Mesoblast (MSB) investor relations material

Executive summary

• Achieved FDA approval and commercial launch of Ryoncil, the first and only FDA-approved mesenchymal stromal cell therapy in the U.S., with rapid onboarding of 32 transplant centers and expanding insurance coverage to over 250 million lives.

• Product pipeline includes late-stage assets in chronic heart failure, chronic low back pain, and inflammatory bowel disease, with multiple pivotal trials planned or underway.

• Strategic focus 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.

Financial highlights

• Revenue from cell therapy products reached $17.2 million, up 191% year-over-year, driven by Ryoncil's launch with $13.2 million in gross sales and $11.3 million in net sales after a 14.6% gross-to-net adjustment.

• Net operating cash spend was $50 million, a 3% increase from the prior year, reflecting commercial build-out and product launch costs.

• Cash on hand as of June 30 was $162 million USD.

• Cost of revenues was $1.2 million (10% of net sales), with a gross margin of 90%.

• SG&A expenses rose to $39.3 million, up $14.3 million year-over-year, reflecting commercial expansion.

Outlook and guidance

• Expectation of continued sales growth as more transplant centers are onboarded and payer coverage expands.

• Pivotal trials for label expansion in adult GVHD and inflammatory colitis to commence this year.

• Accelerated approval filing for Revascor in heart failure is being prepared, with FDA alignment on confirmatory trial design.

• Chronic low back pain Phase III trial is actively enrolling, targeting 300 patients with a 12-month pain reduction endpoint.