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Mesoblast Limited (AU:MSB)
ASX:MSB

Mesoblast Limited (MSB) AI Stock Analysis

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AU

Mesoblast Limited

(Sydney:MSB)

Rating:46Neutral
Price Target:
AU$1.50
▼(-13.79%Downside)
The overall score reflects Mesoblast Limited's strategic achievements like FDA approval and fundraising, juxtaposed with financial challenges such as declining revenues and negative profit margins. While technical indicators suggest weak momentum, the cautious optimism from the earnings call provides some positive outlook.

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 Limited generates revenue primarily through the development and commercialization of its proprietary cell-based therapies. The company's revenue streams include milestone payments from strategic alliances and licensing agreements with pharmaceutical companies, sales of its developed products upon regulatory approval, and potential royalties from marketed products. Additionally, Mesoblast engages in collaborations and partnerships with healthcare and research organizations, which contribute to its financial growth through shared development costs and revenue-sharing arrangements. The company's business model also involves seeking regulatory approvals in various global markets, which, once obtained, allow for the commercialization and sale of their products, thereby contributing to its revenue.

Mesoblast Limited Earnings Call Summary

Earnings Call Date:May 28, 2025
(Q2-2025)
|
% Change Since: 6.42%|
Next Earnings Date:Aug 27, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant achievements, including the FDA approval of a key product and successful fundraising, alongside a strategic pipeline expansion. However, financial losses and dependency on future regulatory approvals present challenges. Overall, the sentiment reflects a positive outlook with caution about future regulatory and financial hurdles.
Q2-2025 Updates
Positive Updates
Successful FDA Approval of RYONCIL
RYONCIL, the first mesenchymal stromal cell therapy, has been approved by the FDA for treating children with severe steroid-refractory acute graft-versus-host disease. The product has demonstrated a 70% overall response rate at day 28 in a Phase 3 trial.
Financial Strength and Fundraising
Mesoblast's cash balance was USD 38 million at the end of 2024, with pro forma cash of approximately USD 200 million after a successful global private placement raising USD 161 million.
Reduction in Operating Cash Spend
Net operating cash spend was USD 20.7 million for the first half of FY 2025, a 22% reduction compared to the first half of FY 2024.
Pipeline Expansion and Strategic Partnerships
Plans to expand RYONCIL for inflammatory bowel disease and adult GVHD. Strategy includes partnerships for distribution in Europe and potential partnerships in the US for chronic low back pain.
Negative Updates
Significant Loss After Tax
Despite positive developments, the loss after tax was USD 47.9 million for the half year, driven by non-cash balance sheet adjustments from the FDA approval.
Dependency on Regulatory Approval
Plans for accelerated approval for heart failure treatment hinge on upcoming FDA meetings, creating uncertainty in timelines and market entry.
Company Guidance
During the call, Mesoblast provided comprehensive guidance on their financial and operational performance for the half year ended December 31, 2024. Key financial metrics included a cash balance of USD 38 million, with pro forma cash reaching approximately USD 200 million following a successful USD 161 million global private placement. Net operating cash spend was reduced by 22% to USD 20.7 million compared to the first half of FY 2024. The FDA approval of RYONCIL led to a USD 23 million reversal of a provision against inventory, now recognized as an asset. Non-cash adjustments, such as the revaluation of contingent consideration and warrant liability, increased by USD 4 million and USD 16 million respectively, due to FDA approval, contributing to a loss after tax of USD 47.9 million. On the operational side, Mesoblast emphasized the launch strategy and pricing for RYONCIL, highlighting a wholesale acquisition cost of USD 194,000 per infusion. They outlined plans to expand their sales force and target high-volume transplant centers, as well as their strategy for label expansion into other inflammatory diseases.

Mesoblast Limited Financial Statement Overview

Summary
Income Statement
Balance Sheet
Cash Flow
Breakdown
Jun 2024Jun 2023Jun 2022Jun 2021Jun 2020
Income StatementTotal Revenue
5.90M7.50M10.21M7.46M32.16M
Gross Profit
-35.17M-47.42M-53.36M-78.28M-49.34M
EBIT
-84.15M-69.29M-80.57M-109.10M-74.87M
EBITDA
-56.08M-58.55M-76.57M-107.60M-75.41M
Net Income Common Stockholders
-87.96M-81.89M-91.35M-98.81M-77.94M
Balance SheetCash, Cash Equivalents and Short-Term Investments
62.56M70.92M60.03M136.88M129.33M
Total Assets
669.15M669.41M662.14M744.72M733.60M
Total Debt
118.92M116.50M106.91M105.50M99.31M
Net Debt
56.36M45.58M46.87M-31.39M-30.01M
Total Liabilities
188.80M167.58M165.10M163.32M184.28M
Stockholders Equity
480.36M501.84M497.04M581.40M549.33M
Cash FlowFree Cash Flow
-48.79M-63.58M-66.01M-108.33M-58.61M
Operating Cash Flow
-48.46M-63.27M-65.78M-106.68M-56.37M
Investing Cash Flow
-97.00K-194.00K-232.00K-1.65M-3.27M
Financing Cash Flow
40.25M74.50M-9.87M114.47M137.04M

Mesoblast Limited Technical Analysis

Technical Analysis Sentiment
Positive
Last Price1.74
Price Trends
50DMA
1.78
Negative
100DMA
2.20
Negative
200DMA
1.87
Negative
Market Momentum
MACD
-0.04
Negative
RSI
51.20
Neutral
STOCH
37.30
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 1.74 is above the 20-day moving average (MA) of 1.71, below the 50-day MA of 1.78, and below the 200-day MA of 1.87, indicating a neutral trend. The MACD of -0.04 indicates Negative momentum. The RSI at 51.20 is Neutral, neither overbought nor oversold. The STOCH value of 37.30 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 (53)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
53
Neutral
$5.23B3.23-44.27%2.82%16.82%0.11%
AUMSB
46
Neutral
$2.04B-21.31%
$322.47M12.6719.93%0.51%
$1.13B13.0051.39%
AUOCC
50
Neutral
AU$307.31M-29.77%6.07%59.09%
$264.72M-31.16%
AUPTX
56
Neutral
AU$37.85M-36.95%11.11%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AU:MSB
Mesoblast Limited
1.74
0.72
69.76%
CLVLF
Clinuvel Pharmaceuticals
7.33
-2.47
-25.20%
NURPF
Neuren Pharmaceuticals Limited
9.55
-3.39
-26.20%
AU:OCC
Orthocell Ltd
1.22
0.86
238.89%
PRRUF
Immutep Ltd
0.19
-0.09
-32.14%
AU:PTX
Prescient Therapeutics Limited
0.05
0.00
0.00%

Mesoblast Limited Corporate Events

Mesoblast Limited Announces Substantial Holding Update
Jun 3, 2025

Mesoblast Limited has announced a substantial holding update, indicating significant voting power and relevant interests held by various entities, including State Street Corporation and its subsidiaries. The update highlights the extensive involvement of institutional investors and financial entities in the company’s shares, which may influence Mesoblast’s market dynamics and stakeholder interests.

The most recent analyst rating on (AU:MSB) stock is a Buy with a A$1.10 price target. To see the full list of analyst forecasts on Mesoblast Limited stock, see the AU:MSB Stock Forecast page.

Mesoblast Secures Seven-Year FDA Orphan-Drug Exclusivity for Ryoncil®
May 15, 2025

Mesoblast Limited has received a seven-year orphan-drug exclusive approval from the FDA for its product Ryoncil® (remestemcel-L), used in treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. This exclusivity prevents the approval of similar mesenchymal stromal or stem cell products for the same indication during this period. Additionally, Mesoblast holds biologic exclusivity until December 2036, protecting against biosimilar market entry. These exclusivities, combined with Mesoblast’s strong intellectual property portfolio, provide a significant commercial barrier to competitors, reinforcing the company’s market position and offering long-term protection in major markets.

The most recent analyst rating on (AU:MSB) stock is a Buy with a A$3.40 price target. To see the full list of analyst forecasts on Mesoblast Limited stock, see the AU:MSB Stock Forecast page.

JPMorgan Acquires Substantial Stake in Mesoblast Limited
May 13, 2025

JPMorgan Chase & Co. and its affiliates have become substantial holders in Mesoblast Limited, acquiring a 5.03% voting power in the company as of May 9, 2025. This development may influence Mesoblast’s market positioning and stakeholder interests, as JPMorgan’s involvement could bring increased financial scrutiny and potential strategic opportunities.

The most recent analyst rating on (AU:MSB) stock is a Buy with a A$1.10 price target. To see the full list of analyst forecasts on Mesoblast Limited stock, see the AU:MSB Stock Forecast page.

JPMorgan Ceases Substantial Holding in Mesoblast Limited
May 8, 2025

Mesoblast Limited has announced that JPMorgan Chase & Co. and its affiliates have ceased to be a substantial holder in the company. This change in substantial holding involves various transactions, including securities lending and proprietary trading, which have impacted the voting securities of Mesoblast Limited. The cessation of JPMorgan’s substantial holding may influence the company’s market perception and stakeholder dynamics.

State Street Corporation Ceases Substantial Holding in Mesoblast Limited
May 7, 2025

Mesoblast Limited, a company involved in the biotechnology sector, announced a change in substantial holding as State Street Corporation and its subsidiaries ceased to be substantial holders. This change in substantial holding may impact Mesoblast’s shareholder composition and influence its market positioning, as State Street Corporation’s involvement in voting securities has altered.

Mesoblast Limited Announces New Substantial Holder
May 2, 2025

Mesoblast Limited has announced a new substantial holder, Aware Super Pty Ltd, which has acquired a significant voting power in the company. This change in substantial holding may impact Mesoblast’s strategic decisions and influence its market position, as the new holder has the power to control voting rights and securities disposal.

Mesoblast Expands U.S. Market with Ryoncil® Launch and Advances Other Therapies
Apr 30, 2025

Mesoblast Limited announced the commercial availability of Ryoncil® (remestemcel-L) for treating children with acute GVHD in the U.S., following FDA approval. The company is expanding its reach with plans to onboard more transplant centers and increase insurance coverage. Additionally, Mesoblast is progressing with its Revascor® and rexlemestrocel-L therapies, with ongoing FDA discussions and trials aimed at addressing chronic heart failure and low back pain, respectively. The company also strengthened its financial position with a successful global private placement and enhanced its board of directors.

Mesoblast Limited Appoints New Director Lyn Cobley
Apr 29, 2025

Mesoblast Limited announced the appointment of Lyn Cobley as a new director, effective April 29, 2025. Cobley holds 33,000 ordinary shares through Synergy Finance Pty Ltd as trustee for Cobley Superfund. This appointment may influence the company’s strategic direction and stakeholder confidence, given Cobley’s experience and interests in the company.

Mesoblast Strengthens Board with Financial Expert Lyn Cobley
Apr 29, 2025

Mesoblast Limited has appointed Lyn Cobley, a seasoned leader in the financial services industry, to its Board of Directors. This strategic move follows the recent FDA approval of RYONCIL and aims to bolster Mesoblast’s commercialization efforts and expansion into new indications for prevalent diseases. Cobley’s extensive experience in corporate finance and governance is expected to enhance Mesoblast’s strategic leadership as it continues to develop and commercialize its cell therapy products.

Mesoblast Limited Announces Director’s Interest Change
Apr 24, 2025

Mesoblast Limited has announced a change in the director’s interest, specifically involving Gregory George. The change includes the acquisition of 50,000 American Depositary Shares (ADS) and the expiry of a put option over the same amount. This update reflects ongoing adjustments in the company’s director-level securities holdings, which could influence stakeholder perceptions and the company’s market dynamics.

Mesoblast Expands Ryoncil Coverage to Over 100 Million US Lives
Apr 17, 2025

Mesoblast has successfully expanded the coverage of its FDA-approved therapy, Ryoncil, to over 100 million insured lives in the United States. This expansion includes Medicaid and commercial payers, highlighting the therapy’s growing acceptance and potential impact on treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. The increased coverage is expected to enhance Mesoblast’s market position and provide broader access to its innovative treatment, potentially benefiting stakeholders and patients alike.

Mesoblast Limited Announces Cessation of Securities
Apr 14, 2025

Mesoblast Limited has announced the cessation of 30,000 securities due to the lapse of conditional rights, as the conditions were not met or became incapable of being satisfied. This announcement may impact the company’s capital structure and could have implications for its stakeholders, reflecting the challenges in meeting certain operational conditions.

Mesoblast Limited Issues Over 8 Million New Securities
Apr 14, 2025

Mesoblast Limited has announced the issuance of over 8 million ordinary fully paid securities, which were issued on March 27, 2025. This move is part of the company’s ongoing efforts to manage its equity securities, potentially impacting its market positioning and providing new opportunities for stakeholders.

Mesoblast Limited Announces Quotation of New Securities
Apr 14, 2025

Mesoblast Limited announced the quotation of 7,255,000 ordinary fully paid securities on the Australian Securities Exchange (ASX) as part of an employee incentive scheme. This move is expected to enhance the company’s market presence and provide additional liquidity, potentially benefiting stakeholders by aligning employee interests with company performance.

Mesoblast Limited Issues New Equity Securities Under Employee Incentive Scheme
Apr 14, 2025

Mesoblast Limited announced the issuance of 7,275,000 unquoted equity securities as part of an employee incentive scheme. This move is likely to impact the company’s financial structure and could enhance employee motivation, potentially influencing the company’s market position and stakeholder interests.

Mesoblast Limited Announces Director’s Change in Securities Interest
Apr 8, 2025

Mesoblast Limited has announced a change in the interest of its director, Dr. Silviu Itescu, in the company’s securities. The change involves the acquisition of 3,108,000 options, bringing the total number of options held by Dr. Itescu to 16,449,558, following shareholder approval at the 2024 Annual General Meeting. This adjustment in director’s interest reflects the company’s ongoing governance and shareholder engagement practices, potentially impacting investor perceptions and the company’s market dynamics.

Mesoblast Limited Issues New Equity Securities for Employee Incentive
Apr 8, 2025

Mesoblast Limited has announced the issuance of 4,839,000 unquoted equity securities, specifically options expiring on various dates and at various prices, as part of an employee incentive scheme. This strategic move aims to align employee interests with company performance, potentially enhancing operational efficiency and stakeholder value in the competitive biotechnology sector.

Mesoblast Products Exempt from U.S. Tariffs, Strengthening Market Position
Apr 3, 2025

Mesoblast Limited announced that its allogeneic cellular products, including Ryoncil and Revascor, are designated as ‘U.S. Country of Origin’ and will not be subject to U.S. tariffs on imported products. This designation, based on the products being manufactured from U.S. donors, allows Mesoblast to avoid potential cost increases and maintain competitive pricing in the U.S. market, potentially strengthening its position in the industry and providing reassurance to stakeholders about the stability of its operations.

Mesoblast Seeks FDA Meeting for Accelerated Approval of Revascor
Apr 3, 2025

Mesoblast Limited has filed a request for a Type B meeting with the FDA to discuss the accelerated approval pathway for its product Revascor, intended for treating ischemic chronic heart failure with reduced ejection fraction and inflammation. This meeting, expected to occur this quarter, aims to obtain FDA feedback on chemistry, manufacturing, and controls, as well as alignment on potency assays and the design of a confirmatory trial. The outcome of this meeting could significantly impact Mesoblast’s operations by potentially expediting the approval process for Revascor, thereby enhancing its industry positioning and offering new treatment options for patients with heart failure.

Mesoblast Secures Medicaid Coverage for Ryoncil, Expanding Access for Pediatric Patients
Mar 31, 2025

Mesoblast Limited has announced its entry into the Medicaid National Drug Rebate Agreement with the U.S. Centers for Medicare & Medicaid Services for its product Ryoncil, providing access to children covered by Medicaid with steroid-refractory acute graft versus host disease (SR-aGvHD). This development marks a significant commercial milestone for Mesoblast, as it ensures that Ryoncil is available to all U.S. children with SR-aGvHD, regardless of their insurance status, potentially enhancing the company’s market position and impact on stakeholders.

Mesoblast Launches Ryoncil® in U.S. for Pediatric SR-aGvHD
Mar 27, 2025

Mesoblast Limited has announced the commercial availability of Ryoncil® (remestemcel-L) in the United States, marking a significant milestone as the first FDA-approved mesenchymal stromal cell (MSC) therapy for any indication. Ryoncil® is designed to treat pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates. Mesoblast has established a patient access hub, MyMesoblast™, to assist with insurance coverage and financial assistance, ensuring broad access to this potentially life-saving therapy. The company is actively engaging with insurers to expand coverage, with nine commercial payers already on board, covering approximately 37 million lives in the U.S. This development reflects Mesoblast’s commitment to delivering innovative cellular medicines to patients in need.

Mesoblast’s Ryoncil Gains Comprehensive U.S. Drug Pricing Compendia Inclusion
Mar 14, 2025

Mesoblast Limited announced that its product Ryoncil is now listed in all four major drug pricing compendia in the United States, following FDA approval of revised labeling. This development allows treatment centers to order Ryoncil kits tailored to patient dosages, potentially enhancing accessibility and standardizing pricing. The inclusion in these compendia is expected to bolster Mesoblast’s market positioning by facilitating easier access and ordering for healthcare providers, thereby potentially increasing the product’s adoption and utilization.

Mesoblast Unveils First FDA-Approved Stem Cell Therapy
Mar 13, 2025

Mesoblast Limited announced the presentation of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy, at the ISCT. This approval marks a significant milestone for the company, potentially enhancing its industry positioning and offering promising implications for stakeholders involved in the development and commercialization of stem cell therapies.

Mesoblast Director Increases Stake with ADS Acquisition
Mar 13, 2025

Mesoblast Limited announced a change in the director’s interest notice, detailing the acquisition of 74,621 American Depositary Shares (ADS) by G to the Fourth Investments, LLC, a company associated with Director Gregory George. This transaction, valued at approximately US$961,088.35, reflects an on-market purchase, indicating continued investment and confidence in the company’s growth prospects. The change in director’s interest is a significant move that could influence stakeholder perceptions and potentially impact Mesoblast’s market positioning.

Mesoblast CEO to Present at ISCT Virtual Town Hall on Groundbreaking Cell Therapy
Mar 12, 2025

Mesoblast Limited announced that its CEO, Silviu Itescu, will deliver a featured presentation at the ISCT North America Regional Virtual Town Hall, highlighting RYONCIL as the first FDA-approved mesenchymal stromal cell therapy. This event underscores Mesoblast’s leadership in the cellular medicine industry and its commitment to expanding its innovative therapies to treat various inflammatory diseases, potentially enhancing its market position and stakeholder value.

Mesoblast Joins S&P/ASX 200 Index, Marking Growth Milestone
Mar 5, 2025

Mesoblast Limited announced its inclusion in the S&P/ASX 200 Index, a significant institutional benchmark in Australia, reflecting the company’s growth and market recognition. This inclusion is expected to enhance Mesoblast’s visibility and credibility within the financial markets, potentially attracting more institutional investors and strengthening its position in the biotechnology industry. The company’s focus on developing innovative cellular medicines for inflammatory diseases, along with its strategic partnerships and extensive intellectual property portfolio, positions it well for future growth and expansion.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.