Successful Ryoncil Launch and Revenue Contribution
Ryoncil launched April 2025 and drove the period: net product revenues of USD 49.0M in H1 FY26, representing ~95.5% of total revenues (USD 51.3M). Management reports quarter-on-quarter revenue growth since launch.
Very High Gross Margin
Reported gross margin of 93% for the period. Management noted gross profit excluding amortization of approximately USD 44.2M.
Strong Market Access and Commercial Momentum
49 treatment centers onboarded to date; Ryoncil listed on the formulary at 30 centers. Coverage established across payers representing over 280 million lives, Medicaid coverage in all states, and a specific J-code (J3402) effective Oct 1 to streamline billing. 13 hospitals use the Optum Frontier specialty pharmacy to reduce site financial burden.
Clear Market Penetration Targets and Uptake
Company is on track to achieve 20% pediatric market penetration by the end of year 1 post-launch and assumes a 40% peak share in its models for the pediatric population.
Robust Cash and Financing Position
USD 130M cash on hand as of Dec 31, 2025, plus a new USD 125M nondilutive credit facility (USD 75M drawn at closing; USD 50M available to draw through June 2026). Facility is lower cost, non-asset-cross-collateralized, and repayable without prepayment penalties.
Improved Net Loss YoY
Net loss of USD 40.2M in H1 FY26, improved from a USD 48.0M loss in the prior year period (approximate 16.3% improvement), with prior-year comparatives impacted by a one-time USD 23M inventory provision reversal.
Revascor (LVAD) Strong Randomized Data
LVAD II (159 patients, 2:1) and supportive LVAD I showed statistically significant reductions in major bleeding events and related hospitalizations through 6 and 12 months. Company reported ~fivefold reduction in major bleeding events/hospitalizations over 12 months versus control and evidence the treatment mitigates right-heart-failure-related mortality (control HR >7 for death if right-heart hospitalization occurred; treated group showed near abolition of early mortality risk).
Strategic Regulatory Pathway for Revascor
Based on randomized controlled data and orphan designation, Mesoblast is moving from seeking accelerated approval to filing for full BLA approval for the LVAD/right heart failure indication; BLA filing expected next quarter.
Progress on Second-Generation rexlemestrocel-L (Back Pain)
First Phase III (404 patients) completed with FDA feedback that a 12-month pain reduction endpoint is approvable. A confirmatory Phase III is enrolling 300 patients across ~40 U.S. sites with enrollment expected complete in March/April 2026; data readout and potential BLA filing expected in calendar 2027.
Operational Priorities and Manufacturing Focus
Management emphasized building manufacturing capacity/diversification, cost efficiencies, and commercial manufacturing readiness for both Ryoncil and rexlemestrocel-L to support commercialization and filings (CMC/potency activities underway).
FY26 Ryoncil Guidance
Company projects full-year FY26 Ryoncil net revenues of USD 110M–120M (fiscal year ending June 2026).