Mesoblast posts US$120m revenue as RYONCIL ramps
Mesoblast has reported total revenue of US$120.3 million for the fiscal year ended 30 June 2026, up from US$17.2 million in the prior year, as its flagship cell therapy RYONCIL completed its first full year of commercial sales in the United States.
Net product revenue from RYONCIL (remestemcel-L-rknd) reached US$115.2 million after a gross-to-net adjustment of 13.4%, generating a reported gross profit of US$103.6 million. The company's net loss narrowed by 44% to US$57.5 million, compared with US$102.1 million in FY2025. Cash on hand at period end stood at US$103 million, supported by a new US$125 million five-year non-dilutive credit facility that retired two higher-cost borrowing arrangements.
RYONCIL commercial execution
Mesoblast said it has now onboarded more than 50 transplant sites since RYONCIL's US launch, including 14 of the 15 largest centres by transplant volume. Payer coverage has expanded to more than 280 million covered lives, and median time from patient identification to treatment initiation has fallen from 29 days at launch to 8 days, a metric the company views as a proxy for commercial maturity.
The company is now pursuing label expansion. A registrational trial of RYONCIL in adult patients with severe steroid-refractory acute graft-versus-host disease (SR-aGvHD), used alongside ruxolitinib as second-line therapy, is currently enrolling. Mesoblast estimates the adult SR-aGvHD market is approximately three times larger than the paediatric indication it currently holds. Data presented in February at the Tandem Meetings showed 76% Day 100 survival in adolescents and adults treated with RYONCIL after failure of ruxolitinib or other agents, compared with historical survival rates of 20 to 30%. Separately, the FDA has cleared an IND for a registrational trial of RYONCIL in ambulatory children aged 5 to 9 with Duchenne muscular dystrophy.
Phase 3 back pain readout and pipeline
Mesoblast has completed treatment of 350 patients in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain associated with inflammatory degenerative disc disease. The trial was expanded from an original 300-patient target following investigator demand. Top-line results are expected in mid-2027, with the primary endpoint targeting durable pain reduction at 12 months from a single intra-discal injection. Secondary endpoints include functional improvement, quality-of-life measures, and opioid cessation. The company has received a BLA filing number from the FDA and is discussing a modular review request for rexlemestrocel-L in a separate heart failure indication.
The allogeneic cell therapy sector is increasingly competitive. Several academic medical centres and specialist biotechs are advancing mesenchymal stromal cell programmes for inflammatory and degenerative indications, though no direct MSC-based competitor has yet achieved commercial scale comparable to RYONCIL in the US. The back pain readout in mid-2027 will be closely watched: chronic low back pain is a vast indication with a total addressable market the company sizes at more than US$10 billion, but regulatory precedent for cell therapies in musculoskeletal pain remains limited, and the FDA's expectations for this modality in a non-life-threatening indication are less well-defined than in acute inflammatory disease.
Looking further out, Mesoblast unveiled two next-generation technology platforms at its April R&D Day: CAR-modified mesenchymal stromal cells, built on Mayo Clinic research published in Nature Biomedical Engineering, and oncolytic virus-loaded MSCs developed under an exclusive licence from Baylor College of Medicine. Both remain early-stage, but they signal an intent to broaden beyond the company's current remestemcel-L and rexlemestrocel-L platforms into oncology and autoimmune indications such as ulcerative colitis and lupus nephritis.
Chief executive Silviu Itescu said the FY2026 result reflected "continued growth in RYONCIL market adoption and focus on disciplined capital allocation while investing in our high-value opportunities."