Ryoncil® Sales Increase 60% in December Quarter to US$35.1M

Rhea-AI Summary

Mesoblast (Nasdaq:MESO) reported Ryoncil sales of US$35.1 million for the quarter ended December 31, 2025, a 60% increase versus the prior quarter. The company said Ryoncil is the first FDA-approved MSC product and will be evaluated in a pivotal adult second-line SR-aGvHD trial, targeting a market roughly three times larger than the pediatric market. Mesoblast also entered a US$125 million five-year interest-only facility with its largest shareholder that lowered its cost of capital, allowed repayment in full of its prior senior secured loan, and enabled partial repayment of a subordinated royalty facility, which the company expects to be fully repaid by mid-CY2026. The facility reportedly has no exit fees, no encumbrance of material assets or IP, and permits additional unsecured debt and licensing.

Positive

• Ryoncil revenue of US$35.1M in Dec quarter (+60% quarter-on-quarter)
• Closed a US$125M five-year facility with lower overall cost enabling full repayment of prior senior secured loan
• Subordinated royalty facility partly repaid and expected fully repaid by mid-CY2026
• Planned pivotal adult SR-aGvHD trial targets a market ~3x larger than pediatric market

Negative

• Subordinated royalty facility remains until fully repaid by mid-CY2026

News Market Reaction

+3.17%

19 alerts

+3.17% News Effect

+9.7% Peak in 8 hr 24 min

+$85M Valuation Impact

$2.76B Market Cap

1.3x Rel. Volume

On the day this news was published, MESO gained 3.17%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.7% during that session. Our momentum scanner triggered 19 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $85M to the company's valuation, bringing the market cap to $2.76B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Ryoncil gross revenue: US$35.1M Quarterly revenue growth: 60% New credit facility: US$125M +5 more

8 metrics

Ryoncil gross revenue US$35.1M Quarter ended Dec 31, 2025

Quarterly revenue growth 60% Ryoncil revenue vs prior quarter ended Sep 30, 2025

New credit facility US$125M Five-year facility with largest shareholder

Adult SR-aGvHD market size ≈3x pediatric Adult second-line SR-aGvHD vs pediatric market

Ryoncil net product sales $11.3M From launch through Jun 30, 2025 (20-F)

Net loss $102.1M Year ended Jun 30, 2025 (20-F)

Cumulative losses $1,010.9M Since inception through Jun 30, 2025 (20-F)

Cash balance $161.6M As of Jun 30, 2025 (20-F)

Market Reality Check

Price: $17.45 Vol: Volume 251,322 vs 20-day ...

normal vol

$17.45 Last Close

Volume Volume 251,322 vs 20-day average 215,142 (relative volume 1.17x). normal

Technical Price $19.87 trades above 200-day MA at $14.46 and is within $1.13 of the 52-week high $21.00.

Peers on Argus

MESO is up 3.17% while key biotech peers DYN (-3.59%), SRPT (-0.34%), AUPH (-3.5...

MESO is up 3.17% while key biotech peers DYN (-3.59%), SRPT (-0.34%), AUPH (-3.58%) and IMCR (-3.78%) are down, and HRMY is modestly up (0.85%), indicating a stock-specific move rather than a sector-wide rotation.

Historical Context

5 past events · Latest: Jan 01 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 01	Board leadership changes	Neutral	+0.7%	Updated board roles to support shift toward commercialization focus.
Dec 29	New credit facility	Positive	-2.0%	Drew US$75M from lower-cost five-year facility to retire senior debt.
Dec 11	Clinical meta-analysis	Positive	-1.8%	Meta-analysis showed remestemcel‑L superior to ruxolitinib in SR‑aGvHD outcomes.
Dec 03	Conference participation	Neutral	+2.2%	Participation and fireside chat at a major healthcare investor conference.
Nov 24	Trading update	Positive	+1.6%	AGM update highlighted strong Ryoncil® revenue growth quarter over quarter.

Pattern Detected

Recent news often tied to Ryoncil® progress and financing shows mixed price reactions, with some positive clinical and balance sheet updates followed by short-term share price weakness.

Recent Company History

Over the past few months, Mesoblast has focused on commercializing Ryoncil® and strengthening its capital structure. An AGM trading update on Nov 24, 2025 highlighted Ryoncil® quarterly revenue of more than US$30.0M versus US$21.9M in the prior quarter. Subsequent news covered conference participation, an independent meta-analysis favoring remestemcel‑L in SR‑aGvHD, and a new lower-cost five-year credit facility used to retire senior debt. Board leadership changes effective Jan 1, 2026 reflected the shift toward revenue-generating commercialization, which this latest revenue and financing update builds upon.

Market Pulse Summary

This announcement highlights substantial Ryoncil® momentum, with quarterly revenue of US$35.1M up 60...

Analysis

This announcement highlights substantial Ryoncil® momentum, with quarterly revenue of US$35.1M up 60% from the prior quarter, and details a new US$125M five‑year facility that retired higher‑cost senior debt and eased asset encumbrances. The news reinforces Mesoblast’s shift toward commercialization seen in prior trading updates and governance changes. Investors may watch future Ryoncil® revenue trends, adult SR‑aGvHD trial progress, and ongoing debt reduction against the backdrop of historical net losses.

Key Terms

mesenchymal stromal cell, u.s. food and drug administration, fda, steroid-refractory acute graft-versus-host disease, +3 more

7 terms

mesenchymal stromal cell medical

"Ryoncil® is the first mesenchymal stromal cell (MSC) product approved..."

Mesenchymal stromal cells are a type of adult cell found in bone marrow, fat and other tissues that can act like a repair crew, supporting tissue healing, reducing inflammation and helping other cells grow. Investors care because these cells are the basis for many experimental therapies and diagnostics; clinical success, manufacturing scale-up, safety and regulatory approval determine commercial potential and can strongly affect a company’s valuation.

u.s. food and drug administration regulatory

"product approved by the U.S. Food and Drug Administration (FDA) for any..."

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"product approved by the U.S. Food and Drug Administration (FDA) for any..."

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

steroid-refractory acute graft-versus-host disease medical

"approved for children under age 12 with steroid-refractory acute graft-versus-host disease..."

A severe condition that can follow a stem cell or bone marrow transplant in which the donor immune cells attack the patient’s organs and tissues; “steroid-refractory” means it does not improve after standard steroid treatment. Investors pay attention because it represents an urgent unmet medical need that drives demand for new drugs, influences clinical trial success and regulatory approvals, and can materially affect the commercial prospects and valuation of companies developing effective therapies — like a fire that the usual extinguisher cannot put out.

sr-agvhd medical

"for adults with SR-aGvHD, a market approximately three times larger..."

Steroid-refractory acute graft-versus-host disease (sr‑aGVHD) is a severe immune reaction that can occur after a patient receives a donor stem cell or bone marrow transplant; it means the inflammation did not improve after standard steroid therapy. For investors, it signals a high medical need and potential market opportunity for new therapies because affected patients face worse outcomes, longer hospital stays and higher costs, similar to a fire that keeps flaring up despite the usual extinguisher.

subordinated royalty facility financial

"Additionally, Mesoblast partly repaid its subordinated royalty facility which..."

A subordinated royalty facility is a type of financing where a lender provides cash in exchange for a fixed percentage of future product sales or revenues, rather than regular interest payments. It matters to investors because the lender gets paid from future cash flows but only after higher-priority creditors are satisfied, so it can raise funds without immediate share dilution yet reduces the company’s future revenue available to equity holders and increases credit complexity.

intellectual property financial

"does not encumber any of Mesoblast's material assets or intellectual property..."

Intellectual property are legal rights that protect creations of the mind—such as inventions, brand names, designs, software, or secret formulas—giving the owner control over who can use, copy or sell them. For investors, IP is like owning a blueprint or recipe: it can generate steady income through exclusive sales or licensing, boost a company’s competitive edge and valuation, and also create costs or risks if rights must be defended or challenged in court.

AI-generated analysis. Not financial advice.

Strong Balance Sheet Reflects Revenue Growth and New $125M Five-Year Facility

NEW YORK, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced gross revenue of US$35.1 million on Ryoncil^® (remestemcel-L-rknd) sales for the quarter ended December 31, 2025.¹ This represents a 60% increase on the prior quarter ended September 30, 2025.

Ryoncil^® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication. Ryoncil^® is the only FDA-approved product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD),² and will now be evaluated in a pivotal trial as part of a second-line regimen for adults with SR-aGvHD, a market approximately three times larger than the pediatric market.

The increase in quarterly revenues continues to strengthen Mesoblast's balance sheet after the Company announced it entered into a US$125 million facility with its largest shareholder which substantially lowered the company’s cost of capital and freed up its major assets to provide flexibility for strategic partnerships and commercialization.

The new facility enabled Mesoblast to repay in full its prior senior secured loan. Additionally, Mesoblast partly repaid its subordinated royalty facility which will continue to reduce from ongoing revenue and will be fully repaid by mid-CY2026. The new US$125 million five-year interest-only facility has a substantially lower overall cost compared with previous facilities, can be repaid at any time without incurring early prepayment or make-whole fees, does not include exit fees, does not encumber any of Mesoblast's material assets or intellectual property, and has no restrictions on additional unsecured debt or licensing activities.

“Our strong balance sheet, continued growth in quarterly sales of Ryoncil^®, and a new lower-cost financing facility provides greater flexibility for strategic partnerships and pursuit of label expansion for Ryoncil^®,” said Mesoblast Chief Executive Dr. Silviu Itescu.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast

References / Footnotes

1. The revenues included in this press release are based on management’s initial analysis of operations for the second quarter ended December 31, 2025, and are subject to completion of Mesoblast’s financial closing procedures and audit.
2. Please see the full Prescribing Information at www.ryoncil.com.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

Corporate Communications / Investors
Paul Hughes
T: +61 3 9639 6036
Media – Global	Media – Australia
Allison Worldwide	BlueDot Media
Emma Neal	Steve Dabkowski
T: +1 603 545 4843	T: +61 419 880 486
E: emma.neal@allisonworldwide.com	E: steve@bluedot.net.au

FAQ

How much did Mesoblast (MESO) sell in Ryoncil in the December 2025 quarter?

Mesoblast reported US$35.1 million in Ryoncil sales for the quarter ended December 31, 2025.

What does the US$125M five-year facility announced by Mesoblast (MESO) mean for the company?

The US$125 million interest-only facility with its largest shareholder lowers Mesoblast's cost of capital, allowed repayment of its prior senior secured loan, and provides flexibility for partnerships and commercialization.

When will Mesoblast fully repay the subordinated royalty facility?

Mesoblast expects the subordinated royalty facility to be fully repaid by mid-CY2026 from ongoing revenue.

What is Mesoblast (MESO) planning for Ryoncil in adults with SR-aGvHD?

Ryoncil will be evaluated in a pivotal trial as part of a second-line regimen for adults with steroid-refractory aGvHD, a market about three times larger than the pediatric market.

Does the new Mesoblast facility restrict future licensing or debt activities?

According to the company, the facility does not encumber material assets or IP and has no restrictions on additional unsecured debt or licensing activities.