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]

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]