What the changes say
- GE HealthCare faces evolving healthcare industry consolidation, ongoing regulatory and post-market scrutiny, and complex spin-off tax and relationship risks.
What changed since the prior 10-K
New
- NewGeneral Risks
Our inability to obtain and maintain regulatory authorizations for and supply commercial quantities of our offerings as quickly and effectively as our competitors could limit market acceptance. Furthermore, our markets are continually evolving and thus revenues and income are difficult to forecast
Healthcare industry consolidation and shifting care venues may reduce our customer base, pricing power, and market share.
Dropped
- Dropped
Having a diverse and inclusive workplace can also enhance our ability to attract and retain talent and is an important driver of our ability to compete and innovate. As such, our inability to attract and retain diverse talent can have adverse consequences on our business
- Dropped
The opinion of counsel and the opinion of EY do not address any U.S. state or local or foreign tax consequences of the Spin-Off
- Dropped
investigation, or complaint and any adverse publicity surrounding such allegations or actions could have a material adverse effect on our business results, cash flows, financial condition, or prospects
- DroppedRISKS RELATING TO FINANCING AND CAPITAL MARKETS ACTIVITIES
We or GE may fail to perform under various transaction agreements executed as part of the Spin-Off
Reworded
- 96% rewrittenGeneral Risks
If the Spin-Off is determined to be a taxable transaction, it could result in significant tax liability to GE and its stockholders and we could have an indemnification obligation to GE, which could adversely affect our business, financial condition, cash flows, and results of operations
Clarified that tax opinions do not cover state, local, or foreign tax consequences of the Spin-Off.
Was: If our Spin-Off from GE is determined to be a taxable transaction, it could result in significant tax liability to GE and its stockholders and we could have an indemnification obligation to GE, which could adversely affect our business, financial condition, cash flows, and results of operations
- 83% rewrittenGeneral Risks
Certain of our directors and employees may have actual or potential conflicts of interest because of their financial interests in GE or because of their previous or continuing positions with GE
Minor stylistic and formatting adjustments regarding potential conflicts of interest with GE.
- 79% rewrittenGeneral Risks
Changes in applicable tax laws and regulations, as well as adverse outcomes of ongoing and future tax audits, could adversely affect our business and our ability to use deferred tax assets
Expanded tax risk scope from specific jurisdictions to multiple jurisdictions.
- 72% rewrittenGeneral Risks
Developments following regulatory authorization, including results in post-approval device or pharmaceutical Phase 4 trials or other studies, could adversely affect sales or decrease demand for our medical devices or pharmaceutical products
Abbreviated United States to U.S. in the discussion of post-approval regulatory trials.
- 67% rewrittenGeneral Risks
If we are unable to attract or retain key talent and qualified employees or maintain relations with our employees, unions, and other employee representatives, it could adversely affect our business
Combined talent retention risks with a newly added mention of U.S. and international collective bargaining agreements.
Was: If we are unable to attract or retain key personnel and qualified employees or maintain relations with our employees, unions, and other employee representatives, it could adversely affect our business
- 54% rewrittenGeneral Risks
We operate in highly competitive markets, competition may increase in the future, and our industry may be disrupted, requiring us to lower prices or resulting in a loss of market share
Refined wording on competitive disadvantages from competitor responses and technological obsolescence.
- 53% rewrittenGeneral Risks
Various other assessments and assumptions regarding acquisition targets may prove to be incorrect, and actual developments may differ significantly from our expectations
Removed references to strategic alliances while updating language on dispositions of non-core assets.
- 51% rewrittenGeneral Risks
Global geopolitical and economic instability, as well as continuing uncertainties and challenging conditions in regional economies, could adversely affect our business
Added trade policies to macroeconomic risks and shortened United States to U.S.
- 32% rewrittenGeneral Risks
Increasing attention to sustainability matters, including EH&S matters, may impose additional costs on our business and expose us to new risks
Was: Increasing attention to ESG matters, including EH&S matters, may impose additional costs on our business and expose us to new risks
- 27% rewrittenGeneral Risks
We are exposed to risks associated with product liability claims that have been and may be brought against us or as a result of the actions or inactions of our customers or third parties that are outside of our control
- 27% rewrittenGeneral Risks
Certain provisions in our certificate of incorporation, bylaws, and Delaware law may discourage takeovers and limit the power of our stockholders
- 25% rewrittenGeneral Risks
We are subject to stringent privacy laws and information security regulations
- 23% rewrittenGeneral Risks
Our increasing focus on and investment in cloud, edge computing, AI, and software offerings present risks to our business. We may not be successful in driving the global deployment and customer adoption of digital offerings, including cloud-enabled, AI-enabled, and software solutions
Was: Our increasing focus on and investment in cloud, edge computing, AI, and software offerings present risks to our business. We may not be successful in driving the global deployment and customer adoption of digital offerings characterized by digital applications and solutions
- 21% rewrittenGeneral Risks
We may become involved in litigation, arbitration, and governmental proceedings, including those stemming from third-party conduct beyond our control
All 31 risk factors
Headings as the filing states them, in filing order.
General Risks
- 01We operate in highly competitive markets, competition may increase in the future, and our industry may be disrupted, requiring us to lower prices or resulting in a loss of market share54% rewritten
- 02Our inability to obtain and maintain regulatory authorizations for and supply commercial quantities of our offerings as quickly and effectively as our competitors could limit market acceptance. Furthermore, our markets are continually evolving and thus revenues and income are difficult to forecastNew
- 03Global geopolitical and economic instability, as well as continuing uncertainties and challenging conditions in regional economies, could adversely affect our business51% rewritten
- 04Public health crises and epidemics and pandemics have had and, in the future, may have a material adverse impact on our business, as well as on the operations and financial performance of customers and suppliers in industries that we serve
- 05Efforts by public and private payers to control the growth of healthcare costs may lead to lower reimbursements or increased utilization controls related to the use of our products by healthcare providers, which may affect the price of and demand for our products, services, or solutions
- 06Our inability to successfully complete strategic transactions could adversely affect our business
- 07Various other assessments and assumptions regarding acquisition targets may prove to be incorrect, and actual developments may differ significantly from our expectations53% rewritten
- 08If we do not successfully manage our collaboration arrangements, licensing arrangements, joint ventures, or strategic alliances with third parties, we may not realize the expected benefits from such arrangements, which could adversely affect our business
- 09Our increasing focus on and investment in cloud, edge computing, AI, and software offerings present risks to our business. We may not be successful in driving the global deployment and customer adoption of digital offerings, including cloud-enabled, AI-enabled, and software solutions23% rewritten
- 10Any interruption in the operations of our facilities, or our suppliers’, customers’, or third-party providers’ facilities, may impair our ability to deliver products or provide services
- 11Increased cybersecurity requirements, vulnerabilities, threats, and more sophisticated and targeted cybercrimes pose a risk to our systems, networks, products, solutions, services, and data, as well as our reputation, which could adversely affect our business
- 12We may be unable to obtain, maintain, protect, or effectively enforce our IP rights
- 13If we are unable to attract or retain key talent and qualified employees or maintain relations with our employees, unions, and other employee representatives, it could adversely affect our business67% rewritten
- 14Increasing attention to sustainability matters, including EH&S matters, may impose additional costs on our business and expose us to new risks32% rewritten
- 15Our research and development efforts may not succeed in developing commercially successful products and technologies, which could adversely affect our business
- 16The FDA and equivalent global agencies tightly regulate and actively enforce the laws and regulations governing the development, authorization, and commercialization of medical devices and pharmaceutical products
- 17The failure to comply with the FCPA and similar anti-corruption and anti-bribery laws globally has resulted in, and could continue to result in, civil or criminal sanctions and adversely affect our business
- 18We are subject to anti-kickback and false claims laws (including as these laws relate to off-label promotion of products) and failure to comply with these laws could adversely affect our business, including via sanctions and conditions on business activity
- 19We are subject to antitrust and competition laws that can result in sanctions and conditions on the way we conduct our business
- 20We are subject to stringent privacy laws and information security regulations25% rewritten
- 21Changes in applicable tax laws and regulations, as well as adverse outcomes of ongoing and future tax audits, could adversely affect our business and our ability to use deferred tax assets79% rewritten
- 22If the Spin-Off is determined to be a taxable transaction, it could result in significant tax liability to GE and its stockholders and we could have an indemnification obligation to GE, which could adversely affect our business, financial condition, cash flows, and results of operations96% rewritten
- 23We are exposed to risks associated with product liability claims that have been and may be brought against us or as a result of the actions or inactions of our customers or third parties that are outside of our control27% rewritten
- 24We may become involved in litigation, arbitration, and governmental proceedings, including those stemming from third-party conduct beyond our control21% rewritten
- 25Developments following regulatory authorization, including results in post-approval device or pharmaceutical Phase 4 trials or other studies, could adversely affect sales or decrease demand for our medical devices or pharmaceutical products72% rewritten
- 26Complying with our requirements under our debt instruments could adversely affect our business, results of operations, cash flows, and financial condition
- 27We have significant postretirement benefit liabilities, including pension, healthcare, and life insurance benefit obligations, and the actual costs and related cash flows of these obligations are uncertain and could exceed current estimates
- 28Changes in foreign currency exchange rates, equity prices, and interest rates, and unfavorable changes in economic conditions or uncertainties that affect the capital markets, could adversely affect our financial performance
- 29Future material impairments in the value of our long-lived assets, including goodwill, could adversely affect our business
- 30Certain of our directors and employees may have actual or potential conflicts of interest because of their financial interests in GE or because of their previous or continuing positions with GE83% rewritten
- 31Certain provisions in our certificate of incorporation, bylaws, and Delaware law may discourage takeovers and limit the power of our stockholders27% rewritten
Other GE HealthCare Technologies 10-Ks
- FY2024 10-K risk factors34 risks
GE HealthCare faces high regulatory scrutiny from the FDA and global agencies across its medical devices and pharmaceutical products. The company carries significant debt of $8,951 million alongside substantial postretirement benefit and pension liabilities. Heavy reliance on international revenue exposes operations to global economic instability and foreign currency exchange fluctuations.
Filed Feb 13, 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.