Amarin Corp Plc (AMRN)

[HDGabor]

m-

Until now, JT was able to remain vague on EU strategy, as anything more would have been speculative and conditional on approval.

Vague?

There are other questions to be addressed. Like timeline, peak sales and total projected spend to reach peak sales.

Did you hear about COVID-19? Most (if not all?) of the companies do not provide guidance for the future recently.

I see it - what will happen in the EU - as plain and simple, just take JT's world as it is ... do not try to see something that is not there.

So in Europe, we anticipate our spending really being gauged on a country-by-country basis by the level of market access. So if we're not -- if we're approved, but don't yet have reimbursement, it doesn't make sense for us to be spending a lot in that particular country.

So right now because Germany has a somewhat unique situation where they allow you to declare a price for its first year of commercialization, while you're negotiating the second year of pricing, we have begun to build commercial staffing in Germany. We began this year with about 40 people. We talked about ending the year with roughly 200 people. But in other countries, say, France or the U.K., we've got a team that's much more limited. In those other countries that are important to us, we have started whatever pre approval communications we can relative to market access, but the formal market access discussions can't start until after the label is approved.

And as a result, we've got some sort of country heads in place. We've got some market access people in place. We've got some medical people in place. But the real staffing and the real spending in Europe won't start in each country until after we have the reimbursement. So a likely scenario is that Germany and maybe some other countries get started up early. And then as we're growing revenues in Germany, other countries will come on board, and our spending will be somewhat gated by the time of the market access.

The biggest spending possible would be if all the countries provided market access right from the get-go. That's unlikely. It's actually a good situation. I'd love to have that situation take place. But it's -- there's not a whole lot of precedence for France and Italy moving that quickly, for example.

So it's going to be a year of execution in Europe heavily focused on market access, and we think our arguments there are good.

We're going into Europe with outcomes data, most drugs don't go into Europe with outcomes data. We've got a very low number needed to treat. And I think today, more than ever, we think that the decision of not partnering and going direct with the self launch in Europe made then, and makes today, the most sense.

Now that it doesn't mean that in some smaller countries in Europe, we won't elect to regionally partner. There are big markets like Germany and France and Spain and Italy and the U.K. which make -- which clearly justify making an investment in self launch. But then there are some smaller countries where relying on local companies, we think, would probably be a better use of our resources. But the big-opportunity countries, we'll be self-launching into.

Best,
G