I can't attend the AGM this year be here's a wish list of items I hope they provide clarification on:
1. Have sales commenced in Germany and if not, why? In the 18/05/16 announcement they said 13 insurers in Germany had agreed to make Scenesse available. The announcement on 22/06/16 said First treatments were expected in July and that "Insurers in Germany and Austria have also facilitated access to Scenesse for EPP patients" (in addition to the Netherlands). Then the chairs letter to shareholders on 20/09/16 mentioned sales had commenced in Netherlands and Austria but no mention of Germany... So what's the hold up?
2. What went wrong with the NICE HST evaluation? Seems like they were led up the garden path if they were advised to apply for a HST evaluation, only to find out 7 months later that they must go through the STA procedure. When is the STA procedure likely to be completed?
3. When will final results for CUV 103 (Singapore p2 vitiligo trial) be released? Why has the trial taken so long to complete and why has enrolment in the trial been so seemingly poor? I.e. in the 6/05/14 announcement they said 60 patients would be recruited for a 7 month trial with 3 month follow up. Then 18 months later (a week after last years AGM) they released interim results and said only 8 patients had been enrolled (4 were active, 3 were placebo and 1 withdrew). At that time they also said a further 13 patients were being treated under an open label protocol scheduled to be completed in February 2016 (9 months ago). How can they expect to get meaningful p values with results from such a small sample size?
4. Now that the necessary combination therapy preclinical trial has been completed in the US (announced 3/08/16) when is the next US trial Vitiligo trial likely to commence? How much will it cost and how will it be funded? When will they seek out a partner (they've said in the past that they wont go it alone with such a large indication)?
5. Can they tell us anything specific about the progress of the topical formulations by Vallurex? When will they be ready for human testing?
6. What ever became of the HHD physician-led phase 2 study on 10 patients in Rome (announced 10/02/14)? The milestone summary on page 17 of the 2016 annual report suggests it never went ahead?? I.e. no blue marks or dots on the right side of the page showing it's progress.
7. When will we start getting some financial forecasts?
8. Have they thought any further about listing in US? This was discussed at the last AGM.
9. What is the strategy for expansion into other indications / products?
To be honest I doubt they'll answer most of these questions but you never know! I'm happy with the rise in SP this year but communications with investors is still as poor as ever. For that reason I'll be voting against the remuneration package again this year.
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