Successful Commercial Launch of Ryoncil®
Mesoblast (NASDAQ:MESO) reported strong initial results from the commercial launch of Ryoncil®, its FDA-approved mesenchymal stromal cell product for steroid-refractory acute graft-versus-host disease in children. The company achieved $13.2 million in gross revenue from Ryoncil® sales in its first quarter post-launch (March 28 - June 30, 2025).
Key operational highlights include: onboarding of 25+ transplant centers, coverage expansion to over 250 million US lives, and implementation of mandatory state CMS coverage effective July 1. The company maintains a strong cash position of $162 million and secured seven years of orphan-drug exclusivity plus biologic exclusivity through 2036.
Additionally, Mesoblast is advancing its pipeline with ongoing developments in chronic heart failure and chronic low back pain treatments.
Mesoblast (NASDAQ:MESO) ha riportato risultati iniziali positivi dal lancio commerciale di Ryoncil®, il suo prodotto a base di cellule stromali mesenchimali approvato dalla FDA per la malattia da trapianto contro l'ospite acuta refrattaria agli steroidi nei bambini. L'azienda ha raggiunto un fatturato lordo di 13,2 milioni di dollari dalle vendite di Ryoncil® nel primo trimestre dopo il lancio (28 marzo - 30 giugno 2025).
I principali punti operativi includono: l'inserimento di oltre 25 centri trapianti, l'espansione della copertura a più di 250 milioni di persone negli USA e l'attuazione della copertura obbligatoria statale CMS a partire dal 1° luglio. L'azienda mantiene una solida posizione di cassa di 162 milioni di dollari e ha ottenuto sette anni di esclusività come farmaco orfano, oltre all'esclusività biologica fino al 2036.
Inoltre, Mesoblast sta portando avanti il suo portafoglio di prodotti con sviluppi in corso per trattamenti di insufficienza cardiaca cronica e dolore cronico alla parte bassa della schiena.
Mesoblast (NASDAQ:MESO) informó resultados iniciales sólidos tras el lanzamiento comercial de Ryoncil®, su producto de células estromales mesenquimales aprobado por la FDA para la enfermedad de injerto contra huésped aguda refractaria a esteroides en niños. La compañía alcanzó 13,2 millones de dólares en ingresos brutos por ventas de Ryoncil® en su primer trimestre tras el lanzamiento (28 de marzo - 30 de junio de 2025).
Los aspectos operativos clave incluyen: la incorporación de más de 25 centros de trasplante, la expansión de la cobertura a más de 250 millones de personas en EE. UU. y la implementación de la cobertura obligatoria estatal CMS a partir del 1 de julio. La empresa mantiene una sólida posición de efectivo de 162 millones de dólares y aseguró siete años de exclusividad como medicamento huérfano, además de exclusividad biológica hasta 2036.
Además, Mesoblast está avanzando en su cartera con desarrollos en curso para tratamientos de insuficiencia cardíaca crónica y dolor lumbar crónico.
Mesoblast (NASDAQ:MESO)는 FDA 승인 받은 스테로이드 내성 급성 이식편대숙주병 치료제인 Ryoncil®의 상업적 출시 초기 강력한 성과를 보고했습니다. 회사는 출시 후 첫 분기(2025년 3월 28일 ~ 6월 30일) 동안 Ryoncil® 판매로 1,320만 달러의 총수익을 달성했습니다.
주요 운영 성과로는 25개 이상의 이식 센터 온보딩, 미국 내 2억 5천만 명 이상의 보험 적용 확대, 7월 1일부터 시행된 주정부 CMS 의무 보험 적용이 포함됩니다. 회사는 1억 6,200만 달러의 강력한 현금 보유고를 유지하며, 2036년까지 7년간 희귀의약품 독점권과 생물학적 독점권을 확보했습니다.
또한, Mesoblast는 만성 심부전 및 만성 요통 치료제 개발을 지속적으로 진행하고 있습니다.
Mesoblast (NASDAQ:MESO) a annoncé de solides résultats initiaux suite au lancement commercial de Ryoncil®, son produit à base de cellules stromales mésenchymateuses approuvé par la FDA pour la maladie du greffon contre l'hôte aiguë réfractaire aux stéroïdes chez l'enfant. La société a réalisé un chiffre d'affaires brut de 13,2 millions de dollars grâce aux ventes de Ryoncil® lors de son premier trimestre post-lancement (du 28 mars au 30 juin 2025).
Les principaux faits marquants opérationnels incluent : l'intégration de plus de 25 centres de transplantation, une extension de la couverture à plus de 250 millions de personnes aux États-Unis et la mise en place d'une couverture CMS obligatoire au niveau des états à partir du 1er juillet. La société dispose d'une solide trésorerie de 162 millions de dollars et bénéficie d'une exclusivité médicament orphelin de sept ans ainsi que d'une exclusivité biologique jusqu'en 2036.
Par ailleurs, Mesoblast fait progresser son portefeuille avec des développements en cours pour des traitements de l'insuffisance cardiaque chronique et des douleurs lombaires chroniques.
Mesoblast (NASDAQ:MESO) meldete starke erste Ergebnisse aus der kommerziellen Einführung von Ryoncil®, seinem von der FDA zugelassenen mesenchymalen Stromazellprodukt für steroidrefraktäre akute Graft-versus-Host-Erkrankung bei Kindern. Das Unternehmen erzielte im ersten Quartal nach dem Start (28. März - 30. Juni 2025) einen Bruttoumsatz von 13,2 Millionen US-Dollar durch Ryoncil®-Verkäufe.
Wichtige operative Highlights umfassen: die Einbindung von mehr als 25 Transplantationszentren, die Erweiterung der Abdeckung auf über 250 Millionen US-Bürger sowie die Umsetzung der verpflichtenden staatlichen CMS-Abdeckung ab dem 1. Juli. Das Unternehmen hält eine starke Barposition von 162 Millionen US-Dollar und sicherte sich sieben Jahre Orphan-Drug-Exklusivität sowie biologische Exklusivität bis 2036.
Darüber hinaus treibt Mesoblast seine Pipeline mit laufenden Entwicklungen bei Behandlungen für chronische Herzinsuffizienz und chronische Rückenschmerzen voran.
- Generated $13.2M revenue from Ryoncil® in first quarter post-launch
- Strong market position with 7-year orphan drug exclusivity and biologic exclusivity through 2036
- Coverage expanded to over 250M US lives with mandatory state CMS coverage
- Robust cash position of $162M as of June 30, 2025
- Successfully onboarded 25+ transplant centers, targeting 80% of US pediatric transplants
- Net operating cash spend of $16.6M for the quarter exceeds product revenue
- Still pending onboarding of remaining major transplant centers
- Executive compensation reductions indicate cost management concerns
Insights
Mesoblast reports strong $13.2M first-quarter Ryoncil sales with expanding coverage and exclusivity protections through 2044.
Mesoblast's first-quarter commercial performance for Ryoncil® shows promising market traction with
The company has secured critical reimbursement infrastructure with coverage reaching over 250 million US lives through commercial and government payers. The July 1 milestone of mandatory Medicaid coverage across all states removes a significant market access barrier, likely accelerating Q3 adoption. Their established MyMesoblast™ patient access hub addresses remaining reimbursement hurdles.
Ryoncil enjoys substantial market protection through three complementary exclusivity mechanisms: 7-year orphan drug exclusivity, biologic reference exclusivity until 2036, and patent protection through 2044. This comprehensive barrier to competition provides an extended runway for market development.
With
Activity Report for Quarter Ended June 30, 2025 (Appendix 4C)
NEW YORK, July 17, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced gross revenue from sales of Ryoncil® (remestemcel-L-rknd) through the first quarter post product launch.
Ryoncil® is the first and only FDA approved mesenchymal stromal cell (MSC) product in the Unites States and became commercially available for purchase on March 28, 2025, within one quarter of receiving FDA approval for treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children.
Mesoblast Chief Executive Dr. Silviu Itescu said, “We are pleased with the commercial launch activities of Ryoncil® in the first quarter post-launch and look forward to updating on the current quarter's progress now that mandatory state CMS coverage has become effective as of July 1, and we complete onboarding of the remaining major U.S. transplant centers.”
FINANCIAL HIGHLIGHTS FOR QUARTER ENDED JUNE 30, 2025
- US
$13.2 million gross revenue (unaudited) from sales of Ryoncil® post-launch March 28 through to June 30.1 - US
$1.6 million revenue from royalties on sales of TEMCELL® HS Inj.2 sold in Japan by our licensee. - US
$16.6 million net operating cash spend for the quarter. - US
$162 million (A$247 million )3 cash on hand at June 30, 2025.
OPERATIONAL HIGHLIGHTS FOR RYONCIL® IN SR-aGvHD
- Mesoblast has onboarded more than 25 transplant centers since product launch and expects during this quarter to complete the onboarding process across all 45 priority transplant centers that account for approximately
80% of U.S. pediatric transplants. - Coverage for Ryoncil® continues to expand with over 250 million US lives insured by commercial and government payers. Federal Medicaid coverage by Centers for Medicare and Medicaid (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.
- During the quarter, Ryoncil® received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for treatment of SR-aGvHD in pediatric patients 2 months of age and older. This period of statutory exclusivity means that the FDA will not approve another MSC product for this indication during the 7-year period from the approval of Ryoncil®.
- Separately, Mesoblast has biologic exclusivity preventing another sponsor from referencing the Ryoncil® biologic license application (BLA) until December 2036, twelve years from its first approval which would prevent market entry by a biosimilar.
- These statutory exclusivities are in addition to Mesoblast’s strong U.S. intellectual property position on MSC composition of matter, manufacturing and indications, including SR-aGvHD, that provide a commercial barrier to entry against competitors through 2044.
- In July, Mesoblast held a Type B meeting with FDA for Ryoncil® to discuss a pivotal trial in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product’s label from children to adults with SR-aGvHD. Meeting minutes are expected in the coming weeks.
OPERATIONAL HIGHLIGHTS FOR REXLEMESTROCEL IN CHRONIC INFLAMMATORY HEART FAILURE AND LOW BACK PAIN
- Mesoblast met with FDA in June in follow-up to the successful Type B meeting in early 2024 where FDA stated that the results of the presented studies with Revascor® in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation could support accelerated approval under the existing Regenerative Medicine Advanced Therapy (RMAT) designation for end-stage HFrEF patients with a left ventricular assist device (LVAD),
- Mesoblast and FDA are aligned on items required for filing a biologics license application (BLA) for Revascor® regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.
- The 300-patient randomized controlled confirmatory Phase 3 trial of Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product candidate rexlemestrocel-L is actively enrolling in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease (DDD) of less than five years duration at multiple sites across the U.S.
Other
Fees to Non-Executive Directors were US
A copy of the Appendix 4C – Quarterly Cash Flow Report for the fourth quarter FY2025 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) 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
- Includes initial inventory purchases by our distributor.
- TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.
- Translated at 1A$:0.655US$ being the June 30, 2025 rate as reported by the Reserve Bank of Australia.
- 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.
Release authorized by the Chief Executive.
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| Media – Global | |
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| Emma Neal | |
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| E: emma.neal@allisonworldwide.com | |
| Media – Australia | |
| BlueDot Media | |
| Steve Dabkowski | |
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| E: steve@bluedot.net.au |
FAQ
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