Mesoblast Limited Overview
The ISIN on the request list, US5907171046, belongs to the Nasdaq-listed American Depositary Shares (ADS). It is not the ISIN of the ASX ordinary shares. Both lines are listed below.
Mesoblast is the first company to win US FDA approval for an industrially manufactured allogeneic mesenchymal stromal cell (MSC) therapy. Its product, Ryoncil® (remestemcel-L-rknd), was approved in December 2024 for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children aged two months and older.
After two decades as a clinical-stage platform company, FY2026 was its first full commercial year:
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Ryoncil generated US$115.2 million of net product revenue.
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Gross profit was US$103.6 million.
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The net loss narrowed 44% to US$57.5 million.
The investment case now rests on three things:
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A label-expansion engine for Ryoncil: adult SR-aGvHD, where the market is about three times the pediatric one, and Duchenne muscular dystrophy.
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Two late-stage "blockbuster" programmes built on rexlemestrocel-L:
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chronic low back pain (CLBP), with Phase 3 data due in 2027;
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end-stage heart failure with LVADs, where a BLA is being prepared.
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A next-generation platform: CAR-engineered MSCs and oncolytic-virus-loaded MSCs.
Key moats are a portfolio of more than 1,100 patents and applications running to at least 2044, first-mover regulatory precedent, and proprietary manufacturing know-how. Key vulnerabilities are single-product concentration and reliance on a single contract manufacturer (Lonza Singapore).
Company's own description
In its FY2026 results release, Mesoblast calls itself a world leader in allogeneic, off-the-shelf cellular medicines for severe and life-threatening inflammatory conditions. It says its mesenchymal lineage cell platform responds to severe inflammation by releasing anti-inflammatory factors that modulate multiple arms of the immune system.
The company develops products on two technology platforms:
Remestemcel-L: (marketed as Ryoncil®): bone-marrow-derived MSCs given intravenously.
Rexlemestrocel-L: (development name REVASCOR® in cardiology): STRO-1/STRO-3-selected mesenchymal precursor cells (MPCs) given locally, by intramyocardial or intradiscal injection.
The company says it has commercial partnerships in Japan, Europe and China. Its manufacturing process produces industrial-scale, cryopreserved, off-the-shelf products with defined pharmaceutical release criteria (FY2026 6-K, Exhibit 99.1).
Independent characterisation
Mesoblast is a single-commercial-asset specialty biopharma moving out of the R&D-stage biotech category. The business has three economic layers.
1. US specialty hospital product. Ryoncil is sold directly in the United States to transplant centres, mostly academic pediatric bone-marrow-transplant programmes.
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Distribution runs through specialty distribution and specialty pharmacy channels. The FY2026 presentation notes 13 accounts using specialty pharmacy and more than 30 formulary approvals.
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Reimbursement is supported by a permanent J-code, received in October 2025, and Medicaid coverage.
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Payer coverage exceeds 280 million covered lives (about 98% of US lives).
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Average gross-to-net deductions were 13.4% in FY2026.
2. Royalty and licensing annuity.
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JCR Pharmaceuticals sells TEMCELL® HS Inj. (the same MSC technology) in Japan and pays Mesoblast a royalty.
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Historically, Takeda paid a royalty on Alofisel® in Europe under a patent licence.
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Royalty revenue was US$5.1 million in FY2026, down from US$5.9 million in FY2025.
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The TEMCELL royalty stream is now the sole security for the US$125 million credit facility.
3. Pipeline optionality monetised through regional licences.
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Grünenthal holds rights to rexlemestrocel-L for CLBP in Europe and Latin America/Caribbean.
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Tasly holds rights to rexlemestrocel-L for chronic heart failure in China.
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Mesoblast states that all assets are wholly owned and unencumbered in US markets.
Revenue model mix
| Revenue type (USD Mn) | FY2025 | FY2026 |
|---|---|---|
| Product sales, net | 11.3 | 115.2 |
| Royalty revenue | 5.9 | 5.1 |
| Total revenue | 17.2 | 120.3 |
Source: FY2026 consolidated income statement (6-K, 27 August 2026).
Product revenue was 95.8% of FY2026 revenue (derived), against 65.5% in FY2025. Mesoblast has no subscription or service revenue.
Value chain position
Upstream and manufacturing.
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Bone marrow comes from screened donors. Single-donor master cell banks are expanded to thousands of doses.
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Manufacturing is outsourced to Lonza Bioscience Singapore Pte Ltd under a commercial manufacturing services agreement.
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Lonza Walkersville, Inc. (Maryland, US) has historically supported clinical supply.
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The 20-F says Mesoblast does not intend to build internal manufacturing.
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Fetal bovine serum is a critical, limited-source consumable.
Process IP and quality control. Mesoblast owns the process IP and the potency-assay matrix used to release each batch. The matrix covers IL-2Rα inhibition and Cell Adhesion and Proliferation (CAP). It now also includes the T-cell Proliferation Inhibition BioAssay (TIBA), approved by FDA in September 2026.
Downstream.
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Cryogenic third-party logistics deliver product to transplant centres.
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Mesoblast runs in-house commercial, medical affairs, market access and patient services teams.
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Median time from patient identification to treatment fell from 29 days at launch to 8 days (FY2026 release).
Customer types and end-markets
| Customer / end-market | Product | Status |
|---|---|---|
| US pediatric allogeneic bone-marrow-transplant centres (>50 onboarded, including 14 of the 15 largest, which account for nearly half of pediatric transplant volume) | Ryoncil | Commercial |
| Government (Medicaid) and commercial payers | Ryoncil | Coverage for ~98% of US lives |
| Adult transplant centres (~40 US sites, representing ~60% of the ~8,500 annual US adult allogeneic transplants) | Ryoncil (adult SR-aGvHD) | Registration trial enrolling |
| Pediatric neuromuscular centres (DMD, ~15,000 US children) | Ryoncil | IND cleared for registrational trial |
| Pain specialists and anaesthesiologists (CLBP) | Rexlemestrocel-L | Phase 3 treatment complete; readout 2027 |
| Advanced heart failure / LVAD centres | REVASCOR (rexlemestrocel-L) | BLA filing number received; modular review requested |
| Japanese hospitals, via JCR | TEMCELL | Partner-commercial (royalty) |
Strategy
Stated strategic themes (FY2026 results and R&D Day, paraphrased)
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Grow the Ryoncil revenue base and use its profits to fund the Phase 3 pipeline. Management frames FY2026 as the transition from an R&D company to a commercial one.
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Four commercial priorities (FY2026 presentation):
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empower caregivers to ask for Ryoncil for their children;
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reinforce superior outcomes and earlier use;
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proactively identify and prioritise appropriate patients;
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enhance access and reimbursement pull-through.
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Label expansion:
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adult SR-aGvHD, both third line after ruxolitinib failure and second line combined with ruxolitinib (adult market about three times the pediatric market);
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pediatric rare inflammatory diseases, such as DMD.
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Blockbuster programmes: rexlemestrocel-L in CLBP (BLA after the 2027 readout) and REVASCOR in end-stage heart failure (BLA filing, then a label extension to NYHA II/III).
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Next-generation platform leadership: CAR-MSC and OV-MSC.
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Disciplined capital allocation: non-dilutive financing; working toward profitability.
Strategic initiatives, last 24 months (October 2024 to October 2026)
| Initiative | Date | Description | Status |
|---|---|---|---|
| Ryoncil US launch infrastructure | Mar 2025 onward | Commercial, medical affairs, market access, patient services, distribution | Executed; >50 centres; 98% lives covered |
| Permanent J-code | Oct 2025 | Reimbursement coding | Achieved |
| Debt refinancing | Dec 2025 – Jun 2026 | US$125 million, 8% fixed, unencumbered except for the TEMCELL royalty | Completed; fully drawn |
| Shelf registrations | Late Dec 2025 / Jan 2026 | US$250 million and US$9.48 million US shelf registrations (Simply Wall St summary) | Capital-raising capacity in place |
| Board renewal | Jan 2026 | New Chair and ARC Chair | Done |
| Adult SR-aGvHD registration trial | Initiated 2026 | 180 patients, ~40 sites; interim analysis Q4 CY2027 | Enrolling |
| DMD registrational IND | Apr 2026 | Go directly to a registrational trial | IND cleared |
| R&D Day | 8 Apr 2026 | Commercial strategy to double net revenues (time frame not specified in sources reviewed); pipeline showcase | Held |
| CAR-MSC acquisition | Apr 2026 | Mayo Clinic IP via start-up acquisition (1,260,589 shares) | Completed |
| OV-MSC licence | FY2026 | Baylor College of Medicine oncolytic virus platform | Completed |
| CLBP Phase 3 completion | Apr–Aug 2026 | Recruitment target met in April; 300 treated by July; 350 treated by August | Follow-up to 12 months |
| REVASCOR BLA | Jul 2026 | Filing number received; modular review requested | Pending FDA discussion |
| TIBA potency assay | Sep 2026 | FDA-approved additional release assay | Supports a second manufacturing site |
| Second manufacturing site | 2026–2027 (inferred) | Diversification away from the single Lonza Singapore site | Not formally announced |
| Strategic partnering | Ongoing | Inflammatory indications; NYHA II/III heart failure | No new deal announced |
ESG and cost programmes. No formal ESG commitments, emissions targets or cost-reduction programme with numeric targets were identified. Mesoblast cut operating cash burn in FY2023–FY2024 (a targeted 23% reduction to about US$48 million in FY2024, which was achieved).
Medium-term targets and guidance
| Item | Guidance / target | Source |
|---|---|---|
| FY2026 Ryoncil net revenue | US$110–120 million (actual: US$115.2 million) | February 2026 half-year release |
| FY2027 revenue | No numeric guidance identified. Management expects continued growth (described as double-digit in one transcript summary). | FY2026 call |
| Revenue ambition | "Double net revenues" through the commercial strategy (R&D Day headline); horizon not specified | 8 April 2026 release |
| Profitability | "Working towards profitability"; no date given | FY2026 presentation |
| CLBP readout | Mid/H2 CY2027; potential approval CY2028 | FY2026 release and presentation |
| Adult aGvHD interim analysis | Q4 CY2027 | FY2026 presentation |
Products & Services
All products sit in Mesoblast's single segment. They are organised below by technology platform.
Remestemcel-L platform (intravenous MSCs)
| Attribute | Detail |
|---|---|
| Description | Allogeneic, culture-expanded bone-marrow MSCs, cryopreserved and infused intravenously |
| Indication | Steroid-refractory acute graft-versus-host disease in pediatric patients aged 2 months and older. The company describes it as the only FDA-approved product for children under 12 with SR-aGvHD. |
| Approval and launch | FDA approval December 2024; US launch March 2025 |
| Exclusivity | 12-year US biologic exclusivity to about December 2036 (reported in aggregator summaries of company disclosures); orphan drug designation (FDA and EMA) |
| Release potency assays | IL-2Rα inhibition and CAP; TIBA added September 2026 |
| Clinical evidence | Pivotal single-arm Phase 3 (GVHD001) in children. Company-reported real-world data (January 2026): 84% early survival in children, all with Grade III/IV disease, after 28 days of treatment. |
| Pricing | Not stated in the filings reviewed. Trade press at launch reported a wholesale acquisition cost of about US$194,000 per infusion (about US$1.55 million per full course). |
| Gross-to-net | 13.4% (FY2026) |
| Reimbursement | Permanent J-code (October 2025); Medicaid; coverage for ~98% of US lives; >30 formulary approvals |
| Target customer | Pediatric allogeneic bone-marrow-transplant centres |
| Programme | Stage | Design / key facts | Timing |
|---|---|---|---|
| Adult SR-aGvHD, second line with ruxolitinib (Grade III/IV) | Registration trial enrolling | 180 adults randomised 1:1 to ruxolitinib versus ruxolitinib + Ryoncil. Primary endpoint: Day-28 overall response. Secondary endpoint: Day-180 survival. ~40 US centres. | Interim analysis expected Q4 CY2027, when the first 102 patients reach Day 28; total duration ~18 months |
| Adult SR-aGvHD, third line (after ruxolitinib failure) | Label-extension strategy using expanded-access (EIND) data | 76% Day-100 survival in adolescents and adults versus ~20–30% historical (ASTCT/CIBMTR Tandem Meetings, February 2026). Addressable market is >600 US adults per year with Grade III/IV disease refractory to ruxolitinib. | Regulatory strategy; filing timing not disclosed |
| Duchenne muscular dystrophy (ambulatory boys aged 5–9) | IND cleared to go straight to a registrational trial (April 2026) | ~15,000 affected US children | Start timing not disclosed |
| Biologic-resistant inflammatory bowel disease | Development | Listed in the company boilerplate | — |
| Pediatric inflammatory rare diseases (general) | Strategy | Partnering sought for inflammatory conditions in children and adults | — |
Ryoncil® (remestemcel-L-rknd): pediatric SR-aGvHD (marketed, US)
TEMCELL® HS Inj.: Japan (partner-marketed)
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Licensed to JCR Pharmaceuticals, which sells it for aGvHD in Japan. JCR also holds Japanese rights in certain other fields, including hypoxic ischemic encephalopathy (HIE).
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Mesoblast earns a royalty. TEMCELL royalties were US$8.7 million in FY2022 and US$7.1 million in FY2023 (FY2023 20-F); these figures are affected by the yen exchange rate.
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The royalty stream secures the US$125 million George facility.
Ryoncil label-expansion programmes
Rexlemestrocel-L platform (mesenchymal precursor cells, local delivery)
| Attribute | Detail |
|---|---|
| Formulation | MPCs plus hyaluronic acid carrier, given as a single intradiscal injection |
| Prior data | MSB-DR003 (Phase 3; n=202 in the analysed sub-population) showed durable pain reduction through 36 months with rexlemestrocel-L + HA (FY2026 presentation). This prior trial is understood not to have met all registrational objectives, hence a confirmatory trial. |
| Pivotal trial | Randomised, controlled Phase 3; enrolment expanded from 300 to 350 because of investigator demand; treatment of all 350 completed August 2026 |
| Primary endpoint | Durable pain reduction at 12 months. Secondary endpoints: function, quality of life, opioid cessation. |
| FDA status | RMAT designation; FDA confirmed a path to approval (19 January 2026 ASX release) |
| Readout | Press release says top-line results mid-CY2027; investor presentation says H2 CY2027. Treat as mid-to-late CY2027. Potential approval CY2028. |
| Market | ~7 million US patients with moderate/severe DDD-related CLBP refractory to conventional therapy; company total addressable market (TAM) >US$10 billion |
| Partner | Grünenthal: exclusive rights in Europe and Latin America/Caribbean |
| Attribute | Detail |
|---|---|
| Lead indication | Prevention of life-threatening gastrointestinal / major mucosal bleeding caused by right-ventricular dysfunction in end-stage HFrEF patients with an LVAD |
| Evidence | Two randomised LVAD trials showed reduced major GI bleeding. In ischemic LVAD patients, mortality was 30% versus 9% (p=0.03), per company presentation. DREAM-HF (Class II/III HFrEF) also exists; it missed its primary endpoint in 2020 (reported) but supports the label-extension thesis. |
| Designations | Orphan drug designation (LVAD mucosal bleeding; hypoplastic left heart syndrome, HLHS); Rare Pediatric Disease designation (HLHS); RMAT designation |
| Regulatory | BLA filing number received; modular review requested (1 July 2026); to be discussed with FDA in the next quarter |
| Follow-on | Label extension to NYHA Class II/IIIA HFrEF, potentially with a strategic partner |
| Partner | Tasly: exclusive China rights for chronic heart failure |
| TAM | >US$10 billion for chronic heart failure (company); >US$1 billion for end-stage LVAD (company slide) |
Rexlemestrocel-L for chronic low back pain (CLBP) due to inflammatory degenerative disc disease
REVASCOR® (rexlemestrocel-L) for chronic heart failure (HFrEF)
Other legacy MPC candidates
These are listed by data aggregators (for example, MPC-300-IV for biologic-refractory rheumatoid arthritis and diabetic nephropathy). They are not prioritised in FY2026 disclosures, and their status is not disclosed.
Next-generation platforms (preclinical)
| Platform | Source | Target indications | Status |
|---|---|---|---|
| CAR-MSC (chimeric antigen receptor-engineered MSCs) | Exclusive worldwide licence to Mayo Clinic IP, obtained by acquiring a Mayo-formed start-up (April 2026) | Ulcerative colitis and Crohn's disease (gut-homing CARs); lupus nephritis and other B-cell autoimmune diseases (CD19-directed CAR-MSC) | Preclinical. Mayo provides in-kind support, including GMP manufacturing activities. |
| OV-MSC (oncolytic-virus-loaded MSCs) | Exclusive licence to an oncolytic-virus platform from Baylor College of Medicine (FY2026) | Systemic delivery to primary and metastatic solid tumours | Preclinical |
Manufacturing and process technologies
These are the process and quality technologies behind the products rather than products themselves.
Planar (2D) process: Current commercial process run at Lonza Singapore.
Process improvements: 3D bioreactor programme and media modification for yield and cost (FY2026 20-F risk factors).
Potency assay matrix: IL-2Rα inhibition, CAP and TIBA.
Financial Narrative
Income statement, core metrics (chartable)
Sources by year:
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FY2022–FY2023: FY2023 20-F and results release.
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FY2024: FY2024 results release (StockTitan, Moomoo transcription).
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FY2025–FY2026: FY2026 6-K income statement.
Notes:
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Net margins are derived.
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The FY2024 release restates FY2023 EPS as -10.53 US cents, against -11.08 in the FY2023 release. This is likely a weighted-share or presentation difference; both figures are noted.
Income statement, extended detail (partial disclosure)
"n/d" means not disclosed in the sources retrieved; "n/a" means not applicable.
Presentation change. From FY2025 the income statement presents R&D and SG&A only. Manufacturing costs are allocated to R&D (product development) and cost of revenue. FY2022–FY2023 figures are therefore not like-for-like with FY2025–FY2026.
FY2025 R&D distortion. FY2025 R&D was flattered by a US$23.0 million inventory benefit: pre-launch manufacturing costs previously expensed were capitalised at approval. Adjusted for this, FY2026 R&D rose by US$39.7 million, made up of:
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US$17.3 million of product development (both platforms);
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US$21.2 million of Phase 3 trials and regulatory filings.
Margin profile
Revenue CAGR.
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FY2022–FY2026: +85.3% (derived; US$10.2 million to US$120.3 million over four years).
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FY2023–FY2026 (three years): +152.3% (derived).
Balance sheet
Cash sources: FY2022 (FY2022 release), FY2023 (FY2023 release), FY2024 (Wikipedia and FY2025 cash flow opening balance of US$62.96 million; the FY2024 release quoted US$63.3 million, a minor discrepancy), FY2025–FY2026 (FY2026 balance sheet).
FY2025–FY2026 balance sheet detail (chartable)
A negative net debt figure means net cash.
Intangibles detail (FY2026 20-F). In-process R&D acquired totals US$325.1 million:
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Cardiovascular products: US$254.4 million.
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Intravenous products for metabolic diseases and inflammatory/immunologic conditions: US$70.7 million.
The marketed-product intangible for Ryoncil (US$102.7 million reclassified in December 2024) is amortised straight-line over 21 years. The goodwill sub-total is not separately verified.
Cash flow
Sources: FY2022–FY2024 results releases; FY2025–FY2026 cash flow statement.
FY2025–FY2026 cash flow detail (chartable)
Intra-year trajectory. FY2026 H2 operating cash spend was only US$13.4 million, against US$50 million in the prior-year comparable half. The March 2026 quarter spend was US$4.1 million. This puts Mesoblast close to operating cash-flow breakeven on a run-rate basis, before the FY2027 increase in Phase 3 and manufacturing spend.
Interest paid. Cash interest jumped to US$17.8 million in FY2026 because accrued interest and royalty-linked amounts were settled when the Oaktree and NovaQuest facilities were retired. The new facility costs about US$10 million a year (US$125 million at 8%).
Ratios
"n/m" means not meaningful.
Commentary on trends, inflections and drivers
1. Revenue inflection (FY2025–FY2026).
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From FY2022 to FY2024, revenue fell from US$10.2 million to about US$5.9 million. It was pure royalty income, eroded by yen depreciation (US$1.0 million of the FY2023 decline was foreign exchange) and the loss of milestone income.
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After approval, revenue rose sevenfold in FY2026 to US$120.3 million.
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Management's FY2026 guidance of US$110–120 million of Ryoncil net revenue (February 2026) was met at US$115.2 million, near the midpoint. This is an important credibility marker for a management team historically associated with regulatory delays.
2. Gross margin structure.
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Gross margin excluding amortization is above 90%, which is unusually high for a cell therapy.
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This reflects allogeneic, off-the-shelf economics: one donor yields thousands of doses, against the patient-specific manufacturing of autologous CAR-T therapies.
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Amortization of the Ryoncil intangible (US$6.1 million in FY2026) is the main gap between reported and underlying gross margin.
3. Operating cost re-acceleration is deliberate.
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R&D more than doubled on a reported basis, because Phase 3 CLBP enrolment, the adult GvHD trial start, BLA preparation for REVASCOR and manufacturing for BLA lots all hit the year.
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SG&A rose about US$18 million for the US launch infrastructure.
4. Below-the-line noise.
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Contingent-consideration remeasurements (linked to future payments to former Osiris and other sellers) swung from -US$14.9 million to +US$12.1 million, a US$27 million year-on-year swing. This explains a large part of the net-loss improvement.
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Underlying operating loss excluding these remeasurements improved more modestly, from US$58.9 million to US$46.0 million (derived).
5. Capital structure.
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Mesoblast moved from net cash of about US$40 million (FY2025, after the January 2025 placement) to modest net debt of about US$16 million (FY2026).
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The debt itself is now cheaper (8% fixed against higher-cost Oaktree and NovaQuest instruments), interest-only to December 2030, and secured only by the TEMCELL royalty.
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Management states that cash plus Ryoncil cash generation is sufficient for the next 12 months, and the going-concern basis is supported. The 20-F still flags that funding beyond 12 months may need partnerships or capital.
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Revenue Lines
| Revenue line (USD Mn) | FY2024 | FY2025 | FY2026 |
|---|---|---|---|
Product sales net (Ryoncil) | 0.0 | 11.3 | 115.2 |
Royalty and commercialization revenue | 5.9 | 5.9 | 5.1 |
Total revenue | 5.9 | 17.2 | 120.3 |
Revenue by Segment (%) and Segment Margins & Growth (%)
| Metric | FY2025 | FY2026 |
|---|---|---|
Product share of total revenue (%) | 65.5 | 95.8 |
Royalty share of total revenue (%) | 34.5 | 4.2 |
Total revenue YoY growth (%) | 191.0 | 599.2 |
Reported gross margin on total revenue (%) | 70.2 | 86.1 |
Gross margin excluding amortization (%) | 93.0 | 91.2 |
Revenue History
| Quarter | Ryoncil revenue (USD Mn) | Basis | Source |
|---|---|---|---|
Q4 FY2025 (Mar–Jun 2025, launch period) | 11.3 | Net product sales for FY2025 | FY2026 income statement comparative |
Q1 FY2026 (Sep 2025 quarter) | ~21.9 gross | Derived from the 60% QoQ growth to US$35.1 million | 9 Jan 2026 release |
Q2 FY2026 (Dec 2025 quarter) | 35.1 gross | Gross revenue | 9 Jan 2026 release |
H1 FY2026 | ~48.7 net | FY net US$115.2 million minus H2 net US$66.5 million; reported in summaries as "US$49 million" | Feb 2026 half-year results; FY2026 release |
Q3 FY2026 (Mar 2026 quarter) | 30.3 net | Net revenue | 7 Apr 2026 release |
Q4 FY2026 (Jun 2026 quarter) | 36.0 net | Net revenue | 10 Jul 2026 release |
Cumulative since launch |
| Net | FY2026 investor presentation |
Income Statement and Per-Share Data
| Metric | FY2022 | FY2023 | FY2024 | FY2025 | FY2026 |
|---|---|---|---|---|---|
Total revenue (USD Mn) | 10.2 | 7.5 | 5.9 | 17.2 | 120.3 |
Net loss after tax (USD Mn) | -91.3 | -81.9 | -88.0 | -102.1 | -57.5 |
Basic and diluted EPS (US cents) | -14.08 | -11.08 | -8.91 | -8.46 | -4.44 |
Dividends per share (US cents) | 0 | 0 | 0 | 0 | 0 |
Net margin (%) | -895 | -1,092 | -1,492 | -594 | -48 |
Income Statement
| Metric (USD Mn) | FY2022 | FY2023 | FY2024 | FY2025 | FY2026 |
|---|---|---|---|---|---|
Cost of revenues | — | — | — | -5.1 | -16.7 |
Gross profit (reported) | — | — | — | 12.1 | 103.6 |
Gross profit excluding amortization | — | — | — | 16.0 | 109.7 |
Research & development | -32.8 | -27.2 | — | -34.8 | -97.5 |
Manufacturing (separate line, pre-FY2025) | -30.7 | -27.7 | — | — | — |
SG&A / management & administration | -27.2 | -25.4 | — | -39.3 | -57.3 |
Fair value remeasurement of contingent consideration | 0.9 | 8.8 | -9.7 | -14.9 | 12.1 |
Fair value remeasurement of warrants | 5.9 | -2.2 | — | -5.0 | 0.9 |
Other operating income and expenses | — | — | — | 3.1 | 5.3 |
Finance costs | — | — | — | -23.0 | -23.8 |
Loss before income tax | -91.6 | -82.1 | — | -101.8 | -56.9 |
Operating loss (derived: PBT + finance costs) | — | — | — | -78.8 | -33.0 |
Operating loss excluding FV remeasurements (derived) | — | — | — | -58.9 | -46.0 |
EBITDA proxy (derived: operating loss + amortization; depreciation not disclosed) | — | — | — | -74.9 | -26.9 |
Margin (%)
| Margin (%) | FY2025 | FY2026 |
|---|---|---|
Gross margin (reported) | 70.2 | 86.1 |
Gross margin excluding amortization | 93.0 | 91.2 |
Operating margin (derived) | -458.1 | -27.4 |
EBITDA-proxy margin (derived) | -435.5 | -22.4 |
Net margin | -593.9 | -47.8 |
Balance Sheet
| Item (USD Mn, at 30 June) | FY2022 | FY2023 | FY2024 | FY2025 | FY2026 |
|---|---|---|---|---|---|
Cash and cash equivalents | 60.4 | 71.3 | 63.0 | 161.6 | 102.9 |
Total assets | — | — | 669.2 | 784.7 | 773.1 |
Intangible assets (incl. goodwill and IPR&D) | — | — | — | 571.8 | 566.4 |
Total equity | — | — | — | 597.4 | 568.4 |
Balance Sheet (FY2025–FY2026)
| Line item (USD Mn) | FY2025 | FY2026 |
|---|---|---|
Trade and other receivables | 14.9 | 57.7 |
Inventory | 22.2 | 28.1 |
Total current assets | 204.4 | 197.5 |
Intangible assets | 571.8 | 566.4 |
Total assets | 784.7 | 773.1 |
Trade and other payables | 19.1 | 46.8 |
Borrowings, current | 54.2 | 10.6 |
Borrowings, non-current | 67.7 | 108.6 |
Total borrowings | 121.9 | 119.2 |
Lease liabilities, total | 6.3 | 8.1 |
Warrant liability | 5.7 | 8.9 |
Total current liabilities | 102.6 | 81.1 |
Total liabilities | 187.2 | 204.7 |
Total equity | 597.4 | 568.4 |
Accumulated losses | -1,010.9 | -1,068.4 |
Working capital (derived) | 101.7 | 116.4 |
Net debt excluding leases (derived) | -39.7 | 16.3 |
Net debt including leases (derived) | -33.4 | 24.4 |
Cash Flow
| Metric (USD Mn) | FY2022 | FY2023 | FY2024 | FY2025 | FY2026 |
|---|---|---|---|---|---|
Net operating cash flow | -65.8 | -63.3 | -48.5 | -50.0 | -43.8 |
Cash Flow (FY2025–FY2026)
| Line item (USD Mn) | FY2025 | FY2026 |
|---|---|---|
Receipts from customers | 5.7 | 88.4 |
Payments to suppliers and employees | -60.1 | -136.2 |
Net operating cash flow | -50.0 | -43.8 |
Capex (PP&E) | -0.7 | -0.8 |
Free cash flow (derived: OCF minus capex) | -50.6 | -44.7 |
Proceeds from borrowings | 0.0 | 121.0 |
Repayment of borrowings | -7.8 | -125.0 |
Interest and finance costs paid | -5.3 | -17.8 |
Proceeds from share issues | 161.2 | 2.6 |
Proceeds from option exercises | 5.2 | 7.7 |
Dividends paid | 0.0 | 0.0 |
Share buybacks | 0.0 | 0.0 |
Net change in cash | 97.5 | -60.2 |
Returns & Leverage Ratios (%) and Financial Ratios (x)
| Ratio | FY2025 | FY2026 | Comment |
|---|---|---|---|
ROE (%) | n/m | -9.9 | Net loss / average equity (derived) |
ROA (%) | n/m | -7.4 | Net loss / average total assets (derived) |
ROIC (%) | n/m | n/m | Negative NOPAT; not meaningful |
Current ratio (x) | 1.99 | 2.43 | Derived |
Debt / equity (x) | 0.20 | 0.21 | Total borrowings / equity (derived) |
Net debt / EBITDA (x) | n/m | n/m | EBITDA negative |
Interest coverage (x) | -3.4 | -1.4 | Operating loss / finance costs (derived) |
Asset turnover (x) | n/m | 0.15 | Revenue / average assets (derived) |
Days sales outstanding (days) | n/m | 175 | Receivables / revenue × 365 (derived; inflated by June-quarter billing and launch dynamics) |
Days inventory outstanding (days) | n/m | 615 | Inventory / cost of revenue × 365 (derived; cell-bank inventory is long-lived) |
Cash conversion cycle | n/m | n/m | Not meaningful at this stage of commercialisation |
Revenue by Region
| Region (USD Mn) | FY2024 | FY2025 | FY2026 |
|---|---|---|---|
United States (product sales) | 0.0 | 11.3 | 115.2 |
Japan and Europe (royalties, combined) | 5.9 | 5.9 | 5.1 |
Total | 5.9 | 17.2 | 120.3 |
Geographic Revenue
| Region | FY2025 YoY growth (%) | FY2026 YoY growth (%) |
|---|---|---|
United States | n/m (launch) | 922 |
Japan and Europe (royalties) | 0 | -14 |
Valuation Snapshot
| Metric | Value | Source / date |
|---|---|---|
MESO (Nasdaq ADS) price | ~US$15.35 | Yahoo Finance, late Sep 2026 |
MESO 52-week range | US$12.66–21.50 (later US$13.05–21.50) | Yahoo / RTTNews |
MSB (ASX) price | ~A$2.1–2.4 | InvestSMART, Jul–Aug 2026 |
Market capitalisation | ~US$2.0 billion | Yahoo, Sep 2026 |
1-year performance (ASX) | About -5% over 12 months to 27 Aug 2026 (Motley Fool). Another Motley Fool note in mid-2026 cited about -35% over the year. The window differs; the conflict is noted. | Motley Fool Australia |
MESO since start of 2025 | US$19.80 at the start of 2025 | MarketBeat |
Beta (5Y monthly) | ~0.8 (Yahoo) versus 2.08 (MarketBeat); sources conflict | Yahoo / MarketBeat |
Valuation Multiples
| Multiple | Mesoblast | Peer comment |
|---|---|---|
P/E | n/m (loss-making) | n/m |
EV (USD Bn) | ~2.02 (market cap 1.99 + borrowings 0.119 + leases 0.008 − cash 0.103) | — |
EV/Sales, FY2026 (x) | ~16.8 | High-growth commercial-stage biotech range |
EV/EBITDA | n/m (negative) | n/m |
P/B (x) | ~3.5 (equity US$568.4 million) | Book is dominated by intangibles (US$566.4 million) |
Analyst Ratings & Targets
| Broker | Rating | Target | Date |
|---|---|---|---|
Piper Sandler | Overweight | US$39 (raised from US$35) | 27 Aug 2026 |
Jefferies | — | — | Early 2026 |
Bell Potter | Positive (headline asked whether shares could rise over 100% in 12 months) | — | Sep 2026 |
Weiss Ratings | Sell | — | Aug 2026 |
Yahoo 1-year target estimate | US$37.00 | — | Sep 2026 |
MarketBeat consensus | Hold; average target US$39 | — | Aug 2026 |
Capital Instruments
| Instrument | Amount (USD Mn) | Rate | Maturity | Security |
|---|---|---|---|---|
Dr Gregory George credit line, tranche 1 | 75.0 | 8.00% fixed | 5 years from Dec 2025; interest-only to Dec 2030 | TEMCELL royalty (after the NovaQuest payoff) |
Dr Gregory George credit line, tranche 2 | 50.0 | 8.00% fixed | Same | Same |
Lease liabilities | 8.1 | — | Various | — |
Warrant liability | 8.9 | — | Non-cash | — |
Analyst Conclusions
Management guidance
-
No numeric FY2027 guidance was identified.
-
Management expects continued Ryoncil growth and has signalled an ambition to "double net revenues" (R&D Day).
-
Spending priorities are Phase 3 programmes, manufacturing for BLA lots and commercial inventory, and continued progress toward profitability.
Consensus expectations
No full consensus revenue or EPS was verified. Aggregators (Alphaspread) imply very high multi-year revenue CAGRs, driven by CLBP and adult GvHD optionality.
Bull case
-
Durable, high-margin cash engine. US$115 million of first-year Ryoncil revenue at about 91% underlying gross margin, with H2 cash burn of US$13.4 million, means the base business can largely self-fund. Adult second-line plus third-line SR-aGvHD (about 3× the pediatric market) could multiply Ryoncil sales from 2028.
-
CLBP is a mispriced binary. A positive 12-month readout in a 350-patient, well-powered trial would open a market above US$10 billion with an RMAT-designated product and an FDA-confirmed path. At an EV of about US$2 billion, the market is assigning modest probability-weighted value.
-
De-risked balance sheet and CMC. 8% interest-only debt to 2030, all US assets unencumbered for partnering, and FDA approval of TIBA reduce financing and manufacturing tail risks that historically dominated the story.
Bear case
-
Pediatric ceiling and quarterly volatility. Pediatric SR-aGvHD is a small orphan population, and quarterly net revenue moved from about US$30 million (December, net-equivalent) to US$30.3 million (March) to US$36 million (June). Growth may plateau before adult data arrive in late 2027.
-
Binary clinical risk with a mixed track record. DREAM-HF missed its primary endpoint, the earlier CLBP study did not deliver registrational success, and the company received two CRLs. A CLBP failure in 2027 would remove the largest part of the long-term thesis.
-
Concentration and governance. About 96% of revenue comes from one product made at one third-party site, and the sole lender is the largest shareholder and a director. Receivables (US$57.7 million) and inventory (US$28.1 million) are rising faster than cash collection.
Key catalysts and monitorables (next 12 months)
| Expected timing | Catalyst / monitorable |
|---|---|
| Oct 2026 | Q1 FY2027 Ryoncil revenue update and Appendix 4C |
| Nov 2026 | AGM: vote on warrants for Dr George (deadline 30 Nov 2026); board renewal (adding US commercial expertise) |
| Q4 CY2026 | FDA discussion of REVASCOR modular BLA review |
| CY2026–2027 | Adult SR-aGvHD trial site activation and enrolment pace (~40 sites); DMD registrational trial start |
| H1 CY2027 | H1 FY2027 results; FY2027 revenue run-rate; gross-to-net trend; DSO normalisation |
| CY2027 | Second manufacturing site announcement; partnering deals (heart failure NYHA II/III, inflammatory indications, ex-US) |
| Mid/H2 CY2027 (just beyond 12 months) | CLBP Phase 3 top-line data |
| Q4 CY2027 | Adult aGvHD interim analysis |
Concluding analyst verdict
Mesoblast has done what many skeptics thought it never would. It secured the first FDA approval for an MSC therapy and turned it, within 15 months, into a US$115 million product with gross margins above 90% and a near-breakeven second-half cash burn. FY2026 marks a real regime change: the debate is no longer about whether the platform can be approved and manufactured to FDA standards, but about how large the franchise can become.
The quality of the FY2026 print is mixed but improving. Revenue met guidance. Operating cash burn fell to US$43.8 million for the year and US$13.4 million in the second half. The refinancing replaced costly structured debt with an 8% interest-only facility secured only by a legacy royalty.
Against that, a US$27 million swing in non-cash contingent-consideration remeasurements flatters the headline improvement in net loss. Working capital is absorbing cash. Revenue remains concentrated in one pediatric orphan indication made at one contract site.
At an enterprise value of about US$2.0 billion (about 17× FY2026 sales), the market is paying for growth beyond the pediatric label but not for full pipeline success. That seems broadly rational. Two binary readouts in 2027 will define the next valuation leg:
-
adult SR-aGvHD, with an interim analysis in Q4 CY2027;
-
CLBP, with top-line data in mid/H2 CY2027.
Management's credibility on timelines, historically its main weakness, has improved through 2026: guidance was met, enrolment targets were beaten, and the potency assay was approved.
Verdict: a constructive but high-variance profile. The commercial base and balance sheet now give Mesoblast enough runway to reach its 2027 catalysts without forced dilution. That is a material change from its history.
Investors should track Ryoncil quarterly net revenue (sustained growth above about US$36 million per quarter), receivables collection, progress toward a second manufacturing site, and governance around the related-party lender. The risk-reward is asymmetric toward the CLBP outcome. Position sizing should reflect a meaningful probability of trial failure, given the company's mixed history in randomised studies.
End of dossier. All figures in US dollars unless stated. "n/d" means not disclosed in sources reviewed; "n/m" means not meaningful; "derived" means calculated by the analyst from reported line items. Where sources conflict, both values are noted in the relevant section.
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View Subscription PlansExecutive Leadership
Executive Leadership Team
| Name | Title | Tenure / background | Source |
|---|---|---|---|
Dr Silviu Itescu | Chief Executive Officer and Executive Director (founder) | Founder in 2004. Physician-scientist with a background in transplant immunology and cardiology at Columbia University (reported). Bought shares on market in July 2026 (Appendix 3Y, 21 July 2026). | FY2026 20-F; ASX |
Andrew Chaponnel | Chief Financial Officer (served as interim CFO from at least August 2024; current title per FY2026 calls) | Presented FY2024 to FY2026 financial results | FY2024 earnings call transcript; FY2026 call |
Niva Sivakumar | Company Secretary | Signed the August 2026 6-K | 6-K, 27 Aug 2026 |
Paul Hughes | Corporate Communications / Investors; previously signed 6-Ks as Company Secretary | Investor contact on the FY2026 release | 6-K filings |
Board of Directors
| Director | Role | Committees | Joined | Background |
|---|---|---|---|---|
Philip Facchina | Non-executive Chair (from 1 January 2026) | — | March 2021 | More than 40 years in corporate strategy and healthcare finance |
William Burns | Vice-Chair; independent NED | Chair, Nomination and Remuneration Committee | — | Former senior Roche pharmaceuticals executive (reported) |
Jane Bell | Non-executive director | — | — | Chair through the approval and launch period; retired as Chair on 1 January 2026 |
Lyn Cobley | Independent NED | Chair, Audit and Risk Committee (from 1 January 2026) | April 2025 | Former CEO of Westpac Institutional Bank; former Group Treasurer of Commonwealth Bank of Australia; senior roles at Barclays Capital and Citibank; current CBA director |
Dr Gregory George MD PhD | Non-executive director; largest shareholder | — | — | Provider of the US$125 million credit facility (related-party transaction) |
Dr Eric Rose | Non-executive director | — | — | Cardiothoracic surgeon; Appendix 3Y filings January and March 2026 |
Dr Philip Krause | Non-executive director | — | — | Former senior FDA vaccine regulator (reported); Appendix 3Y filed 24 August 2026 |
Dr Silviu Itescu | Executive director, CEO | — | 2004 | Founder |
Board & Management Changes
| Date | Change | Context |
|---|---|---|
Aug 2024 | Andrew Chaponnel serving as interim CFO | — |
Apr 2025 | Lyn Cobley appointed to the board | Corporate finance depth ahead of refinancing |
| 2025 | Dr Gregory George joins the board | Largest shareholder representation |
1 Jan 2026 | Bell steps down as Chair; Facchina becomes Chair; Cobley becomes ARC Chair; Burns stays Vice-Chair | Foreshadowed at the 2025 AGM; described as reflecting the transition to a commercial company |
12 Mar 2026 | Appointment of Head of Clinical Development and Medical Affairs | Ahead of Phase 3 readouts and BLAs |
Major Shareholders
| Holder category | Stake | Source / comment |
|---|---|---|
Insiders (aggregate) | ~18.8% | MarketBeat (basis unclear; may relate to ADS float) |
US institutions (ADS) | ~1.43% of ADS | MarketBeat; understates total institutional ownership because most holdings are ASX ordinary shares |
Competitive Landscape
Key Competitors
| # | Competitor | Area | Product / approach | Relative positioning versus Mesoblast |
|---|---|---|---|---|
| 1 | Incyte | Acute GvHD (second line) | Jakafi® (ruxolitinib), the only FDA-approved second-line agent for adult SR-aGvHD | Incumbent standard of care. Mesoblast is positioning Ryoncil as a combination partner, not a replacement. |
| 2 | Novartis | GvHD ex-US | Jakavi® (ruxolitinib) ex-US | Global incumbent; former Mesoblast partner (ARDS) |
| 3 | Sanofi | Chronic GvHD | Rezurock® (belumosudil) | Adjacent (chronic, not acute) GvHD market |
| 4 | Syndax / Incyte | Chronic GvHD | Niktimvo® (axatilimab) | Adjacent cGvHD |
| 5 | Cynata Therapeutics (ASX: CYP) | aGvHD | iPSC-derived MSCs (CYP-001), Phase 2 | Most direct MSC challenger; earlier-stage |
| 6 | Pluri / other MSC developers (e.g., Longeveron, Brainstorm) | Various | Allogeneic MSC platforms | Mostly clinical-stage; none FDA-approved for an MSC indication |
| 7 | Boston Scientific (Relievant) | CLBP | Intracept® basivertebral nerve ablation for vertebrogenic pain | Device alternative in interventional back pain |
| 8 | Medtronic / Abbott / Nevro | CLBP | Spinal cord stimulation | Established interventional alternatives for refractory pain |
| 9 | Vertex Pharmaceuticals | Pain (systemic) | Journavx® (suzetrigine), a non-opioid NaV1.8 inhibitor | Systemic non-opioid analgesia; could compete for the refractory pain population |
| 10 | DiscGenics; Spine BioPharma | Degenerative disc disease | Discogenic progenitor cells (IDCT); SB-01 peptide | Direct biologic disc competitors, clinical-stage |
| 11 | Abbott | LVAD / heart failure | HeartMate 3 LVAD | Device platform defining the REVASCOR target population (complementary) |
| 12 | BioCardia | Heart failure cell therapy | CardiAMP (autologous) | Clinical-stage cardiac cell-therapy competitor |
Peer Comparison FY2026
| Metric | Mesoblast (FY2026, June YE) | Incyte (CY2024) | Vertex (CY2024) | Boston Scientific (CY2024) |
|---|---|---|---|---|
Revenue (USD Bn) | 0.12 | 4.24 | 11.02 | 16.75 |
Revenue growth (%) | 599 | ~15 | ~12 | ~18 |
Gross margin (%) | 86 | — | — | — |
Net margin (%) | -48 | — | — | — |
R&D intensity (% of revenue) | 81 | — | — | — |



