Delcath(DCTH) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $85.2 million, representing over 40% volume growth compared to the previous year [6][7] - The fourth quarter revenue was $20.7 million, with gross margins of 85% for the quarter and 86% for the full year, compared to 86% and 83% in the prior year [18][21] - The net loss for the fourth quarter was $1.9 million, an improvement from a $3.4 million loss in the same quarter of the previous year, while the full year net income was $2.7 million compared to a loss of $26.4 million in 2024 [20] Business Line Data and Key Metrics Changes - Revenue from HEPZATO was $19 million in the fourth quarter and $78.8 million for the full year, compared to $13.7 million and $32.3 million in the same periods of 2025 [18] - CHEMOSAT revenue was $1.7 million for the fourth quarter and $6.4 million for the full year, compared to $1.4 million and $4.9 million in 2024 [18] Market Data and Key Metrics Changes - The company operates 28 active treatment centers and aims to expand to 40 by the end of 2026, with significant interest from leading cancer centers [9][10] - The average number of new patients treated per site per month was approximately 0.75 in early 2026, up from 0.5 in 2025 [11] Company Strategy and Development Direction - The company’s commercial strategy focuses on three priorities: expanding site capacity, changing prescribing patterns, and developing referral networks [8][15] - The CHOPIN data publication is expected to drive revenue acceleration and enhance the company’s market position [6][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth driven by site activations and the anticipated impact of the CHOPIN results [6][15] - The company expects to guide total revenue of at least $100 million for 2026, reflecting a greater than 20% increase in HEPZATO procedure volume [22][23] Other Important Information - Research and development expenses for 2025 were $29.2 million, with an expected increase of nearly 90% in 2026 due to ongoing clinical trials [19] - The company ended 2025 with approximately $91 million in cash and investments, indicating a strong financial position [22] Q&A Session Summary Question: Clarification on guidance assumptions and seasonality - Management confirmed that seasonality is expected in the third quarter, with modest growth anticipated from Q2 to Q3 [25][26] Question: Difference between HEPZATO KIT REMS site and clinical trial sites - Management clarified that only compliant REMS sites accepting referrals will be listed on the HEPZATO KIT website [30][31] Question: Timing of CHOPIN study publication and its impact - Management indicated that the CHOPIN study publication is imminent and will be used to inform treating physicians and potentially update guidelines [39][40] Question: Average treatments per patient and new patient starts - The average number of treatments per patient remains around 4, with new patient starts expected to average close to 0.5 per site per month [44][46] Question: Potential catalysts for the third quarter - Management acknowledged that while seasonality may impact the third quarter, the CHOPIN publication could serve as a catalyst for growth [56][58]