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

Jeff Castelli: Yes, thanks, Catherine. We haven’t disclosed exactly what the requested testing was. What we have said is it was something that during the submission we had provided in silico, data, all sorts of sort of modeling to show that there was €“ we’d address all the requirements for regulations, what we got CSC doc was, like we needed to have a test to actually measure for this confirmatory testing of these molecules. So we are, as we said, during the call initially, we are well on track, we don’t believe there currently is any risk to that timeline, the app for the four month clock delay, we’re on track to provide that validated data with a validated assay. And to be on track for that CHMP opinion here in the second quarter.

Operator: One moment for our next question. And our next question will come from Salveen Richter of Goldman Sachs. Your line is open.

Unidentified Analyst: Hi, it’s on for Salveen. Thank you for taking our question. Two quick ones. Will you be updating the street post the inspection of the WuXi site by the FDA? And can you provide any color on the pricing of AT-GAA now that we have PDUFA timeline?

Bradley Campbell: Yes, thanks for the questions. So it relates to the updates and manufacturing. As long as there’s no material impact to our anticipated timelines, we won’t provide any updates on the outcome of the manufacturing, inspection of course if there’s a material change or impact, then we would provide that in due course. As it relates to pricing, I think we’ve described previously is that we would continue to follow our pricing and access strategy and promise which is parody or modest discount standard of care. Our focus is to maximize access to therapy. And we’ve found with Galafold that that’s the best way to execute on against that strategy and to maximize the number of patients who are eligible to receive therapy.

Operator: One moment for our next question. And our next question will come from Yun Zhong of BTIG. Your line is open.

Yun Zhong: Hi, good morning. Thanks very much for taking the question. So on Galafold, the 65 versus 35 ex-U.S. versus U.S. sales, is that mainly, depending on or driven by the number of patients, given that it’s been a few years after U.S. approval? And I was wondering what could be the implication for AT-GAA? Do you think there could be any big differences in terms of both disease prevalence, depending on geographic regions can that can potentially impact your launch strategy for AT-GAA versus what you did for Galafold?

Unidentified Company Representative: Hi, and thanks for the question. Yes and Brad maybe talk a little bit about the distribution of revenue and Fabry. And, and what we might expect based on current distribution of sales and patients for Pompe Disease.

Bradley Campbell: Yes, so the performance in the U.S. was very strong. Last year, we had a strong growth in the fourth quarter of 21.4%. We talked about, the trends we’ve seen over the last six to eight months in terms of, new patient ads. We’ve also talked about, in general terms about market share within the amenable population. And the U.S. is, one of these markets where we gradually see a greater proportion of naive patients contributing to growth, but there’s still a fair amount of switches probably more than some of the markets where we’ve been the longest like, like the U.K. or France, for example. As we look at the split of revenues on a global basis, if you, if you consider Pompe, there’s a bit of a difference from a pricing standpoint, between price in the U.S. and price in Europe.