Johnson & Johnson (JNJ): what its 10-K says it depends on

Suppliers

Third-party manufacturers

depends onnamed as a risk

However, we cannot guarantee that these third-party manufacturers will be able to meet our near-term or long-term manufacturing requirements, which could result in lost sales and have an adverse effect on our business.Risk factors (Item 1A)

Partners and platforms

Genmab A/S

depends on · approximately $2.4 billion

For the fiscal 2025 and 2024, royalty amounts to Genmab were approximately $2.4 billion and $2.0 billion, respectively.Business (Item 1)

Pharmacyclics LLC (AbbVie)

depends on

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.Business (Item 1)

Other companies

STELARA (ustekinumab)

earns from · approximately 6.5% of the Company's total revenuesnamed as a risk

The Company expects continued launches of biosimilar versions of STELARA globally which will continue to negatively impact the Company’s sales of STELARA.Business (Item 1)

DARZALEX (daratumumab)

earns from · approximately 15.0% of the Company's total revenues

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.Business (Item 1)

TREMFYA (guselkumab)

earns from · approximately 5.5% of the Company's total revenues

Sales of the Company’s third largest product, TREMFYA (guselkumab), accounted for approximately 5.5% of the Company's total revenues for fiscal 2025.Business (Item 1)

Talc litigation (JOHNSON'S Baby Powder)

named as a risk

For example, the Company is a defendant in numerous lawsuits arising out of the use of body powders containing talc, primarily JOHNSON’S Baby Powder.Risk factors (Item 1A)

Also named by CL

Orthopaedics business separation

named as a risk

The Company is targeting completion of the planned separation in 18 to 24 months after initial announcement.Risk factors (Item 1A)

Places

Europe

earns from · approximately 23%named as a risk

In fiscal 2025, approximately 43% of the Company’s sales occurred outside of the U.S., with approximately 23% in Europe, 5% in the Western Hemisphere, excluding the U.S., and 15% in the Asia-Pacific and Africa region.Risk factors (Item 1A)

Also named by ADSK, AME, AMRC, ATR, BCSF, BKNG, BMI, BMY and 60 more

Asia-Pacific and Africa

earns from · 15%named as a risk

In fiscal 2025, approximately 43% of the Company’s sales occurred outside of the U.S., with approximately 23% in Europe, 5% in the Western Hemisphere, excluding the U.S., and 15% in the Asia-Pacific and Africa region.Risk factors (Item 1A)

China

subject tonamed as a risk

In addition, China has introduced broad personal information protection and data security regulations, with more anticipated, thereby increasing China’s scrutiny of company compliance and data transfer practices.Business (Item 1)

Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more

Argentina

operates innamed as a risk

Specifically, the Company has accounted for operations in Argentina, Turkey, Venezuela and Egypt as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%.Risk factors (Item 1A)

Also named by BALL, C, ECL, FISV, GMED, INGR, KMB, MDLZ and 6 more

Venezuela

operates innamed as a risk

Specifically, the Company has accounted for operations in Argentina, Turkey, Venezuela and Egypt as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%.Risk factors (Item 1A)

Also named by BKR, CL, COP, CRC, CVX, EME, FLS, PBF and 3 more

Turkey

operates innamed as a risk

Specifically, the Company has accounted for operations in Argentina, Turkey, Venezuela and Egypt as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%.Risk factors (Item 1A)

Also named by BALL, COR, ECL, IQV, META, YUM

Egypt

operates innamed as a risk

Specifically, the Company has accounted for operations in Argentina, Turkey, Venezuela and Egypt as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%.Risk factors (Item 1A)

Also named by APA, BALL, MDLZ, UBER

Hazards

Russia-Ukraine war

named as a risk

Most recently, we have experienced, and expect to continue to experience, impacts to the Company's business resulting from the Russia-Ukraine war, conflict in the Middle East as well as increasing tensions between the U.S. and China.Risk factors (Item 1A)

Also named by ADSK, ATR, AVAV, CSCO, CTVA, EMR, FIS, FLO and 21 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

For example, changes to the U.S. FDA’s timing or requirements for approval or clearance of our products may have a negative impact on our ability to bring new products to market.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Centers for Medicare & Medicaid Services (CMS)

subject tonamed as a risk

In January 2026, CMS published the Selected Drug list for 2028, which includes ERLEADA.Business (Item 1)

Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more

Laws and programs

U.S. tariffs

subject tonamed as a risk

In addition, the U.S. government has imposed and/or announced the potential imposition of tariffs on products manufactured in other jurisdictions.Risk factors (Item 1A)

Also named by A, AAPL, ACHR, ADI, AEHR, AEP, AIOT, AKAM and 170 more

U.S. Foreign Corrupt Practices Act (FCPA)

subject tonamed as a risk

Also, in many countries outside the U.S., the healthcare providers who prescribe human pharmaceuticals are employed by the government and the purchasers of human pharmaceuticals are government entities; therefore, the Company’s interactions with these prescribers and purchasers are subject to regulation under the FCPA.Risk factors (Item 1A)

Also named by A, ADBE, ADP, AIR, AJG, ALB, AME, AMZN and 112 more

Inflation Reduction Act of 2022 (IRA)

subject tonamed as a risk

Specifically, the Inflation Reduction Act of 2022 (IRA) has changed Medicare Part D benefit design and has subjected certain of the Company's products to government-established pricing beginning in 2026 and may subject additional products in the future.Risk factors (Item 1A)

Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more

340B Drug Pricing Program

subject tonamed as a risk

Further, increased third-party utilization of the 340B Federal Drug Discount Program from expanded interpretations of the statute and program abuse may have a negative impact on the Company's financial performance.Risk factors (Item 1A)

Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more

Medicare Part D

earns fromnamed as a risk

In addition, change to Medicare Part D could have a negative impact on U.S. Innovative Medicine sales.Risk factors (Item 1A)

Also named by ABBV, AMGN, BMY, CI, CNC, CVS, ELV, INCY and 5 more

Medicare Drug Price Negotiation Program

subject tonamed as a risk

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.Business (Item 1)

Also named by IONS, NBIX, PFE

Medicaid Rebate Program

subject tonamed as a risk

In addition, the marketing, pricing and sale of the Company’s products are subject to regulation, investigations and legal actions including under the Federal Food, Drug, and Cosmetic Act, the Medicaid Rebate Program, federal and state false claims acts, state unfair trade practices acts and consumer protection laws.Risk factors (Item 1A)

European Union privacy and cybersecurity regulation (NIS2, EHDS, Data Act, Cyber Resilience Act, AI Act)

subject tonamed as a risk

In the EU, multiple directives and laws (including NIS2, EHDS, the Data Act, the Cyber Resilience Act, and the AI Act) are rapidly changing privacy and cybersecurity compliance requirements while introducing new enforcement risks.Business (Item 1)