Labcorp Holdings (LH) risk factors, FY2025 10-K

Labcorp Holdings's FY2025 10-K, filed Feb 24, 2026, lists 40 risk factors in 5 groups. Against the prior year's 42: 5 new, 7 dropped, 28 substantially reworded.

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Risk factors listed
405 groups
New this year
5vs 42 last year
Dropped
7since the prior 10-K
Substantially reworded
28of those kept
Section length
8k wordsItem 1A

What the changes say

  • Increased focus on evolving FDA regulations for laboratory-developed tests, including the impact of the final rule.

What changed since the prior 10-K

New

  • NewRisks Related to the Company’s Business and Operations

    Failure to develop or acquire licenses for new or improved testing technologies, or the Company’s customers using new technologies to replace offerings currently provided by the Company could adversely affect its business

    Failure to develop or acquire new testing technologies or licenses could cause customers to use competing offerings, hurting the business.

  • NewRisks Related to Financial Matters

    The Company’s quarterly results of operations may vary significantly from quarter to quarter making it harder to predict future results

    Quarterly results may vary significantly from quarter to quarter due to global economic changes, tariffs, and project delays, making future performance hard to predict.

  • NewRisks Related to Regulatory and Compliance Matters

    Government payers, including Medicare and Medicaid, and private insurers, such as MCOs, continue to implement measures to control healthcare costs, utilization, and delivery. These efforts include changes of reimbursement rates, coverage criteria, and administrative requirements

    Government and private payers continue implementing cost-control measures, such as PAMA Medicare reimbursement freezes and rate reductions, impacting diagnostic service payments.

  • NewRisks Related to Regulatory and Compliance Matters

    The Company’s diagnostic instruments, test kits, reagents, and point-of-care devices are subject to regulation by the FDA, which oversees their development, manufacturing, labeling, marketing, and performance. The FDA regularly inspects facilities and may take enforcement actions for noncompliance

    The FDA asserted authority to regulate laboratory-developed tests as medical devices, which could increase regulatory burdens and enforcement risks for noncompliant tests.

  • NewRisks Related to Regulatory and Compliance Matters

    Outside the U.S., the Company is subject to similar regulations, including the EU IVDR, which imposes classification, quality, and safety standards. Compliance with these evolving international frameworks may increase costs and affect the Company’s ability to support clinical trials and offer laboratory services

    International regulations like the EU IVDR and environmental, health, and safety laws increase compliance costs and operational risks.

Dropped

  • DroppedRisks Related to the Company’s Business and Operations Including Global Economic and Geopolitical Factors

    A 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

  • DroppedRisks Related to the Company’s Business and Operations Including Global Economic and Geopolitical Factors

    From 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

  • DroppedRisks Related to Financial Matters

    The Company’s quarterly operating results may vary

  • DroppedRisks Related to Financial Matters

    The spin-off of Fortrea may not achieve the intended results

    Increasing patient cost-sharing through deductibles, coinsurance, and copayments could adversely impact collections.

  • DroppedRisks Related to Technology and Cybersecurity

    Any 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

  • DroppedRisks 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

  • DroppedRisks 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

    Discontinuations or recalls of reagents, test kits, or instruments by manufacturers could affect costs and revenue.

Reworded

  • 100% rewrittenRisks Related to the Company’s Business and Operations

    Changes or disruption in services, supplies, or transportation provided by third parties have impacted, and could in the future materially impact, the Company’s operations and business

    Added specific mention of reagent and test kit recalls, alongside supply chain and transport disruptions from geopolitical instability and vendor noncompliance.

    Was: Changes 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

  • 100% rewrittenRisks Related to Regulatory and Compliance Matters

    Changes 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

    Expanded to cover broad global and domestic insurance and payer regulation changes, including PAMA timelines and claims edits.

  • 100% rewrittenRisks Related to Regulatory and Compliance Matters

    Animal populations may suffer diseases that can damage BLS’s inventory, harm its reputation, or result in other liability

    Clarified that BLS preclinical services rely on research animal populations and disease outbreaks can cause inventory loss and reputational damage.

  • 100% rewrittenRisks 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 on the Company

    Added specific penalties like license suspension and animal confiscation for failing to comply with the Animal Welfare Act.

    Was: 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

  • 99% rewrittenRisks Related to Financial Matters

    BLS’s revenues depend on R&D spending by companies in the pharmaceutical, biotechnology and medical device industries

    Updated to link BLS revenues directly to pharma and biotech R&D funding constraints and outsourcing trends.

    Was: BLS’s revenues depend on the pharmaceutical, biotechnology and medical device industries

  • 99% rewrittenRisks Related to Technology and Cybersecurity

    Failure in the information technology systems of the Company or its vendors and other third-party service providers, or newly acquired businesses, or delays or failures in the development and implementation of new systems or updates or enhancements to existing systems, could adversely affect the Company’s business

    Expanded IT system risks to explicitly include newly acquired businesses and third-party compliance with privacy and safety laws.

    Was: Failure 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

  • 99% rewrittenRisks Related to Technology and Cybersecurity

    The use of AI and machine learning tools in the Company’s operations and the services of third-parties may introduce risks that could adversely affect the Company’s business, financial condition, and reputation

    Added risks regarding AI tool obsolescence, emerging regulations, competitive disadvantages, and security vulnerabilities.

    Was: The 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

  • 97% rewrittenRisks Related to Regulatory and Compliance Matters

    The Company’s international operations could subject it to additional risks and expenses that could adversely impact the business or results of operations

    Expanded international risks to include foreign regulatory approval challenges, pricing, reimbursement, staffing, and intellectual property enforcement.

  • 96% rewrittenRisks 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

  • 96% rewrittenRisks Related to Regulatory and Compliance Matters

    The Company and its third-party service providers are subject to numerous federal, state, and international laws governing national security, and the privacy and security of personal and health information. Noncompliance may result in fines, penalties, litigation, or criminal sanctions

    Was: If 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

  • 96% rewrittenRisks Related to the Company’s Business and Operations

    Operations may be disrupted and adversely impacted by events beyond the Company’s control, including natural disasters, adverse weather, geopolitical events, public health crises, supply chain disruptions, and inaccessibility of natural resources

    Was: Operations 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

  • 96% rewrittenRisks Related to the Company’s Business and Operations

    Changes 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

  • 89% rewrittenRisks Related to Technology and Cybersecurity

    Failure 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

  • 89% rewrittenRisks Related to Financial Matters

    A significant increase in the Company’s days sales outstanding could have an adverse effect on the Company’s business, including by increasing its bad debt or decreasing its cash flow

    Was: A 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

  • 87% rewrittenRisks Related to Financial Matters

    The 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

  • 85% rewrittenRisks Related to Financial Matters

    The 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

  • 84% rewrittenRisks Related to Financial Matters

    Foreign currency exchange fluctuations could have an adverse effect on the Company’s business

  • 82% rewrittenRisks Related to Regulatory and Compliance Matters

    The Company could face significant monetary damages and penalties and/or exclusion from government programs if it violates anti-fraud and abuse laws

  • 79% rewrittenRisks Related to the Company’s Business and Operations

    Continued and increased consolidation of pharmaceutical, biotechnology and medical device companies, health systems, physicians and other customers could adversely affect the Company’s business

  • 78% rewrittenRisks 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

  • 75% rewrittenRisks Related to Legal Matters

    The 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

  • 66% rewrittenRisks Related to the Company’s Business and Operations

    An inability to attract, retain, and develop experienced and qualified personnel, including personnel in key roles and critical positions, and increased personnel costs, could adversely affect the Company’s business

    Was: An 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

  • 61% rewrittenRisks Related to Regulatory and Compliance Matters

    International operations may increase the Company’s exposure to liabilities under applicable anti-corruption laws

  • 59% rewrittenRisks Related to the Company’s Business and Operations

    General or macro-economic factors and significant fluctuations in economic conditions in the U.S. and globally may have a material adverse effect on the Company

    Was: General 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

  • 51% rewrittenRisks Related to the Company’s Business and Operations

    The failure to establish, update, or perform to appropriate quality standards could adversely affect the Company’s business and reputation

  • 45% rewrittenRisks Related to Financial Matters

    The Company might not be able to engage in certain desirable capital raising or strategic transactions as a result of the Spin-off and may not achieve its intended results

    Was: The Company might not be able to engage in certain desirable capital-raising or strategic transactions

  • 45% rewrittenRisks Related to the Company’s Business and Operations

    Increased competition, including price competition, could have an adverse effect on the Company’s revenues and profitability

  • 35% rewrittenRisks Related to Legal Matters

    Changes 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

All 40 risk factors

Headings as the filing states them, in filing order.

Risks Related to the Company’s Business and Operations

  1. 01General or macro-economic factors and significant fluctuations in economic conditions in the U.S. and globally may have a material adverse effect on the Company59% rewritten
  2. 02Operations may be disrupted and adversely impacted by events beyond the Company’s control, including natural disasters, adverse weather, geopolitical events, public health crises, supply chain disruptions, and inaccessibility of natural resources96% rewritten
  3. 03An inability to attract, retain, and develop experienced and qualified personnel, including personnel in key roles and critical positions, and increased personnel costs, could adversely affect the Company’s business66% rewritten
  4. 04Changes in government regulation or in practices relating to the pharmaceutical, biotechnology, or medical device industries could decrease the need for certain services that BLS provides96% rewritten
  5. 05Increased competition, including price competition, could have an adverse effect on the Company’s revenues and profitability45% rewritten
  6. 06Failure to develop or acquire licenses for new or improved testing technologies, or the Company’s customers using new technologies to replace offerings currently provided by the Company could adversely affect its businessNew
  7. 07Changes or disruption in services, supplies, or transportation provided by third parties have impacted, and could in the future materially impact, the Company’s operations and business100% rewritten
  8. 08A 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
  9. 09Unfavorable 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
  10. 10Continued and increased consolidation of pharmaceutical, biotechnology and medical device companies, health systems, physicians and other customers could adversely affect the Company’s business79% rewritten
  11. 11Damage or disruption to the Company’s facilities or operations therein could adversely affect the Company’s business
  12. 12The failure to establish, update, or perform to appropriate quality standards could adversely affect the Company’s business and reputation51% rewritten

Risks Related to Financial Matters

  1. 13The 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 scope87% rewritten
  2. 14A significant increase in the Company’s days sales outstanding could have an adverse effect on the Company’s business, including by increasing its bad debt or decreasing its cash flow89% rewritten
  3. 15BLS’s revenues depend on R&D spending by companies in the pharmaceutical, biotechnology and medical device industries99% rewritten
  4. 16Foreign currency exchange fluctuations could have an adverse effect on the Company’s business84% rewritten
  5. 17The 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 operations85% rewritten
  6. 18The Company’s level of indebtedness and debt service requirements could adversely affect the Company’s liquidity, results of operations, and business78% rewritten
  7. 19The Company’s quarterly results of operations may vary significantly from quarter to quarter making it harder to predict future resultsNew
  8. 20The Company might not be able to engage in certain desirable capital raising or strategic transactions as a result of the Spin-off and may not achieve its intended results45% rewritten

Risks Related to Technology and Cybersecurity

  1. 21Failure 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 actions89% rewritten
  2. 22Failure in the information technology systems of the Company or its vendors and other third-party service providers, or newly acquired businesses, or delays or failures in the development and implementation of new systems or updates or enhancements to existing systems, could adversely affect the Company’s business99% rewritten
  3. 23Cybersecurity incidents and unauthorized access to the Company's or its customers’ data could harm the Company’s reputation and adversely affect its business96% rewritten
  4. 24The use of AI and machine learning tools in the Company’s operations and the services of third-parties may introduce risks that could adversely affect the Company’s business, financial condition, and reputation99% rewritten

Risks Related to Regulatory and Compliance Matters

  1. 25Changes 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 Company100% rewritten
  2. 26Government payers, including Medicare and Medicaid, and private insurers, such as MCOs, continue to implement measures to control healthcare costs, utilization, and delivery. These efforts include changes of reimbursement rates, coverage criteria, and administrative requirementsNew
  3. 27The Company could face significant monetary damages and penalties and/or exclusion from government programs if it violates anti-fraud and abuse laws82% rewritten
  4. 28The Company and its third-party service providers are subject to numerous federal, state, and international laws governing national security, and the privacy and security of personal and health information. Noncompliance may result in fines, penalties, litigation, or criminal sanctions96% rewritten
  5. 29The Company’s international operations could subject it to additional risks and expenses that could adversely impact the business or results of operations97% rewritten
  6. 30International operations may increase the Company’s exposure to liabilities under applicable anti-corruption laws61% rewritten
  7. 31Increased 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 operations of BLS or the Company
  8. 32Animal populations may suffer diseases that can damage BLS’s inventory, harm its reputation, or result in other liability100% rewritten
  9. 33Failure 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 on the Company100% rewritten
  10. 34The Company’s diagnostic instruments, test kits, reagents, and point-of-care devices are subject to regulation by the FDA, which oversees their development, manufacturing, labeling, marketing, and performance. The FDA regularly inspects facilities and may take enforcement actions for noncomplianceNew
  11. 35Outside the U.S., the Company is subject to similar regulations, including the EU IVDR, which imposes classification, quality, and safety standards. Compliance with these evolving international frameworks may increase costs and affect the Company’s ability to support clinical trials and offer laboratory servicesNew
  12. 36Views 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

  1. 37Adverse results in material litigation matters could have a material adverse effect on the Company’s business
  2. 38The 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 Company75% rewritten
  3. 39Changes 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 Company35% rewritten
  4. 40Contract services in the drug development industry create liability risks

Other Labcorp Holdings 10-Ks

  • FY2024 10-K risk factors
    42 risks

    Labcorp faces high regulatory exposure regarding laboratory-developed tests, pricing pressure from government healthcare programs, and stringent data security mandates.

    Filed Feb 25, 2025

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.