What changed in this filing

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Item 1A. Risk Factors

2025-12-05 compared with 2024-12-06 · 98 added, 95 removed, 538 unchanged (26% of the section changed)

23 unchanged sentences

We have significant manufacturing and distribution sites in North America, Latin America and Europe.

More than half of our net sales for the fiscal years ended October 31, 2024, and 2023, were derived from the sale of products outside the United States.

Approximately half of our net sales for the fiscal years ended October 31, 2025, and 2024, were derived from the sale of products outside the United States.

We believe that sales outside the United States will continue to account for a material portion of our total net sales for the foreseeable future.

23 unchanged sentences

However, any of these factors could adversely affect our international operations and, consequently, our business.

Economic and trade sanctions could make it more difficult or costly for us to conduct our operations or achieve our business objectives.

Economic and trade sanctions, including tariff and import/export regulations by the U.S.

and foreign governments, could make it more difficult or costly for us to conduct our operations or achieve our business objectives.

Our business must be conducted in compliance with applicable economic and trade sanctions laws and regulations, including those administered and enforced by the U.S.

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A failure to comply with these laws and regulations could result in civil or criminal sanctions, including the imposition of fines and the denial of export privileges, which could have a material adverse effect on our business.

Changes in import and export policies, including new, increased or retaliatory tariffs, sanctions and countersanctions and customs restrictions by the U.S.

and foreign governments, may disrupt our supply chain, adversely affect our relationships with customers and impact our competitiveness.

It may be time-consuming and expensive for us to alter our business operations to adapt to or comply with any such changes.

If we are unable to effectively manage these risks, our business, financial condition and results of operations could be materially and adversely affected.

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Acquisitions and other strategic transactions that we have made and may make in the future involve numerous risks.

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• difficulties in, and expenses related to, the integration of the operations, technologies, information technology and other enterprise resource planning systems, products and personnel of the acquired company and establishment of appropriate accounting controls and reporting procedures, data protection systems and other regulatory compliance procedures, including but not limited to third-party compliance and due diligence;

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• increased leverage and the risk of lack of access to available financing, including financing for the acquisition or refinancing of debt owed by us on a timely basis and on reasonable terms;

13 unchanged sentences

We manufacture a significant portion of the medical device products we sell.

Any prolonged disruption in the operations of our existing manufacturing or distribution facilities or our fertility and stem cell storage facilities, whether due to work stoppages, technical or labor difficulties, integration difficulties, destruction of or damage to any facility (as a result of natural disaster, use and storage of hazardous materials or other events), enforcement action by the FDA or other regulatory body if we are found to be in non-compliance with current cGMP or similar foreign requirements or other reasons, could have a material adverse effect on our business.

Any prolonged disruption in the operations of our existing manufacturing or distribution facilities or our fertility and stem cell storage facilities, whether due to work stoppages, technical or labor difficulties, integration difficulties, destruction of or damage to any facility (as a result of natural disaster, use and storage of hazardous materials or other events), enforcement action by the FDA or other regulatory body if we are found to be in non-compliance with current cGMP, QSR or similar foreign requirements or other reasons, could have a material adverse effect on our business.

In addition, materials such as silicone hydrogel require improvements to our manufacturing processes to make them cost-effective.

2 unchanged sentences

CooperVision manufactures molded contact lenses, which represent the majority of our contact lens revenues, primarily at our facilities in Costa Rica, Hungary, Puerto Rico, the United Kingdom and the United States, with other smaller facilities also existing in multiple locations around the world.

CooperSurgical manufactures the majority of its products in Costa Rica, the United Kingdom and the United States, with other smaller locations also existing in multiple locations around the world.

CooperSurgical manufactures the majority of its products in Costa

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Rica, the United Kingdom and the United States, with other smaller locations also existing in multiple locations around the world.

We manufacture certain products at only one manufacturing site for certain markets, and certain of our products are approved for manufacturing only at one site.

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Cybersecurity threats continue to increase in frequency and sophistication;

a successful cybersecurity attack could interrupt or disrupt our information technology systems, or those of our third-party service providers, or cause the

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loss of confidential or protected data which could disrupt our business, force us to incur excessive costs or cause reputational harm.

a successful cybersecurity attack could interrupt or disrupt our information technology systems, or those of our third-party service providers, or cause the loss of confidential or protected data which could disrupt our business, force us to incur excessive costs or cause reputational harm.

Security breaches, computer malware and computer hacking attacks have become more prevalent across industries and may occur on our systems or those of our third-party service providers or partners.

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We cannot be assured that there will not be associated excessive costs or disruptions in portions of our business in the course of our maintenance, support and/or upgrade of these systems.

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We are in the midst of a multiyear process of implementing new enterprise resource planning (ERP) systems at CooperVision and CooperSurgical.

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If any of such systems or programs were to experience service interruptions, fail or create erroneous information in our hardware or software network infrastructure, possible consequences include our loss of communication links, inability to track sales and interruption of other operational or financial processes, which in turn could adversely affect our financial results, stock price and reputation.

We identified a material weakness in our internal control over financial reporting related to an ineffective information technology (IT) general control for the U.S.

operations within the CooperSurgical segment which, if not remediated appropriately or timely, could affect our ability to record, process and report financial information accurately and prepare financial statements within required time periods and could subject us to litigation or investigations, negatively affect investor confidence and adversely impact our stock price.

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We previously identified a material weakness in our internal control over financial reporting related to an ineffective information technology (IT) general control for the U.S.

operations within the CooperSurgical segment which was remediated as of October 31, 2025.

We may experience additional material weakness in the future which could affect our ability to record, process and report financial information accurately and prepare financial statements within required time periods and could subject us to litigation or investigations, negatively affect investor confidence and adversely impact our stock price.

Internal controls related to the operation of technology systems are critical to maintaining adequate internal control over financial reporting.

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Manual controls that rely on system-generated data or reports from the affected IT environment or process level automated controls in the affected IT environment were ineffective because they could have been adversely impacted.

In response to the material weakness, management, with the oversight of the Audit Committee, has begun to implement steps to remediate the material weakness.

If we are unable to remediate the material weakness, 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, which could subject us to reputational harm, legal claims or proceedings, regulatory investigations and enforcement actions, significant costs from remedial actions, additional management resources, and payment of legal and other expenses, negatively affect investor confidence in our financial statement and adversely impact our stock price.

In response to the material weakness, management, with the oversight of the Audit Committee, implemented steps to remediate the material weakness.

If we are unable to maintain effective internal control over financial reporting or disclosure controls and procedures in the future, our ability to record, process and report financial information accurately, and to prepare financial statements within required time periods, could be adversely affected, which could subject us to reputational harm, legal claims or proceedings, regulatory investigations and enforcement actions, significant costs from remedial actions, additional management resources, and payment of legal and other expenses, negatively affect investor confidence in our financial statement and adversely impact our stock price.

Pricing pressure from our competitors, customers and changes in third-party coverage and reimbursement may adversely affect demand for our products and negatively impact our operating results.

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Such trends may adversely affect demand for our products and may drive down the prices we are able to charge for our products, both of which would negatively affect our operating results.

We rely on independent suppliers in our supply chain for raw materials, packaging materials and components, mechanical equipment and some finished goods;

We rely on independent suppliers and third-party logistics providers in our supply chain for raw materials, packaging materials and components, mechanical equipment and some finished goods;

we could experience inventory shortages if any of these suppliers encounter a manufacturing or distribution disruption.

1 unchanged sentence

However, in certain instances we acquire components and materials from sole or primary suppliers to make our silicone hydrogel contact lens, certain medical devices and IVF products.

We also source mechanical equipment and in certain instances finished goods from OEM suppliers.

We also source mechanical equipment and in certain instances finished goods from original equipment manufacturers.

Supply of these goods, items and materials is protected by contractual agreements, availability of alternative suppliers and/or safety stocks.

However, if current suppliers fail to supply sufficient goods, items or materials to us on a timely basis, or at all for any reason, we could experience inventory shortages and disruption in our supply of products.

For example, among other situations, some of the primary material used to make our silicone hydrogel contact lens products, including MyDay, Biofinity, Avaira and clariti, are supplied by few or sole suppliers, and the failure of a key or sole supplier to timely supply sufficient items and materials necessary for the manufacture of our silicone hydrogel contact lenses could in turn disrupt our supply of those lenses to the market, which would have a material adverse effect on our business.

For example, among other situations, some of the primary material used to make our silicone hydrogel contact lens products, including MyDay,

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Biofinity, Avaira and clariti, are supplied by few or sole suppliers, and the failure of a key or sole supplier to timely supply sufficient items and materials necessary for the manufacture of our silicone hydrogel contact lenses could in turn disrupt our supply of those lenses to the market, which would have a material adverse effect on our business.

Our supply chain and our cost of goods also may be negatively impacted by unanticipated price increases due to factors such as inflation, including wage inflation, or to supply restrictions beyond our control or the control of our suppliers.

We also rely on third-party logistics providers for storage and distribution of our components and products.

Because we have limited control over their operations, any disruption in these relationships—whether due to labor shortages, transportation delays, capacity constraints—could adversely affect our ability to deliver products to customers on time and result in increased costs, reputational harm and potential liability.

If we are unable to promptly transition to alternative providers in the event of a disruption, our business, financial condition, and results of operations could be materially and adversely affected.

If we fail to protect our intellectual property adequately, our business could suffer.

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• be expensive and time consuming to prosecute or defend;

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• result in a finding that we do not have certain intellectual property rights or that such rights lack sufficient scope or strength;

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Enforcing or defending our registered and unregistered trademarks might result in significant litigation costs and damages, including the inability to continue using certain trademarks.

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The laws of foreign countries in which we do business or contemplate doing business in the future may not recognize intellectual property rights or protect them to the same extent as do the laws of the United States.

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• require us to enter into royalty or licensing agreements in order to obtain the right to use a necessary product, component or process.

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We cannot be certain of the outcome of any litigation.

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The development of a market for our products or services may be influenced by many factors, some of which are out of our control, including:

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• acceptance of our products or services by eye care or other health care practitioners;

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The market for contact lenses is intensely competitive and is characterized by declining sales volumes for older product lines and growing demand for silicone hydrogel-based products.

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and to achieve manufacturing efficiencies and sufficient manufacturing capacity and capabilities for such products.

Our ability to respond to these competitive pressures will depend on our ability to decrease our costs and maintain gross margins and operating results and to introduce new products successfully, on a timely basis in the Americas, EMEA and Asia Pacific, and to achieve manufacturing efficiencies and sufficient manufacturing capacity and capabilities for such products.

Any significant decrease in our costs per lens will depend, in part, on our ability to increase sales volume and production capabilities and our ability to secure adequate supply of materials used in production at reasonable costs.

11 unchanged sentences

In addition, some of CooperSurgical’s markets, such as genomics, contraception and cord blood and cord tissue storage, are characterized by rapid technological advancement.

We face the risk that demand for our products will not grow or will decline if our competitors are more successful than us at innovating in these and other areas.

There is also risk that emerging technologies or technology advancements could reduce the medical value of certain of our products and services, such as cord blood and cord tissue storage, which could adversely affect our business.

We face the risk that demand for our products will not grow or will decline if our competitors are more

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successful than us at innovating in these and other areas.

There is also a risk that emerging technologies or technology advancements could reduce the medical value of certain of our products and services, such as cord blood and cord tissue storage, which could adversely affect our business.

In recent years, CooperSurgical has also expanded direct-to-consumer products and services, which requires implementing new competitive strategies and increases the importance of customer service and consumer reputation as competitive factors.

11 unchanged sentences

Research and development time commitments, higher feasibility risk with longer term projects, greater dependence on, and reduced control over, third-party deliverables, the cost of obtaining necessary regulatory approval or certification and other costs related to product innovations can be substantial.

We cannot be assured that we will successfully obtain necessary regulatory approvals, certifications or clearances for our new products or that our new

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products will successfully compete in the marketplace and, as a result, justify the expense involved in their development and regulatory approval or certification.

We cannot be assured that we will successfully obtain necessary regulatory approvals, certifications or clearances for our new products or that our new products will successfully compete in the marketplace and, as a result, justify the expense involved in their development and regulatory approval or certification.

In addition, our competitors may have developed or may in the future develop new products or technologies.

3 unchanged sentences

We have made, and will continue to make, expenditures to comply with such laws and requirements.

Future events, such as changes in existing laws and regulations, or the enforcement thereof, or the discovery of contamination at our facilities, may give rise to additional compliance or remediation costs that could have a material adverse effect on our business.

Future events, such as changes in existing laws and regulations, new laws and regulations or the enforcement thereof, or the discovery of contamination at our facilities, may give rise to additional compliance or remediation costs that could have a material adverse effect on our business.

Such laws and requirements are constantly changing, are different in every jurisdiction and can impose substantial fines and sanctions for violations.

6 unchanged sentences

In October 2023, California adopted new carbon and climate-related reporting requirements for large public and private companies doing business in the state.

Further, the SEC adopted a final rule on the Enhancement and Standardization of Climate-Related Disclosures in 2024.

Further, the SEC adopted a final rule on the Enhancement and Standardization of Climate-Related Disclosures in March 2024.

In March 2025, the SEC ended its defense of the climate-related disclosure rules adopted in March 2024.

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International ESG disclosure standards have also been produced (and further standards will be produced) under the auspices of the International Sustainability Standards Board (ISSB), which some countries (such as the UK) have indicated they may incorporate into ESG disclosure standards required of certain companies.

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Complying with these demands or requirements could cause us to incur additional manufacturing, operating or product development costs.

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If we do not adapt to or comply with new regulations, or fail to meet evolving investor, industry or stakeholder expectations and concerns regarding ESG issues, investors may reconsider their capital investment in our Company, and customers and consumers may choose to stop purchasing our products, which could have a material adverse effect on our reputation and business.

If we do not adapt to or comply with existing and/or new regulations, or fail to meet evolving investor, industry or stakeholder expectations and concerns regarding ESG issues, investors may reconsider their capital investment in our Company, and customers and consumers may choose to stop purchasing our products, which could have a material adverse effect on our reputation and business.

If we do not retain our key personnel and attract and retain other highly skilled employees, our business could suffer.

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The success of our business is heavily dependent on the leadership of our key management personnel.

Our success also depends on our ability to recruit, develop and retain and motivate highly skilled sales, marketing, manufacturing engineering and scientific personnel.

Our success also depends on our ability to recruit, develop, retain and motivate highly skilled sales, marketing, manufacturing engineering and scientific personnel.

Competition for these persons in our industry is intense, and we may not be able to successfully recruit, train or retain qualified personnel.

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From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of drugs and medical devices.

In addition, the FDA may change its premarket clearance and approval policies for drugs and medical devices, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared products on a timely basis.

In addition, the FDA may change its premarket clearance and approval policies for drugs and medical devices, adopt additional regulations or revise existing regulations, or take other

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actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared products on a timely basis.

For example, over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products.

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The EU IVDR fully applies since May 26, 2022, but there is a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be fully compliant with the regulation.

Both regulations have been adopted to establish a

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uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices (including IVDs) and ensure a high level of safety and health while supporting innovation.

Both regulations have been adopted to establish a uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices (including IVDs) and ensure a high level of safety and health while supporting innovation.

These modifications may have an effect on the way we intend to develop our business in the EU and EEA.

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Manufacturers based outside of the UK need to appoint a UK Responsible Person to register devices with the MHRA.

On January 9, 2024, the MHRA published a roadmap setting out its plans and timelines for towards the reform of the regulatory framework for medical devices in the UK.

Regulations implementing core elements of the new framework are intended to be in place by 2025.

Pending such reform of the UK regulatory framework, the government has confirmed that general medical devices compliant with the EU MDD with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2028.

Medical devices, including custom-made devices, compliant with the EU MDR can be placed on the Great Britain market up until June 30, 2030.

The rules for placing medical devices on the market in Northern Ireland, which is part of the UK, differ from those in Great Britain (England, Scotland and Wales) and continue to be based on EU law.

These developments, or the perception that any related developments could occur, have had and may continue to have a material adverse effect on global economic conditions and financial markets, and our business may be impacted and the demand for our products could be depressed.

However, consultations are underway which propose substantial reforms to the Great Britain regulatory regime for medical devices and IVDs, including with respect to market access and conformity assessment procedures.

Any divergent requirements between the UK and the EU may increase the cost and complexity of running our business.

Our products are subject to reporting requirements and recalls, even after receiving regulatory clearance, approval or certification, which could harm our reputation and business.

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Recalls of any of our products may divert managerial and financial resources and have an adverse effect on our financial condition and results of operations.

A recall could harm our reputation with customers and consumers which could reduce the sales of our products.

A recall could harm our reputation with customers

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and consumers which could reduce the sales of our products.

In addition, the FDA or other foreign governmental agencies may implement enforcement actions in connection with a recall which could impair our product offerings and be harmful to our business and financial results.

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On January 31, 2024, the FDA issued a final rule to amend the QSR regulations to align more closely with the International Organization for Standardization standards.

Accordingly, this could impose additional or different regulatory

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requirements on CooperVision and CooperSurgical that could increase the costs of compliance or otherwise create competition that may negatively affect our business.

Accordingly, this could impose additional or different regulatory requirements on CooperVision and CooperSurgical that could increase the costs of compliance or otherwise create competition that may negatively affect our business.

The manufacture of drug-device combination products, such as Paragard, is complex and requires significant expertise and capital investment.

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The process of obtaining, renewing and maintaining regulatory clearances and approvals to market product, particularly from the FDA, can be costly and time consuming.

We cannot be assured that such clearances and approvals will be granted on a timely basis, if at all, and significant delays in the introduction of any new products or product enhancements may occur, which could adversely affect our competitive position and results of operations.

We cannot be assured that such clearances

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and approvals will be granted on a timely basis, if at all, and significant delays in the introduction of any new products or product enhancements may occur, which could adversely affect our competitive position and results of operations.

In addition, the FDA and authorities in foreign jurisdictions may change their policies, adopt additional regulations or revise existing regulations, each of which could prevent or delay premarket approval or clearance of our products, increase the cost of compliance, impose additional regulatory requirements on us, or otherwise impact our ability to market our currently approved or cleared products.

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Regulatory agencies may further scrutinize our practices with respect to effective communication of risk information, benefits or claims with respect to such products.

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Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products and product candidates.

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In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as suppliers and/or sub-contractors and, where necessary, the facilities of professional users.

Failure to comply with regulatory requirements (as applicable) could require time and resources to respond to the regulatory authorities’ observations and to implement corrective and preventive actions, as appropriate.

Failure to comply with regulatory requirements (as applicable) could require time and resources to respond to the regulatory

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authorities’ observations and to implement corrective and preventive actions, as appropriate.

Regulatory authorities have broad compliance and enforcement powers and if such issues cannot be resolved to their satisfaction can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties.

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Many of the regulations applicable to our devices and products in such countries are similar to those of the FDA.

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The advertising and promotion of medical devices is subject to some general principles set forth in the EU legislation.

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Similar tests are also known as In-House Tests (IH-Tests) in the EU and LDTs have historically been subject to enforcement discretion by the FDA and were not previously regulated under the 98/79EC in-vitro diagnostic directive (IVDD) of the EU.

On May 6, 2024, the FDA published a final rule on the regulation LDTs, making explicit that LDTs are medical devices under the FDCA.

In addition, the FDA is finalizing a policy under which the FDA will provide greater oversight of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach over the course of four years, as well as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.

We offer certain genetic testing services to help identify the likelihood of pregnancy as well as identify possible disorders or diseases of a child prior to birth, and we have historically marketed these tests as LDTs in the United States.

As a result, our tests may now be subject to the FDA’s enforcement of its medical device regulations and the applicable FDCA provisions, subject to the four year phase-out of enforcement discretion beginning in May of 2025.

Compliance with the new requirements may require additional analytical or clinical studies or other actions in order to continue marketing our tests during the phase-out period, which could increase costs and expenses or otherwise negatively affect our business.

The FDA LDT regulation is currently subject to legislative challenges which may result in less stringent requirements or a decrease in FDA enforcement of LDT requirements.

Therefore, the costs to comply with the FDA LDT regulation and its impact on our business is difficult to predict.

As a result, our tests may be subject to the FDA’s enforcement of its medical device regulations and the applicable FDCA provisions.

On May 6, 2024, the FDA published a final rule on the regulation LDTs, making explicit that LDTs are medical devices under the FDCA.

Although since then the FDA has rescinded its prior rule regulating LDTs as medical devices, it is unclear whether the FDA may seek greater oversight of LDTs in other ways, which could increase costs and expenses or otherwise negatively affect our business.

Similarly, in the EU, the regulatory landscape has evolved to include the definition of an IH-Test as is an IVD that is developed and produced by a laboratory on a non-industrial scale and is provided to health institutions in accordance with Article 5 of the EU IVDR.

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We may be required to expend additional time and resources to comply with the requirements of the EU IVDR, resulting in additional expenses for offering our current and any future tests as well as possibly delaying or suspending development or commercialization of such tests.

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We expect that new proposals or legislative changes may be introduced from time to time both in the U.S.

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The law also requires us to maintain a state laboratory license to conduct testing in that state.

In addition, we are subject to the UK Human Fertilization &

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Embryology Association (HFEA) regulating IVF.

In addition, we are subject to the UK Human Fertilization & Embryology Association (HFEA) regulating IVF.

Our laboratories are located in Japan, the United Kingdom and United States, and we must maintain the requisite licenses in each jurisdiction.

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Three federal agencies are responsible for administering the CLIA program in the United States:

the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the FDA.

the CMS, the Centers for Disease Control and Prevention (CDC), and the FDA.

The CMS in particular has the authority to impose a wide range of sanctions, including revocation of CLIA certification along with a bar on the ownership or operation of a CLIA-certified laboratory by any owners or operators of the deficient laboratory.

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Any regulatory changes could have adverse consequences for us and make it more difficult or expensive for us to conduct our business by requiring pre-market clearance or approval and compliance with additional post-market regulatory requirements with respect to those products.

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Disruptions at the FDA and other government agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.

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Disruptions at the FDA, foreign agencies and notified bodies and other agencies may also slow the time necessary for new drugs and medical devices or modifications to cleared or approved drugs and medical devices to be reviewed, approved and/or certified by necessary government agencies or notified bodies, which would adversely affect our business.

For example, over the last several years, the United

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States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities.

For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities.

Ongoing federal efforts to streamline government operations, including agency-wide efficiency programs, may further impact the resources and staffing levels available to the FDA.

These changes could result in longer review times for our regulatory submissions.

Any delays or disruptions in FDA review processes could adversely affect our product development timelines, market entry strategies, and overall business performance.

In the EU, notified bodies must be officially designated to certify products and services in accordance with the EU MDR and EU IVDR.

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If a person knowingly or intentionally obtains or discloses PHI in violation of HIPAA requirements, criminal penalties may also be imposed.

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We maintain technical, organizational and contractual safeguards that we believe are reasonable and appropriate to protect the privacy and security of PHI and other personally identifiable information consistent with applicable laws and our contractual obligations;

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EU and EEA member states and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations.

For example, the GDPR imposes stringent operational requirements for processors and controllers of personal data in the context of an establishment in the

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EEA or the processing of personal data of individuals within the EEA and increases the scrutiny of transfer of personal data from the EEA.

For example, the GDPR imposes stringent operational requirements for processors and controllers of personal data in the context of an establishment in the EEA or the processing of personal data of individuals within the EEA and increases the scrutiny of transfer of personal data from the EEA.

Following the UK's withdrawal from the EEA and the EU, and the expiry of the transition period, companies will have to comply with the GDPR and the GDPR as incorporated into the UK national law (the UK GDPR).

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• Establishment of the Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

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• Payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain health care services through bundled payment models;

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In foreign countries where we market our products, recent healthcare reform has taken place as well.

For instance, in December 2021, the EU Regulation No 2021/2282 on Health Technology Assessment (HTA) amending Directive

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2011/24/EU was adopted.

For instance, in December 2021, the EU Regulation No 2021/2282 on Health Technology Assessment (HTA) amending Directive 2011/24/EU was adopted.

This Regulation intends to boost cooperation among EU member states in assessing health technologies, including certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas.

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Such laws include:

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• the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, in return for, either the referral of an individual or the purchase, lease, or order, or arranging for or recommending the purchase, lease, or order of any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid.

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These prohibitions apply regardless of any intent by the parties to induce or reward referrals or the reasons for the financial relationship and the referral;

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causing to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.

• the federal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent, or knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.

In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute or Stark Law constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

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Participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs and potentially limit our ability to offer certain marketplace discounts.

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Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state health care programs, including Medicare, Medicaid, Veterans Administration health programs and TRICARE.

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We expect to generate an increasing portion of our revenue and incur a significant portion of our expenses in currencies other than U.S.

To the extent we are unable to materially offset non-functional currency flows, exchange rate fluctuations could

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have a positive or negative impact on our financial condition and results of operations.

To the extent we are unable to materially offset non-functional currency flows, exchange rate fluctuations could have a positive or negative impact on our financial condition and results of operations.

Because our consolidated financial results are reported in U.S.

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Our failure to comply with those covenants could result in an event of default which, if not cured or waived, could result in the acceleration of all of our debt, which could adversely affect our business.

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Volatility in the securities markets, interest rates, and other factors could substantially increase our defined benefit plan costs.

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Tax authorities could challenge our positions related to transfer pricing and intercompany transactions, including the valuation of intangible assets.

Tax examinations can result in costly litigation with significant interest and penalties and ultimate settlement can take several

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Tax examinations can result in costly litigation with significant interest and penalties and ultimate settlement can take several years.

For example, we have engaged (and expect to continue to engage) with tax authorities over tax positions we have taken in connection with our acquisitions, and such examinations could cause us to incur significant expense (and adverse determinations by the tax authority could result in penalties) which could have an adverse effect on our financial results.

Our effective tax rate could fluctuate based on the geographic composition of income, which could significantly change based on our business results and acquisitions.

Our effective tax rate could also fluctuate based on changes in estimates, changes in excess tax benefits from share-based compensation, changes in non-deductible expenses, and the valuation of deferred tax assets and liabilities.

Our effective tax rate could also fluctuate based on changes in estimates, changes in excess tax benefits from share-based compensation, changes in nondeductible expenses, changes in tax laws and the valuation of deferred tax assets and liabilities.

These fluctuations could have an adverse effect on our financial results.

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