Monitor top-line results from the Phase 3 CLBP trial expected mid-CY2027 and progress of the adult SR-aGvHD registration trial. Also watch for BLA modular review updates for rexlemestrocel-L in LVAD patients and any label expansion catalysts for Ryoncil.
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Executive Summary
Mesoblast filed its FY2026 annual report (20-F) via a 6-K, reporting first full-year product revenue of $115.2M from Ryoncil (approved Dec 2024), total revenue of $120.3M (vs $17.2M in FY2025), a net loss of $57.5M (improved from $102.1M), and cash of $102.9M. The company refinanced debt with a $125M non-dilutive credit line at 8% interest, reducing borrowing costs. The filing confirms commercial launch progress and pipeline milestones (Phase 3 CLBP enrollment complete, adult SR-aGvHD trial started, DMD IND cleared), but the company remains unprofitable with accumulated losses of $1.07B.
Key Facts
- FY2026 net product sales of Ryoncil: $115.2M (first full year of commercialization)
- Total FY2026 revenue: $120.3M vs $17.2M in FY2025
- Net loss: $57.5M vs $102.1M in FY2025 (improvement of $44.6M)
- Cash and cash equivalents: $102.9M as of June 30, 2026
- Net cash used in operating activities: $43.8M (reduced from $50.0M in FY2025)
- Entered $125M five-year non-dilutive credit facility at 8% interest, replacing higher-cost debt
- Accumulated losses since inception: $1.07B
- Phase 3 CLBP trial of rexlemestrocel-L completed treatment of 350 patients
- Adult SR-aGvHD registration trial commenced enrollment
- FDA cleared IND for registrational Phase 3 trial in Duchenne muscular dystrophy
- Ryoncil received specific HCPCS J-Code and coverage for >280 million lives
- Gross profit margin on Ryoncil (excluding amortization): 91%
- Research and development expenses: $97.5M (up 180% from $34.8M)
- Selling, general and administration expenses: $57.3M (up 46% from $39.3M)
- Finance costs: $23.9M (up 4% from $23.0M)
- Fair value remeasurement of contingent consideration: $12.1M gain vs $14.9M loss in FY2025
- Outstanding ordinary shares outstanding: 1,296,862,776 as of June 30, 2026
- Employees: 108 as of June 30, 2026 (up from 81 in FY2025)
Financial Impact
First full-year product revenue of $115.2M from Ryoncil, total revenue $120.3M, net loss $57.5M, cash $102.9M. Gross profit margin on Ryoncil 91%.
Risk Factors
- Company remains unprofitable with $1.07B accumulated losses
- Reliance on single contract manufacturer Lonza for commercial supply
- Ongoing clinical and regulatory risks for pipeline candidates
- Potential for future dilution if additional capital raises needed
- Foreign exchange exposure on USD-denominated debt in Australian entity
Investment Themes
Documents Analyzed
This report is based on 3 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001345099-26-000087 |
| Exhibit: exhibit992annualreportag.htm | 0001345099-26-000087 |
| Exhibit: exhibit993annualreportag.htm | 0001345099-26-000087 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | 6-K | $13.28 $11.95 | ▼ −10.02% | ▼ −10.44% | $13.18 (−0.75%) |
Oct 15, 2026 12d ago | 6-K | $13.95 $13.28 | ▼ −4.80% | ▼ −3.70% | $13.18 (−5.52%) |
Oct 13, 2026 14d ago | 6-K | $13.90 $13.79 | ▼ −0.76% | ▲ +0.33% | $13.18 (−5.15%) |
Sep 23, 2026 4w ago | 6-K | $15.48 $15.12 | ▼ −2.33% | ▼ −2.87% | $13.18 (−14.86%) |
Aug 27, 2026 8w ago | 20-F | $18.18 $17.44 | ▼ −4.07% | ▼ −3.84% | $13.18 (−27.50%) |
Aug 26, 2026 8w ago | Press Release | $18.18 $17.44 | ▼ −4.07% | ▼ −3.84% | $13.18 (−27.50%) |
Aug 24, 2026 9w ago | 6-K | $16.64 $17.19 | ▲ +3.31% | ▲ +2.99% | $13.18 (−20.79%) |
Aug 16, 2026 10w ago | Press Release | $17.02 $16.67 | ▼ −2.06% | ▼ −1.38% | $13.18 (−22.56%) |
Jul 30, 2026 12w ago | 6-K | $14.55 $14.17 | ▼ −2.61% | ▼ −3.32% | $13.18 (−9.42%) |
Jul 14, 2026 15w ago | 6-K | $16.74 $18.24 | ▲ +8.96% | ▲ +8.56% | $13.18 (−21.27%) |
US Market Status
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