Delcath Systems (DCTH) Earnings Call Presentation

Company Overview - Delcath is focused on liver-dominant cancers with a high unmet medical need[16, 22] - The company's lead product is the HEPZATO KIT, a liver-directed treatment for metastatic uveal melanoma (mUM)[38] - Delcath has an experienced management team with expertise in commercializing high-value, specialty products[10, 14, 100] - The company has a strong financial position with $58.9 million in cash and investments as of March 31, 2025, and no outstanding debt obligations[15] HEPZATO KIT Commercialization - HEPZATO KIT received FDA approval in August 2023 for mUM[17] - In Q1 2025, total revenue was $19.8 million with gross margins of 86%[14] - Full-year revenue guidance for 2025 is $94 to $98 million[14] - The company is expanding its commercial presence, with 19 active centers as of May 8, 2025, and 29 sites accepting referrals[65] - The US mUM total addressable market (TAM) is approximately $500 million[15] Clinical Development and Pipeline - Delcath has IND approval for Phase 2 trials in metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC)[14] - Phase 2 trials for mCRC and mBC are planned to initiate enrollment in Q3/Q4 2025 and Q4 2025, respectively[17] - The company is evaluating HEPZATO in combination with SOC (trifluridine-tipiracil and bevacizumab) in liver-dominant mCRC, enrolling approximately 90 patients[17] - The company is also evaluating HEPZATO in combination with SOC (eribulin, vinorelbine or capecitabine) in liver-dominant HER2-negative mBC, enrolling approximately 90 patients[18] Financial Performance - Q1 2025 net income was $1.1 million, and adjusted EBITDA was $7.6 million (Non-GAAP)[15] - Q1 2025 operating cash flow was $2.2 million[15] - The company received approximately $16 million from warrant exercises through May 5th at a $10 strike price[15]