uniQure(QURE) - 2021 Q4 - Annual Report

COVID-19 Impact - The company reported a significant impact from the ongoing COVID-19 pandemic on its business and operations[16] - The ongoing Covid pandemic has materially and adversely affected the company's business, operations, and supply chain[16] Clinical Trials and Product Development - There are delays and challenges in the progress of clinical trials, which may affect the safety and efficacy demonstration of product candidates[16] - The company has encountered delays in clinical trials and may fail to demonstrate the safety and efficacy of its product candidates[16] - There is uncertainty regarding the successful commercialization of product candidates and potential delays could materially harm the business[16] - The company relies on third parties for clinical trials, which may not perform satisfactorily, impacting timelines and regulatory compliance[16] Regulatory Compliance - Regulatory compliance is critical for the manufacturing facility, and failure to maintain approvals could materially harm the business[16] - The company is subject to significant government regulations and approvals for its manufacturing facility, and failure to comply could materially harm the business[16] - Data protection laws in various jurisdictions pose compliance challenges, and failure to comply may result in penalties affecting the business[19] - The company faces potential penalties for non-compliance with data protection laws, which could adversely affect its financial condition[19] Funding and Financial Challenges - The company may need to raise additional funding, which could be challenging and affect product development efforts[16] - The company may need to raise additional funding, which may not be available on acceptable terms, potentially affecting product development efforts[16] Competition and Market Risks - The company is exposed to competition and pricing pressures that could adversely affect product revenue[16] - The company faces competition and challenges in recruiting and retaining employees, which could adversely affect its operations[16] Intellectual Property Risks - Intellectual property licensing from third parties may not be available on commercially reasonable terms, impacting product commercialization[16] - The company relies on licenses of intellectual property from third parties, which may not be available in the future on commercially reasonable terms[16] Internal Controls and Security - Internal control failures could lead to inaccurate reporting and negatively impact investor confidence and share price[19] - Internal computer systems may suffer security breaches or disruptions, potentially disrupting product development programs[19]