Successful Commercial Launch of Ryoncil®

Core Viewpoint - Mesoblast Limited has reported strong initial sales of its FDA-approved product Ryoncil, generating gross revenue of US$13.2 million from March 28 to June 30, 2025, following its launch for treating steroid-refractory acute graft-versus-host disease in pediatric patients [1][6][10]. Financial Highlights - Gross revenue from Ryoncil sales reached US$13.2 million (unaudited) from March 28 to June 30, 2025 [6]. - The company reported US$1.6 million in revenue from royalties on sales of TEMCELL HS Inj. in Japan [6]. - Net operating cash spend for the quarter was US$16.6 million [6]. - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6]. Operational Highlights - More than 25 transplant centers have been onboarded since the product launch, with plans to complete onboarding across all 45 priority centers that account for approximately 80% of U.S. pediatric transplants [6]. - Ryoncil's coverage is expanding, with over 250 million U.S. lives insured by commercial and government payers, and mandatory Medicaid coverage effective July 1 [6]. - A patient access hub, MyMesoblast™, has been established to assist patients with insurance coverage and access to Ryoncil [6]. Regulatory and Exclusivity Status - Ryoncil received seven years of orphan-drug exclusive approval from the FDA for treating SR-aGvHD in pediatric patients aged 2 months and older [6]. - Mesoblast holds biologic exclusivity preventing another sponsor from referencing Ryoncil's biologic license application until December 2036 [6]. - The company has a strong U.S. intellectual property position on MSC technology, providing commercial barriers to entry against competitors through 2044 [6][12]. Future Developments - Mesoblast held a Type B meeting with the FDA to discuss a pivotal trial for Ryoncil in adults with SR-aGvHD, aiming to extend the product's label [6].