Mesoblast (MSB) H1 2025 earnings summary

Executive summary

• Ryoncil® (remestemcel-L) received FDA approval in December 2024 as the first mesenchymal stromal cell therapy for pediatric steroid-refractory acute GvHD (SR-aGvHD), with U.S. launch planned for March 2025, targeting 45 transplant centers covering 80% of patients.

• $161 million was raised in a global private placement, boosting pro-forma cash to $200 million as of December 31, 2024, to support commercialization and pipeline development.

• The pipeline includes pivotal phase III programs for rexlemestrocel-L in chronic low back pain (CLBP) and REVASCOR® in heart failure, with label expansion strategies for Ryoncil® in pediatric/adult GvHD and inflammatory bowel disease.

• Revenues for H1 FY2025 were $3.2 million, primarily from royalties, with a net loss of $47.9 million, up from $32.5 million year-over-year, driven by higher R&D and share-based expenses.

• Operating cash outflows were tightly controlled, reduced by 22% year-over-year to $20.7 million.

Financial highlights

• Cash and cash equivalents at December 31, 2024, were $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.

• Total revenue for H1 FY2025 was $3.2 million, down from $3.4 million in H1 FY2024, mainly from royalties.

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

• Manufacturing gain of $14.7 million due to reversal of a $23 million inventory provision after FDA approval of Ryoncil®.

Outlook and guidance

• Ryoncil® to be available in U.S. hospitals for pediatric SR-aGvHD in March 2025, with label extension studies in pediatric/adult GvHD and inflammatory bowel disease to commence.

• Accelerated approval pathway for REVASCOR® in heart failure is being pursued, with upcoming FDA meetings and confirmatory trials planned.

• Rexlemestrocel-L phase III trial for chronic low back pain is ongoing, with ramped-up enrollment and a 12-month primary endpoint.

• Sufficient cash reserves, including the January 2025 placement, to fund forecast expenditure for at least the next twelve months, including the US launch of Ryoncil® and continued pipeline development.

• Anticipates continued operating losses as commercialization and development activities expand; additional capital may be required beyond the next year.