Mesoblast (MSB) H1 2025 earnings summary

Executive summary

• FDA approval of RYONCIL® (remestemcel-L) in December 2024 as the first mesenchymal stromal cell therapy for pediatric steroid-refractory acute GvHD in the US, with launch planned for March 2025 and a robust global patent portfolio.

• Raised $161 million in a global private placement, boosting pro-forma cash to $200 million as of December 31, 2024, to support US launch and pipeline advancement.

• Pipeline includes two major phase III products (rexlemestrocel-L for CLBP and REVASCOR for HFrEF/HLHS) and expansion strategies for pediatric/adult inflammatory diseases.

• Net loss for the half-year ended December 31, 2024 was $47.9 million, up from $32.5 million year-over-year, driven by higher R&D and share-based payment expenses.

• Revenues were $3.2 million, down 7% year-over-year, primarily from royalties on licensed products.

Financial highlights

• Cash balance at December 31, 2024 was $38 million, with pro-forma cash of $200 million post-placement.

• Net operating cash spend for H1 FY2025 was $20.7 million, a 22% reduction year-over-year.

• Loss after tax for H1 FY2025 was $47.9 million, compared to $32.5 million in H1 FY2024.

• $23 million inventory provision reversed following FDA approval of RYONCIL, recognized as an inventory asset.

• Manufacturing commercialization recognized income of $14.7 million due to inventory provision reversal.

Outlook and guidance

• RYONCIL to be available in U.S. hospitals for pediatric SR-aGvHD in March 2025, targeting 80% of patients via 45 high-volume centers.

• Label extension studies in pediatric/adult GvHD and inflammatory bowel disease to commence; phase 3 trial for RYONCIL in adult SR-aGvHD to start with BMT CTN.

• Accelerated approval pathway for REVASCOR® in heart failure being pursued, with pre-BLA FDA meetings planned.

• Rexlemestrocel-L phase III trial for chronic low back pain ongoing, with ramped-up enrollment and potential for approval filing after 12-month endpoint.

• Sufficient cash reserves to fund forecast expenditure for at least the next twelve months, including US launch and pipeline development.