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DCTH · Delcath Systems, Inc.

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$16.73 -0.63 (-3.63%) At close · Aug 14
Market Cap
$580.51M
Shares
34.70M
All earnings calls

Earnings call · FY2025 Q4

Delcath Systems, Inc. Q4 FY2025 Earnings Call

Delcath Systems, Inc. Q4 FY2025 Earnings Call

Concluded Feb 26, 2026
Feb 26, 2026 40 turns
Period
FY2025 Q4
Runtime
Sources
3 artifacts

Executive readout · one minute

What matters this quarter

Delcath reported record preliminary 2025 revenue of approximately $85.2 million (over 40% volume growth) and achieved positive operating cash flow in Q4 2025, while expanding to 25-28 active Hepzato treatment sites and targeting 40 by year-end 2026.

Seasonality and capacity variability 20 Referral network development 15 CHOPIN trial data and clinical evidence 11 Pipeline: metastatic colorectal and breast cancer trials 10 NCCN guideline consideration 9 Site activation and commercial expansion 9

Management tone

Confident

Net tone +55 · moderate hedging

Grounding quotes
  • “2025 was a pivotal year in which we achieved over 40% volume growth and achieved record annual revenue of $85,200,000.”
  • “Entering our third year of launch with strong momentum, we are confident that continued site activations and commercial expansion, and the CHOPIN results will drive meaningful revenue acceleration and create substantial shareholder value.”
  • “The pace of activations will likely be variable, given the planned timing of the Salesforce expansion, as well as the anticipated increase in interest and support following the pending publication of CHOPIN results.”
  • “We anticipate some seasonal loss of capacity in the late summer.”

Research coverage

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Revenue · derived Q4 $20.73M +37.3% YoY
Gross margin · derived Q4 85.5% -0.4 pp YoY
Net income · derived Q4 -$1.90M

Research materials

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Key takeaways

What improved, and what deserves a closer read.

Constructive signals

  • Record full-year 2025 revenue of approximately $85.2 million with over 40% volume growth
  • Positive operating cash flow achieved in Q4 2025
  • Three new REMS-certified sites added early in the year (MD Anderson, UT Southwestern, Mayo Clinic Scottsdale), bringing total to 28 active treatment centers with a target of 40 by year-end 2026
  • Approximately $91.0 million in cash and short-term investments with no debt as of December 31, 2025, up from $88.9 million at September 30, 2025
  • Q4 2025 revenue of approximately $20.7 million, with HEPZATO KIT revenue of approximately $19.0 million
  • New patient starts per site per month running at approximately 0.75 in the first two months of 2026 versus the 0.5 full-year 2025 average

Risks & pressure points

  • Preliminary results are unaudited and not reviewed by auditors, with actual results subject to variation
  • Competitive clinical trials (Replimune expansion and Thomas Jefferson single-center trials) described as a steady headwind on patient enrollment
  • Expectation of seasonal loss of capacity in late summer 2026 similar to 2025 pattern
  • Site activations weighted to second half of 2026, with potential lumpiness in near-term capacity growth
  • Metastatic breast cancer program has only one active clinical trial site with physicians requiring extensive education on liver-directed therapy

Key moments

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“We currently have—excuse me for that little glitch on the screen here. We have organized our commercial strategy around three priorities: expanding site capacity, changing prescribing patterns, and building referral networks.” Gerard Michel, CEO
“Turning to 2026 guidance, we are guiding to total revenue of at least $100,000,000 for the year, which represents greater than a 20% increase in Hepzato Kit procedure volume and greater than 10% growth in ChemoSAT.” Sandra Pennell, CFO
Full-screen source Call document