Item 1A. Risk Factors
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Item 1A. Risk Factors
Our business operations could be affected by factors that are not presently known
to us or that we currently
consider not to be material to our operations, so you should not consider
the risks disclosed in this section to
necessarily represent a complete statement of all risks and uncertainties.
The Company believes that the following
risks could have a material adverse impact on our business, reputation, financial
results, financial condition and/or
the trading price of our common stock.
The order in which these factors appear does not necessarily reflect
their
relative importance or priority.
COMPANY RISKS
We are dependent upon third parties for the manufacture and supply of a significant volume of our products.
We obtain a significant volume of the products we distribute from third parties, with whom we generally do not
have long-term contracts.
While there is typically more than one source of supply, some key suppliers, in the
aggregate, supply a significant portion of the products we sell.
In 2023, our top 10 health care distribution suppliers
and our single largest supplier accounted for approximately 25% and 4%, respectively, of our aggregate purchases.
Because of our dependence upon such suppliers, our operations are
subject to the suppliers’ ability and willingness
to supply products in the quantities that we require, and the risks include delays
caused by interruption in
production based on conditions outside of our control, including
a supplier’s failure to comply with applicable
government requirements (which may result in product recalls and/or
cessation of sales) or an interruption in the
suppliers’ manufacturing capabilities.
In the event of any such interruption in supply, we would need to identify
and obtain acceptable replacement sources on a timely basis.
There is no guarantee that we would be able to obtain
such alternative sources of supply on a timely basis, if at all, and an extended
interruption in supply, particularly of
a high-sales volume product, could result in a significant disruption in our
sales and operations, as well as damage
to our relationships with customers and our reputation.
In addition, certain of our suppliers have had their ability to
service certain markets restricted or negatively impacted because
of allegations of forced labor in their supply
chain.
Forced labor legislation affecting the supply chain has increased around
the world, and the United States
recently passed the Uyghur Forced Labor Prevention Act.
Our supply chain could be materially disrupted if our
suppliers fail to comply with, or are unable to satisfy our demand
for products, as a result of applicable forced labor
legislation and regulations.
Our
future
growth
(especially
for
our
technology
and
value-added
services
segment)
is
dependent
upon
our
ability
to
develop
or
acquire
and
maintain
and
protect
new
products
and
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
(particularly for our technology and value-added services segment)
products and services and to market them
quickly and cost-effectively.
Our ability to anticipate customer needs and emerging trends and develop or acquire
new products, services and technologies at competitive prices requires significant
resources, including employees
with the requisite skills, experience and expertise, particularly in our
technology segment, including dental practice
management, patient engagement and demand creation software solutions.
The failure to successfully address these
challenges could materially disrupt our sales and operations.
Additionally, our software and e-services products,
like software products generally, may contain undetected errors or bugs when introduced or as new versions are
released.
Any such defective software may result in increased expenses
related to the software and could adversely
affect our relationships with customers as well as our reputation.
With respect to certain software and e-services
that we develop, we rely primarily upon copyright, trademark and
trade secret laws, as well as contractual and
common law protections and confidentiality obligations.
We cannot provide assurance that such legal protections
will be available, adequate or enforceable in a timely manner to protect
our software or e-services products.
Risks inherent in acquisitions, dispositions and joint ventures could
offset the anticipated benefits.
One of our business strategies has been to expand our domestic and
international markets in part through
acquisitions and joint ventures and we expect to continue to make acquisitions
and enter into joint ventures in the
future.
Such transactions require significant management attention,
may place significant demands on our
operations, information systems, legal, regulatory, compliance, financial, and human resources functions, and
there
is risk that one or more may not succeed.
We cannot be sure, for example, that we will achieve the benefits of
revenue growth that we expect from these acquisitions or joint ventures
or that we will avoid unforeseen additional
costs, taxes, or expenses.
Our ability to successfully implement our acquisition and joint venture
strategy depends
upon, among other things, the following:
the availability of suitable acquisition or joint venture candidates at
acceptable prices;
our ability to consummate such transactions, which could potentially
be prohibited due to U.S. or
foreign antitrust regulations;
the liquidity of our investments and the availability of financing on
acceptable terms;
our ability to retain customers or product lines of the acquired businesses or
joint ventures;
our ability to retain, recruit and incentivize the management of the
companies we acquire; and
our ability to successfully integrate these companies’ operations, services,
products and personnel with
our culture, management policies, legal, regulatory, and compliance policies, cybersecurity systems and
policies, internal procedures, working capital management, financial,
and operational controls and
strategies.
Furthermore, some of our acquisitions and future acquisitions may give
rise to an obligation to make contingent
payments or to satisfy certain repurchase obligations, which payments
could have material adverse impacts on our
financial results individually or in the aggregate.
Additionally, when we decide to sell assets or a business, we may encounter difficulty in finding buyers or
executing alternative exit strategies on acceptable terms in a timely manner, which could delay
the accomplishment
of our strategic objectives.
Alternatively, we may dispose of assets or a business at a price or on terms that are less
than we had anticipated.
Dispositions may also involve continued financial involvement
in a divested business,
such as through transition service agreements, indemnities or other current
or contingent financial obligations.
Under these arrangements, performance by the acquired or divested
business, or other conditions outside our
control, could affect our future financial results.
Certain provisions in our governing documents and other documents to
which we are a party may discourage
third parties from seeking to acquire us that might otherwise result in
our stockholders receiving a premium
over the market price of their shares.
The provisions of our certificate of incorporation and by-laws may
make it more difficult for a third-party to
acquire us, may discourage acquisition bids and may impact the price
that certain investors might be willing to pay
in the future for shares of our common stock.
These provisions, among other things require (i) the affirmative vote
of the holders of at least 60% of the shares of common stock entitled to vote
to approve a merger, consolidation, or
a sale, lease, transfer or exchange of all or substantially all of our assets;
and (ii) the affirmative vote of the holders
of at least 66 2/3% of our common stock entitled to vote to (a)
remove a director; and (b) to amend or repeal our
by-laws, with certain limited exceptions.
In addition, certain of our employee incentive plans provide
for
accelerated vesting of stock options and other awards upon termination without
cause within two years following a
change in control, or grant the plan committee discretion to accelerate
awards upon a change of control.
Further,
certain agreements between us and our executive officers provide for increased severance
payments and certain
benefits if those executive officers are terminated without cause by us or if they terminate
for good reason, in each
case within two years following a change in control or within ninety days prior
to the effective date of the change in
control or after the first public announcement of the pendency of the change
in control.
Adverse changes in supplier rebates or other purchasing incentives
could negatively affect our business.
The terms
on which
we purchase
or sell
products from
many suppliers
may entitle
us to
receive a
rebate or
other
purchasing incentive based on the attainment of certain growth
goals.
Suppliers may reduce or eliminate rebates or
incentives
offered
under
their
programs,
or
increase
the
growth
goals
or
other
conditions
we
must
meet
to
earn
rebates
or
incentives
to
levels
that
we
cannot
achieve.
Increased
competition
either
from
generic
or
equivalent
branded products
could result
in us
failing to
earn rebates
or incentives
that are
conditioned upon
achievement of
growth goals.
Additionally, factors outside
of our control, such as customer
preferences, consolidation of suppliers
or supply issues, can have a material impact on
our ability to achieve the growth goals established by
our suppliers,
which
may
reduce the
amount of
rebates
or
incentives we
receive.
The
occurrence
of
any
of
these events
could
have an adverse impact on our business, financial condition or operating
results.
Sales of corporate brand products entail additional risks, including the risk that such sales could
adversely affect
our relationships with suppliers.
We offer
certain corporate brand products that are available exclusively from us.
The sale of such products subjects
us to the risks generally encountered by entities that source, market and sell corporate brand products, including but
not
limited to
potential product
liability risks,
mandatory or
voluntary product
recalls, potential
supply chain
and
distribution
chain
disruptions,
and
potential
intellectual
property
infringement
risks.
Any
failure
to
adequately
address
some
or
all
of
these
risks
could
have
an
adverse
effect
on
our
business, financial
condition
or
operating
results.
In
addition,
an
increase
in
the
sales
of
our
corporate
brand
products
may
negatively
affect
our
sales
of
products owned by our
suppliers which, consequently,
could adversely impact certain
of our supplier relationships.
Our ability to locate qualified, economically stable suppliers who satisfy our requirements, and to
acquire sufficient
products in
a timely
and effective
manner,
is critical
to ensuring,
among other
things, that
customer confidence
is
not diminished.
In addition, we
are exposed to
the risk
that our competitors
or our large
customers may introduce
their own
private label,
generic, or
low-cost products
that compete
with our
products at
lower price
points.
Such
products could
capture significant
market share
or decrease
market prices
overall, eroding
our sales
and margins.
Any failure
to develop sourcing
relationships with a
broad and deep
supplier base could
have an adverse
effect on
our business, financial condition or operating results.
INDUSTRY RISKS
Security risks generally associated with our information systems and our
technology products and services have
in the recent past adversely affected our business and results of operations, and could
in the future materially
adversely affect our business and our results of operations if such products, services,
or systems (or third-party
systems we rely on) are interrupted, damaged by unforeseen events, are subject
to cyberattacks or fail for any
extended period of time.
We rely on information systems (“IS”) in our business to obtain, rapidly process, analyze, manage and store
customer, product, supplier and employee data to, among other things:
maintain and manage worldwide systems to facilitate the purchase and
distribution of thousands of
inventory items from numerous distribution centers;
receive, process and ship orders on a timely basis;
manage the accurate billing and collections for our customers;
process payments to suppliers;
provide products and services that maintain certain of our customers’ electronic
medical or dental
records (including protected health information of their patients); and
maintain and manage global human resources, compensation and payroll
systems.
In addition to health information in our customers’ electronic
medical and dental records, certain of our IS stores
other sensitive personal and financial information, such as healthcare
and other information related to our
employees, as well as other sensitive information such as credit card
information from our third-party business
partners, that is confidential,
and in many cases subject to privacy laws.
Our IS are vulnerable to, among other things, natural disasters,
power losses, computer viruses, telecommunication
failures, cybersecurity threats and other criminal activity. Information security risks have significantly increased
in
recent years in part because of an overall increase in cyber incidents,
their increased sophistication, and the
involvement of organized crime, hackers, terrorists and foreign state agents. The healthcare
industry in particular
has been targeted by threat actors seeking to undermine companies’ cybersecurity
defensive measures.
We have processes in place intended to ensure that our security measures keep pace with new and emerging risks.
We regularly review,
monitor and implement multiple layers of security through technology, processes and our
people.
We utilize security technologies designed to protect and maintain the integrity of our IS and data, and our
defenses are monitored and routinely tested internally and by external
parties.
Despite these efforts, our facilities
and systems and those of our third-party service providers have been,
and may in the future be, vulnerable to
privacy and security incidents, cybersecurity attacks and data breaches,
acts of vandalism or theft, computer viruses
and other malicious code, misplaced or lost data, programming and/or human
errors,
attacks or other acts
undermining IS of third party business partners including our customers,
or other similar events that could impact
the security, reliability and availability of our systems.
In addition, hardware, software or applications developed
internally or procured from third parties may contain defects
in design or manufacture or other problems that could
unexpectedly compromise information security.
As a practical matter, so long as we depend on IS to operate our
business, and our business partners do the same, there can be no guaranty
that such measures will successfully stop
any one particular cybersecurity incident given the constantly evolving
nature of the threat.
We may also incur
substantial costs as we update our cybersecurity defense systems and our general
computer controls to meet
evolving challenges, and legislative or regulatory action related to cybersecurity
may increase our costs to develop
or implement new technology products and services.
A cyberattack that bypasses or compromises our IS cybersecurity / or general
information technology (“IT”)
controls (including third-party systems we rely on) causing an IS security breach
may lead, and has in the past led,
to a disruption of our IS business systems (including third-party systems we
rely on), interruption of operations
(including, without limitation, receiving, verifying, and processing customer orders,
customer service, accounts
payable, warehouse management and shipping, and systems tied to internal
controls over financial reporting), the
loss or alteration of business, financial, and other protected information,
a negative impact on our financial
performance, and to an adverse impact on our financial accounting
and reporting controls.
A cyberattack that bypasses or compromises our IS cybersecurity / or general
computer controls or those of third
parties with whom we engage may also lead to claims against us by
affected parties and/or governmental agencies,
and involve fines and penalties, as well as substantial defense and settlement
expenses.
Any of these impacts may
alone, or collectively, have a material impact on our business.
A successful cyberattack has, and may again in the
future, disrupt our business operations, adversely impact our financial
accounting and reporting of results of
operations, divert the attention of management, and adversely impact
our results of operations.
In addition, we develop products and provide services to our customers
that are technology-based, and a
cyberattack that bypasses the IS supporting our products or services causing
a security breach and/or perceived
security vulnerabilities in our products or services could also cause significant
loss of business and reputational
harm, and actual or perceived vulnerabilities may lead to claims against
us by our customers and/or governmental
agencies.
In addition, certain of our practice management products and services
purchased by health care
providers, such as physicians and dentists, are used to store and manage patient
medical or dental records.
These
customers are subject to laws and regulations which require that they
protect the privacy and security of those
records, and our products may be used as part of these customers’ comprehensive
data security programs, including
in connection with their efforts to comply with applicable privacy and security laws.
In addition to immaterial and unrelated prior incidents at certain of
our subsidiaries, in October 2023, Henry Schein
experienced a cybersecurity incident that primarily affected the operations of our
North American and European
dental and medical distribution businesses.
Henry Schein One, our practice management software, revenue
cycle
management and patient relationship management solutions business was
not affected, and our manufacturing
businesses were mostly unaffected.
Once we became aware of the issue, we took steps to assess, contain
and
remediate this incident.
We restored affected systems and applications, our distribution operations resumed and we
reactivated our ecommerce platform.
We also notified law enforcement and our employees, customers, suppliers
and investors, informing them of both the incident and management’s efforts to mitigate its impact on our daily
operations and data maintained on the Company’s systems.
Subsequently, on or about November 8, 2023, we
determined that the threat actor obtained personal and sensitive information
maintained on our systems belonging to
certain third parties and since that date we have notified affected parties and potentially
affected parties as
appropriate.
The scope of personal and sensitive data impacted is still under investigation.
On November 22, 2023,
we experienced a related disruption to our ecommerce platform and
related applications, which has since been
remediated.
The October 2023 cybersecurity incident disrupted key
business operations, adversely impacted our
financial results for the fourth quarter and full year 2023, diverted
attention of management, and caused the
Company to incur significant remediation costs.
We continue to review the effects of the incident on the
Company’s business as we do expect some short-term residual impact on our financial results in 2024.
In January
2024, two putative class actions were filed against us based on the incident
and one of these actions is still pending.
We are spending, and plan to expend in the future, additional resources to continue to protect against, or to address
problems caused by, business interruptions, and data security breaches.
In addition, customers and suppliers may impose additional cybersecurity
requirements on us as a result of the
incident we experienced in October 2023, and some customers and suppliers
have made such requests to date.
We
cannot guarantee that we will be able to satisfy such additional requirements,
and failure to satisfy such
requirements could result in a loss of revenue or diminished product
availability that could materially affect our
business adversely.
We also may be perceived as a more vulnerable target of the cyber hackers as a result of the
October 2023 incident.
If the Company is subject to more attacks in the future as a result of
the recent incident, this
could materially affect our business adversely.
We maintain cyber insurance, subject to certain retentions and policy limitations.
With respect to the October 2023
cybersecurity incident, we have a $60 million insurance policy, following a $5 million retention.
The health care products distribution industry is highly competitive
(including, without limitation, competition
from third-party online commerce sites) and consolidating, and we may not
be able to compete successfully.
We compete with numerous companies, including several major manufacturers and distributors.
Some of our
competitors have greater financial and other resources than we do, which
could allow them to compete more
successfully.
Most of our products are available from several sources and our customers
tend to have relationships
with several distributors.
Competitors could obtain exclusive rights to market particular
products, which we would
then be unable to market.
Manufacturers also could increase their efforts to sell directly to end-users and
thereby
eliminate or reduce our role in distribution.
Industry consolidation among health care product distributors and
manufacturers, price competition, product unavailability, whether due to our inability to gain access to products or
to interruptions in manufacturing supply, or the emergence of new competitors, also could increase competition.
Consolidation has also increased among manufacturers of health care
products, which could have a material
adverse effect on our margins and product availability.
We could be subject to charges and financial losses in the
event we fail to satisfy minimum purchase commitments contained
in some of our contracts.
Additionally,
traditional health care supply and distribution relationships are being challenged
by electronic online commerce
solutions.
The continued advancement of online commerce by third
parties will require us to cost-effectively adapt
to changing technologies, to enhance existing services and to differentiate our business
(including with additional
value-added services) to address changing demands of consumers and
our customers on a timely basis.
The
emergence of such potential competition and our inability to anticipate and
effectively respond to changes on a
timely basis could have a material adverse effect on our business.
The health care industry is experiencing changes due to political, economic
and regulatory influences that could
materially adversely affect our business.
The health care industry is highly regulated and subject to changing
political, economic, and regulatory influences.
In recent years, the health care industry has undergone, and is in the process of undergoing,
significant changes
driven by various efforts to reduce costs, including, among other factors: trends
toward managed care; collective
purchasing arrangements and consolidation among office-based health care practitioners;
and changes in
reimbursements to customers, including increased attention to value-based payment
arrangements, as well as
growing enforcement activities (and related monetary recoveries) by governmental
officials.
Both our profitability
and the profitability of our customers may be materially adversely affected by laws
and regulations reducing
reimbursement rates for pharmaceuticals, medical supplies and devices,
and/or medical treatments or services, or
changes to the methodology by which reimbursement levels are determined.
If we are unable to react effectively to
these and other changes in the health care industry, our business could be materially adversely affected.
The ACA
greatly expanded health insurance coverage in the United States and has been
the target of litigation and
Congressional reform efforts since its adoption.
Any outcome of future court cases that change the ACA, in
addition to future legislation, regulation, guidance and/or Executive Orders
that do the same, could have a
significant impact on the U.S. healthcare industry and the ability or willingness
of individuals to engage with it.
Expansion of GPOs, DSOs or provider networks and the multi-tiered
costing structure may place us at a
competitive disadvantage.
The health care products industry is subject to a multi-tiered costing structure, which
can vary by manufacturer
and/or product.
Under this structure, certain institutions can obtain more favorable
prices for health care products
than we are able to obtain.
The multi-tiered costing structure continues to expand as many large integrated health
care providers and others with significant purchasing power, such as GPOs and DSOs, demand more favorable
pricing terms.
Additionally, the formation of provider networks, GPOs and DSOs may shift purchasing decisions
to entities or persons with whom we do not have a historical relationship
and may threaten our ability to compete
effectively, which could in turn negatively impact our financial results.
In addition, such organizations may
establish direct relationships with manufacturers, thereby either eliminating
or reducing the services historically
provided by distributors.
Although we are seeking to obtain similar terms from manufacturers
to access lower
prices demanded by GPO and DSO contracts or other contracts,
and to develop relationships with existing and
emerging provider networks, GPOs and DSOs, we cannot guarantee that such terms will
be obtained or contracts
executed.
Increases in shipping costs or service issues with our third-party shippers
could harm our business.
Our ability to meet our customers’ expedited delivery expectations is an
integral component of our business
strategy for which our customers rely.
Shipping is a significant expense in the operation of our business.
We ship
almost all of our orders through third-party delivery services, and typically bear
the cost of shipment.
Accordingly,
any significant increase in shipping rates could have a material adverse
effect on our business, financial condition
or operating results.
While we have recently experienced increases in the cost of shipping,
we do not expect these
additional expenses to be material to our results.
However, it is possible that such costs could be material in the
future.
Similarly, strikes or other service interruptions by those shippers, including at transportation centers or
shipping ports, could cause our operating expenses to rise and materially
adversely affect our ability to deliver
products on a timely basis.
MACRO-ECONOMIC AND POLITICAL RISKS
Uncertain global and domestic macro-economic and political conditions
could materially adversely affect our
results of operations and financial condition.
Uncertain global and domestic macro-economic and political conditions
that affect the economy and the economic
outlook of the United States, Europe, Asia, and other parts of the
world could materially adversely affect our results
of operations and financial condition.
These uncertainties, include, among other things:
election results;
changes to laws and policies governing foreign trade, tariffs and sanctions, or greater
restrictions on
imports and exports;
supply chain disruptions;
changes in laws and policies governing health care or data privacy;
changes to the relationship between the United States and China;
sovereign debt levels;
the inability of political institutions to effectively resolve actual or perceived
economic, currency or
budgetary crises or issues;
consumer confidence;
unemployment levels (and a corresponding increase in the uninsured
and underinsured population);
changes in regulatory and tax regulations;
interest rate fluctuations, and strengthening of the dollar, which have and will continue to
impact our
results of operations;
availability of capital;
increases in fuel and energy costs;
the effect of inflation on our ability to procure products and our ability to increase
prices over time and
pass through to our customers price increases we may receive;
changes in tax rates and the availability of certain tax deductions;
increases in labor costs or health care costs;
the threat or outbreak of war, terrorism or public unrest (including, without limitation, the war in
Ukraine, the Israel-Gaza war and other unrest and threats in the Middle East,
and the possibility of a
wider European or global conflict); and
changes in laws and policies governing manufacturing, development, and
investment in territories and
countries where we do business.
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,
and/or higher income or corporate
taxes, which could depress spending overall.
Recessionary or inflationary conditions and depressed levels of
consumer and commercial spending may also cause customers to
reduce, modify, delay,
or cancel plans to purchase
our products and may cause suppliers to reduce their output or change
their terms of sale.
We have experienced
inflationary pressures, including higher freight costs and interest expense.
Although inflation impacts both our
revenues and costs, the depth and breadth of our product portfolio often
allows us to offer lower-cost national brand
solutions or corporate brand alternatives to our more price-sensitive
customers who are unable to absorb price
increases, thus positioning us to protect our gross profit.
The strengthening of the dollar, likewise, has impacted
our revenues and costs, but neither inflation nor exchange rates have
materially impacted our results of operations
in fiscal year 2023.
We generally sell products to customers with payment terms.
If customers’ cash flow or
operating and financial performance deteriorate, or if they are unable to
make scheduled payments or obtain credit,
they may not be able to, or may delay, payment to us.
Likewise, for similar reasons suppliers may restrict credit or
impose different payment terms.
REGULATORY
AND LITIGATION RISKS
Failure to comply with existing and future regulatory requirements
could materially adversely affect our
business.
We strive to be compliant with the applicable laws, regulations and guidance described below in all material
respects, and believe we have effective compliance programs and other controls
in place to ensure substantial
compliance.
However, compliance is not guaranteed either now or in the future as certain laws, regulations
and
guidance may be subject to varying and evolving interpretations that could
affect our ability to comply, as well as,
future changes, additions and enforcement approaches, including in light
of political changes.
When we discover
situations of non-compliance we seek to remedy them and bring
the affected area back into compliance.
Changes
with respect to the applicable laws, regulations and guidance described below
may require us to update or revise
our operations, services, marketing practices, and compliance programs
and controls, and may impose additional
and unforeseen costs on us, pose new or previously immaterial risks to us, or
may otherwise have a material
adverse effect on our business.
There can be no assurance that current and future government
regulations will not
adversely affect our business, and we cannot predict new regulatory priorities, the
form, content or timing of
regulatory actions, and their impact on the health care industry and on our
business and operations.
Global efforts toward healthcare cost containment continue to exert pressure on
product pricing.
In the United
States, in addition to other government efforts to control health care costs, there has been
increased scrutiny on drug
pricing and concurrent efforts to control or reduce drug costs by Congress, the President,
executive branch agencies
and various states.
We and our subsidiaries may be required to report drug pricing data under federal laws and
regulations.
At the state level, several states have adopted laws, that may
apply to some of our operations, that
require drug manufacturers, including re-packagers or re-labelers, to provide
advance notice of certain price
increases and to report information relating to those price increases, while
others have taken legislative or
administrative action to establish prescription drug affordability boards or
multi-payer purchasing pools to reduce
the cost of prescription drugs.
At the federal level, several related bills have been introduced
and regulations
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
information regarding certain financial
relationships we have with covered recipients, including physicians, dentists,
teaching hospitals, and certain other
non-physician practitioners.
We and our subsidiaries may be required to report information under certain state
transparency laws that address circumstances not covered by the Sunshine
Act, and some of these state laws, as
well as the federal law, can be unclear.
We are also subject to foreign regulations requiring transparency of certain
interactions between suppliers and their customers.
While we believe we have substantially compliant programs
and controls in place satisfying the above laws and requirements,
such compliance imposes additional costs on us
and the requirements are sometimes unclear.
In the United States, government actions to seek to increase health-
related price transparency may also affect our business.
Our business is subject to additional requirements under various local, state,
federal and international laws and
regulations applicable to the sale and distribution of, and third-party payment
for, pharmaceuticals and medical
devices and HCT/P products.
Among the federal laws with which we must comply are the Controlled Substances
Act, the FDC Act, the Federal Drug Quality and Security Act, including DSCSA,
Section 361 of the Public Health
Services Act and Section 401 of the Consolidated Appropriations Act
of the Social Security Act.
Among other
things, such laws, and the regulations promulgated thereunder:
regulate the introduction, manufacture, advertising, marketing and promotion,
sampling, pricing and
reimbursement, labeling, packaging, storage, handling, returning or
recalling, reporting, and
distribution of, and record keeping for drugs, HCT/P products and
medical devices,
including
requirements with respect to unique medical device identifiers;
subject us to inspection by the FDA and DEA and similar state authorities;
regulate the storage, transportation and disposal of certain of our products
that are considered
hazardous materials;
require us to advertise and promote our drugs and devices in accordance
with applicable FDA
requirements;
require us to report average sales price (ASP) for drugs or biologicals payable
under Medicare Part B to
CMS with or without a Medicaid drug rebate agreement;
require registration with the FDA and the DEA and various state agencies;
require record keeping and documentation of transactions involving drug
products;
require us to design and operate a system to identify and report suspicious
orders of controlled
substances to the DEA and certain states;
require us to manage returns of products that have been recalled and subject
us to inspection of our
recall procedures and activities;
impose on us reporting requirements if a pharmaceutical, HCT/P product or
medical device causes
serious illness, injury or death;
require manufacturers, wholesalers, re-packagers and dispensers of prescription
drugs to identify and
trace certain prescription drugs as they are distributed;
require the licensing of prescription drug wholesalers and third-party
logistics providers; and
mandate compliance with standards for the recordkeeping, storage
and handling of prescription drugs,
and associated reporting requirements.
The FDA has become increasingly active in addressing the regulation of
computer software and digital health
products intended for use in health care settings.
The Cures Act, signed into law on December 13, 2016, among
other things, amended the medical device definition to exclude certain software
from FDA regulation, including
certain clinical decision support software.
On September 27, 2019, the FDA issued a suite of guidance documents
on digital health products, which incorporated applicable Cures Act standards,
and on September 28, 2022, the
FDA subsequently finalized certain of these guidance documents, including
regarding the types of clinical decision
support tools and other software that are exempt from regulation by the FDA as
medical devices, and the FDA
continues to issue new guidance in this area.
Certain of our businesses involve the development and
sale of
software and related products to support physician and dental practice management,
and it is possible that the FDA
or foreign government authorities could determine that one or more of our products
is subject to regulation as a
medical device, which could subject us or one or more of our businesses to
substantial additional requirements,
costs and potential enforcement actions or liabilities for noncompliance with
respect to these products. Some of our
imaging software is regulated as a medical device which subjects our businesses
to substantial additional
requirements, costs and potential enforcement actions or liabilities for noncompliance
with respect to these
products.
Applicable federal, state, local, and foreign laws and regulations also may require
us to meet various standards
relating to, among other things, licensure or registration, program eligibility, procurement, third-party
reimbursement, sales and marketing practices, product integrity, and supply tracking to product manufacturers,
product labeling, personnel, privacy and security of health or other personal
information, installation, maintenance
and repair of equipment and the importation and exportation of products.
The FDA and DEA, as well as CMS
(including with respect to complex Medicare reimbursement requirements
applicable to our specialty home medical
supplies business) and state Medicaid agencies, have recently increased
their regulatory and enforcement activities
and, in particular, the DEA has heightened enforcement activities due to the opioid crisis in the United States.
Our
business is also subject to requirements of similar and other foreign governmental
laws and regulations affecting
our operations abroad.
The failure to comply with any of these laws or regulations, or new interpretations
of existing laws and regulations,
or the imposition of any additional laws and regulations, could
materially adversely affect our business.
The costs
to us associated with complying with the various applicable statutes
and regulations, as they now exist and as they
may be modified, could be material.
Allegations by a governmental body that we have not complied
with these
laws could have a material adverse effect on our businesses.
While we believe that we are substantially compliant
with applicable laws and regulations, and believe we have adequate
compliance programs and controls in place to
ensure substantial compliance, if it is determined that we have not complied
with these laws, we are potentially
subject to warning letters, substantial civil and criminal penalties,
mandatory recall of product, seizure of product
and injunction, consent decrees and suspension or limitation of payments
to us, product sale and distribution.
If we
enter into settlement agreements to resolve allegations of non-compliance, we
could be required to make settlement
payments or be subject to civil and criminal penalties, including
fines and the loss of licenses.
Non-compliance
with government requirements could also adversely affect our ability to participate
in important federal and state
government health care programs, such as Medicare and Medicaid,
and damage our reputation.
The EU Medical Device Regulation (“MDR”) may adversely affect our business.
The EU MDR, applicable since May 26, 2021, significantly modifies and intensifies
the regulatory compliance
requirements for the medical device industry as a whole.
Among other things, the EU MDR:
strengthens the rules on placing devices on the market and reinforces surveillance
once they are
available;
establishes explicit provisions on manufacturers’ responsibilities
for the follow-up of the quality,
performance and safety of devices placed on the market;
improves the traceability of medical devices throughout the supply chain to the end-user
or patient
through a unique identification number;
sets up a central database to provide patients, healthcare professionals and
the public with
comprehensive information on products available in the EU;
strengthens rules for the assessment of certain high-risk devices, such
as implants, which may have to
undergo an additional check by experts before they are placed on the market; and
identifies importers and distributors and medical device products through
registration in a database
(EUDAMED not due, for the time being, until the end of 2027 at
the earliest, as mentioned above).
In particular, the EU MDR imposes strict requirements for the confirmation that a product
meets the regulatory
requirements, including regarding a product’s clinical evaluation and a company’s quality systems, and for the
distribution, marketing and sale of medical devices, including post-market surveillance.
As mentioned above,
pursuant to Regulation 2023/607 and subject to certain conditions, medical devices
that (i) obtained a certificate
under the EU Medical Device Directive from May 25, 2017, (ii) which was
still valid on May 26, 2021, and (iii)
has not been subsequently withdrawn may, for the moment, continue to be placed on the market or put into service
until December 31, 2027 for higher risk devices or December 31, 2028 for medium
and lower risk devices.
Nevertheless, EU MDR requirements regarding the distribution,
marketing and sale including quality systems and
post-market surveillance have to be observed by manufacturers, importers
and distributors as of the application date
(i.e., May 26, 2021).
The modifications created by the EU MDR may have an impact
on the way we design and
manufacture products and the way we conduct our business in
the EEA.
If we fail to comply with laws and regulations relating to health care
fraud or other laws and regulations, we
could suffer penalties or be required to make significant changes to our operations,
which could materially
adversely affect our business.
Certain of our businesses are subject to federal and state (and similar
foreign) health care fraud and abuse, referral
and reimbursement laws and regulations with respect to their operations.
Some of these laws, referred to as “false
claims laws,” prohibit the submission or causing the submission of false or fraudulent
claims for reimbursement to
federal, state, and other health care payers and programs.
Other laws, referred to as “anti-kickback laws,” prohibit
soliciting, offering, receiving or paying remuneration in order to induce or reward
the referral of a patient or
ordering, purchasing, leasing or arranging for, or recommending ordering, purchasing or leasing of,
items or
services that are paid for by federal, state and other health care payers and programs.
Certain additional state and
federal laws, such as the federal Physician Self-Referral Law, commonly known as the “Stark Law,” prohibit
physicians and other health care professionals from referring a patient
to an entity with which the physician (or
family member) has a financial relationship, for the furnishing of certain designated
health services (for example,
durable medical equipment and medical supplies), unless an exception applies.
Violations of Anti-Kickback
statutes or the Stark Law may be enforced as violations of the federal False Claims
Act.
The fraud and abuse laws and regulations have been subject to heightened
enforcement activity over the past few
years, and significant enforcement activity has been the result of “relators” who
serve as whistleblowers by filing
complaints in the name of the United States (and if applicable, particular states)
under applicable false claims laws,
and who may receive up to 30% of total government recoveries.
Penalties under fraud and abuse laws may be
severe, including treble damages and substantial civil penalties under
the federal False Claims Act, as well as
potential loss of licenses and the ability to participate in federal and state
health care programs, criminal penalties,
or imposition of a corporate compliance monitor, which could have a material adverse effect on our business.
Also,
these measures may be interpreted or applied by a prosecutorial, regulatory or
judicial authority in a manner that
could require us to make changes in our operations or incur substantial defense
and settlement expenses.
Even
unsuccessful challenges by regulatory authorities or private relators could result
in reputational harm and the
incurring of substantial costs.
Most states have adopted similar state false claims laws, and these state
laws have
their own penalties which may be in addition to federal False Claims
Act penalties, as well as other fraud and abuse
laws.
With respect to measures of this type, the United States government (among others) has expressed concerns
about
financial relationships between suppliers on the one hand and physicians,
dentists, and other health care providers,
on the other.
As a result, we regularly review and revise our marketing practices
as necessary to facilitate
compliance.
Our aspirations, goals and disclosures related to environmental, social
and governance matters and the focus on
regulators and private litigants among other things on related claims made
by companies and funds expose us to
numerous risks, including reputational, financial, legal and other risks,
that could have an adverse impact on us,
including on our stock price.
California has adopted stringent new climate disclosure requirements,
as has the EU,
and the SEC appears about to adopt expansive new disclosure requirements
on climate change.
In the EU, the Directive No. 2019/1937 of October 23, 2019,
on the protection of persons who report breaches of
Union law,
organizes the legal protection of whistleblowers.
This Directive covers whistleblowers reporting
breaches of certain EU laws, in particular as regards public health, the above-mentioned
Directive No. 2001/83,
Regulation No. 726/2004 or, as regards data protection, the GDPR.
The Directive protects a wide range of people
and includes former employees.
All private companies with 50 or more employees are required
to create effective
internal reporting channels.
All EU Member States other than Poland and Estonia have now implemented
the
Directive.
We also are subject to the requirements of the new Directive No. 2022/2464 on corporate sustainability reporting
(“CSR Directive”) adopted on December 14, 2022 and which has to be
implemented by EU members states by July
6, 2024, at the latest.
By amending Directives No. 2004/109, No. 2006/43, No. 2013/34
and Regulation No.
537/2014, the CSR Directive strengthens the existing rules on non-financial
reporting by setting new requirements
for large companies to publish sustainability-related information and, in particular, disclose details about
their risks
and impacts on environmental matters.
We
also are subject to certain United States and foreign laws and regulations
concerning the conduct of our foreign
operations, including the U.S. Foreign Corrupt Practices Act, the U.K. Bribery
Act, German anti-corruption laws
and other anti-bribery laws and laws pertaining to the accuracy of our internal
books and records, which have been
the focus of increasing enforcement activity globally in recent years.
Our businesses are generally subject to
numerous other laws and regulations that could impact our financial
results, including, without limitation,
securities, antitrust, consumer protection, and marketing laws and regulations.
In the EU, both active and passive bribery are criminalized.
The EU Council Framework Decision 2003/568/JHA
of 22 July 2003
on combating corruption in the private sector
establishes more detailed rules on the liability of
legal persons and deterrent sanctions.
However, the liability of legal persons is regulated at a national level.
Failure to comply with fraud and abuse laws and regulations, and other
laws and regulations, could result in
significant civil and criminal penalties and costs, including the loss of
licenses and the ability to participate in
federal and state health care programs, and could have a material adverse
effect on our business.
We may
determine to enter into settlements, make payments, agree to consent decrees
or enter into other arrangements to
resolve such matters.
Intentional or unintentional failure to comply with settlement agreements
or consent decrees
could materially adversely affect our business.
While we believe that we are substantially compliant with applicable fraud and
abuse and other laws and
regulations, and believe we have adequate compliance programs and controls
in place to ensure substantial
compliance, we cannot predict whether changes in applicable law, or interpretation of laws, or changes in our
services or marketing practices in response to changes in applicable law or
interpretation of laws, could have a
material adverse effect on our business.
If we fail to comply with laws and regulations relating to the collection,
storage and processing of sensitive
personal information or standards in electronic health records or transmissions,
we could be required to make
significant changes to our products, or incur substantial fines, penalties, or
other liabilities.
Our businesses that involve physician and dental practice management
products, and our specialty home medical
supply businesses, include electronic information technology systems
that store and process personal health,
clinical, financial, and other sensitive information of individuals.
These information technology systems may be
vulnerable to breakdown, wrongful intrusions, data breaches and
malicious attack, which could require us to
expend significant resources to eliminate these problems and address
related security concerns, 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
that protect the privacy and security of personal information, such as HIPAA, CAN-SPAM, TCPA,
Section 5 of the
FTC Act, the CCPA, and the CPRA that became effective on January 1, 2023.
Laws and regulations relating to
privacy and data protection are continually evolving and subject to
potentially differing interpretations.
These
requirements may not be harmonized, may be interpreted and applied in
a manner that is inconsistent from one
jurisdiction to another or may conflict with other rules or our practices.
Our businesses’ failure to comply with
these laws and regulations could expose us to breach of contract claims, substantial
fines, penalties and other
liabilities and expenses, costs for remediation and harm to our reputation.
Also, evolving laws and regulations in
this area could restrict the ability of our customers to obtain, use or disseminate patient
information, or could
require us to incur significant additional costs to re-design our products
to reflect these legal requirements, which
could have a material adverse effect on our operations.
In addition, the European Parliament and the Council of the EU adopted
the GDPR effective from May 25, 2018,
which increased privacy rights for Data Subjects, including individuals
who are our customers, suppliers and
employees.
The GDPR extended the scope of responsibilities for data controllers
and data processors, and
generally imposes increased requirements and potential penalties on companies,
such as us, that are either
established in the EU and process personal data of Data Subjects (regardless
the Data Subject location), or that are
not established in the EU but that offer goods or services to Data Subjects in the EU
or monitor their behavior in the
EU. Noncompliance can result in penalties of up to the greater of EUR 20
million, or 4% of global company
revenues (sanction that may be public), and Data Subjects may seek damages.
Member states may individually
impose additional requirements and penalties regarding certain limited
matters (for which the GDPR left some
room of flexibility), such as employee personal data.
With respect to the personal data it protects, the GDPR
requires, among other things, controller accountability, consents from Data Subjects or another acceptable legal
basis to process the personal data, notification within 72 hours
of a personal data breach where required, data
integrity and security, and fairness and transparency regarding the storage, use or other processing of the personal
data.
The GDPR also provides rights to Data Subjects relating notably
to information, access, rectification, erasure
of the personal data and the right to object to the processing.
On August 20, 2021, China promulgated the PIPL, which took effect on November
1, 2021.
The PIPL imposes
specific rules for processing personal information and it also specifies
that the law shall also apply to personal
information activities carried out outside China but for the purpose
of providing products or services to PRC
citizens.
Any non-compliance with these laws and regulations may subject
us to fines, orders to rectify or terminate
any actions that are deemed illegal by regulatory authorities, other penalties,
as well as reputational damage or legal
proceedings against us, which may affect our business, financial condition or results
of operations.
The PIPL
carries maximum penalties of CNY50 million or 5% of the annual revenue
of entities that process personal data.
In the United States, the CCPA, which increases the privacy protections afforded California residents, became
effective January 1, 2020.
The CCPA generally requires companies, such as us, to institute additional protections
regarding the collection, use and disclosure of certain personal information
of California residents.
Compliance
with the obligations imposed by the CCPA depends in part on how particular regulators interpret and apply them.
Regulations were released in August of 2020, but there remains some
uncertainty about how the CCPA will be
interpreted by the courts and enforced by the regulators.
If we fail to comply with the CCPA or if regulators assert
that we have failed to comply with the CCPA, we may be subject to certain fines or other penalties and litigation,
any of which may negatively impact our reputation, require us to expend
significant resources, and harm our
business.
Furthermore, California voters approved the CPRA on November 3,
2020, which will amend and expand
the CCPA, including by providing consumers with additional rights with respect to their personal information, and
creating a new state agency to enforce CCPA and CPRA.
The CPRA came into effect on January 1, 2023, applying
to information collected by businesses on or after January 1, 2022.
Other states, as well as the federal government, have increasingly
considered the adoption of similarly expansive
personal privacy laws, backed by significant civil penalties for non-compliance.
While we believe we have
substantially compliant programs and controls in place to comply with
the GDPR, CCPA, PIPL and CPRA
requirements, our compliance with data privacy and cybersecurity laws
is likely to impose additional costs on us,
and we cannot predict whether the interpretations of the requirements, or
changes in our practices in response to
new requirements or interpretations of the requirements, could have a
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
manage patient medical or dental records.
These customers and we are subject to laws, regulations and
industry
standards, such as HIPAA and the Payment Card Industry Data Security Standards, which require the protection of
the privacy and security of those records.
Our products or services may be used as part of these customers’
comprehensive data security programs, including in connection with their
efforts to comply with applicable data
privacy and security laws and contractual requirements.
Perceived or actual security vulnerabilities in our products
or services, or the perceived or actual failure by us or our customers who
use our products or services to comply
with applicable legal or contractual data privacy and security requirements,
may not only cause us significant
reputational harm, but may also lead to claims against us by our customers
and/or governmental agencies and
involve substantial fines, penalties and other liabilities and expenses
and costs for remediation.
Additionally, under
the GDPR, health data belong to the category of “sensitive data” and benefit
from specific protection.
Processing
of such data is generally prohibited, except for specific exceptions.
Certain of our businesses involve the manufacture and sale of electronic
health record (EHR) systems and other
products linked to government supported incentive programs, where
the EHR systems must be certified as having
certain capabilities designated in evolving standards, such as those adopted
by CMS and ONC.
In order to maintain
certification of our EHR products, we must satisfy the changing governmental
standards.
If any other EHR systems
do not meet these standards, yet have been relied upon by health care providers
to receive federal incentive
payments, we may be exposed to risk, such as under federal health care
fraud and abuse laws, including the False
Claims Act.
Additionally, effective September 1, 2023, the OIG for HHS issued a final rule implementing civil
money penalties for information blocking as established by the Cures Act.
OIG incorporated regulations published
by ONC as the basis for enforcing information blocking penalties.
Each information blocking violation carries a $1
million penalty.
While we believe we are substantially in compliance with such certifications
and with applicable
fraud and abuse laws and regulations and that we have adequate compliance
programs and controls in place to
ensure substantial compliance, we cannot predict whether changes in
applicable law, or interpretation of laws, or
resulting changes in our compliance programs and controls, could have a
material adverse effect on our business.
Moreover, in order to satisfy our customers and comply with evolving legal requirements, our products
may need to
incorporate increasingly complex functionality, such as with respect to reporting and information blocking.
Although we believe we are positioned to accomplish this, the effort may involve
increased costs, and our failure to
implement product modifications, or otherwise satisfy applicable standards,
could have a material adverse effect on
our business.
Additionally, as electronic medical devices are increasingly connected to each other and to other technology, the
ability of these connected systems to safely and effectively exchange and use exchanged
information becomes
increasingly important.
As a medical device manufacturer, we must manage risks including those associated with
an electronic interface that is incorporated into a medical device.
Tax legislation could materially adversely affect our financial results and tax liabilities.
We are subject to the tax laws and regulations of the United States federal, state, and local governments, as well as
foreign jurisdictions.
From time to time, various legislative initiatives may be proposed
that could materially
adversely affect our tax positions.
There can be no assurance that our effective tax rate will not be
materially
adversely affected by legislation resulting from these initiatives.
In addition, tax laws and regulations are extremely
complex and subject to varying interpretations.
Although we believe that our historical tax positions are sound and
consistent with applicable laws, regulations and existing precedent,
there can be no assurance that our tax positions
will not be challenged by relevant tax authorities or that we would be
successful in any such challenge.
We face inherent risk of exposure to product liability, intellectual property infringement and other claims in the
event that the use of the products we sell results in injury.
Our business involves a risk of product liability, intellectual property infringement and other claims in the ordinary
course of business, and from time to time we are named as a defendant
in cases as a result of our distribution of
products.
Additionally, we own interests in companies that manufacture certain dental and medical products.
As a
result, we could be subject to the potential risk of product liability, intellectual property infringement or other
claims relating to the manufacture and distribution of products by
those entities.
In addition, as our corporate brand
business continues to grow, purchasers of such products may increasingly seek recourse directly from us, rather
than the ultimate product manufacturer, for product-related claims.
Another potential risk we face in the
distribution of our products is liability resulting from counterfeit or tainted products
infiltrating the supply chain.
In
addition, some of the products that we transport and sell are considered hazardous
materials.
The improper
handling of such materials or accidents involving the transportation
of such materials could subject us to 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
to our operations on a timely basis and result in government enforcement
actions and/or sanctions.
Government-imposed import policies and legislation regulating the
import of goods and prohibiting the use of
forced labor or human trafficking could result in delays or the inability to import
goods in a timely manner that are
necessary to our operations, and such policies or legislation could also
result in financial penalties, other sanctions,
government enforcement actions and reputational harm.
While the Company has policies against and seeks to
avoid the import of goods that are manufactured in whole or in part by forced
labor or through human trafficking,
as a result of legislative and governmental policy initiatives, we may be
subject to increasing potential delays,
added costs, supply chain disruption and other restrictions.
GENERAL RISKS
Our business operations, results of operations, cash flows, financial condition
and liquidity may be negatively
impacted by the effects of disease outbreaks, epidemics, pandemics, or similar wide-spread
public health
concerns and other natural or man-made disasters, such as terrorism, civil
unrest, fire, and extreme weather
.
Our business operations, results of operations, cash flows, financial condition
and liquidity may be negatively
impacted by the effects of disease outbreaks, epidemics, pandemics, similar wide-spread
public health concerns and
other natural or man-made disasters, such as terrorism, civil unrest, fire,
and extreme weather (“disasters”).
For
example, as a global healthcare solutions company, the COVID-19 pandemic and the governmental responses
to it
had, and may again have, a material adverse effect on our business, results of operations
and cash flows and may
result in a material adverse effect on our financial condition and liquidity.
The impacts and potential impacts from
the COVID-19 pandemic included, and could include as a result of other disasters,
the following, among other
impacts:
significant volatility in supply, demand and selling prices for personal protective equipment (PPE), test
kits and related products;
reduction in peoples’ ability and willingness to be in public;
reduction in peoples’ ability and willingness to seek elective care;
interrupted operations of industries that use or manufacture the products
we distribute;
impact of adapted business practices;
significant changes in political conditions;
volatility in the financial market; and
unavailability or impairment of our manufacturing, distribution, or other
facilities, or firmwide systems
such as our information systems.
The impact from disasters may also exacerbate other risks discussed herein,
any of which could have a material
adverse effect on us.
Our global operations are subject to inherent risks that could materially
adversely affect our business.
Our global operations are subject to risks that could materially adversely affect our business.
The risks that our
global operations are subject to include, among other things:
difficulties and costs relating to staffing and managing foreign operations;
difficulties and delays inherent in sourcing products, establishing channels of distribution
and contract
manufacturing in foreign markets;
fluctuations in the value of foreign currencies;
uncertainties relating to trade agreements and international trade relationships;
longer payment cycles of foreign customers and difficulty of collecting receivables
in foreign
jurisdictions;
repatriation of cash from our foreign operations to the United States;
regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining
to the accuracy of our internal books and records;
litigation risks, new or unanticipated litigation developments and
the status of litigation matters;
unexpected difficulties in importing or exporting our products and import/export
tariffs, quotas,
sanctions or penalties;
limitations on our ability under local laws to protect our intellectual
property;
unexpected regulatory, legal, economic and political changes in foreign markets;
changes in tax regulations that influence purchases of capital equipment;
civil disturbances, geopolitical turmoil, including terrorism, war or political
or military coups; and
risks associated with climate change, including physical risks such as
impacts from extreme weather
events and other potential physical consequences, regulatory and technological
requirements, market
developments, stakeholder expectations and reputational risk.
Our future success is substantially dependent upon our senior
management, and our revenues and profitability
depend on our relationships with capable sales representatives,
service technicians, and other personnel who
interact directly with our customers, as well as customers, suppliers
and manufacturers of the products that we
distribute.
Our future success is substantially dependent upon the efforts and abilities of
members of our existing senior
management, particularly Stanley M. Bergman, Chairman and Chief Executive Officer.
In November 2022, Mr.
Bergman’s employment agreement was extended through December 31, 2025.
Although the Company has an
internal succession plan for its senior leadership team, including Mr. Bergman, the loss of the services of Mr.
Bergman could have a material adverse effect on our business.
We do not currently have “key man” life insurance
policies on any of our employees.
Competition for senior management is intense, burnout and turn-over rates
are
increasing workplace concerns, and we may not be successful in
attracting and retaining key personnel.
Additionally, our future revenues and profitability depend on our ability to maintain satisfactory relationships with
qualified sales representatives, service technicians, and other personnel
who interact directly with our customers, as
well as customers, suppliers, and manufacturers.
If we fail to maintain our existing relationships with such persons
or fail to acquire relationships with such key persons in the future,
our business may be materially adversely
affected.
Disruptions in the financial markets may materially adversely
affect the availability and cost of credit to us.
Our ability to make scheduled payments or refinance our obligations with
respect to indebtedness will depend on
our operating and financial performance, which in turn is subject to prevailing
economic conditions and financial,
business and other factors beyond our control.
Disruptions in the financial markets may materially adversely affect
the availability and cost of credit to us.
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