Mesoblast (MESO) reports US$115M first full-year Ryoncil sales and strong Q4
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
Mesoblast Limited reported preliminary net revenue from Ryoncil® (remestemcel-L-rknd) of US$36 million for the fourth quarter and US$115 million for the first full year ended June 30, 2026. Management highlights strong uptake since launch and states that revenues have already exceeded initial projections.
The company expects continued revenue growth in the coming fiscal year, citing momentum across major U.S. pediatric centers, and describes its capital position as strong with operational activities well funded through revenue growth and a new five-year facility. Ryoncil® is described as the first FDA-approved mesenchymal stromal cell therapy and the only approved product for children under 12 with steroid-refractory acute graft-versus-host disease. The revenue figures are based on preliminary estimates and remain subject to customary year-end closing and audit procedures.
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Insights
Ryoncil® is generating meaningful early revenue, but figures are preliminary and wider profitability is not disclosed.
Mesoblast reports preliminary Ryoncil® net revenue of US$36 million for the fourth quarter and US$115 million for its first full commercial year to June 30, 2026. Management states that uptake has exceeded its initial projections and that momentum is strong across major U.S. pediatric centers.
The company describes its capital position as strong, with operational activities well funded through revenue growth and a new five-year facility, suggesting current operations are supported without detailing full income statement or cash flow metrics. Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy and currently the only option for children under 12 with steroid-refractory acute graft-versus-host disease, which may support continued demand.
Management also outlines a broader pipeline, including Ryoncil® label extensions and rexlemestrocel-L for heart failure and chronic low back pain, underpinned by over 1,000 granted patents or applications with protection extending to at least 2044 in major markets. The company notes these revenue numbers are preliminary and subject to completion of year-end closing and audit procedures, so finalized figures will follow in subsequent financial reporting.
Key Figures
Ryoncil Q4 net revenue: US$36 million
Ryoncil full-year net revenue: US$115 million
Intellectual property assets: Over 1,000 patents or patent applications
+2 more
5 metrics
Ryoncil Q4 net revenue
US$36 million
Net revenue for the fourth quarter ended June 30, 2026
Ryoncil full-year net revenue
US$115 million
Net revenue for the full year ended June 30, 2026
Intellectual property assets
Over 1,000 patents or patent applications
Global IP portfolio covering MSC compositions, manufacturing and indications
Pediatric age range
Children under age 12; patients 2 months and older
Ryoncil indication for pediatric SR-aGvHD
IP protection horizon
Through to at least 2044
Commercial protection in major markets from Mesoblast’s patent portfolio
Key Terms
allogeneic cellular medicines, mesenchymal stromal cell, steroid-refractory acute graft-versus-host disease, remestemcel-L-rknd, +1 more
5 terms
allogeneic cellular medicines medical
"Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines"
Allogeneic cellular medicines are treatments made from living cells that are donated by one person and used to treat another. They function like biological patches or replacements, helping the body repair or fight disease. For investors, these medicines represent a promising area of healthcare innovation with the potential for widespread use, as they can be produced in large quantities and stored for off-the-shelf availability.
mesenchymal stromal cell medical
"Ryoncil is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration"
Mesenchymal stromal cells are a type of adult cell found in bone marrow, fat and other tissues that can act like a repair crew, supporting tissue healing, reducing inflammation and helping other cells grow. Investors care because these cells are the basis for many experimental therapies and diagnostics; clinical success, manufacturing scale-up, safety and regulatory approval determine commercial potential and can strongly affect a company’s valuation.
steroid-refractory acute graft-versus-host disease medical
"only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease"
A severe condition that can follow a stem cell or bone marrow transplant in which the donor immune cells attack the patient’s organs and tissues; “steroid-refractory” means it does not improve after standard steroid treatment. Investors pay attention because it represents an urgent unmet medical need that drives demand for new drugs, influences clinical trial success and regulatory approvals, and can materially affect the commercial prospects and valuation of companies developing effective therapies — like a fire that the usual extinguisher cannot put out.
remestemcel-L-rknd medical
"Ryoncil (remestemcel-L-rknd) net revenue of US$36 million for the quarter"
rexlemestrocel-L medical
"Rexlemestrocel-L is being developed for heart failure and chronic low back pain"
FAQ
What net revenue did Mesoblast (MESO) report from Ryoncil for Q4 2026?
Mesoblast reported preliminary Ryoncil® net revenue of US$36 million for the fourth quarter ended June 30, 2026. Management attributes this to strong uptake across major U.S. pediatric centers and says revenues have exceeded its initial projections.
What is Mesoblast’s first full-year Ryoncil revenue disclosed in this 6-K?
For the full year ended June 30, 2026, Mesoblast reported preliminary Ryoncil® net revenue of US$115 million. The company describes this as reflecting strong post-launch uptake and notes the figures are based on management estimates pending year-end closing and audit.
What indication is Ryoncil approved for according to Mesoblast’s July 2026 update?
Ryoncil® is described as the only FDA-approved product for children under 12 with steroid-refractory acute graft-versus-host disease. It is also noted as the first mesenchymal stromal cell therapy approved by the U.S. Food and Drug Administration for any indication.
How does Mesoblast (MESO) characterize its capital position in this report?
Mesoblast states that its capital position is strong, with operational activities described as well funded through revenue growth. It also notes a new five-year facility, which management says has freed up label extension and blockbuster products for strategic initiatives.
What are Mesoblast’s future development plans mentioned in the July 2026 6-K?
Mesoblast plans additional Ryoncil® indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, and is developing rexlemestrocel-L for heart failure and chronic low back pain, supported by a broad mesenchymal stromal cell technology platform.
How extensive is Mesoblast’s intellectual property portfolio as described here?
Mesoblast reports having over 1,000 granted patents or patent applications covering its mesenchymal stromal cell technologies. It states that this portfolio provides commercial protection extending through to at least 2044 in all major markets.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934
Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934
For the month of July 2026
Commission File Number 001-37626
Mesoblast Limited
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of Registrant’s name into English)
Australia
(Jurisdiction of incorporation or organization)
(Jurisdiction of incorporation or organization)
Silviu Itescu
Chief Executive Officer and Executive Director
Level 38
55 Collins Street
Melbourne 3000
Australia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:
Form 20-F ☑ Form 40-F ☐
INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K
On July 10, 2026, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.1, and is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly organized.
Mesoblast Limited | ||||||||||||||
| /s/ Paul Hughes | ||||||||||||||
| Paul Hughes | ||||||||||||||
| Company Secretary | ||||||||||||||
Dated: July 10, 2026
INDEX TO EXHIBITS
| Item | ||||||||
99.1 | Press release of Mesoblast Ltd, dated July 10, 2026. | |||||||
RYONCIL® DELIVERS NET REVENUE OF US$36M FOR THE FOURTH QUARTER ENDED 30 JUNE 2026 Continued Growth Underpins First Full Year Net Revenue of US$115M New York, USA: July 9 and Melbourne, Australia: July 10, 2026: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net revenue of US$36 million for the quarter and US$115 million for the full year ended June 30, 2026. “We are very pleased with the strong uptake of Ryoncil® since launch, and with revenues that have already exceeded our initial projections,” said Mesoblast Chief Executive Dr. Silviu Itescu. Dr. Itescu added: “We anticipate continued revenue growth in the coming fiscal year in line with momentum we are seeing across major U.S. pediatric centers. Our capital position is strong, operational activities are well funded through revenue growth, and the new five-year facility has freed up our label extension and blockbuster products for strategic initiatives.” 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).1 The results presented herein are based on management’s preliminary estimates and remain subject to completion of customary year end closing and audit procedures. 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. Exhibit 99.1
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 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 – Global Media – Australia Rubenstein BlueDot Media Caroline Nelson Steve Dabkowski T: +1 703 489 3037 T: +61 419 880 486 E: cnelson@rubenstein.com E: steve@bluedot.net.au