Ryoncil® Net Revenues Increase 69% in Second Quarter Post Launch

NEW YORK, Oct. 19, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the first quarter ended September 30, 2025.

Mesoblast Chief Executive Dr. Silviu Itescu said, "Revenues from sales of Ryoncil^® continue to increase, driven by greater physician adoption with reimbursement from both commercial and government payers. Having a permanent J-Code assigned by Centers for Medicare and Medicaid Services (CMS), which became active October 1, should serve to further enhance product adoption."

FINANCIAL HIGHLIGHTS FOR QUARTER ENDED SEPTEMBER 30, 2025

• Revenue from cell therapy products was US$20.6 million, up from US$12.9 million in the previous quarter ended June 30, 2025, and over ten times greater than prior corresponding Q1 FY25.
• Revenue growth for the September 2025 quarter compared with the June 2025 quarter was driven by a 66% increase in Ryoncil^® gross sales to US$21.9 million and 69% increase in net sales to US$19.1 million after 12.7% gross to net adjustment.
• US$14.9 million net operating cash spend, a reduction of US$1.7 million versus the prior quarter ended June 30.
• US$145 million cash on hand at September 30, 2025.
• Entered into convertible note subscription agreements to issue, at its sole discretion, up to US$50.0 million of unsecured convertible notes. The funding is available at Mesoblast's option, following shareholder approval at this year's annual general meeting, to repay or reduce the amount owing to its secured lenders under the existing loan agreements and for general working capital purposes.
  
  

OPERATIONAL HIGHLIGHTS

• Ryoncil^® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).¹
• A specific Healthcare Common Procedure Coding System (HCPCS) J-Code was assigned to Ryoncil^® by United States Medicare & Medicaid Services (CMS) and became active for billing and reimbursement on October 1, 2025. Formal recognition by CMS is a significant milestone for Ryoncil^® as the product becomes easier to bill and pay for.²
• The new permanent J-Code, J3402, provides a standardized, clear, permanent, and specific billing pathway for Ryoncil^® by Medicaid, facilitating reimbursement and broader patient access for this important therapy. Additionally, commercial payers look to the permanent J-code to update their coverage systems.
• Mesoblast has onboarded 40 transplant centers since product launch. Across the U.S. market we have identified 45 priority transplant centers that account for approximately 80% of U.S. pediatric transplants.
• Coverage for Ryoncil^® continues to expand with over 260 million US lives insured by commercial and government payers. Federal Medicaid coverage by CMS is in place and mandatory fee-for-service Medicaid coverage for Ryoncil^® became effective July 1 in all US states.
  • To assist patients and institutions with insurance coverage, financial assistance, and access programs, ensuring that no patient is left behind in receiving this potentially life-saving therapy, Mesoblast has established a patient access hub termed MyMesoblast™, where Ryoncil^® is available for ordering. Additional information is available on ryoncil.com, where valuable resources for healthcare providers, patients and caregivers can be found.
  • In July, Mesoblast met with FDA to discuss a pivotal trial for Ryoncil^® in adults with severe SR-aGvHD. Given the continued unmet need in adults with severe SR-aGvHD, Mesoblast intends to conduct a pivotal study of Ryoncil^® on top of approved second-line therapy in patients with severe SR-aGvHD.
  • This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend Ryoncil's^® label from children to adults with SR-aGvHD, a population approximately three times the size of the pediatric SR-aGvHD population.

Other

Fees to Non-Executive Directors were US$113,942 and salary payments (including short term incentives) to full-time Executive Directors were US$1,067,942, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.³

A copy of the Appendix 4C – Quarterly Cash Flow Report for the first quarter FY2026 is available on the investor page of the company's website www.mesoblast.com.

About Mesoblast

Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast's Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

1. Please see the full Prescribing Information at www.ryoncil.com
2. Coding and coverage decisions are made by payers, and coverage cannot be guaranteed
3. As required by ASX listing rule 4.7 and reported in Item 6 of the Appendix 4C, reported are the aggregated total payments to related parties being Executive Directors and Non-Executive Directors.
   
   

Forward-Looking Statements

This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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