Weak Cash ConversionMaterial gap between reported profits and cash generation signals persistent working‑capital or timing pressures. Low operating cash conversion can limit reinvestment capacity, make funding capex or commercial expansion harder, and raise reliance on external financing during growth phases.
Outpatient Reimbursement UncertaintyPotential need for a costly, time‑consuming RCT to secure CMS outpatient coverage creates structural timing and adoption risk for an important growth channel. Delayed or unfavorable reimbursement decisions could leave outpatient demand upside unrealized and compress expected addressable market expansion.
Production Timing & Margin DragSlowed output for facility validation and a ~$3.6–3.7m variance reduce near‑term throughput and margins. While tied to regulatory qualification, these timing effects can delay commercial supply, create lumpy revenue recognition, and temporarily constrain the expected scale benefits from the new plant.