Risk factor changes · ABT

What changed in Abbott Laboratories's risk factors

Item 1A (Risk Factors) of Abbott Laboratories's FY2025 10-K compared with its FY2024 10-K, sentence by sentence.

Newer: 10-K filed 2026-02-20 · Older: 10-K filed 2025-02-21

New in the latest 10-K 10

• A breach or unauthorized disclosure of protected personal information could result in adverse consequences, including regulatory inquiries or litigation, increased costs and expenses, reputational damage, lost revenue, and fines or penalties.
• Abbott plans to fund the Exact Sciences acquisition with approximately $20 billion of borrowings.
• Economic, Geopolitical and Industry Risks Changes in geopolitical and macroeconomic conditions could negatively affect Abbott s business, financial condition, and results of operations .
• As a global healthcare company with sales outside of the U.S. making up approximately 61 percent of Abbott s net sales in 2025, Abbott s business is subject to geopolitical and macroeconomic risks that are beyond its control.
• These risks include the enactment of trade protection measures such as tariffs, import or export licensing requirements, other governmental restrictions such as trade sanctions, and changes to international trade agreements; government actions such as price controls, limitations on participation in local enterprises, expropriation, and nationalization; restrictions on local currency conversion and/or cash extraction; changes in inflation (including the cost of raw materials, labor, commodities, and supplies) and interest rates; and fluctuations in foreign currency exchange rates.
• Abbott is also subject to other geopolitical risks, such as war, political and geopolitical instability, terrorist attacks and related military action. 12 Table of Contents For example, the global economy has been impacted by geopolitical tensions focused on trade, which has increased uncertainty for global businesses such as Abbott.
• The U.S. government has imposed tariffs on imports into the U.S., and it may impose additional tariffs in the future.
• Some countries may retaliate with trade protection measures, including reciprocal tariffs.
• These tariffs or other trade protection measures could have a negative impact on macroeconomic conditions, including inflation rates, foreign currency exchange rates, and interest rates, as well as causing potential disruptions to Abbott s global supply chain, which could adversely affect its business.
• Additionally, the ongoing Russia-Ukraine conflict has resulted in sanctions, economic and currency volatility, higher inflation, heightened cybersecurity risks, and operational and supply chain disruptions.

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Removed words are struck through; added words are highlighted.

• Abbott may not complete these transactions in a timely manner, on a cost-effective basis, or at all, and the expected benefits may not realize be realized or may not be realized within the expected benefits. time period.
• Abbott could also experience negative effects on its reported results of operations from acquisition or disposition-related charges, amortization of expenses related to intangibles intangible assets and charges for impairment of long-lived assets.
• In addition, third party third-party hacking attempts may cause Abbott s information systems and related products, protected data, or proprietary information to be compromised or stolen.
• A breach or unauthorized disclosure of protected personal information could result in adverse consequences, including regulatory inquiries or litigation, increased costs and expenses, reputational damage, lost revenue, and fines or penalties. 9 Table of Contents Abbott invests in its information systems and technology and in the protection of its products and data to reduce the risk of a cybersecurity incident or other significant disruption, and monitors its information systems on an ongoing basis for any current or potential cybersecurity threats or vulnerabilities and as well as for changes in technology and the regulatory environment.
• Similarly, there can be no assurance that third party third-party information technology providers or other partners with whom Abbott contracts will not suffer a significant cybersecurity incident or disruption that impacts Abbott.
• Any significant cybersecurity incident or other disruption affecting Abbott s information systems or products could have a material adverse effect on Abbott s business, financial condition and results of operations. 9 Table of Contents Abbott s research and development efforts to develop commercially successful products and technologies and its efforts to develop and maintain new business and operating models necessary to support data-driven healthcare solutions may not succeed, either of which may cause Abbott s revenue and profitability to decline.
• In addition, Abbott is developing new business and operating models necessary to support the creation of data-driven healthcare solutions such as data-centric prevention and treatment strategies, new products and technologies that incorporate data insights, and product technology strategies that focus on connectivity and data creation collection and management.
• In addition, third-party manufacturers and single suppliers are currently used for certain products and materials.
• To the extent that Abbott or one of its suppliers or manufacturers experiences significant manufacturing problems, this could have a material adverse effect on Abbott s revenues and profitability.
• Abbott has indebtedness, will incur additional indebtedness in connection with the Exact Sciences acquisition, which could adversely affect its business, including decreasing its business flexibility.
• As of December 31, 2024, 2025, Abbott's consolidated indebtedness was approximately $14.1 $12.9 billion.
• This increase in Abbott's consolidated indebtedness could have the effect, among other things, of reducing Abbott's flexibility to respond to changing business 10 Table of Contents and economic conditions, and reducing funds available for working capital, capital expenditures, acquisitions, and other general corporate purposes. conditions.
• Consequently, Abbott cannot assure that it will be able to obtain additional financing or refinancing on terms acceptable to Abbott or at all, which could adversely impact Abbott's ability to make scheduled payments with respect to its consolidated indebtedness and its profitability and financial condition. 10 Table of Contents Additionally, further borrowing could cause a deterioration of Abbott's credit ratings.
• These requirements include, among other things, regulations regarding manufacturing practices, testing requirements, product labeling, postmarket post-market changes to products, advertising, and postmarketing post-marketing reporting, including adverse event reports and field alerts.
• In addition, violations of these laws, or allegations of such 11 Table of Contents violations, could disrupt Abbott s business and result in a material adverse effect on Abbott s revenues, profitability, and financial condition.
• Both in the U.S. and internationally, government authorities may enact changes in regulatory requirements, make legislative or administrative reforms to existing reimbursement programs, make adverse decisions relating to Abbott s products coverage or reimbursement, or make changes to patient access to healthcare, all of which could adversely impact the demand for and usage of Abbott s products or the prices that Abbott s customers are willing to pay for them. 11 Table of Contents Further, in the U.S., a number of the provisions of the Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 address access to healthcare products and services.
• These provisions have been and may continue to be modified, expanded, repealed, or otherwise invalidated, in whole or in part.
• The expiration or loss of intellectual property protection and licenses may affect Abbott s future revenues and operating income. earnings.
• Although most of the challenges to Abbott s intellectual property have come from other companies, governments may also challenge or diminish intellectual property protections.
• To the extent that countries do not enforce Abbott s intellectual property rights, Abbott s future revenues and operating income earnings could be reduced.
• To the extent these cost containment efforts are not offset by greater patient access to healthcare or other factors, Abbott s future revenues and operating income earnings will be reduced.
• Resolving an intellectual property infringement claim can be costly and time 12 Table of Contents consuming and may require Abbott to enter into license agreements.
• Further, the development of new technology, technologies, including disruptive technologies such as artificial intelligence, healthcare products and medicines, and the development of new treatments for disease could significantly change the competitive landscape of the healthcare industry and negatively impact the demand for certain Abbott products.
• Abbott cannot predict with certainty the timing or impact of the introduction of competitors products and technological advances. advances on Abbott's results of operations.
• Sales outside of the U.S. in 2024 2025 made up approximately 61 percent of Abbott s net sales.
• While Abbott enters into hedging arrangements to mitigate some of its foreign currency exposure, Abbott cannot predict with any certainty changes in foreign currency exchange rates or its ability to mitigate these risks.
• Information on Abbott s hedging arrangements is contained in Note 12 to the consolidated financial statements in this report. 13 Table of Contents Adverse changes in tax laws, regulations or interpretations, both in the U.S. and internationally, could have a material adverse effect on Abbott s effective tax rate, financial condition and results of operations.
• Many other factors can affect Abbott s profitability and its financial condition, including: changes in or interpretations of laws and regulations, including changes in accounting standards, taxation requirements, product approval standards, product labeling standards, manufacturing standards, source and use laws, and environmental laws; differences between the fair value measurement of assets and liabilities and their actual value, particularly for pensions, retiree healthcare, stock compensation, intangibles, intangible assets, goodwill, and contingent consideration; and for contingent liabilities such as litigation, the absence of a recorded amount, or an amount recorded at the minimum, compared to the actual amount; changes in the rate of inflation (including the cost of raw materials, labor, commodities, and supplies), interest rates, market value of Abbott s equity investments, and the performance of investments held by Abbott or Abbott s employee benefit trusts; changes in the creditworthiness of counterparties that transact business with or provide services to Abbott or Abbott s employee benefit trusts; changes additional challenges of doing business internationally, including differing local product preferences and product requirements, difficulty in business, economic, establishing, staffing, and geopolitical conditions, including: war, political instability, terrorist attacks, the threat of future terrorist activity managing operations, and related military action; differing labor regulations; climate and public health-related events, including global climate change, extreme weather and natural disasters; disasters, public health crises such as widespread outbreaks of infectious diseases, and the cost and availability of insurance due to any of the foregoing events; labor disputes, strikes, slow-downs, or other forms of labor or union activity; activity, and pressure from third-party interest groups; changes in Abbott s business units and investments and changes in the relative and absolute contribution of each to earnings and cash flow resulting from evolving business strategies, and changing product mix; 14 Table of Contents changes in the buying patterns of a major distributor, retailer, wholesaler, or other customer resulting from buyer purchasing decisions, pricing, seasonality, or other factors, or other problems with licensors, suppliers, distributors, and business partners; and legal challenges, any of which could preclude or delay commercialization of products or adversely affect profitability, including claims asserting statutory or regulatory violations, and adverse litigation decisions. 14 Table of Contents CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This Form 10-K contains forward-looking statements that are based on management s current expectations, estimates, and projections.
• To date, Abbott has been able to manage these disruptions without material impact to its results of operations.
• However, it is difficult to predict the future implications and consequences of the situation conflict on local, regional regional, or global economies and Abbott s operations. operations Abbott is subject to cost containment efforts that could cause a reduction in future revenues and operating earnings.

Removed since the previous 10-K 22

• Any significant cybersecurity incident or other disruption affecting Abbott s information systems or products could have a material adverse effect on Abbott s business, financial condition and results of operations.
• Additionally, further borrowing could cause a deterioration of Abbott's credit ratings.
• For information on the impact of Abbott's voluntary recall and manufacturing stoppage, see the discussion in the Financial Review section in Item 7, Management s Discussion and Analysis of Financial Condition and Results of Operations, of this report.
• Further, in the U.S., a number of the provisions of the Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 address access to healthcare products and services.
• Any material litigation regarding Abbott s patents and trademarks is described in the section captioned Legal Proceedings.
• Economic, Geopolitical and Industry Risks Abbott is subject to cost containment efforts that could cause a reduction in future revenues and operating income.
• Information on Abbott s hedging arrangements is contained in Note 12 to the consolidated financial statements in this report.
• Abbott is subject to risks related to public health crises, such as widespread outbreaks of infectious diseases, which could have a material effect on Abbott s business, financial condition and results of operations.
• As a global healthcare company, public health crises, such as the widespread outbreaks of infectious diseases, may negatively impact certain Abbott's operations.
• Health concerns and significant changes in political or economic conditions caused by such outbreaks can cause, and during the COVID-19 pandemic caused, significant reductions in demand for certain products, increased difficulty in serving customers, disruptions to manufacturing and supply chains, and negative effects on certain of Abbott s operations as well as the operations of its suppliers, distributors and other third-party partners.
• Furthermore, such widespread outbreaks may impact, and during the COVID-19 pandemic impacted, the broader 13 Table of Contents economies of affected countries, including negatively impacting economic growth, the proper functioning of financial and capital markets, inflation rates, foreign currency exchange rates, and interest rates.
• For information on the impact that the COVID-19 pandemic had on Abbott s business, see the discussion in the Financial Review section in Item 7, Management s Discussion and Analysis of Financial Condition and Results of Operations, of this report.
• The international nature of Abbott s business subjects it to additional business risks that may cause its revenue and profitability to decline.
• Abbott s business is subject to risks associated with managing a global supply chain and doing business internationally.
• Sales outside of the United States in 2024 made up approximately 61 percent of Abbott s net sales.
• Additional risks associated with Abbott s international operations include: differing local product preferences and product requirements; trade protection measures, including tariffs, import or export licensing requirements, other governmental restrictions such as trade sanctions, and changes to international trade agreements; difficulty in establishing, staffing, and managing operations; differing labor regulations; potentially negative consequences from changes in or interpretations of tax laws; geopolitical and economic instability, including sovereign debt issues; restrictions on local currency conversion and/or cash extraction; price controls, limitations on participation in local enterprises, expropriation, nationalization, and other governmental action; inflation, recession, and fluctuations in interest rates; diminished protection of intellectual property; and potential penalties or other adverse consequences for violations of anti-corruption, anti-bribery, anti-competition, and other similar laws and regulations, including the Foreign Corrupt Practices Act and the U.K.
• Bribery Act.
• Events contemplated by these risks may, individually or in the aggregate, have a material adverse effect on Abbott s revenues and profitability.
• Many of these factors may manifest individually or collectively, such as Russia s invasion of Ukraine which resulted in political instability, sanctions, economic and currency volatility, inflation and other operational and supply disruptions.
• There could be additional sanctions, economic volatility, cybersecurity threats, political instability, transportation and other supply disruptions, as well as collection default or liquidity risks or limited availability of resources to conduct essential business processes that could have a material adverse impact to Abbott s operations and financial condition.
• The resolution and long-term impact of this matter are uncertain and difficult to predict.
• CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This Form 10-K contains forward-looking statements that are based on management s current expectations, estimates, and projections.

Source: SEC EDGAR filings, compared sentence by sentence by EdgarStack. Sentence matching is automated and may pair or split passages imperfectly; check the linked filings before relying on any passage. A software tool, not financial advice. Not affiliated with the U.S. Securities and Exchange Commission.