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]