Risk Factors Update Summary

• Ability to successfully commercialize LUMRYZ in the U.S. and other jurisdictions is crucial.
• Increased reliance on third parties for manufacturing and supply chain may lead to delays.
• Entered into a royalty purchase agreement for $75,000, with $30,000 received in August 2023.
• Plans for commercial infrastructure, marketing, market access, and commercial activities have been expanded.
• Expansion of full-time employees from 41 to 154 indicates significant organizational growth.
• Potential risks associated with geopolitical instability and inflation could impact business operations.
• Expectations regarding pricing, reimbursement, and market size for LUMRYZ have been detailed.
• Received orphan drug exclusivity for LUMRYZ until May 2030, subject to exceptions.
• Commercial launch of LUMRYZ for cataplexy or EDS in adults living with narcolepsy announced.
• Net operating losses in the U.S. increased from $124.2 million to $212.4 million in 2023.
• Incurred a net loss of $137 million in 2023, with cash used in operating activities of $70 million.
• Ordinary shares outstanding increased from 64.5 million to 90.4 million in 2023.
• Submitted an sNDA for LUMRYZ in the pediatric narcolepsy population, awaiting FDA approval in September 2024.
• FDA approval granted for LUMRYZ, with seven years of orphan drug exclusivity until May 1, 2030.
• Potential impact of financial services industry disruptions on liquidity and operations should be monitored.
• Increased sales organization and commercial infrastructure expenses for LUMRYZ commercial launch.
• Numerous LUMRYZ-related U.S. patents issued, with expiration dates from mid-2037 to early-2042.
• Changes in interest rates and inflation may affect the ability to refund or roll over debt.
• Reliance on single-source providers for LUMRYZ development, manufacture, and supply, posing risks.
• Potential competition for LUMRYZ detailed, including generic manufacturers and other approved drugs.
• Potential delays or refusals by DEA for sodium oxybate importation could impact clinical trials.