Risk Factors Update Summary

• Implementing a new global ERP system requires significant investment of capital and human resources.
• Addition of subsidized fitness centers and wellness programs may enhance employee benefits.
• Total revenues increased from $2.1 billion in 2022 to $4 billion in 2023.
• Gene therapy products may face challenges in pricing, coverage, and acceptance compared to traditional products.
• Conditional approval for ROCTAVIAN in the EU may impact market exclusivity and commercialization.
• Delays or cost overruns during ERP implementation could result in much higher costs.
• ROCTAVIAN for Severe Hemophilia A was conditionally approved by the EC in August 2022 and FDA in June 2023.
• The number of full-time employees increased from 3,082 in 2022 to 3,401 in 2023.
• ALDURAZYME for MPS I decreased from $131.2 million to $161 million.
• Failure to implement appropriate internal controls for the new ERP system may lead to inaccurate information.
• Net product revenues for various products changed, e.g., VIMIZIM increased from $663 million to $701 million.
• Introduction of IRA legislation may significantly impact drug pricing and reimbursement strategies.
• PALYNZIQ for PKU decreased from $303.9 million to $255 million.
• Changes in management may lead to operational risks and impact strategic direction.
• Increased employee turnover and competition for talent may affect business efficiency and morale.
• Regulatory changes in tax laws may lead to increased cash tax rates and uncertainty.
• Enhanced privacy laws and data protection regulations may require additional safeguards for personal information.