Thought I’d do an update to crystallise my thoughts also the 10 people who read Clinuvel posts on HC can read.
I was a bit too pessimistic in my earlier post. Clinuvel are ticking things off nicely. The period since final EMA approval in April this year has been the best period for Clinuvel since forever.
Pricing is done in Netherlands, Germany, Austria, some Swiss insurers, one Italian region (for all Italian citizens who wish to travel). To get this level of support in this time frame is actually impressive, especially when the price was more than anyone expected. UK will come online in the future, but this was always going to take longer. Sweden and France are unknown but the UK price may assist here.
The number of potential EU EPP patients is also becoming clearer and a number between 1000-2000 is likely within the next 1-2 years. Netherlands- 240, Germany - 600, Italy- 140, Switzerland- 50, Austria- 150, UK- 300
The biggest surprise to me was the FDA EPP progress. Initially, Fast Track designation, which probably doesn’t mean that much and could have been applied for 5 years ago. Then the news that the FDA have reviewed the data and will allow dossier submission without the need for further trials. Whether the Pre-NDA meeting will take place before or after the FDA meeting with patients in October is unknown. However, I am feeling positive about US approval now within the next 18 months. That alone should double the share price. Desiree Lyon reported on Facebook that the FDA had previously indicated that more trials were in order but have now agreed with some pressure from Mrs Lyon that no more trials will be conducted. It appears that she said that no one would cooperate in further trials because there is already enough data. Pretty ballsy! Now, I lost a lot of money when the FDA told PXS to do another trial after EU approval and sales had commenced, so I am not prepared to get too excited just yet. PXS lost 90% of its value within 12 months of this news.
Whilst there is still a distinct lack of interest in Clinuvel and its success is never mentioned in press about Australia’s biotech there is clearly accumulation going on. The share price is being held down by persistent bot activity over the last several weeks. This is causing the sell side to slowly build. My uninformed opinion is that this is a very clear deliberate strategy by someone wishing to gain as many shares without raising the share price.
The recent 4C showed record sales (just) but revenue is growing, no debt and costs well controlled. Expected growth in revenue next quarter should see Clinuvel cash flow positive from this point onwards. The prelim final report due in a few weeks may be more revealing.
Vitiligo is also back on the agenda with the final preclinical data completed. Good news will be that Clinuvel can progress directly to a ph3. But more likely a ph2b will be required setting the program back at least 18 months. My best hope here is prompt FDA EPP approval and then an out licensing deal for vitiligo to big pharma.
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