Choosing VP as the new orphan indication is a brilliant move. I was expecting XP, but this makes much more sense from a business perspective.
First, they will use the established framework of the EPP centers in Europe to conduct the trial(s). Likely, they will do the same in the US for the pivotal
phase 2/3 or 3 that will follow the initial 2a. This is less costly and scientifically easier than stating all over in XP where they have
no network yet. If they follow the same strategy, they will probably initiate XP trials in Japan once Scenesse
is approved for EPP there in a year to two.
Also prevalence is much higher for VP than in XP. VP = 1:100.000 (much higher in South Africa) and XP 1:1.000.000.
That gives us at least app. 6000 patients in Europe and 3000 in the US. 15.000 in South Africa.
They will dose VP patients every 28 days mirroring the dosing cycle in treating Vitiligo. It seems they plan to use
the data collected during the upcoming VP trials to also support the future NDA for Vitiligo. Smart move using synergies.
Even if they cut the price per implant down to $6000 that’s a very significant business case. We don’t know how many implants
they plan to administer yearly to VP patients but let’s assume 6 to be conservative.
Uptake will probably be fairly high since there is no alternative, so let’s assume we can treat 4000 patients in Europe and 2000 in the US
which is probably still conservative.
6000 patients paying 6000 USD 6 times a year = 216 m. USD. In my book that represents <60 USD pps. Add South Africa and that number
explodes but I will leave that out for now. Also, they may not lower the price per implant at all and then my numbers double (!).
Add EPP at the new lower price per implant administered 6 times a year (which is probably coming up) to 3000 patients coming up
and that’s 108 m. USD = < 30 USD. Add Australia and Japan and the number is even higher.
VP and EPP combined represents a future share price of 100 USD at the very least. 150 - 200 USD if they don’t lower the implant price.
The FDA and EMA are very likely to approve an sNDA and I expect the best possible scenario is a PDUFA for VP sometime in 2021 but
already now it should represent a risk weighted value of somewhere between 10-30 %. If they show good results in the phase 2a
which I expect they will the value will be higher also given the fact that the likelyhood of regulatory approval is extremely high for
a second indication.
At the current price per implant stand by my previous calculations and think that EPP is worth at least
50 USD in Europe and the US combined short to medium term. That number will go down if they lower the price per implant, of course.
I’d say that neither Vitiligo nor any of the other opportunities are reflected in today’s pps. Enfance, topicals etc. Right now, the pps
merely reflects the opportunity for EPP in Europe and we’re still on the very low side. VP ought to add a few Bucks today and 5-10 USD when the market realizes that it’s
a less risky endeavor than gaining regulatory approval for a new drug.
There’s still a lot of work to be done and it will be interesting to follow the work with VP and hopefully soon also Vitiligo.
My 12-18 months target is 50 USD. By then, we are either approved in the US or very close to be approved. VP trials
have hopefully been successful in Europe, the cosmetic line is underway, Vitiligo is revived, regulatory approval in Australia and
Japan is underway and Enfance for treating the pediatric population is hopefully also moving along.
