Risk Factors Update Summary
- Expanded regulatory risks include potential penalties, fines, and injunctions for non-compliance with FDA regulations.
- The company has terminated investments in biotherapeutics and other programs, renegotiating agreements. This may lead to uncertain future revenue streams.
- Increased focus on data protection laws and regulations, including GDPR, may result in fines up to €20 million or 4% of global turnover.
- The company is refining its strategic focus, potentially missing more profitable opportunities. This could impact revenue.
- Changes in UK and EU data protection laws could impact business operations and data transfer mechanisms.
- The company faces competition from established players like DSM, Novozymes, and others, impacting market share.
- Reputational risks due to non-compliance with ESG practices may lead to customer scrutiny and potential loss of business.
- The company is working to qualify new contract manufacturers for enzyme production, including CDX-616.
- Potential reputational damage from perceived inadequate action in ESG areas could negatively impact the company's image.
- The company uses hazardous materials, facing potential liability for injury or contamination resulting from their use.
- Uncertainty in the relationship between UK and EU data protection laws may affect business operations and data transfer mechanisms.
- The company's ability to use net operating loss carryforwards may be limited, impacting future taxable income.
- Subjective assessment of ESG criteria by stakeholders could lead to misrepresentation of the company's sustainability policies.
- The company's ongoing efforts to deploy technology in life science tools markets may fail, affecting business prospects.
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=1200375&owner=exclude
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