Globus Medical (GMED) risk factors, FY2025 10-K

Globus Medical's FY2025 10-K, filed Feb 24, 2026, lists 60 risk factors in 7 groups. Against the prior year's 82: 3 new, 25 dropped, 18 substantially reworded.

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Risk factors listed
607 groups
New this year
3vs 82 last year
Dropped
25since the prior 10-K
Substantially reworded
18of those kept
Section length
22k wordsItem 1A

What the changes say

  • Globus added risks concerning FDA medical device approvals, human tissue supply limitations for biologics, and product liability exposure.
  • Tariff risks were updated following the Supreme Court ruling striking down certain 2025 import tariffs.
  • Integration risk disclosures expanded to include both the NuVasive and Nevro mergers.

What changed since the prior 10-K

New

  • NewRisks Related to our Legal and Regulatory Environment

    novo classification, or approvals through the PMA process to market a medical device in the U.S. or internationally can be costly and time-consuming, and we may not be able to obtain these clearances, grants of de novo classification, or approvals on a timely basis, if at all

    Stricter FDA premarket clearance or PMA requirements for products like SECURE-C, Simplify, and Senza could delay sales.

  • NewRisks Related to our Legal and Regulatory Environment

    render for us, our business could be materially adversely affected. In addition, there is similar legislation in Europe and the UK which we must abide by, including Directive 2004/23/EC in relation to human tissues and cells requiring that donation be unpaid (except for expenses and inconvenience) and voluntary

    Fewer than five third-party suppliers provide allograft implants, and seasonal mortality changes cause human tissue shortages.

  • NewRisks Related to our Intellectual Property and Potential Litigation

    unsafe condition or injury to patients. The medical devices industry has been particularly prone to potential product liability claims that are inherent in the testing, manufacture and sale of medical devices and products for surgery procedures

    Product liability claims or recalls involving tissue damage or motor impairment could exceed insurance and harm finances.

Dropped

  • DroppedRisks Related to Our Business and Our Industry

    Our sales and operating results may be negatively affected and we may not grow if we are unable to compete successfully

  • DroppedRisks Related to Our Business and Our Industry

    The increasing utilization of artificial intelligence (“AI”) in the medical device and healthcare industries presents novel obstacles and risks to our business

  • DroppedRisks Related to our Legal and Regulatory Environment

    We are subject to environmental laws and regulations that can impose significant costs and expose us to potential financial liabilities

  • DroppedRisks Related to our International Operations

    Our results of operations could suffer if we are unable to manage our planned international expansion effectively

  • DroppedRisks Related to Our Business and Our Industry

    the time commitment that may be required for training

  • DroppedRisks Related to Our Business and Our Industry

    with the surgeons they serve. If our direct sales representatives or independent distributors fail to adequately promote, market and sell our products, our sales could significantly decrease

  • DroppedRisks Related to Our Business and Our Industry

    greater ability to cross-sell their products or to incentivize hospitals or surgeons to use their products

  • DroppedRisks Related to Our Business and Our Industry

    Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel

  • DroppedRisks Related to Our Business and Our Industry

    obtain the necessary regulatory clearances or approvals for new products or product enhancements

  • DroppedRisks Related to Our Business and Our Industry

    increased legal and accounting compliance costs

  • DroppedRisks Related to Our Business and Our Industry

    our research and development data

  • DroppedRisks Related to Our Business and Our Industry

    computer systems, or Internet, telecommunications or data network failures

  • DroppedRisks Related to our Legal and Regulatory Environment

    product import and export

  • DroppedRisks Related to our Legal and Regulatory Environment

    the manufacturing process or facilities we use may not meet applicable requirements

  • DroppedRisks Related to our International Operations

    political, social and economic instability and increased security concerns

  • DroppedRisks Related to our Financial Results and Need for Financing

    our ability to expand the geographic reach of our sales and marketing efforts

  • DroppedRisks Related to our Financial Results and Need for Financing

    We have a significant amount of outstanding indebtedness, and our financial condition and results of operations could be adversely affected if we do not effectively manage our liabilities

  • DroppedRisks Related to our Financial Results and Need for Financing

    unanticipated general and administrative expenses

  • DroppedRisks Related to our Intellectual Property and Potential Litigation

    attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all

  • DroppedRisks Related to the Ownership of our Class A Common Stock

    If we fail to properly manage our anticipated growth, our business could suffer

  • DroppedRisks Relating to the Integration of NuVasive

    Integrating the NuVasive business into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of the NuVasive Merger, which may adversely affect the Company’s business results and negatively affect the value of the Company’s common stock

  • DroppedRisks Relating to the Integration of NuVasive

    effecting actions that may be required in connection with obtaining regulatory or other governmental approvals

  • DroppedRisks Relating to the Integration of NuVasive

    The Company expects to incur substantial expenses related to the integration of NuVasive and may be unable to realize the anticipated synergies, which could adversely affect the Company’s business, financial condition and results of operations

  • DroppedRisks Relating to the Integration of NuVasive

    Certain contractual counterparties may seek to modify contractual relationships with the Company, which could have an adverse effect on the Company’s business and operations

  • DroppedRisks Relating to the Integration of NuVasive

    The Company may be exposed to increased litigation, which could have an adverse effect on the Company’s business and operations

Reworded

  • 100% rewrittenRisks Relating to Our Acquisitions

    Integrating acquired businesses into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of such acquisitions, which may adversely affect the Company’s business results and negatively affect the value of the Company’s Class A common stock

    Expanded to cover integration risks and synergy realization for both the NuVasive and Nevro mergers.

    Was: Integrating the NuVasive business into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of the NuVasive Merger, which may adversely affect the Company’s business results and negatively affect the value of the Company’s common stock

  • 93% rewrittenRisks Related to Our Business and Our Industry

    If we are unable to maintain and expand our network of direct sales representatives and independent distributors, we may not be able to generate anticipated sales

    Added specific warnings that the loss of direct sales representatives or independent distributors could significantly decrease sales.

  • 79% rewrittenRisks Related to Our Business and Our Industry

    If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected

    Detailed specific IT system vulnerabilities including natural disasters, cyberattacks, human errors, and telecommunications failures.

  • 78% rewrittenRisks Related to our International Operations

    Tariff policies and potential countermeasures have and may continue to increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations

    Updated to reflect the U.S. Supreme Court's February 2026 ruling striking down certain 2025 tariff impositions while noting ongoing tariff volatility.

    Was: Tariff policies and potential countermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations

  • 77% rewrittenRisks Related to Our Business and Our Industry

    PODs are medical device distributors that are owned, directly or indirectly, by physicians. These physicians derive a proportion of their revenue from selling or arranging for the sale of medical devices for use in procedures at hospitals that agree to purchase from or through the POD

    Retained physician-owned distributorships risk text while re-indexing the disclosure.

  • 75% rewrittenRisks Related to the Ownership of our Class A Common Stock

    Our amended and restated certificate of incorporation and amended and restated bylaws (the “Bylaws”) contain other provisions that could delay or prevent a change of control of the Company or changes in our Board that our stockholders might consider favorable

    Updated corporate takeover defense references to apply generally to the Company rather than specific share classes.

    Was: Our amended and restated certificate of incorporation and amended and restated bylaws contain other provisions that could delay or prevent a change of control of our company or changes in our Board that our stockholders might consider favorable

  • 73% rewrittenRisks Related to Our Business and Our Industry

    If we do not enhance our existing product offerings and introduce new products through our research and development and product development efforts, we may be unable to effectively compete

    Added obtaining necessary regulatory clearances for new products as a core factor for successful product introductions.

  • 71% rewrittenRisks Related to our Legal and Regulatory Environment

    Governmental regulation and limited sources and suppliers could restrict our procurement and use of tissue

    Retained National Organ Transplant Act restrictions on human bone tissue procurement without substantive textual changes.

  • 67% rewrittenRisks Related to the Ownership of our Class A Common Stock

    The widespread outbreak of a communicable disease, or any other public health crisis, could adversely affect our financial condition and results of operations

    Was: We could be negatively affected by the widespread outbreak of a communicable disease, or any other public health crisis that results in disruptions to hospitals and other healthcare facilities

  • 66% rewrittenRisks Related to Our Business and Our Industry

    Many of our current and potential competitors are major medical device companies that have substantially greater financial, technical and marketing resources than we do, and they may succeed in developing products that would render our products obsolete or non-competitive

  • 65% rewrittenRisks Related to our Legal and Regulatory Environment

    Our medical device products and operations are subject to extensive governmental regulation both in the U.S. and abroad, and our failure to comply with applicable requirements could cause our business to suffer

  • 63% rewrittenRisks Relating to Our Acquisitions

    We have and may continue seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us

    Was: We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us

  • 62% rewrittenRisks Related to our Intellectual Property and Potential Litigation

    We may incur product liability losses and insurance coverage may be inadequate or unavailable to cover these losses

  • 59% rewrittenRisks Related to our Intellectual Property and Potential Litigation

    Patent litigation is highly prevalent in the medical device industry, and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from marketing our existing or future products

    Was: The medical device industry is characterized by patent litigation and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from marketing our existing or future products

  • 58% rewrittenRisks Related to our Financial Results and Need for Financing

    Our quarterly and annual operating results may fluctuate significantly

  • 58% rewrittenRisks Related to our Financial Results and Need for Financing

    Our future capital needs are uncertain, and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all

  • 37% rewrittenRisks Related to Our Business and Our Industry

    The increasing utilization of AI in the medical device and healthcare industries presents novel obstacles and risks to our business

  • 29% rewrittenRisks Related to the Ownership of our Class A Common Stock

    Because of their significant stock ownership, our Executive Chairman, our other executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions

    Was: Because of their significant stock ownership, our Executive Chairman, our chief executive officer, our other executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions

All 60 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Our Industry

  1. 01To be commercially successful, we must convince surgeons and hospitals that our products are an attractive alternative to our competitors’ products and that our Enabling Technologies and Musculoskeletal Solutions products are an attractive alternative to existing surgical treatments of musculoskeletal disorders
  2. 02Pricing pressure from our competitors and our customers may impact our ability to sell our products at prices necessary to support our current business strategies
  3. 03If our hospital and other healthcare provider customers are unable to obtain adequate coverage and reimbursement for their purchases of our Musculoskeletal Solutions products, we may not be able to sell our Musculoskeletal Solutions products at prices necessary to maintain our profitability or at all
  4. 04If we are unable to maintain and expand our network of direct sales representatives and independent distributors, we may not be able to generate anticipated sales93% rewritten
  5. 05We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales, operating results, and growth may be negatively affected
  6. 06Many of our current and potential competitors are major medical device companies that have substantially greater financial, technical and marketing resources than we do, and they may succeed in developing products that would render our products obsolete or non-competitive66% rewritten
  7. 07We are dependent on a limited number of third-party suppliers, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of products or materials in a timely manner, could harm our business
  8. 08PODs are medical device distributors that are owned, directly or indirectly, by physicians. These physicians derive a proportion of their revenue from selling or arranging for the sale of medical devices for use in procedures at hospitals that agree to purchase from or through the POD77% rewritten
  9. 09The safety and efficacy of our products is not yet supported by long-term clinical data, which could limit sales, and our products might therefore prove to be less safe and effective than initially thought
  10. 10If we do not enhance our existing product offerings and introduce new products through our research and development and product development efforts, we may be unable to effectively compete73% rewritten
  11. 11We are required to maintain high levels of inventory, which could consume a significant amount of our resources and reduce our cash flows
  12. 12We rely on information technology systems and network infrastructure to operate and manage our business, if we experience a breach, cyber-attack or other disruption to these systems or data, our business, results of operations and financial condition could be adversely affected
  13. 13We are subject to data privacy laws and our failure to comply with them could subject us to substantial liabilities
  14. 14If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected79% rewritten
  15. 15The increasing utilization of AI in the medical device and healthcare industries presents novel obstacles and risks to our business37% rewritten
  16. 16Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business, results of operations or financial condition
  17. 17If our Enabling Technologies products require significant amounts of service after sale or we receive a significant number of warranty claims, our costs may increase, and our financial results may be adversely affected
  18. 18We experience long and variable capital sales cycles for our Enabling Technologies products, which may cause fluctuations in our financial results
  19. 19Our IONM business exposes us to risks inherent with the sale of services

Risks Related to our Legal and Regulatory Environment

  1. 20Our medical device products and operations are subject to extensive governmental regulation both in the U.S. and abroad, and our failure to comply with applicable requirements could cause our business to suffer65% rewritten
  2. 21novo classification, or approvals through the PMA process to market a medical device in the U.S. or internationally can be costly and time-consuming, and we may not be able to obtain these clearances, grants of de novo classification, or approvals on a timely basis, if at allNew
  3. 22Modifications to our products may require new 510(k) or de novo clearances, HDEs, PMAs or PMA supplements, or may require us to cease marketing or recall the modified products until clearances or approvals are obtained
  4. 23Our HCT/P products are subject to extensive government regulation, and our failure to comply with these requirements could cause our business to suffer
  5. 24If we or our suppliers fail to comply with the FDA’s good manufacturing practice regulations and similar international regulations, this could impair our ability to market our products in a cost-effective and timely manner
  6. 25Any of these sanctions could have a material adverse effect on our reputation, business, results of operations and financial condition
  7. 26A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us
  8. 27We may be subject to enforcement action if we engage in the off-label promotion of our products
  9. 28Governmental regulation and limited sources and suppliers could restrict our procurement and use of tissue71% rewritten
  10. 29render for us, our business could be materially adversely affected. In addition, there is similar legislation in Europe and the UK which we must abide by, including Directive 2004/23/EC in relation to human tissues and cells requiring that donation be unpaid (except for expenses and inconvenience) and voluntaryNew
  11. 30Negative publicity concerning methods of tissue recovery and screening of donor tissue in our industry could reduce demand for our regenerative biologics products and impact the supply of available donor tissue
  12. 31We are subject to environmental laws and regulations that can impose significant costs and expose us to potential financial liabilities
  13. 32We or our suppliers may be the subject of claims for non-compliance with FDA regulations in connection with the processing, manufacturing or distribution of our proposed allograft or other regenerative biologics implants and products
  14. 33We and our distributor sales representatives might be subject to claims for failing to comply with U.S. federal, state, local and foreign fraud and abuse laws, including anti-kickback laws and other anti-referral laws

Risks Related to our International Operations

  1. 34We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries
  2. 35We are subject to risks associated with our non-U.S. operations
  3. 36Our results of operations could suffer if we are unable to manage our planned international expansion effectively
  4. 37These risks may limit or disrupt our expansion, restrict the movement of funds or result in the deprivation of contractual rights or the taking of property by nationalization or expropriation without fair compensation
  5. 38We are subject to risks arising from currency exchange rate fluctuations on our international transactions and translation of local currency results into U.S. dollars, which could adversely affect our profitability
  6. 39Tariff policies and potential countermeasures have and may continue to increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations78% rewritten

Risks Related to our Financial Results and Need for Financing

  1. 40We will need to generate significant sales to remain profitable
  2. 41We may be unable to grow our revenue or earnings as anticipated, which may have a material adverse effect on our results of operations
  3. 42Our quarterly and annual operating results may fluctuate significantly58% rewritten
  4. 43The availability of funding under existing credit arrangements may be limited, and our cash and cash equivalents are subject to volatility
  5. 44Our future capital needs are uncertain, and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all58% rewritten
  6. 45Our existing revolving credit facility contains restrictive covenants that may limit our operating flexibility

Risks Related to our Intellectual Property and Potential Litigation

  1. 46Our ability to protect our intellectual property and proprietary technology is uncertain
  2. 47Patent litigation is highly prevalent in the medical device industry, and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from marketing our existing or future products59% rewritten
  3. 48We may be subject to damages resulting from claims that we, our employees or our independent distributors have wrongfully used or disclosed alleged trade secrets, proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
  4. 49We may incur product liability losses and insurance coverage may be inadequate or unavailable to cover these losses62% rewritten
  5. 50unsafe condition or injury to patients. The medical devices industry has been particularly prone to potential product liability claims that are inherent in the testing, manufacture and sale of medical devices and products for surgery proceduresNew

Risks Related to the Ownership of our Class A Common Stock

  1. 51Because of their significant stock ownership, our Executive Chairman, our other executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions29% rewritten
  2. 52We are a “controlled company” within the meaning of the New York Stock Exchange Rules, and we take, and intend to continue to take, advantage of exemptions from certain corporate governance requirements
  3. 53Our Board is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval
  4. 54Our amended and restated certificate of incorporation and amended and restated bylaws (the “Bylaws”) contain other provisions that could delay or prevent a change of control of the Company or changes in our Board that our stockholders might consider favorable75% rewritten
  5. 55If we do not successfully implement our business strategy, our business and results of operations will be adversely affected
  6. 56Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile
  7. 57We are exposed to the credit risk of some of our customers, which could result in material losses
  8. 58The widespread outbreak of a communicable disease, or any other public health crisis, could adversely affect our financial condition and results of operations67% rewritten

Risks Relating to Our Acquisitions

  1. 59We have and may continue seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us63% rewritten
  2. 60Integrating acquired businesses into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of such acquisitions, which may adversely affect the Company’s business results and negatively affect the value of the Company’s Class A common stock100% rewritten

Other Globus Medical 10-Ks

  • FY2024 10-K risk factors
    82 risks

    Globus Medical relies heavily on the success of its NuVasive integration, surgeon adoption, and key executives like David C. Paul.

    Filed Feb 20, 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.