Time to take a look at how the landscape has changed for this disease recently.
Reimbursement.
Si mentioned in the Q2 financial results webcast in Feb/Mar 2023, that CAR-T therapy for Acute Lymphoblastic Leukemia ( ALL) in children would be a good comparator when thinking of treatment cost due to similar treatment course in terms of complexity and cost.
Novartis have a CAR-T therapy for childhood (ALL), called Kymriah, which has a sticker price of $475,000 USD for one injection ( which is the entire treatment course )
https://www.fiercepharma.com/pharma/group-says-novartis-kymriah-should-cost-160-000
So, we have a ballpark treatment figure of $475,000 USD.
There are approximately 688 cases of childhood SRaGVHD in the USA in 2018
The company was previously planning to initially target hospitals that serve 50% of the entire USA childhood GvHD population.
Lets assume that market is penetrated, and they end up with 344 patients after a couple of years ( 50% of childhood USA SRaGVHD ).
I have deliberately left off the other 688 children, who get aGVHD and adults for now.
From the 475,000 USD sticker price
Take 10% royalty for Osiris
Take 50% manufacturing cost ( this has been quoted to be somewhere between 40 and 60, but that was prior to CAR-T therapy and pharmoeconomics increasing the likely price. )
Leaves 190,000 USD profit per treatment.
190,000 x 344 = 65 Million USD.
That is 65 million, based on 50% market pentration of only the Child SRaGVHD market in the USA.
With a PE of 40:1 ( It's much higher than that right now !!!!! ) , that would support a share price around $5.35 AUD, and we have been there before just before last PDUFA.
CSL's current PE is near 45:1, and their share price has gone backwards over the last 3 years.
Lets consider the label extention.... only into adults with SRaGVHD.
50% market penetration into that would include 1031 patients.
At the same sticker price ( who knows, it may be charged that way ) , yielding $190,000 from every patient.
$196 million USD
With a 40:1 PE, that would support a share price of $16.15 AUD.
The above is my opinion, since the pricing, the penetration and the speed at which it will happen is currently unknown.
It's based on SI's comments on possible pricing, research into the GVHD USA market size, and previous comments about profit margins made by the company in the past. Based on TEMCELL market pentration in Japan, achieving near 40% in 3 years.
In my opinion, easily over $5 on approval. Adult expansion is the companies next immediate target.
Good luck and DYOR.
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