What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-02-24 compared with 2025-02-25 · 509 added, 438 removed, 836 unchanged (53% of the section changed)

11 unchanged sentences

COMPANY RISKS

We are dependent upon third parties for the manufacture and supply of a significant volume of our products and

We are dependent upon third parties for the manufacture/supply of a significant volume of our products and

where we manufacture products, we are dependent upon third parties

for raw materials and purchased

for raw materials/purchased components.

We obtain a significant volume of the products we distribute from third parties, with whom we generally do not

6 unchanged sentences

our aggregate purchases.

Additionally, where we are the manufacturer of certain dental specialty products we sell

in the areas of oral surgery, implants, orthodontics and endodontics, we are dependent upon third parties for raw

materials and purchased components.

Because of our dependence upon such suppliers, our operations

to the suppliers’ ability and willingness to supply products in the quantities

that we require, and the risks include

delays caused by interruption in production based on conditions outside

of our control, including a supplier’s failure

to comply with applicable government requirements (which may

result in product recalls and/or cessation of sales)

or an interruption in the suppliers’ manufacturing capabilities.

In the event of any such interruption in supply, we

would need to timely identify and obtain acceptable replacement sources.

There is no guarantee that we would be

able to obtain such alternative sources of supply on a timely basis,

if at all, and an extended interruption in supply,

particularly of a high-sales volume and/or high-margin product, could result in a

significant disruption in our sales

and operations, as well as damage to our relationships with customers

and our reputation.

In recent periods, we

have experienced increased costs and shortages of purchased components,

which has had a negative impact on our

profit margins and on our sales for certain product categories, due to our inability

to fully satisfy demand.

Additionally, where we are the manufacturer of products for our speciality business (

dental implants, endodontics, and orthopedics), we are dependent upon third parties

for raw materials and

purchased components.

Although no single supplier is material, because of our dependence

upon such suppliers,

our operations are subject to the suppliers’ ability and willingness to supply

products in the quantities that we

require, and the risks include delays caused by interruption in production

based on conditions outside of our

control, including a supplier’s failure to comply with applicable government

requirements (which may result in

product recalls, product detentions, and/or cessation of sales) or an interruption

in the suppliers’ manufacturing

capabilities.

In the event of any such interruption in supply, we would need to timely identify and obtain acceptable

replacement sources.

There is no guarantee that we would be able to obtain such alternative

sources of supply on a

timely basis, if at all, and an extended interruption in supply, particularly of a high-sales volume and/or high-

margin product, could result in a significant disruption in our sales and operations,

as well as damage to our

relationships with customers and our reputation.

We may be unsuccessful in achieving our strategic growth objectives.

1 unchanged sentence

Strategy” above.

continue to execute the BOLD+1 strategic priorities with the next evolution

of our strategic plan.

In particular, we

5 unchanged sentences

investments through our growth

Our business could be affected by the recently signed Strategic Partnership Agreement.

Our business could be affected by the Strategic Partnership Agreement with KKR.

On January 29, 2025, we announced a strategic investment by

1 unchanged sentence

leading global investment firm, and a Strategic Partnership Agreement (the “Partnership

Agreement”) with

In addition to KKR’s current holdings, KKR will make an additional $250 million investment in the

Company’s common stock.

As a result, KKR will become the largest non-index fund stockholder of the Company

with a 12% position.

KKR will also have the ability to purchase additional shares

via open market purchases up to

a total equity stake of 14.9% of the outstanding common shares of

Under the Partnership

Agreement, two representatives of KKR (the “Investor Designees”) will join our

Agreement”) with KKR.

Under the Partnership Agreement, two independent directors, Max Lin and

“Dan” Daniel, joined our

Board of Directors.

Investor Designees will also be nominated by our Board of Directors

to stand for election at our 2025 annual

meeting of stockholders for a term expiring at our 2026 annual meeting

of stockholders.

As part of the Partnership

Agreement, KKR has agreed to customary voting and other provisions.

Consummation of the transactions

contemplated by the Partnership Agreement is subject to customary

closing conditions, including the expiration or

On May16, 2025, we issued 3,285,151 shares of common stock

to funds affiliated with KKR

for an investment of $250 million, at approximately $76.10 per share.

Pursuant to the Partnership Agreement, KKR

also has the ability to purchase additional shares via open market purchases

up to a total equity stake of 14.9% of

the outstanding shares of common stock of the Company.

On November 4, 2025, the Company and KKR entered

into an amendment to the Partnership Agreement that increased the beneficial ownership

limit from 14.9% to19.9%

of the outstanding shares of the Company’s common stock that KKR is permitted to acquire during the

The standstill provisions, including the increased ownership limit,

continue in effect for a period of six

months following the later of the expiration of the term of the Partnership Agreement

and the date on which no

KKR director appointed pursuant to the Partnership Agreement is serving on

the Company’s Board of Directors.

On December 7, 2025, pursuant to the Partnership Agreement, KKR notified

the Company of its election to

exercise the Extension Election (as defined in the Partnership Agreement) whereby

the Company’s Board of

Index to Financial Statements

termination of any waiting period under the Hart-Scott-Rodino Act

and certain foreign regulatory approvals.

Partnership Agreement may have unintended consequences, such as

uncertainty about our management, operations,

or future strategic direction, which could result in the loss of future

business opportunities or negatively impact our

ability to attract and retain qualified talent.

Directors will renominate KKR’s designees, Max Lin and William K.

“Dan” Daniel, to stand for election at the

Company’s 2026 annual meeting of stockholders for a term expiring at the Company’s 2027 annual meeting of

stockholders.

The Partnership Agreement may have unintended consequences,

such as uncertainty about our

management, operations, or future strategic direction, which could

result in the loss of future business opportunities

or negatively impact our ability to attract and retain qualified talent.

KKR also invests in many different types of

businesses, and has or may

continue to invest in customers, suppliers, joint venture partners, or

other entities that have relationships with the

Company, or in competitors of such entities,

which may create unintended conflicts resulting in a loss of business.

businesses, and has or may continue to invest in customers, suppliers,

joint venture partners, or other entities that

have relationships with the Company, or in competitors of such entities, which may create unintended conflicts

resulting in a loss of business.

Our future growth (especially for our Global Technology and Global Specialty Products segments) is dependent

19 unchanged sentences

customer and patient experiences and drive efficiencies in certain areas of our business,

While these innovations

can present benefits to the Company, they also create risks and challenges.

If investments in such emerging

including, without

limitation, making AI features available within our practice management

systems, which, among other things, helps

dentists and clinical staff detect caries.

While these innovations can present benefits to the Company, they also

create risks and challenges.

The use of AI in healthcare offerings poses certain clinical risks resulting

potential misdiagnosis or misinformation provided from AI applications, diminishing

critical judgment, or loss of

interpersonal care from clinicians.

These deficiencies could undermine the decisions, predictions,

or analysis AI

applications produce, as well as their adoption, subjecting us to competitive

harm, legal liability (including under

new proposed legislation regulating AI in jurisdictions such as the EU

or new applications of existing data

protection, privacy, intellectual property, and other laws), regulatory actions, and reputational harm.

some AI scenarios, such as using AI applications to generate patient data

(including, without limitation, using AI to

capture and summarize patient interactions, and voice-activated perio charting),

present ethical, privacy, or other

social issues, risking reputational harm and/or reduced market demand

or acceptance of AI solutions.

safeguards we have designed to promote the ethical implementation

of AI may not be sufficient to protect us

against negative outcomes.

All of these risks are amplified by the critical nature of healthcare decisions

sensitivity of health-related information, and the occurrence of any of

the above could have a material adverse

effect on our business, financial condition or operating results.

Additionally, if investments in emerging

technologies are less successful at attracting and retaining customers than

4 unchanged sentences

Additionally, widely

assessable generative AI that rapidly surpasses our organizational ability to understand

accessible generative AI that rapidly surpasses our organizational ability to understand

associated risks and

opportunities (including employees’ failure to comply with policies governing

AI usage) could endanger our

intellectual property, lead to misuse of data and cause reputational harm.

opportunities (including employees’ failure to comply with principles,

policies and processes governing AI usage)

could endanger our intellectual property, lead to misuse or loss of data and cause reputational harm and other fines,

penalties or losses.

Risks inherent in acquisitions, dispositions and joint ventures could

11 unchanged sentences

acceptable prices;

Index to Financial Statements

our ability to consummate such transactions, which could potentially

be prohibited due to U.S.

antitrust regulations;

foreign antitrust regulations;

the liquidity of our investments and the availability of financing on

5 unchanged sentences

our ability to successfully integrate these companies’ operations, systems,

services, products and personnel

with our culture, management policies, legal, regulatory and compliance

policies, information technology

and cybersecurity systems and policies, internal procedures, working capital

management, financial,

operational and internal controls and strategies.

services, products and

personnel with our culture, management policies, legal, regulatory and compliance

information technology and cybersecurity systems and policies,

internal procedures, working capital

management, financial, operational and internal controls and strategies.

Furthermore, some of our acquisitions and future acquisitions may give

8 unchanged sentences

Dispositions may also involve continued financial

Index to Financial Statements

involvement in a divested business, such as through transition service agreements,

63 unchanged sentences

owned by our suppliers which,

Index to Financial Statements

consequently, could adversely impact certain of our supplier relationships.

2 unchanged sentences

to acquire sufficient products in a timely and

effective manner, is critical to ensuring, among other things, that customer confidence is not diminished.

effective manner, are critical to ensuring, among other things, that customer confidence is not diminished.

addition, we are exposed to the risk that our competitors or our large customers may

17 unchanged sentences

costs, such as professional fees, and the

diversion of management’s and our Board of Directors’ attention and resources from our businesses and strategic

Index to Financial Statements

diversion of management’s and our Board of Directors’ attention and resources from our business and strategic

Additionally, it could cause uncertainty about our management, operations or future strategic direction,

3 unchanged sentences

Activists or other stockholders holding a large portion of our outstanding shares

could also have

the ability to exert influence on actions requiring a stockholder vote,

including the election of directors and the

approval of certain extraordinary business transactions.

These risks could cause volatility in the trading price of our

common stock based on factors other than the fundamentals of our

could also exert

influence on actions requiring a stockholder vote, including the election of directors

and the approval of certain

extraordinary business transactions.

These risks could cause volatility in the trading price of our common

based on factors other than the fundamentals of our business.

INDUSTRY RISKS

17 unchanged sentences

provide products and services that maintain certain of our customers’ electronic

medical or dental records

(including protected health information of their patients);

medical or dental

records (including protected health information of their patients);

maintain and manage global human resources, compensation and payroll

4 unchanged sentences

effectively protect and support the current and future information requirements of the business.

In addition to health

information in our customers’ electronic medical and dental records,

certain of our IS stores other sensitive personal

and financial information, such as health care and other information related

to our employees and individuals we

service, as well as other sensitive information such as credit card

information from our third-party business

partners, that is confidential, and in many cases subject to privacy laws.

In addition to

health information in our customers’ electronic medical and dental records, certain

of our IS store other sensitive

personal and financial information, such as health care and other information

related to our employees and

individuals we service, as well as other sensitive information such as

credit card information from our third-party

business partners, that is confidential, and in many cases subject to privacy

Our IS are susceptible to, among other things, natural disasters, power

5 unchanged sentences

organized crime, hackers, terrorists and foreign state agents.

In particular, the health care industry has been

targeted by threat actors seeking to undermine companies’ cybersecurity defensive

We have processes in

place intended to ensure that our security measures keep pace with

new and emerging risks.

We regularly review,

monitor and implement multiple layers of security through technology, processes and our people.

security technologies designed to protect and maintain the integrity of

our IS and data, and our defenses are

monitored and routinely tested internally and by external parties.

Despite these efforts, our facilities and systems

and those of our third-party service providers have been, and may in

the future be, vulnerable to privacy and

security incidents, cybersecurity attacks and data breaches, acts of vandalism

or theft, computer viruses and other

malicious code, misplaced or lost data, programming and/or human errors,

attacks or other acts undermining IS of

third party business partners including our customers, or other similar events

that could impact the security,

The health care industry has been targeted by threat

actors seeking to undermine companies’ cybersecurity defensive

Moreover, cyberattacks have become

more difficult to detect and respond to.

They increasingly exploit AI and machine learning techniques,

Index to Financial Statements

generative AI-phishing, deepfake impersonations, automated vulnerability

discovery, adaptive malware and large-

scale credential-stuffing campaigns.

New subsidiaries that we acquire and non-integrated subsidiaries have

and may continue to be, targets to cyberattacks as we update their defensive measures

to meet our standards.

have processes in place intended to ensure that our security measures

keep pace with new and emerging risks.

regularly review, monitor and implement multiple layers of security through technology, processes and our people.

We utilize security technologies designed to protect and maintain the integrity of our IS and data, and our defenses

are monitored and routinely tested internally and by external parties.

Despite these efforts, our facilities and

systems and those of our third-party service providers have been, and

may in the future be, vulnerable to privacy

and security incidents, cybersecurity attacks and data breaches, acts of

vandalism or theft, computer viruses and

other malicious code, misplaced or lost data, programming and/or human

errors, attacks or other acts undermining

IS of third party business partners including our customers, or other similar

events that could impact the security,

reliability and availability of our systems.

8 unchanged sentences

particular cybersecurity incident given the constantly evolving nature of

We have incurred and may in

the future incur substantial costs as we update our cybersecurity defense

systems and our general computer controls

Index to Financial Statements

to meet evolving challenges, and legislative or regulatory action related

to cybersecurity may increase our costs to

develop or implement new technology products and services.

A cyberattack that bypasses or compromises our IS cybersecurity and/or

general information technology (“IT”)

controls (including third-party systems we rely on) causing an IS security breach

may lead, and has in the past led,

to a disruption of our IS business systems (including third-party systems we

rely on), interruption of operations

(including, without limitation, receiving, verifying and processing customer orders,

customer service, accounts

payable, warehouse management and shipping and systems tied

to internal controls over financial reporting), the

loss or alteration of business, financial and other protected information,

a negative impact on our financial

performance, and to an adverse impact on our financial accounting

and reporting controls.

A cyberattack that

bypasses or compromises our IS cybersecurity and/or general computer

controls or those of third parties with whom

we engage may also lead to claims against us by affected parties and/or governmental

agencies, and involve fines

and penalties, as well as substantial defense and settlement expenses.

Any of these impacts may alone, or

collectively, have a material impact on our business.

A successful cyberattack has, and may again in the future,

disrupt our business operations, adversely impact our financial accounting

and reporting of results of operations,

divert the attention of management, and adversely impact our results of

We have incurred, continue to

incur, and may in the future incur substantial costs as we update our cybersecurity defense systems

and our general

computer controls to meet evolving challenges, and legislative or regulatory

action related to cybersecurity which

may increase our costs to develop or implement new technology products

and services.

A cyberattack that bypasses or compromises our, or our vendors’, IS cybersecurity and/or general

technology (“IT”) controls (including third-party systems we rely on)

causing an IS security breach may lead, and

has in the past led, to a disruption of our, or our vendors’, IS business systems (including third-party systems

rely on), interruption of operations (including, without limitation, receiving,

verifying and processing customer

orders, customer service, accounts payable, warehouse management and

shipping and systems tied to internal

controls over financial reporting), the loss or alteration of business,

financial and other protected information, a

negative impact on our financial performance, and to an adverse

impact on our financial accounting and reporting

A cyberattack that bypasses or compromises our IS cybersecurity

and/or general computer controls or

those of third parties with whom we engage may also lead to claims against

us by affected parties and/or

governmental agencies, and involve fines and penalties, as well as substantial

defense and settlement expenses.

Any of these impacts may alone, or collectively, have a material impact on our business.

A successful cyberattack

has, and may again in the future, disrupt our business operations, adversely

impact our financial accounting and

reporting of results of operations, divert the attention of management,

and adversely impact our results of

In addition, we develop products and provide services to our customers

18 unchanged sentences

in connection with their efforts to comply with applicable privacy and security laws.

In addition to immaterial and unrelated prior incidents at certain of

our subsidiaries, in October 2023 Henry Schein

In addition to immaterial and unrelated incidents at certain of our subsidiaries,

in October 2023 Henry Schein

experienced a cybersecurity incident that primarily affected the operations of our

5 unchanged sentences

businesses were mostly unaffected.

The October 2023 cybersecurity incident disrupted key business

adversely impacted our financial results for the fourth quarter and full year 2023,

diverted attention of management,

and caused the Company to incur significant remediation costs.

The incident had residual impact on our financial

results in 2024, and we continue to review the effects of the incident on the Company’s business.

We have spent,

and plan to expend in the future, additional resources to continue

to protect against, or to address problems caused

by, business interruptions and data security breaches.

We also may be perceived as a more vulnerable target of the

cyber hackers as a result of the October 2023 incident.

Nevertheless, the October 2023 cybersecurity incident disrupted

operations, adversely impacted our financial results for the fourth quarter

and full year 2023, diverted attention of

management, and caused the Company to incur significant remediation

The incident had residual impact on

our financial results in 2024.

We have spent, and plan to expend in the future, additional resources to continue to

Index to Financial Statements

protect against, or to address problems caused by, business interruptions and data security breaches.

be perceived as a more vulnerable target of the cyber hackers as a result of the October

2023 incident.

The health care products distribution industry is highly competitive

26 unchanged sentences

by online commerce solutions.

Index to Financial Statements

The continued advancement of online commerce by third parties and online

12 unchanged sentences

political, economic and regulatory influences.

In recent years, the health care industry has been undergoing significant changes driven

by various efforts to reduce

costs, including, among other factors:

Uncertainty surrounding possible changes to the health care environment,

including changes to regulatory

enforcement priorities, may directly or indirectly adversely affect us.

In recent years, the health care industry has

been undergoing significant changes driven by various efforts to reduce costs, including, among

other factors:

trends toward managed care;

purchasing arrangements and

consolidation among office-based health care practitioners;

and changes in reimbursements

to customers, including

increased attention to value-based payment arrangements, as well as enforcement

activities (and related monetary

recoveries) by governmental officials.

Both our profitability and that of our customers may be

materially adversely

affected by laws and regulations reducing reimbursement rates for pharmaceuticals,

medical supplies and devices,

and/or medical treatments or services, or changes to the methodology

by which reimbursement levels are

If we are unable to react effectively to these and other changes in the

health care industry, our business

could be materially adversely affected.

The ACA greatly expanded health insurance coverage

in the United States

and has been the target of legal and political challenges since its adoption.

Any outcome of these challenges that

changes the ACA could have a significant impact on the U.S.

industry and the ability or willingness of

individuals to engage with it.

Expansion of GPOs, DSOs, MSOs or provider networks and the multi-tiered

costing structure may place us at a

collective purchasing arrangements and

consolidation among office-based health care

practitioners;

and changes in reimbursements to customers, including increased

attention to value-based payment

arrangements, as well as enforcement activities (and related

monetary recoveries) by governmental officials.

our profitability and that of our customers may be materially adversely

affected by laws and regulations reducing

reimbursement rates for pharmaceuticals, medical supplies and devices,

and/or medical treatments or services,

changes to the methodology by which reimbursement levels are determined,

or regulating pricing, contracting and

discounting practices with respect to medical products and services.

It is possible that the adoption of the One Big

Beautiful Bill Act could impact eligibility for participation in Medicare

and Medicaid programs, resulting in a

change in utilization of the health care system.

In addition, a number of states are considering and enacting laws

regulations to expand their oversight of health care transactions, which

may impact the financial stability and

strategic opportunities of certain of our customers.

If we are unable to react effectively to these and other changes

in the health care industry, our business could be materially adversely affected.

The ACA greatly expanded health

insurance coverage in the United States and has been the target of legal and political

challenges since its adoption.

Any outcome of these challenges that changes the ACA could have

a significant impact on the U.S.

industry and the ability or willingness of individuals to engage with it.

Expansion of GPOs, DSOs, MSOs or provider networks and the

multi-tiered costing structure may place us at a

competitive disadvantage.

9 unchanged sentences

Additionally, the formation of provider networks, GPOs, DSOs and MSOs may shift

Index to Financial Statements

purchasing decisions to entities or persons with whom we do not have a historical

24 unchanged sentences

we do not expect these

additional expenses to be material to our results now, however, they could be material in the future.

strikes or other service interruptions by those shippers, including at transportation

centers or shipping ports, could

cause our operating expenses to rise and materially adversely affect our ability

to deliver products on a timely basis.

Index to Financial Statements

additional expenses to be material to our results now, however they could become material in a future fiscal period.

Similarly, strikes or other service interruptions by those shippers, including at transportation centers or shipping

ports, could cause our operating expenses to rise and materially adversely

affect our ability to deliver products on a

timely basis.

MACRO-ECONOMIC AND POLITICAL RISKS

5 unchanged sentences

outlook of the United States, Europe, Asia and other parts of the

world could have a material adverse effect our

world could have a material adverse effect on our

business, financial condition or operating results.

These uncertainties, include, among other things, those listed

under “Managements Discussion and Analysis of Financial Condition and

Results of Operations, Cautionary Note

under “Management’s Discussion and Analysis of Financial Condition and Results of Operations, Cautionary

Regarding Forward-Looking Statements.”

37 unchanged sentences

may otherwise have a material adverse

Index to Financial Statements

effect on our business.

32 unchanged sentences

, physicians, dentists, teaching hospitals, other health care

practitioners).

We may be required to report information under state transparency laws that address circumstances

not covered by the Sunshine Act.

We are also subject to similar foreign transparency laws.

While we believe we

Index to Financial Statements

have substantially compliant programs and controls in place satisfying

the above laws and requirements, such

compliance imposes additional costs on us and the requirements

are sometimes unclear.

practitioners) as well as physician ownership or investment interest.

We may be required to report information

under state transparency laws that address circumstances not covered

by the Sunshine Act.

We are also subject to

similar foreign transparency laws.

While we believe we have substantially compliant programs and controls

place satisfying the above laws and requirements, such compliance imposes

additional costs on us and the

requirements are sometimes unclear.

Our business is subject to additional requirements under various local, state,

4 unchanged sentences

Among the federal laws with which we must comply are the Controlled Substances

Act, the FDC Act, the Federal Drug Quality and Security Act, including DSCSA,

and Section 361 of the Public

Health Services Act.

Among other things, such laws and the regulations promulgated

Act, the Food, Drug & Cosmetic Act, the Federal Drug Quality and Security

Act, including the Drug Supply Chain

Security Act, and Section 361 of the Public Health Services Act.

Among other things, such laws and the

regulations promulgated thereunder:

regulate the introduction, manufacture, advertising, marketing, promotion,

1 unchanged sentence

reimbursement, labeling, packaging, storage, handling, returning,

recalling, reporting, distribution of, and

recordkeeping for drugs, HCT/P products and medical devices, including

unique device identifiers;

recalling, reporting, distribution of,

disposal, and recordkeeping for drugs, HCT/P products and medical devices,

including unique device

subject us to inspection by the FDA, OSHA, and DEA and similar state

regulate the storage, transportation and disposal of

hazardous materials;

regulate the storage, transportation and disposal of hazardous materials;

require us to advertise and promote our drugs and devices in accordance

1 unchanged sentence

require us to report average sales price (ASP) to CMS for drugs or biologicals

payable under Medicare Part

B with or without a Medicaid drug rebate agreement;

payable under Medicare

Part B with or without a Medicaid drug rebate agreement;

require registration with the FDA and the DEA and various state agencies;

require us to design and operate a system to identify and report suspicious

orders of controlled substances

to the DEA and certain states;

orders of controlled

substances to the DEA and certain states;

require us to manage returns of products that have been recalled and subject

us to inspection of our recall

procedures and activities;

us to inspection of our

recall procedures and activities;

impose on us reporting requirements if a pharmaceutical, HCT/P product or

2 unchanged sentences

require manufacturers, wholesalers, re-packagers and dispensers of prescription

drugs to identify and trace

certain prescription drugs as they are distributed;

drugs to identify and

trace certain prescription drugs as they are distributed;

require the licensing of prescription drug wholesalers and third-party

2 unchanged sentences

handling and documentation of

transactions involving prescription drugs and associated reporting requirements.

transactions involving prescription drugs and devices and associated

reporting requirements.

The FDA regulates certain computer software and digital health products intended

4 unchanged sentences

software and related products to support physician

Index to Financial Statements

and dental practice management, and it is possible that the FDA or

5 unchanged sentences

respect to these products.

For example, some of our imaging software is

regulated as a medical device which

For example, some of our imaging software is regulated

as a medical device which

subjects our businesses to substantial additional requirements, costs

9 unchanged sentences

equipment and the importation and exportation of products.

The FDA and DEA, as well as CMS (including with

respect to complex Medicare reimbursement requirements applicable to our

specialty home medical supplies

business) and state Medicaid agencies, have recently increased their regulatory

and enforcement activities and, in

particular, the DEA has heightened enforcement activities due to the opioid crisis in the United

The FDA, DEA, OCR, and state privacy regulators, as

well as CMS (including with respect to complex Medicare reimbursement

requirements applicable to our specialty

home medical supplies business) and state Medicaid agencies, have

recently increased their regulatory and

enforcement activities and, in particular, the DEA has heightened enforcement activities due to the

opioid crisis in

the United States.

The failure to comply with any of these laws or regulations, or new interpretations

11 unchanged sentences

in place to ensure substantial

Index to Financial Statements

compliance, if it is determined that we have not complied with these laws,

17 unchanged sentences

for the medical device industry as a

Among other things, the EU MDR:

Among other things, as mentioned above, the EU

strengthens the rules on placing devices on the market and reinforces

4 unchanged sentences

improves the traceability of medical devices throughout the supply chain to

the end-user or patient through

a unique identification number;

the end-user or patient

through a unique identification number;

sets up a central database (EUDAMED) to provide patients, health care

professionals and the public with

comprehensive information on devices, importers, and distributors registered

professionals and the public

with comprehensive information on devices, importers, and distributors

registered in the EU;

strengthens rules for the assessment of certain high-risk devices, such

15 unchanged sentences

December 31, 2028 for medium and lower risk devices.

The modifications

created by the EU MDR may have an

The modifications created by the EU MDR may have an

impact on the way we design and manufacture products and the way we

conduct our business in the EEA.

Index to Financial Statements

If we fail to comply with laws and regulations relating to health care

35 unchanged sentences

or imposition of a corporate compliance

Index to Financial Statements

monitor, which could have a material adverse effect on our business.

10 unchanged sentences

federal False Claims Act penalties, and other fraud and abuse laws.

The United States government (among others) has expressed concerns

about financial relationships between

suppliers or manufacturers on the one hand and physicians, dentists

and other health care providers, on the

As a result, we regularly review and revise our marketing practices

as necessary to facilitate compliance.

government and industry trade associations (among others) have expressed

concerns about financial

relationships between suppliers or manufacturers on the one hand and

physicians, dentists and other health care

providers, on the other.

As a result, we regularly review and revise our marketing

practices as necessary to

facilitate compliance.

Our aspirations, goals and disclosures related to environmental, social

5 unchanged sentences

California has adopted stringent new climate disclosure requirements, as

As of April 4, 2024, the SEC

has temporarily suspended implementation of its climate disclosure rules.

In the EU, Directive No.

2019/1937 of October 23, 2019,

on the protection of persons who report breaches of

organizes the legal protection of whistleblowers.

This Directive covers whistleblowers reporting

breaches of EU laws and regulations and protects a wide range of people

including former employees.

companies with 50 or more employees are required to create effective internal reporting

All EU Member

States have now implemented the Directive.

We also are subject to the requirements of Directive No.

2022/2464 on corporate sustainability reporting (“CSRD”)

that became effective on January 5, 2023.

CSRD requires in-scope companies to report on sustainability-related

information that is material from a financial risk or opportunity perspective

to their business and from an impact

perspective on the environment or society.

The materiality of sustainability matters is subjective and

interpreted differently by various stakeholders.

CSRD, its transposition into national EU Member State law, and

associated guidance are evolving and reporting requirements may change,

which may further increase the costs of

complying with CSRD.

CSRD has not yet been fully implemented by all EU Member States.

We are subject to Directive (EU) 2022/2464 on corporate sustainability reporting (“CSRD”) which became

effective on January 5, 2023.

CSRD requires in-scope companies to report sustainability-related information

material from both a financial risk or opportunity and an environmental

or social impact perspective, and the

assessment of materiality is inherently subjective.

Furthermore, Directive No.

2025/794 of 14 April 2025, the

“Omnibus” Directive, amended Directive 2022/2464 by introducing a

two-year postponement of the sustainability

reporting requirements for financial years beginning on or after 1

January 2025 and on or after 1

January 2026.

This “Omnibus” legislative package amending the CSRD alters the scope,

thresholds, timing and contents of

reporting obligations, which may increase our costs.

CSRD is being transposed into national law across EU

Member States, and further legislative or implementation changes may

also increase our costs.

We also are subject to certain United States and foreign laws and regulations concerning the conduct of our foreign

9 unchanged sentences

laws and regulations.

Index to Financial Statements

In the EU, Directive No.

2019/1937 of October 23, 2019,

on the protection of persons who report breaches of

organizes the legal protection of whistleblowers.

This Directive covers whistleblowers reporting

breaches of EU laws and regulations and protects a wide range of people,

including former employees.

companies with 50 or more employees are required to create effective internal reporting

All EU Member

States have now implemented the Directive.

In the EU, both active and passive corruption in the private sector are

26 unchanged sentences

adverse effect on our business.

Index to Financial Statements

If we fail to comply with laws and regulations relating to the collection,

18 unchanged sentences

health data), such as HIPAA, CAN-SPAM,

TCPA, Section 5 of the FTC Act, the CCPA

and various other privacy laws that have or will soon come into

Laws and regulations relating to privacy and data protection are

continually evolving and subject to potentially

differing interpretations, including those relating to AI.

These requirements may not be harmonized, may be

interpreted and applied in a manner that is inconsistent from one jurisdiction

to another or may conflict with other

rules or our practices.

In addition, cybersecurity laws such as the federal Cyber Incident

Reporting for Critical

Infrastructure Act of 2022, proposed Federal Acquisition Regulations and

amendments to SEC reporting

requirements may require us to provide notifications about cybersecurity

incidents in limited timeframes and before

investigations are complete.

Our businesses’ failure to comply with these laws and regulations

could expose us to

breach of contract claims, substantial fines, penalties and other

liabilities and expenses, costs for remediation and

harm to our reputation.

Evolving laws and regulations in this area could restrict the

ability of our customers to

obtain, use or disseminate patient information, or could require us

to incur significant additional costs to re-design

our products to reflect these legal requirements, which could have

a material adverse effect on our operations.

TCPA, Section 5 of the FTC Act, the CCPA/CPRA

and various other privacy laws that have or will soon come

Laws and regulations relating to privacy and data protection

are continually evolving and subject to

potentially differing interpretations, including those relating to AI.

These requirements may not be harmonized,

may be interpreted and applied in a manner that is inconsistent from one

jurisdiction to another or may conflict with

other rules or our practices.

In addition to state-specific data breach notification laws (which exist in

and territories), cybersecurity laws such as the federal Cyber Incident

Reporting for Critical Infrastructure Act of

2022, proposed Federal Acquisition Regulations and amendments to SEC

reporting requirements may require us to

provide notifications about cybersecurity incidents in limited timeframes and

before investigations are complete.

Our businesses’ failure to comply with these laws and regulations could expose

us to breach of contract claims,

substantial fines, penalties and other liabilities and expenses, costs

for remediation and harm to our reputation.

Evolving laws and regulations in this area could restrict the ability

of our customers to obtain, use or disseminate

patient information, or could require us to incur significant additional

costs to re-design our products to reflect these

legal requirements, which could have a material adverse effect on our operations.

In addition, the European Parliament and the Council of the EU adopted

the GDPR effective from May 25, 2018,

which increased privacy rights for Data Subjects, including individuals

who are our customers, suppliers and

The GDPR extended the scope of responsibilities for data controllers

and data processors, and

generally imposes increased requirements and potential penalties on companies,

such as us, that are either

established in the EU and process personal data of Data Subjects (regardless

the Data Subject location), or that are

not established in the EU but that offer goods or services to Data Subjects in the EU

or monitor their behavior in the

Noncompliance can result in penalties of up to the greater of EUR 20

million, or 4% of global company

revenues (sanction that may be public), and Data Subjects may seek damages.

Member states may individually

impose additional requirements and penalties regarding certain limited

matters (for which the GDPR left some

room of flexibility), such as employee personal data.

With respect to the personal data it protects, the GDPR

requires, among other things, controller accountability, consents from Data Subjects or another acceptable legal

basis to process the personal data, notification within 72 hours

of a personal data breach where required, data

integrity and security, and fairness and transparency regarding the storage, use or other processing of the personal

the GDPR that has been effective since

May 25, 2018, which increased privacy rights for Data Subjects in

the European Economic Area (EEA), including

individuals who are our customers, suppliers and employees.

The GDPR extended the scope of responsibilities for

data controllers and data processors, and generally imposes increased

requirements and potential penalties on

companies, such as us, that are either established in the EU and process personal

data of Data Subjects (regardless

Index to Financial Statements

the Data Subject location), or that are not established in the EU but

that offer goods or services to Data Subjects in

the EU or monitor their behavior in the EU.

Noncompliance can result

in penalties of up to the greater of EUR 20

million, or 4% of global company revenues (sanction that may be public),

and Data Subjects may seek damages.

Member states may individually impose additional requirements and penalties

regarding certain limited matters (for

which the GDPR left some room of flexibility), such as employee personal data.

With respect to the personal data

it protects, the GDPR requires, among other things, controller accountability, consents from Data Subjects or

another acceptable legal basis to process the personal data, notification

within 72 hours of a personal data breach

where required, data integrity and security, and fairness and transparency regarding the storage, use or other

processing of the personal data.

The GDPR also provides rights to Data Subjects relating notably

to information, access, rectification, erasure

of the personal data and the right to object to the processing.

Despite Brexit, the UK also has data protection laws

equivalent to the GDPR).

to information,

access, rectification, erasure of the personal data and the right to object to

the processing.

Despite Brexit, the UK

also has data protection laws equivalent to the GDPR and has implemented

further data protection related

Switzerland enacted FADP.

Uncertainty about compliance with these data protection

laws remains, with the possibilities that data protection authorities located

in different EU Member States may

interpret GDPR differently, or requirements of national laws may vary between the EU Member States, or guidance

on GDPR and compliance practices may be often updated or otherwise revised.

Any of these events will increase

the complexity and costs of processing personal data in the European Economic

Area, UK or Switzerland or

concerning individuals located in these jurisdictions.

Data protection authorities located in different EU Member States may

interpret GDPR differently, or requirements of national laws may vary between the EU Member States, UK and

Switzerland, or guidance on GDPR and related laws and compliance practices

may be often updated or otherwise

Any of these events will increase the complexity and costs of

processing personal data in the European

Economic Area, UK or Switzerland or concerning individuals located

in these jurisdictions.

Effective November 1, 2021, China’s PIPL imposes specific rules for processing personal information and specifies

11 unchanged sentences

entities that process personal data.

Data protection laws in other countries are also quickly

evolving, with many

Index to Financial Statements

countries having updated, or are in the process of updating, their

laws to bring them more in line with the model

created by GDPR.

Data protection laws in other countries, such as Brazil, are

evolving, with many countries having updated, or are in the process

of updating, their laws to bring them more in

line with the model created by GDPR.

In the United States, the CCPA, effective January 1, 2020, establishes a privacy framework for covered businesses

2 unchanged sentences

severe statutory damages framework for

violations of the CCPA, as well as potentially severe statutory damages and private a right of action against

violations of the CCPA, as well as potentially severe statutory damages and a private right of action against

businesses that suffer a data security breach due to their violation of a duty to

1 unchanged sentence

procedures and practices.

This private right of action may increase the

likelihood of, and risks associated with, data

This private right of action may increase the likelihood of, and risks associated

breach litigation.

3 unchanged sentences

exist under the CCPA.

have enacted or are considering enacting similar privacy laws, which may

subject us to additional requirements and

Effective as of

January 1, 2026, the CCPA/CPRA regulatory framework includes expanded requirements.

Other states have

enacted or are considering enacting similar privacy laws, which may subject

us to additional requirements and

restrictions that could have an impact on our business.

Comprehensive privacy laws in a number of other states are

now in effect, and similarly enacted broad laws relating to privacy, data protection, and information security that

will come into effect later in 2025 and 2026, further complicating our privacy compliance

obligations through the

introduction of increasingly disparate requirements across the various

jurisdictions in which we operate.

Additionally, certain other states have enacted specific health data privacy laws and other states are considering

similar legislation.

Congress is considering legislation that may preempt some or

all of such U.S.

state privacy

laws, but which may also provide a more expansive private right of action

for privacy claims than exists under

As of January 1, 2026, comprehensive privacy laws are now

in effect in 20 states, further complicating our privacy compliance obligations through

the introduction of

increasingly disparate requirements across the various U.S.

jurisdictions

in which we operate.

Additionally, certain

states have enacted specific health data privacy laws and other states

are considering similar legislation.

is considering legislation that may preempt some or all of such U.S.

privacy laws, but which may also provide

a more expansive private right of action for privacy claims than exists under

current state laws.

The evolving complexity of privacy and data security legislation in

the United States may complicate our

compliance efforts and further increase our risk of regulatory enforcement, penalties

and litigation.

believe we have substantially compliant programs and controls in place

to comply with privacy laws domestically

and internationally, our compliance with data privacy and cybersecurity laws is likely to impose additional costs

us, and we cannot predict whether the interpretations of the requirements,

or changes in our practices in response to

new requirements or interpretations of the requirements, could have a

material adverse effect on our business.

Further, countries are applying their data and consumer protection laws to AI, particularly generative

considering and implementing specific legal frameworks with respect

to AI, for example the EU AI Act 2024

(which as with the GDPR, will have extra-territorial effect).

Any failure or perceived failure by us to comply with

such requirements could have an adverse impact on our business.

Anticipated further evolution of regulations and

legislation on this topic may substantially increase the penalties

to which we could be subject in the event of any

and other jurisdictions globally may

complicate our compliance efforts and further increase our risk of regulatory enforcement,

penalties and litigation.

While we believe we have substantially compliant programs and controls

in place to comply with privacy laws

domestically and internationally, our compliance with data privacy and cybersecurity laws is likely to impose

additional costs on us, and we cannot predict whether the interpretations

of the requirements, or changes in our

practices in response to new requirements/interpretations, could have

a material adverse effect on our business.

Our products and services utilize new technologies, such as AI.

The regulatory landscape for AI is changing

rapidly, with both domestic and international activity.

While there is currently no comprehensive federal legislation

concerning the use, development or deployment of AI, regulators

pursue AI-related enforcement actions

under existing federal consumer protection laws and have issued related

Further, state privacy, consumer

Index to Financial Statements

protection and AI-specific laws are proliferating and may be applicable to our

Other countries are also

applying their data and consumer protection laws to AI, particularly

generative AI, and are considering and

implementing specific legal frameworks with respect to AI.

Regulation (EU) 2024/1689 on harmonized rules on

artificial intelligence (the EU AI Act), for example, establishes a comprehensive

regulatory framework for AI that

became law in August 2024 with implementation phased through

As with the GDPR, it has extra-

territorial effect.

Any failure or perceived failure by us to comply with such requirements

could have an adverse

impact on our business.

Anticipated further evolution of regulations and legislation

on this topic may substantially

increase the penalties to which we could be subject in the event of any

non-compliance.

Compliance with these laws is challenging, constantly evolving

and time consuming and federal

regulators, state attorneys general and plaintiff’s attorneys have been and will

likely continue to be active in this

We may incur substantial expense in complying with legal obligations to be imposed by new regulations

and we may be required to make significant changes to our solutions and

expanding business operations, all of

which may adversely affect our operations.

Compliance with these

laws is challenging, constantly evolving and time consuming and federal

regulators, state attorneys general and

plaintiff’s attorneys have been and will likely continue to be active in this space.

We may incur substantial expense

in complying with legal obligations to be imposed by new regulations

and we may be required to make significant

changes to our solutions and expanding business operations, all of which

may adversely affect our operations.

We also sell products and services that health care providers, such as physicians and dentists, use to store and

1 unchanged sentence

These customers and we are subject to laws, regulations and

standards, such as HIPAA and the Payment Card Industry Data Security Standards, which require the protection of

the privacy and security of those records.

Our products or services may be used as part of these customers’

comprehensive data security programs, including in connection with their

efforts to comply with applicable data

privacy and security laws and contractual requirements.

Perceived or actual security vulnerabilities in our products

or services, or the perceived or actual failure by us or our customers who

use our products or services to comply

with applicable legal or contractual data privacy and security requirements,

may not only cause us significant

reputational harm, but may also lead to claims against us by our customers

and/or governmental agencies and

involve substantial fines, penalties and other liabilities and expenses

and costs for remediation.

Additionally, under

the GDPR, health data belong to the category of “sensitive data” and benefit

from specific protection.

of such data is generally prohibited, except for specific exceptions.

standards, such as HIPAA and the Payment Card Industry (PCI) Data Security Standards, which require the

protection of the privacy and security of those records.

Our products or services may be used as part of these

customers’ comprehensive data security programs, including in connection

with their efforts to comply with

applicable data privacy and security laws and contractual requirements.

Perceived or actual security vulnerabilities

in our products or services, or the perceived or actual failure by us

or our customers who use our products or

services to comply with applicable legal or contractual data privacy and

security requirements, may not only cause

us significant reputational harm, but may also lead to claims against us by our

customers and/or governmental

agencies and involve substantial fines, penalties and other liabilities and

expenses and costs for remediation.

Additionally, under the GDPR (and equivalent laws) and U.S.

state privacy laws, health data belong to the category

of “sensitive data” and benefit from specific protection.

Processing of such data is generally prohibited, except for

specific exceptions.

Certain of our businesses involve the manufacture and sale of electronic

5 unchanged sentences

In order to maintain

Index to Financial Statements

certification of our EHR products, we must satisfy the changing governmental

36 unchanged sentences

that could materially

Index to Financial Statements

adversely affect our tax positions.

43 unchanged sentences

that are manufactured in whole or in part

Index to Financial Statements

by forced labor or through human trafficking, as a result of legislative and governmental

5 unchanged sentences

and liquidity may be negatively

impacted by the effects of disease outbreaks, epidemics, pandemics, or similar wide-spread

public health

impacted by the effects of disease outbreaks, epidemics, pandemics, or similar wide-spread public

concerns and other natural or man-made disasters, such as terrorism, civil

19 unchanged sentences

facilities, or firmwide systems such as our IS.

Our global operations are subject to inherent risks that could materially adversely

affect our business.

Our global operations are subject to inherent risks that could materially

adversely affect our business.

Our global operations are subject to risks that could materially adversely affect our business,

1 unchanged sentence

other things:

Index to Financial Statements

difficulties and costs relating to staffing and managing foreign operations;

3 unchanged sentences

uncertainties relating to trade agreements and international trade relationships;

longer payment cycles of foreign customers and difficulty of collecting receivables

in foreign jurisdictions;

longer payment cycles and difficulty of collecting receivables in foreign jurisdictions;

repatriation of cash from our foreign operations to the United States;

regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining to

the accuracy of our internal books and records;

regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining

to the accuracy of our internal books and records;

litigation risks;

unexpected difficulties in importing or exporting our products and import/export

tariffs, quotas, sanctions

or penalties;

tariffs, quotas,

sanctions or penalties;

limitations on our ability under local laws to protect our intellectual

4 unchanged sentences

risks associated with climate change, including physical risks such as

impacts from extreme weather events

and other potential physical consequences, regulatory and technological

impacts from extreme weather

events and other potential physical consequences, regulatory and technological

requirements, market

5 unchanged sentences

products that we distribute.

On July 15, 2025, the Company announced that Mr.

Bergman will retire as the Company’s CEO on December 31,

2025 (which date was extended to March 1, 2026), and that Mr.

Bergman will continue to serve as Chairman of the

Board of Directors of the Company following his retirement.

On January 12, 2026, the Company announced the

appointment of Frederick M.

Lowery as its next CEO, effective March 2, 2026, at

which time he will join the

Company’s Board of Directors.

Our future success is substantially dependent upon the efforts and abilities of

members of our existing senior

management, particularly Stanley M.

Bergman, Chairman and Chief Executive Officer.

In November 2022, Mr.

Bergman’s employment agreement was extended through December 31, 2025.

Although the Company has an

internal succession plan for its senior leadership team, including Mr.

Bergman, the loss of the services of Mr.

Bergman could have a material adverse effect on our business.

We do not currently have “key man” life insurance

Index to Financial Statements

policies on any of our employees.

members of our senior management.

Competition for senior management is intense, burnout and turn-over rates

increasing workplace concerns, and we may not be successful in

attracting and retaining key personnel.

are increasing workplace concerns,

transitions among senior level officers can present challenges as well as opportunities,

and we may not be

successful in attracting and retaining key personnel, or transitioning to

new personnel following departures.

Additionally, our future revenues and profitability depend on our ability to maintain satisfactory relationships with

14 unchanged sentences

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