Cytosorbents (CTSO) 2025 Conference Transcript

Summary of CytoSorbents Conference Call Company Overview - Company: CytoSorbents - Industry: Medical Supplies and Devices - Key Products: - CytoSorb: Blood purification technology for critical care and cardiac surgery - DrugSorb ATR: Investigational product for reducing perioperative bleeding during CABG surgery Core Points and Arguments 1. CytoSorb Product Performance: - Achieved record core non-COVID product sales of $35.6 million in 2024, growing 15% year-over-year [3] - Over 270,000 human treatments in more than 70 countries [3] - High gross margins of 71% [27] 2. DrugSorb ATR Development: - Designed to address bleeding complications in patients on blood thinners during surgery [11] - Received two FDA breakthrough device designations [14] - Aimed at a significant unmet medical need in the US and Canadian markets [3] 3. Technology and Mechanism: - Utilizes a patented polymer bead technology that effectively removes a broad range of harmful substances from blood [4] - CytoSorb targets severe inflammation, which affects up to 60% of ICU patients [7] 4. Clinical Research and Efficacy: - Recent studies show significant reductions in mortality and shock reversal in patients treated with CytoSorb [8][10] - Meta-analysis indicated a 50% reduction in 28-day all-cause mortality in patients treated with CytoSorb [10] 5. Regulatory Updates: - FDA denial letter received on April 25, 2025, but the company plans to file a formal appeal [23][24] - Health Canada submission is under advanced review, with expectations for decisions in 2023 [25] 6. Market Potential: - Total addressable market estimated at $300 million initially, potentially growing to over $1 billion with additional indications [26] 7. Financial Position: - Cash position of $13.1 million at the end of Q1, with a quarterly burn rate of $2.5 million to $3 million [46] - Aiming for cash flow breakeven by the second half of 2025 [28] 8. Sales Strategy: - Plans for a controlled market release in clinical trial centers post-approval, followed by a broader launch in 2026 [36] - Predominantly direct sales force in the US, complemented by perfusionist distributors [37] 9. Challenges in Germany: - Germany accounts for about 40% of revenue but has seen flat growth due to macroeconomic factors [52] - Organizational changes are being made to drive deeper into accounts and improve sales effectiveness [53] Additional Important Information - Cost Savings for Hospitals: - Using DrugSorb can save hospitals $18,000 to $30,000 per patient by reducing the need for prolonged ICU stays to wash out blood thinners [43] - Clinical Trial Insights: - The STAR T trial showed that DrugSorb ATR significantly reduced bleeding severity in CABG patients [19] - Market Preparation: - The company is actively preparing for market entry while awaiting regulatory decisions [31] This summary encapsulates the key points discussed during the conference call, highlighting the company's product performance, regulatory challenges, market potential, and strategic direction.