QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath†or the "Company†), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025. Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited) Final financial results for the fourth quarter and full year 2025 and a detailed business update will ...

Financial Data and Key Metrics Changes - Revenue from HEPZATO sales was $19.3 million in Q3 2025, compared to $10 million in Q3 2024, while CHEMOSAT revenue was $1.3 million, up from $1.2 million in the same period last year [18] - Gross margins improved to 87% in Q3 2025 from 85% in Q3 2024 [18] - Research and development expenses increased to $8.0 million from $3.9 million year-over-year, while selling, general, and administrative expenses rose to $10.3 million from $7.0 million [18] - Net income for Q3 2025 was $0.8 million, down from $1.9 million in Q3 2024 [18] - Positive adjusted EBITDA for Q3 2025 was $5.3 million, compared to $1.0 million in Q3 2024 [18] - The company ended the quarter with approximately $89 million in cash and investments, with a quarterly positive operating cash flow of $4.8 million [19] Business Line Data and Key Metrics Changes - The average revenue per kit sold decreased by approximately 13% due to 340B pricing related to NDRA participation [5] - The total HEPZATO treatment volume in 2025 is projected to increase by nearly 150% compared to 2024 [19] Market Data and Key Metrics Changes - There was a slowdown in the pace of site activation from June to August, but the company activated four new sites in the past two months, bringing the total to 25 REMS-certified treatment sites [6][9] - The company plans to expand to 26-28 active treating centers by the end of 2025 and 40 centers by the end of 2026 [6] Company Strategy and Development Direction - The company aims to build referral networks to treatment locations, particularly as many targeted clinical sites have few metastatic uveal melanoma patients [6] - Delcath is committed to advancing research and development for HEPZATO, with ongoing trials in liver-dominant metastatic colorectal cancer and liver-dominant metastatic breast cancer [15][16] - The company is exploring additional tumor types and indications for HEPZATO, including intrahepatic cholangiocarcinoma, cutaneous metastatic melanoma, and non-small cell lung cancer [16] Management's Comments on Operating Environment and Future Outlook - Management adjusted the 2025 annual guidance to $83-$85 million due to changes in the rate of new patient starts and competitive clinical trial activity [10] - The results from the Chopin trial are expected to lessen competitive impacts as data is disseminated and physicians observe durable patient responses [10] - Management acknowledged the challenges posed by seasonality and competition for clinical trials, particularly during holiday periods [9][10] Other Important Information - The company has no outstanding debt obligations and no outstanding warrants [19] - Forecasts for 2025 gross margins are expected to be between 85%-87% [19] Q&A Session Summary Question: What are the Q4 expectations regarding competitive clinical trial activity and seasonality? - Management expects a modest amount of seasonality in Q4 and has factored in the same level of clinical trial competition seen mid-year [22] Question: How will site additions roll out into 2026? - Management anticipates that site additions will accelerate in the latter half of the year as the company expands to nine regions [26] Question: What steps are being taken to improve utilization at lower volume accounts? - The company is building referral networks and expanding the medical affairs team to address lower utilization sites [28] Question: How does the NDRA program influence profitability and revenue growth? - Management indicated that the NDRA will result in a one-time step down in revenue, but they do not anticipate a dramatic change in average revenue per kit [37] Question: What is the status of the Scandium III trial? - The Scandium III trial is recruiting slowly, and no timeline is available for when data might be reported [43]

Core Insights - Delcath Systems, Inc. reported preliminary revenue results for Q3 2025, indicating a total revenue of approximately $20.5 million from its CHEMOSAT and HEPZATO KIT products [1] - The revenue breakdown shows HEPZATO KIT generated $19.2 million, while CHEMOSAT revenue was not fully disclosed [1] Financial Performance - Total revenue for CHEMOSAT and HEPZATO KIT reached around $20.5 million for the quarter ended September 30, 2025 [1] - HEPZATO KIT specifically contributed $19.2 million to the total revenue [1]

Corporate Presentation 2 NASDAQ: DCTH March 2025 Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potenti ...

Financial Data and Key Metrics Changes - In 2024, Delcath Systems generated $32.3 million in HEPZATO revenue in the U.S., including $13.7 million in Q4 from 14 active treatment centers [9][24] - The company achieved a positive adjusted EBITDA of $4.6 million in Q4, marking a first for the company, and ended the year with $53.2 million in cash and investments, with no debt [11][27] - The net loss for Q4 was $3.4 million, compared to a loss of $11.1 million in the same period in 2023 [26] Business Line Data and Key Metrics Changes - Revenue from HEPZATO sales was $13.7 million in Q4 and $32.3 million for the full year, while CHEMOSAT revenue was $1.4 million in Q4 and $4.9 million for the full year, compared to $0.5 million and $2.1 million respectively in 2023 [24][26] - Gross margins were reported at 86% for Q4 and 83% for the full year [25] Market Data and Key Metrics Changes - In Europe, CHEMOSAT volumes grew by 137% in 2024, with Germany up 75% and other markets like the UK and Turkey doubling year-over-year [10][16] - The company plans to expand into France, Italy, and Spain in 2025, complementing its presence in the UK, Germany, and The Netherlands [17] Company Strategy and Development Direction - The company aims to activate 30 treatment centers by year-end 2025, having activated three new centers in Q4 and two more in 2025, bringing the total to 16 [12][14] - Delcath is increasing its commercial team from four to six regions to support the expansion of HEPZATO and CHEMOSAT [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, stating that 2024 was a transformative year and that the company is well-positioned for growth while investing in R&D initiatives [23] - The management highlighted the importance of reimbursement in driving future growth, particularly in Europe [78] Other Important Information - The company received over $41 million in proceeds from the exercise of warrants during the year [11] - The SCANDIUM 3 trial in Sweden began screening patients, and the CHOPIN trial in the Netherlands completed enrollment with 76 patients [18][19] Q&A Session Summary Question: Changes in treatment cycles with new sites for HEPZATO - Management noted that the average treatment rate is expected to remain steady at around 4.1 treatments per patient, similar to the FOCUS trial results [31][32] Question: SG&A ramp with expansion plans - SG&A expenses are expected to increase by 30% to 40% in 2025, with most expenses starting in the second quarter [39] Question: R&D expenses and cash flow - Management indicated that while they expect to be cash flow positive, they will invest in R&D opportunities as they arise [48] Question: Price increase for HEPZATO - A price increase of approximately 2.74% was implemented, with future increases dependent on inflation [49][50] Question: Referral network effectiveness - The referral network is functioning well, with community referrals to larger academic centers increasing [56] Question: Expansion of treatment indications - Management confirmed that no device modifications are necessary for new indications, and they are focusing on engaging new doctors for upcoming trials [41][42] Question: Gross margin expectations - The company expects gross margins to continue at 86% and potentially reach 90% by the end of 2025 [119] Question: Geographic expansion plans - Management indicated that while modest growth is expected in Europe, strategic value lies in supporting clinical trials and generating publications [78][132]