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Ryoncil drives Mesoblast (NASDAQ: MESO) H1 FY2026 growth and FY26 guidance

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Rhea-AI Filing Summary

Mesoblast Limited reported a sharp jump in activity for the half-year ended December 31, 2025, as the U.S. launch of Ryoncil drove total revenue to US$51.3 million, up from US$3.2 million a year earlier. Net loss narrowed to US$40.2 million from US$47.9 million, helped by high Ryoncil gross margins and tight cost control.

Ryoncil generated US$48.7 million of revenue and a gross profit of US$44.2 million, funding increased R&D spending of US$46.2 million on late-stage programs in chronic low back pain and heart failure. The company ended the period with cash of US$129.975 million, access to a US$125.0 million five-year credit line, and guided full-year fiscal 2026 Ryoncil net revenue to US$110–120 million.

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Insights

Ryoncil commercialization is transforming Mesoblast’s revenue base while funding a larger late-stage pipeline.

Mesoblast shifted from minimal royalties to product-led revenue, with H1 FY2026 revenue of US$51.3 million versus US$3.2 million a year earlier, almost entirely from Ryoncil’s U.S. launch. Ryoncil revenue of US$48.7 million carried a reported 93% gross margin, creating meaningful contribution despite ongoing losses.

Management reinvested this into R&D, spending US$46.2 million on Phase 3 chronic low back pain, heart failure work, lifecycle extensions, and manufacturing. The period-end cash balance of US$129.975 million plus a US$125.0 million credit line, with a US$50.0 million tranche available until June 30, 2026, provides funding flexibility while the company still posted a US$40.2 million net loss.

Operationally, 49 U.S. transplant centers are onboarded toward a 64-center target that covers about 94% of pediatric bone marrow transplants, and payer coverage reportedly extends to 280 million U.S. lives. The company issued fiscal 2026 Ryoncil net revenue guidance of US$110–120 million, and highlighted progress toward a Phase 3 adult graft-versus-host disease study and potential BLAs for chronic low back pain and end-stage heart failure.


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934
For the month of February 2026
Commission File Number 001-37626
Mesoblast Limited
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of Registrant’s name into English)
Australia
(
Jurisdiction of incorporation or organization)

Silviu Itescu
Chief Executive Officer and Executive Director
Level 38
55 Collins Street
Melbourne 3000
Australia
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:
Form 20-F Form 40-F





INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K
On February 27, 2026, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement and investor presentation, which are attached hereto as Exhibit 99.1 and Exhibit 99.2 and are incorporated herein by reference.






SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly organized.

Mesoblast Limited
/s/ Paul Hughes
Paul Hughes
Company Secretary
Dated: February 27, 2026



INDEX TO EXHIBITS
Item
99.1
Press release of Mesoblast Ltd, dated February 27, 2026.
99.2
Investor presentation of Mesoblast Ltd, dated February 27, 2026.




RYONCIL® PROFITS UNDERPINNING SUBSTANTIAL GROWTH PIPELINE Financial Results and Operational Update for Half-Year Ended December 31, 2025 New York, USA: February 26 and Melbourne, Australia: February 27, 2026: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended December 31, 2025 (H1 FY2026). FINANCIAL HIGHLIGHTS FOR H1 FY20261 Performance driven by successful commercial launch of Ryoncil® • Total revenue of US$51.3 million (A$78.3 million),2 up from US$3.2 million. • Successful U.S. commercial launch of Ryoncil® (remestemcel-L-rknd) generated gross sales of US$57.0 million and revenue of US$48.7 million after gross to net adjustment. • Ryoncil® gross profit, excluding amortization, was US$44.2 million versus nil in the prior year period. Direct selling costs were US$7.7 million. • The strong operating performance in the period allowed us to invest in R&D, including to support the Phase 3 trial on the blockbuster chronic low back pain indication, for clinical programs for lifecycle extension, and for commercial manufacturing of Ryoncil® inventory as well as for launch of second- generation product. • Reported net loss of US$40.2 million compared to US$47.9 million, an improvement of US$7.8 million. Excluding a US$23.0 million inventory reversal reported in the prior year period, the improvement in net loss year-over-year would have been US$30.7 million. • Net operating cash spend of US$30.3 million. Mesoblast expects to see reduction in net cash spend over the remainder of the fiscal period based on projected receipts from quarterly revenues. • Period-end cash balance of US$130.0 million. Mesoblast entered into a US$125.0 million five-year non-dilutive credit-line facility. The second tranche of US$50.0 million is available to be drawn at our option until June 30, 2026. OPERATIONAL HIGHLIGHTS FOR H1 FY2026 Successful Ryoncil® commercial launch • To date 49 transplant centers have been onboarded, with a target of 64 centers which account for 94% of transplants performed in the U.S. Ryoncil®. • Coverage by government and commercial payers already extends to 280 million U.S. lives with Federal Medicaid coverage by U.S. Centers for Medicare & Medicaid Services (CMS) and mandatory fee-for- service Medicaid coverage in all U.S. states. • Issuance on October 1, 2025, of a specific Healthcare Common Procedure Coding System (HCPCS) J- Code by CMS for billing and reimbursement resulted in growth of Ryoncil® usage under CMS coverage versus commercial coverage in the last quarter.3 • 84% of patients in ‘real-world’ clinical setting able to complete the initial 28-day treatment regimen as per the FDA approval label and alive.4 • 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. • Ryoncil® lifecycle extension: Mesoblast intends to expand the clinical indications of Ryoncil® for life-cycle extension in both adults and children with life-threatening inflammatory conditions. The final protocol design for the Phase 3 trial of Ryoncil® as part of the second-line treatment regimen in adults


 
with steroid-refractory acute graft versus host disease (SR-aGvHD), a population approximately three times the size of the pediatric SR-aGvHD population, is locked down following a recent meeting with FDA and will be provided to the Institutional Review Board (IRB) in March for site initiation. Mesoblast’s second generation product rexlemestrocel-L to create multiple revenue streams in blockbuster indications • Mesoblast will seek to use its data from large randomized controlled trials in chronic discogenic low back pain (CLBP) and inflammatory chronic heart failure with low ejection fraction to support approvals for rexlemestrocel-L, aligning with recent announcements by the FDA that a single pivotal trial is the new default option for FDA approval.5 • Confirmatory Phase 3 trial for chronic discogenic low back pain (CLBP): During the period, Mesoblast received positive feedback from FDA on potential filing of a Biologics License Application (BLA) confirming 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. Mesoblast’s second randomized controlled Phase 3 trial in CLBP is on track to complete its 300-patient enrollment target in March/April this year with the trial actively recruiting across 40 sites in the U.S. • BLA filing for end-stage patients with chronic heart failure with low ejection fraction (HFrEF): Mesoblast has generated new data showing that a single administration of rexlemestrocel- L at the time of open heart surgery and device implantation to support the left ventricle in end-stage patients with HFrEF, reduces right heart failure hospitalizations, mortality from right heart failure, and portal hypertension with major bleeding events. With these new data, existing Orphan Drug designation for treating this group of patients, and FDA’s stated preference for randomized controlled trials, Mesoblast is moving from filing for accelerated approval to filing for full FDA approval next quarter. A confirmatory study would no longer be needed, if approved. • 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 HFrEF patients with LVADs. FY2026 Net Revenue Guidance Mesoblast anticipates full-year fiscal 2026 Ryoncil® net revenue to range between US$110 million and US$120 million. Commentary Mesoblast Chief Executive Dr. Silviu Itescu, commented on the result: “Today we report strong operational and financial performance for the first half of FY2026, a period that marks an important inflection point in Mesoblast’s evolution from clinical development to sustainable commercial execution. Sales momentum for Ryoncil® continued to build, driving meaningful revenue and reinforcing the product’s value in addressing significant unmet medical need and the strength of our commercial strategy. Importantly, we have improved the Company’s financial position with positive cash flow generated from Ryoncil® sales, disciplined cost management, and a strategic refinancing, providing greater flexibility to support expansion and late-stage clinical programs. As we enter the second half of FY2026, we remain focused on accelerating commercial uptake, advancing regulatory and label expansion opportunities, and maintaining financial discipline to deliver sustainable long-term shareholder value.” Conference Call There will be a webcast today, beginning at 5.00pm EST (Thursday, February 26); 9.00am AEDT (Friday, February 27). It can be accessed via: https://webcast.openbriefing.com/msb-hyr-2026/ The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com Other Please refer ‘Risk Factors’ and ‘Management’s Discussion and Analysis’ sections in our Form 6-K filed with SEC and Appendix 4D filed with ASX. 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. See summary consolidated financial tables at the end of this release. 2. Translated at the average US$:A$ exchange rate for the six months ended December 31, 2025 as reported by the Reserve Bank of Australia, being 0.65539. 3. Coding and coverage decisions are made by payers, and coverage cannot be guaranteed. 4. Mesoblast ASX announcement January 27, 2026. 5. Prasad V, Makary MA. One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two- Trial Dogma. N Engl J Med 2026;394:815-817. 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. Not financial product advice This announcement does not constitute financial product advice or investment advice (nor tax, accounting or legal advice) and has been prepared without taking into account the objectives, financial situation or needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate professional advice. Disclaimer To the maximum extent permitted by law, Mesoblast and its directors, officers, employees, advisers and agents disclaim any obligation or undertaking to release any updates or revisions to the information to reflect any change in expectations or assumptions, and disclaim all responsibility and liability for these forward-looking statements (including, without limitation, any liability for negligence). 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 Rubenstein BlueDot Media Caroline Nelson Steve Dabkowski T: +1 703 489 3037 T: +61 419 880 486 E: cnelson@rubenstein.com E: steve@bluedot.net.au


 
Consolidated Income Statement Six Months Ended December 31, (in U.S. dollars, in thousands, except per share amount) 2025 2024 Revenue: Product sales, net 48,685 — Royalty revenue 2,657 3,156 Total revenues 51,342 3,156 Cost of revenues (including amortization of currently marketed intangible assets, December 31, 2025: $3.082 million & 2024: $Nil) (7,604) — Research & development (46,162) (5,085) Selling, general and administration (28,541) (18,012) Fair value remeasurement of contingent consideration 7,641 (4,303) Fair value remeasurement of warrant liability (4,498) (11,978) Other operating income and expenses 3,217 (673) Finance costs (15,112) (10,827) Loss before income tax (39,717) (47,722) Income tax benefit/(expense) (445) (212) Loss attributable to the owners of Mesoblast Limited (40,162) (47,934) Losses per share from continuing operations attributable to the ordinary equity holders of the Group: Cents Cents Basic - losses per share (3.11) (4.20) Diluted - losses per share (3.11) (4.20) Consolidated Statement of Comprehensive Income Six Months Ended December 31, (in U.S. dollars, in thousands) 2025 2024 Loss for the period (40,162) (47,934) Other comprehensive income/(loss) Items that may be reclassified to profit and loss Exchange differences on translation of foreign operations 237 (113) Items that will not be reclassified to profit and loss Financial assets at fair value through other comprehensive income 163 194 Other comprehensive income for the period, net of tax 400 81 Total comprehensive losses attributable to the owners of Mesoblast Limited (39,762) (47,853)


 
Consolidated Balance Sheet (in U.S. dollars, in thousands) As of December 31, 2025 As of June 30, 2025 Assets Current Assets Cash & cash equivalents 129,975 161,551 Trade & other receivables 43,300 14,866 Inventory 21,664 22,246 Prepayments 7,544 5,687 Total Current Assets 202,483 204,350 Non-Current Assets Property, plant and equipment 1,793 1,702 Right-of-use assets 6,486 4,121 Financial assets at fair value through other comprehensive income 1,551 1,388 Other non-current assets 1,194 1,296 Intangible assets 568,800 571,826 Total Non-Current Assets 579,824 580,333 Total Assets 782,307 784,683 Liabilities Current Liabilities Trade and other payables 33,576 19,082 Provisions and other liabilities 11,201 20,985 Borrowings 66,738 54,155 Lease liabilities 2,382 2,680 Warrant liability 14,172 5,724 Total Current Liabilities 128,069 102,626 Non-Current Liabilities Provisions and other liabilities 11,030 10,793 Borrowings 60,132 67,739 Lease liabilities 5,892 3,583 Deferred consideration 2,500 2,500 Total Non-Current Liabilities 79,554 84,615 Total Liabilities 207,623 187,241 Net Assets 574,684 597,442 Equity Issued Capital 1,519,456 1,508,846 Reserves 106,293 99,499 Accumulated losses (1,051,065) (1,010,903) Total Equity 574,684 597,442


 
Consolidated Statement of Cash Flow Six Months Ended December 31, (in U.S. dollars, in thousands) 2025 2024 Cash flows from operating activities Receipts from customers 28,033 3,063 Payments to suppliers and employees (inclusive of goods and services tax) (61,020) (24,159) Interest received 2,642 441 Income taxes refund/(paid) 1 (2) Government grants and tax incentives and credits received — 2 Net cash (outflows) in operating activities (30,344) (20,655) Cash flows from investing activities Payments for property, plant and equipment (422) (106) (Payments for)/Receipt from investment in sublease (125) 124 Payments for intellectual property (60) — Receipt of security deposits — 609 Net cash (outflows)/inflows in investing activities (607) 627 Cash flows from financing activities Proceeds from borrowings 71,039 — Proceeds from issue of warrants 3,961 — Repayment of borrowings (69,338) (2,608) Payment of transaction costs from borrowings (4,288) (644) Interest and other costs of finance paid (7,099) (2,720) Proceeds from issues of shares and other equity securities 1,557 — Payment of transaction costs from issues of shares and other equity securities (128) (24) Proceeds from exercise of options 3,994 1,341 Proceeds from settlement of lease liabilities 314 — Payments for lease liabilities (1,140) (971) Proceeds from exercise of warrants — 1,362 Net cash (outflows) by financing activities (1,128) (4,264) Net (decrease) in cash and cash equivalents (32,079) (24,292) Cash and cash equivalents at beginning of period 161,551 62,960 Foreign exchange gains/(losses) on the translation of foreign bank accounts 503 (639) Cash and cash equivalents at end of period 129,975 38,029


 
Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases February 2026 ASX: MSB; Nasdaq: MESO Financial Results and Operational Update for the period ended December 31, 2025


 
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS This presentation includes forward-looking statements and forecasts 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. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “could,” and similar expressions or phrases identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and future events , recent changes in regulatory laws, and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. These statements may relate to, but are not limited to: expectations with respect to sales and revenue, expectations regarding the safety or efficacy of, or potential applications for, Mesoblast's adult stem cell technologies; expectations regarding the strength of Mesoblast's intellectual property, the timeline for Mesoblast's regulatory approval process, and the scalability and efficiency of manufacturing processes; expectations about Mesoblast's ability to grow its business and statements regarding its relationships with current and potential future business partners and future benefits of those relationships; statements concerning Mesoblast's share price or potential market capitalization; and statements concerning Mesoblast's capital requirements and ability to raise future capital, among others. 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. You should read this presentation together with our financial statements and the notes related thereto, as well as the 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, include, without limitation: risks inherent in the development and commercialization of potential products; uncertainty of clinical trial results or regulatory approvals or clearances; government regulation; the need for future capital; dependence upon collaborators; and protection of our intellectual property rights, among others. 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. 2


 
To be the world’s leading and most innovative cell therapy company, commercializing off-the-shelf allogeneic cellular medicines to treat serious and life-threatening inflammatory illnesses Our Mission 3


 
• Continue strong growth in RYONCIL® sales driven by market adoption • Build strong cash flow, judicious use of funds for operations, and optimal capital structure • Culture transition to efficient commercial organization • Expand RYONCIL (remestemcel-L-rknd) label indications, and obtain approval for rexlemestrocel-L products • Manufacturing focus to increase diversification, capacity and cost efficiencies • Appropriate commercial partnering backed by demonstrable value drivers (FDA approval, strong revenues, advanced clinical programs) Corporate Priorities 2026 4


 
• Received U.S. FDA approval RYONCIL December 2024 • RYONCIL is the first and only FDA-approved allogeneic mesenchymal stromal cell (MSC) product • Launched April 2025, with revenues growing quarter on quarter • Significant unmet need with continued uptake and increasing adoption • Net revenue from RYONCIL of US$49M in H1 FY26 Successful Launch 5


 
Financial Update Six months ending December 31, 2025 (H1 FY26)


 
Income statement 1H FY26 7 P&L for the half year ended US$ million December 2025 December 2024 Revenue: Product sales, net 48.7 - Royalty revenue 2.7 3.2 Total revenues 51.3 3.2 Cost of revenues (7.6) - R&D expenses (46.2) (5.1) Selling, general and administration (28.5) (18.0) Reval. of contingent consideration 7.6 (4.3) Reval. of warrant liability (4.5) (12.0) Other op. income and expenses 3.2 (0.7) Finance costs (15.1) (10.8) Loss before income tax (39.7) (47.7) Income tax benefit/(expense) (0.4) (0.2) Loss after income tax (40.2) (47.9) • Product revenue of US$49M • Gross margin of 93% for RYONCIL • R&D investment US$46M for our clinical activities, commercial manufacturing and BLA preparations • Prior period R&D included US$23M inventory gain • SG&A up US$10M reflecting cost of commercial team and launch of RYONCIL


 
Successful U.S. commercial launch of RYONCIL • RYONCIL gross profit, excluding amortization expense, was US$44.2M. Direct selling costs were US$7.7M Strong operating performance in the period allowed us to invest in: • R&D, including to support the Phase 3 trial on the blockbuster chronic low back pain indication • Clinical programs for lifecycle extension • Commercial manufacturing of Ryoncil® inventory as well as for launch of second-generation product RYONCIL profitability to fund growth pipeline 8


 
Net operating cash usage for H1 FY26 was US$30.3M Mesoblast expects to see reduction in net cash spend over the remainder of the fiscal period based on projected receipts from quarterly revenues Operating plan includes spend on Phase 3 programs, manufacturing for BLA filing and commercial inventory New credit-line totaling US$125M replaces existing higher-cost debt Strong Financial Position Cash balance US$130M at Dec 31, 2025 9 BLA: Biologics License Application (FDA)


 
Revenue Guidance FY2026 10 Mesoblast anticipates full-year fiscal 2026 Ryoncil® net revenue to range between US$110 million and US$120 million


 
RYONCIL® Update Steroid-Refractory Acute Graft Versus Host Disease (SR-aGvHD)


 
49 centers onboarded 64 centers ≈ 94% of pediatric BMTs 280 million US lives covered under insurance Specific HCPCS J-Code was assigned by CMS Patient hub established Success of Commercial Launch US$49M Net revenue Dec half BMT: bone marrow transplant | HCPCS: Healthcare Common Procedure Coding System | CMS: Centers for Medicare & Medicaid Services12


 
Three Strategic Commercial Priorities for Continued Growth 13 Proactively identify and prioritize appropriate patients Empower caregivers to demand Ryoncil® for their children Reinforce superior patient outcomes in first-line


 
Pivotal study of RYONCIL as part of second-line treatment regimen in adults with severe SR-aGvHD Approx. 50% adults with severe SR-aGvHD fail existing second- line treatment, and these have 25% survival at 100 days1-3 Working with NIH-funded BMT-CTN Final protocol design for registrational study in adults has been locked-down following FDA meeting Following central IRB approval in March, site initiation and patient enrollment to commence Label Expansion into Adults SR-aGvHD: steroid-refractory acute graft versus host disease | NIH: National Institute of Health | BMT CTN: Bone & Marrow Transplant Clinical Trials Network Use of RYONCIL under EAP in patients aged 12 and older with SR-aGvHD who failed ruxolitinib or other second-line agents was associated with 76% survival at Day 1004 RYONCIL in Adult aGvHD 1. Jagasia M, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14; 135(20): 1739–1749; 2. Abedin S, et al. Ruxolitinib resistance or intolerance in steroid-refractory acute graft versus-host disease — a real-world outcomes analysis. British Journal of Haematology, 2021;195:429–43; 3. Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med 2020;382:1800-1810; 4. Kurtzberg J, et al. Ryoncil (Remestemcel-L) for Third-Line Treatment of SR-aGvHD in Adolescents and Adults [Poster presentation]. 2025 Transplantation & Cellular Therapy Tandem Meetings 14


 
Increase revenue growth to fund multiple label expansion opportunities in pediatric and adult inflammatory diseases Evaluating multiple indications to unlock value, including inflammatory bowel, neurodegenerative, and respiratory conditions Portfolio prioritized to maximise shareholder return utilizing internal investment versus strategic partnership initiatives Extension Strategy for RYONCIL 15


 
Rexlemestrocel-L Update Discogenic Chronic Low Back Pain (CLBP)


 
Phase 3 CLBP Program Update 19 • First 404-patient randomized controlled Phase 3 trial completed including ~40% of patients who were opioid dependent • Mesoblast received positive feedback from FDA on potential filing of a BLA confirming that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy • 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 • RMAT received for rexlemestrocel-L as potential opioid-sparing therapy in CLBP


 
Actively recruiting a 300-patient confirmatory Phase 3 trial across 40 sites in the U.S., primary endpoint 12-month reduction in pain Enrollment expected to be completed March/April Data readout & BLA filing expected CY27 Commercial manufacturing to leverage existing capacity and cost efficiencies Phase 3 CLBP Program Update >7m patients (est.) suffer from CLBP due to DDD in each of the U.S. and E.U.51-3 CLBP: chronic low back pain | BLA: Biologics License Application (FDA) | DDD: degenerative disc disease 1. Decision Resources: Chronic Pain December 2015; 2. LEK & NCI opinion leader interviews, and secondary analysis; 3. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014 18


 
REVASCOR® Update (rexlemestrocel-L) Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) and Persistent Inflammation • NYHA Class II/III HFrEF • End-stage HFrEF with LV assist device 19


 
LVAD implantation improves overall survival in end-stage HFrEF However, underlying causes of heart failure (eg inflammation) persist and right ventricular pump function continues to deteriorate Progressive right heart failure occurs in 15-30% of patients and is the primary cause of multi-organ failure and death Life-threatening major mucosal bleeding events (MMBE) due to progressive right heart failure and portal hypertension occur in ~30% of patients and are the main cause of recurrent hospitalizations End-stage HFrEF with LVAD HFrEF: heart failure with reduced ejection fraction | LVAD: left ventricular assist device 20


 
LVAD study II randomized 159 patients 2:1 and provided primary evidence of REVASCOR’s efficacy in reducing MMBE LVAD study I randomized 30 patients 2:1 and provided supportive evidence of REVASCOR’s efficacy in reducing MMBE Intramyocardial injections of either REVASCOR or control at time of LVAD implantation Both trials showed that REVASCOR reduced cumulative incidence of MMBE (life-threatening GI bleeding) and related hospitalizations through 6 months (both p < 0.05) REVASCOR in end-stage HFrEF with LVAD HFrEF: heart failure with reduced ejection fraction | LVAD: left ventricular assist device ~ MMBE: major mucosal bleeding event 21


 
Rate of total number of MMBE per 100 subject-months within 6 months and 12 months by REVASCOR (MPC) compared to controls Treatment with REVASCOR resulted in a significantly reduced total number of MMBE REVASCOR reduces MMBE in LVAD HFrEF: heart failure with reduced ejection fraction | LVAD: left ventricular assist device | RHF: right heart failure | MMBE: major mucosal bleeding event 22


 
LVAD II: Ischemic controls have higher hospitalization rates from RHF than non- ischemic controls over 12 months REVASCOR (MPC) reduces these rates to levels in non-ischemics REVASCOR reduces RHF hospitalizations HFrEF: heart failure with reduced ejection fraction | LVAD: left ventricular assist device | RHF: right heart failure | MMBE: major mucosal bleeding event 23


 
LVAD II: Compared with the high risk of early death in ischemic controls with RHF (A), REVASCOR (MPC) reduced risk by >4-fold in ischemic patients with RHF (B) REVASCOR reduces RHF early deaths HFrEF: heart failure with reduced ejection fraction | LVAD: left ventricular assist device | RHF: right heart failure | MMBE: major mucosal bleeding event 24 Controls REVASCOR (MPC)


 
Reduction in inflammatory cytokines protects at-risk right ventricular myocardium Strengthened right ventricle reduces ICU hospitalization rates from Right Heart Failure (RHF) and improves survival Strengthened right ventricle decreases risk of portal hypertension and GI bleeding Potential for REVASCOR in other diseases causing RHF, including primary pulmonary hypertension and chronic lung diseases REVASCOR for treatment of RHF HFrEF: heart failure with reduced ejection fraction | LVAD: left ventricular assist device | RHF: right heart failure | MMBE: major mucosal bleeding event 25


 
With the new data, existing Orphan Drug designation for treating this group of patients, and FDA’s stated preference for randomized controlled trials, Mesoblast is moving from filing for accelerated approval to filing for full FDA approval Unlike an accelerated approval, a full approval does not require a confirmatory study Aligned with FDA on items required for filing BLA regarding CMC potency assays for product release, commercial manufacturing scale-up underway Expect to file BLA for full approval next quarter CHF Program Update Filing for a full approval to improve RHF & reduce GI bleeding in end-stage HFrEF CHF: Chronic Heart Failure | LVAD: left ventricular assist device |CMC: chemistry, manufacturing, and controls | BLA: Biologics License Application (FDA) 26


 
RYONCIL, first & only FDA approved MSC product ✓Delivered net revenue US$49 million in H1 FY26 ✓Onboarded 49 centers; 64 centers account for ~94% of U.S. pediatric BMTs ✓ Initiating label expansion to adult aGvHD; 3-4x larger market v. pediatric ✓ Prioritize portfolio including inflammatory bowel, neurodegenerative, and respiratory conditions Rexlemestrocel-L second generation platform ✓ Enrollment for CLBP for expected to complete in Mar/Apr ✓ BLA filing next quarter for full approval for RHF in end-stage HfrEF Optimizing manufacturing & logistics to support future growth US$130m cash on hand at Dec 31, 2025. New credit-line with US$50 million available Mesoblast anticipates full-year fiscal 2026 Ryoncil® net revenue to range between US$110 million and US$120 million Summary & Upcoming Milestones 27


 
Thank You


 

FAQ

How much revenue did Mesoblast (MESO) report for H1 FY2026?

Mesoblast reported total revenue of US$51.3 million for the half-year ended December 31, 2025, up from US$3.2 million a year earlier. The increase was driven mainly by Ryoncil product sales in the United States after its commercial launch.

What were Mesoblast’s profits and losses for the half-year 2025 period?

Mesoblast recorded a net loss of US$40.2 million for the half-year ended December 31, 2025, improving from a US$47.9 million loss in the prior-year period. Higher product margins partially offset increased research, development, and selling expenses.

How is Ryoncil performing commercially for Mesoblast (MESO)?

Ryoncil generated US$48.7 million in revenue and US$44.2 million in gross profit in H1 FY2026. Mesoblast has onboarded 49 U.S. transplant centers toward a 64-center target and reports payer coverage extending to about 280 million insured lives.

What revenue guidance did Mesoblast provide for FY2026 Ryoncil sales?

Mesoblast anticipates full-year fiscal 2026 Ryoncil net revenue between US$110 million and US$120 million. This outlook reflects ongoing uptake in U.S. transplant centers and existing government and commercial payer coverage for the product.

What is Mesoblast’s cash position and debt capacity after H1 FY2026?

Mesoblast ended the period with US$129.975 million in cash and access to a US$125.0 million five-year credit-line facility. A second tranche of US$50.0 million under this facility is available to be drawn at the company’s option until June 30, 2026.

Which late-stage clinical programs is Mesoblast funding from Ryoncil profits?

Mesoblast is using Ryoncil cash flow to support Phase 3 chronic low back pain trials, heart failure programs with rexlemestrocel-L, lifecycle extensions for Ryoncil, and commercial manufacturing. R&D expenses reached US$46.2 million in the half-year period.

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