Mesoblast Limited (ASX: MSB; Nasdaq: MESO) has reported total revenue of US$51.3 million (A$78.3 million) for the half-year ended 31 December 2025, a 16-fold increase from the US$3.2 million recorded in the same period a year earlier.
The result, released simultaneously in New York on 26 February and Melbourne on 27 February, marks what the company calls a critical inflection point: the transition from two decades of clinical development into sustainable, large-scale commercial execution.
The engine behind the turnaround is Ryoncil (remestemcel-L-rknd), the world’s first FDA-approved mesenchymal stromal cell (MSC) therapy, indicated for steroid-refractory acute graft versus host disease in paediatric patients.
Figure 1: Financial Results and Operational Update of Mesoblast for Half-Year Ended December 31, 2025
Ryoncil Delivers US$44 Million Gross Profit in Its Commercial Debut
Ryoncil generated gross sales of US$57.0 million in the half, with net product revenue of US$48.7 million after standard gross-to-net adjustments. Gross profit, excluding amortisation, reached US$44.2 million, compared to nil in the prior corresponding period. Direct selling costs came in at US$7.7 million.
Key commercial milestones Ryoncil achieved in the half include:
- 49 transplant centres onboarded, targeting 64 centres that collectively perform 94% of all transplants in the United States
- Coverage extended to 280 million US lives, with Federal Medicaid coverage and mandatory fee-for-service Medicaid coverage across all US states now in place
- A dedicated CMS billing J-Code issued on 1 October 2025, which drove accelerated uptake under government coverage in the final quarter
- 84% of patients in a real-world setting completed the initial 28-day treatment regimen per the FDA-approved label and remained alive
The reported net loss for the half narrowed to US$40.2 million, down from US$47.9 million a year earlier. Adjusting for a US$23.0 million inventory reversal booked in the previous period, the underlying improvement in net loss year-on-year amounts to US$30.7 million, a substantial swing in the right direction.
US$130 Million Cash Balance Underpins the Growth Pipeline
Mesoblast ended the period with a cash balance of US$130.0 million. The company also secured a US$125.0 million five-year non-dilutive credit facility, with a second tranche of US$50.0 million available to draw at its option until 30 June 2026.
Net operating cash spend stood at US$30.3 million for the half. Mesoblast expects this figure to shrink over the remainder of the financial year as quarterly Ryoncil revenue receipts build. The company guides for full-year FY2026 Ryoncil net revenue of between US$110 million and US$120 million.
Also Read: What Are ASX Growth Shares and How Do They Work?
Second-Generation Drug Targets Blockbuster Chronic Pain and Heart Failure Approvals
Beyond Ryoncil, Mesoblast is advancing its second-generation product rexlemestrocel-L toward full FDA approval filings across two indications with significant commercial potential.
For chronic discogenic low back pain (CLBP), the FDA has confirmed that a clinically meaningful reduction in pain intensity at 12 months can support a Biologics Licence Application (BLA). The Phase 3 trial actively recruits across 40 US sites and targets completion of its 300-patient enrolment in March or April 2026.
For end-stage heart failure patients with low ejection fraction, new data shows that a single administration of rexlemestrocel-L at the time of open-heart surgery reduces right heart failure hospitalisations, associated mortality, and portal hypertension with major bleeding events. Mesoblast now plans to file for full FDA approval, bypassing accelerated approval, next quarter. If approved, the company would not require a confirmatory study.
CEO Signals a New Commercial Era for the Company
Mesoblast Chief Executive Dr Silviu Itescu described the result as evidence of a company that has fundamentally changed its trajectory.
“Today we report strong operational and financial performance for the first half of FY2026, a period that marks an important inflection point in Mesoblast’s evolution from clinical development to sustainable commercial execution,” Dr Itescu said.
He added that positive cash flow from Ryoncil sales, disciplined cost management, and a strategic refinancing now give the company greater flexibility to advance both its commercial expansion and its late-stage clinical programs.
Investor Outlook: Strong Fundamentals, Near-Term Headwinds on the ASX
Despite the transformative revenue result, Mesoblast shares fell 4.75% on the ASX on 27 February to close at $2.305, reflecting a broader market reassessment of the stock’s near-term trajectory. The decline extends a difficult stretch for shareholders, with MSB down 13.99% over the past month and 15.26% since the start of 2026.
Share price snapshot (ASX: MSB, 27 February 2026):
- Last price: $2.305 (-$0.115, -4.75%)
- Market capitalisation: $2.97 billion
- 1-week: -4.75%
- 1-month: -13.99%
- 2026 Year-to-Date: -15.26%
- 1-year: -6.30%
- vs Sector (1 year): +24.26%
- vs ASX 200 (1 year): -17.58%
The significant underperformance against the healthcare sector, which gained 24.26% over the same twelve months, suggests the market remains cautious about the pace of Ryoncil’s commercial ramp-up and the timeline to full profitability, even as the underlying clinical and commercial story strengthens considerably.
At a market cap of just under $3 billion, Mesoblast now carries meaningful commercial revenue underpinning its valuation for the first time in its history. Upcoming BLA filings for rexlemestrocel-L in heart failure and chronic back pain represent the next potential re-rating catalysts for investors who take a longer-term view on the company’s substantial pipeline..
Sources:
- Mesoblast ASX Announcement: https://investorsmedia.mesoblast.com/static-files/4e8f46c6-b19e-4696-97ef-7e9db0693715
- Prasad V, Makary MA.; One Pivotal Trial, the New Default Option for FDA Approval; Ending the Two-Trial Dogma New England Journal of Medicine, 2026;394:815–817 https://www.nejm.org
- Ryoncil Full Prescribing Information (FDA-Approved Label) https://www.ryoncil.com
US Centers for Medicare & Medicaid Services (CMS); HCPCS J-Code Issuance (1 October 2025) https://www.cms.gov
