Press Releases April 6, 2026

Ryoncil® Continues Successful First Year Launch with Net Sales of US$30.3M in March Quarter

Mesoblast reports strong first-year Ryoncil® sales of US$30.3 million in Q1 2026, nearing US$100 million total revenue since launch

By Nina Shah MESO
Ryoncil® Continues Successful First Year Launch with Net Sales of US$30.3M in March Quarter
MESO

Mesoblast Limited announced that its FDA-approved cell therapy Ryoncil® generated net sales of US$30.3 million in Q1 2026, with strong growth in February and March offsetting January seasonality. Total revenue from Ryoncil® since launch approaches US$100 million, strengthening Mesoblast's balance sheet and supporting ongoing label extension and late-stage development programs. The company will host an inaugural R&D Day to outline growth strategies and pipeline progress.

Key Points

  • Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy, targeting pediatric steroid-refractory acute graft-versus-host disease, with expanding indications in development including adult SR-aGvHD and biologic-resistant inflammatory bowel disease.
  • Strong quarterly sales despite seasonality demonstrate growing market adoption and commercial momentum, benefiting Mesoblast’s financial position and investment capacity.
  • Mesoblast’s proprietary manufacturing process enables industrial-scale, off-the-shelf cell therapies, positioning it as a leader in cellular medicines for inflammatory and other severe diseases.

Strong growth in February/March following January seasonality

Net revenue approaches US$100M since launch

NEW YORK, April 06, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net sales were US$30.3 million for the quarter ended March 31, 2026.1 Strong sales in February and March offset holiday seasonality in January. Revenue generated during this first year of Ryoncil® launch approaches US$100 million.

Ryoncil® revenue strengthens Mesoblast's balance sheet and supports label extension and late-stage blockbuster programs. Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication and is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).2

“Revenue for Ryoncil® continues to be impressive,” said Mesoblast Chief Executive Dr. Silviu Itescu. “We will outline our growth strategy for Ryoncil® as well as our robust late-stage product pipeline at our inaugural R&D event this week.”

Mesoblast will host its inaugural R&D Day on Wednesday, April 8, 2026, in New York City. The event will be webcast live from 8:00am to 11:00am EST and will include presentations from Mesoblast’s senior leadership team and from key opinion leaders.

The webcast can be accessed via: https://webcast.openbriefing.com/msb-inv-2026/

A replay of the webcast will be available shortly after the conclusion of event on 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. The revenues included in this press release are based on management’s initial analysis of operations for the third quarter ended March 31, 2026, and are subject to completion of Mesoblast’s financial closing procedures and audit.
  2. Please see the full Prescribing Information at www.ryoncil.com

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.

Release authorized by the Chief Executive.

For more information, please contact:

Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036   Media – GlobalMedia – AustraliaRubensteinBlueDot MediaCaroline NelsonSteve DabkowskiT: +1 703 489 3037T: +61 419 880 486E:[email protected]:[email protected]



Risks

  • Revenue figures are preliminary and subject to final financial closing and audit, which may affect reported sales amounts.
  • Regulatory and market acceptance risks remain for stem-cell based therapies, potentially impacting commercialization and reimbursement prospects.
  • Competitive pressures and ongoing clinical trial outcomes could affect future approval, market penetration, and stock performance.

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