I am extremely concerned that people are not doing their basic homework anymore . I suspect@Sven62 has overlooked all the budgeted repayments of interest and principal for both the Hercules and NovaQuest facilities during the referenced two year period (see terms below). These are not indicative of the likely cash burn. Refinancing these loan facilities on more favourable terms should be a doddle, now that Ryoncil is approved and the placing has strengthened the balance sheet…so our cash requirements are likely to change considerably post any refinancing.
As for the cash burn. During the next 2 years we have to finance a US$30m CLBP trial, a second manufacturing audit for Rexlemestrocel prior to a new BLA for end stage heart disease, as well as potential provision for HLHS application and confirmatory trial and a 240 patient CHF trial over three years . In addition to finding a suitable second site in the US for manufacturing (Lonza Houston ? or alternative supplier) which would be a logical next move… we also need to finance sufficient inventory to support the new submissions. Then Silviu will need to provide for a sixty patient adult trial for acute sr GVHD. On top of that, reimbursement from insurers might involve extended debtor days of potentially 60-90 days for reimbursement to be received. . When the Company is budgeting I am sure the auditors will want to see conservative assumptions such as not wanting to include off label sales until reimbursement options are clarified particularly in adult steroid and treatment refractory acute GVHD..where demand may eventually prove to be quadruple the paediatric . Silviu has referred to assumptions , based on Temcell adoption in Japan (such as 30% market share in the first few years from launch ) which I think are likely to be easily beaten as Ryoncil has total exclusivity in the under twelve age grouping. I believe that Temcell were initially restricted to sites participating in the clinical trial when launched and clinicians did not have sufficient stocks at launch or an EAP which Ryoncil will benefit from , that involved a large number of participating paediatric transplant centres in the USA. (See below).
To suggest that Mesoblast will not be generating significant sales from Ryoncil in the first two years, is,I believe, an erroneous assumption. Time will tell if I am right . I certainly feel a lot more bullish about reference pricing post the latest video presentation made by the Company. The market could be in for a big surprise if we achieve similar pricing as sickle sale therapies. OP
Please do not rely on the facts ,speculation or opinions, contained in the above post when making an investment decision.
In the clinical trials of Temcell, the primary endpoint was set as complete response over 28 days’ treatment duration. Overall, the complete response of the patients treated with Temcell was non-inferior to that of patients treated with current second-line agents. In addition, in a phase II/III open-label, uncontrolled study (JR-031-301), the survival rate at 180 days post-first infusion was 60.0% (15/25 subjects), which was higher than that in the placebo group in a separate clinical trial (grade-III/IV subpopulation in Study 280, which showed similar acute GVHD severity to that in the patients in JR-031-301). Thus, the clinical efficacy of Temcell was confirmed in acute GVHD.
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