Mesoblast (US:MESO)2020-03-01 03:05Financial Data and Key Metrics Changes - Overall revenue grew 43% to $19.2 million from $13.5 million in the previous period [14] - Commercialization revenue from TEMCELL royalty increased 73% to $3.8 million from $2.2 million [14] - Milestone revenue from strategic partnerships rose 36% to $15 million from $11 million [14] - Loss after tax reduced by 32%, driven by increased revenue and a 22% decline in R&D expenses [15] Business Line Data and Key Metrics Changes - TEMCELL royalties contributed significantly to revenue growth, reflecting strong product adoption in Japan [9] - The company has two Phase 3 product candidates targeting heart failure and back pain, with trial readouts expected this year [5][8] Market Data and Key Metrics Changes - The U.S. addressable market for steroid-refractory acute graft versus host disease is anticipated to be approximately 8 times larger than in Japan [9] - The market opportunity for Ryoncil in acute graft versus host disease is substantial, with high mortality rates in severe cases [18] Company Strategy and Development Direction - The company completed the BLA filing for Ryoncil for treating steroid-refractory acute graft versus host disease in children, with plans for a U.S. launch in 2020 [6][20] - A lifecycle expansion strategy is in place for remestemcel-L, targeting additional indications including chronic graft versus host disease and biologic-refractory Crohn's disease [8][20] - Strategic partnerships are being established for product development and commercialization in various regions, including Europe and Latin America [10][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming U.S. launch of Ryoncil and the potential for sequential approval in Europe [34] - The company is optimistic about the Phase 3 trial outcomes for Revascor in heart failure, citing previous positive data from Phase 2 trials [35][36] - The management highlighted the importance of addressing the significant unmet needs in heart failure and chronic lower back pain markets [22][27] Other Important Information - The company has established manufacturing capabilities that meet international regulatory standards, ensuring product consistency and scalability [11] - The intellectual property estate includes over 1,000 patents, providing strong protection for the company's core commercial focus [10] Q&A Session Summary Question: What is the go-to-market strategy for Ryoncil in the U.S. and plans for Europe? - The company plans to target pediatric transplants in 15 centers in the U.S. with a small, efficient sales force and has established a relationship with Lonza for manufacturing [34] Question: What data supports a positive outcome for Revascor in the upcoming Phase 3 trial? - Previous Phase 2 trials showed a clear dose response and significant impact on reducing hospitalizations and mortality, providing confidence for the Phase 3 trial [35][36] Question: What is the expected timeline for the pivotal trial for chronic GVHD? - The company is still finalizing the number of patients and sites for the trial, with a focus on severe cases where existing therapies are least effective [39] Question: How many sales representatives will be on the ground for the U.S. launch? - The company is looking at a sales force of approximately 12 to 15 representatives [40] Question: What are the expectations for expenses over the next 12 to 24 months? - Overall cash burn is expected to decrease, with some resources shifting towards the commercial team and pre-launch inventory [59]