Regulatory SetbackFailure to secure EMA support for adolescent label expansion curtails a clear route to enlarge addressable market and delays revenue upside from younger patients. Prolonged regulatory uncertainty increases commercialization timelines and costs for alternative approval pathways.
Rising Operating ExpensesSustained increases in personnel and distribution costs raise the company’s fixed cost base. If revenue growth doesn’t accelerate commensurately, margin compression and variability in free cash flow could persist, limiting reinvestment capacity and dividend sustainability over the medium term.
Revenue ConcentrationHeavy reliance on a single flagship product concentrates commercial, regulatory, and reimbursement risk. While pipeline programs exist, they are not yet commercialized; a product-specific adverse event, pricing pressure, or reimbursement change could meaningfully impact revenue stability over the next several quarters.