Risk Factors Update Summary
- Significant decline in revenue and gross margin from generic products, with revenue declining significantly.
- Reliance on self-insurance for legal risks, including opioid-related litigation, with potential financial and reputational impacts.
- Received a CRL from the FDA for IPX203 on June 30, 2023, resubmitted NDA on February 7, 2024. This might result in delayed approval for IPX203.
- Increased shipping costs due to disruptions in the global supply chain, impacting business operations.
- Change in listing requirements from New York Stock Exchange to Nasdaq may impact stock liquidity.
- Competitors updated, including addition of Dr. Reddy's Laboratories Ltd. and Amphastar Pharmaceuticals.
- Increased risk due to extreme weather events compromising facilities and resulting in significant repair costs.
- Majority ownership by Amneal Group increases risk of significant stock price decline.
- Heightened risk due to increased competition for generic products, especially during U.S. presidential election years.
- Potential foreclosure due to pledged shares could lead to substantial decline in stock price.
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=1723128&owner=exclude
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