Revenue Concentration RiskNearly all revenue comes from one newly launched product, creating structural concentration risk. Any setbacks—slower adoption, reimbursement changes, supply issues or competition—would materially affect cash generation and corporate outlook until pipeline diversifies revenue.
Negative Operating Cash FlowThe company continues to consume operating cash (H1 operating cash use ≈ $30.3M) and post net losses, requiring ongoing financing or facility draws. Persistent negative operating cash flow pressures liquidity and raises execution risk if commercial ramp or milestone receipts slow.
Rising R&D And SG&A From Scale-upSharp increases in R&D and commercialization costs strain margins and cash as the company scales. Elevated spend is necessary for trials, filings and market development, but it lengthens the path to break‑even and makes near‑term cash planning sensitive to execution and reimbursement outcomes.