Mesoblast Ltd Posts US$115M FY26 Ryoncil Revenue as Q4 Hits US$36M
Mesoblast caps FY26 with US$115M in Ryoncil revenue as Q4 hits US$36M
In its revenue update for the quarter and full year ended 30 June 2026, Mesoblast Limited (ASX:MSB; Nasdaq:MESO) reported Ryoncil® net revenue of US$36 million for Q4 FY26 and US$115 million for the full year.
The company noted the results have already exceeded management’s initial projections. This marks the first full year of commercial revenue for a recently launched FDA-approved product.
In its first full commercial half-year, Mesoblast recorded US$49 million in Ryoncil revenue at a 93% gross margin, issuing full-year guidance of US$110-120 million, a range the company has now exceeded at US$115 million.
Importantly, these figures are based on management’s preliminary estimates and remain subject to completion of customary year-end closing and audit procedures.
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Q4 FY26 revenue performance
The headline revenue figures for the fourth quarter and full year are set out below.
| Metric | Period | Net Revenue (USD) |
|---|---|---|
| Ryoncil® net revenue | Q4 (quarter ended 30 Jun 2026) | US$36M |
| Ryoncil® net revenue | Full year FY26 | US$115M |
Management attributed the performance to strong uptake since launch and growth momentum across major U.S. pediatric centers.
Dr. Silviu Itescu, Chief Executive, Mesoblast
“We are very pleased with the strong uptake of Ryoncil® since launch, and with revenues that have already exceeded our initial projections.”
What is Ryoncil and why it matters
Ryoncil® (remestemcel-L-rknd) is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication. It is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).
Key product facts:
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First FDA-approved MSC therapy for any indication.
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Approved for pediatric patients 2 months and older.
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Marketed under the Ryoncil® brand.
Capital position and the investment case
Management described the company’s financial foundation as solid, framing operations as revenue-supported and backed by a substantial patent estate.
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The capital position was described as “strong”, with operational activities “well funded through revenue growth.”
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A new five-year facility has, per management, “freed up our label extension and blockbuster products for strategic initiatives.”
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The intellectual property portfolio spans over 1,000 granted patents or patent applications, with protection extending to at least 2044 in all major markets.
Revenue-funded operations combined with a long patent runway underpin the commercial thesis behind Ryoncil®.
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Growth outlook and pipeline
Management pointed to continued momentum heading into the next fiscal year, while retaining forward-looking caveats around future performance.
Dr. Silviu Itescu, Chief Executive, Mesoblast
“We anticipate continued revenue growth in the coming fiscal year in line with momentum we are seeing across major U.S. pediatric centers.”
Beyond the approved pediatric indication, the company outlined several programmes in development. These candidates are not approved and remain in clinical development:
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Ryoncil® is being developed for SR-aGvHD in adults and biologic-resistant inflammatory bowel disease.
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Rexlemestrocel-L is being developed for heart failure and chronic low back pain.
The rexlemestrocel-L regulatory pathway advanced materially in mid-2026 when Mesoblast secured a BLA filing number from the FDA and requested modular review for its end-stage heart failure indication, supported by RMAT and Orphan Drug designations that enable priority and rolling review eligibility.
- The company has established commercial partnerships in Japan, Europe and China.
With a commercial product now generating full-year revenue and a pipeline targeting additional indications, Mesoblast’s FY26 results provide an early read on the commercial trajectory of its cellular medicines platform, subject to the completion of year-end audit procedures.
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