Financial Data and Key Metrics Changes - The company ended Q4 with 8.1 million for the fourth quarter [31] - Revenue from sales of CHEMOSAT was 0.6 million for the same period in 2022 [32] - Selling, general and administrative expenses increased to 3.8 million due to activities preparing for the commercial launch [51] Business Line Data and Key Metrics Changes - The company expects to have 4 active sites treating commercial patients by the end of Q1 2024, including Moffitt Cancer Center, Stanford University Cancer Center, and Thomas Jefferson University [6] - Average treatments per site are expected to increase from approximately 1 per month early in Q2 to a run rate of 2 treatments per month by late Q4 [7] Market Data and Key Metrics Changes - The company is working with over 20 leading cancer centers across the U.S. that have expressed interest in incorporating HEPZATO KIT into their practices [41] - The establishment of a permanent J-code for HEPZATO is expected to simplify the reimbursement process and increase the pace of facilities conducting their first commercial treatment [8][20] Company Strategy and Development Direction - The company is increasing its site activation guidance from 15 to 20 active sites by the end of 2024, with a pacing of 10 active sites by the end of Q2 and 15 by the end of Q3 [18] - The company plans to pursue additional indications for HEPZATO, targeting unmet medical needs in liver cancers [30][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 7 million private placement to ensure sufficient cash for operations until achieving $10 million in quarterly revenue [50] - The company has trained over 90 healthcare professionals across approximately 20 institutions in the U.S. [21] Q&A Session Summary Question: What therapies are patients being treated with and what is the interest in combination therapies? - Management indicated that patients have varied treatment histories, with some having prior systemic or liver-directed treatments, and there is interest in combination therapies with ongoing trials [54][57] Question: What is the base case outlook for the company's finances going forward? - The base case is to achieve cash flow positivity and fund new development from cash flows without additional financing, assuming the stock performs well [58] Question: How many patients have been treated commercially so far and what are the trends? - Approximately 80% of the first quarter's revenue is expected to come from Moffitt, with patients returning for repeat treatments [61][74] Question: What percentage of the overall market do you expect to cover by the end of this year? - It is estimated that over 75% of patients who have one or more referrals at the first 20 sites will be covered [67][80] Question: What reimbursement processes have been encountered so far? - The company faced challenges in obtaining reimbursement codes initially but managed to activate four sites using a miscellaneous code before the J-code became effective [68]
Delcath(DCTH) - 2023 Q4 - Earnings Call Transcript