Mesoblast Posts $102M FY2025 Loss with $161M Cash, Launches Ryoncil in US
Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.
- FDA approval and US launch of Ryoncil for pediatric SR-aGVHD
- FY2025 net loss of $102.1 million amid ongoing operating expenses
- Strong cash position with $161.6 million reserves
- Strategic partnerships with Grünenthal, JCR, Takeda, and Tasly
- Focus on advancing late-stage candidates Revascor and MPC-06-ID
FDA Approval and Commercial Launch
Mesoblast Limited, a biotechnology company specializing in allogeneic cellular medicines, has reached a pivotal milestone with the FDA approval of its first product, Ryoncil (remestemcel-L), in December 2024. This approval marks the first mesenchymal stromal cell (MSC) therapy authorized in the United States for any indication, specifically targeting pediatric steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged two months and older.
Following the approval, Mesoblast launched Ryoncil commercially in the US market in March 2025. The company has onboarded over 30 transplant centers and secured insurance coverage for more than 250 million lives, including mandatory Medicaid coverage across all US states. These efforts translated into $11.3 million in net product sales by the end of the fiscal year, underscoring the initial commercial traction of this groundbreaking therapy.
Financial Performance and Capital Position
Despite the commercial progress, Mesoblast reported a net loss of $102.1 million for FY2025, reflecting the substantial costs associated with clinical development, manufacturing scale-up, and the establishment of commercial infrastructure. The company has incurred operating losses since inception and anticipates continuing to do so in the near term as it advances its product pipeline and expands commercialization efforts.
Mesoblast’s balance sheet remains robust, with cash and cash equivalents totaling $161.6 million as of June 30, 2025. This liquidity, combined with anticipated revenue from Ryoncil sales, is expected to support the company’s operating cash needs over the next twelve months. The company is also in advanced discussions to refinance existing debt facilities to manage upcoming maturities.
Strategic Partnerships and Pipeline Development
Mesoblast continues to leverage strategic collaborations to broaden its global footprint and advance its late-stage product candidates. Key partnerships include Grünenthal GmbH for commercialization of MPC-06-ID in Europe and Latin America, JCR Pharmaceuticals in Japan for MSC-based therapies, Takeda Pharmaceutical for the adipose-derived MSC product Alofisel in Europe, and Tasly Pharmaceutical Group for cardiovascular products in China.
The company is actively progressing its pipeline, with Revascor (rexlemestrocel-L) targeting chronic heart failure and MPC-06-ID advancing in Phase 3 trials for chronic low back pain due to degenerative disc disease. Mesoblast recently aligned with the FDA on key components of the Biologics License Application (BLA) filing for Revascor, including manufacturing controls and confirmatory trial design.
Governance, Risk Management, and ESG Commitment
Mesoblast maintains a strong governance framework with a board comprising industry veterans and experts in biotechnology and finance. The company emphasizes risk management, particularly in clinical development, manufacturing, and regulatory compliance, to mitigate operational uncertainties.
In its ESG statement, Mesoblast highlights its commitment to sustainability through ethical business practices, patient safety, diversity and inclusion, and environmental stewardship. The company’s mission to deliver innovative treatments for underserved conditions underpins its social impact and long-term value creation strategy.
Outlook and Market Implications
Mesoblast’s transition from a research-focused biotech to a commercial-stage company is underscored by the successful launch of Ryoncil. However, the path ahead involves scaling manufacturing, expanding market access, and securing reimbursement to realize the full commercial potential of its therapies. The company’s financial results reflect the significant investment required to achieve these goals.
Investors and analysts will be closely watching the progress of ongoing clinical trials, regulatory filings for label expansions, and the commercial uptake of Ryoncil and other product candidates. The company’s ability to manage operational risks and capitalize on strategic partnerships will be critical to its future success.
Bottom Line?
Mesoblast’s FDA milestone and commercial launch of Ryoncil signal a new phase, but sustained profitability hinges on pipeline progress and market adoption.
Questions in the middle?
- How will Mesoblast manage the transition from operating losses to sustained profitability?
- What are the timelines and prospects for regulatory approvals of Revascor and other late-stage candidates?
- How will evolving reimbursement landscapes impact the commercial success of Ryoncil and future products?
