IMO, you are too optimistic wrt to the milestone payment triggered by NDA submission.
The 111 mil amount is in AU$ and consists of around AU$46 mil for one third of PRV (US$100 / 3 / 0.72) - I used 0.72 as exchange rate.
So the rest of AU$65 mil is split between 2 regulatory milestones. More likely, imo, the split is 1/4 for NDA submission and 3/4 for NDA approval.
In an earlier post, I was very conservative and said several millions AUD for NDA submission, now, I believe 1/4 is more likely, which comes to around AU$16 mil.
I would prefer Neuren to partner with a big US pharma for P3 trial in US for nnz2591 rather than go it alone, even though it means to share the pie with our partner. However the upfront payment, milestone payments and royalties would be more generous than Acadia deal, because we would negotiate from a much stronger position than Acadia deal.
I have few reasons for it:
- US pharma has much more experience when it comes to dealing with FDA (we botched the IND submission for nnz2591 and I may say the IND is an easier step than the NDA submission/approval)
- stronger man power to run the P3 trials; don't forget the internal costs to run a P3 trial, as LT mentioned few times about Acadia;
- I am sure that the real $ cost of running P3 trial would exceed the budgeted cost and this would lead to delays in the trial
- a personal opinion, I may be wrong, is that FDA would approve an NDA submitted by a US pharma easier than submitted by a foreign minnow pharma company;
Between divi payment (unfranked, unfortunately because Neuren has not paid income tax in prior years) and share buy back, I would prefer dividend payment because I don't want to sell my shares, even though dividend is taxable at marginal tax rate.
However, there is a third way, it's called return of capital, it's not taxable because is not seen as income, instead it reduces the investor's adjusted cost basis. Investor is going to pay more tax when he sells the shares because the cost basis has been reduced.
Return of capital - Wikipedia
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Ann: Q4 2021 quarterly activity and cash flow report, page-31
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