It is very difficult to give that question an answer that does it justice.
The crux of the conundrum lies in not the approval itself, but around all the other approvals and events that may be about to happen as a result.
The potential approval on Thursday AUS time, represents about up to 200 patients per year, and around *$500,000 US per treatment with similar market penetration rates as JCR pharma in Japan with the sister product.
That would give gross sales figure of around $150 million AUD per annum after 3 - 4 years of market penetration.
* The big assumption here is the price, and this may be a little low. We simply don't know yet what it is set at apart from SI saying it will be priced similar to other treatments that were around $500,000 USD.
MSB mentioned the first priority after approval, would be getting another trial going for adults.
My guess is this would be completed by the end of 2024 using biomarker scores at week 2 or 3.
If this trial is successful, label extension will be rapid, then the sales increases by about *6 times, new yealry sales 1.05 Billion AUD
While the above is occurring, the CLPB pivotal trial will be running at the same time. This trial is expected to replicate the previous phase 3, and previous phase 2 results again, and if so will be approved for back pain potentially in 2025 / 2026
This is a blockbuster, with multi billion dollar revenues yearly easily possible.
It uses the least ammount of cells, and is the easiest procedure ( walk in walk out - day surgery ) to complete, and will be cheaper than spinal fusion surgery. If they manage to even capture 20% of the spinal fusion surgery patients it's likely over a billion in revenue yearly.
Some time likely before the end of this year, MSB will meet with the FDA to discuss the next step for Chronic heart failure. FDA could come back with run another phase 3, which will likely take 3 - 5 years, or they may grant Accelerated approval, in which case MSB needs to partner and the terms will be favourable to MSB in this case.
Ontop of all those, we also have interest from NIH about another ARDS trial in the USA, that may target all cause ARDS. They are awaiting the FDA's ruling on Remestemcel, as are the partners looking at CHF and back pain, and SI mentioned that registories like CIBMTR might be willing to sponsor the adult GvHD trial to help get the therapy approved sooner.
So....
In 10 years, company could be generating 5 - 10 billion in sales per year......... or just 150 million if none of the rest occurs and every other trial is a catastrophe.
Somewhere between those two.
Profit margin on sales will be around 40% increasing to 60%, that was mentioned by MSB a while back
CSL net profit in 2022, was 2.2 billion USD.
MSB would need about 5 Billion in sales worst case to match this........you can decided where this might go.
CSL have about half as many shares than MSB on issue, so If MSB hit 5 billion in sales, SP might be half of CSL's ( around $150 AUD)
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