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Mesoblast Limited (AU:MSB)
ASX:MSB

Mesoblast Limited (MSB) AI Stock Analysis

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AU:MSB

Mesoblast Limited

(Sydney:MSB)

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Neutral 55 (OpenAI - 4o)
Rating:55Neutral
Price Target:
AU$3.00
▲(8.30% Upside)
Mesoblast Limited's overall score is driven by strong revenue growth and strategic product launches, as highlighted in the earnings call. However, significant profitability and cash flow challenges, along with a negative P/E ratio, weigh on the score. Technical indicators suggest short-term bullish momentum, but caution is advised due to potential overbought conditions.
Positive Factors
Revenue Growth
The substantial revenue growth indicates strong market acceptance and potential for Mesoblast's products, supporting long-term business expansion.
Product Launch Success
Successful launch of Ryoncil demonstrates Mesoblast's capability to bring innovative therapies to market, enhancing its competitive position.
Strong Financial Position
A robust cash position provides Mesoblast with the financial flexibility to invest in R&D and navigate potential market challenges.
Negative Factors
Profitability Challenges
Persistent profitability issues could hinder long-term sustainability, as high operating costs continue to impact the bottom line.
Increased Operating Expenses
Rising expenses related to commercial operations may pressure margins, affecting Mesoblast's ability to achieve profitability.
Regulatory Challenges
Regulatory hurdles in expanding product indications could delay market entry and revenue realization, impacting growth prospects.

Mesoblast Limited (MSB) vs. iShares MSCI Australia ETF (EWA)

Mesoblast Limited Business Overview & Revenue Model

Company DescriptionMesoblast Limited engages in the development of regenerative medicine products in Australia, the United States, 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 offers Remestemcel-L that is in Phase III clinical trials for the treatment of systemic inflammatory diseases, including steroid refractory acute graft versus host disease, acute respiratory distress syndrome, and biologic refractory inflammatory bowel disease; and Remestemcel-L, which is in Phase III clinical trials to treat chronic heart failure and chronic low back pain due to degenerative disc disease. It is also developing MPC-300-IV to treat biologic refractory rheumatoid arthritis diabetic nephropathy; and MPC-25-IC for the treatment or prevention of acute myocardial infarction. 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. to treat 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 proprietary cell therapy products, which are developed for various medical applications. The company's revenue model includes sales of its products once they receive regulatory approval and enter the market. Additionally, Mesoblast has entered into strategic partnerships and collaborations with pharmaceutical companies, which can provide upfront payments, milestone payments upon achieving specific regulatory or commercial goals, and royalties on future sales. These partnerships are crucial for funding the development of its products and expanding its market reach. Furthermore, Mesoblast may also generate revenue from licensing its technologies to third parties, contributing to its overall earnings.

Mesoblast Limited 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 reflects a strong positive trajectory for Mesoblast, driven by the successful commercial launch of Ryoncil and significant revenue growth. Despite increased expenses and some regulatory challenges, the company shows robust market potential and financial health.
Q4-2025 Updates
Positive Updates
Ryoncil Commercial Launch Success
Ryoncil, the first FDA-approved mesenchymal stromal cell therapy, launched with 32 transplant centers onboarded, and aims to reach 45 centers covering 80% of pediatric bone marrow transplants in the U.S. by the end of the quarter. Coverage includes over 250 million insured lives in the U.S.
Revenue Surge
Revenue from cell therapy products reached $17.2 million, up 191% from the prior year, driven by the successful launch of Ryoncil.
High Market Potential
Ryoncil's addressable market is approximately $1 billion, with potential label extensions for adults with acute GvHD and inflammatory bowel disease, adding opportunities of more than $5 billion.
Strong Financial Position
The company's cash on hand as of June 30, 2025, was $162 million.
Promising Trial Outcomes
Pivotal Phase III trial results for Ryoncil showed a 70% day 28 response rate with nearly 50% long-term survival in severe disease patients.
Negative Updates
Increased Operating Expenses
Selling, general, and admin expenses increased by $14.3 million to $39.3 million, related to the commercial team build and product launch.
Non-cash Losses
Recognized a $14.9 million loss in revaluation of contingent consideration and a $5 million warrant remeasurement loss due to FDA approval and share price changes.
Challenges with Adult GvHD Trial
The need for a pivotal trial for Ryoncil in adults with severe acute GvHD indicates ongoing regulatory and clinical challenges.
Company Guidance
During the Mesoblast financial results call for the fiscal year ended June 30, 2025, CEO Dr. Silviu Itescu highlighted significant growth and strategic developments. The company reported a 191% increase in revenue from cell therapy products, with total revenues reaching $17.2 million, largely driven by the successful commercial launch of Ryoncil, which generated $13.2 million in gross sales. Ryoncil, approved for pediatric steroid-refractory acute graft-versus-host disease, has been made available across 32 transplant centers in the U.S., aiming to cover 80% of pediatric bone marrow transplants by the end of the quarter. The company also noted expanding coverage, with over 250 million insured lives in the U.S., including Medicaid coverage in all states. Mesoblast's cash on hand as of June 30 was $162 million, and they maintain a gross margin of 90%. Looking forward, Mesoblast plans to expand Ryoncil's label to include adult acute GvHD and to initiate a pivotal study for inflammatory bowel disease. Additionally, their second-generation product, rexlemestrocel-L, is in a confirmatory Phase III trial for chronic low back pain, with the potential to address a market exceeding $10 billion annually.

Mesoblast Limited Financial Statement Overview

Summary
Mesoblast Limited shows strong revenue growth but faces significant profitability and cash flow challenges. The low debt-to-equity ratio is positive, but negative return on equity and persistent net losses highlight ongoing financial struggles.
Income Statement
45
Neutral
Mesoblast Limited has shown significant revenue growth of 203.3% in the latest year, which is a positive indicator. However, the company is struggling with profitability, as evidenced by negative net profit margins and EBIT margins. The gross profit margin is positive, but the net income remains negative, indicating high operating costs or other expenses impacting the bottom line.
Balance Sheet
50
Neutral
The company's debt-to-equity ratio is relatively low at 0.21, suggesting a conservative approach to leverage. However, the return on equity is negative, indicating that the company is not generating profits from its equity base. The equity ratio is stable, but the negative ROE highlights profitability challenges.
Cash Flow
40
Negative
The free cash flow has grown significantly by 140.5%, which is a positive sign. However, the operating cash flow remains negative, and the operating cash flow to net income ratio is also negative, indicating cash flow challenges. The free cash flow to net income ratio is slightly above 1, suggesting that free cash flow is covering net losses, but overall cash flow health is weak.
BreakdownTTMDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue5.67M17.20M5.90M7.50M10.21M7.46M
Gross Profit-22.57M12.07M-35.17M-47.42M-53.36M-78.28M
EBITDA-49.42M-73.66M-56.08M-58.55M-76.57M-84.65M
Net Income-103.35M-102.14M-87.96M-81.89M-91.35M-98.81M
Balance Sheet
Total Assets653.32M784.68M669.15M669.41M662.14M744.72M
Cash, Cash Equivalents and Short-Term Investments38.03M161.16M62.56M70.92M60.03M136.88M
Total Debt126.11M128.16M118.92M116.50M106.91M105.50M
Total Liabilities192.06M187.24M188.80M167.58M165.10M163.32M
Stockholders Equity461.26M597.44M480.36M501.84M497.04M581.40M
Cash Flow
Free Cash Flow-21.07M-50.68M-48.79M-63.58M-66.01M-108.33M
Operating Cash Flow-20.66M-49.95M-48.46M-63.27M-65.78M-106.68M
Investing Cash Flow618.00K120.00K-97.00K-194.00K-232.00K-1.65M
Financing Cash Flow4.39M147.34M40.25M74.50M-9.87M114.47M

Mesoblast Limited Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2.77
Price Trends
50DMA
2.57
Positive
100DMA
2.46
Positive
200DMA
2.15
Positive
Market Momentum
MACD
0.09
Negative
RSI
60.17
Neutral
STOCH
53.89
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AU:MSB, the sentiment is Positive. The current price of 2.77 is above the 20-day moving average (MA) of 2.56, above the 50-day MA of 2.57, and above the 200-day MA of 2.15, indicating a bullish trend. The MACD of 0.09 indicates Negative momentum. The RSI at 60.17 is Neutral, neither overbought nor oversold. The STOCH value of 53.89 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AU:MSB.

Mesoblast Limited Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
78
Outperform
$2.41B16.2854.79%12.35%26.73%
73
Outperform
AU$616.97M17.0115.90%0.41%7.76%1.55%
56
Neutral
AU$93.58M-9.78-49.72%10.78%
55
Neutral
AU$3.55B-21.21-18.95%198.58%3.97%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
AU$552.65M-8.89-35.86%-19.21%
41
Neutral
AU$276.51M-28.41-89.70%42.05%-0.84%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AU:MSB
Mesoblast Limited
2.77
0.94
51.37%
AU:CUV
Clinuvel Pharmaceuticals
12.29
0.20
1.65%
AU:NEU
Neuren Pharmaceuticals Limited
19.01
5.71
42.93%
AU:OCC
Orthocell Ltd
1.02
-0.16
-13.56%
AU:IMM
Immutep Ltd
0.38
0.03
10.29%
AU:PTX
Prescient Therapeutics Limited
0.09
0.05
125.00%

Mesoblast Limited Corporate Events

Mesoblast to Participate in Piper Sandler Healthcare Conference
Dec 4, 2025

Mesoblast Limited announced its participation at the Piper Sandler 37th Annual Healthcare Conference in New York, where CEO Silviu Itescu will engage in a fireside chat. This participation underscores Mesoblast’s active engagement with the healthcare investment community and highlights its strategic focus on expanding the reach of its innovative cellular therapies. The company’s presence at such events is crucial for maintaining its industry positioning and fostering relationships with stakeholders, potentially impacting its market influence and growth trajectory.

Mesoblast and BMT CTN Launch Pivotal Trial for Ryoncil® in Adult aGvHD
Nov 21, 2025

Mesoblast Limited, in collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network, is initiating a pivotal trial for Ryoncil® as a first-line treatment for adults with severe acute graft versus host disease (aGvHD) who are refractory to steroids. This trial aims to address the high non-responsiveness and mortality rates in these patients, offering a potentially life-saving treatment that has shown promising survival rates in previous studies. The trial represents a significant market opportunity, expanding the use of Ryoncil® beyond the pediatric population and addressing a major unmet medical need.

Mesoblast Appoints New CFO Amidst Commercial Transition
Nov 17, 2025

Mesoblast Limited has appointed James M. O’Brien as its new Chief Financial Officer, a strategic move as the company transitions to a fully integrated commercial organization. O’Brien’s extensive experience in financial management within the life sciences and pharmaceutical industries is expected to bolster Mesoblast’s financial leadership, aiding in the commercialization of its products and potential expansion into new markets.

Mesoblast to Discuss Opioid Reduction Data with FDA
Nov 5, 2025

Mesoblast Limited announced a scheduled meeting with the FDA to discuss data from its Phase 3 study of rexlemestrocel-L for opioid reduction in chronic low back pain patients. The study showed significant opioid cessation results, highlighting the potential impact of rexlemestrocel-L as a non-opioid treatment option amid the ongoing opioid crisis in the US. The FDA has recognized the importance of developing non-opioid treatments, and Mesoblast is actively recruiting for a confirmatory Phase 3 trial. The outcome of these discussions could significantly influence Mesoblast’s positioning in the market and offer a promising solution for patients with chronic low back pain.

Mesoblast Director Increases Shareholding Through Option Exercise
Oct 28, 2025

Mesoblast Limited announced a change in the director’s interest, with William Burns exercising options to acquire 120,000 ordinary shares, increasing his total holdings to 226,250 shares. This transaction, valued at A$157,200, reflects strategic financial management and potentially strengthens the director’s commitment to the company’s future growth.

Mesoblast Limited’s 2025 Annual Report Highlights Corporate Governance Commitment
Oct 27, 2025

Mesoblast Limited has released its Annual Report for 2025, highlighting its commitment to corporate governance and ethical management. The report, approved by the Board of Directors, outlines the company’s governance framework, emphasizing its dedication to transparency and accountability, which is crucial for maintaining stakeholder trust and industry leadership.

Mesoblast Limited Announces 2025 Annual General Meeting
Oct 27, 2025

Mesoblast Limited has announced its Annual General Meeting (AGM) scheduled for November 25, 2025, in Melbourne. The company encourages shareholders to attend in person or view the meeting online. Shareholders can vote in person or by proxy and are invited to submit questions in advance. This AGM is a crucial event for stakeholders to engage with the company’s management and discuss its performance and strategic direction.

Mesoblast Limited Releases 2025 Corporate Governance Statement
Oct 27, 2025

Mesoblast Limited has released its corporate governance statement for the financial year ending June 30, 2025, which is available on their website. The statement outlines the company’s adherence to the ASX Corporate Governance Council’s principles and recommendations, highlighting their commitment to transparency and accountability in management and oversight. This release is significant as it reinforces Mesoblast’s dedication to maintaining high governance standards, potentially impacting investor confidence and stakeholder trust.

Mesoblast Sees 69% Revenue Surge for Ryoncil® Amid Expanding Market Reach
Oct 20, 2025

Mesoblast Limited reported a significant 69% increase in net revenues for its product Ryoncil® in the second quarter following its launch, driven by increased physician adoption and reimbursement from commercial and government payers. The assignment of a permanent J-Code by the Centers for Medicare and Medicaid Services is expected to further enhance product adoption. The company has onboarded 40 transplant centers and expanded coverage to over 260 million US lives. Mesoblast is also planning a pivotal trial for Ryoncil® in adults with severe SR-aGvHD, potentially expanding its market reach. The company holds a strong cash position and is exploring additional funding options to support its operations and growth.

JPMorgan Chase & Co. Ceases Substantial Holding in Mesoblast Limited
Oct 14, 2025

JPMorgan Chase & Co. and its affiliates have ceased to be substantial holders in Mesoblast Limited, a company involved in the development of regenerative medicine products. The change in their substantial holding status is due to various transactions involving securities lending, purchasing, and sales, as well as the rehypothecation of client securities. This shift in holdings may impact Mesoblast’s market perception and investor confidence, as JPMorgan’s involvement was significant in terms of voting securities.

Mesoblast Limited Announces Cessation of Securities
Oct 14, 2025

Mesoblast Limited announced the cessation of certain securities, with 120,000 options lapsing due to unmet conditions and over 2 million options expiring without exercise. This development may impact the company’s financial strategy and investor relations, as it reflects on the company’s ability to meet certain operational milestones.

Mesoblast Limited to Quote 3 Million New Securities on ASX
Oct 14, 2025

Mesoblast Limited announced the application for the quotation of 3,000,000 ordinary fully paid securities on the Australian Securities Exchange (ASX). These securities are issued under an employee incentive scheme and are not subject to transfer restrictions. This move is part of Mesoblast’s strategy to enhance its market presence and incentivize its workforce, potentially impacting its operational dynamics and stakeholder engagement positively.

Mesoblast Reports 66% Revenue Surge for Ryoncil in Second Quarter
Oct 7, 2025

Mesoblast Limited reported a significant 66% increase in revenue for its product Ryoncil, reaching US$21.9 million in the second quarter post-launch. This growth is attributed to the adoption of Ryoncil for treating pediatric steroid-refractory acute graft-versus-host disease, supported by reimbursement from commercial and government payers. The recent assignment of a permanent J-Code by the Centers for Medicare and Medicaid Services is expected to further enhance product adoption. This development strengthens Mesoblast’s position in the cellular medicine industry and indicates positive implications for stakeholders, highlighting the company’s potential for continued growth and market expansion.

Mesoblast’s Ryoncil® Gains Medicare & Medicaid J-Code for Enhanced Access
Oct 3, 2025

Mesoblast Limited announced that its product Ryoncil® has received a permanent J-Code from the United States Medicare & Medicaid Services, facilitating easier billing and reimbursement. This milestone is expected to enhance patient access to Ryoncil®, particularly for children with life-threatening steroid-refractory acute graft-versus-host disease, and improve the product’s commercialization prospects.

Mesoblast’s U.S. Origin Cell Therapies Exempt from Tariffs
Sep 26, 2025

Mesoblast Limited announced that its allogeneic cell therapy products, manufactured in the U.S. from U.S. donors, are designated as U.S. origin products and are not subject to tariffs on imported branded or patented pharmaceutical products. This designation, particularly for Ryoncil®, the only FDA-approved allogeneic mesenchymal stromal cell therapy, reinforces Mesoblast’s strategic positioning in the market by ensuring cost stability and regulatory compliance, potentially benefiting stakeholders by maintaining competitive pricing and access in the U.S. market.

State Street Corporation Ceases Substantial Holding in Mesoblast Limited
Sep 22, 2025

Mesoblast Limited has announced that State Street Corporation and its subsidiaries have ceased to be substantial holders in the company as of September 18, 2025. This change in substantial holding could impact Mesoblast’s shareholder composition and influence voting dynamics, potentially affecting the company’s strategic decisions and market positioning.

State Street Corporation Ceases Substantial Holding in Mesoblast Limited
Sep 15, 2025

Mesoblast Limited has announced that State Street Corporation and its subsidiaries have ceased to be substantial holders of the company’s voting securities as of September 11, 2025. This change in substantial holding may impact Mesoblast’s shareholder structure and could influence the company’s strategic decisions and market perception.

Mesoblast Highlights Successful Launch of Ryoncil® at Global Conferences
Sep 15, 2025

Mesoblast Limited announced the successful commercial launch of Ryoncil® (remestemcel-L-rknd), the first FDA-approved mesenchymal stromal cell product, at global healthcare conferences. The company reported strong initial sales for treating pediatric SR-aGvHD and plans to expand Ryoncil® into adult SR-aGvHD and inflammatory bowel disease, alongside advancing its second-generation product Rexlemestrocel-L. This launch and expansion strategy is expected to enhance Mesoblast’s market positioning and operational growth in the cellular medicine industry.

Mesoblast Director Increases Stake with Significant Share Acquisition
Sep 12, 2025

Mesoblast Limited has announced a change in the director’s interest, specifically pertaining to Gregory George. The company disclosed that George, through G to the Fourth Investments, LLC, acquired 9,640,072 shares and 325,901 American Depositary Shares (ADS), each representing 10 ordinary shares, in an on-market purchase. This acquisition reflects a significant investment amounting to approximately US$18.8 million, indicating a potential strategic move to strengthen his stake in the company.

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