Biggest changeRisk Factors Summary The following is a summary of the principal risks that could adversely affect our business, operations and financial results: • Conditions in the global economy, especially with respect to the particular markets we serve and the volatility of the financial markets may adversely affect our business and financial statements. • International economic, political, legal compliance and business factors could negatively affect our financial statements. • Significant developments or uncertainties stemming from trade policies could adversely affect our business. • Our growth could suffer if the markets into which we sell our products and services decline. • Our financial results are subject to fluctuations in the cost and availability of commodities. • If we cannot adjust our manufacturing capacity or the purchases required for our manufacturing activities to reflect changes in market conditions and customer demand, our profitability may suffer, and our reliance upon sole or limited resources of supply for certain materials, components and services could cause production interruptions, delays and inefficiencies. • If we suffer loss to our facilities, supply chains, distribution systems or information technology systems due to a cybersecurity incident, catastrophe or other events, our operations could be seriously harmed. • The manufacture of many of our products is a highly exacting and complex process. • A significant disruption in, or breach in security of, our information technology systems or data or violation of data privacy laws could adversely affect our business, operations, reputation and financial statements. • We currently outsource certain elements of our information technology systems to third-party services providers and their failure to adequately perform their services or attacks to their information systems could have a material adverse impact on our business operations and make our systems vulnerable to attacks. • Data privacy and security laws relating to the handling of personal information (including personal health information) are evolving across the world and may be drafted, interpreted or applied in a manner that results in increased costs, legal claims, fines against us, reputational damage or impedes delivery. • Our growing use of AI systems to automate processes and analyze data poses inherent risks. • Our growth depends in part on the timely development, commercialization, and customer acceptance of new and enhanced products and services based on technological innovation. • Our ability to manage executive leadership transitions and to attract, develop and retain our key personnel is critical to our success. • Any inability to consummate acquisitions at our historical rate and at appropriate prices, and to make appropriate investments that support our long-term strategy, could negatively impact our growth rate and stock price. • Our acquisition of businesses, investments, joint ventures and other strategic relationships could negatively impact our financial statements. • The indemnification provisions of acquisition agreements by which we have acquired companies may not fully protect us and as a result we may face unexpected liabilities. • Divestitures or other dispositions could negatively impact our business, and contingent liabilities from businesses that we or our predecessors have sold could adversely affect our financial statements. • Inventories maintained by our distributors and customers may fluctuate from time to time. • We are dependent upon a limited number of distributors for a significant portion of our sales. • If we do not or cannot adequately protect our intellectual property, or if third parties infringe our intellectual property rights, we may suffer competitive injury or expend significant resources enforcing our rights. • Third parties may claim that we are infringing or misappropriating their intellectual property rights and we could suffer significant litigation expenses, losses or licensing expenses or be prevented from selling products or services. 17 • Defects and unanticipated use or inadequate disclosure with respect to our products or services (including software), or allegations thereof, could adversely affect our business, reputation and financial statements. • Our restructuring and site consolidation actions could have long-term adverse effects on our business. • Climate related risks and regulations may have an impact on our business. • We have outstanding indebtedness of approximately $1.4 billion as of February 7, 2025, and in the future, we may incur additional indebtedness. • We may not be able to generate sufficient cash to service all of our indebtedness. • We may be unable to raise the funds necessary to repurchase the convertible notes for cash following a fundamental change, or to pay any cash amounts due upon conversion. • The conditional conversion feature of the convertible notes, if triggered, may adversely affect our financial condition and operating results. • The capped call transactions may affect the value of the convertible notes and our common stock. • We are subject to counterparty risk with respect to the capped calls transactions. • Our variable rate indebtedness exposes us to interest rate volatility. • The industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs. • We face intense competition. • Changes in governmental regulations may reduce demand for our products or services or increase our expenses. • Certain of our businesses are subject to extensive regulation by the FDA and comparable agencies of other countries. • Off-label marketing or misleading advertising of our products could result in substantial penalties. • Certain modifications to our products may require new 510(k) clearances or other marketing authorizations and may require us to recall or cease marketing our products. • Our operations, products and services expose us to the risk of environmental, health and safety liabilities. • Our businesses are subject to extensive regulation. • The price of our common stock may continue to be volatile. • Certain provisions in our governing documents and of Delaware law may prevent or delay an acquisition of us, which could decrease the trading price of our common stock. • Our governing documents contain exclusive forum provisions for certain types of actions and proceedings. • Conversion of the convertible notes may dilute the ownership interest of our stockholders. • The issuance or sale of shares of our common stock, or rights to acquire shares of our common stock, could depress the trading price of our common stock and the convertible notes. • We have recognized substantial impairment charges for our goodwill and indefinite-lived intangible assets and may be required to recognize additional impairment charges for assets in the future. • Changes in accounting standards and subjective assumptions, estimates and judgements by management related to complex accounting matters could significantly affect our financial results or financial condition. • Foreign currency exchange rates may adversely affect our financial statements. • Changes in tax law relating to multinational corporations could adversely affect our tax position. • We are subject to a variety of litigation and other legal and regulatory proceedings in the course of our business. • Work stoppages, union and works council campaigns and other labor disputes could adversely impact our productivity and results of operations. 18 Risks Related to Our Business Conditions in the global economy, especially with respect to the particular markets we serve and the volatility of the financial markets may adversely affect our business and financial statements.
Biggest changeRisk Factors Summary The following is a summary of the principal risks that could adversely affect our business, operations and financial results: • Conditions in the global economy, especially with respect to the particular markets we serve and the volatility of the financial markets may adversely affect our business and financial statements. • International economic, political, legal compliance and business factors could negatively affect our financial statements. • Significant developments or uncertainties stemming from trade policies could adversely affect our business. • Our growth could suffer if the markets into which we sell our products and services decline. • Our financial results are subject to fluctuations in the cost and availability of commodities. • If we cannot adjust our manufacturing capacity or the purchases required for our manufacturing activities to reflect changes in market conditions and customer demand, our profitability may suffer, and our reliance upon sole or limited resources of supply for certain materials, components and services could cause production interruptions, delays and inefficiencies. • A significant disruption in, or breach in security of, our information technology systems or data or violation of data privacy laws could adversely affect our business, operations, reputation and financial statements. • Our growing use of artificial intelligence systems to automate processes and analyze data poses inherent risks. • If we suffer loss to our facilities, supply chains, distribution systems or information technology systems due to a cybersecurity incident, catastrophe or other events, our operations could be seriously harmed. • The manufacture of many of our products is a highly exacting and complex process. • We currently outsource certain elements of our information technology systems to third-party services providers and their failure to adequately perform their services or attacks to their information systems could have a material adverse impact on our business operations and make our systems vulnerable to attacks. • Data privacy and security laws relating to the handling of personal information (including personal health information) are evolving across the world and may be drafted, interpreted or applied in a manner that results in increased costs, legal claims, fines against us, reputational damage or impedes delivery. • Our growth depends in part on the timely development, commercialization, and customer acceptance of new and enhanced products and services based on technological innovation. • Our success depends on our ability to attract, develop and retain our key personnel. • Any inability to consummate acquisitions at our historical rate and at appropriate prices, and to make appropriate investments that support our long-term strategy, could negatively impact our growth rate and stock price. • Our acquisition of businesses, investments, joint ventures and other strategic relationships could negatively impact our financial statements. • The indemnification provisions of acquisition agreements by which we have acquired companies may not fully protect us and as a result we may face unexpected liabilities. • Divestitures or other dispositions could negatively impact our business, and contingent liabilities from businesses that we or our predecessors have sold could adversely affect our financial statements. • Inventories maintained by our distributors and customers may fluctuate from time to time. • We are dependent upon a limited number of distributors for a significant portion of our sales. • If we do not or cannot adequately protect our intellectual property, or if third parties infringe our intellectual property rights, we may suffer competitive injury or expend significant resources enforcing our rights. • Third parties may claim that we are infringing or misappropriating their intellectual property rights and we could suffer significant litigation expenses, losses or licensing expenses or be prevented from selling products or services. • Defects and unanticipated use or inadequate disclosure with respect to our products or services (including software), or allegations thereof, could adversely affect our business, reputation and financial statements. 19 • Our restructuring and site consolidation actions could have long-term adverse effects on our business. • Climate related risks and regulations may have an impact on our business. • We have outstanding indebtedness of approximately $1.5 billion as of February 6, 2026, and in the future, we may incur additional indebtedness. • We may not be able to generate sufficient cash to service all of our indebtedness. • We may be unable to raise the funds necessary to repurchase the convertible notes for cash following a fundamental change, or to pay any cash amounts due upon conversion. • The conditional conversion feature of the convertible notes, if triggered, may adversely affect our financial condition and operating results. • Our variable rate indebtedness exposes us to interest rate volatility. • The industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs. • We face intense competition. • Changes in governmental regulations may reduce demand for our products or services or increase our expenses. • Certain of our businesses are subject to extensive regulation by the FDA and comparable agencies of other countries. • Off-label marketing or misleading advertising of our products could result in substantial penalties. • Certain modifications to our products may require new 510(k) clearances or other marketing authorizations and may require us to recall or cease marketing our products. • Our operations, products and services expose us to the risk of environmental, health and safety liabilities. • Our businesses are subject to extensive regulation. • The price of our common stock may continue to be volatile. • Certain provisions in our governing documents and of Delaware law may prevent or delay an acquisition of us, which could decrease the trading price of our common stock. • Our governing documents contain exclusive forum provisions for certain types of actions and proceedings. • Conversion of the convertible notes may dilute the ownership interest of our stockholders. • The issuance or sale of shares of our common stock, or rights to acquire shares of our common stock, could depress the trading price of our common stock and the convertible notes. • We have recognized substantial impairment charges for our goodwill and indefinite-lived intangible assets and may be required to recognize additional impairment charges for assets in the future. • Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our financial results or financial condition. • Foreign currency exchange rates may adversely affect our financial statements. • Changes in tax law relating to multinational corporations could adversely affect our tax position. • We are subject to a variety of litigation and other legal and regulatory proceedings in the course of our business. • Work stoppages, union and works council campaigns and other labor disputes could adversely impact our productivity and results of operations. 20 Risks Related to Our Business Conditions in the global economy, especially with respect to the particular markets we serve and the volatility of the financial markets may adversely affect our business and financial statements.
Acquisitions, investments, joint ventures and strategic relationships involve a number of financial, accounting, managerial, operational, legal, compliance and other risks and challenges, including the following, any of which could adversely affect our business and financial statements: ◦ Any business, technology, service or product that we acquire or invest in could under-perform relative to our expectations and the price that we paid or not perform in accordance with our anticipated timetable, or we could fail to operate any such business profitably. ◦ We may incur or assume significant debt in connection with our acquisitions, investments, joint ventures or strategic relationships, which could also cause a deterioration of our credit ratings, result in increased borrowing costs and interest expense and diminish our future access to the capital markets. ◦ Acquisitions, investments, joint ventures or strategic relationships could cause our financial results to differ from our own or the investment community’s expectations in any given period, or over the long-term. ◦ Pre-closing and post-closing earnings charges could adversely impact operating results in any given period, and the impact may be substantially different from period to period. ◦ Acquisitions, investments, joint ventures or strategic relationships could create demands on our management, operational resources and financial and internal control systems that we are unable to effectively address. ◦ We have in the past and could in the future experience difficulty in integrating personnel, operations and financial and other controls and systems and retaining key employees and customers. ◦ We may be unable to achieve cost savings or other synergies anticipated in connection with an acquisition, investment, joint venture or strategic relationship. 28 ◦ We may assume unknown liabilities, known contingent liabilities that become realized, known liabilities that prove greater than anticipated, internal control deficiencies or exposure to regulatory sanctions resulting from the acquired company’s or investee’s activities and the realization of any of these liabilities or deficiencies may increase our expenses, adversely affect our financial position or cause us to fail to meet our public financial reporting obligations. ◦ In connection with acquisitions and joint ventures, we often enter into post-closing financial arrangements such as purchase price adjustments, earn-out obligations and indemnification obligations, which may have unpredictable financial results. ◦ As a result of our acquisitions and investments, we have recorded significant goodwill and other assets on our balance sheet and if we are not able to realize the value of these assets, or if the fair value of our investments declines, we may be required to incur impairment charges. ◦ We may have interests that diverge from those of our joint venture partners or other strategic partners and we may not be able to direct the management and operations of the joint venture or other strategic relationship in the manner we believe is most appropriate, exposing us to additional risk. ◦ Investing in or making loans to early-stage companies often entails a high degree of risk, and we may not achieve the strategic, technological, financial or commercial benefits we anticipate; we may lose our investment or fail to recoup our loan; or our investment may be illiquid for a greater-than-expected period of time.
Acquisitions, investments, joint ventures and strategic relationships involve a number of financial, accounting, managerial, operational, legal, compliance and other risks and challenges, including the following, any of which could adversely affect our business and financial statements: ◦ Any business, technology, service or product that we acquire or invest in could under-perform relative to our expectations and the price that we paid or not perform in accordance with our anticipated timetable, or we could fail to operate any such business profitably. 28 ◦ We may incur or assume significant debt in connection with our acquisitions, investments, joint ventures or strategic relationships, which could also cause a deterioration of our credit ratings, result in increased borrowing costs and interest expense and diminish our future access to the capital markets. ◦ Acquisitions, investments, joint ventures or strategic relationships could cause our financial results to differ from our own or the investment community’s expectations in any given period, or over the long-term. ◦ Pre-closing and post-closing earnings charges could adversely impact operating results in any given period, and the impact may be substantially different from period to period. ◦ Acquisitions, investments, joint ventures or strategic relationships could create demands on our management, operational resources and financial and internal control systems that we are unable to effectively address. ◦ We have in the past and could in the future experience difficulty in integrating personnel, operations and financial and other controls and systems and retaining key employees and customers. ◦ We may be unable to achieve cost savings or other synergies anticipated in connection with an acquisition, investment, joint venture or strategic relationship. ◦ We may assume unknown liabilities, known contingent liabilities that become realized, known liabilities that prove greater than anticipated, internal control deficiencies or exposure to regulatory sanctions resulting from the acquired company’s or investee’s activities and the realization of any of these liabilities or deficiencies may increase our expenses, adversely affect our financial position or cause us to fail to meet our public financial reporting obligations. ◦ In connection with acquisitions and joint ventures, we often enter into post-closing financial arrangements such as purchase price adjustments, earn-out obligations and indemnification obligations, which may have unpredictable financial results. ◦ As a result of our acquisitions and investments, we have recorded significant goodwill and other assets on our balance sheet and if we are not able to realize the value of these assets, or if the fair value of our investments declines, we may be required to incur impairment charges. ◦ We may have interests that diverge from those of our joint venture partners or other strategic partners and we may not be able to direct the management and operations of the joint venture or other strategic relationship in the manner we believe is most appropriate, exposing us to additional risk. ◦ Investing in or making loans to early-stage companies often entails a high degree of risk, and we may not achieve the strategic, technological, financial or commercial benefits we anticipate; we may lose our investment or fail to recoup our loan; or our investment may be illiquid for a greater-than-expected period of time.
Our success will depend on several factors, including our ability to: ◦ correctly identify customer needs and preferences and predict future needs and preferences; ◦ allocate our research and development funding to products and services with higher growth prospects; ◦ anticipate and respond to our competitors’ development of new products and services and technological innovations; ◦ differentiate our offerings from our competitors’ offerings and avoid commoditization; ◦ innovate and develop new technologies and applications, and acquire or obtain rights to third-party technologies that may have valuable applications in our served markets; ◦ obtain adequate intellectual property rights with respect to key technologies before our competitors do; ◦ successfully commercialize new technologies in a timely manner, price them competitively and cost-effectively manufacture and deliver sufficient volumes of new products of appropriate quality on time; ◦ obtain necessary regulatory approvals of appropriate scope (including by demonstrating satisfactory clinical results where required); and ◦ stimulate customer demand for and convince customers to adopt new technologies, including assisted or artificial intelligence.
Our success will depend on several factors, including our ability to: ◦ correctly identify customer needs and preferences and predict future needs and preferences; ◦ allocate our research and development funding to products and services with higher growth prospects; ◦ anticipate and respond to our competitors’ development of new products and services and technological innovations; ◦ differentiate our offerings from our competitors’ offerings and avoid commoditization; 27 ◦ innovate and develop new technologies and applications, and acquire or obtain rights to third-party technologies that may have valuable applications in our served markets; ◦ obtain adequate intellectual property rights with respect to key technologies before our competitors do; ◦ successfully commercialize new technologies in a timely manner, price them competitively and cost-effectively manufacture and deliver sufficient volumes of new products of appropriate quality on time; ◦ obtain necessary regulatory approvals of appropriate scope (including by demonstrating satisfactory clinical results where required); and ◦ stimulate customer demand for and convince customers to adopt new technologies, including assisted or artificial intelligence.
These changes, as well as other impacts from market demand, government regulations, third-party coverage and reimbursement policies and societal pressures have started changing the way health care is delivered, reimbursed and funded and may cause participants in the health care industry and related industries that we serve to purchase fewer of our products and services, reduce the prices they are willing to pay for our products or services, reduce the amounts of reimbursement and funding available for our products and services from governmental agencies or third-party payors, heighten clinical data requirements, reduce the volume of medical procedures that use our products and services, affect the acceptance rate of new technologies and products and increase our compliance and other costs.
These changes, as well as other impacts from market demand, government regulations, third-party coverage and reimbursement policies and societal pressures have started changing the way health care is delivered, reimbursed and funded and may cause participants in the health care industry and related industries that we serve to purchase fewer of our products and services, reduce the prices they are willing to pay for our products or services, reduce the amounts of reimbursement and funding available for our products and services from governmental agencies or third-party payors, heighten clinical data requirements, reduce the volume of medical procedures that use our products and services, implement policies that affect the acceptance rate of new technologies and products and increase our compliance and other costs.
Our international business (and particularly our business in emerging markets) is subject to risks that are customarily encountered in non-U.S. operations, including: ◦ interruption in the transportation of materials to us and finished goods to our customers; ◦ differences in terms of sale, including payment terms; ◦ local product preferences and product requirements; ◦ changes in a country’s or region’s political or economic conditions, such as the devaluation of particular currencies; ◦ trade protection measures, sanctions, increased trade barriers, imposition of significant tariffs on imports or exports, embargoes and import or export restrictions and requirements; 19 ◦ regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining to the accuracy of our internal books and records; ◦ unexpected changes in laws or regulatory requirements, including changes in tax laws; ◦ capital controls and limitations on ownership and on repatriation of earnings and cash; ◦ the potential for nationalization of enterprises; ◦ changes in medical reimbursement policies and programs; ◦ limitations on legal rights and our ability to enforce such rights; ◦ difficulty in staffing and managing widespread operations; ◦ differing labor regulations; ◦ difficulties in implementing restructuring actions on a timely or comprehensive basis; ◦ differing protection of intellectual property; ◦ greater uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, including with respect to product and other regulatory approvals; and ◦ other factors beyond our control, such as terrorism, war, natural disasters and pandemics.
Our international business (and particularly our business in emerging markets) is subject to risks that are customarily encountered in non-U.S. operations, including: ◦ interruption in the transportation of materials to us and finished goods to our customers; ◦ differences in terms of sale, including payment terms; ◦ local product preferences and product requirements; ◦ changes in a country’s or region’s political or economic conditions, such as the devaluation of particular currencies; ◦ trade protection measures, sanctions, increased trade barriers, imposition of significant tariffs on imports or exports, embargoes and import or export restrictions and requirements; 21 ◦ regulatory requirements, including, without limitation, anti-bribery, anti-corruption and laws pertaining to the accuracy of our internal books and records; ◦ unexpected changes in laws or regulatory requirements, including changes in tax laws; ◦ capital controls and limitations on ownership and on repatriation of earnings and cash; ◦ the potential for nationalization of enterprises; ◦ changes in medical reimbursement policies and programs; ◦ limitations on legal rights and our ability to enforce such rights; ◦ difficulty in staffing and managing widespread operations; ◦ differing labor regulations; ◦ difficulties in implementing restructuring actions on a timely or comprehensive basis; ◦ differing protection of intellectual property; ◦ greater uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, including with respect to product and other regulatory approvals; and ◦ other factors beyond our control, such as terrorism, war, natural disasters and pandemics.
While we believe we have substantially compliant programs and controls in place satisfying the above laws and requirements, such compliance imposes additional costs on us and the requirements are sometimes unclear. 37 To varying degrees, these regulators require us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution and post-marketing surveillance of our products.
While we believe we have substantially compliant programs and controls in place satisfying the above laws and requirements, such compliance imposes additional costs on us and the requirements are sometimes unclear. To varying degrees, these regulators require us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution and post-marketing surveillance of our products.
Even if we successfully defend against claims of infringement or misappropriation, we may incur significant costs and diversion of management attention and resources, which could adversely affect our business and financial statements. Defects and unanticipated use or inadequate disclosure with respect to our products or services (including software), or allegations thereof, could adversely affect our business, reputation and financial statements.
Even if we successfully defend against claims of infringement or misappropriation, we may incur significant costs and diversion of management attention and resources, which could adversely affect our business and financial statements. 31 Defects and unanticipated use or inadequate disclosure with respect to our products or services (including software), or allegations thereof, could adversely affect our business, reputation and financial statements.
Business—Competition . ” In order to compete effectively, we must retain longstanding relationships with major customers and continue to grow our business by establishing relationships with new customers and external experts, continually developing new products and services to maintain and expand our brand recognition and leadership position in various product and service categories and penetrating new markets, including emerging markets.
Business—Competition . ” In order to compete effectively, we must retain longstanding relationships with major customers and DSOs and continue to grow our business by establishing relationships with new customers, DSOs and external experts, continually developing new products and services to maintain and expand our brand recognition and leadership position in various product and service categories and penetrating new markets, including emerging markets.
We cannot assure you that these indemnification provisions will protect us fully or at all, and as a result we may face unexpected liabilities that adversely affect our financial statements. Divestitures or other dispositions could negatively impact our business, and contingent liabilities from businesses that we or our predecessors have sold could adversely affect our financial statements.
We cannot assure you that these indemnification provisions will protect us fully or at all, and as a result we may face unexpected liabilities that adversely affect our financial statements. 29 Divestitures or other dispositions could negatively impact our business, and contingent liabilities from businesses that we or our predecessors have sold could adversely affect our financial statements.
In addition, we may be excluded from important market segments or unable to enter into contracts with group purchasing organizations and integrated health networks on terms acceptable to us, and even if we do enter into such contracts they may be on terms that negatively affect our current or future profitability.
In addition, we may be excluded from important market segments or unable to enter into contracts with group purchasing organizations, DSOs, and integrated health networks on terms acceptable to us, and even if we do enter into such contracts they may be on terms that negatively affect our current or future profitability.
All of the factors described above could adversely affect our business and financial statements. We face intense competition and if we are unable to compete effectively, we may experience decreased demand and decreased market share. Even if we compete effectively, we may be required to reduce prices for our products and services.
All of the factors described above could adversely affect our business and financial statements. 35 We face intense competition and if we are unable to compete effectively, we may experience decreased demand and decreased market share. Even if we compete effectively, we may be required to reduce prices for our products and services.
If these competitors’ products capture significant market share or decrease market prices overall, this could have an adverse effect on our financial statements. 36 Risks Related to Laws and Regulations Changes in governmental regulations may reduce demand for our products or services or increase our expenses.
If these competitors’ products capture significant market share or decrease market prices overall, this could have an adverse effect on our financial statements. Risks Related to Laws and Regulations Changes in governmental regulations may reduce demand for our products or services or increase our expenses.
The industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, including the following: ◦ Governmental and private health care providers and payors around the world are increasingly utilizing managed care for the delivery of health care services, centralizing purchasing, limiting the number of vendors that may participate in purchasing programs, forming group purchasing organizations and integrated health delivery networks and pursuing consolidation to improve their purchasing leverage and using competitive bid processes to procure health care products and services. 35 ◦ Certain of our customers, and the end-users to whom our customers supply products, rely on government funding of and reimbursement for health care products and services and research activities.
The industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, including the following: ◦ Governmental and private health care providers and payors around the world are increasingly utilizing managed care for the delivery of health care services, centralizing purchasing, limiting the number of vendors that may participate in purchasing programs, forming group purchasing organizations, DSOs, and integrated health delivery networks and pursuing consolidation to improve their purchasing leverage and using competitive bid processes to procure health care products and services. ◦ Certain of our customers, and the end-users to whom our customers supply products, rely on government funding of and reimbursement for health care products and services and research activities.
We may request additional label indications for our current products, and the FDA may deny those requests outright, require additional expensive performance or clinical data to support any additional indications or impose limitations on the intended use of any cleared products as a condition of clearance.
We may request additional use indications for our current products, and the FDA may deny those requests outright, require additional expensive performance or clinical data to support any additional indications or impose limitations on the intended use of any cleared products as a condition of clearance.
Any of these factors could adversely affect our growth and results of operations in any given period. Our financial results are subject to fluctuations in the cost and availability of commodities that we use in our operations. As further discussed in the section entitled “Item 1.
Any of these factors could adversely affect our growth and results of operations in any given period. 23 Our financial results are subject to fluctuations in the cost and availability of commodities that we use in our operations. As further discussed in the section entitled “Item 1.
In addition to the environmental, health, safety, health care, medical device, anticorruption, data privacy and other regulations noted elsewhere in this Annual Report, our businesses are subject to extensive regulation by U.S. and non-U.S. governmental and self-regulatory entities at the supranational, federal, state, local and other jurisdictional levels, including laws governing payments to government officials, bribery, fraud, kickbacks and false claims, pricing, sales and marketing practices, conflicts of interest, competition, employment practices and workplace behavior, export and import compliance, economic and trade sanctions, money laundering and data privacy. 39 We cannot provide assurance that our internal controls and compliance systems will always protect us from acts committed by our employees, agents or business partners (or of businesses we acquire or partner with) that would violate U.S. and/or non-U.S. laws - In particular, the U.S.
In addition to the environmental, health, safety, health care, medical device, anticorruption, data privacy and other regulations noted elsewhere in this Annual Report, our businesses are subject to extensive regulation by U.S. and non-U.S. governmental and self-regulatory entities at the supranational, federal, state, local and other jurisdictional levels, including laws governing payments to government officials, bribery, fraud, kickbacks and false claims, pricing, sales and marketing practices, conflicts of interest, competition, employment practices and workplace behavior, export and import compliance, economic and trade sanctions, money laundering and data privacy. 38 We cannot provide assurance that our internal controls and compliance systems will always protect us from acts committed by our employees, agents or business partners (or of businesses we acquire or partner with) that would violate U.S. and/or non-U.S. laws.
We may not have sufficient funds to satisfy all amounts due under the other indebtedness and the Notes. The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results.
We may not have sufficient funds to satisfy all amounts due under the other indebtedness and the Notes. 34 The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results.
The third-party insurance coverage that we maintain will vary from time to time in both type and amount depending on cost, availability and our decisions regarding risk retention, and may be unavailable or insufficient to protect us against such losses. 22 The manufacture of many of our products is a highly exacting and complex process, and if we directly or indirectly encounter problems manufacturing products, our reputation, business and financial statements could suffer.
The third-party insurance coverage that we maintain will vary from time to time in both type and amount depending on cost, availability and our decisions regarding risk retention, and may be unavailable or insufficient to protect us against such losses. 26 The manufacture of many of our products is a highly exacting and complex process, and if we directly or indirectly encounter problems manufacturing products, our reputation, business and financial statements could suffer.
Factors that may cause the market price of our common stock to fluctuate, some of which may be beyond our control, include: ◦ our quarterly or annual earnings, or those of other companies in our industry; ◦ actual or anticipated fluctuations in our operating results; ◦ changes in earnings estimated by securities analysts or our ability to meet those estimates; ◦ the operating and stock price performance of other comparable companies; ◦ changes to the regulatory and legal environment in which we operate; ◦ macroeconomic conditions, inflation, interest rates, fluctuating foreign currency exchange rates, slow economic growth, continuing supply chain disruptions, and global conflicts, including the Russia-Ukraine war and the Israel-Hamas war; ◦ unusual events such as significant acquisitions by us and our competitors, divestitures, litigation, regulatory actions and other factors, including factors unrelated to our operating performance; ◦ announcements by us or our competitors of new products or technological innovation; 40 ◦ overall market fluctuations and domestic and worldwide economic conditions; and ◦ other factors described in these “Risk Factors” and elsewhere in this Annual Report.
Factors that may cause the market price of our common stock to fluctuate, some of which may be beyond our control, include: ◦ our quarterly or annual earnings, or those of other companies in our industry; ◦ actual or anticipated fluctuations in our operating results; ◦ changes in earnings estimated by securities analysts or our ability to meet those estimates; ◦ the operating and stock price performance of other comparable companies; ◦ investor interest in the dental industry; ◦ changes to the regulatory and legal environment in which we operate; ◦ macroeconomic conditions, inflation, interest rates, fluctuating foreign currency exchange rates, slow economic growth, continuing supply chain disruptions, and global conflicts, including the Russia-Ukraine war and the Israel-Hamas war; ◦ unusual events such as significant acquisitions by us and our competitors, divestitures, litigation, regulatory actions and other factors, including factors unrelated to our operating performance; 39 ◦ announcements by us or our competitors of new products or technological innovation; ◦ overall market fluctuations and domestic and worldwide economic conditions; and ◦ other factors described in these “Risk Factors” and elsewhere in this Annual Report.
Sustained geopolitical tensions could lead to long-term changes in global trade and supply chains, and decoupling of global trade networks, which could have a material adverse effect on our business and growth prospects. Our growth could suffer if the markets into which we sell our products and services decline, do not grow as anticipated or experience cyclicality.
Sustained geopolitical tensions could lead to long-term changes in global trade and supply chains, and decoupling of global trade networks, which could have a material adverse effect on our business, results of operations and growth prospects. Our growth could suffer if the markets into which we sell our products and services decline, do not grow as anticipated or experience cyclicality.
Increasing protectionism and economic nationalism may lead to further changes in trade policies and regulations, domestic sourcing initiatives, or other formal and informal measures that could make it more difficult to sell our products in, or restrict our access to, some markets. In particular, trade tensions between the U.S. and China have led to increased tariffs and trade restrictions.
Increasing protectionism and economic nationalism may lead to further changes in trade policies and regulations, domestic sourcing initiatives, or other formal and informal measures that could make it more difficult to sell our products in, or restrict our access to, certain markets. In particular, trade tensions between the U.S. and China have led to increased tariffs and trade restrictions.
In addition, our issuance of additional shares of common stock will dilute the ownership interests of our existing common stockholders, including holders of Notes who have received shares of our common stock upon conversion of their Notes. 42 General Risks We have recognized substantial impairment charges for our goodwill and indefinite-lived intangible assets and may be required to recognize additional impairment charges for such assets in the future.
In addition, our issuance of additional shares of common stock will dilute the ownership interests of our existing common stockholders, including holders of Notes who have received shares of our common stock upon conversion of their Notes. 41 General Risks We have recognized substantial impairment charges for our goodwill and indefinite-lived intangible assets and may be required to recognize additional impairment charges for such assets in the future.
Sustained inflation, increases in interest rates, slower global economic growth, threatened or actual recessions, continuing supply chain disruptions, geopolitical tensions, actual or anticipated default on sovereign debt, volatility in the currency and credit markets, consumer confidence, high levels of unemployment or underemployment (and a corresponding increase in the uninsured and underinsured population), reduced levels of capital expenditures, changes or anticipation of potential changes in government trade, fiscal, tax and monetary policies, changes in capital requirements for financial institutions, government deficit reduction and budget negotiation dynamics, sequestration, austerity measures, social or political unrest, the impact of the COVID-19 pandemic and other challenges that affect the global economy have previously and may continue to adversely affect us and our distributors, customers and suppliers.
Sustained inflation, increases in interest rates, slower global economic growth, threatened or actual recessions, continuing supply chain disruptions, geopolitical tensions, actual or anticipated default on sovereign debt, volatility in the currency and credit markets, consumer confidence, high levels of unemployment or underemployment (and a corresponding increase in the uninsured and underinsured population), reduced levels of capital expenditures, changes or anticipation of potential changes in government trade, fiscal, tax and monetary policies, changes in capital requirements for financial institutions, government deficit reduction and budget negotiation dynamics, sequestration, austerity measures, social or political unrest, and other challenges that affect the global economy have previously and may continue to adversely affect us and our distributors, customers and suppliers.
Certain of our U.S. and non-U.S. employees are subject to collective labor arrangements. We are subject to potential work stoppages, union and works council campaigns and other labor disputes, any of which could adversely impact our financial statements and business, including our productivity and reputation. 44 ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
Certain of our U.S. and non-U.S. employees are subject to collective labor arrangements. We are subject to potential work stoppages, union and works council campaigns and other labor disputes, any of which could adversely impact our financial statements and business, including our productivity and reputation. 43 ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
Additionally, certain provisions in the Notes and the Indentures governing the Notes could make a third party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then holders of the Notes will have the right to require us to repurchase their Notes for cash.
Additionally, certain provisions in the Notes and the Indenture governing the Notes could make a third party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then holders of the Notes will have the right to require us to repurchase their Notes for cash.
Although these export controls and sanctions did not have a material impact on our financial position or results of operations as of and for the year ended December 31, 2024, the outcome and future impacts of the conflict and governmental responses thereto remain highly uncertain.
Although these export controls and sanctions did not have a material impact on our financial position or results of operations as of and for the year ended December 31, 2025, the outcome and future impacts of the conflict and governmental responses thereto remain highly uncertain.
In either case, and in other cases, our obligations under the Notes and the Indentures could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that holders of our securities may view as favorable.
In either case, and in other cases, our obligations under the Notes and the Indenture could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that holders of our securities may view as favorable.
Furthermore, trade disputes and protectionist measures, or continued uncertainty about such matters, could result in declining consumer confidence and slowing economic growth or recession, and could cause our customers to reduce, cancel, or alter the timing of their purchases with us.
Furthermore, trade disputes and protectionist measures, or continued uncertainty about such matters, could result in declining consumer confidence and slowing economic growth or recession, and could cause our customers to reduce, cancel, or alter the timing of their purchases.
If interest rates continue to increase, our debt service obligations on certain of our variable rate indebtedness will increase even though the amount borrowed remains the same, and our net income and cash flows, including cash available for servicing our indebtedness, will correspondingly decrease.
If interest rates increase, our debt service obligations on certain of our variable rate indebtedness will increase even though the amount borrowed remains the same, and our net income and cash flows, including cash available for servicing our indebtedness, will correspondingly decrease.
Any of these events could significantly harm our business and results of operations and cause our stock price to decline. 38 Certain modifications to our products may require new 510(k) clearances or other marketing authorizations and may require us to recall or cease marketing our products.
Any of these events could significantly harm our business and results of operations and cause our stock price to decline. 37 Certain modifications to our products may require new 510(k) clearances or other marketing authorizations and may require us to recall or cease marketing our products.
Certain provisions in our second amended and restated certificate of incorporation, as amended, our third amended and restated bylaws, the Indentures governing the Notes, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our common stock.
Certain provisions in our second amended and restated certificate of incorporation, as amended, our third amended and restated bylaws, the Indenture governing the Notes, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our common stock.
For example, we have incorporated machine-learning into certain of our software to provide AI analysis of dental patient images designed to enhance a dentist’s own analysis. Flaws, biases or malfunctions in these systems could lead to operational disruptions, data loss, or erroneous decision-making, impacting our operations, financial condition and reputation.
For example, we have incorporated machine-learning into certain of our software to provide artificial intelligence analysis of dental patient images designed to enhance a dentist’s own analysis. Flaws, biases or malfunctions in these systems could lead to operational disruptions, data loss, or erroneous decision-making, impacting our operations, financial condition and reputation.
Trade policies and disputes at times result in increased tariffs, trade barriers, and other protectionist measures, which can increase our manufacturing costs, make our products less competitive, reduce demand for our products, limit our ability to sell to certain customers, limit our ability to procure components or raw materials, or impede or slow the movement of our goods across borders.
Trade policies and disputes may result in increased tariffs, trade barriers, and other protectionist measures, which can increase our manufacturing costs, make our products less competitive, reduce demand for our products, limit our ability to sell to certain customers, limit our ability to procure components or raw materials, or impede or slow the movement of our goods across borders.
Ethical and legal challenges may arise, including biases or discrimination in AI outcomes, non-compliance with data protection regulations, and lack of transparency. The legal and regulatory landscape and industry standards surrounding AI technologies is rapidly evolving and uncertain, and compliance may impose significant operational costs and may limit our ability to develop, deploy or use AI technologies.
Ethical and legal challenges may arise, including biases or discrimination in artificial intelligence outcomes, non-compliance with data protection regulations, and lack of transparency. The legal and regulatory landscape and industry standards surrounding artificial intelligence technologies is rapidly evolving and uncertain, and compliance may impose significant operational costs and may limit our ability to develop, deploy or use artificial intelligence technologies.
Any such regulatory changes could have a significant effect on our operating and financial decisions, including those involving capital expenditures to reduce emissions and comply with other regulatory requirements. 32 Risks Related to Our Indebtedness We have outstanding indebtedness of approximately $1.4 billion, and in the future, we may incur additional indebtedness.
Any such regulatory changes could have a significant effect on our operating and financial decisions, including those involving capital expenditures to reduce emissions and comply with other regulatory requirements. Risks Related to Our Indebtedness We have outstanding indebtedness of approximately $1.5 billion, and in the future, we may incur additional indebtedness.
Any of these risks could negatively affect our financial statements, business, growth rate, competitive position, results of operations and financial condition. For example, we generate approximately 9% of our annual sales from Greater China. Accordingly, our business, financial condition and results of operations may be adversely influenced by evolving political, economic and social conditions in China generally.
Any of these risks could negatively affect our financial statements, business, growth rate, competitive position, results of operations and financial condition. For example, we generate approximately 7% of our annual sales from China. Accordingly, our business, financial condition and results of operations may be adversely influenced by evolving political, economic and social conditions in China generally.
Foreign Corrupt Practices Act, the UK Bribery Act and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business, and we operate in countries that have experienced corruption.
In particular, the U.S. Foreign Corrupt Practices Act, the UK Bribery Act and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business, and we operate in countries that have experienced corruption.
Historically, a substantial portion of our sales had come from a limited number of distributors, particularly Henry Schein, which accounted for approximately 10% of our sales in 2024 and 2023. It is anticipated that Henry Schein will continue to be the largest contributor to our sales for the foreseeable future.
Historically, a substantial portion of our sales had come from a limited number of distributors, particularly Henry Schein, which accounted for approximately 12% of our sales in 2025 and 10% of our sales in 2024. It is anticipated that Henry Schein will continue to be the largest contributor to our sales for the foreseeable future.
For additional information regarding these risks, please refer to Note 15 to our Consolidated Financial Statements included in this Annual Report.
For additional information regarding these risks, please refer to Note 13 to our Consolidated Financial Statements included in this Annual Report.
Our businesses operate in industries that are intensely competitive and have been subject to increasing consolidation. Because of the range of the products and services we sell and the variety of markets we serve, we encounter a wide variety of competitors. See “Item 1.
Our businesses operate in industries that are intensely competitive and have been subject to increasing consolidation, including the growing significance of DSOs. Because of the range of the products and services we sell and the variety of markets we serve, we encounter a wide variety of competitors. See “Item 1.
As a result, the tax laws in the U.S. and other countries in which we do business could change on a prospective or retroactive basis, and any such changes could adversely affect our business and financial statements. 43 We are subject to a variety of litigation and other legal and regulatory proceedings in the course of our business that could adversely affect our business and financial statements.
As a result, the tax laws in the U.S. and other countries in which we do business could change on a prospective or retroactive basis, and any such changes could adversely affect our business, financial condition, and results of operations. 42 We are subject to a variety of litigation and other legal and regulatory proceedings in the course of our business that could adversely affect our business and financial statements.
International economic, political, legal, compliance and business factors could negatively affect our financial statements. In 2024, 52% of our sales were derived from customers outside the U.S. In addition, many of our manufacturing operations, suppliers and employees are located outside the U.S.
International economic, political, legal, compliance and business factors could negatively affect our financial statements. In 2025, 53% of our sales were derived from customers outside the U.S. In addition, many of our manufacturing operations, suppliers and employees are located outside the U.S.
We cannot predict whether additional U.S. and foreign customs quotas, duties (including antidumping or countervailing duties), tariffs, taxes or other charges or restrictions, requirements as to where raw materials must be purchased or other restrictions on our imports will be imposed in the future or adversely modified, or what effect such actions would have on our costs of operations.
We cannot predict whether additional U.S. and foreign customs quotas, duties (including antidumping or countervailing duties), tariffs, taxes or other charges or restrictions, requirements as to where raw materials must be purchased or other restrictions on our imports will be imposed in the future or adversely modified, whether retaliatory tariffs and trade measures will be imposed by other counties on U.S. exports, or what effect such actions would have on our costs of operations.
Changes in tax law relating to multinational corporations could adversely affect our tax position. The U.S. Congress, government agencies in non-U.S. jurisdictions where we and our affiliates do business, and the Organisation for Economic Co-operation and Development (“OECD”) have recently focused on issues related to the taxation of multinational corporations.
Changes in tax law relating to multinational corporations could adversely affect our tax position. The U.S. Congress, government agencies in non-U.S. jurisdictions where we and our affiliates do business and the Organisation for Economic Co-operation and Development, have continued to focus on issues related to the taxation of multinational corporations.
Future quotas, duties or tariffs may adversely affect our business, financial condition, results of operations or cash flows. Future trade agreements could also provide our competitors with an advantage over us, or increase our costs, either of which could adversely affect our business, financial condition, results of operations or cash flows.
Existing and future quotas, duties or tariffs may adversely affect our business, financial condition, results of operations or cash flows. Future trade agreements could also provide our competitors with an advantage, or increase our costs, either of which could adversely affect our business, financial condition, results of operations or cash flows.
A default under the 2028 Convertible Notes Indenture, the 2025 Convertible Notes Indenture (together, the “Indentures”), or the fundamental change itself could also lead to a default under agreements governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full.
A default under the 2028 Convertible Notes Indenture (the “Indenture”), or the fundamental change itself could also lead to a default under agreements governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full.
In addition, we are exposed to the risk that our competitors or our customers may introduce private label, generic, or low-cost products that compete with our products at lower price points. New disruptive technologies may emerge that displace our existing technologies.
In addition, we are exposed to the risk that our competitors or our customers may introduce private label, generic, or low-cost products that compete with our products at lower price points. New disruptive technologies, including those that incorporate artificial intelligence, may emerge that displace our existing technologies.
Borrowings under certain of our facilities, including our Second Amended Credit Agreement, are made at variable rates of interest and expose us to interest rate volatility. Interest rates increased during 2022 and 2023.
Borrowings under certain of our facilities, including our Second Amended Credit Agreement, are made at variable rates of interest and expose us to interest rate volatility.
When growth in the global economy or in any of the markets we serve slows for a significant period, there is significant deterioration in the global economy or such markets or when improvements in the global economy do not benefit the markets we serve, our business and financial statements could be adversely affected.
When growth in the global economy or in any of the markets we serve slows for a significant period, there is significant deterioration in the global economy or such markets or when improvements in the global economy do not benefit the markets we serve, we may be unable to execute on our growth strategy and our business and financial statements could be adversely affected.
We have and are continuing to incorporate AI, including machine learning, in certain of our internal operations and may in the future incorporate AI into certain of our products and services, with the intent to enhance their operation and effectiveness.
We have and are continuing to incorporate artificial intelligence, including machine learning, in certain of our internal operations and into certain of our products and services, with the intent to enhance their operation and effectiveness.
Most of our products are medical devices subject to regulation by the U.S. Food and Drug Administration (the “FDA”), by other federal and state governmental agencies, by comparable agencies of other countries and regions, by certain accrediting bodies and by regulations governing hazardous materials (or the manufacture and sale of products containing any such materials).
Most of our products are medical devices subject to regulation by the FDA, by other federal and state governmental agencies, by comparable agencies of other countries and regions, by certain accrediting bodies and by regulations governing hazardous materials (or the manufacture and sale of products containing any such materials).
These provisions may also prevent or discourage attempts to remove and replace incumbent directors. 41 Our second amended and restated certificate of incorporation, as amended, designates the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us and our directors, officers, employees and stockholders.
Our second amended and restated certificate of incorporation, as amended, designates the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us and our directors, officers, employees and stockholders.
Section 203 provides that, subject to limited exceptions, persons that acquire, or are affiliated with a person that acquires, more than 15% of the outstanding voting stock of a Delaware corporation (an “interested stockholder”) shall not engage in any business combination with that corporation, including by merger, consolidation or acquisitions of additional shares, for a three-year period following the date on which the person became an interested stockholder, unless (i) prior to such time, the board of directors of such corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; (ii) upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of such corporation at the time the transaction commenced (excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) the voting stock owned by directors who are also officers or held in employee benefit plans in which the employees do not have a confidential right to tender or vote stock held by the plan); or (iii) on or subsequent to such time the business combination is approved by the board of directors of such corporation and authorized at a meeting of stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock of such corporation not owned by the interested stockholder.
Section 203 provides that, subject to limited exceptions, persons that acquire, or are affiliated with a person that acquires, more than 15% of the outstanding voting stock of a Delaware corporation (an “interested stockholder”) shall not engage in any business combination with that corporation, including by merger, consolidation or acquisitions of additional shares, for a three-year period following the date on which the person became an interested stockholder, unless (i) prior to such time, the board of directors of such corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; (ii) upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of such corporation at the time the transaction commenced (excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) the voting stock owned by directors who are also officers or held in employee benefit plans in which the employees do not have a confidential right to tender or vote stock held by the plan); or (iii) on or subsequent to such time the business combination is approved by the board of directors of such corporation and authorized at a meeting of stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock of such corporation not owned by the interested stockholder. 40 We believe these provisions will protect our stockholders from coercive or otherwise unfair takeover tactics by requiring potential acquirers to negotiate with our Board of Directors and by providing our Board of Directors with more time to assess any acquisition proposal.
Compliance with the varying data privacy regulations across the U.S. and around the world is complex and have required significant expenditures and may require additional expenditures and changes in our products or business models that increase complexity and competition.
Business—Regulatory Matters—Data Privacy and Security Laws.” Compliance with the varying data privacy regulations across the U.S. and around the world is complex and has required significant expenditures and may require additional expenditures and changes in our products or business models that increase complexity and competition.
However, these provisions will apply even if the offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board of directors determines is in the best interests of us and our stockholders.
These provisions are not intended to make us immune from takeovers. However, these provisions will apply even if the offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our Board of Directors determines is in the best interests of us and our stockholders.
For example, our corporate headquarters and many of our operations, including certain of our manufacturing facilities, are located in California, which is prone to earthquakes and wildfires, in addition to the other risks discussed above. In January 2025, several wildfires impacted Los Angeles County.
For example, our corporate headquarters and many of our operations, including certain of our manufacturing facilities, are located in California, which is prone to earthquakes and wildfires, in addition to the other risks discussed above.
Our failure to repurchase the Notes or to pay the cash amounts due upon conversion when required will constitute a default under the indentures governing the 2028 Convertible Notes and the 2025 Convertible Notes between us and Wilmington Trust, National Association, as trustee, dated as of August 10, 2023 and May 21, 2020, respectively.
Our failure to repurchase the Notes or to pay the cash amounts due upon conversion when required will constitute a default under the indenture governing the Notes between us and Wilmington Trust, National Association, as trustee, dated as of August 10, 2023.
From our IPO through February 7, 2025, the sales price of our common stock as reported by the NYSE has ranged from a low sales price of $10.08 on March 19, 2020 to a high sales price of $52.03 on March 29, 2022.
From our IPO through February 6, 2026, the sales price of our common stock as reported by the New York Stock Exchange or NYSE, has ranged from a low sales price of $10.08 on March 19, 2020 to a high sales price of $52.03 on March 29, 2022.
Any of these factors could result in production interruptions, delays, extended lead times and inefficiencies. The supply chains for our businesses have also been impacted by the COVID-19 related lockdowns in China and the Russia-Ukraine conflict. Failure to obtain the needed supply of these products or to offset the increased costs could adversely impact our operating results.
Any of these factors could result in production interruptions, delays, extended lead times and inefficiencies. The supply chains for our businesses have also been impacted by global conflicts, including the Russia-Ukraine war and the Israel-Hamas war. Failure to obtain the needed supply of these products or to offset the increased costs could adversely impact our operating results.
In addition, government enforcement actions can be costly and interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in fines, reputational damage and civil lawsuits, any of which may adversely affect our business, reputation and financial statements. 26 Our growing use of AI systems to automate processes and analyze data poses inherent risks.
In addition, government enforcement actions can be costly and interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in fines, reputational damage and civil lawsuits, any of which may adversely affect our business, reputation and financial statements.
We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness, which may not be successful and may adversely affect our ability to pay dividends (if we pay dividends in the future).
The risks described above will increase with the amount of indebtedness we incur, and in the future, we may incur significant indebtedness in addition to the indebtedness described above. 33 We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness, which may not be successful and may adversely affect our ability to pay dividends (if we pay dividends in the future).
We have a limited trading history and there may be wide fluctuations in the market value of our common stock as a result of many factors.
There may be wide fluctuations in the market value of our common stock as a result of many factors.
We continue to implement significant restructuring and site consolidation and centralization activities across our businesses to adjust our cost structure and to increase our operational efficiency, and we may engage in similar activities in the future.
Our restructuring and site consolidation actions could have long-term adverse effects on our business. We continue to implement significant restructuring and site consolidation and centralization activities across our businesses to adjust our cost structure and to increase our operational efficiency, and we may engage in similar activities in the future.
Our outsourcing relationships with third-parties involve access to certain of our sensitive information which may expose us to enhanced risks, attacks, and disruptions. 24 Data privacy and security laws relating to the handling of personal information (including personal health information) are evolving across the world and may be drafted, interpreted or applied in a manner that results in increased costs, legal claims, fines against us, reputational damage or impedes delivery.
Data privacy and security laws relating to the handling of personal information (including personal health information) are evolving across the world and may be drafted, interpreted or applied in a manner that results in increased costs, legal claims, fines against us, reputational damage or impedes delivery.
As of December 31, 2024, the net carrying value of our goodwill and other intangible assets totaled approximately $2.9 billion. In accordance with generally accepted accounting principles, we periodically assess these assets to determine if they are impaired.
Following the recording of $1.1 billion and $0.3 million in goodwill and indefinite-lived intangible assets impairment charges in 2024 and 2023, respectively, the net carrying value of our goodwill and other intangible assets totaled approximately $3.0 billion as of December 31, 2025. In accordance with generally accepted accounting principles, we periodically assess these assets to determine if they are impaired.
If we are unable to fully recover higher commodity costs through price increases or offset these increases through cost reductions, or if there is a time delay between the increase in costs and our ability to recover or offset these costs, our margins and profitability could decline and our financial statements could be adversely affected. 21 If we cannot adjust our manufacturing capacity or the purchases required for our manufacturing activities to reflect changes in market conditions and customer demand, our profitability may suffer.
If we are unable to fully recover higher commodity costs through price increases or offset these increases through cost reductions, or if there is a time delay between the increase in costs and our ability to recover or offset these costs, our margins and profitability could decline and our financial statements could be adversely affected.
Our subcontractors and vendor to whom we outsource our information technology systems are also subject to the requirements of data privacy and security laws, regulations, and controls.
Our subcontractors and vendors to whom we outsource our information technology systems are also subject to the requirements of data privacy and security laws, regulations, and controls. For a discussion of these data privacy and security laws and regulations, please refer to “Item 1.
The effects of climate-related risks could also impair the availability and cost of certain products, commodities and energy (including utilities), which in turn may impact our ability to procure goods or services required for the operation of our business at the quantities and levels we require.
The effects of climate-related risks could also impair the availability and cost of certain products, commodities and energy (including utilities), which in turn may impact our ability to procure goods or services required for the operation of our business at the quantities and levels we require. 32 The regulations surrounding greenhouse gas emissions disclosures and sustainability reporting have also continued to evolve, with compliance requirements varying by jurisdiction.
As a result, the amount of interest we may pay on our variable rate indebtedness is difficult to predict. Risks Related to Our Industry The industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, which could adversely affect our financial statements.
Risks Related to Our Industry The industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, which could adversely affect our financial statements.
Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Off-label marketing or misleading advertising of our products could result in substantial penalties.
Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Off-label marketing or misleading advertising of our products could result in substantial penalties. The FDA, the FTC and, in some cases, the EPA strictly regulate the promotional claims that may be made about approved or cleared products.
In addition, regulators, customers, investors, employees and other stakeholders are focusing more on environmental matters and related disclosures. These changing rules, regulations and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent meeting such regulations and expectations and complying with disclosure requirements.
These changing rules, regulations and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent meeting such regulations and expectations and complying with disclosure requirements.
We cannot predict the costs to comply with these laws or the costs associated with a potential data breach, which could have a material adverse effect on our business, results of operations, financial position and cash flows, and our business reputation.
We cannot predict the costs to comply with these laws or the costs associated with a potential data breach, which could have a material adverse effect on our business, results of operations, financial position and cash flows, and our business reputation. 25 We have installed privacy/security protection systems and devices on our network in an attempt to prevent cyberthreats and other unauthorized access to information.
All of these events or circumstances, among others, could have an adverse effect on our business, results of operations, financial position and cash flows, and they could harm our business reputation.
All of these events or circumstances, among others, could have an adverse effect on our business, results of operations, financial position and cash flows, and they could harm our business reputation. Our growing use of artificial intelligence systems to automate processes and analyze data poses inherent risks.
The levels of inventory maintained by our distributors and other channel partners, and changes in those levels, can also significantly impact our results of operations in any given period. In addition, the consolidation of distributors and customers in certain of our served industries could adversely impact our business and consolidated financial statements.
The levels of inventory maintained by our distributors and other channel partners, and changes in those levels, can also significantly impact our results of operations in any given period.
Complying with the EU MDR required modifications to our quality management systems, additional resources in certain functions, and required and will continue to require updates to technical files, among other changes. Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements.
Complying with the EU MDR required modifications to our quality management systems, additional resources in certain functions, and required and will continue to require updates to technical files, among other changes.
Additionally, if our business relationship with a third-party provider of information technology systems or services is negatively affected, or if one of our providers were to terminate its agreement with us without adequate notice, we would suffer a significant business disruption. 23 Any of the cyberattacks, breaches or other disruptions or damage described above could interrupt our operations or the operations of our customers, suppliers, partners or distributors; prevent order placement and fulfillment; delay production and shipments; result in theft of our and our customers’ intellectual property and trade secrets; damage customer, patient, business partner and employee relationships; harm our reputation; result in defective products or services; or lead to legal or regulatory claims, proceedings, liability and/or penalties.
Any of the cyberattacks, breaches or other disruptions or damage described above could interrupt our operations or the operations of our customers, suppliers, partners or distributors; prevent order placement and fulfillment; delay production and shipments; result in theft of our and our customers’ intellectual property and trade secrets; damage customer, patient, business partner and employee relationships; harm our reputation; result in defective products or services; or lead to legal or regulatory claims, proceedings, liability and/or penalties.
As of February 7, 2025, we had outstanding indebtedness of approximately $1.4 billion, including approximately $793.6 million under our Second Amended Credit Agreement, $489.9 million under our 2028 Convertible Notes, $116.1 million under our 2025 Convertible Notes (together with the 2028 Convertible Notes, the “Notes”), and had an additional $750.0 million of borrowing capacity under the revolving credit facility pursuant to the Second Amended Credit Agreement, with the ability to request further increases to the revolving credit facility up to the greater of consolidated EBITDA or $525.0 million.
As of February 6, 2026, we had outstanding indebtedness of approximately $1.5 billion, including approximately $960.6 million under our second amended credit agreement (the “Second Amended Credit Agreement”), $492.7 million under our 2028 Convertible Notes (the “Notes”), with an aggregate available borrowing capacity up to $750.0 million, with a maximum alternative currency sublimit of $675.0 million, under the revolving credit facility (the “Revolving Credit Facility”) pursuant to the Second Amended Credit Agreement, with the ability to request further increases up to the greater of consolidated EBITDA or $525.0 million.
We may conduct future offerings of our common stock, preferred stock or other securities that are convertible into or exercisable for our common stock to finance our operations or fund acquisitions, or for other purposes. In addition, we have reserved 20,656,197 shares of common stock for the exercise of stock options or vesting of restricted stock units.
We may conduct future offerings of our common stock, preferred stock or other securities that are convertible into or exercisable for our common stock to finance our operations or fund acquisitions, or for other purposes.
Similarly, under the Physician Payment Sunshine Act, we are required to collect and report detailed information regarding certain financial relationships we have with covered recipients, including physicians, dentists, teaching hospitals, and certain other non-physician practitioners.
Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements. 36 Similarly, under the Physician Payment Sunshine Act, we are required to collect and report detailed information regarding certain financial relationships we have with covered recipients, including physicians, dentists, teaching hospitals, and certain other non-physician practitioners.
In addition, the U.S. has recently implemented new tariffs on China and proposed to significantly increase tariffs on foreign imports into the U.S. from other countries, particularly from Canada and Mexico.
The U.S. has significantly increased tariffs on products imported from China into the U.S. and implemented new tariffs on imports into the U.S. from other countries, particularly from Canada, Mexico, and the EU.