Key Takeaways:
Mesoblast reported Ryoncil net revenue of $36 million for the fourth quarter and $115 million for the first full year since the drug's FDA approval.
"We are very pleased with the continued momentum in uptake of Ryoncil in children with life-threatening steroid-refractory acute GvHD across major U.S. pediatric centers," Chief Executive Dr. Silviu Itescu said.
The company ended the fiscal year with $103 million in cash after extinguishing debt obligations, with net operating cash spend of $43.8 million for FY26. Mesoblast has commenced trials to extend Ryoncil's label from children to adults with steroid-refractory acute graft versus host disease, a patient population roughly three times larger. The company also received clearance to proceed with a registrational trial for Ryoncil in children with Duchenne muscular dystrophy.
Beyond Ryoncil, Mesoblast's pipeline candidate rexlemestrocel-L reached its target of at least 300 patients in a pivotal Phase 3 trial for chronic low back pain, with results to be followed over 12 months. The company has also filed for a biologic license for rexlemestrocel-L in heart failure.
Mesoblast secured a worldwide license for chimeric antigen receptor technology, aiming to develop new products for ulcerative colitis, Crohn's disease, and lupus nephritis. The company expects up to 40 U.S. trial sites to enroll adults in the SR-aGvHD expansion, representing about 60 percent of the annual U.S. bone marrow transplant population.
The first-year revenue confirms commercial demand for the first FDA-approved mesenchymal stromal cell therapy. Investors will watch for adult SR-aGvHD trial enrollment data and the chronic low back pain readout as the next key catalysts.
This article is for informational purposes only and does not constitute investment advice.
