Mesoblast Limited
- Open
- 15.61
- Day high
- 15.73
- Day low
- 15.24
- Prev close
- 14.83
- Volume
- 292K
- Mkt cap
- $2.0B
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- 3.5
- P/S
- 30.4
- Yield
- —
- Per share
- —
- ▲Insiders net buying $938K over the last 3 months (7 open-market buys, 0 sales)
- 🏛Institutions mixed (13F)
Mesoblast Limited (MESO) is a Healthcare company listed on NASDAQ. The stock is up 35% over the past year. Over the trailing 3 months, insiders filed 7 open-market buys and 0 sales (SEC Form 4).
Mesoblast Limited (MESO) financials & analyst ratings
Fundamentals (TTM)
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
MESO earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Sep 3, 2025 | $-0.20 | $-0.21 | -6.4% | $7M | -77.1% |
| Feb 26, 2025 | $-0.25 | $-0.02 | +91.6% | $2M | -78.9% |
| Jul 4, 2024 | $-0.35 | $-0.26 | +25.7% | — | — |
| Aug 30, 2023 | $-0.32 | $-0.28 | +12.5% | $2M | -10.3% |
| May 25, 2023 | $-0.36 | $-0.26 | +27.8% | $2M | -9.4% |
| Feb 27, 2023 | $-0.30 | $-0.34 | -13.3% | $2M | -5.7% |
| Nov 22, 2022 | $-0.20 | $-0.24 | -20.0% | $1M | -58.4% |
| Aug 30, 2022 | $-0.10 | $-0.34 | -240.0% | $2M | -70.7% |
| May 31, 2022 | $-0.16 | $-0.32 | -100.0% | $2M | -4.2% |
| Feb 24, 2022 | $-0.39 | $-0.40 | -3.7% | $2M | -31.9% |
| Nov 23, 2021 | $-0.30 | $-0.34 | -13.3% | $4M | +46.1% |
| Aug 31, 2021 | $-0.32 | $-0.34 | -6.3% | $2M | +6.7% |
MESO insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 10,000 | $1.43 |
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 5,240 | $1.43 |
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 5,000 | $1.43 |
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 105,000 | $1.46 |
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 500,000 | $1.44 |
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 4,760 | $1.44 |
| Apr 13, 2026 | George Gregorydirector, 10 percent owner: | Buy | 20,000 | $1.43 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 5,000 | $14.30 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 4,000,000 | $1.42 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 2,324,072 | $1.48 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 886,890 | $1.43 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 500,000 | $14.39 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 10,000 | $14.40 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 4,760 | $14.40 |
| Apr 10, 2026 | George Gregorydirector, 10 percent owner: | Buy | 20,000 | $14.30 |
Source: MESO SEC Form 4 filings, latest Apr 13, 2026. For informational purposes only — not investment advice.
See the full MESO insider & 13F page →Mesoblast Limited company profile
Overview
Mesoblast Limited (NASDAQ:MESO) is an Australian biopharmaceutical company founded in 2004 and headquartered in Melbourne. The company specializes in developing and commercializing allogeneic cellular medicines based on mesenchymal stromal cells (MSCs), a type of adult stem cell. Mesoblast went public in 2010 and has since established itself as a pioneer in the regenerative medicine field. The company achieved a significant milestone in 2024 with the FDA approval of RYONCIL, the first mesenchymal stromal cell therapy approved in the United States, marking its transition from a pure development-stage company to one with commercial operations.
Business
Mesoblast operates in the regenerative medicine sector of biotechnology, focusing on developing cellular therapies using mesenchymal stromal cells (MSCs). These are specialized adult stem cells found in bone marrow and other tissues that have the ability to differentiate into various cell types including bone, cartilage, and fat cells. More importantly for Mesoblast's applications, MSCs possess potent anti-inflammatory and tissue repair properties, making them valuable for treating diseases characterized by inflammation and tissue damage. The company's product portfolio centers around two main platforms. RYONCIL (remestemcel-L) represents their first commercial product, approved by the FDA for treating steroid-refractory acute graft-versus-host disease (GVHD) in children. GVHD is a serious complication that occurs after bone marrow transplants when the donated immune cells attack the patient's organs. The second platform, Rexlemestrocel-L, is being developed for multiple indications including chronic low back pain due to degenerative disc disease and heart failure. The company also has additional programs in development, including MPC-300-IV for rheumatoid arthritis and diabetic nephropathy. Mesoblast's approach differs from traditional pharmaceuticals in that their products are living cell therapies that must be manufactured under strict conditions and administered intravenously in hospital settings. The company has established strategic partnerships globally, including agreements with Tasly Pharmaceutical Group in China, JCR Pharmaceuticals in Japan, and Grünenthal in Europe for various indications.
Revenue model
Mesoblast generates revenue through multiple business models. The primary revenue source is product sales from RYONCIL, which carries a wholesale acquisition cost of $194,000 per intravenous infusion. The company targets the 45 highest-volume transplant centers in the United States, which account for approximately 80% of pediatric GVHD patients. Given the severity of the condition and lack of effective alternatives, the pricing reflects the significant medical value provided. The company also receives royalty payments from licensing agreements, particularly from TEMCELL sales in Japan through their partnership with JCR Pharmaceuticals, which generated $8.7 million in royalties in fiscal 2022. Additional milestone payments and upfront fees from strategic partnerships contribute to revenue, though these are typically one-time or infrequent payments. Several factors influence Mesoblast's profitability margins. Positive factors include the high-value, specialized nature of their products which command premium pricing, the limited competition in approved mesenchymal stromal cell therapies, and the potential for label expansions that could significantly increase addressable markets without proportional increases in development costs. The company's manufacturing capabilities and intellectual property portfolio, with over 1,000 patents extending to 2037, provide additional competitive advantages. However, margin pressures come from the high costs of maintaining cell therapy manufacturing facilities, extensive regulatory requirements for biologics, the need for specialized cold-chain distribution, and significant ongoing clinical trial expenses for pipeline products. The company's current cash burn rate of approximately $20-25 million per quarter reflects these operational challenges, though management has implemented cost reduction measures including salary cuts and workforce reductions to improve efficiency.
Competitive moat
Mesoblast's competitive moat is moderately strong but faces several challenges. The company's primary advantages include being the first to achieve FDA approval for a mesenchymal stromal cell therapy in the United States, giving it significant first-mover advantage in an emerging therapeutic category. Their extensive intellectual property portfolio with over 1,000 patents provides substantial protection through 2037 and beyond, covering both the cell therapy technology and manufacturing processes. The company has also developed proprietary manufacturing capabilities and established relationships with key transplant centers through expanded access programs, creating switching costs for healthcare providers already familiar with their products. The regulatory pathway for cell therapies involves substantial barriers to entry, requiring specialized expertise and significant capital investment that deters many potential competitors. However, the moat faces potential erosion from several sources. Large pharmaceutical companies with greater resources could enter the mesenchymal stromal cell space through acquisitions or internal development programs. The underlying science of MSCs is well-understood, and while Mesoblast has patents on specific formulations and processes, the fundamental approach could potentially be replicated with different methodologies. Additionally, alternative treatment approaches for their target indications, including gene therapies, small molecule drugs, or other cell therapy platforms, could reduce demand for their products. The company's financial constraints also limit their ability to defend their market position through aggressive R&D investment or marketing compared to larger pharmaceutical companies. The relatively small addressable markets for some of their initial indications may not justify significant competitive investment from larger players, which paradoxically both protects and limits Mesoblast's growth potential.
Risks & safety
Mesoblast's margin of safety is currently limited, reflecting the inherent risks of a development-stage biotechnology company transitioning to commercialization. • Liquidity position: $38 million cash as of Q2 2025, with pro forma cash of approximately $200 million following a recent $161 million private placement, providing roughly 2-3 years of runway at current burn rates • Cash burn: Net operating cash usage of $20.7 million in the most recent half-year, representing a 22% improvement from prior periods due to cost reduction initiatives • Current ratio: 0.96, indicating current liabilities slightly exceed current assets, though this improved significantly with the recent capital raise • Debt levels: Debt-to-equity ratio of 0.27, representing manageable leverage levels for a biotechnology company • Valuation metrics: Trading at 4.9x book value, which is elevated but not uncommon for biotechnology companies with approved products and significant intellectual property assets • Revenue visibility: Limited revenue base of approximately $1.6 million quarterly from RYONCIL launch, creating uncertainty around commercial uptake and future cash generation The company's financial position improved substantially with the recent private placement, but success depends heavily on successful commercialization of RYONCIL and advancement of pipeline programs to value-creating milestones.
Recent development
Over the past few years, Mesoblast has undergone a significant transformation from a pure development-stage company to one with an approved commercial product. The most significant milestone was achieving FDA approval for RYONCIL in 2024 after overcoming regulatory challenges including a Complete Response Letter that required additional manufacturing and potency data. The company successfully resubmitted their Biologics License Application and received approval for treating steroid-refractory acute GVHD in pediatric patients. The commercial launch of RYONCIL represents a strategic pivot toward building internal commercialization capabilities. Management deployed nine key account managers to target the 45 highest-volume transplant centers, leveraging existing relationships built through expanded access programs. The company is also pursuing label expansion opportunities, including studies for inflammatory bowel disease and adult GVHD populations, which could significantly expand the addressable market. In parallel, Mesoblast has advanced their Rexlemestrocel-L platform through multiple clinical programs. The chronic low back pain program completed its first Phase III trial and is currently enrolling a second confirmatory Phase III study. For heart failure applications, the company is pursuing an accelerated approval pathway with the FDA, focusing on end-stage ischemic heart failure patients where traditional treatments have limited effectiveness. The company has also implemented significant cost management initiatives, including voluntary salary reductions for senior management, workforce optimization, and strategic partnerships to share development costs. The recent $161 million private placement provides financial runway to execute on commercial and development objectives while the company works toward profitability through RYONCIL sales growth and potential additional approvals.
MESO company profile · for informational purposes only — not investment advice.
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