What changed in this filing

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Item 1. Business

2026-02-11 compared with 2025-02-13 · 70 added, 52 removed, 164 unchanged (43% of the section changed)

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The Innovative Medicine segment is focused on the following therapeutic areas:

Immunology (e.g., rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease and psoriasis), Infectious Diseases (e.g., HIV/AIDS), Neuroscience (e.g., mood disorders, neurodegenerative disorders and schizophrenia), Oncology (e.g., prostate cancer, hematologic malignancies, lung cancer and bladder cancer), Cardiovascular and Metabolism (e.g., thrombosis, diabetes and macular degeneration) and Pulmonary Hypertension (e.g., Pulmonary Arterial Hypertension).

Oncology (e.g., prostate cancer, hematologic malignancies, lung cancer and bladder cancer), Immunology (e.g., rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease and psoriasis), Neuroscience (e.g., mood disorders, neurodegenerative disorders and schizophrenia), Pulmonary Hypertension (e.g., Pulmonary Arterial Hypertension), Infectious Diseases (e.g., HIV/AIDS) and Cardiovascular and Metabolism (e.g., thrombosis, diabetes and macular degeneration).

Medicines in this segment are distributed directly to retailers, wholesalers, distributors, hospitals and healthcare professionals for prescription use.

Key products in the Innovative Medicine segment include:

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

DARZALEX (daratumumab), a treatment for multiple myeloma;

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

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

IMBRUVICA (ibrutinib), a treatment for certain B-cell malignancies, or blood cancers and chronic graft versus host disease;

RYBREVANT (amivantamab), a fully-human bispecific antibody for adults with EGFR-mutated non-small cell lung cancer and LAZCLUZE (lazertinib), an oral, brain-penetrant EGFR tyrosine kinase inhibitor for non-small cell lung cancer;

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), a subcutaneous therapy for patients with non-small cell lung cancer;

TALVEY (talquetamab-tgvs) a bispecific antibody for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy;

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

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

REMICADE (infliximab), a treatment for a number of immune-mediated inflammatory diseases;

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SIMPONI ARIA (golimumab), an intravenous treatment for adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis and active polyarticular juvenile idiopathic arthritis (pJIA) in people 2 years of age and older;

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 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;

2025 Annual Report

ulcerative colitis;

TREMFYA (guselkumab), a treatment for patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis;

CAPLYTA (lumateperone) is used in adults along with an antidepressant to treat major depressive disorder (MDD), depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate;

or to treat schizophrenia;

CONCERTA (methylphenidate HCl) extended-release tablets CII, a treatment for attention deficit hyperactivity disorder;

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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

2024 Annual Report

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;

IMBRUVICA (ibrutinib), a treatment for certain B-cell malignancies, or blood cancers and chronic graft versus host disease;

DARZALEX (daratumumab), a treatment for multiple myeloma;

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;

OPSUMIT (macitentan) as monotherapy or in combination, indicated for the long-term treatment of pulmonary arterial hypertension (PAH);

OPSUMIT (macitentan)/OPSYNVI (macitentan/tadalafil) as monotherapy or in combination, indicated for the long-term treatment of pulmonary arterial hypertension (PAH);

UPTRAVI (selexipag), the only approved oral and intravenous, selective IP receptor agonist targeting a prostacyclin pathway in PAH;

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 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.

The MedTech segment develops and manufactures a broad portfolio of products used in cardiovascular, orthopaedics, surgery, and vision supporting physicians, hospitals, eye care professionals and healthcare systems across a wide range of acute and elective procedures.

These products are designed to address disease states where procedural intervention plays a central role in treatment and patient outcomes.

The Cardiovascular portfolio includes electrophysiology products used to diagnose and treat heart rhythm disorders, mechanical circulatory support technologies (Abiomed) used in patients with cardiogenic shock or those undergoing a high-risk percutaneous coronary intervention (PCI), circulatory restoration products (Shockwave) for the treatment of calcified coronary artery disease (CAD) and peripheral artery disease (PAD), and neurovascular care that treats stroke and other conditions.

These offerings are primarily delivered through minimally invasive, catheter based approaches and are used by interventional cardiologists, electrophysiologists and neurointerventional specialists.

The Orthopaedics portfolio includes products and enabling technologies that support joint reconstruction, trauma, spine, sports-related injuries, and others.

The Surgery portfolio includes a range of surgical products and enabling technologies for use across open, laparoscopic and robotic surgical procedures.

This portfolio includes instrumentation, energy devices, stapling systems, wound closure, biosurgery products, and digital and robotic technologies designed to support procedural consistency and efficiency across multiple surgical specialties.

The Surgery portfolio also includes solutions that focus on breast aesthetics and reconstruction (Mentor).

These products are used in hospitals and surgical centers worldwide and are supported by ongoing development of surgical techniques and clinical evidence.

The Vision portfolio includes contact lenses marketed under the ACUVUE brand, TECNIS premium intraocular lenses for cataract surgery, and other products used in cataract and refractive procedures.

Vision products are used by eye care professionals and ophthalmic surgeons and span both corrective and surgical vision care.

These MedTech 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.

In October 2025, the Company announced its intention to separate its Orthopaedics business.

The Company intends to explore multiple paths to effect the planned separation with a targeted completion within 18 to 24 months after the initial announcement.

Geographic areas

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They own, or are licensed under, a significant number of patents in the U.S.

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.

and other countries relating to their products, product uses, formulations and manufacturing processes.

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.

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 15.0% of the Company's total revenues for fiscal 2025.

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.

(a wholly-owned subsidiary of the Company) has an exclusive license to those patent families.

Royalty rate ranges from 12% to 20% of total DARZALEX net sales.

For the fiscal 2025 and 2024, royalty amounts to Genmab were approximately $2.4 billion and $2.0 billion, respectively.

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.

owns separate patent portfolios related to DARZALEX FASPRO and DARZALEX IV.

Sales of the Company’s second largest product, STELARA (ustekinumab) accounted for approximately 6.5% of the Company's total revenues for fiscal 2025.

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.

Third parties have filed biologics license applications with the U.S.

FDA, the European Medicines Agency, and other government authorities seeking approval to market biosimilar versions of STELARA around the globe.

The Company expects continued launches of biosimilar versions of STELARA globally which will continue to negatively impact the Company’s sales of STELARA.

Sales of the Company’s third largest product, TREMFYA (guselkumab), accounted for approximately 5.5% of the Company's total revenues for fiscal 2025.

Janssen Biotech, Inc.

owns multiple patent families related to TREMFYA, including a composition patent family projected to expire in the United States in 2031.

In addition, Janssen Biotech, Inc.

is a party to license agreements related to TREMFYA with an aggregate royalty rate of approximately 5.0% of total TREMFYA net sales payable to third parties.

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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and other countries where such products are marketed.

The Company considers these trademarks in the aggregate to be of material importance in the operation of its businesses.

Worldwide sales do not reflect any significant degree of seasonality;

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

2025 Annual Report

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

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

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.

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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.

In some cases, the Company’s subsidiaries may deem it advisable to initiate product recalls regardless of whether it has been required or directed to.

In some cases, the Company’s subsidiaries may deem it advisable to initiate field actions, such as product recalls, regardless of whether it has been required or directed to.

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 safety 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, 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 could ban such products, detain or seize adulterated or misbranded products, order a recall, repair, replacement, or refund of such products, withdraw approval/clearance/classification 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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Various state and federal transparency laws and regulations require disclosures of payments and other transfers of value made to certain healthcare practitioners, including physicians, teaching hospitals, and certain non-physician practitioners.

Federal and foreign laws governing international business practices require strict compliance with anti-bribery standards and certain prohibitions with respect to payments to any foreign government official.

Federal and foreign laws governing international business practices require strict compliance with anti-corruption standards and certain prohibitions with respect to payments to any foreign government official.

Payors and Pharmacy Benefit Managers (PBMs) are a potent force in the marketplace, and increased attention is being paid to the impact of PBM practices on healthcare cost and access in the U.S.

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.

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.

The federal Inflation Reduction Act of 2022 (IRA) 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.

In 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.

with Pharmacyclics LLC, an AbbVie company.

The Selected Drug list also included other medicines targeting disease states that are prevalent in 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 selected products are subject to a government-established price for the Medicare population beginning in 2026.

CMS has indicated that, beginning in 2027, it will remove Xarelto and Stelara from the Selected Drug List, such that the products will no longer be subject to the IRA's minimum pricing provisions.

In January 2026, CMS published the Selected Drug list for 2028, which includes ERLEADA.

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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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 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.

While 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, CMS has publicly announced the maximum fair price for each of the selected drugs and has recently begun implementing the program.

In December 2025, Janssen sought review by the U.S.

Supreme Court of the Third Circuit majority's affirmance of the district court's denial of its summary judgment motion.

In January 2026, the Company reached an agreement with the U.S.

Administration to improve access to medicines and lower costs for U.S.

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, including models or other mechanisms to increase pricing controls and/or transparency.

There are a number of additional bills pending in Congress and healthcare reform proposals at the state level that would affect drug pricing, including in the Medicare and Medicaid programs.

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In addition, business practices in the healthcare industry have come under increased scrutiny, particularly in the U.S., by government agencies and state attorneys general, and resulting investigations and prosecutions carry the risk of significant civil and criminal penalties.

Of note is the increased enforcement activity by data protection authorities in various jurisdictions, particularly in the European Union, where significant fines have been levied on companies for data breaches, violations of privacy requirements, and unlawful cross-border data transfers.

Of note is the increased enforcement activity by data protection authorities in various jurisdictions,

2025 Annual Report

particularly in the European Union, where significant fines have been levied on companies for data breaches, violations of privacy requirements, and unlawful cross-border data transfers.

In the U.S., the Federal Trade Commission has stepped up enforcement of data privacy with several significant settlements (including settlements concerning the downstream sharing of personal information and use and disclosure of personal health data) and there have been a material increase in class-action lawsuits linked to the collection and use of biometric data and use of tracking technologies.

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These processes also are subject to complex and lengthy regulatory approvals.

2024 Annual Report

Employees and human capital management

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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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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 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.

To prioritize learning, the Company has an annual Global Learning Day in which employees are encouraged to set aside a full day to explore skill-building courses on its state-of-the-art learning platform, J&J Learn.

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.

As a result, and as guided by applicable laws, external insights and employee feedback, we continually strive to meet the needs of our global workforce of individuals from many different backgrounds, abilities, cultures and perspectives.

We are committed to cultivating an inclusive, Credo‑based work environment where employees are recognized and rewarded based on merit.

Compensation and benefits

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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 through its press releases and media statements at www.jnj.com/mediacenter , investor.jnj.com and www.factsabouttalc.com .

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