Patent Litigation UncertaintyOngoing patent litigations create uncertainty around the timing of generic entry and may pressure pricing and expected market exclusivity.
Regulatory Hurdle For NEXLIZETHealth Canada request for additional manufacturing information on NEXLIZET introduces a regulatory hurdle that could delay approvals or limit market access.
Revenue Dependence On Partner PerformanceRevenue from the Japanese market depends on milestone payments and royalties tied to a partner's commercial performance, limiting direct control over sales outcomes.