Risk factor changes · TMO
What changed in Thermo Fisher Scientific's risk factors
Item 1A (Risk Factors) of Thermo Fisher Scientific's FY2025 10-K compared with its FY2024 10-K, sentence by sentence.
7new sentences
42reworded
1removed
184unchanged
New in the latest 10-K 7
- Chinese regulations requiring the use of local suppliers, which compel companies that do business in China to partner with local companies to conduct business and provide incentives to government-backed local customers to buy from local suppliers; the imposition of governmental controls; diverse data privacy, protection and localization requirements; supply interruptions, which could disrupt our ability to produce our products; increases in materials, energy, labor or other manufacturing-related costs or higher supply chain logistics costs; negative consequences from changes in or interpretation of laws and regulations, including those related to tax and import/export; difficulty in staffing and managing widespread operations; differing labor regulations; differing protection of intellectual property; unexpected changes in regulatory requirements; and geopolitical uncertainty or turmoil, including terrorism and war.
- In October 2025, the federal government entered a shutdown due to a lapse in appropriations, resulting from an inability by Congress to pass a budget or continuing resolution.
- For example, we are incorporating AI and machine learning technologies into our products, services and internal processes.
- Failure to keep pace with rapid developments in AI technologies could adversely affect our competitive position and results of operations.
- Improper or unauthorized use of AI by our employees or third parties working on our behalf could create additional risks, including exposure of confidential information, errors in output, or the generation of inaccurate, misleading or biased results, which could negatively impact our customers, stakeholders and reputation.
- The integration of AI, including generative AI, into our products, services or internal operations may expose us to increased risks of intellectual property infringement or misappropriation.
- As of December 31, 2025, numerous countries where we operate have enacted legislation, or have indicated their intent to adopt legislation, to implement certain aspects of the Pillar Two rules.
Reworded 42
Removed words are struck through; added words are highlighted.
- Both domestic and international markets experienced significant inflationary pressures in
20242025 and inflation rates in the U.S., as well as in other countries in which we operate, continue at elevated levels. - If the global economy and financial markets, or economic conditions in Europe, the U.S. or other key markets, are unstable, that could adversely affect the business, results of operations and financial condition of the company and its customers, distributors, and suppliers, having the effect of: reducing demand for some of our
products;products and services; increasing the rate of order cancellations or delays; increasing the risk of excess and obsolete inventories; increasing pressure on the prices for our products and services; causing supply interruptions, which could disrupt our ability to produce our products; and creating longer sales cycles, and greater difficulty in collecting sales proceeds and slower adoption of new technologies. 9 THERMO FISHER SCIENTIFIC INC. - In
2024,2025, currency translation hadanunfavorablea favorable effect of$0.08$0.37 billion on revenues due to thestrengtheningweakening of the U.S. dollar relative to other currencies in which the company sells products and services. - Accordingly, our prior results have been and our future results could be harmed by a variety of factors, including:
9THERMOFISHERSCIENTIFICINC.tariffs imposed by the U.S. on goods from other countries and tariffs imposed by other countries, on certain U.S. goods (including volatility resulting from the imposition of (and changing policies around) tariffs and related countermeasures); interruption to transportation flows for delivery of raw materials or parts to us and finished goods to our customers; changes in a specific country's or region's political, economic, social or other conditions; changes in diplomatic and trade relationships, including new tariffs, trade protection measures, import or export licensing requirements, trade embargoes and sanctions and other trade barriers;tariffsimposedbytheU.S.ongoodsfromothercountriesandtariffsimposedbyothercountriesonU.S.goods,includingthetariffsadoptedbytheU.S.governmentonvariousimportsfromChinaandbytheChinesegovernmentoncertainU.S.goods;theimpact of public health emergencies, pandemics, epidemics or other health outbreaks on the globaleconomy,suchastheCOVID-19pandemic;economy; uncertainties regarding the collectability of accounts receivable;theimpositionofgovernmentalcontrols;diversedataprivacyandprotectionrequirements;supplyinterruptions,whichcoulddisruptourabilitytoproduceourproducts;increasesinmaterials,energy,labororothermanufacturing-relatedcostsorhighersupplychainlogisticscosts;negativeconsequencesfromchangesinorinterpretationoflawsandregulations,includingthoserelatedtotaxandimport/export;difficultyinstaffingandmanagingwidespreadoperations;differinglaborregulations;differingprotectionofintellectualproperty;unexpectedchangesinregulatoryrequirements;andgeopoliticaluncertaintyorturmoil,includingterrorismandwar. - Our customers include pharmaceutical and
chemicalbiotechnology companies, laboratories, universities, healthcare providers, government agencies and public and private research institutions. - Many factors, including public policy spending
priorities,priorities such as national procurement initiatives, available resources, cost reimbursement policies, and product and economic cycles, have had and we expect to have a significant effect on the capital spending policies of these entities. AnA similar impasse in federal government budget decisions could lead to substantial delays or reductions in federal spending. 10 THERMO FISHER SCIENTIFIC INC.- The ability of our employees to work may be significantly impacted by future epidemics and
pandemics.pandemics, including their residual effects. - Business Risks We must develop new products, adapt to rapid and significant technological change, respond to introductions of new products and services by competitors and maintain quality to remain competitive.
- Our growth strategy includes significant investment in and expenditures for product and service development.
- We sell our products and services in several industries that are characterized by rapid and significant technological changes, frequent new product and service introductions and enhancements and evolving industry standards.
- Competitive factors include technological innovation, including the
increasedadoptiontimely, responsible anduseeffective adoption ofartificialintelligence,emerging technologies (such as AI), price, service and delivery, breadth of product line, customer support, e-business capabilities and the ability to meet the special requirements of customers. - Our competitors may adapt more quickly to new technologies and changes in customers requirements than we
can.can, and may achieve cost or quality advantages that we cannot match. - Without the timely introduction of new products, services and enhancements, our products and services will likely become technologically obsolete over time, in which case our revenues and operating results would suffer.
10THERMOFISHERSCIENTIFICINC. - Many of our existing products and services and those under development are technologically innovative and require significant planning, design, development and testing at the technological, safety, quality, product and manufacturing-process levels.
- Our customers use many of our products and services to develop, test and manufacture their own products.
- As a result, we must anticipate industry trends and develop products and services in advance of the commercialization of our customers products.
- To address this issue, we are pursuing a number of strategies to improve our internal growth, including: strengthening our presence in selected geographic markets; allocating research and development funding to products with higher growth prospects; developing new applications for our technologies; expanding our service offerings; continuing key customer initiatives; combining sales and marketing operations in appropriate markets to compete more effectively; finding new markets for our
products;products and services; and continuing the development of commercial tools and infrastructure to increase and support cross-selling opportunities of products and services to take advantage of our depth in product offerings. - We may not be able to successfully implement these strategies, and these strategies may not result in the expected growth of our business. 11 THERMO FISHER SCIENTIFIC INC.
- As a result of these acquisitions, we recorded significant goodwill and indefinite-lived intangible assets (primarily
tradenames)trade names) on our balance sheet, which amount to approximately$45.85$49.36 billion and$1.24$1.23 billion, respectively, as of December 31,2024.2025. - In addition, we have definite-lived intangible assets totaling
$14.30$14.60 billion as of December 31,2024.2025. - If we are not able to realize the value of the goodwill and intangible assets, we may be required to incur material charges relating to the impairment of those assets.
11THERMOFISHERSCIENTIFICINC. - The supply chains for our businesses could also be disrupted by supplier capacity constraints, bankruptcy or exiting of the business for other reasons, decreased availability or increased cost of key raw materials or commodities, such as energy, and external events such as global economic downturns and macroeconomic trends, sanctions and trade restrictions, natural disasters, pandemic health issues, geopolitical developments, war, terrorist actions, cybersecurity incidents including but not limited to ransomware attacks, misuse of AI and machine learning technologies, governmental actions and legislative or regulatory changes.
- Despite our efforts, any particular system we operate or use may be susceptible to compromise of a vulnerability or a privileged account, damage or interruption from natural disasters, power loss, telecommunication failures, data center failure, third party provider failures (including failures at cloud services), hardware and software failures, improper or unauthorized use of AI, human error or sabotage, terrorist attacks, geopolitical events, computer hackers, computer viruses, ransomware, phishing, computer denial-of-service attacks, unauthorized access to customer or employee data or company trade secrets, and other attempts to harm our systems and access our information.
- We and our third-party providers experience cyber-attacks and other attempts to gain unauthorized access to our products, services, and systems and data on a regular basis, and we anticipate continuing to be subject to such attempts as cyber-attacks 12 THERMO FISHER SCIENTIFIC INC. become increasingly sophisticated and more difficult to predict and protect against, particularly with the advancement of
artificialintelligence.AI. - Our success in doing so is largely dependent upon various factors, including a highly competitive market, sought-after skills, management changes, competitor recruitment, and maintaining an attractive workplace
culture.culture (including where there is high demand for new products, services, and technologies, such as related to AI). - We cannot ensure that we will be able to hire or retain the personnel necessary for our operations or that the departure of any personnel will not have a material impact on our financial condition and results of operations.
12THERMOFISHERSCIENTIFICINC. - Moreover, these types of events could negatively impact customer spending in the impacted regions or depending upon the severity, globally, which could also adversely impact our operating results. 13 THERMO FISHER SCIENTIFIC INC.
- Increasing attention to
environmental,socialandgovernancesustainability matters may impact our business, financial results, stock price or reputation. - We face increasing scrutiny from stakeholders related to our
environmental,socialandgovernancesustainability practices and disclosures. - Food and Drug Administration s (the FDA) regulation of the drug discovery and development process could have an adverse effect on the demand for these products, and increased FDA regulation of
13THERMOFISHERSCIENTIFICINC.laboratory-developed tests could delay and add to the cost of commercialization of these products, as well as subject us to additional regulatory controls. - We have agreements relating to the sale of our products and services to government entities and, as a result, we are subject to various statutes and regulations that apply to companies doing business with the government.
- In addition, such problems or failures could subject us to litigation claims, including claims from our customers for reimbursement for the cost of lost or damaged active pharmaceutical ingredients, the cost of which could be significant. 14 THERMO FISHER SCIENTIFIC INC.
- More recently, privacy and data protection regulators are paying special attention to emerging issues linked to new digital technologies, such as the use of
artificialintelligence,AI, biometrics, and surveillance technologies, which pose unique challenges to existing privacy and data protection paradigms. - European laws require us to have an approved legal mechanism to transfer personal data out of Europe, and the EU
GeneralDataProtectionRegulationGDPR imposes significantly stricter requirements in how we collect and process personal data. - The importance of privacy and data protection laws, rules and regulations for our industry specifically is constantly growing, as personal data is an integral part of doing business in our sectors, and the legal standards are evolving and becoming more complex worldwide.
14THERMOFISHERSCIENTIFICINC. - In addition, such a failure could expose us to contractual or product liability claims, contractual claims 15 THERMO FISHER SCIENTIFIC INC. from our customers, including claims for reimbursement for lost or damaged active pharmaceutical ingredients or personal injury, as well as ongoing remediation and increased compliance costs, any or all of which could be significant.
- Bribery Act 2010 and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government
15THERMOFISHERSCIENTIFICINC.officials for the purpose of obtaining or retaining business, and we operate in many parts of the world that have experienced governmental corruption to some degree. - In addition, our trade secrets may otherwise become known or be independently developed by our competitors. 16 THERMO FISHER SCIENTIFIC INC.
- The OECD and implementing countries are expected to continue
16THERMOFISHERSCIENTIFICINC.to make further revisions to their legislation and release additional guidance.
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- As of December 31,
2024,2025, we had approximately$31.27$39.38 billion in outstanding indebtedness. - Also, an acceleration of the debt under certain of our debt instruments would trigger an event of default under other of our debt instruments. 17 THERMO FISHER SCIENTIFIC INC.
Removed since the previous 10-K 1
- While it is uncertain whether the United States will enact legislation to adopt the Pillar Two rule, numerous countries have enacted legislation, or have indicated their intent to adopt legislation, to implement certain aspects of the Pillar Two rules effective January 1, 2024, with general implementation of the remaining global minimum tax rules by January 1, 2025.
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