Delcath(US:DCTH)2022-05-10 19:13Financial Data and Key Metrics Changes - Product revenues for Q1 2022 were approximately $207,000, a decrease from $261,000 in the prior year quarter due to the resumption of direct sales of CHEMOSAT in Europe [21] - Other income for the quarter increased to $171,000 compared to $127,000 in the prior year quarter [21] - Research and development expenses rose to $4.2 million from $3.7 million in the prior year quarter, primarily due to higher professional service costs related to the pre-NDA meeting with the FDA [22] - Selling, general and administrative expenses increased to approximately $3.6 million from $3.3 million in the prior year quarter, attributed to pre-launch costs for HEPZATO [23] - Cash, cash equivalents, and restricted cash totaled $20.5 million as of March 31, 2022, down from $27 million on December 31, 2021 [24] Business Line Data and Key Metrics Changes - HEPZATO's NDA resubmission is planned for the third quarter of 2022, with no significant new issues arising from the pre-NDA meeting with the FDA [6][9] - CHEMOSAT's safety and efficacy data from various studies in Europe continue to support its market presence, with a focus on increasing sales and distribution activities [7][13] Market Data and Key Metrics Changes - The company resumed direct responsibility for sales, marketing, and distribution of CHEMOSAT in Europe, with plans to expand into additional markets [16][48] - The company anticipates that Europe will become a meaningful revenue contributor, especially with the upcoming US commercial launch [17] Company Strategy and Development Direction - The company aims to open 10 expanded access sites for HEPZATO by the expected launch, focusing on a niche market with significant unmet needs [11] - Plans to expand the PHP platform into other indications, with a focus on ICC and CRC trials, are underway [18][19] - The management team is being strengthened to support both development and commercialization efforts in the US and Europe [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the pre-NDA meeting with the FDA, indicating a positive outlook for HEPZATO's NDA resubmission [28][29] - The company is facing challenges related to nursing shortages impacting clinical trial resources, which is a broader industry issue [33] - Management is adjusting spending on new indications due to the current market environment, focusing on low-cost initiatives [41] Other Important Information - The company received Medical Device Regulation certification for CHEMOSAT in Europe, changing its designation from Class IIb to Class III [15][16] - The company is actively working on reimbursement strategies in the UK and other European markets [45][46] Q&A Session Summary Question: Insights from the pre-NDA meeting with the FDA and vendor delays - Management noted that the pre-NDA meeting provided positive signals regarding efficacy analysis and clarified FDA expectations, with no significant downsides [27][28] - Delays from a vendor were attributed to the need for quality tests on off-the-shelf components, but management is confident in resolving these issues soon [30][31] Question: EAP site readiness and enrollment - Management highlighted that nursing shortages are impacting the ability to enroll patients in the EAP, but they are optimistic about meeting their goal of 10 sites [32][33] Question: Maturity of survival data and R&D expenses - Management confirmed that survival data will continue to mature over the next year, with updates expected at ASCO [35] - R&D expenses are expected to remain high for another quarter before potentially declining [36] Question: Impact of market conditions on future indications and restricted cash - Management is slowing down spending on new indications due to market conditions but is still focused on low-cost initiatives [41] - Restricted cash can be released through additional equity financing, with discussions possible if needed [42]