Core Viewpoint - Delcath Systems, Inc. has announced preliminary financial results for Q4 and the full year 2025, highlighting significant revenue growth and ongoing clinical advancements in the treatment of liver cancers [1][2]. Financial Results - Total revenue for Q4 2025 is expected to be approximately $20.7 million, while full-year revenue is projected at $85.2 million [6]. - Revenue from the HEPZATO KIT for Q4 and the full year is anticipated to be around $19.0 million and $78.8 million, respectively [6]. - CHEMOSAT revenue for Q4 and the full year is expected to be approximately $1.7 million and $6.4 million, respectively [6]. - The company has repurchased 628,572 common shares for $6.0 million under a $25.0 million Share Buyback Program [6]. - As of December 31, 2025, Delcath had approximately $91.0 million in cash and short-term investments, an increase from $88.9 million as of September 30, 2025, with no debt [6]. Business Highlights - There was approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024 [6]. - The company plans to enhance the adoption of HEPZATO by raising awareness of the CHOPIN study findings among treating physicians [5]. - Independent investigators presented positive results from the Phase 2 CHOPIN trial at the 2025 European Society of Medical Oncology Annual Congress, showing significant improvement in one-year progression-free survival when combining CHEMOSAT with ipilimumab and nivolumab [6]. - Recent publications have emphasized the efficacy of percutaneous hepatic perfusion (PHP) in managing metastatic uveal melanoma, showcasing long-term survival outcomes and clinical experiences [6]. Product Information - Delcath Systems focuses on interventional oncology, specifically targeting primary and metastatic liver cancers with its proprietary products, HEPZATO KIT and CHEMOSAT [7]. - HEPZATO KIT is a combination drug and device product approved by the FDA for treating adult patients with metastatic uveal melanoma with unresectable hepatic metastases [8]. - In Europe, CHEMOSAT is regulated as a Class III medical device and has been utilized in major medical centers for various liver cancer treatments [9].
Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2025 Financial Results