Delcath Systems (NASDAQ:DCTH) reported record results for 2025 and outlined a commercial and clinical roadmap that management believes can support continued growth, emphasizing expanding treatment-center capacity, increasing new patient starts, and strengthening referral networks. On the company’s fourth-quarter and year-end 2025 earnings call, executives also provided 2026 revenue guidance of at least $100 million and discussed expected seasonality, pricing dynamics tied to 340B eligibility, and plans to broaden the company’s U.S. commercial footprint.
2025 performance and launch metrics
Chief Executive Officer Gerard Michel said 2025 was a “pivotal year,” citing “over 40% volume growth” and record revenue of $85.2 million, including $20.7 million in the fourth quarter. The company ended the year with 28 active treatment centers.
Commercial strategy: sites, prescribing patterns, and referrals
Management framed its commercial efforts around three priorities:
- Expanding site capacity by increasing the number of active sites and the number of patients each site can treat.
- Changing prescribing patterns by broadening which patients physicians consider appropriate for treatment.
- Building referral networks to ensure eligible patients are identified early and referred to treating centers.
On site expansion, Michel said Delcath brought three new sites online earlier in the year—MD Anderson, UT Southwestern, and Mayo Clinic Scottsdale—bringing the total to 28 REMS-certified treatment sites. The company is targeting 40 active treatment centers by the end of 2026. Michel noted the pace of activations could be variable, and he expects more activations in the second half of 2026 than the first half, aligning with salesforce expansion timing and anticipated interest following publication of CHOPIN results.
Delcath is expanding its U.S. commercial team to cover nine regions, with each region staffed by a liver-directed therapy manager, an oncology manager, and a clinical specialist. Michel also said the company revamped its medical affairs organization, including new leadership and an expanded team of medical science liaisons.
On utilization, Michel said Delcath treated new patients per site per month at approximately 0.75 during the first two months of 2026, similar to the pace in the first quarter of 2025. For the full year 2025, he said the average was 0.5 new patients per site per month, with “significant seasonality.” He reminded investors that new patient starts impact revenue for the following three quarters.
Regarding referrals, Michel said many metastatic uveal melanoma patients are initially managed at community or non-PHP institutions, making early identification and referral critical. The company is using multiple data sources to identify oncologists with newly diagnosed metastatic patients and engaging them through its field teams to educate on options and treating-center locations.
CHOPIN data and guideline discussions
Michel repeatedly highlighted the CHOPIN Phase 2 investigator-initiated trial evaluating sequencing percutaneous hepatic perfusion (PHP) with checkpoint inhibitors (ipilimumab and nivolumab). He said the study showed “statistically significant and clinically meaningful” improvements in one-year progression-free survival, overall survival, and objective response rates versus PHP alone, within a “very short 10-week treatment window.” Michel said this sequencing can help address concerns about delaying systemic therapy and may broaden comfort around treating patients with extrahepatic disease.
Management said publication of CHOPIN is “slated” and described timing as “imminent.” In response to a question, Michel said he believed publication would likely occur “within the next month or so,” while noting he could not promise timing because it is investigator-led.
Michel also said some leading centers are already adopting “CHOPIN-inspired protocols,” and Delcath is engaging key opinion leaders to support potential updates to NCCN guidelines following publication. When asked about timing, Michel noted guidelines typically follow a November schedule but can have off-cycle meetings; he emphasized that guideline changes are largely physician-driven, with the company able to provide information and support discussions.
Financial results, cash flow, and 2026 guidance
Chief Financial Officer Sandra Pennell reported fourth-quarter revenue of $19.0 million from HEPZATO and $1.7 million from CHEMOSAT, compared with $13.7 million and $1.4 million, respectively, in the year-ago period. For full-year 2025, Delcath reported $78.8 million in HEPZATO revenue and $6.4 million in CHEMOSAT revenue, compared with $32.3 million and $4.9 million in 2024.
Gross margin was 85% in the fourth quarter and 86% for the full year, versus 86% and 83% in the prior-year periods. Pennell said fourth-quarter R&D expense rose to $9.4 million from $2.9 million, and full-year R&D increased to $29.2 million from $13.9 million, driven by clinical team investments and initiation of Phase II trials in metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC). She said Delcath expects R&D expenses to increase in 2026 by “nearly 90%.”
SG&A expenses were $10.5 million in the fourth quarter (vs. $7.7 million) and $43.0 million for the year (vs. $29.6 million). Pennell said SG&A is expected to increase in 2026 by “nearly 50%” due to commercial expansion.
Delcath posted a fourth-quarter 2025 net loss of $1.9 million, compared with a $3.4 million loss a year earlier, and full-year 2025 net income of $2.7 million, compared with a $26.4 million loss in 2024. Adjusted EBITDA was $2.4 million in the fourth quarter and $25.1 million for the year, compared with $4.6 million and an adjusted EBITDA loss of $2.5 million in the prior-year periods.
The company ended the year with approximately $91 million in cash and investments, with quarterly operating cash flow of $8.3 million and full-year operating cash flow of $22.5 million. Pennell said Delcath repurchased 628,572 shares for $6 million through Dec. 31, 2025 under a $25 million authorization, and the company has no outstanding debt or warrants.
For 2026, Delcath guided to total revenue of at least $100 million, which Pennell said assumes greater than 20% increase in HEPZATO KIT procedure volume and greater than 10% growth in CHEMOSAT. The guidance includes a 340B pricing change; Pennell said the company expects an average selling price of around $175,000 per HEPZATO kit, roughly a 10% discount to the published list price, with quarter-to-quarter variability depending on customer mix and 340B eligibility.
Management also discussed seasonality, with Michel and Pennell expecting a third-quarter slowdown related in part to staffing constraints at sites during summer vacations. Pennell said the company could see “flat to modest growth from Q2 to Q3” similar to 2025, followed by growth resuming from Q3 to Q4.
About Delcath Systems (NASDAQ:DCTH)
Delcath Systems, Inc is a specialty pharmaceutical and medical technology company focused on the development and commercialization of its proprietary Hepatic CHEMOSAT® Delivery System, designed to deliver high-dose chemotherapeutic agents directly to the liver while minimizing systemic exposure. The company’s core technology performs isolated hepatic perfusion, enabling oncologists to administer concentrated melphalan to patients with primary and metastatic liver tumors, including those arising from ocular melanoma.
