11 unchanged sentences
COMPANY RISKS
−Removed: Our business, results of operations, cash flows, financial condition and
−Removed: liquidity may be negatively impacted by
−Removed: the effects of disease outbreaks, epidemics, pandemics, or similar wide-spread public health
−Removed: concerns and other
−Removed: natural disasters
−Removed: The COVID-19 pandemic and the responses of governments
−Removed: to it had, and may again have, a
−Removed: material adverse effect on our business, results of operations and cash flows and may result
−Removed: in a material
−Removed: adverse effect on our financial condition and liquidity.
−Removed: Our business, results of operations, cash flows, financial condition and
−Removed: liquidity may be negatively impacted by the
−Removed: effects of disease outbreaks, epidemics, pandemics, similar wide-spread public health concerns
−Removed: and other natural
−Removed: The COVID-19 pandemic has had, and continues to have, an
−Removed: unprecedented impact on society, worldwide
−Removed: economic activity, and the health care sector (particularly, the dental market).
−Removed: As a global healthcare solutions
−Removed: company, the COVID-19 pandemic and the governmental responses to it had, and may again have, a material
−Removed: adverse effect on our business, results of operations and cash flows and may result
−Removed: in a material adverse effect on
−Removed: our financial condition and liquidity.
−Removed: Even after the COVID-19 pandemic has begun to subside, we may again
−Removed: experience material adverse impacts to our business, results of operations
−Removed: and cash flows as a result of, among other
−Removed: things, its global economic impact, including any recession that
−Removed: may occur in the future, or a prolonged period of
−Removed: economic slowdown or the reluctance of patients to return for elective dental
−Removed: or medical care.
−Removed: The impacts and
−Removed: potential impacts from the COVID-19 pandemic include, but are not
−Removed: Significant volatility in supply, demand and selling prices for personal protective equipment (PPE), COVID-19
−Removed: tests and other COVID-19 related products.
−Removed: Available supply,
−Removed: customer demand and selling prices for PPE,
−Removed: COVID-19 tests and other COVID-19 related products
−Removed: fluctuated in fiscal 2022 and we expect such volatility to
−Removed: continue for the duration of the COVID-19 pandemic.
−Removed: This has resulted
−Removed: in inventory reserves, fluctuating margins
−Removed: and increased revenue related to such products.
−Removed: The volatility in sales of COVID-19 test kits has moderated,
−Removed: at a significantly lower level of sales compared with 2021, resulting in
−Removed: us recording an inventory obsolescence
−Removed: reserve of $17 million for COVID-19 test kits during the year
−Removed: ended December 31, 2022 and we expect further
−Removed: declines in sales volumes.
−Removed: Our estimates for supply, demand and selling prices are inherently uncertain and if
−Removed: supply, demand, selling prices or other market dynamics significantly fluctuate in the future beyond our current
−Removed: assumptions, additional inventory reserves may be required, margins may be reduced and/or
−Removed: revenue may decline
−Removed: for such products, each which could materially adversely impact our business,
−Removed: results of operations and cash flows.
−Removed: Additionally, governmental policies designed to reduce the transmission of COVID-19 and variants thereof could
−Removed: once again lead to the closure of dental offices or deferral of elective procedures and
−Removed: wellness exams by medical
−Removed: and dental patients.
−Removed: Such previous closures and restrictions impacted our
−Removed: customers’ spending with us and had, and
−Removed: if reinstated may again have, a material adverse effect on our business, results of operations
−Removed: and cash flows.
−Removed: Although we believe that most practices currently are able to access
−Removed: adequate supply, we still may be unable to
−Removed: supply our customers with the specific brand and/or quantity of certain PPE products,
−Removed: COVID-19 tests and other
−Removed: COVID-19 related products they demand, which may lead to our
−Removed: customers seeking alternative sources of supply.
−Removed: Healthcare professionals’ inability to obtain a sufficient quantity and/or brand of certain PPE, COVID-19
−Removed: other COVID-19 related products would adversely impact our business,
−Removed: results of operations and cash flows, and
−Removed: could materially adversely affect our financial condition and liquidity;
−Removed: Reduction in Peoples’ Ability and Willingness to be in Public.
−Removed: Restrictions recommended by several public health
−Removed: organizations, and implemented, from time to time, by federal, state and local governments,
−Removed: to slow and limit the
−Removed: transmission of COVID-19 and variants thereof has caused and may in
−Removed: the future cause some people to be less
−Removed: willing to go to elective medical and dental appointments, which could
−Removed: again materially adversely affect demand
−Removed: for our products.
−Removed: A lengthened period of materially suppressed demand could again cause
−Removed: material adverse impacts
−Removed: on our business, results of operations and cash flows and could materially
−Removed: adversely affect our financial condition
−Removed: and liquidity;
−Removed: Negative impact on our workforce and impact of adapted business practices.
−Removed: The spread of COVID-19 and
−Removed: variants thereof caused us to modify our business practices (including
−Removed: employee travel, employee work locations,
−Removed: and physical participation in meetings, events and conferences), and
−Removed: we may take further actions as may be required
−Removed: by government authorities or our customers or that we determine are in the
−Removed: best interests of our employees.
−Removed: COVID-19 pandemic continues to unfold, we continue to evaluate
−Removed: appropriate actions for our business.
−Removed: of the COVID-19 pandemic, many of our office-based workers shifted abruptly to
−Removed: working remotely.
−Removed: COVID-19 pandemic has evolved, we have modified our work
−Removed: arrangements to implement more flexible working
−Removed: arrangements for our office-based workers, including permanent work from home,
−Removed: hybrid and office-based
−Removed: arrangements.
−Removed: Implementing these modified business practices
−Removed: to include remote work arrangements could have a
−Removed: negative impact on employee morale, strain our business continuity plans,
−Removed: introduce operational risk (including but
−Removed: not limited to cybersecurity risks), and impair our ability
−Removed: to efficiently operate our business;
−Removed: Significant changes in political conditions.
−Removed: Significant changes in political conditions in markets in which
−Removed: purchase and distribute our products have occurred and are expected to
−Removed: continue at least during the pendency of the
−Removed: pandemic, including quarantines, governmental or regulatory actions, closures
−Removed: or other restrictions that limit or
−Removed: close our operating facilities, restrict our employees’ ability to
−Removed: travel or perform necessary business functions, or
−Removed: otherwise constrain the operations of our business partners, suppliers or
−Removed: customers, which may materially adversely
−Removed: affect our business, results of operations, cash flows, financial condition
−Removed: and liquidity;
−Removed: in the financial markets.
−Removed: in the financial markets may materially adversely affect the
−Removed: availability and cost of credit to us;
−Removed: The impact of the COVID-19 pandemic may also exacerbate other risks discussed
−Removed: below, any of which could have
−Removed: a material adverse effect on us.
We are dependent upon third parties for the manufacture and supply of a significant volume of our products.
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interruption in supply, particularly of
−Removed: a high sales volume product, could result in a significant disruption
−Removed: in our sales and operations, as well as damage
+Added: a high-sales volume product, could result in a significant disruption in our
+Added: sales and operations, as well as damage
to our relationships with customers and our reputation.
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of allegations of forced labor in their supply
−Removed: Forced labor legislation affecting the supply chain has increased around the
−Removed: world, and the United States
+Added: Forced labor legislation affecting the supply chain has increased around
+Added: the world, and the United States
recently passed the Uyghur Forced Labor Prevention Act.
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resources, including employees
−Removed: with the requisite skills, experience and expertise, particularly in our technology
−Removed: segment, including dental practice
+Added: with the requisite skills, experience and expertise, particularly in our
+Added: technology segment, including dental practice
management, patient engagement and demand creation software solutions.
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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 related
−Removed: to the software and could adversely
+Added: Any such defective software may result in increased expenses
+Added: related to the software and could adversely
affect our relationships with customers as well as our reputation.
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our software or e-services products.
−Removed: Risks inherent in acquisitions,
−Removed: dispositions and joint ventures could offset the anticipated benefits.
+Added: Risks inherent in acquisitions, dispositions and joint ventures could
+Added: offset the anticipated benefits.
One of our business strategies has been to expand our domestic and
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may place significant demands on our
−Removed: operations, information systems, legal, regulatory, compliance-functions and financial resources, and there is risk
−Removed: that one or more may not succeed.
−Removed: We cannot be sure, for example, that we will achieve the benefits of revenue
−Removed: growth that we expect from these acquisitions or joint ventures or
−Removed: that we will avoid unforeseen additional costs,
−Removed: taxes or expenses.
−Removed: Our ability to successfully implement our acquisition
−Removed: and joint venture strategy depends upon,
−Removed: among other things, the following:
+Added: operations, information systems, legal, regulatory, compliance, financial, and human resources functions, and
+Added: is risk that one or more may not succeed.
+Added: We cannot be sure, for example, that we will achieve the benefits of
+Added: revenue growth that we expect from these acquisitions or joint ventures
+Added: or that we will avoid unforeseen additional
+Added: costs, taxes, or expenses.
+Added: Our ability to successfully implement our acquisition and joint venture
+Added: strategy depends
+Added: upon, among other things, the following:
the availability of suitable acquisition or joint venture candidates at
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products and personnel with
−Removed: our culture, management policies, legal, regulatory and compliance policies,
−Removed: cybersecurity systems and
+Added: our culture, management policies, legal, regulatory, and compliance policies, cybersecurity systems and
policies, internal procedures, working capital management, financial,
and operational controls and
−Removed: Furthermore, some of our acquisitions and future acquisitions may give rise to
−Removed: an obligation to make contingent
+Added: Furthermore, some of our acquisitions and future acquisitions may give
+Added: rise to an obligation to make contingent
payments or to satisfy certain repurchase obligations, which payments
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of our strategic objectives.
−Removed: Alternatively, we may dispose of assets or a business at a price or on terms that are
+Added: Alternatively, we may dispose of assets or a business at a price or on terms that are less
than we had anticipated.
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control, could affect our future financial results.
−Removed: Certain provisions in our governing documents and other documents to which we
−Removed: are a party may discourage
+Added: Certain provisions in our governing documents and other documents to
+Added: which we are a party may discourage
third parties from seeking to acquire us that might otherwise result in
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and (ii) the affirmative vote of the holders
−Removed: of at least 66 2/3% of our common stock entitled to vote to (a) remove
+Added: of at least 66 2/3% of our common stock entitled to vote to (a)
+Added: remove a director;
and (b) to amend or repeal our
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In addition, certain of our employee incentive plans provide
−Removed: accelerated vesting of stock options and other awards upon termination without cause
−Removed: within two years following a
+Added: accelerated vesting of stock options and other awards upon termination without
+Added: cause within two years following a
change in control, or grant the plan committee discretion to accelerate
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many suppliers
−Removed: purchasing incentive based on
−Removed: the attainment of
−Removed: certain growth goals.
−Removed: Suppliers may
−Removed: reduce or eliminate rebates
+Added: purchasing incentive based on the attainment of certain growth
+Added: Suppliers may reduce or eliminate rebates or
branded products
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growth goals.
−Removed: Additionally,
−Removed: factors outside of
−Removed: our control, such
−Removed: as customer preferences,
−Removed: consolidation of suppliers
+Added: Additionally, factors outside
+Added: of our control, such as customer
+Added: preferences, consolidation of suppliers
or supply issues, can have a material impact on
−Removed: our ability to achieve the growth goals established
−Removed: by our suppliers,
−Removed: which may reduce the amount of rebates or incentives we receive.
−Removed: The occurrence of any of these events
−Removed: an adverse impact on our business, financial condition or operating
+Added: our ability to achieve the growth goals established by
+Added: our suppliers,
+Added: incentives we
+Added: have an adverse impact on our business, financial condition or operating
Sales of corporate brand products entail additional risks, including the risk that such sales could
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our relationships with suppliers.
−Removed: offer certain corporate brand products that are available exclusively from us.
−Removed: of such products subjects
+Added: certain corporate brand products that are available exclusively from us.
+Added: The sale of such products subjects
us to the risks generally encountered by entities that source, market and sell corporate brand products, including but
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business, financial
−Removed: consequently,
−Removed: relationships.
−Removed: requirements,
+Added: products owned by our
+Added: suppliers which, consequently,
+Added: could adversely impact certain
+Added: of our supplier relationships.
+Added: Our ability to locate qualified, economically stable suppliers who satisfy our requirements, and to
+Added: acquire sufficient
and effective
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not diminished.
−Removed: sourcing relationships
−Removed: deep supplier
−Removed: adverse effect on our business, financial condition or operating results.
+Added: In addition, we
+Added: are exposed to
+Added: that our competitors
+Added: customers may introduce
+Added: private label,
+Added: low-cost products
+Added: products could
+Added: capture significant
+Added: market prices
+Added: overall, eroding
+Added: to develop sourcing
+Added: relationships with a
+Added: broad and deep
+Added: supplier base could
+Added: have an adverse
+Added: our business, financial condition or operating results.
INDUSTRY RISKS
+Added: Security risks generally associated with our information systems and our
+Added: technology products and services have
+Added: in the recent past adversely affected our business and results of operations, and could
+Added: in the future materially
+Added: adversely affect our business and our results of operations if such products, services,
+Added: or systems (or third-party
+Added: systems we rely on) are interrupted, damaged by unforeseen events, are subject
+Added: to cyberattacks or fail for any
+Added: extended period of time.
+Added: We rely on information systems (“IS”) in our business to obtain, rapidly process, analyze, manage and store
+Added: customer, product, supplier and employee data to, among other things:
+Added: maintain and manage worldwide systems to facilitate the purchase and
+Added: distribution of thousands of
+Added: inventory items from numerous distribution centers;
+Added: receive, process and ship orders on a timely basis;
+Added: manage the accurate billing and collections for our customers;
+Added: process payments to suppliers;
+Added: provide products and services that maintain certain of our customers’ electronic
+Added: medical or dental
+Added: records (including protected health information of their patients);
+Added: maintain and manage global human resources, compensation and payroll
+Added: In addition to health information in our customers’ electronic
+Added: medical and dental records, certain of our IS stores
+Added: other sensitive personal and financial information, such as healthcare
+Added: and other information related to our
+Added: employees, as well as other sensitive information such as credit card
+Added: information from our third-party business
+Added: partners, that is confidential,
+Added: and in many cases subject to privacy laws.
+Added: Our IS are vulnerable to, among other things, natural disasters,
+Added: power losses, computer viruses, telecommunication
+Added: failures, cybersecurity threats and other criminal activity.
+Added: Information security risks have significantly increased
+Added: recent years in part because of an overall increase in cyber incidents,
+Added: their increased sophistication, and the
+Added: involvement of organized crime, hackers, terrorists and foreign state agents.
+Added: The healthcare
+Added: industry in particular
+Added: has been targeted by threat actors seeking to undermine companies’ cybersecurity
+Added: defensive measures.
+Added: We have processes in place intended to ensure that our security measures keep pace with new and emerging risks.
+Added: We regularly review,
+Added: monitor and implement multiple layers of security through technology, processes and our
+Added: We utilize security technologies designed to protect and maintain the integrity of our IS and data, and our
+Added: defenses are monitored and routinely tested internally and by external
+Added: Despite these efforts, our facilities
+Added: and systems and those of our third-party service providers have been,
+Added: and may in the future be, vulnerable to
+Added: privacy and security incidents, cybersecurity attacks and data breaches,
+Added: acts of vandalism or theft, computer viruses
+Added: and other malicious code, misplaced or lost data, programming and/or human
+Added: attacks or other acts
+Added: undermining IS of third party business partners including our customers,
+Added: or other similar events that could impact
+Added: the security, reliability and availability of our systems.
+Added: In addition, hardware, software or applications developed
+Added: internally or procured from third parties may contain defects
+Added: in design or manufacture or other problems that could
+Added: unexpectedly compromise information security.
+Added: As a practical matter, so long as we depend on IS to operate our
+Added: business, and our business partners do the same, there can be no guaranty
+Added: that such measures will successfully stop
+Added: any one particular cybersecurity incident given the constantly evolving
+Added: nature of the threat.
+Added: We may also incur
+Added: substantial costs as we update our cybersecurity defense systems and our general
+Added: computer controls to meet
+Added: evolving challenges, and legislative or regulatory action related to cybersecurity
+Added: may increase our costs to develop
+Added: or implement new technology products and services.
+Added: A cyberattack that bypasses or compromises our IS cybersecurity / or general
+Added: information technology (“IT”)
+Added: controls (including third-party systems we rely on) causing an IS security breach
+Added: may lead, and has in the past led,
+Added: to a disruption of our IS business systems (including third-party systems we
+Added: rely on), interruption of operations
+Added: (including, without limitation, receiving, verifying, and processing customer orders,
+Added: customer service, accounts
+Added: payable, warehouse management and shipping, and systems tied to internal
+Added: controls over financial reporting), the
+Added: loss or alteration of business, financial, and other protected information,
+Added: a negative impact on our financial
+Added: performance, and to an adverse impact on our financial accounting
+Added: and reporting controls.
+Added: A cyberattack that bypasses or compromises our IS cybersecurity / or general
+Added: computer controls or those of third
+Added: parties with whom we engage may also lead to claims against us by
+Added: affected parties and/or governmental agencies,
+Added: and involve fines and penalties, as well as substantial defense and settlement
+Added: Any of these impacts may
+Added: alone, or collectively, have a material impact on our business.
+Added: A successful cyberattack has, and may again in the
+Added: future, disrupt our business operations, adversely impact our financial
+Added: accounting and reporting of results of
+Added: operations, divert the attention of management, and adversely impact
+Added: our results of operations.
+Added: In addition, we develop products and provide services to our customers
+Added: that are technology-based, and a
+Added: cyberattack that bypasses the IS supporting our products or services causing
+Added: a security breach and/or perceived
+Added: security vulnerabilities in our products or services could also cause significant
+Added: loss of business and reputational
+Added: harm, and actual or perceived vulnerabilities may lead to claims against
+Added: us by our customers and/or governmental
+Added: In addition, certain of our practice management products and services
+Added: purchased by health care
+Added: providers, such as physicians and dentists, are used to store and manage patient
+Added: medical or dental records.
+Added: customers are subject to laws and regulations which require that they
+Added: protect the privacy and security of those
+Added: records, and our products may be used as part of these customers’ comprehensive
+Added: data security programs, including
+Added: in connection with their efforts to comply with applicable privacy and security laws.
+Added: In addition to immaterial and unrelated prior incidents at certain of
+Added: our subsidiaries, in October 2023, Henry Schein
+Added: experienced a cybersecurity incident that primarily affected the operations of our
+Added: North American and European
+Added: dental and medical distribution businesses.
+Added: Henry Schein One, our practice management software, revenue
+Added: management and patient relationship management solutions business was
+Added: not affected, and our manufacturing
+Added: businesses were mostly unaffected.
+Added: Once we became aware of the issue, we took steps to assess, contain
+Added: remediate this incident.
+Added: We restored affected systems and applications, our distribution operations resumed and we
+Added: reactivated our ecommerce platform.
+Added: We also notified law enforcement and our employees, customers, suppliers
+Added: and investors, informing them of both the incident and management’s efforts to mitigate its impact on our daily
+Added: operations and data maintained on the Company’s systems.
+Added: Subsequently, on or about November 8, 2023, we
+Added: determined that the threat actor obtained personal and sensitive information
+Added: maintained on our systems belonging to
+Added: certain third parties and since that date we have notified affected parties and potentially
+Added: affected parties as
+Added: The scope of personal and sensitive data impacted is still under investigation.
+Added: On November 22, 2023,
+Added: we experienced a related disruption to our ecommerce platform and
+Added: related applications, which has since been
+Added: The October 2023 cybersecurity incident disrupted key
+Added: business operations, adversely impacted our
+Added: financial results for the fourth quarter and full year 2023, diverted
+Added: attention of management, and caused the
+Added: Company to incur significant remediation costs.
+Added: We continue to review the effects of the incident on the
+Added: Company’s business as we do expect some short-term residual impact on our financial results in 2024.
+Added: 2024, two putative class actions were filed against us based on the incident
+Added: and one of these actions is still pending.
+Added: We are spending, and plan to expend in the future, additional resources to continue to protect against, or to address
+Added: problems caused by, business interruptions, and data security breaches.
+Added: In addition, customers and suppliers may impose additional cybersecurity
+Added: requirements on us as a result of the
+Added: incident we experienced in October 2023, and some customers and suppliers
+Added: have made such requests to date.
+Added: cannot guarantee that we will be able to satisfy such additional requirements,
+Added: and failure to satisfy such
+Added: requirements could result in a loss of revenue or diminished product
+Added: availability that could materially affect our
+Added: business adversely.
+Added: We also may be perceived as a more vulnerable target of the cyber hackers as a result of the
+Added: October 2023 incident.
+Added: If the Company is subject to more attacks in the future as a result of
+Added: the recent incident, this
+Added: could materially affect our business adversely.
+Added: We maintain cyber insurance, subject to certain retentions and policy limitations.
+Added: With respect to the October 2023
+Added: cybersecurity incident, we have a $60 million insurance policy, following a $5 million retention.
The health care products distribution industry is highly competitive
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then be unable to market.
−Removed: Manufacturers also could increase their
−Removed: efforts to sell directly to end-users and thereby
+Added: Manufacturers also could increase their efforts to sell directly to end-users and
eliminate or reduce our role in distribution.
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timely basis could have a material adverse effect on our business.
−Removed: The repeal or judicial prohibition on implementation of the Affordable Care Act
−Removed: could materially adversely
−Removed: affect our business.
−Removed: The ACA greatly expanded health insurance coverage in the United States
−Removed: and has been the target of litigation and
−Removed: Congressional reform efforts since its adoption.
−Removed: Supreme Court, in upholding the constitutionality of the
−Removed: ACA and its individual mandate provision in 2012, simultaneously
−Removed: limited ACA provisions requiring Medicaid
−Removed: expansion, making such expansion a state-by-state decision.
−Removed: In 2017, the U.S.
−Removed: Congress effectively repealed the
−Removed: individual mandate provision by eliminating the financial penalty for non-compliance.
−Removed: In the most recent
−Removed: ACA litigation, a federal appeals court found the individual mandate to be unconstitutional,
−Removed: and returned the case to
−Removed: a lower federal court for consideration of whether the remainder of the ACA
−Removed: could survive the excision of the
−Removed: individual mandate.
−Removed: This decision was appealed to the U.S.
−Removed: Supreme Court, and the Supreme
−Removed: Court issued a
−Removed: decision on June 17, 2021.
−Removed: Without reaching the merits of the case, the Supreme Court held that the plaintiffs in
−Removed: the case did not have standing to challenge the ACA.
−Removed: Any outcome of future 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.
−Removed: For instance, the American Rescue Plan Act of 2021 enhanced
−Removed: premium tax credits, which has resulted in an expansion of the number of people
−Removed: covered under the ACA.
−Removed: changes are time-limited, with some enhancements in place for 2021
−Removed: only and others available through the end of
−Removed: The health care industry is experiencing changes due to political, economic and
−Removed: regulatory influences that could
+Added: The health care industry is experiencing changes due to political, economic
+Added: and regulatory influences that could
materially adversely affect our business.
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these and other changes in the health care industry, our business could be materially adversely affected.
−Removed: Expansion of group purchasing organizations (“GPO”), dental support organizations
−Removed: (“DSO”) or provider
−Removed: networks and the multi-tiered costing structure may place us at a competitive
−Removed: disadvantage.
+Added: greatly expanded health insurance coverage in the United States and has been
+Added: the target of litigation and
+Added: Congressional reform efforts since its adoption.
+Added: Any outcome of future court cases that change the ACA, in
+Added: addition to future legislation, regulation, guidance and/or Executive Orders
+Added: that do the same, could have a
+Added: significant impact on the U.S.
+Added: healthcare industry and the ability or willingness
+Added: of individuals to engage with it.
+Added: Expansion of GPOs, DSOs or provider networks and the multi-tiered
+Added: costing structure may place us at a
+Added: competitive disadvantage.
The health care products industry is subject to a multi-tiered costing structure, which
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effectively, which could in turn negatively impact our financial results.
−Removed: Although we are seeking to obtain similar
−Removed: terms from manufacturers to access lower prices demanded by GPO and
−Removed: DSO contracts or other contracts, and to
−Removed: develop relationships with existing and emerging provider networks, GPOs and DSOs,
−Removed: we cannot guarantee that
−Removed: such terms will be obtained or contracts executed.
+Added: In addition, such organizations may
+Added: establish direct relationships with manufacturers, thereby either eliminating
+Added: or reducing the services historically
+Added: provided by distributors.
+Added: Although we are seeking to obtain similar terms from manufacturers
+Added: to access lower
+Added: prices demanded by GPO and DSO contracts or other contracts,
+Added: and to develop relationships with existing and
+Added: emerging provider networks, GPOs and DSOs, we cannot guarantee that such terms will
+Added: be obtained or contracts
Increases in shipping costs or service issues with our third-party shippers
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election results;
−Removed: changes to laws and policies governing foreign trade (including, without
−Removed: limitation, the United States-
−Removed: Mexico-Canada Agreement (USMCA), the EU-UK Trade and Cooperation Agreement of December
−Removed: 2020 (that went into effect in 2021) and other international trade agreements);
−Removed: greater restrictions on imports and exports;
+Added: changes to laws and policies governing foreign trade, tariffs and sanctions, or greater
+Added: restrictions on
+Added: imports and exports;
supply chain disruptions;
changes in laws and policies governing health care or data privacy;
−Removed: tariffs and sanctions;
changes to the relationship between the United States and China;
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changes in regulatory and tax regulations;
−Removed: interest rate fluctuations,
−Removed: and strengthening of the dollar, which have and will continue to impact our
+Added: interest rate fluctuations, and strengthening of the dollar, which have and will continue to
results of operations;
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changes in tax rates and the availability of certain tax deductions;
−Removed: increases in labor costs;
−Removed: increases in health care costs;
−Removed: our aspirations, goals and disclosures related to environmental, social and
−Removed: governance (ESG) matters;
+Added: increases in labor costs or health care costs;
the threat or outbreak of war, terrorism or public unrest (including, without limitation, the war in
−Removed: Ukraine and the possibility of a wider European or global conflict);
+Added: Ukraine, the Israel-Gaza war and other unrest and threats in the Middle East,
+Added: and the possibility of a
+Added: wider European or global conflict);
changes in laws and policies governing manufacturing, development, and
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consumer and commercial spending may also cause customers to
−Removed: reduce, modify, delay or cancel plans to purchase
+Added: reduce, modify, delay,
+Added: or cancel plans to purchase
our products and may cause suppliers to reduce their output or change
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The strengthening of the dollar, likewise, has impacted
−Removed: our revenues and costs, but neither inflation nor exchange rates have materially
−Removed: impacted our results of operations
+Added: our revenues and costs, but neither inflation nor exchange rates have
+Added: materially impacted our results of operations
in fiscal year 2023.
1 unchanged sentence
If customers’ cash flow or
−Removed: operating and financial performance deteriorate, or if they are unable to make scheduled
−Removed: payments or obtain credit,
+Added: operating and financial performance deteriorate, or if they are unable to
+Added: make scheduled payments or obtain credit,
they may not be able to, or may delay, payment to us.
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the affected area back into compliance.
−Removed: Administration has indicated that it will be more aggressive in its pursuing
−Removed: alleged violations of law, and it has
−Removed: revoked certain guidance that would have limited governmental use of informal
−Removed: agency guidance to pursue such
−Removed: violations, as well as indicating it was more prepared to pursue individuals
−Removed: for corporate law violations, including
−Removed: an aggressive approach to anti-corruption activities.
−Removed: Changes with respect to the applicable laws, regulations and
−Removed: guidance described below may require us to update or revise our operations,
−Removed: services, marketing practices, and
−Removed: compliance programs and controls, and may impose additional and unforeseen
−Removed: costs on us, pose new or previously
−Removed: immaterial risks to us, or may otherwise have a material adverse effect on our business.
−Removed: There can be no assurance
−Removed: that current and future government regulations will not adversely
−Removed: affect our business, and we cannot predict new
−Removed: regulatory priorities, the form, content or timing of regulatory actions,
−Removed: and their impact on the health care industry
−Removed: and on our business and operations.
+Added: with respect to the applicable laws, regulations and guidance described below
+Added: may require us to update or revise
+Added: our operations, services, marketing practices, and compliance programs
+Added: and controls, and may impose additional
+Added: and unforeseen costs on us, pose new or previously immaterial risks to us, or
+Added: may otherwise have a material
+Added: adverse effect on our business.
+Added: There can be no assurance that current and future government
+Added: regulations will not
+Added: adversely affect our business, and we cannot predict new regulatory priorities, the
+Added: form, content or timing of
+Added: regulatory actions, and their impact on the health care industry and on our
+Added: business and operations.
Global efforts toward healthcare cost containment continue to exert pressure on
1 unchanged sentence
In the United
−Removed: States, in addition to other government efforts to control health care costs, there has been increased
−Removed: scrutiny on drug
+Added: States, in addition to other government efforts to control health care costs, there has been
+Added: increased scrutiny on drug
pricing and concurrent efforts to control or reduce drug costs by Congress, the President,
1 unchanged sentence
and various states.
−Removed: At the state level, several states have adopted laws that require drug manufacturers
−Removed: advance notice of certain price increases and to report information
−Removed: relating to those price increases, while others
−Removed: have taken legislative or administrative action to establish prescription drug
−Removed: affordability boards or multi-payer
−Removed: purchasing pools to reduce the cost of prescription drugs.
−Removed: At the federal level, several related bills have been
−Removed: introduced and regulations proposed which, if enacted or finalized,
−Removed: respectively, would impact drug pricing and
−Removed: related costs.
+Added: We and our subsidiaries may be required to report drug pricing data under federal laws and
+Added: At the state level, several states have adopted laws, that may
+Added: apply to some of our operations, that
+Added: require drug manufacturers, including re-packagers or re-labelers, to provide
+Added: advance notice of certain price
+Added: increases and to report information relating to those price increases, while
+Added: others have taken legislative or
+Added: administrative action to establish prescription drug affordability boards or
+Added: multi-payer purchasing pools to reduce
+Added: the cost of prescription drugs.
+Added: At the federal level, several related bills have been introduced
+Added: and regulations
+Added: proposed which, if enacted or finalized, respectively, would impact drug pricing and related costs.
Under the Sunshine Act, we are required to collect and report detailed
10 unchanged sentences
While we believe we have substantially compliant programs
−Removed: and controls in place satisfying the above laws and requirements, such
−Removed: compliance imposes additional costs on us
+Added: and controls in place satisfying the above laws and requirements,
+Added: such compliance imposes additional costs on us
and the requirements are sometimes unclear.
40 unchanged sentences
serious illness, injury or death;
−Removed: require manufacturers, wholesalers, repackagers and dispensers of prescription
+Added: require manufacturers, wholesalers, re-packagers and dispensers of prescription
drugs to identify and
29 unchanged sentences
respect to these products.
+Added: imaging software is regulated as a medical device which subjects our businesses
+Added: to substantial additional
+Added: requirements, costs and potential enforcement actions or liabilities for noncompliance
+Added: with respect to these
Applicable federal, state, local, and foreign laws and regulations also may require
1 unchanged sentence
relating to, among other things, licensure or registration, program eligibility, procurement, third-party
−Removed: reimbursement, sales and marketing practices, product integrity and
−Removed: supply tracking to product manufacturers,
+Added: reimbursement, sales and marketing practices, product integrity, and supply tracking to product manufacturers,
product labeling, personnel, privacy and security of health or other personal
4 unchanged sentences
applicable to our specialty home medical
−Removed: supplies business), have recently increased their regulatory and enforcement
−Removed: activities and, in particular, the DEA
−Removed: has heightened enforcement activities due to the opioid crisis in the United States.
−Removed: One of our businesses was
−Removed: suspended in October 2021 by CMS from receiving payments from
−Removed: Medicare, although it was permitted to continue
−Removed: to perform and bill for Medicare services.
−Removed: On September 30, 2022, CMS terminated the suspension of Medicare
−Removed: As a result of the termination of the suspension, we recognized $4
−Removed: million of previously deferred
−Removed: revenue during the year ended December 31, 2022.
−Removed: Our business is also subject to requirements of similar and
−Removed: other foreign governmental laws and regulations affecting our operations abroad.
+Added: supplies business) and state Medicaid agencies, have recently increased
+Added: their regulatory and enforcement activities
+Added: and, in particular, the DEA has heightened enforcement activities due to the opioid crisis in the United States.
+Added: business is also subject to requirements of similar and other foreign governmental
+Added: laws and regulations affecting
+Added: our operations abroad.
The failure to comply with any of these laws or regulations, or new interpretations
5 unchanged sentences
may be modified, could be material.
−Removed: Allegations by a governmental body that we have not complied with
+Added: Allegations by a governmental body that we have not complied
laws could have a material adverse effect on our businesses.
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could be required to make settlement
−Removed: payments or be subject to civil and criminal penalties, including fines
−Removed: and the loss of licenses.
+Added: payments or be subject to civil and criminal penalties, including
+Added: fines and the loss of licenses.
Non-compliance
3 unchanged sentences
and damage our reputation.
−Removed: The EU Medical Device Regulation may adversely affect our business.
+Added: The EU Medical Device Regulation (“MDR”) may adversely affect our business.
The EU MDR, applicable since May 26, 2021, significantly modifies and intensifies
2 unchanged sentences
Among other things, the EU MDR:
−Removed: strengthens the rules on placing devices on the market and reinforce surveillance once
−Removed: establishes explicit provisions on manufacturers’
−Removed: responsibilities for the follow-up of the quality,
+Added: strengthens the rules on placing devices on the market and reinforces surveillance
+Added: once they are
+Added: establishes explicit provisions on manufacturers’ responsibilities
+Added: for the follow-up of the quality,
performance and safety of devices placed on the market;
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registration in a database
−Removed: (EUDAMED not due until 2024 and after as mentioned above).
+Added: (EUDAMED not due, for the time being, until the end of 2027 at
+Added: the earliest, as mentioned above).
In particular, the EU MDR imposes strict requirements for the confirmation that a product
2 unchanged sentences
distribution, marketing and sale of medical devices, including post-market surveillance.
−Removed: Medical devices that have
−Removed: been assessed and/or certified under the EU Medical Device Directive
−Removed: may continue to be placed on the market
−Removed: until 2024 (or until the expiry of their certificates, if applicable and earlier).
−Removed: However, on January 6, 2023, the EU
−Removed: Commission submitted a proposed amendment to extend the MDR transitional
−Removed: periods until December 31, 2028,
−Removed: for certain medical devices to ensure continued access to medical devices
−Removed: for patients and to allow medical devices
−Removed: already placed on the market in accordance with the current legal framework
−Removed: to remain on the market.
−Removed: to monitor developments and whether the proposed amendment and
−Removed: new deadlines will be approved by the
−Removed: European Parliament and Council.
−Removed: Nevertheless, EU MDR requirements
−Removed: regarding the distribution, marketing and
−Removed: sale including quality systems and post-market surveillance have to be observed
−Removed: by manufacturers, importers and
−Removed: distributors as of the application date (i.e., May 26, 2021).
−Removed: The modifications created by the EU MDR may have an impact on the
−Removed: way we design and manufacture products
−Removed: and the way we conduct our business in the European Economic Area.
+Added: As mentioned above,
+Added: pursuant to Regulation 2023/607 and subject to certain conditions, medical devices
+Added: that (i) obtained a certificate
+Added: under the EU Medical Device Directive from May 25, 2017, (ii) which was
+Added: still valid on May 26, 2021, and (iii)
+Added: has not been subsequently withdrawn may, for the moment, continue to be placed on the market or put into service
+Added: until December 31, 2027 for higher risk devices or December 31, 2028 for medium
+Added: and lower risk devices.
+Added: Nevertheless, EU MDR requirements regarding the distribution,
+Added: marketing and sale including quality systems and
+Added: post-market surveillance have to be observed by manufacturers, importers
+Added: and distributors as of the application date
+Added: (i.e., May 26, 2021).
+Added: The modifications created by the EU MDR may have an impact
+Added: on the way we design and
+Added: manufacture products and the way we conduct our business in
If we fail to comply with laws and regulations relating to health care
5 unchanged sentences
foreign) health care fraud and abuse, referral
−Removed: and reimbursement laws and regulations with
−Removed: respect to their operations.
+Added: and reimbursement laws and regulations with respect to their operations.
Some of these laws, referred to as “false
3 unchanged sentences
Other laws, referred to as “anti-kickback laws,” prohibit
−Removed: soliciting, offering, receiving or paying remuneration in order to induce the referral
−Removed: of a patient or ordering,
−Removed: purchasing, leasing or arranging for, or recommending ordering, purchasing or leasing of, items or services
−Removed: paid for by federal, state and other health care payers and programs.
−Removed: Certain additional state and federal laws, such
−Removed: as the federal Physician Self-Referral Law, commonly known as the “Stark Law,” prohibit physicians and other
−Removed: health professionals from referring a patient to an entity with which the
−Removed: physician (or family member) has a
−Removed: financial relationship, for the furnishing of certain designated health services
−Removed: (for example, durable medical
−Removed: equipment and medical supplies), unless an exception applies.
−Removed: Violations of Anti-Kickback statutes or the Stark
−Removed: Law may be enforced as violations of the federal False Claims Act.
+Added: soliciting, offering, receiving or paying remuneration in order to induce or reward
+Added: the referral of a patient or
+Added: ordering, purchasing, leasing or arranging for, or recommending ordering, purchasing or leasing of,
+Added: services that are paid for by federal, state and other health care payers and programs.
+Added: Certain additional state and
+Added: federal laws, such as the federal Physician Self-Referral Law, commonly known as the “Stark Law,” prohibit
+Added: physicians and other health care professionals from referring a patient
+Added: to an entity with which the physician (or
+Added: family member) has a financial relationship, for the furnishing of certain designated
+Added: health services (for example,
+Added: durable medical equipment and medical supplies), unless an exception applies.
+Added: Violations of Anti-Kickback
+Added: statutes or the Stark Law may be enforced as violations of the federal False Claims
The fraud and abuse laws and regulations have been subject to heightened
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as necessary to facilitate
+Added: Our aspirations, goals and disclosures related to environmental, social
+Added: and governance matters and the focus on
+Added: regulators and private litigants among other things on related claims made
+Added: by companies and funds expose us to
+Added: numerous risks, including reputational, financial, legal and other risks,
+Added: that could have an adverse impact on us,
+Added: including on our stock price.
+Added: California has adopted stringent new climate disclosure requirements,
+Added: as has the EU,
+Added: and the SEC appears about to adopt expansive new disclosure requirements
+Added: on climate change.
In the EU, the Directive No.
2 unchanged sentences
organizes the legal protection of whistleblowers.
−Removed: This Directive covers whistleblowers
+Added: This Directive covers whistleblowers reporting
breaches of certain EU laws, in particular as regards public health, the above-mentioned
2 unchanged sentences
726/2004 or, as regards data protection, the GDPR.
−Removed: The Directive protects a wide range of
+Added: The Directive protects a wide range of people
and includes former employees.
−Removed: All private companies with 50 or
−Removed: more employees are required to create effective
+Added: All private companies with 50 or more employees are required
+Added: to create effective
internal reporting channels.
−Removed: Though it was required before December 17, 2021,
−Removed: at the latest, the implementation of
−Removed: this Directive by EU member states is still underway for some of
−Removed: At the end of January 2023 and according
−Removed: to information available on public sources, sixteen EU member states have
−Removed: fully implemented it (France, Belgium,
−Removed: Denmark, Finland, Latvia, The Netherlands, Ireland, Croatia, Cyprus, Greece, Lithuania,
−Removed: Romania, Malta, Portugal,
−Removed: Sweden and Bulgaria) while the process is ongoing in the others with varying
−Removed: degrees of progress.
+Added: All EU Member States other than Poland and Estonia have now implemented
We also are subject to the requirements of the new Directive No.
2022/2464 on corporate sustainability reporting
−Removed: ("CSR Directive") adopted on December 14, 2022 and has to be
+Added: (“CSR Directive”) adopted on December 14, 2022 and which has to be
implemented by EU members states by July
4 unchanged sentences
537/2014, the CSR Directive strengthens the existing rules on non-financial
−Removed: reporting by setting new requirements for large
−Removed: companies to publish sustainability-related information and, in particular, disclose details about their
−Removed: impacts on environmental matters.
+Added: reporting by setting new requirements
+Added: for large companies to publish sustainability-related information and, in particular, disclose details about
+Added: and impacts on environmental matters.
also are subject to certain United States and foreign laws and regulations
26 unchanged sentences
resolve such matters.
−Removed: Intentional or unintentional failure to comply with consent decrees could
−Removed: materially adversely
−Removed: affect our business.
+Added: Intentional or unintentional failure to comply with settlement agreements
+Added: or consent decrees
+Added: could materially adversely affect our business.
While we believe that we are substantially compliant with applicable fraud and
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products, and our specialty home medical
−Removed: supply business, include electronic information technology systems that
−Removed: store and process personal health, clinical,
−Removed: financial and other sensitive information of individuals.
−Removed: These information technology systems may be vulnerable
−Removed: to breakdown, wrongful intrusions, data breaches and malicious attack,
−Removed: which could require us to expend
−Removed: significant resources to eliminate these problems and address related security
−Removed: concerns, and could involve claims
−Removed: against us by private parties and/or governmental agencies.
+Added: supply businesses, include electronic information technology systems
+Added: that store and process personal health,
+Added: clinical, financial, and other sensitive information of individuals.
+Added: These information technology systems may be
+Added: vulnerable to breakdown, wrongful intrusions, data breaches and
+Added: malicious attack, which could require us to
+Added: expend significant resources to eliminate these problems and address
+Added: related security concerns, and could involve
+Added: 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, the Controlling the Assault of Non-
−Removed: Solicited Pornography and Marketing Act, the Telephone Consumer Protection Act of 1991, Section 5 of the
−Removed: Federal Trade Commission Act, the CCPA, and the CPRA that becomes effective on January 1, 2023.
−Removed: regulations relating to privacy and data protection are continually evolving
−Removed: and subject to potentially differing
−Removed: interpretations.
−Removed: These requirements
−Removed: may not be harmonized, may be interpreted and applied in a
−Removed: manner that is
−Removed: inconsistent from one jurisdiction to another or may conflict with other
−Removed: rules or our practices.
−Removed: Our businesses’
−Removed: failure to comply with these laws and regulations could expose us to breach of
−Removed: contract claims, substantial fines,
−Removed: penalties and other liabilities and expenses, costs for remediation and harm to
−Removed: our reputation.
−Removed: Also, evolving laws
−Removed: and regulations in this area could restrict the ability of our customers to obtain,
−Removed: use or disseminate patient
−Removed: information, or could require us to incur significant additional costs to
−Removed: re-design our products to reflect these legal
−Removed: requirements, which could have a material adverse effect on our operations.
+Added: that protect the privacy and security of personal information, such as HIPAA, CAN-SPAM, TCPA,
+Added: Section 5 of the
+Added: FTC Act, the CCPA, and the CPRA that became effective on January 1, 2023.
+Added: Laws and regulations relating to
+Added: privacy and data protection are continually evolving and subject to
+Added: potentially differing interpretations.
+Added: requirements may not be harmonized, may be interpreted and applied in
+Added: a manner that is inconsistent from one
+Added: jurisdiction to another or may conflict with other rules or our practices.
+Added: Our businesses’ failure to comply with
+Added: these laws and regulations could expose us to breach of contract claims, substantial
+Added: fines, penalties and other
+Added: liabilities and expenses, costs for remediation and harm to our reputation.
+Added: Also, evolving laws and regulations in
+Added: this area could restrict the ability of our customers to obtain, use or disseminate patient
+Added: information, or could
+Added: require us to incur significant additional costs to re-design our products
+Added: to reflect these legal requirements, which
+Added: could have a material adverse effect on our operations.
In addition, the European Parliament and the Council of the EU adopted
the GDPR effective from May 25, 2018,
−Removed: which increased privacy rights for individuals (“Data Subjects”), including
−Removed: individuals who are our customers,
−Removed: suppliers and employees.
−Removed: The GDPR extended the scope of responsibilities for data controllers and data
−Removed: processors, and generally imposes increased requirements and potential
−Removed: penalties on companies, such as us, that are
−Removed: either established in the EU and process personal data of Data Subjects
−Removed: (regardless the Data Subject location), or
−Removed: that are not established in the EU but that offer goods or services to Data Subjects
−Removed: in the EU or monitor their
−Removed: behavior in the EU.
−Removed: Noncompliance can result in penalties of up to
−Removed: the greater of EUR 20 million, or 4% of global
−Removed: company revenues (sanction that may be public), and Data Subjects may
−Removed: seek damages.
−Removed: Member states may
−Removed: individually impose additional requirements and penalties regarding certain
−Removed: limited matters (for which the GDPR
−Removed: left some room of flexibility), such as employee personal data.
−Removed: With respect to the personal data it protects,
−Removed: GDPR requires, among other things, controller accountability, consents from Data Subjects or another acceptable
−Removed: legal basis to process the personal data, notification within 72 hours of
−Removed: a personal data breach where required, data
+Added: which increased privacy rights for Data Subjects, including individuals
+Added: who are our customers, suppliers and
+Added: The GDPR extended the scope of responsibilities for data controllers
+Added: and data processors, and
+Added: generally imposes increased requirements and potential penalties on companies,
+Added: such as us, that are either
+Added: established in the EU and process personal data of Data Subjects (regardless
+Added: the Data Subject location), or that are
+Added: not established in the EU but that offer goods or services to Data Subjects in the EU
+Added: or monitor their behavior in the
+Added: Noncompliance can result in penalties of up to the greater of EUR 20
+Added: million, or 4% of global company
+Added: revenues (sanction that may be public), and Data Subjects may seek damages.
+Added: Member states may individually
+Added: impose additional requirements and penalties regarding certain limited
+Added: matters (for which the GDPR left some
+Added: room of flexibility), such as employee personal data.
+Added: With respect to the personal data it protects, the GDPR
+Added: requires, among other things, controller accountability, consents from Data Subjects or another acceptable legal
+Added: basis to process the personal data, notification within 72 hours
+Added: of a personal data breach where required, data
integrity and security, and fairness and transparency regarding the storage, use or other processing of the personal
14 unchanged sentences
of operations.
−Removed: carries maximum penalties of CNY50 million or 5% of the annual revenue of
−Removed: entities that process personal data.
+Added: carries maximum penalties of CNY50 million or 5% of the annual revenue
+Added: of entities that process personal data.
In the United States, the CCPA, which increases the privacy protections afforded California residents, became
19 unchanged sentences
considered the adoption of similarly expansive
−Removed: personal privacy laws, backed
−Removed: by significant civil penalties for non-compliance.
−Removed: Virginia and Colorado were both
−Removed: successful in passing privacy legislation in 2021, becoming effective on January
−Removed: 1, 2023 and July 1, 2023,
−Removed: respectively.
−Removed: Connecticut and Utah also passed comprehensive privacy laws
−Removed: that will go into effect in July 1, 2023
−Removed: and December 31, 2023.
−Removed: While we believe we have substantially compliant programs and controls
−Removed: comply with the GDPR, CCPA, PIPL and CPRA requirements, our compliance with data privacy and cybersecurity
−Removed: laws is likely to impose additional costs on us, and we cannot predict whether
−Removed: the interpretations of the
−Removed: requirements, or changes in our practices in response to new requirements
−Removed: or interpretations of the requirements,
−Removed: could have a material adverse effect on our business.
+Added: personal privacy laws, backed by significant civil penalties for non-compliance.
+Added: While we believe we have
+Added: substantially compliant programs and controls in place to comply with
+Added: the GDPR, CCPA, PIPL and CPRA
+Added: requirements, our compliance with data privacy and cybersecurity laws
+Added: is likely to impose additional costs on us,
+Added: and we cannot predict whether the interpretations of the requirements, or
+Added: changes in our practices in response to
+Added: new requirements or interpretations of the requirements, could have a
+Added: material adverse effect on our business.
We also sell products and services that health care providers, such as physicians and dentists, use to store and
4 unchanged sentences
Our products or services may be used as part of these customers’
−Removed: comprehensive data security programs, including in connection with their efforts to comply with
−Removed: applicable data
+Added: comprehensive data security programs, including in connection with their
+Added: efforts to comply with applicable data
privacy and security laws and contractual requirements.
8 unchanged sentences
and costs for remediation.
−Removed: Under the GDPR, health data belong to the category of “sensitive data” and benefit
−Removed: from specific protections.
−Removed: Processing of such data is generally prohibited, except for specific exceptions.
−Removed: Certain of our businesses involve the manufacture and sale of EHR systems
−Removed: and other products linked to
−Removed: government supported incentive programs, where the EHR systems
−Removed: must be certified as having certain capabilities
−Removed: designated in evolving standards, such as those adopted by CMS and ONC.
−Removed: In order to maintain certification of our
−Removed: EHR products, we must satisfy the changing governmental standards.
−Removed: If any of our EHR systems do not meet these
−Removed: standards, yet have been relied upon by health care providers to receive
−Removed: federal incentive payments, we may be
−Removed: exposed to risk, such as under federal health care fraud and abuse
−Removed: laws, including the False Claims Act.
−Removed: believe we are substantially in compliance with such certifications and with applicable
−Removed: fraud and abuse laws and
−Removed: regulations and that we have adequate compliance programs and controls
−Removed: in place to ensure substantial compliance,
−Removed: we cannot predict whether changes in applicable law, or interpretation of laws, or resulting changes in our, could
−Removed: have a material adverse effect on our business.
+Added: Additionally, under
+Added: the GDPR, health data belong to the category of “sensitive data” and benefit
+Added: from specific protection.
+Added: of such data is generally prohibited, except for specific exceptions.
+Added: Certain of our businesses involve the manufacture and sale of electronic
+Added: health record (EHR) systems and other
+Added: products linked to government supported incentive programs, where
+Added: the EHR systems must be certified as having
+Added: certain capabilities designated in evolving standards, such as those adopted
+Added: by CMS and ONC.
+Added: In order to maintain
+Added: certification of our EHR products, we must satisfy the changing governmental
+Added: If any other EHR systems
+Added: do not meet these standards, yet have been relied upon by health care providers
+Added: to receive federal incentive
+Added: payments, we may be exposed to risk, such as under federal health care
+Added: fraud and abuse laws, including the False
+Added: Additionally, effective September 1, 2023, the OIG for HHS issued a final rule implementing civil
+Added: money penalties for information blocking as established by the Cures Act.
+Added: OIG incorporated regulations published
+Added: by ONC as the basis for enforcing information blocking penalties.
+Added: Each information blocking violation carries a $1
+Added: million penalty.
+Added: While we believe we are substantially in compliance with such certifications
+Added: and with applicable
+Added: fraud and abuse laws and regulations and that we have adequate compliance
+Added: programs and controls in place to
+Added: ensure substantial compliance, we cannot predict whether changes in
+Added: applicable law, or interpretation of laws, or
+Added: resulting changes in our compliance programs and controls, could have a
+Added: material adverse effect on our business.
Moreover, in order to satisfy our customers and comply with evolving legal requirements, our products
24 unchanged sentences
there can be no assurance that our tax positions
−Removed: will not be challenged by relevant tax authorities or that we would be successful
−Removed: in any such challenge.
+Added: will not be challenged by relevant tax authorities or that we would be
+Added: successful in any such challenge.
We face inherent risk of exposure to product liability, intellectual property infringement and other claims in the
3 unchanged sentences
in cases as a result of our distribution of
−Removed: Additionally, we own interests in companies that manufacture certain dental products.
−Removed: As a result, we
−Removed: could be subject to the potential risk of product liability, intellectual property infringement or other claims relating
−Removed: to the manufacture and distribution of products by those entities.
−Removed: In addition, as our corporate brand business
−Removed: continues to grow, purchasers of such products may increasingly seek recourse directly from us, rather than the
−Removed: ultimate product manufacturer, for product-related claims.
−Removed: Another potential risk we face in the distribution of our
−Removed: products is liability resulting from counterfeit or tainted products infiltrating
−Removed: the supply chain.
−Removed: In addition, some of
−Removed: the products that we transport and sell are considered hazardous materials.
−Removed: The improper handling of such
−Removed: materials or accidents involving the transportation of such materials could
−Removed: subject us to liability or at least legal
−Removed: action that could harm our reputation.
+Added: Additionally, we own interests in companies that manufacture certain dental and medical products.
+Added: result, we could be subject to the potential risk of product liability, intellectual property infringement or other
+Added: claims relating to the manufacture and distribution of products by
+Added: those entities.
+Added: In addition, as our corporate brand
+Added: business continues to grow, purchasers of such products may increasingly seek recourse directly from us, rather
+Added: than the ultimate product manufacturer, for product-related claims.
+Added: Another potential risk we face in the
+Added: distribution of our products is liability resulting from counterfeit or tainted products
+Added: infiltrating the supply chain.
+Added: addition, some of the products that we transport and sell are considered hazardous
+Added: handling of such materials or accidents involving the transportation
+Added: of such materials could subject us to liability or
+Added: 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
11 unchanged sentences
labor or through human trafficking,
−Removed: as a result of legislative and governmental policy initiatives, we may be subject
−Removed: to increasing potential delays,
+Added: as a result of legislative and governmental policy initiatives, we may be
+Added: subject to increasing potential delays,
added costs, supply chain disruption and other restrictions.
GENERAL RISKS
−Removed: Security risks generally associated with our information systems and our
−Removed: technology products and services could
−Removed: materially adversely affect our business, and our results of operations could be
−Removed: materially adversely affected if
−Removed: such products, services or systems (or third-party systems we rely on) are
−Removed: interrupted, damaged by unforeseen
−Removed: events, are subject to cyberattacks or fail for any extended period
−Removed: We rely on information systems (IS) in our business to obtain, rapidly process, analyze, manage and store customer,
−Removed: product, supplier and employee data to, among other things:
−Removed: maintain and manage worldwide systems to facilitate the purchase and
−Removed: distribution of thousands of
−Removed: inventory items from numerous distribution centers;
−Removed: receive, process and ship orders on a timely basis;
−Removed: manage the accurate billing and collections for thousands of
−Removed: process payments to suppliers;
−Removed: provide products and services that maintain certain of our customers’ electronic
−Removed: medical or dental
−Removed: records (including protected health information of their patients).
−Removed: Information security risks have generally increased in recent years, and a cyberattack
−Removed: that bypasses our IS security
−Removed: systems (including third-party systems we rely on) causing an IS security breach
−Removed: may lead to a material disruption
−Removed: of our IS business systems (including third-party systems we rely on) and/or
−Removed: the loss of business information, as
−Removed: well as claims against us by affected parties and/or governmental agencies, and involve
−Removed: fines and penalties, costs
−Removed: for remediation, and substantial defense and settlement expenses.
−Removed: In addition, we develop products and provide
−Removed: services to our customers that are technology-based, and a cyberattack
−Removed: that bypasses the IS security systems of our
−Removed: products or services causing a security breach and/or perceived security
−Removed: vulnerabilities in our products or services
−Removed: could also cause significant loss of business and reputational harm, and actual
−Removed: or perceived vulnerabilities may lead
−Removed: to claims against us by our customers and/or governmental agencies.
−Removed: In particular, certain of our practice
−Removed: management products and services purchased by health care providers, such
−Removed: as physicians and dentists, are used to
−Removed: store and manage patient medical or dental records.
−Removed: These customers are subject to laws and regulations which
−Removed: require that they protect the privacy and security of those records, and our
−Removed: products may be used as part of these
−Removed: customers’ comprehensive data security programs, including in connection
−Removed: with their efforts to comply with
−Removed: applicable privacy and security laws.
−Removed: Perceived or actual security vulnerabilities in our products or services,
−Removed: perceived or actual failure by us or our customers who use our products
−Removed: to comply with applicable legal
−Removed: requirements, may not only cause reputational harm and loss of business,
−Removed: but may also lead to claims against us by
−Removed: our customers and/or governmental agencies and involve damages, fines and
−Removed: penalties, costs for remediation, and
−Removed: substantial defense and settlement expenses.
−Removed: In addition, a cyberattack on a third-party that we use to manage
−Removed: portion of our information systems could result in the same effects.
−Removed: Additionally, legislative or regulatory action
−Removed: related to cybersecurity may increase our costs to develop or implement
−Removed: new technology products and services.
−Removed: From time to time, we have had to address immaterial security incidents
−Removed: (“security incidents”).
−Removed: There can be no
−Removed: assurance that we will not experience material security incidents in the future.
−Removed: incidents can be difficult to
−Removed: detect and any delay in identifying them could increase their harm.
−Removed: While we have implemented measures to
−Removed: protect our IS systems, such measures may not prevent these events.
−Removed: Any such security incidents could disrupt our
−Removed: operations, harm our reputation or otherwise have a material adverse effect on our
−Removed: We have various
−Removed: insurance policies, including cybersecurity insurance, covering risks and
−Removed: in amounts that we consider adequate.
−Removed: There can be no assurance that the insurance coverage we maintain is sufficient or
−Removed: will be available in adequate
−Removed: amounts or at a reasonable cost to cover costs and expenses related
−Removed: to security incidents.
−Removed: Furthermore, procedures and safeguards must continually evolve to meet new
−Removed: IS challenges, and enhancing
−Removed: protections, and conducting investigations and remediation, may impose additional
−Removed: Finally, our business may be interrupted by shortfalls of IS systems providers engaged by our customers, such
−Removed: Internet-based services upon which our customers depend to access certain of
−Removed: our products.
−Removed: Our global operations are subject to inherent risks that could materially adversely
−Removed: affect our business.
+Added: Our business operations, results of operations, cash flows, financial condition
+Added: and liquidity may be negatively
+Added: impacted by the effects of disease outbreaks, epidemics, pandemics, or similar wide-spread
+Added: public health
+Added: concerns and other natural or man-made disasters, such as terrorism, civil
+Added: unrest, fire, and extreme weather
+Added: Our business operations, results of operations, cash flows, financial condition
+Added: and liquidity may be negatively
+Added: impacted by the effects of disease outbreaks, epidemics, pandemics, similar wide-spread
+Added: public health concerns and
+Added: other natural or man-made disasters, such as terrorism, civil unrest, fire,
+Added: and extreme weather (“disasters”).
+Added: example, as a global healthcare solutions company, the COVID-19 pandemic and the governmental responses
+Added: had, and may again have, a material adverse effect on our business, results of operations
+Added: and cash flows and may
+Added: result in a material adverse effect on our financial condition and liquidity.
+Added: The impacts and potential impacts from
+Added: the COVID-19 pandemic included, and could include as a result of other disasters,
+Added: the following, among other
+Added: significant volatility in supply, demand and selling prices for personal protective equipment (PPE), test
+Added: kits and related products;
+Added: reduction in peoples’ ability and willingness to be in public;
+Added: reduction in peoples’ ability and willingness to seek elective care;
+Added: interrupted operations of industries that use or manufacture the products
+Added: we distribute;
+Added: impact of adapted business practices;
+Added: significant changes in political conditions;
+Added: volatility in the financial market;
+Added: unavailability or impairment of our manufacturing, distribution, or other
+Added: facilities, or firmwide systems
+Added: such as our information systems.
+Added: The impact from disasters may also exacerbate other risks discussed herein,
+Added: any of which could have a material
+Added: adverse effect on us.
+Added: Our global operations are subject to inherent risks that could materially
+Added: adversely affect our business.
Our global operations are subject to risks that could materially adversely affect our business.
4 unchanged sentences
manufacturing in foreign markets;
−Removed: fluctuations in the value of foreign currencies (including, without limitation,
−Removed: in connection with
−Removed: uncertainties relating to the EU-UK Trade and Cooperation Agreement of December 2020, which
−Removed: into effect in 2021, including for example potential implementation issues, potential
−Removed: disputes over the
−Removed: interpretation of the provisions of the Agreement and possible changes
−Removed: to the Agreement restricting the
−Removed: free movement of goods between the U.K.
−Removed: and the European Union;
+Added: fluctuations in the value of foreign currencies;
+Added: uncertainties relating to trade agreements and international trade relationships;
longer payment cycles of foreign customers and difficulty of collecting receivables
1 unchanged sentence
repatriation of cash from our foreign operations to the United States;
−Removed: regulatory requirements, including,
−Removed: without limitation, anti-bribery, anti-corruption and laws pertaining
+Added: regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining
to the accuracy of our internal books and records;
4 unchanged sentences
sanctions or penalties;
−Removed: limitations on our ability under local laws to protect our intellectual property;
+Added: limitations on our ability under local laws to protect our intellectual
unexpected regulatory, legal, economic and political changes in foreign markets;
7 unchanged sentences
developments, stakeholder expectations and reputational risk.
−Removed: public health emergencies, including COVID-19.
Our future success is substantially dependent upon our senior
management, and our revenues and profitability
−Removed: depend on our relationships with capable sales personnel as well as
−Removed: customers, suppliers and manufacturers of
−Removed: the products that we distribute.
−Removed: Our future success is substantially dependent upon the efforts and abilities of members
−Removed: of our existing senior
+Added: depend on our relationships with capable sales representatives,
+Added: service technicians, and other personnel who
+Added: interact directly with our customers, as well as customers, suppliers
+Added: and manufacturers of the products that we
+Added: Our future success is substantially dependent upon the efforts and abilities of
+Added: members of our existing senior
management, particularly Stanley M.
Bergman, Chairman and Chief Executive Officer.
−Removed: The loss of the services of
+Added: In November 2022, Mr.
+Added: Bergman’s employment agreement was extended through December 31, 2025.
+Added: Although the Company has an
+Added: internal succession plan for its senior leadership team, including Mr.
+Added: Bergman, the loss of the services of Mr.
Bergman could have a material adverse effect on our business.
−Removed: We have an employment agreement with Mr.
−Removed: We do not currently have “key man” life insurance policies on any of our employees.
−Removed: Competition for
−Removed: senior management is intense, burnout and turn-over rates are increasing workplace
−Removed: concerns during and after the
−Removed: COVID-19 pandemic, and we may not be successful in attracting and
−Removed: retaining key personnel.
−Removed: Additionally, our
−Removed: future revenues and profitability depend on our ability to maintain satisfactory
−Removed: relationships with qualified sales
−Removed: personnel as well as customers, suppliers and manufacturers.
−Removed: If we fail to maintain our existing relationships with
−Removed: such persons or fail to acquire relationships with such key persons in the
−Removed: future, our business may be materially
−Removed: adversely affected.
−Removed: Disruptions in the financial markets may materially adversely affect the availability
−Removed: and cost of credit to us.
+Added: We do not currently have “key man” life insurance
+Added: policies on any of our employees.
+Added: Competition for senior management is intense, burnout and turn-over rates
+Added: increasing workplace concerns, and we may not be successful in
+Added: attracting and retaining key personnel.
+Added: Additionally, our future revenues and profitability depend on our ability to maintain satisfactory relationships with
+Added: qualified sales representatives, service technicians, and other personnel
+Added: who interact directly with our customers, as
+Added: well as customers, suppliers, and manufacturers.
+Added: If we fail to maintain our existing relationships with such persons
+Added: or fail to acquire relationships with such key persons in the future,
+Added: our business may be materially adversely
+Added: Disruptions in the financial markets may materially adversely
+Added: affect the availability and cost of credit to us.
Our ability to make scheduled payments or refinance our obligations with
5 unchanged sentences
the availability and cost of credit to us.
−Removed: Unresolved Staff Comments
−Removed: We have no unresolved comments from the staff of the SEC that were issued 180 days or more preceding the end of
−Removed: our 2022 fiscal year.
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.