CytoSorbents(US:CTSO)2025-06-23 07:46Financial Performance - Q1 2025 product sales were $8.7 million, a 3% year-over-year decrease, but flat on a constant currency basis[18] - Product gross margin was 71% in Q1 2025, consistent with the average from 2024[18] - Total operating expenses decreased by 12% year-over-year, from $11.5 million to $10.1 million[50] - Net loss improved by 17% year-over-year, from $6.1 million ($0.11/share) to $1.5 million ($0.02/share)[50] DrugSorb-ATR Regulatory Update - The company submitted a De Novo submission to the FDA and a Medical Device License application to Health Canada, but received a denial letter from the FDA on April 25, 2025[36] - The company plans to file a formal appeal within 60 days of the FDA letter[36] - Health Canada submission is in advanced review, with a decision expected in 2025[36] DrugSorb-ATR Market Opportunity - DrugSorb-ATR addresses a $300+ million initial market opportunity, which could exceed $1 billion as Brilinta becomes generic and DrugSorb-ATR expands to additional indications[33] CytoSorb Core Business - Core product sales reached a record $35.6 million in 2024[14] - The company aims to return Germany to growth in the second half of 2025 after flat sales for two consecutive years[18] - The company is managing its total core business toward near breakeven in the second half of 2025[18] Balance Sheet - The company received $6.8 million from a successful Rights Offering[51] - The company released $5.0 million of restricted cash[51] - The company had $13.1 million in cash, cash equivalents, and restricted cash at March 31, 2025[51]