TLDR
- Ryoncil sales soar 66% after CMS J-Code streamlines reimbursements.
- Mesoblast trims cash outflow, strengthens liquidity for expansion.
- Nationwide Medicaid coverage boosts Ryoncil’s U.S. adoption.
- FDA talks advance Ryoncil adult trial for larger SR-aGvHD market.
- Strategic growth, payer confidence position Mesoblast for success.
Mesoblast Limited (Nasdaq: MESO) closed down 5.64% at $17.07 on October 17, 2025, despite reporting strong quarterly gains.
Mesoblast Limited, MESO
The company posted a surge in Ryoncil sales, alongside financial improvements and strategic developments in the U.S. transplant market. This comes as Mesoblast continues expanding access to its flagship therapy following a new CMS billing code.
Ryoncil Sales Surge After Permanent J-Code Activation
Ryoncil gross sales rose 66% quarter-over-quarter to $21.9 million, significantly lifting Mesoblast’s cell therapy product revenue to $20.6 million. The Centers for Medicare and Medicaid Services activated a permanent J-Code, J3402, on October 1, streamlining reimbursements for Ryoncil. This regulatory milestone improved billing ease, enabling broader coverage from both government and private payers.
Net sales of Ryoncil reached $19.1 million after a 12.7% gross-to-net adjustment, a 69% rise from the previous quarter. The standardized billing code increased confidence in payer systems, encouraging more transplant centers to adopt the treatment. As a result, over 260 million U.S. lives are now covered for Ryoncil through commercial and public insurance.
Mesoblast has added 40 transplant centers since launch and identified 45 key centers that conduct 80% of pediatric transplants. The company continues to focus on SR-aGvHD in children under 12, where Ryoncil remains the only FDA-approved MSC therapy. A patient support platform, MyMesoblast, has also been launched to facilitate access, provide financial assistance, and facilitate product ordering.
Financial Performance Strengthens Amid Operational Expansion
For the quarter ended September 30, 2025, Mesoblast reduced net operating cash outflow to $14.9 million, down from $16.6 million in June. The company reported $145 million in cash reserves, maintaining liquidity to support growth initiatives. It entered agreements to issue up to $50 million in unsecured convertible notes, pending shareholder approval.
These funds will support repayment of secured loans and general operations as Mesoblast scales product availability. The expanded cash position and reduced spending underscore disciplined financial management as the company executes its commercial strategy. Continued momentum in revenue generation reflects growing Ryoncil uptake and operational efficiencies.
Mesoblast confirmed ongoing discussions with the FDA to advance clinical trials for Ryoncil in adult SR-aGvHD cases. This follows unmet demand in the adult segment, which is approximately three times larger than the pediatric population. The planned trial will be conducted with the NIH-funded BMT-CTN to pursue broader label expansion.
U.S. Market Developments Support Long-Term Outlook
The company’s CMS-recognized J-Code allows more predictable reimbursement, increasing product adoption across priority transplant centers. Federal Medicaid coverage is effective in all U.S. states as of July 1, 2025. This development ensures nationwide access and payment support for Ryoncil in pediatric SR-aGvHD.
Mesoblast’s focused U.S. strategy aims to convert clinical acceptance into sustained commercial returns. The company continues to educate physicians, streamline logistics, and expand patient reach through its partnerships with hubs and hospitals. Ryoncil’s rapid integration into transplant centers affirms its role in the treatment ecosystem.
Future revenue may benefit further from label expansion and growing payer confidence. The ongoing pivotal trial initiative for adults signals the next major opportunity. As Mesoblast scales its presence, the market outlook for Ryoncil remains strongly positioned.
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