Mesoblast Delivers 66% Quarterly Revenue Growth, Expands Global Regenerative Medicine Leadership

About Mesoblast Ltd

Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a Melbourne-headquartered biotechnology company and recognised global leader in allogeneic (off-the-shelf) cellular medicines designed to treat severe and life-threatening inflammatory conditions. The company’s innovative cell therapy platform harnesses mesenchymal lineage cells, which release anti-inflammatory factors that modulate the immune system and help counteract damaging inflammatory responses.

Operating across Australia, the United States, and Singapore, Mesoblast has established strong commercial and research partnerships in Japan, Europe, and China, positioning itself as a pioneering force in the global regenerative medicine landscape. Its therapies are uniquely designed to address immune dysregulation at the cellular level, creating new treatment possibilities for diseases that have been historically difficult to manage.

Strategic Developments

The company’s lead product, Ryoncil (remestemcel-L-rknd), achieved a major commercial milestone with gross revenue of US$21.9 million in the September quarter, marking a 66% increase compared to the June 2025 quarter. This growth underscores accelerating adoption following the product’s U.S. FDA approval — a world-first for any mesenchymal stromal cell (MSC) therapy.

Ryoncil is specifically approved for the treatment of paediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD), a severe and often fatal complication following bone marrow transplantation. It remains the only FDA-approved MSC product for children under 12 years of age, positioning Mesoblast at the forefront of paediatric regenerative medicine.

Chief Executive Dr Silviu Itescu said the company is encouraged by the uptake of Ryoncil and growing reimbursement coverage from both commercial insurers and U.S. government payers. He noted that adoption is expected to increase further following the introduction of a permanent J-Code by the Centers for Medicare and Medicaid Services (CMS), which took effect from 1 October 2025. This classification simplifies hospital billing and reimbursement, paving the way for broader market access and a more predictable revenue cycle.

Growth Pipeline and Future Opportunities

Building on Ryoncil’s success, Mesoblast is actively broadening its clinical program to target a wider range of inflammatory and degenerative diseases. The company is progressing clinical studies for adult SR-aGvHD and biologic-resistant inflammatory bowel disease (IBD) — both areas of significant unmet medical need. In parallel, Mesoblast is advancing Rexlemestrocel-L, another allogeneic stromal cell therapy from its proprietary platform, aimed at treating chronic heart failure and chronic low back pain. These programs target multi-billion-dollar global markets, reflecting the company’s strategy to build a diversified therapeutic portfolio capable of generating recurring long-term revenues.

The ability to apply a single cell therapy platform across multiple indications represents one of Mesoblast’s most valuable competitive advantages. Each product is designed to leverage the same manufacturing and quality infrastructure, enabling scalability and reducing time to commercialisation.

Intellectual Property and Manufacturing Strength

Mesoblast’s competitive edge is reinforced by a robust and extensive global intellectual property portfolio that includes over 1,000 granted patents and applications. These patents cover compositions of matter, manufacturing processes, and therapeutic applications, providing long-term protection for the company’s innovations across major jurisdictions until at least 2041.

The company’s proprietary manufacturing process produces industrial-scale, cryopreserved, off-the-shelf cellular medicines that can be stored and distributed globally with defined pharmaceutical release standards. This ensures consistent product quality, patient accessibility, and cost efficiency — essential prerequisites for sustainable commercialisation in the cell therapy industry.

Mesoblast’s manufacturing and quality systems are designed for compliance with global regulatory frameworks, enabling alignment with both U.S. FDA and European Medicines Agency (EMA) requirements. These capabilities establish the foundation for reliable large-scale supply, particularly as demand grows with expanding reimbursement coverage.

Industry Context

The global biotechnology sector is witnessing a paradigm shift toward cellular and regenerative medicine, with therapies like Ryoncil redefining standards of care in immune-mediated and degenerative diseases. While the sector remains highly competitive, Mesoblast’s early regulatory approval, strong intellectual property position, and scalable production infrastructure give it a unique advantage over peer-stage companies. Moreover, increasing clinical validation of cell-based therapies is driving investor interest and institutional adoption. As reimbursement frameworks mature and public confidence in stem-cell-based treatments deepens, Mesoblast is strategically positioned to capture outsized market share — particularly in the U.S., where payer-backed commercialisation is now well underway.The company’s dual ASX–Nasdaq listing also provides access to global capital markets and a diverse investor base, supporting future funding for its expanding clinical and manufacturing programs.

Conclusion

Mesoblast’s second-quarter results represent more than just a sales milestone — they mark the company’s successful transition from a clinical-stage innovator to a commercial-scale biopharmaceutical enterprise. Its consistent revenue growth, expanding therapeutic pipeline, and robust manufacturing capacity provide a clear pathway toward sustained profitability and global impact.

With structural tailwinds in regenerative medicine, expanding regulatory acceptance, and a defensible IP framework extending for more than 15 years, Mesoblast is well positioned to strengthen its leadership in next-generation cellular therapies. Continued progress in adoption and clinical expansion could see the company emerge as a key global player in the new era of advanced biotherapeutics.