−Removed: The following is a summary of the significant risk factors that could materially impact our business, financial condition or future results, including risks related to our businesses, our international operations, our regulatory environments, ownership of our common stock, and other general risks:
−Removed: • We rely heavily on information and technology to operate our businesses and product portfolios, and any cyber incidents could harm our operations and have a material impact on our business and financial results.
−Removed: • Evolving governmental oversight of the use of personal information, cross-border data transfer restrictions and the use of emerging technologies, including AI, as well as other technology regulations, may adversely affect our business.
−Removed: • We may be unable to develop innovative products and solutions to stimulate customer demand.
−Removed: • Damage to our reputation or brand could negatively impact our business, financial condition or results of operations.
−Removed: • Our ongoing business operations may be disrupted for a significant period of time, resulting in material operating costs and financial losses.
−Removed: • We may be unable to execute key strategic initiatives due to competing priorities and strategies of our distribution partners and other factors, which may result in financial losses and operational inefficiencies.
−Removed: • Our acquisitions, exiting of businesses, divestitures or strategic investments may result in financial results that are different than expected and create certain risks for our business and operations.
−Removed: • We may fail to realize the expected benefits of our strategic initiatives, including executed, announced, or potential future restructuring and other business transformation efforts.
−Removed: • We have recognized substantial goodwill and indefinite-lived intangible asset impairment charges and may be required to recognize additional goodwill and indefinite-lived intangible asset impairment charges in the future.
−Removed: • Our failure to protect our proprietary technology could have an adverse impact on our competitive position.
−Removed: • Our financial results may be adversely impacted if our products or services are found to infringe upon the intellectual property rights of others.
−Removed: • Changes in our credit ratings or macroeconomic impacts on credit markets may increase our cost of capital and limit financing options.
−Removed: • Our indebtedness could adversely affect our financial condition and prevent us from fulfilling our debt or contractual obligations.
−Removed: • Our foreign currency hedging and cash management transactions may be ineffective or only partially mitigate the impact of exchange rate fluctuations, exposing us to unexpected volatility.
−Removed: • Due to the global nature of our business, including increasing exposure to markets outside of the United States, political or economic changes or other factors could harm our business and financial performance.
−Removed: • Management previously identified material weaknesses in our internal control over financial reporting, some of which resulted in errors in previously issued financial statements.
−Removed: These material weaknesses were all remediated as of December 31, 2023.
−Removed: If we experience additional material weaknesses in the future, we may be unable to accurately and timely report financial results or comply with the requirements for public companies, which could cause the price of our common stock to decline or limit our access to the capital markets.
−Removed: • Lack of global standardized processes could result in control deficiencies and adversely impact management’s assertions and financial reporting.
−Removed: • We may be subject to additional litigation and regulatory examinations, investigations, proceedings or court orders relating to the completed 2022 internal investigation regarding certain financial reporting matters.
−Removed: If any of these items are resolved adversely to us, it could harm our business, financial condition and results of operations.
−Removed: • We may be unable to obtain necessary product approvals and marketing clearances.
−Removed: • Changes in tax rules or interpretations of tax rules, operating structures, transfer pricing regulations, country profitability mix and regulations and tax investigations, audits, or other proceedings that we are subject to may harm our business, financial condition and results of operations, including by adversely affecting our effective tax rate.
−Removed: • We voluntarily suspended the sale and marketing of our direct-to-consumer Byte aligner systems and impression kits, and subsequently determined to cease offering these aligners to new patients while repurposing Byte technologies and capabilities to support other products within our aligner portfolio.
−Removed: As a result, we have experienced a material impact on our results of operations, and we may be required to take additional significant impairment charges if we are unsuccessful in our efforts to reposition Byte.
−Removed: • Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our revenue to decline.
−Removed: • Challenges may be asserted against our products due to real or perceived quality, health or environmental issues.
−Removed: • If we fail to comply with laws and regulations relating to health care fraud, we could suffer penalties or be required to make significant changes to our operations, which could adversely affect our business.
−Removed: • Our business is subject to extensive, complex and changing domestic and foreign laws, rules, regulations, self-regulatory codes, directives, circulars and orders which, if not complied with, subject us to civil or criminal penalties or other liabilities.
−Removed: • The market price for our common stock may continue to be volatile as a result of a number of factors, including our quarterly operating results.
−Removed: • Certain provisions in our governing documents, and of Delaware law, may make it more difficult for a third party to acquire us.
−Removed: • Our business may be adversely affected by changes in global economic conditions, including inflation, rising interest rates, and supply chain shortages.
−Removed: • Talent gaps and failure to manage and retain top talent may impact our ability to manage our operations, execute strategic initiatives and grow our business.
−Removed: • We face the inherent risk of legal actions, including litigation, product liability claims, and other regulatory or compliance matters.
−Removed: • Climate change and related natural disasters could negatively impact our business and financial results.
−Removed: • Expectations relating to environmental, social and governance considerations may expose us to potential liabilities, increased costs, reputational harm, and other adverse effects on our business.
−Removed: Below is a full description of each of such significant risk factors.
RISKS RELATED TO OUR BUSINESSES
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In particular, the 2022 launch of DS Core, our cloud platform that integrates digital dentistry workflows across devices, and the 2024 launch of Primescan 2, a cloud-native intraoral scanner, have introduced new potential vulnerabilities to cyber attacks.
−Removed: The breadth and complexity of our information and technology systems have increased and we expect that they will continue to increase as we expand the services enabled by DS Core and further develop our ERP systems and product offerings to utilize artificial intelligence (“AI”) and analytics.
+Added: The breadth and complexity of our information and technology systems have increased and we expect that they will continue to increase as we expand the services enabled by DS Core and further develop our Enterprise Resource Planning (“ERP”) systems and product offerings to utilize artificial intelligence (“AI”) and analytics (such as DS Core).
As a result, we will increasingly be exposed to risks inherent in the development, integration and operation of the evolving information and technology supporting our product platforms, as well as our own internal infrastructure, including:
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Like other large, global companies, during the normal course of business, we have experienced and expect to continue to experience cyber threats, attacks and other attempts to compromise our information systems, with such attacks and threats rapidly increasing in both sophistication and frequency.
−Removed: However, none, to our knowledge, have had a material adverse effect on our business, financial condition or results of operations to date.
−Removed: Our policies, required employee training (including that which relates to phishing prevention), procedures and technical safeguards may be insufficient to prevent or detect improper access to confidential, proprietary or sensitive data, including personal data.
−Removed: Cyberattacks could also cause us to incur significant costs, disrupt key business operations and divert attention of management and key information technology resources.
+Added: Although past cybersecurity incidents have not had a material effect on
+Added: our business or operations, and although we and our service providers take efforts to ensure the integrity of our systems and anticipate, detect, avoid or mitigate such threats, we cannot provide assurances that a future cyberattack would not result in material harm to our business and results of operations.
+Added: Our policies, required employee training (including phishing prevention), procedures and technical safeguards may be insufficient to prevent or detect improper access to confidential, proprietary or sensitive data, including personal data.
+Added: Cyberattacks could cause us to incur significant costs, disrupt key business operations and divert attention of management and key information technology resources.
We also face the ongoing challenge of controlling access to our information and technology infrastructure.
−Removed: We have experienced various cyber incidents in the past and have implemented new controls, governance, protections and procedures as a result.
+Added: We have implemented new controls, governance, protections and procedures as a result of cyber incidents experienced in the past.
If we do not successfully manage these access controls, it could expose us to the risk of security breaches or disruptions.
−Removed: Although past cybersecurity incidents have not had a material effect on our business or operations, and although we and our service providers take efforts to ensure the integrity of our systems and anticipate, detect, avoid or mitigate such threats, we cannot provide assurances that a future cyberattack would not result in material harm to our business and results of operations.
Disaster recovery plans, where in place, might not adequately protect us in the event of a system failure.
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Our use of AI in our products and processes and the use of AI by our business partners may lead to novel cybersecurity, legal and regulatory risks, which could have a material adverse effect on our operations and reputation as well as the operations of our business partners.
−Removed: Additionally, we seek to maintain insurance coverage for cybersecurity risks, but such insurance has become increasingly difficult to secure and, in some cases, policies may not provide adequate coverage for possible losses.
−Removed: Further, as cybersecurity risks evolve, such insurance may not be available to us on commercially reasonable terms, or at all.
−Removed: Uninsured losses or operational losses that result from large deductible payments under commercial insurance coverage might have an adverse impact on our business operations, financial position or results of operations.
Evolving governmental oversight of the use of personal information, cross-border data transfer restrictions and the use of emerging technologies, including AI, as well as other technology regulations, may adversely affect our business.
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and foreign laws and regulations, including oversight by regulatory or governmental bodies.
−Removed: The EU General Data Protection Regulation (“GDPR”), for example, imposes stringent data protection requirements and provides significant penalties for noncompliance.
−Removed: Fines for noncompliance can amount to up to €20 million or 4% of the total worldwide annual sales from the preceding financial year (whichever is higher) and may be imposed in conjunction with the exercise of the authority’s investigatory and corrective powers.
−Removed: The GDPR’s extraterritorial scope makes it applicable to our U.S.-based legal entities whenever our business activities process the personal data of EU residents.
+Added: The EU General Data Protection Regulation (“GDPR”), for example, has an extraterritorial scope that makes it applicable to our U.S.-based legal entities whenever we process the personal data of EU residents and impose stringent data protection requirements and provides significant penalties for noncompliance.
Privacy laws, rules and regulations are also rapidly developing in other regions, including China, Brazil and South Korea, and the United States.
−Removed: In the United States, the federal Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”) impose certain requirements on covered entities and their business associates
−Removed: to protect the privacy and security of protected health information (“PHI”) and to provide notification in the event of a breach of PHI.
−Removed: Department of Health and Human Services Office for Civil Rights (“OCR”), which is responsible for enforcing HIPAA, also may enter into resolution agreements requiring the payment of civil money penalties and/or the establishment of corrective action plans to address violations of HIPAA.
−Removed: Pursuant to HIPAA, OCR has adopted privacy regulations to govern the use and disclosure of PHI and data security regulations that require the implementation of safeguards to protect electronic PHI.
+Added: In the United States, the federal Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”) impose requirements on covered entities and their business associates to protect the privacy and security of protected health information (“PHI”) and to provide notification in the event of a breach of PHI.
Our Company, through its various subsidiaries, functions as both a covered entity and a business associate under HIPAA.
−Removed: Where necessary, we have segregated our data to ensure that PHI is handled in accordance with HIPAA requirements.
We believe that we have implemented appropriate policies and procedures and security measures necessary to comply with HIPAA.
−Removed: However, despite our compliance efforts, we may suffer a serious breach of PHI or be subject to a cyberattack that compromises the PHI that we maintain.
+Added: However, despite our compliance efforts, we may suffer a serious breach of PHI or be subject to a cyberattack that compromises the PHI that we maintain, which may require that we pay monetary civil penalties or establish corrective action plans.
Additionally, federal and state privacy and security-related laws may be more restrictive than HIPAA and could impose additional penalties:
• For example, the Federal Trade Commission uses its consumer protection authority to initiate enforcement actions in response to alleged privacy violations and data breaches.
−Removed: The California Consumer Privacy Act (“CCPA”) created additional data privacy obligations for covered companies and a private right of action with statutory damages for certain data breaches.
−Removed: In addition, the California Privacy Rights Act further expanded the CCPA to provide even greater rights to California consumers with respect to their data.
−Removed: Other states have followed California by implementing data privacy laws, including, but not limited to, Colorado, Connecticut, Utah, Virginia, and Washington.
+Added: • Additionally, the California Consumer Privacy Act (“CCPA”) creates additional data privacy obligations for covered companies and other states have followed California by implementing data privacy laws, including, but not limited to, Colorado, Connecticut, Utah, Virginia, and Washington.
+Added: These laws and other state laws contain breach notification requirements.
If we suffer a serious breach of personal data, we may be subject to breach notification requirements, government investigations, media inquiries, civil and criminal fines and penalties, litigation, and negative public perception, and we may be required to expend substantial financial and personnel resources.
Any liability from failing to comply with applicable privacy and data protection laws could adversely affect our operations and our financial condition.
−Removed: These varying laws, rules, regulations and industry standards impact our businesses to the extent we rely on the use of personal data, including PHI, and create significant compliance challenges.
+Added: These varying laws, rules, regulations and industry standards impact our businesses to the extent we rely on the use of PII, including PHI, and create significant compliance challenges.
In addition, certain privacy and data protection laws may apply to us indirectly through our customers, manufacturers, suppliers or other third-party partners.
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Any inability, or perceived inability, to adequately address privacy and data protection concerns or to comply with applicable laws, regulations, policies, industry standards, contractual obligations, or other legal obligations (including at newly acquired companies) could result in additional cost and liability to us or our officers, damage our reputation, inhibit sales, and otherwise adversely affect our business.
−Removed: Moreover, global regulation related to the provision of services on the Internet is increasing, as governments continue to adopt new laws and regulations addressing data privacy and the collection, processing, storage and use of personal information.
−Removed: Such laws and regulations are subject to new and differing interpretations and may be inconsistent among jurisdictions.
−Removed: These and other requirements could restrict our ability to store and process data or impact our ability to offer future digital dentistry products and services in certain locations.
−Removed: The costs of compliance with and other burdens imposed by these types of laws, regulations and standards may limit the adoption of our products or services or lead to significant fines, penalties or liabilities for noncompliance, any of which could harm our business.
In addition, the legal and regulatory landscape surrounding AI technologies is rapidly evolving and uncertain, especially in the areas of intellectual property, cybersecurity, and privacy and data protection.
−Removed: For example, there is uncertainty around the validity and enforceability of intellectual property rights related to the use, development, and deployment of AI.
−Removed: Compliance with new or changing laws, regulations or industry standards relating to AI may impose significant operational costs and may limit the ability of the Company and our business partners to develop, deploy or use AI technologies.
+Added: For example, the EU AI Act was enacted on August 1, 2024, with some provisions effective in February of 2025, and becoming fully effective on August 2, 2026.
+Added: Additionally, there is uncertainty around the validity and enforceability of intellectual property rights related to the use, development, and deployment of AI.
+Added: Compliance with new or changing laws, regulations or industry standards relating to AI may impose significant operational costs and may limit the ability of the Company and its business partners to develop, deploy or use AI technologies.
Failure to appropriately respond to this evolving landscape may result in legal liability, regulatory action, or brand and reputational harm.
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Although we currently maintain liability insurance intended to cover cyber and certain other privacy and security breach-related claims, we cannot ensure that our insurance coverage will be adequate to cover liabilities arising out of claims asserted against us in the future if the outcomes of such claims are unfavorable to us.
−Removed: Liabilities in excess of our insurance coverage,
−Removed: including coverage for cyber liability and certain other privacy and security breach-related claims, could have a material adverse effect on our business, financial condition, results of operations, cash flows and the trading price of our securities.
+Added: Insurers are seeking to limit liability and/or deny coverage for AI-related claims due to uncertainty created by the speed of technology advancement.
+Added: Liabilities for claims outside or in excess of our insurance coverage could have a material adverse effect on our business, financial condition, results of operations, cash flows and the trading price of our securities.
+Added: Damage to our reputation or brand could negatively impact our business, financial condition or results of operations.
+Added: We seek to maintain our reputation, and successful promotion of our brand depends on multiple factors, including our marketing efforts and our ability to deliver a superior customer experience, develop innovative products, and differentiate our offerings from those of our competitors.
+Added: Additionally, the strength of our brand relies on continued effective use of our distribution network and customer service platforms.
+Added: The promotion of our brand requires us to make substantial expenditures, including continued investments in enhancing customer experience.
+Added: Our brand promotion activities may not be successful in maintaining or increasing our current level of revenue.
+Added: If we do not successfully position our brand and reputation as an industry leader, our business and operating results may be adversely affected.
+Added: Additionally, our brand depends on our reputation for offering high-quality solutions meeting the highest safety standards.
+Added: A serious breach of our quality assurance or quality control procedures, deterioration of our quality image, impairment of our customer or consumer relationships or failure to adequately protect the relevance of our brands may lead to litigation, customers purchasing from our competitors, other brands or private labels not manufactured by us, or regulatory enforcement action, any of which could have a material negative impact on our business, financial condition or results of operations.
+Added: We may be unable to execute key strategic initiatives due to competing priorities and strategies of our distribution partners and other factors, which may result in financial losses and operational inefficiencies.
+Added: We may be unable to execute our key strategic activities and investments due to operational disruptions impacting our distributors or the competing priorities of our distribution partners, which may introduce additional products that compete with our products at lower price points.
+Added: If these competing products capture significant market share or result in a decrease in market prices overall, there could be negative impacts on our results of operations and financial condition.
+Added: We generate a substantial portion of our revenue through a limited number of distributors who we also rely on to provide important service and support to end-users.
+Added: We have attempted to mitigate any risks related to this concentration through
+Added: diversifying our distributor base, particularly in the United States beginning in 2026.
+Added: The dental market continues to be impacted by price competition, driven in part by the consolidation of dental practices, the growing significance of Dental Support Organizations, innovation, and end-user price sensitivity.
+Added: There can be no assurance our distribution partners will purchase products from us at a similar rate as in the past.
+Added: Changes in our distributors, our promotional strategies, and investments may adversely impact our distributor relationships, including their effectiveness in selling our projects, which could have a material adverse effect on our results of operations and financial condition.
+Added: In addition, changes in the capital structure or ownership of distributors could result in changes to our relationship, including shifts in strategies related to inventory management, customer service and servicing the installed base of our products.
+Added: We rely in part on our distributor and customer relationships to predict future demand levels and estimate the impact on our financial results.
+Added: Predications of retail or end customer demand, which influence distributor demand for Dentsply Sirona products, may fluctuate, and may be different from actual demand.
+Added: There can be no assurance that distributors’ and customers’ demand for our products will be consistent with historical demand.
+Added: Any disruptions to our distributors’ operations or systems may result in delays in orders and shipments and may prevent our products from being timely delivered to the market.
+Added: Our acquisitions, exiting of businesses, divestitures or strategic investments may result in financial results that are different than expected and create certain risks for our business and operations.
+Added: We have made, and may continue to make in the future, acquisitions to enhance our business and product portfolio, which require us to invest significant resources to integrate the businesses we acquire.
+Added: We also periodically evaluate our businesses and assets for potential disposition as a key part of our strategy.
+Added: The success of each acquisition or divestiture depends in part on our ability to realize opportunities and manage risks, including challenges executing transactions, higher operating expenses, litigation, adverse effects on existing business relationships with suppliers and customers, and the potential loss of key employees, customers, distributors, vendors, and other business partners.
+Added: The process of continuing to evaluate acquisitions, divestitures or strategic investments may be costly, time-consuming and complex, including requiring management to devote significant time and attention to these types of transactions that may distract our management and disrupt our ongoing business operations or relationships.
+Added: We may incur significant legal, accounting and advisory fees and other expenses, some of which may be incurred regardless of whether we successfully enter into a transaction.
+Added: We may not achieve expected returns and benefits in connection with acquisitions or dispositions as a result of various factors, including integration challenges, such as those relating to personnel and technology, and we may not achieve financial results consistent with revenue growth expectations and cost synergies or savings anticipated from integration or disposition activities.
+Added: Dispositions may also involve continued involvement in a divested business, such as through continuing equity ownership, transition service agreements, guarantees, indemnities or other financial obligations.
+Added: Under these arrangements, the performance of the divested business, or other conditions outside our control, could affect our future financial results.
+Added: We may fail to realize the expected benefits of our strategic initiatives, including executed, announced, or potential future restructuring and other business transformation efforts.
+Added: We undertake strategic initiatives in an attempt to improve the effectiveness and efficiency of our organization, support growth initiatives and improve operating and financial results.
+Added: Our ability to achieve benefits from our strategic initiatives within the expected timeframe is subject to many estimates, assumptions, and other factors that we may not be able to control.
+Added: We may also undertake restructuring plans that lead to our incurring charges to execute the plans, which charges may be higher than anticipated, reducing our profitability in the periods such charges are incurred.
+Added: We executed a restructuring plan in 2024 (the “2024 Plan”).
+Added: Actions taken under the 2024 Plan sought to streamline our operations and global footprint, as well as improve alignment of our cost structure with strategic growth objectives.
+Added: The 2024 Plan is substantially complete as of December 31, 2025.
+Added: In addition, we implemented a new restructuring plan in 2026 (the “2026 Plan”) to improve operational performance and drive stockholder value creation.
+Added: In connection with the 2026 Plan, the Company expects to incur non-
+Added: recurring charges in the approximate range of $55 million to $65 million, the majority of which will be expensed and paid in cash in 2026 and 2027.
+Added: The 2026 Plan is anticipated to result in approximately $120 million in annualized cost savings.
+Added: We currently use disparate systems, including ERP systems, across the organization, which may reduce our ability to obtain and analyze business data in a timely manner, increase costs for system upgrades, and pose business partner connection challenges.
+Added: Non-standardized processes may lead to inaccurate, incomplete or delayed financial and management reporting, which may result in misleading or inaccurate reporting for key business decisions or noncompliance with applicable business and regulatory requirements, potentially causing penalties or fines.
+Added: We continue to focus on standardizing our processes, improving our financial systems, maintaining effective internal controls and centralizing transaction management and execution to provide continued assurance with respect to our financial reports and prevent financial misstatement or fraud.
+Added: In 2025, we continued implementing a new global ERP system, which will upgrade and standardize our existing information systems.
+Added: Beginning in 2023 and continuing through 2025, we made capital investments to support the implementation of this new global ERP system, which has resulted in significant costs and uses of cash that are expected to continue in the future.
+Added: Execution of the implementation plan is expected to take several years to complete, and cost overruns or any disruptions, delays or complications could lead to higher than anticipated capital investments and related costs, potentially adverse impacts to sales and shipping activities, distract from our core business, or result in failures to produce financial information accurately and timely and may adversely impact our financial results.
+Added: The implementation of a new global ERP system may not be fully successful in providing standardization sufficient to address these risks even once completed.
+Added: The failure to either deliver the application on time, adequately design the ERP system or anticipate organization readiness and training needs could lead to business disruptions.
+Added: The quarterly timing of sales may also be impacted as distributors adjust their buying patterns and inventory levels in anticipation of potential business disruptions related to the implementation of our new ERP system.
+Added: Failure or abandonment of any part of the ERP system could result in a write-off of part or all of the costs that have been capitalized on the project.
+Added: Due to the complexities inherent in implementing these types of cost reduction and restructuring activities, and the timing of strategic investments, we may fail to realize expected efficiencies and benefits or may experience a delay in realizing such efficiencies and benefits, and our operations and business could be disrupted.
+Added: Company management may be required to divert their focus to these disruptions, and implementation may require agreements with third parties, such as labor unions or works councils.
+Added: Risks associated with these actions and other workforce management issues include delays in workforce reductions, additional unexpected costs, changes in restructuring plans that modify the number of employees affected, negative impacts on our relationship with labor unions or works councils, adverse effects on employee morale, and failure to meet operational targets due to the loss of employees, any of which may impair our ability to achieve anticipated cost reductions or may otherwise harm our business, and could have a material adverse effect on our sales growth and other results of operations, cash flows or financial condition, or competitive position.
We may be unable to develop innovative products and solutions to stimulate customer demand.
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Additionally, the rapid pace of technological advancements may accelerate amortization faster than we anticipated or impair investments in our software technology, which could negatively impact our results.
−Removed: Damage to our reputation or brand could negatively impact our business, financial condition or results of operations.
−Removed: We seek to maintain our reputation, and successful promotion of our brand depends on multiple factors, including our marketing efforts and our ability to deliver a superior customer experience, develop innovative products, and differentiate our offerings from those of our competitors.
−Removed: Additionally, the strength of our brand relies on continued effective use of our distribution network and customer service platforms.
−Removed: The promotion of our brand requires us to make substantial expenditures, including continued investments in enhancing customer experience.
−Removed: Our brand promotion activities may not be successful in maintaining or increasing our current level of revenue.
−Removed: If we do not successfully position our brand and reputation as an industry leader, our business and operating results may be adversely affected.
−Removed: Additionally, our brand depends on our reputation for offering high-quality solutions meeting the highest of safety standards.
−Removed: A serious breach of our quality assurance or quality control procedures, deterioration of our quality image, impairment of our customer or consumer relationships or failure to adequately protect the relevance of our brands may lead to litigation, customers purchasing from our competitors, other brands or private labels not manufactured by us, or regulatory enforcement action, any of which could have a material negative impact on our business, financial condition or results of operations.
Our ongoing business operations may be disrupted for a significant period of time, resulting in material operating costs and financial losses.
−Removed: We operate in approximately 150 countries and our suppliers’ manufacturing facilities are located in multiple locations around the world.
+Added: We sell to customers in approximately 140 countries and our manufacturing facilities, along with those of our suppliers, are located in multiple countries around the world.
Potential events such as extreme weather, natural disasters, regional epidemics or global pandemics, worker strikes and social and political actions, such as trade wars, regional wars or conflicts or other events beyond our control, could impact our ongoing business operations, including due to disruptions at critical third-party vendors or the loss of critical information technology and telecommunications systems.
+Added: There is potential that global climate change could result in certain types of natural disasters occurring more frequently or with increased intensity and such climate events could disrupt our third-party suppliers, production, and distribution of our products.
+Added: Current or future insurance arrangements may not provide protection for costs that may arise from such events, particularly if such events are catastrophic in nature or occur in combination.
Although we maintain multiple manufacturing facilities, a large number of the products manufactured by us are manufactured in facilities that are the sole source of such products.
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If our incident response, disaster recovery and business continuity plans do not resolve these issues in an effective and timely manner, such events could result in an interruption in our operations and could cause material negative impacts on our business, financial condition or results of operations.
−Removed: Additionally, a significant portion of our injectable anesthetic products, orthodontic products, certain dental cutting instruments, catheters, nickel titanium products and certain other products and raw materials are purchased from a limited number of suppliers and in certain cases single source suppliers pursuant to agreements that are subject to periodic renewal, some of which may also compete with us.
+Added: Additionally, certain raw materials are purchased from a limited number of suppliers, including in certain cases single source suppliers pursuant to agreements that are subject to periodic renewal, some of which may also compete with us.
As there are a limited number of suppliers for these products, there can be no assurance that we will be able to obtain an adequate supply of these products and raw materials in the future at acceptable prices.
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Any transition to alternate suppliers may result in delays in shipment, increase expenses and limit our ability to deliver products to customers.
−Removed: We may be unable to execute key strategic initiatives due to competing priorities and strategies of our distribution partners and other factors, which may result in financial losses and operational inefficiencies.
−Removed: We may be unable to execute our key strategic activities and investments due to operational disruptions impacting our distributors or the competing priorities of our distribution partners, which may introduce additional products that compete with our products at lower price points.
−Removed: If these competing products capture significant market share or result in a decrease in market prices overall, there could be negative impacts on our results of operations and financial condition.
−Removed: We generate a substantial portion of our revenue through a limited number of distributors that provide important support to end-users.
−Removed: Together, our two largest distributors, Patterson Companies, Inc.
−Removed: (“Patterson”) and Henry Schein, Inc.
−Removed: (“Henry Schein”), accounted for approximately 13% of our annual revenue for the year ended December 31, 2024.
−Removed: In July 2024, we delivered a one-year notice of non-renewal to Patterson in connection with its non-exclusive distribution agreements for the distribution of dental equipment in the United States and Canada.
−Removed: It is anticipated that Patterson will continue to be one of our two largest distributors as a percentage of our global revenue during the one-year notice period.
−Removed: We intend to engage in discussions for new distribution agreements with Patterson.
−Removed: However, failure to successfully renegotiate the distribution agreements or secure new agreements with another distributor could have a material adverse effect on our business, operating results and financial condition.
−Removed: We have not incurred any charges against earnings in 2024 related to non-renewal of the distribution agreements.
−Removed: Additionally, the dental market continues to be impacted by price competition, driven in part by the consolidation of dental practices, the growing significance of DSOs, innovation, and end-user price sensitivity.
−Removed: There can be no assurance that our distribution partners will purchase any minimum quantity of products from us or that they will continue to purchase any products at all.
−Removed: If Patterson or Henry Schein ceases to purchase a significant volume of products from us, or if changes in our promotional strategies and investments result in changes in our distributor relationships, it could have a material adverse effect on our results of operations and financial condition.
−Removed: In addition, changes in the capital structure or ownership of distributors could result in changes to our relationship, including shifts in strategies related to inventory management, customer service and servicing the installed base of Dentsply Sirona products.
−Removed: Changes to agreements with distributors, including expiration of existing agreements, could result in a reduction in the amount of inventory ordinarily held in the absence of contractual minimum inventory requirements.
−Removed: We rely in part on our distributor and customer relationships and predictions of distributor and customer inventory levels in projecting future demand levels and financial results.
−Removed: These inventory levels may fluctuate, and may differ from our predictions, resulting in our projections of future results being different than expected.
−Removed: These changes may be influenced by
−Removed: changing relationships with distributors and customers, economic conditions, and customer preference for particular products.
−Removed: There can be no assurance that distributors and customers will maintain levels of inventory in accordance with our predictions or past history or that the timing of customers’ inventory changes will be in accordance with our expectations.
−Removed: Any disruptions to our distributors’ operations or systems may result in delays in orders and shipments and may prevent our products from being timely delivered to the market.
−Removed: Our acquisitions, exiting of businesses, divestitures or strategic investments may result in financial results that are different than expected and create certain risks for our business and operations.
−Removed: We intend to continue utilizing acquisitions, dispositions, and strategic investments as a part of our strategy for growth and to improve financial results.
−Removed: We have made, and may continue to make in the future, acquisitions to enhance our business and product portfolio, which require us to invest significant resources to integrate the businesses we acquire.
−Removed: We also periodically evaluate our businesses and assets for potential disposition as a key part of our strategy, including the previously disclosed evaluation of strategic alternatives for our Wellspect Healthcare business.
−Removed: The success of each acquisition or divestiture depends in part on our ability to realize opportunities and manage risks, including challenges executing transactions, higher operating expenses, litigation, adverse effects on existing business relationships with suppliers and customers, and the potential loss of key employees, customers, distributors, vendors, and other business partners.
−Removed: The process of continuing to evaluate acquisitions, divestitures or strategic investments may be costly, time-consuming and complex, including requiring management to devote significant time and attention to these types of transactions that may distract our management and disrupt our ongoing business operations or relationships.
−Removed: We may incur significant legal, accounting and advisory fees and other expenses, some of which may be incurred regardless of whether we successfully enter into a transaction.
−Removed: We may not achieve expected returns and benefits in connection with acquisitions as a result of various factors, including integration challenges, such as those relating to personnel and technology, and we may not achieve financial results consistent with revenue growth expectations and cost synergies anticipated from integration activities.
−Removed: After reaching an agreement for the acquisition or disposition of assets or a business, the transaction may remain subject to regulatory and governmental approvals and the satisfaction of pre-closing conditions, which may prevent us from completing a given transaction in a timely manner, or at all.
−Removed: Acquisitions may require us to incur debt, assume contingent liabilities and/or additional risks, or create additional expenses to consummate the transaction, any of which might adversely affect our financial results.
−Removed: When we pursue the divestiture of a business, we may encounter difficulty in finding buyers or executing alternative exit strategies in a timely manner, which could delay the accomplishment of our strategic objectives.
−Removed: Alternatively, we may dispose of a business at a valuation or on terms that are less favorable than we had anticipated, or with the exclusion of select assets.
−Removed: Dispositions may also involve continued involvement in a divested business, such as through continuing equity ownership, transition service agreements, guarantees, indemnities or other financial obligations.
−Removed: Under these arrangements, the performance of the divested business, or other conditions outside our control, could affect our future financial results.
−Removed: If we are not successful in setting forth a new strategic vision for Wellspect, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and the value of our securities may be adversely impacted.
−Removed: We may fail to realize the expected benefits of our strategic initiatives, including executed, announced, or potential future restructuring and other business transformation efforts.
−Removed: In order to improve performance and drive value creation, we implemented a restructuring plan during 2024 (the “2024 Plan”).
−Removed: In connection with the 2024 Plan, we anticipate a net reduction in our global workforce of approximately 2% to 4%.
−Removed: The proposed changes are subject to co-determination processes with employee representative groups in countries where required.
−Removed: Actions taken under the 2024 Plan will seek to further streamline our operations and global footprint, as well as improve alignment of our cost structure with strategic growth objectives.
−Removed: In addition, we made restructuring changes during 2023 (the “2023 Plan”).
−Removed: The 2023 Plan plans included implementation of a new operating model with five global business units designed to align our product portfolio with our growth strategy, infrastructure optimization to support efficiency, and other initiatives aimed at delivering cost savings.
−Removed: We are also in the process of implementing a new global ERP system, which will upgrade and standardize our existing information systems.
−Removed: Beginning in 2023 and continuing through 2024, we made capital investments in this system, which has resulted in significant costs and uses of cash that are expected to continue in the future.
−Removed: Implementation is expected to take several years to complete, and cost overruns or any disruptions, delays or complications could lead to higher than anticipated capital investments and related costs, distract from our core business, or result in failures to produce financial information accurately and timely and may adversely impact our financial results.
−Removed: The failure to either deliver the application on time or
−Removed: anticipate readiness and training needs could lead to business disruptions.
−Removed: The quarterly timing of sales may also be impacted as distributors adjust their buying patterns and inventory levels in anticipation of potential business disruptions related to the implementation of our new ERP system.
−Removed: Failure or abandonment of any part of the ERP system could result in a write-off of part or all of the costs that have been capitalized on the project.
−Removed: Additionally, our ability to achieve benefits from our strategic initiatives within the expected timeframe is subject to many estimates, assumptions, and other factors that we may not be able to control.
−Removed: We may also incur charges related to restructuring plans that are higher than anticipated, which would reduce our profitability in the periods such charges are incurred.
−Removed: Due to the complexities inherent in implementing these types of cost reduction and restructuring activities, and the timing of strategic investments, we may fail to realize expected efficiencies and benefits or may experience a delay in realizing such efficiencies and benefits, and our operations and business could be disrupted.
−Removed: Company management may be required to divert their focus to these disruptions, and implementation may require the agreement of third parties, such as labor unions or works councils.
−Removed: Risks associated with these actions and other workforce management issues include delays in workforce reductions, additional unexpected costs, changes in restructuring plans that modify the number of employees affected, negative impacts on our relationship with labor unions or works councils, adverse effects on employee morale, and failure to meet operational targets due to the loss of employees, any of which may impair our ability to achieve anticipated cost reductions or may otherwise harm our business, and could have a material adverse effect on our sales growth and other results of operations, cash flows or financial condition, or competitive position.
We have recognized substantial goodwill and indefinite-lived intangible asset impairment charges and may be required to recognize additional goodwill and indefinite-lived intangible asset impairment charges in the future.
−Removed: We have acquired other companies and intangible assets and may not realize all the economic benefit from those acquisitions, which could cause an impairment of goodwill or intangibles.
+Added: We have acquired companies resulting in the recognition of goodwill and intangible assets.
+Added: Actual performance of acquired companies may differ from forecasts or projections, leading to the anticipated economic benefit from those acquisitions not being realized, which could result in an impairment of goodwill or intangible assets.
We review amortizable intangible assets for impairment when events indicate the carrying value may not be recoverable.
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There can be no assurance that our future asset impairment testing will not result in a material charge to earnings.
−Removed: In the quarter ended March 31, 2024, we identified indicators of a more likely than not impairment related to certain indefinite-lived imaging product trade names within the Connected Technology Solutions segment.
−Removed: The decline in fair value of these indefinite-lived trade names was driven by declines in volumes during the three months ended March 31, 2024, which was due in part to a loss in market share from competitive pricing pressures, as well as unfavorable economic conditions in certain markets.
−Removed: These factors contributed to a reduction in forecasted revenues in the near term.
−Removed: The trade names were evaluated for impairment using an income approach, specifically a relief from royalty method.
−Removed: As a result, we recorded an indefinite-lived intangible asset impairment charge of $6 million for the three months ended March 31, 2024.
−Removed: In the quarter ended September 30, 2024, the Company identified indicators of a more likely than not impairment for two of its reporting units, Orthodontic Aligner Solutions and Implant & Prosthetic Solutions, which together comprise all of the Orthodontic and Implant Solutions segment.
−Removed: As a result, the Company recorded pre-tax goodwill impairment charges as of September 30, 2024 of $145 million for the Orthodontic Aligner Solutions reporting unit and $359 million for the Implant & Prosthetic Solutions reporting unit, both within the Orthodontic and Implant Solutions segment.
−Removed: The impairment charge related to the Orthodontic Aligner Solutions reporting unit resulted in a full write-off of the remaining goodwill balance for this reporting unit.
−Removed: In the quarter ended December 31, 2024, the Company identified indicators of a more likely than not impairment for its Implant & Prosthetic Solutions reporting unit within the Orthodontic and Implant Solutions segment.
−Removed: The decline in fair value of this reporting unit was driven by a weaker trend in sales volumes, particularly in North America, increased competition from lower-priced alternatives impacting global markets, and adverse macroeconomic pressures impacting demand for elective
−Removed: dental procedures and premium implant solutions.
−Removed: These factors contributed to reduced forecasted revenues, lower operating margins, and reduced expectations for future cash flows.
−Removed: As a result, the Company recorded a pre-tax goodwill impairment charge as of December 31, 2024 of $269 million for the Implant & Prosthetic Solutions reporting unit within the Orthodontic and Implant Solutions segment.
−Removed: For further information, see Note 11, Goodwill and Intangible Assets, in the Notes to Consolidated Financial Statements in Item 8 of this Form 10-K.
−Removed: Additionally, in the quarter ended December 31, 2024, the Company also identified indicators of more likely than not impairments for certain indefinite-lived intangible assets including trade names and trademarks within the Connected Technology Solutions segment, and certain trade names within the Implant & Prosthetic Solutions reporting unit within the Orthodontic and Implant Solutions segment.
−Removed: The decline in fair value of the trade names and trademarks was driven by weakened demand for our premium equipment and implant products, competitive pricing pressures, and a sustained higher cost of capital, which are contributing to reduced forecasted revenues.
−Removed: As a result, the Company recorded indefinite-lived intangible asset impairment charges of $82 million and $1 million for the Connected Technology Solutions and Orthodontic and Implant Solutions segments, respectively, for the three months ended December 31, 2024.
−Removed: For further information, see Note 11, Goodwill and Intangible Assets, in the Notes to Consolidated Financial Statements in Item 8 of this Form 10-K.
−Removed: The remaining goodwill balance of the Implant & Prosthetic Solutions reporting unit was $503 million as of December 31, 2024, and the carrying values of indefinite-lived intangible assets with impairments in the fourth quarter were $76 million and $149 million for the Implant & Prosthetic Solutions and Connected Technology Solutions reporting units, respectively, as of December 31, 2024.
−Removed: As the fair values of the Implant & Prosthetic Solutions reporting unit and the indefinite-lived assets within the Implant & Prosthetic Solutions and Connected Technology Solutions reporting units, respectively, continue to approximate carrying value as of December 31, 2024, any further decline in key assumptions could result in future additional impairment.
−Removed: At December 31, 2024, we have $337 million of indefinite-lived intangible assets and $1,597 million of goodwill recorded on our balance sheet.
−Removed: Our failure to protect our proprietary technology could have an adverse impact on our competitive position.
+Added: For further information regarding the specifics of our impairments, see Note 11, Goodwill and Intangible Assets, in the Notes to Consolidated Financial Statements in Item 8 of this Form 10-K.
+Added: Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third parties.
Our financial results may be adversely impacted if third parties infringe upon our intellectual property rights or misappropriate our technologies and trademarks.
To protect our rights to our intellectual property, we rely on a combination of patent and trademark law, trade secret protection, confidentiality agreements and contractual arrangements with our employees, strategic partners, and others.
−Removed: We cannot assure you that any of our patents, the patents we license or any patents which we receive or license in the future will provide us with a competitive advantage or afford us protection against infringement, or that the patents will not be successfully challenged or circumvented by third parties.
−Removed: The protective steps that we have taken may be inadequate to detect, protect against or deter misappropriation.
−Removed: Effective patent, trademark and trade secret protection may not be available in every country in which we will offer our products.
+Added: However, we cannot be assured that the protective steps that we have taken will be adequate to detect, protect against or deter misappropriation.
+Added: Effective patent, trademark and trade secret protection may not be available in
+Added: every country in which we will offer our products.
In addition, there is a risk of employees inadvertently inputting trade secret information into AI technologies, thereby enabling third parties to access such information.
Any failure to adequately protect our intellectual property rights could devalue our proprietary content and impair our ability to compete effectively.
−Removed: Further, defending or enforcing our intellectual property rights could result in the expenditure of significant resources.
−Removed: Litigation may be necessary to assert claims against others, enforce patents owned by or licensed to us, protect our trade secrets or know-how, or determine the enforceability, scope, and validity of our proprietary rights.
−Removed: An adverse determination in such proceedings could subject us to significant liabilities, allow our competitors to market competitive products without obtaining a license from us, prohibit us from marketing our products or require us to seek licenses from third parties.
−Removed: If we cannot obtain such licenses, we may be restricted or prevented from commercializing our products.
+Added: Litigation may be necessary to assert claims against others, enforce patents owned by or licensed to us, protect our trade secrets or know-how, or determine the enforceability, scope, and validity of our proprietary rights or to defend third-party claims that we have infringed on proprietary rights of others.
+Added: An adverse determination in such proceedings could subject us to significant liabilities, allow our competitors to market competitive products without obtaining a license from us, prohibit us from marketing our products, require us to seek licenses from third parties, require us to pay substantial damages, including but not limited to treble damages, attorneys’ fees and costs, for past infringement, or we could be at risk for an injunction if it is ultimately determined that our products infringe a third party’s intellectual property rights.
+Added: If we cannot obtain third-party licenses when necessary, we may be restricted or prevented from commercializing our products.
If we become involved in litigation, we may incur substantial expense, and the proceedings may divert the attention of key personnel, even if we ultimately prevail.
−Removed: Our success will depend in part on our ability to obtain patents for technology in our products and defend infringement on our patents by third parties that relate to our products, technologies, and processes, both in the United States and in other countries.
+Added: Our success will depend in part on our ability to obtain patents for technology in our products, defend infringement on our patents by third parties that relate to our products, technologies, and processes, both in the United States and in other countries, and defend against claims that we are infringing on the intellectual property of others.
Risks and uncertainties that we face with respect to our patents and patent applications include the following:
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• the allowed claims of any patents that are issued may not provide meaningful protection;
−Removed: • other companies may challenge patents licensed or issued to us;
• disputes may arise regarding inventions and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by us and our respective licensors;
• other companies may design around the technologies patented by us.
−Removed: Our financial results may be adversely impacted if our products or services are found to infringe upon the intellectual property rights of others.
−Removed: From time to time, third parties may claim that one or more of our products or services infringe their intellectual property rights.
−Removed: Litigation may be necessary to defend against any such claims of infringement asserted against us.
−Removed: In addition, it may be necessary to participate in proceedings declared by the U.S.
−Removed: Patent and Trademark Office, the European Patent Office or other foreign patent offices to determine the priority of inventions, which could result in substantial costs.
−Removed: Acquisitions by us of products, technologies or processes that are found to infringe upon others’ intellectual property rights could further increase the risk of litigation or other proceedings and related costs.
−Removed: The enforcement, defense and prosecution of intellectual property rights involve complex legal and factual questions.
−Removed: As a result, these proceedings are costly and time-consuming, and their outcome is uncertain.
Changes in our credit ratings or macroeconomic impacts on credit markets may increase our cost of capital and limit financing options.
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• limiting our ability to obtain additional financing, which could worsen if any adverse changes in our credit ratings occur.
−Removed: We have debt securities outstanding of approximately $1.7 billion as of December 31, 2024.
−Removed: We also can incur up to $700 million of indebtedness under the multi-currency revolving credit facility (“2023 Credit Facility”), as discussed below, and may incur significantly more indebtedness in the future.
Our credit facilities contain restrictive covenants, including some which require that we maintain certain ratios, that could limit our ability to engage in activities that may be in our long-term best interests.
−Removed: We may need to reduce the amount of our indebtedness outstanding from time to time to comply with the ratios
−Removed: required by such covenants, although no assurance can be given that we will be able to do so.
+Added: We may need to reduce the amount of our indebtedness outstanding from time to time to comply with the ratios required by such covenants, although no assurance can be given that we will be able to do so.
Our failure to comply with those covenants could result in an event of default which, if not cured or waived, could result in the acceleration of all of our debt, which could adversely affect our business, earnings and financial condition.
Such failure to comply with covenants may also hurt our reputation and credibility with our stockholders and our debt holders and may compromise our future ability to finance our operations through the public equity or debt markets.
−Removed: There is no guarantee that we will be able to renew or replace our existing debt agreements as they become due, including debt instruments with principal of $128 million maturing in December 2025.
+Added: There is no guarantee that we will be able to renew or replace our existing debt agreements as they become due.
A failure to renew or replace such agreements and instruments would harm our overall liquidity.
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Due to the global nature of our business, movements in foreign exchange rates may impact our consolidated statements of operations, consolidated balance sheets and consolidated statement of cash flows.
−Removed: With approximately two-thirds of our sales located outside the United States, our consolidated net sales are impacted negatively by the strengthening and positively by the weakening of the U.S.
+Added: With approximately two-thirds of our sales occurring outside the United States, our consolidated net sales are impacted negatively by the strengthening and positively by the weakening of the U.S.
dollar as compared to certain foreign currencies.
+Added: Changes in trade policy, supply chain constraints, higher energy costs, labor shortages, and geopolitical tensions have all contributed to the risk of higher inflation and general economic uncertainty across the industry and the regions in which the Company operates.
Additionally, movements in certain foreign exchange rates may impact our results of operations, financial condition, and liquidity since a number of our manufacturing and distribution operations are located outside of the United States.
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• longer payment cycles;
+Added: • uncertainty regarding energy costs and labor availability;
• changes in regulatory requirements and tariffs, including restrictions in China on the proportion of certain medical equipment which can be imported;
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• trade policy changes.
−Removed: Changes in or the imposition of tariffs, including the tariffs imposed or proposed by the Trump Administration in early 2025 and retaliatory tariffs imposed or proposed by other countries, could make it significantly more difficult or costly for us to export our products to other countries.
−Removed: In particular, these tariffs currently affect some of the components of our products we
−Removed: import from China and other countries, and we may be required to raise our prices on those products due to these tariffs or share the cost of such tariffs with our customers, which could harm our operating performance.
−Removed: We monitor and evaluate the potential impact of the effective and proposed tariffs as well as other recent changes in foreign trade policy on our supply chain, costs, sales and profitability, and we seek to implement strategies to mitigate such impact, including reviewing sourcing options and working with our vendors and merchants to seek to minimize products coming from China and other countries, both for existing products and for new product development, and we seek to select suppliers in low cost regions where tariff issues are less challenging.
−Removed: These measures could also result in increased costs for goods imported into the United States, supply chain inefficiencies and decreased availability of certain materials with respect to other countries.
−Removed: This could require us to increase prices to our customers, which may reduce demand.
−Removed: If we are unable to increase prices at a sufficient level to offset tariffs, we would be required to lower our margin on products sold.
−Removed: We cannot predict what additional actions may ultimately be taken by the United States or other governments with respect to tariffs or trade relations, what products may be subject to such actions (including subject to United States export control restrictions), or what actions may be taken by other countries in retaliation.
−Removed: The adoption and expansion of trade restrictions, the occurrence of a trade war, or other governmental action related to trade policies has the potential to impact demand for our products, our costs, our customers and our suppliers, which could adversely impact our business, financial condition and results of operations.
+Added: The Company’s business is subject to risks related to, among other factors, tariffs and other trade protection measures put in place by the United States and other countries.
+Added: government has implemented or is in the process of implementing various tariffs on the importation of goods from certain countries, a number of which are applicable to the Company’s supply chain, operations, and sales, and the tariffs enacted or proposed by the Trump Administration and retaliatory tariffs by other countries could make it significantly more difficult or costly for the Company to import certain products or materials to the United States, or export products or materials from the United States to other countries.
+Added: Currently, a small portion of the products, materials, and components used in our products are imported from China, and a significant share of the dental equipment that we sell in the United States is manufactured in Europe.
+Added: Europe is also a major market for our products, including certain consumable products made in the United States, while sales in China represent less than 5% of our global sales on an annual basis.
+Added: We continue to monitor and evaluate the ongoing and potential impacts of the tariffs and changes in trade policy, whether implemented or proposed, on our supply chain, costs, net sales and profitability.
+Added: We have implemented and continue to evaluate additional strategies that would mitigate such impacts, including competitive pricing strategies to offset tariffs and evaluating potential sourcing options that work with our vendors and merchants to seek to minimize products sourced from high tariff rate countries, both for existing products and for new product development.
+Added: Furthermore, changes in trade policies can lead to supply chain constraints, higher energy costs, labor shortages, and contribute to the risk of higher inflation and general economic uncertainty across the industry and the regions in which the Company operates.
+Added: The impact that these tariffs and changes in trade policy will ultimately have on our financial results remains uncertain, including the impact on demand for our products in certain markets if prices rise as a consequence of import tariffs.
Specifically, the Chinese government has implemented a volume-based procurement process designed to decrease prices for medical devices and other products, which has in the past resulted in, and could in the future result in, reduced margins on covered devices and products, required renegotiation of distributor arrangements, or an incurrence of inventory-related charges.
−Removed: For further information, see Part 1.
−Removed: Item 1, “Business - Regulation.” We cannot predict future impacts of the volume-based procurement program on our business, including any expansion of the program to include additional products within our portfolio.
−Removed: Certain of these risks may be heightened because of changing political climates.
−Removed: For example, due to the invasion of Ukraine by Russia, various countries and international organizations have imposed sanctions on Russia, including its major financial institutions and certain other businesses and individuals, Belarus, the Crimea Region of Ukraine, the so-called Donetsk People’s Republic, and the so-called Luhansk People’s Republic.
−Removed: Russia also imposed currency control measures aimed at restricting the outflow of foreign currency and capital from Russia, imposed restrictions on transacting with non-Russian parties, banned exports of various products, and imposed other restrictions, including reducing the ability of companies to remit cash from their Russian-based operations to locations outside of Russia.
−Removed: Beginning in September 2024, as a result of further restrictions by European financial institutions on receiving payments from Russia, our capacity to receive intercompany payments for the delivery of our products into Russia has been partially reduced, which further limits our ability to use cash received from sales in Russia for our general purposes.
−Removed: The continuation of the conflict may result in additional sanctions being imposed on Russia and related individuals and entities, with Russia potentially responding in kind.
−Removed: The length, impact, and outcome of this ongoing military conflict is highly unpredictable and could lead to significant market and other disruptions, which, along with the spillover effect of ongoing civil, political, and economic disturbances on surrounding areas, may significantly devalue currencies we use or have other adverse impacts, including increased costs of raw materials, manufacturing or shipping delays or increases in inflation rate, cyberattacks and supply chain challenges.
−Removed: Export controls implemented as part of sanctions could also restrict the sale of products containing U.S.-developed software and technology into Russia.
−Removed: For the year ended December 31, 2024, net sales in Russia and Ukraine were approximately 2% of our consolidated net sales, and net assets in these countries were $64 million.
−Removed: These net assets include $39 million of cash and cash equivalents held within Russia as of December 31, 2024, as well as inventory and trade accounts receivable.
−Removed: A significant escalation or expansion of economic disruption could interrupt our supply chain, broaden inflationary costs, impair our assets located in Russia, result in a loss of sales, and have a material adverse effect on our results of operations.
−Removed: The terrorist attacks by Hamas militants crossing the border from Gaza to Israel in October 2023 and the subsequent military response by the Israeli government in Gaza has resulted in significant unrest within that region.
−Removed: During 2024, the state of Israel has also been a target of coordinated missile and drone attacks launched by the Republic of Iran and its proxies.
−Removed: In January 2025, a cease-fire agreement was signed between Hamas and the Israeli government;
−Removed: however, its potential to lead to a long-term peace deal or greater stability remains uncertain.
−Removed: A potential resumption of violence or the involvement of other terrorist groups or foreign powers in the region could impact our employees and operations in future periods.
−Removed: Additionally, in May 2024, in response to ongoing military actions, the government of Turkey implemented restrictions on the import of goods manufactured within Israel for sale in the Turkish market.
−Removed: Sales of our products made in Israel and sold in Turkey represent approximately 1% of our global sales of Implant & Prosthetic Solutions reporting unit, but this product category is an area of relatively high potential growth.
−Removed: It is not clear when these restrictions will be lifted or if other countries will institute similar restrictions.
−Removed: Our operations in Israel consist of two manufacturing facilities for implant products, with one site in northern Israel and one in southern Israel, which together employ approximately 350 associates.
−Removed: These facilities continue to operate.
−Removed: We could face future production slowdowns or closures due to the impacts of the war, including having employees called to active military duty, or due to other resource constraints, such as the inability to source materials for production.
−Removed: For the year ended December 31, 2024, net sales of products produced at these sites comprised approximately 3% of our consolidated net sales and 13% of the net sales attributed to our Orthodontic and Implant Solutions segment.
−Removed: Net assets within Israel totaled $180 million as of December 31, 2024, consisting primarily of acquired technology, property, plant and equipment, cash and inventory associated with our operations in country.
−Removed: Our operations in Israel have not been materially impacted by the conflict, and consequently, we have not recorded any allowance for doubtful accounts, inventory reserves, or fixed asset impairments through the year ended December 31, 2024.
−Removed: The Company continues to monitor developments and prepare contingency plans to limit potential disruptions.
−Removed: Additionally, we sell products from across our portfolio to distributors and dental practices within Israel and its neighbors which may face reduced patient traffic and demand for our products in the near term.
−Removed: Net sales for products sold to our customers in Israel comprised approximately 1% of our consolidated net sales for the year ended December 31, 2024 .
−Removed: While Israel does not constitute a material portion of our business, a significant escalation or expansion of the conflict could result in loss of sales and market position, disrupt our supply chain, broaden inflationary costs including energy prices, and have a material adverse effect on our results of operations.
−Removed: Additionally, other events, such as the outbreak of a global pandemic or other adverse public health developments could materially affect our business in a number of ways, including:
−Removed: • reduced demand for our products in certain regions or our inability to timely meet our customer’s orders,
−Removed: • the failure of third parties to meet their obligations to us, or significant disruptions in their ability to do so, and
−Removed: • uncertainty in the global financial markets.
−Removed: RISKS RELATED TO OUR INTERNAL CONTROLS
−Removed: Management previously identified material weaknesses in our internal control over financial reporting, some of which resulted in errors in previously issued financial statements, which have been remediated as of December 31, 2023.
−Removed: If we experience additional material weaknesses in the future, we may be unable to accurately and timely report financial results or comply with the requirements for public companies, which could cause the price of our common stock to decline or limit our access to the capital markets.
−Removed: A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
−Removed: In 2022 and 2023, we identified material weaknesses in our internal control over financial reporting, some of which resulted in errors in previously issued financial statements.
−Removed: These material weaknesses were all remediated as of December 31, 2023.
−Removed: Although we devote substantial resources to prevent material weaknesses from occurring, it cannot be assured that our measures will be sufficient.
−Removed: Accordingly, there is a reasonable possibility that a reoccurrence of the material weaknesses previously identified or the occurrence of other material weaknesses or deficiencies identified in the future could result in a
−Removed: material misstatement of our financial statements, potentially causing us to fail to meet our obligations under securities laws, stock exchange listing rules, or debt instrument covenants to file periodic financial reports on a timely basis.
−Removed: Any material weaknesses identified in the future could adversely affect investor confidence in our financial statements, cause the price of our common stock to decline, or limit our access to the capital markets.
−Removed: Lack of global standardized processes could result in control deficiencies and adversely impact management’s assertions and financial reporting.
−Removed: We currently use disparate systems, including Enterprise Resource Planning (“ERP”) systems, across the organization, which may reduce our ability to obtain and analyze business data in a timely manner, increase costs for system upgrades, and pose business partner connection challenges.
−Removed: Non-standardized processes may lead to inaccurate, incomplete or delayed financial and management reporting, which may result in misleading or inaccurate reporting for key business decisions or noncompliance with applicable business and regulatory requirements, potentially causing penalties or fines.
−Removed: We continue to focus on standardizing our processes, improving our financial systems, maintaining effective internal controls and centralizing transaction management and execution to provide continued assurance with respect to our financial reports and prevent financial misstatement or fraud.
−Removed: In 2024, we continued implementing a new global ERP system, which will upgrade and standardize our existing information systems.
−Removed: However, this new system will take several years and require significant resources to implement, and may not be fully successful in providing standardization sufficient to address these risks even once completed.
+Added: We cannot predict future impacts of the volume-based procurement program on our business, including any expansion of the program to include additional products within our portfolio.
+Added: Furthermore, geopolitical conflicts are expected to continue to shape market dynamics and pose general threats to financial stability in affected regions, including ongoing tensions from both the Russia-Ukraine conflict and the conflict in the Middle East.
+Added: These conflicts are highly unpredictable and could lead to significant market and other disruptions, which along with the spillover effect of ongoing civil, political, and economic disturbances on surrounding areas, may significantly devalue currencies we use or have other adverse impacts, including increased costs of raw materials, manufacturing or shipping delays or increases in inflation rate, cyberattacks and supply chain challenges.
RISKS RELATED TO OUR REGULATORY ENVIRONMENTS
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Several securities class action lawsuits were filed against us following our announcement on May 10, 2022 of the AFC’s internal investigation.
−Removed: We may face additional litigation and regulatory examinations, investigations, proceedings or court orders, including additional cease and desist orders, the suspension of trading of our securities, delisting of our securities, the assessment of civil monetary penalties and other equitable remedies.
+Added: While the related SEC investigation has been closed, we may face additional litigation and regulatory examinations, investigations, proceedings or court orders, including additional cease and desist orders, the suspension of trading of our securities, delisting of our securities, the assessment of civil monetary penalties and other equitable remedies.
Our management has devoted and may be required to further devote significant time and attention to these matters.
If any of these matters are resolved against us, it could harm our reputation, business, financial condition and results of operations.
−Removed: Additionally, while we cannot estimate our potential exposure to these matters at this time, we have already expended a significant amount of time and resources investigating and defending against the claims underlying these matters and expect to continue to do so.
−Removed: Accordingly, the ongoing SEC investigation and any related litigation could distract management and entail risks and uncertainties, the outcome of which could adversely affect our results of operations and our reputation.
+Added: Additionally, while we cannot estimate our potential exposure to these matters at this time, we have already expended a significant amount of time and resources investigating and defending against the claims underlying these matters and expect to
+Added: continue to do so.
For further information, see Note 21, Commitments and Contingencies, discussing the securities class action lawsuits, in the Notes to Consolidated Financial Statements in Item 8 of this Form 10-K.
We may be unable to obtain necessary product approvals and marketing clearances.
−Removed: We must obtain certain approvals and marketing clearances from, governmental authorities, including the FDA and similar health authorities in foreign countries to market and sell select products in those countries.
−Removed: These agencies regulate the marketing, manufacturing, labeling, packaging, advertising, sales and distribution of medical devices.
+Added: We must obtain certain approvals and marketing clearances from governmental authorities, including the FDA and similar health authorities in foreign countries to market and sell select products in the United States and foreign countries.
+Added: These agencies regulate the marketing, manufacturing, labeling, packaging, advertising, sales, installation, service, and distribution of medical devices and pharmaceuticals.
The FDA enforces additional regulations regarding the safety of X-ray emitting devices.
2 unchanged sentences
A 510(k) application is required to market certain classes of new or modified medical devices.
−Removed: If specifically required by the FDA, a pre-market approval, or PMA, may be necessary.
+Added: If specifically required by the FDA, a pre-market approval may be necessary.
Such proceedings are potentially expensive and time-consuming and may hinder a product’s entry into the marketplace.
−Removed: Moreover, there can be no assurance that the review or approval process for these products by the FDA or any other governmental authority will occur in a timely fashion, if at all, or that additional regulations will not be adopted or current regulations amended in a manner that will adversely affect us.
+Added: There can be no assurance that the review or approval process for these products by the FDA or any other governmental authority will occur in a timely fashion, or that additional regulations will not be adopted or current regulations amended in a manner that will adversely affect us.
The FDA also oversees the content of advertising and marketing materials relating to medical devices that received FDA clearance.
−Removed: Failure to comply with the FDA’s advertising guidelines may result in the imposition of penalties, enforcement actions, or import bans, and other negative consequences.
+Added: Failure to comply with the FDA’s advertising guidelines may result in the imposition of penalties, enforcement actions, import bans, or other negative consequences.
We are also subject to other federal, state, and local laws, regulations and recommendations relating to safe working conditions, and to laboratory and manufacturing practices.
3 unchanged sentences
Our products that fall into the category of Class I under the EU MDD were mandated to be certified under the EU MDR.
−Removed: These regulations applied to all medical device manufacturers who market their medical devices in the EU, and manufacturers were required to perform significant upgrades to quality systems and processes On March 20, 2023, the EU Commission extended the MDR transitional periods until December 31, 2027 for higher risk devices and until December 31, 2028 for other medical devices.
−Removed: We remain focused on ensuring that all our medical device products will be fully certified by the deadlines.
+Added: These regulations applied to all medical device manufacturers who market their medical devices in the EU, and manufacturers were required to perform significant upgrades to quality systems and processes.
+Added: On March 20, 2023, the EU Commission extended the MDR transitional periods until December 31, 2027 for higher risk devices and until December 31, 2028 for other medical devices.
+Added: We remain focused on ensuring that applicable medical device products will be fully certified by the deadlines.
Additionally, given the exit of the UK from the EU, the EU CE marking will be recognized in the UK through the earlier of the expiration of the product’s CE certificate or June 2028.
10 unchanged sentences
Our effective tax rate could be adversely affected by changes in the mix of earnings in countries with different statutory tax rates, changes in the valuation of deferred tax assets and liabilities, changes in tax laws and regulations, and changes in interpretations of tax laws.
−Removed: Certain governments are considering, and may adopt, tax reform measures that could significantly increase our worldwide tax liabilities.
+Added: Certain governments have adopted or are considering tax reform measures that could significantly increase our worldwide tax liabilities.
+Added: • On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, making various changes to the U.S.
+Added: In particular, OBBBA reinstated the deduction for research and development expenditures within the United States and introduced new provisions for the immediate deduction of certain capital expenditures.
+Added: These changes may have an impact on our future tax payments.
• The Organisation for Economic Co-operation and Development (“OECD”) and other government bodies have focused on the taxation of multi-national corporations, including in the area of “base erosion and profit shifting,” where payments are made from affiliates in jurisdictions with high tax rates to affiliates in jurisdictions with lower rates.
−Removed: Some of these proposals include a two-pillar approach to global taxation, focusing on global profit allocation and a global minimum tax rate (“Pillar Two”).
−Removed: On December 12, 2022, the European Union member states agreed to implement the OECD’s global corporate minimum tax rate of 15%, which became effective as of January 2024.
+Added: On December 12, 2022, the European Union member states agreed to implement the OECD’s global corporate minimum tax rate of 15% (“Pillar Two”), which became effective as of January 2024.
Other countries have made, or are actively considering, changes to their tax laws to adopt certain parts of the OECD’s proposals.
−Removed: Due to the large scale of our global business activities, the enactment of Pillar Two legislation could increase tax uncertainty and have a material effect on the Company’s effective tax rate, financial position, results of operations, and cash flows.
+Added: However, on June 28, 2025, the G7 issued a joint statement stating that Pillar Two will operate alongside the U.S.
+Added: system of tax and proposed that U.S.-parented multinational groups not be subject to certain provisions of Pillar Two.
+Added: Other OECD countries are likely to consider changes to their own tax laws and the implementation of Pillar Two.
+Added: Additional changes to tax laws or inconsistent application of existing tax laws, including Pillar Two, could increase tax uncertainty and have a material effect on the Company’s effective tax rate, financial position, results of operations, and cash flows.
The Company will continue to monitor and reflect the impact of such legislative changes in future financial statements as appropriate.
2 unchanged sentences
Potential outcomes of the German Tax Investigation involve a number of uncertainties, including those relating to the application of tax law and regulations, and there can be no assurance that the German Tax Investigation will be resolved favorably.
−Removed: Our management has devoted and may be required to further devote significant time
−Removed: and attention to the German Tax Investigation.
+Added: Our management has devoted and may be required to further devote significant time and attention to the German Tax Investigation.
If the German Tax Investigation is resolved against us, it could harm our reputation, business, ability to attract talent, particularly professionals with backgrounds in international tax and tax accounting, financial condition and results of operations.
3 unchanged sentences
We voluntarily suspended the sale and marketing of our direct-to-consumer Byte aligner systems and impression kits, and subsequently determined to cease offering these aligners to new patients while repurposing Byte technologies and capabilities to support other products within our aligner portfolio.
−Removed: As a result, we have experienced a material impact on our results of operations, and we may be required to take additional significant impairment charges if we are unsuccessful in our efforts to reposition Byte.
+Added: As a result, we have experienced a material impact on our results of operations, and we may be required to take additional significant impairment charges if we are unsuccessful in our efforts to reallocate Byte resources.
On October 24, 2024, we announced the voluntary suspension of the sale and marketing of our direct-to-consumer Byte aligner systems and impression kits.
−Removed: In January 2025, we announced that Byte aligners would no longer be offered to new patients, and we now plan to utilize certain Byte resources elsewhere in the aligners portfolio to create orthodontic demand, support a digital clinical workflow, enhance the customer experience, and improve patient monitoring.
−Removed: The initial suspension and subsequent decisions regarding Byte products has had a material impact on our results of operations.
+Added: In January 2025, we announced that Byte aligners would no longer be offered to new patients.
+Added: The initial suspension and subsequent decisions regarding Byte products had a material impact on our results of operations.
The sales of Byte aligner systems and impression kits represented approximately 2% of our annual revenue for the year ended December 31, 2025, and the assets related to the Byte aligner business are approximately 5% of the Company’s assets as of December 31, 2025.
+Added: Although we have not accepted any new Byte aligner patients since October 24, 2024, we have continued to provide support for non-contraindicated Byte aligner patients currently undergoing treatment.
We also incurred charges relating to customer refunds and asset write-offs.
For further information, see Note 18, Restructuring and Other Costs, in the Notes to Consolidated Financial Statements in Item 8 of this Form 10-K.
−Removed: There is no guarantee that we will be successful in our endeavor to leverage Byte technologies and capabilities in a manner that is accretive to sales and profit.
−Removed: If we are unsuccessful in these efforts, we may be required to incur additional significant impairment charges.
−Removed: In addition, although we have not accepted any new patients since October 24, 2024, we will continue to provide support for non-contraindicated Byte aligner patients currently undergoing treatment.
−Removed: With respect to these patients, we continue to experience regulatory uncertainties.
−Removed: For example, some state legislatures have passed legislation and other state legislatures have proposed legislation designed to preclude or significantly limit teledentistry, and various state legislatures are continuing to consider such legislation.
−Removed: Furthermore, our ability to conduct business in each state is dependent, in part, upon that state dental board’s regulation of the practice of dentistry.
−Removed: Some state dental boards established rules in a manner that purports to limit or restrict our Byte business, which currently focuses on the provision of Byte aligners to certain existing patients.
−Removed: It is possible that the laws, rules and regulations governing the practice of dentistry and orthodontics in one or more states may change or be interpreted in a manner unfavorable to our business.
−Removed: If adverse laws or regulations are adopted or any such claims are successful, and we were unable to adapt our business model accordingly, our current operations in such states would be disrupted, which could have a material adverse effect o n our business, financial condition, and results of operations.
Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our revenue to decline.
1 unchanged sentence
Third-party payors are increasingly challenging the price and cost-effectiveness of medical products and services.
+Added: For example, the U.S.
+Added: Centers for Medicare and Medicaid Services is considering a proposed rule which might, among other things, subject urological supplies to the Durable Medical Equipment, Prosthetics, Orthotics, and supplies Competitive Bidding Program.
+Added: Such a change could lead to lower reimbursement levels for these products.
While we cannot predict what effect the policies of government entities and other third-party payors will have on future sales of our products, there can be no assurance that such policies would not cause our revenue to decline.
8 unchanged sentences
Nevertheless, public reports and concerns regarding the potential hazards of BPA could contribute to a perceived safety risk for our products that contain BPA or other substances.
−Removed: If we fail to comply with laws and regulations relating to health care fraud, we could suffer penalties or be required to make significant changes to our operations, which could adversely affect our business.
−Removed: We are subject to federal, state, local and foreign laws, rules, regulations, self-regulatory codes, circulars, and orders relating to health care fraud (“Healthcare Fraud Laws”).
−Removed: Some of these laws, referred to as “false claims laws,” prohibit the submission, or causing the submission, of false or fraudulent claims for reimbursement to health care payors and programs.
−Removed: Other laws, referred to as “anti-kickback laws,” prohibit soliciting, offering, receiving, or paying remuneration in order to induce the referral of a patient or ordering, purchasing, leasing or arranging for or recommending ordering, purchasing or leasing, of items or services that are paid for by health care payors and programs.
−Removed: government has expressed concerns about financial relationships between suppliers and physicians and dentists.
−Removed: Under the reporting and disclosure obligations of the U.S.
−Removed: Physician Payment Sunshine Act and similar Healthcare Fraud Laws, the general public and government officials will be provided with access to detailed information with regard to payments or other transfers of value to certain practitioners (including physicians, dentists and teaching hospitals) by applicable drug and device manufacturers, including us.
−Removed: This information may lead to greater scrutiny, which may result in modifications to established practices and additional costs.
−Removed: Failure to comply with Healthcare Fraud Laws could result in significant civil and criminal penalties and costs, including the loss of licenses and the ability to participate in governmental health care programs, and could have a material adverse impact on our business.
−Removed: Also, these laws may be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that could require us to make changes in our operations or incur substantial defense and settlement expenses.
−Removed: Even unsuccessful challenges by regulatory authorities or private relators could result in reputational harm and the incurring of substantial costs.
−Removed: In addition, many of these laws are vague or indefinite and have not been interpreted by courts, and have been subject to frequent modification and varied interpretation by prosecutorial and regulatory authorities, increasing compliance risks.
−Removed: We cannot predict whether changes in Healthcare Fraud Laws, or the interpretation thereof, or changes in our services or practices in response, could adversely affect our business.
Our business is subject to extensive, complex, and changing domestic and foreign laws, rules, regulations, self-regulatory codes, directives, circulars and orders which, if not complied with, subject us to civil or criminal penalties or other liabilities.
13 unchanged sentences
Our internal policies, procedures and Code of Ethics and Business Conduct mandate compliance with these anti-corruption laws.
−Removed: However, we operate in some countries known to experience corruption.
+Added: However, we operate in some countries perceived to have a higher risk of corruption.
Despite our training and compliance programs, we cannot provide assurance that our internal policies and procedures will always protect us from violations of such anti-corruption laws committed by our employees or affiliated entities or their respective officers, directors, employees and agents.
Failure to comply with the FCPA and other laws governing the conduct of business with government entities may subject us to criminal and civil penalties and other remedial measures, which could have a material adverse impact on our business, financial condition, results of operations and liquidity.
−Removed: Any ongoing investigation of potential violations of the FCPA or other anti-corruption laws by the United States or foreign authorities could harm our reputation and have an adverse impact on our business, financial condition and results of operations.
+Added: Any ongoing investigation of potential violations of the FCPA
+Added: or other anti-corruption laws by the United States or foreign authorities could harm our reputation and have an adverse impact on our business, financial condition and results of operations.
+Added: Legislation or regulations that potentially impose restrictions, caps, taxes, or other controls on emissions of greenhouse gases such as carbon dioxide, could adversely affect our operations and financial results.
+Added: • The European Union’s Corporate Sustainability Reporting Directive (“CSRD”) requires impacted companies to make extensive sustainability and climate-related disclosure.
+Added: In December 2025, the EU Parliament approved changes to the CSRD due to the Omnibus simplification package, altering reporting deadlines (so-called “stop the clock”) and to reduce the number of reporting requirements through revised European Sustainability Reporting Standards (“ESRS”).
+Added: The revised ESRS are expected to be adopted by the European Commission in the first half of 2026.
+Added: These changes, and any other new or pending legal or regulatory matters, may result in the expenditure of additional resources or costs to comply with such requirements.
+Added: • The state of California has also enacted a series of environmental laws related to climate disclosures with which we are required to comply in 2026, pending the outcome of legal challenges.
+Added: • On March 27, 2025, the SEC voted to cease defending the previously-proposed climate-related disclosure rules.
+Added: It is unclear whether similar rules will ever be implemented.
+Added: • Other international jurisdictions are proposing climate and ESG-related disclosure legislation.
+Added: Climate-related rules will increase compliance costs and could increase litigation risks related to disclosures, which could materially and adversely affect our financial performance.
Compliance with numerous applicable existing and new Applicable Laws could require us to incur substantial regulatory compliance costs.
−Removed: For example, we are currently in the process of implementing enhancements to our post-market surveillance processes and reportability criteria, which has resulted in an increase in the number of regulatory reports that we have filed, including retrospective reports, for complaints regarding medical devices.
There can be no assurance that governmental authorities will not raise compliance concerns or perform audits to confirm compliance with such Applicable Laws.
2 unchanged sentences
Any such actions could result in higher than anticipated costs or lower than anticipated revenue and could have a material adverse effect on our reputation, business, financial condition and results of operations.
+Added: We are subject to federal, state, local and foreign laws, rules, regulations, self-regulatory codes, circulars, and orders relating to health care fraud (“Healthcare Fraud Laws”).
+Added: Some of these laws, referred to as “false claims laws,” prohibit the submission, or causing the submission, of false or fraudulent claims for reimbursement to health care payors and programs.
+Added: Other laws, referred to as “anti-kickback laws,” prohibit soliciting, offering, receiving, or paying remuneration in order to induce the referral of a patient or ordering, purchasing, leasing or arranging for or recommending ordering, purchasing or leasing, of items or services that are paid for by health care payors and programs.
+Added: Additionally, under the reporting and disclosure obligations of the U.S.
+Added: Physician Payment Sunshine Act and similar Healthcare Fraud Laws, the general public and government officials will be provided with access to detailed information with regard to payments or other transfers of value to certain practitioners (including physicians, dentists and teaching hospitals) by applicable drug and device manufacturers, including us.
+Added: This information may lead to greater scrutiny, which may result in modifications to established practices and additional costs.
+Added: We cannot predict whether changes in Healthcare Fraud Laws, or the interpretation thereof, or changes in our services or practices in response, could adversely affect our business.
RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
21 unchanged sentences
Our business may be adversely affected by changes in global economic conditions, including inflation, rising interest rates, and supply chain shortages.
−Removed: Our business, operating results, financial condition and liquidity may be adversely affected by changes in global economic conditions, including inflation, supply chain disruptions, credit market conditions, consumer and business confidence, and other factors generally beyond our control.
+Added: Our business, operating results, financial condition, credit rating, access to credit markets, and liquidity may be adversely affected by changes in global economic conditions, including inflation, supply chain disruptions, credit market conditions, consumer and business confidence, and other factors generally beyond our control.
We expect the current global supply chain and labor market challenges and inflationary pressures will continue to negatively affect our results of operations.
−Removed: Specifically, the Company continues to experience higher prices and supply chain disruptions for certain raw materials, particularly electronic components, and wage inflation.
+Added: Specifically, the Company continues to experience higher prices and supply chain disruptions for certain raw materials and wage inflation.
Certain dental specialty products, dental equipment and related products that support discretionary dental procedures, especially elective procedures in implants and aligners, may also be especially susceptible to changes in economic conditions.
3 unchanged sentences
Tightening of credit in financial markets has adversely impacted our customers’ and suppliers’ ability to obtain financing and could result in additional impacts in the future, including a decrease in or cancellation of orders for our products and services, inability of customers to make payments, and increased risk of supplier financial distress.
−Removed: The Company has sought to offset the elevated costs resulting from raw material cost inflation with annual price increases but has been only partially successful.
−Removed: Should the higher inflationary environment continue, we may not be able to increase the
−Removed: prices of our offerings sufficiently to keep up with the rate of inflation.
−Removed: Any of the above factors could individually or in combination have a material adverse effect on our operating results, financial condition and liquidity.
−Removed: Talent gaps and failure to manage and retain top talent may impact our ability to manage our operations, execute strategic initiatives and grow our business.
−Removed: Our success is dependent on our ability to successfully manage our human capital through talent acquisition, engagement, development, and retention.
−Removed: To achieve our strategic initiatives, we need to attract, manage, and retain employees with the right skills, competencies, and experiences to execute our strategy and support the growth of the business.
−Removed: The failure to attract and retain such employees to fill key roles, or to upskill employees to fill any potential skill gaps, may adversely affect our business performance, competitive position, and future prospects.
−Removed: We also must retain a pipeline of team members to provide for continuity of succession for senior executive positions.
−Removed: To attract and retain qualified employees, we must offer competitive compensation and benefits and effectively manage employee performance and development.
−Removed: Leadership transitions or other senior management changes may adversely affect our ability to attract and retain talent.
−Removed: Our inability to attract and retain talent may negatively impact business continuity, new product launches, and innovation initiatives.
−Removed: Further, such organizational challenges may make it difficult to maintain our culture, resulting in employees not adhering to the desired values of the organization.
+Added: Talent gaps and challenges in managing and retaining top talent may impact our ability to operate effectively, execute strategic initiatives, and deliver for our customers.
+Added: Our success depends on our ability to attract, engage, develop, and retain employees with the skills and experience necessary to execute our strategy.
+Added: Failure to fill key roles, retain critical talent, or upskill employees to address emerging skill gaps may negatively affect our performance, competitive position, and long‑term prospects.
+Added: Maintaining a strong succession pipeline for senior leadership roles is essential to ensuring continuity for our customers.
We face the inherent risk of legal actions, including litigation, product liability claims, and other regulatory or compliance matters.
9 unchanged sentences
Successful product warranty claims brought against us could reduce our profits and/or impair our financial condition and damage our reputation.
−Removed: Climate change and related natural disasters could negatively impact our business and financial results.
−Removed: We have sales or operations in approximately 150 countries and our suppliers’ manufacturing facilities are in many locations around the world.
−Removed: While we seek to mitigate our risks associated with climate events, we recognize that there are inherent climate-related risks regardless of where we conduct our businesses.
−Removed: Global climate change is expected to result in certain types of natural disasters occurring more frequently or with increased intensity and such climate events could disrupt the production and distribution of our products.
−Removed: Current or future insurance arrangements may not provide protection for costs that may arise from such events, particularly if such events are catastrophic in nature or occur in combination.
−Removed: Accordingly, a natural disaster impacting a significant manufacturing or distribution facility, besides potentially adversely impacting operations of key suppliers, has the potential to disrupt our and our customers’ businesses and may cause us to experience work stoppages, project delays, financial losses and additional costs to resume operations, including increased insurance costs or loss of coverage, legal liability and reputational losses.
−Removed: Increasing natural disasters in connection with climate change could also impact our third-party vendors, service providers or other stakeholders, including disruptions in supply chains, information technology or other necessary services for our Company.
−Removed: Expectations relating to environmental, social and governance considerations may expose us to potential liabilities, increased costs, reputational harm, and other adverse effects on our business.
−Removed: Many governments, regulators, investors, and other stakeholders are increasingly focused on environmental, social and governance (“ESG”) considerations relating to businesses, including climate change, pollution, greenhouse gas emissions, human and civil rights, and diversity, equity and inclusion.
−Removed: The increased emphasis on ESG matters has resulted in, and may continue to result in, the adoption of laws and regulations, including additional reporting requirements, leading to increased compliance costs, as well as increased scrutiny regarding our ESG activities and disclosures, which may lead to increased litigation.
−Removed: We make statements about our ESG goals and initiatives through our Sustainability Report, our other non-financial reports, information provided on our website, press statements and other communications.
−Removed: Many of the statements in those voluntary disclosures are based on hypothetical expectations, assumptions, and predictions that may or may not be representative of current or actual risks or events or forecasts of expected risks or events, including the costs associated therewith.
−Removed: Responding to these ESG considerations and implementing these goals and initiatives involves risks and uncertainties, may require investments, and depends in part on third-party performance or data that is outside our control which may not be independently verified.
−Removed: Our disclosure framework may need to be changed from time to time due to evolving standards and practices, which may result in a lack of consistent or meaningful comparative data from period to period.
−Removed: In addition, our interpretation of reporting frameworks or standards may differ from those of others and such frameworks or standards may change over time, either of which could revise our goals or reported progress in achieving such goals.
−Removed: Further, we cannot guarantee that we will achieve our ESG goals and initiatives.
−Removed: Increased and varied focus and activism related to ESG may hinder our access to capital, as investors may reconsider their capital investment because of their assessment of our ESG practices.
−Removed: In addition, some stakeholders may disagree with our goals and initiatives.
−Removed: Any failure, or perceived failure, by us to achieve our goals, further our initiatives, adhere to our public statements, comply with ESG laws and regulations, or meet evolving and varied stakeholder expectations and standards could result in legal and regulatory proceedings against us and could materially adversely affect our business, reputation, results of operations, financial condition and stock price.
−Removed: Furthermore, in recent years, “anti-ESG” sentiment has gained momentum across the United States, with several states and the federal government having proposed or enacted anti-ESG policies, legislation or initiatives or issued related legal opinions.
−Removed: The Trump Administration also recently issued an executive order opposing diversity, equity and inclusion (“DEI”) initiatives in the private sector, which may draw additional attention to companies which provide products and services to the U.S.
−Removed: Such anti-ESG and anti-DEI policies, legislation, initiatives, litigation, legal opinions, and scrutiny could result in our facing additional compliance obligations, becoming the subject of investigations, enforcement actions or litigation, or sustaining reputational harm.
−Removed: Legislation or regulations that potentially impose restrictions, caps, taxes, or other controls on emissions of greenhouse gases such as carbon dioxide, could adversely affect our operations and financial results.
−Removed: The European Union’s Corporate Sustainability Reporting Directive (“CSRD”) requires impacted companies, including multi-national companies with an EU presence, to make extensive sustainability and climate-related disclosure.
−Removed: The state of California has also enacted a series of environmental laws related to climate disclosures with which we are required to comply.
−Removed: Additionally, the SEC adopted climate-related disclosure rules, which would require the Company to make new climate-related disclosures.
−Removed: Subsequently, the SEC voluntarily stayed the implementation of such rules, pending the completion of judicial review by the Court of Appeals for the Eighth Circuit, and it is unclear whether and how the final rules will be implemented.
−Removed: Climate-related rules will increase compliance costs and could increase litigation risks related to disclosures made pursuant to the rules, either of which could materially and adversely affect our financial performance.
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.