Mesoblast reported first full-year commercial revenue of $115 million in fiscal 2026, while narrowing its net loss to $57.5 million as the company advances multiple late-stage programs. The Australian biotech’s fourth-quarter revenue reached $36 million, falling short of the $36.91 million consensus estimate by approximately 2.5%. Shares of Mesoblast slipped 2.04% to $16.84 in regular trading, though edged up 0.95% in after-hours activity.
The company’s gross profit on total sales excluding amortization totaled $110 million for the fiscal year, with product development costs rising to $17.3 million. Research and development spending on Phase III programs reached $21.2 million, while sales and marketing expenses amounted to $18 million. Cash and equivalents stood at $103 million as of June 30, 2026, with full-year net cash usage of $43.8 million. Second-half cash burn declined 73% year-over-year to $13.4 million.
Mesoblast’s lead therapy, RYONCIL (remestemcel-L), generated cumulative net revenue of $125 million since launch, driven by adoption across more than 50 U.S. transplant centers. Insurance coverage spans over 98% of U.S. lives, with mandatory federal Medicaid inclusion in every state. The company secured a J-code in October 2025, facilitating broader reimbursement. Management highlighted an 84% early survival rate in pediatric acute graft-versus-host disease (aGVHD) cases treated with RYONCIL.
The adult aGVHD market presents an opportunity of more than 2,000 annual cases in the U.S., with steroid-refractory patients comprising roughly half of that total. Ruxolitinib remains the only second-line approved therapy, showing a 42% day-28 response rate for Grade 3/4 cases and 20%-30% day-100 survival for non-responders. Compassionate care expanded IND data for RYONCIL in adults demonstrated a 76% day-100 survival rate. A randomized controlled trial of 180 patients evaluating ruxolitinib alone versus ruxolitinib plus RYONCIL is enrolling across 40 U.S. sites, with an interim analysis planned for the fourth quarter of 2027.
Development milestones include an FDA-cleared IND for a Phase III trial in Duchenne muscular dystrophy, with a pivotal study expected to begin within 12 months. A Phase III trial in chronic low back pain completed enrollment at 350 patients, up from an initial 300, with top-line data expected in the second half of 2027. Mesoblast’s global intellectual property portfolio includes over 1,100 patents and applications, providing protection through at least 2044.
Chief Executive Officer Dr. Silviu Itescu emphasized the company’s leadership in allogeneic cellular therapies, noting that RYONCIL is the only FDA-approved product of its type. He described the therapy as “a highly profitable single product on a standalone basis,” with revenue reinvested into manufacturing and late-stage programs. Chief Financial Officer Jim O’Brien guided toward reduced cash burn in fiscal 2027 compared to fiscal 2026 and reiterated management’s expectation of achieving profitability in the next fiscal year and beyond.
