I posted this on ShareCafe and thought I’d share it here, too.
To reach 1500+ patients in the US, many will have to be diagnosed first.
There are app. 500 known EPP patients in the US today as far as I understand and I expect a swift uptake in most of
this population. Awareness will rise and more patients will probably be diagnosed over the coming years but I don’t think
we can expect 1000 patients right off the bat. However, I think 6 implants are likely in the US.
UK has app. 350 known EPP patients and if NICE surrenders I’m expecting around half of them to be
eligible for Scenesse during a managed access agreement unless the new PASS data gives us a better
QALY measure and full access. I think 3-4 implants will be maximum in rainy Britain.
My expectation is that we will reach 1000 patients treated in Europe soon.
NICE will have to accept the new efficacy data, and the Scandinavian countries
will follow. Denmark, Norway, Sweeden have app. EPP 100-150 eligible patients in total.
Germany will continue to grow and probably reach 500 patients treated soon.
Currently, only 4 patients are treated in Austria but the Ombudsman has requested
broader access so maybe we can get to 30-40 patients there, too. Switzerland and
Italy will also expand and The Netherlands are probably already maxed out. France is evaluating Scenesse for reimbursement as we speak. Spain could also
deliver 100+ patients. This is my short term base scenario for Europe. 1000+ patients at an average of
3 implants which results in US$45 m. revenues.
Add the 3-400 patients who I think we will be treating in the US within a year and we
have minimum 1300 patients of whom 300 will be getting up to 6 implants. Let’s assume the US patients will
be granted reimbursement for 5 implants in average and that’s US$ 22 m. per year short term.
So my most conservative estimate is US$ 67 m. in revenues short term which would result in
US$ 25 pps with a 25 multiple which I find reasonable.
After FDA approval Clinuvel is de-risked and the rest of the pipeline should also begin to
get some option value. Today, I don’t think Vitiligo, lotions, Enfance, XP or any
other aspect of Clinuvel than EPP in the EU or US is being given any value at all.
Australia and Japan as imminent targets for EPP should at least be given a risk weighed
value of something. Especially Japan is huge. When we are fully up and running in
Australia and Japan my EPP numbers double !
And if we move into one or two phase 3 trials for Vitiligo, the market will have to
begin seeing some value here, too. Vitiligo could be an enormous for the company and
even with 20 % risk weighted value being ascribed to Vitiligo today that ought to
add US$ 200 m. to our market cap. Imagine if we were a pre approval company with ONLY
Vitiligo but good results in Phase 2 and now moving into Phase 3. Such a company
could easily be trading at a market cap of 200 m. We have FDA approval for the drug
now so Vitiligo expectations has to begin adding some value, soon. And then there is the
rest of the pipeline.
My best estimate of fair value today is US$ 35 pps. which corresponds with
Sphene and Moelis’ 12 month targets of AU$ 50-58.
If all stars align and we get a move on, I think US$ 100 pps. is
possible within 2-3 years. When I dream, I see the company being acquired
at that stage at a 100 % premium which would give me an easy exit at US$ 200.
