Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q2 2020 Earnings Conference Call - Final Transcript
Jul 30, 2020 • 04:30 pm ET
Thank you. [Operator Instructions] Our first question comes from the line of Liana Moussatos with Wedbush. Your line is open. Please go ahead.
Congratulations on your progress. I'm focused right now on Europe, Q4 potential approval, if that happens. What do you have to do to get the first launch? And how long will it take? And what are you doing to prepare for that now?
Thanks, Liana. This is Jayson. So I'll give you a high-level answer to that, and then I'll hand over to Andrew, who can give you a little bit more detail. So one of the things that has not, because that sort of got impacted by the COVID-19 situation, is the European regulatory process, which, as you heard Dan earlier, layout has pretty much progressed as we had expected it to. So as you say, we do expect approval at the end of this year in Europe.
We have built a European core commercial organization over the course of the last 18 months, but we have also actually built the core of the German launch organization in Germany. And we have also appointed a general manager in France and the U.K. as we think about rollout in Europe. And I think you know well that when you get approval in Europe, you really get the opportunities to launch immediately in Germany, and most of the markets require a reimbursement process before you can actually fully operationalize your launch. So again, that's sort of the high picture of what we've done.
Let me hand over to Andrew and have him put some meat on the bone for you.
Yes. Liana, with the assumption that we would receive approval towards the end of the year, clearly, we wouldn't launch into the holiday period. So we've been looking at launching sometime in the first part of 2021. That said, upon approval, what that does allow us to do is to begin to promote and to increase the awareness of PALFORZIA as an approved treatment option in a number of European markets, even if you haven't actually started putting products into the marketplace, including Germany. And I mention Germany because Germany would be one of our first two lead markets, so Germany, along with the private market in the U.K., which would be ahead of some sort of formal submission to NICE.
So as Jayson mentioned, we've been building an infrastructure in Germany and in the U.K. and also France, because France is an important market as well now in anticipation of launching in those countries. And when you're launching in Europe, it tends to happen over a number of months. And so it's probably about an 18-month to 24-month process to go from your lead markets through all of the reimbursement dossier submissions and eventual -- eventually launching across markets in Europe. So that's sort of what it looks like right now, assuming we would get the approvals towards the end of this year.
Thank you. And