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CytoSorbents(CTSO) - 2025 Q1 - Quarterly Report
CTSOCytoSorbents(CTSO)2025-05-14 20:14
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Financial Performance - Total product revenue for Q1 2025 was 8.7million,adecreaseof8.7 million, a decrease of 0.3 million, or 3%, compared to Q1 2024[90] - Gross profit for Q1 2025 was 6.2million,adecreaseof6.2 million, a decrease of 0.7 million, or 10%, with gross margins of 71.1% compared to 76.5% in Q1 2024[93] - Loss from operations improved by 17% to approximately 3.9millioninQ12025,downfrom3.9 million in Q1 2025, down from 4.7 million in Q1 2024, driven by a 12% reduction in total operating expenses[97] Expenses - Research and development expenses decreased by approximately 0.5million,or260.5 million, or 26%, to 1.7 million in Q1 2025, due to reduced clinical trial costs[94] - Selling, general and administrative expenses decreased by approximately 0.9million,or90.9 million, or 9%, to 8.4 million in Q1 2025, primarily due to lower royalty expenses[95] Currency and Financial Position - The gain on foreign currency transactions was approximately 3.0millioninQ12025,comparedtoalossofapproximately3.0 million in Q1 2025, compared to a loss of approximately 1.4 million in Q1 2024[96] - Current assets as of March 31, 2025, were approximately 25.4million,whilecurrentliabilitieswereapproximately25.4 million, while current liabilities were approximately 9.7 million[98] - As of March 31, 2025, the Company has approximately 13.1millionincash,including13.1 million in cash, including 11.6 million in unrestricted cash[101] Capital Raising and Commitments - The company completed a shareholder Rights Offering in January 2025, providing 5.4millioninnetproceeds,andanadditional5.4 million in net proceeds, and an additional 1.4 million from the exercise of Series A Right Warrant in February 2025[90] - The Company raised 6.25millioningrossproceedsfromitsRightsOffering,with6.25 million in gross proceeds from its Rights Offering, with 5.4 million net of fees, by selling 6.25 million Units[100] - The Company has an effective shelf registration statement allowing it to raise up to 150million,withapproximately150 million, with approximately 149.6 million available as of March 31, 2025[99] - The Avenue Capital Commitment includes a loan of up to 20million,with20 million, with 15 million available in the first tranche and a second tranche of 5millioncontingentonFDAapproval[103]−ProceedsfromtheAvenueCapitalCommitmentwereusedtopayoffexistingdebtandforworkingcapitalpurposes[106]RegulatoryandMarketDevelopments−TheDrugSorb−ATRapplicationisunderadvancedreviewinCanada,withanestimatedtotaladdressablemarketof5 million contingent on FDA approval[103] - Proceeds from the Avenue Capital Commitment were used to pay off existing debt and for working capital purposes[106] Regulatory and Market Developments - The DrugSorb-ATR application is under advanced review in Canada, with an estimated total addressable market of 300 million today, potentially exceeding $1 billion over time[88] - The Company anticipates regulatory approval and introduction of DrugSorb-ATR in the U.S. and Canada in 2025[102] - The FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, with a formal appeal expected if issues are not resolved by June 25, 2025[105] Operational Efficiency - The Company has lowered its spending significantly over the past year while maintaining tight control over expenditures[100] - The Company is exploring additional sources of liquidity, including equity securities issuance and debt financing[102] - The Company’s financial statements are prepared on a going concern basis, indicating uncertainties regarding future capital requirements[102]