Summary of Delcath Systems Q1 2026 Earnings Call

1Key Financial Results and Metrics

Total Revenue: $25 million, up from $19.8 million in Q1 2025.

HEPZATO KIT Revenue: $23.3 million; CHEMOSAT Revenue: $1.7 million.

Gross Margin: 85%, slightly down from 86% in Q1 2025.

R&D Expenses: $9.8 million, increased from $5 million in the prior year, reflecting ongoing clinical investments.

SG&A Expenses: $13.1 million, up from $11.3 million, due to commercial expansion and marketing.

Net Loss: $1.1 million, compared to a net income of $1.1 million in Q1 2025.

Adjusted EBITDA: $3.4 million, down from $7.6 million in the previous year.

Cash Position: $89.3 million in cash and investments, with no debt; $0.9 million cash provided by operations.

Share Buyback: Approximately $3 million spent on repurchasing shares under a $25 million program.

2Strategic Updates and Business Highlights

Center Activations: 4 new center activations in Q1, with a total of 29 REMS-certified sites; discussions ongoing with over 50 potential new centers.

New Patient Starts: Approximately 0.7 new patients per site per month, consistent with Q1 2025.

Clinical Development: 13 sites activated for metastatic colorectal cancer trials, with 7 patients enrolled; 4 sites prepared for metastatic breast cancer trials.

CHOPIN Trial Impact: Positive results from the CHOPIN trial are influencing treatment patterns and driving new patient volumes.

3Forward Guidance and Outlook

2026 Revenue Guidance: At least $100 million, reflecting a 20% increase in HEPZATO kit volume over 2025.

Gross Margin Forecast: Expected to remain between 85% to 87%.

Adjusted EBITDA: Anticipated to be positive for the remainder of the year.

Center Activation Targets: Adjusted to 37 active centers by year-end, with a goal of 40 by Q1 2027.

4Bad News, Challenges, or Points of Concern

Net Loss: Transition from net income to a loss raises concerns about profitability.

Slower Site Activation: Adjusted expectations for center activations due to variability in readiness and patient scheduling.

Clinical Trial Enrollment: Slower-than-expected enrollment in clinical trials, particularly in metastatic colorectal cancer.

European Market Challenges: Growth hampered by reimbursement issues; modest growth expected in Europe.

5Notable Q&A Insights

Volume Dynamics: Higher patient volume per site attributed to CHOPIN trial results and new site activations.

Spending Trajectory: R&D spending expected to increase by 70%-75% over 2025, with SG&A expenses projected to rise by 60%.

Referral Processes: Challenges in measuring the effectiveness of referral networks; ongoing efforts to incentivize oncology managers to enhance referrals.

CHOPIN Data Impact: Both new and existing sites are increasingly adopting CHOPIN-like protocols, indicating a positive shift in treatment strategies.

Breast Cancer Data: Concerns regarding adverse event profiles; however, the data is seen as manageable and beneficial for recruitment. Overall, Delcath Systems reported a solid first quarter with revenue growth and strategic advancements, though challenges in profitability and clinical trial enrollment remain key areas of focus.