It's occured to me that sharing Ecoools thoughts here is probably not a sin like it is on that other site... its been over a week from him but some of his recent thoughts are something to keep pondering.
full convo here:
https://finance.yahoo.com/quote/MESO/community?p=MESO (noting that the stock exchange remains the superior platform for discussions
)
Ecoool Turtle9 days ago
ARDS Partnership
In the Edison presentation, the Prof said "we're working together with our partners as we prepare for a potential pivotal trial to meet the EUA potentially that the FDA has identified for us..."
That was a big surprise to me - I hadn't heard or read about anything to do with partners on Covid19 ARDS in recent releases. I have said on this forum that they should abandon ARDS unless a partner were willing to take it forward and fund the trial and massive manufacturing upgrade if approved.
So I'm intrigued as to whether this means NIH is back in discussions about another trial, or whether there is another partner on the horizon. I would assume the former as we all know about the NIH funding the previous trial - and you would think that if there's a new partner (pharma, funding or otherwise) that is close enough to be preparing a pivotal trial, then that would merit an announcement.
This implies there is actual activity going on in the preparation of an ARDS trial, that there are actual partners out there and that they are actively in discussions with Meso regarding this potential pivotal trial. That's big news as far as I'm concerned.
I'd go further and say that if the partner is the NIH, then that is a strong indication that they thought the results of the trial a year ago were strong enough to support an FDA approval if the trial design and endpoints are altered to reflect what was learned in that first big Covid ARDS trial. It further indicates that the NIH thinks there is reason to spend another $40-50m on a Meso trial despite all of the new treatments for Covid-19 which have been approved recently. Of course none of these recently approved trials come close to Meso's success in treating moderate to severe Covid-19 ARDS particularly in under-65 year olds.
Those discussions (or "working together") with "our partners" must include funding as Meso would need $US40-50m for another ARDS trial and that is money better spent on preparing for commercialisation of aGvHD by continuing to build the pre-launch stockpile. They would also need enough doses of Rem-L for at least 200 people in an ARDS trial (probably 240) and while ARDS patients only need one-quarter of the dose per kg of an aGvHD patient, it's safe to suggest the ARDS patients would weigh around double the aGvHD kids average weight, so in total they'd need half the number of cells per treatment vs a paediatric aGvHD patient. So, a 240 ARDS patient trial (120 in the cell treatment group) would pull 60 full treatments for paediatric aGvHD patients off the market. This assumes half of the trial is under-65 year olds who get cells and half get no cells in the control group.
Furthermore, if they decide to design the ARDS trial to treat a group of over-65 year-olds and they provide double dosing for over-65s (which is quite likely being discussed), then maybe you would be reducing the aGvHD stockpile by 90 treatments.
Losing 90 treatments is probably doable, given that the ARDS trial won't start immediately and it may take 6 months to enrol and dose them all, during which time they can afford to keep producing more cells. At $8m cost of goods each quarter, that would be $20m at sales value (gross margin 60%) and would equate to another 66 aGvHD treatments each quarter (or 132 over 6 months), more than replacing the 60-90 treatments lost to aGvHD if they do an ARDS trial.
NB this gross margin is on the 1st gen manufacturing and will increase dramatically if/when Meso convert to the 3-D bioreactors.
My current assumption that they would've built up about 283 full paediatric aGvHD treatments in inventory by end-Dec last year. I presume they would want at least 250 treatments for the first year of demand, building up to 400 treatments for future years, just in US kids.
Funding an ARDS trial is therefore likely to be covered by this new partner (best guess is NIH). Enough cells will be available without eating into the first year's aGvHD requirement once sales start. BUT ARDS will require a much bigger partnership to fund the massive manufacturing upgrade which would be required. "Otherperspective" on HC raises the intriguing possibility of royalty funding.
I looked at selling forward a percentage of the royalty stream on just one product on the same terms as Royalty Pharma funding Cytokinetics. While the debt side has a similar IRR (or slightly more expensive) than Meso's current debt, the selling of a royalty of 4.5% up to $US1bn in sales and 3.5% above $US1bn for $US150m would be much more attractive than an equity raising at current prices. As a comparison, a capital raising now of $US150m (or $A215m) would probably have to be done at a 10% discount ie $A1.00 and the 215m shares issued would be 33% of current issued capital - that would be an unacceptable dilution, especially if we could get the same amount of money from Royalty Pharma for just $45m plus 3.5% of sales over $US1bn on just one of the blockbusters. Intriguing!
in response to another post by Left-e:
I was trying to be conservative and make sure that an ARDS trial wouldn’t compromise the aGvHD launch. I also think we should be talking about the average weight for very sick kids (generally with nasty gut problems if they have grade C or D aGvHD and so weigh less than average) versus older adults who are the preponderance of the moderate to severe COVID-19 ARDS patients (even in the under 65 population the patients tend to be older and more obese than average - not all of course, but greater than average adult weight is a reasonable bet).
I know they had been talking about an ARDS trial to support an EUA, but I thought this a bad idea unless they had a funding partner - the news for me in this presentation by the Prof is that they are working with their partners - and that’s what I think the big deal is