CytoSorbents Reports First Quarter 2025 Financial Results and Provides Business Update

Core Viewpoint - CytoSorbents Corporation reported its financial results for Q1 2025, highlighting strong revenue growth in the EU despite temporary disruptions in Germany, and ongoing efforts to advance its product pipeline, particularly DrugSorb™-ATR, which aims to address life-threatening bleeding in cardiac surgery patients [1][4][5]. Financial Results - Product revenue for Q1 2025 was $8.7 million, a decrease of 3$9.0 million in Q1 2024, remaining flat on a constant currency basis [8]. - Gross margin decreased to 71% from 77% in Q1 2024 [8]. - Operating loss improved by 17% to $3.9 million compared to$4.7 million in Q1 2024, reflecting a 12% reduction in operating expenses [8]. - Net loss was $1.5 million or$0.02 per share, compared to a net loss of $6.1 million or$0.11 per share in Q1 2024 [8]. - Adjusted net loss was $3.7 million or$0.06 per share, compared to an adjusted net loss of $3.7 million or$0.07 per share in Q1 2024 [8]. - Adjusted EBITDA loss improved by 17% to $2.7 million compared to a loss of$3.3 million in Q1 2024 [8]. - Total cash, cash equivalents, and restricted cash increased to $13.1 million at March 31, 2025, from$9.8 million as of December 31, 2024 [8]. Business Highlights - The company is focused on bringing DrugSorb™-ATR to the North American market, addressing the unmet need for reducing life-threatening bleeding in patients on Brilinta® during CABG surgery [5][6]. - The FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, but the company plans to resolve the outstanding items through a formal appeal process, expecting a final regulatory decision in 2025 [6][7]. - Real-world adoption of DrugSorb-ATR is increasing, with more heart centers incorporating the technology into standard care based on evidence from the international STAR Registry [7]. - The company completed a shareholder rights offering, raising $6.8 million, which increased liquidity and allowed for the release of$5.0 million of restricted cash [9]. Operational Developments - CytoSorbents opened a new regional sales subsidiary in Dubai, UAE, expanding its global footprint into the Middle East and Africa [9]. - The company appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR [9].