Mesoblast (US:MESO)2019-08-30 01:39Financial Data and Key Metrics Changes - The company reported record royalty revenue from JCR Pharma on sales of TEMCELL, which increased to $5 million for FY2019, a 37% increase over the prior year [31] - Royalties for the most recent quarter saw a 54% increase to $1.7 million, indicating strong growth [32] - The company completed the year with just over $50 million in cash, using only $19 million in the prior quarter [39] Business Line Data and Key Metrics Changes - The lead product remestemcel-L for steroid refractory acute graft versus host disease is preparing for a U.S. launch, with a rolling BLA submission initiated [15][43] - Revascor for advanced heart failure has completed patient enrollment in its Phase 3 trial, with 566 patients randomized [18] - The MPC-06-ID for chronic lower back pain is in a Phase 3 program with 404 patients, with results expected in the first half of 2020 [24][50] Market Data and Key Metrics Changes - The U.S. addressable market for steroid-refractory acute graft versus host disease is estimated to be approximately $700 million [43] - The advanced heart failure market targets about 1.3 million patients in the U.S., representing 15% of the total heart failure pool [99] Company Strategy and Development Direction - The company is focused on expanding its commercialization efforts, particularly for remestemcel-L and Revascor, with plans for label extensions and partnerships [26][50] - The strategy includes building a targeted sales force and ramping up manufacturing capabilities to meet commercial demand [28][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of TEMCELL and its potential performance in the U.S. market [33] - The company anticipates significant upcoming milestones that will position it for strong returns in the coming fiscal year [111] Other Important Information - The company has over 995 patents and patent applications, providing a substantial competitive advantage [30] - Recent appointments to the board and senior executive team are aligned with commercialization plans [26] Q&A Session Summary Question: When could the confirmatory Phase 3 trial for end-stage heart failure start? - The trial is expected to commence over the next few months, with agreements being finalized [55] Question: Will there be any other information available before the MPC-06 results in mid-2020? - No additional information will be disclosed until the full dataset is available [57] Question: What is the expected timeline for royalty revenue from TEMCELL in 2020? - Continued growth is anticipated, with a ramp-up expected throughout the year [59][60] Question: Can you provide details on the clinical trial design for chronic GVHD? - The trial will be investigator-initiated, with established data supporting the efficacy of mesenchymal lineage cells [73] Question: What is the expected trial size for the confirmatory LVAD trial? - The trial size will be slightly larger than the previous 159-patient trial, with specifics to be finalized [108]