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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended
December 31, 2022
OR
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
Commission File Number
0-16211
DENTSPLY SIRONA Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
39-1434669 |
(State or other jurisdiction of incorporation or
organization) |
(I.R.S. Employer Identification No.) |
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13320 Ballantyne Corporate Place, Charlotte, North
Carolina
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28277-3607 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area
code: (844)
848-0137
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol |
Name of each exchange on which registered |
Common Stock, par value $.01 per share |
XRAY |
The Nasdaq Stock Market LLC |
Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities
Act.
Yes o No x
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Act.
Yes o No x
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes x No o
Indicate by check mark whether the Registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this
chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit such
files).
Yes x No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of "large accelerated filer," "accelerated filer,"
"smaller reporting company" and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large Accelerated Filer
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x |
Accelerated Filer
o
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Non-Accelerated Filer
o
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Smaller Reporting Company
☐
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Emerging Growth Company
☐
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
o
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Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the
registered public accounting firm that prepared or issued its audit
report. ☒
If securities are registered pursuant to Section 12(b) of the Act,
indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an
error to previously issued financial statements.
o
Indicate by check mark whether any of those error corrections are
restatements that required a recovery analysis of incentive-based
compensation received by any of the registrant’s executive officers
during the relevant recovery period pursuant to §240.10D-1(b).
o
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act)
Yes ☐ No x
The aggregate market value of the voting common stock held by
non-affiliates of the registrant computed by reference to the
closing price as of the last business day of the registrant's most
recently completed second quarter ended
June 30, 2022,
was $7,664,602,549.
Based on the closing price on
June 30, 2022.
For purpose of this calculation only, without determining whether
the following are affiliates of the registrant, the registrant has
assumed that (i) its directors and executive officers are
affiliates, and (ii) no party who has filed a Schedule 13D or 13G
is an affiliate.
The number of shares of the registrant’s common stock outstanding
as of the close of business on February 16, 2023 was
215,361,909.
DOCUMENTS INCORPORATED BY REFERENCE
Certain portions of the definitive Proxy Statement of DENTSPLY
SIRONA Inc. (the “Proxy Statement”) to be used in connection with
the 2023 Annual Meeting of Stockholders are incorporated by
reference into Part III of this Form 10-K to the extent provided
herein. Except as specifically incorporated by reference herein the
Proxy Statement is not deemed to be filed as part of this Form
10-K.
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DENTSPLY SIRONA Inc. |
Table of Contents |
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PART I
FORWARD-LOOKING STATEMENTS
Information included in or incorporated by reference in this Form
10-K, and other filings with the U.S. Securities and Exchange
Commission (the “SEC”) and the Company’s press releases or other
public statements, contains or may contain forward-looking
statements. Please refer to a discussion of our forward-looking
statements and associated risks in Item 1 “Business-
Forward-Looking Statements and Associated Risks” and Item 1A “Risk
Factors” of this Form 10-K.
GENERAL
Unless otherwise stated herein or the context otherwise indicates,
reference throughout this Form 10-K to “Dentsply Sirona”, or the
“Company,” “we,” “us” or “our” refers to financial information and
transactions of DENTSPLY SIRONA Inc., together with its
subsidiaries on a consolidated basis.
INDUSTRY AND MARKET DATA
Unless indicated otherwise, the information concerning our industry
contained in this Form 10-K is based on our general knowledge of
and expectations concerning the industry. The Company’s market
position, market share and industry market size are based on data
from various industry analyses, our internal research and data, and
adjustments and assumptions we believe to be reasonable. The
Company has not independently verified data from industry analyses
and cannot guarantee their accuracy or completeness. In addition,
we believe that data regarding the industry, market size and its
market position and market share within such industry provide
general guidance but are inherently imprecise. Further, the
Company's estimates and assumptions involve risks and uncertainties
and are subject to change based on various factors, including those
discussed in Item 1A “Risk Factors” of this Form 10-K. These and
other factors could cause results to differ materially from those
expressed in the estimates and assumptions.
Item 1. Business
Overview
DENTSPLY SIRONA Inc. (“Dentsply Sirona” or the “Company”) is the
world’s largest manufacturer of professional dental products and
technologies, with a 136-year history of innovation and service to
the dental industry and patients worldwide. Dentsply Sirona
develops, manufactures, and markets comprehensive solutions
including technologically-advanced dental equipment as well as
dental and healthcare consumable products under a strong portfolio
of world class brands. Dentsply Sirona’s products provide
innovative, high-quality and effective solutions to advance patient
care and deliver better, safer and faster dentistry. The
Company introduced the first dental electric drill over 131 years
ago, the first dental X-ray unit approximately 100 years ago, the
first dental computer-aided design/computer-aided manufacturing
(“CAD/CAM”) system approximately 30 years ago, and numerous other
significant innovations including pioneering ultrasonic scaling to
increase the speed, effectiveness and comfort of cleaning and
revolutionizing both file and apex locater technology to make root
canal procedures easier and safer. Dentsply Sirona continues to
make significant investments in research and development
(“R&D”), and its track record of innovative and profitable new
products continues today. Dentsply Sirona’s worldwide headquarters
is located in Charlotte, North Carolina and its shares of common
stock are listed in the United States on Nasdaq under the symbol
XRAY.
The Company conducts its business through two reportable segments:
(1) Technologies & Equipment (“T&E”) and (2) Consumables.
For the year ended December 31, 2022, T&E net revenues
represented approximately 59.1% of worldwide net revenues, while
Consumables net revenues represented the remaining 40.9% of
worldwide net revenues.
The business is conducted in the United States of America (“U.S.”
or "United States"), as well as in over 150 foreign countries,
principally through its foreign subsidiaries. Dentsply Sirona has a
long-established presence in the European market, particularly in
Germany, Sweden, France, the United Kingdom ("UK"), Switzerland and
Italy. The Company also has a significant market presence in the
Asia-Pacific region, Central and South America, the Middle-East
region, and Canada.
Principal Products and Product Categories
The worldwide professional dental industry encompasses the
diagnosis, treatment and prevention of disease and ailments of the
teeth, gums and supporting bone. The Company offers a broad suite
of products which together provide digital workflows for dental
practitioners to make the highest use of technological advancements
throughout each stage of patient care. Dentsply Sirona’s principal
product categories are dental technology and equipment products and
dental consumable products. Additionally, the Company manufactures
and sells healthcare consumable products for urological
applications. As part of its technology and equipment solutions,
the Company also offers an open, cloud-based platform for digital
services. These products and solutions are produced by the Company
globally and are distributed throughout the world under some of the
most well-established brand names and trademarks in these
industries, including but not limited to: AH PLUS, ANKYLOS, AQUASIL
ULTRA, ARTICADENT, ASTRA TECH, ATLANTIS, AXANO, AXEOS, BYTE,
CALIBRA CEMENTS, CAULK, CAVITRON, CELTRA, CERAMCO, CERCON, CEREC,
CEREC MCX, CITANEST, CONFORM FIT, DAC, DELTON, DENTSPLY, DETREY, DS
CORE, DYRACT, ESTHET.X, FRIOS, IMPLANT EV, INLAB, INTEGO, IPN,
LOFRIC, LUCITONE, MAILLEFER, MIDWEST, MIS, MTM, NAVINA, NUPRO,
OMNICAM, OMNITAPER EV, ORAQIX, ORIGO, ORTHOPHOS, OSSEOSPEED, OSSIX,
PALODENT, PRIME & BOND, PROFILE, PRIMEMILL, PRIMEPRINT,
PRIMESCAN, PRIMETAPER EV, PROGLIDER, PROTAPER ULTIMATE, RECIPROC,
PUREVAC, SANI-TIP, SCHICK, SIDEXIS, SIMPLANT, SINIUS, SIROLASER,
SIRONA, SLIMLINE, SMARTLITE PRO, SPECTRA ST, STYLUS, SULTAN,
SUREFIL, SURESMILE, SYMBIOS, T1, T2, T3, T4, TENEO, THERMAFIL,
TRIODENT, TRUBYTE, TRUNATOMY, VDW, VIPI, WAVEONE, WELLSPECT, XENO,
XIVE, XYLOCAINE and ZHERMACK.
Technologies & Equipment Segment
Equipment & Instruments
The Equipment & Instruments product category consists of basic
and high-tech dental equipment such as treatment centers, imaging
equipment, motorized dental handpieces, and other instruments for
dental practitioners and specialists. Imaging equipment serves as
the starting point for the Company’s digital workflow offerings and
consists of a broad range of diagnostic imaging systems for 2D or
3D, panoramic, and intra-oral applications. Treatment centers
comprise a broad range of products from basic dental chairs to
sophisticated chair-based units with integrated diagnostic, hygiene
and ergonomic functionalities, as well as specialist centers used
in preventive treatment and for training purposes. This product
group also includes other lab equipment such as amalgamators,
mixing machines and porcelain furnaces.
Implants
The Implants product offering includes technology to support
signature digital workflows for implant systems, a portfolio of
innovative dental implant products, bone regenerative and
restorative solutions, and educational programs, all of which
provide dental professionals with a completely new way of
practicing implantology. The Implants business is supported by key
technologies including custom abutments, advanced tapered immediate
load screws and regenerative bone growth factor.
CAD/CAM
Dental CAD/CAM technologies are products designed for dental
offices to support numerous digital dental procedures including
dental restorations. This product category includes a
full-chairside economical restoration of esthetic ceramic dentistry
offering called CEREC, as well as stand-alone CAD/CAM, digital
impressions ("DI") intra-oral scanners, mills, and services. The
full-chairside offering enables dentists to practice same day or
single visit dentistry.
Orthodontics
The Company’s Orthodontics product category primarily includes a
dentist-directed aligner solution, SureSmile, and a
direct-to-consumer aligner solution, Byte. The Orthodontics product
category also includes a High Frequency Vibration ("HFV")
technology device known as VPro or as HyperByte within Byte's
product offering. The aligner offerings include software technology
that enables aligner treatment planning and for SureSmile seamless
connectivity of a digital workflow from diagnostics through
treatment delivery.
Healthcare
This category consists mainly of urology catheters and other
healthcare-related consumable products.
Consumables Segment
Dental consumable products consist of value-added dental supplies
and small equipment used in dental offices for the treatment of
patients. It also includes specialized treatment products used
within the dental office and laboratory settings including products
used in the preparation of dental appliances by dental
laboratories.
Endodontic & Restorative Products
The Company's Endodontic & Restorative products frequently work
together to provide a tandem solution in high-tech dental
procedures. The Endodontic products include drills, filers,
sealers, irrigation needles and other tools or single-use solutions
which support root canal procedures. Restorative products include
dental prosthetics, such as artificial teeth, dental ceramics,
digital dentures, precious metal dental alloys, and crown and
bridge porcelain products.
Other Consumables
The remaining consumables products include small equipment products
such as intraoral curing light systems, dental diagnostic systems
and ultrasonic scalers and polishers, as well as other dental
supplies including dental anesthetics, prophylaxis paste, dental
sealants, impression materials, teeth whiteners and topical
fluoride.
Net sales for each product category as a percentage of the
Company's total net sales for the year ended December 31, 2022,
were as follows:
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% of Net Sales |
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Equipment & Instruments |
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17.3 |
% |
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Implants |
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14.5 |
% |
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CAD/CAM |
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12.8 |
% |
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Orthodontics |
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7.6 |
% |
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Healthcare |
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6.9 |
% |
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Technology & Equipment segment revenue |
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59.1 |
% |
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Endodontic & Restorative |
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29.8 |
% |
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Other consumables |
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11.1 |
% |
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Consumables segment revenue |
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40.9 |
% |
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Total net sales |
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100.0 |
% |
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Dental Industry, Sales and Distribution
The Company believes that the dental industry is attractive and
will grow over the long-term based on the following
factors:
•Increasing
worldwide population, including a shift towards aging demographics,
which will require greater dental care.
•Natural
teeth are being retained longer - individuals with natural teeth
are much more likely to visit a dentist than those without any
natural teeth.
•Increasing
demand for aesthetic dentistry and the use of aligners as an
orthodontic treatment.
•Continued
opportunities in emerging markets related to the rise in
discretionary incomes making dental services an increasing
priority.
•Increasing
demand for single visit dentistry versus historical multi-visit
procedure requirements, and for higher quality of patient care in
terms of comfort and ease of product use and handling.
•Increasing
demand for earlier preventive care - dentistry has evolved from a
profession primarily dealing with pain, infections, and tooth decay
to one with increased emphasis on earlier diagnosis, preventive
care, and the role oral health plays in overall
health.
•Increasing
opportunity for digital collaboration between General Practitioners
(“GPs”), specialists, labs, and patients is creating widening
demand for fully integrated solutions such as cloud-based platforms
and services facilitated by GPs.
•Increasing
demand for more efficiency and better workflow in the dental
office, including digital tools such as the enhanced power of
diagnostic equipment through 3D imaging. The rapid pace of digital
technology adoption including the digitization of clinical
workflows is becoming a category standard versus traditional manual
processes.
The Company is able to navigate macroeconomic challenges and is
well positioned to execute on its strategy of enabling dentists to
have superior integrated workflows through its robust market
offerings in all key areas of dental procedures (implants,
endodontic, restorative and aligners) as well as digital
infrastructure (CAD/CAM and imaging) utilized in dental practices
around the globe.
As of December 31, 2022, Dentsply Sirona employed approximately
5,000 highly-trained, sales and technical staff specialized in each
of our various products and solutions to provide comprehensive
marketing, sales, and technical support services to meet the needs
of our distributors, dealers and end-users.
Sales and Distribution
Dentsply Sirona distributes approximately two-thirds of its dental
consumable and technology and equipment products through
third-party distributors. Certain highly technical products such as
dental technology equipment, dental ceramics, crown and bridge
porcelain products, endodontic instruments and materials,
orthodontic aligners and appliances, and dental implants are often
sold directly to the dental laboratory or dental professionals in
some markets. Additionally, the Company’s Byte business produces
aligners which are sold direct to consumers under doctor-directed,
personalized treatment plans.
For the year ended December 31, 2021, no customer accounted for 10%
or more of consolidated net sales or consolidated accounts
receivable balance. Customers that accounted for 10% or more of net
sales and accounts receivable for the years ended December 31, 2022
and 2020 were as follows:
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2022 |
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2020 |
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% of net sales |
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% of accounts receivable |
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% of net sales |
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% of accounts receivable |
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Henry Schein, Inc. |
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11 |
% |
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15 |
% |
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14 |
% |
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N/A |
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Patterson Companies, Inc. |
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N/A |
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12 |
% |
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10 |
% |
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18 |
% |
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Although a significant portion of the Company's sales are made to
distributors, dealers and importers, Dentsply Sirona focuses much
of its marketing efforts on the dentists, dental hygienists, dental
assistants, dental laboratories and dental schools which are the
end-users of its products. As part of this end-user “pull through”
marketing approach, the Company conducts extensive distributor,
dealer and end-user marketing programs. Additionally, the Company
trains laboratory technicians, dental hygienists, dental assistants
and dentists in the proper use of its products and introduces them
to the latest technological developments at its educational courses
conducted throughout the world. The Company also maintains ongoing
consulting and educational relationships with various dental
associations and recognized worldwide opinion leaders in the dental
field.
Operating Principles
The Company's focus includes the creation of more meaningful
solutions for dentists built around the following five key
operating principles:
•Approach
customers as one:
Put the customer at the center of how Dentsply Sirona is organized.
The Company has an integrated approach
to customer service, direct and indirect selling, and clinical
education to strengthen the relationship with the customer and
better serve the customers' needs.
•Create
innovative solutions that customers love to use:
A comprehensive R&D program that prioritizes strategic spending
building the next generation of digital workflow technologies and
service offerings, resulting in more impactful innovations each
year.
•Think
and act with positive intent and the highest integrity:
Execute the business in a way that empowers our people, respects
the communities in which we do business, and establishes trust with
our partners and stakeholders.
•Operate
sustainably in everything we do:
Take a thoughtful, proactive approach to creating a sustainable
company through investments in our employees, customers, and the
environment.
•Use
size and global breadth to our advantage:
The Company is focused on integrating its dental product portfolios
to unlock operational efficiencies, including
performance improvements in procurement, logistics, manufacturing,
sales force and marketing programs; and at the same time
simplifying the business on a worldwide scale. In combination,
these initiatives will improve organizational efficiency and better
leverage the Company’s selling, general and administrative
infrastructure.
Product Development
While the Company enjoys market leadership in several of its
product categories, continuous innovation and product development
are critical for it to continue to grow its share in markets it
serves. Many of Dentsply Sirona’s existing products are undergoing
brand extensions, and the Company also continues to focus efforts
on successfully launching innovative products that have a more
significant impact on how dental and clinical professionals treat
their patients. In particular, the Company has continued to
prioritize investments supporting digitally enhanced workflows
through each stage of patient care, including imaging and scanning
technologies used in diagnosis, treatment planning software, and
customized products to deliver treatment. During 2022, the Company
unveiled its cloud solution DS Core, an open platform developed in
collaboration with Google Cloud that integrates digital dentistry
workflows across its devices, services, and technologies. The DS
Core digital platform is designed to enable more precise and
simplified cloud storage, optimize diagnostic capabilities, and
streamline existing workflows and collaboration with laboratory
partners and specialists. Through R&D investments, the Company
has accelerated a number of other new product developments during
the year which enhance the digital dentistry offering for both
equipment and consumables products. Innovations include the
Company’s Primeprint Solution to provide medical-grade 3D printing,
Primescan Connect which offers a laptop-based version of Primescan,
the SmartLite Pro EndoActivator which serves as a new irrigation
solution for root canal procedures, and the Axano treatment center
combining smart design with efficient workflows. During the year,
the Company also introduced its premium EV Implants System for
providing implants that are harmonized, simplified and digitally
enabled, as well as its enhanced orthodontic offering SureSmile
Solutions that includes the addition of a whitening kit, retainers,
and the VPro orthodontic device which uses high-frequency vibration
to reduce discomfort in aligner treatment.
During 2021, product launches included software upgrades for CEREC
and SureSmile introduction of PrimeTaper, a self-tapping implant
with a tapered design; and ProTaper Ultimate, the next generation
of endodontic files. The Company also acquired key supporting
technologies in OSSIX bone regenerative collagen through the
purchase of Datum Dental, and the new VPro aligner treatment
devices through the acquisition of substantially all of the assets
of Propel Orthodontics LLC ("Propel"). During 2020, the Company
introduced Axeos, a new digital imaging product with a 3D wide
field of view and Primemill, a time saving grinding and milling
restoration machine. New products introduced within the past three
years accounted for approximately 14% of 2022 sales.
R&D investments include activities to accelerate product and
clinical innovation and discipline, and develop potential
improvements to the manufacturing process. These investments also
support engineering efforts that incorporate customer feedback into
continuous improvement for current and next-generation products,
with an objective to achieve more frequent development and release
cycles. The Company also undertakes pre-commercialization trials
and testing of technological improvements prior to inception of the
manufacturing process. As is true across its other functions, the
Company is continually transforming how R&D is conducted by
identifying best practices, driving efficiencies, and optimizing
cost structure to enable a more effective development process with
a strategic focus on innovation process discipline. We are also
looking to increasingly utilize an enterprise approach to funding
that employs a returns-based mindset and allocates R&D spend
towards those areas with the highest return.
In addition to internal product development, the Company also
pursues external R&D opportunities, including acquisitions,
licensing, or other arrangements with third parties. Initiatives to
support technological development also include collaborations with
research institutions and dental and medical schools. The Company
annually supports the achievements of dental students conducting
innovative research through its
Student Competition for Advancing Dental Research and its
Application Awards
program. The Company is also committed to participation in clinical
research demonstrating the efficacy of our products prior to market
introduction, and in supporting the clinical education and
technical training of dental professionals. Dentsply Sirona has 55
academies and education centers that are home to state-of-the-art
training facilities for dental professionals who seek a
comprehensive variety of clinical and technical continuing
education curriculum. The academies offering hands-on teaching,
live lectures, and on-demand webinars and courses which are taught
by a diverse range of internationally known experts in all fields
of dentistry. The Company
provides over 7,000 training courses through our DS Academy
annually, with approximately 300,000 dental professionals
participating.
Through our internal research centers as well as through our
collaborations with external research institutions, dental and
medical schools, the Company directly invests in the development of
new products, improvement of existing products and advances in
technology. These investments include an emphasis on research in
digital data sharing technology, including the incorporation of
long-term artificial intelligence and machine learning. The
continued development of these areas is a critical step in meeting
the Company’s strategic goal as a leader in defining the future of
dentistry. The Company’s long-term plans for investment in product
development include an objective to maintain a level of R&D
spend that is at least 4% of annual net sales with a focus on
innovation and expansion of digital, software, services, and other
platform offerings.
Acquisition Activities
Dentsply Sirona believes that the dental technology and consumable
products industries continue to experience consolidation with
respect to both product manufacturing and distribution, although
they remain fragmented thereby creating a number of acquisition
opportunities.
The Company views acquisitions as a key part of its long-term
growth strategy. These acquisition activities are intended to
supplement the Company’s organic growth and assure ongoing
expansion of its business to capitalize on significant growth
drivers, including new technologies, additional products,
organizational strength and geographic breadth. During the first
quarter of the year ended December 31, 2021, the Company purchased
Datum Dental, Ltd., a producer and distributor of specialized
regenerative dental material based in Israel, which provided the
Company with a key technology to serve the implants markets. The
Company followed in the second quarter of the year ended December
31, 2021 with the purchase of substantially all of the assets of
Propel, a U.S. based company which manufactures and sells
orthodontic devices and provides in-office and at-home orthodontic
accessory devices, this investment is expected to further
accelerate the growth and profitability of the Company's combined
aligners business. In the third quarter of the year ended December
31, 2021, the Company completed its acquisition of a partially
owned affiliate based in Switzerland that primarily develops highly
specialized software, which is expected to further accelerate the
development of the Company's specialized software related to
CAD/CAM systems. During the year ended December 31, 2020, the
Company made various investments, including the acquisition of
Byte, a direct-to-consumer aligners business, which complements the
Company's existing aligner product by adding a digital component
and is expected to enhance scale and accelerate the growth of the
Company's combined aligners business going forward. This
acquisition was representative of the Company's strategy of
matching technological advancement in digital dentistry with
innovative marketing and delivery in order to reach areas of
high-growth potential for customer demand. For more information
regarding the Company's acquisition activity, refer to Note 6,
Business Combinations, in the Notes to the Consolidated Financial
Statements in Part II, Item 8 of this Form 10-K.
Operating and Technical Expertise
Dentsply Sirona believes that its manufacturing capabilities are
important to its success. The manufacturing processes of the
Company’s products require substantial and varied technical
expertise. Complex materials technology and processes are necessary
to manufacture the Company’s products. Where the Company can
improve quality and customer service and lower costs, we endeavor
to automate our global manufacturing operations.
Financing
Information about Dentsply Sirona’s working capital, liquidity and
capital resources is provided in Part II, Item 7 “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” of this Form 10-K.
Competition
The Company conducts its operations, both domestic and foreign,
under highly competitive market conditions. Competition in the
dental and healthcare consumable products and dental technology and
equipment products industries is based primarily upon product
performance, quality, safety and ease of use, as well as price,
customer service, innovation and acceptance by clinicians,
technicians and patients. Dentsply Sirona believes that its
principal strengths include its well-established brand names, its
reputation for high quality and innovative products, its leadership
in product development and manufacturing, its global sales force,
the breadth of its product line and distribution network, its
commitment to customer satisfaction and support of the Company’s
products by dental and medical professionals.
The size and number of the Company’s competitors vary by product
line and from region to region. There are many companies that
produce some, but no competitor produces all of the same types of
products as those produced by the Company.
Regulation
The development, manufacture, sale and distribution of the
Company’s products are subject to comprehensive governmental
regulation both within and outside the U.S. The following sections
describe certain, but not all, of the significant regulations that
apply to the Company. For a description of the risks related to the
regulations that the Company is subject to, please refer to Item
1A. “Risk Factors” of this Form 10-K.
The majority of the Company’s products are classified as medical
devices and are subject to restrictions under domestic and foreign
laws, rules, regulations, self-regulatory codes, circulars and
orders, including, but not limited to, the U.S. Food, Drug, and
Cosmetic Act (the “FDCA”), Council Directive 93/42/EEC on Medical
Devices (“MDD”) (1993) in the European Union ("EU"), which will be
updated to the EU Medical Device Regulation (“MDR”) in 2021 (and
implementing and local measures adopted thereunder) and similar
international laws and regulations. The FDCA requires these
products, when sold in the U.S., to be safe and effective for their
intended use and to comply with the regulations administered by the
U.S. Food and Drug Administration (“FDA”). Certain medical device
products are also regulated by comparable agencies in non-U.S.
countries in which they are produced or sold.
Dental and medical devices sold by the Company in the U.S. are
generally classified by the FDA into a category that renders them
subject to the same controls that apply to all medical devices,
including regulations regarding alteration, misbranding,
notification, record-keeping and good manufacturing practices. In
the EU, the Company’s products are subject to the medical device
laws of the various member states, which are based on a Directive
of the European Commission. Such laws generally regulate the safety
of the products in a similar way to the FDA regulations. The
Company products in Europe bear the CE mark showing that such
products comply with European regulations. The Company’s products
classified by EU MDD were mandated to be certified under the new
MDR. These regulations also applied to all medical device
manufacturers who market their medical devices in the EU and all
such manufacturers had to perform significant upgrades to quality
systems and processes including technical documentation and subject
them to new certification under EU MDR in order to continue to sell
those products in the EU. Although all medical device manufacturers
were required to certify their Class I (as defined in the EU MDR
regulations) products by May 2021, the EU MDR regulations for
additional Classes of medical devices is mandated to be fully
enforceable by May 2024. This also includes completion of certified
quality management systems to manufacturers quality management
systems. The Company remains focused on ensuring that all its
products that are considered to be medical devices will be fully
certified as required by the EU MDR dates and
timelines.
Recently, the Chinese government launched a national program for
volume-based, centralized medical device and consumables
procurement with minimum quantity commitments in an attempt to
negotiate lower prices from drug manufacturers and reduce the price
of medical devices and other products. Under the program, the
government will award contracts to the lowest bidders who are able
to satisfy the quality and quantity requirements. The successful
bidders will be guaranteed a sale volume for at least a year,
giving the winner an opportunity to gain or increase market share.
The volume guarantee is intended to make manufacturers more willing
to cut their prices in order to win a bid and may also enable
successful bidders to lower their distribution and commercial
costs. Many types of drugs are covered under the program, including
drugs made by international pharmaceutical companies and generics
made by domestic Chinese manufacturers. The program, which is
anticipated to take effect in the first half of 2023, could in the
future result in reduced margins on covered devices and products,
required renegotiation of distributor arrangements, and incurrence
of inventory-related charges. The Company currently expects that
sales of our Implants products in China will be negatively affected
by price reductions.
The Company is also subject to domestic and foreign laws, rules,
regulations, self-regulatory codes, circulars and orders regarding
anti-bribery and anti-corruption, including, but not limited to,
the U.S. Foreign Corrupt Practices Act (“FCPA”), the U.S. Federal
Anti-Kickback Statute (“AKS”), the UK’s Bribery Act 2010 (c.23),
Brazil’s Clean Company Act 2014 (Law No. 12,846) China’s National
Health and Family Planning Commission (“NHFPC”) circulars No. 40
and No. 50, and similar international laws and regulations. The
FCPA and similar anti-bribery and anti-corruption laws applicable
in non-U.S. jurisdictions generally prohibit companies and their
intermediaries from improperly offering or paying anything of value
to foreign government officials for the purpose of obtaining or
retaining business. Some of the Company’s customer relationships
are with governmental entities and therefore may be subject to such
anti-bribery laws. The AKS and similar fraud and abuse laws
applicable in non-U.S. jurisdictions prohibit persons from
knowingly and willfully soliciting, offering, receiving or
providing remuneration, directly or indirectly, in exchange for or
to induce either the referral of an individual, or the furnishing
or arranging for a good or service, for which payment may be made
under a health care program, such as, in the U.S., Medicare or
Medicaid.
The Company’s production and sale of products is further subject to
regulations concerning the supply of conflict minerals, various
environmental regulations such as the Federal Water Pollution
Control Act (the “Clean Water Act”) and others enforced by the
Environmental Protection Agency (“EPA”) or equivalent state
agencies, and the Patient Protection and Affordable Care Act as
amended by the Health Care and Education Reconciliation Act (the
“Health Care Reform Law”). In the sale, delivery and servicing of
the Company’s products to other countries, it must also comply with
various domestic and foreign export control and trade embargo laws
and regulations, including those administered by the Department of
Treasury’s Office of Foreign Assets Control (“OFAC”), the
Department of Commerce’s Bureau of Industry and Security (“BIS”)
and similar international governmental agencies, which may require
licenses or other authorizations for transactions relating to
certain countries and/or with certain individuals identified by the
respective government. Despite the Company’s internal compliance
program, policies and procedures may not always protect it from
reckless or criminal acts committed by its employees or agents.
Violations of these requirements are punishable by criminal or
civil sanctions, including substantial fines and imprisonment. Due
in part to its direct-to-consumer model, the Company’s Byte aligner
business in the U.S. is subject to various state laws, rules and
policies which govern the practice of dentistry within such state.
Byte contracts with an expansive nationwide network of independent
licensed dentists and orthodontists for the provision of clinical
services, including the oversight and control of each customer’s
clinical treatment in order to comply with these regulations and
ensure that the business does not violate rules pertaining to the
corporate practice of dentistry.
The Company is subject to domestic and foreign laws, rules,
regulations, self-regulatory codes, circulars and orders governing
data privacy and transparency, including, but not limited to, the
Health Insurance Portability and Accountability Act of 1996
(“HIPAA”) as amended by the Health Information Technology for
Economic and Clinical Health Act of 2009 (the “HITECH Act”), the
California Consumer Privacy Act, the European General Data
Protection Regulation (the “GDPR”), China’s Personal Information
Protection Law, the Physician Payments Sunshine Provisions of the
Patient Protection and Affordable Care Act, the EU Directive
2002/58/EC (and implementing and local measures adopted
thereunder), France’s Data Protection Act of 1978 (rev. 2004) and
France’s Loi Bertrand, certain rules issued by Denmark’s Health and
Medicines Authority, and similar international laws and
regulations. HIPAA, as amended by the HITECH Act, the GDPR and
similar data-privacy laws applicable in non-U.S. jurisdictions,
restrict the use and disclosure of personal health information,
mandate the adoption of standards relating to the privacy and
security of individually identifiable health information and
require us to report certain breaches of unsecured, individually
identifiable health information. The Physician Payments Sunshine
Provisions of the Patient Protection and Affordable Care Act
require the Company to record all transfers of value to physicians
and teaching hospitals and to report this data to the Centers for
Medicare and Medicaid Services for public disclosure. Similar
reporting requirements have also been enacted in several states,
and an increasing number of countries worldwide either have adopted
or are considering similar laws requiring transparency of
interactions with health care professionals.
The Company believes it is in substantial compliance with the laws
and regulations that regulate its business. There are, however,
significant uncertainties involving the application of various
legal requirements, the violation of which could result in, among
other things, sanctions. See Item 1A, "Risk Factors” of this Form
10-K for additional detail.
Sources and Supply of Raw Materials and Finished Goods
The Company manufactures the majority of the products that it
sells. The Company sources the necessary raw materials from various
suppliers, and no single supplier accounts for more than 10% of our
supply requirements.
Intellectual Property
Products manufactured by Dentsply Sirona are sold primarily under
its own tradenames and trademarks. Dentsply Sirona also owns and
maintains more than 5,000 patents throughout the world and has also
licensed a number of patents owned by others.
Our policy is to protect its products and technology through
patents and trademark registrations both in the U.S. and in
significant international markets. The Company monitors trademark
use worldwide and promotes enforcement of its patents and
trademarks in a manner that is designed to balance the cost of such
protection against obtaining the greatest value for the Company.
Dentsply Sirona believes its patents and trademark properties are
important and contribute to the Company’s marketing position but it
does not consider its overall business to be materially dependent
upon any individual patent or trademark. Additional information
regarding certain risks related to our intellectual property is
included in Item 1A “Risk Factors” of this Form 10-K and is
incorporated herein by reference.
Human Capital
Our employees are core to our Company, and their contributions
enable the success of our business. As of December 31, 2022,
our organization and its subsidiaries employed over 15,000
employees across the globe. Of these employees, approximately 3,600
were employed in the U.S. Some employees outside of the U.S. and
particularly in Europe are covered by collective bargaining, union
contracts, worker councils or other similar programs. Our talent
strategy prioritizes attracting, engaging, developing, and
retaining talent to support our business strategy. We strive to
foster a diverse and inclusive environment where every employee can
grow and perform at their best.
Attract, Engage, Develop & Retain
In 2022, we continued to evolve our talent strategy to support
business priorities. We continued deployment of our Emerging Talent
program focused on attracting early-career employees through
strategic partnerships with Historically Black Colleges and
Universities and local trade schools. The comprehensive program
provides rotational assignments, on-the-job experiences, networking
events, development sessions and executive interactions. We offer
global learning and development opportunities including a
partnership with LinkedIn Learning which offers thousands of
on-demand learning modules in multiple languages and our custom
leadership development framework to assess, develop and coach
leaders at multiple levels. Our robust set of tools for goal
setting and development planning is designed to support
future-focused growth including our employee-led career mapping and
global mentor matching programs. We also offer regular performance
feedback, development planning and talent review processes in an
automated format for our professional employees.
To keep employees connected, engaged and informed, we continued to
hold virtual town halls and live video chats. These events provide
multiple opportunities for our global workforce to submit questions
to our executive leadership team. Employee feedback is an important
element of our culture. We launch global engagement surveys at
least every 18 months and strategically deploy pulse and lifecycle
surveys throughout the year. We leverage insights from these
surveys to drive actions that improve the employee experience,
supporting talent attraction, engagement, and
retention.
Compensation and Benefits
As part of the our total rewards philosophy, we offer competitive
compensation and benefit programs designed to attract and retain
top talent. We are committed to providing and administering these
programs in a way that treats our employees at all levels fairly
and equitably. Our total rewards offerings vary by country and
include an array of programs that support our employees’ financial,
physical, and mental well-being, including annual performance
incentive opportunities, pension and retirement savings programs,
health and welfare benefits, paid time off (including for
charitable actions), leave programs, flexible work schedules and
employee assistance programs.
Diversity, Equity & Inclusion
Diversity in our organization is a source of great strength. We
provide opportunities for all employees to bring their perspective,
experience, and lens to the workplace. Our commitment to a diverse
workforce helps us create robust solutions to our customers’
challenges and drive innovation. We strive to foster an environment
in which our teams feel inspired and empowered to do their best
work and bring new ideas to the table. We have a Diversity, Equity
& Inclusion strategy focused on embedding diversity, equity
& inclusion into our culture.
As part of our sustainability program, BEYOND-Taking Action for a
Brighter World, we are striving to achieve global gender pay equity
and global gender parity by 2025. We are members of the Paradigm
for Parity cross-sector diversity commitment – a coalition of more
than 130 CEOs, executives, board members, founders and experts
dedicated to providing women and men equal opportunity and power
and achieving gender parity by 2030.
Diversity, Equity & Inclusion Council
Our Diversity, Equity & Inclusion Council is a group of
demographically and functionally diverse employees from across the
world dedicated to enabling our diversity, equity & inclusion
efforts and championing initiatives that support the organization
internally and externally. A top priority of the Diversity, Equity
& Inclusion Council is to equip leaders to discuss and be
accountable for driving sustained diversity, equity, and inclusion
progress.
Employee Resource Groups
The purpose of our employee resource groups is to foster a diverse,
equitable, and inclusive environment enabling employees to bring
their best to work as they participate in successfully executing
our strategy. As of December 31, 2022, our employees have led the
successful establishment of seven employee resource groups
consisting of approximately 2,000 members from across the globe.
Our employee resource groups focus on developing talent, increasing
employee engagement, and creating awareness through allyship. We
consistently recognize high participation in employee resource
group-led events.
Training and Awareness
We offer a catalog of on-demand diversity, equity & inclusion
training options aimed at strengthening awareness. A standout
offering is our ongoing “Conversations of Understanding” sessions.
Employees are invited to register for these small group discussions
where internal volunteers share experiences on varying diversity,
equity, & inclusion topics to generate healthy discussion and
awareness.
Talent Acquisition
Our organization has talent sourcing guidelines requiring diverse
and internal candidate interview slates for Director-level and
above roles. To increase internal mobility, we offer career
development options and utilize our talent review processes to
highlight diverse talent. We educate our hiring managers on
inclusive hiring practices.
Measuring Progress
Our executive leadership team regularly monitors and actions on
diversity metrics, including attraction, engagement, advancement,
and retention of diverse talent. We actively partner with an
external consultancy to identify available talent pools in all our
geographic markets and establish benchmarks for diverse
representation across function, geography and level. All executive
leaders create annual action plans and progress is reviewed
quarterly.
Employee Health & Safety Matters
The health and safety of our employees are of utmost importance to
us. We have a dedicated Employee Health & Safety ("EHS")
program that provides global processes and trainings and monitors
our progress against set goals. Our actions are in line with EHS
frameworks and certifications such as OHSAS 18001 and ISO 45001. We
also have a Corporate Crisis Management Team, prepared to respond
to crisis situations we may be confronted on a global scale with in
a prompt and efficient manner.
Other Factors Affecting the Business
The Company’s business is subject to quarterly fluctuations in
demand due to price changes, marketing and promotional programs,
management of inventory levels by distributors, and implementation
of strategic initiatives which may impact sales levels in any given
period. Demand can also fluctuate based on the timing of dental
tradeshows where promotions are offered, major new product
introductions, and variability in dental patient traffic, which can
be exacerbated by seasonal or severe weather patterns, or other
demographic disruptions such as the recent COVID-19 pandemic. Some
dental practices in certain countries may also delay purchasing
equipment and restocking consumables until year-end due to tax
planning which can impact the timing of our consolidated net sales,
net income and cash flows. Sales for the industry and the Company
are generally strongest in the second and fourth quarters and
weaker in the first and third quarters, due to the effects of the
items noted above and due to the impact of holidays and vacations,
particularly throughout Europe.
Although the backlog on products is generally not material to the
financial statements due in part to the Company's efforts to
maintain short lead times within its manufacturing, levels can
fluctuate and affect sales in certain periods due to supply chain
disruption and unavailability of required inputs.
Securities Exchange Act Reports
The SEC maintains a website that contains reports, proxy and
information statements, and other information regarding issuers,
including the Company, that file electronically with the SEC. The
public can obtain any documents that the Company files with the SEC
at http://www.sec.gov. The Company files annual reports, quarterly
reports, proxy statements and other documents with the SEC under
the Securities Exchange Act of 1934, as amended (“Exchange
Act”).
Dentsply Sirona also makes available free of charge through the
investor section of its website at www.dentsplysirona.com its
annual report on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K and amendments to these reports filed or
furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as
soon as reasonably practicable after such materials are filed with
or furnished to the SEC. The information contained on, or that may
be accessed through, the Company’s website is not incorporated by
reference into, and is not a part of, this report.
Forward-Looking Statements and Associated Risks
All statements in this Form 10-K that do not directly and
exclusively relate to historical facts constitute “forward-looking
statements.” These statements represent current expectations and
beliefs, and no assurance can be given that the results described
in such statements will be achieved. Such statements are subject to
numerous assumptions, risks, uncertainties and other factors that
could cause actual results to differ materially from those
described in such statements, many of which are outside of our
control. No assurance can be given that any expectation, belief,
goal or plan set forth in any forward-looking statement can or will
be achieved, and readers are cautioned not to place undue reliance
on such statements which speak only as of the date they are made.
We do not undertake any obligation to update or release any
revisions to any forward-looking statement or to report any events
or circumstances after the date of this Form 10-K or to reflect the
occurrence of unanticipated events.
You should carefully consider these and other relevant factors,
including those risk factors in Item 1A, “Risk Factors” of this
Form 10-K and any other information included or incorporated by
reference in this report, and information which may be contained in
the Company’s other filings with the SEC, when reviewing any
forward-looking statement. Investors should understand it is
impossible to predict or identify all such factors or risks. As
such, you should not consider either the foregoing lists, or the
risks identified in the Company’s SEC filings, to be a complete
discussion of all potential risks or uncertainties associated with
an investment in the Company.
Item 1A. Risk Factors
Summary
The following is a summary of the significant risk factors that
could materially impact our business, financial condition or future
results, including risks related to our businesses, our
international operations, our regulatory environments, ownership of
our common stock, COVID-19, and other general risks:
•Management
identified material weaknesses in our internal control over
financial reporting that resulted in errors in previously issued
financial statements. If we fail to remediate these material
weaknesses or experiences additional material weaknesses in the
future, we may be unable to accurately and timely report financial
results or comply with the requirements of being a public company,
which could cause the price of our common stock to decline and harm
our business.
•We
restated certain of our previously issued consolidated financial
statements, which resulted in unanticipated costs and may affect
investor confidence and raise reputational issues.
•We
may be subject to litigation and regulatory examinations,
investigations, proceedings or court orders as a result of or
relating to our internal investigation and if any of these items
are resolved adversely against us, it could harm our business,
financial condition and results of operations.
•Our
failure to timely file our periodic reports with the SEC limits our
access to the public markets to raise debt or equity capital, and
restricts our ability to issue equity securities.
•Lack
of global standardized processes, centralization of transaction
management and/or execution could result in control deficiencies
and impact management’s assertions and financial
reporting.
•We
rely heavily on information and technology to operate both our
businesses and our technology dependent product solutions
portfolios, and any continued cyber incidents with respect to our
supporting information and technology infrastructure, whether by
deliberate attacks or unintentional events, could harm our
operations.
•Privacy
concerns and laws, evolving regulation of cross-border data
transfer restrictions and other regulations may adversely affect
our business.
•We
may be unable to develop innovative products and solutions or
stimulate customer demand.
•Our
ongoing business operations may be disrupted for a significant
period of time, resulting in material operating costs and financial
losses.
•We
may be unable to execute key strategic initiatives due to competing
priorities and strategies of our distribution partners and other
factors, which may result in financial losses and operational
inefficiencies.
•The
success of our business depends in part on achieving our strategic
objectives, including through acquisitions, dispositions, and
strategic investments and initiatives.
•We
may fail to realize the expected benefits of our strategic
initiatives, including announced or potential future restructuring
and transformation efforts.
•We
have recognized substantial goodwill and indefinite-lived
intangible asset impairment charges, most recently in Q3 and Q4
2022, and may be required to recognize additional goodwill and
indefinite-lived intangible asset impairment charges in the
future.
•Our
failure to obtain patents and, consequently, to protect our
proprietary technology could have an adverse impact on our
competitive position.
•Our
profitability could suffer if third parties infringe upon our
intellectual property rights or if our products are found to
infringe upon the intellectual property rights of
others.
•Changes
in our credit ratings or macroeconomic impacts on credit markets
may increase our cost of capital and limit financing
options.
•A
breach of the covenants under our debt instruments outstanding from
time to time could result in an event of default under the
applicable agreement.
•We
may not be able to repay our outstanding debt in the event that we
do not generate sufficient cash flow to service our debts and cross
default provisions may be triggered due to a breach of covenants
under our existing indebtedness.
•Our
foreign currency hedging and cash management transactions may be
ineffective or only partially mitigate the impact, exposing us to
unexpected interest rate volatility.
•Due
to the international nature of our business, including increasing
exposure to markets outside of the U.S., political or economic
changes or other factors could harm our business and financial
performance.
•Due
to our international operations, we are exposed to the risk of
changes in foreign exchange rates.
•Changes
in or interpretations of tax rules, operating structures, transfer
pricing regulations, country profitability mix and regulations may
adversely affect our effective tax rate.
•We
may be unable to obtain necessary product approvals and marketing
clearances.
•Inadequate
levels of reimbursement from governmental or other third-party
payers for procedures using our products may cause our revenue to
decline.
•Challenges
may be asserted against our products due to real or perceived
quality, health or environmental issues.
•If
we fail to comply with laws and regulations relating to health care
fraud, we could suffer penalties or be required to make significant
changes to our operations, which could adversely affect our
business.
•Our
business is subject to extensive, complex and changing domestic and
foreign laws, rules, regulations, self-regulatory codes,
directives, circulars and orders that failure to comply with which,
if not complied with, could subject us to civil or criminal
penalties or other liabilities.
•Our
quarterly operating results and market price for our common stock
may continue to be volatile.
•Certain
provisions in our governing documents, and of Delaware law, may
make it more difficult for a third party to acquire
us.
•Our
revenue, results of operations, cash flow, and liquidity may be
materially adversely impacted by the ongoing COVID-19
outbreak.
•Our
business may be adversely affected by changes in global economic
conditions, including inflation, rising interest rates, and supply
chain shortages.
•The
loss of members of our senior management and the resulting
management transition might have an adverse impact on our future
operating results.
•Talent
gaps and failure to manage and retain top talent may impact our
ability to grow the business.
•We
face the inherent risk of litigation and claims.
•Climate
change and related natural disasters could negatively impact our
business and financial results.
•Expectations
relating to environmental, social and governance considerations may
expose us to potential liabilities, increased costs, reputational
harm, and other adverse effects on our business.
Below is a full description of each of such significant risk
factors.
RISKS RELATED TO OUR RESTATEMENT AND INTERNAL CONTROLS
Management identified material weaknesses in our internal control
over financial reporting that resulted in errors in previously
issued financial statements. If we fail to remediate these material
weaknesses or experiences additional material weaknesses in the
future, we may be unable to accurately and timely report financial
results or comply with the requirements of being a public company,
which could cause the price of our common stock to decline and harm
our business.
Management identified material weaknesses in internal controls over
financial reporting in conjunction with the Audit and Finance
Committee’s investigation as described in the Explanatory Note of
Amendment No. 1 to the Annual Report on Form 10-K for the fiscal
year ended December 31, 2021 (the “2021 Form 10-K/A”). The
description of the material weaknesses that were determined to
exist as of December 31, 2021 is included under Item 8 of this Form
10-K. Management began implementing the remediation efforts in
2022; however, as of December 31, 2022, the material weaknesses
previously identified have not yet been remediated.
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting such
that there is a reasonable possibility that a material misstatement
of our annual or interim financial statements will not be prevented
or detected in a timely basis.
While we are devoting substantial resources to the planning and
ongoing implementation of remediation efforts to address the
identified material weaknesses and prevent additional material
weaknesses from occurring, it cannot be assured that the measures
we have taken to date, and are continuing to implement, will be
sufficient to remediate these material weaknesses or to avoid
potential future material weaknesses. We cannot estimate how long
the remediation process will take at this time, and may identify
deficiencies or other material weaknesses, in addition to the ones
already identified, that we may not be able to remediate in a
timely manner. Accordingly, there is a reasonable possibility that
the material weaknesses identified, or other material weaknesses or
deficiencies identified in the future, could result in a
misstatement of accounts or disclosures that would result in a
material misstatement of our financial statements that would not be
prevented or detected on a timely basis or cause us to fail to meet
our obligations under securities laws, stock exchange listing
rules, or debt instrument covenants to file periodic financial
reports on a timely basis.
Further, because of its inherent limitations, including the
possibility of human error, the circumvention or overriding of
controls, or fraud, even our remediated and effective internal
control over financial reporting may not prevent or detect all
misstatements and may not provide reasonable assurances with
respect to the preparation and presentation of financial
statements. In addition, projections of any evaluation of
effectiveness of internal control over financial reporting to
future periods are subject to the risk that the control may become
either obsolete or inadequate as a result of changes in conditions,
or that the degree of compliance with the policies or procedures
may deteriorate.
Any of these failures could result in adverse consequences that
could materially and adversely affect our business, including an
adverse impact on the market price of our common stock, potential
action by the SEC, shareholder lawsuits, delisting of our stock,
and general damage to our reputation. We have incurred and expect
to incur additional costs to rectify the material weaknesses or new
issues that may emerge, and the existence of these issues could
adversely affect our reputation or investor perceptions. We
maintain director and officer liability insurance, for which we
must pay substantial premiums. The additional reporting and other
obligations resulting from these material weaknesses, including any
litigation or regulatory inquiries that may result therefrom,
increase legal and financial compliance costs and the costs of
related legal, accounting and administrative
activities.
We restated previously issued consolidated financial statements,
which resulted in unanticipated costs and may affect investor
confidence and raise reputational issues.
As disclosed in Note 1, Significant Accounting Policies and
Restatement of the 2021 Form 10-K/A, we restated our consolidated
financial statements and related disclosures for the three and nine
months ended September 30, 2021 and for the year ended December 31,
2021 following the identification of certain misstatements
contained in those financial statements, which resulted in an
overstatement of Net sales for the fiscal year ended December 31,
2021 by approximately $20 million. We determined that it was
appropriate to correct the misstatements in our previously issued
financial statements by amending and restating the Annual Report on
Form 10-K for the fiscal year ended December 31, 2021, originally
filed with the SEC on March 1, 2022. The restatement also included
corrections for additional identified out-of-period and uncorrected
misstatements in the impacted periods. As a result, we incurred
unanticipated costs for accounting and legal fees in connection
with or related to the restatement, and became subject to a number
of additional risks and uncertainties, which may affect investor
confidence in the accuracy of our financial disclosures and may
raise reputational issues for our business.
We may be subject to litigation and regulatory examinations,
investigations, proceedings or court orders as a result of or
relating to our internal investigation and if any of these items
are resolved adversely against us, it could harm our business,
financial condition and results of operations.
As previously disclosed, we voluntarily contacted the SEC to advise
that the Audit and Finance Committee was conducting an independent
investigation regarding certain financial reporting matters, and we
are continuing to cooperate with the SEC. The SEC's investigation
is ongoing and was not resolved when the Audit and Finance
Committee completed the internal investigation or when the 2021
Form 10-K/A was filed. We intend to fully cooperate with the SEC
regarding this matter. Additionally, several securities class
action lawsuits were filed against us following our announcement on
May 10, 2022 of the Audit and Finance Committee's internal
investigation. Our reported material weaknesses in internal control
over financial reporting subjects us to additional litigation and
regulatory examinations, investigations, proceedings or court
orders, including additional cease and desist orders, the
suspension of trading of our securities, delisting of our
securities, the assessment of civil monetary penalties and other
equitable remedies. Our management has devoted and may be required
to devote significant time and attention to these matters. If any
of these matters are resolved adversely against us, it could harm
our reputation, business, financial condition and results of
operations. Additionally, while we cannot estimate our potential
exposure to these matters at this time, we have already expended a
significant amount of time and resources investigating the claims
underlying and defending these matters and expect to continue to
need to expend our resources to conclude these matters.
Accordingly, the ongoing SEC investigation and any potential
related litigation could result in distraction to management and
entail risks and uncertainties, the outcome of which could
adversely affect our results of operations and our reputation. For
further information, see Note 22, Commitments and Contingencies,
discussing the securities class action lawsuits, in the Notes to
Consolidated Financial Statements in Item 8 of this Form
10-K.
Our failure to timely file our periodic reports with the SEC limits
our access to the public markets to raise debt or equity capital,
and restricts our ability to issue equity securities.
We did not timely file our Quarterly Reports on Form 10-Q for the
fiscal quarters ended March 31, 2022 and June 30, 2022 within each
respective timeframe required by the SEC. This limits our ability
to access the public markets to raise debt or equity capital, which
could prevent us from pursuing transactions or implementing
business strategies that we might otherwise believe are beneficial
to our business. We are not currently eligible to use a
registration statement on Form S-3 that allows us to continuously
incorporate by reference our SEC reports into the registration
statement, or to use “shelf” registration statements to conduct
offerings, until approximately one year from the date we regained
status as a current filer. If we wish to pursue a public offering
now, we would be required to file a registration statement on Form
S-1 and have it reviewed and declared effective by the SEC. Doing
so would take significantly longer than using a registration
statement on Form S-3 and would increase our transaction costs, and
the necessity of using a Form S-1 for a public offering of
registered securities could, to the extent we are not able to
conduct offerings using alternative methods, adversely impact our
ability to raise capital or complete acquisitions of other
companies in a timely manner.
Lack of global standardized processes, centralization of
transaction management and/or execution could result in control
deficiencies and impact management’s assertions and financial
reporting.
Our implementation of our business plans, restructuring plans and
compliance with regulations requires that we effectively manage our
financial infrastructure, including standardizing processes,
maintaining proper financial reporting and internal controls. We
continue to focus on standardizing our processes, improving our
financial systems, maintaining effective internal controls and
centralizing transaction management and/or execution so as to
provide continued assurance with respect to our financial reports,
support the continued growth of the business, and prevent financial
misstatement or fraud. Non-standardized processes and ineffective
controls could result in an inability to aggregate and analyze data
in a timely and accurate manner and may lead to inaccurate or
incomplete financial and management reporting and delays in
financial reporting to management, regulators and/or shareholders.
Inaccurate or incomplete financial reporting and disclosures could
also result in noncompliance with applicable business and
regulatory requirements and the incurring of related penalties. For
further information in connection with the risks of inaccurate or
incomplete financial reporting and disclosures, see Item 1A. Risk
Factors — Risks Related to Our Restatement and Internal Controls
—“Management identified material weaknesses in our internal control
over financial reporting that resulted in errors in financial
statements. If we fail to remediate these material weaknesses or
experiences additional material weaknesses in the future, we may be
unable to accurately and timely report financial results or comply
with the requirements of being a public company, which could cause
the price of our common stock to decline and harm our
business.”
Further, we currently have disparate systems, including enterprise
resource planning systems, across the organization which may result
in the potential inability to obtain and analyze business data and
increases in budgets due to higher costs stemming from system
upgrades, and may pose business partner connection challenges. As a
result, the data required to manage the business may not be
complete, accurate or consistent, resulting in the potential for
misleading or inaccurate reporting for key business decisions.
Management’s planned efforts to implement a more centralized
enterprise resource planning system across the organization in part
to alleviate these risks will result in additional costs in future
periods, and any cost overrun or any disruptions, delays or
complications in the course of making this transition could
compound those costs, distract from operation of our core business,
or result in failures to produce financial information accurately
and timely.
RISKS RELATED TO OUR BUSINESSES
We rely heavily on information and technology to operate both our
businesses and our technology dependent product solutions
portfolios, and any continued cyber incidents with respect to our
supporting information and technology infrastructure, whether by
deliberate attacks or unintentional events, could harm our
operations.
We are exposed to the risk of cyber incidents, which can result
from deliberate attacks or unintentional events, in the normal
course of business. We use web-enabled and other integrated
information and technology systems in delivering our products and
services and expect that the breadth and complexity of our
information and technology systems will increase as we expand our
product offerings to utilize artificial intelligence and analytics.
As a result, we will increasingly be exposed to risks inherent in
the development, integration and operation of our evolving
information and technology supporting our product platforms, as
well as our own internal infrastructure, including:
• security breaches, viruses, cyberattacks,
ransomware or other malware or other failures or
malfunctions;
• disruption, impairment or failure of data
centers or hardware, telecommunications facilities or other
infrastructure platforms;
• failures during the process of upgrading
or replacing software, databases or components contained in the
information and technology infrastructure;
• the compromise or unauthorized disclosure
of sensitive or proprietary information related to our business and
customers;
• excessive costs, excessive delays or other
deficiencies in systems development and deployment;
and
• an unintentional event that involves a
third-party gaining unauthorized access to our systems or
proprietary information.
Any disruptions to or deterioration of our service providers’
information and technology infrastructures could pose a threat to
our operations and harm our business.
We continue to observe an increase in levels of cyber threats
focused on gaining unauthorized access to our information and
technology infrastructure for purposes of misappropriating assets
or sensitive information, corrupting data, or causing operational
disruption. Although we take measures designed to protect such
information from unauthorized access, use or disclosure, our and
our service providers’ infrastructures and storage applications may
be impaired due to unauthorized access by hackers, ransomware,
phishing attacks, human error, malfeasance, natural disasters,
telecommunications and electrical failures and other disruptions.
Cyber threats are rapidly evolving and are becoming increasingly
sophisticated, with an increase in cyber incidents that appear to
be associated with the Ukraine-Russia military conflict. Like other
large, global companies, during the normal course of business, we
have experienced and expect to continue to experience cyber
threats, attacks and other attempts to compromise our information
system, although none, to our knowledge, has had a material adverse
effect on our business, financial condition or results of
operations to date. Anyone who circumvents our security measures
could misappropriate proprietary information, including information
regarding us, our employees, our service providers and/or our
clients, or cause interruptions in our operations. We cannot
provide assurances that, although past cybersecurity incidents have
not had a material effect on our business or operations to date and
despite our efforts to ensure the integrity of our systems and the
measures that we or our service providers take to anticipate,
detect, avoid or mitigate such threats, a future cyber-attack would
not result in material harm to us or our business and results of
operations. For example, certain techniques used to obtain
unauthorized access, introduce malicious software, disable or
degrade service, or sabotage systems may be designed to remain
dormant until a triggering event and we may be unable to anticipate
these techniques or implement adequate preventive measures since
techniques change frequently or are not recognized until launched,
and because cyber attacks can originate from a wide variety of
sources. These data breaches and any unauthorized access or
disclosure of our information could compromise intellectual
property and expose sensitive business information. Our policies,
employee training (including phishing prevention training),
procedures and technical safeguards may be insufficient to prevent
or detect improper access to confidential, proprietary or sensitive
data, including personal data. Cyber attacks could also cause us to
incur significant remediation costs, disrupt key business
operations and divert attention of management and key information
technology resources.
We also face the ongoing challenge of managing access controls to
our information and technology infrastructure. We have experienced
various types of cyber incidents in the past and as the result of
such incidents, we have implemented new controls, governance,
technical protections and other procedures. If we do not
successfully manage these access controls, it could expose us to
risk of security breaches or disruptions. Any such security
breaches or disruptions could compromise the security or integrity
of our networks or result in the loss, misappropriation, and/or
unauthorized access, use, modification or disclosure of, or the
prevention of access to, sensitive data or confidential information
(including trade secrets or other intellectual property,
proprietary business information, and personal information). If our
information systems are breached again, sensitive and proprietary
data is compromised, surreptitiously modified, rendered
inaccessible for any period of time or made public, or if we fail
to make adequate or timely disclosures to affected individuals,
appropriate state and federal regulatory authorities or law
enforcement agencies, it could result in significant fines,
penalties, court orders, sanctions and proceedings or actions
against us by governmental or other regulatory authorities,
customers or third parties. We may incur substantial costs and
suffer other negative consequences such as liability, reputational
harm and significant remediation costs and experience material harm
to our business and financial results if we experience cyber
incidents in the future.
The materialization of any of these risks may impede the
utilization of Company product offerings, the processing of data
and the day-to-day management of our business and could result in
the corruption, loss or unauthorized disclosure of proprietary,
confidential or other data. Disaster recovery plans, where in
place, might not adequately protect us in the event of a system
failure. Further, we currently do not have excess or standby
computer processing or network capacity everywhere in the world to
avoid disruption in the receipt, processing and delivery of data in
the event of a system failure. Despite any precautions we take,
damage from fire, floods, hurricanes, power loss,
telecommunications failures, computer viruses, break-ins, human
error and similar events at our various computer facilities could
result in interruptions in the flow of data to our
servers.
Additionally, we seek to maintain insurance coverage for risks
associated with cybersecurity, but such insurance has become
increasingly difficult to secure and, in some cases, policies may
not provide adequate coverage for possible losses. Further, as
cybersecurity risks evolve, such insurance may not be available to
us on commercially reasonable terms or at all. Uninsured losses or
operational losses that result from large deductible payments under
commercial insurance coverage might have an adverse impact on our
business operations and our financial position or results of
operations.
The legislative and regulatory framework for privacy and data
protection issues worldwide continues to evolve. We collect
personally identifiable information ("PII") and other data as part
of our business processes and activities. This data is subject to a
variety of U.S. and foreign laws and regulations, including
oversight by various regulatory or other governmental bodies. Many
foreign countries and governmental bodies have laws and regulations
concerning the collection and use of PII and other data obtained
from their residents or by businesses operating within their
jurisdictions. The EU General Data Protection Regulation ("GDPR"),
for example, imposes stringent data protection requirements and
provides significant penalties for noncompliance. Any inability, or
perceived inability, to adequately address privacy and data
protection concerns, even if unfounded, or comply with applicable
laws, regulations, policies, industry standards, contractual
obligations, or other legal obligations (including at newly
acquired companies) could result in additional cost and liability
to us or our officials, damage our reputation, inhibit sales, and
otherwise adversely affect our business.
Any of the foregoing incidents could also subject us to liability,
expose us to significant expense, or cause significant harm to our
reputation, all of which could result in lost revenue. While we
have invested and continue to invest in information technology risk
management and disaster recovery plans, these measures cannot fully
insulate us from cyber incidents, technology disruptions or data
loss and the resulting adverse effect on our operations and
financial results.
Privacy concerns and laws, evolving regulation of cross-border data
transfer restrictions and other regulations may adversely affect
our business.
Global regulation related to the provision of services on the
Internet is increasing, as federal, state and foreign governments
continue to adopt new laws and regulations addressing data privacy
and the collection, processing, storage and use of personal
information. Such laws and regulations are subject to new and
differing interpretations and may be inconsistent among
jurisdictions. These and other requirements could reduce demand for
our services or restrict our ability to store and process data or,
in some cases, impact our ability to offer future digital dentistry
services in certain locations or our ability to deploy our
solutions globally. The costs of compliance with and other burdens
imposed by these types of laws, regulations and standards may limit
the use and adoption of our services, reduce overall demand for our
services, lead to significant fines, penalties or liabilities for
noncompliance, any of which could harm our business.
The importance of privacy laws, rules and regulations specifically
for the healthcare and med-tech industry is constantly growing, as
personal data has become an integral part of doing business in our
sector, and the legal standards are evolving and becoming more
complex worldwide. For instance, the GDPR, applicable as of 2018
and still one of the strictest and most comprehensive privacy laws
in the world, is being continuously enforced, and increasingly
heavy fines are now being levied on businesses. Fines for
noncompliance with the GDPR can amount to up to €20 million or 4%
of the total worldwide annual turnover from the preceding financial
year (whichever is higher) and may be imposed in conjunction with
the exercise of the authority's investigatory and corrective
powers. The GDPR's extraterritorial scope makes it applicable to
our U.S. based legal entities whenever our business activities,
systems and products process the personal data of EU residents.
Additionally, privacy laws, rules and regulations are also rapidly
developing in other regions, including China, Brazil, South Korea,
and is expanding through the U.S., state by state (e.g.,
California, Virginia, Colorado, Connecticut, and Utah), in parallel
with federal privacy laws protecting sensitive health information.
These varying laws, rules, regulations and industry standards
impact our businesses to the extent we rely on the use of personal
data and create significant compliance challenges while maintaining
our global reach. In addition, certain privacy and data protection
laws may apply to us indirectly through our customers,
manufacturers, suppliers or other third-party partners. For
example, non-compliance with applicable laws or regulations a
third-party partner that is processing personal data on our behalf
may be deemed non-compliance by us or a failure by us to conduct
proper due diligence on the third party. We also could be subject
to additional expenses and liabilities in the event of an
information security incident, including a cybersecurity breach, or
the failure of an information technology system owned or operated
by us or a third party with which we partner or its
vendor.
We may be unable to develop innovative products and solutions or
stimulate customer demand.
The worldwide markets for dental and medical products is highly
competitive and is driven by rapid and significant technological
change, change in consumer preferences, new intellectual property
associated with that technological change, evolving industry
standards, and new product introductions. Additionally, some
markets for products are also subject to significant negative price
pressures. Our patent portfolio continues to change with patents
expiring through the normal course of their life. There can be no
assurance that our products will not lose their competitive
advantage or become noncompetitive or obsolete as a result of such
factors, or that we will be able to generate any economic return on
our investment in product development. If product demand decreases,
or if our newly introduced products are not accepted by our
customers, our revenue and profit could be negatively impacted.
Important factors that could cause demand for our products to
decrease include changes in:
•business
conditions, including downturns in the dental industry, regional
economies, and the overall economy;
•the
level of customers’ inventories;
•competitive
and pricing pressures, including actions taken by competitors;
and
•customer
product needs and customer/patient lifecycle.
If we fail to further develop our innovation efforts or if our
R&D does not effectively respond to changes in consumer
preferences or market competition leading to technology or product
obsolescence, we may lose market share and revenue. Additionally,
if our products or technologies lose their competitive advantage or
become noncompetitive or obsolete, our business could be negatively
affected. We have identified new products as an important part of
our growth opportunities. There is no assurance that entirely new
technology or approaches to dental treatment or competitors’ new
products will not be introduced that could render our products
obsolete. Additionally, the rapid pace of technological
advancements may accelerate the need to amortize or impair
investments in our software technology faster than we anticipated,
which could negatively impact our results.
Our ongoing business operations may be disrupted for a significant
period of time, resulting in material operating costs and financial
losses.
We operate in more than 150 countries and our and our suppliers’
manufacturing facilities are located in multiple locations around
the world. Potential events such as extreme weather, natural
disasters, worker strikes and social and political actions, such as
trade wars, or other events beyond our control, could impact our
ongoing business operations, including potential critical
third-party vendor disruptions or failure to adhere to contractual
obligations affecting our supply chain and manufacturing needs or
the loss of critical information technology and telecommunications
systems. Although we maintain multiple manufacturing facilities, a
large number of the products manufactured by us are manufactured in
facilities that are the sole source of such products. As there are
a limited number of alternative suppliers for these products, any
disruption at a particular Company manufacturing facility could
lead to delays, increased expenses, and may damage our business and
results of operations. If our incident response, disaster recovery
and business continuity plans do not resolve these issues in an
effective and timely manner, such events could result in an
interruption in our operations and could cause material negative
impacts to our product availability and sales, the efficiency of
our operations and our financial results.
Additionally, a significant portion of our injectable anesthetic
products, orthodontic products, certain dental cutting instruments,
catheters, nickel titanium products and certain other products and
raw materials are purchased from a limited number of suppliers and
in certain cases single source suppliers pursuant to agreements
that are subject to periodic renewal, some of which may also
compete with us. As there are a limited number of suppliers for
these products, there can be no assurance that we will be able to
obtain an adequate supply of these products and raw materials in
the future. Any delays in delivery of or shortages in these
products could interrupt and delay manufacturing of our products
and result in the cancellation of orders for these products. In
addition, these suppliers could discontinue the manufacture or
supply of these products to us at any time or supply products to
competitors. We may not be able to identify and integrate
alternative sources of supply in a timely fashion or at all. Any
transition to alternate suppliers may result in delays in shipment
and increased expenses and may limit our ability to deliver
products to customers.
We may be unable to execute key strategic initiatives due to
competing priorities and strategies of our distribution partners
and other factors, which may result in financial losses and
operational inefficiencies.
We continue to generate a substantial portion of our revenue
through a limited number of distributors that provide important
sales, distribution and service support to the end-user customers.
Together, our two largest distributors, Patterson and Henry Schein,
accounted for approximately 17% of our annual revenue for the year
ended December 31, 2022, and it is anticipated that they will
continue to be the largest distribution contributors to our revenue
through 2023. We may be unable to execute our key strategic
activities and investments due to the competing priorities of our
distribution partners which may introduce competing private label,
generic, or low-cost products that compete with our products at
lower price points, particularly in the Technologies &
Equipment segment products that are sold and serviced through
distributor channels. If these competing products capture
significant market share or result in a decrease in market prices
overall, this could have a negative impact on our results of
operations and financial condition.
Additionally, some parts of the dental market continue to be
impacted by price competition that is driven in part by the
consolidation of dental practices, innovation and product
advancements, and the price sensitivity of end-user customers.
There can be no assurance that our distribution partners will
purchase any specified minimum quantity of products from us or that
they will continue to purchase any products at all. If Patterson or
Henry Schein ceases to purchase a significant volume of products
from us, or if changes in our promotional strategies and
investments result in changes in our distributor relationships or
short-term uneven growth, it could have a material adverse effect
on our results of operations and financial condition.
We rely in part on our dealer and customer relationships and
predictions of dealer and customer inventory levels in projecting
future demand levels and financial results. These inventory levels
may fluctuate, and may differ from our predictions, resulting in
our projections of future results being different than expected.
These changes may be influenced by changing relationships with the
dealers and customers, economic conditions and customer preference
for particular products. There can be no assurance that dealers and
customers will maintain levels of inventory in accordance with our
predictions or past history, or that the timing of customers’
inventory build-up or liquidation will be in accordance with our
predictions or past history. Additionally, we periodically upgrade
or replace our various software systems, including our customer
relationship management systems. If we encounter unforeseen
problems with new systems or in migrating away from our existing
applications and systems, our operations and our ability to manage
our business could be negatively impacted.
The success of our business depends in part on achieving our
strategic objectives, including through acquisitions, dispositions,
and strategic investments and initiatives.
We utilize and intend to continue utilizing acquisitions and
dispositions of assets and businesses, and strategic investments as
part of our strategy. We may not achieve expected returns and
benefits in connection with this strategy as a result of various
factors, including integration and collaboration challenges, such
as personnel and technology. In addition, we may not achieve the
full revenue growth expectations and cost synergies anticipated to
result from related integration activities.
Further, acquisitions, dispositions and strategic investments may
distract our management’s time and attention and disrupt our
ongoing business operations or relationships with customers,
employees, suppliers or other parties. We continue to evaluate the
potential disposition of assets and businesses that may no longer
help us achieve our strategic objectives, and to view acquisitions
as a key part of our growth strategy.
After reaching an agreement with a seller for the acquisition or
buyer for the disposition of assets or a business, the transaction
may remain subject to necessary regulatory and governmental
approvals on acceptable terms as well as the satisfaction of
pre-closing conditions, which may prevent us from completing the
transaction in a timely manner, or at all. From a workforce
perspective, risks associated with acquisitions and dispositions
include, among others, delays in anticipated workforce reductions,
additional unexpected costs, changes in restructuring plans that
increase or decrease the number of employees affected, negative
impacts on our relationship with labor unions, adverse effects on
employee morale, and the failure to meet operational targets due to
the loss of employees, any of which may impair our ability to
achieve anticipated cost reductions or may otherwise harm our
business, and could have a material adverse effect on our
competitive position, results of operations, cash flows or
financial condition.
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 a business at a price or on terms
that are less than we had anticipated, or with the exclusion of
select assets. Dispositions may also involve continued financial
involvement in a divested business, such as through continuing
equity ownership, transition service agreements, guarantees,
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.
Additionally, if we make acquisitions, it may incur debt, assume
contingent liabilities and/or additional risks, or create
additional expenses, any of which might adversely affect our
financial results. Any financing that we might need for
acquisitions may only be available on terms that restrict our
business or that impose additional costs that reduce our operating
results.
We may fail to realize the expected benefits of our strategic
initiatives, including announced or potential future restructuring
and transformation efforts.
In order to operate more efficiently and control costs, we recently
announced our plans to make organizational restructuring changes in
order to simplify structure, enhance profitability, improve
operational performance and drive growth. These plans include
implementation of a new operating model with five global business
units designed to drive enterprise integration and align the
product portfolio with our growth strategy, commencement of our
central functions and infrastructure optimization to support
efficiency of the overall organization, creation of a Senior Vice
President of Quality and Regulatory role, designed to elevate the
quality and regulatory affairs function within the management team,
simplification of the management structure to bring the Company
in-line with the industry best practices, and other initiatives
aimed at delivering cost savings to fund critical investments in
2023 and to position the Company for sustainable future growth. The
failure to efficiently execute such initiatives as part of our
business strategy could minimize the expected benefits to the
organization resulting in potential impacts to ongoing operations
and cost overruns.
Additionally, our ability to achieve the benefits from these
initiatives within the expected time frame is subject to many
estimates and assumptions and other factors that we may not be able
to control. We may also incur significant charges related to
restructuring plans, which would reduce our profitability in the
periods such charges are incurred.
Due to the complexities inherent in implementing these types of
cost reduction and restructuring activities, and the quarterly
phasing of related investments, we may fail to realize expected
efficiencies and benefits, such as the goals for net sales growth,
or may experience a delay in realizing such efficiencies and
benefits, and our operations and business could be disrupted.
Company management may be required to divert their focus to
managing these disruptions, and implementation may require the
agreement of third parties, such as labor unions or works councils.
Risks associated with these actions and other workforce management
issues include delays in implementation of anticipated workforce
reductions, additional unexpected costs, changes in restructuring
plans that increase or decrease the number of employees affected,
negative impact on our relationship with labor unions or works
councils, adverse effects on employee morale, and the failure to
meet operational targets due to the loss of employees, any of which
may impair our ability to achieve anticipated cost reductions or
may otherwise harm our business, and could have a material adverse
effect on our sales growth and other results of operations, cash
flows or financial condition, or competitive position.
We have recognized substantial goodwill and indefinite-lived
intangible asset impairment charges, most recently in Q3 and Q4
2022, and may be required to recognize additional goodwill and
indefinite-lived intangible asset impairment charges in the
future.
We review amortizable intangible assets for impairment when events
or changes in circumstances indicate the carrying value may not be
recoverable. We test goodwill and indefinite-lived intangibles for
impairment at least annually. The valuation models used to
determine the fair value of goodwill or indefinite-lived intangible
assets are dependent upon various assumptions and reflect
management's best estimates. We have acquired other companies and
intangible assets and may not realize all the economic benefit from
those acquisitions, which could cause an impairment of goodwill or
intangibles.
In preparing the financial statements for the quarter ended
September 30, 2022, we identified a triggering event and recorded a
$1,187 million non-cash goodwill impairment charge associated with
two reporting units within the Technologies & Equipment
segment.
At December 31, 2022, the remaining goodwill related to the Digital
Dental Group and Equipment & Instruments reporting units was
$235 million and $193 million, respectively. As the fair
value of these reporting units approximate carrying value as of
December 31, 2022, any further decline in key assumptions could
result in additional impairment in future periods.
In addition, we tested the indefinite-lived intangible assets
related to these businesses, along with certain indefinite-lived
intangibles related to the Consumables segment, and determined that
certain tradenames and trademarks were impaired, resulting in the
recording of an impairment charge of $94 million for the three
months ended September 30, 2022.
During the quarter ended December 31, 2022, we identified a
triggering event due to reductions of near-term forecasts for
specific tradenames and continued adverse macroeconomic factors,
including the impact of foreign exchange rates, resulting in the
recording of an impairment charge of $6 million for the three
months ended December 31, 2022.
As the fair value of these indefinite-lived intangible assets
impaired in the third and fourth quarters approximate carrying
value as of December 31, 2022, any further decline in key
assumptions could result in additional impairment in future
periods. At December 31, 2022, we have $455 million in
indefinite-lived intangible assets and $2.7 billion of goodwill
recorded on our balance sheet.
The goodwill and indefinite-lived intangible asset impairment
analyses are sensitive to changes in key assumptions used, such as
discount rates, revenue growth rates, perpetual revenue growth
rates, royalty rates, and operating margin percentages of the
business as well as current market conditions affecting the dental
and medical device industries in both the U.S. and globally. Given
the uncertainty in the marketplace and other factors affecting
management’s assumptions underlying our discounted cash flow model,
the assumptions and projections used in the analyses may not be
realized and our current estimates could vary significantly in the
future, which may result in an additional goodwill or
indefinite-lived intangible asset impairment charge at that
time.
Our failure to obtain patents and, consequently, to protect our
proprietary technology could have an adverse impact on our
competitive position.
Our success will depend in part on our ability to obtain and
enforce claims in our patents directed to our products,
technologies and processes, both in the U.S. and in other
countries. Risks and uncertainties that we face with respect to our
patents and patent applications include the following:
•the
pending patent applications that we have filed, or to which we have
exclusive rights, may not result in issued patents or may take
longer than we expect to result in issued patents;
•the
allowed claims of any patents that are issued may not provide
meaningful protection;
•we
may be unable to develop additional proprietary technologies that
are patentable;
•the
patents licensed or issued to us may not provide a competitive
advantage;
•other
companies may challenge patents licensed or issued to
us;
•disputes
may arise regarding inventions and corresponding ownership rights
in inventions and know-how resulting from the joint creation or use
of intellectual property by us and our respective licensors;
and
•other
companies may design around the technologies patented by
us.
Our profitability could suffer if third parties infringe upon our
intellectual property rights or if our products are found to
infringe upon the intellectual property rights of
others.
Our profitability could suffer if third parties infringe upon our
intellectual property rights or misappropriate our technologies and
trademarks for their own businesses. To protect our rights to our
intellectual property, we rely on a combination of patent and
trademark law, trade secret protection, confidentiality agreements
and contractual arrangements with our employees, strategic partners
and others. We cannot assure you that any of our patents, any of
the patents of which we are a licensee or any patents which may be
issued to us or which we may license in the future, will provide us
with a competitive advantage or afford us protection against
infringement by others, or that the patents will not be
successfully challenged or circumvented by third parties, including
our competitors. The protective steps that we have taken may be
inadequate to deter misappropriation of our proprietary
information. We may be unable to detect or protect against the
unauthorized use or misappropriation of, or take appropriate steps
to enforce, our intellectual property rights. Effective patent,
trademark and trade secret protection may not be available in every
country in which we will offer, or intend to offer, our products.
Any failure to adequately protect our intellectual property could
devalue our proprietary content and impair our ability to compete
effectively. Further, defending our intellectual property rights
could result in the expenditure of significant financial and
managerial resources.
Litigation may also be necessary to enforce our intellectual
property rights or to defend against any claims of infringement of
rights owned by third parties that are asserted against us. In
addition, we may have to participate in one or more interference
proceedings declared by the U.S. Patent and Trademark Office, the
European Patent Office or other foreign patent governing
authorities, to determine the priority of inventions, which could
result in substantial costs. Acquisitions by us of products or
businesses that are found to infringe upon the intellectual
property rights of others and the resulting changes to the
competitive landscape of the industry could further increase this
risk.
If we become involved in litigation or interference proceedings, we
may incur substantial expense, and the proceedings may divert the
attention of our technical and management personnel, even if we
ultimately prevail. An adverse determination in proceedings of this
type could subject us to significant liabilities, allow our
competitors to market competitive products without obtaining a
license from us, prohibit us from marketing our products or require
us to seek licenses from third parties that may not be available on
commercially reasonable terms, if at all. If we cannot obtain such
licenses, we may be restricted or prevented from commercializing
our products.
The enforcement, defense and prosecution of intellectual property
rights, including the U.S. Patent and Trademark Office’s, the
European Patent Office’s and other foreign patent offices’
interference proceedings, and related legal and administrative
proceedings in the U.S. and elsewhere, involve complex legal and
factual questions. As a result, these proceedings are costly and
time-consuming, and their outcome is uncertain. Litigation may be
necessary to:
• assert against others or defend us against
claims of patent or trademark infringement;
• enforce patents owned by, or licensed to
us from, another party;
• protect our trade secrets or know-how;
or
• determine the enforceability, scope and
validity of our proprietary rights or the proprietary rights of
others.
Changes in our credit ratings or macroeconomic impacts on credit
markets may increase our cost of capital and limit financing
options.
We utilize the short and long-term debt markets to obtain capital
from time to time. Our continued access to sources of liquidity
depends on multiple factors, including global economic conditions,
the condition of global credit markets, the availability of
sufficient amounts of financing, operating performance, and credit
ratings. Macroeconomic conditions, such as the COVID-19 pandemic,
may result in significant disruption in the credit markets, which
may adversely affect our ability to refinance existing debt or
obtain additional financing to support operations or to fund new
acquisitions or capital-intensive internal
initiatives.
Any adverse changes in our credit ratings may result in increased
borrowing costs for future long-term debt or short-term borrowing
facilities which may in turn limit financing options, including
access to the unsecured borrowing market. There is no guarantee
that additional debt financing will be available in the future to
fund obligations, or that it will be available on commercially
reasonable terms, in which case we may need to seek other sources
of funding. In addition, the terms of future debt agreements could
include additional restrictive covenants that would reduce
flexibility.
A breach of the covenants under our debt instruments outstanding
from time to time could result in an event of default under the
applicable agreement.
We have debt securities outstanding of approximately $1.8 billion.
We also have the ability to incur up to $700 million of
indebtedness under the revolving credit facility (“2018 Credit
Facility”), as discussed below, and may incur significantly more
indebtedness in the future.
Our current debt agreements contain a number of covenants and
financial ratios, which we are required to satisfy. Under the Note
Purchase Agreement dated December 11, 2015, we are required to
maintain ratios of debt outstanding to total capital not to exceed
the ratio of 0.6 to 1.0, and operating income excluding
depreciation and amortization to interest expense of not less than
3.0 times, in each case, as such terms are defined in the Note
Purchase Agreement. Many of our subsequent private outstanding debt
agreements have been amended to reflect these covenants. We may
need to reduce the amount of our indebtedness outstanding from time
to time in order to comply with such ratios, though no assurance
can be given that we will be able to do so. Our failure to maintain
such ratios or a breach of the other covenants under our debt
agreements outstanding from time to time could result in an event
of default under the applicable agreement. Such a default may allow
the creditors to accelerate the related indebtedness and may result
in the acceleration of any other indebtedness.
Any future violations of the covenants under our debt agreements
may hurt our reputation and credibility with our stockholders and
our debt holders and may compromise our future ability to finance
our operations through the public equity or debt
markets.
Breach of covenants could have additional negative consequences
including, but not limited to the following:
•making
it more difficult for us to satisfy our obligations with respect to
our indebtedness;
•requiring
us to dedicate significant cash flow from operations to the payment
of principal and interest on our indebtedness, which would reduce
the funds we have available for other purposes, including working
capital, capital expenditures, R&D and acquisitions;
and
•reducing
our flexibility in planning for or reacting to changes in our
business and market conditions.
Even absent a breach of covenants, there is no guarantee that we
will be able to renew or replace our existing debt agreements as
they become due, including the 2018 Credit Facility maturing in
2024, which would harm our overall liquidity.
We may not be able to repay our outstanding debt in the event that
we do not generate sufficient cash flow to service our debts and
cross default provisions may be triggered due to a breach of
covenants under our existing indebtedness.
Our ability to make payments on our indebtedness and contractual
obligations, and to fund our operations depends on our future
performance and financial results, which, to a certain extent, are
subject to general economic, financial, competitive, regulatory and
other factors and the interest rate environment that are beyond our
control. Although management believes that we have and will
continue to have sufficient liquidity, there can be no assurance
that our business will generate sufficient cash flow from
operations in the future to service our debt, pay our contractual
obligations and operate our business.
Our foreign currency hedging and cash management transactions may
be ineffective or only partially mitigate the impact of exchange
rate fluctuations, exposing us to unexpected interest rate
volatility.
As part of our risk management program, we use foreign currency
exchange forward contracts. While intended to reduce the effects of
exchange rate fluctuations, these transactions may limit our
potential gains or expose us to loss. Should our counterparties to
such transactions or the sponsors of the exchanges through which
these transactions are offered fail to honor their obligations due
to financial distress or otherwise, we would be exposed to
potential losses or the inability to recover anticipated gains from
these transactions.
We enter into foreign currency exchange forward contracts as
economic hedges of trade commitments or anticipated commitments
denominated in currencies other than the functional currency to
mitigate the effects of changes in currency rates. Although we do
not enter into these instruments for trading purposes or
speculation, and although our management believes all of these
instruments are economically effective for accounting purposes as
hedges of underlying physical transactions, these foreign exchange
commitments are dependent on timely performance by our
counterparties. Their failure to perform could result in us having
to close these hedges without the anticipated underlying
transaction and could result in losses if foreign currency exchange
rates have changed.
We enter into interest rate swap agreements from time to time to
manage some of our exposure to interest rate volatility. These swap
agreements involve risks, such as the risk that counterparties may
fail to honor their obligations under these arrangements. In
addition, these arrangements may not be effective in reducing our
exposure to changes in interest rates. If such events occur, our
results of operations may be adversely affected.
Most of our cash deposited with banks is not insured and would be
subject to the risk of bank failure. Our total liquidity also
depends in part on the availability of funds under our 2018 Credit
Facility. The failure of any bank in which we deposit our funds or
that is part of our 2018 Credit Facility could reduce the amount of
cash we have available for operations and additional investments in
our business.
RISKS RELATED TO OUR INTERNATIONAL OPERATIONS
Due to the international nature of our business, including
increasing exposure to markets outside of the U.S., political or
economic changes or other factors could harm our business and
financial performance.
Approximately two-thirds of our sales are located in regions
outside the U.S. In addition, we anticipate that sales outside of
the U.S. will continue to expand and account for a significant
portion of our revenue. Operating internationally is subject to a
number of uncertainties, including, but not limited to, the
following:
•economic
and political instability;
•import
or export licensing requirements;
•additional
compliance-related risks;
•trade
restrictions and tariffs;
•product
registration requirements;
•longer
payment cycles;
•changes
in regulatory requirements and tariffs, including recent
restrictions in China on the proportion of certain medical
equipment which can be imported;
•potentially
adverse tax consequences; and
•trade
policy changes
Specifically, the Chinese government has implemented a volume-based
procurement process designed to decrease prices for medical devices
and other products, which has in the past resulted in, and could in
the future result in, reduced margins on covered devices and
products, required renegotiation of distributor arrangements, an
incurrence of inventory-related charges. For further information,
please see Part 1. Item 1, "Business - Regulation." As a result of
such program, which is anticipated to take effect in the first half
of 2023, the Company expects that sales of our Implants products in
China will be negatively affected by price reductions. Sales in
China have also been negatively affected by purchasing behavior in
anticipation of government regulations which will require certain
amounts of medical equipment purchased by state enterprises to be
sourced locally. Additionally, changes in or the imposition of
tariffs could make it more difficult or costly for us to export our
products to other countries. These measures could also result in
increased costs for goods imported into the U.S. This in turn could
require us to increase prices to our customers which may reduce
demand, or, if we are unable to increase prices, result in lowering
our margin on products sold. We cannot predict future trade policy
or the terms of any renegotiated trade agreements and their impact
on our business. The adoption and expansion of trade restrictions,
the occurrence of a trade war, or other governmental action related
to tariffs or trade agreements or policies has the potential to
adversely impact demand for our products, our costs, our customers
and our suppliers, which in turn could adversely impact our
business, financial condition and results of
operations.
Certain of these risks may be heightened as a result of changing
political climates which may lead to changes in areas such as trade
restrictions and tariffs, regulatory requirements and exchange rate
fluctuations, which may adversely affect our business and financial
performance. For example, as a result of escalating tensions and
the subsequent invasion of Ukraine by Russia, the U.S., other North
Atlantic Treaty Organization member states, the EU and other
countries have imposed sanctions on Russia, including its major
financial institutions and certain other businesses and
individuals, Belarus, the Crimea Region of Ukraine, the so-called
Donetsk People’s Republic and the so-called Luhansk People’s
Republic. Russia also imposed significant currency control measures
aimed at restricting the outflow of foreign currency and capital
from Russia, imposed various restrictions on transacting with
non-Russian parties, banned exports of various products, and
imposed other economic and financial restrictions. These include
restrictions on the ability of companies to repatriate or otherwise
remit cash from their Russian-based operations to locations outside
of Russia. Russia may further respond in kind, and the continuation
of the conflict may result in additional sanctions being enacted by
the U.S., other North Atlantic Treaty Organization member states,
the EU or other countries. The length, impact, and outcome of this
ongoing military conflict is highly unpredictable and could lead to
significant market and other disruptions, which, along with the
spillover effect of ongoing civil, political and economic
disturbances on surrounding areas, may significantly devalue
currencies utilized by us or have other adverse impacts including
increased costs of raw materials and inputs, manufacturing or
shipping delays or increases in inflation rate, cyber attacks and
supply chain challenges. Export controls implemented as part of
sanctions could also restrict the sale of equipment or products
containing U.S. developed software and technology into
Russia.
For the year ended December 31, 2022, net sales in Russia and
Ukraine were approximately 3% of our consolidated net sales, and
net assets in these countries were $83 million as of December 31,
2022. These net assets include $71 million of cash and cash
equivalents, which as a result of current control measures by the
Russian government we are limited in our ability to transfer out of
Russia without incurring substantial costs, if at all. The full
impact of these events on economic conditions in the region is
currently unknown and could have a material adverse effect on our
results of operations, cash flows or financial
condition.
Due to our international operations, we are exposed to the risk of
changes in foreign exchange rates.
Due to the international nature of our business, movements in
foreign exchange rates may impact our consolidated statements of
operations, consolidated balance sheets and cash flows. With
approximately two-thirds of our sales located outside the U.S., our
consolidated net sales are impacted negatively by the strengthening
or positively by the weakening of the U.S. dollar as compared to
certain foreign currencies. Additionally, movements in certain
foreign exchange rates may unfavorably or favorably impact our
results of operations, financial condition and liquidity as a
number of our manufacturing and distribution operations are located
outside of the U.S. Although we currently use and may in the future
use certain financial instruments to attempt to mitigate market
fluctuations in foreign exchange rates, there can be no assurance
that such measures will be effective or that they will not create
additional financial obligations for us.
RISKS RELATED TO OUR REGULATORY ENVIRONMENTS
Changes in or interpretations of tax rules, operating structures,
transfer pricing regulations, country profitability mix and
regulations may adversely affect our effective tax
rate.
As a company with international operations, we are subject to
income taxes, as well as non-income-based taxes, in the U.S. and
various foreign jurisdictions. Significant judgment is required in
determining our worldwide tax liabilities. Although we believe our
estimates are reasonable at the time made, the actual outcome could
differ from the amounts recorded in our financial statements (and
such differences may be material). If the IRS, or other tax
authorities, disagree with the positions we take, we could have
additional tax liability, and this could have a material impact on
our results of operations and financial position. Our effective tax
rate could be adversely affected by changes in the mix of earnings
in countries with different statutory tax rates, changes in the
valuation of deferred tax assets and liabilities, changes in tax
laws and regulations, and changes in interpretations of tax laws.
Due to economic and political conditions, tax rates in various
jurisdictions may be subject to significant change and could
materially impact our effective tax rate.
Our corporate structure is intended to enhance our operational and
financial efficiency and increase our overall profitability. The
tax authorities of the countries in which we operate may challenge
our methodologies for transfer pricing or change the way in which
certain transactions are taxed which could increase our effective
tax rate (and such increase may be material). In addition, certain
governments are considering, and may adopt, tax reform measures
that could significantly increase our worldwide tax
liabilities.
The Organization for Economic Co-operation and Development and
other government bodies have focused on issues related to the
taxation of multinational corporations, including, in the area of
“base erosion and profit shifting,” where payments are made from
affiliates in jurisdictions with high tax rates to affiliates in
jurisdictions with lower tax rates. Some of these proposals include
a two-pillar approach to global taxation, focusing on global profit
allocation and a global minimum tax rate (“Pillar Two”). On
December 12, 2022, the European Union member states agreed to
implement the OECD’s global corporate minimum tax rate of 15%, to
be effective as of January 2024. Other countries are also actively
considering changes to their tax laws to adopt certain parts of the
OECD’s proposals. In December 2022, South Korea enacted new global
minimum tax rules to align with Pillar Two. The enactment of Pillar
Two legislation in other countries could have a material effect on
the Company's effective tax rate, financial position, results of
operations, and cash flows. The Company will continue to monitor
and reflect the impact of such legislative changes in future
financial statements as appropriate.
We may be unable to obtain necessary product approvals and
marketing clearances.
We must obtain certain approvals by, and marketing clearances from,
governmental authorities, including the FDA and similar health
authorities in foreign countries to market and sell our select
products in those countries. These agencies regulate the marketing,
manufacturing, labeling, packaging, advertising, sale and
distribution of medical devices. The FDA enforces additional
regulations regarding the safety of X-ray emitting devices. Our
products are currently regulated by such authorities and our new
products require approval by, or marketing clearance from, various
governmental authorities, including the FDA. Various U.S. states
also impose manufacturing, licensing, and distribution
regulations.
The FDA review process typically requires extended proceedings
pertaining to the safety and efficacy of new products. A 510(k)
application is required in order to market certain classes of new
or modified medical devices. If specifically required by the FDA, a
pre-market approval, or PMA, may be necessary. Such proceedings,
which must be completed prior to marketing a new medical device,
are potentially expensive and time consuming. They may delay or
hinder a product’s timely entry into the marketplace. Moreover,
there can be no assurance that the review or approval process for
these products by the FDA or any other applicable governmental
authority will occur in a timely fashion, if at all, or that
additional regulations will not be adopted or current regulations
amended in such a manner as will adversely affect us. The FDA also
oversees the content of advertising and marketing materials
relating to medical devices which have received FDA clearance.
Failure to comply with the FDA’s advertising guidelines may result
in the imposition of penalties.
We are also subject to other federal, state and local laws,
regulations and recommendations relating to safe working
conditions, laboratory and manufacturing practices. The extent of
government regulation that might result from any future legislation
or administrative action cannot be accurately predicted and
inadequate employee training for critical compliance and regulatory
requirements may result in the failure to adhere to applicable
laws, rules and regulations.
Similar to the FDA review process, the EU review process typically
requires extended proceedings pertaining to the safety and efficacy
of new products. Such proceedings, which must be completed prior to
marketing a new medical device, are potentially expensive and time
consuming and may delay or prevent a product’s entry into the
marketplace.
Our products that fall into the category of Class I as classified
by EU MDD were mandated to be certified under the new EU MDR. These
regulations as well applied to all medical device manufacturers who
market their medical devices in EU and all had to perform
significant upgrades to quality systems and processes including
technical documentation and subject them to new certification under
EU MDR in order to continue to sell those products in the EU.
Although all medical device manufacturers were required to certify
their Class I products by May 2021, the EU MDR regulations for
additional Classes of medical devices is mandated to be fully
enforceable by May 2024. This also includes completion of certified
quality management systems to manufacturers quality management
systems. We remain focused on ensuring that all our products that
are considered to be medical device will be fully certified as
required by the EU MDR dates and timelines. Additionally, the UK
has negotiated an exit from the EU, (commonly referred to as
Brexit) and, as a result, the EU CE marking will be recognized in
the UK through June 2023. Following June 2023, the UK may impose
its own differing regulatory requirements for products being
imported from the EU into the UK.
Failure to comply with these rules, regulations, self-regulatory
codes, circulars and orders 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 impact on our business.
Also, these regulations may be interpreted or applied by a
prosecutorial, regulatory or judicial authority in a manner that
could require us to make changes in operations or incur substantial
defense and settlement expenses. Even unsuccessful challenges by
regulatory authorities or private regulators could result in
reputational harm and the incurring of substantial costs. In
addition, many of these laws are vague or indefinite and have not
been interpreted by the courts, and have been subject to frequent
modification and varied interpretation by prosecutorial, regulatory
authorities, increasing compliance risks.
Inadequate levels of reimbursement from governmental or other
third-party payors for procedures using our products may cause our
revenue to decline.
Third-party payors, including government health administration
authorities, private health care insurers and other organizations
regulate the reimbursement of fees related to certain diagnostic
procedures or medical treatments. Third-party payors are
increasingly challenging the price and cost-effectiveness of
medical products and services. While we cannot predict what effect
the policies of government entities and other third-party payors
will have on future sales of our products, there can be no
assurance that such policies would not cause our revenue to
decline.
Challenges may be asserted against our products due to real or
perceived quality, health or environmental issues.
We manufacture and sell a wide portfolio of dental and medical
device products. While we endeavor to ensure that our products are
safe and effective, there can be no assurance that there may not be
challenges from time to time regarding the real or perceived
quality, health or environmental impact of our products or certain
raw material components of our products. We manufacture and sell
dental filling materials that may contain bisphenol-A, commonly
called BPA. BPA is found in many everyday items, such as plastic
bottles, foods, detergents and toys, and may be found in certain
dental composite materials or sealants either as a by-product of
other ingredients that have degraded, or as a trace material left
over from the manufacture of other ingredients used in such
composites or sealants. The FDA currently allows the use of BPA in
dental materials, medical devices, and food packaging.
Nevertheless, public reports and concerns regarding the potential
hazards of BPA could contribute to a perceived safety risk for our
products that contain mercury or BPA. Adverse publicity about the
quality or safety of our products, whether or not ultimately based
on fact, may have an adverse effect on our brand, reputation and
operating results and legal and regulatory developments in this
area may lead to litigation and/or product limitations or
discontinuation.
If we fail to comply with laws and regulations relating to health
care fraud, we could suffer penalties or be required to make
significant changes to our operations, which could adversely affect
our business.
We are subject to federal, state, local and foreign laws, rules,
regulations, self-regulatory codes, circulars and orders relating
to health care fraud, including, but not limited to, the U.S.
Federal Anti-Kickback Statute, the UK Bribery Act 2010 (c.23),
Brazil’s Clean Company Act 2014 (Law No. 12,846) and China’s
National Health and Family Planning Commission (“NHFPC”) circulars
No. 49 and No. 50. 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 payors 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 payors and
programs.
The U.S. government has expressed concerns about financial
relationships between suppliers on the one hand and physicians and
dentists on the other. As a result, we regularly review and revise
our marketing practices as necessary to facilitate compliance. In
addition, under the reporting and disclosure obligations of the
U.S. Physician Payment Sunshine Act and similar foreign laws,
rules, regulations, self-regulatory codes, circulars and orders,
such as France’s Loi Bertrand and rules issued by Denmark’s Health
and Medicines Authority, the general public and government
officials will be provided with access to detailed information with
regard to payments or other transfers of value to certain
practitioners (including physicians, dentists and teaching
hospitals) by applicable drug and device manufacturers subject to
such reporting and disclosure obligations, which includes us. This
information may lead to greater scrutiny, which may result in
modifications to established practices and additional
costs.
Failure to comply with health care fraud laws, rules, regulations,
self-regulatory codes, circulars and orders 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
impact on our business. Also, these laws 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. In addition, many of these laws are vague or
indefinite and have not been interpreted by the courts, and have
been subject to frequent modification and varied interpretation by
prosecutorial, regulatory authorities, increasing compliance
risks.
We cannot predict whether changes in applicable laws, rules,
regulations, self-regulatory codes, circulars and orders, or the
interpretation thereof, or changes in our services or marketing
practices in response, could adversely affect our
business.
Our business is subject to extensive, complex and changing domestic
and foreign laws, rules, regulations, self-regulatory codes,
directives, circulars and orders that failure to comply with which,
if not complied with, could subject us to civil or criminal
penalties or other liabilities.
We are subject to extensive domestic and foreign laws, rules,
regulations, self-regulatory codes, circulars and orders which are
administered by various international, federal and state
governmental authorities, including, among others, the FDA, the
Office of Foreign Assets Control of the U.S. Department of the
Treasury (“OFAC”), the Bureau of Industry and Security of the U.S.
Department of Commerce (“BIS”), the U.S. Federal Trade Commission,
the U.S. Department of Justice, the Environmental Protection Agency
(“EPA”), and other similar domestic and foreign authorities. These
laws, rules, regulations, self-regulatory codes, circulars and
orders include, but are not limited to, the U.S. Food, Drug and
Cosmetic Act, the European Council Directive 93/42/EEC on Medical
Devices (“MDD”) (1993) (and implementing and local measures adopted
thereunder), the Federal Health Information Technology for Economic
and Clinical Health Act (“HITECH Act”), the Federal Health
Insurance Portability and Accountability Act of 1996 (“HIPAA”),
France’s Data Protection Act of 1978 (rev. 2004), the U.S. Foreign
Corrupt Practices Act (the “FCPA”), the U.S. Federal Anti-Kickback
Statute and similar international anti-bribery and anti-corruption
laws, the Physician Payments Sunshine Act, regulations concerning
the supply of conflict minerals, various environmental regulations
such as the Federal Water Pollution Control Act (the “Clean Water
Act”), the Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Reconciliation Act (the “Health
Care Reform Law”), and regulations relating to trade, import and
export controls and economic sanctions. Such laws, rules,
regulations, self-regulatory codes, circulars and orders are
complex and are subject to change.
The FCPA generally prohibits companies and their affiliates from
making improper payment to non-U.S. officials for the purpose of
obtaining or retaining business, and also includes certain books
and records and internal accounting controls requirements. Our
internal policies, procedures and Code of Ethics and Business
Conduct mandate compliance with these anti-corruption laws.
However, we operate in some countries known to experience
corruption. Despite our training and compliance programs, we cannot
provide assurance that our internal policies and procedures will
always protect us from violation of such anti-corruption laws
committed by our affiliated entities or their respective officers,
directors, employees and agents. If we are not in compliance with
the FCPA and other laws governing the conduct of business with
government entities (including local laws), we may be subject to
criminal and civil penalties and other remedial measures, which
could have a material adverse impact on our business, financial
condition, results of operations and liquidity. Any ongoing
investigation of any potential violations of the FCPA or other
anti-corruption laws by the U.S. or foreign authorities could harm
our reputation and have an adverse impact on our business,
financial condition and results of operations.
On December 31, 2020, we acquired Byte, a leading provider in the
direct-to-consumer, doctor-directed aligner market. Byte’s business
in the U.S. is subject to various state laws, rules and policies
which govern the practice of dentistry within such state. Byte
contracts with an expansive nationwide network of independent
licensed dentists and orthodontists for the provision of clinical
services, including the oversight and control of each customer’s
clinical treatment; however, there can be no assurance that such
business model will not be challenged as the corporate practice of
dentistry by state governmental authorities, trade associations, or
others. Additionally, future legislative or regulatory changes
within such states may have a negative impact on Byte’s business
model.
Compliance with the numerous applicable existing and new laws,
rules, regulations, self-regulatory codes, circulars and orders
could require us to incur substantial regulatory compliance costs.
There can be no assurance that governmental authorities will not
raise compliance concerns or perform audits to confirm compliance
with such laws, rules, regulations, self-regulatory codes,
circulars and orders. For example, most of our products are
classified as medical devices or pharmaceuticals which are subject
to extensive regulations promulgated by the U.S. federal
government, state governments and comparable regulatory agencies in
other countries, including the requirement to obtain licenses for
the manufacture or distribution of such products. Failure to comply
with applicable laws, rules, regulations, self-regulatory codes,
circulars or orders could result in a range of governmental
enforcement actions, including fines or penalties, injunctions
and/or criminal or other civil proceedings. Any such actions could
result in higher than anticipated costs or lower than anticipated
revenue and could have a material adverse effect on our reputation,
business, financial condition and results of
operations.
RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
Our quarterly operating results and market price for our common
stock may continue to be volatile.
We experience significant fluctuations in quarterly sales and
earnings due to a number of factors, some of which are
substantially outside of our control, including but not limited
to:
•general
economic conditions, as well as those specific to the healthcare
industry and related industries;
•changes
in income tax laws and incentives that could create adverse tax
consequences;
•the
execution of restructuring plans;
•the
complexity of our organization;
•our
ability to supply products to meet customer demand;
•the
timing of new product introductions by us and our
competitors;
•the
timing of industry trade shows;
•changes
in customer inventory levels;
•developments
in government or third party payor reimbursement
policies;
•changes
in customer preferences and product mix;
•fluctuations
in manufacturing costs;
•competitors’
sales promotions;
•fluctuations
in currency exchange rates; and
•the
impact of COVID-19.
As a result, we may fail to meet the expectations of investors and
securities analysts, which could cause our stock price to
decline.
Certain provisions in our governing documents, and of Delaware law,
may make it more difficult for a third party to acquire
us.
Certain provisions of our Certificate of Incorporation and By-laws
and of Delaware law could have the effect of making it difficult
for a third party to acquire a controlling interest in us. Such
provisions include, among others, a provision allowing the Board of
Directors to issue preferred stock having rights senior to those of
the common stock and certain requirements which make it difficult
for stockholders to amend our By-laws and prevent them from calling
special meetings of stockholders. Delaware law imposes some
restrictions on mergers and other business combinations between us
and any “interested stockholder” with beneficial ownership of 15%
or more of our outstanding common stock.
GENERAL RISKS
Our revenue, results of operations, cash flow and liquidity may be
materially adversely impacted by the ongoing COVID-19
outbreak.
We continue to closely monitor the global impacts of the COVID-19
pandemic. The COVID-19 pandemic has negatively impacted business
and healthcare activity globally and has created significant
volatility, uncertainty and economic disruption in the U.S. and
international markets and within the markets in which we operate.
The pandemic has adversely affected and is likely to further
adversely affect nearly all aspects of our business and markets,
including our sales, operations, cash flow and workforce and the
operations of our customers, suppliers, vendors and business
partners. Specifically, authorities in China periodically
re-imposed severe restrictions on individual and business
activities during 2022, resulting in a loss of sales due to
distribution constraints and lower demand from reduced patient
traffic locally. Although certain of these restrictions were lifted
late in the year, this also coincided with resurgence of COVID-19
infections from variants of the virus. Adverse trends in certain
regions and particularly China could persist if these restrictions
are renewed as a result of additional outbreaks. More generally,
the impact of the pandemic may increase the possibility of
uncertainty in the global financial markets, high inflation and
extended economic downturn, which could reduce our ability to incur
debt or access capital and impact our results and financial
condition even after local conditions improve. There are no
assurances that the credit markets or the capital markets will be
available to us in the future or that the lenders participating in
our credit facilities will be able to provide financing in
accordance with their contractual obligations.
We do not yet know the full extent of the ultimate impact of the
continued COVID-19 pandemic on our business, operations, or the
global economy. The extent of such impact will depend on future
developments, including the severity and frequency of any future
COVID-19 variants and related outbreaks, and actions taken to
address the impacts, among others. Even after the COVID-19 pandemic
has subsided, we may continue to experience materially adverse
effects on our results of operations and financial condition. To
the extent that the COVID-19 outbreak continues to adversely affect
the business and financial performance, it could also heighten many
of the other risks described in this report.
Our business may be adversely affected by changes in global
economic conditions, including inflation, rising interest rates,
and supply chain shortages.
Our business, operating results, financial condition and liquidity
may be adversely affected by changes in global economic conditions
including inflation, supply chain disruptions credit market
conditions, levels of consumer and business confidence, and other
factors that are generally beyond our control. The current global
supply chain and labor market challenges and inflationary pressures
have negatively affected, and we expect will continue to negatively
affect, our results of operations. Specifically, the Company has
recently experienced higher prices and supply chain disruption for
certain of our raw materials, particularly for electronic
components used in our products. As it pertains to demand for our
products, certain dental specialty products and dental equipment
and related products that support discretionary dental procedures,
especially elective procedures in implants and aligners, may also
be susceptible to unfavorable changes in economic conditions.
Decreases in consumer discretionary spending could negatively
affect our business and result in a decline in sales and financial
performance.
Additionally, interest rate increases have created financial market
volatility which could further negatively impact financial markets,
lead to an economic downturn or recession, and tighten availability
of, and increase the costs of capital for the Company. These and
any other unfavorable economic conditions could increase our
funding costs, limit our access to the capital markets or result in
a decision by lenders not to extend credit to us. Tightening of
credit in financial markets also could adversely affect the ability
of our customers and suppliers to obtain financing for significant
purchases and operations, could result in a decrease in or
cancellation of orders for our products and services, could impact
the ability of our customers to make payments, and could increase
the risk of supplier financial distress.
The Company has sought to offset the elevated costs resulting from
raw material cost inflation with annual price increases but has
been only partially successful. Should the higher inflationary
environment continue, we may not be able to increase the prices of
our offerings sufficiently to keep up with the rate of inflation.
Any of the above factors could individually or in combination have
a material adverse effect on our operating results, financial
condition and liquidity.
The loss of members of our senior management and the resulting
management transition might have an adverse impact on our future
operating results.
On April 11, 2022, we announced that our Executive Vice President,
Chief Financial Officer resigned from his position effective May 6,
2022. Additionally, on April 19, 2022, we announced that we
terminated our Chief Executive Officer, effective immediately. The
Board of Directors appointed an Interim Chief Executive Officer,
effective as of April 19, 2022, and Interim Chief Financial Officer
which became effective on May 6, 2022.
On August 25th, we announced the appointment of our new Chief
Executive Officer, which became effective on September 12, 2022,
and on September 22, 2022, we announced the appointment of our new
Chief Financial Officer, which became effective on September 26,
2022. These leadership transitions along with other senior
management changes may be inherently difficult to manage and cause
operational and administrative inefficiencies,
added costs, decreased employee morale, uncertainty and decreased
productivity among our employees, increased likelihood of turnover,
and the loss of personnel with deep institutional knowledge, which
could result in significant disruptions to our operations. In
addition, we must successfully integrate the new management team
members within our organization in order to achieve our operating
objectives, and changes in key management positions may temporarily
affect our financial performance and results of operations as new
management becomes familiar with our business. These changes could
also increase the volatility of our stock price. If we are unable
to mitigate these or other similar risks, our business, results of
operations and financial condition may be adversely
affected.
Talent gaps and failure to manage and retain top talent may impact
our ability to grow the business.
Our success is dependent on our ability to successfully manage our
human capital through talent acquisition, engagement, development,
and retention. To achieve our strategic initiatives, we need to
attract, manage, and retain employees with the right skills,
competencies and experiences to support the growth of the business
and the failure to attract and retain such employees to fill key
roles may adversely affect our business performance, competitive
position and future prospects. We also must retain a pipeline of
team members to provide for continuity of succession for senior
executive positions. In order to attract and retain qualified
employees, we must offer competitive compensation and effectively
manage employee performance and development. The recent leadership
transitions along with other senior management changes may
adversely affect our ability to attract and retain talent. Our
inability to attract and retain talent may negatively impact
business continuity, new product launches, and innovation
initiatives. Further, such organizational challenges may make it
difficult to maintain our culture, resulting in employees not
adhering to the desired values of the organization.
We face the inherent risk of litigation and claims.
We face the risk of purported securities class actions,
investigations by governmental agencies, product liability and
other types of legal actions or claims, including possible recall
actions affecting our products. We have insurance policies,
including directors’ and officers’ insurance and product liability
insurance, covering these risks in amounts that are considered
adequate; however, we cannot provide assurance that the maintained
coverage is sufficient to cover future claims or that the coverage
will be available in adequate amounts or at a reasonable cost.
Also, other types of claims asserted against us may not be covered
by insurance. A successful claim brought against us in excess of
available insurance, or another type of claim which is uninsured or
that results in significant adverse publicity against us, could
harm our business and our overall cash flows.
Various parties, including us, own and maintain patents and other
intellectual property rights applicable to the dental and medical
device fields. Although we believe that we operate in a manner that
does not infringe upon any third-party intellectual property
rights, it is possible that a party could assert that one or more
of our products infringe upon such party’s intellectual property
and force us to pay damages and/or discontinue the sale of certain
products.
Additionally, we generally warrant each of our products against
defects in materials and workmanship for a period of one year from
the date of shipment or installation plus any extended warranty
period purchased by the customer. The future costs associated with
providing product warranties could be material. Successful product
warranty claims brought against us could reduce our profits and/or
impair our financial condition, and damage our
reputation.
Climate change and related natural disasters could negatively
impact our business and financial results.
We operate in more than 150 countries and our suppliers’
manufacturing facilities are located in multiple locations around
the world. While we seek to mitigate our business risks associated
with climate events, we recognize that there are inherent
climate-related risks regardless of where we conduct our
businesses. Global climate change is expected to result in certain
types of natural disasters occurring more frequently or with more
intense effects. Any natural disaster, power outages or other
climate events in such a location or the increased frequency of
extreme weather could disrupt the production and distribution of
our products in these locations. Current or future insurance
arrangements may not provide protection for costs that may arise
from such events, particularly if such events are catastrophic in
nature or occur in combination. Accordingly, a natural disaster has
the potential to disrupt our and our clients’ businesses and may
cause us to experience work stoppages, project delays, financial
losses and additional costs to resume operations, including
increased insurance costs or loss of cover, legal liability and
reputational losses. Increasing natural disasters in connection
with climate change could also impact our third-party vendors,
service providers or other stakeholders, including disruptions in
supply chains, or information technology or other necessary
services for our Company.
Expectations relating to environmental, social and governance
considerations may expose us to potential liabilities, increased
costs, reputational harm, and other adverse effects on our
business.
Many governments, regulators, investors, employees, customers and
other stakeholders are increasingly focused on environmental,
social and governance considerations relating to businesses,
including climate change and greenhouse gas emissions, human and
civil rights, and diversity, equity and inclusion. In addition, we
make statements about our environmental, social and governance
goals and initiatives through our Sustainability Report, our other
non-financial reports, information provided on our website, press
statements and other communications. Responding to these
environmental, social and governance considerations and
implementation of these goals and initiatives involves risks and
uncertainties, may require investments, and depends in part on
third-party performance or data that is outside our control. We
cannot guarantee that we will achieve our announced sustainability
goals and initiatives. In addition, some stakeholders may disagree
with our goals and initiatives. Any failure, or perceived failure,
by us to achieve our goals, further or initiatives, adhere to our
public statements, comply with federal, state or international
environmental, social and governance laws and regulations, or meet
evolving and varied stakeholder expectations and standards could
result in legal and regulatory proceedings against us and
materially adversely affect our business, reputation, results of
operations, financial condition and stock price.
Federal, state, and local governments are beginning to respond to
climate change issues. This increased focus on sustainability may
result in new legislation or regulations and customer requirements
that could negatively affect us. Environmental laws, for example,
particularly with respect to climate change and the emission of
greenhouse gases, are also becoming more stringent throughout the
world. We may incur additional costs or be required to make changes
to our operations in order to comply with any new regulations or
customer requirements. Legislation or regulations that potentially
impose restrictions, caps, taxes, or other controls on emissions of
greenhouse gases such as carbon dioxide, could adversely affect our
operations and financial results.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
The following is a listing of Dentsply Sirona’s principal
manufacturing and distribution locations:
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Location |
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Function |
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Leased
or Owned
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United States: |
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Milford, Delaware (2) |
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Manufacture of dental consumable products |
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Owned |
Sarasota, Florida (1) |
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Manufacture of orthodontic accessory products |
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Owned |
Waltham, Massachusetts (1) |
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Manufacture and distribution of dental implant products |
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Leased |
Long Island City, New York (1) |
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Manufacture of dental equipment products |
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Leased |
Lancaster, Pennsylvania (3) |
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Distribution of dental consumable and dental equipment
products |
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Leased |
Johnson City, Tennessee (2) |
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Manufacture and distribution of endodontic instruments and
materials |
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Leased |
Richardson, Texas (1) |
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Manufacture of orthodontic products |
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Leased |
Gardena, California (1) |
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Distribution of orthodontic products |
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Leased |
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Foreign: |
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Pirassununga, Brazil (2) |
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Manufacture and distribution of artificial teeth |
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Owned |
Bensheim, Germany (1) |
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Manufacture and distribution of dental equipment |
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Owned |
Hanau, Germany (1) (2) |
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Manufacture and distribution of precious metal dental alloys,
dental ceramics and dental implant products |
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Owned |
Konstanz, Germany (2) |
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Manufacture and distribution of dental consumable
products |
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Owned |
Munich, Germany (2) |
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Manufacture and distribution of endodontic instruments and
materials |
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Owned |
Bar Lev Industrial Park, Israel (1) |
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Manufacture and distribution of dental implant products |
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Owned/Leased |
Badia Polesine, Italy (2) |
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Manufacture and distribution of dental consumable
products |
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Owned/Leased |
Otawara, Japan (1) (2) |
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Manufacture and distribution of precious metal dental alloys,
dental consumable products and orthodontic products |
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Owned |
Venlo, Netherlands (3) |
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Distribution of dental consumable products |
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Leased |
Mölndal, Sweden (1) |
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Manufacture and distribution of dental implant products and
healthcare consumable products |
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Owned |
Ballaigues, Switzerland (2) |
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Manufacture and distribution of endodontic instruments, plastic
components and packaging material |
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Owned |
Ankara, Turkey (1) |
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Manufacture and distribution of healthcare consumable
products |
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Owned |
Mexicali, Mexico (1) |
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Manufacture of orthodontic products |
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Leased |
San Jose Province, Costa Rica (1) |
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Manufacture of orthodontic products |
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Leased |
(1) These properties are included in the Technologies &
Equipment segment.
(2) These properties are included in the Consumables
segment.
(3) These properties are distribution warehouse not managed by
named segments.
In addition, the Company maintain sales and distribution offices at
certain of our foreign and domestic manufacturing facilities, as
well as at various other U.S. and international locations. Most of
these sites around the world that are used exclusively for sales
and distribution are leased. We believe that our properties and
facilities are well maintained and are generally suitable and
adequate for the purposes for which they are used.
We also lease our worldwide headquarters located in Charlotte,
North Carolina.
Item 3. Legal Proceedings
The Company is, from time to time, subject to a variety of
litigation and similar proceedings incidental to our business.
These legal matters primarily involve claims for damages arising
out of the use of our products and services and claims relating to
intellectual property matters including patent infringement,
employment matters, tax matters, commercial disputes, competition
and sales and trading practices, personal injury and insurance
coverage. We may also become subject to lawsuits as a result of
past or future acquisitions or as a result of liabilities retained
from, or representations, warranties or indemnities provided in
connection with, divested businesses. Some of these lawsuits may
include claims for punitive and consequential, as well as
compensatory damages. Based upon our experience, current
information and applicable law, we do not believe that these
proceedings and claims will have a material adverse effect on our
consolidated results of operations, financial position or
liquidity. However, in the event of unexpected further
developments, it is possible that the ultimate resolution of these
matters, or other similar matters, if unfavorable, may be
materially adverse to our business, financial condition, results of
operations or liquidity. For additional details, see Part II, Item
8, Note 22, Commitments and Contingencies, in the Notes to
Consolidated Financial Statements of this Form 10-K, which is
incorporated by reference.
Item 4. Mine Safety Disclosures
Not Applicable.
PART II
Item 5. Market for Registrant’s Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities
The Company’s common stock is traded on the Nasdaq National Market
under the symbol “XRAY.” Approximately 93,713 holders of our common
stock are in “street name” or beneficial holders, whose shares are
held of record by banks, brokers and other financial institutions.
In addition, we estimate, based on information supplied by our
transfer agent, that there are 220 holders of record of the our
common stock.
Stock Repurchase Program
On July 28, 2021 the Board of Directors approved a share repurchase
program, up to $1.0 billion. At December 31, 2022, the
Company had authorization to repurchase $740 million in shares of
common stock remaining under this program. Share repurchases may be
made through open market purchases, Rule 10b5-1 plans, accelerated
share repurchase transactions and other structured share
repurchases, privately negotiated transactions or other
transactions in such amounts and at such times as we consider
appropriate based upon prevailing market and business conditions
and other factors.
During the three months ended December 31, 2022, we had no
repurchases of common shares under the stock repurchase
program.
On March 8, 2022, the Company entered into an Accelerated Share
Repurchase Agreement ("ASR Agreement") with a financial institution
to purchase the Company's common stock based on the volume-weighted
average price of the Company's common stock during the term of the
agreement, less a discount. The ASR agreement was accounted for as
an initial delivery of common shares in a treasury stock
transaction on March 9, 2022 of $120 million and a forward
contract indexed to the Company's common stock for an amount of
common shares to be determined on the final settlement date. The
forward contract met all applicable criteria for equity
classification and was not accounted for as a derivative
instrument. Therefore, the forward contract was recorded as Capital
in excess of par value and upon final settlement was recorded as
Treasury Stock in the Consolidated Balance Sheets at December 31,
2022. The initial delivery and final settlement of common stock
reduced the weighted average common shares outstanding for both
basic and diluted EPS. The forward contract did not impact the
weighted average common shares outstanding for diluted
EPS.
For the year ended December 31, 2022, we repurchased
approximately 3.1 million shares at a cost of $150 million for an
average price of $48.22.
Performance Graph
The information contained in the Performance Graph section shall
not be deemed to be filed as part of this Annual Report and does
not constitute soliciting material and should not be deemed filed
or incorporated by reference into any other filing of the Company
under the Securities Act of 1933, as amended, or the Exchange Act,
except to the extent we specifically incorporate the graph by
reference.
The graph below compares DENTSPLY SIRONA Inc.'s cumulative 5-year
total shareholder return on common stock with the cumulative total
returns of the S&P 500 Index and the S&P Health Care index.
The graph tracks the performance of a $100 investment in DENTSPLY
SIRONA’s Inc.'s common stock and in each index (with the
reinvestment of all dividends) from December 31, 2017 to
December 31, 2022. The S&P 500 Index and the S&P
Health Care Index are included for comparative purposes only. They
do not necessarily reflect management’s opinion that such indices
are an appropriate measure of the relative performance of the stock
involved, and they are not intended to forecast or be indicative of
possible future performance of the Company’s common
stock.
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12/17 |
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12/18 |
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12/19 |
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12/20 |
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12/21 |
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12/22 |
DENTSPLY SIRONA Inc. |
100.00 |
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57.00 |
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87.29 |
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81.51 |
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87.47 |
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50.63 |
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S&P 500 |
100.00 |
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95.62 |
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125.72 |
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148.85 |
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191.58 |
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156.89 |
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S&P Health Care |
100.00 |
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106.47 |
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128.64 |
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145.93 |
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184.07 |
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180.47 |
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Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
OVERVIEW
The following Management’s Discussion and Analysis of Financial
Conditions and Results of Operations (“MD&A”) is intended to
help the reader understand the Company’s operations and business
environment. MD&A is provided as a supplement to, and should be
read in conjunction with, the Consolidated Financial Statements and
Notes to Consolidated Financial Statements contained in Item 8 of
this Form 10-K. The following discussion includes
forward-looking statements that involve certain risks and
uncertainties. See Part I, Item 1, “Business - Forward-Looking
Statements and Associated Risks” in the beginning of this Form
10-K. The MD&A includes the following
sections:
•Business
- a general description of Dentsply Sirona’s business and how
performance is measured;
•Results
of Operations - an analysis of the Company’s consolidated results
of operations for the years ended December 31, 2022 and
2021;
•Critical
Accounting Policies and Estimates - a discussion of accounting
policies that require critical judgments and estimates;
and
•Liquidity
and Capital Resources - an analysis of cash flows; debt and other
obligations; off-balance sheet arrangements; and aggregate
contractual obligations.
2022 Operational Highlights
For the year ended December 31, 2022,
•Net
sales decreased 7.3% compared to the prior year. On an organic
basis (a Non-GAAP measure as defined under the heading "Key
Performance Measurements" below) net sales decreased 0.5% for the
year ended December 31, 2022 compared to prior year. Net sales were
negatively impacted by approximately 6.8% due to the strengthening
of the U.S. dollar over the prior year period.
•Net
loss was $950 million as compared to net income of $411 million for
the prior year primarily due to an goodwill impairment charge of
$1,187 million. Diluted loss per share was $4.41 per share compared
to net income per share of $1.87 in the prior year.
•Cash
from operations was $517 million, as compared to $657 million in
the prior year.
Material Weaknesses in Internal Control Over Financial Reporting
Identified During the Recent Investigation
As previously disclosed, management determined there were material
weaknesses in the Company’s internal control over financial
reporting as of December 31, 2021, which have not been remediated
as of December 31, 2022. For more information about the identified
material weaknesses in internal control over financial reporting
and the Company’s remedial actions, please see Part II, Item 8
Management’s Report on Internal Control Over Financial Reporting
and Part II, Item 9A Controls and Procedures of this Form
10-K.
Company Profile
DENTSPLY SIRONA Inc. (“Dentsply Sirona” or the “Company”), is the
world’s largest manufacturer of professional dental products and
technologies, with a 136-year history of innovation and service to
the dental industry and patients worldwide. Dentsply Sirona
develops, manufactures, and markets a comprehensive solutions
offering including dental equipment and dental consumable products
under a strong portfolio of world class brands. The Company also
manufactures and markets healthcare consumable products. Dentsply
Sirona’s products provide innovative, high-quality and effective
solutions to advance patient care and deliver better, safer and
faster dentistry. Dentsply Sirona’s worldwide headquarters is
located in Charlotte, North Carolina. The Company’s shares of
common stock are listed in the U.S. on Nasdaq under the symbol
XRAY.
BUSINESS
The Company operates in two operating segments, Technologies &
Equipment and Consumables.
The Technologies & Equipment segment is responsible for the
design, manufacture, sales and distribution of products including
dental implants, CAD/CAM systems, orthodontic aligner products,
imaging systems, treatment centers, instruments, as well as certain
healthcare device products, primarily catheters.
The Consumables segment is responsible for the design, manufacture,
sales and distribution of dental consumable products which include
categories of preventive, restorative, endodontic, and dental
laboratory application.
The impacts of COVID-19 and the Company’s response
The COVID-19 pandemic has created significant volatility and
uncertainty in the overall markets particularly in the year that
followed the initial outbreak late in 2019, leading to changes in
consumer behavior, government restrictions on individuals and
businesses, and significant disruption to supply chains in several
sectors, including dental equipment and medical
supplies.
The Company’s 2020 results were materially impacted by this
disruption at the outset of the pandemic, including the closure or
reduced operations of dental practices. During 2021, demand for the
Company’s products largely recovered, although the Company
continued to be impacted by shortages and higher prices for certain
raw materials, as well as increasing distribution and labor
costs.
The Company's financial results and operations continue to be
affected by the COVID-19 pandemic and the pressure it has placed on
inflation, supply chains, distribution networks and consumer
behavior. Key impacts for the year ended December 31, 2022 are as
follows:
•As
further described in the "Results of Operations" discussion below,
the Company continues to experience supply chain challenges
resulting from the pandemic including increased lead times, limited
availability of certain components, raw material price increases,
and higher procurement and shipping costs. As a result of supply
chain constraints, the Company has worked during the course of the
year to reduce an elevated backlog primarily in connection with
orders on hand for imaging equipment which it is unable to fill due
to continued shortages of electronic components. The Company is
continuing to take steps to mitigate the impact of these trends,
including seeking alternative supplier sources for key raw
materials.
•Sales
continue to be impacted in certain geographic areas by public
response to the COVID-19 pandemic. Towards the end of the first
quarter of 2022, authorities in China started to periodically
re-impose severe restrictions on individual and business activities
in response to the resurgence of COVID-19 infections from variants
of the virus, resulting in a loss of sales due to distribution
constraints and lower demand from reduced patient traffic locally.
Primarily as a result of these factors, sales in China declined by
$93 million during 2022 relative to 2021. Adverse trends in certain
regions could persist if these restrictions are renewed as a result
of additional outbreaks. While most government authorities have not
re-imposed restrictions with significant impacts, it continues to
be unclear when the remaining constraints will be lifted, and to
what degree future variants of the virus or renewed restrictions in
other markets may impact short-term demand for the Company's
products more broadly.
The impact of developments in Ukraine
In February 2022, as a result of the invasion of Ukraine by Russia,
economic sanctions were imposed by the U.S., the EU, and certain
other countries on Russian financial institutions and businesses.
Due to the medical nature of our products, the current sanctions
have not materially restricted the Company's ability to continue
selling many of our products to customers located in Russia. The
Company also sources certain raw materials and components from
Russia and Ukraine, and to minimize the adverse impacts from
disrupted supply chains related to these items, the Company has
purchased sufficient quantities for the near term, and are in
process of identifying alternate sources for the longer term. The
Company’s operations in Ukraine consist primarily of R&D
activities, which continue uninterrupted from other locations in
order to focus on the safety of employees. Overall, the Company's
operations in Russia and Ukraine have not been materially impacted
by the conflict, and consequently, the Company has not recorded any
allowance for doubtful accounts, inventory reserves, or asset
impairments during the year ended December 31, 2022 as a result of
these developments.
For the year ended December 31, 2022, net sales in Russia and
Ukraine were approximately 3% of our consolidated net sales, and
net assets in these countries were $83 million.
These
net assets include
$71 million of cash
and cash equivalents held within Russia as of December 31, 2022.
Due to
currency control measures imposed by the Russian government which
include restrictions on the ability of companies to repatriate or
otherwise remit cash from their Russian-based operations to
locations outside of Russia, we may be limited in our ability to
transfer this cash balance out of Russia without incurring
substantial costs, if at all.
While neither Russia nor Ukraine constitutes a material portion of
our business, a significant escalation or expansion of economic
disruption or the conflict's current scope could result in a loss
of sales, disrupt our supply chain, broaden inflationary costs, and
have a material adverse effect on our results of operations. For
additional discussion of associated risks, refer to Part I, Item
1A, "Risk Factors" -
Risks Related to Our International Operations.
The impact of global economic conditions
In addition to the residual impacts of the COVID-19 pandemic and
the war in Ukraine, markets in several regions particularly in
Europe have experienced varying degrees of recessionary pressures
and face continued concerns about the systemic impacts of adverse
economic conditions and geopolitical issues. In addition, changes
in economic conditions, supply chain constraints, logistics
challenges, labor shortages, and the conflict in Ukraine have all
contributed to a period of higher inflation across the industry and
the regions in which the Company operates.
As a result, the Company has experienced higher prices for certain
of our raw materials, particularly for electronic components which
have in some cases required incremental procurement costs such as
brokers' fees during the year, and a consequently negative impact
to margins. The Company has also experienced delays in converting
our backlog due to continued supply chain disruptions, which has
negatively impacted both revenues and margins. Although the Company
has experienced recent improvement in its supply chain, we expect a
continuation of these trends including disruptions and inflationary
pressure on the cost of both raw material and wages, the effect of
which will depend on the Company’s ability to successfully mitigate
and offset the related impacts.
The deterioration in macroeconomic conditions has also negatively
affected demand for the Company's products and may continue to do
so into the future. Specifically, the increase in interest rates
during the year has put pressure on the ability of our customers to
obtain financing for equipment purchases which affects volumes for
these products. Additionally, the recessionary environment in
general particularly for certain regions such as southern Europe
has depressed demand for elective procedures including sales of
implants and aligner solutions.
In anticipation of a continued inflationary trend and potentially
deteriorating macroeconomic environment, the Company has attempted
to mitigate these pressures through the following
actions:
•Driving
strategic procurement initiatives to leverage alternative sources
of raw materials and transportation;
•Implementing
cost-containment measures, as well as intensifying continuous
improvement and restructuring programs in our manufacturing and
distribution facilities; and
•Optimizing
our customer management and implementing strategic investments in
our commercial sales organization in key markets, particularly the
U.S.
As explained further in the Results of Operations section below,
the Company has partly offset these elevated costs in certain areas
of the business with price increases during the year. Should the
higher inflationary environment continue, the Company may be likely
to continue to be unable to raise the prices of our products and
services sufficiently to keep up with the rate of inflation which
could have a material adverse effect on our results of operations
and financial condition.
Key Performance Measurements
The principal measurements used by the Company in evaluating its
business performance are: (1) organic sales by segment and
geographic region; and (2) adjusted operating income and margins of
each reportable segment, which excludes the impacts of purchase
accounting, corporate expenses, and certain other items to enhance
the comparability of results period to period.
The Company defines "organic sales" as the reported net sales
adjusted for: (1) net sales from acquired and divested businesses
recorded prior to the first anniversary of the acquisition or
divestiture; (2) net sales attributable to discontinued product
lines in both the current and prior year periods; and (3) the
impact of foreign currency changes, which is calculated by
translating current period net sales using the comparable prior
period’s currency exchange rates.
The "organic sales" measure is not calculated in accordance with US
GAAP; therefore, this item represents a Non-GAAP measure. This
Non-GAAP measure may differ from those used by other companies and
should not be considered in isolation from, or as a substitute for,
measures of financial performance prepared in accordance with US
GAAP. Organic sales is an important internal measure for the
Company, and its senior management who receive a monthly analysis
of operating results that includes organic sales. The performance
of the Company is measured on this metric along with other
performance metrics.
The Company discloses organic sales to allow investors to evaluate
the performance of the Company’s operations exclusive of the items
listed above that impact the comparability of results from period
to period and may not be indicative of past or future performance
of the normal operations of the Company. The Company believes that
this supplemental information is helpful in understanding
underlying net sales trends.
Business Drivers
The primary drivers of organic sales include macroeconomic factors,
global dental industry demand, innovation and new product launches
by the Company, as well as continued investments in sales and
marketing resources to drive demand creation, including clinical
education. Management believes that the Company’s ability to
execute its strategies should allow it to grow faster than the
underlying dental industry over time. On a short-term basis, sudden
changes in the macroeconomic environment, supply chain challenges,
or changes in distributor inventory levels can and have impacted
the Company's sales. Demand can also fluctuate based on the timing
of dental tradeshows where promotions are offered, major new
product introductions, and variability in dental patient traffic,
which can be exacerbated by seasonal or severe weather patterns, or
other demographic disruptions such as the recent COVID-19
pandemic.
The Company has a focus on maximizing operational excellence on a
global basis. The Company has expanded the use of technology as
well as process improvement initiatives to enhance global
efficiency. In addition, management continues to evaluate the
worldwide consolidation and simplification of operations and
functions to further reduce costs. While the Company continues
consolidation initiatives which can have an adverse impact on
reported results in the short term, the Company expects that the
continued benefits from these global efficiency efforts will
optimize cost structure. Meanwhile, the Company intends to continue
pursuing opportunities to expand the Company’s product offerings,
technologies, and sales and service infrastructure through
partnerships. Although the professional dental market has
experienced consolidation, it remains fragmented. Management
believes that there will continue to be adequate opportunities to
participate as a consolidator in the industry for the foreseeable
future.
The Company’s business is subject to quarterly fluctuations in net
sales and operating income. Annual price increases, promotional
activities, as well as changes in inventory levels at distributors
contribute to this fluctuation. Distributor inventory levels tend
to increase in the period leading up to a price increase and
decline in the period following the implementation of a price
increase, although these fluctuations are mitigated by limits on
purchases ahead of these increases. Changes in dealer inventory
levels have impacted the Company’s consolidated net sales in the
past, and may continue to do so in the future. In addition, the
Company may from time to time, engage in new distributor
relationships that could cause fluctuations of consolidated net
sales and operating income. Distributor inventory levels may
fluctuate, and may differ from the Company’s projections, resulting
in the Company’s forecast of future results being different than
expected.
There can be no assurance that the Company’s dealers and customers
will maintain levels of inventory or patterns of build and
liquidation timing in accordance with the Company’s predictions or
past history. As of January 1, 2022, certain dealers’ inventory of
the Company’s CAD/CAM products in the U.S. were higher than at the
beginning of fiscal year 2021 by approximately $50 million due to
lower-than-expected retail sales as well as timing-related
purchases by dealers in the fourth quarter of 2021, partly driven
by incentives offered during the latter half of 2021. During 2022,
the levels of inventory at our distributors were reduced by
approximately $60 million, returning to a level more aligned with
our historical expectations.
The Company anticipates that inventory levels may continue to
fluctuate as dealers and customers manage the effects of supply
chain constraints on their businesses. Any of these fluctuations
could be material to the Company’s consolidated financial
statements. For more information about the drivers of our business
and related risks, see Part I, Item 1, "Business" and Part I, Item
1A, "Risk Factors."
Restructuring Programs
On February 14, 2023, the Board of Directors of the Company
approved a plan to restructure the Company’s business to improve
operational performance and drive shareholder value creation. This
plan consists of the following planned measures: (a) implement a
new operating model with five global business units designed to
drive enterprise integration and align the product portfolio with
our growth strategy; (b) commencement of central functions and
infrastructure optimization to support efficiency of the overall
organization; (c) creation of a Senior Vice President of the
Quality and Regulatory role, designed to elevate the quality and
regulatory affairs function within the management team; (d)
simplify the management structure to bring the Company in-line with
industry best practices; and (e) deliver cost savings to fund
critical investments in 2023 and beyond to position the Company for
sustainable future growth.
The restructuring plan anticipates a reduction in the Company’s
global workforce of approximately 8% to 10%, subject to
co-determination processes with employee representative groups in
countries where required. The Company expects to incur up to $165
million in one-time charges, comprising $130 million in
restructuring expenditures and charges, the majority of which will
be expensed as cash expenditures in 2023, primarily related to
employee transition, severance payments and employee benefits; and
$35 million in other non-recurring costs related to the
restructuring activity which mostly consist of legal, consulting
and other professional service fees. The Company anticipates that
the restructuring plan will be substantially completed within the
next eighteen months and result in $200 to $225 million in net
annual cost savings.
Impact of Foreign Currencies
Due to the Company’s global footprint, movements in foreign
currency exchange rates may have a material impact on its reported
net sales and pre-tax income. With approximately two-thirds of the
Company’s net sales originating from regions outside the U.S, the
Company’s net sales and results of operations are negatively
impacted by the strengthening, or positively impacted by the
weakening, of the U.S. dollar compared to the primary currencies in
which the Company operates.
While the Company employs financial instruments to hedge some of
its transactional foreign exchange exposure, these activities do
not insulate it completely from those exposures, particularly from
the currency exposure arising from translation of non-U.S. dollar
functional currency subsidiaries. During fiscal year 2022, both net
sales and gross profit were adversely impacted due to the
significant strengthening of the U.S. dollar against foreign
currencies. The continued strength of the U.S. dollar could
continue to adversely impact the Company's results.
RESULTS OF OPERATIONS
Net Sales
A reconciliation of net sales to organic sales for the year ended
December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
3,922 |
|
|
$ |
4,231 |
|
|
$ |
(309) |
|
|
(7.3 |
%) |
Foreign exchange impact |
|
|
|
|
|
|
|
(6.8 |
%) |
Acquisitions |
|
|
|
|
|
|
|
0.1 |
% |
Divestitures and discontinued products |
|
|
|
|
|
|
|
(0.1 |
%) |
Organic sales |
|
|
|
|
|
|
|
(0.5 |
%) |
Percentages are based on actual values and may not recalculate due
to rounding.
The decrease in organic sales was primarily due to
overall weaker performance in the U.S., as explained below,
including sales of CAD/CAM and Endodontic & Restorative
consumables products, and the ongoing
impact of global supply chain constraints and reduction in volumes
due to product availability, particularly for certain Equipment
& Instruments products which rely on electronic components.
Sales were also negatively impacted by reduced demand from patient
traffic in certain markets as a result
of COVID-19 variants
and related restrictions, particularly in China. These negative
drivers were mostly offset by strong regional performance in the
Europe and demand for Orthodontic products, as well as a benefit
from price increases.
Net Sales by Segment
Technologies & Equipment
A reconciliation of net sales to organic sales for the year ended
December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
2,318 |
|
|
2,504 |
|
|
$ |
(186) |
|
|
(7.4 |
%) |
Foreign exchange impact |
|
|
|
|
|
|
|
(7.9 |
%) |
Acquisitions |
|
|
|
|
|
|
|
0.1 |
% |
|
|
|
|
|
|
|
|
|
Organic sales |
|
|
|
|
|
|
|
0.4 |
% |
Percentages are based on actual values and may not recalculate due
to rounding.
The increase in organic sales was primarily due to higher demand
for Orthodontics and Equipment & Instruments, as well as a
benefit from price increases. These positive drivers were offset by
the impact of ongoing global supply chain constraints
and lower volumes due to product availability, particularly for
certain Equipment & Instruments products which rely on
electronic components,
as well as the impact of COVID-19 reducing demand in certain
markets, particularly China. Sales of CAD/CAM products in the U.S.
were also negatively impacted by high dealer inventory levels at
the start of fiscal year 2022, as explained below.
Consumables
A reconciliation of net sales to organic sales for the year ended
December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
1,604 |
|
|
$ |
1,727 |
|
|
$ |
(123) |
|
|
(7.1 |
%) |
Foreign exchange impact |
|
|
|
|
|
|
|
(5.2 |
%) |
|
|
|
|
|
|
|
|
|
Divestitures and discontinued products |
|
|
|
|
|
|
|
(0.2 |
%) |
Organic sales |
|
|
|
|
|
|
|
(1.7 |
%) |
Percentages are based on actual values and may not recalculate due
to rounding.
The decrease in organic sales was due to lower Endodontic &
Restorative volumes, particularly in the U.S. and China, with sales
volumes in the latter having been affected by COVID-19 variants and
the impact of government regulations stemming from the pandemic.
Sales during the comparative twelve months of 2021 benefited from
our customers restocking their inventory of consumables products as
part of the overall recovery from the pandemic. The decline in
sales volume was partly offset by strong performance for preventive
consumables products and
a benefit from price increases across the segment.
Net Sales by Region
United States
A reconciliation of net sales to organic sales for the year ended
December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
1,392 |
|
|
$ |
1,480 |
|
|
$ |
(88) |
|
|
(5.9 |
%) |
Foreign exchange impact |
|
|
|
|
|
|
|
(1.4 |
%) |
Acquisitions |
|
|
|
|
|
|
|
0.2 |
% |
Divestitures and discontinued products |
|
|
|
|
|
|
|
(0.1 |
%) |
Organic sales |
|
|
|
|
|
|
|
(4.6 |
%) |
Percentages are based on actual values and may not recalculate due
to rounding.
The decrease in organic sales was attributable to both the
Technologies & Equipment and the Consumables segments and was
primarily due to weaker retail performance in several product
groups overall and lower wholesale volumes for CAD/CAM products,
due in part to higher dealer inventory at the beginning of fiscal
year 2022 which was subsequently reduced throughout the year. The
level of inventory for CAD/CAM units held by dealers was reduced by
approximately $60 million during 2022, compared to a build in
inventory levels of approximately $50 million in 2021 partly as a
result of incremental incentives offered during the latter half of
that period which did not recur in 2022. Sales volumes were also
negatively impacted by ongoing global supply chain constraints
affecting the ability to fulfill certain Equipment &
Instruments orders, particularly for imaging products. These
negative drivers were partly offset by growth in demand for
Orthodontics products.
Europe
A reconciliation of net sales to organic sales for the year ended
December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
1,559 |
|
|
$ |
1,675 |
|
|
$ |
(116) |
|
|
(6.9 |
%) |
Foreign exchange impact |
|
|
|
|
|
|
|
(9.8 |
%) |
|
|
|
|
|
|
|
|
|
Divestitures and discontinued products |
|
|
|
|
|
|
|
(0.1 |
%) |
Organic sales |
|
|
|
|
|
|
|
3.0 |
% |
Percentages are based on actual values and may not recalculate due
to rounding.
The increase in organic sales was primarily due to overall higher
demand for Endodontic & Restorative products. Sales for
Equipment & Instruments, CAD/CAM, and Orthodontics products
were higher as a result of favorable market trends and demand in
the first three quarters of the year, as well as a benefit from
price increases. Organic sales growth in Europe declined during the
fourth quarter, partly as a result of lower demand for Implants
products. Organic
sales for fiscal year 2022 was partly suppressed by ongoing global
supply chain constraints, particularly for certain Equipment &
Instruments products which rely on electronic
components.
Rest of World
A reconciliation of net sales to organic sales for the year ended
December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
971 |
|
|
$ |
1,076 |
|
|
$ |
(105) |
|
|
(9.8 |
%) |
Foreign exchange impact |
|
|
|
|
|
|
|
(9.6 |
%) |
|
|
|
|
|
|
|
|
|
Divestitures and discontinued products |
|
|
|
|
|
|
|
(0.1 |
%) |
Organic sales |
|
|
|
|
|
|
|
(0.1 |
%) |
Percentages are based on actual values and may not recalculate due
to rounding.
Organic sales showed a slight decline driven primarily by lower
demand in China resulting from the adverse impact of COVID-19 and
government restrictions affecting patient traffic. Beginning in the
third quarter of 2022, we began to see softer demand for Implants
products in China ahead of the local volume based procurement
program taking effect in the first half of 2023. For additional
details see Part I, Item I, "Business." These negative drivers were
mostly offset due to overall growth in sales for CAD/CAM products.
Absent the significant decline in sales for China, we also saw
strong retail demand across the region for restorative and
preventive consumables products.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Gross profit |
|
$ |
2,127 |
|
|
$ |
2,347 |
|
|
$ |
(220) |
|
|
(9.4 |
%) |
|
|
|
|
|
|
|
|
|
Gross profit as a percentage of net sales |
|
54.2 |
% |
|
55.5 |
% |
|
(130) bps
|
|
|
Percentages are based on actual values and may not recalculate due
to rounding.
The decrease in the gross profit rate as a percentage of net sales
was primarily driven by foreign currency headwinds, increased
inflationary pressures on material and distribution costs in the
current year, and unfavorable mix driven by lower demand for higher
margin products. This was partially offset by price increases, a
reduction in customer sales incentives for certain products, and
lower warranty provisions relative to the prior year. Inflationary
pressure on direct material remained strong throughout the second
half of 2022, resulting in an increased inventory balance which is
expected to negatively impact cost of goods sold in 2023 as the
inventory is sold.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses
(“SG&A”) |
|
$ |
1,589 |
|
|
$ |
1,551 |
|
|
$ |
38 |
|
|
2.4 |
% |
Research and development expenses ("R&D") |
|
174 |
|
|
171 |
|
|
3 |
|
|
1.6 |
% |
Goodwill impairment |
|
1,187 |
|
|
— |
|
|
1,187 |
|
|
NM |
Intangible asset impairment and other costs |
|
114 |
|
|
17 |
|
|
97 |
|
|
NM |
|
|
|
|
|
|
|
|
|
SG&A as a percentage of net sales |
|
40.5 |
% |
|
36.6 |
% |
|
390 bps
|
|
|
R&D as a percentage of net sales |
|
4.4 |
% |
|
4.1 |
% |
|
30 bps
|
|
|
Percentages are based on actual values and may not recalculate due
to rounding.
NM - Not meaningful
SG&A Expenses
SG&A expenses
increased primarily
due to
costs related to the recently concluded internal investigation
conducted by the Audit and Finance Committee and related
remediation activities, including various legal, accounting and
other professional services fees, as well as turnover and other
employee-related costs. We
also incurred higher headcount and travel expenses during the
current year following the recovery from the COVID-19
pandemic.
These increases were partly offset
by lower expense for sales commissions and a benefit from foreign
currency translation.
R&D Expenses
R&D expenses showed a slight increase due to increased
investments in digital workflow solutions, product development
initiatives, software development including clinical application
suite and cloud deployment. R&D expense as a percentage of net
sales increased primarily due to lower sales in 2022 as compared to
the prior year. We expect to continue to maintain a level of
investment in R&D that is at least 4% of annual net
sales.
Goodwill Impairment
For the year ended December 31, 2022, the Company recorded a
goodwill impairment charge of $1,187 million related to two
reporting units within the Technologies & Equipment
segment.
There were no impairments recorded in the year ended
December 31, 2021. As the fair value of these reporting units
continues to approximate carrying value as of December 31, 2022,
any further decline in key assumptions could result in additional
impairments in future periods.
For further details see Item 8, Note 12, Goodwill and Intangible
Assets, in the Notes to the Audited Consolidated Financial
Statements of this Form 10-K.
Intangible Asset Impairment and Other Costs
During the year ended December 31, 2022, we recorded net
expense of $114 million of intangible asset impairment and other
costs which consist primarily of an impairment charge of $100
million related to certain tradenames and trademarks within both
the Technology & Equipment segment and Consumables segment and
$14 million of other costs, which consist primarily of
restructuring costs in connection with the various restructuring
initiatives. During the year ended December 31, 2021, we
recorded net expense of $17 million of restructuring costs in
connection with the various restructuring initiatives. As the fair
value of these indefinite-lived intangible assets continues to
approximate carrying value as of December 31, 2022, any further
decline in key assumptions could result in additional impairments
in future periods. For further details see Item 8, Note 19,
Intangible Asset Impairment and Other
Costs, in the Notes to the Audited Consolidated Financial
Statements of this Form 10-K.
Segment Adjusted Operating Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages)(a)
|
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Technologies & Equipment
|
|
$ |
399 |
|
|
$ |
543 |
|
|
$ |
(144) |
|
|
(26.5 |
%) |
|
|
|
|
|
|
|
|
|
Consumables |
|
495 |
|
|
539 |
|
|
(44) |
|
|
(8.2 |
%) |
Percentages
are based on actual values and may not recalculate due to
rounding.
(a) See Note 7, Segment and Geographic Information, in the Notes to
Consolidated Financial Statements in Item 8 of this Form 10-K for a
reconciliation from segment adjusted operating income to
consolidated US GAAP income.
The decrease in adjusted operating income for both Technologies
& Equipment and Consumables was primarily driven by the
decrease in sales volumes and the higher costs for raw materials,
labor, and distribution costs in the current year as a result of
supply chain constraints and global currency inflation, offset by
benefits from price increases.
Other Income and Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
$ |
60 |
|
|
$ |
55 |
|
|
$ |
5 |
|
|
9.6 |
% |
Other expense (income), net |
|
58 |
|
|
8 |
|
|
50 |
|
|
NM |
Net interest and other expense |
|
$ |
118 |
|
|
$ |
63 |
|
|
$ |
55 |
|
|
|
Percentages are based on actual values and may not recalculate due
to rounding.
NM - Not meaningful
Interest expense, net
Net interest expense for the year ended December 31, 2022
increased by $5 million as compared to the year ended
December 31, 2021, driven primarily by higher interest rates
on short-term and other borrowings partially offset by lower
average borrowings in 2022 relative to the prior year
period.
Other expense (income), net
Other expense (income), net for the year ended December 31,
2022 compared to the year ended December 31, 2021 was as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
|
|
|
|
|
|
Loss (gain) on sales or disposal of non-core businesses |
|
$ |
3 |
|
|
$ |
(7) |
|
|
$ |
10 |
|
Foreign exchange losses (gains)
(a)
|
|
11 |
|
|
(6) |
|
|
17 |
|
Loss from equity method investments |
|
36 |
|
|
10 |
|
|
26 |
|
Defined benefit pension plan expenses (income) |
|
7 |
|
|
10 |
|
|
(3) |
|
Other non-operating loss |
|
1 |
|
|
1 |
|
|
— |
|
Other expense (income), net |
|
$ |
58 |
|
|
$ |
8 |
|
|
$ |
50 |
|
(a) Foreign exchange losses (gains) are primarily related to the
revaluation of intercompany payables and loans.
Loss from equity method investments for the year ended
December 31, 2022 increased by $26 million as compared to the
year ended December 31, 2021 and primarily relates to a
write-off of the Company's ownership position in a privately-held
dental investment company following impairment of underlying
investments held by the investment company and the Company's
determination that the remaining investment is not
recoverable.
Income Taxes and Net (Loss) Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
(in millions, except per share data and percentages) |
|
2022 |
|
2021 |
|
$ Change |
|
|
|
|
|
|
|
(Benefit) provision for income taxes |
|
$ |
(105) |
|
|
$ |
134 |
|
|
$ |
(239) |
|
|
|
|
|
|
|
|
Effective income tax rate |
|
9.9 |
% |
|
24.6 |
% |
|
|
|
|
|
|
|
|
|
Net (loss) income attributable to Dentsply Sirona |
|
$ |
(950) |
|
|
$ |
411 |
|
|
$ |
(1,361) |
|
|
|
|
|
|
|
|
Net (loss) income per common share - diluted
(a)
|
|
$ |
(4.41) |
|
|
$ |
1.87 |
|
|
|
Percentages are based on actual values and may not recalculate due
to rounding.
(a) For the year ended December 31, 2022, our net loss per share
was calculated on a non-diluted basis.
(Benefit) provision for income taxes
We recorded an income tax benefit of $105 million and an income tax
expense of $134 million for the year ended December 31, 2022
and December 31, 2021, respectively. The decrease in the
effective tax rate from 24.6% to 9.9% is primarily due to the
impairment of goodwill recorded in 2022.
Further information regarding the details of income taxes is
presented in Note 17, Income Taxes, in the Notes to Consolidated
Financial Statements in Item 8 of this Form 10-K.
Discussion of the results of operations for the year ended December
31, 2020 was included in Part II, Item 7 “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” in
the Company’s Form 10-K for the year ended December 31, 2021, as
amended and filed with the SEC on November 7, 2022.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The preparation of the Company’s consolidated financial statements
in conformity with US GAAP requires the Company to make estimates
and assumptions about future events that affect the amounts
reported in the consolidated financial statements and accompanying
notes. Future events and their effects cannot be determined with
absolute certainty. Therefore, the determination of estimates
requires the exercise of judgment. Actual results could differ from
those estimates, and such differences may be material to the
consolidated financial statements. The process of determining
significant estimates is fact specific and takes into account
factors such as historical experience, current and expected
economic conditions, product mix and in some cases, actuarial
techniques. The Company evaluates these significant factors as
facts and circumstances dictate. Some events as described below
could cause results to differ significantly from those determined
using estimates. The Company has identified the following
accounting estimates as those which are critical to its business
and results of operations.
Business Acquisitions
The Company acquires businesses as well as partial interests in
businesses. Acquired businesses are accounted for using the
acquisition method of accounting which requires the Company to
record assets acquired and liabilities assumed at their respective
fair values with the excess of the purchase price over estimated
fair values recorded as goodwill. The assumptions made in
determining the fair value of acquired assets and assumed
liabilities as well as asset lives can materially impact the
results of operations.
The Company obtains information during due diligence and through
other sources to get respective fair values. Examples of factors
and information that the Company uses to determine the fair values
include: tangible and intangible asset evaluations and appraisals,
and evaluations of existing contingencies, liabilities, and product
line integration information. If the initial valuation for an
acquisition is incomplete by the end of the reporting period in
which the acquisition occurred, the Company will record a
provisional estimate in the financial statements. The provisional
estimate will be finalized as soon as information becomes available
but will only occur up to one year from the acquisition date. More
information on the assumptions used to estimate the fair values of
acquired intangible assets is included in Note 1, Significant
Accounting Policies, in the Notes to Consolidated Financial
Statements in Item 8 of this Form 10-K.
Goodwill and Indefinite-Lived Intangible Assets
The Company follows the accounting standards for goodwill and
indefinite-lived intangibles, which require an annual test for
impairment to goodwill using a fair value approach. In addition to
minimum annual impairment tests, the Company also performs
impairment assessments more frequently if events or changes in
circumstances indicate that the goodwill or indefinite-lived assets
might be impaired. If the carrying value of a reporting unit with
goodwill exceeds the implied fair value of that reporting unit, an
impairment charge is recognized for the excess amount. Similarly,
if the carrying amount of an indefinite-lived intangible asset
exceeds its fair value, an impairment loss is recognized on the
intangible.
Impairment Assessment
Assessment of the potential impairment of goodwill and
indefinite-lived intangible assets is an integral part of the
Company’s normal ongoing review of operations. Testing for
potential impairment of these assets is dependent on significant
assumptions and reflects management’s best estimates at a
particular point in time. The dynamic economic environments in
which the Company’s businesses operate and key economic and
business assumptions with respect to projected selling prices,
increased competition and introductions of new technologies can
significantly affect the outcome of impairment tests. Estimates
based on these assumptions may differ significantly from actual
results. Changes in factors and assumptions used in assessing
potential impairments can have a significant impact on the
existence and magnitude of impairments, as well as the time at
which such impairments are recognized. If there are unfavorable
changes in these assumptions, particularly changes in the Company’s
discount rates, revenue growth rates, and operating margins, the
Company may be required to recognize impairment
charges.
In particular, the determination of fair value involves
uncertainties around the forecasted cash flows as it requires
management to make assumptions and apply judgment to estimate
future business expectations. Those future expectations include,
but are not limited to, the current and ongoing impact of the
COVID-19 pandemic, distribution channel changes, impact from
competition, and new product developments for these reporting
units. The Company also considers the current and projected market
and economic conditions for dental and medical device industries,
both in the U.S. and globally, when determining its assumptions.
Operating cash flow assumptions may also be impacted by assumptions
regarding costs and benefits from restructuring initiatives, tax
rates, foreign exchange rates, capital spending and working capital
changes.
A change in any of these estimates and assumptions used in the
annual test, as well as unfavorable changes in the ongoing COVID-19
pandemic, or in the overall markets served by these reporting
units, among other factors, could have a negative material impact
to the fair value of the reporting units and indefinite-lived
intangible assets and could result in a future impairment charge.
There can be no assurance that the Company's future goodwill and
indefinite-lived impairment testing will not result in a material
adverse impact to the Company's results of operations.
Information with respect to the Company’s significant accounting
policies on goodwill and indefinite-lived intangible assets are
included in Note 1, Significant Accounting Policies, in the Notes
to Consolidated Financial Statements in Item 8 of this Form
10-K.
Goodwill Impairment
Goodwill represents the excess cost over the fair value of the
identifiable net assets of business acquired. Goodwill is not
amortized; instead, it is tested for impairment annually or more
frequently if events or circumstances indicate that the carrying
value of goodwill may be impaired, or if a decision is made to sell
a business. Judgment is involved in determining if an indicator of
impairment has occurred during the course of the year. Such
indicators may include a decline in expected cash flows,
unanticipated competition or slower growth rates, among others.
When testing goodwill for impairment, the Company may assess
qualitative factors for its reporting units to determine whether it
is more likely than not that the fair value of a reporting unit is
less than its carrying amount including goodwill. Alternatively,
the Company may bypass this qualitative assessment and perform the
quantitative goodwill impairment test. It is important to note that
fair values which could be realized in an actual transaction may
differ from those used to evaluate the impairment of
goodwill.
Goodwill is allocated among reporting units and evaluated for
impairment at that level. The Company’s reporting units are either
an operating segment or one level below its operating segments, as
determined in accordance with ASC 350.
The quantitative evaluation of impairment involves comparing the
current fair value of each reporting unit to its net book value,
including goodwill. The Company uses a discounted cash flow model
(“DCF model”) as its valuation technique to measure the fair value
for its reporting units when testing for impairment, as management
believes forecasted operating cash flows are the best indicator of
such fair value. The discounted cash flow model uses five- to ten-
year forecasted cash flows plus a terminal value based on
capitalizing the last period’s cash flows using a perpetual growth
rate. The significant assumptions and estimates involved in the
application of the DCF model to forecast operating cash flows
include, but are not limited to the discount rates, revenue growth
rates (including perpetual growth rates), future operating margin
percentages, and net working capital changes of the reporting
unit’s business. These assumptions may vary significantly among the
reporting units. Operating cash flow forecasts are based on
approved business-unit operating plans for the early years and
historical relationships and projections in later years. In the
development of the forecasted cash flows, the Company applies
revenue, gross profit, and operating expense assumptions taking
into consideration historical trends as well as future
expectations. The revenue growth rate assumptions were developed in
consideration of future expectations which included, but were not
limited to, the current and ongoing impact of the COVID-19
pandemic, distribution channel changes, impact from competition,
and new product developments for these reporting units. Discount
rates are estimated for geographic regions and applied to the
reporting units located within the regions. These rates are
developed based on market participant data, which included
assumptions regarding the Company’s weighted-average cost of
capital adjusted for the relevant risk associated with
business-specific characteristics and the uncertainty related to
the reporting unit's ability to execute on the projected cash
flows. As part of the annual test, the Company reconciled the
aggregate fair values of its reporting units to its market
capitalization, which included a reasonable control premium based
on market conditions. The Company has not materially changed its
methodology for goodwill impairment testing for the years
presented.
Indefinite-Lived Intangible Asset Impairment
Indefinite-lived intangible assets consist of tradenames,
trademarks and in-process R&D and are not subject to
amortization; instead, they are tested for impairment annually or
more frequently if events or circumstances indicate that the
carrying value of indefinite-lived intangible assets may be
impaired or if a decision is made to sell a business. A significant
amount of judgment is involved in determining if an indicator of
impairment has occurred during the course of the year. Such
indicators may include a decline in expected cash flow,
unanticipated competition or slower growth rates, among others. It
is important to note that fair values that could be realized in an
actual transaction may differ from those used to evaluate the
impairment of indefinite-lived assets.
The fair value of acquired tradenames and trademarks is estimated
by the use of a relief from royalty method, which values an
indefinite-lived intangible asset by estimating the royalties saved
through the ownership of an asset. Under this method, an owner of
an indefinite-lived intangible asset determines the arm’s length
royalty that likely would have been charged if the owner had to
license the asset from a third party. The royalty rate, which is
based on the estimated rate applied against forecasted sales, is
tax-effected and discounted at present value using a discount rate
commensurate with the relative risk of achieving the cash flow
attributable to the asset. Management judgment is necessary to
determine key assumptions, including revenue growth rates,
perpetual revenue growth rates, royalty rates, and discount rates.
Other assumptions are consistent with those applied to goodwill
impairment testing.
Goodwill and Indefinite-Lived Intangible Asset Impairment
Results
No goodwill or indefinite-lived intangible impairment was
identified as of April 1, 2022 in conjunction with the annual
test.
In the third quarter of 2022, the Company experienced adverse
macroeconomic factors as a result of weakened global demand, higher
cost of capital, unfavorable foreign currency impacts, and
increased raw material, supply chain and service costs, which
contributed to reduced forecasted revenues, lower operating
margins, and reduced expectations for future cash flows. As a
result, the Company identified indicators of a "more likely than
not" impairment related to its Digital Dental Group and Equipment
& Instruments reporting units and indefinite-lived intangible
assets, included within the Technologies & Equipment segment,
and indicators of a "more likely than not" impairment related to
its indefinite-lived intangibles assets for the Consumables
reporting unit within the Consumables segment. As such, an interim
impairment test was performed ("the interim test"). The Company
recorded a pre-tax goodwill impairment charge related to the
Digital Dental Group and Equipment & Instruments reporting
units within the Technologies & Equipment segment of $1,100
million and $87 million, respectively, and an indefinite-lived
intangible asset impairment charge of $66 million and $26 million
for the Digital Dental Group and Equipment & Instruments
reporting units, respectively, within the Technologies &
Equipment segment and a $2 million impairment charge for the
Consumables reporting unit within the Consumables reporting unit
for the three months ended September 30, 2022.
In the fourth quarter of 2022, reductions in near-term forecasts
for specific tradenames and continued adverse macroeconomic
factors, including the impact of foreign exchange rates, resulted
in indicators of a "more likely than not" impairment for certain
indefinite-lived intangible assets within the Equipment &
Instruments reporting unit within the Technologies & Equipment
segment and the Consumables reporting unit within the Consumables
segment. As such, an impairment test was performed during the
fourth quarter, resulting in an intangible asset impairment charges
of $2 million and $4 million for indefinite-lived intangible assets
within the Equipment & Instruments and Consumables reporting
units, respectively, for the three months ended December 31,
2022.
For 2022, the goodwill impairment charge was recorded in Goodwill
impairment in the Consolidated Statements of Operations, and the
intangibles impairment charges were recorded in Intangible asset
impairment and other costs in the Consolidated Statements of
Operations. For further information on our annual and interim
tests, see Note 12, Goodwill and Intangible Assets, in the Notes to
Consolidated Financial Statements in Item 8 of this Form
10-K.
No goodwill or indefinite-lived intangible impairment was
identified for the year ended December 31, 2021.
In 2020, the Company recorded impairment charges of $157 million
and $39 million related to goodwill and certain tradenames and
trademarks, respectively, for the Equipment & Instruments
reporting unit within the Technologies & Equipment segment as a
result of changes in forecasted revenues, operating margins, and
discount rates due to the negative impacts of the COVID-19
pandemic. The goodwill impairment charge was recorded in Goodwill
impairment in the Consolidated Statements of Operations, and the
intangibles impairment charge was recorded in Intangible asset
impairment and other costs in the Consolidated Statements of
Operations.
Income Taxes
Income taxes are determined using the liability method of
accounting for income taxes. The Company’s tax expense includes
U.S. and international income taxes plus the provision for U.S.
taxes on undistributed earnings of international subsidiaries not
considered to be permanently invested.
The Company applies a recognition threshold and measurement
attribute for the financial statement recognition and measurement
of a tax position taken or expected to be taken in a tax return.
The Company recognizes in the consolidated financial statements the
impact of a tax position if that position is more likely than not
of being sustained upon examination by the taxing authorities based
on the technical merits of the position.
Certain items of income and expense are not reported in tax returns
and financial statements in the same year. The tax effect of such
temporary differences is reported as deferred income taxes.
Deferred tax assets are recognized if it is more likely than not
that the assets will be realized in future years. The Company
establishes a valuation allowance for deferred tax assets for which
realization is not likely. At December 31, 2022, the Company
has a valuation allowance of $645 million against the benefit of
certain deferred tax assets of foreign and domestic
subsidiaries.
The Company’s tax positions are subject to ongoing examinations by
the tax authorities. The Company operates within multiple taxing
jurisdictions throughout the world and in the normal course of
business is examined by taxing authorities in those jurisdictions.
Adjustments to the uncertain tax positions are recorded when taxing
authority examinations are completed, statutes of limitation are
closed, changes in tax laws occur or as new information comes to
light with regard to the technical merits of the tax
position.
LIQUIDITY AND CAPITAL RESOURCES
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Year Ended December 31, |
(in millions) |
2022 |
|
2021 |
|
$ Change |
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|
|
|
|
Cash provided by (used in): |
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|
|
|
|
|
Operating activities |
|
$ |
517 |
|
|
$ |
657 |
|
|
$ |
(140) |
|
Investing activities |
|
(138) |
|
|
(358) |
|
|
220 |
|
Financing activities |
|
(329) |
|
|
(379) |
|
|
50 |
|
Effect of exchange rate changes on cash and cash
equivalents |
|
(24) |
|
|
(19) |
|
|
(5) |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
26 |
|
|
$ |
(99) |
|
|
$ |
125 |
|
|
|
|
|
|
|
|
Cash provided by operating activities decreased primarily as a
result of lower sales during the current period, as well as a
build-up in inventory partly as a consequence of temporary COVID-19
related shutdowns in China. These decreases in operating cash were
offset by other changes in working capital including higher
liabilities for trade accounts payables and lower accounts
receivable. For the year ended December 31, 2022, the number of
days for sales outstanding in accounts receivable decreased by 5
days to 55 days at December 31, 2022 as compared to 60 days at
December 31, 2021, and the number of days of sales in
inventory increased by 27 days to 137 days at December 31, 2022 as
compared to 110 days at December 31, 2021.
The decrease in cash used in investing activities was primarily due
to activity in 2021 including lower cash paid for acquisitions of
$248 million, partially offset by lower proceeds from the sale of
non-strategic businesses or product lines of $28 million, higher
capital expenditures of $7 million, and higher cash proceeds from
net investment hedges of $11 million.
The Company estimates capital expenditures to be in the range of
approximately
$150 million to $170 million for the full year 2023 and expects
these investments to include expansion of facilities to provide
incremental space for
growth and to consolidate operations for enhanced
efficiencies.
The decrease in cash used in financing activities was primarily
driven by lower net payments on debt of $42 million during 2022
compared to prior year, lower stock repurchases of $50 million and
lower proceeds from exercises of stock options of $45 million.
Primarily as a result of this activity, combined with a decrease of
$60 million due to exchange rate fluctuations on debt denominated
in foreign currencies, the Company's total borrowings decreased by
a net $151 million during the year ended December 31,
2022.
During the year ended December 31, 2022, the Company repurchased
approximately 3.1 million shares under its open market share
repurchase plan for a cost of $150 million at a
volume-weighted average price of $48.22. On July 28, 2021, the
Board of Directors of the Company approved an increase in the value
of shares of common stock that may be repurchased under the share
repurchase program to $1 billion. At December 31, 2022, $740
million of authorization remains available for future share
repurchases. Additional share repurchases, if any, may be made
through open market purchases, Rule 10b5-1 plans, accelerated share
repurchases, privately negotiated transactions, or other
transactions in such amounts and at such times as the Company
considers appropriate based upon prevailing market and business
conditions and other factors. At December 31, 2022, the
Company held 49.3 million shares of treasury stock.
The Company's ratio of total net debt to total capitalization was
as follows:
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Year Ended December 31, |
(in millions, except percentages) |
|
2022 |
|
2021 |
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|
|
|
|
Current portion of debt |
|
$ |
118 |
|
|
$ |
182 |
|
Long-term debt |
|
1,826 |
|
|
1,913 |
|
Less: Cash and cash equivalents |
|
365 |
|
|
339 |
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Net debt |
|
$ |
1,579 |
|
|
$ |
1,756 |
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|
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Total equity |
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3,812 |
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|
4,997 |
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Total capitalization |
|
$ |
5,391 |
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|
$ |
6,753 |
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|
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|
|
Total net debt to total capitalization ratio |
|
29.3 |
% |
|
26.0 |
% |
At December 31, 2022, the Company had a total remaining
borrowing capacity of $632 million under lines of credit,
including lines available under its short-term arrangements and
revolving credit facility. The Company's borrowing capacity
includes a $700 million credit facility from 2018 available through
July 28, 2024. The Company also has available an aggregate $500
million under a U.S. dollar commercial paper facility. The $700
million revolver serves as a back-up to the commercial paper
facility, thus the total available credit under the commercial
paper facility and the multi-currency revolving credit facility in
the aggregate is $700 million. The Company had $95 million
outstanding borrowings under the commercial paper facility at
December 31, 2022 resulting in $605 million remaining
available under the revolving credit and commercial paper
facilities. The Company also has access to $50 million in
uncommitted short-term financing under lines of credit from various
financial institutions. The lines of credit have no major
restrictions and are provided under demand notes between the
Company and the lending institutions. At December 31, 2022,
the Company has $22 million outstanding under short-term borrowing
arrangements.
The Company’s revolving credit facility, term loans and senior
notes contain certain covenants relating to the Company's
operations and financial condition. The most restrictive of these
covenants are: a ratio of total debt outstanding to total capital
not to exceed 0.6, and a ratio of operating income excluding
depreciation and amortization to interest expense of not less than
3.0 times, in each case, as such terms are defined in the relevant
agreement. Any breach of any such covenants would result in a
default under the existing debt agreements that would permit the
lenders to declare all borrowings under such debt agreements to be
immediately due and payable and, through cross default provisions,
would entitle the Company's other lenders to accelerate their
loans. At December 31, 2022, the Company was in compliance
with these covenants.
Additionally, the Company is required under certain of its debt
agreements to deliver or make available to borrowers its unaudited
financial statements on a timely basis each quarter along with the
necessary certifications. As a result of the Company’s temporary
failure to file its unaudited financial statements for the fiscal
quarters ended March 31, 2022 and June 30, 2022 by the reporting
deadlines, the Company obtained the consents of the requisite
lenders and noteholders of its outstanding indebtedness to extend
the time period for delivery of such unaudited financial statements
until November 14, 2022. Those financial statements were delivered
on November 9, 2022 and therefore, the Company did not suffer an
event of default as a result of the previously delayed
filings.
The Company expects on an ongoing basis to be able to finance
operating cash requirements,
capital expenditures, and debt service
from the current cash, cash equivalents, cash flows from operations
and amounts available under its existing borrowing facilities. The
Company's credit facilities are further discussed in Note 15,
Financing Arrangements, to the Consolidated Financial Statements in
Part II, Item 8 of this Form 10-K.
The cash held by foreign subsidiaries for permanent reinvestment is
generally used to finance the subsidiaries' operating activities
and future foreign investments. The Company has the ability to
repatriate cash to the U.S., which could result in an adjustment to
the tax liability for foreign withholding taxes, foreign and/or
U.S. state income taxes, and the impact of foreign currency
movements. At
December 31, 2022,
management believed that sufficient liquidity was available in the
U.S. and expects this to remain for the next twelve months. The
Company has repatriated and expects to continue repatriating
certain funds from its non-U.S. subsidiaries that are not needed to
finance local operations, however, these particular repatriation
activities have not and are not expected to result in a significant
incremental tax liability to the Company.
The Company continues to review its debt portfolio and may
refinance additional debt or add debt in the near-term based on
strategic capital management. The Company believes there is
sufficient liquidity available for the next twelve
months.
Off Balance Sheet Arrangements
At December 31, 2022, the Company held $42 million of
precious metals on consignment from several financial institutions.
Under these consignment arrangements, the financial institutions
own the precious metal, and, accordingly, the Company does not
report this consigned inventory as part of its inventory on the
Consolidated Balance Sheets. These consignment agreements allow the
Company to acquire the precious metal at market rates at a point in
time, which is approximately the same time, and for the same price
as alloys are sold to the Company's customers. In the event that
the financial institutions would discontinue offering these
consignment arrangements, and if the Company could not obtain other
comparable arrangements, the Company may be required to obtain
third party financing to fund an ownership position to maintain
precious metal inventory at operational levels. For additional
details, see Item 7A "Quantitative and Qualitative Disclosure About
Market Risk - Consignment Arrangements."
Contractual Obligations
The Company's scheduled contractual cash obligations at
December 31, 2022 were as follows:
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Within
1 Year
|
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Years 2-3
|
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Years 4-5
|
|
Greater
Than
5 Years
|
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Total |
(in millions) |
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|
Long-term borrowings, including finance leases |
|
$ |
1 |
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|
$ |
227 |
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|
$ |
303 |
|
|
$ |
1,340 |
|
|
$ |
1,871 |
|
Operating leases |
|
61 |
|
|
84 |
|
|
41 |
|
|
37 |
|
|
223 |
|
Purchase commitments |
|
176 |
|
|
193 |
|
|
43 |
|
|
— |
|
|
412 |
|
Interest on long-term borrowings, net of interest rate swap
agreements
|
|
47 |
|
|
91 |
|
|
73 |
|
|
81 |
|
|
292 |
|
Postemployment obligations |
|
25 |
|
|
47 |
|
|
51 |
|
|
128 |
|
|
251 |
|
Precious metal consignment agreements |
|
42 |
|
|
— |
|
|
— |
|
|
— |
|
|
42 |
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|
|
$ |
352 |
|
|
$ |
642 |
|
|
$ |
511 |
|
|
$ |
1,586 |
|
|
$ |
3,091 |
|
Due to the uncertainty with respect to the timing of future cash
flows associated with the Company's unrecognized tax benefits at
December 31, 2022, the Company is unable to make reasonably
reliable estimates of the period of cash settlement with the
respective taxing authority; therefore, $55 million of unrecognized
tax benefits has been excluded from the contractual obligations
table above. See Note 17, Income Taxes, in the Notes to
Consolidated Financial Statements in Item 8 of this Form
10-K.
Material Trends in Capital Resources
Beginning in the second quarter of 2022, the Company's financial
results have been impacted by the costs associated with the
internal investigation conducted by the Audit and Finance Committee
and assisted by independent legal counsel and forensic accountants.
These costs have included professional service fees associated with
the investigation itself, as well as third party accounting and
legal costs incurred by management to make assessments and
revisions and begin remediation activities in response to the
investigation's findings. Additionally, the Company has incurred
severance costs associated with its remedial personnel actions, as
well as costs in connection with retention of key personnel. These
costs totaled approximately $61 million for the year ended December
31, 2022. Although the internal investigation has been completed,
related costs are expected to continue as a material trend into
2023 as the Company works to complete its remediation activities
described in Part II, Item 9A Controls and Procedures of this Form
10-K, and incurs legal defense costs pertaining to the matters
described in Note 22 Commitments and Contingencies to the financial
statements included in Part II, Item 8.
NEW ACCOUNTING PRONOUNCEMENTS
Refer to Note 1, Significant Accounting Policies, in the Notes to
Consolidated Financial Statements in Item 8 of this Form 10-K for a
discussion of recent accounting guidance and
pronouncements.
Item 7A. Quantitative and Qualitative Disclosure About Market
Risk
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET
RISK
The Company’s major market risk exposures are changing interest
rates, movements in foreign currency exchange rates and potential
price volatility of commodities used by the Company in its
manufacturing processes. The Company’s policy is to manage risk of
exposure to interest rates through the use of a combination of
fixed and floating rate debt as well as interest rate swaps. The
Company employs foreign currency denominated debt and currency
swaps which serve to partially offset the Company’s exposure on its
net investments in subsidiaries denominated in foreign currencies.
The Company’s policy generally is to hedge major foreign currency
transaction exposures through foreign exchange forward contracts.
These contracts are entered into with major financial institutions
thereby minimizing the risk of credit loss. In order to limit the
unanticipated earnings fluctuations from volatility in commodity
prices, the Company selectively enters into commodity swaps to
convert variable raw material costs to fixed costs. The Company
does not hold or issue derivative financial instruments for
speculative or trading purposes. The Company is subject to other
foreign exchange market risk exposure in addition to the risks on
its financial instruments, such as possible impacts on its pricing
and production costs, which are difficult to reasonably predict,
and have therefore not been included below.
Foreign Exchange Risk Management
The Company enters into derivative financial instruments to hedge
the foreign exchange revaluation risk associated with recorded
assets and liabilities that are denominated in a non-functional
currency. The Company hedges various currencies, primarily in
euros, Swedish kronor, Canadian dollars, British pounds, Swiss
francs and Japanese yen. The gains and losses on these derivative
transactions offset the gains and losses generated by the
revaluation of the underlying non-functional currency
balances.
The Company primarily uses forward foreign exchange contracts and
cross currency basis swaps to hedge these risks. The Company uses a
layered hedging program to hedge select anticipated foreign
currency cash flows to reduce volatility in both cash flows and
reported earnings of the consolidated Company. These cash flow
hedges have maturities of six to 18 months and do not change the
underlying long-term foreign currency exchange risk. The Company
accounts for the forward foreign exchange contracts as cash flow
hedges. The Company has numerous investments in foreign
subsidiaries the most significant of which are denominated in
euros, Swiss francs, Japanese yen and Swedish kronor. The net
assets of these subsidiaries are exposed to volatility in currency
exchange rates.
Currently, the Company uses both derivative and non-derivative
financial instruments, including foreign currency denominated debt
held at the parent company level and foreign exchange forward
contracts to hedge some of this exposure. Translation gains and
losses related to the net assets of the foreign subsidiaries are
offset by gains and losses in the non-derivative and derivative
financial instruments designated as hedges of net investment. At
December 31, 2022, a 10% weakening of the U.S. dollar against
all other currencies would decrease the net fair value associated
with the forward foreign exchange contracts by approximately $42
million.
Interest Rate Risk Management
The Company enters into financial instruments, including
derivatives, that expose the Company to market risk related to
changes in interest rates. The Company uses a combination of
financial instruments, including long-term and short-term
financing, variable-rate commercial paper and derivative interest
rate swaps to manage the interest rate mix of our total debt
portfolio and related overall cost of borrowing.
At December 31, 2022, an increase of 1% in the interest rates
on the variable interest rate instruments would decrease the
Company's fair value associated with the derivative interest rate
swaps by approximately $11 million.
Consignment Arrangements
The Company holds on a consignment basis, from various financials
institutions, the precious metals used in the production of
precious metal dental alloy products. Under these consignment
arrangements, the financial institutions own the precious metal,
and, accordingly, the Company does not report this inventory on
consignment as part of its inventory on the Consolidated Balance
Sheet. The consignment agreements allow the Company to take
ownership of the metal at approximately the same time customer
orders are received and to closely match the price of the metal
acquired to the price charged to the customer (i.e., the price
charged to the customer is largely a pass through). These
agreements are cancellable by either party at the end of each
consignment period, which typically run for a period of one to nine
months; however, because the Company typically has access to
numerous financial institutions with excess capacity, consignment
needs created by cancellations can be shifted among the other
institutions
As precious metal prices fluctuate, the Company evaluates the
impact of the precious metal price fluctuation on its target gross
margins for precious metal dental alloy products and may revise the
prices customers are charged for precious metal dental alloy
products accordingly. While the Company does not separately invoice
customers for the precious metal content of precious metal dental
alloy products, the underlying precious metal content is the
primary component of the cost and sales price of the precious metal
dental alloy products. For practical purposes, if the precious
metal prices go up or down by a small amount, the Company will not
immediately modify prices, as long as the cost of precious metals
embedded in the Company’s precious metal dental alloy price closely
approximates the market price of the precious metal. If there is a
significant change in the price of precious metals, the Company
adjusts the price for the precious metal dental alloys, maintaining
its margin on the products.
At December 31, 2022, the Company had approximately 31,000
troy ounces of precious metal, primarily gold, platinum, palladium
and silver on consignment for periods of less than one year with a
market value of $42 million. Under the terms of the consignment
agreements, the Company also makes compensatory payments to the
consignor banks based on a percentage of the value of the consigned
precious metals inventory. At December 31, 2022, the average
annual rate charged by the consignor banks was 2.6%. These
compensatory payments are considered to be a cost of the metals
purchased and are recorded as part of the cost of products
sold.
Item 8. Financial Statements and Supplementary
Data
1.Financial
Statements
The following consolidated financial statements of the Company are
filed as part of this Form 10-K:
2.Financial
Statement Schedule for the Years Ended December 31, 2022, 2021, and
2020.
The following financial statement schedule is filed as part of this
Form 10-K and is covered by the Report of Independent Registered
Public Accounting Firm
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Schedule II - Valuation and Qualifying Accounts for the Years Ended
December 31,
2022, 2021, and 2020.
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Management’s Report on Internal Control Over Financial
Reporting
The management of the Company is responsible for establishing and
maintaining adequate internal control over financial reporting, as
such term is defined in Rules 13a-15(f) and 15d-15(f) under the
Securities Exchange Act of 1934, as amended. Internal control over
financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with accounting principles generally accepted in the
United States of America. Internal control over financial reporting
includes those policies and procedures that pertain to the
maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of
the Company; provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements
in accordance with generally accepted accounting principles, and
that receipts and expenditures of the Company are being made only
in accordance with authorizations of management and directors of
the Company; and provide reasonable assurance regarding prevention
or timely detection of unauthorized acquisition, use, or
disposition of the Company’s assets that could have a material
effect on the financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements. In
addition, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
Management of the Company assessed the effectiveness of the
Company’s internal control over financial reporting as of December
31, 2022. In making its assessment, management used the criteria
established in
Internal Control - Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (“COSO”).
Management has concluded that the material weaknesses described
herein, which were previously identified and reported in the 2021
Form 10-K/A, continue to exist as of December 31, 2022. As a
result, management has concluded that the Company’s internal
control over financial reporting was not effective as of December
31, 2022 based on the criteria established in
Internal Control - Integrated Framework
(2013) issued by the COSO.
Material Weaknesses
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material misstatement
of the Company's annual or interim financial statements will not be
prevented or detected on a timely basis.
Management identified the following material weaknesses in the
Company's internal control over financial reporting:
a.The
Company did not design and maintain an effective internal control
environment as former management failed to set an appropriate tone
at the top. Specifically, certain members of senior management,
including the Company’s former Chief Executive Officer and former
Chief Financial Officer, engaged in conduct that was inconsistent
with the Company’s culture of compliance and Code of Ethics and
Business Conduct.
b.The
Company did not maintain a sufficient complement of personnel with
an appropriate level of knowledge about accounting for variable
consideration related to customer incentive arrangements in a
manner commensurate with our financial reporting
requirements.
These material weaknesses contributed to the following additional
material weakness:
c.The
Company did not design and maintain effective controls associated
with approving, communicating, and accounting for incentive
arrangements with customers, impacting the completeness and
accuracy of revenues, including variable
consideration.
These material weaknesses previously resulted in the restatement of
our consolidated financial statements for the year ended December
31, 2021, and the unaudited interim financial information for the
three and nine months ended September 30, 2021. These material
weaknesses also resulted in adjustments to substantially all of our
accounts and disclosures for the interim and annual periods related
to 2019, 2020, and 2021. Additionally, each of these material
weaknesses could result in a misstatement of substantially all of
our account balances or disclosures that would result in a material
misstatement to the annual or interim consolidated financial
statements that would not be prevented or detected.
The Company’s independent registered public accounting firm,
PricewaterhouseCoopers LLP, has audited the effectiveness of the
Company’s internal control over financial reporting as of December
31, 2022, as stated in their report, which appears
herein.
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/s/ |
Simon D. Campion |
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/s/ |
Glenn G. Coleman |
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Simon D. Campion |
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Glenn G. Coleman |
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President and Chief Executive Officer |
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Executive Vice President and |
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Chief Financial Officer |
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March 1, 2023 |
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March 1, 2023 |
Report of Independent Registered Public Accounting
Firm
To the Board of Directors and Stockholders
of DENTSPLY SIRONA Inc.
Opinions on the Financial Statements and Internal Control over
Financial Reporting
We have audited the accompanying consolidated balance sheets of
DENTSPLY SIRONA Inc. and its subsidiaries (the “Company”) as of
December 31, 2022 and 2021, and the related consolidated statements
of operations, of comprehensive income, of changes in equity and of
cash flows for each of the three years in the period ended December
31, 2022, including the related notes and financial statement
schedule listed in the accompanying index (collectively referred to
as the “consolidated financial statements”). We also have audited
the Company's internal control over financial reporting as of
December 31, 2022, based on criteria established in
Internal Control - Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to
above present fairly, in all material respects, the financial
position of the Company as of December 31, 2022 and 2021, and the
results of its operations and its cash flows for each of the three
years in the period ended December 31, 2022 in conformity with
accounting principles generally accepted in the United States of
America. Also in our opinion, the Company did not maintain, in all
material respects, effective internal control over financial
reporting as of December 31, 2022, based on criteria established
in
Internal Control - Integrated Framework
(2013) issued by the COSO because material weaknesses in internal
control over financial reporting existed as of that date related to
lack of an effective internal control environment as former
management failed to set an appropriate tone at the top, lack of a
sufficient complement of personnel with an appropriate level of
knowledge about accounting for variable consideration related to
customer incentive arrangements in a manner commensurate with the
Company’s financial reporting requirements, and lack of effective
controls over approving, communicating, and accounting for
incentive arrangements with customers, impacting the completeness
and accuracy of revenues, including variable
consideration.
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material misstatement
of the annual or interim financial statements will not be prevented
or detected on a timely basis. The material weaknesses referred to
above are described in the accompanying Management's Report on
Internal Control Over Financial Reporting. We considered these
material weaknesses in determining the nature, timing, and extent
of audit tests applied in our audit of the 2022 consolidated
financial statements, and our opinion regarding the effectiveness
of the Company’s internal control over financial reporting does not
affect our opinion on those consolidated financial
statements.
Basis for Opinions
The Company's management is responsible for these consolidated
financial statements, for maintaining effective internal control
over financial reporting, and for its assessment of the
effectiveness of internal control over financial reporting included
in management's report referred to above. Our responsibility is to
express opinions on the Company’s consolidated financial statements
and on the Company's internal control over financial reporting
based on our audits. We are a public accounting firm registered
with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audits in accordance with the standards of the
PCAOB. Those standards require that we plan and perform the audits
to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due
to error or fraud, and whether effective internal control over
financial reporting was maintained in all material
respects.
Our audits of the consolidated financial statements included
performing procedures to assess the risks of material misstatement
of the consolidated financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such
procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the consolidated financial
statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as
well as evaluating the overall presentation of the consolidated
financial statements. Our audit of internal control over financial
reporting included obtaining an understanding of internal control
over financial reporting, assessing the risk that a material
weakness exists, and testing and evaluating the design and
operating effectiveness of internal control based on the assessed
risk. Our audits also included performing such other procedures as
we considered necessary in the circumstances. We believe that our
audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial
Reporting
A company’s internal control over financial reporting is a process
designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted
accounting principles. A company’s internal control over financial
reporting includes those policies and procedures that (i) pertain
to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of
the assets of the company; (ii) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the
company are being made only in accordance with authorizations of
management and directors of the company; and (iii) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matters communicated below are matters arising
from the current period audit of the consolidated financial
statements that were communicated or required to be communicated to
the audit committee and that (i) relate to accounts or disclosures
that are material to the consolidated financial statements and (ii)
involved our especially challenging, subjective, or complex
judgments. The communication of critical audit matters does not
alter in any way our opinion on the consolidated financial
statements, taken as a whole, and we are not, by communicating the
critical audit matters below, providing separate opinions on the
critical audit matters or on the accounts or disclosures to which
they relate.
Annual and Interim Goodwill Impairment Assessments – Certain
Reporting Units
As described in
Notes 1 and 12 to the consolidated financial statements, the
Company’s consolidated net goodwill balance was $2,688
million
as of December 31, 2022, of which a significant portion relates to
certain reporting units. Goodwill is tested for impairment at the
reporting unit level annually as of April 1 of each year, or more
frequently if events or circumstances indicate that the carrying
value of goodwill may be impaired. Management performs impairment
tests by comparing the fair value of each reporting unit to its
carrying amount to determine if there is a potential impairment. In
the third quarter of 2022, management identified indicators of a
"more likely than not" impairment related to its Digital Dental
Group and Equipment & Instruments reporting units within the
Technologies & Equipment segment. The Company has experienced
adverse macroeconomic factors as a result of weakened global
demand, higher cost of capital, unfavorable foreign currency
impacts, and increased raw material, supply chain and service
costs, which are contributing to reduced forecasted revenues, lower
operating margins, and reduced expectations for future cash flows.
As a result of the interim test, management recorded a pre-tax
goodwill impairment charge related to the Digital Dental Group and
Equipment & Instruments reporting units within the Technologies
& Equipment segment of $1,100 million and $87 million,
respectively. As disclosed by management, the Company uses a
discounted cash flow model as its valuation technique to measure
the fair value for its reporting units. The discounted cash flow
model uses five- to ten- year forecasted cash flows plus a terminal
value based on capitalizing the last period’s cash flows using a
perpetual growth rate. As disclosed by management, the significant
assumptions in the application of the discounted cash flow model
include, but are not limited to, the discount rates, revenue growth
rates, perpetual revenue growth rates, operating margin
percentages, and net working capital changes of the reporting
unit’s business.
The principal considerations for our determination that performing
procedures relating to the annual and interim goodwill impairment
assessments of certain reporting units is a critical audit matter
are (i) the significant judgment by management when developing the
fair value estimates of the reporting units, (ii) a high degree of
auditor judgment, subjectivity, and effort in performing procedures
and evaluating management’s significant assumptions related to the
discount rates, revenue growth rates, perpetual revenue growth
rates, and operating margin percentages for the annual assessment
and discount rates, revenue growth rates, perpetual revenue growth
rates, operating margin percentages, and net working capital
changes for the interim assessment, and (iii) the audit effort
involved the use of professionals with specialized skill and
knowledge.
Addressing the matter involved performing procedures and evaluating
audit evidence in connection with forming our overall opinion on
the consolidated financial statements. These procedures included
testing the effectiveness of controls relating to management’s
goodwill impairment assessments, including controls over the
valuation of the Company’s reporting units. These procedures also
included, among others, testing management’s process for developing
the fair value estimates of certain of the Company’s reporting
units; evaluating the appropriateness of the discounted cash flow
models; testing the completeness and accuracy of underlying data
used in the discounted cash flow models; and evaluating the
reasonableness of significant assumptions used by management
related to the discount rates, revenue growth rates, perpetual
revenue growth rates, operating margin percentages, and net working
capital changes. Evaluating management’s assumptions related to
revenue growth rates, perpetual revenue growth rates, operating
margin percentages, and net working capital changes involved
evaluating whether the assumptions used by management were
reasonable considering (i) the current and past performance of the
reporting units; (ii) the consistency with external market and
industry data; and (iii) whether these assumptions were consistent
with evidence obtained in other areas of the audit. Professionals
with specialized skill and knowledge were used to assist in
evaluating (i) the appropriateness of the Company’s discounted cash
flow models and (ii) the reasonableness of the assumptions related
to the discount rates, perpetual revenue growth rates, and net
working capital changes.
Uncertain Tax Position Related to a Worthless Stock
Deduction
As described in Notes 1 and 22 to the consolidated financial
statements, management applies a recognition threshold and
measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a
tax return. Management recognizes in the consolidated financial
statements the impact of a tax position if that position is more
likely than not of being sustained upon examination by the taxing
authorities based on the technical merits of the position.
Management has recorded the full benefit of the tax deduction taken
associated with a worthless stock deduction. As a result of an
audit by the Internal Revenue Service (IRS) for 2013, the Company’s
worthless stock deduction of $546 million has been disallowed. In
March 2019, the Company submitted a formal protest disputing on
multiple grounds the proposed taxes and have not accrued a
liability relating to the proposed tax adjustments. If the
worthless stock deduction was ultimately disallowed, the Company
would be subject to additional income tax expense.
The principal considerations for our determination that performing
procedures relating to the uncertain tax position related to a
worthless stock deduction is a critical audit matter are (i) the
significant judgment by management when determining the uncertain
tax position, (ii) a high degree of auditor judgment, subjectivity,
and effort in performing procedures and evaluating audit evidence
related to management’s accurate measurement of the uncertain tax
position, and (iii) the audit effort involved the use of
professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating
audit evidence in connection with forming our overall opinion on
the consolidated financial statements. These procedures included
testing the effectiveness of controls relating to the recognition
and measurement of the uncertain tax position related to the
worthless stock deduction. These procedures also included, among
others, evaluating the appropriateness of management’s assessment
by reviewing the technical merits of the tax position taken;
evaluating the tax documentation provided by management; and
evaluating the status and results of the income tax audit, and
correspondence with the IRS. Professionals with specialized skill
and knowledge were used to assist in the evaluation of management’s
interpretation and application of relevant tax laws in the United
States and in evaluating the reasonableness of management’s
assessment of whether the tax position will be
sustained.
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/s/ |
PricewaterhouseCoopers LLP |
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PricewaterhouseCoopers LLP |
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Charlotte, North Carolina |
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March 1, 2023 |
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We have served as the Company’s auditor since 2000.
DENTSPLY SIRONA INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in millions, except per share amounts)
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Year Ended December 31, |
|
2022 |
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2021 |
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2020 |
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Net sales |
$ |
3,922 |
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|
$ |
4,231 |
|
|
$ |
3,339 |
|
Cost of products sold |
1,795 |
|
|
1,884 |
|
|
1,683 |
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|
|
Gross profit |
2,127 |
|
|
2,347 |
|
|
1,656 |
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|
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|
Selling, general, and administrative expenses |
1,589 |
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|
1,551 |
|
|
1,302 |
|
Research and development expenses |
174 |
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|
171 |
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|
123 |
|
Goodwill impairment |
1,187 |
|
|
— |
|
|
157 |
|
Intangible asset impairment and other costs |
114 |
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|
17 |
|
|
77 |
|
|
|
|
|
|
|
Operating (loss) income |
(937) |
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|
608 |
|
|
(3) |
|
|
|
|
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|
Other income and expenses: |
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|
|
|
|
Interest expense, net |
60 |
|
|
55 |
|
|
46 |
|
Other expense (income), net |
58 |
|
|
8 |
|
|
1 |
|
|
|
|
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|
|
(Loss) income before income taxes |
(1,055) |
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|
545 |
|
|
(50) |
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(Benefit) provision for income taxes |
(105) |
|
|
134 |
|
|
23 |
|
|
|
|
|
|
|
Net (loss) income |
(950) |
|
|
411 |
|
|
(73) |
|
|
|
|
|
|
|
Less: Net income (loss) attributable to noncontrolling
interests |
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
Net (loss) income attributable to Dentsply Sirona |
$ |
(950) |
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|
$ |
411 |
|
|
$ |
(73) |
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|
|
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|
Net (loss) income per common share attributable to Dentsply
Sirona: |
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|
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|
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Basic |
$ |
(4.41) |
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|
$ |
1.88 |
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|
$ |
(0.33) |
|
Diluted |
$ |
(4.41) |
|
|
$ |
1.87 |
|
|
$ |
(0.33) |
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
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Basic |
215.5 |
|
|
218.4 |
|
|
219.2 |
|
Diluted |
215.5 |
|
|
220.2 |
|
|
219.2 |
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
DENTSPLY SIRONA INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in millions)
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|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
2020 |
|
|
|
|
|
|
Net (loss) income |
$ |
(950) |
|
|
$ |
411 |
|
|
$ |
(73) |
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|
|
|
|
|
|
Other comprehensive (loss) income, net of tax: |
|
|
|
|
|
Foreign currency translation adjustments |
(156) |
|
|
(181) |
|
|
184 |
|
Net gain (loss) on derivative financial
instruments |
29 |
|
|
25 |
|
|
(32) |
|
|
|
|
|
|
|
Pension liability adjustments |
91 |
|
|
26 |
|
|
(13) |
|
Total other comprehensive (loss) income |
(36) |
|
|
(130) |
|
|
139 |
|
|
|
|
|
|
|
Total comprehensive (loss) income |
(986) |
|
|
281 |
|
|
66 |
|
|
|
|
|
|
|
Less: Comprehensive (loss) income attributable to noncontrolling
interests |
— |
|
|
(2) |
|
|
1 |
|
|
|
|
|
|
|
Comprehensive (loss) income attributable to Dentsply
Sirona |
$ |
(986) |
|
|
$ |
283 |
|
|
$ |
65 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
DENTSPLY SIRONA INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in millions, except per share amounts)
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|
December 31, |
|
2022 |
|
2021 |
|
|
|
|
Assets |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
365 |
|
|
$ |
339 |
|
Accounts and notes receivable-trade, net |
632 |
|
|
750 |
|
Inventories, net |
627 |
|
|
515 |
|
Prepaid expenses and other current assets |
269 |
|
|
248 |
|
Total Current Assets |
1,893 |
|
|
1,852 |
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|
|
|
|
Property, plant and equipment, net |
761 |
|
|
773 |
|
Operating lease right-of-use assets, net |
200 |
|
|
198 |
|
Identifiable intangible assets, net |
1,903 |
|
|
2,319 |
|
Goodwill, net |
2,688 |
|
|
3,976 |
|
Other noncurrent assets |
198 |
|
|
121 |
|
Total Assets |
$ |
7,643 |
|
|
$ |
9,239 |
|
|
|
|
|
Liabilities and Equity |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
279 |
|
|
$ |
262 |
|
Accrued liabilities |
727 |
|
|
760 |
|
Income taxes payable |
46 |
|
|
57 |
|
Notes payable and current portion of long-term debt |
118 |
|
|
182 |
|
Total Current Liabilities |
1,170 |
|
|
1,261 |
|
|
|
|
|
Long-term debt |
1,826 |
|
|
1,913 |
|
Operating lease liabilities |
149 |
|
|
149 |
|
Deferred income taxes |
287 |
|
|
391 |
|
Other noncurrent liabilities |
399 |
|
|
528 |
|
Total Liabilities |
3,831 |
|
|
4,242 |
|
|
|
|
|
Commitments and contingencies (Note 22)
|
|
|
|
|
|
|
|
Equity: |
|
|
|
Preferred stock, $1.00 par value; 0.25 million shares authorized;
no shares issued
|
— |
|
|
— |
|
Common stock, $0.01 par value;
|
3 |
|
|
3 |
|
400.0 million shares authorized at December 31, 2022 and
2021
|
|
|
|
264.5 million shares issued at December 31, 2022 and
2021
|
|
|
|
215.3 million and 217.4 million shares outstanding at
December 31, 2022 and 2021, respectively
|
|
|
|
Capital in excess of par value |
6,629 |
|
|
6,606 |
|
Retained earnings |
456 |
|
|
1,514 |
|
Accumulated other comprehensive loss |
(628) |
|
|
(592) |
|
Treasury stock, at cost, 49.3 million and 47.1 million shares at
December 31, 2022 and 2021, respectively
|
(2,649) |
|
|
(2,535) |
|
Total Dentsply Sirona Equity |
3,811 |
|
|
4,996 |
|
|
|
|
|
Noncontrolling interests |
1 |
|
|
1 |
|
Total Equity |
3,812 |
|
|
4,997 |
|
Total Liabilities and Equity |
$ |
7,643 |
|
|
$ |
9,239 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DENTSPLY SIRONA INC. AND SUBSIDIARIES |
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY |
(in millions, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock
|
|
Capital in
Excess of
Par Value
|
|
Retained
Earnings
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Treasury
Stock
|
|
Total
Dentsply
Sirona
Equity
|
|
Noncontrolling
Interests
|
|
Total
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2019 |
$ |
3 |
|
|
$ |
6,587 |
|
|
$ |
1,359 |
|
|
$ |
(602) |
|
|
$ |
(2,301) |
|
|
$ |
5,046 |
|
|
$ |
2 |
|
|
$ |
5,048 |
|
Net loss |
— |
|
|
— |
|
|
(73) |
|
|
— |
|
|
— |
|
|
(73) |
|
|
— |
|
|
(73) |
|
Other comprehensive income |
— |
|
|
— |
|
|
— |
|
|
138 |
|
|
— |
|
|
138 |
|
|
1 |
|
|
139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
— |
|
|
1 |
|
|
— |
|
|
— |
|
|
10 |
|
|
11 |
|
|
— |
|
|
11 |
|
Stock based compensation expense |
— |
|
|
47 |
|
|
— |
|
|
— |
|
|
— |
|
|
47 |
|
|
— |
|