Delcath Systems, Inc.

What they do

Delcath Systems develops and commercializes drug/device combination products for liver-directed treatment of cancers. Its lead product, HEPZATO KIT, is FDA-approved for adult patients with uveal melanoma with unresectable hepatic metastases. In Europe, it sells CHEMOSAT, a standalone hepatic delivery device. The company operates as one segment with manufacturing and R&D in Queensbury, NY and a sub-lease in Ireland.

Revenue drivers

• HEPZATO KIT (U.S.) — Combination drug/device product for liver-directed treatment of metastatic uveal melanoma; generated $27.1M of $29.1M total revenue in Q2 2026.
• CHEMOSAT (Europe) — Hepatic delivery system sold as a medical device in Europe; generated $2.0M in Q2 2026, up from $1.7M in Q2 2025.

Recent performance

In Q2 2026, total revenue was $29.1M, up from $24.2M in Q2 2025; HEPZATO revenue grew to $27.1M from $22.5M. Gross margins improved to 90% from 86%. Net income was $2.7M, flat versus prior year, while non-GAAP adjusted EBITDA fell to $7.6M from $9.8M. Cash and investments were $95.9M at June 30, 2026, with no debt.

Strategy

Management is focused on expanding the active treatment center network (31 centers as of Q2 2026) and driving physician adoption of HEPZATO, especially in combination with systemic therapies. The company is investing in clinical trials for additional indications, including HER2-negative metastatic breast cancer and combination trials with tebentafusp and nivolumab/relatlimab. It also continues to support independent investigator studies in breast and colorectal cancers. Managing supply chain through stockpiled inventory and multi-supplier contracts is a stated priority.

Risks

• Dependence on HEPZATO KIT — Nearly all US revenue comes from HEPZATO; any supply, reimbursement, or clinical setback would materially affect results.
• Regulatory and compliance risk — FDA regulates HEPZATO as a drug; ongoing compliance with NDRA and other obligations is required, with potential fines or sales restrictions.
• Clinical trial and adoption risk — Future revenue growth depends on positive trial results and broader market acceptance beyond uveal melanoma; delays or failures could impede growth.
• Litigation risk — Company faces claims and litigation in the ordinary course, including the medac matter referenced in the 10-K, with uncertain outcomes.

Outlook

Management raised 2026 revenue guidance to $104M-$108M, implying at least 28% HEPZATO volume growth over 2025. Full-year gross margins are expected in the range of 86% to 89%, with positive adjusted EBITDA. The company expects continued clinical trial progress and expansion of its active treatment center network.