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

However, we, with our partners in WuXi have already started the process of standing up the new facility in Ireland. And I think, as we’ve mentioned before, we expect that capacity to come online, in in sort of the 24, 25 timeline. And that would be really when you’re starting to see the meat of the balance of Europe coming on board and starting to see some rest of world countries as well. And so that will become I think, the primary source of capacity for the long-term manufacturer of the product. So really feel really good about where we are today with a clear plan of how to continue to grow and support the globalization of the product launch.

Joseph Schwartz: Thanks Brad. And could it was done previously, how does that change? The interpretation, if at all, and what feedback did you hear in general from physicians who saw all the data that you reported it world?

Bradley Campbell: Yes, Joe, what you stated a little bit, I think the question the first part of the question was, in the way we displayed the data, and we presented it — as present predict present perfect predicted value, excuse me, versus change from baseline. And then the second question was, what was the response from the audience at world? I’ll take the second one first. And then and then I’ll ask Jeff to comment on the first one. So I think overall, it was great to be in person at world as you can imagine, tons of activities with patients, with physicians, excuse me, both in Pompe and Fabry. I think the overall receptivity was fantastic. And to continue to see new data coming out from our program. And again, just being having a chance to interact in person at the World Conference was really was really exciting and energizing.

And I think it really teases up well for the continued pre-launch activities headed into the third quarter. Jeff, you want to talk specifically about Joe’s question around the change from baseline versus present predicted and why that makes sense.

Jeff Castelli: Yes, and thanks Joe for the question. So you percent predicted six minute walk is, takes into account things like patient’s height, but importantly, age. And as you go on longer durations of follow up, it’s pretty standard to use percent predicted six minute walk to kind of account for the fact that over two years over four years, patients are certainly aging and that should be accounted for in the calculation of how far they should walk in six minutes. So over a one year study, like propel, using meters makes sense. But as we go longer-term follow up, I think you’ll see across programs, people usually use percent predicted six minute walk. We did report in the supplement world, the meters data, and it looks very comparable to the percent predicted, it’s just that that’s kind of the more standard way for long-term follow up.

And as Brad said, I think we had a really positive reception to that data. We also had our four year data represented, which was very consistent showing kind of a durability of effect in the Phase I/II throughout the four years in here and propel over the two years.

Joseph Schwartz: Thank you.

Operator: And one moment for our next question. And our next question comes from Dae Gon Ha of Stifel. Your line is open.

Dae Gon Ha: Good morning, guys. Thanks for taking my questions. And congrats on the progress.Two part question on the HVGA if I may. Just thinking about your market research and your physician interactions, kind of curious if you can maybe walk us through what the CRE next fee is — take was based on your data that’s been generated and PROPEL as well as Phase I/II, and post Nexviazyme just wanting to see if they have a different view there or what the evolution of that process is. Second part is, now that you have the OLV data presented at World, maybe digging a little deeper on Joe’s question, what’s been sort of the physician feedback on that naïve segment? What’s been sort of the receptivity or willingness to try AT-GAA for the naïve patients?