Highlights

  • H1 total revenue surged to USD 51.3 million (AD 78.3 million) from USD 3.2 million, driven by the commercial launch of Ryoncil®.
  • Gross profit from Ryoncil® reached USD 44.2 million, with direct selling costs of USD 7.7 million.
  • Net loss narrowed to USD 40.2 million, down from USD 47.9 million in H1 FY2025, while period-end cash balance stood at USD 130 million.

Mesoblast Ltd (ASX:MSB) (Nasdaq:MESO) shares fell 7.02% to AUD 2.25 on 27 February 2026, following the release of its half-year financial results for the period ended 31 December 2025. The stock has declined 6.25% over the past five days and 8.54% over the past year.

Revenue Growth Driven by Ryoncil®

Mesoblast’s financial performance in H1 FY2026 was heavily influenced by the successful U.S. commercial launch of Ryoncil® (remestemcel-L-rknd). Gross sales of Ryoncil® reached USD 57.0 million, translating into USD 48.7 million revenue after gross-to-net adjustments. This resulted in a gross profit of USD 44.2 million, compared to nil in the previous corresponding period.

Total revenue for the half-year rose to USD 51.3 million (AD 78.3 million), reflecting the strong uptake of Ryoncil® at 49 transplant centers across the U.S., with coverage expected to extend to 64 centers performing 94% of relevant transplants.

Operational Highlights and Lifecycle Expansion

Mesoblast continues to expand Ryoncil® indications for both pediatric and adult patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD). The company is progressing Phase 3 trials for Ryoncil® lifecycle extension and its second-generation product, rexlemestrocel-L, targeting chronic low back pain (CLBP) and inflammatory chronic heart failure.

The Phase 3 CLBP trial is set to complete its 300-patient enrollment by March/April 2026 across 40 U.S. sites. Positive feedback from the FDA supports potential Biologics License Application (BLA) filings for these indications, leveraging single pivotal trial pathways.

Financial Position and Cash Flow

Despite reporting a net loss of USD 40.2 million, Mesoblast reduced its loss compared to H1 FY2025 (USD 47.9 million). Net operating cash outflows totaled USD 30.3 million. The period-end cash balance was USD 130 million, supplemented by a five-year USD 125 million non-dilutive credit facility, with USD 50 million available for drawdown until 30 June 2026.

The operating performance allows continued investment in R&D, commercial manufacturing of Ryoncil®, and clinical programs for rexlemestrocel-L.

Mesoblast’s H1 FY2026 results demonstrate significant revenue growth driven by the commercial launch of Ryoncil® and strategic development of its cellular therapy pipeline. The company maintains a robust cash position and access to additional financing to support lifecycle expansion and late-stage clinical programs.

FAQs

Q1: What was Mesoblast’s H1 FY2026 revenue?
Total revenue increased to USD 51.3 million (AD 78.3 million), up from USD 3.2 million in H1 FY2025.

Q2: How did the Ryoncil® launch perform?
Ryoncil® generated USD 57.0 million in gross sales, with a net revenue of USD 48.7 million and gross profit of USD 44.2 million.

Q3: What is the cash position of Mesoblast?
The company ended the period with USD 130 million in cash and a USD 125 million five-year credit facility, with USD 50 million available for drawdown.