CytoSorbents Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

Core Viewpoint - CytoSorbents Corporation reported strong financial results for Q4 and full year 2024, highlighting significant growth in product sales and advancements in regulatory milestones, setting a positive outlook for 2025 [1][3][7]. Financial Performance - Q4 2024 product revenue reached $9.2 million, a 25% increase from $7.3 million in Q4 2023, with a product gross margin of 71% compared to 68% in the previous year [7]. - Full year 2024 product revenue was $35.6 million, reflecting a 15% year-over-year increase from $31.1 million in 2023 [7]. - The operating loss for 2024 improved by 47% to $16.8 million from $32 million in 2023, driven by higher revenue and a 22% reduction in operating expenses [7]. - The net loss for 2024 was $20.7 million, or $0.38 per share, compared to a net loss of $29.2 million, or $0.65 per share in 2023 [7]. Sales Growth and Market Strategy - The core business experienced a 15% growth in 2024, with over $35 million in high-margin CytoSorb sales, driven by 28% growth in direct sales outside Germany and 22% growth in Distributor/Partner sales [4][7]. - The company is focusing on restoring sales growth in Germany, which has been flat for two consecutive years, through a reorganization of the direct sales team and strategy [6][13]. Regulatory Developments - CytoSorbents anticipates regulatory decisions from Health Canada and the US FDA regarding DrugSorb-ATR in 2025, with significant strides made in bringing this therapy to market [7][19]. - The FDA accepted the De Novo application for DrugSorb-ATR, entering an interactive review phase, which is crucial for potential U.S. marketing approval [7][19]. Clinical Advancements - New clinical data presented at international conferences indicate that early and intensive treatment with CytoSorb significantly improves survival rates in patients with septic shock and multiorgan failure [5]. - The company is preparing for a controlled market release of DrugSorb-ATR at key clinical trial sites, pending regulatory approval, to gather real-world feedback and refine commercialization strategies [10][11]. Market Potential - The total addressable market for DrugSorb-ATR in the U.S. and Canada is projected to grow from $300 million to over $1 billion as the product establishes itself in the market [9].