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

So overall, the U.S. market is the largest market. We see the Pompe market being made of about 40%, of sales coming from the U.S. 36%, 37%, coming from Europe and 23% coming from rest of world. From a patient number standpoint, the actual number of patients treated we estimate in Europe is greater than the U.S. We estimate north of 1300 patients treated for Pompe within Continental Europe, another 200 from the U.K, and in the U.S., that compares with around slightly north of 800 patients. So I think that gives you the overall geographical split that highlights that, the European approval and the U.K. approvals are also some very significant opportunities for us.

Operator: Our moment for our next question. Our next question will come from Gil Blum of Needham Company. Your line is open.

Gil Blum: Hey, good morning, and thank you for squeezing me in. A bit of a follow up on earlier question about Lumizyme and Nexviazyme dynamics. You guys have any detail on how many of those new Nexviazyme patients are naïve versus switch if at all? Thank you.

Bradley Campbell: Little hard to tease that out. And I don’t want to speak on behalf of Sanofi obviously. But we know that there I’m sure United States putting on naïve patients as well as switch patients based on their public commentary. And you look we believe that, that it’s great for patients to have choice and for a new therapy to be out there. And so I think it’s fantastic for the community that there are multiple treatment options, and that were just eager to provide a third treatment option for patients. So a little tough to tell exactly what the distribution is, but I’m sure there’s some component of that going on. And Gil something we’ve seen very much in the public market is, as you see more players entering a rare disease space, you also see stronger growth for the overall market.

We need to keep in mind that those diseases are unfortunately, significantly under diagnosed and undertreated. So as you see Amicus coming to the Pompe market, you will see more efforts to raise this awareness, to support diagnostics initiatives, and hopefully get overall, more patients having choices of therapies.

Gil Blum: Thank you.

Operator: One moment for our next question. And our next question comes from Zhiqiang Shu of Berenberg. Your line is open. Again, our next question comes from Zhiqiang Shu of Berenberg. Your line is open.

Zhiqiang Shu: Sorry, I was on mute. Thanks for taking the question. Congrats on the progress. I was wondering if you can comment on the significance of achieving profitability in the second half and your confidence, maintaining that status going forward? And maybe related to that wondering your thoughts on continued investment in the early stage of discovery programs. Thank you very much.

Bradley Campbell: Yes. Thank you for the questions. Look, I think from a profitability perspective, I think that’s a really important milestone for any company, who started as a preclinical research phase company has now made it to launching our second product. So I think for Amicus for our employees, for our investors, I think it’s just a really important milestone. We haven’t given guidance yet. And what that means the long-term, but we certainly see ourselves continuing to, to be prudent in our financial use of resources, but also seeing our top line revenue continue to grow. And hopefully now with the addition of a second product. So we’ll talk more about kind of what that looks like in the future as we get closer to 2024.