Cytosorbents Corporation Q3 FY2025 earnings call

• Core CytoSorb business: Q3 2025 revenue growth led by distributor territories and other direct markets. Gross margin remained strong at ~70%. Germany sales restructuring underway to improve performance. - DrugSorb-ATR: FDA upheld denial of original de novo submission but no safety issues. Filed pre-submission meeting request, expect pre-sub meeting in late 2025/early 2026, new de novo filing in Q1 2026, mid-2026 regulatory decision. - Financials: Q3 2025 revenue $9.5M, gross margin 70%. Operating expenses $9.5M, net loss $3.2M. Implemented 10% workforce reduction and amended loan agreement with Avenue Partners for funding and extensions.

In the third quarter of 2025, CytoSorbents' core product CytoSorb had revenue of $9.5 million, up 10% from $8.6 million in the prior year (4% on constant currency basis). Trailing 12-month core product sales reached $37 million. Gross margin was approximately 70%. Distributor and partner sales grew 14% to $15.6 million, direct sales outside Germany rose ~24% to $8.8 million, while Germany sales declined modestly by 3% to $12.6 million. The investigational device DrugSorb-ATR is aimed at the U.S. market with ongoing regulatory efforts.

• Aim to achieve cash flow breakeven starting Q1 2026. - Expect mid-2026 regulatory decision for DrugSorb-ATR. - Amended loan agreement provides $2.5M immediate funding and interest-only period extensions until DrugSorb-ATR FDA approval.

• Regulatory risk: Uncertainty in FDA review of DrugSorb-ATR new de novo submission. - Execution risk: Ensuring successful restructuring of German sales team to improve performance. - Market risk: Uncertainty in DrugSorb-ATR market adoption and growth potential.

Q: Clarify gross margin in Q4 2026 and beyond?

A: Pleased with 70% level, see opportunities for improvement with efficiencies and potential volume growth.

Q: Any milestones for German sales force restructuring to see effect?

A: Work in progress, tracking rep performance and efficiency metrics, expecting improvement in future quarters.

Q: Differentiate between pre-submission package and full de novo application for DrugSorb-ATR?

A: Pre-submission meeting is to align with FDA's concerns and guidance, then incorporate into the full de novo submission to avoid surprises.

Q: Feedback from World Sepsis Day webcast?

A: Excellent response, highlighting CytoSorb's role in controlling cytokine storm and broader effects in sepsis and septic shock treatment