Delcath Systems, Inc. Q4 FY2025 earnings call

Gerard Michel mentioned 2025 was pivotal with over 40% volume growth and record annual revenue of $85,200,000. Organized commercial strategy around three priorities: expanding site capacity, changing prescribing patterns, building referral networks. Track progress via number of site activations, rate of new patient starts per site per month, average number of treatments per patient. Had strong surge in activations early 2025 with three new sites (MD Anderson, UT Southwestern, Mayo Clinic, Scottsdale). Targeting 40 active treatment centers by 2026. Revamped medical affairs team. CHOPIN results on Hepzato PHP sequenced with checkpoint inhibitors slated for publication. Ongoing metastatic colorectal cancer trial continuing activation of new sites, targeting 26 trial sites by mid-2026 and interim data in late 2027. Metastatic breast cancer trial has one active site, targeting 15 trial sites by late 2026. Evaluating combination PHP immune checkpoint inhibitor trials across various tumor types

In 2025, revenue from Hepzato was $78,800,000 and from ChemoSAT was $6,400,000. Fourth quarter 2025 revenue from Hepzato was $19,000,000 and from ChemoSAT was $1,700,000. Gross margins were 85% in the fourth quarter and 86% for the full year. Research and development expenses for the quarter were $9,400,000 compared to $2,900,000 in the prior year. Full year 2025 SG&A was $43,000,000 vs $29,600,000 in 2024. Full year 2025 R&D was $29,200,000 vs $13,900,000 in 2024. Fourth quarter 2025 net loss was $1,900,000 vs $3,400,000 in prior year. Full year 2025 net income was $2,700,000 vs loss of $26,400,000 in 2024. Adjusted EBITDA for full year was $25,100,000 vs loss of $2,500,000 in 2024. Non-GAAP positive adjusted EBITDA for fourth quarter was $2,400,000 vs $4,600,000 in prior year. Ended 2025 with approx $91,000,000 in cash and investments. Quarterly positive operating cash flow of $8,300,000 and full year $22,500,000. 628,572 common shares repurchased for $6,000,000 under $25,000,000 share buyback program. 2026 guidance is total revenue of at least $100,000,000, >20% increase in Hepzato Kit procedure volume, >10% growth in ChemoSAT, gross margins between 84% and 87%

Total revenue guidance for 2026 is at least $100,000,000. Hepzato Kit procedure volume to increase by >20%, ChemoSAT to grow by >10%. 2026 R&D expenses expected to increase by nearly 90% primarily due to CRC. 2026 SG&A expenses expected to increase by nearly 50% primarily due to sales and marketing initiatives and commercial expansion. Forecast for 2026 gross margins between 84% and 87%

Seasonality can impact capacity as key personnel take vacation and sites can't easily add new patients. Uncertainty around timing and impact of CHOPIN results publication. Variability in realized pricing due to concentrated customer base and 340B eligibility fluctuating. Competition from other trials taking patients out of the mix. Difficulty in efficiently referring patients to other centers during seasonality when sites lose capacity

Q: Marie Yoko Thibault asked about seasonality assumptions and pricing trends.

A: Gerard Michel said expect seasonality in third quarter, not all last year's seasonality due to pricing. Sandra Pennell said 2026 price around $175,000, mix favorable.

Q: Marie Yoko Thibault asked about difference between Hepzato Kit REMS site, Hepzato Kit site and clinical trial centers.

A: Gerard Michel said look at hepszatokitrems.com for number of treating centers, only put clinical trial centers on there that are going to be commercial centers.

Q: John Lawrence Newman asked about CHOPIN study use and timing, and clinical studies vs cash flow.

A: Gerard Michel said CHOPIN results imminent, will be used multifacetedly, not focusing on short-term cash flow for long-term value.

Q: Chase Richard Knickerbocker asked about average treatments per patient, new patient starts, center adds and R&D/SG&A spend.

A: Gerard Michel said average treatments per patient around four, interval between treatments closer to eight. Sandra Pennell said 2026 R&D to increase nearly 90% due to CRC, SG&A to increase nearly 50% due to sales/marketing and commercial expansion.

Q: Sudan Naveen Loganathan asked about catalysts for third quarter to mitigate seasonality.

A: Gerard Michel said seasonality due to physician schedules, CHOPIN could increase site activations but being reasonably conservative in guidance.

Q: Charles Wallace asked about discount expansion and gross margin.

A: Gerard Michel said discount modeling at 10%, Sandra Pennell said 2026 gross margins between 84% and 87%.

Q: William Maughan asked about volume increase from 340B pricing and competitive trials.

A: Gerard Michel said can't state if volume increased due to 340B, IDEA trial finished, Replimune trials took patients.

Q: Yale Jen asked about referral development and site patient numbers.

A: Gerard Michel said referral development critical, some centers need more room time and teams to increase capacity.

Q: Yale Jen asked about NCCN guideline prediction.

A: Gerard Michel said NCCN has off-cycle meetings, physician-initiated activity, hopeful for guideline changes