Mesoblast H2 Earnings Call Highlights

RYONCIL generated $115 million in fiscal 2026 revenue, its first full year of commercial sales, while Mesoblast reduced its net loss by 44% to $57.5 million. The company ended the year with $103 million in cash and significantly lower second-half cash burn. Commercial momentum continued, with more than 50 treatment centers onboarded and insurance coverage reaching over 98% of U.S. lives. Mesoblast expects double-digit RYONCIL growth over the next 12 months and is conducting a 180-patient adult GVHD trial that could support label expansion. The pipeline advanced in Duchenne muscular dystrophy, chronic low back pain and heart failure: the FDA cleared a Phase III Duchenne trial, enrollment was completed in a 350-patient back-pain study, and the company is pursuing approval for REVASCOR in high-risk heart-failure patients. Mesoblast reported $115 million in net revenue for fiscal 2026, its first full year of commercial sales for RYONCIL, the company’s FDA-approved allogeneic mesenchymal stromal cell therapy for children with steroid-refractory acute graft-versus-host disease, or GVHD. Chief Executive Officer Silviu Itescu said fourth-quarter net revenue reached $36 million, while gross profit excluding amortization expenses totaled $110 million for the full year. The company described RYONCIL as the first and only FDA-approved mesenchymal stromal cell product in the U.S. Chief Financial Officer Jim O’Brien said Mesoblast reduced its net loss after tax by 44% to $57.5 million. The company ended the fiscal year with $103 million in cash and reported net cash usage of $43.8 million for the year. Cash burn in the second half was $13.4 million, compared with $50 million in the corresponding prior-year period. Mesoblast said more than 50 treatment centers have been onboarded for RYONCIL, and insurance coverage now extends to more than 98% of U.S. lives. The company also received a J-code in October 2025, which Itescu said contributed to revenue growth. In real-world use, Itescu said RYONCIL has shown 84% early survival among treated children with acute GVHD. He said the company’s priorities over the next year include increasing adoption in the pediatric market, encouraging earlier use of the therapy, and expanding into adult GVHD. Mesoblast is enrolling a 180-patient randomized trial in adults with Grade 3 or 4 steroid-refractory acute GVHD. The study compares ruxolitinib alone with ruxolitinib plus RYONCIL. Itescu said the trial is enrolling across more than 40 U.S. sites and is expected to take about 18 months to complete. The company expects an interim analysis in the fourth quarter of 2027 after approximately 100 patients, or 57% of the planned enrollment, have been enrolled. Itescu said either a successful interim analysis or a positive result from the full trial could support a supplemental biologics license application, or sBLA, for an adult label expansion. Discussing patients who have failed ruxolitinib, Itescu cited compassionate-use results showing 76% survival at day 100 among adolescents and adults treated with RYONCIL, compared with survival of roughly 20% to 30% in reports involving patients treated with other third-line agents after ruxolitinib failure. When asked about revenue expectations, Itescu did not provide formal guidance but said the company expects “double-digit growth” over the coming 12 months. He said management expects to have a clearer view of growth by the middle of the fiscal year. The FDA cleared Mesoblast’s investigational new drug application for a Phase III trial of RYONCIL in pediatric Duchenne muscular dystrophy.