Dentsply SIRONA (XRAY) risk factors, FY2024 10-K

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 business
3. 03We may be unable to develop innovative products and solutions to stimulate customer demand
4. 04Damage to our reputation or brand could negatively impact our business, financial condition or results of operations
5. 05Our ongoing business operations may be disrupted for a significant period of time, resulting in material operating costs and financial losses
6. 06We 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
7. 07Our 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
8. 08We may fail to realize the expected benefits of our strategic initiatives, including executed, announced, or potential future restructuring and other business transformation efforts
9. 09We 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
10. 10Our failure to protect our proprietary technology could have an adverse impact on our competitive position
11. 11Our financial results may be adversely impacted if our products or services are found to infringe upon the intellectual property rights of others
12. 12Changes in our credit ratings or macroeconomic impacts on credit markets may increase our cost of capital and limit financing options
13. 13Our indebtedness could adversely affect our financial condition and prevent us from fulfilling our debt or contractual obligations
14. 14Our 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. 15Due 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
2. 16While 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

RISKS RELATED TO OUR INTERNAL CONTROLS

1. 17Lack of global standardized processes could result in control deficiencies and adversely impact management’s assertions and financial reporting

RISKS RELATED TO OUR REGULATORY ENVIRONMENTS

1. 18We may be unable to obtain necessary product approvals and marketing clearances
2. 19Similar 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
3. 20The Company will continue to monitor and reflect the impact of such legislative changes in future financial statements as appropriate
4. 21There 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
5. 22Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our revenue to decline
6. 23Challenges may be asserted against our products due to real or perceived quality, health or environmental issues
7. 24If 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
8. 25Our 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

RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK

1. 26The 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. 27Certain provisions in our governing documents, and of Delaware law, may make it more difficult for a third party to acquire us

GENERAL RISKS

1. 28Our business may be adversely affected by changes in global economic conditions, including inflation, rising interest rates, and supply chain shortages
2. 29Talent gaps and failure to manage and retain top talent may impact our ability to manage our operations, execute strategic initiatives and grow our business
3. 30We face the inherent risk of legal actions, including litigation, product liability claims, and other regulatory or compliance matters
4. 31Climate change and related natural disasters could negatively impact our business and financial results
5. 32Expectations relating to environmental, social and governance considerations may expose us to potential liabilities, increased costs, reputational harm, and other adverse effects on our business