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Mesoblast (NASDAQ: MESO) Ryoncil sales hit US$30.3M, near US$100M first-year mark

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6-K

Rhea-AI Filing Summary

Mesoblast Limited reports that Ryoncil® (remestemcel-L-rknd) generated net sales of US$30.3 million for the quarter ended March 31, 2026, marking a strong finish to Ryoncil’s first year on the market. February and March sales offset weaker, holiday-affected demand in January, and total Ryoncil® revenue since launch now approaches US$100 million, helping to strengthen the company’s balance sheet and fund label extension and late-stage programs.

Ryoncil® is described as the first mesenchymal stromal cell therapy approved by the U.S. FDA for any indication and the only FDA-approved treatment for children under 12 with steroid-refractory acute graft-versus-host disease. Mesoblast will present its Ryoncil® growth strategy and late-stage pipeline at an inaugural R&D Day in New York on April 8, 2026, alongside updates on its broader allogeneic cell therapy portfolio.

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Insights

Ryoncil’s first-year sales near US$100M, backing Mesoblast’s cell-therapy strategy.

Mesoblast highlights Ryoncil® net sales of US$30.3 million for the quarter ended March 31, 2026, with total launch revenue approaching US$100 million. This shows early commercial traction for a first-in-class mesenchymal stromal cell therapy in pediatric steroid-refractory acute graft-versus-host disease.

Management frames this revenue as strengthening the balance sheet and funding label extensions and late-stage programs, including additional inflammatory indications and rexlemestrocel-L for heart failure and chronic low back pain. The company also emphasizes more than 1,000 patents with protection into at least 2044, supporting long-term exclusivity.

The planned R&D Day on April 8, 2026 is positioned to outline the growth strategy for Ryoncil® and the broader pipeline. Subsequent disclosures will clarify how recurring Ryoncil® revenue, new indications, and partnerships in regions such as Japan, Europe and China translate into sustainable cash flows and commercialization scale.

Ryoncil net sales US$30.3 million Quarter ended March 31, 2026
Ryoncil revenue since launch Approaches US$100 million First year of product launch
R&D Day timing 8:00am–11:00am EST Inaugural R&D Day on April 8, 2026
Patent portfolio size Over 1,000 patents/applications Global IP covering MSC compositions, manufacturing, indications
IP protection horizon Through at least 2044 Commercial protection in major markets
steroid-refractory acute graft-versus-host disease medical
"Ryoncil® ... for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients"
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.
mesenchymal stromal cell medical
"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.
allogeneic cellular medicines medical
"a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions"
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.
remestemcel-L-rknd medical
"Ryoncil® (remestemcel-L-rknd) net sales were US$30.3 million"
rexlemestrocel-L medical
"Rexlemestrocel-L is being developed for heart failure and chronic low back pain"
forward-looking statements regulatory
"This press release includes forward-looking statements that relate to future events or our future financial performance"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Form 6-K: How Foreign Companies Report to the SEC →

UNITED STATES
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
For the month of April 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)

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 April 7, 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/ Niva Sivakumar
Niva Sivakumar
Company Secretary
Dated: April 8, 2026


INDEX TO EXHIBITS
Item
 99.1
Press release of Mesoblast Ltd, dated April 7, 2026.




RYONCIL® CONTINUES SUCCESSFUL FIRST YEAR LAUNCH WITH NET SALES OF US$30.3M IN MARCH QUARTER Strong growth in February/March following January seasonality Net revenue approaches US$100M since launch New York, USA: April 6 and Melbourne, Australia: April 7, 2026: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), 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. Exhibit 99.1

 

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 – 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

 

Source: View Original Filing on SEC EDGAR

FAQ

What Ryoncil sales did Mesoblast (MESO) report for the March 31, 2026 quarter?

Mesoblast reported Ryoncil net sales of US$30.3 million for the quarter ended March 31, 2026. Strong February and March sales offset January seasonality, contributing meaningfully to the therapy’s first-year commercial performance and supporting the company’s late-stage development programs.

How much revenue has Ryoncil generated since launch for Mesoblast (MESO)?

Mesoblast states that Ryoncil revenue during its first year on the market approaches US$100 million. This early revenue base helps strengthen the company’s balance sheet and underpins funding for label extensions and other late-stage allogeneic cell therapy programs in inflammatory diseases.

What indication is Ryoncil approved for according to Mesoblast’s 6-K filing?

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. It is indicated for pediatric patients two months and older, addressing a severe complication of stem cell transplantation.

What is Mesoblast’s upcoming R&D Day mentioned in the April 2026 6-K?

Mesoblast will host an inaugural R&D Day on April 8, 2026, in New York City, webcast from 8:00am to 11:00am EST. Management plans to outline Ryoncil’s growth strategy and detail its late-stage pipeline, with a replay available on the company’s website after the event.

What pipeline therapies beyond Ryoncil does Mesoblast (MESO) highlight?

Mesoblast highlights additional cell therapies based on its remestemcel-L and rexlemestrocel-L platforms. Ryoncil is being developed for adult SR-aGvHD and biologic-resistant inflammatory bowel disease, while rexlemestrocel-L targets conditions such as heart failure and chronic low back pain.

How strong is Mesoblast’s intellectual property position according to this report?

Mesoblast reports a global portfolio of over 1,000 patents and patent applications. These cover mesenchymal stromal cell compositions, manufacturing methods and indications, with commercial protection extending through at least 2044 across major markets, supporting long-term exclusivity for its cell therapies.

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