Ryoncil® Net Revenues Increase for the Quarter to US$30M

Rhea-AI Summary

Mesoblast (Nasdaq: MESO) reported Ryoncil® gross sales of US$35M (a 60% QoQ increase) and net revenues US$30M for the quarter ended Dec 31, 2025. The company secured a US$125M non-dilutive credit facility (initial US$75M drawn), held US$130M cash, and had net operating cash spend of US$16M for the quarter.

Clinical updates: 21 of 25 early real-world Ryoncil patients (84%) completed 28-day treatment; pivotal adult SR-aGvHD trial to begin site enrollment; FDA gave positive feedback on a BLA pathway for rexlemestrocel-L in CLBP and MSB-DR004 is recruiting to 300 patients.

Positive

• Ryoncil gross sales +60% QoQ to US$35M
• Net revenues of US$30M for the quarter
• Secured US$125M non-dilutive credit facility at 8.00% with US$75M initial draw
• Clinical progress: 21/25 (84%) real-world Ryoncil patients completed 28-day regimen

Negative

• Initial US$75M of new facility unsecured until other secured debt repaid by July 8, 2026
• Net operating cash spend of US$16M for the quarter
• Four of first 25 real-world Ryoncil patients died within 28 days of severe SR-aGvHD

Key Figures

Ryoncil gross sales: US$35 million Ryoncil net revenues: US$30 million Credit-line total: US$125 million +5 more

8 metrics

Ryoncil gross sales US$35 million Quarter ended December 31, 2025; 60% increase vs prior quarter

Ryoncil net revenues US$30 million Quarter ended December 31, 2025

Credit-line total US$125 million New non-dilutive credit-line at fixed 8.00% rate, five-year interest-only

Interest rate 8.00% per annum New credit-line replacing higher-cost debt facilities

Initial draw US$75 million Portion of new facility drawn; unsecured until prior secured debt repaid

Quarter-end cash US$130 million Cash balance at December 31, 2025

Net operating cash spend US$16 million Net operating cash outflow for the quarter

Ryoncil survival 21 of 25 patients (84%) Real-world post-launch pediatric SR-aGvHD, completing 28-day regimen

Market Reality Check

Price: $18.70 Vol: Volume 118,505 is below t...

low vol

$18.70 Last Close

Volume Volume 118,505 is below the 20-day average of 221,605, suggesting limited pre-news positioning. low

Technical Shares at $18.70 are trading above the 200-day MA of $14.88, reflecting a pre-news uptrend.

Peers on Argus

MESO fell 2.45% with several biotech peers also down: IMCR -5.64%, SRPT -3.75%, ...

MESO fell 2.45% with several biotech peers also down: IMCR -5.64%, SRPT -3.75%, HRMY -2.20%, DYN -1.17%, while AUPH rose 0.62%. This points to broader sector pressure alongside company-specific news.

Historical Context

5 past events · Latest: Jan 26 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 26	Ryoncil outcomes update	Positive	+2.6%	Reported 84% survival among first 25 real-world pediatric Ryoncil® patients.
Jan 18	FDA feedback CLBP	Positive	-3.5%	FDA acknowledged pain benefits for rexlemestrocel-L and 12-month efficacy path.
Jan 08	Ryoncil sales, financing	Positive	+3.2%	Quarterly Ryoncil® sales rose 60% and a lower-cost US$125M facility was secured.
Jan 01	Board leadership changes	Neutral	+0.7%	Reassigned chair and committee roles to support commercialization focus.
Dec 29	Debt facility, repayment	Neutral	-2.0%	Drew US$75M from new five-year facility to retire senior and royalty debt.

Pattern Detected

Recent Ryoncil® sales and financing updates with positive tone often saw modestly positive price reactions, while favorable regulatory feedback has previously coincided with short-term pullbacks.

Recent Company History

Over the last month, Mesoblast has reported several key milestones. On Dec 29, 2025, it secured a new five-year credit facility to retire senior debt. On Jan 1, 2026, board leadership roles were re-aligned to support commercialization. A Jan 8 update highlighted a 60% quarterly increase in Ryoncil® sales and a US$125M facility, followed by Jan 18 FDA feedback acknowledging rexlemestrocel-L pain benefits. On Jan 26, real-world Ryoncil® survival data were released. Today’s quarter update integrates these themes with detailed financial and operational metrics.

Market Pulse Summary

This announcement combines detailed quarterly Ryoncil® performance, including net revenues of US$30M...

Analysis

This announcement combines detailed quarterly Ryoncil® performance, including net revenues of US$30M, with real-world survival outcomes and confirmation of a US$125M non-dilutive, lower-cost credit-line. It also highlights progress toward pivotal trials in adult SR-aGvHD and chronic low back pain, plus commercial manufacturing scale-up. Investors may track future quarterly cash spend versus the reported US$16M outflow, enrollment completion in the 300-patient Phase 3 trial, and any further updates on label expansion efforts.

Key Terms

mesenchymal stromal cell, steroid-refractory acute graft-versus-host disease, sr-agvhd, biologics license application, +1 more

5 terms

mesenchymal stromal cell medical

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

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.

steroid-refractory acute graft-versus-host disease medical

"children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD)."

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

"children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD)."

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.

biologics license application regulatory

"feedback from FDA on potential filing of a Biologics License Application (BLA) for its"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

phase 3 trial medical

"Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial"

A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.

AI-generated analysis. Not financial advice.

Activity Report for Quarter Ended December 31, 2025 (Appendix 4C)

NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the second fiscal quarter ended December 31, 2025.

“This quarter was highlighted by continued strong Ryoncil^® sales and the establishment of a new lower-cost non-dilutive financing facility both of which enable greater flexibility for strategic partnerships and pursuit of label expansion for Ryoncil^®,” said Mesoblast Chief Executive Dr. Silviu Itescu.

FINANCIAL HIGHLIGHTS FOR QUARTER ENDED DECEMBER 31, 2025¹

• Ryoncil^® gross sales for the quarter were US$35 million, a 60% increase on the prior quarter ended September 30, 2025, and net revenues were US$30 million.¹
• Mesoblast entered into a new non-dilutive credit-line totaling US$125 million at a fixed interest rate of 8.00% per annum, a substantial reduction from Mesoblast's current debt facilities, with a five-year interest only period. The initial US$75 million drawn is unsecured until the remainder of the secured debt is repaid, no later than July 8, 2026, after which the entire new facility will be secured solely with the Temcell² royalty.
• Mesoblast had US$130 million of cash at December 31, 2025. Net operating cash spend for the quarter was US$16 million. Mesoblast expects to see reduction in net cash spend over the remainder of the fiscal period based on projected receipts from quarterly revenues and tight control of operating expenses.
  

OPERATIONAL HIGHLIGHTS FOR QUARTER ENDED DECEMBER 31, 2025

• Ryoncil^® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).³

• While many patients are at various stages of treatment with Ryoncil^®, the company provided an update on outcomes of the first 25 patients treated with Ryoncil^® in a ‘real-world’ clinical setting post launch. Of these, 21 were alive (84%) and completed the initial 28-day treatment regimen as per the FDA approval label. The four patients who did not complete the 28-day treatment course had been offered and failed other therapies prior to use of Ryoncil^® and died of severe SR-aGvHD within 28 days.
• These early data are consistent with the prior clinical experience with Ryoncil^®. The outcomes highlight our focus on getting patients on Ryoncil^® therapy as early as possible following steroid resistance to enable completion of an initial 28-day treatment course and maximize survival.
• Given the continued unmet need in adults with severe SR-aGvHD, a pivotal trial of Ryoncil^® is expected to commence site enrollment this quarter for label extension of Ryoncil^® for use in adults - a population approximately three times the size of the pediatric SR-aGvHD population.
  • During the reporting period, Mesoblast received positive feedback from FDA on potential filing of a Biologics License Application (BLA) for its allogeneic cell therapy product rexlemestrocel-L in patients with chronic discogenic low back pain (CLBP). This follows FDA’s Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial (MSB-DR003) on pain reduction and relationship to decreased use or elimination of opioids for up to three years following a single rexlemestrocel-L administration.
  • FDA acknowledged that the effects on pain intensity appear to favor the active arm. FDA also confirmed that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy and stated that the robust results on opioid reduction from at least one adequate and well controlled trial could be included in the Clinical Studies section of product labeling.
  • The confirmatory Phase 3 trial, MSB-DR004, is actively recruiting across 40 sites in the U.S. and is expected to complete the 300-patient enrollment target in the coming three months.
  • Commercial manufacturing scale-up work for rexlemestrocel-L is well progressed to support BLA filings for both CLBP and, in the first instance, for end-stage chronic heart failure (CHF) patients with LVADs.

Other
Fees to Non-Executive Directors were US$131,183, consulting payments to Non-Executive Directors were US$223,614, and salary payments to full-time Executive Directors were US$398,753, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.⁴

A copy of the Appendix 4C – Quarterly Cash Flow Report for the second quarter FY2026 is available on the investor page of the company’s website www.mesoblast.com.

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 Twitter: @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. TEMCELL^® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd Please see the full Prescribing Information at www.ryoncil.com
3. Please see the full Prescribing Information at www.ryoncil.com
4. As required by ASX listing rule 4.7 and reported in Item 6 of the Appendix 4C, reported are the aggregated total payments to related parties being Executive Directors and Non-Executive Directors.

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
Allison Worldwide
Emma Neal
T: +1 603 545 4843
E: emma.neal@allisonworldwide.com
Media – Australia
BlueDot Media
Steve Dabkowski
T: +61 419 880 486
E: steve@bluedot.net.au

FAQ

What were Mesoblast's Ryoncil® sales and net revenues for the quarter ended Dec 31, 2025 (MESO)?

Ryoncil® gross sales were US$35 million and net revenues were US$30 million for the quarter. According to the company, gross sales rose 60% from the prior quarter, contributing to stronger commercial cash receipts and revenue recognition in Q2 FY2026.

What is the structure and size of Mesoblast's new financing facility announced Jan 28, 2026 (MESO)?

Mesoblast secured a US$125 million non-dilutive credit line at a fixed 8.00% interest rate with a five-year interest-only period. According to the company, US$75 million was initially drawn and the remainder becomes secured after existing debt is repaid by July 8, 2026.

How did early real-world Ryoncil® outcomes look in the first 25 treated patients reported by Mesoblast (MESO)?

Of the first 25 real-world patients, 21 (84%) were alive and completed the 28-day treatment course. According to the company, four patients who had failed prior therapies died of severe SR-aGvHD within 28 days, aligning with prior clinical experience.

What regulatory progress did Mesoblast report for rexlemestrocel-L and its Phase 3 program (MESO)?

FDA provided positive feedback that a 12-month pain reduction could support efficacy and opioid-reduction data could be included in labeling. According to the company, this follows a Type B meeting and supports potential BLA filing plans for CLBP.

What is Mesoblast's cash position and near-term cash outlook after the quarter ended Dec 31, 2025 (MESO)?

Mesoblast held US$130 million in cash and reported net operating cash spend of US$16 million for the quarter. According to the company, they expect reduced net cash spend going forward based on projected revenue receipts and tighter operating expense control.