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DELCATH SYSTEMS (DCTH)

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Earnings summaries and quarterly performance for DELCATH SYSTEMS.

Recent press releases and 8-K filings for DCTH.

Delcath Systems Announces Preliminary Q4 and Full Year 2025 Financial Results
DCTH
Earnings
Share Buyback
Revenue Acceleration/Inflection
  • Delcath Systems expects preliminary total revenue of $20.7 million for Q4 2025 and $85.2 million for the full year 2025.
  • The company's cash and short-term investments increased to $91.0 million as of December 31, 2025, from $88.9 million on September 30, 2025, with no debt and positive operating cash for Q4 2025.
  • Delcath repurchased 628,572 common shares for $6.0 million in 2025 under its $25.0 million Share Buyback Program.
  • HEPZATO KIT revenue is projected at $19.0 million for Q4 2025 and $78.8 million for the full year 2025, driven by approximately 140% growth in procedure volume in 2025.
Jan 12, 2026, 9:41 PM
Delcath Systems Reports Strong FY Revenue and Initiates Share Buyback
DCTH
Earnings
Share Buyback
Revenue Acceleration/Inflection
  • Delcath Systems reported preliminary Q4 revenue of approximately $20.7 million and full-year revenue of $85.2 million, both exceeding consensus estimates.
  • The HEPZATO KIT was the primary driver of sales, accounting for $19.0 million in Q4 and $78.8 million for the full year.
  • The company concluded the year with a strong financial position, holding $91.0 million in cash and no debt.
  • Delcath's board authorized a $25.0 million share repurchase program, under which $6.0 million has already been executed, repurchasing 628,572 shares.
  • CEO Gerard Michel stated plans to utilize the company's cash to expand commercial adoption of HEPZATO and initiate additional clinical programs in 2026.
Jan 9, 2026, 3:00 PM
Delcath Systems Announces Preliminary Q4 and Full Year 2025 Financial Results
DCTH
Earnings
Share Buyback
Guidance Update
  • Delcath Systems expects total revenue of approximately $20.7 million for the fourth quarter of 2025 and $85.2 million for the full year 2025.
  • HEPZATO KIT revenue is projected to be approximately $19.0 million for Q4 and $78.8 million for the full year 2025, while CHEMOSAT revenue is expected to be approximately $1.7 million for Q4 and $6.4 million for the full year.
  • As of December 31, 2025, the company had approximately $91.0 million in cash and short-term investments and no debt, an increase from $88.9 million as of September 30, 2025.
  • The company repurchased 628,572 common shares for $6.0 million through December 31, 2025, under its approved $25.0 million Share Buyback Program.
  • HEPZATO procedure volume experienced approximately 140% growth in 2025 compared to 2024, with 25 active centers.
Jan 9, 2026, 1:05 PM
Delcath Systems Announces Publication of Subgroup Analyses of Phase 3 FOCUS Study
DCTH
  • Delcath Systems announced the publication of subgroup analyses from its Phase 3 FOCUS study of the HEPZATO KIT (Melphalan/Hepatic Delivery System) for patients with unresectable metastatic uveal melanoma (mUM).
  • The analysis, published in the Journal of Cancer Research and Clinical Oncology, assessed efficacy and safety across various patient subgroups, including age, sex, geographic region, tumor involvement, and prior therapies.
  • Key efficacy findings include significantly higher overall response rates (ORR) for patients with tumor burden below the median (51.1% vs. 22.2%) and significantly longer median progression-free survival (PFS) for this group (11.3 vs. 5.8 months).
  • Patients with smaller extent of tumor liver involvement, tumor burden below the median, and low/normal LDH also showed significantly longer median overall survival (OS).
  • The study demonstrated a consistent safety profile across subgroups, with no evidence of cumulative toxicity or treatment-related deaths, and highlighted the importance of continued treatment up to six cycles to optimize tumor response.
Dec 31, 2025, 1:00 PM
Delcath Systems Announces Share Repurchase Program
DCTH
Share Buyback
Earnings
  • Delcath Systems' Board of Directors has approved a $25 million share repurchase program.
  • This program allows the company to buy back up to 8.6% of its shares through open market purchases and has no set expiration date, providing flexibility.
  • For the quarter, Delcath reported an earnings per share (EPS) of $0.02, meeting consensus estimates, while revenue was $20.56 million, slightly below the consensus estimate of $23.22 million.
  • The repurchase plan underscores management's confidence in the company's financial health and future prospects.
Nov 21, 2025, 5:17 AM
Delcath Systems Announces Publication of Real-World Evidence for Liver-Directed Therapy in Metastatic Uveal Melanoma
DCTH
New Projects/Investments
Product Launch
  • Delcath Systems announced the publication of a retrospective analysis supporting the early use of liver-directed therapy with PHP (percutaneous hepatic perfusion) in achieving long-term survival for metastatic uveal melanoma (mUM) patients.
  • The study, published in the International Journal of Cancer, found that 82% of long-term survivors received liver-directed therapy as their first-line treatment in the metastatic setting.
  • Notably, PHP demonstrated a 100% disease control rate when used as first-line liver-specific therapy, outperforming other options.
  • This real-world evidence reinforces the value of Delcath's HEPZATO KIT and CHEMOSAT products as foundational components of multimodal treatment strategies for liver cancers.
Nov 13, 2025, 1:30 PM
Delcath Systems Reports Mixed Q3 2025 Results
DCTH
Earnings
Revenue Acceleration/Inflection
New Projects/Investments
  • Delcath Systems reported mixed financial results for the third quarter of 2025, with earnings of $0.02 per share matching analyst expectations but down from $0.06 per share a year earlier.
  • Revenue significantly increased by 83.6% to $20.56 million, primarily driven by HEPZATO KIT™ sales of $19.3 million.
  • Despite revenue growth, net income declined to $0.8 million from $1.9 million, impacted by higher operating expenses, including increased research and development to $8.0 million and selling, general, and administrative expenses to $10.3 million.
  • The company achieved an improved gross margin of 87% and a notable rise in adjusted EBITDA to $5.3 million, though its stock has underperformed the market this year, falling over 20%.
Nov 4, 2025, 3:04 PM
Delcath Systems Reports Q3 2025 Financial Results and Business Updates
DCTH
Earnings
Guidance Update
New Projects/Investments
  • Delcath Systems reported Q3 2025 revenue of $19.3 million for HEPZATO and $1.3 million for CHEMOSAT, compared to $10 million and $1.2 million respectively in Q3 2024. The company adjusted its 2025 annual guidance to $83-$85 million.
  • Gross margins were 87% in Q3 2025, up from 85% in Q3 2024, with a forecast of 85%-87% for full-year 2025. Net income for Q3 2025 was $0.8 million, and non-GAAP adjusted EBITDA was $5.3 million.
  • The company ended Q3 2025 with approximately $89 million in cash and investments and $4.8 million in positive operating cash flow, with no outstanding debt.
  • Delcath currently has 25 REMS-certified treatment sites and aims for 26-28 by the end of 2025 and 40 by the end of 2026. Patient dosing for the metastatic colorectal cancer trial began in August 2025, with the metastatic breast cancer trial expected to start in Q1 2026.
Nov 4, 2025, 1:30 PM
Delcath Systems Reports Strong Third Quarter 2025 Financial Results and Provides Full Year Guidance
DCTH
Earnings
Guidance Update
New Projects/Investments
  • Delcath Systems reported total revenue of $20.6 million for the third quarter ended September 30, 2025, a significant increase from $11.2 million in the same period of 2024, primarily driven by HEPZATO KIT revenue of $19.3 million.
  • The company achieved net income of $0.8 million and non-GAAP positive adjusted EBITDA of $5.3 million for Q3 2025, compared to net income of $1.9 million and adjusted EBITDA of $1.0 million in Q3 2024.
  • As of September 30, 2025, Delcath Systems held $88.9 million in cash and investments and generated $4.8 million in cash from operations during the quarter.
  • For the full fiscal year 2025, the company anticipates total CHEMOSAT and HEPZATO KIT revenue to be in the range of $83 to $85 million, representing an approximate 150% increase in volume over 2024, with gross margins expected between 85% to 87%.
  • Delcath made progress in its clinical programs, including the first patient dosed in a global Phase 2 trial for HEPZATO in liver-dominant metastatic colorectal cancer and positive results from the Phase 2 CHOPIN trial for CHEMOSAT in metastatic uveal melanoma.
Nov 4, 2025, 1:02 PM
Delcath Systems Reports Third Quarter 2025 Results and Updates 2025 Financial Guidance
DCTH
Earnings
Guidance Update
New Projects/Investments
  • Delcath Systems reported total revenue of $20.6 million for the third quarter ended September 30, 2025, an increase from $11.2 million in the prior year, with HEPZATO KIT revenue reaching $19.3 million.
  • The company achieved a gross margin of 87% and a Non-GAAP positive adjusted EBITDA of $5.3 million for Q3 2025, alongside $4.8 million in cash provided by operations.
  • Net income for Q3 2025 was $0.8 million, compared to $1.9 million in Q3 2024.
  • Delcath provided full-year 2025 revenue guidance for total CHEMOSAT and HEPZATO KIT in the range of $83 million to $85 million, with expected gross margins of 85% to 87%.
  • Business highlights include 25 active centers across the U.S. and the initiation of a global Phase 2 trial for HEPZATO in liver-dominant metastatic colorectal cancer, with topline data expected in 2028.
Nov 4, 2025, 1:00 PM