Amicus Therapeutics Inc Q1 2023 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Malcolm A. Kuno - JPMorgan Chase & Co, Research Division - Analyst : This is actually Malcolm Kuno on for Anupam. So looking past the third quarter approval, what observations have you learned from Sanofi's launch in Pompe that you can perhaps apply to your own launch? And then how should we view your launch curve relative to that competition?

Question: Eliana Rachel Merle - UBS Investment Bank, Research Division - Analyst : Just wondering if you could elaborate a little bit on the comments and observations received from the FDA inspection and maybe just kind of what drives your confidence that all of these are addressable. And then just a question procedurally on how to think about the time frame like from inspection to approval. I guess just in situations like this with deferred action? How should we think about the typical time frame and maybe also just next steps from here in terms of the time lines for addressing the comment and observations?

Question: Kristen Brianne Kluska - Cantor Fitzgerald & Co., Research Division - Analyst : I wanted to ask what your latest thoughts are on how you might position AT-GAA relative to the benefits across respiratory outcomes and different measurements there. I know you presented more data at Worlds this year. And in the past, you've cited this as a really important endpoint considering it's a leading cause of mortality for these patients.

Question: Zhiqiang Shu - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : I wanted to ask your -- today announced the expansion of supply and manufacturing agreement with WuXi on its Ireland facility. I guess, can you talk about the transition plan from the China facility to the Ireland facility? And also, do you expect the FDA inspection on the Ireland facility in due course?