Thomas Kerr's questions to Cytosorbents (CTSO) leadership • Q2 2025
Question
Thomas Kerr of Zacks Small Cap Research sought clarification on Canada's 'request for reconsideration' process for DrugSorb ATR, the planned commercial rollout strategy in the U.S. upon approval, how new sepsis data affects the business model, and the gross margin outlook for the remainder of the year.
Answer
CEO Phillip Chan clarified that the Canadian process is a formal appeal, similar to the FDA's, which has been deferred with Health Canada's agreement until after the FDA decision. CFO Peter Mariani described the U.S. launch as a 'purposeful rollout' focused initially on clinical trial sites. Dr. Chan explained that sepsis is a core, not new, application, and the new data helps refine best practices to drive better outcomes. Mr. Mariani noted that while Q2 gross margins were ~71%, they see opportunities for improvement through production efficiencies and the potential launch of the higher-margin DrugSorb ATR.