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 net revenue of $49 million in H1 FY 2026 and 49 treatment centers onboarded, supported by broad payer coverage for 280 million US lives.

• Revenue surged to $51.3 million for the six months ended December 31, 2025, driven by the commercial launch of Ryoncil/RYONCIL for pediatric SR-aGVHD.

• Strategic focus on label expansion, new indications, and advancing pipeline assets including Revascor and rexlemestrocel-L, with ongoing investment in late-stage clinical programs and manufacturing scale-up.

• Cash reserves stood at $130 million at period end, supported by a new $125 million credit facility.

Financial highlights

• Total revenues for H1 FY 2026 were $51.3 million, with product revenue of $49 million and gross margin of 93%.

• R&D expenses were $46.2 million, up sharply year-over-year, and SG&A expenses increased to $28.5 million, reflecting commercialization investments.

• Net loss for H1 FY 2026 was $40.2 million, improved from $48 million in the prior year.

• Cash on hand at December 31, 2025, was $130 million; net operating cash usage for H1 FY 2026 was $30.3 million.

Outlook and guidance

• Projected full-year FY 2026 Ryoncil/RYONCIL net revenue between $110 million and $120 million.

• Operating cash flow usage/net cash spend expected to decline in H2 FY 2026 due to increased revenues and cost controls.

• Targeting 20% pediatric market share 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 expected to complete by March/April, with data readout and BLA filing targeted for 2027.