DCTH — Delcath Systems, Inc.

Summary of Delcath Systems Q1 2026 Earnings Call

1. Key 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.

2. Strategic 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.

3. Forward 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.

4. Bad 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.

5. Notable 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.