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

But I think you hit on the really important point, which is our job this year is to put as many patients as possible who are appropriate onto AT-GAA, of course, with the expanded access and on-going extension studies, but then of course, with the new commercial patients as well. So our focus is maximize the number of patients on therapy. And that gives you a really strong run rate going into next year.

Ritu Baral: Great Thanks for taking the questions.

Bradley Campbell: Thanks Ritu.

Operator: One moment for our next question. And our next question comes from Tazeen Ahmad of Bank of America. Your line is open.

Tazeen Ahmad: Hi, guys. Good morning. And thank you for taking my question. Perhaps just a simple one for me. So when you say that the infection has been scheduled, does that mean that FDA kind of just decides who they want to send over, and that team just goes? Or does there has to be some process that includes for example, the State Department needing to pre clear it, just wondering what the technicalities are on that? Thanks.

Bradley Campbell: Yes, thanks Tazeen for the question. At this point it, what we understand from the FDA, this kind of business, as usual, is relates to the inspection. So of course, they’ll need, pieces and those kinds of things. But that process is underway. From what we understand, we feel very confident that they now have an inspection scheduled and we’ll be able to, to execute upon that inspection. To give you an example, we have our own team members who are now going to China to visit the site who haven’t been able to get there for all the reasons we’ve discussed for a number of years now. So our understanding is that it’s business as usual. And we should be very competent in those days, of course, caveat by you never know what’s going to happen. But I think where we are at this point, what we’ve seen, what we’re seeing from our own team, is that it’s business as usual, and there’s no special requirements in order for them to be able to execute inspection.

Tazeen Ahmad: Okay, thank you.

Bradley Campbell: Thanks Tazeen.

Operator: One moment for our next question. And our next question will come from Ellie Merle of UBS. Your line is open.

Ellie Merle: Hey guys thanks so much for taking the question. Jeff, in some of maybe your pre commercial work, how should we think about the uptake in switches from Lumizyme or Myozyme relative to say switches from I guess in the U.S. And then I guess just what’s the feedback from physicians on how often they see their Pompe patients and like whether patients might say be called in whether it has been to get or whether it be to get AT-GAA given the potential approval? Thanks.

Bradley Campbell: Sure. Thanks, Ellie for the questions. Maybe I’ll take a stab at the first one. And then and then Jeff can talk to the kind of frequency of interactions with physicians and patients. So in terms of who we would be targeting, for our, our launch in the United States, where I think we anticipate a label for experienced patients. We would I think, target any segment where physicians or patients feel like there’s a need or an opportunity to try new therapy. And so for us, that could mean both the lumizyme patients as well as the Nexviazyme patients. And again, I would just, the thing that we are most focused on is the is the unique data that we have with from the only study that studied in a controlled portion, patients who are on enzyme replacement therapy switching to another therapy during that controlled phase.