CytoSorbents(US:CTSO)2024-11-07 21:10Revenue and Sales Performance - Product revenue for Q3 2024 was $8.6 million, an 11% increase compared to $7.8 million in Q3 2023[2] - Total revenue for Q3 2024 was $9.4 million, a 7% increase compared to $8.8 million in Q3 2023[2] - CytoSorb product sales generated nearly $34 million in trailing 12-month revenue across 76 countries, with approximately 70% gross margins[5] - Total revenue for the nine months ended September 30, 2024, was $29,071,316, compared to $27,681,164 for the same period in 2023[16] - CytoSorb sales for the nine months ended September 30, 2024, increased to $26,381,455 from $23,681,183 in the same period in 2023[16] Profitability and Losses - Net loss improved to $2.3 million or $0.04 per share in Q3 2024, compared to a net loss of $9.2 million or $0.21 per share in Q3 2023[2] - Adjusted EBITDA loss improved to $3.6 million in Q3 2024, compared to a loss of $5.6 million in Q3 2023[2] - Net loss for the nine months ended September 30, 2024, was $12,835,098, compared to $22,672,487 for the same period in 2023[16] - Net loss for Q3 2024 was $2.334 million, compared to $9.194 million in Q3 2023[19] - Adjusted EBITDA for Q3 2024 was $(3.557) million, compared to $(5.576) million in Q3 2023[19] - Adjusted net loss per share for Q3 2024 was $(0.08), compared to $(0.14) in Q3 2023[18] - Net loss for the nine months ended September 30, 2024 was $12.835 million, compared to $22.672 million in the same period of 2023[19] - Net loss for the full year 2023 was $28.5 million, with quarterly losses ranging from $5.8 million to $9.2 million[21] - Adjusted EBITDA for 2023 was $(25.9) million, with quarterly figures ranging from $(5.9) million to $(7.8) million[21] - Net loss for the first nine months of 2024 was $12.8 million, with quarterly losses decreasing from $6.4 million to $2.3 million[23] - Adjusted EBITDA for the first nine months of 2024 was $(9.3) million[23] Gross Margins and Profit - Product gross margins decreased to 61% in Q3 2024, down from 72% in Q3 2023 due to a planned production slowdown and a resolved manufacturing issue[2] - Gross profit for the nine months ended September 30, 2024, was $18,354,922, compared to $17,080,743 for the same period in 2023[16] Regulatory and Market Opportunities - The total addressable market (TAM) for DrugSorb-ATR in North America is estimated at $300 million, with potential growth to over $600 million post-Brilinta generics and further expansion to $1-2 billion with broader applications[4] - The company submitted a De Novo application for DrugSorb-ATR to the U.S. FDA on September 27, 2024, and received acceptance for substantive review on October 22, 2024[3] - CytoSorbents received MDSAP certification on November 1, 2024, enabling compliance with regulatory requirements in the U.S., Canada, Brazil, Japan, and Australia[3] - The company submitted a Medical Device License (MDL) application to Health Canada for DrugSorb-ATR on November 1, 2024[3] Financial Position and Assets - Cash and cash equivalents decreased to $5,685,328 as of September 30, 2024, from $14,131,137 as of December 31, 2023[15] - Total current assets decreased to $16,597,368 as of September 30, 2024, from $25,702,823 as of December 31, 2023[15] - Total liabilities increased to $34,804,921 as of September 30, 2024, from $29,985,471 as of December 31, 2023[15] - Total stockholders' equity decreased to $12,999,090 as of September 30, 2024, from $23,275,163 as of December 31, 2023[15] - Total stockholders' equity as of September 30, 2024 was $12.999 million[17] - Accumulated deficit as of September 30, 2024 was $(295.340) million[17] Expenses and Compensation - Research and development expenses for the nine months ended September 30, 2024, decreased to $5,619,040 from $11,632,416 in the same period in 2023[16] - Stock-based compensation expense for Q3 2024 was $0.781 million[17] - Non-cash stock-based compensation expense for Q3 2024 was $0.458 million[19] - Non-cash stock-based compensation expense for 2023 totaled $3.7 million[21] - Non-cash stock-based compensation expense for the first nine months of 2024 was $2.2 million[23] - Depreciation and amortization expense for the first nine months of 2024 was $1.2 million[23] - Interest expense for the first nine months of 2024 was $775,000[23] Share and Earnings Metrics - Basic and diluted net loss per common share for the nine months ended September 30, 2024, was $(0.24), compared to $(0.52) for the same period in 2023[16] - Weighted average common shares outstanding for Q3 2024 was 54.453 million[18] - Weighted average common shares outstanding for 2024 YTD was approximately 54.3 million, with a loss per share of $(0.24)[22] - Adjusted net income (loss) per common share for 2024 YTD was $(0.21)[22] Foreign Currency and Other Items - Foreign currency translation loss for Q3 2024 was $(2.650) million[19]