What changed in this filing

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Item 1. Business

2023-03-01 compared with 2022-03-01 · 136 added, 129 removed, 157 unchanged (63% of the section changed)

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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 130 years ago, the first dental X-ray unit approximately 100 years ago, the first dental computer-aided design/computer-aided manufacturing (“CAD/CAM”) system over 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.

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.

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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.”), as well as in over 150 foreign countries, principally through its foreign subsidiaries.

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.

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Additionally, the Company manufactures and sells healthcare consumable products for urological applications.

These products 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, AXEOS, BYTE, CALIBRA, CAULK, CAVITRON, CELTRA, CERAMCO, CERCON, CEREC, CEREC MCX, CITANEST, CONFORM FIT, DELTON, DENTSPLY, DETREY, DYRACT, ESTHET.X, FRIOS, GALILEOS, INLAB, INTEGO, IPN, LOFRIC, LUCITONE, MAILLEFER, MIDWEST, MTM, NUPRO, OMNICAM, ORAQIX, ORIGO, ORTHOPHOS, OSSEOSPEED, PALODENT PLUS, PRIME & BOND, PROFILE, PRIMEMILL, PRIMESCAN, PROGLIDER, PROTAPER, RECIPROC, PUREVAC, RINN, SANI-TIP, SCHICK, SIMPLANT, SINIUS, SIROLASER, SIRONA, SLIMLINE, STYLUS, SULTAN, SUREFIL, SURESMILE, SYMBIOS, T1, T2, T3, T4, TENEO, THERMAFIL, TRIODENT, TRUBYTE, TRUNATOMY, VIPI, WAVEONE, WELLSPECT, XENO, XIVE, XYLOCAINE and ZHERMACK.

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

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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 dentist 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.

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.

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.

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 aesthetic ceramic dentistry offering called CEREC, as well as stand-alone CAD/CAM, digital impressions ("DI") intra-oral scanners, mills, and services.

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.

The Company’s Orthodontic product group primarily includes a dentist-directed clear aligner solution, SureSmile, and a direct-to-consumer clear aligner solution, Byte.

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 clear aligners offerings include software technology that enables clear aligner treatment planning and for SureSmile seamless connectivity of a digital workflow from diagnostics through treatment delivery.

Certain lower-margin products within the the Company's traditional Orthodontic business have been discontinued during the course of 2020 and 2021 as part of management’s portfolio optimization restructuring actions as described further in Item 7, Management Discussion and Analysis.

The Implants business is supported by key technologies including custom abutments, advanced tapered immediate load screws and regenerative bone growth factor.

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.

This category consists mainly of urology catheters and other healthcare-related consumable products.

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Endodontic & Restorative Products

The Company's Endodontic and Restorative products frequently work together to provide a tandem solution in high-tech dental procedures.

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.

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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.

Certain lower-margin laboratory products within the Other Consumables category have been discontinued during the course of 2020 and 2021 as part of management’s portfolio optimization restructuring actions as described further in Item 7, Management Discussion and Analysis.

Net sales for each product category as a percent of the Company's total net sales for the year ended December 31, 2021, were as follows:

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:

% of Net Sales

Equipment & Instruments 17.3 %

Implants 14.5 %

CAD/CAM 12.8 %

Orthodontics 7.6 %

Implants 14.7 %

Healthcare 6.9 %

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Total net sales 100.0 %

Markets, Sales and Distribution

The Company believes that the market for its products will grow over the long-term based on the following factors:

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 appeal of clear aligners as an orthodontic treatment.

• 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.

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• 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 demand for more efficiency and better workflow in the dental office, including digital and integrated solutions such as the enhanced power of diagnostic equipment through 3D imaging.

• 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’s business is less susceptible than many other industries to general downturns in the economies in which it operates.

• The Company is well positioned to meet macroeconomic challenges and execute on a strategy of delivering value through digital workflows due to its leading 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.

Dentsply Sirona employs approximately 5,000 highly-trained, product-specific sales and technical staff to provide comprehensive marketing, and services tailored to the sales and technical support requirements of its distributors, dealers and end-users.

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 clear aligners and appliances, and dental implants are often sold directly to the dental laboratory or dental professionals in some markets.

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 were as follows:

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:

% of net sales % of accounts receivable % of net sales % of accounts receivable

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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 the Company does:

• 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.

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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 of the dental markets it serves.

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.

During 2021 the Company 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.

The Company’s position as an integrated global business allows for the rapid deployment of these innovations throughout the markets it serves to achieve rapid globalization and economies of scale.

New products introduced within the past three years accounted for approximately 24% of 2021 sales.

New advances in technology are also anticipated to have a significant influence on future products in digital dentistry, including both equipment and consumables.

Through investments in research and development, the Company has accelerated multiple new product development initiatives during the year, such as the rollout of software upgrades for CEREC;

the user interface for SureSmile aligners;

introduction of PrimeTaper, a self-tapping implant with a tapered design;

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.

During 2020, the Company introduced Axeos, a new digital imaging product with a 3D wide field of view.

During 2021, the Company 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").

R&D investments include activities to accelerate product and clinical innovation and develop potential improvements to the manufacturing process.

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 and faster concept-to-market timelines.

The Company is undergoing a strategic shift away from a budget dedicated to specific products and deliverables to a focus on strategic market areas with more agile funding.

Focused, cross-functional teams are being increasingly utilized to offer innovative products efficiently, to concentrate resources on the most viable and clinically relevant technologies and to maximize cost and time savings as they are brought into production.

In addition to internal product development, the Company also pursues external research and development opportunities, including acquisitions, licensing, or other arrangements with third parties.

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 2021 Student Competition for Advancing Dental Research and its Application Awards (SCADA) program.

The Company is also committed to participation in clinical research demonstrating the efficacy of our products prior to market introduction, for example the success of the implant registry site utilized for research involvement in conjunction with the PrimeTaper launch.

During 2021, the Company announced that it was opening a 70,000-square-foot innovation center close to its corporate office, which will house key functions such as 3D printing and complement its other flagship innovation centers in Germany and Sweden.

Through these internal research centers as well as through its 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.

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 research and development 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.

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 growth strategy.

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 year ended December 31, 2021, the Company continued this trend, beginning with the first quarter purchase of 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 with the purchase of substantially all of the assets of Propel, a domestic company which manufactures and sells orthodontic devices and provides in-office and at-home orthodontic accessory devices, an investment which is expected to further accelerate the growth and profitability of the Company's combined clear aligners business.

In the third quarter, 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 clear aligners business, which complements the Company's existing clear aligner product by adding a digital component and is expected to enhance scale and accelerate the growth and profitability of the Company's combined clear aligners business going forward.

This acquisition is 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.

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.

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Complex materials technology and processes are necessary to manufacture the Company’s products.

Where it can improve quality and customer service and lower costs, the Company endeavors to automate its global manufacturing operations.

Where the Company can improve quality and customer service and lower costs, we endeavor to automate our global manufacturing operations.

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.

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There are many companies that produce some, but no competitor produces all of the same types of products as those produced by the Company.

The development, manufacture, sale and distribution of the Company’s products are subject to comprehensive governmental regulation both within and outside the United States.

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.

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“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 United States Food, Drug, and Cosmetic Act (the “FDCA”), Council Directive 93/42/EEC on Medical Devices (“MDD”) (1993) in the European Union, which will be updated to the European Union 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 United States, to be safe and effective for their intended use and to comply with the regulations administered by the United States Food and Drug Administration (“FDA”).

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 of the types sold by Dentsply Sirona 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 European Union, Dentsply Sirona’s products are subject to the medical device laws of the various member states, which are based on a Directive of the European Commission.

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.

Dentsply Sirona products in Europe bear the CE mark showing that such products comply with European regulations.

The Company’s products that fall in category of Class I as classified by EU Medical Device Directive were mandated to be certified under the new European Union Medical Device Regulation (“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 MDR in order to continue to sell those products in the European Union (“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.

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.

Dentsply Sirona remains focused on ensuring that all its products that are considered to be medical device will be fully certified as required by the EU MDR dates and timelines.

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 United States Foreign Corrupt Practices Act (“FCPA”), the U.S.

Federal Anti-Kickback Statute (“AKS”), the United Kingdom’s Bribery Act 2010 (c.23), Brazil’s Clean Company Act 2014 (Law No.

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.

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.

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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 United States, 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”).

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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, China’s Personal Information Protection Law, the Physician Payments Sunshine Provisions of the Patient Protection and Affordable Care Act, the European Union’s General Data Production Regulation, the EU Directive 2002/58/EC (and implementing and local measures adopted thereunder), France’s Data Protection Act of 1978 (rev.

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, and similar data-privacy laws applicable in non-U.S.

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.

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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 Dentsply Sirona’s supply requirements.

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

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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.

Dentsply Sirona’s policy is to protect its products and technology through patents and trademark registrations both in the U.S.

Our policy is to protect its products and technology through patents and trademark registrations both in the U.S.

and in significant international markets.

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Human Capital

We believe that our employees are true assets to our organization and contribute to the success of our business.

On December 31, 2021, our organization and its subsidiaries employed approximately 15,000 employees across the globe who are relied on to accomplish the strategic objectives that enable us to lead the dental industry.

Of these employees, approximately 3,600 were employed in the United States.

Some employees outside of the United States are covered by collective bargaining, union contracts, worker councils or other similar programs.

As an organization we value and invest in our talent which leads to our belief of a positive relationship with our employees.

Our talent strategy focuses on attracting, engaging, developing and retaining talent to support our business strategy.

We further strive to offer an inclusive environment where every employee can grow and perform.

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 2021, we continued to evolve our strategy for attracting, engaging, developing and retaining talent.

Led by the feedback and engagement of our employees, we established a new Vision, Values, Mission and Operating Principles.

We launched our first central emerging talent program focused on attracting early-career employees through strategic partnerships with core schools, Historically Black Colleges and Universities and local trade schools.

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 a global approach to learning and development through a partnership with LinkedIn Learning via thousands of on-demand learning modules in multiple languages.

We deployed a custom leadership development framework to assess, develop and coach leaders at multiple levels.

Our quarterly performance feedback, development planning and talent review processes have been automated for professional employees.

A robust set of aids for goal setting and development planning has been designed to support future-focused growth.

We are currently piloting employee-led experience mapping and virtual mentoring with the plan to launch globally.

We continue to conduct virtual town halls and video chats, to keep our employees informed and to provide multiple opportunities for employees globally to ask questions of our leaders.

We place an emphasis on employee feedback and evaluation, which are gathered through engagement surveys every 18 months to all employees in addition to pulse surveys strategically employed throughout the year.

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 Company’s total rewards philosophy, we offer competitive compensation and benefit programs designed to attract and retain top talent.

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, leave programs, flexible work schedules and employee assistance programs.

Diversity and Inclusion

We view diversity in our organization as a core source of strength and we seek to provide opportunities for all employees to bring their perspective, experience and whole self to the workplace.

We believe our commitment to a diverse workforce drives innovation and customer-centricity.

We have an established Diversity & Inclusion Council, helping create accountability for results, providing governance and oversight on diversity efforts and promoting organization-wide communication on progress.

We have a Diversity & Inclusion functional leader who focuses on developing awareness through training, career coaching, networking and talent development.

We measure our progress against key metrics using benchmarking data.

Diversity & Inclusion Council

Our Diversity & Inclusion Council is a group of demographically and functionally diverse employees from across the world dedicated to enabling the Diversity & Inclusion function and championing initiatives that support the organization internally and externally.

A top priority of the Diversity & Inclusion Council is to increase the skills of our leaders on how to discuss and be accountable for driving sustained diversity, equity and inclusion goals.

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 fully participate in successfully executing our strategy.

As of December 31, 2021, our employees have led the successful establishment of 7 Employee Resource Groups consisting of over 1,600 members.

Our Employee Resource Groups have been focused on developing talent, increasing employee engagement and creating awareness.

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 & Inclusion training options aimed at strengthening awareness.

A standout option of our offerings 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 and inclusion topics.

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 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 for open positions.

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

Executive management reviews our Diversity & Inclusion metrics regularly, including attraction, engagement, advancement and retention.

We are actively partnering with an external consultancy to identify available talent pools in all our geographic markets and establish benchmarks throughout.

All executive leaders have action plans in place and are accountable for progress.

Environmental, Health & Safety Matters

Dentsply Sirona believes that Environmental, Health & Safety ("EHS") is critical to the success of our customers and our Company.

We are committed to environmental stewardship and to health and safety excellence in our global operations and distribution.

As such, we have adopted policies that call for compliance with applicable laws and regulations governing the protection of the environment, health and safety of our employees, and neighboring communities.

The Company believe that its operations comply in all material respects with applicable environmental laws and regulations.

Safety is integrated into the way we do business.

Our safety program is structured on the foundation that every employee is engaged and committed to improving safe operating practices and eliminating or reducing the risk for injuries or illnesses.

When health and safety incidents do occur, we strive to determine the causes and eliminate the potential for future similar incidents.

Our EHS policies and standards are a key element of the foundation upon which we develop, market, manufacture, and distribute products and services to our global customers.

We operate our manufacturing facilities using a common set of internal standards.

These standards support a consistent approach to EHS performance improvement.

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 of consolidated net sales, net income and cash flows.

The Company typically implements most of its price changes in the beginning of the first or fourth quarter.

Price changes, other marketing and promotional programs including trade shows, management of inventory levels by distributors and the implementation of strategic initiatives, may impact sales levels in any given period.

In addition, major new product introductions may also impact net sales as older products become less desirable compared to the new products.

Sales for the industry and the Company are generally strongest in the second and fourth calendar quarters and weaker in the first and third calendar quarters, due to the effects of the items noted above and due to the impact of holidays and vacations, particularly throughout Europe.

The Company tries to maintain short lead times within its manufacturing, as such, the backlog on products is generally not material to the financial statements.

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

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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 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.

Information on the Company’s website does not constitute part of this document.

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

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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.

Furthermore, many of these risks and uncertainties are currently amplified by and may continue to be amplified by the novel coronavirus (“COVID-19”) pandemic and the impact of varying private and governmental responses that affect our customers, employees, vendors and the economies and communities where they operate.

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.

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Investors should understand it is impossible to predict or identify all such factors or risks.

As such, you should not consider either 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.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business