New York, State/Province — October 19, 2025 — Leads & Copy — Mesoblast Limited (Nasdaq:MESO; ASX:MSB) reported highlights of its activities for the first quarter ended September 30, 2025, including increased revenues from sales of Ryoncil®, driven by physician adoption and reimbursement from commercial and government payers.
The company reported cell therapy product revenue of US$20.6 million, up from US$12.9 million in the previous quarter and over ten times greater than the prior corresponding period. Ryoncil® gross sales increased by 66% to US$21.9 million, and net sales increased by 69% to US$19.1 million. Net operating cash spend was US$14.9 million, a reduction of US$1.7 million versus the prior quarter, with US$145 million cash on hand at September 30, 2025.
Mesoblast entered into convertible note subscription agreements to issue up to US$50.0 million of unsecured convertible notes, available at the company’s option following shareholder approval. The company said that Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the FDA for any indication and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD). A Healthcare Common Procedure Coding System (HCPCS) J-Code was assigned to Ryoncil® by United States Medicare & Medicaid Services (CMS) and became active for billing and reimbursement on October 1, 2025.
Mesoblast has onboarded 40 transplant centers since product launch and has identified 45 priority transplant centers that account for approximately 80% of U.S. pediatric transplants. Coverage for Ryoncil® continues to expand with over 260 million US lives insured by commercial and government payers. In July, Mesoblast met with FDA to discuss a pivotal trial for Ryoncil® in adults with severe SR-aGvHD and intends to conduct a pivotal study of Ryoncil® on top of approved second-line therapy in patients with severe SR-aGvHD, with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN).
Dr. Silviu Itescu, Chief Executive of Mesoblast, noted that the permanent J-Code assigned by Centers for Medicare and Medicaid Services (CMS), which became active October 1, should further enhance product adoption.
Contact:
Paul Hughes: +61 3 9639 6036
Emma Neal, Allison Worldwide: +1 603 545 4843, emma.neal@allisonworldwide.com
Steve Dabkowski, BlueDot Media: +61 419 880 486, steve@bluedot.net.au
Source: Mesoblast Limited
