What changed in this filing

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Item 1. Business

2025-02-13 compared with 2024-02-16 · 65 added, 75 removed, 151 unchanged (48% of the section changed)

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Johnson & Johnson was incorporated in the State of New Jersey in 1887.

The Executive Committee of Johnson & Johnson is the principal management group responsible for the strategic operations and allocation of the resources of the Company.

This Committee oversees and coordinates the activities of the Company's two business segments:

Innovative Medicine (previously referred to as Pharmaceutical) and MedTech.

Within the strategic parameters provided by the Committee, senior management groups at U.S.

The Chief Operating Decision Maker (CODM) is the Company's Chief Executive Officer (Principal Executive Officer).

The Executive Committee is Johnson & Johnson’s senior leadership team responsible for setting the strategy and priorities of the Company and driving accountability at all levels.

Within the strategic parameters provided by the Executive Committee, senior management groups at U.S.

and international operating companies are each responsible for their own strategic plans and the day-to-day operations of those companies.

Each subsidiary within the business segments is, with limited exceptions, managed by residents of the country where located.

Segments of business

Following the completion of the separation of the Consumer Health business (Kenvue) in August 2023, the Company is now organized into two business segments:

The Company is organized into two business segments:

Innovative Medicine and MedTech.

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STELARA (ustekinumab), a treatment for adults and children with moderate to severe plaque psoriasis, for adults with active psoriatic arthritis, for adults with moderately to severely active Crohn's disease and treatment of moderately to severely active ulcerative colitis;

TREMFYA (guselkumab), a treatment for adults with moderate to severe plaque psoriasis and active psoriatic arthritis;

TREMFYA (guselkumab), a treatment for adults with moderate to severe plaque psoriasis and active psoriatic arthritis and ulcerative colitis;

EDURANT (rilpivirine), PREZISTA (darunavir) and PREZCOBIX/REZOLSTA (darunavir/cobicistat), antiretroviral medicines for the treatment of human immunodeficiency virus (HIV) in combination with other antiretroviral products and SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide), a once-daily single tablet regimen for the treatment of HIV;

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SPRAVATO (Esketamine), a nasal spray, used along with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions;

CARVYKTI (ciltacabtagene autoleucel), a chimeric antigen receptor (CAR)-T-cell therapy for the treatment of patients with relapsed/refractory multiple myeloma;

ZYTIGA (abiraterone

CARVYKTI (ciltacabtagene autoleucel), a chimeric antigen receptor (CAR)-T-cell therapy for the treatment of patients with relapsed/refractory multiple

2024 Annual Report

acetate), a treatment for patients with prostate cancer;

ZYTIGA (abiraterone acetate), a treatment for patients with prostate cancer;

ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer;

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DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a treatment for multiple myeloma and light chain (AL) Amyloidosis;

TECVAYLI (teclistamab-cqyv), a ready-to-use bispecific antibody for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy;

XARELTO (rivaroxaban), an oral anticoagulant for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment and reduction of risk of recurrence of DVT and PE to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD), for the treatment and secondary prevention of thromboembolism in pediatric patients, and for thromboprophylaxis in pediatric patients following the Fontan procedure;

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Many of these medicines were developed in collaboration with strategic partners or are licensed from other companies and maintain active lifecycle development programs.

The MedTech segment includes a broad portfolio of products used in the Interventional Solutions, Orthopaedics, Surgery and Vision categories.

Interventional Solutions include electrophysiology products (Biosense Webster) to treat heart rhythm disorders, the heart recovery portfolio (Abiomed) which includes technologies to treat severe coronary artery disease requiring high-risk PCI or AMI cardiogenic shock, and Neurovascular care (Cerenovus) that treats hemorrhagic and ischemic stroke.

The Orthopaedics portfolio (DePuy Synthes) includes products and enabling technologies that support Hips, Knees, Trauma, and Spine, Sports & Other.

The Surgery portfolios include advanced and general surgery technologies (Ethicon), as well as solutions that focus on breast aesthetics (Mentor), and Ear, Nose and Throat (Acclarent) procedures.

Johnson & Johnson Vision products include ACUVUE Brand contact lenses and TECNIS intraocular lenses for cataract surgery.

These products are distributed to wholesalers, hospitals and retailers, and used predominantly in the professional fields by physicians, nurses, hospitals, eye care professionals and clinics.

The MedTech segment includes a broad portfolio of products used in the cardiovascular, orthopaedics, surgery, and vision categories.

The Cardiovascular (previously referred to as Interventional solutions) portfolio includes electrophysiology products to treat heart rhythm disorders, the heart recovery portfolio (Abiomed) which includes technologies to treat severe coronary artery disease requiring high-risk PCI or AMI cardiogenic shock, circulatory restoration products (Shockwave) for the treatment of calcified coronary artery disease (CAD) and peripheral artery disease (PAD), and neurovascular care that treats hemorrhagic and ischemic stroke.

The Orthopaedics portfolio includes products and enabling technologies that support hips, knees, trauma, spine, sports, and others.

The Surgery portfolios include advanced and general surgery technologies, as well as solutions that focus on breast aesthetics and reconstruction (Mentor).

Vision products include ACUVUE brand contact lenses and TECNIS intraocular lenses for cataract surgery.

These products are distributed to wholesalers, hospitals, and retailers and are used predominantly in the professional fields by physicians, nurses, hospitals, eye care professionals, and clinics.

Geographic areas

Johnson & Johnson and its subsidiaries (the Company) have approximately 131,900 employees worldwide engaged in the research and development, manufacture and sale of a broad range of products in the healthcare field.

The Company conducts business in virtually all countries of the world with the primary focus on products related to human health and well-being.

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However, the principal markets, products and methods of distribution in the international business vary with the country and the culture.

The products sold in international business include those developed in the U.S.

The products sold in the international business include those developed in the U.S.

and by subsidiaries abroad.

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and other countries relating to their products, product uses, formulations and manufacturing processes, which in the aggregate are believed to be of material importance to the Company in the operation of its businesses.

The Company’s subsidiaries face patent challenges from third parties, including challenges seeking to manufacture and market generic and biosimilar versions of the Company's key

pharmaceutical products prior to expiration of the applicable patents covering those products.

Significant legal proceedings and claims involving the Company's patent and other intellectual property are described in Note 19 Legal proceedings—Intellectual property of the Notes to Consolidated Financial Statements included in Item 8 of this Report.

Sales of the Company’s largest product, STELARA (ustekinumab) accounted for approximately 12.8% of the Company's total revenues for fiscal 2023.

Accordingly, the patents related to this product are believed to be material to the Company.

Janssen Biotech, Inc., a wholly-owned subsidiary of Johnson & Johnson, owns patents specifically related to STELARA.

The latest expiring United States composition of matter patent expired in 2023.

As a result of settlements and other agreements with third parties, the Company does not anticipate the launch of a biosimilar version of STELARA before January 1, 2025 in the United States.

The latest expiring European composition of matter patent (Supplementary Protection Certificate) expires in 2024.

Sales of the Company’s second largest product, collectively DARZALEX (daratumumab) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), accounted for approximately 11.4% of the Company's total revenues for fiscal 2023.

Accordingly, the patents related to this product are believed to be material to the Company.

The Company’s subsidiaries face patent challenges from third parties, including challenges seeking to manufacture and market generic and biosimilar versions of the Company's key pharmaceutical products prior to expiration of the applicable patents covering those products.

Significant legal proceedings

and claims involving the Company's patent and other intellectual property are described in Note 19 Legal proceedings—Intellectual property of the Notes to Consolidated Financial Statements included in Item 8 of this Report.

Sales of the Company’s largest product, collectively DARZALEX (daratumumab) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), accounted for approximately 13.1% of the Company's total revenues for fiscal 2024.

Accordingly, the patents related to these products are believed to be material to the Company.

Genmab A/S owns two patent families related to DARZALEX, and Janssen Biotech, Inc.

has an exclusive license to those patent families.

The two patent families both expire in the United States in 2029, and in Europe, compound patent protection in select countries extends to 2031/2032.

The two patent families both expire in the United States in 2029, and in Europe, compound/use patent protection in select countries extends to 2031/2032.

Janssen Biotech, Inc.

owns a separate patent portfolio related to DARZALEX FASPRO.

Sales of the Company’s second largest product, STELARA (ustekinumab) accounted for approximately 11.7% of the Company's total revenues for fiscal 2024.

According to patent settlement and license agreements, the Company expects continued launches of biosimilar versions of STELARA in Europe and the United States in 2025 which will impact the Company’s sales of STELARA.

The Company’s subsidiaries have made a practice of selling their products under trademarks and of obtaining protection for these trademarks by all available means.

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however, spending has typically been heavier in the fourth quarter of each year than in other quarters.

This reflects increased spending decisions, principally for research and development activity.

This reflects increased spending decisions, principally for advertising and research and development activity.

In all of their product lines, the Company's subsidiaries compete with companies both locally and globally.

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The Company’s compliance with these requirements is not expected to have a material effect upon its capital expenditures, cash flows, earnings or competitive position.

2023 Annual Report

The Company’s businesses are subject to varying degrees of governmental regulation in the countries in which operations are conducted, and the general trend is toward increasingly stringent regulation and enforcement.

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Similar trends are also evident in major markets outside of the U.S.

The new medical device regulatory framework and the evolving privacy, data localization, and emerging cyber security laws and regulations around the world are examples of such increased regulation.

2024 Annual Report

The medical device regulatory framework and the evolving privacy, data localization, and emerging cyber security laws and regulations around the world are examples of such increased regulation.

Within the U.S., an increasing number of U.S.

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These laws can also restrict transfers of data across borders, potentially impacting how data-driven health care solutions are developed and deployed globally in a compliant manner.

Moreover, as a result of the broad scale release and availability of Artificial Intelligence (AI) technologies such as generative AI, a global trend towards more comprehensive and nuanced regulation (e.g., White House’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence;

the EU AI Act) to ensure the ethical use, privacy, and security of AI is underway that includes standards for transparency, accountability, and fairness, which will require compliance developments or enhancements.

Moreover, as a result of the broad scale release and availability of Artificial Intelligence (AI) technologies such as generative AI, a global trend towards more comprehensive and nuanced regulation to ensure the ethical use, privacy, and security of AI is underway that includes standards for transparency, accountability, and fairness, which will require compliance developments or enhancements.

The regulatory agencies under whose purview the Company operates have administrative powers that may subject it to actions such as product withdrawals, recalls, seizure of products and other civil and criminal sanctions.

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FDA and regulatory agencies around the globe are also increasing their enforcement activities.

FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our pharmaceutical products or medical technologies are ineffective or pose an unreasonable health risk, the U.S.

FDA could ban such products, detain or seize adulterated or misbranded products, order a recall, repair, replacement, or refund of such products, refuse to grant pending applications for marketing authorization or require certificates of foreign governments for exports, and/or require us to notify health professionals and others that the products present unreasonable risks of substantial harm to the public health.

FDA could ban such products, detain or seize adulterated or misbranded products, order a recall, repair, replacement, or refund of such products, withdraw approval for such products, refuse to grant pending applications for marketing authorization or require certificates of foreign governments for exports, and/or require us to notify health professionals and others that the products present unreasonable risks of substantial harm to the public health.

FDA may also assess civil or criminal penalties against us, our officers or employees and impose operating restrictions on a company-wide basis, or enjoin and/or restrain certain conduct resulting in violations of applicable law.

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Department of Justice.

Any adverse regulatory action, depending on its magnitude, may restrict us from effectively marketing and selling our products and limit our ability to obtain future clearances or approvals, and could result in a substantial modification to our business practices and operations.

Any adverse regulatory action, depending on its magnitude, may restrict us from effectively marketing and selling our products and limit our ability to obtain future clearances, classifications or approvals, and could result in a substantial modification to our business practices and operations.

Equivalent enforcement mechanisms exist in different countries in which we conduct business.

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Our business has been and continues to be affected by federal and state legislation that alters the pricing, coverage, and reimbursement landscape.

At the federal level, in August 2022, President Biden signed into law the Inflation Reduction Act

(IRA), which includes provisions that effectively authorize the government to establish prices for certain high-spend single-source drugs and biologics reimbursed by the Medicare program, starting in 2026 for Medicare Part D drugs and 2028 for Medicare Part B drugs.

At the federal level, in August 2022, President Biden signed into law the Inflation Reduction Act (IRA), which includes provisions that effectively authorize the government to establish prices for certain high-spend single-source drugs and biologics reimbursed by the Medicare program, starting in 2026 for Medicare Part D drugs and 2028 for Medicare Part B drugs.

On August 29, 2023, the Centers for Medicare & Medicaid Services (“CMS”) published the first “Selected Drug” list, which includes XARELTO and STELARA as well as IMBRUVICA, which is developed in collaboration and co-commercialized in the U.S.

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The Selected Drug list also included other medicines targeting disease states that are prevalent in the Medicare population.

There remains uncertainty, however, regarding how the federal government will establish prices for the selected products, as the IRA specifies a ceiling price but not a minimum price.

In any event, we anticipate that the selected products will be subjected to a government-established price for the Medicare population.

Although CMS published an explanation for how it determined prices for selected drugs in December 2024, uncertainty remains as to the methodology used to determine these prices.

The IRA specifies a ceiling price but not a minimum price for selected drugs and does not require CMS to use a specific framework for determining selected drug prices.

In any event, we anticipate that the selected products will be subjected to a government-established price for the Medicare population beginning in 2026.

The IRA also contains provisions that impose rebates if certain prices increase at a rate that outpaces the rate of inflation, beginning October 1, 2022, for Medicare Part D drugs and January 1, 2023, for Medicare Part B drugs.

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(Janssen) filed litigation against the U.S.

Department of Health and Human Services as well as the Centers for Medicare and Medicaid Services challenging the constitutionality of the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program.

Department of Health and Human Services as well as the Centers for Medicare and Medicaid Services challenging the constitutionality of the IRA's Medicare Drug Price Negotiation Program.

The litigation requests a declaration that the IRA violates Janssen’s rights under the First Amendment and the Fifth Amendment to the Constitution and therefore that Janssen is not subject to the IRA’s mandatory pricing scheme.

The impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as litigation filed by Janssen and other pharmaceutical companies remains ongoing and CMS has yet to publicly announce the maximum fair price for each of the selected drugs.

The impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as litigation filed by Janssen and other pharmaceutical companies remains ongoing and while CMS has publicly announced the maximum fair price for each of the selected drugs, implementation of the program is still in progress.

In April 2024, Janssen appealed the district court’s denial of its summary judgment motion to the Third Circuit.

Additionally, we expect continued scrutiny on drug pricing and government price reporting from Congress, agencies, and other bodies at the federal and state levels, which may result in additional regulations or other mechanisms to increase pricing transparency and controls.

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Employees and human capital management

As of December 31, 2023, the number of employees was approximately:

As of December 29, 2024 and December 31, 2023 the number of employees was approximately:

Employees (1)

139,800 134,400

Full-time equivalent (FTE) positions (2)

138,100 131,900

(1) “Employee” is defined as an individual working full-time or part-time, excluding fixed term employees, interns and co-op employees.

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Contingent workers, contractors and subcontractors are also excluded.

Shockwave has been included in the fiscal 2024 headcount in the above table.

(2) FTE represents the total number of full-time equivalent positions and does not reflect the total number of individual employees as some work part-time.

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The Company’s human capital management strategy is built on three fundamental focus areas:

• Attracting and recruiting the best talent

• Developing and retaining talent

• Attracting and recruiting top talent

• Developing and retaining top talent

• Empowering and inspiring talent

Underpinning these focus areas are ongoing efforts to cultivate and foster a culture built on diversity, equity and inclusion (DEI), innovation, health, well-being and safety, where the Company's employees are encouraged to succeed both professionally and personally while helping the Company achieve its business goals.

Underpinning these focus areas are ongoing efforts to cultivate and foster a culture built on innovation, health, well-being and safety, inclusion and belonging where the Company's employees are encouraged to succeed both professionally and personally while helping the Company achieve its business goals.

Culture and employee engagement

At the Company, employees are guided by Our Credo which sets forth the Company's responsibilities to patients, consumers, customers, healthcare professionals, employees, communities and shareholders.

Employees worldwide must adhere to the Company’s Code of Business Conduct which sets basic requirements and serves as a foundation for the Company policies, procedures and guidelines, all of which provide additional guidance on expected employee behaviors in every market where it operates.

At Johnson & Johnson, employees are guided by Our Credo, which sets forth the Company's responsibilities to patients, consumers, customers, healthcare professionals, employees, communities and shareholders.

Employees worldwide must adhere to the Company’s Code of Business Conduct, which sets fundamental requirements and serves as a foundation for the Company policies, procedures and guidelines, all of which provide additional guidance on expected employee behaviors in every market where it operates.

The Company conducts global surveys that offer its employees the ability to provide feedback and valuable insight to help address potential human resources risks and identify opportunities to improve.

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In furtherance of this objective, the Company deploys a global approach to ensure development is for everyone, regardless of where they are on their career journey.

To prioritize learning, the Company recently held Johnson & Johnson's first Global Learning Day.

Employees were encouraged to set aside a full day to explore skill-building courses across five areas:

leadership, business skills, digital upskilling, DEI, and well-being, on J&J Learn, the Company's new learning platform.

Diversity, equity, and inclusion (DEI)

The Company is committed to workplace diversity and to cultivating, fostering, and advancing a culture of equity and inclusion.

The Company’s evidenced-based global enterprise Diversity, Equity and Inclusion strategy recognizes how DEI accelerates the Company's ability to meet the changing needs of the communities the Company serves in, as outlined in Our Credo.

The Company’s DEI Vision is:

Be yourself, change the world .

The Company's DEI Mission is:

Make diversity, equity and inclusion how we work everyday .

The Company's enterprise DEI Strategy is aligned to the DEI Vision and Mission and rests on four core pillars:

• Build a workforce of individuals with diverse backgrounds, cultures, abilities and perspectives

• Foster a culture of inclusion where every individual belongs

• Transform talent and business processes to achieve equitable opportunities for all

• Drive innovation and growth with our business to serve diverse markets around the world

The Company's DEI strategy is guided by internal and external insights, global best practices and continual employee feedback and recognizes that while diversity changes by location, inclusion is the same everywhere.

2023 Annual Report

To prioritize learning, the Company recently held Johnson & Johnson's second Global Learning Day.

Employees were encouraged to set aside a full day to explore skill-building courses on J&J Learn, the new state-of-the-art learning platform.

Our workforce

As stated in Our Credo, we are responsible to our employees who work with us throughout the world.

The Company is committed to cultivating, fostering and advancing an inclusive, credo-based work environment for employees that recognizes and rewards based on merit.

The Company is dedicated to the values in Our Credo and strives to meet the needs of its employees and stakeholders through compliance with law and the following evidence based strategies:

• Sustain a global workforce of individuals with many different backgrounds, abilities, cultures and perspectives

• Maintain a work environment where each person’s dignity is respected and they have an opportunity to advance based on their merit

• Drive innovation and growth with our business to serve markets around the world

Our approach with respect to our workforce is guided by applicable laws, internal and external insights, global best practices and employee feedback.

Compensation and benefits

As part of the Company's total rewards philosophy, the Company offers competitive compensation and benefits to attract and retain top talent.

The Company is committed to fairness and equitable treatment in its compensation and benefits for employees at all levels.

The Company is committed to fair treatment in its compensation and benefits for employees at all levels.

The Company observes legal minimum wage provisions and exceeds them where possible.

The Company's total rewards offerings include an array of programs to support its employees' well-being, including annual performance incentive opportunities, pension and retirement savings programs, health and welfare benefits, paid time off, leave programs, flexible work schedules and employee assistance programs.

In recognition of the Company’s commitment to help employees balance their personal and professional responsibilities, the Company enhanced its caregiver, bereavement, and volunteer paid leave benefits, effective July 2023.

Health, wellness and safety

The Company’s investment in employee health, well-being and safety is built on its conviction that advancing health for humanity starts with advancing the health of its employees.

With the right awareness, focus, practices and tools, the Company ensures that all its employees around the world, as well as temporary contractors and visitors to the Company's sites, can work safely.

With the right awareness, focus, practices and tools, the Company works to ensure that all its employees around the world, as well as contingent workers, contractors and visitors to the Company's sites, can work safely.

The Company has continuously expanded health and well-being programs throughout the Company and across the globe, incorporating new thinking and technologies to keep its offerings best-in-class and to help employees achieve their personal health goals.

The programs and practices the Company advances for total health—physical, mental, emotional and financial—ensure employee health protection for emerging health risks.

The Company continues to address our employees needs through J&J Flex, a hybrid model that empowers the Company’s office-based employees to find the right productivity and balance of in-person and remote work.

The programs and practices the Company provides—physical, mental, emotional and financial—help promote holistic employee health.

The Company continues to address our employees needs through J&J Flex, a hybrid model that empowers the Company’s office-based employees to find a balance of in-person and remote work, while preserving the Company's culture and need for face-to-face engagement and leadership.

2024 Annual Report

Available information

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The Company's SEC filings are also available at the SEC’s website at www.sec.gov .

Investors and the public should note that the Company also announces information at www.factsaboutourprescriptionopioids.com , www.factsabouttalc.com and www.LLTManagementInformation.com .

Investors and the public should note that the Company also announces information through its press releases and media statements at www.jnj.com/mediacenter , investor.jnj.com and www.factsabouttalc.com .

We use these websites to communicate with investors and the public about our products, litigation and other matters.

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Therefore, we encourage investors and others interested in the Company to review the information posted to these websites in conjunction with www.jnj.com , the Company's SEC filings, press releases, public conference calls and webcasts.

In addition, the Amended and Restated Certificate of Incorporation, By-Laws, the written charters of the Audit Committee, the Compensation & Benefits Committee, the Nominating & Corporate Governance Committee, the Regulatory Compliance & Sustainability Committee, the Science & Technology Committee and any special committee of the Board of Directors and the Company’s Principles of Corporate Governance, Code of Business Conduct (for employees), Code of Business Conduct & Ethics for Members of the Board of Directors and Executive Officers, and other corporate governance materials, are available at www.investor.jnj.com/governance/corporate-governance-overview on the Company's website and will be provided without charge to any shareholder submitting a written request, as provided above.

The information on www.jnj.com , www.factsaboutourprescriptionopioids.com , www.factsabouttalc.com and www.LLTManagementInformation.com is not, and will not be deemed, a part of this Report or incorporated into any other filings the Company makes with the SEC.

In addition, the Restated Certificate of Incorporation, as amended, Amended and Restated By-Laws, the written charters of the Audit Committee, the Compensation & Benefits Committee, the Nominating & Corporate Governance Committee, the Regulatory Compliance & Sustainability Committee, and the Science & Technology Committee of the Board of Directors, and the Company’s Principles of Corporate Governance, Code of Business Conduct (for employees), Code of Business Conduct & Ethics for Members of the Board of Directors and Executive Officers, and other corporate governance materials are available on the Company's website at www.investor.jnj.com/governance/corporate-governance-overview and will be provided without charge to any shareholder submitting a written request, as provided above.

The information on www.jnj.com , investor.jnj.com and www.factsabouttalc.com is not, and will not be deemed, a part of this Report or incorporated into any other filings the Company makes 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