What changed in this filing

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Item 1. Business

2026-02-20 compared with 2025-02-24 · 88 added, 90 removed, 250 unchanged (42% of the section changed)

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By combining the power of science with meaningful consumer insights and our digital strategy, we empower consumers to live healthier lives every day.

Built on more than a century of heritage and trusted by generations, our differentiated portfolio of iconic brands—including Tylenol ® , Neutrogena ® , Listerine ® , Johnson’s ® , BAND-AID ® Brand, Aveeno ® , Zyrtec ® , and Nicorette ® —is backed by science and recommended by healthcare professionals, which further reinforces our consumers’ connections to our brands.

Built on more than a century of heritage and trusted by generations, our differentiated portfolio of iconic brands—including Aveeno ® , BAND-AID ® Brand, Johnson’s ® , Listerine ® , Neutrogena ® , Nicorette ® , Tylenol ® , and Zyrtec ® —is backed by science and recommended by healthcare professionals, which further reinforces our consumers’ connections to our brands.

Our portfolio includes Self Care, Skin Health and Beauty, and Essential Health products, allowing us to connect with consumers across North America, Asia Pacific (“APAC”), Europe, Middle East, and Africa (“EMEA”), and Latin America (“LATAM”) in their daily rituals and the moments that matter most.

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With a sole focus on consumer health, our marketing organization operates efficiently by leveraging our precision marketing, e-commerce, and broader digital capabilities to develop unique consumer insights and further enhance the relevance of our brands.

Similarly, our research and development organization combines these consumer insights with deep, multi-disciplinary scientific expertise, and engagement with healthcare professionals, to drive innovative new products, solutions, and experiences centered around consumer health.

Underpinned by Kenvue’s Healthy Lives Mission, our comprehensive Environmental, Social, and Governance (“ESG”) strategy, our core capabilities are supported by our commitment to building a resilient and sustainable business that creates value for all our stakeholders over the long term.

Since the Separation (as defined below) from J&J, as described below, we have been executing a significant transformation agenda, spanning from exiting the Transition Services Agreement (as defined in “Risk Factors—Summary of Risk Factors—Risks Related to Our Relationship with J&J” in Part I, Item 1A) while standing up, modernizing, and optimizing our own systems, to instituting a new operating model, as we reinvent our ways of working and strengthen and scale our commercial capabilities.

We have been focused on driving productivity and realizing Our Vue Forward (as defined in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Key Factors Affecting Our Results—Restructuring,” in Part II, Item 7) and other cost savings across the organization to fuel investments behind our brands, so that we can drive sustainable and profitable growth.

Similarly, our research and development organization combines these consumer insights with deep, multi-disciplinary scientific expertise, and active engagement with healthcare professionals, to drive innovative new products, solutions, and experiences centered around consumer health.

Underpinned by Kenvue’s Healthy Lives Mission, our comprehensive sustainability strategy, our core capabilities are supported by our commitment to building a resilient and sustainable business that creates value for all our stakeholders over the long term.

Since the Separation from J&J, as described below, we have been significantly transforming, including from exiting the Transition Services Agreement and the Transition Manufacturing Agreement with J&J (as defined in Part I, Item 1A, “Risk Factors—Summary of Risk Factors—Risks Related to Our Relationship with J&J”) while standing up, disentangling, modernizing, and optimizing our own systems, strengthening our Leadership Team, instituting a new operating model, reinventing our ways of working, and enhancing our commercial capabilities.

We have been focused on driving productivity and realizing cost savings from Our Vue Forward (as defined in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Key Factors Affecting Our Results—Restructuring”) across the organization to fuel investments behind our brands and unlock operational efficiencies, so that we can drive sustainable and profitable growth.

Proposed Transaction with Kimberly-Clark

On November 2, 2025, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Kimberly-Clark Corporation, a Delaware corporation (“K-C” or, with reference to the post-closing period, the “combined company”), Vesta Sub I, Inc., a Delaware corporation and a direct wholly owned subsidiary of K-C (“First Merger Sub”), and Vesta Sub II, LLC, a Delaware limited liability company and a direct wholly owned subsidiary of K-C (“Second Merger Sub”).

The Merger Agreement provides for the combination of the Company and K-C upon the terms and subject to the conditions set forth therein (the “Proposed Transaction”), as described in Note 1, “Description of the Company and Summary of Significant Accounting Policies—Proposed Transaction with Kimberly-Clark,” to the Consolidated Financial Statements included herein.

On January 29, 2026, our shareholders approved the adoption of the Merger Agreement and K-C’s shareholders approved the issuance of K-C common stock in connection with the Proposed Transaction, in each case at a special meeting of shareholders held for that purpose.

Additionally, the waiting period applicable to the Proposed Transaction under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired on February 4, 2026.

The Proposed Transaction remains subject to the satisfaction or waiver of other customary closing conditions, including the receipt of a number of foreign regulatory approvals, as described in the Merger Agreement.

Separation from J&J

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In April 2023, J&J completed the transfer of substantially all of the assets and liabilities of the Consumer Health Business to us and our subsidiaries.

In May 2023, we completed an initial public offering (the “Kenvue IPO”) of approximately 10.4% of our outstanding common stock and began trading on the New York Stock Exchange (“NYSE”) under the ticker symbol “KVUE.” Following the Kenvue IPO, J&J owned approximately 89.6% of our outstanding common stock.

In July 2023, J&J announced an exchange offer (the “Exchange Offer”) under which its shareholders could exchange shares of J&J common stock for shares of our common stock owned by J&J.

In August 2023, J&J completed the Exchange Offer and exchanged shares representing 80.1% of our common stock, completing the Separation from J&J and transition to being a fully independent public company.

In May 2023, we completed an initial public offering (the “Kenvue IPO”) and began trading on the New York Stock Exchange (“NYSE”) under the ticker symbol “KVUE.” In July 2023, J&J announced an exchange offer (the “Exchange Offer”) under which its shareholders could exchange shares of J&J common stock for shares of our common stock owned by J&J.

In August 2023, J&J completed the Exchange Offer, completing the Separation and Kenvue’s transition to being a fully independent public company.

In May 2024, J&J completed an additional exchange offer (the “Debt-for-Equity-Exchange”) through which J&J exchanged indebtedness of J&J for shares of our common stock owned by J&J.

Following the completion of the Debt for Equity Exchange, J&J no longer owned any shares of our common stock.

Following the completion of the Debt-for-Equity Exchange, J&J did not own any shares of our common stock.

See Note 1, “Description of the Company and Summary of Significant Accounting Policies—Description of the Company and Business Segments,” to the Consolidated Financial Statements included herein for additional information.

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and Other Self Care (Digestive Health, Smoking Cessation, Eye Care, and Other).

Major brands in the segment include Tylenol ® , Motrin ® , Nicorette ® , Benadryl ® , Zyrtec ® , Zarbee’s ® , ORSL TM , Rhinocort ® , and Calpol ® .

Major brands in the segment include Benadryl ® , Calpol ® , Motrin ® , Nicorette ® , Rhinocort ® , Tylenol ® , Zarbee’s ® , and Zyrtec ® .

Our Self Care brands offer accessibility to healthcare solutions with over-the-counter (“OTC”) medicines and other naturally inspired products.

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and Hair, Sun, and Other.

Major brands in the segment include Neutrogena ® , Aveeno ® , Dr.Ci:Labo ® , OGX ® , Le Petit Marseillais ® , Lubriderm ® , and Rogaine ® .

Major brands in the segment include Aveeno ® , Dr.Ci:Labo ® , Le Petit Marseillais ® , Lubriderm ® , Neutrogena ® , OGX ® , and Rogaine ® .

Our portfolio of skin and hair care brands focus on dermatological solutions by leveraging partnerships with skin experts and scientific expertise to create differentiated, science-backed products recommended by healthcare professionals.

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and Other Essential Health (Women’s Health, Wound Care, and Other).

Major brands in the segment include Listerine ® , Johnson’s ® , BAND-AID ® Brand, Stayfree ® , o.b.

® tampons, Carefree ® , and Desitin ® .

Major brands in the segment include BAND-AID ® Brand, Carefree ® , Desitin ® , Johnson’s ® , Listerine ® , o.b.

® tampons, and Stayfree ® .

Our Essential Health brands raise standards of personal care across baby care, wound care, oral care, and menstrual health categories.

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It is our global scale and improving modern marketing capabilities that enable deep connections with consumers.

In 2024 we created the Global Content Factory, a production agency ecosystem that we employ to drive relevant content in all of our markets while reducing our costs.

We leverage insights across our product offerings to understand the constantly changing consumer behaviors and expectations, which allow us to evolve our brand messaging to ensure that we drive relevance with consumers and healthcare professionals, ultimately seeking to increase reach, stimulate demand, and drive growth.

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Product Development and Innovation

Our research and development organization combines multi-disciplinary scientific expertise with active engagement with healthcare professionals, placing human empathy at the core of our product development process.

Our research and development organization combines deep, multi-disciplinary scientific expertise with active engagement with healthcare professionals, placing human empathy at the heart of our product development process.

We leverage our extensive capabilities and deep consumer insights to develop innovative products and experiences that meet the specific needs of our consumers, enhancing their overall standard of everyday care.

Across our portfolio of iconic brands, we earn consumers’ trust through modern, science-backed innovations that deliver reliable personal care products and technologies that improve well-being.

Our global team of approximately 1,600 scientists, doctors, pharmacists, and engineers with expertise across a range of core disciplines, including formulation science, regulatory affairs, quality, medical affairs, medical safety, clinical operations, microbiology, translational science, and packaging.

Our research and development organization operates a global network of innovation hubs located close to consumers in key geographic markets.

Our global research and development teams collaborate across the product development lifecycle, partnering with consumers and leveraging our long-standing relationships with healthcare professionals and academic institutions to co-create a continuous pipeline of meaningful innovation.

Our global team of approximately 1,600 scientists, doctors, pharmacists, and engineers has expertise across a range of core disciplines, including formulation science, regulatory affairs, quality, medical affairs, medical safety, clinical operations, microbiology, translational science, and packaging.

The teams collaborate across the product development lifecycle, partnering with consumers and leveraging our long-standing relationships with healthcare professionals and academic institutions to co-create a continuous pipeline of meaningful innovation.

Our research and development organization operates a global network of innovation and development hubs located close to consumers in key geographic markets.

We have built extensive capabilities through our translational science and consumer insights teams to understand the key needs and current challenges of our consumers and healthcare professionals, ensuring our products are centered around human empathy.

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Our global and balanced manufacturing footprint provides us with the flexibility and agility to benefit from economies of scale and global supply chain agreements, enabling us to grow our business and expand margins.

We are continuously modernizing and optimizing our supply chain operations while better connecting with and serving our customers.

We modernize and optimize our supply chain operations while better connecting with and serving our customers.

Our end-to-end, digitally connected supply chain ecosystem is designed to optimize the flexibility and agility of our route-to-market.

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Our supply chain network is purpose-built to deploy resources across the globe where they are most needed.

Our sourcing, manufacturing, and demand planning capabilities are continuously optimized to meet evolving market dynamics.

We optimize our sourcing, manufacturing, and demand planning capabilities to meet evolving market dynamics.

Our extensive distribution network and sales organization enable us to establish strategic partnerships with key suppliers and retailers across multiple markets and channels, where we further leverage our scale to drive flexible manufacturing capacity and supply chain optimization.

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The principal raw materials used in our products include resins, silicon, pulp and corn derivatives, paper, agrochemicals, vegetable oils, and oleochemicals.

The majority of raw and packaging materials used are purchased from third parties and available from several sources.

The majority of raw and

packaging materials used are purchased from third parties and available from several sources.

We do purchase certain raw and packaging materials from single-source suppliers or a limited number of suppliers;

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Manufacturing Footprint

Our in-house manufacturing footprint delivered over 60% of our sales volume during the fiscal year 2024, with the remaining sales volume being supplied by an extensive network of external manufacturing facilities operated by trusted third-party

Our in-house manufacturing footprint delivered approximately 60% of our sales volume during the fiscal year 2025, with the remaining sales volume being supplied by an extensive network of external manufacturing facilities operated by trusted third-party suppliers.

This combination provides us with significant operational flexibility enhancing our ability to respond to demand while optimizing capital allocation.

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• Essential Health .

Church & Dwight, Colgate-Palmolive, Kimberly Clark, Procter & Gamble, Unilever, and private-label brands

Church & Dwight, Colgate-Palmolive, Haleon, Kimberly-Clark, Procter & Gamble, and private-label brands

See Part I, Item 1A, “Risk Factors” for additional information on our competitive risks.

Healthy Lives Mission

Our ESG management approach is designed to effectively govern and manage impacts and risks while also enabling us to identify opportunities that accelerate innovation and profitable growth and drive business value for all our stakeholders.

Our Healthy Lives Mission, which is our ESG strategy, includes public goals and commitments intended to position our brands as more positive choices for both people and the planet and to help manage ESG-related impacts, risks, and opportunities.

Kenvue’s Healthy Lives Mission is our call for everyday care in action and is supported by three pillars:

nurture Healthy People, enrich a Healthy Planet, and maintain Healthy Practice.

Within these three pillars, we are focused on nine priority areas for which we have established goals and commitments to hold ourselves accountable and demonstrate progress as outlined in our Healthy Lives Mission Report.

We will continue to provide more details about our progress against these goals and commitments in our upcoming Healthy Lives Mission Report.

For more information on our climate-related risks and opportunities informed by the recommendations

of the Task Force on Climate-related Financial Disclosures (“TCFD”), see our inaugural TCFD Report, which will be reviewed and updated periodically.

Kenvue’s Healthy Lives Mission, our sustainability strategy, includes public targets and is designed to effectively govern and manage impacts and risks while also enabling us to identify opportunities that accelerate innovation and profitable growth and drive business value for all our stakeholders.

Our Healthy Lives Mission is our call for everyday care in action, and we are focused on priority areas for which we have established goals and commitments to hold ourselves accountable and demonstrate progress as outlined in our annual Healthy Lives Mission Report.

We will continue to provide more details about our progress in our annual Healthy Lives Mission Report.

For more information on our climate-related risks and opportunities informed by the recommendations of the Task Force on Climate-related Financial Disclosures (“TCFD”), see our TCFD Report, which will be reviewed and updated periodically.

Our Healthy Lives Mission Report and TCFD Report are available at kenvue.com/our-commitments .

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As of December 28, 2025, we had approximately 22,000 employees, with approximately 23% located in North America, 28% in EMEA, 30% in APAC, and 19% in LATAM.

Approximately 99% of our global employees were full time and 1% were part-time employees.

Our global workforce covers a broad range of functions, including manufacturing employees making up 23% of our workforce.

Approximately 99% of our global employees were full-time and 1% were part-time.

Our global workforce covers a broad range of functions, with manufacturing employees making up 23% of our workforce.

At Kenvue, we believe everyday care is for everyone, everywhere.

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Our talent practices aim to drive higher levels of transparency, empowerment, and accountability that enables superior performance through high levels of engagement.

For example, we have initiatives in place to help ensure our hiring practices are fair, consistent, objective, and do not discriminate based on any legally protected category, so that our employees design and create everyday care products that are accessible to everyone.

We have initiatives in place to help ensure our hiring practices are fair, consistent, objective, and do not discriminate based on any legally protected category, so that our employees design and create everyday care products that are accessible to everyone.

We base talent decisions only on merit, considering qualifications, experience, skills, performance, and achievements.

Additionally, we nurture a sense of belonging for Kenvuers through numerous employee resource groups known as Kenvuer Impact Networks, mentorship programs, and other initiatives that are open to all Kenvuers.

In addition, we offer flexible work arrangements that enable agile ways of working and promote inclusion, health, well-being, empowerment, and accountability.

Learning and Development

We invest in the learning and development of all Kenvuers to ensure their skills remain relevant and keep pace with the rapid evolution in the marketplace.

Learning can happen in different ways, including on-the-job, on special assignment, and e-learning or in-classroom training, to develop functional and/or leadership skills.

Ultimately, our goal is to ensure this ongoing commitment to development and growth yields superior performance and higher levels of engagement that differentiates us from our competitors.

Learning to develop functional and/or leadership skills can happen in different ways, including on-the-job, on special assignment, and e-learning or in-classroom training.

Ultimately, our aim is to ensure this ongoing commitment to development and growth yields superior performance and higher levels of engagement that differentiates us from our competitors.

We believe that an engaged workforce is more likely to deliver higher levels of performance and further differentiates us in the marketplace.

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We reward and recognize superior performance and closely align Kenvuer compensation with company and individual performance.

We provide base pay that is competitive for a Kenvuer’s position considering skill level, experience, geographic location, and other business-related factors.

Our total rewards programs are designed to provide base pay that is competitive for a Kenvuer’s position considering skill level, experience, geographic location, and other business-related factors.

In addition to base pay, we seek to motivate and reward Kenvuers with annual cash incentives and equity-based awards, depending on job level.

Additionally, we conduct periodic benchmarking and comparative analyses to help ensure Kenvue’s compensation programs remain competitive and that employee pay is appropriate based on skills, expertise, education, and tenure.

Additionally, we periodically benchmark to help ensure Kenvue’s compensation programs remain competitive, and we regularly assess the appropriateness of employee pay based on skills, expertise, education, and tenure.

We offer competitive benefits packages, which vary by country and region, in support of the physical, emotional, and financial well-being of Kenvuers.

These benefits packages may include retirement plans, life insurance, medical and dental insurance, health savings accounts, well-being reimbursement programs, adoption assistance, fertility benefits, and parental and family leave.

In addition, we offer flexible work arrangements that enable agile ways of working and promote inclusion, health, well-being, empowerment, and accountability.

We strive to create an environment where Kenvuers feel a strong sense of belonging, are empowered to care for their health and well-being and that of their families, can grow and have fulfilling careers, and are recognized and valued for their contributions.

Workplace Safety

We have robust processes to identify potential safety risks associated with workplace activities and to develop measures and implement controls to mitigate possible exposure to hazards.

Within our facilities, we have processes to identify potential safety risks and develop and implement controls to mitigate possible exposure to hazards.

We support Kenvuers with general safety training and have implemented specific programs for those working in potentially high-risk environments.

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Establishing, maintaining, protecting, and enforcing our intellectual property and other proprietary rights in the United States and around the world is important to our success, and we consider these rights, in the aggregate, to be material to our business.

To facilitate the Separation and enable our operations to continue with minimal interruption following the Separation, J&J has granted licenses to use certain intellectual property rights retained by J&J that we used in the conduct of its business prior to the Separation, including the “Johnson & Johnson” name and signature and other legacy J&J branding, for a limited duration following the Separation.

For additional information about these licenses, see the Company’s definitive proxy statement for the 2024 Annual Meeting of Shareholders (the “2024 Proxy Statement”).

These licenses provide for terms of varying durations based on our particular use of a licensed intellectual property right.

For additional information about

these licenses, see the Company’s definitive proxy statement for the 2025 Annual Meeting of Shareholders (the “2025 Proxy Statement”).

Our brands are critical to our success, and trademark protection is an important part of establishing and maintaining brand recognition for our products in the United States and around the world.

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We seek to obtain protection for these trademarks and trade names by all appropriate means, and we consider them, in the aggregate, to be material to our business.

For trademarks registered in the United States, a Declaration of Use must be filed between the fifth and sixth years after initial registration, then may be renewed in the 10th year, and

renewed every 10 years after that, so long as the mark is still being used in commerce.

For trademarks registered in the United States, a Declaration of Use must be filed between the fifth and sixth years after initial registration, then may be renewed in the 10th year, and renewed every 10 years after that, so long as the mark is still being used in commerce.

Trademarks registered in other countries generally have varying terms and renewal policies.

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We are subject to extensive government regulations in the United States and around the world.

federal authorities, including the FDA, the Federal Trade Commission (“FTC”), the Consumer Product Safety Commission (“CPSC”), the Occupational Safety and Health Administration (“OSHA”), the Environmental Protection Agency (“EPA”), and the Drug Enforcement Administration (“DEA”), regulate various aspects of our business, along with parallel authorities at the state and local levels and comparable authorities in other jurisdictions.

federal authorities, including the FDA, the Federal Trade Commission (the “FTC”), the Consumer Product Safety Commission (the “CPSC”), the Occupational Safety and Health Administration (the “OSHA”), the Environmental Protection Agency (the “EPA”), and the Drug Enforcement Administration (the “DEA”), regulate various aspects of our business, along with parallel authorities at the state and local levels and comparable authorities in other jurisdictions.

Government regulations in the United States and around the world apply to many areas of our business, including most aspects of our products.

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The process of obtaining regulatory approvals and complying with applicable national and local regulations in the United States and around the world is complex, time-consuming, and costly and may impact our business strategies.

In addition, the global regulatory landscape is subject to rapid and unexpected changes and the general trend toward increasingly stringent regulation and enforcement around the world in recent years.

In addition, the global regulatory landscape is subject to rapid and unexpected changes, and there has been a general trend toward increasingly stringent regulation and enforcement around the world in recent years.

For additional information about risks associated with government regulations, see Part I, Item 1A, “Risk Factors—Risks Related to Government Regulation and Legal Proceedings.”

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Accordingly, certain of our products are subject to varying levels of regulation in different geographic markets.

The following description discusses the material effects of the regulatory landscape applicable to our business, with particular focus on the United States, the European Union (“EU”), and China, which are some of our key geographic markets for our business from a regulatory perspective and markets that we believe are representative of the material differences in the regulation of our business across the various geographic markets in which we operate.

The following description discusses the material effects of the regulatory landscape applicable to our business, with particular focus on the United States, the European Union (the “EU”), and China, which are some of our key geographic markets for our business from a regulatory perspective and markets that we believe are representative of the material differences in the regulation of our business across the various geographic markets in which we operate.

Quality and Safety

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Products are required to be manufactured in our facilities in accordance with current Good Manufacturing Practices (“cGMP”) or similar manufacturing standards in each country in which we manufacture products.

In addition, many of our products are subject to regulation by the CPSC under the Poison Prevention Packaging Act (“PPPA”), the Consumer Product Safety Act, the Federal Hazardous Substances Act, and other laws enforced by the CPSC.

In addition, many of our products are subject to regulation by the CPSC under the Poison Prevention Packaging Act (the “PPPA”), the Consumer Product Safety Act, the Federal Hazardous Substances Act, and other laws enforced by the CPSC.

These statutes and related regulations establish safety standards and bans for consumer products.

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The monographs establish the conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective and can be marketed without an NDA and FDA premarket approval.

Products marketed under the OTC monograph system are required to conform to specific quality, formula, and labeling

requirements.

Products marketed under the OTC monograph system are required to conform to specific quality, formula, and labeling requirements.

Monograph drug products that do not comply with these standards can be deemed unapproved new drugs and can be required to be withdrawn from the market.

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For example, in September 2021, the FDA issued a Proposed Order Amending the OTC Monograph for Sunscreen Drug Products requiring additional data for certain ingredients to ensure their safety.

In addition, certain of our OTC products, including certain Zyrtec ® , Zyrtec-D ® , Pepcid ® , and certain Imodium ® and Motrin ® products, are approved by the FDA through the NDA process rather than through the monograph system.

In addition, the DEA regulates certain of our OTC products containing pseudoephedrine (“PSE”), such as Sudafed ® and Zyrtec-D ® , pursuant to the Combat Methamphetamine Epidemic Act (“CMEA”).

In addition, certain of our OTC products, including certain Imodium ® , Motrin ® , Pepcid ® , and Zyrtec ® products, are approved by the FDA through the NDA process rather than through the monograph system.

Among other requirements, the CMEA sets daily and 30-day sales limits for PSE products purchased by consumers.

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Our OTC products containing PSE are also subject to heightened regulatory regimes in other jurisdictions around the world.

In the EU, our OTC products, including certain Nicorette ® products that are not marketed by us in the United States, are subject to extensive pre- and post-marketing regulation by regulatory authorities at both the EU and EU Member State level.

In the EU, our OTC products, including Nicorette ® products that are not marketed by us in the United States, are subject to extensive pre- and post-marketing regulation by regulatory authorities at both the EU and EU Member State level.

There are several administrative mechanisms to request regulatory approval of OTC products, including 1) the standalone national procedure for authorization in a single EU Member State, 2) the mutual recognition procedure, which is used when a product is already authorized in at least one EU Member State and approval is sought in at least one other EU Member State, and 3) the decentralized procedure, which is used when a product has not yet been authorized in the EU and authorization is sought simultaneously in several EU Member States.

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For example, in the EU, medications containing PSE have historically been regulated as OTC products.

During the fiscal three months ended December 29, 2024, Belgium, Luxembourg, and France changed the regulatory status of medications containing PSE from OTC to prescription-based.

In China, our OTC products are regulated by the National Medical Products Administration (“NMPA”), which is the primary authority for the safety and registration of medicines, medical devices, and cosmetics.

During the fiscal twelve months ended December 29, 2024, Belgium, Luxembourg, and France changed the regulatory status of medications containing PSE from OTC to prescription-only.

In China, our OTC products are regulated by the National Medical Products Administration (the “NMPA”), which is the primary authority for the safety and registration of medicines, medical devices, and cosmetics.

A number of our products marketed in the United States, including many of our products in the Skin Health and Beauty segment, are considered cosmetics regulated by the FDA through the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

Our cosmetic products include Aveeno ® Restorative Skin Therapy Oat Repairing Cream, Aveeno ® Restorative Skin Therapy Sulfate-Free Body Wash, Johnson’s ® Baby Powder, and certain of our Listerine ® mouthwash products.

Our cosmetic products include certain products under our Aveeno ® , Neutrogena ® , Lubriderm ® , and Johnson’s ® brands and certain of our Listerine ® mouthwash products.

Cosmetics are not subject to premarket approval by the FDA, but certain ingredients, such as certain color additives, are required to be preauthorized, and the FDA seeks to ensure cosmetic products are not adulterated or misbranded.

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In the event that the FDA determines that one of our products fails to comply with FDA regulations, we may be required, or we may independently decide, to conduct a recall or market withdrawal of that product or to correct the failure by making changes to that product, including its manufacturing, formulation, or label.

In addition, the Modernization of Cosmetics Regulation Act, enacted in December 2022, is expected to expand the FDA’s regulatory authority over cosmetic products, including by providing the FDA with new mandatory recall authority over cosmetics and by requiring the registration of cosmetic manufacturing facilities, the reporting of certain adverse events, the issuance of cGMP requirements, and the establishment of safety substantiation requirements.

In addition, the Modernization of Cosmetics Regulation Act, enacted in December 2022, expanded the FDA’s regulatory authority over cosmetic products, including by providing the FDA with new mandatory recall authority over cosmetics and by requiring the registration of cosmetic manufacturing facilities, the reporting of certain adverse events, the issuance of cGMP requirements, and the establishment of safety substantiation requirements.

In addition, certain of our cosmetic products, including those containing low-viscosity hydrocarbons such as baby oil, are regulated by the CPSC under the PPPA.

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Medical devices are subject to regulation in the various jurisdictions in which we operate.

Although there is variation among jurisdictions in how our products are classified, medical devices are broadly defined as products which a manufacturer intends

to be used to treat, cure, prevent, mitigate, or diagnose disease.

Although there is variation among jurisdictions in how our products are classified, medical devices are broadly defined as products which a manufacturer intends to be used to treat, cure, prevent, mitigate, or diagnose disease.

Medical devices generally achieve their purpose by physical modes of action;

the principal intended action may not be pharmacological, immunological, or metabolic.

Certain of our products marketed in the United States, such as BAND-AID ® Brand Adhesive Bandages (including Ourtone TM Adhesive Bandages), and Listerine ® Sensitivity Defense Mouthrinse are medical devices regulated by the FDA through a system that, unless exempt, requires us to receive premarket clearance for commercial distribution known as a 510(k) clearance.

Certain of our products marketed in the United States, such as BAND-AID ® Brand Adhesive Bandages (including Ourtone ® Adhesive Bandages) and Listerine ® Clinical Solutions – Sensitive Teeth mouthrinse, are medical devices regulated by the FDA through a system that, unless exempt, requires us to receive premarket clearance for commercial distribution known as a 510(k) clearance.

To obtain 510(k) clearance, a device is required to be determined to be substantially equivalent in intended use and in safety and efficacy to a benchmark device, or “predicate,” that is already legally in commercial distribution.

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If we determine that a new 510(k) clearance is not required but the FDA subsequently disagrees, the FDA may retroactively require us to obtain a new 510(k) clearance and may require us to cease marketing, or conduct a recall, of the modified device until the new 510(k) clearance is obtained.

In the EU, manufacturers may self-certify compliance of certain medical devices by submitting notifications to the competent authority, with files open to inspection by a competent authority.

In May 2021, the Medical Device Regulation (Regulation (EU) 2017/745) (“MDR”) came into effect in the EU.

The MDR is more comprehensive than the prior regime as it greatly increases the rigor and robustness of the regulations governing medical device products.

All medical devices are expected to meet the MDR requirements, and there is no “grandfathering” of products.

In addition, all approved products and their manufacturers are subject to re-review on periodic cycles of up to every four years.

In the EU, the Medical Device Regulation (Regulation (EU) 2017/745) allows manufacturers to self-certify compliance of certain medical devices by submitting notifications to the competent authority, with files open to inspection by a competent authority.

For other medical devices, a third-party organization designated by an EU Member State must certify.

In addition, all approved products and their manufacturers are subject to re-review on periodic cycles of up to every five years.

In recent years, we have also introduced certain connected health offerings as non-medical device apps, including certain products that are not offered in the United States and, as such, are not regulated as medical devices by the health authorities in the countries in which they are offered.

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The FDA is also responsible for taking action against any misbranded dietary supplement product after it reaches the market.

In addition, while our labeling and advertising claims for our monograph drug products, such as certain Benadryl ® , Tylenol ®, and Neutrogena ® products, and advertising claims for NDA products are not subject to approval by the FDA, labeling claims for our NDA products, such as certain Zyrtec ® , Pepcid ® , Imodium ® , and Motrin ® products, are approved by the FDA.

In addition, while our labeling and advertising claims for our monograph drug products, such as certain Benadryl ® , Neutrogena ® , and Tylenol ® products, and advertising claims for NDA products are not subject to approval by the FDA, labeling claims for our NDA products, such as certain Imodium ® , Motrin ® , Pepcid ® , and Zyrtec ® products, are approved by the FDA.

In certain circumstances, we may also be subject to additional regulations depending on the nature of the labeling and product claims.

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Department of Agriculture enforces federal standards for organic production and use of the term “organic” on product labeling.

The FTC regulates the use of endorsements and testimonials in advertising as well as relationships between us, on the one hand, and advertisers and influencers, on the other hand, pursuant to principles described in the FTC’s Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”).

Endorsements and Testimonials in Advertising (the “Endorsement Guides”).

The Endorsement Guides provide that an endorsement should reflect the honest opinion of the endorser and cannot be used to make a claim about a product that the product’s marketer could not itself legally make.

The Endorsement Guides also stipulate that, if there is a connection between an endorser and the marketer that consumers would not expect and this connection would affect how consumers evaluate the endorsement, then that connection should be disclosed.

If our advertising claims or claims made by our social media influencers

or by other endorsers with whom we have a material connection do not comply with the Endorsement Guides or any requirements of the FTC Act or similar state requirements, then the FTC and state authorities could subject us to investigations and enforcement actions, impose penalties, require us to pay monetary consumer redress, require us to revise our marketing materials, or require us to accept burdensome injunctions, any of which could adversely affect us.

Furthermore, the National Advertising Division (“NAD”) of the Better Business Bureau administers a self-regulatory program of the advertising industry to ensure truth and accuracy in national advertising.

NAD monitors national advertising and entertains inquiries and challenges from competitors and consumers.

We may also be subject to various state consumer protection laws, including California’s Proposition 65, which requires a specific warning on any product that contains a substance listed by California as having been found to cause cancer or birth defects, unless the level of such substance in the product is below a safe harbor level.

If our advertising claims or claims made by our social media influencers or by other endorsers with whom we have a material connection do not comply with the Endorsement Guides or any requirements of the Federal Trade Commission Act of 1914 (the “FTC Act”) or similar state requirements, then the FTC and state authorities could subject us to investigations and enforcement actions, impose penalties, require us to pay monetary consumer redress, require us to revise our marketing materials, or require us to accept burdensome injunctions, any of which could adversely affect us.

Furthermore, the National Advertising Division (the “NAD”) of the Better Business Bureau administers a self-regulatory program of the advertising industry to ensure truth and accuracy in national advertising.

The NAD monitors national advertising and entertains inquiries and challenges from competitors and consumers.

We are also subject to various state consumer protection laws, including California’s Proposition 65, which requires a specific warning on any product that contains a substance listed by California as having been found to cause cancer or birth defects, unless the level of such substance in the product is below a safe harbor level, and we may be subject to investigations by the various state attorneys general who enforce those consumer protection laws.

For example, in November 2025, we received a non-public Civil Investigative Demand (“CID”) from the Attorney General of the State of Texas pursuant to the Texas Deceptive Trade Practices-Consumer Protection Act.

The CID seeks documents related to certain Aveeno ® Baby products that are labelled as “hypoallergenic.” Although we will produce documents and information responsive to the CID, efforts to ensure that we are and remain compliant with the various state consumer protection laws may involve substantial costs, and we cannot predict the outcome of any such investigations or their potential impact on our business.

In the EU, advertising of products is subject both to general consumer advertising requirements pursuant to the Unfair Commercial Practices Directive (Directive 2005/29/EC), which imposes a general prohibition on misleading and aggressive advertising, as well as more specific regulations in respect of various product classifications.

For example, pursuant to Directive 2001/83/EC, advertisements of our OTC products must, among other requirements, 1) be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product, 2) not refer to claims of recovery in improper, alarming, or misleading terms, and 3) not suggest that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product.

The EU has also established a legal framework for cosmetic labeling claims based on the Cosmetics Products Regulation (Regulation (EC) No.

The EU has also established a legal framework for cosmetic labeling claims based on the Cosmetics Product Regulation (Regulation (EC) No.

So-called “responsible persons” must ensure that a cosmetic product made available on the market is safe for human health when used under normal or reasonably foreseeable conditions, taking into account presentation, labeling, instructions for use and disposal, and any other indication or information provided by the responsible person.

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and the cleanup of contamination in the environment.

For more information on the broad range of environmental, health, and safety laws that Kenvue is subject to.

See Part I, Item 1A, “Risk Factors — Risks Related to Government Regulation and Legal Proceedings — We are subject to a broad range of environmental, health, and safety laws and regulations, and the impact of any obligations under these laws and regulations could adversely affect us.”

For more information on the broad range of environmental, health, and safety laws that Kenvue is subject to, see Part I, Item 1A, “Risk Factors—Risks Related to Government Regulation and Legal Proceedings—We are subject to a broad range of environmental, health, and safety laws and regulations, and the impact of any obligations under these laws and regulations could adversely affect us.”

We are also subject to extensive and evolving regulations regarding the manufacturing, processing, distribution, importing, exporting, registration, and labeling of our products and their raw materials.

In the EU, the Registration, Evaluation, Authorisation, and Restriction of Chemicals (“REACH”) regulations came into effect in 2007, with implementation rolling out over time.

In the EU, the Registration, Evaluation,

Authorisation, and Restriction of Chemicals (“REACH”) regulations came into effect in 2007, with implementation rolling out over time.

Registered chemicals then can be subject to further evaluation and potential restrictions.

Since the promulgation of REACH, other countries have enacted or are in the process of implementing similar comprehensive chemical regulations.

Our operations are also subject to regulation under OSHA and parallel state and local occupational health and safety standards, as well as occupational health and safety standards applicable to our operations in other jurisdictions.

These standards establish certain employer responsibilities, including requirements to maintain a workplace free of recognized hazards likely to cause serious injury or death, certain medical and hygiene standards, licensing, and permitting obligations and various recordkeeping, disclosure, and procedural requirements.

Our operations are also subject to regulation under the OSHA and parallel state and local occupational health and safety standards, as well as occupational health and safety standards applicable to our operations in other jurisdictions.

Privacy and Data Protection

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We are also subject to federal health information privacy laws.

Outside the United States, the European Union’s General Data Protection Regulation (“EU GDPR”) and the United Kingdom’s General Data Protection Regulation (“U.K.

Outside the United States, the European Union’s General Data Protection Regulation (the “EU GDPR”) and the United Kingdom’s General Data Protection Regulation (“U.K.

GDPR”), together with national legislation, regulations, and guidelines of the EU Member States and the United Kingdom governing the processing of personal data, impose strict obligations and restrictions on the ability to collect, analyze, store, transfer, and otherwise process personal data, including health data and adverse event reporting.

In China, we are subject to the Personal Information Protection Law (“PIPL”), which applies to the processing of personal information of natural persons within China, the processing of personal information outside China where the purpose is to provide products and services within China, and the analysis or assessment of the activities of individuals within China.

In China, we are subject to the Personal Information Protection Law (the “PIPL”), which applies to the processing of personal information of natural persons within China, the processing of personal information outside China where the purpose is to provide products and services within China, and the analysis or assessment of the activities of individuals within China.

While similar to the EU GDPR, the PIPL contains unique requirements not found in the EU GDPR.

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We are subject to various anti-corruption laws and regulations, such as the U.S.

Foreign Corrupt Practices Act (“FCPA”), that generally prohibit companies from promising, offering, or giving anything of value to foreign officials with the corrupt intent of influencing the foreign official for the purpose of obtaining or retaining business or gaining any improper advantage.

Foreign Corrupt Practices Act (the “FCPA”), that generally prohibit companies from promising, offering, or giving anything of value to foreign officials with the corrupt intent of influencing the foreign official for the purpose of obtaining or retaining business or gaining any improper advantage.

Similar to the U.S.

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Treasury Department’s Office of Foreign Assets Control) and other authorities that may prohibit us or our affiliates from doing business in certain countries or restrict the type of business that may be conducted by us or our affiliates.

For example, actions taken in response to the ongoing military conflict between Russia and Ukraine (the “Russia-Ukraine War”) have included the imposition of export controls and broad financial and economic sanctions against Russia, Belarus, and specific areas of Ukraine.

In addition, we are subject to trade controls (including import and export restrictions, such as tariffs, sanctions, quotas, or trade barriers) imposed by the United States and other jurisdictions around the world.

Enforcement activities under these laws and regulations could subject us to additional administrative and legal proceedings and actions, which could include claims for civil penalties, criminal sanctions, and administrative remedies.

While seasonality has a limited impact on the consolidated Net sales within all three of our reportable segments, we are subject to certain degrees of seasonal sales fluctuations.

For example, in our Self Care segment, certain of our OTC products, such as Tylenol ® and Motrin ® , are typically purchased more frequently in preparation for the cold and flu season in the winter or, in the case of Zyrtec ® and Benadryl ® , during high allergy seasons in the spring and the fall.

In addition, in our Skin Health and Beauty

segment, sales of our products that contain SPF are typically higher in preparation for the summer, and sales of our products that contain moisturizers are typically higher in the fall and the winter.

While seasonality has a limited impact on the Net sales within our consolidated results, we are subject to certain degrees of seasonal sale fluctuations.

For example, in our Self Care segment, certain of our OTC products, such as Motrin ® and Tylenol ® , are typically purchased more frequently in preparation for the cold and flu season in the winter or, in the case of Benadryl ® and Zyrtec ® , during high allergy seasons in the spring and the fall.

In addition, in our Skin Health and Beauty segment, sales of our products that contain SPF are typically higher in preparation for the summer, and sales of our products that contain moisturizers are typically higher in the fall and the winter.

Finally, in our Essential Health segment, certain of our wound care products are typically purchased more frequently in the summer months.

Available Information

The Company’s main corporate website address is kenvue.com .

All of the Company’s SEC filings are available free of charge on the Company’s investor relations website at investors.kenvue.com , as soon as reasonably practicable after having been electronically filed or furnished to the SEC.

Our main corporate website address is kenvue.com .

Our SEC filings are available free of charge on our investor relations website at investors.kenvue.com as soon as reasonably practicable after having been electronically filed or furnished to the SEC.

We file annual reports, quarterly reports, current reports, proxy statements, and other documents with the SEC under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The SEC maintains an internet site that contains reports, proxy statements, information statements, and other information regarding issuers that file electronically with the SEC at https://www.sec.gov .

The Company encourages investors and others interested in the Company to review the information posted to its investor relations site, the Company’s SEC filings, press releases, public conference calls, and webcasts.

We encourage investors and others interested in the Company to review the information posted to our investor relations site, our SEC filings, press releases, public conference calls, and webcasts.

Use of Website to Provide Information

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In order to receive notifications regarding new postings to our website, investors are encouraged to enroll on our website to receive automatic email alerts.

None of the information on our website is incorporated into this Annual Report on Form 10-K or any other filings the Company makes with the SEC.

None of the information on our website is incorporated into this Annual Report on Form 10-K or any other filings we make with the SEC.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business