Risk Factors Update Summary
- Expanded regulatory requirements include pricing laws, competition laws, and environmental matters.
- Sales of generics medicines historically and expected to represent a significant portion of total revenues.
- Delays in regulatory approvals led to substantial additional costs, e.g., delays in approvals for various medicines.
- Total revenues from sales of generic medicines decreased from $8,601 million to $8,734 million.
- The company faces increasing competition in the generic market, impacting sales and profitability.
- Increased scrutiny from the DOJ with a civil investigation and criminal indictment for price-fixing.
- Sales of complex, high-value generics products are increasingly important, impacting overall performance.
- Failure to develop and commercialize biosimilars could lead to loss of opportunities and increased competition.
- Settlement of nationwide opioid claims finalized, contingent on sufficient state participation, impacting operations.
- Net sales may be affected by fluctuations in drug prices, delays in payments, and loss of business.
- Changes in credit ratings could impact the company's financial strength and share price.
- ESG-related regulations require detailed sustainability reporting, impacting operations, reputation, and compliance costs.
- Material weakness in internal control over financial reporting identified, affecting accurate financial reporting and reputation.
- Shareholder rights and responsibilities may impact equity ownership and shareholder duties.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=818686&owner=exclude
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