Mesoblast Limited

For the half year ended December 31, 2025, total revenue was $51.3 million, driven by Ryoncil; net product revenue was $49 million; and gross margin was 93%. R&D expense was $46.2 million, SG&A was $28.5 million, and net loss was $40.2 million, versus $48 million in the prior year period. Operating cash flow usage for the first half was $30.3 million, and cash on hand at December 31 was $130 million. Management guided to full-year fiscal 2026 Ryoncil net revenue of $110 million to $120 million and said second-half operating cash usage should decline versus the first half. The company also entered a $125 million nondilutive credit facility on December 30, with $75 million drawn at closing and a $50 million tranche available through June 2026; the subordinated royalty facility is expected to be fully repaid by mid-2026.

Silviu Itescu framed 2026 around accelerating Ryoncil adoption, strengthening cash generation, and advancing the second-generation platform. He emphasized a transition to a more efficient commercial organization, expansion into adult GVHD and other inflammatory diseases, and a focus on manufacturing capacity, diversification, and lower costs. His tone was confident and highly optimistic, especially around the breadth of the pipeline and the company’s ability to create value through both approvals and partnerships.

Jim O’Brien highlighted that the half-year results were driven by Ryoncil, with $51.3 million of total revenue, $49 million of net product revenue, and 93% gross margin. He walked through operating costs of $46.2 million in R&D and $28.5 million in SG&A, noting that the prior-year R&D comparison was distorted by a $23 million inventory provision reversal. He said operating cash flow usage was $30.3 million in the first half and should decline in the second half because of expected revenue receipts and disciplined cost control. He also detailed the financing move: a $125 million nondilutive facility, $75 million drawn to repay prior debt, and $50 million available, with lower cost of capital and no asset coverage or exit fees.

Analysts focused on the Ryoncil pediatric penetration target, the assumptions behind the 20% year-end share goal, and how high management thinks penetration can ultimately go; management said it assumes a 40% peak share and about 375 patients, and that the 20% target is for the end of the fiscal year. Questions also centered on Revascor’s filing path and whether the label would be limited to ischemic patients; management said it will seek a label for the full population because the pivotal study met endpoints across all patients, while acknowledging ischemic patients appear higher-risk and may show greater benefit. On back pain, analysts asked whether the ongoing Phase III would be included in the FDA package; management clarified that the new trial is intended to be the primary data set, with the prior study supportive, and that filing should wait until the new study reads out in 2027.