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
Our business, 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 disasters
.
The COVID-19 pandemic and the responses of governments
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.
Our business, 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
disasters. The COVID-19 pandemic has had, and continues to have, an
unprecedented impact on society, worldwide
economic activity, and the health care sector (particularly, the dental market). 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. Even after the COVID-19 pandemic has begun to subside, we may again
experience material adverse impacts to our business, results of operations
and cash flows as a result of, among other
things, its global economic impact, including any recession that
may occur in the future, or a prolonged period of
economic slowdown or the reluctance of patients to return for elective dental
or medical care. The impacts and
potential impacts from the COVID-19 pandemic include, but are not
limited to:
Significant volatility in supply, demand and selling prices for personal protective equipment (PPE), COVID-19
tests and other COVID-19 related products.
Available supply,
customer demand and selling prices for PPE,
COVID-19 tests and other COVID-19 related products
fluctuated in fiscal 2022 and we expect such volatility to
continue for the duration of the COVID-19 pandemic. This has resulted
in inventory reserves, fluctuating margins
and increased revenue related to such products.
The volatility in sales of COVID-19 test kits has moderated,
albeit
at a significantly lower level of sales compared with 2021, resulting in
us recording an inventory obsolescence
reserve of $17 million for COVID-19 test kits during the year
ended December 31, 2022 and we expect further
declines in sales volumes.
Our estimates for supply, demand and selling prices are inherently uncertain and if
supply, demand, selling prices or other market dynamics significantly fluctuate in the future beyond our current
assumptions, additional inventory reserves may be required, margins may be reduced and/or
revenue may decline
for such products, each which could materially adversely impact our business,
results of operations and cash flows.
Additionally, governmental policies designed to reduce the transmission of COVID-19 and variants thereof could
once again lead to the closure of dental offices or deferral of elective procedures and
wellness exams by medical
and dental patients. Such previous closures and restrictions impacted our
customers’ spending with us and had, and
if reinstated may again have, a material adverse effect on our business, results of operations
and cash flows.
Although we believe that most practices currently are able to access
adequate supply, we still may be unable to
supply our customers with the specific brand and/or quantity of certain PPE products,
COVID-19 tests and other
COVID-19 related products they demand, which may lead to our
customers seeking alternative sources of supply.
Healthcare professionals’ inability to obtain a sufficient quantity and/or brand of certain PPE, COVID-19
tests and
other COVID-19 related products would adversely impact our business,
results of operations and cash flows, and
could materially adversely affect our financial condition and liquidity;
Reduction in Peoples’ Ability and Willingness to be in Public.
Restrictions recommended by several public health
organizations, and implemented, from time to time, by federal, state and local governments,
to slow and limit the
transmission of COVID-19 and variants thereof has caused and may in
the future cause some people to be less
willing to go to elective medical and dental appointments, which could
again materially adversely affect demand
for our products.
A lengthened period of materially suppressed demand could again cause
material adverse impacts
on our business, results of operations and cash flows and could materially
adversely affect our financial condition
and liquidity;
Negative impact on our workforce and impact of adapted business practices.
The spread of COVID-19 and
variants thereof caused us to modify our business practices (including
employee travel, employee work locations,
and physical participation in meetings, events and conferences), and
we may take further actions as may be required
by government authorities or our customers or that we determine are in the
best interests of our employees. As the
COVID-19 pandemic continues to unfold, we continue to evaluate
appropriate actions for our business. At the onset
of the COVID-19 pandemic, many of our office-based workers shifted abruptly to
working remotely. As the
COVID-19 pandemic has evolved, we have modified our work
arrangements to implement more flexible working
arrangements for our office-based workers, including permanent work from home,
hybrid and office-based
arrangements. Implementing these modified business practices
to include remote work arrangements could have a
negative impact on employee morale, strain our business continuity plans,
introduce operational risk (including but
not limited to cybersecurity risks), and impair our ability
to efficiently operate our business;
Significant changes in political conditions.
Significant changes in political conditions in markets in which
we
purchase and distribute our products have occurred and are expected to
continue at least during the pendency of the
pandemic, including quarantines, governmental or regulatory actions, closures
or other restrictions that limit or
close our operating facilities, restrict our employees’ ability to
travel or perform necessary business functions, or
otherwise constrain the operations of our business partners, suppliers or
customers, which may materially adversely
affect our business, results of operations, cash flows, financial condition
and liquidity;
Volatility
in the financial markets.
Volatility
in the financial markets may materially adversely affect the
availability and cost of credit to us;
The impact of the COVID-19 pandemic may also exacerbate other risks discussed
below, any of which could have
a material adverse effect on us.
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 2022, our top 10 health care distribution suppliers
and our single largest supplier accounted for approximately 28% 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-functions and financial resources, 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.
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
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 repeal or judicial prohibition on implementation of the Affordable Care Act
could materially adversely
affect our business.
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.
The U.S. Supreme Court, in upholding the constitutionality of the
ACA and its individual mandate provision in 2012, simultaneously
limited ACA provisions requiring Medicaid
expansion, making such expansion a state-by-state decision.
In 2017, the U.S. Congress effectively repealed the
ACA’s
individual mandate provision by eliminating the financial penalty for non-compliance.
In the most recent
ACA litigation, a federal appeals court found the individual mandate to be unconstitutional,
and returned the case to
a lower federal court for consideration of whether the remainder of the ACA
could survive the excision of the
individual mandate.
This decision was appealed to the U.S. Supreme Court, and the Supreme
Court issued a
decision on June 17, 2021.
Without reaching the merits of the case, the Supreme Court held that the plaintiffs in
the case did not have standing to challenge the ACA.
Any outcome of future 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.
For instance, the American Rescue Plan Act of 2021 enhanced
premium tax credits, which has resulted in an expansion of the number of people
covered under the ACA.
These
changes are time-limited, with some enhancements in place for 2021
only and others available through the end of
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.
Expansion of group purchasing organizations (“GPO”), dental support organizations
(“DSO”) 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.
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 (including, without
limitation, the United States-
Mexico-Canada Agreement (USMCA), the EU-UK Trade and Cooperation Agreement of December
2020 (that went into effect in 2021) and other international trade agreements);
greater restrictions on imports and exports;
supply chain disruptions;
changes in laws and policies governing health care or data privacy;
tariffs and sanctions;
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;
increases in health care costs;
our aspirations, goals and disclosures related to environmental, social and
governance (ESG) matters;
the threat or outbreak of war, terrorism or public unrest (including, without limitation, the war in
Ukraine 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 2022.
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.
The Biden
Administration has indicated that it will be more aggressive in its pursuing
alleged violations of law, and it has
revoked certain guidance that would have limited governmental use of informal
agency guidance to pursue such
violations, as well as indicating it was more prepared to pursue individuals
for corporate law violations, including
an aggressive approach to anti-corruption activities.
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.
At the state level, several states have adopted laws that require drug manufacturers
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, repackagers 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.
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), 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.
One of our businesses was
suspended in October 2021 by CMS from receiving payments from
Medicare, although it was permitted to continue
to perform and bill for Medicare services.
On September 30, 2022, CMS terminated the suspension of Medicare
payments.
As a result of the termination of the suspension, we recognized $4
million of previously deferred
revenue during the year ended December 31, 2022.
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 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 reinforce 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 until 2024 and after 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.
Medical devices that have
been assessed and/or certified under the EU Medical Device Directive
may continue to be placed on the market
until 2024 (or until the expiry of their certificates, if applicable and earlier).
However, on January 6, 2023, the EU
Commission submitted a proposed amendment to extend the MDR transitional
periods until December 31, 2028,
for certain medical devices to ensure continued access to medical devices
for patients and to allow medical devices
already placed on the market in accordance with the current legal framework
to remain on the market. We continue
to monitor developments and whether the proposed amendment and
new deadlines will be approved by the
European Parliament and Council. 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 European Economic Area.
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 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 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.
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. Though it was required before December 17, 2021,
at the latest, the implementation of
this Directive by EU member states is still underway for some of
them. At the end of January 2023 and according
to information available on public sources, sixteen EU member states have
fully implemented it (France, Belgium,
Denmark, Finland, Latvia, The Netherlands, Ireland, Croatia, Cyprus, Greece, Lithuania,
Romania, Malta, Portugal,
Sweden and Bulgaria) while the process is ongoing in the others with varying
degrees of progress.
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 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 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 business, 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, the Controlling the Assault of Non-
Solicited Pornography and Marketing Act, the Telephone Consumer Protection Act of 1991, Section 5 of the
Federal Trade Commission Act, the CCPA, and the CPRA that becomes 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 individuals (“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.
Virginia and Colorado were both
successful in passing privacy legislation in 2021, becoming effective on January
1, 2023 and July 1, 2023,
respectively.
Connecticut and Utah also passed comprehensive privacy laws
that will go into effect in July 1, 2023
and December 31, 2023.
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.
Under the GDPR, health data belong to the category of “sensitive data” and benefit
from specific protections.
Processing of such data is generally prohibited, except for specific exceptions.
Certain of our businesses involve the manufacture and sale of 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 of our 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.
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, 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 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
Security risks generally associated with our information systems and our
technology products and services could
materially adversely affect our business, and our results of operations could be
materially adversely affected 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 thousands of
customers;
process payments to suppliers; and
provide products and services that maintain certain of our customers’ electronic
medical or dental
records (including protected health information of their patients).
Information security risks have generally increased in recent years, and a cyberattack
that bypasses our IS security
systems (including third-party systems we rely on) causing an IS security breach
may lead to a material disruption
of our IS business systems (including third-party systems we rely on) and/or
the loss of business information, as
well as claims against us by affected parties and/or governmental agencies, and involve
fines and penalties, costs
for remediation, and substantial defense and settlement expenses.
In addition, we develop products and provide
services to our customers that are technology-based, and a cyberattack
that bypasses the IS security systems of 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 particular, 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.
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
to comply with applicable legal
requirements, may not only cause reputational harm and loss of business,
but may also lead to claims against us by
our customers and/or governmental agencies and involve damages, fines and
penalties, costs for remediation, and
substantial defense and settlement expenses.
In addition, a cyberattack on a third-party that we use to manage
a
portion of our information systems could result in the same effects.
Additionally, legislative or regulatory action
related to cybersecurity may increase our costs to develop or implement
new technology products and services.
From time to time, we have had to address immaterial security incidents
(“security incidents”).
There can be no
assurance that we will not experience material security incidents in the future. Security
incidents can be difficult to
detect and any delay in identifying them could increase their harm.
While we have implemented measures to
protect our IS systems, such measures may not prevent these events.
Any such security incidents could disrupt our
operations, harm our reputation or otherwise have a material adverse effect on our
business.
We have various
insurance policies, including cybersecurity insurance, covering risks and
in amounts that we consider adequate.
There can be no assurance that the insurance coverage we maintain is sufficient or
will be available in adequate
amounts or at a reasonable cost to cover costs and expenses related
to security incidents.
Furthermore, procedures and safeguards must continually evolve to meet new
IS challenges, and enhancing
protections, and conducting investigations and remediation, may impose additional
costs on us.
Finally, our business may be interrupted by shortfalls of IS systems providers engaged by our customers, such
as
Internet-based services upon which our customers depend to access certain of
our products.
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 (including, without limitation,
in connection with
Brexit);
uncertainties relating to the EU-UK Trade and Cooperation Agreement of December 2020, which
went
into effect in 2021, including for example potential implementation issues, potential
disputes over the
interpretation of the provisions of the Agreement and possible changes
to the Agreement restricting the
free movement of goods between the U.K. and the European Union;
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;
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; and
public health emergencies, including COVID-19.
Our future success is substantially dependent upon our senior
management, and our revenues and profitability
depend on our relationships with capable sales personnel 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.
The loss of the services of
Mr. Bergman could have a material adverse effect on our business. We have an employment agreement with Mr.
Bergman.
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 during and after the
COVID-19 pandemic, 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
personnel 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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