Financial Data and Key Metrics Changes - In 2024, the company generated 13.7 million in Q4 from 14 active treatment centers [9][24] - The company achieved a positive adjusted EBITDA of 53.2 million in cash and investments, with no debt [11][23] Business Line Data and Key Metrics Changes - HEPZATO sales for Q4 were 1.4 million, up from 32.3 million, and CHEMOSAT was 2.1 million for CHEMOSAT in 2023 [24] - Gross margins were reported at 86% for Q4 and 83% for the full year [25] Market Data and Key Metrics Changes - CHEMOSAT volumes in Europe grew 137% in 2024, with Germany up 75% and other markets like the UK and Turkey doubling year-over-year [16] - The company activated three new U.S. treatment centers in Q4 and has plans to reach 30 active centers by year-end 2025 [12][14] Company Strategy and Development Direction - The company aims to expand its R&D capabilities to maximize the hepatic delivery system's potential for treating other liver-dominant cancers [11][21] - The strategic value of the European presence lies in supporting clinical trials and generating publications, with plans to expand into France, Italy, and Spain in 2025 [17] - The company is increasing its commercial team and expanding from four to six regions to enhance operational efficiency [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, stating that the first year of HEPZATO's U.S. launch has been a success and has brought the company close to cash flow break-even [22][23] - The company plans to continue investing in high-impact R&D initiatives while maintaining a focus on revenue growth [23] 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 per site is expected to remain steady at around 4.1 treatments, similar to the FOCUS trial [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 prioritize R&D opportunities over maintaining positive cash flow [47][48] Question: Price increase for HEPZATO - A price increase of approximately 2.74% was implemented, with future increases dependent on inflation rates [49][50] Question: Referral network effectiveness - The referral network is functioning well, with community centers referring patients to larger academic centers [56] Question: Expansion of treatment indications - Management confirmed that no device modifications are necessary for new indications, and they are focusing on engaging existing treatment sites [41] Question: Expectations for European market growth - Management anticipates modest growth in Europe, contingent on reimbursement developments [76][78] Question: Timeline for activating new treatment centers - More centers are expected to come online in the second half of the year, with a goal of reaching 30 active centers by year-end [88] Question: Competitive landscape for HEPZATO - Management believes that HEPZATO will complement systemic therapies, emphasizing the need for liver-directed treatments [94][96]
Delcath(DCTH) - 2024 Q4 - Earnings Call Transcript