Banner Year for Mesoblast With First FDA Product Approval and Successful Commercial Launch of Ryoncil®

Core Insights - Mesoblast Limited achieved FDA approval for Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) product in the U.S., and successfully launched it for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients [2][10][34] - The company aims to transform into a commercial biotechnology entity with plans for additional approved indications for Ryoncil and the launch of next-generation platform technologies targeting heart failure and chronic low back pain [2][6] Financial Highlights - Total revenue from cell therapy products reached US$17.2 million, a 191% increase from the previous year, driven by Ryoncil's launch [6][31] - Net operating cash spend was US$50.0 million, a 3% increase year-over-year, reflecting costs associated with the commercial team and product launch [6] - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6] Product and Market Opportunities - Ryoncil has a potential annual addressable market of approximately $1 billion for pediatric and adult SR-aGvHD, with additional markets for biologic-refractory inflammatory bowel disease exceeding $5 billion, heart failure with reduced ejection fraction (HFrEF) over $10 billion, and chronic low back pain (CLBP) also exceeding $10 billion [7][35] - The company is developing Ryoncil for additional indications, including adult SR-aGvHD and inflammatory bowel disease, and has a pipeline of therapies targeting unmet medical needs [7][35] Operational Developments - Ryoncil became commercially available on March 28, 2025, shortly after FDA approval [10] - The company has expanded coverage for Ryoncil, with over 250 million U.S. lives insured and federal Medicaid coverage effective July 1, 2025 [11] - Mesoblast has onboarded 32 transplant centers and aims to onboard the top 45 centers that account for 80% of pediatric bone marrow transplants in the U.S. [11] Corporate Governance - The Board of Directors was strengthened with the appointments of Dr. Gregory George and Ms. Lyn Cobley, bringing extensive experience in medical science and financial services [30]