Risk Factors Update Summary

• Net loss decreased from $289.1 million to $132.5 million in 2022, with accumulated deficit at $1.2 billion.
• The Windsor Framework fundamentally changes the regulation of medicinal products in Northern Ireland.
• Operating expenses increased substantially and are expected to rise further as activities expand.
• The MHRA will now be responsible for approving all medicinal products destined for the UK.
• Recent portfolio reprioritization and strategic restructuring may lead to cost savings or disruptions.
• The proposed EU pharmaceutical legislation revisions may impact the company's long-term business significantly.
• Failure to comply with FDA regulations on product promotion for unapproved uses may lead to penalties.
• Changes in tax laws, such as the Tax Act and the IRA, may affect the company's financial condition.
• The company's ability to develop and market new drug products may be impacted by ongoing litigation.
• Regulatory authorities closely monitor post-approval marketing and promotion of medicines to ensure compliance.