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Mesoblast (MSB) investor relations material
Mesoblast H1 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- RyoncilⓇ net revenues rose 60% to US$30M, with strong cash reserves and expanded financing.MSB
Q2 202629 Jan 2026 - RYONCIL BLA resubmitted, cash burn cut 23%, and FDA decision expected by January 2025.MSB
Q4 202423 Jan 2026 - Pivotal FDA decision for pediatric GVHD expected, with major expansion and filings ahead.MSB
Maxim Group’s 2024 Healthcare Virtual Summit19 Jan 2026 - Disciplined financials, clinical progress, and FDA-focused strategies drive near-term milestones.MSB
AGM 202414 Jan 2026 - FDA approves first MSC therapy for pediatric steroid-refractory acute GVHD, with 70% response rate.MSB
FDA Announcement10 Jan 2026 - First FDA-approved allogeneic cell therapy for pediatric GVHD launching, with broad pipeline and strong cash position.MSB
Emerging Growth Conference 7923 Dec 2025 - FDA approval and $161M raise support US launch, but losses and risks remain.MSB
H1 202519 Dec 2025 - Ryoncil's robust launch and pipeline expansion drive growth, with adult trials and global filings ahead.MSB
Piper Sandler 37th Annual Healthcare Conference4 Dec 2025 - RYONCIL's US launch drives revenue growth as label expansion and pivotal trials advance.MSB
AGM 2025 Presentation25 Nov 2025
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