Delcath Systems Earnings Call Transcripts
Fiscal Year 2025
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Record 2025 revenue of $85.2M driven by >40% volume growth and expanding treatment centers, with 2026 guidance of at least $100M revenue and strong gross margins. CHOPIN trial data publication and commercial expansion are expected to further accelerate growth.
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Q3 2025 featured strong revenue growth, positive Chopin trial results, and expanded site activations, though average revenue per kit declined due to NDRA pricing. Guidance reflects seasonality and clinical trial competition, with robust cash reserves supporting ongoing R&D and expansion.
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The CHOPIN phase II trial showed that combining PHP with ipilimumab and nivolumab significantly improved progression-free and overall survival in metastatic uveal melanoma, with manageable toxicity. Experts consider the results practice-changing and anticipate broader adoption and protocol expansion, especially in the U.S.
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HEPZATO KIT's commercial rollout is driving revenue growth, with 22 active centers and plans to reach 40 next year. Expansion into new cancer indications and compliance with NDRA are shaping financial and operational strategies, while ongoing trials aim to broaden clinical adoption.
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Revenue grew over 20% sequentially to $24.2M, with strong HEPZATO adoption and positive net income. Guidance was adjusted for slower site activations, but gross margins and cash flow remain robust. Expansion into new indications and 340B participation are expected to drive future growth.
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Q1 2025 saw robust revenue growth, positive net income, and expansion to 19 active U.S. centers, with strong gross margins and no debt. Clinical trial progress and new patient access initiatives support a positive outlook, despite European reimbursement challenges.
Fiscal Year 2024
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2024 saw a successful U.S. launch of HEPZATO, driving $32.3M in revenue and positive Q4 adjusted EBITDA, with 16 active centers and plans to reach 30 by year-end 2025. Gross margins reached 86% in Q4, and R&D investment is set to rise as new trials begin.
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Q3 2024 revenue surged 44% sequentially to $11.2 million, driven by U.S. HEPZATO growth and expanding center activations. Gross margin reached 85%, and the company is well-funded for new clinical trials in colorectal and breast cancer, with no outstanding debt.
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Q2 2024 revenue reached $7.8M, driven by strong U.S. HEPZATO sales and over 100% YoY growth in European CHEMOSAT sales. Gross margin was 80%, with site activations and treatment rates ahead of projections. Break-even is targeted at $13M quarterly revenue by Q1 2025.