Envista Holdings Corp (NVST) Business
This page reproduces the company's own Item 1 Business text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
Informational only - not investment advice. See Disclaimer.
ITEM 1. BUSINESS
Overview
Envista is a global family of more than 30 trusted dental brands, including Nobel Biocare, Ormco, DEXIS, and Kerr, united by a shared purpose: to partner with professionals to improve lives. We help our customers deliver the best possible patient care through industry-leading products, solutions, and technology. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers a wide range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the human smile. We further support the dental community with leading solutions in restoratives, endodontics, rotary, infection prevention, and loupes.
We were formed in 2018 as a wholly-owned subsidiary of Danaher Corporation. In 2019, we completed our initial public offering and separated from Danaher Corporation.
With a foundation comprised of the proven Envista Business System (“EBS”) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, we are well equipped to meet the end-to-end needs of dental professionals worldwide. We are one of the largest global dental products companies, with strong positions in some of the most attractive segments of the dental products industry. We serve dental professionals in over 130 countries through one of the largest commercial organizations in the dental products industry and through our distribution partners. In 2025, we generated total sales of $2.7 billion, of which approximately 85% were derived from sales of consumable products, services, and spare parts.
Our business is operated through two segments: Specialty Products & Technologies, which is comprised of our Dental Implant Solutions and Orthodontic Solutions businesses, and Equipment & Consumables, which is comprised of our Diagnostic and Consumables Solutions businesses.
The following table presents the Company’s revenues disaggregated by geographical region for the years ended December 31, 2025 and 2024 ($ in millions).
| Specialty Products & Technologies | Equipment & Consumables | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Year ended December 31, 2025 | ||||||||||
| Geographical region: | ||||||||||
| North America (U.S. and Canada) | $ | 720.5 | $ | 674.7 | $ | 1,395.2 | ||||
| Western Europe | 498.0 | 117.3 | 615.3 | |||||||
| Other developed markets | 89.5 | 33.3 | 122.8 | |||||||
| Emerging markets | 444.8 | 141.4 | 586.2 | |||||||
| Total | $ | 1,752.8 | $ | 966.7 | $ | 2,719.5 | ||||
| Year ended December 31, 2024 | ||||||||||
| Geographical region: | ||||||||||
| North America (U.S. and Canada) | $ | 684.0 | $ | 621.3 | $ | 1,305.3 | ||||
| Western Europe | 439.4 | 106.6 | 546.0 | |||||||
| Other developed markets | 86.1 | 34.2 | 120.3 | |||||||
| Emerging markets | 406.9 | 132.1 | 539.0 | |||||||
| Total | $ | 1,616.4 | $ | 894.2 | $ | 2,510.6 |
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Our Business Segments
The table below describes the percentage of our total annual sales attributable to each of our segments over each of the three years ended December 31. For additional information regarding sales, operating profit and identifiable assets by segment, please refer to Note 21 in our Consolidated Financial Statements included elsewhere in this Annual Report.
| 2025 | 2024 | 2023 | |||
|---|---|---|---|---|---|
| Specialty Products & Technologies | 64% | 64% | 64% | ||
| Equipment & Consumables | 36% | 36% | 36% |
Specialty Products & Technologies
Our Specialty Products & Technologies segment primarily develops, manufactures and markets dental implant systems, including regenerative solutions, dental prosthetics and associated treatment software and technologies, as well as orthodontic bracket systems, aligners, lab products, and loupes. We typically market these products directly to end-users through our commercial organization, and 84% of our 2025 sales for this segment were direct sales. In 2025, our Specialty Products & Technologies segment generated $1,752.8 million of sales, representing year-over-year sales and core sales increase of 8.4% and 6.3%, respectively. In 2025, 41% of segment sales were derived from North America, 28% from Western Europe, 5% from other developed markets, and 26% from emerging markets. Sales of consumable products, services and spare parts comprised 93% of segment sales in 2025. We believe strong industry fundamentals and the introduction of new product solutions in this segment will continue to drive growth for us.
Dental Implant Solutions
We are a world leader in the field of innovative Dental Implant Solutions, offering a full portfolio of solutions that enable dentists to deliver single-tooth to full-mouth restorations. One of our brands, Nobel Biocare, is the pioneer of implant science grounded in clinical research and has introduced a number of innovations that have become widely adopted in the implant industry. Our comprehensive product offering includes dental implant systems, guided surgery systems, biomaterials, and prefabricated and custom-built prosthetics. Other well-known brands in our portfolio include Alpha-Bio TecTM, Implant DirectTM, and NobelProceraTM. We also offer a comprehensive education program to train our broad range of clinical customers, from clinicians performing basic implant procedures to the most advanced practitioners, with the goal of enhancing patient access to high-quality dental care. Our customers include oral surgeons, periodontists, prosthodontists, and general dentists.
Our Dental Implant Solutions brands have a long history of innovation, which include both the first documented case of a titanium dental implant being placed in a human and the introduction of the concept of living bone adhering to an artificial implant (known as osseointegration). Today, our Nobel Biocare brand offers several implant systems and is integrating them with the DTX suite of software applications described below. Through our Implant Direct and Alpha-Bio Tec value implant businesses, we also offer a variety of implant systems that cover a broad range of price points in the market. Our Matricel and Osteogenics acquisitions added innovative regenerative solutions that are highly complementary to the implant treatment.
Since being acquired in 2014, Nobel Biocare has focused on reinvigorating its product offerings and has released over 30 new products. Among these are comprehensive software packages which are used for treatment planning of dental implants procedures and prosthetics. These software offerings are integrated in our broader DTX software suite, which also includes the ‘DTX StudioTM Clinic’ software.
Orthodontic Solutions
For over 60 years, our Orthodontic Solutions businesses have provided orthodontic professionals with high quality, innovative products backed by educational support to enhance the lives of their patients. We are a leading manufacturer and provider of advanced orthodontic technology and services designed to move malpositioned teeth and jaws. Our products include brackets and wires, tubes and bands, clear aligners, digital orthodontic treatments, retainers, and other orthodontic laboratory products, and are marketed under the OrmcoTM, DamonTM, InsigniaTM, AOATM, and SparkTM brands. We also offer a comprehensive education system to train our clinical customers on the use of our products to address the full range of treatments from basic to the most advanced, with the goal of enhancing patient access to high-quality dental care. Customers of our Orthodontic Solutions business are primarily orthodontists.
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Our clear aligner system, Spark, is designed for mild to complex malocclusion and is made with TruGEN™ and TruGEN XR™, the latest generation of aligner materials. It is designed to deliver higher sustained force retention for efficiency and a high level of transparency for aesthetics. Spark aligners are also designed with polished, scalloped edges to enhance patient comfort. Over the past four years, we have launched a suite of upgrades to our Spark clear aligner Approver™ software designed to improve the customer experience with flexibility and customization features. We have partnered with industry-leading intra-oral scanner companies, including our own DEXIS IOS scanner, as part of our commitment to making imaging integrations seamless. We believe that Spark will provide growth opportunities for our Orthodontic Solutions business.
Equipment & Consumables
Our Equipment & Consumables segment primarily develops, manufactures, and markets dental equipment and supplies used in dental offices, including digital imaging systems, software, and other visualization/magnification systems; endodontic systems and related products; restorative materials and instruments, rotary burs, impression materials, bonding agents and cements; and infection prevention products. In 2025, our Equipment & Consumables segment generated $966.7 million of sales. In 2025, 70% of segment sales were derived from North America, 12% from Western Europe, 3% from other developed markets, and 15% from emerging markets. We distribute our Equipment & Consumables segment products primarily through our channel partners, representing approximately 89% of sales in this segment in 2025. Sales from consumable products, services and spare parts comprised approximately 70% of segment sales in 2025.
Diagnostic Solutions
Our Diagnostic Solutions business is focused on dental imaging, X-ray, and intraoral scanner solutions used in dental offices, clinics and hospitals. Our Diagnostic Solutions business was the pioneer in 2D/panoramic and 3D imaging and has one of the largest installed bases of dental imaging devices utilized in dental practices. We hold a leading position in 3D imaging through the i-CATTM and DEXIS brands. Our DEXIS brand is an industry leader in intraoral X-Ray digital sensors, which provide two-dimensional images of the mouth. The acquisition of our intraoral scanner business in April 2022 added intraoral scanners and related software to our portfolio. In 2025, we expanded our intraoral scanner portfolio with the launch of DEXIS Imprevo.
The ‘DTX Studio Clinic’ software package is offered with many of our imaging products, consolidating a broad variety of clinical patient images (e.g., 2D x-rays, CBCT scans, intraoral scans, and clinical photography) into one intelligent ecosystem. With the complete DTX Studio platform, clinicians can manage the entire digital workflow—from image acquisition and diagnosis to implant surgery and restoration planning—within one connected system. The integrated 2D and 3D artificial intelligence tools power advanced automation that highlights key findings, accelerates planning, and streamlines collaboration. We believe this enables significant clinical workflow efficiencies and more predictable clinical outcomes, which benefit clinicians and their patients.
Consumables Solutions
Our Consumables Solutions business markets a broad offering of general dental products that are used in dental offices, clinics and hospitals. Our products are marketed under a variety of brands, including KerrTM, MetrexTM, Total Care, PentronTM, OptibondTM, HarmonizeTM, SonicfillTM, Sybron EndoTM and CaviWipesTM.
Our products have strong brand and product recognition across many product categories, including restorative, endodontics, and infection control. We offer several products designed to repair and restore fractured or otherwise damaged teeth. We also offer cements and bonding agents. Our Endodontics business offers a variety of products used in the endodontic workflow which help clinicians to locate, shape, clean and fill root canals. We also produce curing lights and other products including impression materials, burs, and waxes under several brands. Through our Metrex brand, we have a strong position within infection prevention products, which include the CaviWipesTM and CaviCideTM product lines, and are well positioned in both the dental and general medical market segments. In 2025, we expanded our Metrex hydrogen peroxide offerings and our commitment to eco-friendly infection prevention with the launch of our CaviCideTM HP liquid surface disinfectant.
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Our Priorities
Our priorities are focused in three areas:
•Growth: We are investing in innovation, commercialization, and clinical education in our businesses to accelerate growth.
•Operations: We are utilizing EBS to improve manufacturing performance and our operations.
•People: We have refreshed our senior leadership team and we are making meaningful investments in engagement and talent development.
Our Strategy
Our strategic focus is comprised of three key elements:
•“Establish a Strong Foundation”: EBS is a set of lean, innovation, growth and leadership-focused tools and processes that helps differentiate us from our competitors. Beginning in 2016, we consolidated our operating companies, substantially reduced our manufacturing sites, and consolidated sales offices. We simplified our portfolio by reducing the number of our diagnostics brands and exiting lower growth/margin businesses. We have also executed cost-reduction initiatives. We continue to pursue a number of ongoing strategic initiatives across our operating companies relating to efficient sourcing and improvements in manufacturing and back-office support, all with a focus on continually improving quality, delivery, cost, growth and innovation.
◦“Reinvest for Growth”: Streamlining our business operations and reducing costs has allowed us to reposition ourselves to create a digital and consumable workflow-oriented portfolio. We have invested in our Specialty Products & Technologies segment, adding manufacturing capacity and personnel to these businesses, with plans for further investment in 2026. We intend to drive shareholder value by deploying capital to acquire or invest in other businesses that strategically fit into or extend our product offering into new or attractive adjacent markets; the Osteogenics acquisition in 2022 is an example of this strategy in action. We have expanded our clinical training and education infrastructure to deepen dental practitioners’ experience of the strength of our products and to further enhance patient access to high quality dental care. We believe these investments better position us to effectively meet the needs of our customers, particularly the growing Dental Service Organization (“DSO”) segment, which values a comprehensive, end-to-end product offering with the ability to roll out new technologies and procedure-focused trainings at scale.
◦“Maintain and Pursue Long-Term Industry Leadership”: As we seek to continue to improve our business and drive increased cash flow, we expect to strategically invest in innovation to better serve our customers and accelerate organic growth. We have invested significant resources in the following areas which we believe will help drive long-term industry leadership:
•Digital Workflow: We have developed our diagnostic and treatment planning software, DTX, to meet the growing demands for digital connectivity of dental practices.
▪Specialty Products & Technologies: We have launched several new products in our Orthodontic Solutions business over the past few years, which have contributed meaningfully to our overall sales in the segment. Since 2020, we have expanded capacity for our SparkTM clear aligners and in 2025, we shipped our one millionth Spark case. Our research and development (“R&D”) expenditures in our Dental Implant Solutions business accelerated the development of new implant systems. We will continue to invest in our global commercial footprint and product innovation to grow our strong position in the Implant and Orthodontics markets, both of which are underpenetrated.
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▪Emerging Markets: We are a leading dental product provider in emerging markets (which we have historically defined as developing markets of the world experiencing periods of accelerated growth in gross domestic product and infrastructure, including Eastern Europe, the Middle East, Africa, Latin America and Asia (with the exception of Japan and Australia)) with product management, operations, regulatory affairs, sales and marketing, and customer service resources focused on these markets. We have grown our emerging markets business from one that generated less than $30 million in sales in 2011 to one that generated approximately $586 million in sales in 2025. We expect to continue to invest in emerging markets as we believe this will be a strong growth driver for our business in the future and is in line with our purpose of improving access to dental care. We have succeeded in emerging markets by harnessing our existing go-to-market infrastructure, building familiarity with local customer needs and regulations, and establishing dedicated locally-based management resources.
Our Industry
The dental market is large, attractive, and has a number of secular drivers that we believe will support future growth. These include the digitization of dental practices globally, which is transforming the way dentists diagnose and treat patients, leading to better clinical outcomes. In addition, we believe future growth of the dental products industry will be driven by an aging population, the current under penetration of dental procedures—especially in emerging markets— improving access to complex procedures due to increasing technological innovation, an increasing demand for cosmetic dentistry, and growth of DSOs, which are expected to drive increasing penetration and access to care globally. Within the global dental products industry, we believe segments such as Dental Implant Solutions, Orthodontic Solutions, and Diagnostic Solutions will grow at a more rapid pace than the overall market.
While both equipment and consumable products represent significant expenditures for dental service providers, the sales dynamics for each differ. The sale of equipment depends on technological advancements, dentists’ willingness to invest in new technologies, opening of new offices and replacement demand. On the other hand, consumable products are more dependent on patient volume. We believe large multi-category manufacturers that provide a broad range of equipment and consumable products have more recession-resilient portfolios and can gain a meaningful competitive advantage over their peers. Larger customers increasingly seek the benefits of purchasing the full range of dental products from a single supplier and consolidate suppliers, and digital dentistry adoption creates links between different products in the dental practitioners’ offices.
While developed markets represent a significant portion of the global dental products industry, we have also been focused on building significant scale in emerging markets. Prevalence and penetration of treatments is largely tied to socio-economic factors such as availability and affordability of care. We expect generally improving economic trends and increased consumer disposable income in emerging markets, as well as advancements in technological innovation that reduce complexity and cost and increase efficiency, will help drive penetration of dental care in these under-served markets.
Key Solutions Within the Dental Products Industry
◦Dental Implant Solutions: The implant industry is large and enjoys higher margins and growth than the overall dental products market. The U.S. and the Greater China region represent key growth drivers for this industry. In the U.S., implant penetration far lags other developed markets such as Germany, Spain and Italy. In China, the prevalence of severe tooth loss is higher than in the U.S., while implant penetration is far below the U.S. We expect product innovation and increased affordability to help drive future growth in emerging markets.
◦Orthodontic Solutions: Traditional wires and brackets systems continue to be the preferred choice in complex and young adult cases, due to their better clinical outcomes. In recent years, clear aligners have also become an increasingly popular treatment option. With the technology continuing to advance and more clinicians becoming proficient in aligner therapy, the addressable market for orthodontic treatment has expanded. Going forward, we believe orthodontic solutions will continue to grow at a fast pace as aesthetics become increasingly important to patients.
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◦Diagnostic Solutions: Imaging (both x-ray and other visualization solutions) is often the first step of many dental exams and therefore serves as the entry-point for many high-value treatments. The rapid adoption of digital technologies within diagnostic solutions has transformed dental practices and has increased access to care as well as the quality of care delivered to patients. We believe enhanced connectivity amongst different types of dental imaging/diagnostic equipment and integration with downstream treatment planning and treatment delivery solutions will further improve dental workflows and lead to better treatment outcomes. We believe digitalization and connectivity will continue to drive growth in this area.
Competition
Although our businesses generally operate in highly competitive markets, our competitive position cannot be determined accurately in the aggregate or by segment because none of our competitors offer all of the same product and service lines and serve all of the same markets as we do. Because of the range of the products and services we sell and the variety of markets we serve, we encounter a wide variety of competitors, including well-established regional competitors, competitors who are more specialized than we are in particular markets or product categories, as well as larger companies or divisions of larger companies with substantial sales, marketing, research and financial capabilities. We face increased competition in a number of our served markets as a result of the entry of competitors based in low-cost manufacturing locations, and increasing consolidation in particular markets. Key competitive factors vary among our businesses and product and service lines, but include the specific factors noted above with respect to each segment and typically also include price, quality, performance, delivery speed, applications expertise, distribution channel access, service and support, technology and innovation, breadth of product, service and software offerings and brand name recognition. For a discussion of risks related to competition, please refer to “Item 1A. Risk Factors—Risks Related to Our Industry.”
Our Competitive Strengths
We believe we have significant competitive strengths, including:
◦Premier portfolio with leadership in attractive segments. The breadth and depth of our product offerings address a broad range of dentists’ clinical needs from consumable products to digital equipment solutions. Our catalog of products covers the spectrum from value-focused products to premium brands, allowing providers to fully address patient needs in different market segments. Within our product portfolio, we believe we are one of the largest and most product diverse manufacturers in implants and orthodontics and have one of the largest installed bases of imaging devices. Our broad product offering positions us particularly well to serve the needs of DSOs, which have been one of the fastest growing segments of our customer base.
◦Track record of innovation. Our businesses have a long track record of successful innovation such as NobelActive® dental implants, OrascopticTM dental loupes, Spark clear aligners, Damon bracket and wire system and the DEXIS OP 3DTM imaging system. Our new product development activities are complemented by externally sourcing technologies through a broad network of partnerships, collaborations, and investments involving third-party research institutions, universities and innovative start-up companies.
◦Envista Business System. We believe our deep-rooted commitment to EBS helps drive our success and market leadership and differentiates us in the dental industry. EBS encompasses not only lean tools and processes, but also methods for driving innovation, growth and leadership.
◦Brand leadership with a long track record and strong brand recognition. We built our business around brands with long histories of innovation and quality, and as a result, we enjoy strong brand recognition in the dental products market. We believe the heritage and leadership of our well-known brands in the dental products industry enhances our connections with both patients and providers and supports our strong market position.
◦Global commercial reach. We serve dental professionals in over 130 countries through one of the largest customer-facing sales teams in the dental products industry and through a diverse, global dealer network. In 2025, we generated 53% of our sales from markets outside of the U.S.
◦Strong position in emerging markets. Emerging markets represented 22% of our total sales in 2025. We are a leading dental provider in emerging markets with dedicated product management, operations, regulatory affairs, sales and marketing, and customer service resources focused on these markets. With this structure, we believe that we are well positioned to capture additional share in emerging markets.
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◦Experienced management team with extensive industry experience. Our executive officer team has extensive global dental and healthcare industry experience and a proven track record of applying core principles of EBS as a continuous improvement approach to execute on our strategic and operational goals. Under their leadership, we have undertaken several key initiatives to better position our business for organic and inorganic growth. We believe our management team will continue to drive growth and profitability in our business in the future.
International Operations
We are a global dental company. Our products and services are available worldwide, and our principal markets outside the U.S. are in Europe, Asia, the Middle East and Latin America. In 2025, we generated 51% of our sales in North America, 23% of our sales in Western Europe, 22% of our sales in emerging markets and 4% of our sales in other developed markets.
We also have operations around the world, and this geographic diversity allows us to draw on the skills of a worldwide workforce, provides greater stability to our operations, allows us to drive economies of scale, provides sales streams that may help offset economic trends that are specific to individual economies and offers us an opportunity to access new markets for products. We believe that our future growth depends in part on our ability to continue developing products and sales models that successfully target emerging markets.
The manner in which our products and services are sold outside the U.S. differs by business and by region. Most of our sales in non-U.S. markets are made by our subsidiaries located outside the U.S., though we also sell from the U.S. into non-U.S. markets through various representatives and distributors and, in some cases, directly. In countries with low sales volumes, we generally sell through representatives and distributors.
Information about the effects of foreign currency fluctuations on our business is set forth in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.” For a discussion of risks related to our non-U.S. operations and foreign currency exchange, please refer to “Item 1A. Risk Factors—Risks Related to Our Business” and “Risk Factors—General Risks.”
Sales and Distribution
Typical customers and end-users of our products include dental specialists such as orthodontists, periodontists, implantologists and endodontists, general dentists, dental hygienists, oral surgeons, dental laboratories and other oral health professionals, including DSOs, as well as educational, medical and governmental entities and third-party distributors. These customers choose dental products based on the factors described under the section entitled “Business—Competition.”
Our commercial organization includes over 3,000 employees with deep clinical, product and workflow expertise who interact with dental practitioners on a daily basis. Through our trusted brands, innovative product offerings and comprehensive customer service, we have established strong relationships globally with key constituencies, including DSOs, dental specialists, general dentists, and dental laboratories. We believe the continuing expansion of our global commercial organization will provide us with significant opportunities for future growth as we increase our penetration in various geographic markets.
In 2025, we distributed approximately 42% of our products through third-party distributors. One customer, Henry Schein, Inc. (“Henry Schein”), accounted for approximately 12% of our sales for 2025 and 10% of our sales for 2024 and 2023. Other than Henry Schein, no single customer accounted for more than 10% of combined sales in 2025, 2024, or 2023.
While a sizable portion of our sales are derived from distributors, most of our marketing and advertising activities are directed towards the end-users of our products, the dental professional. In addition to our marketing efforts, as noted above, we conduct significant training and education programs globally for dental professionals to enhance patient access to high-quality dental care. In these programs, our employees and/or experts in the respective clinical fields demonstrate the proper use of our products. We maintain educational and consulting relationships with key experts who assist us in developing new products, new indicated uses for our products and educational programs for health care providers and consumers. We also maintain educational and consulting relationships with dental associations around the world.
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Research and Development
Innovation is a core part of our strategy. We conduct R&D activities for the purpose of designing and developing new products and applications that address customer and patient needs and emerging trends, as well as enhancing the functionality, effectiveness, ease of use and reliability of our existing products. Our R&D efforts include internal initiatives as well as collaborations with external parties such as research institutions, dental and medical schools and initiatives that use licensed or acquired technology. We expect to continue to invest in R&D with the goal of maintaining or improving our competitive position, and entering new markets.
We generally conduct R&D activities on a business-by-business basis, primarily in North America, the Middle East, and Europe. We anticipate that we will continue to make significant expenditures for R&D as we seek to provide a continuing flow of innovative products to maintain and improve our competitive position. For a discussion of the risks related to the need to develop and commercialize new products and product enhancements, please refer to “Item 1A. Risk Factors—Risks Related to Our Business.” Customer-sponsored R&D was not significant in 2025, 2024, or 2023.
Intellectual Property
We own numerous patents, trademarks, copyrights, trade secrets and licenses to intellectual property owned by others. Although in the aggregate our intellectual property is important to our operations, we do not consider any single patent, trademark, copyright, trade secret or license to be of material importance to any segment or to the business as a whole. Our products and technologies are protected by over 1,500 granted patents. From time to time, we engage in litigation to protect our intellectual property rights. For a discussion of risks related to our intellectual property, please refer to “Item 1A. Risk Factors—Risks Related to Our Business.” All capitalized brands and product names throughout this document are trademarks owned by, or licensed to, us.
Human Capital Resources
As of December 31, 2025, we employed approximately 12,000 persons, of whom approximately 3,000 were employed in the U.S. and approximately 9,000 were employed outside of the U.S. We have collective bargaining arrangements and union contracts in certain countries, particularly in Europe where certain of our employees are represented by unions and/or works councils. For a discussion of risks related to employee relations, please refer to “Item 1A. Risk Factors—General Risks.”
Our success depends on our ability to attract, develop and retain a talented employee base. We aspire to help our employees thrive both personally and professionally. As part of these efforts, we strive to embody our core values, offer a competitive compensation and benefits program, foster a culture of engagement, and provide professional development opportunities.
Our Board of Directors is actively engaged in overseeing our people and culture strategy and reviews human capital matters, including periodic updates on succession planning, leadership development, talent acquisition and retention, employee engagement, total rewards, and culture of the Company, among other topics. The Compensation Committee of the Board of Directors oversees our executive and equity compensation programs. We evaluate and manage risks relating to our human capital strategy as part of our enterprise risk management program.
Core Values
We endeavor to embody our CIRCLe values in everything we do and in our various programs and initiatives:
•Customer Centricity
•Innovation
•Respect
•Continuous Improvement
•Leadership
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Compensation and Benefits Program
Our compensation programs and practices are designed to attract employees, motivate and reward performance, drive growth and support retention. We offer competitive compensation packages based on market data, which include base salary with annual merit increases and may also include annual cash performance incentives, commissions, overtime opportunities, allowances and, in some countries where these are customary, additional monthly payments. In addition, employees in select senior management roles may receive long-term compensation in the form of equity awards. We regularly review our compensation structure to ensure that we remain competitive, reward top performance, as well as to ensure internal equity. In the U.S., our benefits package includes health (medical, dental & vision) insurance, paid time off, paid parental leave, a retirement plan and life and disability coverage. Outside of the U.S., we offer our employees robust benefits based on local regulations and best practices of the countries in which we operate. Globally, we offer an Employee Assistance Program to all employees to support the mental health and well-being of employees and their families.
Culture of Engagement
We are dedicated to building a world-class culture of engagement. Throughout our organization, we continuously work to
improve the experience of our employees to ensure that they can do their best work, make a meaningful impact, and advance in their personal and professional growth. We believe that belonging is a cornerstone of an energizing employee culture, and we strive to cultivate a sense of connection, authenticity, and acceptance throughout our Company. We foster strong interpersonal relationships, encourage open communication, and celebrate contributions.
Learning and Development Opportunities
We aim to empower our employees to thrive in their current roles, as well as to support employees’ aspirations to move into different roles. We have a promote-from-within culture with opportunities across our operating companies. We periodically assess succession planning for certain key positions and review our workforce to identify high potential employees for future growth and development. We support our employees through a multitude of training and development programs including training on EBS, individual development plans (which encourage our employees to take charge of their learning and growth opportunities), job rotations, and various management trainings. This commitment to our employees’ professional development reflects both our Continuous Improvement and Leadership core values.
Employee Engagement
We conduct employee engagement surveys to solicit employees’ input and perspectives on our performance. In 2025, we had a 95% participation rate in this survey, with 73% of respondents reporting feeling engaged at work and 80% believing their managers are leading effectively. We use the feedback from these surveys to better understand whether our employees have the tools, resources, training and development opportunities to succeed. These surveys help us benchmark our progress over time and compare our results with companies in our sector. Communication is at the core of our engagement efforts and we host numerous CEO Forums for all employees, to keep our employees informed and to provide opportunities for employees globally to ask questions of senior management.
Community
Our employees have a long history of providing support and care in our communities, donating time, resources, and funds to local causes. In March 2021, we leveraged our expertise in oral health and founded the Envista Smile Project, a 501(c)(3) philanthropic foundation designed to improve the smiles and oral health of disadvantaged communities by supporting increased access to oral care and oral health education. The Envista Smile Project’s mission is to collaborate with dental professionals and Envista employee volunteers to donate products, treatment, and oral health education to communities in need around the world. The Envista Smile Project’s giving strategy focuses on three areas: mission trips, education, and donations to oral health focused, non-profit organizations.
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Safe Work Environment
We value the safety of our employees and utilize our bi-annual EHS Risk Assessment tool to increase environmental health and safety (“EHS”) results and engagement. EHS significant sites, such as manufacturing, distribution, R&D sites and large offices, are supported through a combination of on-site and remote EHS professionals. Incident reporting and investigation, auditing, and corporate oversight provide for a collaborative and transparent environment to address and minimize potential gaps.
Additional information about our human capital resources, as well as information related to our sustainability efforts, is included in our annual Sustainability Report (located on the Investors subpage of our website www.envistaco.com). Information on our website, including the Sustainability Report, shall not be deemed incorporated by reference into this Annual Report.
Materials
Our manufacturing operations employ a wide variety of raw materials, including metallic-based components, electronic components, chemicals, and plastics, and prices of oil and gas also affect our costs for freight and utilities. We purchase raw materials from a large number of independent sources around the world. For certain components that require particular specifications or qualifications there may be a single supplier or a limited number of suppliers that can readily provide such components. We utilize a number of techniques to address potential disruption in, and other risks relating to, our supply chain, including in certain cases the use of safety stock, alternative materials and qualification of multiple supply sources. During 2025, we had no raw material shortages that had a material effect on our business. For a further discussion of risks related to the materials and components required for our operations, please refer to “Item 1A. Risk Factors—Risks Related to Our Business.”
Seasonal Nature of Business
General economic conditions impact our business and financial results, and certain of our businesses experience seasonal and other trends related to the end markets and regions that they serve. For example, sales of capital equipment have historically been stronger in the fourth calendar quarter. However, as a whole, we are not subject to material seasonality.
Regulatory Matters
We face extensive government regulation both within and outside the U.S. relating to the development, manufacture, marketing, sale and distribution of our products, software and services. The following sections describe certain significant regulations applicable to our operations. These are not the only regulations that our businesses must comply with. For a description of risks related to the regulations that our businesses are subject to, please refer to “Item 1A. Risk Factors—Risks Related to Laws and Regulations.”
Medical Device Regulations
Most of our 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”). The FDCA requires these products, when sold in the U.S., to be safe and effective for their intended uses and to comply with the regulations administered by the U.S. Food and Drug Administration (the “FDA”). The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, packaging, marketing, distribution, import and export and record keeping for such products. Certain medical device products are also regulated by comparable agencies in non-U.S. countries in which they are produced or sold.
Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device or a new indication for use of an existing medical device obtain either a Section 510(k) premarket notification clearance or a premarket approval (“PMA”) before introducing it into the U.S. market. The type of marketing authorization is generally linked to the classification of the device. The FDA classifies medical devices into one of three classes (Class I, II or III) based on the degree of risk the FDA determines to be associated with a device and the level of regulatory control deemed necessary to ensure the device’s safety and effectiveness.
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Our products are either classified as Class I or Class II devices in the U.S. Most of our Class II and certain of our Class I devices are marketed pursuant to 510(k) pre-marketing clearances. The FDA also enforces additional regulations regarding the safety of X-ray emitting devices that we currently market. The process of obtaining a Section 510(k) clearance generally requires the submission of performance data and clinical data, which in some cases can be extensive, to demonstrate that the device is “substantially equivalent” to a device that was on the market before 1976 or to a device that has been found by the FDA to be “substantially equivalent” to such a pre-1976 device. As a result, FDA clearance requirements may extend the development process for a considerable length of time.
Medical devices can be marketed only for the indications for which they are cleared or approved. After a device has received 510(k) clearance for a specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change in the design, materials, method of manufacture or intended use, may require a new 510(k) clearance or PMA approval and payment of an FDA user fee. The determination as to whether or not a modification could significantly affect the device’s safety or effectiveness is initially left to the manufacturer using available FDA guidance; however, the FDA may review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing and recall the modified device until 510(k) clearance or PMA approval is obtained.
Any medical devices we manufacture and distribute are subject to pervasive and continuing regulation by the FDA and certain state agencies. These include product listing and establishment registration requirements, which help facilitate FDA inspections and other regulatory actions. As a medical device manufacturer, all of our manufacturing facilities are subject to inspection on a routine basis by the FDA. However, the frequency of these inspections has decreased over time because most of our sites participate in the Medical Device Single Audit Program (“MDSAP”), which enables a single third-party audit to meet the quality management system requirements of multiple regulatory authorities, including those in the United States, Canada, Japan, Brazil, and Australia. Nevertheless, the timing and frequency of investigations can be difficult to predict.
We are required to adhere to the Current Good Manufacturing Practices (“cGMP”) requirements, as set forth in the Quality Systems Regulation (“QSR”), which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process. The FDA has issued a final rule adopting the new Quality Management System Regulation (“QMSR”) which will replace most elements of the existing QSR by incorporating ISO 13485:2016 by reference. The QMSR became effective on February 2, 2026.
We must also comply with post-market surveillance regulations, including medical device reporting (“MDR”) requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to a death or serious injury. We must also report any incident in which our product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to recur.
Labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission. Medical devices approved or cleared by the FDA may not be promoted for unapproved or uncleared uses, otherwise known as “off-label” promotion. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
In the European Union (“EU”), our products are subject to the medical device laws of the various member states, which for many years were based on Directives of the European Commission. However, in May 2017, the EU adopted new, formal regulations to replace such Directives; specifically, the EU Medical Device Regulation (the “EU MDR”) which imposes stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. The EU regulations were adopted with staggered transitional periods that have since been updated. In February 2023, the European Parliament and European Council adopted legislation that extended the majority of the compliance dates for EU MDR to 2027 or 2028, based upon the risk class of the device. Regulatory requirements in the United Kingdom (“UK”) are also changing as a result of Brexit (the UK’s withdrawal from the EU), and regulatory requirements in Switzerland are changing as a result of the country’s withdrawal from its Mutual Recognition Agreement with the EU Commission. Complying with the EU MDR and the evolving regulatory regimes in the UK and Switzerland requires modifications to our quality management systems, additional resources in certain functions and updates to technical files, among other changes. In December 2025, the EU introduced major revisions to the medical device regulatory scheme aimed at creating a framework for artificial-intelligence powered devices and enhancing the efficiency of the registration process; these reforms are being closely monitored to determine whether adoption of such changes is forthcoming.
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Other Healthcare Laws
In addition to the U.S. Foreign Corrupt Practices Act, the UK Bribery Act and similar anti-bribery laws, we are also subject to various health care related laws regulating fraud and abuse, research and development, pricing and sales and marketing practices, including the U.S. federal regulations described below. Many states, foreign countries and supranational bodies have also adopted laws and regulations similar to, and in some cases more stringent than, the U.S. federal regulations discussed above and below.
◦The Federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration in any form (including any kickback, bribe, or certain rebate), directly or indirectly, to induce or reward the referral of business payable under a government healthcare program, such as Medicare or Medicaid, or in return for the purchase, lease, order, arranging for, or recommendation of items or services covered under a government health care program. A person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute to have committed a violation.
◦The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) prohibits knowingly and willfully (1) executing, or attempting to execute, a scheme to defraud any health care benefit program, including private payors, or (2) falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services. Similar to the Federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate the statute to have committed a violation.
◦The False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program, knowingly makes, uses or causes to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.
◦The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.
◦The Open Payments Act requires manufacturers of medical devices covered under Medicare, Medicaid or the Children’s Health Insurance Program, subject to specific exceptions, to record payments and other transfers of value to a broad range of healthcare providers (including dentists) and teaching hospitals and to report this data as well as ownership and investment interests held by the physicians described above and their immediate family members to the Department of Health and Human Services (“HHS”) for subsequent public disclosure. Similar reporting requirements have also been enacted on the state level, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring transparency of interactions with health care professionals.
Federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers. Analogous U.S. state laws and regulations, such as state anti-kickback and false claims laws, also may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers. Further, there are state laws that require medical device manufacturers to comply with the voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
For a discussion of risks related to regulation by the FDA and comparable agencies of other countries, and the other regulatory regimes referenced above, please refer to “Item 1A. Risk Factors—Risks Related to Laws and Regulations.”
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Healthcare Reform
In the U.S., both at the federal level and the state level, and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system. For example, there have been numerous political and legal efforts to expand, repeal, replace or modify the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA”), since the law’s enactment. Federal regulatory agencies continue to interpret and modify PPACA regulations and guidance related to the PPACA, often as a result of presidential directives or the interplay with state law requirements.
Moreover, there continues to be heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for medical products. Individual states in the U.S. have also become increasingly active in implementing regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation from other countries and bulk purchasing.
Coverage and Reimbursement
Dental procedures and products are often paid for out-of-pocket. For products where third-party coverage and reimbursement is available, sales will depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party payors are increasingly reducing reimbursements for medical products and services and, in international markets, many countries have instituted price ceilings on specific products and therapies. For example, China has implemented volume-based procurement (“VBP”) policies, a series of centralized reforms instituted in China on both a national and regional basis that has resulted in significant price cuts for medical and dental consumables. Price ceilings, decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce dentist usage and patient demand for the product.
Data Privacy and Security Laws
As a global manufacturer of medical devices having access to and processing confidential, personal and/or sensitive data in the normal course of our business, we are subject to an increasing number of U.S. (federal and state) and international data privacy and security laws and regulations governing the collection, use, disclosure and protection of health-related or other personal information. Failure to comply with these requirements can subject our company to legal, regulatory, and reputational risks, as well as the financial costs associated with compliance or that can accompany regulatory investigations, enforcement actions, or private litigation as applicable.
Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act
In the U.S., HIPAA and the accompanying Privacy Rule, Security Rule, and Breach Notification Rule, as well as business associate agreements entered into with our customers in some cases, require certain of our operations to maintain controls to protect the confidentiality, availability, and integrity of individually identifiable information, known as patient health information (“PHI”). Entities found to be in violation of HIPAA, whether as the result of a breach, privacy complaint, failure to perform a risk assessment, or for other reasons, may be subject to significant fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle non-compliance allegations. Penalties for HIPAA violations can range from $141 to $2.1 million dollars per violation, with a maximum fine of $2.1 million for identical violations during a calendar year. In 2018, a nation-wide health benefit company paid $16 million to HHS following a data breach. Under the law, state attorneys general have authority to bring civil enforcement actions under HIPAA, and attorneys general are actively engaged in enforcement. In addition, any penalties assessed under HIPAA could be in addition to other penalties assessed by a state for a data breach in violation of state laws.
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The HITECH Act was enacted as an update to HIPAA and makes business associates (as defined under HIPAA) of covered entities directly liable for compliance with certain HIPAA requirements, strengthens the limitations on the use and disclosure of PHI without individual authorizations, and contemplates enforcement of noncompliance with HIPAA due to willful neglect. These changes have stimulated increased enforcement activity and have enhanced the potential that health care providers will be subject to financial penalties for violations of HIPAA. In addition, the Secretary of HHS is required to perform periodic audits to ensure covered entities (and their business associates) comply with applicable HIPAA requirements, increasing the likelihood that a HIPAA violation may result in an enforcement action.
In early 2025, HHS issued a proposed new rule that included significant changes to the HIPAA Security Rule requirements. The changes focus heavily on strengthening cybersecurity for electronic protected health information by mandating Multi-Factor Authentication, requiring encryption for electronic protected health information at rest and in transit, and removing the “addressable” versus “required” distinction for security controls, making most technical safeguards contained in the HIPAA Security Rule mandatory. Other material changes include an explicit requirement to undertake annual security audits, a requirement to maintain more detailed risk analyses, an obligation to conduct specific vulnerability scanning/penetration testing, and the adoption of stricter incident response/disaster recovery plans (including 72-hour recovery goals). If the proposed rule becomes final, the implementation of these requirements may require expenditure of resources to reach compliance.
Other U.S. Federal and State Security and Privacy Laws
In addition to HIPAA, there are a growing number of federal, state, and industry-related privacy and security requirements in the U.S. that address privacy and security with respect to certain entities, processing activities, or types of data information. For example, health-related data falling outside of PHI regulated by HIPAA may be governed by some comprehensive state privacy laws (e.g., California Consumer Privacy Act (“CCPA”)), as well as targeted laws such as Washington’s My Health My Data Act, or Illinois’s Biometric Information Privacy Act (“BIPA”). In addition, various laws and regulations apply to the security, collection, processing, storage, use, disclosure and other processing of certain types of data, including the Electronic Communications Privacy Act (“ECPA”), the Computer Fraud and Abuse Act (“CFAA”), the Gramm-Leach-Bliley Act (“GLBA”), and state and local laws relating to privacy and data security, to the extent applicable. The Federal Trade Commission (“FTC”) and many state attorneys general have also interpreted and are continuing to interpret federal and state consumer protection laws to impose standards for the online collection, use, dissemination, processing and security of data. Processing of payment card data is subject (via agreements with major card issuers) to the Payment Card Industry Data Security Standards (“PCI-DSS”). Collection of information from website visitors may be subject to comprehensive state privacy laws that require disclosure or opt out rights, or vulnerable to private litigation under traditional surveillance laws that have been expansively interpreted (e.g., California’s California Invasion of Privacy Act (“CIPA”), Florida’s Florida Security of Communications Act (“FSCA”)). Federal laws and regulations such as the CAN-SPAM Act, the TCPA (as well as state “mini-TCPA” laws), the FTC Telemarketing Sales Rule, as well as Section 5 of the FTC Act (“unfair and deceptive practices”) and corollary state statutes restrict the use of information in marketing activities using certain data and technologies, requiring proper disclosure, compliance, and honoring of opt out rights. Finally, similar to the cross-border restrictions found in international data protection laws, the U.S. recently finalized the DOJ Bulk Transfer Rule (implementing Executive Order 14117), which restricts the export of bulk sensitive personal data (e.g., health, genomic, or financial information) to certain countries of concern.
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A growing number of states (approximately 20) have enacted comprehensive consumer privacy laws, which require certain disclosures in privacy notices, and which grant individuals certain rights with respect to their personal information, including the right to request access, correction, or deletion thereof. While some of these laws exempt entities subject to HIPAA, others do not, or only exempt PHI, meaning we may be subject to these laws with respect to collection, use, sharing, and processing of other, non-PHI, personal information. Most state privacy and data breach notification laws do not include a private right of action, reserving enforcement authority exclusively to the state attorney general, although a few do allow private rights of action in limited circumstances. For example, the CCPA allows for private rights of action related to data breaches. In addition, all 50 states and the District of Columbia have adopted data breach notification laws that impose, in varying degrees, an obligation to notify affected individuals, and in some cases state regulatory authorities and consumer credit bureaus, in the event of a data breach or compromise, when personal information has or may have been accessed or acquired by an unauthorized person. Compliance with each of these various laws could impose significant costs, as well as legal, regulatory, or financial exposure if we are found not to be in compliance. Large-scale data breaches may be subject to private litigation under common law or other theories unrelated to the data breach notification laws. Thus, the fragmented and continually evolving federal and state cybersecurity and privacy landscape may cause us to incur significant compliance costs or drive changes to our business practices and policies, or may expose us to the potential for significant regulatory fines and penalties, or in some cases awards or settlements in civil litigation.
International privacy and security laws and regulations
As a company with international locations and operations, we may also be subject to a number of international laws regarding privacy and security.
In the EU, we are subject to the General Data Protection Regulation (“GDPR”), the primary data protection law in the European Economic Area, including the European Union (collectively, the “EU”), as well as associated EU member state data protection laws, the UK GDPR in the United Kingdom (amended in 2025 by the UK Data (Use and Access) Act), and the Swiss Federal Act on Data Protection. These laws impose significant requirements for covered businesses (controllers and processors) of personal data, including, for example, standards for obtaining consent from individuals to process their personal data, more robust disclosures to individuals, an individual data rights regime, timelines for data breach notifications, limitations on retention and secondary uses of information, requirements pertaining to health data and pseudonymised (i.e., deidentified) data, restrictions on cross-border data transfers outside of the EU, and obligations when we contract third-party processors in connection with the processing of personal data. The GDPR allows EU member state regulatory authorities (“data protection authorities”) certain flexibility to make additional laws and regulations concerning the same issues, including, for example, further limiting the processing of genetic, biometric or health data. Failure to comply with the requirements of the GDPR or its member state implementations may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher. Other administrative penalties may be imposed under the applicable national data protection laws of the EU member states. In addition to GDPR, the EU Data Act took effect on September 12, 2025 and imposes requirements on connected products or services with fines of up to €20,000,000 or 4% of worldwide annual turnover, whichever is higher. Additionally, the EU NIS2 directive imposes cybersecurity obligations and incident notification requirements with fines of up to €10,000,000 or 2% of worldwide annual turnover, whichever is higher.
On August 20, 2021, China promulgated the Personal Information Protection Act Law (“PIPL”), which took effect on November 1, 2021. The PIPL imposes specific rules for processing personal information and it also specifies that the law shall also apply to personal information activities carried out outside China but for the purpose of providing products or services to PRC citizens. It also contains certain requirements and restrictions before personal data may be transferred outside of the country. The PIPL carries maximum penalties of CNY50 million or 5% of the annual revenue of entities that process personal data. Regulations and guidance regarding the PIPL continue to evolve.
Numerous other countries throughout the world have or are in the process of passing laws that contain similar requirements to the GDPR and the PIPL. For example, Brazil’s Lei Geral de Protecao de Dados (LGPD), similar to GDPR, gives consumers more control over how their personal information gets collected and used by external entities, with maximum penalties of up to R$50 million per infraction. A number of countries in the APAC region have recently adopted data protection laws similar to GDPR which contain similar restrictions, such as in Indonesia, Malaysia, Cambodia, and India. Data residency and localization laws have also been passed or are under consideration in several countries (such as Russia), which require personal information relating to their citizens to be maintained on local servers and impose additional data transfer restrictions.
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Artificial Intelligence
Finally, the last few years have seen a number of federal and state regulatory efforts around the use of artificial intelligence. Like privacy and security, this is a quickly evolving patchwork of guidance, rules, and regulations from a number of legislative bodies, agencies, and other authorities. In the EU, even more comprehensive and prescriptive requirements over artificial intelligence have been enacted in the form of the EU AI Act, which went into effect on August 1, 2024. In the U.S., more than 1,000 artificial intelligence-related bills were introduced in state legislative sessions in the past year or two, and a growing number of states have enacted artificial intelligence-related laws or regulations – including California, Colorado, Utah, Arkansas, Montana, and New Jersey. Much like cybersecurity and privacy in the U.S., some of these requirements aim to comprehensively regulate developers and deployers of artificial intelligence, while others target specific risks, such as children’s online privacy, deepfakes or chatbots, or other specific issues. Moreover, the White House issued an executive order to develop a national policy framework on artificial intelligence, and further purports to preempt any state artificial intelligence laws inconsistent with its policies; this executive order is currently being challenged on constitutional and other grounds. Such quickly evolving legal and regulatory changes could potentially apply to and thus impact our business practices and operations.
For a discussion of risks related to compliance with data privacy and security laws, please refer to “Item 1A. Risk Factors—Risks Related to Our Business.”
Environmental Laws and Regulations
Our operations and properties are subject to laws and regulations relating to environmental protection, including those governing air emissions, water discharges and waste management, and workplace health and safety. In addition, certain of our products are regulated by the U.S. Environmental Protection Agency (the “EPA”) and comparable state regulatory agencies. For a discussion of the environmental laws and regulations that our operations, products and services are subject to and other environmental contingencies, please refer to Note 13 to our Consolidated Financial Statements included in this Annual Report. For a discussion of risks related to compliance with environmental and health and safety laws and risks related to past or future releases of, or exposures to, hazardous substances, please refer to “Item 1A. Risk Factors—Risks Related to Laws and Regulations.”
Export/Import Compliance
We are required to comply with various U.S. export/import control and economic sanctions laws, including the regulations administered by the U.S. Department of Treasury, Office of Foreign Assets Control, which implement economic sanctions imposed against designated countries, governments and persons based on U.S. foreign policy and national security considerations, and the import regulatory activities of the U.S. Customs and Border Protection. Other nations’ governments have implemented similar export and import control regulations, which may affect our operations or transactions subject to their jurisdictions. For a discussion of risks related to export/import control and economic sanctions laws, please refer to “Item 1A. Risk Factors—Risks Related to Laws and Regulations.”
Acquisitions
We continually evaluate potential investments and acquisitions that either strategically fit with our existing portfolio or expand our portfolio into new and attractive business areas. Our operations and results can be affected by the rate and extent to which appropriate acquisition opportunities are available, acquired businesses are effectively integrated and anticipated synergies or cost savings are achieved.
Restructuring Activities
We implemented restructuring activities across our businesses to execute our strategy, streamline operations, take advantage of available capacity and resources and to adjust our cost structure. For additional information regarding our restructuring activities, please refer to Note 18 to our Consolidated Financial Statements included elsewhere in this Annual Report.