Risk Factors Update Summary
- Privacy laws similar to CCPA enacted in Virginia, Colorado, Utah, and Connecticut. Similar laws under consideration in other states.
- Addition of YUTIQ as a product, expanding commercial sales to the U.S. and Nordic countries.
- Potential significant penalties due to non-compliance with evolving privacy laws and regulations.
- Failure to meet Nasdaq listing requirements could result in delisting, affecting stock liquidity and shareholder trading.
- Inclusion of YUTIQ in regulatory approval and commercialization discussions, impacting revenue diversification.
- Patent rights for ILUVIEN and YUTIQ expiring in the near-to-medium-term, impacting commercialization efforts.
- Adoption of the 2024 Equity Inducement Plan for granting inducement awards to employees and directors.
- Increased reliance on third-party manufacturers for ILUVIEN and YUTIQ, affecting supply chain risks.
- Risk of unauthorized sales through parallel importing or diversion of products as distribution expands.
- Implementation of technical safeguards, incident response, and recovery plans to address cybersecurity threats.
- Expansion of ILUVIEN sales to additional countries like the Netherlands, Belgium, Luxembourg, Italy, and Spain.
- Potential impact of geopolitical conflicts on global markets and industries, affecting business stability.
- Uncertainty in achieving profitability and positive cash flow through YUTIQ commercialization in the U.S.
- Regulatory uncertainties in obtaining approvals for ILUVIEN and YUTIQ in new markets, affecting market penetration.
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=1267602&owner=exclude
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