Risk Sleuth
ABBV · 10-K filed 20 Feb 2026 · year to 31 Dec 2025

AbbVie

32 named things its latest annual report says its results depend on, each in the company's own words. 24 of them are also named by other companies we've read.

Customers

McKesson Corporation

earns fromnamed as a risk
In 2025, three wholesale distributors (McKesson Corporation, Cardinal Health, Inc. and Cencora, Inc.) accounted for substantially all of AbbVie's pharmaceutical product sales in the United States.Risk factors (Item 1A)

Also named by AMGN, CAH, COR, GILD, HALO, HROW, HSIC, LLY and 1 more

Cardinal Health, Inc.

earns fromnamed as a risk
In 2025, three wholesale distributors (McKesson Corporation, Cardinal Health, Inc. and Cencora, Inc.) accounted for substantially all of AbbVie's pharmaceutical product sales in the United States.Risk factors (Item 1A)

Also named by AMGN, BAX, COR, CVS, GILD, HROW, LLY, MCK and 1 more

Cencora, Inc.

earns fromnamed as a risk
In 2025, three wholesale distributors (McKesson Corporation, Cardinal Health, Inc. and Cencora, Inc.) accounted for substantially all of AbbVie's pharmaceutical product sales in the United States.Risk factors (Item 1A)

Also named by AMGN, CAH, GILD, HROW, LLY, MCK

Pharmacy benefit managers (PBMs)

earns fromnamed as a risk
Various factors, including market factors, consolidation among PBMs and the ability of private payers to control patient access to products, including through formulary management and utilization controls, may provide payers the leverage to negotiate higher or additional rebates or discounts that could have a material adverse effect on AbbVie's operations.Risk factors (Item 1A)

Also named by AMGN, HROW, NBIX, WMT

Suppliers

Single-source suppliers of raw materials

depends onnamed as a risk
The failure of AbbVie's suppliers, and particularly its single-source suppliers, to fulfill their contractual obligations in a timely manner or as a result of regulatory noncompliance or physical disruption at a manufacturing site may impair AbbVie's ability to deliver its products to customers on a timely and competitive basis, which could adversely affect AbbVie's business and results of operations.Risk factors (Item 1A)

Partners and platforms

GSK

depends on
Botox Therapeutic is marketed by GSK in Japan.Business (Item 1)

Also named by IONS

Competitors

Humira biosimilars

competes withnamed as a risk
Humira faces direct biosimilar competition globally and AbbVie will continue to face competitive pressure from these biologics and from orally administered products.Business (Item 1)

Rinvoq (upadacitinib) generics

competes withnamed as a risk
Given the settlement and license agreements, which are subject to standard acceleration provisions, assuming pediatric exclusivity is granted, no generic entry for Rinvoq tablets is expected prior to April 2037 in the United States.Business (Item 1)

Places

United States

concentrated in · approximately 24%named as a risk
Net revenues outside of the United States made up approximately 24% of AbbVie's total net revenues in 2025.Risk factors (Item 1A)

Also named by ADP, AJG, AMGN, APA, AXGN, AXP, BALL, BAM and 139 more

European Union

subject tonamed as a risk
In particular, many European countries have ongoing government-mandated price reductions for many pharmaceutical products, and AbbVie anticipates continuing pricing pressures in Europe.Risk factors (Item 1A)

Also named by ADM, AVY, BA, DXCM, ENB, FPI, GEHC, GS and 4 more

Commodities and inputs

Euro

exposed to its price · $14,505named as a risk
AbbVie's primary net foreign currency exposures are the Euro, Canadian dollar, Japanese yen and British pound.Market risk (Item 7A)

Also named by ABNB, ABT, ADBE, ADI, AME, AMG, AMGN, AMP and 186 more

Canadian dollar

exposed to its price · 1,042named as a risk
AbbVie's primary net foreign currency exposures are the Euro, Canadian dollar, Japanese yen and British pound.Market risk (Item 7A)

Also named by ADBE, AMG, AYI, BBY, BWXT, CBRE, CDRE, CDW and 67 more

British pound

exposed to its price · 560named as a risk
AbbVie's primary net foreign currency exposures are the Euro, Canadian dollar, Japanese yen and British pound.Market risk (Item 7A)

Also named by ADBE, AJG, AME, AMP, APA, BF/B, BRO, CACI and 39 more

Japanese yen

exposed to its price · 799named as a risk
AbbVie's primary net foreign currency exposures are the Euro, Canadian dollar, Japanese yen and British pound.Market risk (Item 7A)

Also named by ABT, ACN, ADBE, ALK, AMAT, AMKR, BMY, COO and 24 more

Cell lines (biological materials)

depends onnamed as a risk
For example, access to and supply of necessary biological materials, such as cell lines, may be limited and current governmental regulations restrict access to and regulate the transport and use of such materials.Risk factors (Item 1A)

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, including rejection of an NDA or BLA.Business (Item 1)

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

Centers for Medicare and Medicaid Services (CMS)

subject tonamed as a risk
Under the IRA, HHS can effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D.Risk factors (Item 1A)

Also named by CDNA, CHE, DGX, DOC, ENSG, GD, GEHC, GHC and 6 more

Laws and programs

Medicaid

subject tonamed as a risk
Specifically, U.S. federal laws require pharmaceutical manufacturers to pay certain statutorily-prescribed rebates to state Medicaid programs on prescription drugs reimbursed under state Medicaid plans and the efforts by states to seek additional rebates may affect AbbVie's business.Business (Item 1)

Also named by ABT, ARE, ARWR, BAX, BMY, BSX, CHE, CNC and 39 more

Inflation Reduction Act of 2022 (IRA)

subject tonamed as a risk
In particular, the IRA will have the effect of reducing prices and reimbursements for certain of our products, which could significantly impact AbbVie’s results of operations.Risk factors (Item 1A)

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

340B Drug Pricing Program

subject tonamed as a risk
Adverse outcomes in 340B-related litigation or significant changes to our 340B approach could adversely affect our revenues and results of operations.Risk factors (Item 1A)

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

Medicare Part D

subject tonamed as a risk
In August 2023, the U.S. Department of Health and Human Services (HHS), through CMS, selected Imbruvica as one of 10 medicines subject to government-set prices in Medicare Part D beginning January 1, 2026, and in January 2025, selected Vraylar and Linzess as two of 15 medicines subject to government-set prices in Medicare Part D beginning January 1, 2027.Business (Item 1)

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

EU Medical Device Regulation (MDR)

subject tonamed as a risk
Medical device products that are marketed in the European Union must comply with the requirements of the Medical Device Regulation (MDR), which came into effect in May 2021.Business (Item 1)

Also named by BAX, BDX, BSX, CAH, COO, DXCM, EW, GEHC and 4 more

Medicare Part B

subject tonamed as a risk
In January 2026, Botox was selected as one of 15 medicines subject to government-set prices in Medicare Parts B and D beginning January 1, 2028.Business (Item 1)

Also named by COR, HROW, REGN, UTHR

Biologics Price Competition and Innovation Act

subject tonamed as a risk
The law provides a pathway for approval of biosimilars following the expiration of 12 years of regulatory exclusivity for the innovator biologic and a potential additional 180 day-extension term for conducting pediatric studies.Business (Item 1)

Also named by AMGN, KRYS

Leahy-Smith America Invents Act

subject tonamed as a risk
In addition, petitioners have filed, and may continue to file, challenges to the validity of AbbVie's patents under the 2011 Leahy-Smith America Invents Act, which created inter partes review and post grant review procedures for challenging patent validity in administrative proceedings at the United States Patent and Trademark Office.Risk factors (Item 1A)

Also named by RMBS

U.S. government most-favored-nation pricing agreement

subject tonamed as a risk
In January 2026, AbbVie entered into a voluntary agreement with the United States government to provide certain pricing concessions and U.S.-based research and development and capital investments in exchange for exemptions from tariffs and future pricing mandates during the three-year agreement period.Risk factors (Item 1A)

Japan National Health Insurance Drug Price List

subject tonamed as a risk
In Japan, the National Health Insurance system maintains a Drug Price List specifying which pharmaceutical products are eligible for reimbursement and the Ministry of Health, Labour and Welfare sets the prices of the products on this list.Business (Item 1)

Tariffs on pharmaceutical products

subject tonamed as a risk
Changes in global trade policy, including the potential imposition of import or export tariffs, trade restrictions, or other measures affecting pharmaceutical products or related inputs, could increase manufacturing and procurement costs, reduce margins or disrupt supply continuity.Risk factors (Item 1A)

Affordable Care Act

subject to
Under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (together, the Affordable Care Act), AbbVie pays a fee related to its pharmaceuticals sales to government programs.Business (Item 1)

Also named by ABT, ADP, AFL, BBSI, BRO, BWIN, COR, DOC and 8 more

Superfund (CERCLA)

subject to
Abbott was identified as one of many potentially responsible parties in investigations and/or remediations at several locations in the United States, including Puerto Rico, under the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund.Business (Item 1)

Also named by ABT, AMD, CRS, ED, FLS, IR, KVUE, MO and 4 more

Hatch-Waxman Act

subject to
The Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act) permits a patent holder to seek a patent extension, commonly called a “patent term restoration,” for patents on products (or processes for making the product) regulated by the FFDCA.Business (Item 1)

Also named by INCY, LLY, LNTH, VTRS

Veterans Health Care Act of 1992

subject to
Similarly, the Veterans Health Care Act of 1992, as a prerequisite to participation in Medicaid and other federal health care programs, requires that manufacturers extend additional discounts on pharmaceutical products to various federal agencies, including the United States Department of Veterans Affairs, Department of Defense and Public Health Service entities and institutions.Business (Item 1)