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. In March and April 2020, the dental market was severely impacted by
COVID-19, with many, if not a majority, of practices being closed or open on a limited basis only. Although dental
practice openings and patient volume recovery in the United States and
many other countries have rebounded faster
than originally anticipated, patient volumes have remained below pre-COVID-19
levels.
Material uncertainty
remains and the potential for additional significant resurgences of COVID-19
could cause a significant reduction in
dental practice openings and patient volume recovery, or further delay the return to normal operations. Even
after
COVID-19 has subsided, 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 reductions in demand or significant volatility in demand for certain of our products.
For example, in
March and April 2020, many dental offices in the United States performed only emergency procedures,
and
rescheduled wellness exams and elective procedures. Dental offices in other countries
also experienced closures or
restricted operations, as did medical offices around the world. Such 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 dental practice openings and
patient volume recovery have
rebounded faster than originally anticipated, capacity constraints
in offices and demand-side factors may again lead
to reductions in demand or significant volatility in demand for our products. Additionally, significant reduction in
demand for certain of our products or customers’ decisions to delay
the purchase of large equipment may result in
us having increased inventory;
Shortage of Certain Personal Protective Equipment (PPE
). Supply chain disruptions for PPE and an increased
demand for these products has resulted, and may continue to result,
in backorders of certain PPE and a potential
scarcity in raw materials to make certain PPE. Prices for certain PPE have been
volatile. Although we believe that
most practices currently are able to access adequate supply, with some exceptions in certain markets depending on
a number of factors, including the progress of the virus and efforts to combat it, we
still may be unable to supply
our customers with the quantity of certain PPE products they demand,
which may lead to our customers seeking
alternative sources of supply. Furthermore, healthcare professionals’ inability to obtain a sufficient quantity of
certain PPE would
adversely impact our business, results of operations and cash flows,
and could materially
adversely affect our financial condition and liquidity. Conversely, we recorded significant charges throughout the
year beginning in the second quarter for PPE inventory due to volatility
of pricing for PPE, and, depending upon
the course of the pandemic, if PPE pricing or demand decreases, our
margins and the value of certain our PPE
inventory could be further negatively impacted in future periods, which
could result in a material adverse impact on
our business, results of operations and cash flows and our financial condition
and liquidity;
Reduction in Peoples’ Ability and Willingness to be in Public.
Restrictions recommended by several public health
organizations, and implemented by many local governments, to slow and limit the transmission
of COVID-19
(including business closures and restrictions, stay-at-home and similar measures)
were implemented and then lifted
or partially lifted in some locations and reinstituted in others. Ongoing
social distancing ordinances and similar
restrictions, and the actual and potential for additional resurgences of COVID-19
has in some locations and may in
other locations result in the re-imposition or tightening of governmental
social distancing and other restrictions,
and/or cause 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;
Potential delays in customer payments, or defaults on our customer credit arrangements.
We generally sell
products to customers with payment terms. If customers’ cash
flows or operating and financial performance
deteriorate due to the impact of COVID-19, or if they are unable to make scheduled
payments or obtain credit, they
may not be able to pay, or may delay payment to us. Likewise, for similar reasons, suppliers may restrict credit or
impose more stringent payment terms. The inability of current and/or
potential customers to pay us for our products
and/or services or any demands by suppliers for more stringent payment terms
may materially adversely affect our
business, results of operations, cash flows, financial condition and
liquidity and may limit the amounts we can
borrow under our trade accounts receivable securitization;
Impact on third parties’ ability to meet their obligations to us; impact on our ability to meet obligations
to third
parties.
Failure of third parties on which we rely, including our suppliers, contract manufacturers, distributors,
contractors (including third-party shippers), banks, joint venture partners
and external business partners, to meet
their obligations to us, or significant disruptions in their ability to do
so, which may be caused by their own
financial or operational difficulties, or by travel restrictions and border closures, may materially
adversely affect
our business, results of operations, cash flows, financial condition and
liquidity. Certain of our contracts with
supply partners contain minimum purchase requirements or include rebate provisions
if we satisfy certain sales or
purchasing targets that, in certain cases we have not been able to satisfy and in other
cases we may not be able to
fully satisfy, due to the impact of the COVID-19 pandemic. Rebate income recognized in fiscal 2020 is less than
rebates earned over the prior fiscal year. Our failure to satisfy such contractual provisions or renegotiate
more
favorable terms could materially adversely affect our business, results of operations
and cash flows;
Negative impact on our workforce and impact of adapted business practices.
The spread of COVID-19 caused us
to implement temporary cost reduction measures (including a payroll
cost reduction plan centered around
furloughs, reduced pay and work hours, voluntary unpaid time off, suspension of Company
contributions to certain
retirement plans and job reductions), all of which have now ended (except
for a small number of TSMs who remain
on furlough), modify our business practices (including employee
travel, employee work locations, and cancellation
of physical participation in meetings, events and conferences), and
we may take further actions as may be required
by government authorities or that we determine are in the best interests
of our employees. As the COVID-19
pandemic continues to unfold, we will continue to evaluate appropriate actions
for our business. Many of our
employees shifted abruptly to working remotely and our non-essential workers
who are able to work from home
continue to do so. An extended period of modified business practices
and 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;
Potential impact on our ability to meet obligations under credit facilities.
Although in fiscal 2020 we entered into
amendments to our material credit facilities to, among other things,
extend the maturity dates and temporarily
provide additional flexibility under certain covenants, an extended negative
impact of COVID-19 on our business,
results of operations, cash flows, financial condition and liquidity could
impact our ability to meet our obligations
under credit facilities or outstanding long term debt, which contain
maximum leverage ratios, and customary
representations, warranties and affirmative covenants;
Volatility
in the financial markets.
Volatility
in the financial markets may materially adversely affect the
availability and cost of credit to us;
Refocusing management resources to mitigate effects of COVID-19
. Our management is focused on mitigating the
effects of COVID-19, which has required, and may continue to require for the duration of
the pandemic, a large
investment of time and resources across the Company, and may delay certain strategic and other plans, which could
materially adversely affect our business;
Potential
increased costs associated with our self-insured medical insurance programs.
We may incur significant
employee health care costs under our self-insurance medical insurance programs
if a large number of our
employees and/or their covered family members become ill from COVID-19;
and
Reputational risk associated with response to COVID-19.
If we do not respond appropriately to the COVID-19
pandemic, or if customers do not perceive our response to be adequate, we could
suffer damage to our reputation
and our brands, which could materially adversely affect our business.
The impact of COVID-19 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 substantially all of our products.
We obtain substantially all 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 2020, our top 10 health care distribution suppliers and
our
single largest supplier accounted for approximately 30%
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.
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.
While
certain
software
and
e-services
that
we
develop are protected
under patent law,
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.
Our expansion through acquisitions and joint ventures involves
risks and may not result in the benefits and
revenue growth we expect.
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 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 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, 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.
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:
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
the affirmative vote of the holders of at least 66 2/3% of our common stock entitled
to vote to (i)
remove a director; and (ii) 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.
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 U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and
Education Reconciliation
Act, each enacted in March 2010, as amended (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 a decision is expected soon.
Any outcome of this case that changes 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 our operations.
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”) or provider networks
and the multi-tiered costing
structure may place us at a competitive disadvantage.
The medical 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 medical 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, demand more favorable pricing terms.
Additionally,
the formation of provider networks and GPOs 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 contracts or other contracts, and to
develop relationships with existing and
emerging provider networks and GPOs, 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.
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. Similarly, strikes
or other service interruptions by those shippers 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 macro-economic and political conditions could
materially adversely affect our results of
operations and financial condition.
Uncertain global 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, and other international trade agreements);
greater restrictions on imports and exports;
supply chain disruptions due to social issues;
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;
increases in interest rates;
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;
changes in tax rates and the availability of certain tax deductions;
increases in health care costs;
the threat or outbreak of war, terrorism or public unrest; 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 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 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.
The laws and regulations that govern our business and operations are
subject to varying and evolving
interpretations, future changes, additions, and enforcement approaches
(including in light of political changes, such
as with respect to the new administration of President Biden) that
affect our ability to comply.
For example,
President Biden’s administration has authorized and encouraged a freeze on certain federal regulations
that have
been published but are not yet effective, as well as a review of all federal regulations
issued during President
Trump’s administration.
Changes with respect to the applicable laws and regulations 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 Physician Payment Sunshine Act, we are required to collect
and report detailed information regarding
certain financial relationships we have with covered recipients, such as
physicians, dentists and teaching hospitals.
We or our subsidiaries may be required to report information under certain state transparency laws that address
circumstances not covered by the Physician Payment Sunshine Act, and
some of these state laws, as well as the
federal law, can be ambiguous.
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 ambiguous.
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, human cells, tissue and cellular and tissue-based products (“HCT/P products”).
Among the federal laws
with which we must comply are the Controlled Substances Act,
the U.S. Food, Drug, and Cosmetic Act, as
amended (“FDC Act”), the Federal Drug Quality and Security Act, including
Drug Supply Chain Security Act
(“DSCSA”), and Section 361 of the Public Health Services Act. Among
other things, such laws, and the regulations
promulgated thereunder:
regulate the storage and distribution, labeling, packaging, handling, reporting,
record keeping,
introduction, manufacturing and marketing of drugs, HCT/P products
and medical devices, including
requirements with respect to unique medical device identifiers;
subject us to inspection by the U.S. Food and Drug Administration (“FDA”)
and the U.S. Drug
Enforcement Administration (“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 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;
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 21st Century Cures Act (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.
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.
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 and 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 penalties, including warning letters, substantial civil and
criminal penalties, mandatory recall
of product, seizure of product and injunction, consent decrees and suspension
or limitation of 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 Medical Device Regulation No. 2017/745 (“EU MDR”) was meant
to become applicable three years after
publication (in May 2020). However, on April 23, 2020, to allow EEA national authorities, notified bodies,
manufacturers and other actors to focus fully on urgent priorities related to the COVID-19
pandemic, the European
Council and Parliament adopted Regulation 2020/561, postponing the date
of application of the EU MDR by one
year (to May 2021).
The EU MDR significantly modifies and intensifies the regulatory
compliance requirements
for the medical device industry as a whole.
Once applicable, the EU MDR will among other things:
Strengthen the rules on placing devices on the market and reinforce surveillance
once they are
available;
Establish explicit provisions on manufacturers’
responsibilities for the follow-up of the quality,
performance and safety of devices placed on the market;
Improve the traceability of medical devices throughout the supply chain
to the end-user or patient
through a unique identification number;
Set up a central database to provide patients, healthcare professionals and
the public with
comprehensive information on products available in the EU;
Strengthen 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
Identify importers and distributors and medical device products through
registration in a database
(EudaMed not due until 2022 and after).
In particular, the EU MDR imposes stricter 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, 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.
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.
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, and 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.
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 23 October 2019
on the protection of persons who report breaches of
Union law
which organizes the legal protection of whistleblowers must be implemented by EU
member states by
December 17, 2021. 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.
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 confidentiality
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 the
HIPAA, the Controlling the Assault of
Non-Solicited Pornography and Marketing Act, the Telephone Protection and Electronic Protection Act of 1991,
Section 5 of the Federal Trade Commission Act, the CCPA, and the CPRA that becomes effective on January 1,
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 European Union
have adopted the GDPR, which
increases privacy rights for individuals in Europe, or “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 offer goods or
services to Data Subjects or monitor their behavior (including by
companies based outside of Europe).
Noncompliance can result in penalties of up to the greater of EUR 20
million, or 4% of global company revenues.
Data Subjects also have the right to seek compensation for damages.
EU member states may individually impose
additional requirements and penalties regarding certain matters,
such as employee 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 new obligations imposed by the CCPA depends in part on how particular regulators interpret and apply
them, and because the CCPA is relatively new,
and its implementing regulations were released in August of
2020,
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 will come 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 and CPRA requirements,
our compliance with these measures 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 EU 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 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 by the Office of the
National Coordinator for Health Information
Technology of HHS (“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, our products may need to incorporate increasingly complex
reporting
functionality.
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 private-label 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.
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.
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 may 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, including
for example potential implementation problems such as border delays, as
well as potential changes to
the U.K. regulatory scheme to replace EU requirements;
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;
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
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 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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