Mesoblast has reported a sharp rise in revenue as sales of its cell therapy Ryoncil accelerated in the United States, while its chronic low back pain program moved closer to a decisive clinical readout.
The company recorded US$120.3 million in revenue for the year to June 30, up from US$17.2 million a year earlier. Ryoncil generated US$115.2 million in net product sales in its first full year on the US market, producing gross profit of US$103.6 million.
Mesoblast’s net loss narrowed 44 per cent to US$57.5 million, from US$102.1 million. Operating cash outflow fell to US$43.8 million, and the company ended the year with US$102.9 million in cash, after refinancing through a US$125 million five-year non-dilutive credit facility.
Ryoncil, approved in the US for children with steroid-refractory acute graft-versus-host disease, has been adopted by more than 50 paediatric transplant centres, including 14 of the 15 largest. Mesoblast says payer coverage now extends to more than 280 million lives and the median time from identifying a patient to treatment has fallen from 29 days to eight.
The company is now seeking to expand Ryoncil into adults with severe steroid-refractory graft-versus-host disease, a market it estimates is three times larger than the paediatric setting. A registration trial of Ryoncil with ruxolitinib is enrolling patients at up to 40 US sites.
Mesoblast also completed treatment of 350 patients in its phase 3 trial of rexlemestrocel-L for chronic low back pain linked to inflammatory degenerative disc disease. The trial will assess pain reduction 12 months after a single intradiscal injection, with results expected in mid-2027.
The company has also requested a modular FDA review of rexlemestrocel-L for preventing life-threatening gastrointestinal bleeding in end-stage heart failure patients supported by left ventricular assist devices.
Mesoblast’s progress now depends on sustaining Ryoncil’s early launch performance while producing positive late-stage data in its larger pipeline programs.
