Delcath(DCTH) - 2022 Q1 - Quarterly Report

Financial Performance - For the three months ended March 31, 2022, Delcath recorded approximately $378,000 in revenue, a slight decrease from $388,000 in the same period of 2021, primarily due to the transition to direct sales in Europe [70]. - Cost of goods sold for the same period was approximately $33,000, down from $112,000 in the prior year, attributed to the direct sales transition in Europe [71]. - Revenue for the three months ended March 31, 2022, was approximately $378,000, a slight decrease from $388,000 in the same period of 2021 [70]. - Cost of goods sold decreased to approximately $33,000 for the three months ended March 31, 2022, compared to $112,000 in the prior year period [71]. Expenses - Research and development expenses increased to $4.2 million from $3.7 million year-over-year, mainly due to costs associated with the pre-NDA meeting and NDA submission preparations [72]. - Selling, general and administrative expenses rose to $3.6 million from $3.3 million, reflecting higher costs in preparation for the commercialization of HEPZATO in the U.S. [73]. - Other expenses increased significantly to $0.6 million from $20,000, primarily due to interest and amortization expenses related to debt financing [74]. - Research and development expenses increased to $4.2 million for the three months ended March 31, 2022, up from $3.7 million in the prior year, primarily due to pre-NDA meeting preparations [72]. - Selling, general and administrative expenses rose to $3.6 million for the three months ended March 31, 2022, compared to $3.3 million in the same period of 2021, driven by commercialization preparations for HEPZATO [73]. - Other expenses increased to $0.6 million for the three months ended March 31, 2022, from $20,000 in the prior year, mainly due to interest and amortization expenses [74]. Cash and Commitments - As of March 31, 2022, Delcath had cash, cash equivalents, and restricted cash totaling $20.5 million, with $6.4 million used in operating activities during the quarter [75]. - The company has capital commitments of $6.1 million for accounts payable and $2.9 million for loan principal payments over the next twelve months [78]. - The Avenue Loan Agreement provides Delcath with a term loan of up to $20 million, with an interest rate of 10.95% as of March 31, 2022, maturing on August 1, 2024 [81]. - The Avenue Loan Agreement provides a term loan of up to $20.0 million, with an interest rate of 10.95% as of March 31, 2022, maturing on August 1, 2024 [81]. Regulatory and Product Development - Delcath plans to submit a new drug application for HEPZATO to the FDA by the end of Q3 2022, following a successful FOCUS Trial [68]. - The company is preparing to submit a new drug application (NDA) for HEPZATO to the FDA by the end of Q3 2022, following positive results from the FOCUS Trial [68]. - CHEMOSAT received Medical Device Regulation certification in Europe on February 28, 2022, and the company has taken direct responsibility for its sales and marketing in Europe [69]. - The company has received six orphan drug designations from the FDA for melphalan and one for doxorubicin, targeting various types of cancer [68].