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.

To support treatment access, the company has implemented a patient support hub MyMesoblast™ which coordinates insurance, financial assistance, and ordering for Ryoncil®. Healthcare providers, patients, and caregivers can access related resources through the product’s official website. In regulatory developments, Ryoncil® has received a seven-year period of orphan-drug exclusivity from the FDA, applicable to its approved paediatric SR-aGvHD indication. Additionally, the product holds biologic exclusivity until December 2036, limiting reference to its biologics license application for biosimilar development. These protections are supplemented by Mesoblast’s U.S. intellectual property portfolio, which covers manufacturing processes and therapeutic indications and currently extends through 2044.

A Type B meeting between Mesoblast and the FDA was held in July to discuss a pivotal trial of Ryoncil® for adult SR-aGvHD patients. The trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), with the aim of expanding the product’s label. Meeting minutes are expected shortly. In parallel, Mesoblast continues to engage with the FDA regarding Revascor®, its cell therapy candidate for end-stage ischemic heart failure with reduced ejection fraction (HFrEF) in patients supported by left ventricular assist devices (LVADs). Following earlier regulatory meetings, Mesoblast and the FDA are aligned on requirements for filing a Biologics License Application (BLA), including chemistry, manufacturing and control (CMC) measures, potency assays, and the design of a post-approval confirmatory trial.

The company’s Phase 3 trial of rexlemestrocel-L, a second-generation cell therapy candidate, remains ongoing. This 300-patient study targets chronic low back pain due to inflammatory degenerative disc disease of less than five years’ duration and is being conducted at multiple sites across the U.S. Non-executive directors received AUD 71,577 in fees and AUD 122,767 in consulting payments during the quarter. Executive directors, including the CEO and Chief Medical Officer, received US$267,465 in salaries. Since August 2023, all directors have voluntarily reduced their cash remuneration in exchange for equity-based incentives.

MSB trading at 30.17% higher at AUD 2.33 per share as on 18 July 2025.