Delcath Systems
Commercializing HEPZATO in the United States and CHEMOSAT in Europe for liver-directed oncology.
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Profile
Sells hepatic delivery products through HEPZATO KIT, a drug-device combination in the United States for eligible metastatic uveal melanoma patients, and CHEMOSAT, a Europe-sold device configuration for percutaneous hepatic perfusion. Revenue comes from product sales, with commercialization tied to trained treatment centers and reimbursement access.
Builds hepatic delivery systems for liver-directed cancer therapy. HEPZATO KIT combines melphalan with Delcath's Hepatic Delivery System in the United States for eligible adult metastatic uveal melanoma patients, while CHEMOSAT is the Europe-sold device configuration used for percutaneous hepatic perfusion.
Commercial execution depends on specialized treatment centers. United States sites must complete REMS training and certification, and field teams work with hospitals and cancer centers to activate referral and treatment capacity. Most current product sales come from HEPZATO, with CHEMOSAT providing the European channel.
The business is shaped by product-specific reimbursement, procedure adoption, and the approved label. HEPZATO carries FDA-managed safety controls, and CHEMOSAT operates under European medical-device regulation.
Company facts
Key statistics
Year to date +64.1% · Average volume (30d) 620.2K
Analysts
Ratings
Target range
Latest analyst notes
| Date | Firm | Action | Rating | Prior target | Target |
|---|---|---|---|---|---|
| Aug 7, 2026 | H.C. Wainwright | Reiterate | Buy | $30 | $32 |
| Jul 13, 2026 | BTIG | Reiterate | Buy | $19 | $17 |
| Feb 26, 2026 | Evercore ISI | Target | $27 | ||
| Feb 26, 2026 | BTIG | Reiterate | Buy | $19 | |
| Oct 21, 2025 | Craig-Hallum | Target | $20 |
Earnings
EPS
Revenue
History
| Report date | EPS est | EPS | Surprise | Revenue est | Revenue | Surprise | Next session |
|---|---|---|---|---|---|---|---|
| Aug 6, 2026Q2 FY26 | −$0.09 | $0.07 | +178.5% | $26.3M | $29.1M | +11.0% | +22.49% |
| May 7, 2026Q1 FY26 | −$0.09 | −$0.03 | +68.1% | $23.5M | $25.0M | +6.3% | +2.14% |
| Feb 26, 2026Q4 FY25 | −$0.06 | −$0.05 | +20.6% | $20.6M | $20.7M | +0.7% | −1.11% |
| Nov 4, 2025Q3 FY25 | $0.02 | $0.02 | 0.0% | $20.4M | $20.6M | +1.0% | −4.41% |
Financial highlights
| 12 quarters | Q1 FY25 | Q2 FY25 | Q3 FY25 | Q4 FY25 | Q1 FY26 | Q2 FY26 | |
|---|---|---|---|---|---|---|---|
| Revenue | $19.8M | $24.2M | $20.6M | $20.7M | $25.0M | $29.1M | |
| Gross profit | $16.9M | $20.8M | $17.9M | $17.7M | $21.3M | $26.1M | |
| Operating income | $642.0K | $2.6M | −$388.0K | −$2.2M | −$1.6M | $2.4M | |
| Net income | $1.1M | $2.7M | $830.0K | −$1.9M | −$1.1M | $2.7M | |
| Diluted EPS | $0.03 | $0.07 | $0.02 | −$0.05 | −$0.03 | $0.07 | |
| Gross margin | 85.6% | 86.3% | 87.2% | 85.5% | 85.1% | 89.8% | |
| Operating margin | 3.2% | 10.7% | -1.9% | -10.5% | -6.5% | 8.2% |
Fiscal years (4-quarter sums)FY21 $3.6M · FY22 $2.7M · FY23 $2.1M · FY24 $37.2M · FY25 $85.2M
Revenue by geography · Q2 FY26
Balance sheet, Jun 30, 2026Cash & short-term investments $95.9M · Total debt $2.5M · Total assets $137.0M · Shareholders' equity $121.1M
Dividends
No dividends on record.
Ownership
Shares outstanding 34.52M · Float 28.60M · 82.9% free float
Top shareholders13F · 13D/G · Form 4
| Holder | Shares | % outstanding | Form | Filed |
|---|---|---|---|---|
| Rosalind Advisors, Inc. | 3.30M | 9.56% | 13F | Aug 14, 2026 |
| BlackRock, Inc. | 1.84M | 5.30% | 13G | Jul 28, 2026 |
| Daniel Kaufman | 1.77M | 5.08% | 13G | Mar 20, 2026 |
| Vanguard Capital Management LLC | 1.22M | 3.54% | 13F | Aug 13, 2026 |
| Propel Bio Management, LLC | 871.5K | 2.52% | 13F | Aug 13, 2026 |
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| Mar 6, 2026 | Sandra Pennell | officer: Chief Financial Officer | +5,533 | $9.04 |
| Mar 2, 2026 | Gerard J. Michel | director, officer: CHIEF EXECUTIVE OFFICER | +11,200 | $8.96 |
| Nov 21, 2025 | John Richard Sylvester | director | +4,386 | $8.89 |
| Nov 11, 2025 | Gerard J. Michel | director, officer: CHIEF EXECUTIVE OFFICER | +11,500 | $8.53 |
Peers
- Immunocore (ADR)
Approved systemic mUM standard for HLA-A*02:01 patients
- Boston Scientific
Large Y-90 and embolization portfolio for liver tumors
- IDEAYA Biosciences
Late-stage darovasertib program for HLA-A2-negative mUM
- Medtronic
Covidien ablation tools overlap in liver-tumor procedures
- Merit Medical Systems
Embolotherapy supplier with TACE and liver-metastasis products
- AngioDynamics
NanoKnife IRE platform targets difficult liver and solid tumors
- Replimune Group
RP2 oncolytic immunotherapy trial in metastatic uveal melanoma
CompareAfter-hours close
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| Delcath Systems | $16.00 | −2.02% | $564.1M | 1,256.9 | — | 5.9 | +20.6% |
| Immunocore (ADR) | $36.62 | −0.03% | $1.86B | — | — | 4.6 | −13.7% |
| Boston Scientific | $46.85 | +0.03% | $69.62B | 19.0 | 14.2 | 3.3 | +7.5% |
| IDEAYA Biosciences | $40.11 | −0.05% | $3.81B | — | — | 16.3 | — |
| Medtronic | $91.58 | +0.42% | $116.78B | 24.5 | 15.3 | 3.2 | +9.9% |
| Merit Medical Systems | $90.49 | +0.10% | $5.40B | 37.4 | 20.7 | 3.4 | +9.5% |
| AngioDynamics | $15.85 | −0.06% | $655.1M | — | — | 2.0 | +8.1% |
| Replimune Group | $15.45 | −0.39% | $1.30B | — | — | — | — |
| Median | 24.5 | 15.3 | 3.4 | +8.1% |