2025 YTD - Things are going well

I'm just going to put the BB aside for now and look at this year so far. The lack of BB is my main gripe with Clinuvel, if they just did what they said in that regard like every other company does it would be nearly all positive. So in summary, they have done well this year, keeping an eye on the bigger picture it's looking great IMO and in certain aspects they are so far ahead of any peers in the small/tiny Biotech space it is not funny.

* Half year results from Feb 25. An absolute cracker result with cash flowing in and EPS up very nicely (27.1%) to hopefully surpass 80 cents per share this year. NPAT after tax up a very solid 28.7% which is great and I like the Profit before tax which was up 48.1% to nearly $22 Million in what is the weaker half by far for Clinuvel due to seasonality. The extra expenses for running a blockbuster phase 3 trial slated for completion this year are fine - have you ever heard of such a small/tiny Biotech running an absolute blockbuster phase 3 trial while consistently growing profits? Financial performance is where Clinuvel excels, no other company near this size is putting out results like this year after year. FY2022 $20.9 Million NPAT. FY2023 $30.6 Million NPAT. FY2024 $35.6 Million NPAT. FY2025 we don't know yet but just adding last years 2nd half to this years 1st half would give about $40 Million NPAT? They are printing cash at ever growing rates.

* One month ago they completed recruitment of 210 patients in a blockbuster phase 3 trial for Vitiligo. Important to remember this drug is already FDA, EMA approved and has years of safety data and about 95% patient retention for EPP patients which is remarkable. It works and changes lives. Double data as the control group of this study now gets treated after acting as a control and this hopefully will lead to FDA submission from this phase 3 alone?

* In January there was a Vitiligo update with photos of some remarkable repigmentation. Efficacy looks outstanding and global Vitiligo expert and Clinuvel board member Dr Grimes remarked on how fast it occurs. A further global update this week was also great news with some bullish statements on Vitiligo from the CEO and further positive news about the 'spontaneous repigmentation' some patients achieved after therapy. Further info of expecting to see 9% penetration in target market for total 5931 patients in Yrs 1-2. That exciting potential figure again of $490 - $570 Million USD. ($750 Million to $880 Million AUD). Vitiligo if approved will be a massive event for Clinuvel and patients alike. Treatment centres are ready to go (and the number is growing all the time), billing codes and already established distribution channels with no 'middle man' to share profits with or Big pharma.

* The AAD event looks like it will help with the recruitment of new treatment centres while raising awareness of the unique, safe, non-immunosuppressing drug that Clinuvel has. "100 new potential centres identified across three days" of the AAD. Next AAD in Denver next March.

* February showed Preliminary results from the adolescent EPP study positive with all eligible patients requesting further treatment under special access. Clinuvel already treating some children. Label extension filing 2H 2025.

* Positive preliminary data in March from the absolute mega blockbuster indication of Stroke. Longer term possibility here, probably would have to partner with a Big Pharma for that one I reckon. Exciting still that a safe and already approved drug could be a player in an area where most are untreated and Big pharma have never really succeeded.

* Also in March the share buyback program was 'renewed'. Won't say much here but it is a great concept, should help all stakeholders (except shorters) and will reduce the number of shares on issue to 48.5 Million from an already incredibly low number of just 50 Million CUV shares on issue. Permanent improvements to EPS and less shares to pay dividends to. No one can say the BB has failed, it just has never been implemented which is a major negative surprise considering the fighting statements which came with the BB and also for the simple fact that most companies which announce buybacks just go out and do what they said.

* January announcement on Argentinian distribution agreement with Diligens.

* in the last week of December, the Canadian drug submission was validated, I guess we will hear if it is approved in the next 6 months or so and with some centres already trained up it should add to growth pretty quickly.

* Finally the rather big news of EMA dosage expansion to 6+ from the current 3 or 4 could be close. Nothing about this from Clinuvel yet but an EMA agenda did have 'for adoption' in regard to this. Does it mean approved and a large jump in revenues/profits? I guess we will also hear about this one pretty soon. Great for growth.

So growing profits and an enormous cash pile all the time, and expanding to new and bigger markets is what it is all about. They are doing the former better than any small peer and with the latter they appear to finally be getting their act together. There is also the Ozempic potential real tanning photo cosmetic announced for next year in Bulletin 2 which came out in January but I will leave that for some other time. Find me another company with these profits, cash, non big Pharma partnership, blockbuster potential and a valuation of only about $300 Million (Cash removed) and I will be extremely surprised.

All IMO DYOR