Delcath Systems — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the quarter ended September 30, 2026, was $35.1 million, a 70.4% increase from $20.6 million in the same period in 2025.
• HEPZATO KIT™ revenue reached $32.7 million, up from $19.3 million in Q3 2025.
• CHEMOSAT® revenue was $2.4 million, compared to $1.3 million in Q3 2025.
• Gross margins improved to 89% from 87% in the prior year quarter.
• Net income was $7.0 million, compared to $0.8 million in Q3 2025.
• Non-GAAP adjusted EBITDA was $11.5 million, more than doubling from $5.3 million in Q3 2025.
• Cash provided by operations was $8.2 million, up from $4.8 million in the prior year quarter.
• Research and development expenses were $11.0 million, increasing from $8.0 million in Q3 2025.
• Selling, general and administrative expenses were $13.1 million, up from $10.3 million in Q3 2025.
• Cash and investments totaled $104.3 million as of September 30, 2026, with no debt outstanding.
• Accounts receivable increased to $20.2 million from $11.7 million as of December 31, 2025.

Guidance and Future Outlook:

• Increased 2026 full-year revenue guidance to a range of $115 million to $117 million.
• The updated guidance reflects an expected increase in HEPZATO KIT volume of at least 41% over 2025.
• Full-year 2026 gross margins are projected to range between 87% and 89%.
• The company expects to report positive adjusted EBITDA for the full year 2026.
• Management plans to submit an Investigational New Drug (IND) application for cholangiocarcinoma in early 2027.
• Pending FDA agreement, preclinical development of an oxaliplatin-based PHP product is targeted for completion by mid-2027.

Business Segments and Product Lines:

• The company operates with 33 active treatment centers.
• HEPZATO volume grew approximately 72% in the third quarter of 2026 compared to the third quarter of 2025.
• Advanced the global Phase 2 DELUMA trial (NCT06875128) evaluating HEPZATO in combination with standard-of-care therapy for liver-dominant HER2-negative metastatic breast cancer.
• The first patient in the DELUMA trial was dosed on July 9, 2026, at the European Institute of Oncology in Milan, Italy.
• The DELUMA trial is designed to enroll approximately 90 patients across more than 20 U.S. and European sites.

Management Commentary and Tone:

• CEO Gerard Michel expressed confidence in the long-term opportunity, citing continued momentum in commercial operations and clinical development.
• Management highlighted growing physician experience with HEPZATO, strong engagement across the treatment center network, and increasing interest in combining HEPZATO with systemic therapies.

Risks and Challenges:

• Forward-looking statements are subject to risks including uncertainties regarding the successful commercialization of HEPZATO KIT.
• Risks include the ability to secure adequate supply of critical components for manufacturing and assembling the HEPZATO KIT.
• Potential challenges involve successful FDA inspections of company and third-party supplier/manufacturing facilities.
• Uncertainties exist regarding the successful implementation of the HEPZATO KIT Risk Evaluation and Mitigation Strategy (REMS).
• Risks include the ability to obtain reimbursement for HEPZATO KIT and successfully enter into necessary purchase and sale agreements with users.

Other Key Points:

• The company reported $104.3 million in cash and investments with zero debt as of September 30, 2026.
• HEPZATO KIT is approved in the U.S. for adult patients with metastatic uveal melanoma with unresectable hepatic metastases.
• CHEMOSAT is approved in Europe as a Class III medical device for percutaneous hepatic perfusion procedures.
• The company holds 34,771,239 common shares issued and outstanding as of September 30, 2026.
• Diluted income per common share for the quarter was $0.17, compared to $0.02 in the prior year quarter.