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

10/19/2025 – 07:48 PM

Activity Report for Quarter Ended September 30, 2025 (Appendix 4C)

NEW YORK, Oct. 19, 2025 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a biopharmaceutical company focused on developing allogeneic cellular medicines for inflammatory diseases, today announced its financial results and operational highlights for the first quarter of fiscal year 2026, ending September 30, 2025. The company’s performance is anchored by promising increases in revenue derived from its cell therapy products, particularly Ryoncil, and strategic financial maneuvers aimed at bolstering its cash reserves.

“Ryoncil’s continued revenue growth reflects increasing physician adoption, propelled by the availability of governmental and commercial reimbursements,” stated Dr. Silviu Itescu, CEO of Mesoblast. “The activation of a permanent J-Code by the Centers for Medicare and Medicaid Services (CMS) on October 1, 2025, should catalyze further product uptake by streamlining billing and reimbursement processes.”

Financial Performance & Strategic Liquidity

Mesoblast reported cell therapy revenues of US$20.6 million, surpassing the previous quarter’s US$12.9 million, and marking a tenfold increase Year-over-Year. The primary driver behind this growth was Ryoncil, which saw gross sales rise by 66% to US$21.9 million, and net sales, after a 12.7% gross to net adjustment, climb by 69% to US$19.1 million. That adjustment reflects typical discounts, rebates and allowances common in the biopharma industry. The company has been focusing on streamlining operational expenses, resulting in net operating expenditure decrease to US$14.9 million, compared to the prior quarter.

At the close of the quarter, the company held US$145 million in cash and is actively exploring opportunities to strengthen its financial flexibility. A cornerstone of this strategy involves securing convertible note subscription agreements, potentially unlocking up to US$50.0 million. Subject to shareholder approval, these funds may be utilized to pay down or reduce sums due to secured lenders per existing loan agreements, and to fortify general working capital.

Operational Highlights

Ryoncil, known as remestemcel-L-rknd, holds the distinction of being the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and is currently indicated for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children under 12. The commercial environment for Ryoncil has improved markedly with the activation of a permanent, specific Healthcare Common Procedure Coding System (HCPCS) J-Code, J3402, now live for billing and reimbursement since October 1, 2025.

Formal J-Code recognition by CMS streamlines the billing process, addressing potential roadblocks and facilitating broader patient access to the therapy. Federal Medicaid coverage became mandatory on July 1, 2025, and the company has already onboarded 40 transplant centers. To focus on critical access points, management has prioritized 45 transplant centers across the U.S. market that cater to 80% of U.S. pediatric transplants.

Building on this momentum, the company announced discussions with the FDA to conduct a pivotal trial to extend Ryoncil’s label to include adults with severe SR-aGvHD. Mesoblast aims to collaborate with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN) to advance clinical research in an area where the company believes there remains significant unmet clinical need. In anticipation of extended trials and product offerings, broader coverage for Ryoncil continues to roll out with insurance coverage now spanning over 260 million people spanning commercial and government payers. To assist patients and institutions with insurance coverage, financial assistance, and access programs, assuring that no patient is left unassisted, Mesoblast supports the MyMesoblast™ program by which Ryoncil is available for ordering across the country.

Analyst Perspective

The company’s Q1 2026 results demonstrate solid advancements in commercializing Ryoncil. The permanent J-code for Ryoncil is a crucial reimbursement milestone, paving the way for easier billing and broader adoption. However, questions remain as to the pace of adoption within transplant centers and the magnitude of gross-to-net sales adjustments on revenue growth – investors will be looking for sustained momentum in the coming quarters. The potential expansion of Ryoncil’s label to include adult patients with SR-aGvHD, if successful, could significantly expand the drug’s market opportunity. Also of interest will be how the company utilizes and manages upcoming debt. Mesoblast secured convertible note subscription agreements to issue convertible notes, up to US$50 Million, subject shareholder approval, which at management’s sole discretion, will enable them to reduce the amount owing to its secured lenders under the existing loan agreements and for general working capital.

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.
   Release authorized by the Chief Executive.

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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