Wasn't much discussion of this important release so worth having a read of it again. As mentioned by others Clinuvel ordinary with their China/Japan announcements over the years and these now just appear to be thought bubbles from the past with no follow up, Neuracthel looks to be following a similar path after some early hype and the current paediatric trial should have been done years ago in the opinions of many. Luckily nothing is priced in at CUV so if they can deliver on Vitiligo and other parts of the program in the next couple of years then the share price will be many multiples higher, shorters have held down the price very effectively but they are now taking an enormous risk with continued shorting that Clinuvel will simply not deliver on pretty much anything and that holders will suddenly sell who have proven to be some of the most loyal holders of any company on the ASX due to their belief in the technology. Some management decisions, optics and announcements have been poor, and who could not forget the recent lacklustre webinar after the half yearly? However, the other side is the company is actually doing very, very well from a financial perspective and in terms of the outlook of the R&D pipeline - the risk/reward has NEVER been better from an investment outlook. I prefer to look to the future in this regard, but a lot of long term holders are rightly peeved because many announcements were never delivered on and many other issues like Michelin catered Soirees in Monaco and share grants have grated on many. A first strike was strongly delivered at the AGM and it would seem a second strike is going to be very, very hard to avoid. The share buyback is fantastic in that shareholder interests may finally be a more central part of the thinking and other recent changes in the executive give hope that positive changes are happening, including the return of Dr Rodenburger who helped deliver FDA approval for EPP and will hopefully deliver again on the blockbuster Vitiligo with that very same drug. Ultimately the share price is the scorecard as Australia's best Biotech CEO said (Perrault CSL), if the CUV share price was $40+ much would be forgiven, but it is not and everything comes sharply into focus, and that scrutiny is natural and understandable. Again, credit should be given because EPP is a tricky disease and CUV delivered here, Disc and MT have performed very poorly in this disease and may never gain FDA approval. Clinuvel have an EPP monopoly for many years to come and that is all good for shareholders.
Going back to the Strategic Update at last years AGM Wolgen was very dismissive of competitors 'no competition on the horizon' were the words I believe, and this Sydney presentation again gave a breakdown of the competition and showed how poorly they have performed. Amazingly cash burning Disc medicine is still valued MUCH higher than money printing Clinuvel despite flunking their EPP phase 2 which was their lead program. I was going to check the last AGM but had no time so maybe someone can help me out here, in relation to VP I think they mentioned VP label expansion or new submission 1H 2024. That is another one that will be worth monitoring, will we see anything in the next 6 weeks?
As I said recently, I think the main thing for now is that the blockbuster Phase 3 into Vitiligo seems to be tracking well. The recruitment completion for CUV105 in Oct 24 was stated. FDA submission in 2 years 2026 stated. Vitiligo TAM mentioned $4.5 BILLION USD and 9% penetration years 1-2 giving $490 - $570 Million USD. Compelling evidence of the effectiveness of Clinuvel treatment of Vitiligo shown and very supportive statements from experts. I think standard of care very likely and the beautiful thing is the drug is already FDA approved so safety very well established and the path to approval much easier.
Clinuvel know the share price has been manipulated by shorters and that is why they initiated the share buyback. At these levels nothing is priced in except for EPP and everything else you get for free. Average analyst PT is mid $20s just for EPP and only one analyst is pricing in Vitiligo right now and they have a PT around $50, so when will other analysts start to price in the blockbuster which is in Phase 3 right now and slated for FDA submission in 2 years? Again on EPP the MT competitor drug was mentioned in the Sydney presentation about how it failed to meet primary endpoint and compassionate use has been discontinued - this would appear to indicate a largish pool of EPP patients actively seeking treatment are now available for recruiting for the very effective Clinuvel drug. Might be some good growth in EPP to come especially if they get the paediatric approval.
A quick mention to the Stroke program, absolutely not priced in at all unlike other Biotechs whose whole valuation could be for such a program. Here at CUV it is a footnote but it is massive and exciting. One of the biggest killers in the world and largely untreatable, so an incredible opportunity and possibly the one that will lead to a takeover by Big Pharma, I have a good feeling on this, there was some info in the Sydney update and I am eagerly awaiting the trial results.
As for the share buyback, this is a fantastic concept, but to meet the 1.5 Million share buyback target in 12 months that will mean 125000 shares need to be bought every month. So far in one and a half months we have just 37000 shares bought, they need to do better. A much bigger and better company in Cochlear announced a $75 Million buyback last year and delivered in full, the CUV buyback will be about $25 Million I reckon. This is pretty amazing because Cochlear is 30 times bigger by market cap and their share buyback was only 3 times bigger than the CUV buyback in my estimates. COH with a P/E 70 and CUV with P/E 20 (or less if cash is deducted) - the impact of this buyback should be really profound unless shorters keep pumping in fake liquidity as they have already done. Already Clinuvel is looking to be a pretty big contrast to the other top 20 most shorted ASX stocks IMO, many of them will have trouble simply staying afloat while the CUV share buyback is only using a tiny portion of their massive cash reserves. And hardly any companies in the ASX, let alone the top 20 most shorted, have a Phase 3 trial running in a blockbuster indication with an already FDA approved drug. And as the CEO said in the recent newsletter.
"We have chosen the moment of a repurchase as first clinical results for 2024 are published, andwe will
keep at ituntil those who gamble against the Company have understood the message. Given the
expected future cash flows, we are in the position to prolong the program when required"
Well they are fighting words, but so far those who gamble against the company have clearly not got the message as they have simply pumped 500000 fake liquidity shares into the market on the Sell side to control the share price (which otherwise would have rocketed to the mid $20s IMO). IMO Clinuvel should buy a quick 300 or 400 thousand shares and see if the shorters want to double down with that fake liquidity and make CUV a top 10 most shorted stock. As that statement says CUV can always go again with another one or more buybacks to send their message. And to finally deliver on the scoreboard.
All IMO DYOR
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