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 Q4 2025, up from $13.7 million in Q4 2024, while CHEMOSAT revenue was $1.7 million compared to $1.4 million in the same period [18] - For the full year, HEPZATO revenue was $78.8 million, significantly higher than $32.3 million in 2024, and CHEMOSAT revenue increased to $6.4 million from $4.9 million [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, compared to 0.5 for the full year of 2025 [11] Company Strategy and Development Direction - The company has organized its commercial strategy around 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 for total revenue of at least $100 million in 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, up from $13.9 million in 2024, with expectations for a nearly 90% increase in 2026 [19] - The company ended 2025 with approximately $91 million in cash and investments, and no outstanding debt obligations [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 commercial sites - Management clarified that HEPZATO KIT REMS sites must be compliant and cannot accept referrals until they have treated their first patient [30][32] Question: Timing of CHOPIN study publication and its impact - Management indicated that the CHOPIN study publication is imminent, expected within a month, and will be used to inform treating physicians [39][40] Question: Average treatments per patient and new patient starts - The average number of treatments per patient remains around 4.1, with new patient starts expected to average close to 0.5 per site per month [44][48] Question: Potential catalysts for the third quarter - Management acknowledged that while seasonality is a concern, the CHOPIN publication could serve as a catalyst for increased site activations [58][59]

Delcath(DCTH) - 2025 Q4 - Earnings Call Transcript - Reportify