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

And then separate question for Daphne, understanding the pushes and pulls of variability throughout this year. But if we think about modest contribution revenue wise from AT-GAA, I guess, how much or should we really be thinking about given that the second half non-GAAP profitability kind of also hinges on that progress? I hope that makes sense

Bradley Campbell: Okay, so thanks for the questions, first of all. So we’ve got sort of impressions of data pre and post, I guess, launch of next Lyzyme. And then Jeff, talking a little bit more about the different segments we showed at, at world, both the switch patients and naïve patients. And then I guess one last question to Daphne around how AT-GAA revenue impacts our goals for non-GAAP profitability for the second half of the year. So, as relates to the first one, honestly, I then I said in the call and I’ll highlight it again here. I think the most differentiating data we have is in is in those switch patients. And, and I think that will continue to be a hallmark and highlight of, of the labels that we have that we anticipate, as well as the information were presenting to physicians.

And frankly, that’s, that’s kind of regardless of what happens on the next Lyzyme side. Again, we’re the only company to have sponsored in the control arm of our pivotal study, experience patients switching from that one as a replacement therapy to AT-GAA. And I think that’s just a critical difference. The other thing, of course, we were really pleased to see was the consistency and the durability of those data, as we now see that the long two year data from PROPEL. And then as Jeff highlighted the reprise of the four year data from the Phase I/II study. So I think that consistency and durability is also really important. Jeff, do you want to talk quickly about the impact we also saw in the naïve patient segments from the long-term extension, and then Daphne can get to the financial question.

Jeff Castelli: Yes. Thanks, Brad. And thanks Dae Gon for the question. So as we think about the naïve patients as a reminder, and PROPEL was 80% about your experience patients and only 20% were naïve. And then the naïve where we saw both the Lumizyme arm and ATZ arm perform better than any other arms we’ve seen in naïve basis and other studies, they were very similar kind of in the quite significant benefit we saw. We were encouraged by in the, additional year of follow up is we saw patients continue to show at least stability even increases on gains, from that large increase they had. So the two year results, and those naïve patients, combining sort of Lumizyme and AT-GAA together or two years at AT-GAA are really quite remarkable in terms of the increases.

No FEC, because these patients had much higher baselines, we did see sort of both groups had that small decline. It was good to see that that stabilized, whether that was a true decline or not in the original kind of . But certainly we’re seeing really robust improvements and six minute walk and stability and FEC and his naïve patients. And for Phase I/II after four years, we saw improvements in both six-minute walk and FEC and citations that were maintained for four years. So net net, I think as physicians looked at the data, certainly the bulk of our data is in the year he experienced, as Brad said, the more difficult to treat patients. And I think they assume that the benefits observed there would carry over to the 90s. And then our naïve data is also supportive.

So I think we offer a good value proposition for naïve. We generated positive feedback from physicians, obviously, we’ll see where the labels are in different geographies. And that could play a part in terms of prescribing for naïves, but we believe we have a great value proposition for both experienced and naïve.