Delcath(US:DCTH)2023-08-08 16:00Financial Performance - Total revenues for the three months ended June 30, 2023, were $495,000, a decrease of 38% compared to $797,000 for the same period in 2022[112]. - Gross profit for the three months ended June 30, 2023, was $345,000, down from $617,000 in the same period of 2022, reflecting lower demand for CHEMOSAT[112][113]. - The net loss for the three months ended June 30, 2023, was $7.2 million, compared to a net loss of $10.2 million for the same period in 2022[112]. - Total revenues for the three months ended June 30, 2023, were $495,000, a decrease of 37.9% compared to $797,000 for the same period in 2022[112]. - Gross profit for the three months ended June 30, 2023, was $345,000, down 44.1% from $617,000 in the prior year[112]. - The net loss for the three months ended June 30, 2023, was $7.202 million, compared to a net loss of $10.159 million for the same period in 2022, reflecting a 29.2% improvement[112]. Expenses - Research and development expenses for the three months ended June 30, 2023, were $3.6 million, a decrease of 37% compared to $5.6 million in the same period of 2022[112][115]. - Selling, general and administrative expenses increased to $4.8 million for the three months ended June 30, 2023, compared to $4.5 million in the same period of 2022, due to preparations for commercial launch[112][116]. - Research and development expenses for the three months ended June 30, 2023, were $3.555 million, a decrease of 36.4% from $5.606 million in 2022, attributed to the completion of clinical trial activities[115]. - Selling, general and administrative expenses increased to $4.787 million for the three months ended June 30, 2023, up 6.5% from $4.497 million in 2022, due to preparations for commercial launch[116]. Cash and Capital - As of June 30, 2023, the company had cash, cash equivalents, and restricted cash totaling $14.6 million, an increase from $11.8 million at December 31, 2022[118]. - The company used $13.9 million of cash for operating activities during the six months ended June 30, 2023[118]. - Capital commitments for the next twelve months include $6.6 million for accounts payable and lease liabilities, and $5.1 million for loan principal payments[124]. - The company has entered into an ATM Sales Agreement allowing for the sale of up to $17.0 million in common stock, with approximately $4.0 million sold to date[125]. - The Avenue Loan Agreement has a principal amount of up to $20 million, with an interest rate of 15.95% as of June 30, 2023, maturing on August 1, 2024[126]. Regulatory and Supply Chain - The PDUFA target action date for the HEPZATO KIT is set for August 14, 2023, following the NDA resubmission to the FDA[109]. - The company is focused on securing a long-term supply of critical components necessary for the HEPZATO KIT, including melphalan, to mitigate supply chain risks[110]. - The company expects to utilize cash and cash equivalents for activities related to the HEPZATO NDA resubmission and commercialization efforts, as well as ongoing support for CHEMOSAT and future clinical trials[123]. - The company is focused on securing a long-term supply of melphalan, with sufficient quantities to meet forecasted demand during a planned shutdown of the current manufacturer[110]. - CHEMOSAT received Medical Device Regulation (MDR) certification in Europe, and the company has taken direct responsibility for its sales and marketing in the region[111]. Stock and Financing - The company has issued 24,900 shares of Series F-1 Convertible Preferred Stock in a private placement, raising approximately $24.9 million before expenses[128]. - As of June 30, 2023, 15,276 shares of Series F-1 Preferred Stock were converted into 4,629,539 shares of common stock[131]. - The company anticipates needing to raise additional capital if there is a substantial delay in the approval of HEPZATO, which could affect its ability to meet obligations within twelve months[122].