Mesoblast Chief Executive Dr. Silviu Itescu said, "Revenues from sales of Ryoncil® continue to increase, driven by greater physician adoption with reimbursement from both commercial and government payers. Having a permanent J-Code assigned by Centers for Medicare and Medicaid Services (CMS), which became active October 1, should serve to further enhance product adoption."
FINANCIAL HIGHLIGHTS FOR QUARTER ENDED SEPTEMBER 30, 2025
Revenue from cell therapy products was US$20.6 million, up from US$12.9 million in the previous quarter ended June 30, 2025, and over ten times greater than prior corresponding Q1 FY25.
Revenue growth for the September 2025 quarter compared with the June 2025 quarter was driven by a 66% increase in Ryoncil® gross sales to US$21.9 million and 69% increase in net sales to US$19.1 million after 12.7% gross to net adjustment.
US$14.9 million net operating cash spend, a reduction of US$1.7 million versus the prior quarter ended June 30.
US$145 million cash on hand at September 30, 2025.
Entered into convertible note subscription agreements to issue, at its sole discretion, up to US$50.0 million of unsecured convertible notes. The funding is available at Mesoblast's option, following shareholder approval at this year's annual general meeting, to repay or reduce the amount owing to its secured lenders under the existing loan agreements and for general working capital purposes.
OPERATIONAL HIGHLIGHTS
Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).1
A specific 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. Formal recognition by CMS is a significant milestone for Ryoncil® as the product becomes easier to bill and pay for.2
The new permanent J-Code, J3402, provides a standardized, clear, permanent, and specific billing pathway for Ryoncil® by Medicaid, facilitating reimbursement and broader patient access for this important therapy. Additionally, commercial payers look to the permanent J-code to update their coverage systems.
Mesoblast has onboarded 40 transplant centers since product launch. Across the U.S. market we have 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. Federal Medicaid coverage by CMS is in place ...
