Delcath Systems, Inc. Q2 FY2025 earnings call

• Revenue reached $24.2 million, a 20% increase from the first quarter of 2025. U.S. HEPZATO sales were $22.5M, CHEMOSAT in Europe was $1.7M.
• Generated $7.3M in positive cash from operations, net income $2.7M, adjusted EBITDA $9.8M. Ended quarter with no debt and ~$81M in cash/investments.
• Finished Q2 with 20 treating sites, activated Northwestern Memorial Hospital, University of Miami Hospital, and University of Virginia Medical Center; 10 centers accepting referrals. Targeting world-class cancer centers.
• Set goal of 40 sites by end of next year. Expanded U.S. sales force to 6 regions. Average treatments ~2 per month per center.
• Proceeded with NDRA, HEPZATO KIT sold at 340B prices to eligible facilities, ~50% volume distribution. Q3 net effect: 10%-15% reduction in revenue per kit but offset by volume growth.
• R&D: Preparations for trials in liver-dominant metastatic colorectal cancer and liver-dominant metastatic breast cancer. Phase II trials cleared by FDA, colorectal trial CTA authorized in Europe/U.K. Patient dosing for colorectal trial to begin soon, breast cancer enrollment in Q1 2026.

In the second quarter of 2025, Delcath Systems generated total revenue of $24.2 million. U.S. sales of HEPZATO were $22.5 million, which accounts for approximately 92.97% of the total revenue. CHEMOSAT sales in Europe were $1.7 million, making up about 7.03% of the total revenue. The company generated $7.3 million in positive cash from operations, had a net income of $2.7 million, and adjusted EBITDA of $9.8 million. They ended the quarter with no debt and approximately $81 million in cash and investments.

• Full year revenue guidance adjusted to $93M-$96M.
• Forecast 2025 gross margins between 83% and 85%.
• Expect to remain cash flow positive throughout 2025.
• R&D spend: Q2 R&D increased ~37% over Q1, expect Q3 to increase ~40%, Q4 ~25%-30% over Q3, full year 2025 R&D spend ~140% increase from 2024, including significant stock comp.

• Complexities in activating large institutions for novel product, affecting site opening pace.
• Impact of NDRA on revenue per HEPZATO kit, with potential 10%-15% reduction in Q3.
• Uncertainties in clinical trial outcomes and their impact on product expansion and sales.

Q: On treatment rates at sites, will they change beyond this year and with new sites?

A: Gerard J. Michel said some centers reach capacity, may need to refer to other centers or help expand capacity; if successful, may see increasing growth beyond 2 treatments per month.

Q: ESMO presentation data on CHOPIN trial?

A: Vojo Vukovic said CHOPIN trial compares PHP alone vs CHEMOSAT with ipi/nivo, primary endpoint 1-year progression-free survival, results to be presented at ESMO.

Q: Can NDRA lead to higher treatments per month at centers?

A: Gerard J. Michel said NDRA removes conversation about margins, putting decision on patient benefit; not expecting 50% increase in volume, but it's a win for patient focus.

Q: Impact of European clinical trials on CHEMOSAT sales?

A: Gerard J. Michel said longer term, European clinical trials will help CHEMOSAT sales, but it will take quarters to years to make material difference.