Delcath(US:DCTH)2020-08-14 02:29Financial Data and Key Metrics Changes - The product revenue for Q2 2020 was approximately $262,000, an increase from $221,000 in the prior year [27] - Selling, general, and administrative expenses were approximately $2.3 million, down from $2.7 million in the prior year [28] - Research and Development expenses increased to $2.2 million from $1.7 million in the prior year [28] - The net loss for Q2 2020 was $4.3 million, improved from a net loss of $6.0 million in the same period in 2019 [29] - Cash resources totaled $16.2 million as of June 30, 2020, compared to $10.2 million at December 31, 2019, and $1.4 million at June 30, 2019 [29] Business Line Data and Key Metrics Changes - The company completed a $22 million capital raise during the quarter, which supports the ongoing Phase 3 registration FOCUS trial for Melphalan/HDS [9] - Over 1,000 commercial procedures have been performed in the EU using the CHEMOSAT technology, although market penetration remains low due to reimbursement issues [23] Market Data and Key Metrics Changes - The U.S. market opportunity for metastatic ocular melanoma is estimated to be in the hundreds of millions of dollars, with approximately 1,500 new cases annually [13] - Initial surveys indicate a high unmet medical need and potential for Melphalan/HDS to be positioned as a frontline therapy if approved [12] Company Strategy and Development Direction - The company is focused on making Melphalan/HDS available as the only labeled therapy for metastatic ocular melanoma in the U.S. [8] - There is a strategic emphasis on expanding the U.S. opportunity beyond the initial indication of ocular melanoma [15] - A comprehensive review of clinical and commercial data is underway to guide future pipeline projects [17] Management's Comments on Operating Environment and Future Outlook - The management highlighted the transformational changes over the past year, including restructuring and recapitalization [7] - The ongoing COVID-19 pandemic has impacted clinical trials, but the company has managed to keep patients on protocol [21] - The goal is to report Phase 3 top-line data by the end of 2020 or early 2021, with an NDA resubmission expected by mid-2021 [22] Other Important Information - The company has received FDA feedback regarding potential protocol modifications for the Phase 3 study in intrahepatic cholangiocarcinoma [16] - The partnership with Medac is crucial for European commercialization, and the company is actively reviewing Medac's performance to ensure optimal execution [24] Q&A Session Summary Question: Expected cash milestones from Medac - The milestones are not substantial but sufficient to ensure cash runway through NDA filing [32] Question: Impact of COVID-19 on ongoing trials - The company managed to keep all ongoing patients on protocol despite the pandemic [34] Question: Spending trends during pre-commercialization - The company maintains a quarterly spend of about $4.5 to $5 million, with some fluctuations expected [36] Question: Parameters for product launch resources - The company is receiving commercialization guidance from a former Chief Commercialization Officer on how to proceed [37] Question: Timing for pursuing expanded indications - The company is assessing which indications to pursue without interfering with NDA submission timelines [38] Question: FDA feedback on intrahepatic cholangiocarcinoma - The company received guidance from the FDA, which is part of a broader strategic review [40] Question: Rolling submission pathway for NDA - The company plans a resubmission with a six-month review clock, with no current plans for a rolling submission [42]