CytoSorbents(CTSO) - 2024 Q4 - Annual Report

Financial Performance - Total product revenue for the year ended December 31, 2024, was $35.6 million, an increase of$4.5 million, or 15%, compared to $31.1 million in 2023[252]. - Gross profit for the year ended December 31, 2024, was approximately$25.1 million, an increase of $3.2 million, or 14$22.0 million in 2023[256]. - Loss from operations improved by 47% to approximately $16.8 million for the year ended December 31, 2024, down from$31.9 million in 2023, due to revenue growth and a 22% reduction in total operating expenses[260]. - The company experienced a loss on foreign currency transactions of approximately $4.2 million for the year ended December 31, 2024, compared to a gain of approximately$1.9 million in 2023[262]. - The company recorded approximately $3.76 million in stock-based compensation expense for the year ended December 31, 2024, including 1,214,400 performance awards granted[280]. Expenses Management - Research and development expenses decreased by approximately$8.7 million, or 56%, to $6.9 million for the year ended December 31, 2024, primarily due to the completion of the STAR-T clinical trial[257]. - Selling, general and administrative expenses decreased by approximately$3.3 million, or 9%, to $35.0 million for the year ended December 31, 2024, mainly due to reductions in salaries and professional expenses[259]. - The company continues to manage resources proactively, focusing on regulatory submissions and maintaining tight control over expenditures[268]. - The company has adjusted its accounting policy for grants, retroactively reclassifying grant income as a reduction of research and development expenses[279]. Financing Activities - The company secured a$20 million credit facility in June 2024, with an initial tranche of $15 million available at closing[266]. - The company raised a total of$7.3 million through the Rights Offering and Series A Right Warrants, increasing unrestricted cash to $15.6 million as of December 31, 2024, compared to$3.3 million previously reported[270]. - The Rights Offering closed on January 10, 2025, raising gross proceeds of $6.25 million from the sale of 6.25 million Units, each comprising one share of common stock and two Right Warrants[271]. - Approximately 1.4 million Series A Right Warrants were exercised at an exercise price of$1.13 per warrant, generating an additional $1.6 million in gross proceeds[271]. - The Avenue Capital Group has committed to loan the company up to$20 million, with $15 million available in the first tranche and a second tranche of up to$5 million contingent on FDA approval[273]. - The proceeds from the Avenue Capital Commitment will be used to pay off existing debt and for working capital, with interest rates set at a minimum of 5% above the Prime Rate or 13.5%[275]. - The company is actively pursuing various financing sources, including equity and debt financing, to meet its increasing capital needs[272]. Regulatory and Operational Updates - The company submitted a De Novo medical device application for DrugSorb-ATR to the FDA on September 27, 2024, which was accepted for substantive review in October 2024[250]. - The company expects to receive regulatory approval for DrugSorb-ATR in the U.S. and Canada in 2025, which is critical for future capital requirements[272]. - As of December 31, 2024, the company had current assets of approximately $21.6 million and current liabilities of approximately$9.9 million[264]. - The company operates leased facilities in Princeton, New Jersey, and Berlin, Germany, with a monthly base rent of approximately $121,000 as of December 31, 2024[283].