Delcath(US:DCTH)2023-11-14 03:07Financial Data and Key Metrics Changes - The company ended Q3 2023 with $40.5 million in cash, with cash used in operations approximately $9.2 million for the third quarter and $23.1 million for the first nine months of the year [24] - R&D expenses increased to $4.7 million in Q3 2023 from $4.1 million in Q3 2022, attributed to FDA inspection activities [25] - Selling, general and administrative expenses rose from $4.8 million to $6.2 million due to preparations for the commercial launch [25] Business Line Data and Key Metrics Changes - The company is focused on the commercialization of HEPZATO KIT, which received FDA approval on August 14, 2023, for treating metastatic uveal melanoma [13][23] - The company anticipates starting commercial sales in January 2024, with plans to have at least 10 treatment sites operational by the end of Q2 2024 [23][38] Market Data and Key Metrics Changes - The company is working with over 20 sites to build referral networks and has initiated the formulary approval process in 13 hospitals [15][36] - The company expects to have five active treatment sites by the end of Q1 2024, increasing to 10 by the end of Q2 and 15 by the end of 2024 [38] Company Strategy and Development Direction - The company is focused on building a robust supply chain to avoid stockouts and ensure a smooth launch of HEPZATO KIT [2] - The strategy includes training treatment teams and working with medical oncologists to integrate HEPZATO KIT into their practices [15][36] - The company aims to establish HEPZATO KIT as the standard of care for liver-directed therapy in metastatic uveal melanoma patients [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for HEPZATO KIT, citing positive feedback from medical professionals and the need for the product in treating metastatic uveal melanoma [36] - The company is optimistic about the approval process with Value Analysis Committees, expecting quicker approvals due to the lack of standard care for the targeted patient population [93] Other Important Information - The company is working on obtaining necessary reimbursement codes from CMS, which are crucial for the commercial launch [20][77] - The company has faced delays in product availability due to complexities in working with contract manufacturers for melphalan [84][91] Q&A Session Summary Question: How active is Delcath in the Value Analysis Committee approval process? - Management indicated that while Delcath supports the process, it is primarily an internal hospital procedure, and they have received positive feedback so far [68][49] Question: How do you see HEPZATO being used post KIMMTRAK? - Management noted that some patients may be too far progressed for HEPZATO, but there is potential for liver-directed therapy to be used first in certain cases [29][121] Question: What is the expected inventory level for the launch? - The company aims to maintain at least a year's worth of inventory, ensuring adequate supply for anticipated demand [96] Question: How long do Value Analysis Committee approvals typically take? - Management expects these approvals to take closer to three months rather than the typical nine months due to the urgency and need for the product [93] Question: What is the expected patient volume for the first year? - Management anticipates that by the end of the first quarter, five sites will be operational, with a gradual increase in patient treatments as more sites come online [108]