LivaNova (LIVN) risk factors, FY2025 10-K

LivaNova's FY2025 10-K, filed Feb 25, 2026, lists 31 risk factors in 4 groups. Against the prior year's 30: 7 new, 6 dropped, 14 substantially reworded.

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Risk factors listed
314 groups
New this year
7vs 30 last year
Dropped
6since the prior 10-K
Substantially reworded
14of those kept
Section length
12k wordsItem 1A

What the changes say

  • LivaNova expanded risk disclosures regarding global trade tariffs, artificial intelligence integration, and shareholder activism.

What changed since the prior 10-K

New

  • NewRisks Relating to the Company’s Business and Operations

    Changes in global trade policies, including the imposition of tariffs, trade restrictions, export controls, sanctions, or other protectionist or retaliatory measures by the U.S. or other jurisdictions, may adversely affect LivaNova’s business, financial condition, and results of operations

    Tariffs, trade restrictions, and export controls on foreign-sourced Cardiopulmonary products from Italy and Germany or U.S.-made Neuromodulation products could increase costs and disrupt supply chains.

  • NewRisks Relating to the Company’s Business and Operations

    Failure to protect, maintain, or upgrade LivaNova’s IT systems or products, or safeguard against cybersecurity incidents, service disruptions, or data corruption could have a material adverse effect on LivaNova’s business, results of operations, financial condition and reputation

    Cybersecurity threats to IT systems, integrated software in medical products, and sensitive patient health data could disrupt operations and compromise confidential business information.

  • NewRisks Relating to the Company’s Business and Operations

    The incorporation and use of AI technologies may present risks and challenges that could adversely affect LivaNova’s business, operations, and reputation

    Using AI technologies to develop medical therapies carries risks of implementation failure, system malfunctions, data loss, and evolving regulatory challenges.

  • NewRisks Relating to the Company’s Business and Operations

    If LivaNova’s investments, alliances, acquisitions, or divestitures are unsuccessful, the Company may not realize the intended benefits

    Strategic investments, alliances, acquisitions, or divestitures like winding down non-core assets may fail to deliver intended benefits or integration challenges.

  • NewRisks Relating to the Company’s Business and Operations

    Shareholder activism and increased investor engagement could divert management’s attention, disrupt the Company’s operations, and adversely affect the business and share price

    Activist investors and proxy contests could divert management attention, cause executive distraction, and create ordinary share price volatility.

  • NewRisks Related to LivaNova’s Indebtedness

    LivaNova may not have sufficient cash flow from its business operations to pay when due, or be able to raise the funds necessary to pay when due, amounts owed with respect to LivaNova’s indebtedness, which could adversely affect LivaNova’s business and results of operations

    Insufficient cash flow from operations could impair LivaNova's ability to service or refinance outstanding debt, revolving credit facilities, and term loans.

  • NewRisks Related to LivaNova’s Indebtedness

    The effective interest rate of the 2029 Notes is significantly greater than the stated interest rate, which may result in volatility to the Company’s reported interest expense and financial results and could adversely affect the price at which LivaNova’s ordinary shares trade

    The 2029 Notes create an original issue discount amortized as interest expense, resulting in an effective interest rate higher than the stated rate.

Dropped

  • DroppedRisks Relating to the Company’s Business and Operations

    Cybersecurity incidents or other disruptions to LivaNova’s information technology systems could lead to reduced revenue, increased costs, liability claims, regulatory fines, litigation, harm to LivaNova’s competitive position, and loss of reputation

  • DroppedRisks Relating to the Company’s Business and Operations

    expensive to obtain, and LivaNova cannot be certain that the Company’s current levels of insurance will be available in the future on economically reasonable terms

  • DroppedRisks Relating to the Company’s Business and Operations

    LivaNova’s research and development efforts rely upon investments and investment collaborations, and the Company cannot guarantee that any previous or future investments or investment collaborations will be successful

    General cybersecurity incidents and remote work IT dependencies.

  • DroppedRisks Relating to the Company’s Business and Operations

    If LivaNova’s business development and restructuring activities are unsuccessful, the Company may not realize the intended benefits

    Specific 2023 cybersecurity incident investigation and insurance availability.

  • DroppedLegal, Regulatory, and Compliance Risks

    Company’s technology, and may limit LivaNova’s competitive advantage. Third parties could obtain patents that may require LivaNova to negotiate licenses to conduct business, and the required licenses may not be available on reasonable terms or at all

  • DroppedRisks Relating to Tax and LivaNova’s Jurisdiction of Incorporation

    The transferee generally pays the UK stamp duty or SDRT, although the position may be different in the case of a transfer to a depository or into a clearance service. The potential for UK stamp duty or SDRT could adversely affect the trading price of LivaNova’s shares

    General reliance on research and development investment collaborations.

Reworded

  • 99% rewrittenRisks Relating to the Company’s Business and Operations

    Failure to comply with U.S. and international product-related regulatory requirements could have a material adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition

    Updated to explicitly reference the EU Medical Device Regulation (MDR) alongside FDA compliance and audit standards.

    Was: Failure to comply with product-related government regulations may materially adversely affect LivaNova’s business, results of operations, cash flows, and financial condition

  • 81% rewrittenRisks Related to LivaNova’s Indebtedness

    The conditional conversion feature of the 2029 Notes, if triggered, may adversely affect LivaNova’s liquidity and operating results

    Removed references to the expired 2025 Notes and updated 2029 Notes conversion conditions and dates.

    Was: The conditional exchange or conversion features of the 2025 Notes and 2029 Notes, as applicable, if triggered, may adversely affect LivaNova’s liquidity and operating results

  • 56% rewrittenRisks Relating to Tax and LivaNova’s Jurisdiction of Incorporation

    Transfers of LivaNova’s shares, other than those effected by means of the transfer of book-entry interests in DTC, may be subject to UK Stamp Duty or SDRT

    Added explicit mention that the transferee generally pays UK stamp duty or SDRT, which could affect share trading prices.

  • 49% rewrittenLegal, Regulatory, and Compliance Risks

    As a manufacturer of medical devices, LivaNova is exposed to product liability claims that could adversely affect its consolidated financial condition and tarnish the Company’s reputation

    Updated product liability risk terminology from physician misuse to healthcare professional misuse.

  • 46% rewrittenRisks Related to LivaNova’s Indebtedness

    The arbitrage or hedging strategy by purchasers of the 2029 Notes and Option Counterparties in connection with LivaNova’s 2029 Capped Calls may affect the value of LivaNova’s ordinary shares

    Removed references to the expired 2025 Notes and added mention of the 2029 Capped Calls.

    Was: The arbitrage or hedging strategy by purchasers of the 2025 Notes and 2029 Notes and Option Counterparties in connection with LivaNova’s 2025 Capped Calls and 2029 Capped Calls may affect the value of LivaNova’s ordinary shares

  • 43% rewrittenRisks Relating to the Company’s Business and Operations

    The global medical device industry is highly competitive, and LivaNova may be unable to compete effectively

    Added specific R&D resource allocation, AI capabilities, and talent retention as factors influencing competitive success.

  • 34% rewrittenRisks Relating to the Company’s Business and Operations

    LivaNova is subject to the risks of conducting business globally

    Expanded global risk factors to include uncertainties around changing trade agreements, tariffs, and cross-border trade restrictions.

    Was: LivaNova is subject to the risks of conducting business internationally

  • 33% rewrittenRisks Relating to the Company’s Business and Operations

    Public health crises have had, and may continue to have, an adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition, the nature and extent of which are uncertain and unpredictable

    Removed specific references to the COVID-19 pandemic stabilization while retaining generic public health crisis risks.

  • 33% rewrittenLegal, Regulatory, and Compliance Risks

    Inadequate funding for U.S. federal government agencies and government shutdowns could negatively affect LivaNova’s business, results of operations, cash flows, and financial condition

  • 27% rewrittenRisks Relating to the Company’s Business and Operations

    LivaNova’s products are subject to complex laws and regulations, and failure to obtain or maintain product approvals, clearance, or reimbursement may have a material adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition

    Was: LivaNova’s products are subject to complex laws and regulations, and failure to obtain product approvals, clearance, or reimbursement may materially adversely affect LivaNova’s business, results of operations, cash flows, and financial condition

  • 26% rewrittenRisks Relating to Tax and LivaNova’s Jurisdiction of Incorporation

    Changes in tax laws or exposure to additional income tax liabilities could have a material adverse effect on LivaNova’s results of operations and financial condition

    Was: Changes in tax laws or exposure to additional income tax liabilities could have a material impact on LivaNova’s results of operations and financial condition

  • 22% rewrittenRisks Relating to the Company’s Business and Operations

    Reductions and interruptions in LivaNova’s supply chain have had, and may continue to have, adverse effects on LivaNova’s business, results of operations, cash flows, and financial condition

  • 21% rewrittenRisks Related to LivaNova’s Indebtedness

    Any failure by LivaNova to make required payments in respect of its indebtedness (after any applicable grace period) would constitute an event of default in respect of such indebtedness

  • 20% rewrittenRisks Relating to the Company’s Business and Operations

    Quality issues with LivaNova’s processes, products, and services could harm the Company’s reputation for producing high-quality products and erode LivaNova’s competitive advantage, revenue, and market share

All 31 risk factors

Headings as the filing states them, in filing order.

Risks Relating to the Company’s Business and Operations

  1. 01LivaNova is subject to the risks of conducting business globally34% rewritten
  2. 02Changes in global trade policies, including the imposition of tariffs, trade restrictions, export controls, sanctions, or other protectionist or retaliatory measures by the U.S. or other jurisdictions, may adversely affect LivaNova’s business, financial condition, and results of operationsNew
  3. 03Reductions and interruptions in LivaNova’s supply chain have had, and may continue to have, adverse effects on LivaNova’s business, results of operations, cash flows, and financial condition22% rewritten
  4. 04Failure to protect, maintain, or upgrade LivaNova’s IT systems or products, or safeguard against cybersecurity incidents, service disruptions, or data corruption could have a material adverse effect on LivaNova’s business, results of operations, financial condition and reputationNew
  5. 05The global medical device industry is highly competitive, and LivaNova may be unable to compete effectively43% rewritten
  6. 06The incorporation and use of AI technologies may present risks and challenges that could adversely affect LivaNova’s business, operations, and reputationNew
  7. 07If LivaNova’s investments, alliances, acquisitions, or divestitures are unsuccessful, the Company may not realize the intended benefitsNew
  8. 08The continuing development of many of LivaNova’s products depends upon the Company maintaining appropriate working relationships with healthcare professionals
  9. 09Quality issues with LivaNova’s processes, products, and services could harm the Company’s reputation for producing high-quality products and erode LivaNova’s competitive advantage, revenue, and market share20% rewritten
  10. 10If LivaNova’s marketed medical devices are defective or otherwise pose safety risks, the FDA and similar non-U.S. governmental authorities could require their recall or initiate an enforcement action, or LivaNova could initiate a recall of the Company’s products or stop sales of products voluntarily
  11. 11Failure to comply with U.S. and international product-related regulatory requirements could have a material adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition99% rewritten
  12. 12LivaNova’s success depends on its employees and the Company’s ability to attract and retain employees, succession plan, and successfully negotiate with local works councils
  13. 13LivaNova’s products are subject to complex laws and regulations, and failure to obtain or maintain product approvals, clearance, or reimbursement may have a material adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition27% rewritten
  14. 14Global healthcare policy changes may have a material adverse effect on LivaNova’s business, results of operations, financial condition, and cash flows
  15. 15Failure to comply with anti-bribery laws could have a material adverse effect on LivaNova’s business and result in civil and/or criminal sanctions
  16. 16The impact of pending or existing climate change may have a material adverse effect on LivaNova’s future operations
  17. 17LivaNova may incur impairments of intangible assets, goodwill, and other long-lived assets that may adversely affect the Company’s financial results
  18. 18Public health crises have had, and may continue to have, an adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition, the nature and extent of which are uncertain and unpredictable33% rewritten
  19. 19Shareholder activism and increased investor engagement could divert management’s attention, disrupt the Company’s operations, and adversely affect the business and share priceNew

Legal, Regulatory, and Compliance Risks

  1. 20As a manufacturer of medical devices, LivaNova is exposed to product liability claims that could adversely affect its consolidated financial condition and tarnish the Company’s reputation49% rewritten
  2. 21Inadequate funding for U.S. federal government agencies and government shutdowns could negatively affect LivaNova’s business, results of operations, cash flows, and financial condition33% rewritten

Risks Related to LivaNova’s Indebtedness

  1. 22LivaNova may not have sufficient cash flow from its business operations to pay when due, or be able to raise the funds necessary to pay when due, amounts owed with respect to LivaNova’s indebtedness, which could adversely affect LivaNova’s business and results of operationsNew
  2. 23Any failure by LivaNova to make required payments in respect of its indebtedness (after any applicable grace period) would constitute an event of default in respect of such indebtedness21% rewritten
  3. 24The conditional conversion feature of the 2029 Notes, if triggered, may adversely affect LivaNova’s liquidity and operating results81% rewritten
  4. 25The effective interest rate of the 2029 Notes is significantly greater than the stated interest rate, which may result in volatility to the Company’s reported interest expense and financial results and could adversely affect the price at which LivaNova’s ordinary shares tradeNew
  5. 26The arbitrage or hedging strategy by purchasers of the 2029 Notes and Option Counterparties in connection with LivaNova’s 2029 Capped Calls may affect the value of LivaNova’s ordinary shares46% rewritten
  6. 27The Option Counterparties are financial institutions, and LivaNova is subject to the risk that they might default under the 2029 Capped Calls. LivaNova’s exposure to the credit risk of the Option Counterparties is not secured by any collateral

Risks Relating to Tax and LivaNova’s Jurisdiction of Incorporation

  1. 28LivaNova is incorporated in England and Wales and governed by their laws, which may afford less protection to shareholders than under U.S. laws
  2. 29Changes in tax laws or exposure to additional income tax liabilities could have a material adverse effect on LivaNova’s results of operations and financial condition26% rewritten
  3. 30As a public limited company incorporated under the laws of England and Wales, certain LivaNova capital structure decisions require shareholder approval, which may limit the Company’s flexibility to manage its capital structure
  4. 31Transfers of LivaNova’s shares, other than those effected by means of the transfer of book-entry interests in DTC, may be subject to UK Stamp Duty or SDRT56% rewritten

Other LivaNova 10-Ks

  • FY2024 10-K risk factors
    30 risks

    Medical device maker faces heavy regulatory, cybersecurity, and supply chain dependencies globally.

    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.