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Highlights:
- Mesoblast reported AUD 13.2M in gross revenue from Ryoncil® sales post-launch.
- Mesoblast onboarded over 25 of 45 key U.S. transplant centres for Ryoncil® distribution.
- Mesoblast secured federal Medicaid coverage for Ryoncil® effective across all U.S. states from July.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB), an Australian-headquartered company developing allogeneic cellular medicines for inflammatory diseases, has reported unaudited gross revenue of AUD 13.2 million from sales of its FDA-approved product Ryoncil® (remestemcel-L-rknd) in the United States for the quarter ended 30 June 2025. The sales period reflects the product’s initial market availability following its commercial launch on 28 March 2025. Ryoncil®, which is indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in paediatric patients, is the first mesenchymal stromal cell (MSC) therapy approved by the U.S. Food and Drug Administration (FDA). In addition to sales revenue, Mesoblast recorded AUD 1.6 million in royalties from TEMCELL® HS Inj. sales in Japan through its licensing partner.
The company reported a net operating cash outflow of AUD 16.6 million for the quarter and held AUD 162 million in cash reserves as of 30 June 2025. Since the commercial introduction of Ryoncil®, more than 25 of the 45 targeted U.S. transplant centres have been onboarded. These centres account for approximately 80% of U.S. paediatric transplant activity. Mesoblast anticipates completing onboarding across all priority centres during the current quarter. The product’s market access has expanded significantly, with over 250 million U.S. lives now covered by commercial and government health insurers. Federal Medicaid coverage has been in place since Ryoncil®'s launch, and mandatory state-level Medicaid coverage under the fee-for-service model became effective on 1 July 2025.
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