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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 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.
- 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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