Tax and financial reporting · Financial reporting and accounting standards
There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S. GAAP. Any future changes in estimates, judgments and assumptions used or necessary revisions to prior estimates, judgments or assumptions or changes in accounting standards could lead to a restatement or revision to previously issued financial statements.
Tax and financial reporting · Transfer pricing and international tax
If tax authorities determine that the intercompany pricing applied to our cross-border arrangements is inconsistent with the arms' length standard or otherwise ineffective, our tax liabilities could increase. We have potential tax exposures resulting from the varying application of statutes, regulations, and interpretations which include exposures on intercompany pricing of cross-border arrangements among our subsidiaries.
Legal and litigation · Litigation and legal proceedings
We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries. We are or may be involved in various legal proceedings and certain government inquiries or investigations, including, but not limited to, patent infringement, product liability, personal injury, securities fraud, claims with respect to the manufacture, sale, marketing and distribution of opioid products, antitrust matters, breach of contract, consumer protection matters.
Legal and litigation · Intellectual property disputes
Our competitors, including branded pharmaceutical companies, and/or other third parties, may allege that we or our suppliers are infringing upon their intellectual property, including in an 'at risk launch' situation, which could result in substantial monetary damages, impact our ability to launch a product and/or our ability to continue marketing a product.
Industry regulation · Licensing and permits
For example, in December 2024 the FDA issued a warning letter and import alert related to our oral finished dose manufacturing facility in Indore, India. The warning letter and import alert restrict our ability to distribute certain products into the U.S. and have also negatively impacted our ability to sell products made at this facility to customers in other regions.
Data and privacy · Data protection and privacy laws
We are subject to federal, state and international data privacy and security laws and regulations governing the collection, use, disclosure, transmission and protection of personal information, including health-related information. As the legislative and regulatory landscape for data privacy and security continues to evolve around the world, there has been an increasing focus on data privacy and security matters that may affect our business.