Rising Operating ExpensesMaterial expense growth—personnel, commercial distribution and R&D consumables—raises structural operating leverage. If revenue growth remains modest, sustained expense escalation can compress margins, increase cash burn volatility and reduce the pace at which investments translate into profitable scale.
Regulatory & Timing RiskSequential trial completion requirements and pending SEC/ADR feedback create durable timing uncertainty for key filings and market expansions. Delays in approvals or listings will postpone potential new‑indication revenues and heighten execution risk for the company's diversification strategy.
Single‑product ConcentrationRevenue dependence on one product concentrates commercial and reimbursement risk. Long‑term growth and resilience hinge on SCENESSE uptake, payer decisions and site access; any competitive, reimbursement or supply disruption could materially affect company cash flows and strategic flexibility.