Financial Performance - Total revenues for the three months ended September 30, 2024, were $11.2 million, compared to $434,000 for the same period in 2023, representing a significant increase due to the commercial launch of the HEPZATO KIT in the U.S.[125] - Gross profit for the three months ended September 30, 2024, was $9.56 million, compared to $301,000 for the same period in 2023, indicating improved profitability following the product launch[125] - The net income for the three months ended September 30, 2024, was $1.86 million, a significant improvement from a net loss of $20.34 million in the same period in 2023[125] - The company reported a total operating loss of $1.26 million for the three months ended September 30, 2024, compared to a loss of $10.56 million in the same period in 2023, indicating improved operational efficiency[125] - During the quarter ending September 30, 2024, the company recorded at least $10.0 million in quarterly U.S. revenue due to the commercialization of the HEPZATO KIT[147] Expenses - Research and development expenses for the three months ended September 30, 2024, were $3.87 million, a decrease from $4.66 million in the same period in 2023, primarily due to lower costs associated with NDA submission[128] - Selling, general and administrative expenses increased to $6.95 million for the three months ended September 30, 2024, compared to $6.20 million in the same period in 2023, driven by commercial launch activities[129] Cash and Capital Management - As of September 30, 2024, the company had cash and cash equivalents totaling $8.3 million, down from $12.7 million at December 31, 2023, reflecting cash used for operating activities[131] - The company anticipates needing to raise additional capital due to potential delays in site activation for HEPZATO and lower-than-expected revenue from HEPZATO and CHEMOSAT, which raises substantial doubt about its ability to continue as a going concern[134] - Capital commitments over the next twelve months include $6.8 million for accounts payable and $2.0 million for convertible note principal payments[135] - The company filed a universal shelf registration statement allowing it to offer up to $150 million in various securities, including common and preferred stock, debt securities, and warrants[136] - The company expects to raise additional capital if revenue from HEPZATO and CHEMOSAT is less than anticipated, which may involve unfavorable terms[134] Product Development and Market Expansion - The overall response rate (ORR) from the Phase 3 FOCUS Trial was reported at 36.35%, significantly higher than the historical control group's ORR of 5.5%, supporting the clinical adoption of CHEMOSAT[123] - The company plans to initiate studies for the HEPZATO KIT to treat other liver cancers in late 2024 or early 2025, targeting significant unmet medical needs[123] - The commercial expansion of CHEMOSAT in Europe has contributed to increased demand, further enhancing revenue growth[126] - As of October 31, 2024, 12 facilities have treated at least one patient with the HEPZATO KIT, indicating early adoption in clinical settings[123] - The company expects to continue its commercialization efforts for HEPZATO and CHEMOSAT, with a focus on obtaining additional regulatory approvals and building a commercial infrastructure[134] Securities and Financing - As of September 30, 2024, 58,924 shares of Series F Preferred Stock were converted into 15,005,211 shares of common stock[148] - The exercise of all Preferred and Common Warrants from the March 2023 Private Placement could generate approximately $60.0 million in proceeds[145] - The March 2024 Private Placement closed with gross proceeds of approximately $7.0 million before deducting offering expenses[149] - As of September 30, 2024, 1,758,843 Series E and Series E-1 Warrants remain outstanding, with no warrants exercised during the three and nine months ended September 30, 2024[141] - As of September 30, 2024, 1,851,900 Series F Warrants remain outstanding, with no warrants exercised during the three and nine months ended September 30, 2024[142] - The Avenue Loan had an interest rate of 16.20% as of September 30, 2024, and the company made its final payment on the loan on August 1, 2024[139][140]
Delcath(DCTH) - 2024 Q3 - Quarterly Report