Delcath Systems Q1 Earnings Call Highlights

Key Points

• Delcath said Q1 was driven by commercial momentum—four U.S. center activations, record new patient starts and 29 REMS‑certified sites—with management attributing higher utilization to CHOPIN data and trimming its year‑end target to 37 active centers (40 by Q1 2027).
• Financially, Q1 revenue rose to $25.0 million (from $19.8M a year earlier) with an 85% gross margin, a $1.1M net loss, $89.3M in cash, and management reiterated 2026 revenue guidance of at least $100 million while expecting positive adjusted EBITDA for the rest of the year.
• On the clinical front, the mCRC trial has 13 active screening centers (targeting 26) with seven patients enrolled and interim readout expected in late 2027, the breast cancer program is targeting 15 sites by late 2026, and published CHOPIN results showed response rates rising from ~40% with HEPZATO alone to ~76% when combined with immunotherapy.

Delcath Systems NASDAQ: DCTH reported first-quarter 2026 revenue growth and reiterated its full-year outlook, while updating expectations for U.S. treatment-center activations and outlining progress across ongoing clinical programs. Executives pointed to record new patient starts and the impact of recently published CHOPIN data as key drivers of momentum for HEPZATO adoption.

Commercial execution: activations, utilization, and referrals

Chief Executive Officer Gerard Michel said the first quarter was “marked by four center activations and record new patient starts,” calling those metrics core growth drivers. He added that the company is advancing commercial and medical initiatives intended to support long-term growth of HEPZATO, including “building referral networks to quickly connect eligible patients to treating centers.”

Michel said the company has “nearly completed” its U.S. commercial expansion into nine regions, and that an expanded medical science liaison (MSL) team is now “fully trained and in the field educating physicians about metastatic uveal melanoma with a focus on the CHOPIN results.”

As of the call, Delcath had 29 REMS-certified sites and was in active discussions with “over 50 potential new centers,” according to Michel. He also noted that 38 prospective centers have had at least one potential team member travel for preceptorship training, while cautioning that not all will activate and that “the process can take over one year in some cases.”

Given pacing uncertainty, Michel said Delcath is modifying its year-end goal to “37 active centers with 40 active treatment centers sometime in the first quarter of 2027,” downshifting from prior expectations as the company looked for clearer visibility into when sites would be ready to treat patients.

In response to analyst questions, Michel said the company’s pipeline remains “full,” but he is reluctant to forecast near-term activations without confirmation that patients are scheduled or in screening. “If I don’t see anything in the next month or so I kinda reduce it,” he said.

Beyond site count, management emphasized utilization trends. Michel said first-quarter new patient starts per site were “at or slightly higher than the first quarter of 2025 at approximately 0.7 new patients per site per month,” adding that patients typically receive a series of treatments that contribute to revenue over subsequent quarters.

Michel and commercial chief Kevin Muir attributed much of the higher utilization to CHOPIN data and growing real-world confidence among physicians. Michel said, “I think it’s primarily CHOPIN,” also noting that doctors are seeing “the scans and seeing the tumor shrinkage.” Muir added that the “majority” of new sites are expected to use “a CHOPIN-like protocol,” referring to combination treatment approaches.

Michel said Delcath is working to improve referral patterns by identifying physicians treating newly diagnosed metastatic patients and connecting them with a suitable HEPZATO center. However, he acknowledged challenges in measuring referral performance due to HIPAA constraints, saying the company is “grappling” with how to track it with a specific metric.

CHOPIN data and evolving treatment patterns

Michel said publication of CHOPIN results in The Lancet Oncology is already changing treatment patterns at certain centers. He cited a webinar hosted by patient advocacy group A Cure in Sight in which UCLA interventional radiologist Dr. Siddharth Padia discussed treating metastatic uveal melanoma patients with HEPZATO, including patients also receiving immunotherapy.

As a reminder of the study’s findings discussed on the call, Michel said CHOPIN response rates improved from “approximately 40% with HEPZATO alone to about 76% when HEPZATO was combined with immunotherapy,” including some complete responses. He also said the combination arm demonstrated a survival benefit with “a clear separation between survival curves at both 1 and 2 years,” and that Dr. Padia described the results as “extremely encouraging” and consistent with his clinical experience.

Clinical pipeline updates: colorectal and breast cancer programs

Michel provided updates on two ongoing trials outside metastatic uveal melanoma.

• Metastatic colorectal cancer (mCRC): Delcath has activated additional trial sites and now has “a total of 13 centers who can actively screen CRC patients.” Michel said the company is targeting 26 trial sites and is “on track to activate nearly all” by year-end 2026, anticipating interim results in late 2027. To date, seven patients have been enrolled, which Michel said is slower than anticipated but “picking up momentum.” Chief Medical Officer Vojislav Vukovic said the company expects enrollment to proceed through this year and next year, with interim results shared publicly “by the end of next year, 2027.”
• Metastatic breast cancer: Michel said four clinical trial sites are prepared to screen patients, with additional sites opening soon. The company is targeting 15 trial sites and expects to activate them by late 2026. Michel said Delcath will provide guidance on timing of readouts later in the year as operational progress supports more precise forecasting.

On breast cancer data referenced by analysts, Michel said the results reflected heavily pretreated patients and that adverse events, while potentially appearing high “to the untutored,” were “easily managed and all are resolvable.” Vukovic added that patients in the data review had received a median of four prior systemic treatments and likely carried residual toxicities, noting that safety depends on the line of therapy in which the procedure is used.

Addressing questions about the median overall survival cited by an analyst, Vukovic said that for breast cancer patients who develop liver metastases, it is often “the final stage of the disease where patients have just a few months of life left,” adding, “Seeing six months is actually…not so bad,” and that physicians expressed satisfaction with being able to manage that disease stage.

Regarding the number of treatment cycles in European real-world breast cancer experience, Michel noted that the clinical protocol calls for two treatments and said he would expect that to be the median when the prospective trial reads out. Vukovic characterized the European data as “real world clinical practice,” where physicians may have been cautious and focused on controlling disease and prolonging life in heavily pretreated patients.

Michel also said Delcath is seeing interest beyond colorectal and breast cancer and is exploring additional trial designs based on physician input and advisory board feedback, including “a CHOPIN-like combination regimen” across other solid tumors with liver involvement.

Financial results and outlook

Chief Financial Officer Sandra Pennell said first-quarter 2026 total revenue was $25.0 million, up from $19.8 million in the first quarter of 2025. Revenue included $23.3 million of HEPZATO KIT revenue and $1.7 million of CHEMOSAT revenue. Gross margin was 85%, compared to 86% a year earlier.

Operating expenses rose as Delcath increased investment in both clinical and commercial initiatives. Research and development expense was $9.8 million versus $5.0 million in the prior quarter, driven by “continued investment in our clinical organization and the ongoing phase II trial,” Pennell said. Selling, general and administrative expense was $13.1 million, up from $11.3 million in the prior-year quarter, reflecting “continued commercial expansion and increased marketing activities.”

Delcath posted a net loss of $1.1 million, compared with net income of $1.1 million in the first quarter of 2025. Adjusted EBITDA was $3.4 million versus $7.6 million a year earlier.

The company ended the quarter with $89.3 million in cash and investments and no debt. Cash provided by operations was $0.9 million. Pennell also said Delcath repurchased about 300,000 common shares for approximately $3.0 million during the quarter under its $25 million buyback program, bringing total repurchases to $9.0 million to date.

For 2026, Pennell reiterated guidance for total revenue of at least $100 million, which she said reflects 20% growth in HEPZATO KIT volume over 2025. Guidance assumes seasonal trends in the second half similar to 2025, when new patient start rates declined “partially due to scheduling challenges.” Gross margin guidance remains 85% to 87%, and Pennell said the company now expects to report positive adjusted EBITDA for the remainder of the year.

Europe: modest growth expectations amid reimbursement hurdles

Asked about the impact of CHOPIN’s inclusion in clinical practice guidelines and potential European adoption, Michel said growth in Europe is “significantly hampered” by reimbursement issues. He said Delcath is assuming “modest single-digit growth in Europe” for 2026, and pointed to the importance of securing reimbursement in the U.K. and establishing commercial businesses in Spain, France, and Italy.

Michel added that Europe’s near- to medium-term importance is largely in data generation, noting that the device is approved to deliver melphalan to the liver and is “not tied to a specific tumor type.” He said the company manages Europe “on a break-even basis,” and suggested a potential longer-term relaunch as a combination drug-device product could reset pricing, though he described that as “many, many years down the road.”

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.

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