Madeleine Williams

Madeleine Williams asked about repeat utilization trends for pediatric Ryoncil and the factors supporting the FY26 guidance, and sought more color on Mesoblast's confidence in receiving full approval for Revascor following discussions with the FDA.

Answer

CEO Silviu Itescu and CCO Marcelo Santoro highlighted continuous growth in Ryoncil adoption, including repeat use by existing centers and onboarding of large new centers, alongside ongoing physician education for earlier product use and caregiver empowerment. For Revascor, CEO Silviu Itescu expressed confidence in full approval, citing multiple constructive discussions with the FDA, the focus on mortality data, and the agency's preference for randomized controlled trials in orphan indications.

Madeleine Williams asked about repeat utilization of pediatric Ryoncil among centers and how that factors into the FY 2026 guidance. She also inquired about the confidence in receiving full approval for Revascor, given the decision to file for full approval instead of accelerated approval, and the nature of discussions with the FDA.

Answer

CFO and Managing Director Silviu Itescu and Chief Commercial Officer Marcelo Santoro highlighted continuous growth in center adoption, repeat use by existing centers, and the onboarding of large centers, emphasizing physician education and caregiver empowerment. For Revascor, Silviu Itescu stated that multiple discussions with the FDA, particularly regarding mortality data, and recent agency guidance favoring randomized controlled trials for major endpoints in orphan indications, provide confidence for full approval with a single trial.