Delcath (DCTH) Q2 Revenue Jumps 210%

Delcath Systems (DCTH -4.89%), a medical device and pharmaceutical company known for liver-directed cancer therapies, announced its earnings for the second quarter of fiscal 2025 on August 6, 2025. The company reported a sharp increase in revenue, reaching $24.2 million (GAAP).—exceeding analyst GAAP estimates of $22.94 million. Gross margin (GAAP) improved to 86%, and Non-GAAP adjusted EBITDA was $9.8 million, turning positive versus a loss a year ago. Diluted EPS (GAAP) was $0.07, beating the expected $0.03. Delcath’s quarter saw stronger-than-expected adoption of its HEPZATO KIT in the U.S, continued U.S. center expansion, and progress in clinical development for new cancer indications. The results positioned the company above expectations.

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Recent Focus

Delcath Systems is focused on developing and commercializing therapies that deliver high doses of chemotherapy directly to the liver. Its core product, the HEPZATO KIT, is a combination drug and device system for treating uveal melanoma with unresectable liver metastases. HEPZATO KIT received approval from the U.S. Food and Drug Administration (FDA) in August 2023, with its first commercial patients treated in January 2024.

The company’s recent strategy centers on accelerating adoption of HEPZATO KIT in the U.S, securing reimbursement from insurers, and expanding clinical indications to reach more liver cancer patients. Delcath places heavy emphasis on activating treatment centers, enrolling new patients, and building relationships with physicians and payors.

Highlights and Key Metrics From the Quarter

Delcath reported revenue climbed 210.3% year-over-year, reaching $24.2 million, surpassing consensus estimates by $1.26 million, a 5.48% surprise. Revenue gains stemmed almost exclusively from HEPZATO KIT sales in the U.S, which rose sharply to $22.5 million, up from $6.6 million in Q2 2024. Sales of CHEMOSAT, the company’s earlier liver-targeted therapy device marketed in Europe, contributed $1.7 million, compared to $1.2 million in Q2 2024 but still a minor part of total revenue.

Profitability metrics improved across the board. Gross margin (GAAP) reached 86%, up from 80% in Q2 2024, reflecting higher sales volume and improved pricing power. The company swung to positive adjusted EBITDA of $9.8 million compared to a loss of $0.8 million in Q2 2024. Net income (GAAP) was $2.7 million, reversing a $13.7 million GAAP loss one year earlier. EPS (GAAP, diluted) moved to $0.07 from a loss of $0.48 per share.

Operationally, Delcath activated three new U.S. treatment centers, bringing its total to 20 active centers nationwide. An additional 10 centers were accepting referrals as of the end of the quarter, putting the company on track for its stated goal of 30 active centers by year end. Across all centers, utilization held steady at just under two treatments per center each month—matching management's guidance. The price per HEPZATO KIT averaged $185,000, reflecting pricing increases during the period. Management credited strong physician word-of-mouth and expansion of its “Access 360” platform, which helps patients connect with centers and manage out-of-pocket costs, as key drivers behind the commercial ramp.

Clinical and regulatory progress was also notable. The company secured FDA and European authorization to begin Phase 2 studies for HEPZATO in two additional cancer indications: metastatic colorectal cancer and breast cancer with liver-dominant disease. Both studies are designed to evaluate the effectiveness of the HEPZATO KIT as an add-on to standard care in larger patient populations. Enrollment for the metastatic colorectal cancer trial is scheduled to begin in the third or fourth quarter, with the breast cancer trial to follow shortly after. These patient groups represent substantially larger potential markets—about 7,000 patients each annually in the U.S. (based on company market research estimates).

In Europe, CHEMOSAT revenue was $1.7 million, compared to $1.2 million in Q2 2024, but limited reimbursement and much lower pricing continued to hinder significant commercial growth outside Germany. The company highlighted Europe as more of a clinical data source than a major commercial market and maintained a “breakeven” approach to resource deployment there.

R&D (research and development) expenses more than doubled to $6.9 million, reflecting higher clinical trial costs and increased staffing. Selling, general and administrative expenses climbed to $11.4 million, driven by the buildout of the U.S. commercial team and related marketing activity. Stock-based compensation rose to $7.2 million from $3.1 million in Q2 2024. Cash and investments ended the quarter at $81.0 million, up from $58.9 million at Q1 2025, with no outstanding debt. All of these investments contributed to expanding Delcath’s commercial and clinical footprint.

Outlook and What to Watch Next

Looking ahead, Delcath updated its full-year guidance, forecasting revenue to reach $93–96 million, representing growth of more than 150% compared with fiscal year 2024. Gross margin (GAAP) is expected to remain strong at 83–85%, with positive adjusted EBITDA and cash flow in each quarter (non-GAAP). Management restated its intent to finish the year with about 30 active U.S. centers and highlighted continued center activation as the main driver for reaching sales targets.

The company’s outlook depends heavily on sustained HEPZATO KIT adoption, new center activations, and execution on clinical trials for additional indications. Investors should track the pace of U.S. center expansion and utilization per center, as these directly affect sales ramp and revenue consistency.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.