CytoSorbents(US:CTSO)2025-11-13 21:32Financial Performance - Total revenue for the nine months ended September 30, 2025, was $27.8 million, an increase of $1.4 million, or 5.2%, compared to the prior year[105]. - Gross profit for the same period was $19.7 million, reflecting a 5.7% increase year-over-year, with a gross margin of 71%[105]. - For the three months ended September 30, 2025, total revenue was approximately $9.5 million, an increase of approximately $0.9 million, or 10.1%, compared to the same period in 2024[109]. - Gross profit for the three months ended September 30, 2025, was approximately $6.7 million, an increase of 26.8% compared to $5.2 million for the same period in 2024, with gross margins improving to 70.3% from 61.0%[110]. - Total revenue for the nine months ended September 30, 2025, was approximately $27.8 million, a 5.2% increase from $26.4 million in 2024, driven by growth in European territories[116]. - Gross profit for the nine months ended September 30, 2025, was approximately $19.7 million, an increase of 5.7% from $18.6 million in 2024, with gross margins slightly improving to 70.7%[117]. Operating Expenses - The loss from operations improved by 20.6% to approximately $10.4 million, driven by a 5.2% increase in total revenue and a 5.2% reduction in total operating expenses[105]. - The cost of goods sold for the three months ended September 30, 2025, was $2.8 million, representing 29.7% of revenue, down from 39.0% in the prior year[108]. - Research and development expenses for the three months ended September 30, 2025, were $918,000, a decrease from $1.8 million, representing 9.7% of revenue compared to 21.2% in 2024[108]. - Research and development expenses decreased by 49.7% to approximately $0.9 million for the three months ended September 30, 2025, down from $1.8 million in 2024, due to the completion of the STAR-T clinical trial[111]. - Selling, general and administrative expenses increased by 4.2% to approximately $8.6 million for the three months ended September 30, 2025, compared to $8.3 million in 2024, primarily due to regulatory submission costs for DrugSorb-ATR[112]. - Loss from operations decreased by 40.7% to approximately $2.9 million for the three months ended September 30, 2025, from $4.8 million in 2024, attributed to a 5.5% reduction in operating expenses and increased gross profit[114]. - Research and development costs for the nine months ended September 30, 2025, were approximately $3.8 million, a decrease of 31.3% from $5.6 million in 2024, due to reduced clinical trial costs[118]. Strategic Plans and Market Opportunities - The Company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada, with an initial estimated total addressable market of $300 million, potentially growing to over $1 billion[103]. - The Company plans to file a new De Novo application for DrugSorb-ATR with the FDA, with a regulatory decision expected in mid-2026[107]. - The company expects a regulatory decision for DrugSorb-ATR in the U.S. by mid-2026 following a 150-day review process[138]. - Future capital requirements may depend on expanding the customer base and sales force, as well as obtaining regulatory approval for new products[137]. - The company announced plans to file a new De Novo application for DrugSorb-ATR with the FDA after the previous application was denied[138]. Workforce and Cost Management - A strategic workforce and cost reduction plan was initiated, reducing the workforce by approximately 10% and aiming for operating cash flow break-even in the first quarter of 2026[107]. - The company expects to reach operating cash flow break-even in the first quarter of 2026 following a strategic workforce and cost reduction plan that includes a 10% workforce reduction[132]. - The company has taken actions to achieve cash flow breakeven, but failure to do so may necessitate slowing sales and marketing expansion or reducing headcount[137]. Financial Position and Liquidity - As of September 30, 2025, the company had current assets of approximately $21.3 million and current liabilities of approximately $12.6 million, indicating a healthy liquidity position[124]. - As of September 30, 2025, the company had approximately $9.1 million in cash, including $7.6 million in unrestricted cash and cash equivalents[133]. - The total amount of debt drawn under the Loan and Security Agreement was $15.0 million as of September 30, 2025, which would increase to $17.5 million on a proforma basis with an additional $2.5 million from the Amended Loan and Security Agreement[136]. - The company has approximately $1.5 million in non-current restricted cash as of September 30, 2025[135]. - The company has no assurance of securing funding on acceptable terms, which may impact its operational strategies[137]. Currency and Foreign Transactions - Gain on foreign currency transactions for the nine months ended September 30, 2025, was approximately $9.1 million, compared to a gain of $0.7 million in 2024, linked to an increase in the Euro to U.S. dollar exchange rate[122]. Funding and Financing Considerations - The company is considering various sources of liquidity, including public or private equity offerings and debt financing, but faces potential dilution for shareholders[137]. - The company filed a pre-submission meeting request with the FDA on November 7, 2025, to discuss the requirements for the new De Novo submission[138].