Ryoncil® Revenues Increase 66% in Second Quarter Post Launch

Company Overview - Mesoblast Limited is a global leader in developing allogeneic cellular medicines for inflammatory diseases [3][5] - The company is focused on treating severe and life-threatening inflammatory conditions using its proprietary mesenchymal lineage cell therapy technology [3][5] Financial Performance - For the quarter ended September 30, 2025, Mesoblast reported gross revenue of US$21.9 million from Ryoncil sales, marking a 66% increase compared to the previous quarter [1] - The gross to net adjustment for Ryoncil sales remained consistent with prior periods [1] Product Information - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell (MSC) product for any indication and is specifically approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD) [2][4] - The company is developing Ryoncil for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease [5] Market and Adoption - The adoption of Ryoncil has been positively influenced by reimbursement from both commercial and government payers [3] - A permanent J-Code assigned by the Centers for Medicare and Medicaid Services (CMS) became active on October 1, which is expected to further enhance adoption [3] Intellectual Property - Mesoblast has a robust global intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection expected to extend through at least 2041 in major markets [6] Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines that are planned to be readily available to patients worldwide [7]