Mesoblast (MSB) H2 2025 earnings summary

Executive summary

• Achieved first FDA approval and commercial launch of RyoncilⓇ (remestemcel-L), the only FDA-approved MSC therapy in the US for pediatric steroid-refractory acute GvHD, with rapid onboarding of 32 US transplant centers and insurance coverage expanding to over 250 million US lives, including Medicaid in all states.

• Product pipeline includes late-stage assets, rexlemestrocel-L, in phase III trials for chronic heart failure and chronic low back pain, and development for inflammatory bowel disease, targeting large addressable markets.

• Focused on label expansion for RyoncilⓇ into adult GVHD and inflammatory bowel disease, with pivotal trials planned or underway.

• Extensive global intellectual property portfolio with protection through at least 2041 in major markets.

• Board strengthened with appointments of Dr. Gregory George and Ms. Lyn Cobley.

Financial highlights

• Revenue from cell therapy products reached $17.2 million for the year ended June 30, 2025, up 191% year-over-year, driven by RyoncilⓇ launch.

• Gross sales of RyoncilⓇ were $13.2 million, with $11.3 million in net sales after a 14.6% gross-to-net adjustment.

• Net operating cash spend was $50 million, a 3% increase year-over-year, reflecting commercial investment.

• Cash on hand at June 30, 2025, was $162 million.

• Loss after income tax for FY2025 was $102.1 million, compared to $88.0 million in FY2024.

• Gross margin on product sales was 90%, with cost of revenues at $1.2 million.

• SG&A expenses rose to $39.3 million, up $14.3 million, reflecting commercial build-out.

• Recognized a $14.9 million non-cash loss on contingent consideration revaluation and a $5 million warrant remeasurement loss.

• Basic and diluted loss per share was 8.46 US cents, improved from 8.91 US cents in FY2024.

Outlook and guidance

• Expect continued sales growth as more centers are onboarded and insurance coverage expands.

• Pivotal adult GVHD trial to commence this year, with label expansion targeted.

• Confirmatory phase III trial for chronic low back pain is enrolling, with completion expected by end of year or Q1 next year; 12-month follow-up after last patient.

• Preparing for accelerated approval filing for RevascorⓇ in heart failure, with BLA submission aligned with FDA.

• Inflammatory bowel disease pivotal trial design in progress, with updates expected this quarter.