Labcorp Holdings's biggest risks in the FY2024 10-K
- Labcorp faces high regulatory exposure regarding laboratory-developed tests, pricing pressure from government healthcare programs, and stringent data security mandates.
The risks most specific to Labcorp Holdings
- Risks Related to Financial Matters
The Company’s level of indebtedness and debt service requirements could adversely affect the Company’s liquidity, results of operations and business
The Company has $6.2 billion in senior notes, including $1.0 billion payable within 12 months, and a $1.0 billion revolving credit facility.
- Risks Related to Financial Matters
The Company might not be able to engage in certain desirable capital-raising or strategic transactions
Capital-raising and strategic transactions are restricted to preserve the tax-free status of the Fortrea spin-off under Internal Revenue Code Sections 355 and 368.
- Risks Related to Technology and Cybersecurity
Cybersecurity incidents and unauthorized access to the Company's or its customers’ data could harm the Company’s reputation and adversely affect its business
The Company experienced a 2018 ransomware attack and faces ongoing unauthorized attempts to compromise cybersecurity controls and third-party vendor systems.
- Risks Related to Regulatory and Compliance Matters
U.S. Food and Drug Administration (FDA) regulation of laboratory-developed tests (LDTs) and regulation by other countries of diagnostic offerings could have a material adverse effect upon the Company’s business
FDA regulation of laboratory-developed tests and diagnostic offerings could materially and adversely affect the Company's business operations.
- Risks Related to Regulatory and Compliance Matters
marketing, distribution, and surveillance of diagnostics, and it regularly inspects and reviews the manufacturing processes and performance of diagnostics. Dx’s point-of-care testing devices are subject to regulation by the FDA
Historically, LDTs were offered under CLIA without FDA clearance, but shifting federal oversight introduces new compliance requirements and business risks.
- Risks Related to Financial Matters
The spin-off of Fortrea may not achieve the intended results
The June 30, 2023 spin-off of Fortrea poses ongoing risks, including potential failure to receive intended tax-free treatment.
- Risks Related to Regulatory and Compliance Matters
Failure to conduct animal research in compliance with animal welfare laws and regulations could result in sanctions and/or remedies against BLS and have a material adverse effect upon the Company
Preclinical animal research must comply with the U.S. Animal Welfare Act and other regulations, exposing the Company to sanctions if it fails to comply.
All 42 risk factors
Headings as the filing states them, in filing order.
Risks Related to the Company’s Business and Operations Including Global Economic and Geopolitical Factors
- 01General or macro-economic factors and significant fluctuations in economic conditions in the U.S. and globally may have a material adverse effect upon the Company
- 02Operations may be disrupted and adversely impacted by events beyond the Company’s control, including natural disasters, adverse weather, geopolitical events, public health crises, acts of terrorism, disruption to supply chain, and inaccessibility of natural resources
- 03An inability to attract, retain, and develop experienced and qualified personnel, including key management personnel, and increased personnel costs, could adversely affect the Company’s business
- 04A portion of the managed care fee-for-service revenues is collectible from patients in the form of deductibles, coinsurance and copayments. As patient cost-sharing continues to increase, the Company’s collections may be adversely impacted
- 05Changes in government regulation or in practices relating to the pharmaceutical, biotechnology, or medical device industries could decrease the need for certain services that BLS provides
- 06Increased competition, including price competition, could have an adverse effect on the Company’s revenues and profitability
- 07From time to time, manufacturers discontinue or recall reagents, test kits, or instruments used by the Company to perform laboratory testing. Such discontinuations or recalls could adversely affect the Company’s costs, testing volume and revenue
- 08Changes or disruption in services, supplies, or transportation provided by third parties have impacted and could continue to impact or adversely affect the Company’s business
- 09A failure to identify suitable acquisition targets and successfully close and integrate acquisitions could have a material adverse effect on the Company’s business objectives and its revenues and profitability
- 10Unfavorable labor environments, union strikes, work stoppages, union or works council negotiations, or failure to comply with labor or employment laws could adversely affect the Company’s operations and have a material adverse effect upon the Company’s business
- 11Continued and increased consolidation of pharmaceutical, biotechnology and medical device companies, health systems, physicians and other customers could adversely affect the Company’s business
- 12Damage or disruption to the Company’s facilities or operations therein could adversely affect the Company’s business
- 13The failure to establish, update, or perform to appropriate quality standards could adversely affect the Company’s business and reputation
Risks Related to Financial Matters
- 14The Company bears financial risk for contracts that, including for reasons beyond the Company’s control, may be underpriced, subject to cost overruns, delayed, or terminated or reduced in scope
- 15A significant increase in the Company’s days sales outstanding could have an adverse effect on the Company’s business, including its cash flow, by increasing its bad debt or decreasing its cash flow
- 16BLS’s revenues depend on the pharmaceutical, biotechnology and medical device industries
- 17Foreign currency exchange fluctuations could have an adverse effect on the Company’s business
- 18The Company’s uses of financial instruments to limit its exposure to interest rate and currency exchange fluctuations could expose it to risks and financial losses that may adversely affect the Company’s financial condition, liquidity and results of operations
- 19The Company’s level of indebtedness and debt service requirements could adversely affect the Company’s liquidity, results of operations and business
- 20The Company’s quarterly operating results may vary
- 21The Company might not be able to engage in certain desirable capital-raising or strategic transactions
- 22The spin-off of Fortrea may not achieve the intended results
Risks Related to Technology and Cybersecurity
- 23Failure to maintain the security of customer-related information or compliance with security requirements could damage the Company’s reputation with customers, cause it to incur substantial additional costs and become subject to litigation and enforcement actions
- 24Failure in the Company’s information technology systems or delays or failures in the development and implementation of new systems or updates or enhancements to existing systems could disrupt the Company’s operations or customer relationships
- 25Cybersecurity incidents and unauthorized access to the Company's or its customers’ data could harm the Company’s reputation and adversely affect its business
- 26The use of AI and machine learning tools in our operations and the services of our third-parties may introduce risks that could adversely affect our business, financial condition, and reputation
- 27Any cybersecurity incidents affecting the information technology systems of third parties that provide services to the Company could have a material adverse effect on the Company's operations
Risks Related to Regulatory and Compliance Matters
- 28Changes in payer regulations or policies, insurance regulations or approvals, or changes in laws, regulations, or policies in the U.S. or globally, including changes in their interpretation, may adversely affect the Company
- 29The Company could face significant monetary damages and penalties and/or exclusion from government programs if it violates anti-fraud and abuse laws
- 30If the Company and its third-party service providers do not comply with existing or new laws and regulations related to protecting the privacy and security of personal or health information, it could be subject to monetary fines, civil penalties, litigation, or criminal sanctions
- 31The Company’s international operations could subject it to additional risks and expenses that could adversely impact the business or results of operations
- 32International operations may increase the Company’s exposure to liabilities under applicable anti-corruption laws
- 33Increased regulations and restrictions on the import of research animals, limitations of supply of research animals, and actions of animal rights activists may have an adverse effect on the Company
- 34Animal populations may suffer diseases that can damage BLS’s inventory, harm its reputation, or result in other liability
- 35Failure to conduct animal research in compliance with animal welfare laws and regulations could result in sanctions and/or remedies against BLS and have a material adverse effect upon the Company
- 36U.S. Food and Drug Administration (FDA) regulation of laboratory-developed tests (LDTs) and regulation by other countries of diagnostic offerings could have a material adverse effect upon the Company’s business
- 37marketing, distribution, and surveillance of diagnostics, and it regularly inspects and reviews the manufacturing processes and performance of diagnostics. Dx’s point-of-care testing devices are subject to regulation by the FDA
- 38Views on matters relating to corporate responsibility and governance and the perception of the Company’s activities in these areas by stakeholders may impact the Company’s business and reputation
Risks Related to Legal Matters
- 39Adverse results in material litigation matters could have a material adverse effect upon the Company’s business
- 40The failure to successfully obtain, maintain, and enforce intellectual property rights and defend against challenges to the Company’s intellectual property rights could adversely affect the Company
- 41Changes in tax laws and regulations or the interpretation of such may have a significant impact on the financial position, results of operations, and cash flows of the Company
- 42Contract services in the drug development industry create liability risks
Other Labcorp Holdings 10-Ks
- FY2025 10-K risk factors40 risks5 new7 dropped28 reworded
Increased focus on evolving FDA regulations for laboratory-developed tests, including the impact of the final rule.
Filed Feb 24, 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.