Mesoblast (MSB) H1 2026 earnings summary

Executive summary

• Achieved strong growth in Ryoncil/RYONCIL sales following FDA approval and US launch in April 2025, with significant market adoption, onboarding of 49 centers, and broad insurance coverage for over 280 million lives.

• Total revenues for H1 FY26 reached $51.3 million, driven by $49 million in Ryoncil/RYONCIL net product revenue.

• Net loss for H1 FY26 narrowed to $40.2 million, reflecting higher revenues and increased R&D and SG&A expenses.

• Cash reserves stood at $130 million at December 31, 2025, supported by a new $125 million credit facility.

• Strategic focus on expanding Ryoncil/RYONCIL indications, advancing pipeline assets (including Revascor and Rexlemestrocel-L), and optimizing manufacturing and commercial partnerships.

Financial highlights

• Product revenue for H1 FY26 was $49 million, with total revenues at $51.3 million and gross margin of 93%.

• R&D expenses were $46.1–$46.2 million, and SG&A expenses rose to $28.5 million due to commercialization.

• Net loss for the period was $40.2 million, improved from $47.9–$48 million in the prior year.

• Cash balance at December 31, 2025, was $130 million; operating cash outflow was $30.3 million.

• Cost of revenues was $7.6 million, reflecting inventory and amortization costs post-commercialization.

Outlook and guidance

• Full-year FY26 Ryoncil/RYONCIL net revenue is projected between $110 million and $120 million.

• Operating cash flow usage/net cash spend expected to decline in H2 FY26 due to increased revenues and cost controls.

• Targeting 20% pediatric market share for Ryoncil by fiscal year-end, with a long-term goal of 40% peak share.

• BLA filing for full approval of Revascor in end-stage HFrEF anticipated next quarter; CLBP Phase 3 trial enrollment to complete by March/April, with data readout and BLA filing targeted for CY27.

• Existing cash and Ryoncil sales expected to fund operations for at least the next twelve months; additional capital will be required beyond this period.