Risk factor changes · JNJ

What changed in Johnson & Johnson's risk factors

Item 1A (Risk Factors) of Johnson & Johnson's FY2025 10-K compared with its FY2024 10-K, sentence by sentence.

Newer: 10-K filed 2026-02-11 · Older: 10-K filed 2025-02-13

New in the latest 10-K 11

• Risks related to the planned separation of our Orthopaedics business The planned separation of the Company's Orthopaedics business may not be completed on the terms or timeline currently contemplated, if at all, and may not achieve the expected results In October 2025, the Company announced its intention to separate the Company's Orthopaedics business.
• The Company is targeting completion of the planned separation in 18 to 24 months after initial announcement.
• Completion of the planned separation will be subject to the satisfaction of certain conditions, including, among others, consultations with works councils and other employee representative bodies, as may be required, final approval of the Company's Board of Directors, and receipt of other regulatory approvals.
• There can be no assurance regarding the ultimate timing of the planned separation or that such separation will be completed.
• Unanticipated developments could delay, prevent or otherwise adversely affect the planned separation, including but not limited to disruptions in general or financial market conditions or potential problems or delays in obtaining various regulatory approvals or clearances.
• The costs to complete the planned separation will be significant.
• In addition, the Company may be unable to achieve some of the strategic and financial benefits that it expects to achieve from the planned separation of the Company's Orthopaedics business The Company will incur significant expenses in connection with the planned separation.
• In addition, the Company may not be able to achieve the full strategic and financial benefits that are expected to result from the planned separation.
• The anticipated benefits of the planned separation are based on a number of assumptions, some of which may prove incorrect.
• Following the planned separation, the price of shares of the Company's common stock may fluctuate significantly The Company cannot predict the effect of the planned separation on the trading price of shares of its common stock, and market value of shares of its common stock may be less than, equal to or greater than the market value of shares of its common stock prior to the planned separation.
• In addition, the price of the Company's common stock may be more volatile around the time of the planned separation.

Reworded 22

Removed words are struck through; added words are highlighted.

• The Company s subsidiaries operate 64 63 manufacturing facilities as well as sourcing from thousands of suppliers around the world.
• However, we cannot guarantee that these third-party manufacturers will be able to meet our near-term or long-term manufacturing requirements, which could result in lost sales and have an adverse effect on our business. 2024 2025 Annual Report 9 Other risks associated with our reliance on third parties to manufacture these products include reliance on the third party for regulatory compliance and quality assurance, misappropriation of the Company s intellectual property, limited ability to manage our inventory, possible breach of the manufacturing agreement by the third party and the possible termination or nonrenewal of the manufacturing agreement by the third party at a time that is costly or inconvenient for us.
• The industry s failure to mitigate the threat of counterfeit medicines could adversely impact our business and reputation by impacting patient confidence in our authentic products, potentially resulting in lost sales, product recalls, and an increased threat of litigation.
• Outside the U.S., numerous major markets, including the EU, United Kingdom, Japan and China, have pervasive government involvement in funding healthcare and, in that regard, directly or indirectly impose price controls, limit access to, or reimbursement for, the Company s products, or reduce the value of its intellectual property protection. 10 We are The Company is subject to an increasing number of costly and complex governmental regulations in the countries in which operations are conducted which may materially adversely have a material adverse affect on the Company s financial condition and business operations.
• Product concerns, whether raised internally or by litigants, regulators or consumer advocates, and whether or not based on scientific evidence, can result in safety alerts, field actions, such as product recalls, governmental investigations, regulatory action on the part of the U.S.
• The most significant current investigations and litigation brought by government agencies are described in Note 19 Legal proceedings Government proceedings under Notes to the Consolidated Financial Statements included in Item 8 of this Report. 2024 2025 Annual Report 11 Changes in tax laws or exposures to additional tax liabilities could negatively impact the Company s operating results.
• Changes in tax laws or regulations around the world, including in the U.S. and as led by the Organization for Economic Cooperation and Development, such as the enactment by certain EU and non-EU countries, and around the anticipated enactment by additional countries, of a world, including global minimum tax, taxes could negatively impact the Company s effective tax rate and results of operations.
• This change would result in an expense or benefit recorded to in the Company s Consolidated Statement of Earnings.
• New products introduced within the past five years accounted for approximately 25% of 2024 2025 sales.
• Foreign currency exchange : In fiscal 2024, 2025, approximately 43% of the Company s sales occurred outside of the U.S., with approximately 23% in Europe, 5% in the Western Hemisphere, excluding the U.S., and 15% in the Asia-Pacific and Africa region.
• Specifically, the Company has accounted for operations in Argentina, Turkey, Venezuela and Egypt (beginning in the fiscal fourth quarter of 2024) as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%.
• While the Company strives to maintain profit margins in these areas through cost reduction programs, productivity improvements and periodic price increases, it might experience operating losses as a result of continued inflation. 2024 2025 Annual Report 13 In addition, the impact of currency devaluations in countries experiencing high inflation rates or significant currency exchange fluctuations could negatively impact the Company s operating results.
• Anti-bribery Anti-corruption and other regulations : The Company is subject to various federal and foreign laws that govern its international business practices with respect to payments to government officials.
• Most recently, we have experienced, and expect to continue to experience, impacts to the Company's business resulting from the Russia-Ukraine war, rising conflict in the Middle East as well as increasing tensions between the U.S. and China.
• In response to heightened conflict, such as the Russia-Ukraine Russia- Ukraine war, governments may impose export controls and broad financial and economic sanctions.
• Our business and operations may be further impacted by the imposition of tariffs, trade protection measures or other policies - including data localization laws and restrictions on data transfers - adopted by any country that favor domestic companies and technologies over foreign competitors.
• Furthermore, in some countries, such as in Russia, action may be taken that allows companies and individuals to exploit inventions owned by patent holders from the United States and many other countries without consent or compensation and we may not be able to prevent third parties from practicing the Company's inventions in Russia or from selling or importing products in and into Russia. products.
• In addition, the U.S. government has imposed and/or announced the potential imposition of tariffs on products manufactured in other jurisdictions. 14 While certain of the announced tariffs have been delayed, the U.S. government may in the future pause, reimpose or increase tariffs, and countries subject to such tariffs have and in the future may impose reciprocal tariffs or other restrictive trade measures in response.
• Any unsuccessful implementation of our succession plans or failure to ensure effective transfer of knowledge and smooth transitions involving key employees could adversely affect our business, financial condition, or results of operations. 2025 Annual Report 15 Climate change or legal, regulatory or market measures to address climate change may negatively affect our business and results of operations.
• The Company assesses these threats, responds to attacks and breaches that it has experienced, and makes investments to increase internal protection, detection, and response capabilities, as well as ensure the Company s third-party providers have required capabilities and 2024 Annual Report 15 controls, to address this risk.
• Because of the frequently changing attack techniques, along with the increased volume and sophistication of the attacks, attacks and increasing use and reliance on third parties, there is the potential for the Company to be adversely impacted.
• Also, The increasing use of AI and other emerging technology could also increase these risks.

Removed since the previous 10-K 2

• In addition, the U.S. government recently announced tariffs on products manufactured in several jurisdictions, including China, Mexico and Canada, and has 14 made announcements regarding the potential imposition of tariffs on other jurisdictions.
• Climate change or legal, regulatory or market measures to address climate change may negatively affect our business and results of operations.

Source: SEC EDGAR filings, compared sentence by sentence by EdgarStack. Sentence matching is automated and may pair or split passages imperfectly; check the linked filings before relying on any passage. A software tool, not financial advice. Not affiliated with the U.S. Securities and Exchange Commission.