability to sell the affected product or service, and expose us to damages.

In addition, a security breach that impacts personal information could require us to comply with breach notification requirements under applicable data privacy and security laws, result in litigation (including class action litigation) or regulatory action, or otherwise subject us to liability under those laws.

If we experience a significant incident, such as a serious product vulnerability or security breach, or any other disruptions, delays or deficiencies from our ERP systems, it could adversely affect our ability to, among other processes, process orders, procure supplies, manufacture and ship products, track inventory, provide services and customer support, send invoices and track payments, fulfill contractual obligations or otherwise operate our business.

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An actual or perceived vulnerability, failure, disruption or breach of our information systems also could adversely affect the market perception of our products and services, as well as our perception among new and existing customers.

Additionally, a significant security breach could result in theft of trade secrets and intellectual property, cause us to incur increased costs from insurance premiums and remediation measures and subject us to potential liability, litigation and regulatory or other government action.

Additionally, a significant security breach could result in theft of trade secrets and intellectual property, cause us to

incur increased costs from insurance premiums and remediation measures and subject us to potential liability, litigation and regulatory or other government action.

If any of the foregoing were to occur, our business strategy, results of operations or financial condition could be materially and adversely affected.

We attempt to mitigate the above risks by employing a number of measures, including implementing technical, physical and organizational security measures, monitoring and testing our security controls, conducting employee training and maintaining protective systems and contingency plans.

Further, our contractual arrangements with service providers aim to appropriately mitigate third-party cybersecurity risks.

We also maintain insurance coverage for cybersecurity incidents, which may not be adequate or cover all incidents.

It is impossible to eliminate all cybersecurity risk and thus our information systems, products

and services, as well as those of our service providers, remain potentially vulnerable to known or unknown threats.

Additionally, our information systems may be vulnerable to damage or interruption from circumstances beyond our control, including fire, natural disasters, power outages and system failures.

Further, our contractual arrangements with third-party collaboration partners and service providers aim to appropriately mitigate third-party cybersecurity risks.

We also maintain insurance coverage for cybersecurity incidents, although it may not be adequate or cover all incidents.

It is impossible to eliminate all cybersecurity risk and thus our information systems, products and services, as well as those of our third-party collaboration partners and service providers, remain potentially vulnerable to known or unknown threats.

Additionally, our information systems and those of our third-party collaboration partners and service providers may be vulnerable to damage or interruption from circumstances beyond our control, including fire, natural disasters, power outages and system failures.

Cybersecurity risks have generally increased in recent years because of the increased proliferation, sophistication and availability of complex malware and hacking tools to carry out cyber-attacks.

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Interruptions to our third-party IT service providers and/or the inability of our digital solutions to interoperate with certain operating systems could impair the delivery of our cloud-based solutions and negatively impact our business.

We rely on a small number of third-party service providers to host and deliver our cloud-based solutions, and any interruptions or delays in services from these service providers could impair the delivery of our cloud-based solutions.

We rely on a small number of third-party service providers to host and deliver our cloud-based solutions.

We do not control the hosting of these solutions, including data center facilities, or our or other parties’ access to the Internet.

These facilities are vulnerable to damage or interruption from severe weather, natural disasters, fires, power loss, telecommunications failures, global pandemics and similar events.

These facilities are vulnerable to damage or interruption from improper software updates, configuration errors, other service providers, severe weather, natural disasters, fires, power loss, telecommunications failures, global pandemics and similar events.

They are also subject to break-ins, computer viruses, sabotage, intentional acts of vandalism and other misconduct.

Any interruptions or delays in services from these service providers could impair the delivery of our cloud-based solutions and negatively impact our business.

We also depend on the interoperability of our mobile applications with popular mobile operating systems that we do not control, such as Android and iOS.

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We make strategic decisions on whether to apply for intellectual property protection and the types of protection to pursue based on a cost-benefit analysis.

While we endeavor to protect our intellectual property rights in certain jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported, the decision to file for intellectual property protection is made on a case-by-case basis.

While we endeavor to protect our intellectual property rights in certain jurisdictions in which our products are produced or used or into which our products are imported, the decision to file for intellectual property protection is made on a case-by-case basis.

Because of the differences in foreign trademark, patent and other laws concerning proprietary rights, our intellectual property rights may not receive the same degree of protection in foreign countries as they would in the U.S.

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As a result, companies may pursue an “efficient infringement” strategy, having concluded that it is cheaper to infringe third-party intellectual property rights than to acquire, license or otherwise respect them.

There can be no assurance that we will be successful in securing additional patents on commercially desirable improvements, that such additional patents will adequately protect our innovations or offset the effect of expiring patents, or that competitors will not be able to design around our patents.

There can be no assurance that we will be

successful in securing additional patents on commercially desirable improvements, that such additional patents will adequately protect our innovations or offset the effect of expiring patents, or that competitors will not be able to design around our patents.

In addition, third parties may challenge our issued patents through procedures such as Inter-Partes Review (“IPR”).

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For example, the complexity and uncertainty of European patent laws have also increased in recent years.

In Europe, in June 2023, a new unitary

patent system was introduced, which will significantly impact European patents, including those granted before the introduction of the system.

In Europe, in June 2023, a new unitary patent system was introduced, which will significantly impact European patents, including those granted before the introduction of the system.

Under the unitary patent system, after a European patent is granted, the patent owner can request unitary effect, thereby getting a European patent with unitary effect (a “Unitary Patent”).

Each Unitary Patent is subject to the jurisdiction of the Unitary Patent Court (the “UPC”).

As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.

As the UPC is a new court system, there is limited precedent for the court, increasing the uncertainty of any litigation.

Patents granted before the implementation of the UPC will have the option of opting out of the jurisdiction of the UPC and remaining as national patents in the UPC countries.

Patents that we request to be treated or obtain as Unitary Patents remain under the jurisdiction of the UPC and may be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC.

We cannot predict with certainty the long-term effects of the new unitary patent system.

We cannot predict with certainty the long-term effects of the unitary patent system.

Certain of our intellectual property rights are held through license agreements and collaboration arrangements with third parties.

If we cannot retain these agreements or arrangements, we may not be able to sell, develop or commercialize our products.

If we cannot retain these agreements or arrangements, we may not be able to sell, develop or commercialize certain of our products.

We also rely on trade secrets and certain other know-how and unregistered rights in and to our products, and it is possible that others will independently develop the same trade secrets, know-how and unregistered rights or obtain access to our trade secrets, know-how and unregistered rights.

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If we cannot continue to improve upon or develop, obtain and protect proprietary technology, we may lose market share or need to reduce prices as a result of competitors selling lower priced or technologically superior products or services that compete with our products.

Failure to obtain or maintain adequate protection of our intellectual property rights for any reason, including failure to file patent or trademark applications successfully or at all, failure to obtain licenses on commercially reasonable terms if at all, failure to retain intellectual property rights, including upon termination of our licenses or collaboration agreements, or failure to police our intellectual property, including through our licensees, could have a material adverse effect on our business, results of operations and financial condition.

Failure to obtain or maintain adequate protection of our intellectual property rights for any reason, including failure to file patent or trademark applications successfully or at all, failure to obtain licenses on commercially reasonable terms if at all, failure to retain intellectual property rights, including upon termination of our licenses or collaboration agreements, or failure to police our intellectual property, including through our licensees, could adversely affect our business, results of operations and financial condition.

Intellectual property risks, third-party claims of infringement, misappropriation or violation of proprietary rights and other claims against us could adversely affect our ability to market our products and services, require us to redesign our products or services or attempt to seek licenses from third parties, and materially adversely affect our operating results.

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Companies in or related to our industry often aggressively protect and pursue their intellectual property rights.

We are and have been subject to litigation with parties that claim, among other matters, that we infringed their patents or misappropriated intellectual property rights.

We have been subject to litigation with parties that claim, among other matters, that we infringed their patents or misappropriated intellectual property rights.

As the number of companies with which we compete grows and the functionality of products and technology in different industry segments overlap, the risk of third-party infringement claims increases.

We have hired and will continue to hire individuals or contractors who have experience in medical diagnostics and these individuals or contractors may have confidential trade secret or proprietary information of third parties.

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subject us to significant liability in the form of royalty payments, penalties, special and punitive damages and attorneys’ fees;

cause our distributors or end users to reduce or terminate purchases of our products;

cause our customers, including distributors, or end users to reduce or terminate purchases of our products or services;

or require us to re-design our products or processes, any of which could materially and adversely affect our business, financial condition and results of operations.

In addition to the foregoing, we may also be required to indemnify certain customers, distributors and strategic partners under our agreements with such parties if a third party alleges or if a court finds that our products or activities have infringed upon, misappropriated or misused another person’s proprietary rights.

Further, our products may contain technology provided to us by other parties such as contractors, suppliers or customers.

Further, our products and services may be provided or may contain technology provided to us by other parties such as contractors, suppliers or customers.

We may have little or no ability to determine in advance whether such technology infringes the intellectual property rights of a third party.

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The FDA can authorize the emergency use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances after the HHS Secretary has made a declaration of emergency justifying authorization of emergency use, as further described in Part I, Item 1, “Business—Government Regulations” of this Annual Report.

These EUA standards for marketing authorization are lower than if the FDA had reviewed our tests under its traditional marketing authorization pathways, and we cannot assure you that our EUA-approved tests would be cleared or approved under those more onerous clearance and approval standards.

These EUA standards for marketing authorization are lower than if the FDA had reviewed our tests under its traditional marketing authorization pathways, and our EUA-approved tests may not be cleared or approved under those more onerous clearance and approval standards.

The FDA has also established certain conditions of the EUA, including labeling and marketing requirements, which may be unclear and are subject to change.

Some of our current respiratory products were initially authorized by the FDA under EUAs.

Some of our respiratory products were initially authorized or are currently authorized by the FDA under EUAs.

HHS intends to publish advance notice of termination of each EUA declaration pertaining to medical devices in the Federal Register 180 days before the day on which the EUA declaration is terminated.

HHS has not yet published such notice of termination for the EUAs we hold.

While we have been working closely with the FDA to obtain traditional premarket clearance for some of our respiratory products by submitting de novo and 510(k) submissions, the loss of one or more of our EUAs for our respiratory products, if we are unable to timely obtain traditional premarket clearance, could have a material adverse effect on our business, results of operations, financial condition or cash flows.

While we have obtained traditional premarket clearance for some of our respiratory products by submitting de novo and 510(k) submissions, the loss of one or more of our EUAs for our respiratory products that remain on the market pursuant to an EUA, if we are unable to timely obtain traditional premarket clearance, could have a material adverse effect on our business, results of operations, financial condition or cash flows.

If we are unable to obtain or maintain required clearances or approvals for the commercialization of our products in the U.S.

and certain foreign countries, we will not be able to sell those products in such jurisdictions, which could negatively impact our results of operations.

and certain foreign countries where we intend to sell our products, we will not be able to sell those products in such jurisdictions, which could negatively impact our results of operations.

Our future performance depends on, among other matters, if, when and at what cost we will receive regulatory approval, clearances or authorizations for new products in the U.S.

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Approval to commercially distribute biologics is received from the FDA through approval of a BLA and may also require state licensing for the movement of biologics products in interstate commerce.

The FDA may deny 510(k) clearance because, among other reasons, it determines that our product is not substantially equivalent to another U.S.

The FDA may deny 510(k) clearance because, among other reasons, it determines

that our product is not substantially equivalent to another U.S.

legally marketed device.

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We determine in the first instance whether a change to a product requires a new 510(k) clearance or premarket submission, but the FDA may review our decision not to seek a new 510(k).

clearance or approval, and we may be subject to civil, criminal, monetary and non-monetary penalties and damage to our reputation.

If the FDA disagrees with our determinations and requires us to submit a new 510(k), PMA or supplement, or BLA or supplement for any product modification, we may be required to cease marketing such product or to recall the modified product until we obtain clearance or approval, and we may be subject to civil, criminal, monetary and non-monetary penalties and damage to our reputation.

Outside the U.S., commercialization is subject to diverse and evolving regulatory regimes, including, for example, the EU IVDR, Health Canada licensing and the NMPA in China.

These regulatory regimes may require local clinical evidence, language- and country-specific labeling, post-market surveillance and vigilance reporting, and periodic renewals or new registrations for variations.

Timelines, standards of review, and enforcement approaches differ by jurisdiction and are subject to change;

authorities may suspend, revoke or impose conditions on existing authorizations, require product modifications or prohibit marketing.

Our results of operations would be negatively affected by failures or delays in the receipt of regulatory authorizations, approvals or clearances, changes in laws and regulations, the loss of previously received authorizations, approvals or clearances or the placement of limits on the manufacture, marketing and use of our products.

In addition, the advertising, marketing and labeling of medical devices are highly regulated by the FDA and FTC.

Our efforts to promote our products, including via direct-to-consumer marketing or social media initiatives, could subject us to additional scrutiny of our communication of risk information, benefits or claims by the FDA, FTC or both.

In addition, the advertising, marketing and labeling of medical devices are highly regulated by the FDA and FTC and regulators in other jurisdictions.

Our efforts to promote our products, including via direct-to-consumer marketing or social media initiatives, could subject us to additional scrutiny of our communications, including those providing risk information, benefits or claims, by the FDA, FTC or both in the U.S.

and regulators in other jurisdictions.

If the results of clinical studies required to gain regulatory approval to sell our products are not available when expected, or do not demonstrate the safety and effectiveness of those products, we may be unable to obtain regulatory approval and sell those products.

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Even if we successfully manage our clinical studies, we may not obtain favorable results and may not obtain regulatory clearance or approval for the applicable product.

For example, upon reviewing the performance of our Savanna RVP4+ assay against the clinical market’s expectations, we withdrew our FDA 510(k) submission for this assay in March 2024 because the final dataset did not meet our expectations.

If we are unable to market and sell our new products or are unable to obtain clearances or approvals in the time frame needed to execute our product strategies, our business and results of operations would be materially and adversely affected.

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Our businesses are extensively regulated by the FDA and other federal, state and foreign regulatory agencies.

These regulations impact many aspects of our operations, including development, manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, physician interaction and record-keeping.

These regulations impact many aspects of our operations, including development, manufacturing, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, physician interaction and record-keeping.

Any material failure by us to comply with such applicable governmental regulations could result in product recalls, the imposition of fines, restrictions on our ability to conduct or expand our operations or the cessation of all or a portion of our operations.

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The discovery of problems with a product may result in restrictions on the product, including withdrawal of the product from the market.

In addition, in some cases, we may sell products or provide services that are reliant on the use or commercial availability of third-party products, including medical devices or equipment, and regulatory restrictions placed upon any such third-party products could have a material adverse impact on the sales or commercial viability of our related products or services.

In addition, in some cases, we may sell products or provide services that are reliant on the use or commercial availability of third-party products, including medical devices or equipment,

and regulatory restrictions placed upon any such third-party products could have a material adverse impact on the sales or commercial viability of our related products or services.

We are subject to routine inspection by the FDA and other agencies for compliance with such agency’s requirements applicable to our products, including, without limitation, the FDA’s Quality System Regulation and Medical Device Reporting requirements in the U.S., and other applicable regulations worldwide.

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If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products or injunctions against the distribution of our products, termination of our service agreements by our customers, disgorgement of money, operating restrictions and criminal prosecution.

Disruptions at the FDA and other government agencies, including disruptions caused by funding shortages or statutory, regulatory or policy changes, could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent them from performing normal business functions on which the operation of our business may rely, or otherwise prevent new

or modified products from being developed, cleared, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new or modified products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.

The ability of the FDA to review and approve new or modified products in the U.S.

can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.

Average review times at the FDA have fluctuated in recent years as a result of these factors.

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If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, or to provide feedback on our submissions, which could have a material adverse effect on our business.

The FDA has also been subject to reorganizations and reductions in force that could impact the agency’s activities, including the conduct and closeout of inspections, enforcement actions, and reviews of premarket submissions for marketing authorization.

Further, future government shutdowns or other disruptions to normal operations could impact our ability to access the public markets and obtain funding necessary to properly capitalize and continue our operations.

We may encounter challenges entering into contracts with government entities due to government-sponsored tendering requirements, and any contracts that we have entered into or will enter into with government entities may involve future funding, compliance and possible sanctions risks.

We endeavor to enter into contracts with government entities for grant-funded projects or the sale of our products.

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Implementing policies, procedures and controls relating to the accounting and recordkeeping requirements is expensive and time-consuming.

If we fail to comply with these requirements relating to any government contract that we have entered into or will enter into, or we fail an audit, we could be subject to various sanctions, including monetary damages, criminal and civil penalties, termination of contracts and suspension or debarment from government contract work.

If we fail to comply with the requirements relating to any government contract that we have entered into or will enter into, or we fail an audit, we could be subject to various penalties, including monetary damages,

criminal and civil penalties, termination of contracts and suspension or debarment from government contract work.

These requirements complicate our business and increase our compliance burden.

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If one or more of our products is claimed to be defective or does not comply with applicable regulations, we could be subject to claims of liability and harm to our reputation that could adversely affect our business.

Our product development and production processes are complex and could expose our products to claims of defectiveness or claims that they do not comply with applicable regulations.

Our product development and production processes are complex and could expose our products to defectiveness claims or claims that they do not comply with applicable regulations.

Alleged manufacturing and design defects or regulatory non-compliance could lead to recalls (either voluntary or required by the FDA or other government authorities) and could result in the removal of one or more of our products from the market.

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In addition, our marketing of monitoring services may cause us to be subject to various product liability or other claims, including, among others, claims that inaccurate monitoring results lead to injury or death, or, in the case of our toxicology monitoring services, the imposition of criminal sanctions.

The risk of a product liability claim is also heightened for at-home tests that may be purchased and administered by the end-user customer and not a medical professional and our communication of risk

information, benefits or claims, which is highly regulated by the FTC and the FDA, could be alleged to be misleading or erroneous.

The risk of a product liability claim is also heightened for at-home tests that may be purchased and administered by the end-user customer and not a medical professional and our communication of risk information, benefits or claims, which is highly regulated by the FTC and the FDA, could be alleged to be misleading or erroneous.

If the FTC or the FDA alleges or establishes that any of our communications are misleading, we could be subject to litigation and material penalties and fines.

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These laws and regulations, among other things, constrain our business, marketing and other promotional and research activities by limiting the kinds of financial arrangements, including sales programs, we may have with hospitals, physicians or other potential purchasers of our products.

In particular, these laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commissions, customer incentive programs and other business arrangements, as well as interactions with healthcare professionals through consultant arrangements, product training, sponsorships or other activities.

In particular, these laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commissions, customer value programs and other business arrangements, as well as interactions with healthcare professionals through consultant arrangements, product training, sponsorships or other activities.

Efforts to support compliance of our third-party business arrangements with applicable healthcare and other laws and regulations involve substantial costs.

Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, governmental authorities may conclude that our business practices do not comply with healthcare laws and regulations.

Due to the breadth of these laws, the narrowness of available statutory exceptions and regulatory safe harbors, and the range of interpretations to which they are subject, governmental authorities may conclude that our business practices do not comply with healthcare laws and regulations.

To enforce compliance with the healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.

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Department of Health and Human Services Office of Inspector General (“OIG”), the U.S.

Department of Justice (“DOJ”), the state attorney generals and other foreign and domestic government agencies.

Department of Justice (“DOJ”), the state attorneys general and other foreign and domestic government agencies.

Responding to investigations can be time- and resource-consuming and can divert management’s attention from the business.

We may be subject to private qui tam actions brought by individual whistleblowers on behalf of federal or state governments, with potential liability under the FCA, including mandatory treble damages and significant per-claim penalties.

Additionally, as a result of these investigations and qui tam actions, we may need to agree to additional compliance and reporting requirements as part of a consent decree, corporate integrity agreement or other type of government resolution.

Additionally, as a result of these investigations and qui tam actions, we may need to agree to additional compliance and reporting requirements

as part of a consent decree, corporate integrity agreement or other type of government resolution.

Any such investigation, or failure to comply with such investigation, including those led by the OIG or the DOJ, or settlement could increase our costs or otherwise have an adverse effect on our business, financial condition and results of operations.

Even an unsuccessful challenge or investigation into our practices could cause adverse publicity and be costly to respond to.

Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, reputational damage and be costly to respond to.

If our operations are found to be in violation of any of the laws described above or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to significant penalties, including significant criminal, civil and administrative penalties, damages, fines, exclusion from participation in government programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputational harm, oversight if we become subject to a consent decree, corporate integrity agreement or other government resolution, and disgorgement, and we could be required to curtail, restructure or cease our operations.

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We use hazardous materials in our business that may result in substantial compliance costs or claims against us relating to handling, storage or disposal.

Our operations and facilities are subject to various foreign, federal, state and local environmental, health and safety laws, rules, regulations and other requirements, including those governing the generation, use, manufacture, handling, transport, storage, treatment and disposal of, or exposure to, regulated materials, discharges and emissions to air and water, the cleanup of

contamination and occupational health and safety matters.

Compliance with such laws and regulations requires significant effort and costs.

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Further, our workers, properties and equipment may be exposed to potential operational hazards such as fires, safety incidents, releases of regulated materials, malfunction of equipment, accidents and natural disasters, which could result in personal injury or loss of life, damage to or destruction of property and equipment or environmental damage, and could potentially result in a suspension of operations, harm to our reputation and the imposition of civil or criminal fines or penalties, all of which could adversely affect our business.

We will be exposed to significant risks in relation to compliance with anti-bribery and anti-corruption laws and regulations and economic sanctions programs.

We are exposed to significant risks in relation to compliance with anti-bribery and anti-corruption laws and regulations and economic sanctions programs.

Doing business on a worldwide basis requires us to comply with the laws and regulations of the U.S.

government and those of various international and sub-national jurisdictions, and our failure to successfully comply with these rules and regulations may expose us to liabilities.

These laws and regulations apply to companies and individual directors, officers, employees and agents, and may restrict our operations, trade practices, investment decisions and partnering activities.

federal and state governments and those of various international and sub-national jurisdictions, and our failure to successfully comply with these rules and regulations may expose us to liabilities.

These laws and regulations apply to companies and individual directors, officers, employees, agents, partners and other intermediaries working on our behalf, and may restrict our operations, trade practices, investment decisions and partnering activities.

In particular, our international operations are subject to U.S.

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Department of State.

The FCPA prohibits providing anything of value to foreign officials for the purposes of obtaining or retaining business or securing any improper business advantage.

We may deal with state-owned business enterprises, the employees and representatives of which may be considered foreign officials for purposes of the FCPA.

We are subject to the jurisdiction of various governments and regulatory agencies outside of the U.S., which may bring our personnel into contact with foreign officials responsible for issuing or renewing permits, licenses or approvals or for enforcing other governmental regulations.

prohibits providing anything of value to foreign officials for the purposes of obtaining or retaining business or securing any improper business advantage.

We or our intermediaries may deal with state-owned business enterprises, the employees and representatives of which may be considered foreign officials for purposes of the FCPA.

We are subject to the jurisdiction of various governments and regulatory agencies outside of the U.S., which may bring our personnel or intermediaries into contact with foreign officials responsible for issuing or renewing permits, licenses or approvals or for enforcing other governmental regulations.

The FCPA also contains accounting provisions requiring issuers of securities listed in the U.S.

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Economic and trade sanctions restrict our transactions or dealings with certain sanctioned countries, territories and designated persons, absent authorizations or exemptions under applicable law, such as OFAC’s licenses permitting certain humanitarian trade.

While we endeavor to have a strong culture of compliance and an adequate system of internal controls, including procedures to minimize and detect fraud in a timely manner, as well as processes for complying with OFAC authorizations or exemptions, there can be no assurance that our policies and procedures will be followed at all times or will effectively detect and prevent violations of applicable laws by one or more of our employees, consultants, agents or partners and, as a result, we could be subject to penalties and material adverse consequences on our business, financial condition or results of operations.

While we endeavor to have a strong culture of compliance and an adequate system of internal controls, including procedures to minimize and detect fraud in a timely manner, as well as processes for complying with OFAC authorizations or exemptions, our policies and procedures may not be followed at all times or effectively detect and prevent violations of applicable laws by one or more of our employees, consultants, agents or partners or other intermediaries working on our behalf and, as a result, we could be subject to criminal, civil and administrative penalties, including prohibitions on the conduct of our business in certain jurisdictions, debarment or exclusion from federal healthcare or global tender programs, and other material adverse consequences on our business, financial condition or results of operations.

Our collection, use and disclosure of personal information, including health information, and confidential information is subject to federal and state privacy, data security and data protection regulations, as well as privacy, data security and data protection laws outside the U.S., including in the EEA, the U.K.

and China, and our failure to comply with those laws and regulations or to adequately secure this information could result in significant liability or reputational harm.

In the ordinary course of business, we collect, process, transfer, disclose, share and use personal and confidential information, including from customers, employees and business contacts.

In the ordinary course of business, we collect, process, transfer, disclose, share and use personal and confidential information, including information relating to customers, employees and business contacts.

These activities subject us and our partners to federal, state and foreign privacy, data security and data protection laws, regulations, guidance, self-governing rules, industry standards, contractual requirements and other obligations as further described in Part I, Item 1, “Business—Government Regulations” of this Annual Report.

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Because many of these laws and regulations are recent, it is also generally unclear how the laws will be interpreted and enforced in practice by the relevant government authorities as many of the laws are drafted broadly and leave great discretion to the relevant government authorities to exercise.

Any failure or perceived failure by us or our employees, representatives, contractors, consultants, collaborators or other third parties to comply with such requirements or adequately address privacy and data security concerns, even if unfounded, could result in significant cost and liability to us, including civil and/or criminal penalties, injunctions, fines and exposures to private litigation, as a cost of doing business, or due to new or increasing fines or penalties for violations, damage our reputation, and adversely affect our business and results of operations.

Any failure or perceived failure by us or our employees, representatives, contractors, consultants, collaborators or other third parties to comply with such requirements or adequately address privacy and data security concerns, even if unfounded, could result in significant cost and liability to us, including civil and/or criminal penalties, injunctions, fines and exposures to private litigation (including class action litigation), as a cost of doing business, or due to new or increasing fines or penalties for violations, damage our reputation, and adversely affect our business and results of operations.

Further, a cyber-attack or other security breach affecting personal information, including health or employee information, could also result in significant legal and financial exposure and reputational damage that could potentially have an adverse effect on our business, including limiting our ability to process personal information or to operate in certain jurisdictions.

We continue to monitor the evolving privacy, data security and data protection landscape to support our efforts to comply with the requirements in the countries in which we do business.

We monitor the evolving privacy, data security and data protection landscape to support our efforts to comply with the requirements in the countries in which we do business.

However, the costs of compliance and risks of enforcement may increase over time, and any of the foregoing could adversely affect our business, results of operations and financial condition.

We are subject to U.S.

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and other countries in which we do business could change on a prospective or retroactive basis, and any such significant changes could adversely affect our financial statements.

For example, on July 4, 2025, the OBBBA was enacted in the U.S., which included, among other things, the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act and modifications to the international tax framework.

In addition, the amount of income taxes we pay is subject to ongoing audits by U.S.

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tax authorities.

Due to the potential for changes to tax laws (or changes to the interpretation thereof) and the ambiguity and complexity of tax laws, the subjectivity of factual interpretations, the complexity of our foreign operations and intercompany arrangements and other factors, our estimates of income tax assets or liabilities may differ from actual payments,

assessments or receipts.

If these audits result in payments or assessments different from our reserves, our future results may include unfavorable adjustments to our tax liabilities and our financial statements could be adversely affected.

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If we repatriate earnings from foreign jurisdictions that have been considered permanently re-invested under existing accounting standards, it could also increase our effective tax rate.

We continue to monitor changes in tax laws and the impact of proposed and enacted legislation in the U.S.

and in the various foreign jurisdictions in which we operate.

Risks Relating to Corporate Finance

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Such financing activities may also depress the market price of shares of our common stock and impair our ability to raise capital through the sale of additional equity securities.

Moreover, the availability of additional capital, whether debt or equity from private capital sources (including banks) or the public capital markets, fluctuates as our financial condition and industry or market conditions in general change.

Moreover, the availability of additional capital, whether debt or equity from private capital sources (including banks) or the public capital markets, fluctuates as our financial performance and condition and industry or market conditions in general change.

There may be times when the private capital markets and the public debt or equity markets lack sufficient liquidity or when we cannot otherwise raise additional capital or issue additional debt on acceptable terms, or at all.

Our indebtedness could adversely affect our financial condition, limit our ability to raise additional capital to fund our operations and prevent us from fulfilling our obligations under our indebtedness.

Our Credit Agreement governs our senior secured credit facilities, which consist of (i) a Term Loan in an original amount of $2,750.0 million and (ii) an $800.0 million Revolving Credit Facility.

As a result of our indebtedness, a portion of our cash flows will be required to pay interest and principal on our outstanding indebtedness, and we may not generate sufficient cash flows from operations, or have future borrowings available under the Revolving Credit Facility, to enable us to repay our indebtedness or to fund our other liquidity needs.

As of December 29, 2024, we had total indebtedness of $2,483.1 million, and we had availability under our Revolving Credit Facility of $589.0 million (net of $13.0 million of outstanding letters of credit).

Our Credit Agreement governs our senior secured credit facilities, which consist 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.

As a result of our indebtedness, a portion of our cash flows are required to pay interest and principal on our outstanding indebtedness, and we may not generate sufficient cash flows from operations, or have future borrowings available under the Revolving Credit Facility, to enable us to repay our indebtedness or to fund our other liquidity needs.

As of December 28, 2025,

we had total indebtedness of $2.65 billion, and we had availability under our Revolving Credit Facility of $596.6 million (net of $23.4 million of outstanding letters of credit and $80.0 million borrowings outstanding).

Subject to the limits contained in the Credit Agreement, we may incur additional debt from time to time to finance working capital, capital expenditures, investments or business acquisitions, or for other purposes.

If we do so, the risks related to our higher level of debt would increase.

Specifically, our higher level of debt could have important consequences to us and our stockholders, including:

Specifically, our high level of debt could have important consequences to us and our stockholders, including:

• making it more difficult for us to satisfy our obligations with respect to our debt, and if we fail to comply with these obligations, an event of default could result and our credit worthiness may be impacted;

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The terms of the Credit Agreement impose restrictions that may limit our current and future operating flexibility, particularly our ability to respond to changes in the economy or our industry or to take certain actions, which could harm our long-term interests and may limit our ability to make payments on our indebtedness.

The Credit Agreement contains a number of restrictive covenants that impose significant operating and financial restrictions on us and may limit our ability to engage in acts that may be in our long-term best interest, including restrictions on our ability, and the ability of our subsidiaries, to:

• incur additional indebtedness and guarantee indebtedness;

• pay dividends or make other distributions in respect of, or repurchase or redeem, capital stock;

• prepay, redeem or repurchase certain indebtedness;

• make business acquisitions;

• make loans and investments;

• sell, transfer or otherwise dispose of assets;

• incur liens;

• enter into transactions with affiliates;

• enter into new lines of business or alter the businesses we conduct;

• designate any of our subsidiaries as unrestricted subsidiaries;

• enter into agreements restricting our subsidiaries’ ability to pay dividends;

• consolidate, merge, transfer or sell all or substantially all of our assets or the assets of our subsidiaries.

The Credit Agreement contains a number of restrictive covenants that impose significant operating and financial restrictions on us and may limit our ability to engage in acts that may be in our long-term best interest, including, among other matters, limitations on asset sales, mergers, indebtedness, liens, investments and transactions with affiliates.

In addition, the Credit Agreement requires us to comply with two financial covenants consisting of a maximum Consolidated Leverage Ratio (as defined in the Credit Agreement) and a minimum Consolidated Interest Coverage Ratio (as defined in the Credit Agreement).

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Borrowings” for more information related to our financial covenants.

Our ability to comply with these covenants may be affected by financial, business, economic, regulatory and other circumstances and events beyond our control, such as prevailing economic conditions, changes in regulations and industry conditions, and we cannot assure you that we will be able to comply with such covenants.

For example, compliance with the financial covenants would be more difficult to achieve if we were to experience substantially lower revenues or greater costs than budgeted.

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Additionally, our costs under these agreements would likely increase.

A breach of any of the covenants under our Credit Agreement could result in an event of default, which could result in the accelerated payment of outstanding indebtedness or foreclosure on our assets pledged to secure the indebtedness, which could have a material adverse effect on us.

A breach of any of the covenants under our Credit Agreement could result in an event of default, which could result in the accelerated payment of outstanding indebtedness or foreclosure on our assets pledged to secure the indebtedness and we could be forced into bankruptcy or liquidation, which would have a material adverse effect on us.

Risks Relating to Our Employees

We may have difficulty attracting, motivating and retaining executives and other key employees.

Our success will depend in part upon our ability to attract, motivate and retain executives and sales, marketing, manufacturing, technical, scientific, technology and other key personnel.

Our success depends in part upon our ability to attract, motivate and retain executives and sales, marketing, manufacturing, technical, scientific, technology and other key personnel.

Competition for qualified personnel can be intense, both in the industry in which we operate and where our operations are located.

Accordingly, no assurance can be given that we will be able to attract or retain executives or key employees.

As a result, we may not be able to attract or retain executives or key employees.

The loss of any executive or other key personnel, particularly key manufacturing, R&D and technical personnel, could harm our business and prospects and could impede the achievement of our R&D, operations or strategic objectives.

In addition, there could be disruptions to or distractions for the workforce and management, including in connection with recent leadership transitions or activities of labor unions or works councils.

While we may employ the use of certain retention programs, there can be no guarantee that they will prove to be successful.

In addition, there could be disruptions to or distractions for the workforce and management, including in connection with leadership transitions or activities of labor unions or works councils.

While we may employ the use of certain retention programs, they may not prove to be successful.

Furthermore, we may be required to incur significant costs in identifying, hiring, training and retaining replacements for departing employees and may lose significant expertise and talent relating to our business, which may adversely affect our business.

If we are required to make unexpected payments to any defined benefit plans or other post-employment benefit plans (“Benefit Plans”) applicable to our employees, our financial condition may be adversely affected.

Some of our current and former employees participate or participated in Benefit Plans that were sponsored by Ortho prior to the closing of the Combinations.

We assumed certain underfunded and unfunded Benefit Plan liabilities, which amounted to approximately $32.4 million as of December 29, 2024.

Several of these plans are unfunded and, while we do not believe the liabilities in relation to these plans are significant, they must be satisfied as they mature from our cash resources.

We have certain defined benefit plans and related plan assets for employees of our non-U.S.

subsidiaries.

We also have one non-U.S.

post-employment benefit plan and a replacement retiree health care reimbursement plan for certain U.S.

employees, which is funded on a pay-as-you-go basis and not accepting new participants.

Our unfunded defined benefit plan liabilities amounted to approximately $14.4 million as of December 28, 2025, and while we do not believe the liabilities in relation to these plans are significant, they must be satisfied as they mature from our cash resources.

In jurisdictions where the Benefit Plans are intended to be funded with assets in a trust or other funding vehicle, we expect that, while not significant, the liabilities will exceed the corresponding assets in each of the plans.

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We could also be required in some jurisdictions to make accelerated payments up to the full buy-out deficit in our Benefit Plans, which would likely be far higher than the normal ongoing funding cost of the plans.

Our operations and financial condition may be adversely affected to the extent that we are required to (i) make any additional payments to any relevant Benefit Plans in excess of the amounts assumed in our current projections and assumptions or (ii) report higher Benefit Plan expenses under relevant accounting rules.

Our operations and financial condition may be adversely affected to the extent that we are required to (i) make any additional payments to any Benefit Plans in excess of the amounts assumed in our current projections and assumptions or (ii) report higher Benefit Plan expenses under relevant accounting rules.

We are subject to work stoppages, union negotiations, labor disputes and other matters associated with our labor force, which may adversely impact our operations and cause us to incur incremental costs.

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Additionally, future negotiations with unions or works councils in connection with existing labor agreements may (i) result in significant increases in our cost of labor, (ii) divert management’s attention away from operating our business or (iii) break down and result in the disruption of our operations.

The occurrence of any of the preceding outcomes could impair our ability to manufacture our products and result in increased costs and/or decreased operating results.

The occurrence of any of these outcomes could impair our ability to manufacture our products and result in increased costs and/or decreased operating results.

Further, we may be subject to work stoppages at our suppliers or customers that are beyond our control.

General Risk Factors

We identified material weaknesses in our internal control over financial reporting which, if not remediated appropriately or timely, could affect our ability to record, process and report financial information accurately, impair our ability to prepare financial statements, negatively affect investor confidence and cause reputational harm.

Effective internal controls are necessary for us to provide reliable and accurate financial reporting and financial statements for external purposes in accordance with GAAP.

A failure to maintain effective internal control over financial reporting could lead to violations, unintentional or otherwise, of laws and regulations.

As disclosed in Part II, Item 9A, “Controls and Procedures” of this Annual Report, as of December 29, 2024, we identified material weaknesses in our internal control over financial reporting relating to (i) ineffectively designed controls related to financial information generated from certain software solutions and design deficiencies over certain management review controls and (ii) insufficient controls over the evaluation of all available evidence to assess realizability of deferred tax assets.

As a result, our management concluded that disclosure controls and procedures and internal control over financial reporting were not effective as of December 29, 2024.

While we are actively engaged in the process of designing appropriate controls to address these material weaknesses, there can be no assurance that the actions will fully remediate the material weaknesses in a timely manner.

If we are unable to remediate the material weaknesses, or are otherwise unable to maintain effective internal control over financial reporting or disclosure controls and procedures, our ability to record, process and report financial information accurately, and to prepare financial statements within required time periods, could be adversely affected.

Litigation, government investigations or regulatory enforcement actions arising out of any such failure or alleged failure could subject us to civil and criminal penalties that could materially and adversely affect our reputation, financial condition and operating results.

The material weaknesses, remediation actions, and any related litigation, government investigations or regulatory enforcement actions will require management attention and resources and cause us to incur unanticipated costs, and could negatively affect investor confidence in our financial statements, cause us reputational harm and raise other risks to our operations.

We are subject to, and may in the future become subject to, claims and litigation that could result in significant expenses and could ultimately result in an unfavorable outcome for us.

From time to time, we are involved in litigation and other proceedings, including matters related to product liability claims, commercial disputes and intellectual property claims, as well as regulatory, employment and other claims related to our business.

We may become subject to more proceedings as we expand our business, suppliers, customers and markets.

Litigation related to the Company, our business and our operations or financial performance may also involve customers, competitors, suppliers, patients, stockholders, governmental authorities or other third parties.

We are subject to, and may in the future become subject to, disputes, claims and litigation that could result in significant expenses and could ultimately result in an unfavorable outcome for us.

From time to time, we are involved in disputes, litigation and other legal proceedings, including matters related to product liability claims, commercial disputes and intellectual property claims, as well as stockholder, regulatory, employment and other claims related to our business.

We may become subject to more legal proceedings as we expand our business, suppliers, customers and markets.

Litigation related to the Company or our business, operations or financial performance may also involve customers, competitors, suppliers, patients, stockholders, governmental authorities or other third parties.

Litigation can be lengthy, expensive and disruptive to our operations, and results cannot be predicted with certainty.

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Furthermore, in the ordinary course of business, we must frequently make subjective judgments with respect to compliance with applicable laws and regulations.

If regulators disagree with the manner in which we have sought to comply with applicable

laws and regulations, we could be subject to substantial civil and criminal penalties, as well as corrective actions, product recalls, seizures or injunctions with respect to the sale of our products.

If regulators disagree with the manner in which we have sought to comply with applicable laws and regulations, we could be subject to substantial civil and criminal penalties, as well as corrective actions, product recalls, seizures or injunctions with respect to the sale of our products.

The FDA may also withdraw any clearances or approvals we have obtained, or decline to issue additional clearances or approvals for any outstanding 510(k)s, PMAs or BLAs.

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Expectations of our performance related to sustainability matters, or the reporting of such matters, may impose additional costs on us and expose us to new risks.

There is an increasing focus and scrutiny from regulators, investors, customers, suppliers, vendors, employees and other stakeholders concerning corporate responsibility and sustainability in particular.

Government entities are enhancing or advancing legal and regulatory requirements, including disclosure requirements, specific to sustainability matters.

For example, the state of California has adopted new climate change disclosure requirements and the EU has adopted the Corporate Sustainability Reporting Directive.

Compliance with such rules could require significant effort and resources and result in changes to our current sustainability goals.

Regulators, investors, customers, suppliers, vendors, employees and other stakeholders have increased their focus and scrutiny concerning corporate responsibility and sustainability matters.

Government entities in certain jurisdictions where we operate are enhancing, advancing or revising legal and regulatory requirements, including disclosure requirements, specific to sustainability matters.

Compliance with such rules could require significant effort and resources and result in changes to our current sustainability goals or historical reporting.

Additionally, many investors use sustainability factors to help guide their investment strategies and, in some cases, may choose not to invest in us if they believe our sustainability performance is inadequate.

Moreover, a number of customers who are payors or distributors have adopted, or may adopt, procurement policies that include sustainability provisions that their suppliers or manufacturers must comply with, or they may seek to include such provisions in their terms and conditions.

At the same time, stakeholders’ views are evolving and varied, and certain of our investors, customers or other stakeholders may disfavor our pursuit and reporting of sustainability matters.

Standards for tracking and reporting sustainability matters continue to evolve.

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The criteria by which our corporate responsibility practices are assessed must be routinely monitored and may change, which could result in greater expectations of us and cause us to undertake costly initiatives to satisfy such new criteria.

If we elect not to or are unable to satisfy such evolving standards for identifying, measuring and reporting sustainability metrics, including sustainability-related disclosures that may be required of public companies by regulators, stakeholders may conclude that our performance related to corporate responsibility and sustainability matters is inadequate.

Our decisions regarding, or ability to satisfy, such evolving standards for identifying, measuring and reporting sustainability metrics, including sustainability-related disclosures that may be required of public companies by regulators, may not satisfy all of our stakeholders.

Moreover, if our market capitalization increases, we may be benchmarked against larger peer companies, some of which may have more resources than us and thus may have achieved better sustainability performance and/or a higher sustainability rating profile.

We may face reputational damage if our sustainability performance or sustainability rating profile is, or is perceived as being, below that of our competitors or peer companies.

In addition, we could fail, or be perceived as failing, in our achievement of certain sustainability-related initiatives or goals, or we could be criticized for the scope of such initiatives or goals or our standards for measuring and reporting such goals.

We may face reputational damage if our sustainability performance or sustainability rating profile is, or is perceived as being, inconsistent with our competitors or peer companies.

In addition, we could fail, or be perceived as failing, in our achievement of certain sustainability-related initiatives or goals, or we could be criticized for the pursuit and scope of such initiatives or goals or our standards for measuring and reporting such goals.

Our failure to comply with sustainability regulations or to satisfy stakeholder expectations related to our sustainability performance or to accomplish or accurately track and report on our sustainability initiatives or goals on a timely basis, or at all, could result in the loss of business, inability to sell our products in certain jurisdictions, or difficulty obtaining new business or new supplier relationships, adversely affect our reputation, stock price, financial condition, results of operation or growth, expose us to increased scrutiny from stakeholders and enforcement authorities, which may result in litigation or regulatory action or otherwise subject us to liability, and present challenges in attracting and retaining talented employees.

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Our Charter allows our Board to issue up to five million shares of preferred stock and to fix the rights and preferences of such shares without stockholder approval.

Any such issuance could make it more difficult for a third party to acquire our business and may adversely affect the rights of our stockholders.

Our Bylaws include advance notice requirements for stockholder proposals that require stockholders to give written notice of any proposal or director nomination to us within a specified period of time prior to any stockholder meeting and do not permit stockholders to call a special meeting of the stockholders, unless such stockholders hold at least 50% of our stock entitled to vote at the meeting.

Any such issuance could make it more difficult for a third party to acquire the Company and may adversely affect the rights of our stockholders.

call a special meeting of the stockholders, unless such stockholders hold at least 50% of our stock entitled to vote at the meeting.

These provisions may delay, deter or prevent a change in control of us, adversely affecting the market price of our common stock.

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The market price of our common stock may be volatile.

Broad general economic, political, market and industry factors may adversely affect the market price of our common stock, regardless of our actual operating performance and the success of the integration of Quidel and Ortho.

Broad general economic, political, market and industry factors may adversely affect the market price of our common stock, regardless of our actual operating performance.

Factors that could cause fluctuations in the price of our common stock include:

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All of our issued shares of common stock are freely tradable without restriction or further registration under the Securities Act, except for any shares held by our affiliates, as that term is defined under Rule 144 of the Securities Act (“Rule 144”), including certain of our directors, executive officers and other affiliates, which shares may be sold in the public market only if they are registered under the Securities Act or are sold pursuant to an exemption from registration such as Rule 144.

As restrictions on resale end, the market price of our common stock could drop significantly if the holders of these shares sell them or are perceived by the market as intending to sell them.

The market price of our common stock could drop significantly if the holders of these shares sell them or are perceived by the market as intending to sell them.

These factors could also make it more difficult for us to raise additional funds through future offerings of our shares of common stock or other securities.

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Sales of substantial amounts of our common stock (including shares issued in connection with an acquisition), or the perception that such sales could occur, may adversely affect prevailing market prices of our common stock.

If we fail to develop or maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud.

As a result, stockholders could lose confidence in our financial reporting, which would harm our business and the trading price of our common stock.

Effective internal controls are necessary for us to provide reliable financial reports, prevent fraud and operate successfully as a public company.

If we cannot provide reliable financial reports or prevent fraud, our reputation and operating results would be harmed.

We cannot be certain that our efforts to develop and maintain an effective system of internal controls will be successful, that we will be able to maintain adequate controls over our financial processes and reporting in the future, or that we will be able to comply with our obligations under Section 404 of the Sarbanes-Oxley Act of 2002.

Any failure to develop or maintain effective internal controls, or difficulties encountered in implementing or improving internal controls, could harm our operating results or cause us to fail to meet our reporting obligations.

Ineffective internal controls could also cause investors to lose confidence in our reported financial information, which would likely have a negative effect on the trading price of our common stock.

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 1A. Risk Factors