Company: ABBV
Filing Date: 2025-02-14
Form Type: 10-K
Source: 0001551152-25-000020
Chunk: 39

Company: AbbVie Inc.
Filing Date: 2025-02-14
Form: 10-K
Item: Item 1A
Chunk 39
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 risks that may cause its revenue and profitability to decline.

AbbVie's business is subject to risks associated with doing business internationally, including in emerging markets. Net revenues outside of the United States made up approximately 24% of AbbVie's total net revenues in 2024. The risks associated with AbbVie's operations outside the United States include:

•fluctuations in currency exchange rates;

•changes in medical reimbursement policies and programs and pricing restrictions;

•multiple legal and regulatory requirements that are subject to change and that could restrict AbbVie's ability to manufacture, market and sell its products;

•differing local product preferences and product requirements;

•trade protection measures and import or export licensing requirements;

•international trade disruptions or disputes;

•difficulty in establishing, staffing and managing operations;

•differing labor regulations;

•potentially negative consequences from changes in or interpretations of tax laws;

•political and economic instability;

•conflicts or crises in individual countries or regions, including terrorist activities or wars;

•sovereign debt issues;

•price and currency exchange controls, limitations on participation in local enterprises, expropriation, nationalization and other governmental action and regulation;

•inflation, recession and fluctuations in interest rates;

•restrictions on transfers of funds;

•potential deterioration in the economic position and credit quality of certain non-U.S. countries; and

•potential penalties or other adverse consequences for violations of anti-corruption, anti-bribery and other similar laws and regulations, including the United States Foreign Corrupt Practices Act and the United Kingdom Bribery Act.

If AbbVie does not effectively and profitably commercialize its products, AbbVie's revenues and financial condition could be adversely affected.

AbbVie must effectively and profitably commercialize its principal products by creating and meeting continued market demand; achieving market acceptance and generating product sales; ensuring that the active pharmaceutical ingredient(s) for a product and the finished product are manufactured in sufficient quantities and in compliance with requirements of the FDA and similar foreign regulatory agencies and with acceptable quality and pricing to meet commercial demand; and ensuring that the entire supply chain efficiently and consistently delivers AbbVie's products to its customers. The commercialization of AbbVie products may not be successful due to, among other things, unexpected challenges from competitors, new safety issues or concerns being reported that may impact or narrow approved indications, the relative price of AbbVie's product as compared to alternative treatment options and changes to a product's label that further restrict its marketing. If the commercialization