Banner Year for Mesoblast With First FDA Product Approval and Successful Commercial Launch of 搁测辞苍肠颈濒庐
Mesoblast (NASDAQ:MESO) reported significant achievements for FY2025, highlighted by the FDA approval and successful launch of 搁测辞苍肠颈濒庐, the first FDA-approved MSC therapy in the US for steroid-refractory acute graft-versus-host disease in pediatric patients. The company reported product revenue of $17.2 million, up 191% year-over-year, with 搁测辞苍肠颈濒庐 contributing $11.3 million in net sales in its first quarter of launch.
Financial position remains strong with $162 million cash on hand. The company expanded market coverage to over 250 million US lives and onboarded 32 transplant centers. Net loss for FY2025 was $102.1 million, compared to $88.0 million in FY2024. The company is pursuing label extensions for 搁测辞苍肠颈濒庐 in adults with SR-aGvHD and inflammatory bowel disease, while advancing its pipeline including Revascor庐 for heart failure and Rexlemestrocel-L for chronic low back pain.
Mesoblast (NASDAQ:MESO) ha annunciato risultati rilevanti per l鈥檈sercizio 2025, con il punto focale sull鈥檃pprovazione FDA e il lancio riuscito di 搁测辞苍肠颈濒庐, la prima terapia a base di cellule MSC autorizzata negli USA per la malattia da trapianto contro l鈥檕spite acuta resistente agli steroidi nei pazienti pediatrici. L鈥檃zienda ha riportato ricavi da prodotti per 17,2 milioni di dollari, in aumento del 191% rispetto all鈥檃nno precedente; 搁测辞苍肠颈濒庐 ha generato 11,3 milioni di dollari di vendite nette nel suo primo trimestre di commercializzazione.
La posizione finanziaria resta solida con 162 milioni di dollari in cassa. La copertura di mercato 猫 stata estesa a oltre 250 milioni di persone negli USA e sono stati attivati 32 centri trapianto. La perdita netta per l鈥檈sercizio 2025 猫 stata di 102,1 milioni di dollari, rispetto a 88,0 milioni nell鈥檈sercizio 2024. L鈥檃zienda sta cercando di estendere l鈥檌ndicazione di 搁测辞苍肠颈濒庐 agli adulti con SR-aGvHD e alla malattia infiammatoria intestinale, mentre prosegue lo sviluppo del portafoglio, inclusi Revascor庐 per l鈥檌nsufficienza cardiaca e Rexlemestrocel-L per il mal di schiena cronico.
Mesoblast (NASDAQ:MESO) inform贸 logros destacados en el a帽o fiscal 2025, encabezados por la aprobaci贸n de la FDA y el exitoso lanzamiento de 搁测辞苍肠颈濒庐, la primera terapia con MSC aprobada por la FDA en EE. UU. para la enfermedad injerto contra hu茅sped aguda resistente a esteroides en pacientes pedi谩tricos. La compa帽铆a registr贸 ingresos por productos de 17,2 millones de d贸lares, un aumento del 191% interanual; 搁测辞苍肠颈濒庐 aport贸 11,3 millones de d贸lares en ventas netas en su primer trimestre comercial.
La posici贸n financiera se mantiene s贸lida con 162 millones de d贸lares en efectivo. La cobertura de mercado se ampli贸 a m谩s de 250 millones de personas en EE. UU. y se incorporaron 32 centros de trasplante. La p茅rdida neta del a帽o fiscal 2025 fue de 102,1 millones de d贸lares, frente a 88,0 millones en 2024. La compa帽铆a busca ampliar la indicaci贸n de 搁测辞苍肠颈濒庐 a adultos con SR-aGvHD y a la enfermedad inflamatoria intestinal, mientras avanza en su cartera, incluyendo Revascor庐 para insuficiencia card铆aca y Rexlemestrocel-L para dolor lumbar cr贸nico.
Mesoblast (NASDAQ:MESO)電� 2025 須岅硠鞐半弰鞐� 欤检殧 靹标臣毳� 氤搓碃頄堨姷雼堧嫟. FDA 鞀轨澑瓿� 靹标车鞝侅澑 於滌嫓搿� 欤茧氚涭潃 搁测辞苍肠颈濒庐鞚� 靻岇晞 鞀ろ厡搿滌澊霌�-鞝�頃劚 旮夓劚 鞚挫嫕韼鸽寑 靾欖＜氤�(SR-aGvHD)鞐� 雽�頃� 氙戈淡鞐愳劀 鞀轨澑霅� 斓滌磮鞚� MSC 旃橂鞝滌瀰雼堧嫟. 須岇偓電� 鞝滍拡 毵れ稖 1,720毵� 雼煬毳� 旮半頃橂┌ 鞝勲厔 雽�牍� 191% 歃濌皜頄堨溂氅�, 搁测辞苍肠颈濒庐鞚� 於滌嫓 觳� 攵勱赴鞐� 1,130毵� 雼煬鞚� 靾滊Г於�鞚� 彀届稖頄堨姷雼堧嫟.
順勱笀靹� 鞛愳偘鞚� 1鞏�6,200毵� 雼煬搿� 鞛 靸來儨電� 瓴碃頃╇媹雼�. 氙戈淡鞐愳劀鞚� 鞝侅毄 雽�靸� 鞚戈惮毳� 2鞏�5觳滊 氇� 鞚挫儊鞙茧 頇曤寑頄堦碃, 32臧� 鞚挫嫕 靹柬劙毳� 鞓炒霐╉枅鞀惦媹雼�. 2025 須岅硠鞐半弰 靾滌啇鞁れ潃 1鞏�210毵� 雼煬搿� 2024雲勳潣 8,800毵� 雼煬鞐� 牍勴暣 旎胳姷雼堧嫟. 須岇偓電� 搁测辞苍肠颈濒庐鞚� 鞝侅潙歃濎潉 靹膘澑 SR-aGvHD 氚� 鞐检靹� 鞛レ頇橃溂搿� 頇曤寑頃橂姅 鞛戩梾鞚� 歆勴枆 欷戩澊氅�, 鞁秬鞝� 旃橂鞝� Revascor庐鞕� 毵岇劚 鞖旐喌 旃橂鞝� Rexlemestrocel-L 霌� 韺岇澊頂勲澕鞚鸽弰 瓿勳啀 臧滊皽頃橁碃 鞛堨姷雼堧嫟.
Mesoblast (NASDAQ:MESO) a annonc茅 des r茅sultats marquants pour l鈥檈xercice 2025, mis en lumi猫re par l鈥檃pprobation par la FDA et le lancement r茅ussi de 搁测辞苍肠颈濒庐, la premi猫re th茅rapie 脿 base de cellules MSC approuv茅e aux 脡tats鈥慤nis pour la maladie du greffon contre l鈥檋么te aigu毛 r茅sistante aux cortico茂des chez les patients p茅diatriques. La soci茅t茅 a d茅clar茅 des revenus produits de 17,2 millions de dollars, en hausse de 191 % sur un an ; 搁测辞苍肠颈濒庐 a apport茅 11,3 millions de dollars de ventes nettes lors de son premier trimestre de commercialisation.
La situation financi猫re reste solide avec 162 millions de dollars de tr茅sorerie. La couverture du march茅 a 茅t茅 茅tendue 脿 plus de 250 millions de personnes aux 脡tats鈥慤nis et 32 centres de transplantation ont 茅t茅 int茅gr茅s. La perte nette pour l鈥檈xercice 2025 s鈥櫭﹍猫ve 脿 102,1 millions de dollars, contre 88,0 millions en 2024. La soci茅t茅 cherche 脿 茅tendre l鈥檌ndication de 搁测辞苍肠颈濒庐 aux adultes atteints de SR鈥慳GvHD et de maladies inflammatoires de l鈥檌ntestin, tout en faisant progresser sa pipeline, notamment Revascor庐 pour l鈥檌nsuffisance cardiaque et Rexlemestrocel鈥慙 pour le mal de dos chronique.
Mesoblast (NASDAQ:MESO) meldete f眉r das Gesch盲ftsjahr 2025 bedeutende Erfolge, allen voran die FDA-Zulassung und den erfolgreichen Markteintritt von 搁测辞苍肠颈濒庐, der ersten von der FDA zugelassenen MSC-Therapie in den USA f眉r steroidrefrakt盲re akute Graft-versus-Host-Erkrankung bei p盲diatrischen Patienten. Das Unternehmen erzielte Produktums盲tze in H枚he von 17,2 Millionen US-Dollar, ein Plus von 191 % gegen眉ber dem Vorjahr; 搁测辞苍肠颈濒庐 trug im ersten Vertriebsquartal 11,3 Millionen US-Dollar Nettoumsatz bei.
Die Finanzlage bleibt mit 162 Millionen US-Dollar Barmitteln solide. Die Marktabdeckung wurde auf 眉ber 250 Millionen Menschen in den USA ausgeweitet und 32 Transplantationszentren wurden angebunden. Der Nettoverlust f眉r FY2025 belief sich auf 102,1 Millionen US-Dollar gegen眉ber 88,0 Millionen im Gesch盲ftsjahr 2024. Das Unternehmen verfolgt Zulassungserweiterungen f眉r 搁测辞苍肠颈濒庐 bei Erwachsenen mit SR-aGvHD sowie bei entz眉ndlichen Darmerkrankungen und treibt die Pipeline voran, darunter Revascor庐 f眉r Herzinsuffizienz und Rexlemestrocel-L f眉r chronische R眉ckenschmerzen.
- First FDA approval achieved with 搁测辞苍肠颈濒庐 launch generating $11.3M net sales in first quarter
- Revenue from cell therapy products up 191% to $17.2M year-over-year
- Strong cash position of $162M to support commercial expansion
- Coverage expanded to over 250 million US lives with mandatory Medicaid coverage
- Seven years of orphan-drug exclusivity and biologic exclusivity through 2036 for 搁测辞苍肠颈濒庐
- Pipeline advancement in multiple billion-dollar market opportunities
- Net loss increased to $102.1M from $88.0M in previous year
- Selling, General & Administrative expenses increased by $14.3M due to commercial team build
- Loss of $14.9M recognized from contingent consideration revaluation
- Finance costs of $23.0M including $17.7M in non-cash expenditure
Insights
Mesoblast's FDA approval and launch of Ryoncil drove 191% revenue growth to $17.2M with strong pipeline potential across multiple billion-dollar markets.
Mesoblast has achieved a transformative milestone with the FDA approval and successful launch of 搁测辞苍肠颈濒庐 (remestemcel-L-rknd), marking the first and only FDA-approved mesenchymal stromal cell (MSC) therapy in the United States for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients.
The commercial performance is noteworthy, with total product revenues reaching $17.2 million, representing a 191% year-over-year increase. The final quarter launch of 搁测辞苍肠颈濒庐 generated $13.2 million in gross sales and $11.3 million in net sales after adjustments. This rapid uptake is supported by expanding insurance coverage for over 250 million US lives and onboarding of 32 transplant centers with plans to reach 45 centers covering 80% of pediatric bone marrow transplants.
Despite the commercial progress, the company reported a net loss of $102.1 million for FY2025, compared to $88.0 million in FY2024. This reflects increased expenditures on commercial infrastructure, with SG&A expenses rising by $14.3 million to support the product launch. The company maintains a strong cash position of $162 million, which should provide runway for continued commercialization efforts.
Mesoblast's growth strategy focuses on multiple avenues: (1) label expansion for 搁测辞苍肠颈濒庐 into adults with SR-aGvHD (a market three times larger than the pediatric population); (2) expansion into inflammatory bowel disease with a planned pivotal study; (3) advancing Revascor庐 for heart failure with potential accelerated FDA approval; and (4) completing a Phase 3 trial for rexlemestrocel-L in chronic low back pain.
The company has secured seven years of orphan-drug exclusivity for 搁测辞苍肠颈濒庐 plus biologic exclusivity until 2036 and patent protection through 2044, creating substantial barriers to competition. With addressable markets estimated at $1 billion for SR-aGvHD, $5+ billion for inflammatory bowel disease, and $10+ billion each for heart failure and chronic back pain, Mesoblast is positioning its pipeline to target indications with significant commercial potential.
Financial Results and Operational Update for the Full Year Ended June 30, 2025
NEW YORK, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended June 30, 2025.
Mesoblast Chief Executive Dr. Silviu Itescu said, 鈥淭his has been a banner year for the Company, with achievement of FDA approval for Ryoncil庐, the first and only FDA mesenchymal stromal cell (MSC) product in the United States and a successful commercial launch of the product for treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients aged 2 months and older (鈥渃hildren鈥�).鈥�
鈥漌e are working tirelessly to transform Mesoblast into a fast-paced commercial biotechnology company with demonstrable sales of our first commercial product Ryoncil庐. We intend to deliver additional approved indications for sales of Ryoncil庐 and to launch a next-generation platform technology into potential blockbuster indications including heart failure and chronic low back pain.鈥�
FINANCIAL AND CORPORATE HIGHLIGHTS FOR THE YEAR ENDED JUNE 30, 2025
- Revenue from cell therapy products was US
$17.2 million , up191% on prior year.
- Revenue growth was driven by successful launch of Ryoncil庐 in the final quarter, with US
$13.2 million gross sales and US$11.3 million in reported net sales after14.6% gross to net adjustment.
- Net operating cash spend was US
$50.0 million , a3% increase on prior year, inclusive of costs related to commercial team build and product launch.
- Cash on hand at June 30, 2025, was US
$162 million (A$247 million )1.
- Mesoblast was added to the S&P Dow Jones Indices鈥� S&P/ASX 200 Index effective March 6, 2025, on the Australian Stock Exchange (ASX), and to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the annual reconstitution of the 2024 Nasdaq index December 23, 2024.
- Board of Directors was strengthened with appointments of Dr. Gregory George MD PhD and Ms Lyn Cobley.
INVESTMENT HIGHLIGHTS
Mission
Mesoblast is committed to bring to market innovative off-the-shelf allogeneic cellular medicines to treat serious and life-threatening inflammatory illnesses.
Product Portfolio
- Ryoncil庐 the only FDA-approved MSC therapy for any indication; lifesaving for pediatric SR-aGvHD.
- Revascor庐 has potential for FDA accelerated approval in end-stage HFrEF.
- Rexlemestrocel-L in Phase 3 trial for potential approval in CLBP.
- Additional pipeline therapies targeting unmet medical needs.
Market Opportunity
- Steroid-refractory acute GvHD ~
$1 billion annual addressable market for children & adults. - Biologic-refractory inflammatory bowel disease听>US
$5 billion . - Heart failure with reduced ejection fraction (HFrEF) >
$10 billion addressable market. - Chronic low back pain (CLBP) >
$10 billion addressable market. - Additional potential multi-billion-dollar opportunities from existing and future product pipeline based on existing technology platforms.
Competitive Advantage
- Proven scientific approach, with deep understanding of mechanism of action (MOA).
- Robust and extensive intellectual property.
- Extensive positive clinical trial results across multiple indications.
- Demonstrated ability to meet regulatory requirements of FDA.
- Scalability of manufacturing processes and proprietary next generation technology.
Financials and Projections
- Strong balance sheet to support Ryoncil庐 launch and product portfolio.
- Current revenue streams anticipated to expand based on Ryoncil庐 performance.
- Continued prudent cash management strategy.
- Long-term revenue potential from the existing and future pipeline.
Upcoming Milestones
- Commence Ryoncil庐 registration trial for label expansion in adults with severe SR-aGvHD.
- Commence Ryoncil庐 registration trial for label expansion in adults and children with inflammatory colitis.
- Revascor庐 BLA submission for accelerated approval.
- Rexlemestrocel-L CLBP Phase 3 completion and BLA submission.
- Expansion into new indications and markets.
OPERATIONAL HIGHLIGHTS
Ryoncil庐 (remestemcel-L-rknd) for Steroid-Refractory Acute Graft Versus Host Disease (SR-aGvHD) in Children
In December 2024, Ryoncil庐听became听the first and only Food and Drug Administration (FDA) 听mesenchymal stromal cell (MSC) product in the Unites States. Ryoncil庐 became commercially available for purchase on March 28, 2025,听within one quarter of receiving FDA approval听for treatment of SR-aGvHD in children.
Coverage for Ryoncil庐 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庐 became effective July 1, 2025 in all US states.
To date, we have onboarded 32 transplant centers and aim to have onboarded by the end of this quarter the top 45 centers that account for
Assistance to Patients with SR-aGvHD and their Caregivers for Access to Ryoncil庐听
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鈩�, where Ryoncil庐 is available for ordering. Additional information is available on ryoncil.com, where valuable resources for healthcare providers, patients and caregivers can be found.
Ryoncil庐听Lifecycle Extension in Adults with Severe SR-aGvHD
Most of the sites already onboarded for use of Ryoncil庐 in children with SR-aGvHD also perform adult bone marrow transplants. We have an active compassionate care program to provide Ryoncil庐 to adults with SR-aGvHD who have failed other therapies.
Adults with severe SR-aGvHD have a high rate of non-responsiveness to second-line agents such as ruxolitinib. Survival in those with SR-aGvHD who have failed at least one additional agent, such as ruxolitinib, remains as low as 20
Mesoblast recently met with FDA to discuss a pivotal trial for Ryoncil庐 in adults with severe SR-aGvHD. Given the continued unmet need in adults with severe SR-aGvHD, Mesoblast intends to conduct a pivotal study of Ryoncil庐 on top of approved second-line therapy in patients with severe SR-aGvHD.
This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend Ryoncil鈥檚庐 label from children to adults with SR-aGvHD, a population approximately three times the size of the pediatric SR-aGvHD population.
Ryoncil庐 Lifecycle Extension in Inflammatory Diseases
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn鈥檚 disease (CD) remains a major unmet need across the adult and pediatric population where early and durable remission remains especially challenging.
According to recent estimates, more than three million people (
A recent pilot study in adults with inflammatory colitis demonstrated positive outcomes (rapid mucosal healing and disease remission) in biologic refractory patients receiving Ryoncil庐 by direct endoscopic injection to areas of inflammation.9,10 This extends earlier Mesoblast data showing that intravenously delivered remestemcel-L can induce early remission in CD adults who have failed an anti-TNF agent.
Given the effectiveness of Ryoncil庐 in GI-related SR-aGvHD, and the existing data on adult inflammatory colitis, Mesoblast plans to initiate a pivotal study of Ryoncil庐 for early remission in patients with medically-refractory inflammatory colitis.
Ryoncil庐听Market Exclusivity
Ryoncil庐听received seven years of orphan-drug exclusive approval from FDA for treatment of SR-aGvHD听in听pediatric听patients 2 months of age and older,听meaning听that the FDA will not approve another MSC product for this indication during the 7-year听exclusivity听period.听
Mesoblast听also听has biologic exclusivity preventing another sponsor from referencing the听Ryoncil庐听biologic license application (BLA) until December 2036, preventing听market entry by a biosimilar.听Mesoblast鈥檚 strong U.S. intellectual property position on MSC composition of matter, manufacturing and indications, including SR-aGvHD, provide听even further听commercial barriers听to entry against competitors through 2044.
Revascor庐 (rexlemestrocel-L) for Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) and Persistent Inflammation
In November 2024 a publication in the prestigious peer-reviewed European Journal of Heart Failure (EJHF) reported that a single intramyocardial injection of Revascor庐 resulted in improved survival in high-risk NYHA Class II/III patients with ischemic heart failure and inflammation.11 This identifies the HFrEF population that is responsive to Revascor庐 and will be the target of a confirmatory trial after accelerated approval, if received.
In follow-up to the successful Type B meeting in early 2024 under the existing Regenerative Medicine Advanced Therapy (RMAT) designation for Revascor庐 in end-stage HFrEF patients with a left ventricular assist device (LVAD), where FDA stated that the results of the presented studies could support accelerated approval, Mesoblast met with FDA on June 3, 2025 to align on key items for BLA filing.
Mesoblast and FDA are aligned on items required for filing a biologics license application (BLA) for Revascor庐 regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.
Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative Disc Disease
The 300-patient randomized controlled confirmatory Phase 3 trial of Mesoblast鈥檚 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.
FDA has previously agreed on the design of this 300-patient randomized, placebo-controlled confirmatory Phase 3 trial, and the 12-month primary endpoint of pain reduction as an approvable indication.
This endpoint was successfully met in Mesoblast鈥檚 first Phase 3 trial. Key secondary measures include improvement in quality of life and function.
A particular focus is on treatment of patients on opioids, since discogenic back pain accounts for approximately
Rexlemestrocel-L has received RMAT designation from FDA for the treatment of chronic low back pain.
CORPORATE GOVERNANCE
Board of Directors was strengthened with appointments of Dr. Gregory George MD PhD and Ms Lyn Cobley. Dr. George founded and managed the largest privately owned ambulatory surgical center company in the United States, SurgCenter Development. Dr. George brings to the Board his background as a medical scientist with unique operational experience having built a start-up company in the medical field and turning it into a highly efficient multi-billion-dollar commercial organization. Dr George is Mesoblast鈥檚 largest shareholder. Ms Cobley has been a global leader in the financial services industry with over 30 years鈥� experience in senior positions at international and domestic banks. Ms Cobley is currently a director of Commonwealth Bank of Australia, has previously served as CEO of Westpac Institutional Bank, and as Group Treasurer of Commonwealth Bank of Australia, and has held senior roles at Barclays Capital and Citibank Limited.
FINANCIAL RESULTS FOR FULL YEAR ENDED JUNE 30, 2025 (FY2025)
- Total Revenues from cell therapy products were US
$17.2m , up191% on prior year. Revenue growth driven by successful launch of Ryoncil庐 in the final quarter. - Net Product Sales were driven by successful launch of Ryoncil庐 in the final quarter, with US
$13.2 million gross sales and US$11.3 million in reported net sales after14.6% gross to net adjustment. - Royalties from sales of cell therapies by our licensees were US
$5.9m for both FY2025 and FY2024. - Cost of Revenues related to product sales were US
$1.2m (10% of net product sales). Additionally, US$3.9m of expenses related to non-cash amortization of the intangible value of the prior MSC asset acquisition. - Research & Development expenses were US
$34.8m for FY2025, compared with US$39.7m for FY2024, a reduction of12% . - Selling, General & Administration expenses were US
$39.3m for FY2025, an increase of US$14.3m on FY2024 for the commercial team build and product launch. - Contingent Consideration: we recognized a loss of US
$14.9m in FY2025 reflecting a non-cash revaluation of potential future third party payments. - Fair value movement of warrants: As a result of FDA approval of Ryoncil庐 and the consequential share price appreciation, our warrant remeasurement increased by US
$5.0m in FY2025 compared to a gain of US$0.8m for FY2024. - Other operating income & expenses: for FY2025 we recognized a gain of US
$3.1m compared with a gain of US$2.6m for FY2024 due to increased interest income. - Finance Costs of US
$23.0m for FY2025 for borrowing arrangements include US$17.7m of non-cash expenditure comprising accruing interest and other borrowing costs.
Loss after tax for FY2025 was US
Conference Call
There will be a webcast today, beginning at 8.30am AEST (Friday, August 29); 6.30pm EDT (Thursday, August 28). It can be accessed via:
The archived webcast will be available on the Investor page of the Company鈥檚 website:
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鈥檚 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鈥檚 Ryoncil庐 (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 .
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庐 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 are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company鈥檚 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 , LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
References / Footnotes
- Translated at 1A$:0.655US$ being the June 30, 2025 rate as reported by the Reserve Bank of Australia.
- Jagasia M et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14; 135(20): 1739鈥�1749
- Abedin S, et al. Ruxolitinib resistance or intolerance in steroid-refractory acute graft versus-host disease 鈥� a real-world outcomes analysis. British Journal of Haematology, 2021;195:429鈥�43
- CDC Facts and Figures 2015
- Globaldata Pharmapoint 2018
- Dahlhamer JM, MMWR Morb Mortal Wkly Rep. 2016;65(42):1166鈥�1169
- Crohn鈥檚 and Colitis Foundation
- Lightner AL. Surgery for Inflammatory Bowel Disease in the ERA of Biologics. J Gastroinest Surg. 2020 Vol 24: 1430-1435
- Lightner A., et al. A Phase IB/IIA study of remestemcel-L, an allogeneic bone marrow derived mesenchymal stem cell product, for the treatment of medically refractory ulcerative colitis: An interim analysis. Journal of Crohn's and Colitis, Volume 16, Issue Supplement_1, January 2022, Pages i398鈥搃399,
- Lightner A., et al. A Phase IB/IIA study of remestemcel-L, an allogeneic bone marrow derived mesenchymal stem cell product, for the treatment of medically refractory Crohn鈥檚 colitis: A preliminary analysis. Journal of Crohn's and Colitis, Volume 16, Issue Supplement_1, January 2022, Pages i412鈥搃413,
- Perin EC. Et al. Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. Eur J Heart Fail 2024.
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鈥檚 preclinical and clinical studies, and Mesoblast鈥檚 research and development programs; Mesoblast鈥檚 ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast鈥檚 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鈥檚 Ryoncil庐 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鈥檚 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鈥檚 ability to enter into and maintain established strategic collaborations; Mesoblast鈥檚 ability to establish and maintain intellectual property on its product candidates and Mesoblast鈥檚 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鈥檚 expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast鈥檚 financial performance; developments relating to Mesoblast鈥檚 competitors and industry; and the pricing and reimbursement of Mesoblast鈥檚 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鈥檚 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 鈥� Global
Allison Worldwide
Emma Neal
T: +1 603 545 4843
E:
Media 鈥� Australia
BlueDot Media
Steve Dabkowski
T: +61 419 880 486
E:
听
Consolidated Income Statement
| 听 | Year Ended June 30, | ||||
| (in U.S. dollars, in thousands, except per share amount) | 2025 | 听 | 2024 | ||
| Revenue: | 听 | 听 | 听 | ||
| Product sales, net | 11,263 | 听 | 听 | 鈥� | 听 |
| Royalty revenue | 5,935 | 听 | 听 | 5,902 | 听 |
| Total revenues | 17,198 | 听 | 听 | 5,902 | 听 |
| Cost of revenues (including amortization of currently marketed听intangible assets, 2025: | (5,130 | ) | 听 | 鈥� | 听 |
| Research & development | (34,807 | ) | 听 | (39,716 | ) |
| Selling, general and administration | (39,309 | ) | 听 | (24,980 | ) |
| Fair value remeasurement of contingent consideration | (14,887 | ) | 听 | (9,693 | ) |
| Fair value remeasurement of warrant liability | (4,962 | ) | 听 | 779 | 听 |
| Other operating income and expenses | 3,053 | 听 | 听 | 2,570 | 听 |
| Finance costs | (22,968 | ) | 听 | (23,009 | ) |
| Loss before income tax | (101,812 | ) | 听 | (88,147 | ) |
| Income tax benefit/(expense) | (330 | ) | 听 | 191 | 听 |
| Loss attributable to the owners of Mesoblast Limited | (102,142 | ) | 听 | (87,956 | ) |
| 听 | 听 | 听 | 听 | ||
| Losses per share from continuing operations attributable to the ordinary听equity holders of the Group: | Cents | 听 | Cents | ||
| Basic - losses per share | (8.46 | ) | 听 | (8.91 | ) |
| Diluted - losses per share | (8.46 | ) | 听 | (8.91 | ) |
Consolidated Statement of Comprehensive Income
| 听 | Year Ended June 30, | ||||
| (in U.S. dollars, in thousands) | 2025 | 听 | 2024 | ||
| Loss for the period | (102,142 | ) | 听 | (87,956 | ) |
| Other comprehensive (loss)/income | 听 | 听 | 听 | ||
| Items that may be reclassified to profit and loss | 听 | 听 | 听 | ||
| Exchange differences on translation of foreign operations | 1,160 | 听 | 听 | 51 | 听 |
| Items that will not be reclassified to profit and loss | 听 | 听 | 听 | ||
| Financial assets at fair value through other comprehensive听income | 374 | 听 | 听 | (743 | ) |
| Other comprehensive income/(loss) for the period, net of tax | 1,534 | 听 | 听 | (692 | ) |
| Total comprehensive losses attributable to the owners of听Mesoblast Limited | (100,608 | ) | 听 | (88,648 | ) |
Consolidated Balance Sheet
| 听 | As of June 30, | ||||
| (in U.S. dollars, in thousands) | 2025 | 听 | 2024 | ||
| Assets | 听 | 听 | 听 | ||
| Current Assets | 听 | 听 | 听 | ||
| Cash & cash equivalents | 161,551 | 听 | 听 | 62,960 | 听 |
| Trade & other receivables | 14,866 | 听 | 听 | 20,952 | 听 |
| Prepayments | 5,687 | 听 | 听 | 2,551 | 听 |
| Inventory | 22,246 | 听 | 听 | 鈥� | 听 |
| Total Current Assets | 204,350 | 听 | 听 | 86,463 | 听 |
| 听 | 听 | 听 | 听 | ||
| Non-Current Assets | 听 | 听 | 听 | ||
| Property, plant and equipment | 1,702 | 听 | 听 | 1,106 | 听 |
| Right-of-use assets | 4,121 | 听 | 听 | 2,732 | 听 |
| Financial assets at fair value through other comprehensive income | 1,388 | 听 | 听 | 1,014 | 听 |
| Other non-current assets | 1,296 | 听 | 听 | 2,102 | 听 |
| Intangible assets | 571,826 | 听 | 听 | 575,736 | 听 |
| Total Non-Current Assets | 580,333 | 听 | 听 | 582,690 | 听 |
| Total Assets | 784,683 | 听 | 听 | 669,153 | 听 |
| 听 | 听 | 听 | 听 | ||
| Liabilities | 听 | 听 | 听 | ||
| Current Liabilities | 听 | 听 | 听 | ||
| Trade and other payables | 19,082 | 听 | 听 | 7,070 | 听 |
| Provisions and other liabilities | 20,985 | 听 | 听 | 45,038 | 听 |
| Borrowings | 54,155 | 听 | 听 | 13,862 | 听 |
| Lease liabilities | 2,680 | 听 | 听 | 2,626 | 听 |
| Warrant liability | 5,724 | 听 | 听 | 4,647 | 听 |
| Total Current Liabilities | 102,626 | 听 | 听 | 73,243 | 听 |
| 听 | 听 | 听 | 听 | ||
| Non-Current Liabilities | 听 | 听 | 听 | ||
| Provisions and other liabilities | 10,793 | 听 | 听 | 10,620 | 听 |
| Borrowings | 67,739 | 听 | 听 | 100,483 | 听 |
| Lease liabilities | 3,583 | 听 | 听 | 1,952 | 听 |
| Deferred consideration | 2,500 | 听 | 听 | 2,500 | 听 |
| Total Non-Current Liabilities | 84,615 | 听 | 听 | 115,555 | 听 |
| Total Liabilities | 187,241 | 听 | 听 | 188,798 | 听 |
| Net Assets | 597,442 | 听 | 听 | 480,355 | 听 |
| 听 | 听 | 听 | 听 | ||
| Equity | 听 | 听 | 听 | ||
| Issued Capital | 1,508,846 | 听 | 听 | 1,310,813 | 听 |
| Reserves | 99,499 | 听 | 听 | 78,303 | 听 |
| Accumulated losses | (1,010,903 | ) | 听 | (908,761 | ) |
| Total Equity | 597,442 | 听 | 听 | 480,355 | 听 |
Consolidated Statement of Cash Flow
| 听 | Year Ended June 30, | ||||
| (in U.S. dollars, in thousands) | 2025 | 听 | 2024 | ||
| Cash flows from operating activities | 听 | 听 | 听 | ||
| Royalty revenue received | 5,704 | 听 | 听 | 6,776 | 听 |
| Government grants and tax incentives and credits received | 905 | 听 | 听 | 3,819 | 听 |
| Payments to suppliers and employees (inclusive of goods and services tax) | (60,110 | ) | 听 | (60,835 | ) |
| Interest received | 3,549 | 听 | 听 | 1,778 | 听 |
| Income taxes (paid)/received | (2 | ) | 听 | 4 | 听 |
| Net cash (outflows) in operating activities | (49,954 | ) | 听 | (48,458 | ) |
| 听 | 听 | 听 | 听 | ||
| Cash flows from investing activities | 听 | 听 | 听 | ||
| Payments for property, plant and equipment | (680 | ) | 听 | (271 | ) |
| Receipts from investment in sublease | 241 | 听 | 听 | 234 | 听 |
| Receipt of security deposits | 609 | 听 | 听 | 鈥� | 听 |
| Payments for licenses | (50 | ) | 听 | (60 | ) |
| Net cash inflows/(outflows) in investing activities | 120 | 听 | 听 | (97 | ) |
| 听 | 听 | 听 | 听 | ||
| Cash flows from financing activities | 听 | 听 | 听 | ||
| Repayment of borrowings | (7,824 | ) | 听 | (10,000 | ) |
| Payment of transaction costs from borrowings | (1,348 | ) | 听 | (1,559 | ) |
| Interest and other costs of finance paid | (5,266 | ) | 听 | (5,717 | ) |
| Proceeds from issue of shares | 161,205 | 听 | 听 | 65,406 | 听 |
| Proceeds from exercise of options | 5,177 | 听 | 听 | 鈥� | 听 |
| Proceeds from issue of warrants | 1,647 | 听 | 听 | 鈥� | 听 |
| Payments for share issue costs | (4,314 | ) | 听 | (4,356 | ) |
| Payments for lease liabilities | (1,941 | ) | 听 | (3,522 | ) |
| Net cash inflows by financing activities | 147,336 | 听 | 听 | 40,252 | 听 |
| 听 | 听 | 听 | 听 | ||
| Net increase/(decrease) in cash and cash equivalents | 97,502 | 听 | 听 | (8,303 | ) |
| Cash and cash equivalents at beginning of period | 62,960 | 听 | 听 | 71,318 | 听 |
| Foreign exchange gain/(loss) on the translation of foreign bank accounts | 1,089 | 听 | 听 | (55 | ) |
| Cash and cash equivalents at end of period | 161,551 | 听 | 听 | 62,960 | 听 |
FAQ
What were Mesoblast's (MESO) key financial results for FY2025?
What is the market potential for Mesoblast's 搁测辞苍肠颈濒庐 in SR-aGvHD?
How long does Mesoblast have market exclusivity for 搁测辞苍肠颈濒庐?
What is the current insurance coverage for Mesoblast's 搁测辞苍肠颈濒庐?
What are Mesoblast's major pipeline developments beyond 搁测辞苍肠颈濒庐?
