Full Press Release Details
Financial Results and Operational Update for Half-Year Ended December 31, 2025
NEW YORK, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), 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®
OPERATIONAL HIGHLIGHTS FOR H1 FY2026
Successful Ryoncil®commercial launch
Mesoblast’s second generation product rexlemestrocel-L to create multiple revenue streams in blockbuster indications
FY2026 Net Revenue GuidanceMesoblast anticipates full-year fiscal 2026 Ryoncil®net revenue to range between US$110 million and US$120 million.
CommentaryMesoblast 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 CallThere 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
OtherPlease 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 MesoblastMesoblast (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 atwww.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 seewww.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
References / Footnotes
Forward-Looking StatementsThis 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 adviceThis 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.
DisclaimerTo 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 EndedDecember 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 EndedDecember 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 ofDecember 31,2025 | As ofJune 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 EndedDecember 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 |