Delcath(US:DCTH)2021-05-11 17:56Financial Data and Key Metrics Changes - Product revenue for Q1 2021 was approximately $389,000, an increase from $293,000 in the prior year period [20] - Selling, general and administrative expenses rose to approximately $3.3 million from $2.3 million in the prior year quarter [20] - Research and development expenses increased to $3.7 million compared to $3 million in the prior year quarter [20] - Total operating expenses for the quarter were $7 million, up from $5.3 million in the prior year quarter [20] - The net loss for Q1 2021 was $6.8 million, compared to a net loss of $7.9 million in the same period in 2020 [21] - Cash, cash equivalents, and restricted cash totaled $26.7 million at March 31, 2021, compared to $4.7 million at the same time last year [21] Business Line Data and Key Metrics Changes - The FOCUS trial results indicated an overall response rate of 29.2%, significantly exceeding the pre-specified threshold of 8.3% for success [9] - In the per protocol population, the overall response rate was 32.9% for the HEPZATO arm versus 13.8% for the Best Alternative Care arm [10] - The disease control rate was 70.9% for HEPZATO compared to 37.9% for the Best Alternative Care arm [10] Market Data and Key Metrics Changes - The company anticipates a modest uptake in the UK market following changes to NICE guidelines, with a potential one-year lead time for revenue impact [25] - The company is preparing to expand into additional areas of high unmet need, including intrahepatic cholangiocarcinoma and metastatic colorectal cancers [12][14] Company Strategy and Development Direction - The company is focused on preparing for an NDA submission in early 2022 and expanding HEPZATO into additional indications [19] - A commercial launch strategy is being developed, assessing the size of the commercial organization and strategies for coding, pricing, and reimbursement [17] - The company is working with a consulting firm and KOL advisory boards to refine its commercial launch strategy [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the preliminary FOCUS trial data and its potential to establish HEPZATO as the standard of care for metastatic ocular melanoma [10] - The company is optimistic about the prospects for Delcath as it continues to analyze FOCUS trial data and prepare for NDA submission [54] - Management acknowledged the challenges posed by COVID-19 on data monitoring and site access but is actively working to mitigate these issues [13][49] Other Important Information - The FOCUS trial results will be presented at the American Society of Clinical Oncology annual meeting, with a Q&A webinar scheduled for June 7 [11] - The company is exploring the potential for additional chemotherapeutic agents to be used with the HEPZATO device in the future [52] Q&A Session Summary Question: Expectations for spending trends for the rest of the year - Management indicated that stock option expenses will continue at a similar level, with potential increases if new grants are issued [24] Question: Impact of NICE guidelines on revenue - Management expects a gradual revenue increase in the UK over the next three to six months as private insurance coverage begins [25] Question: Overall survival data trends - Management noted that overall survival data is still pending, with expectations to release it by the end of summer [26] Question: Pipeline development status - Management confirmed that planning is on track, with broader tumor-specific advisory boards being organized [29] Question: Expanded access program details - Management is in discussions with several major cancer centers to initiate the expanded access program [33] Question: Update on database and NDA filing - Management reported ongoing data entry and monitoring challenges due to COVID-19 but is implementing remote monitoring solutions [49] Question: Thoughts on partnering strategies - Management is cautious about regional partnerships, preferring to keep the asset clean for potential strategic partnerships in the future [52]