Amicus Therapeutics, Inc. (NASDAQ:FOLD) Q4 2022 Earnings Call Transcript

Dae Gon Ha: Yes, thanks, Jeff. Of course, I would remind folks that how this product is positioned will, of course, depend on which region and what the final labels look like. But I think all just points are very important. Daphne, do want to speak quickly to the contribution of revenue from AT-GAA to the profitability goal.

Daphne Quimi: Sure. So just to just to remind everyone that the profitability metrics, the biggest contributor to that was actually the Galafold revenues. I do want to remind everyone that AT-GAA revenues will have a modest impact, definitely help profitability, but also just a reminder that once approved, the cost, production costs will move from the P&L. So from OpEx and move on to the balance sheet. So I think it’s a combination of all of that. So yes, the approval has p, but it’s, it will impact the P&L in a couple of different ways, not just from

Dae Gon Ha: Great, thanks for taking the question.

Operator: One moment for our next question. Our next question excuse me, will come from Kristen Kluska of Cantor Fitzgerald. Your line is open.

Unidentified Analyst: Good morning everyone. This is Rick on for Kristen. Thanks for taking our question. We’ve got one for you this morning. You previously mentioned mock inspections at the WuXi facility in the lead up to scheduled inspections. Have you been doing or planning any mock inspections that are part of the preparation? And is there any clarity based on what you heard from the agency on what to expect from the real inspection now that it is on the calendar? Thanks.

Bradley Campbell: Yes, great questions. So we were able to conduct a very successful mock inspection. Last year, actually, we had a consultant who was on the ground, who was from China, and then supported by our team here in the United States. So we feel really good about the status of WuXi in manufacturing. And I would just add a few other points that give us confidence in the outcome of that inspection. The first is that, we’ve mentioned this before WuXi, the facility in WuXi, China is a well inspected facility from multiple agencies, both in person and hybrid, for multiple approved products. So they have a very successful, positive history of inspections. Previously, as you mentioned, we’ve done mock inspections and a whole host of pre-approval inspection activities.

As I said, on the call, we’re actually sending or actually answer a question from the follow up, we are sending our team over in the coming weeks, and we will continue to help prepare and make sure everything’s buttoned up. We also as a reminder, a big chunk, and we talked about this during the review, a big chunk of the agency’s review was on the manufacturing. So there are a whole host of questions that we’ve already answered satisfactorily for the agency. And then finally, we’ve pointed to the rich manufacturing history with our product self. We’ve done dozens of successful manufacturing runs at that commercial scale, under the quality key process parameters, critical quality of quality attributes that are part of the overall quality control of the product.

So for all those reasons, we feel really excited and prepared for the inspection. And we’re thrilled now that we have one scheduled and kind of have line of sight to what we hope will be the eventual approval.

Operator: One moment for our next question. And our next question comes from Jeff Hung of Morgan Stanley. Your line is open.

Unidentified Analyst: Hi, good morning. This is Catherine on for Jeff, thank you for taking our question. We just had one. Can you remind us of what confirmatory analytical testing was requested by the EU regulatory authorities for miglustat? And I just have a quick follow up what kind of risk if any, is there that it could take longer for a CHMP opinion? Thank you.

Bradley Campbell: Yes, Jeff, do you want to just give a little bit more color than what we’ve spoken to before?