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Mesoblast (MESO)
:MESO
US Market

Mesoblast (MESO) AI Stock Analysis

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MESO

Mesoblast

(NASDAQ:MESO)

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Neutral 53 (OpenAI - 4o)
Rating:53Neutral
Price Target:
$17.50
▼(-0.85% Downside)
Mesoblast's overall stock score reflects a company with strong growth potential but significant financial challenges. The earnings call provided positive insights into market access and product launches, which are promising for future growth. However, financial performance and valuation concerns weigh down the score, with technical indicators suggesting caution due to overbought conditions.
Positive Factors
Revenue Growth
Strong revenue growth driven by Ryoncil's successful launch indicates robust market demand and enhances long-term financial prospects.
Regulatory Approval
FDA approval of Ryoncil enhances credibility and market access, providing a competitive edge in the regenerative medicine sector.
Insurance Coverage
Extensive insurance coverage for Ryoncil ensures broad patient access, supporting sustained revenue streams and market penetration.
Negative Factors
Profitability Challenges
Ongoing profitability issues indicate operational inefficiencies, which could hinder long-term financial stability and growth.
Increased Expenses
Rising operational expenses due to product launches may pressure margins, affecting the company's ability to achieve profitability.
Cash Flow Concerns
Negative cash flow highlights liquidity challenges, potentially limiting investment in growth initiatives and operational flexibility.

Mesoblast (MESO) vs. SPDR S&P 500 ETF (SPY)

Mesoblast Business Overview & Revenue Model

Company DescriptionMesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines in the United States, Australia, Singapore, the United Kingdom, and Switzerland. The company offers products in the areas of cardiovascular, spine orthopedic disorder, oncology, hematology, and immune-mediated and inflammatory diseases. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage cells. The company's products under the Phase III clinical trials include remestemcel-L for the treatment of steroid refractory acute graft versus host disease, as well as acute respiratory distress syndrome due to COVID-19 infection; Rexlemestrocel-L to treat advanced chronic heart failure; and MPC-06-ID for chronic low back pain due to degenerative disc disease. It is also developing MPC-300-IV for the treatment of biologic refractory rheumatoid arthritis diabetic nephropathy. The company has strategic partnerships with Tasly Pharmaceutical Group to offer MPC-150-IM for heart failure and MPC-25-IC for heart attacks in China; JCR Pharmaceuticals Co. Ltd. for the treatment of wound healing in patients with epidermolysis bullosa; and Grünenthal to develops and commercializes cell therapy for the treatment of chronic low back pain. Mesoblast Limited was incorporated in 2004 and is headquartered in Melbourne, Australia.
How the Company Makes MoneyMesoblast generates revenue primarily through the commercialization of its cellular therapies, which include its lead product candidates such as remestemcel-L and MPC-150-IM. The company earns money through product sales, licensing agreements, and partnerships with pharmaceutical companies for research and development. Significant partnerships, such as those with leading healthcare organizations, help expand its market reach and enhance its product pipeline, providing additional revenue opportunities through milestone payments and royalties on sales. Furthermore, Mesoblast may receive funding from grants and research initiatives aimed at advancing its innovative therapies.

Mesoblast Earnings Call Summary

Earnings Call Date:Aug 28, 2025
(Q4-2025)
|
% Change Since: |
Next Earnings Date:Feb 26, 2026
Earnings Call Sentiment Positive
The earnings call illustrated significant growth and successful product launch achievements, particularly with Ryoncil's market penetration and FDA approval. However, increased operational expenses and revaluation-related losses presented financial challenges. Overall, the company's positive strides in market access and regulatory feedback indicate strong potential for future growth.
Q4-2025 Updates
Positive Updates
Record Revenue Growth
Revenue from cell therapy products reached $17.2 million, up 191% from the prior year, driven by the successful launch of Ryoncil.
Successful Launch of Ryoncil
Ryoncil, the first and only FDA-approved MSC therapy, launched successfully with 32 transplant centers onboarded and coverage for over 250 million lives in the U.S.
Strong Market Access for Ryoncil
Ryoncil is covered by insurance plans representing over 250 million lives, with Medicaid coverage in all states as of July 1.
Promising FDA Feedback for Heart Failure Therapy
FDA indicated support for an accelerated approval pathway for Revascor in heart failure, based on existing data and a planned confirmatory trial.
J-Code Issued for Ryoncil
A specific J-Code for Ryoncil is set to go into effect on October 1, allowing for more efficient billing and reimbursement processes.
Negative Updates
Increased Expenses
Selling, general, and administrative expenses increased by $14.3 million to $39.3 million, related to commercial team build and product launch.
Revaluation Losses
Revaluation of contingent consideration resulted in a loss of $14.9 million, and a warrant remeasurement loss of $5 million due to FDA approval-related share price appreciation.
Company Guidance
During the Mesoblast financial results call for the full year ended June 30, 2025, CEO Dr. Silviu Itescu provided comprehensive guidance on the company's performance and future outlook. The FDA-approved product, Ryoncil, generated $17.2 million in revenue, marking a 191% increase from the previous year, with $13.2 million in gross sales in the final quarter alone. The company onboarded 32 transplant centers and aims to cover the top 45 by the end of the quarter, with coverage extending to over 250 million insured lives in the U.S. Mesoblast's financials showed $162 million in cash on hand, with operating expenses including a $39.3 million increase due to the commercial launch and a $14.9 million non-cash revaluation loss. The company is preparing for further label expansion in adult GvHD and inflammatory bowel disease, with ongoing trials for their second-generation technology, rexlemestrocel-L, targeting heart failure and chronic low back pain, both representing over $10 billion in addressable market opportunities.

Mesoblast Financial Statement Overview

Summary
Mesoblast's financial performance shows significant revenue growth but persistent profitability challenges. The income statement reveals substantial losses, and the balance sheet indicates moderate leverage with a negative return on equity. Cash flow issues persist despite some improvement in cash generation.
Income Statement
35
Negative
Mesoblast's income statement reveals significant challenges. Despite a notable revenue growth rate of 203.32% in the latest year, the company continues to face substantial losses, with a net profit margin of -5.94% and negative EBIT and EBITDA margins. This indicates ongoing operational inefficiencies and a struggle to achieve profitability.
Balance Sheet
45
Neutral
The balance sheet shows a moderate debt-to-equity ratio of 0.21, suggesting manageable leverage levels. However, the return on equity is negative at -17.10%, reflecting the company's inability to generate profits from its equity base. The equity ratio stands at a healthy level, indicating a stable capital structure.
Cash Flow
40
Negative
Cash flow analysis highlights some concerns, with negative operating cash flow and free cash flow. However, the free cash flow to net income ratio is slightly above 1, indicating that the company is generating cash relative to its net losses. The free cash flow growth rate of 140.51% suggests some improvement in cash generation.
BreakdownTTMDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue17.20M17.20M5.90M7.50M10.21M7.46M
Gross Profit-35.86M12.07M-35.17M-47.42M-53.36M-78.28M
EBITDA-58.18M-73.66M-56.08M-58.55M-76.57M-84.65M
Net Income-102.14M-102.14M-87.96M-81.89M-91.35M-98.81M
Balance Sheet
Total Assets784.68M784.68M669.15M669.41M662.14M744.72M
Cash, Cash Equivalents and Short-Term Investments161.16M161.16M62.56M70.92M60.03M136.88M
Total Debt128.16M128.16M118.92M116.50M106.91M105.50M
Total Liabilities187.24M187.24M188.80M167.58M165.10M163.32M
Stockholders Equity597.44M597.44M480.36M501.84M497.04M581.40M
Cash Flow
Free Cash Flow-48.69M-50.68M-48.79M-63.58M-66.01M-108.33M
Operating Cash Flow-47.99M-49.95M-48.46M-63.27M-65.78M-106.68M
Investing Cash Flow120.00K120.00K-97.00K-194.00K-232.00K-1.65M
Financing Cash Flow147.34M147.34M40.25M74.50M-9.87M114.47M

Mesoblast Technical Analysis

Technical Analysis Sentiment
Positive
Last Price17.65
Price Trends
50DMA
16.84
Positive
100DMA
16.25
Positive
200DMA
14.10
Positive
Market Momentum
MACD
0.65
Negative
RSI
61.67
Neutral
STOCH
63.36
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MESO, the sentiment is Positive. The current price of 17.65 is above the 20-day moving average (MA) of 17.36, above the 50-day MA of 16.84, and above the 200-day MA of 14.10, indicating a bullish trend. The MACD of 0.65 indicates Negative momentum. The RSI at 61.67 is Neutral, neither overbought nor oversold. The STOCH value of 63.36 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for MESO.

Mesoblast Risk Analysis

Mesoblast disclosed 79 risk factors in its most recent earnings report. Mesoblast reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Mesoblast Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
81
Outperform
$2.23B11.8025.93%21.13%50.86%
53
Neutral
$2.37B-21.99-18.96%191.53%5.09%
53
Neutral
$2.46B-30.66-37.18%42.57%60.03%
53
Neutral
$1.81B-61.45-7.52%27.51%38.72%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$2.22B-7.03-21.37%47.15%-311.26%
37
Underperform
$6.00B-15.99-95.40%4.32%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
MESO
Mesoblast
18.60
1.84
10.98%
SRPT
Sarepta Therapeutics
20.34
-99.13
-82.97%
COGT
Cogent Biosciences
37.90
30.10
385.90%
ADPT
Adaptive Biotechnologies
16.50
10.50
175.00%
HRMY
Harmony Biosciences Holdings
37.47
3.58
10.56%
IMCR
Immunocore Holdings
35.90
7.48
26.32%

Mesoblast Corporate Events

Mesoblast’s AGM Results: All Resolutions Passed on November 25, 2025
Nov 26, 2025

On November 25, 2025, Mesoblast Limited announced the results of its Annual General Meeting, where all proposed resolutions were passed by a poll. The resolutions included the adoption of the remuneration report, election and re-election of directors, approval of options for long-term and short-term incentives, and the approval of convertible notes and warrants. These outcomes reflect strong shareholder support and are likely to positively impact the company’s strategic direction and stakeholder confidence.

Mesoblast Achieves FDA Approval for Ryoncil®
Nov 25, 2025

On November 25, 2025, Mesoblast Limited announced at its Annual General Meeting that it has achieved FDA approval for Ryoncil®, a mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. This approval marks a significant milestone for Mesoblast, transitioning the company from development to commercialization with strong sales and reimbursement coverage. The success of Ryoncil® validates Mesoblast’s scientific platform and commercialization strategy, and the company is now expanding its use to additional indications and preparing for further FDA approvals for other products in its pipeline.

Mesoblast to Launch Pivotal Ryoncil® Trial for Severe aGvHD in Adults
Nov 24, 2025

On November 21, 2025, Mesoblast Limited announced a collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to initiate a pivotal trial of Ryoncil® for adults with severe acute graft versus host disease (aGvHD) who are refractory to corticosteroids. This trial aims to extend the use of Ryoncil®, already FDA-approved for children, to adults, addressing a significant unmet need due to high mortality rates in patients failing existing therapies. The trial, set to begin enrollment in early 2026, represents a substantial market opportunity, potentially 3-4 times larger than the pediatric market.

Mesoblast Announces Director’s Share Acquisition and New Equity Issuance
Oct 29, 2025

On October 28, 2025, Mesoblast Limited announced a change in director’s interest and the issuance of new equity securities. William Burns, a director, acquired 120,000 ordinary shares through the exercise of options, increasing his total holdings. This move reflects Mesoblast’s ongoing efforts to strengthen its financial position and enhance shareholder value, potentially impacting its market standing and investor relations.

Mesoblast Reports Strong Revenue Growth with Ryoncil® Adoption
Oct 22, 2025

On October 20, 2025, Mesoblast Limited reported a significant increase in revenues for the quarter ended September 30, 2025, driven by the adoption of Ryoncil®, which saw a 69% increase in net sales. The assignment of a permanent J-Code by CMS on October 1, 2025, is expected to further enhance product adoption. Mesoblast has onboarded 40 transplant centers and expanded coverage to over 260 million US lives. The company plans a pivotal trial for Ryoncil® in adults with severe SR-aGvHD, aiming to extend its label to a larger population. Mesoblast’s financial position remains strong with $145 million in cash and new funding options.

Mesoblast’s U.S. Origin Designation Shields Products from Tariffs
Sep 29, 2025

On September 26, 2025, Mesoblast Limited announced that its allogeneic cell therapy products, including Ryoncil®, are designated as U.S. origin products and are not subject to tariffs on imported branded or patented pharmaceutical products. This designation aligns with U.S. FDA and Customs regulatory guidance, ensuring that Mesoblast’s products remain competitive in the market. The announcement underscores Mesoblast’s commitment to manufacturing its therapies from U.S. donors at U.S. sites, which is crucial for maintaining its market position and operational efficiency. This development is significant for stakeholders as it reinforces the company’s strategic positioning in the global market for cellular medicines.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Nov 28, 2025