High Cash Burn And Limited RunwayPersistent, large operating cash outflows require ongoing financing or material margin improvement to avoid dilution. Even with cost actions, current liquidity only extends to Q4‑2027; fundraising or milestone execution will be needed during commercialization, reducing financial flexibility and increasing dilution risk.
Company‑level Losses And Negative MarginsDespite revenue progress, company‑level operating and net margins remain deeply negative, reflecting a cost base far above current revenue. Continued high SG&A for commercialization plus R&D needs mean company profitability depends on sustained revenue growth and tight cost control over multiple years.
Execution Risk In Manufacturing Scale‑up And Europe AccessScaling manufacturing and completing technology transfers are material operational risks that could delay volume growth and margin targets. Separately, unresolved European market access and MFN negotiations create structural uncertainty for ex‑US revenue timing and the company's ability to achieve projected global scale.