Very Weak Net ProfitabilityDespite revenue gains, negligible net margin and near-zero ROE show limited ability to convert sales into retained earnings. Persistently low profitability constrains internal funding for R&D, increases reliance on external capital for growth, and raises execution risk across upcoming quarters.
RUCONEST Market WithdrawalsWithdrawing RUCONEST from some European markets is a structural commercial contraction that reduces addressable market and patient access. It can lower long-term revenue diversification, concentrate sales in fewer markets, and increase sensitivity to pricing or reimbursement in remaining territories.
FDA CRL For Joenja Pediatric SNDAA CRL requiring additional pediatric PK data and analytical clarifications delays U.S. label expansion for Joenja. This regulatory setback can postpone pediatric market revenue, extend development costs, and push back strategic milestones central to medium-term growth and commercialization plans.