Could Mesoblast (ASX: MSB) Be the Next Multibagger Stock?

The search for multibagger stocks often leads investors to overlooked corners of the market—those companies sitting on technology that could reshape an entire field if things go right. In the biotech world, that kind of asymmetric upside usually comes with steep risks, but when breakthroughs happen, the rewards can be extraordinary.

One ASX company now drawing serious attention is Mesoblast (ASX: MSB). After years of development, setbacks, and perseverance, Mesoblast has achieved what almost no other cell-therapy company globally has: an FDA approval. That single milestone, secured in December 2024, has changed the company’s trajectory and pushed the question into the spotlight — could Mesoblast become the next true multibagger?

Let’s break down the story.

What Mesoblast Actually Is (in one clear line)

Mesoblast is an Australian biotech that develops off-the-shelf mesenchymal stromal cell (MSC) therapies for inflammatory and immune disorders — and its flagship therapy Ryoncil (remestemcel-L) became the first FDA-approved MSC therapy for paediatric steroid-refractory acute graft-versus-host disease (SR-aGVHD) in December 2024.

That single approval instantly moved Mesoblast from “experimental biotech” to “commercial cell-therapy company.”

The Financial Picture — What the Numbers Say

Biotech narratives are exciting, but multibagger potential must always be anchored in numbers. Mesoblast’s latest results show a company in transition — from R&D-heavy to revenue-generating, but still burning significant cash.

Here’s the snapshot:

1. FY25 revenue: $26.6 million, up 195% year-on-year thanks to early commercial momentum.
2. FY25 net loss: $157.7 million, reflecting heavy spending on R&D, selling, regulatory, impairments and scaling for launch.
3. Cash reserves: $246.51 million, giving reasonable breathing room for commercialization, though not eliminating future financing needs.
4. Market context: The company has gained institutional and retail attention following the FDA approval, and its market cap has climbed through 2024–25 as investors repositioned expectations.
5. Financing history: Mesoblast has raised capital before, and more raises are likely — both a strength (access to funds) and a risk (dilution).

In short: Mesoblast has real revenue now, but profitability remains a distant target. For a biotech chasing multibagger status, that’s not unusual — but it raises the stakes on execution.

Why Bulls Think Mesoblast Could Become a Multibagger

1. FDA approval — biotech’s biggest and rarest milestone

Getting a product through the FDA is the holy grail for biotech investors. Many promising therapies never make it past trial phases, let alone regulatory review. Mesoblast has done what most cell-therapy companies around the world haven’t managed: secure a full approval.

This does several things:

1. Validates the underlying MSC platform
2. Lowers binary risk for the lead product
3. Opens up U.S. hospital distribution channels
4. Unlocks reimbursement discussions
5. Provides a real revenue engine (even if small today)

For many biotechs, FDA approval alone has historically led to major re-ratings.

2. Large addressable markets and follow-on expansion opportunities

Paediatric SR-aGVHD is a niche but urgent condition. However, Mesoblast’s long-term potential lies in scaling Ryoncil into additional indications, such as:

1. Adult aGVHD
2. Broader inflammatory conditions
3. Additional immune-mediated diseases

If the company secures label expansions or adult approvals, the commercial footprint could multiply quickly. Biotechs often achieve multibagger status when a validated product successfully moves across multiple indications.

3. Global commercial partnership potential

Mesoblast has been laying groundwork internationally — in Japan, China, Europe and other major markets. Strategic partnerships could accelerate the product’s rollout and bring in milestone payments or royalties, reducing funding pressure.

A big-pharma partnership is often a catalyst that sparks rapid share price re-ratings in biotech.

Manufacturing and platform value

Beyond Ryoncil, Mesoblast has:

• Established manufacturing capabilities
• Deep expertise in MSC biology
• Additional pipeline programs

Manufacturing in cell therapy is not trivial — companies that master it become valuable buyout targets. Licensing or spin-out opportunities could unlock further upside.

Why Skeptics Aren’t Convinced (The Risks You Can’t Ignore)

These risks are the reason MSB is not a safe, slow-compounding investment.

1. Commercial execution is tough — especially in cell therapy

Approval is one thing; adoption is another.

Hospitals need to be educated, payers must provide reimbursement, distribution chains have to be built, and manufacturing consistency must be maintained. Many biotechs stumble at this stage.

2. Pricing and reimbursement challenges

Even breakthrough therapies can face:

1. Slow uptake
2. Pushback on pricing
3. Administrative delays
4. Competition from emerging treatments

Sales growth will depend heavily on how smoothly reimbursement and hospital onboarding progresses.

3. Manufacturing and quality-control risks

Cell therapies are complex. Even minor disruptions or FDA manufacturing concerns can slow commercial expansion. Any hiccup could send the share price down sharply.

4. Cash burn and dilution

Despite a healthy cash balance, losses remain significant. Scaling Ryoncil and funding new trials will likely require additional capital — which means dilution is a real probability.

The Big Catalysts That Will Decide the Multibagger Fate

If Mesoblast becomes a multibagger, it will be because of these triggers:

1. Strong quarter-on-quarter sales growth for Ryoncil

This is the #1 factor.
If hospitals adopt the therapy consistently, sales could compound quickly.

2. Favourable reimbursement wins in the U.S. and other markets

Reimbursement is the bridge between approval and real revenue.

3. Label expansions (especially adult SR-aGVHD approval)

An adult approval would multiply the commercial market significantly.

4. Major partnership or licensing deals

The right partner could add distribution power, credibility, and funding.

5. Evidence of stable, scalable manufacturing

Nothing moves numbers more than proving cell therapy can be delivered reliably at scale.

Bottom Line — Is Mesoblast a Multibagger Candidate?

Yes — if you’re willing to take high biotech risk.

Mesoblast now has something incredibly rare: an FDA-approved cell therapy. That alone gives it a genuine shot at outsized upside. If it scales sales, secures reimbursement, expands the label and lands a strong partnership, the company could easily rerate multiple times over.

No — if you want predictable cashflows and low dilution.

FY25’s net loss is large, manufacturing is complex, and execution risk is very real. This is not a defensive or low-volatility stock. It’s a high-risk, high-reward biotech.

Final Thought

Mesoblast today is fundamentally different from what it was even a couple of years ago. It has regulatory validation, a therapy ready for distribution, cash in the bank, and a platform that could expand far beyond its first approval.

But the next chapter isn’t about science — it’s about execution.

For investors hunting for the next potential multibagger, Mesoblast is absolutely worth a place on the watchlist. Just size your position carefully, expect volatility, and follow quarterly sales and reimbursement updates closely.

Disclaimer:

General Financial Product Advice and Regulatory Framework: Pristine Gaze Pty Ltd (ABN 66 680 815 678, ACN 680 815 678) operates as Corporate Authorised Representative (CAR No. 001312049) of Alpha Securities Pty Ltd (AFSL 330757), which is licensed and regulated by the Australian Securities and Investments Commission under the Corporations Act 2001 (Cth). This report contains general financial product advice only and has been prepared without consideration of your personal objectives, financial situation, specific needs, circumstances, or investment experience. The information is not tailored to individual circumstances and may not be suitable for your particular situation. Before acting on any information contained herein, you should carefully consider its appropriateness having regard to your personal objectives, financial situation, and needs, and consider seeking personal financial advice from a qualified financial adviser who can assess your individual circumstances and provide tailored recommendations.

Investment Risks and Market Warnings: All investments carry significant risk, and different investment strategies may carry varying levels of risk exposure including total loss of invested capital. The value of investments and income derived from them can fluctuate significantly due to market conditions, economic factors, company-specific events, regulatory changes, commodity price volatility, currency fluctuations, interest rate movements, and other factors beyond our control. Securities markets are subject to market risk from general economic conditions and investor sentiment, liquidity risk affecting the ability to buy or sell securities at desired prices, credit risk from issuer default or deterioration, operational risk from inadequate internal processes, sector-specific risks including industry regulatory changes, technology obsolescence, management changes, competitive pressures, supply chain disruptions, and mining-specific risks including resource estimation uncertainty, operational hazards, environmental compliance, permitting delays, commodity price cycles, geopolitical factors affecting mining operations, and exploration risks. Small-cap and speculative mining stocks carry additional risks including limited liquidity, higher volatility, dependence on key personnel, limited operating history, uncertain cash flows, and potential failure to achieve commercial production.

Information Accuracy and Limitations: While we endeavour to ensure information accuracy and reliability, we make no representations or warranties (express or implied) regarding the accuracy, reliability, completeness, timeliness, or suitability of information provided, except where liability cannot be excluded under applicable law. This report may include information from third-party sources including company announcements, regulatory filings, research reports, market data providers, financial news services, and publicly available information, which we do not independently verify and for which we assume no responsibility. Past performance, examples, historical data, or projections are not indicative of future results, and no guarantee of future returns is provided or implied. To the maximum extent permitted by law, Pristine Gaze Pty Ltd and Alpha Securities Pty Ltd, together with their respective directors, officers, employees, representatives, and related entities, exclude all liability for any errors, omissions, inaccuracies, loss or damage (including direct, indirect, consequential, or special damages) arising from reliance on information provided, investment decisions made based on this report, market losses, opportunity costs, and technical issues or system failures.