Dentsply SIRONA (XRAY) risk factors, FY2025 10-K

Dentsply SIRONA's FY2025 10-K, filed Feb 26, 2026, lists 31 risk factors in 5 groups. Against the prior year's 32: 8 new, 9 dropped, 13 substantially reworded.

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Risk factors listed
315 groups
New this year
8vs 32 last year
Dropped
9since the prior 10-K
Substantially reworded
13of those kept
Section length
11k wordsItem 1A

What the changes say

  • DENTSPLY SIRONA added risks regarding the suspension of Byte aligners, tax law changes, and new ERP implementation costs.

What changed since the prior 10-K

New

  • NewRISKS RELATED TO OUR BUSINESSES

    diversifying our distributor base, particularly in the United States beginning in 2026

    Beginning in 2026, the company faces risks related to diversifying its U.S. distributor base amidst industry consolidation and price sensitivity.

  • NewRISKS RELATED TO OUR BUSINESSES

    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. The 2026 Plan is anticipated to result in approximately $120 million in annualized cost savings

    Implementing a new global ERP system aims to standardize processes and yield $120 million in annualized savings, but carries recurring charges of $55 million to $65 million in 2026 and 2027.

  • NewRISKS RELATED TO OUR BUSINESSES

    Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third parties

    Employees inputting trade secrets into AI technologies creates a new risk of unauthorized third-party access to proprietary information.

  • NewRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    Certain governments have adopted or are considering tax reform measures that could significantly increase our worldwide tax liabilities

    The U.S. One Big Beautiful Bill Act signed in July 2025 and the OECD global minimum tax rate impact worldwide tax liabilities.

  • NewRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    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. In January 2025, we announced that Byte aligners would no longer be offered to new patients

    Voluntary suspension and permanent discontinuation of new patient sales for Byte aligners impacted 2% of annual revenue and 5% of company assets for 2025.

  • NewRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    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

    New environmental reporting requirements under the EU's CSRD and California climate laws will increase resource expenditures in 2026.

  • NewRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    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 medical device regulations and healthcare fraud laws creates ongoing risks of audits, fines, and injunctions.

  • NewGENERAL RISKS

    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

    Talent gaps and retention challenges could hinder the execution of strategic initiatives and leadership succession.

Dropped

  • DroppedRISKS RELATED TO OUR BUSINESSES

    Our failure to protect our proprietary technology could have an adverse impact on our competitive position

  • DroppedRISKS RELATED TO OUR BUSINESSES

    Our financial results may be adversely impacted if our products or services are found to infringe upon the intellectual property rights of others

  • DroppedRISKS RELATED TO OUR GLOBAL OPERATIONS

    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

  • DroppedRISKS RELATED TO OUR INTERNAL CONTROLS

    Lack of global standardized processes could result in control deficiencies and adversely impact management’s assertions and financial reporting

  • DroppedRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    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. If we are unsuccessful in these efforts, we may be required to incur additional significant impairment charges

  • DroppedRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    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

  • DroppedGENERAL RISKS

    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

  • DroppedGENERAL RISKS

    Climate change and related natural disasters could negatively impact our business and financial results

  • DroppedGENERAL RISKS

    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

Reworded

  • 92% rewrittenRISKS RELATED TO OUR BUSINESSES

    We may fail to realize the expected benefits of our strategic initiatives, including executed, announced, or potential future restructuring and other business transformation efforts

    Updated to state that the 2024 restructuring plan is substantially complete as of December 31, 2025.

  • 86% rewrittenRISKS RELATED TO OUR GLOBAL OPERATIONS

    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

    Added uncertainty regarding energy costs and labor availability to international operational risks.

  • 86% rewrittenRISKS RELATED TO OUR BUSINESSES

    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

    Clarified distributor reliance and mentioned mitigation efforts regarding top distributors Patterson and Henry Schein.

  • 75% rewrittenRISKS RELATED TO OUR BUSINESSES

    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

    Refined language on goodwill and intangible asset impairments based on actual performance differing from forecasts.

  • 51% rewrittenRISKS RELATED TO OUR BUSINESSES

    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

    Expanded potential risks from acquisitions and divestitures to explicitly include litigation and loss of key business partners.

  • 45% rewrittenRISKS RELATED TO OUR BUSINESSES

    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

    Added developing privacy laws in China, Brazil, South Korea, and the United States alongside GDPR.

  • 43% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our revenue to decline

    Added a specific example regarding CMS considering a proposed rule to subject urological supplies to competitive bidding.

  • 33% rewrittenRISKS RELATED TO OUR BUSINESSES

    Our ongoing business operations may be disrupted for a significant period of time, resulting in material operating costs and financial losses

    Updated country count for sales destinations from approximately 150 to 140 countries and added climate change disruption risks.

  • 33% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    The Company will continue to monitor and reflect the impact of such legislative changes in future financial statements as appropriate

  • 31% rewrittenGENERAL RISKS

    Our business may be adversely affected by changes in global economic conditions, including inflation, rising interest rates, and supply chain shortages

  • 31% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    Similar to the FDA review process, the EU review process typically requires extended proceedings on the safety and efficacy of new products. Such proceedings are potentially expensive and time-consuming and may hinder a product’s entry into the marketplace

  • 30% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    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

  • 24% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENTS

    We may be unable to obtain necessary product approvals and marketing clearances

All 31 risk factors

Headings as the filing states them, in filing order.

RISKS RELATED TO OUR BUSINESSES

  1. 01We rely heavily on information 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
  2. 02Evolving 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 business45% rewritten
  3. 03Damage to our reputation or brand could negatively impact our business, financial condition or results of operations
  4. 04We 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 inefficiencies86% rewritten
  5. 05diversifying our distributor base, particularly in the United States beginning in 2026New
  6. 06Our 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 operations51% rewritten
  7. 07We may fail to realize the expected benefits of our strategic initiatives, including executed, announced, or potential future restructuring and other business transformation efforts92% rewritten
  8. 08recurring 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. The 2026 Plan is anticipated to result in approximately $120 million in annualized cost savingsNew
  9. 09We may be unable to develop innovative products and solutions to stimulate customer demand
  10. 10Our ongoing business operations may be disrupted for a significant period of time, resulting in material operating costs and financial losses33% rewritten
  11. 11We 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 future75% rewritten
  12. 12Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third partiesNew
  13. 13Changes in our credit ratings or macroeconomic impacts on credit markets may increase our cost of capital and limit financing options
  14. 14Our indebtedness could adversely affect our financial condition and prevent us from fulfilling our debt or contractual obligations
  15. 15Our 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

RISKS RELATED TO OUR GLOBAL OPERATIONS

  1. 16Due 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 performance86% rewritten

RISKS RELATED TO OUR REGULATORY ENVIRONMENTS

  1. 17We may be unable to obtain necessary product approvals and marketing clearances24% rewritten
  2. 18Similar to the FDA review process, the EU review process typically requires extended proceedings on the safety and efficacy of new products. Such proceedings are potentially expensive and time-consuming and may hinder a product’s entry into the marketplace31% rewritten
  3. 19Certain governments have adopted or are considering tax reform measures that could significantly increase our worldwide tax liabilitiesNew
  4. 20The Company will continue to monitor and reflect the impact of such legislative changes in future financial statements as appropriate33% rewritten
  5. 21On October 24, 2024, we announced the voluntary suspension of the sale and marketing of our direct-to-consumer Byte aligner systems and impression kits. In January 2025, we announced that Byte aligners would no longer be offered to new patientsNew
  6. 22Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our revenue to decline43% rewritten
  7. 23Challenges may be asserted against our products due to real or perceived quality, health or environmental issues
  8. 24Our 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 liabilities30% rewritten
  9. 25Legislation 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 resultsNew
  10. 26Climate-related rules will increase compliance costs and could increase litigation risks related to disclosures, which could materially and adversely affect our financial performanceNew

RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK

  1. 27The market price for our common stock may continue to be volatile as a result of a number of factors, including our quarterly operating results
  2. 28Certain provisions in our governing documents, and of Delaware law, may make it more difficult for a third party to acquire us

GENERAL RISKS

  1. 29Our business may be adversely affected by changes in global economic conditions, including inflation, rising interest rates, and supply chain shortages31% rewritten
  2. 30Talent gaps and challenges in managing and retaining top talent may impact our ability to operate effectively, execute strategic initiatives, and deliver for our customersNew
  3. 31We face the inherent risk of legal actions, including litigation, product liability claims, and other regulatory or compliance matters

Other Dentsply SIRONA 10-Ks

  • FY2024 10-K risk factors
    32 risks

    Operating across 150 countries with two-thirds of sales outside the US exposes Dentsply Sirona to global supply chain, currency, and regulatory volatility. Restructuring under the 2024 Plan targets a 2% to 4% global workforce reduction while addressing ongoing regulatory uncertainties from halting new Byte aligner patients. Complex medical device regulations, including FDA and EU MDR requirements, present significant compliance hurdles and potential delays in product commercialization.

    Filed Feb 27, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.