Ann: Ryoncil Pricing Set and Available This Quarter, page-109

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    How it is currently being reported:

    Stock Titan
    https://www.stocktitan.net/news/MESO/mesoblast-sets-ryoncil-price-based-on-economic-value-of-treatment-xawuefi39g93.html

    Mesoblast Sets Ryoncil® Price Based on Economic Value of Treatment With Planned Product Availability This QuarterMesoblast's FDA approval and pricing announcement for Ryoncil® represents a pivotal inflection point, transforming the company from clinical-stage to commercial. With a wholesale acquisition cost of $194,000 per infusion and standard treatment requiring 8 infusions over 4 weeks, the full treatment cost approaches $1.55 million per patient. This pricing appears strategically calibrated against the reported $2.5 million cost of treating children who die from SR-aGvHD and the $3.2-4.1 million in calculated economic benefits from successful treatment.

    The addressable market of approximately 375 pediatric patients annually creates a theoretical maximum revenue opportunity of $580 million, though realistic market penetration will likely build gradually over several quarters as the company engages with the 45 centers representing 80% of pediatric transplants. The establishment of MyMesoblast™ patient services hub and partnership with Cencora for distribution demonstrates necessary infrastructure for commercialization.

    Financially, Mesoblast has significantly strengthened its position through a $161 million private placement, bringing pro-forma cash to approximately $200 million. With quarterly cash burn of approximately $10 million (reduced by 22% year-over-year), this provides a substantial runway to navigate the commercial launch phase before Ryoncil revenue scales. The FDA approval triggered a $23 million reversal of previously expensed inventory, now recognized as an asset.

    Beyond Ryoncil, Mesoblast's pipeline expansion strategy could significantly amplify the revenue potential. The company is pursuing Ryoncil lifecycle extensions in inflammatory bowel disease, additional SR-aGvHD indications, and advancing Revascor for heart failure conditions. The Rare Pediatric Disease Designation for hypoplastic left heart syndrome could yield a Priority Review Voucher upon approval, potentially worth $100-200 million based on recent market transactions.

    The H1 FY2025 loss of $47.9 million was impacted by non-cash items including share-based payments and warrant remeasurements. Investors should focus on the 22% reduction in operating cash burn as a positive indicator of financial discipline during this transition to commercialization.
 
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