Delcath Systems, Inc. Earnings Recaps
Delcath’s shares rose 35.8% after a record $35.1 million in third-quarter revenue, up 71% year over year, alongside positive operating cash flow. HEPZATO volume growth and improving profitability were the clearest positives, while slower-than-expected breast cancer trial enrollment remains a development risk.
Key takeaways
- Total revenue was $35.1 million versus $20.6 million a year earlier; HEPZATO revenue was $32.7 million, with volume up 72% year over year and 19% sequentially.
- Gross margin expanded to 89% from 87%. Net income was $7.0 million versus $0.8 million, and adjusted EBITDA rose to $11.5 million from $5.3 million.
- The company reported positive operating cash flow and 33 active U.S. treatment centers; it expects at least 36 by year-end.
- Breast cancer trial enrollment is slower than initially anticipated, and the company cannot yet provide a timing estimate for interim analysis. The colorectal trial remains on pace for an interim analysis in mid-2027.
- Delcath plans an IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, aims to begin preclinical development of an oxaliplatin-based PHP program by mid-2027.
Delcath Systems' stock rose modestly by 2.0% following its Q1 2026 earnings, reflecting a mixed reception to solid early patient start metrics and ongoing progress in clinical trial site activations, tempered by cautious pacing on site expansions and patient enrollments.
Key takeaways
- Activated 4 new centers in Q1, progressing toward 37 active centers by year-end and 40 centers expected by early 2027, down from previous pacing projections.
- New patient starts per site tracked slightly above Q1 2025 levels, at approximately 0.7 new patients per site per month, helping to sustain revenue growth.
- Enrollment in metastatic colorectal cancer trial remains slow with only 7 patients enrolled out of 13 active sites, though site activation and training continue to advance.
- Metastatic breast cancer trial progressing with 4 active screening sites and plans to reach 15 sites by late 2026, alongside physician education efforts to build familiarity with liver-directed therapies.
- The company is exploring expanded indications beyond colorectal and breast cancer, driven by interest in combination regimens similar to CHOPIN results.
Delcath Systems reported a mixed third quarter in 2025, with a notable impact from 340B pricing adjustments and seasonality affecting new patient starts, prompting a revised revenue guidance. However, positive clinical results from the CHOPIN trial highlight the potential for future growth.
Key takeaways
- Revenue guidance for 2025 adjusted to $83M-$85M due to slower new patient starts and 340B pricing effects, resulting in a 13% decrease in average revenue per kit.
- Four new treatment sites activated recently, increasing total to 25 REMS-certified centers, with a target of 26-28 centers by the end of 2025.
- Strong clinical trial data from the CHOPIN trial reported at ESMO, showing significant improvements in progression-free survival and overall response rates, positioning HEPZATO as a key therapy for uveal melanoma.
- Competition from various clinical trials noted as a factor in slower patient initiation, though the CHOPIN trial’s compelling results may mitigate this challenge.
- Plans to expand the U.S. sales force further by 2026 to enhance site activation and referral networks to aid growth.