Aug 26, 2026 earnings call — RYONCIL launch, label expansion and rexlemestrocel trials
Mesoblast recorded net revenue of $115 million from RYONCIL in fiscal year 2026, the first full year after launch.
Revenue $0.1B (est $0.1B) · EPS $-0.13 (est $-0.11)
Key quotes
"RYONCIL is commercial today and we seek to have multiple label extensions for this product in order to strongly grow our revenue base."
"The pivotal Phase 3 trial of 350 patients has completed treatment, and we are following these patients through 12 months with the trial to complete mid-2027 calendar year and then if a positive readout positions us for a BLA filing for a blockbuster indication."
"For the year, our net cash usage was $43.8 million."
Analyst Q&A 4
RYONCIL growth and Duchenne choice
Q (Edward Tenthoff · Piper Sandler): He asked what growth to expect for RYONCIL next fiscal year and how far penetration is in steroid-refractory pediatric GvHD. He also asked why Duchenne muscular dystrophy (DMD) was chosen as a secondary pediatric indication.
A: Management said they will assess the next 12 months and review progress by midyear, but they expect double-digit growth in the coming 12-month period. They said Duchenne is a large unmet need, that treating very young children (age three to four) could have maximal benefit, and that RYONCIL’s mechanism could target T cell inflammation and be additive to gene therapies.
"But we certainly expect to see double-digit growth in the coming 12-month period." — Silviu Itescu
Adult GvHD trial enrollment and sBLA plan
Q (Olivia Brayer · Cantor): She asked how enrollment is going for the adult GvHD study and whether the interim analysis next year could support an sBLA. She also asked about the trial powering, assumed treatment effect on top of ruxolitinib, and confidence in enrolling patients to meet the stats goal.
A: They said the trial is running across more than 40 U.S. sites in partnership with the BMT CTN and targets adults with Grade III/IV disease. They expect ruxolitinib alone to have about a 50% response and expect a ruxolitinib plus RYONCIL response north of 70% to 75%, with the study powered about 85% to 90%; an interim analysis at 57% and the full study of 180 patients have both been vetted with the FDA and either outcome could support an sBLA. They added that patients have been enrolled and they expect faster monthly accrual such that roughly 100 patients will be enrolled by the fourth quarter of next year.
"And so both of those, the full powering of the 180 patients and the interim analysis to declare early success have been vetted with the FDA." — Silviu Itescu
FDA talks and DMD trial timing
Q (Madeleine Williams · Canaccord): She asked about FDA discussions on treating later-stage patients earlier and how feasible that is. She also asked if there are clear plans to start a pivotal DMD trial in the next 12 months and whether extra spend is needed to grow pediatric RYONCIL.
A: They said discussions with the FDA are active, that the new FDA leadership has shown flexibility in cell and gene therapy, and that they will meet with the agency this quarter to discuss label extension. For DMD, they said they are in discussions with U.S. clinicians and patient stakeholders to set up sites and that the study is ready to begin once those pieces are in place. On spending, management said they have a clear capital plan to fund key Phase 3 programs, will control costs, and will fund the programs judiciously.
"And there has been evident flexibility shown by the new leadership in other areas of cell and gene therapy." — Silviu Itescu
Cash needs and timing of profitability
Q (John Hester · Bell Potter): He asked whether the company expects to need to raise additional capital given cash of $103 million and net debt of about $15 million. He also asked in what quarter the company expects to be cash flow positive from operations.
A: They said they want to keep options open but expect cash burn in fiscal '27 to be less than fiscal '26 due to RYONCIL growth and expected cash receipts, and that the balance sheet is supportive with long-term debt having a five-year balloon. For the quarter-to-quarter timing of positive cash flow, management declined to give a specific quarter, saying it is early in the fiscal year and quarter-by-quarter fluctuations can happen.
"My expectation is that our cash burn in fiscal '27 will be less than it is in fiscal '26, given the growth of the RYONCIL franchise and the market growth that we expect, cash receipts that we expect." — James O’Brien