Integra Lifesciences Holdings (IART) risk factors, FY2025 10-K

Integra Lifesciences Holdings's FY2025 10-K, filed Feb 26, 2026, lists 33 risk factors in 5 groups. Against the prior year's 36: 4 new, 7 dropped, 12 substantially reworded.

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Risk factors listed
335 groups
New this year
4vs 36 last year
Dropped
7since the prior 10-K
Substantially reworded
12of those kept
Section length
13k wordsItem 1A

What the changes say

  • Acclarent integration added Israeli R&D operations and expanded international regulatory and infrastructure exposure.

What changed since the prior 10-K

New

  • NewRISKS RELATING TO OUR BUSINESS

    We cannot guarantee that any of our acquisitions, investments or alliances will be successful

    Strategic acquisitions and alliances may fail to deliver expected synergies, cost savings, or sales growth.

  • NewRISKS RELATING TO OUR BUSINESS

    Our global business exposes us to certain operational, compliance and economic risks

    Expanding foreign operations, including the Acclarent R&D acquisition in Israel, exposes us to local regulatory and infrastructure hurdles.

  • NewRISKS RELATING TO OUR BUSINESS

    The current tensions in international trade and rising international political tensions and uncertainties may materially adversely affect our business, financial condition, and results of operations

    Tariff uncertainty and Section 232 investigations by the U.S. Department of Commerce on medical consumables threaten international trade.

  • NewRISKS RELATING TO OUR BUSINESS

    We rely on independent suppliers and third-party providers in our supply chain for raw materials, packaging materials and components, sterilization services, and some finished goods; we could experience inventory shortages if any of these suppliers encounter a manufacturing or distribution disruption

    Sole-source suppliers and third-party sterilization services create vulnerability to component defects and inventory shortages.

Dropped

  • DroppedRISKS RELATING TO OUR BUSINESS

    Any and all of the above factors could materially and adversely affect our levels of revenue and our profitability

  • DroppedRISKS RELATING TO OUR BUSINESS

    Matrix for total consideration of $45.0 million. These acquisitions added products to our plastic and reconstructive surgery, ENT, neurosurgery and complex wound management product portfolios and provides additional growth opportunities for our TT segment

  • DroppedRISKS RELATING TO OUR BUSINESS

    A significant portion of our current operations are conducted and located outside the United States, and our growth strategy involves expanding our existing foreign operations and entering into new foreign jurisdictions. We have significant manufacturing and distribution sites in North America, Europe, China and Japan

  • DroppedRISKS RELATING TO OUR BUSINESS

    Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results

  • DroppedRISKS RELATING TO OUR BUSINESS

    Lack of market acceptance for our products or market preference for technologies that compete with our products could reduce our revenues and profitability

    Growth through acquisitions risks costs and integration challenges.

  • DroppedRISKS RELATING TO OUR BUSINESS

    It could be difficult to replace some of our suppliers

    Matrix acquisition added $45 million in products and growth opportunities.

  • DroppedRISKS RELATED TO OUR REGULATORY ENVIRONMENT

    Our business and operations are subject to risks related to climate change

    International operations subject us to anti-bribery and trade laws.

Reworded

  • 99% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENT

    Environmental, social and corporate governance issues, including those related to climate change and sustainability, may have an adverse effect on our business, financial condition and results of operations and damage our reputation

    Expanded to detail specific ESG regulatory and compliance burdens, reporting system investments, and transition risks.

    Was: Environmental, social and corporate governance (ESG) issues, including those related to climate change and sustainability, may have an adverse effect on our business, financial condition and results of operations and damage our reputation

  • 67% rewrittenRISKS RELATING TO OUR BUSINESS

    We may have significant product liability exposure and our insurance may not cover all potential claims

    Removed extraneous macroeconomic and hospital liquidity text, keeping focus strictly on product liability and insurance.

  • 64% rewrittenRISKS RELATED TO TAX AND DEBT

    Changes in tax laws or exposures to additional tax liabilities could negatively impact the Company’s operating results

    Updated to reflect a G7 agreement exempting U.S. companies from certain Pillar Two global minimum tax elements.

  • 58% rewrittenRISKS RELATED TO CYBERSECURITY AND DATA PRIVACY

    Cybersecurity incidents or other disruptions to our information technology systems could adversely affect our business

    Maintained core dependency on information technology and third-party enterprise systems.

  • 55% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENT

    We are subject to stringent domestic and foreign medical device regulations and oversight and any adverse action may adversely affect our ability to compete in the marketplace and our financial condition and business operations

    Maintained description of rigorous FDA and foreign oversight on medical devices and combination products.

  • 44% rewritten

    The continuing worldwide macroeconomic and geopolitical uncertainty may adversely affect our business and prospects

    Added specific references to tariffs, countermeasures, import-export licensing, and armed conflict to macroeconomic risks.

  • 42% rewrittenRISKS RELATING TO OUR BUSINESS

    Our future financial results could be adversely affected by impairments or other charges

    Retained the standard annual impairment testing requirements for goodwill and intangible assets.

  • 41% rewrittenRISKS RELATED TO TAX AND DEBT

    Our leverage and debt service obligations could adversely affect our business

    Updated total consolidated external debt figure from $1.8 billion as of December 31, 2024, to $1.9 billion as of December 31, 2025.

  • 38% rewrittenRISKS RELATING TO OUR BUSINESS

    We may experience difficulties, delays, performance impact or unexpected costs from consolidation of facilities and transfer of manufacturing facilities

  • 35% rewrittenRISKS RELATING TO OUR BUSINESS

    Our operating results may fluctuate

  • 34% rewrittenRISKS RELATED TO CYBERSECURITY AND DATA PRIVACY

    Failure to comply with laws relating to the confidentiality of sensitive personal information or standards related to the transmission of electronic health data, including in international jurisdictions, may require us to make significant changes to our products, or incur penalties or other liabilities

    Was: Failure to comply with laws relating to the confidentiality of sensitive personal information or standards related to the transmission of electronic health data, may require us to make significant changes to our products, or incur penalties or other liabilities

  • 28% rewrittenRISKS RELATED TO OUR REGULATORY ENVIRONMENT

    Our medical device products are subject to reporting requirements and recalls, even after receiving regulatory clearance, approval or certification, which could harm our reputation, business and financial results

All 33 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01The continuing worldwide macroeconomic and geopolitical uncertainty may adversely affect our business and prospects44% rewritten

RISKS RELATING TO OUR BUSINESS

  1. 02Our operating results may fluctuate35% rewritten
  2. 03The industry and market segments in which we operate are highly competitive, and we may be unable to compete effectively with other companies
  3. 04Changes in the healthcare industry may require us to decrease the selling price for our products, may reduce the size of the market for our products, or may eliminate a market, any of which could have a negative impact on our financial performance
  4. 05We cannot guarantee that any of our acquisitions, investments or alliances will be successfulNew
  5. 06Our global business exposes us to certain operational, compliance and economic risksNew
  6. 07The current tensions in international trade and rising international political tensions and uncertainties may materially adversely affect our business, financial condition, and results of operationsNew
  7. 08Exchange rate fluctuations and foreign currency hedges could adversely affect our financial results
  8. 09Our future financial results could be adversely affected by impairments or other charges42% rewritten
  9. 10The guidance on long-lived assets requires that we assess the impairment of our long-lived assets, including finite-lived intangible assets, whenever events or changes in circumstances indicate that the carrying value may not be recoverable as measured by the sum of the expected future undiscounted cash flows
  10. 11We rely on independent suppliers and third-party providers in our supply chain for raw materials, packaging materials and components, sterilization services, and some finished goods; we could experience inventory shortages if any of these suppliers encounter a manufacturing or distribution disruptionNew
  11. 12The availability of amniotic tissue-based products depends upon, among other factors, the availability of tissue from human donors. Access to donated amniotic tissue could also be adversely impacted by regulatory changes or evolving public perceptions of the donor process
  12. 13We may experience difficulties, delays, performance impact or unexpected costs from consolidation of facilities and transfer of manufacturing facilities38% rewritten
  13. 14If any of our facilities or those of our suppliers were damaged and/or our manufacturing or business processes interrupted, we could experience lost revenues and our business could be seriously harmed
  14. 15We may have significant product liability exposure and our insurance may not cover all potential claims67% rewritten
  15. 16Our private label product lines depend significantly on key relationships with third parties, which we could be unable to establish and maintain

RISKS RELATED TO OUR REGULATORY ENVIRONMENT

  1. 17We are subject to stringent domestic and foreign medical device regulations and oversight and any adverse action may adversely affect our ability to compete in the marketplace and our financial condition and business operations55% rewritten
  2. 18Some of our activities may subject us to risks under federal and state laws prohibiting “kickbacks” and false or fraudulent claims
  3. 19Our medical device products are subject to reporting requirements and recalls, even after receiving regulatory clearance, approval or certification, which could harm our reputation, business and financial results28% rewritten
  4. 20The adoption of healthcare reform in the U.S. and initiatives sponsored by other governments may adversely affect our business, results of operations and/or financial condition
  5. 21Certain of our products contain materials derived from animal sources and may become subject to additional regulation
  6. 22We are subject to current and potential future requirements relating to protection of the environment, such as hazardous materials regulations, which may impose significant compliance or other costs on us
  7. 23Environmental, social and corporate governance issues, including those related to climate change and sustainability, may have an adverse effect on our business, financial condition and results of operations and damage our reputation99% rewritten
  8. 24If we do not retain our key personnel and attract and retain other highly skilled employees, our business could suffer

RISKS RELATED TO TAX AND DEBT

  1. 25We may have additional tax liabilities
  2. 26Changes in tax laws or exposures to additional tax liabilities could negatively impact the Company’s operating results64% rewritten
  3. 27Our leverage and debt service obligations could adversely affect our business41% rewritten

RISKS RELATED TO OUR INTELLECTUAL PROPERTY

  1. 28Our intellectual property rights may not provide meaningful commercial protection for our products, potentially enabling third parties to use our technology or very similar technology and could reduce our ability to compete in the market
  2. 29Our competitive position depends, in part, upon unpatented trade secrets, which we may be unable to protect
  3. 30Our success will depend partly on our ability to operate without infringing or misappropriating the proprietary rights of others
  4. 31We may be involved in lawsuits relating to our intellectual property rights and promotional practices, which may be expensive

RISKS RELATED TO CYBERSECURITY AND DATA PRIVACY

  1. 32Cybersecurity incidents or other disruptions to our information technology systems could adversely affect our business58% rewritten
  2. 33Failure to comply with laws relating to the confidentiality of sensitive personal information or standards related to the transmission of electronic health data, including in international jurisdictions, may require us to make significant changes to our products, or incur penalties or other liabilities34% rewritten

Other Integra Lifesciences Holdings 10-Ks

  • FY2024 10-K risk factors
    36 risks

    Acquisition-driven growth strategy carries integration and liability risks across multiple medical device portfolios.

    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.