Risk Factors Update Summary

• The company's ability to generate revenue from WAKIX sales depends heavily on maintaining or increasing sales. This change might result in decreased revenue if sales do not increase or are not maintained.
• Addition of "foreign regulatory authorities" to risk factors, expanding potential regulatory challenges globally.
• The company's financial results have been significantly influenced by sales of WAKIX, which was approved for the treatment of EDS in adult patients with narcolepsy. This change highlights the importance of WAKIX sales for the company's financial performance.
• The company's financial covenants in the Blackstone Credit Agreement may limit operating flexibility and could lead to default if not complied with. This change indicates the potential impact on the company's viability if financial covenants are breached.
• Mention of "over the last several years" instead of specific years, providing a broader timeframe.
• The company relies on third parties for manufacturing and distributing WAKIX and product candidates, which could impact the supply chain. This change emphasizes the importance of third-party relationships for the company's operations and supply chain management.
• The company's ongoing regulatory obligations for WAKIX include conducting post-marketing studies and reporting adverse events. Failure to comply could lead to regulatory enforcement actions. This change highlights the importance of regulatory compliance for the company's operations and commercial success.
• Inclusion of "postponed most inspections" impacting regulatory approval timelines, potentially delaying product launches.
• The company's ability to generate revenue from WAKIX or future product candidates may be adversely affected if there are delays or failures in clinical development or regulatory approval. This change underscores the potential negative impact on revenue generation from product development challenges.
• The company's ongoing clinical trials may be subject to delays or failures, impacting the development and approval of product candidates. This change highlights the risks associated with clinical trial outcomes and their impact on the company's future products.