CytoSorbents(US:CTSO)2025-11-13 22:30Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $9.5 million, an increase of 10% from $8.6 million in Q3 2024, or 4% on a constant currency basis [5][11] - Gross margin improved to approximately 70% compared to 61% in Q3 2024 [5][11] - Adjusted net loss for the quarter improved to $2.6 million, or $0.04 per share, compared to an adjusted net loss of $4.5 million, or $0.08 per share in the prior year [14] Business Line Data and Key Metrics Changes - Core product sales reached a record $37 million for the trailing 12 months as of September 30, 2025, up from $33.8 million a year ago [4][6] - Distributor and partner sales grew 14% to $15.6 million, while direct sales outside Germany rose approximately 24% to $8.8 million [6] - Sales in Germany declined modestly by 3% to $12.6 million [6] Market Data and Key Metrics Changes - CytoSorb is approved in the European Union and available in over 70 countries, with nearly 300,000 treatments performed to date [4] - The U.S. market opportunity for DrugSorb ATR is initially estimated at $300 million, potentially exceeding $1 billion as Brilinta becomes generic [9] Company Strategy and Development Direction - The company focuses on five key initiatives: returning to higher growth in CytoSorb, obtaining U.S. marketing approval for DrugSorb ATR, achieving near-term cash flow break-even, strengthening the balance sheet, and maximizing shareholder value [5][19] - A strategic workforce and cost reduction program has been implemented, including a workforce reduction of approximately 10% [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow break-even beginning in Q1 2026, supported by improvements in operating margins and cash burn [15][18] - The company anticipates a mid-2026 regulatory decision for DrugSorb ATR following a new De Novo filing in Q1 2026 [10] Other Important Information - The company amended its loan agreement with Avenue Capital Group, providing immediate funding of $2.5 million and extending the interest-only period to December 31, 2026 [17] - The company recognizes the need for improved performance in Germany and is restructuring its sales team and approach [6][7] Q&A Session Summary Question: What is the expected gross margin for Q4 and 2026? - Management is pleased with the current 70% gross margin and sees opportunities for improvement as efficiencies increase and volumes rise [23] Question: Are there any milestones for the German sales force restructuring? - Management indicated it is too early to assess the full impact but noted improvements in representative performance and efficiency [24] Question: What is the difference between the pre-submission package and the full application for the FDA? - The pre-submission package aims to align with FDA concerns and guidance, ensuring no surprises in the final De Novo submission [25][26] Question: Feedback from the World Sepsis Day webcast? - The response has been excellent, highlighting the broad applications of CytoSorb in treating sepsis and septic shock [27][29]