Ann: Mesoblast Maintains Momentum with FDA, page-53

@Pledge I believe you are correct. Very encouraging update. Future confirmation of likely market penetration rates and reporting hard sales numbers at the end of the current quarter for Ryoncil , should leave analysts scrambling to revise their forecasts for the next fiscal year to June 2026. I would anticipate reaching $100m annualised sales runrate sometime in the next quarter as hospital penetration reaches close to 85% market coverage !
Regarding profitability, in my opinion this level of sales would already support profitability. Starting an adult sr aGVHD trial would cost Mesoblast approximately US$10m and provide the opportunity to treble sales post a successful label extension. and I would anticipate a partner for the confirmatory heart trial for Grade 2/3 being selected early 2026.
Bearing in mind an adult severe grade sr aGVHD trial could fully recruit 50-60 patients by early next year with a 28-56 day primary endpoint ? sales of Ryoncil could reach over half a billion US dollars run rate in calendar 2027. Furthermore, i think this update implies that we are likely to see a green light for filing the BLA for Rexlemestrocel for end stage heart with LVAD, when the minutes are received shortly. If agreement on potency assays for the pivotal trial is also formally agreed , this removes a major potential risk . In my opinion the shares may double or treble in the next few months to reflect successful commercialisation . What were the shorters thinking ? OP


Please do not rely on the facts or opinions contained in the above post when making an investment decision.