5 unchanged sentences
The Company believes that the following
−Removed: risks could have a material adverse impact on our business, reputation, financial
+Added: risks could have a material adverse impact on our business, reputation, operating
results, financial condition and/or
3 unchanged sentences
COMPANY RISKS
−Removed: We are dependent upon third parties for the manufacture and supply of a significant volume of our products.
+Added: We are dependent upon third parties for the manufacture and supply of a significant volume of our products and
+Added: where we manufacture products, we are dependent upon third parties
+Added: for raw materials and purchased
We obtain a significant volume of the products we distribute from third parties, with whom we generally do not
2 unchanged sentences
aggregate, supply a significant portion of the products we sell.
−Removed: In 2023, our top 10 health care distribution suppliers
−Removed: and our single largest supplier accounted for approximately 25% and 4%, respectively, of our aggregate purchases.
−Removed: Because of our dependence upon such suppliers, our operations are
−Removed: subject to the suppliers’ ability and willingness
−Removed: to supply products in the quantities that we require, and the risks include delays
−Removed: caused by interruption in
−Removed: production based on conditions outside of our control, including
−Removed: a supplier’s failure to comply with applicable
−Removed: government requirements (which may result in product recalls and/or
−Removed: cessation of sales) or an interruption in the
−Removed: suppliers’ manufacturing capabilities.
−Removed: In the event of any such interruption in supply, we would need to identify
−Removed: and obtain acceptable replacement sources on a timely basis.
−Removed: There is no guarantee that we would be able to obtain
−Removed: such alternative sources of supply on a timely basis, if at all, and an extended
−Removed: interruption in supply, particularly of
−Removed: a high-sales volume product, could result in a significant disruption in our
−Removed: sales and operations, as well as damage
−Removed: to our relationships with customers and our reputation.
−Removed: In addition, certain of our suppliers have had their ability to
−Removed: service certain markets restricted or negatively impacted because
−Removed: of allegations of forced labor in their supply
−Removed: Forced labor legislation affecting the supply chain has increased around
−Removed: the world, and the United States
−Removed: recently passed the Uyghur Forced Labor Prevention Act.
−Removed: Our supply chain could be materially disrupted if our
−Removed: suppliers fail to comply with, or are unable to satisfy our demand
−Removed: for products, as a result of applicable forced labor
−Removed: legislation and regulations.
−Removed: acceptance with acceptable margins.
+Added: In 2024, our top 10 Global Distribution and Value-
+Added: Added Services suppliers and our single largest supplier accounted for approximately
+Added: 25% and 4%, respectively, of
+Added: our aggregate purchases.
+Added: Additionally, where we are the manufacturer of certain dental specialty products we sell
+Added: in the areas of oral surgery, implants, orthodontics and endodontics, we are dependent upon third parties for raw
+Added: materials and purchased components.
+Added: Because of our dependence upon such suppliers, our operations
+Added: to the suppliers’ ability and willingness to supply products in the quantities
+Added: that we require, and the risks include
+Added: delays caused by interruption in production based on conditions outside
+Added: of our control, including a supplier’s failure
+Added: to comply with applicable government requirements (which may
+Added: result in product recalls and/or cessation of sales)
+Added: or an interruption in the suppliers’ manufacturing capabilities.
+Added: In the event of any such interruption in supply, we
+Added: would need to timely identify and obtain acceptable replacement sources.
+Added: There is no guarantee that we would be
+Added: able to obtain such alternative sources of supply on a timely basis,
+Added: if at all, and an extended interruption in supply,
+Added: particularly of a high-sales volume and/or high-margin product, could result in a
+Added: significant disruption in our sales
+Added: and operations, as well as damage to our relationships with customers
+Added: and our reputation.
+Added: In recent periods, we
+Added: have experienced increased costs and shortages of purchased components,
+Added: which has had a negative impact on our
+Added: profit margins and on our sales for certain product categories, due to our inability
+Added: to fully satisfy demand.
+Added: We may be unsuccessful in achieving our strategic growth objectives.
+Added: Our 2022 – 2024 BOLD+1 Strategic Plan is defined under “Business, Business
+Added: Strategy” above.
+Added: continue to execute the BOLD+1 strategic priorities with the next evolution
+Added: of our strategic plan.
+Added: In particular, we
+Added: are focused on continuing to grow our Henry Schein specialty brands
+Added: and technology and value-added services
+Added: solutions both organically and inorganically, and to drive greater efficiencies.
+Added: If we are unable to effectively
+Added: implement our strategic plan, we may not achieve our desired return on our
+Added: investments through our growth
+Added: Our business could be affected by the recently signed Strategic Partnership Agreement.
+Added: On January 29, 2025, we announced a strategic investment by
+Added: funds affiliated with KKR & Co.
+Added: leading global investment firm, and a Strategic Partnership Agreement (the “Partnership
+Added: Agreement”) with
+Added: In addition to KKR’s current holdings, KKR will make an additional $250 million investment in the
+Added: Company’s common stock.
+Added: As a result, KKR will become the largest non-index fund stockholder of the Company
+Added: with a 12% position.
+Added: KKR will also have the ability to purchase additional shares
+Added: via open market purchases up to
+Added: a total equity stake of 14.9% of the outstanding common shares of
+Added: Under the Partnership
+Added: Agreement, two representatives of KKR (the “Investor Designees”) will join our
+Added: Board of Directors.
+Added: Investor Designees will also be nominated by our Board of Directors
+Added: to stand for election at our 2025 annual
+Added: meeting of stockholders for a term expiring at our 2026 annual meeting
+Added: of stockholders.
+Added: As part of the Partnership
+Added: Agreement, KKR has agreed to customary voting and other provisions.
+Added: Consummation of the transactions
+Added: contemplated by the Partnership Agreement is subject to customary
+Added: closing conditions, including the expiration or
+Added: Index to Financial Statements
+Added: termination of any waiting period under the Hart-Scott-Rodino Act
+Added: and certain foreign regulatory approvals.
+Added: Partnership Agreement may have unintended consequences, such as
+Added: uncertainty about our management, operations,
+Added: or future strategic direction, which could result in the loss of future
+Added: business opportunities or negatively impact our
+Added: ability to attract and retain qualified talent.
+Added: KKR also invests in many different types of
+Added: businesses, and has or may
+Added: continue to invest in customers, suppliers, joint venture partners, or
+Added: other entities that have relationships with the
+Added: Company, or in competitors of such entities,
+Added: which may create unintended conflicts resulting in a loss of business.
+Added: Our future growth (especially for our Global Technology and Global Specialty Products segments) is dependent
+Added: upon our ability to develop or acquire and maintain and protect
+Added: new products and services and utilize new
+Added: technologies that achieve market acceptance with acceptable margins.
Our future success depends on our ability to timely develop (or obtain the right
to sell) competitive and innovative
−Removed: (particularly for our technology and value-added services segment)
−Removed: products and services and to market them
−Removed: quickly and cost-effectively.
−Removed: Our ability to anticipate customer needs and emerging trends and develop or acquire
−Removed: new products, services and technologies at competitive prices requires significant
−Removed: resources, including employees
−Removed: with the requisite skills, experience and expertise, particularly in our
−Removed: technology segment, including dental practice
−Removed: management, patient engagement and demand creation software solutions.
−Removed: The failure to successfully address these
−Removed: challenges could materially disrupt our sales and operations.
−Removed: Additionally, our software and e-services products,
−Removed: like software products generally, may contain undetected errors or bugs when introduced or as new versions are
−Removed: Any such defective software may result in increased expenses
−Removed: related to the software and could adversely
−Removed: affect our relationships with customers as well as our reputation.
−Removed: With respect to certain software and e-services
−Removed: that we develop, we rely primarily upon copyright, trademark and
−Removed: trade secret laws, as well as contractual and
−Removed: common law protections and confidentiality obligations.
−Removed: We cannot provide assurance that such legal protections
−Removed: will be available, adequate or enforceable in a timely manner to protect
−Removed: our software or e-services products.
+Added: (particularly for our Global Technology and Global Specialty Products segments) products and services and utilize
+Added: new technologies, such as artificial intelligence (“AI”) (among other emerging technologies)
+Added: and to market them
+Added: and/or utilize them quickly and cost-effectively.
+Added: Our ability to anticipate customer needs and emerging trends and
+Added: develop or acquire new products, services and technologies at competitive
+Added: prices requires significant resources,
+Added: including employees with the requisite skills, experience and expertise, particularly
+Added: in our Global Technology
+Added: segment, including dental practice management, patient engagement
+Added: and demand creation software solutions.
+Added: failure to successfully address these challenges could materially disrupt
+Added: our sales and operations.
+Added: We have increased and expect to continue to increase our use of AI technologies in various contexts to improve
+Added: customer and patient experiences and drive efficiencies in certain areas of our business.
+Added: While these innovations
+Added: can present benefits to the Company, they also create risks and challenges.
+Added: If investments in such emerging
+Added: technologies are less successful at attracting and retaining customers than
+Added: similar investments by our competitors,
+Added: or if we are otherwise unsuccessful at realizing the benefits of these
+Added: technological investments generally, this could
+Added: have a material adverse effect on our business, financial condition, or operating
+Added: Additionally, widely
+Added: assessable generative AI that rapidly surpasses our organizational ability to understand
+Added: associated risks and
+Added: opportunities (including employees’ failure to comply with policies governing
+Added: AI usage) could endanger our
+Added: intellectual property, lead to misuse of data and cause reputational harm.
Risks inherent in acquisitions, dispositions and joint ventures could
offset the anticipated benefits.
−Removed: One of our business strategies has been to expand our domestic and
−Removed: international markets in part through
−Removed: acquisitions and joint ventures and we expect to continue to make acquisitions
−Removed: and enter into joint ventures in the
−Removed: Such transactions require significant management attention,
−Removed: may place significant demands on our
−Removed: operations, information systems, legal, regulatory, compliance, financial, and human resources functions, and
−Removed: is risk that one or more may not succeed.
−Removed: We cannot be sure, for example, that we will achieve the benefits of
−Removed: revenue growth that we expect from these acquisitions or joint ventures
−Removed: or that we will avoid unforeseen additional
−Removed: costs, taxes, or expenses.
−Removed: Our ability to successfully implement our acquisition and joint venture
−Removed: strategy depends
−Removed: upon, among other things, the following:
+Added: One of our business strategies has been to expand in part through acquisitions
+Added: and joint ventures and we expect to
+Added: continue to make acquisitions and enter into joint ventures in the future.
+Added: There is risk that one or more may not
+Added: We cannot be sure, for example, that we will achieve the benefits of revenue growth that we expect from
+Added: these transactions or that we will avoid unforeseen additional costs, taxes,
+Added: Our ability to successfully
+Added: implement our acquisition and joint venture strategy depends upon,
+Added: among other things, the following:
the availability of suitable acquisition or joint venture candidates at
2 unchanged sentences
be prohibited due to U.S.
−Removed: foreign antitrust regulations;
+Added: antitrust regulations;
the liquidity of our investments and the availability of financing on
4 unchanged sentences
companies we acquire;
−Removed: our ability to successfully integrate these companies’ operations, services,
−Removed: products and personnel with
−Removed: our culture, management policies, legal, regulatory, and compliance policies, cybersecurity systems and
−Removed: policies, internal procedures, working capital management, financial,
−Removed: and operational controls and
+Added: our ability to successfully integrate these companies’ operations, systems,
+Added: services, products and personnel
+Added: with our culture, management policies, legal, regulatory and compliance
+Added: policies, information technology
+Added: and cybersecurity systems and policies, internal procedures, working capital
+Added: management, financial,
+Added: operational and internal controls and strategies.
Furthermore, some of our acquisitions and future acquisitions may give
3 unchanged sentences
financial results individually or in the aggregate.
−Removed: Additionally, when we decide to sell assets or a business, we may encounter difficulty in finding buyers or
−Removed: executing alternative exit strategies on acceptable terms in a timely manner, which could delay
−Removed: the accomplishment
−Removed: of our strategic objectives.
−Removed: Alternatively, we may dispose of assets or a business at a price or on terms that are less
−Removed: than we had anticipated.
−Removed: Dispositions may also involve continued financial involvement
−Removed: in a divested business,
−Removed: such as through transition service agreements, indemnities or other current
−Removed: or contingent financial obligations.
−Removed: Under these arrangements, performance by the acquired or divested
−Removed: business, or other conditions outside our
−Removed: control, could affect our future financial results.
+Added: Additionally, when we decide to sell assets or a business, we may
+Added: encounter difficulty in finding buyers or timely executing alternative exit strategies
+Added: on acceptable terms, which
+Added: could delay the accomplishment of our strategic objectives.
+Added: Dispositions may also involve continued financial
+Added: Index to Financial Statements
+Added: involvement in a divested business, such as through transition service agreements,
+Added: indemnities or other current or
+Added: contingent financial obligations.
Certain provisions in our governing documents and other documents to
which we are a party may discourage
−Removed: third parties from seeking to acquire us that might otherwise result in
−Removed: our stockholders receiving a premium
+Added: third parties from seeking to acquire us that might otherwise result
+Added: in our stockholders receiving a premium
over the market price of their shares.
14 unchanged sentences
In addition, certain of our employee incentive plans provide
−Removed: accelerated vesting of stock options and other awards upon termination without
−Removed: cause within two years following a
−Removed: change in control, or grant the plan committee discretion to accelerate
−Removed: awards upon a change of control.
−Removed: certain agreements between us and our executive officers provide for increased severance
−Removed: payments and certain
−Removed: benefits if those executive officers are terminated without cause by us or if they terminate
−Removed: for good reason, in each
−Removed: case within two years following a change in control or within ninety days prior
−Removed: to the effective date of the change in
−Removed: control or after the first public announcement of the pendency of the change
+Added: accelerated vesting of equity awards upon termination without cause within
+Added: two years following a change in
+Added: control, or grant the plan committee discretion to accelerate awards
+Added: upon a change of control.
+Added: Further, certain
+Added: agreements between us and our executive officers provide for increased severance
+Added: payments and certain benefits if
+Added: those executive officers are terminated without cause by us or if they terminate
+Added: for good reason, in each case within
+Added: two years following a change in control or within ninety days prior to the
+Added: effective date of the change in control or
+Added: after the first public announcement of the pendency of the change
Adverse changes in supplier rebates or other purchasing incentives
could negatively affect our business.
−Removed: products from
−Removed: many suppliers
−Removed: purchasing incentive based on the attainment of certain growth
+Added: The terms on which we purchase or sell products from many suppliers may
+Added: entitle us to receive a rebate or other
+Added: purchasing incentive based on the attainment of certain growth goals.
Suppliers may reduce or eliminate rebates or
−Removed: branded products
−Removed: or incentives
−Removed: conditioned upon
−Removed: achievement of
+Added: incentives offered under their programs, or increase the growth goals or other conditions
+Added: we must meet to earn
+Added: rebates or incentives to levels that we cannot achieve.
+Added: Increased competition either from generic or equivalent
+Added: branded products could result in us failing to earn rebates or incentives
+Added: that are conditioned upon achievement of
growth goals.
−Removed: Additionally, factors outside
−Removed: of our control, such as customer
−Removed: preferences, consolidation of suppliers
−Removed: or supply issues, can have a material impact on
−Removed: our ability to achieve the growth goals established by
−Removed: our suppliers,
−Removed: incentives we
−Removed: have an adverse impact on our business, financial condition or operating
−Removed: Sales of corporate brand products entail additional risks, including the risk that such sales could
−Removed: adversely affect
−Removed: our relationships with suppliers.
−Removed: certain corporate brand products that are available exclusively from us.
−Removed: The sale of such products subjects
−Removed: us to the risks generally encountered by entities that source, market and sell corporate brand products, including but
−Removed: potential product
−Removed: liability risks,
−Removed: voluntary product
−Removed: recalls, potential
−Removed: business, financial
−Removed: products owned by our
−Removed: suppliers which, consequently,
−Removed: could adversely impact certain
−Removed: of our supplier relationships.
−Removed: Our ability to locate qualified, economically stable suppliers who satisfy our requirements, and to
−Removed: acquire sufficient
−Removed: and effective
−Removed: customer confidence
−Removed: not diminished.
−Removed: In addition, we
−Removed: are exposed to
−Removed: that our competitors
−Removed: customers may introduce
−Removed: private label,
−Removed: low-cost products
−Removed: products could
−Removed: capture significant
−Removed: market prices
−Removed: overall, eroding
−Removed: to develop sourcing
−Removed: relationships with a
−Removed: broad and deep
−Removed: supplier base could
−Removed: have an adverse
−Removed: our business, financial condition or operating results.
+Added: Additionally, factors outside of our control, such as customer preferences, consolidation of suppliers
+Added: or supply issues, can have a material impact on our ability to achieve
+Added: the growth goals established by our suppliers,
+Added: which may reduce the amount of rebates or incentives we receive.
+Added: Sales of corporate brand products and products that we manufacture
+Added: entail additional risks, including the risk
+Added: that such sales could materially adversely affect our relationships with suppliers.
+Added: certain corporate brand products that are available exclusively
+Added: The sale of such corporate brand
+Added: products and the sale of products that we manufacture subject us to
+Added: potential product liability risks, mandatory or
+Added: voluntary product recalls, potential supply chain and distribution chain
+Added: disruptions and potential intellectual
+Added: property infringement risks, among other risks.
+Added: In addition, an increase in the sales of our corporate brand products
+Added: and our own manufactured products may negatively affect our sales of products
+Added: owned by our suppliers which,
+Added: consequently, could adversely impact certain of our supplier relationships.
+Added: Our ability to locate qualified,
+Added: economically stable suppliers who satisfy our requirements, and
+Added: to acquire sufficient products in a timely and
+Added: effective manner, is critical to ensuring, among other things, that customer confidence is not diminished.
+Added: addition, we are exposed to the risk that our competitors or our large customers may
+Added: introduce their own private
+Added: label, generic, or low-cost products that compete with our products at
+Added: lower price points.
+Added: Such products could
+Added: capture significant market share or decrease market prices overall, eroding
+Added: our sales and margins.
+Added: Any failure to
+Added: develop sourcing relationships with a broad and deep supplier base
+Added: could have a material adverse effect on our
+Added: business, financial condition or operating results.
+Added: Our business could be affected by activist investors.
+Added: We actively engage in discussions with our stockholders.
+Added: In other cases, stockholders can engage in certain
+Added: divisive activist tactics, which can take many forms (including potential
+Added: proxy contests).
+Added: Some stockholder
+Added: activism has resulted in, and could in the future result in, substantial
+Added: costs, such as professional fees, and the
+Added: diversion of management’s and our Board of Directors’ attention and resources from our businesses and strategic
+Added: Index to Financial Statements
+Added: Additionally, it could cause uncertainty about our management, operations or future strategic direction,
+Added: which could result in the loss of future business opportunities or negatively
+Added: impact our ability to attract and retain
+Added: qualified talent.
+Added: Activists or other stockholders holding a large portion of our outstanding shares
+Added: could also have
+Added: the ability to exert influence on actions requiring a stockholder vote,
+Added: including the election of directors and the
+Added: approval of certain extraordinary business transactions.
+Added: These risks could cause volatility in the trading price of our
+Added: common stock based on factors other than the fundamentals of our
INDUSTRY RISKS
17 unchanged sentences
provide products and services that maintain certain of our customers’ electronic
−Removed: medical or dental
−Removed: records (including protected health information of their patients);
+Added: medical or dental records
+Added: (including protected health information of their patients);
maintain and manage global human resources, compensation and payroll
−Removed: In addition to health information in our customers’ electronic
−Removed: medical and dental records, certain of our IS stores
−Removed: other sensitive personal and financial information, such as healthcare
−Removed: and other information related to our
−Removed: employees, as well as other sensitive information such as credit card
+Added: There could be an adverse impact on our business, financial condition
+Added: or operating results if we do not maintain an
+Added: adequate information and technology infrastructure (
+Added: , hardware, networks, software, people and processes) to
+Added: effectively protect and support the current and future information requirements of the business.
+Added: In addition to health
+Added: information in our customers’ electronic medical and dental records,
+Added: certain of our IS stores other sensitive personal
+Added: and financial information, such as health care and other information related
+Added: to our employees and individuals we
+Added: service, as well as other sensitive information such as credit card
information from our third-party business
−Removed: partners, that is confidential,
−Removed: and in many cases subject to privacy laws.
−Removed: Our IS are vulnerable to, among other things, natural disasters,
−Removed: power losses, computer viruses, telecommunication
−Removed: failures, cybersecurity threats and other criminal activity.
+Added: partners, that is confidential, and in many cases subject to privacy laws.
+Added: Our IS are susceptible to, among other things, natural disasters, power
+Added: losses, telecommunication failures,
+Added: cybersecurity threats and other criminal activity.
Information security risks have significantly increased
−Removed: recent years in part because of an overall increase in cyber incidents,
−Removed: their increased sophistication, and the
−Removed: involvement of organized crime, hackers, terrorists and foreign state agents.
−Removed: The healthcare
−Removed: industry in particular
−Removed: has been targeted by threat actors seeking to undermine companies’ cybersecurity
−Removed: defensive measures.
−Removed: We have processes in place intended to ensure that our security measures keep pace with new and emerging risks.
+Added: years in part because of an overall increase in cyber incidents, their increased
+Added: sophistication and the involvement of
+Added: organized crime, hackers, terrorists and foreign state agents.
+Added: In particular, the health care industry has been
+Added: targeted by threat actors seeking to undermine companies’ cybersecurity defensive
+Added: We have processes in
+Added: place intended to ensure that our security measures keep pace with
+Added: new and emerging risks.
We regularly review,
−Removed: monitor and implement multiple layers of security through technology, processes and our
−Removed: We utilize security technologies designed to protect and maintain the integrity of our IS and data, and our
−Removed: defenses are monitored and routinely tested internally and by external
−Removed: Despite these efforts, our facilities
−Removed: and systems and those of our third-party service providers have been,
−Removed: and may in the future be, vulnerable to
−Removed: privacy and security incidents, cybersecurity attacks and data breaches,
−Removed: acts of vandalism or theft, computer viruses
−Removed: and other malicious code, misplaced or lost data, programming and/or human
−Removed: attacks or other acts
−Removed: undermining IS of third party business partners including our customers,
−Removed: or other similar events that could impact
−Removed: the security, reliability and availability of our systems.
+Added: monitor and implement multiple layers of security through technology, processes and our people.
+Added: security technologies designed to protect and maintain the integrity of
+Added: our IS and data, and our defenses are
+Added: monitored and routinely tested internally and by external parties.
+Added: Despite these efforts, our facilities and systems
+Added: and those of our third-party service providers have been, and may in
+Added: the future be, vulnerable to privacy and
+Added: security incidents, cybersecurity attacks and data breaches, acts of vandalism
+Added: or theft, computer viruses and other
+Added: malicious code, misplaced or lost data, programming and/or human errors,
+Added: attacks or other acts undermining IS of
+Added: third party business partners including our customers, or other similar events
+Added: that could impact the security,
+Added: reliability and availability of our systems.
In addition, hardware, software or applications developed
−Removed: internally or procured from third parties may contain defects
−Removed: in design or manufacture or other problems that could
−Removed: unexpectedly compromise information security.
−Removed: As a practical matter, so long as we depend on IS to operate our
−Removed: business, and our business partners do the same, there can be no guaranty
−Removed: that such measures will successfully stop
−Removed: any one particular cybersecurity incident given the constantly evolving
−Removed: nature of the threat.
−Removed: We may also incur
−Removed: substantial costs as we update our cybersecurity defense systems and our general
−Removed: computer controls to meet
−Removed: evolving challenges, and legislative or regulatory action related to cybersecurity
−Removed: may increase our costs to develop
−Removed: or implement new technology products and services.
−Removed: A cyberattack that bypasses or compromises our IS cybersecurity / or general
−Removed: information technology (“IT”)
+Added: internally or
+Added: procured from third parties may contain defects in design or manufacture
+Added: or other problems that could unexpectedly
+Added: compromise information security.
+Added: As a practical matter, so long as we depend on IS to operate our business, and
+Added: our business partners do the same, there can be no guaranty
+Added: that such measures will successfully stop any one
+Added: particular cybersecurity incident given the constantly evolving nature of
+Added: We have incurred and may in
+Added: the future incur substantial costs as we update our cybersecurity defense
+Added: systems and our general computer controls
+Added: Index to Financial Statements
+Added: to meet evolving challenges, and legislative or regulatory action related
+Added: to cybersecurity may increase our costs to
+Added: develop or implement new technology products and services.
+Added: A cyberattack that bypasses or compromises our IS cybersecurity and/or
+Added: general information technology (“IT”)
controls (including third-party systems we rely on) causing an IS security breach
4 unchanged sentences
customer service, accounts
−Removed: payable, warehouse management and shipping, and systems tied to internal
−Removed: controls over financial reporting), the
+Added: payable, warehouse management and shipping and systems tied
+Added: to internal controls over financial reporting), the
loss or alteration of business, financial and other protected information,
2 unchanged sentences
and reporting controls.
−Removed: A cyberattack that bypasses or compromises our IS cybersecurity / or general
−Removed: computer controls or those of third
−Removed: parties with whom we engage may also lead to claims against us by
−Removed: affected parties and/or governmental agencies,
−Removed: and involve fines and penalties, as well as substantial defense and settlement
−Removed: Any of these impacts may
−Removed: alone, or collectively, have a material impact on our business.
−Removed: A successful cyberattack has, and may again in the
−Removed: future, disrupt our business operations, adversely impact our financial
−Removed: accounting and reporting of results of
−Removed: operations, divert the attention of management, and adversely impact
−Removed: our results of operations.
+Added: A cyberattack that
+Added: bypasses or compromises our IS cybersecurity and/or general computer
+Added: controls or those of third parties with whom
+Added: we engage may also lead to claims against us by affected parties and/or governmental
+Added: agencies, and involve fines
+Added: and penalties, as well as substantial defense and settlement expenses.
+Added: Any of these impacts may alone, or
+Added: collectively, have a material impact on our business.
+Added: A successful cyberattack has, and may again in the future,
+Added: disrupt our business operations, adversely impact our financial accounting
+Added: and reporting of results of operations,
+Added: divert the attention of management, and adversely impact our results of
In addition, we develop products and provide services to our customers
9 unchanged sentences
providers, such as physicians and dentists, are used to store and manage patient
−Removed: medical or dental records.
−Removed: customers are subject to laws and regulations which require that they
−Removed: protect the privacy and security of those
+Added: medical or dental records, and when
+Added: cloud-based approaches are used, we may be responsible for hosting
+Added: those records.
+Added: These customers, and in some
+Added: cases, we are subject to laws and regulations which require that
+Added: they protect the privacy and security of those
records, and our products may be used as part of these customers’ comprehensive
10 unchanged sentences
businesses were mostly unaffected.
−Removed: Once we became aware of the issue, we took steps to assess, contain
−Removed: remediate this incident.
−Removed: We restored affected systems and applications, our distribution operations resumed and we
−Removed: reactivated our ecommerce platform.
−Removed: We also notified law enforcement and our employees, customers, suppliers
−Removed: and investors, informing them of both the incident and management’s efforts to mitigate its impact on our daily
−Removed: operations and data maintained on the Company’s systems.
−Removed: Subsequently, on or about November 8, 2023, we
−Removed: determined that the threat actor obtained personal and sensitive information
−Removed: maintained on our systems belonging to
−Removed: certain third parties and since that date we have notified affected parties and potentially
−Removed: affected parties as
−Removed: The scope of personal and sensitive data impacted is still under investigation.
−Removed: On November 22, 2023,
−Removed: we experienced a related disruption to our ecommerce platform and
−Removed: related applications, which has since been
−Removed: The October 2023 cybersecurity incident disrupted key
−Removed: business operations, adversely impacted our
−Removed: financial results for the fourth quarter and full year 2023, diverted
−Removed: attention of management, and caused the
−Removed: Company to incur significant remediation costs.
−Removed: We continue to review the effects of the incident on the
−Removed: Company’s business as we do expect some short-term residual impact on our financial results in 2024.
−Removed: 2024, two putative class actions were filed against us based on the incident
−Removed: and one of these actions is still pending.
−Removed: We are spending, and plan to expend in the future, additional resources to continue to protect against, or to address
−Removed: problems caused by, business interruptions, and data security breaches.
−Removed: In addition, customers and suppliers may impose additional cybersecurity
−Removed: requirements on us as a result of the
−Removed: incident we experienced in October 2023, and some customers and suppliers
−Removed: have made such requests to date.
−Removed: cannot guarantee that we will be able to satisfy such additional requirements,
−Removed: and failure to satisfy such
−Removed: requirements could result in a loss of revenue or diminished product
−Removed: availability that could materially affect our
−Removed: business adversely.
−Removed: We also may be perceived as a more vulnerable target of the cyber hackers as a result of the
−Removed: October 2023 incident.
−Removed: If the Company is subject to more attacks in the future as a result of
−Removed: the recent incident, this
−Removed: could materially affect our business adversely.
−Removed: We maintain cyber insurance, subject to certain retentions and policy limitations.
−Removed: With respect to the October 2023
−Removed: cybersecurity incident, we have a $60 million insurance policy, following a $5 million retention.
+Added: The October 2023 cybersecurity incident disrupted key business
+Added: adversely impacted our financial results for the fourth quarter and full year 2023,
+Added: diverted attention of management,
+Added: and caused the Company to incur significant remediation costs.
+Added: The incident had residual impact on our financial
+Added: results in 2024, and we continue to review the effects of the incident on the Company’s business.
+Added: We have spent,
+Added: and plan to expend in the future, additional resources to continue
+Added: to protect against, or to address problems caused
+Added: by, business interruptions and data security breaches.
+Added: We also may be perceived as a more vulnerable target of the
+Added: cyber hackers as a result of the October 2023 incident.
The health care products distribution industry is highly competitive
25 unchanged sentences
traditional health care supply and distribution relationships are being challenged
−Removed: by electronic online commerce
−Removed: The continued advancement of online commerce by third
−Removed: parties will require us to cost-effectively adapt
−Removed: to changing technologies, to enhance existing services and to differentiate our business
−Removed: (including with additional
−Removed: value-added services) to address changing demands of consumers and
−Removed: our customers on a timely basis.
−Removed: emergence of such potential competition and our inability to anticipate and
−Removed: effectively respond to changes on a
−Removed: timely basis could have a material adverse effect on our business.
+Added: by online commerce solutions.
+Added: Index to Financial Statements
+Added: The continued advancement of online commerce by third parties and online
+Added: price transparency requires us to cost-
+Added: effectively adapt to changing technologies, to enhance existing services and to differentiate
+Added: our business (including
+Added: with additional value-added services) to address changing demands
+Added: of consumers and our customers.
+Added: emergence of such competition and our inability to anticipate and effectively respond to changes on
+Added: a timely basis
+Added: could have a material adverse effect on our business, financial condition or operating
The health care industry is experiencing changes due to political, economic
3 unchanged sentences
political, economic and regulatory influences.
−Removed: In recent years, the health care industry has undergone, and is in the process of undergoing,
−Removed: significant changes
−Removed: driven by various efforts to reduce costs, including, among other factors:
−Removed: toward managed care;
−Removed: purchasing arrangements and consolidation among office-based health care practitioners;
−Removed: and changes in
−Removed: reimbursements to customers, including increased attention to value-based payment
−Removed: arrangements, as well as
−Removed: growing enforcement activities (and related monetary recoveries) by governmental
−Removed: Both our profitability
−Removed: and the profitability of our customers may be materially adversely affected by laws
−Removed: and regulations reducing
−Removed: reimbursement rates for pharmaceuticals, medical supplies and devices,
−Removed: and/or medical treatments or services, or
−Removed: changes to the methodology by which reimbursement levels are determined.
−Removed: If we are unable to react effectively to
−Removed: these and other changes in the health care industry, our business could be materially adversely affected.
−Removed: greatly expanded health insurance coverage in the United States and has been
−Removed: the target of litigation and
−Removed: Congressional reform efforts since its adoption.
−Removed: Any outcome of future court cases that change the ACA, in
−Removed: addition to future legislation, regulation, guidance and/or Executive Orders
−Removed: that do the same, could have a
−Removed: significant impact on the U.S.
−Removed: healthcare industry and the ability or willingness
−Removed: of individuals to engage with it.
−Removed: Expansion of GPOs, DSOs or provider networks and the multi-tiered
+Added: In recent years, the health care industry has been undergoing significant changes driven
+Added: by various efforts to reduce
+Added: costs, including, among other factors:
+Added: trends toward managed care;
+Added: purchasing arrangements and
+Added: consolidation among office-based health care practitioners;
+Added: and changes in reimbursements
+Added: to customers, including
+Added: increased attention to value-based payment arrangements, as well as enforcement
+Added: activities (and related monetary
+Added: recoveries) by governmental officials.
+Added: Both our profitability and that of our customers may be
+Added: materially adversely
+Added: affected by laws and regulations reducing reimbursement rates for pharmaceuticals,
+Added: medical supplies and devices,
+Added: and/or medical treatments or services, or changes to the methodology
+Added: by which reimbursement levels are
+Added: If we are unable to react effectively to these and other changes in the
+Added: health care industry, our business
+Added: could be materially adversely affected.
+Added: The ACA greatly expanded health insurance coverage
+Added: in the United States
+Added: and has been the target of legal and political challenges since its adoption.
+Added: Any outcome of these challenges that
+Added: changes the ACA could have a significant impact on the U.S.
+Added: industry and the ability or willingness of
+Added: individuals to engage with it.
+Added: Expansion of GPOs, DSOs, MSOs or provider networks and the multi-tiered
costing structure may place us at a
7 unchanged sentences
The multi-tiered costing structure continues to expand as many large integrated health
−Removed: care providers and others with significant purchasing power, such as GPOs and DSOs, demand more favorable
−Removed: pricing terms.
−Removed: Additionally, the formation of provider networks, GPOs and DSOs may shift purchasing decisions
−Removed: to entities or persons with whom we do not have a historical relationship
−Removed: and may threaten our ability to compete
−Removed: effectively, which could in turn negatively impact our financial results.
−Removed: In addition, such organizations may
−Removed: establish direct relationships with manufacturers, thereby either eliminating
−Removed: or reducing the services historically
−Removed: provided by distributors.
+Added: care providers and others with significant purchasing power, such as GPOs, DSOs and MSOs, demand
+Added: favorable pricing terms.
+Added: Additionally, the formation of provider networks, GPOs, DSOs and MSOs may shift
+Added: purchasing decisions to entities or persons with whom we do not have a historical
+Added: relationship and may threaten our
+Added: ability to compete effectively, which could in turn negatively impact our financial results.
+Added: In addition, such
+Added: organizations may establish direct relationships with manufacturers, thereby
+Added: either eliminating or reducing the
+Added: services historically provided by distributors.
Although we are seeking to obtain similar terms from manufacturers
−Removed: to access lower
−Removed: prices demanded by GPO and DSO contracts or other contracts,
−Removed: and to develop relationships with existing and
−Removed: emerging provider networks, GPOs and DSOs, we cannot guarantee that such terms will
−Removed: be obtained or contracts
+Added: to access lower prices demanded by GPO, DSO and MSO contracts or
+Added: other contracts, and to develop relationships
+Added: with existing and emerging provider networks, GPOs, DSOs and MSOs, we
+Added: cannot guarantee that such terms will
+Added: be obtained or contracts executed.
Increases in shipping costs or service issues with our third-party shippers
9 unchanged sentences
or operating results.
−Removed: While we have recently experienced increases in the cost of shipping,
+Added: While we have recently experienced increases in shipping costs,
we do not expect these
−Removed: additional expenses to be material to our results.
−Removed: However, it is possible that such costs could be material in the
−Removed: Similarly, strikes or other service interruptions by those shippers, including at transportation centers or
−Removed: shipping ports, could cause our operating expenses to rise and materially
−Removed: adversely affect our ability to deliver
−Removed: products on a timely basis.
+Added: additional expenses to be material to our results now, however, they could be material in the future.
+Added: strikes or other service interruptions by those shippers, including at transportation
+Added: centers or shipping ports, could
+Added: cause our operating expenses to rise and materially adversely affect our ability
+Added: to deliver products on a timely basis.
+Added: Index to Financial Statements
MACRO-ECONOMIC AND POLITICAL RISKS
5 unchanged sentences
outlook of the United States, Europe, Asia and other parts of the
−Removed: world could materially adversely affect our results
−Removed: of operations and financial condition.
−Removed: These uncertainties, include, among other things:
−Removed: election results;
−Removed: changes to laws and policies governing foreign trade, tariffs and sanctions, or greater
−Removed: restrictions on
−Removed: imports and exports;
−Removed: supply chain disruptions;
−Removed: changes in laws and policies governing health care or data privacy;
−Removed: changes to the relationship between the United States and China;
−Removed: sovereign debt levels;
−Removed: the inability of political institutions to effectively resolve actual or perceived
−Removed: economic, currency or
−Removed: budgetary crises or issues;
−Removed: consumer confidence;
−Removed: unemployment levels (and a corresponding increase in the uninsured
−Removed: and underinsured population);
−Removed: changes in regulatory and tax regulations;
−Removed: interest rate fluctuations, and strengthening of the dollar, which have and will continue to
−Removed: results of operations;
−Removed: availability of capital;
−Removed: increases in fuel and energy costs;
−Removed: the effect of inflation on our ability to procure products and our ability to increase
−Removed: prices over time and
−Removed: pass through to our customers price increases we may receive;
−Removed: changes in tax rates and the availability of certain tax deductions;
−Removed: increases in labor costs or health care costs;
−Removed: the threat or outbreak of war, terrorism or public unrest (including, without limitation, the war in
−Removed: Ukraine, the Israel-Gaza war and other unrest and threats in the Middle East,
−Removed: and the possibility of a
−Removed: wider European or global conflict);
−Removed: changes in laws and policies governing manufacturing, development, and
−Removed: investment in territories and
−Removed: countries where we do business.
+Added: world could have a material adverse effect our
+Added: business, financial condition or operating results.
+Added: These uncertainties, include, among other things, those listed
+Added: under “Managements Discussion and Analysis of Financial Condition and
+Added: Results of Operations, Cautionary Note
+Added: Regarding Forward-Looking Statements.”
Additionally, changes in government, government debt and/or budget crises may lead to reductions in government
spending in certain countries, which could reduce overall health care spending
−Removed: and/or higher income or corporate
−Removed: taxes, which could depress spending overall.
−Removed: Recessionary or inflationary conditions and depressed levels of
−Removed: consumer and commercial spending may also cause customers to
−Removed: reduce, modify, delay,
−Removed: or cancel plans to purchase
−Removed: our products and may cause suppliers to reduce their output or change
−Removed: their terms of sale.
−Removed: We have experienced
−Removed: inflationary pressures, including higher freight costs and interest expense.
−Removed: Although inflation impacts both our
−Removed: revenues and costs, the depth and breadth of our product portfolio often
−Removed: allows us to offer lower-cost national brand
−Removed: solutions or corporate brand alternatives to our more price-sensitive
−Removed: customers who are unable to absorb price
−Removed: increases, thus positioning us to protect our gross profit.
−Removed: The strengthening of the dollar, likewise, has impacted
−Removed: our revenues and costs, but neither inflation nor exchange rates have
−Removed: materially impacted our results of operations
−Removed: in fiscal year 2023.
−Removed: We generally sell products to customers with payment terms.
−Removed: If customers’ cash flow or
−Removed: operating and financial performance deteriorate, or if they are unable to
−Removed: make scheduled payments or obtain credit,
−Removed: they may not be able to, or may delay, payment to us.
−Removed: Likewise, for similar reasons suppliers may restrict credit or
−Removed: impose different payment terms.
+Added: and/or lead to higher income or
+Added: corporate taxes, which could depress spending overall.
+Added: Recessionary or inflationary conditions and depressed
+Added: levels of consumer and commercial spending may also cause customers
+Added: to reduce, modify, delay,
+Added: or cancel plans to
+Added: purchase our products and may cause suppliers to reduce their output
+Added: or change their terms of sale.
+Added: experienced inflationary pressures, including higher freight costs and
+Added: interest expense, and pressures resulting from
+Added: the strengthening of the dollar, which have and continue to impact our results of operations.
+Added: We generally sell
+Added: products to customers with payment terms.
+Added: If customers’ cash flow or operating and financial performance
+Added: deteriorate, or if they are unable to make scheduled payments or obtain
+Added: credit, they may not be able to, or may
+Added: delay, payment to us.
+Added: Likewise, for similar reasons suppliers may restrict credit or impose
+Added: different payment terms.
AND LITIGATION RISKS
9 unchanged sentences
of political changes.
−Removed: When we discover
−Removed: situations of non-compliance we seek to remedy them and bring
−Removed: the affected area back into compliance.
−Removed: with respect to the applicable laws, regulations and guidance described below
−Removed: may require us to update or revise
−Removed: our operations, services, marketing practices, and compliance programs
−Removed: and controls, and may impose additional
−Removed: and unforeseen costs on us, pose new or previously immaterial risks to us, or
−Removed: may otherwise have a material
−Removed: adverse effect on our business.
+Added: respect to the applicable laws, regulations and guidance described below
+Added: may require us to update or revise our
+Added: operations, services, marketing practices, and compliance programs
+Added: and controls, and may impose additional and
+Added: unforeseen costs on us, pose new or previously immaterial risks to us, or
+Added: may otherwise have a material adverse
+Added: effect on our business.
There can be no assurance that current and future government
−Removed: regulations will not
−Removed: adversely affect our business, and we cannot predict new regulatory priorities, the
−Removed: form, content or timing of
−Removed: regulatory actions, and their impact on the health care industry and on our
−Removed: business and operations.
−Removed: Global efforts toward healthcare cost containment continue to exert pressure on
−Removed: product pricing.
−Removed: In the United
−Removed: States, in addition to other government efforts to control health care costs, there has been
−Removed: increased scrutiny on drug
−Removed: pricing and concurrent efforts to control or reduce drug costs by Congress, the President,
−Removed: executive branch agencies
−Removed: and various states.
−Removed: We and our subsidiaries may be required to report drug pricing data under federal laws and
−Removed: At the state level, several states have adopted laws, that may
−Removed: apply to some of our operations, that
+Added: regulations will not adversely
+Added: affect our business, and we cannot predict new regulatory priorities, the form, content
+Added: or timing of regulatory
+Added: actions, and their impact on the health care industry and on our business
+Added: and operations.
+Added: Global efforts to contain health care costs continue to exert pressure on product pricing.
+Added: In the United States, there
+Added: has been increased scrutiny on drug pricing and concurrent efforts to control or
+Added: reduce drug costs by Congress, the
+Added: President, executive branch agencies and various states.
+Added: We may be required to report drug pricing data under
+Added: federal laws and regulations.
+Added: states have adopted laws, that may apply to some of
+Added: our operations, that
require drug manufacturers, including re-packagers or re-labelers, to provide
advance notice of certain price
−Removed: increases and to report information relating to those price increases, while
−Removed: others have taken legislative or
−Removed: administrative action to establish prescription drug affordability boards or
−Removed: multi-payer purchasing pools to reduce
−Removed: the cost of prescription drugs.
−Removed: At the federal level, several related bills have been introduced
−Removed: and regulations
−Removed: proposed which, if enacted or finalized, respectively, would impact drug pricing and related costs.
+Added: increases and to report information relating to price increases, while
+Added: others have established prescription drug
+Added: affordability boards or multi-payer purchasing pools to reduce the cost of prescription
+Added: At the federal level,
+Added: for example, the Inflation Reduction Act of 2022, among other things,
+Added: requires drug manufacturers that raise certain
+Added: of their drug prices faster than the rate of inflation to pay rebates to Medicare,
+Added: and over time will authorize the
+Added: federal government to negotiate directly with drug manufacturers to
+Added: lower the prices of certain brand-name drugs
+Added: covered by Medicare.
+Added: These various evolving efforts create uncertainty and may adversely affect our business.
Under the Sunshine Act, we are required to collect and report detailed
information regarding certain financial
−Removed: relationships we have with covered recipients, including physicians, dentists,
−Removed: teaching hospitals, and certain other
−Removed: non-physician practitioners.
−Removed: We and our subsidiaries may be required to report information under certain state
−Removed: transparency laws that address circumstances not covered by the Sunshine
−Removed: Act, and some of these state laws, as
−Removed: well as the federal law, can be unclear.
−Removed: We are also subject to foreign regulations requiring transparency of certain
−Removed: interactions between suppliers and their customers.
−Removed: While we believe we have substantially compliant programs
−Removed: and controls in place satisfying the above laws and requirements,
−Removed: such compliance imposes additional costs on us
−Removed: and the requirements are sometimes unclear.
−Removed: In the United States, government actions to seek to increase health-
−Removed: related price transparency may also affect our business.
+Added: relationships we have with covered recipients (
+Added: , physicians, dentists, teaching hospitals, other health care
+Added: practitioners).
+Added: We may be required to report information under state transparency laws that address circumstances
+Added: not covered by the Sunshine Act.
+Added: We are also subject to similar foreign transparency laws.
+Added: While we believe we
+Added: Index to Financial Statements
+Added: have substantially compliant programs and controls in place satisfying
+Added: the above laws and requirements, such
+Added: compliance imposes additional costs on us and the requirements
+Added: are sometimes unclear.
Our business is subject to additional requirements under various local, state,
−Removed: federal and international laws and
+Added: federal and foreign laws and
regulations applicable to the sale and distribution of, and third-party payment
3 unchanged sentences
Act, the FDC Act, the Federal Drug Quality and Security Act, including DSCSA,
−Removed: Section 361 of the Public Health
−Removed: Services Act and Section 401 of the Consolidated Appropriations Act
−Removed: of the Social Security Act.
−Removed: things, such laws, and the regulations promulgated thereunder:
−Removed: regulate the introduction, manufacture, advertising, marketing and promotion,
−Removed: sampling, pricing and
−Removed: reimbursement, labeling, packaging, storage, handling, returning or
−Removed: recalling, reporting, and
−Removed: distribution of, and record keeping for drugs, HCT/P products and
−Removed: medical devices,
−Removed: requirements with respect to unique medical device identifiers;
−Removed: subject us to inspection by the FDA and DEA and similar state authorities;
−Removed: regulate the storage, transportation and disposal of certain of our products
−Removed: that are considered
+Added: and Section 361 of the Public
+Added: Health Services Act.
+Added: Among other things, such laws and the regulations promulgated
+Added: regulate the introduction, manufacture, advertising, marketing, promotion,
+Added: sampling, pricing,
+Added: reimbursement, labeling, packaging, storage, handling, returning,
+Added: recalling, reporting, distribution of, and
+Added: recordkeeping for drugs, HCT/P products and medical devices, including
+Added: unique device identifiers;
+Added: subject us to inspection by the FDA, OSHA, and DEA and similar state
+Added: regulate the storage, transportation and disposal of
hazardous materials;
require us to advertise and promote our drugs and devices in accordance
−Removed: with applicable FDA
−Removed: requirements;
−Removed: require us to report average sales price (ASP) for drugs or biologicals payable
−Removed: under Medicare Part B to
−Removed: CMS with or without a Medicaid drug rebate agreement;
+Added: with FDA regulations;
+Added: require us to report average sales price (ASP) to CMS for drugs or biologicals
+Added: payable under Medicare Part
+Added: B with or without a Medicaid drug rebate agreement;
require registration with the FDA and the DEA and various state agencies;
−Removed: require record keeping and documentation of transactions involving drug
require us to design and operate a system to identify and report suspicious
−Removed: orders of controlled
−Removed: substances to the DEA and certain states;
+Added: orders of controlled substances
+Added: to the DEA and certain states;
require us to manage returns of products that have been recalled and subject
−Removed: us to inspection of our
−Removed: recall procedures and activities;
+Added: us to inspection of our recall
+Added: procedures and activities;
impose on us reporting requirements if a pharmaceutical, HCT/P product or
−Removed: medical device causes
−Removed: serious illness, injury or death;
+Added: medical device causes an
+Added: adverse event, serious illness, injury or death;
require manufacturers, wholesalers, re-packagers and dispensers of prescription
−Removed: drugs to identify and
−Removed: trace certain prescription drugs as they are distributed;
+Added: drugs to identify and trace
+Added: certain prescription drugs as they are distributed;
require the licensing of prescription drug wholesalers and third-party
1 unchanged sentence
mandate compliance with standards for the recordkeeping, storage,
−Removed: and handling of prescription drugs,
−Removed: and associated reporting requirements.
−Removed: The FDA has become increasingly active in addressing the regulation of
−Removed: computer software and digital health
−Removed: products intended for use in health care settings.
−Removed: The Cures Act, signed into law on December 13, 2016, among
−Removed: other things, amended the medical device definition to exclude certain software
−Removed: from FDA regulation, including
−Removed: certain clinical decision support software.
−Removed: On September 27, 2019, the FDA issued a suite of guidance documents
−Removed: on digital health products, which incorporated applicable Cures Act standards,
−Removed: and on September 28, 2022, the
−Removed: FDA subsequently finalized certain of these guidance documents, including
−Removed: regarding the types of clinical decision
−Removed: support tools and other software that are exempt from regulation by the FDA as
−Removed: medical devices, and the FDA
−Removed: continues to issue new guidance in this area.
−Removed: Certain of our businesses involve the development and
−Removed: software and related products to support physician and dental practice management,
−Removed: and it is possible that the FDA
−Removed: or foreign government authorities could determine that one or more of our products
−Removed: is subject to regulation as a
−Removed: medical device, which could subject us or one or more of our businesses to
−Removed: substantial additional requirements,
−Removed: costs and potential enforcement actions or liabilities for noncompliance with
+Added: handling and documentation of
+Added: transactions involving prescription drugs and associated reporting requirements.
+Added: The FDA regulates certain computer software and digital health products intended
+Added: for use in health care settings,
+Added: including, for example, AI and machine learning-enabled medical devices
+Added: and the cybersecurity of medical devices.
+Added: Certain of our businesses involve the development and sale of
+Added: software and related products to support physician
+Added: and dental practice management, and it is possible that the FDA or
+Added: foreign government authorities could determine
+Added: that one or more of our products is subject to regulation as a medical device,
+Added: which could subject our businesses to
+Added: substantial additional requirements, costs, potential enforcement actions
+Added: or liabilities for noncompliance with
respect to these products.
−Removed: imaging software is regulated as a medical device which subjects our businesses
−Removed: to substantial additional
−Removed: requirements, costs and potential enforcement actions or liabilities for noncompliance
−Removed: with respect to these
−Removed: Applicable federal, state, local, and foreign laws and regulations also may require
−Removed: us to meet various standards
−Removed: relating to, among other things, licensure or registration, program eligibility, procurement, third-party
−Removed: reimbursement, sales and marketing practices, product integrity, and supply tracking to product manufacturers,
−Removed: product labeling, personnel, privacy and security of health or other personal
−Removed: information, installation, maintenance
−Removed: and repair of equipment and the importation and exportation of products.
−Removed: The FDA and DEA, as well as CMS
−Removed: (including with respect to complex Medicare reimbursement requirements
−Removed: applicable to our specialty home medical
−Removed: supplies business) and state Medicaid agencies, have recently increased
−Removed: their regulatory and enforcement activities
−Removed: and, in particular, the DEA has heightened enforcement activities due to the opioid crisis in the United States.
−Removed: business is also subject to requirements of similar and other foreign governmental
−Removed: laws and regulations affecting
−Removed: our operations abroad.
+Added: For example, some of our imaging software is
+Added: regulated as a medical device which
+Added: subjects our businesses to substantial additional requirements, costs
+Added: and potential enforcement actions or liabilities
+Added: for noncompliance with respect to these products.
+Added: Applicable federal, state, local and foreign laws and regulations also may
+Added: require us to meet various standards
+Added: relating to, among other things, licensure, registration, program eligibility, procurement, third-party reimbursement,
+Added: sales and marketing practices, product integrity and supply
+Added: tracking to product manufacturers, product labeling,
+Added: personnel, privacy and security of health or other personal information,
+Added: installation, maintenance and repair of
+Added: equipment and the importation and exportation of products.
+Added: The FDA and DEA, as well as CMS (including with
+Added: respect to complex Medicare reimbursement requirements applicable to our
+Added: specialty home medical supplies
+Added: business) and state Medicaid agencies, have recently increased their regulatory
+Added: and enforcement activities and, in
+Added: particular, the DEA has heightened enforcement activities due to the opioid crisis in the United
The failure to comply with any of these laws or regulations, or new interpretations
−Removed: of existing laws and regulations,
−Removed: or the imposition of any additional laws and regulations, could
−Removed: materially adversely affect our business.
−Removed: to us associated with complying with the various applicable statutes
−Removed: and regulations, as they now exist and as they
−Removed: may be modified, could be material.
+Added: of them, or the imposition of any
+Added: additional laws and regulations, could materially adversely affect our business.
+Added: The costs to us associated with
+Added: complying with the various applicable statutes and regulations, as they now
+Added: exist and as they may be modified,
+Added: could be material.
Allegations by a governmental body that we have not complied
−Removed: laws could have a material adverse effect on our businesses.
−Removed: While we believe that we are substantially compliant
−Removed: with applicable laws and regulations, and believe we have adequate
−Removed: compliance programs and controls in place to
−Removed: ensure substantial compliance, if it is determined that we have not complied
−Removed: with these laws, we are potentially
−Removed: subject to warning letters, substantial civil and criminal penalties,
−Removed: mandatory recall of product, seizure of product
−Removed: and injunction, consent decrees and suspension or limitation of payments
−Removed: to us, product sale and distribution.
−Removed: enter into settlement agreements to resolve allegations of non-compliance, we
−Removed: could be required to make settlement
−Removed: payments or be subject to civil and criminal penalties, including
−Removed: fines and the loss of licenses.
−Removed: Non-compliance
−Removed: with government requirements could also adversely affect our ability to participate
−Removed: in important federal and state
+Added: with these laws could have a
+Added: material adverse effect on our businesses.
+Added: While we believe that we are substantially compliant with
+Added: laws and regulations, and have adequate compliance programs and controls
+Added: in place to ensure substantial
+Added: Index to Financial Statements
+Added: compliance, if it is determined that we have not complied with these laws,
+Added: we are potentially subject to warning
+Added: letters, substantial civil and criminal penalties, mandatory recall of product,
+Added: seizure of product and injunction,
+Added: consent decrees and suspension or limitation of payments to us, product
+Added: sale and distribution.
+Added: If we enter into
+Added: settlement agreements to resolve allegations of non-compliance, we
+Added: could be required to make settlement payments
+Added: or be subject to civil and criminal penalties, including fines and
+Added: the loss of licenses.
+Added: Non-compliance with
+Added: government requirements could also adversely affect our ability to participate in
+Added: important federal and state
government health care programs, such as Medicare and Medicaid,
1 unchanged sentence
The EU Medical Device Regulation (“MDR”) may adversely affect our business.
−Removed: The EU MDR, applicable since May 26, 2021, significantly modifies and intensifies
−Removed: the regulatory compliance
−Removed: requirements for the medical device industry as a whole.
+Added: The EU MDR significantly modified the regulatory compliance requirements
+Added: for the medical device industry as a
Among other things, the EU MDR:
−Removed: strengthens the rules on placing devices on the market and reinforces surveillance
−Removed: once they are
+Added: strengthens the rules on placing devices on the market and reinforces
+Added: surveillance thereafter;
establishes explicit provisions on manufacturers’ responsibilities
1 unchanged sentence
performance and safety of devices placed on the market;
−Removed: improves the traceability of medical devices throughout the supply chain to the end-user
−Removed: through a unique identification number;
−Removed: sets up a central database to provide patients, healthcare professionals and
−Removed: the public with
−Removed: comprehensive information on products available in the EU;
+Added: improves the traceability of medical devices throughout the supply chain to
+Added: the end-user or patient through
+Added: a unique identification number;
+Added: sets up a central database (EUDAMED) to provide patients, health care
+Added: professionals and the public with
+Added: comprehensive information on devices, importers, and distributors registered
strengthens rules for the assessment of certain high-risk devices, such
1 unchanged sentence
undergo an additional check by experts before they are placed on the market;
−Removed: identifies importers and distributors and medical device products through
−Removed: registration in a database
−Removed: (EUDAMED not due, for the time being, until the end of 2027 at
−Removed: the earliest, as mentioned above).
−Removed: In particular, the EU MDR imposes strict requirements for the confirmation that a product
−Removed: meets the regulatory
−Removed: requirements, including regarding a product’s clinical evaluation and a company’s quality systems, and for the
−Removed: distribution, marketing and sale of medical devices, including post-market surveillance.
−Removed: As mentioned above,
−Removed: pursuant to Regulation 2023/607 and subject to certain conditions, medical devices
−Removed: that (i) obtained a certificate
−Removed: under the EU Medical Device Directive from May 25, 2017, (ii) which was
−Removed: still valid on May 26, 2021, and (iii)
−Removed: has not been subsequently withdrawn may, for the moment, continue to be placed on the market or put into service
−Removed: until December 31, 2027 for higher risk devices or December 31, 2028 for medium
−Removed: and lower risk devices.
−Removed: Nevertheless, EU MDR requirements regarding the distribution,
−Removed: marketing and sale including quality systems and
−Removed: post-market surveillance have to be observed by manufacturers, importers
−Removed: and distributors as of the application date
−Removed: (i.e., May 26, 2021).
−Removed: The modifications created by the EU MDR may have an impact
−Removed: on the way we design and
−Removed: manufacture products and the way we conduct our business in
+Added: contains specific provisions in the event of interruption or discontinuation
+Added: of supply of a device.
+Added: The EU MDR imposes strict requirements for the confirmation that a
+Added: product meets the regulatory requirements,
+Added: including regarding a product’s clinical evaluation and a company’s quality systems, and for the distribution,
+Added: marketing and sale of medical devices, including post-market surveillance.
+Added: Pursuant to Regulation 2023/607 and
+Added: subject to certain conditions, medical devices that (i) obtained
+Added: a certificate under the EU Medical Device Directive
+Added: from May 25, 2017, (ii) which was still valid on May 26, 2021, and (iii)
+Added: has not been subsequently withdrawn may
+Added: continue to be placed on the market or put into service until December
+Added: 31, 2027 for higher risk devices or
+Added: December 31, 2028 for medium and lower risk devices.
+Added: The modifications
+Added: created by the EU MDR may have an
+Added: impact on the way we design and manufacture products and the way we
+Added: conduct our business in the EEA.
If we fail to comply with laws and regulations relating to health care
7 unchanged sentences
Some of these laws, referred to as “false
−Removed: claims laws,” prohibit the submission or causing the submission of false or fraudulent
−Removed: claims for reimbursement to
+Added: claims laws,” prohibit the submission or causing the submission of false or
+Added: fraudulent claims for reimbursement to
federal, state and other health care payers and programs.
2 unchanged sentences
the referral of a patient or
−Removed: ordering, purchasing, leasing or arranging for, or recommending ordering, purchasing or leasing of,
+Added: ordering, purchasing, leasing or arranging for, or recommending ordering, purchasing or leasing
services that are paid for by federal, state and other health care payers and programs.
Certain additional state and
−Removed: federal laws, such as the federal Physician Self-Referral Law, commonly known as the “Stark Law,” prohibit
−Removed: physicians and other health care professionals from referring a patient
−Removed: to an entity with which the physician (or
−Removed: family member) has a financial relationship, for the furnishing of certain designated
−Removed: health services (for example,
−Removed: durable medical equipment and medical supplies), unless an exception applies.
−Removed: Violations of Anti-Kickback
−Removed: statutes or the Stark Law may be enforced as violations of the federal False Claims
+Added: federal laws, such as the federal Physician Self-Referral Law (“Stark Law”),
+Added: prohibit physicians and other health
+Added: care professionals from referring a patient to an entity with which
+Added: the physician (or family member) has a financial
+Added: relationship, for the furnishing of certain designated health services
+Added: (for example, durable medical equipment and
+Added: medical supplies), unless an exception applies.
The fraud and abuse laws and regulations have been subject to heightened
enforcement activity over the past few
−Removed: years, and significant enforcement activity has been the result of “relators” who
−Removed: serve as whistleblowers by filing
−Removed: complaints in the name of the United States (and if applicable, particular states)
−Removed: under applicable false claims laws,
−Removed: and who may receive up to 30% of total government recoveries.
−Removed: Penalties under fraud and abuse laws may be
−Removed: severe, including treble damages and substantial civil penalties under
−Removed: the federal False Claims Act, as well as
−Removed: potential loss of licenses and the ability to participate in federal and state
−Removed: health care programs, criminal penalties,
−Removed: or imposition of a corporate compliance monitor, which could have a material adverse effect on our business.
−Removed: these measures may be interpreted or applied by a prosecutorial, regulatory or
−Removed: judicial authority in a manner that
−Removed: could require us to make changes in our operations or incur substantial defense
−Removed: and settlement expenses.
−Removed: unsuccessful challenges by regulatory authorities or private relators could result
−Removed: in reputational harm and the
−Removed: incurring of substantial costs.
−Removed: Most states have adopted similar state false claims laws, and these state
−Removed: their own penalties which may be in addition to federal False Claims
−Removed: Act penalties, as well as other fraud and abuse
−Removed: With respect to measures of this type, the United States government (among others) has expressed concerns
−Removed: financial relationships between suppliers on the one hand and physicians,
−Removed: dentists, and other health care providers,
−Removed: on the other.
+Added: years, often as the result of “relators” who serve as whistleblowers by filing
+Added: complaints in the name of the United
+Added: States (and if applicable, particular states) under applicable false claims
+Added: laws, and who may receive up to 30% of
+Added: total government recoveries.
+Added: Penalties under fraud and abuse laws may be severe, including treble damages
+Added: substantial civil penalties under the federal False Claims Act, as
+Added: well as potential loss of licenses and the ability to
+Added: participate in federal and state health care programs, criminal penalties,
+Added: or imposition of a corporate compliance
+Added: Index to Financial Statements
+Added: monitor, which could have a material adverse effect on our business.
+Added: Also, these measures may be interpreted or
+Added: applied by a prosecutorial, regulatory or judicial authority in a
+Added: manner that could require us to make changes in our
+Added: operations or incur substantial defense and settlement expenses.
+Added: Even unsuccessful challenges by regulatory
+Added: authorities or relators could result in reputational harm and the incurring of
+Added: substantial costs.
+Added: Most states have
+Added: adopted similar state false claims acts, and these state laws have their
+Added: own penalties which may be in addition to
+Added: federal False Claims Act penalties, and other fraud and abuse laws.
+Added: The United States government (among others) has expressed concerns
+Added: about financial relationships between
+Added: suppliers or manufacturers on the one hand and physicians, dentists
+Added: and other health care providers, on the
As a result, we regularly review and revise our marketing practices
−Removed: as necessary to facilitate
+Added: as necessary to facilitate compliance.
Our aspirations, goals and disclosures related to environmental, social
4 unchanged sentences
that could have an adverse impact on us.
−Removed: including on our stock price.
−Removed: California has adopted stringent new climate disclosure requirements,
−Removed: as has the EU,
−Removed: and the SEC appears about to adopt expansive new disclosure requirements
−Removed: on climate change.
−Removed: In the EU, the Directive No.
+Added: California has adopted stringent new climate disclosure requirements, as
+Added: As of April 4, 2024, the SEC
+Added: has temporarily suspended implementation of its climate disclosure rules.
+Added: In the EU, Directive No.
2019/1937 of October 23, 2019,
2 unchanged sentences
This Directive covers whistleblowers reporting
−Removed: breaches of certain EU laws, in particular as regards public health, the above-mentioned
−Removed: Directive No.
−Removed: Regulation No.
−Removed: 726/2004 or, as regards data protection, the GDPR.
−Removed: The Directive protects a wide range of people
−Removed: and includes former employees.
−Removed: All private companies with 50 or more employees are required
−Removed: to create effective
−Removed: internal reporting channels.
−Removed: All EU Member States other than Poland and Estonia have now implemented
−Removed: We also are subject to the requirements of the new Directive No.
−Removed: 2022/2464 on corporate sustainability reporting
−Removed: (“CSR Directive”) adopted on December 14, 2022 and which has to be
−Removed: implemented by EU members states by July
−Removed: 6, 2024, at the latest.
−Removed: By amending Directives No.
−Removed: 2004/109, No.
−Removed: and Regulation No.
−Removed: 537/2014, the CSR Directive strengthens the existing rules on non-financial
−Removed: reporting by setting new requirements
−Removed: for large companies to publish sustainability-related information and, in particular, disclose details about
−Removed: and impacts on environmental matters.
−Removed: also are subject to certain United States and foreign laws and regulations
−Removed: concerning the conduct of our foreign
+Added: breaches of EU laws and regulations and protects a wide range of people
+Added: including former employees.
+Added: companies with 50 or more employees are required to create effective internal reporting
+Added: All EU Member
+Added: States have now implemented the Directive.
+Added: We also are subject to the requirements of Directive No.
+Added: 2022/2464 on corporate sustainability reporting (“CSRD”)
+Added: that became effective on January 5, 2023.
+Added: CSRD requires in-scope companies to report on sustainability-related
+Added: information that is material from a financial risk or opportunity perspective
+Added: to their business and from an impact
+Added: perspective on the environment or society.
+Added: The materiality of sustainability matters is subjective and
+Added: interpreted differently by various stakeholders.
+Added: CSRD, its transposition into national EU Member State law, and
+Added: associated guidance are evolving and reporting requirements may change,
+Added: which may further increase the costs of
+Added: complying with CSRD.
+Added: CSRD has not yet been fully implemented by all EU Member States.
+Added: We also are subject to certain United States and foreign laws and regulations concerning the conduct of our foreign
operations, including the U.S.
2 unchanged sentences
and other anti-bribery laws and laws pertaining to the accuracy of our internal
−Removed: books and records, which have been
−Removed: the focus of increasing enforcement activity globally in recent years.
−Removed: Our businesses are generally subject to
−Removed: numerous other laws and regulations that could impact our financial
−Removed: results, including, without limitation,
−Removed: securities, antitrust, consumer protection, and marketing laws and regulations.
−Removed: In the EU, both active and passive bribery are criminalized.
−Removed: The EU Council Framework Decision 2003/568/JHA
−Removed: of 22 July 2003
+Added: books and records.
+Added: Our businesses
+Added: are generally subject to numerous other laws and regulations that
+Added: could impact our financial results, including,
+Added: without limitation, securities, antitrust, consumer protection and marketing
+Added: laws and regulations.
+Added: In the EU, both active and passive corruption in the private sector are
+Added: criminalized.
+Added: The EU Council Framework
+Added: Decision 2003/568/JHA of 22 July 2003
on combating corruption in the private sector
−Removed: establishes more detailed rules on the liability of
−Removed: legal persons and deterrent sanctions.
−Removed: However, the liability of legal persons is regulated at a national level.
+Added: establishes more detailed
+Added: rules on the liability of legal persons and deterrent sanctions.
+Added: However, the liability of legal persons is regulated at
+Added: a national level.
Failure to comply with fraud and abuse laws and regulations, and other
10 unchanged sentences
could materially adversely affect our business.
−Removed: While we believe that we are substantially compliant with applicable fraud and
−Removed: abuse and other laws and
−Removed: regulations, and believe we have adequate compliance programs and controls
−Removed: in place to ensure substantial
−Removed: compliance, we cannot predict whether changes in applicable law, or interpretation of laws, or changes in our
−Removed: services or marketing practices in response to changes in applicable law or
−Removed: interpretation of laws, could have a
−Removed: material adverse effect on our business.
+Added: While we believe that we are substantially compliant with applicable
+Added: laws and regulations, and believe we have
+Added: adequate compliance programs and controls in place to ensure substantial
+Added: compliance, we cannot predict whether
+Added: changes in applicable law, or interpretation of laws, or changes in our services or marketing practices in response
+Added: changes in applicable law or interpretation of laws, could have a material
+Added: adverse effect on our business.
+Added: Index to Financial Statements
If we fail to comply with laws and regulations relating to the collection,
5 unchanged sentences
Our businesses that involve physician and dental practice management
−Removed: products, and our specialty home medical
−Removed: supply businesses, include electronic information technology systems
−Removed: that store and process personal health,
−Removed: clinical, financial, and other sensitive information of individuals.
−Removed: These information technology systems may be
−Removed: vulnerable to breakdown, wrongful intrusions, data breaches and
−Removed: malicious attack, which could require us to
−Removed: expend significant resources to eliminate these problems and address
−Removed: related security concerns, and could involve
−Removed: claims against us by private parties and/or governmental agencies.
+Added: products, equipment and our specialty home
+Added: medical supplies businesses, and our self-funded employee benefits programs
+Added: include information technology (IT)
+Added: systems that store and process personal health, clinical, financial, and
+Added: other sensitive information of individuals.
+Added: These IT systems may be vulnerable to breakdown, wrongful intrusions, data
+Added: breaches and malicious attack, which
+Added: could require us to expend significant resources to eliminate these
+Added: problems and address related security concerns,
+Added: and could involve claims against us by private parties and/or governmental agencies.
We are directly or indirectly subject to numerous and evolving federal, state, local and foreign laws and regulations
−Removed: that protect the privacy and security of personal information, such as HIPAA, CAN-SPAM, TCPA,
−Removed: Section 5 of the
−Removed: FTC Act, the CCPA, and the CPRA that became effective on January 1, 2023.
−Removed: Laws and regulations relating to
−Removed: privacy and data protection are continually evolving and subject to
−Removed: potentially differing interpretations.
−Removed: requirements may not be harmonized, may be interpreted and applied in
−Removed: a manner that is inconsistent from one
−Removed: jurisdiction to another or may conflict with other rules or our practices.
−Removed: Our businesses’ failure to comply with
−Removed: these laws and regulations could expose us to breach of contract claims, substantial
−Removed: fines, penalties and other
−Removed: liabilities and expenses, costs for remediation and harm to our reputation.
−Removed: Also, evolving laws and regulations in
−Removed: this area could restrict the ability of our customers to obtain, use or disseminate patient
−Removed: information, or could
−Removed: require us to incur significant additional costs to re-design our products
−Removed: to reflect these legal requirements, which
−Removed: could have a material adverse effect on our operations.
+Added: that protect the privacy and security of personal information (including
+Added: health data), such as HIPAA, CAN-SPAM,
+Added: TCPA, Section 5 of the FTC Act, the CCPA
+Added: and various other privacy laws that have or will soon come into
+Added: Laws and regulations relating to privacy and data protection are
+Added: continually evolving and subject to potentially
+Added: differing interpretations, including those relating to AI.
+Added: These requirements may not be harmonized, may be
+Added: interpreted and applied in a manner that is inconsistent from one jurisdiction
+Added: to another or may conflict with other
+Added: rules or our practices.
+Added: In addition, cybersecurity laws such as the federal Cyber Incident
+Added: Reporting for Critical
+Added: Infrastructure Act of 2022, proposed Federal Acquisition Regulations and
+Added: amendments to SEC reporting
+Added: requirements may require us to provide notifications about cybersecurity
+Added: incidents in limited timeframes and before
+Added: investigations are complete.
+Added: Our businesses’ failure to comply with these laws and regulations
+Added: could expose us to
+Added: breach of contract claims, substantial fines, penalties and other
+Added: liabilities and expenses, costs for remediation and
+Added: harm to our reputation.
+Added: Evolving laws and regulations in this area could restrict the
+Added: ability of our customers to
+Added: obtain, use or disseminate patient information, or could require us
+Added: to incur significant additional costs to re-design
+Added: our products to reflect these legal requirements, which could have
+Added: a material adverse effect on our operations.
In addition, the European Parliament and the Council of the EU adopted
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of the personal data and the right to object to the processing.
−Removed: On August 20, 2021, China promulgated the PIPL, which took effect on November
−Removed: The PIPL imposes
−Removed: specific rules for processing personal information and it also specifies
−Removed: that the law shall also apply to personal
−Removed: information activities carried out outside China but for the purpose
−Removed: of providing products or services to PRC
−Removed: Any non-compliance with these laws and regulations may subject
−Removed: us to fines, orders to rectify or terminate
−Removed: any actions that are deemed illegal by regulatory authorities, other penalties,
−Removed: as well as reputational damage or legal
−Removed: proceedings against us, which may affect our business, financial condition or results
−Removed: of operations.
−Removed: carries maximum penalties of CNY50 million or 5% of the annual revenue
−Removed: of entities that process personal data.
−Removed: In the United States, the CCPA, which increases the privacy protections afforded California residents, became
−Removed: effective January 1, 2020.
−Removed: The CCPA generally requires companies, such as us, to institute additional protections
−Removed: regarding the collection, use and disclosure of certain personal information
−Removed: of California residents.
−Removed: with the obligations imposed by the CCPA depends in part on how particular regulators interpret and apply them.
−Removed: Regulations were released in August of 2020, but there remains some
−Removed: uncertainty about how the CCPA will be
−Removed: interpreted by the courts and enforced by the regulators.
−Removed: If we fail to comply with the CCPA or if regulators assert
−Removed: that we have failed to comply with the CCPA, we may be subject to certain fines or other penalties and litigation,
−Removed: any of which may negatively impact our reputation, require us to expend
−Removed: significant resources, and harm our
−Removed: Furthermore, California voters approved the CPRA on November 3,
−Removed: 2020, which will amend and expand
−Removed: the CCPA, including by providing consumers with additional rights with respect to their personal information, and
−Removed: creating a new state agency to enforce CCPA and CPRA.
−Removed: The CPRA came into effect on January 1, 2023, applying
−Removed: to information collected by businesses on or after January 1, 2022.
−Removed: Other states, as well as the federal government, have increasingly
−Removed: considered the adoption of similarly expansive
−Removed: personal privacy laws, backed by significant civil penalties for non-compliance.
−Removed: While we believe we have
−Removed: substantially compliant programs and controls in place to comply with
−Removed: the GDPR, CCPA, PIPL and CPRA
−Removed: requirements, our compliance with data privacy and cybersecurity laws
−Removed: is likely to impose additional costs on us,
−Removed: and we cannot predict whether the interpretations of the requirements, or
−Removed: changes in our practices in response to
+Added: Despite Brexit, the UK also has data protection laws
+Added: equivalent to the GDPR).
+Added: Switzerland enacted FADP.
+Added: Uncertainty about compliance with these data protection
+Added: laws remains, with the possibilities that data protection authorities located
+Added: in different EU Member States may
+Added: interpret GDPR differently, or requirements of national laws may vary between the EU Member States, or guidance
+Added: on GDPR and compliance practices may be often updated or otherwise revised.
+Added: Any of these events will increase
+Added: the complexity and costs of processing personal data in the European Economic
+Added: Area, UK or Switzerland or
+Added: concerning individuals located in these jurisdictions.
+Added: Effective November 1, 2021, China’s PIPL imposes specific rules for processing personal information and specifies
+Added: that the law shall also apply to personal information activities carried
+Added: out outside China but for the purpose of
+Added: providing products or services to PRC citizens.
+Added: Any non-compliance with these laws and regulations may
+Added: us to fines, orders to rectify or terminate any actions that are deemed
+Added: illegal by regulatory authorities, other
+Added: penalties, reputational damage, or legal proceedings against us, which
+Added: may affect our business, financial condition
+Added: or results of operations.
+Added: The PIPL carries maximum penalties of CNY50 million or
+Added: 5% of the annual revenue of
+Added: entities that process personal data.
+Added: Data protection laws in other countries are also quickly
+Added: evolving, with many
+Added: Index to Financial Statements
+Added: countries having updated, or are in the process of updating, their
+Added: laws to bring them more in line with the model
+Added: created by GDPR.
+Added: In the United States, the CCPA, effective January 1, 2020, establishes a privacy framework for covered businesses
+Added: such as ours by, among other things, creating an expanded definition of personal information, establishing new data
+Added: privacy rights for California residents and creating a new and potentially
+Added: severe statutory damages framework for
+Added: violations of the CCPA, as well as potentially severe statutory damages and private a right of action against
+Added: businesses that suffer a data security breach due to their violation of a duty to
+Added: implement reasonable security
+Added: procedures and practices.
+Added: This private right of action may increase the
+Added: likelihood of, and risks associated with, data
+Added: breach litigation.
+Added: In addition, California voters adopted the CPRA (effective January 1, 2023)
+Added: which enhances and
+Added: strengthens regulatory requirements and individual protections that currently
+Added: exist under the CCPA.
+Added: have enacted or are considering enacting similar privacy laws, which may
+Added: subject us to additional requirements and
+Added: restrictions that could have an impact on our business.
+Added: Comprehensive privacy laws in a number of other states are
+Added: now in effect, and similarly enacted broad laws relating to privacy, data protection, and information security that
+Added: will come into effect later in 2025 and 2026, further complicating our privacy compliance
+Added: obligations through the
+Added: introduction of increasingly disparate requirements across the various
+Added: jurisdictions in which we operate.
+Added: Additionally, certain other states have enacted specific health data privacy laws and other states are considering
+Added: similar legislation.
+Added: Congress is considering legislation that may preempt some or
+Added: all of such U.S.
+Added: state privacy
+Added: laws, but which may also provide a more expansive private right of action
+Added: for privacy claims than exists under
+Added: current state laws.
+Added: The evolving complexity of privacy and data security legislation in
+Added: the United States may complicate our
+Added: compliance efforts and further increase our risk of regulatory enforcement, penalties
+Added: and litigation.
+Added: believe we have substantially compliant programs and controls in place
+Added: to comply with privacy laws domestically
+Added: and internationally, our compliance with data privacy and cybersecurity laws is likely to impose additional costs
+Added: us, and we cannot predict whether the interpretations of the requirements,
+Added: or changes in our practices in response to
new requirements or interpretations of the requirements, could have a
material adverse effect on our business.
+Added: Further, countries are applying their data and consumer protection laws to AI, particularly generative
+Added: considering and implementing specific legal frameworks with respect
+Added: to AI, for example the EU AI Act 2024
+Added: (which as with the GDPR, will have extra-territorial effect).
+Added: Any failure or perceived failure by us to comply with
+Added: such requirements could have an adverse impact on our business.
+Added: Anticipated further evolution of regulations and
+Added: legislation on this topic may substantially increase the penalties
+Added: to which we could be subject in the event of any
+Added: non-compliance.
+Added: Compliance with these laws is challenging, constantly evolving
+Added: and time consuming and federal
+Added: regulators, state attorneys general and plaintiff’s attorneys have been and will
+Added: likely continue to be active in this
+Added: We may incur substantial expense in complying with legal obligations to be imposed by new regulations
+Added: and we may be required to make significant changes to our solutions and
+Added: expanding business operations, all of
+Added: 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
27 unchanged sentences
In order to maintain
+Added: Index to Financial Statements
certification of our EHR products, we must satisfy the changing governmental
4 unchanged sentences
fraud and abuse laws, including the False
−Removed: Additionally, effective September 1, 2023, the OIG for HHS issued a final rule implementing civil
−Removed: money penalties for information blocking as established by the Cures Act.
−Removed: OIG incorporated regulations published
−Removed: by ONC as the basis for enforcing information blocking penalties.
+Added: Additionally, effective September 1, 2023, the HHS-OIG issued a final rule implementing civil money
+Added: penalties for information blocking as established by the Cures Act.
+Added: OIG incorporated regulations published by
+Added: ONC as the basis for enforcing information blocking penalties.
Each information blocking violation carries a $1
9 unchanged sentences
Moreover, in order to satisfy our customers and comply with evolving legal requirements, our products
−Removed: incorporate increasingly complex functionality, such as with respect to reporting and information blocking.
−Removed: Although we believe we are positioned to accomplish this, the effort may involve
−Removed: increased costs, and our failure to
−Removed: implement product modifications, or otherwise satisfy applicable standards,
−Removed: could have a material adverse effect on
−Removed: our business.
+Added: incorporate increasingly complex functionality, such as reporting and information blocking.
+Added: Although we believe
+Added: we are positioned to accomplish this, the effort may involve increased costs, and
+Added: our failure to implement product
+Added: modifications, or otherwise satisfy applicable standards, could have a
+Added: material adverse effect on our business.
Additionally, as electronic medical devices are increasingly connected to each other and to other technology, the
24 unchanged sentences
in cases as a result of our distribution of
−Removed: Additionally, we own interests in companies that manufacture certain dental and medical products.
−Removed: result, we could be subject to the potential risk of product liability, intellectual property infringement or other
−Removed: claims relating to the manufacture and distribution of products by
−Removed: those entities.
−Removed: In addition, as our corporate brand
−Removed: business continues to grow, purchasers of such products may increasingly seek recourse directly from us, rather
−Removed: than the ultimate product manufacturer, for product-related claims.
−Removed: Another potential risk we face in the
−Removed: distribution of our products is liability resulting from counterfeit or tainted products
−Removed: infiltrating the supply chain.
−Removed: addition, some of the products that we transport and sell are considered hazardous
−Removed: handling of such materials or accidents involving the transportation
−Removed: of such materials could subject us to liability or
−Removed: at least legal action that could harm our reputation.
+Added: Additionally, we own and own interests in companies that manufacture certain dental and medical
+Added: As a result, we could be subject to the potential risk of product liability, intellectual property
+Added: infringement or other claims relating to the manufacture and distribution
+Added: of products by those entities.
+Added: as our corporate brand business continues to grow, purchasers of such products may increasingly seek recourse
+Added: directly from us, rather than the ultimate product manufacturer, for product-related claims.
+Added: Another potential risk
+Added: we face in the distribution of our products is liability resulting from counterfeit
+Added: or tainted products infiltrating the
+Added: supply chain.
+Added: In addition, some of the products that we transport and sell are
+Added: considered hazardous materials.
+Added: improper handling of such materials or accidents involving the transportation
+Added: of such materials could subject us to
+Added: liability or at least legal action that could harm our reputation.
Customs policies or legislative import restrictions could hinder the Company’s ability to import goods necessary
8 unchanged sentences
government enforcement actions and reputational harm.
−Removed: While the Company has policies against and seeks to
−Removed: avoid the import of goods that are manufactured in whole or in part by forced
−Removed: labor or through human trafficking,
−Removed: as a result of legislative and governmental policy initiatives, we may be
−Removed: subject to increasing potential delays,
−Removed: added costs, supply chain disruption and other restrictions.
+Added: Certain of our suppliers have had their ability to service
+Added: certain markets restricted or negatively impacted because of allegations
+Added: of forced labor in their supply chain.
+Added: the Company has policies against and seeks to avoid the import of goods
+Added: that are manufactured in whole or in part
+Added: Index to Financial Statements
+Added: by forced labor or through human trafficking, as a result of legislative and governmental
+Added: policy initiatives, we may
+Added: be subject to increasing potential delays, added costs, supply chain disruption
+Added: and other restrictions.
GENERAL RISKS
11 unchanged sentences
and extreme weather (“disasters”).
−Removed: example, as a global healthcare solutions company, the COVID-19 pandemic and the governmental responses
−Removed: had, and may again have, a material adverse effect on our business, results of operations
−Removed: and cash flows and may
−Removed: result in a material adverse effect on our financial condition and liquidity.
−Removed: The impacts and potential impacts from
−Removed: the COVID-19 pandemic included, and could include as a result of other disasters,
−Removed: the following, among other
−Removed: significant volatility in supply, demand and selling prices for personal protective equipment (PPE), test
−Removed: kits and related products;
−Removed: reduction in peoples’ ability and willingness to be in public;
−Removed: reduction in peoples’ ability and willingness to seek elective care;
−Removed: interrupted operations of industries that use or manufacture the products
−Removed: we distribute;
−Removed: impact of adapted business practices;
−Removed: significant changes in political conditions;
−Removed: volatility in the financial market;
−Removed: unavailability or impairment of our manufacturing, distribution, or other
−Removed: facilities, or firmwide systems
−Removed: such as our information systems.
−Removed: The impact from disasters may also exacerbate other risks discussed herein,
−Removed: any of which could have a material
−Removed: adverse effect on us.
−Removed: Our global operations are subject to inherent risks that could materially
−Removed: adversely affect our business.
+Added: example, as a global health care solutions company, the COVID-19 pandemic and the governmental responses
+Added: had a material adverse effect on our business, financial condition, operating results
+Added: and cash flows.
+Added: and potential impacts from the COVID-19 pandemic included, and could include
+Added: as a result of other disasters,
+Added: adverse impacts such as significant volatility in supply, demand and selling prices, interrupted operations of
+Added: industries that use or manufacture the products we distribute for personal
+Added: protective equipment (PPE), test kits and
+Added: related products, reduction in peoples’ ability and willingness to be in
+Added: public, impact of adapted business practices,
+Added: volatility in the financial markets, and unavailability or impairment
+Added: of our manufacturing, distribution, or other
+Added: facilities, or firmwide systems such as our IS.
+Added: Our global operations are subject to inherent risks that could materially adversely
+Added: affect our business.
Our global operations are subject to risks that could materially adversely affect our business,
−Removed: The risks that our
−Removed: global operations are subject to include, among other things:
+Added: including, among
+Added: other things:
difficulties and costs relating to staffing and managing foreign operations;
4 unchanged sentences
longer payment cycles of foreign customers and difficulty of collecting receivables
−Removed: jurisdictions;
+Added: in foreign jurisdictions;
repatriation of cash from our foreign operations to the United States;
−Removed: regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining
−Removed: to the accuracy of our internal books and records;
−Removed: litigation risks, new or unanticipated litigation developments and
−Removed: the status of litigation matters;
+Added: regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining to
+Added: the accuracy of our internal books and records;
+Added: litigation risks;
unexpected difficulties in importing or exporting our products and import/export
−Removed: tariffs, quotas,
−Removed: sanctions or penalties;
+Added: tariffs, quotas, sanctions
+Added: 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
−Removed: impacts from extreme weather
−Removed: events and other potential physical consequences, regulatory and technological
+Added: impacts from extreme weather events
+Added: and other potential physical consequences, regulatory and technological
requirements, market
2 unchanged sentences
management, and our revenues and profitability
−Removed: depend on our relationships with capable sales representatives,
−Removed: service technicians, and other personnel who
−Removed: interact directly with our customers, as well as customers, suppliers
−Removed: and manufacturers of the products that we
+Added: depend on our relationships with capable personnel, as well as
+Added: customers, suppliers and manufacturers of the
+Added: products that we distribute.
Our future success is substantially dependent upon the efforts and abilities of
9 unchanged sentences
We do not currently have “key man” life insurance
+Added: Index to Financial Statements
policies on any of our employees.
3 unchanged sentences
Additionally, our future revenues and profitability depend on our ability to maintain satisfactory relationships with
−Removed: qualified sales representatives, service technicians, and other personnel
−Removed: who interact directly with our customers, as
−Removed: well as customers, suppliers, and manufacturers.
−Removed: If we fail to maintain our existing relationships with such persons
−Removed: or fail to acquire relationships with such key persons in the future,
−Removed: our business may be materially adversely
+Added: qualified personnel, as well as customers, suppliers and manufacturers.
+Added: If we fail to maintain our existing
+Added: relationships with such persons or fail to acquire relationships with such key
+Added: persons in the future, our business may
+Added: be materially adversely affected.
Disruptions in the financial markets may materially adversely
8 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.