Mesoblast Ltd (NASDAQ:MESO, ASX:MSB) reported a strong September quarter as early momentum from the US launch of Ryoncil® continued to build. Product revenue rose to US$20.6 million, up from US$12.9 million in June, with Ryoncil® gross sales climbing 66% to US$21.9 million and net sales up 69% to US$19.1 million after a 12.7% gross-to-net adjustment.
Operating cash outflow narrowed to US$14.9 million, down US$1.7 million from the prior quarter, and the company closed September with US$145 million in cash.
To add flexibility, Mesoblast executed agreements for up to US$50 million in unsecured convertible notes (subject to shareholder approval), intended primarily to repay or reduce amounts under existing secured loans and for working capital.
Commercial execution remains a focus
Ryoncil®—the first FDA-approved mesenchymal stromal cell therapy and the only approved option for children under 12 with steroid-refractory acute graft-versus-host disease—benefited from expanding payer coverage and operational enablers.
Coverage now spans more than 260 million US lives across commercial and government payers, with mandatory fee-for-service Medicaid coverage effective nationwide from July 1. A key milestone landed on October 1: a permanent CMS J-Code (J3402), providing a standardised billing pathway likely to ease hospital administration and support broader access.
Since launch, 40 transplant centres have been onboarded; management has identified 45 “priority” centres that account for roughly 80% of US pediatric transplants. To consolidate access, Mesoblast has also established the MyMesoblast™ patient support hub for insurance coordination and financial assistance.
Looking to label expansion, the company met with the FDA in July to discuss a pivotal study of Ryoncil® in adults with severe SR-aGvHD. The trial is planned in collaboration with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), aiming to extend Ryoncil’s indication to an adult population that is approximately three times larger than the pediatric cohort.
Cash flow detail in the Appendix 4C shows receipts from customers of US$10.3 million and outlays across R&D (US$7.3 million), manufacturing and operating costs (US$6.0 million), and advertising and marketing (US$4.7 million).
Directors’ and executive payments totaled US$1.18 million for the quarter. Mesoblast estimates funding for ~9.7 quarters at the current burn rate. Financing notes disclose an Oaktree senior facility (fixed 9.75% interest; outstanding US$41.7 million at September 30) and a NovaQuest subordinated loan (15% interest, amortising from first commercial sales), alongside the proposed US$50 million convertible facility (5% coupon, five-year term, US$16.25 per ADR conversion price).
Overall, the quarter reflects accelerating adoption of Ryoncil® underpinned by payer clarity and centre onboarding, strengthening cash discipline, and a clear path to broaden the addressable market via the planned adult SR-aGvHD pivotal trial.