Abbott Laboratories's biggest risks in the FY2024 10-K
- Abbott faces heavy reliance on its global supply chain and complex international markets, with 61 percent of net sales outside the U.S. in 2024.
- Heavy regulatory scrutiny from the FDA and pricing pressures dominate the risk profile alongside $14.1 billion in consolidated indebtedness.
The risks most specific to Abbott Laboratories
- Business and Operational Risks
Disruptions to Abbott’s global supply chain, which is large and complex, could negatively affect Abbott’s results of operations
Disruptions to Abbott's large and complex global supply chain could negatively affect results of operations.
- Business and Operational Risks
Abbott depends on sophisticated information systems and maintains protected personal data, and a significant cybersecurity incident or other disruption affecting these information systems or protected data could have a material adverse effect on Abbott’s business, financial condition and results of operations
A significant cybersecurity incident or disruption affecting Abbott's information systems and protected personal data could materially harm the business.
- Business and Operational Risks
The manufacture of many of Abbott's products is a highly exacting and complex process, and if Abbott or one of its suppliers or manufacturers encounters problems manufacturing products, Abbott’s business could suffer
Manufacturing problems caused by equipment malfunction, protocol failures, or supply chain issues could hurt Abbott's business due to strict regulatory requirements.
- Business and Operational Risks
Abbott has indebtedness, which could adversely affect its business, including decreasing its business flexibility
Abbott's consolidated indebtedness of approximately $14.1 billion as of December 31, 2024, could reduce business flexibility and working capital.
- Legal and Regulatory Risks
It is costly for Abbott to comply with numerous governmental regulations and to develop compliant products and processes, and consequences for non-compliance could have a material adverse effect on Abbott's revenues, profitability, cash flows, and financial condition
Complying with rigorous regulations from the FDA and international authorities is costly and time-consuming, and non-compliance could harm revenues.
- Legal and Regulatory Risks
Fluctuation in foreign currency exchange rates has adversely affected and may continue to adversely affect Abbott’s financial statements and its ability to realize projected sales and earnings
Fluctuations in foreign currency exchange rates can adversely affect financial statements, given that 61 percent of 2024 net sales were outside the U.S.
- Legal and Regulatory Risks
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
Changes in tax laws, such as the OECD two-pillared plan, could materially impact Abbott's effective tax rate and financial condition.
All 23 risk factors
Headings as the filing states them, in filing order.
Business and Operational Risks
- 01Disruptions to Abbott’s global supply chain, which is large and complex, could negatively affect Abbott’s results of operations
- 02Abbott may acquire other businesses, license rights to technologies or products, form alliances, or dispose of or spin-off businesses, which could cause it to incur significant expenses and could negatively affect profitability
- 03Abbott depends on sophisticated information systems and maintains protected personal data, and a significant cybersecurity incident or other disruption affecting these information systems or protected data could have a material adverse effect on Abbott’s business, financial condition and results of operations
- 04Abbott’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
- 05The manufacture of many of Abbott's products is a highly exacting and complex process, and if Abbott or one of its suppliers or manufacturers encounters problems manufacturing products, Abbott’s business could suffer
- 06Abbott has indebtedness, which could adversely affect its business, including decreasing its business flexibility
- 07and economic conditions, and reducing funds available for working capital, capital expenditures, acquisitions, and other general corporate purposes
Legal and Regulatory Risks
- 08It is costly for Abbott to comply with numerous governmental regulations and to develop compliant products and processes, and consequences for non-compliance could have a material adverse effect on Abbott's revenues, profitability, cash flows, and financial condition
- 09Laws and regulations affecting government benefit programs could impose new obligations on Abbott, require Abbott to change its business practices, and restrict its operations, which could result in a material adverse effect on Abbott's revenues, profitability, and financial condition
- 10Changes in the healthcare regulatory environment may adversely impact the demand for and price of Abbott’s products
- 11The expiration or loss of intellectual property protection and licenses may affect Abbott’s future revenues and operating income
- 12Significant safety concerns could arise for Abbott’s products, which could have a material adverse effect on Abbott’s revenues and financial condition
- 13Abbott is subject to cost containment efforts that could cause a reduction in future revenues and operating income
- 14Competitors’ intellectual property may prevent Abbott from selling its products or have a material adverse effect on Abbott’s future profitability and financial condition
- 15New products and technological advances by Abbott’s competitors may negatively affect Abbott’s results of operations
- 16Fluctuation in foreign currency exchange rates has adversely affected and may continue to adversely affect Abbott’s financial statements and its ability to realize projected sales and earnings
- 17Adverse 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
- 18Deterioration in the economic condition and credit quality of certain countries may negatively affect Abbott’s results of operations
- 19Abbott 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
- 20economies 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
- 21The international nature of Abbott’s business subjects it to additional business risks that may cause its revenue and profitability to decline
- 22Other factors can have a material adverse effect on Abbott’s future profitability and financial condition
- 23CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Other Abbott Laboratories 10-Ks
- FY2025 10-K risk factors20 risks2 new5 dropped4 reworded
Abbott plans about $20 billion of borrowing for the Exact Sciences acquisition, making leverage and refinancing more prominent risks.
Filed Feb 20, 2026
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.