The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Yes. So maybe you could give a two minute intro about the company and then we can go into specifically.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay, perfect. And maybe we'll start with Pompeii and then you can talk to us about the guidance that you gave. And then yes, so how are you
getting to that $62 million to $67 million? And like what are the drivers that you look at what's early in the year? How are you thinking about
seasonality or of geographic anomalies, for example?
Yes. And getting to that number, I think people would be looking for color that I think sell-side was probably a bit more bullish about what first
yourselves would be. So interested in hearing how we should be thinking about it because maybe we've not been thinking about it correctly?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: That's good color. And you mentioned that 25% of your patients are ones that are switching from Lumizyme. Why would they skip over next five
months?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Our doctor checks, for example, say, we want to leave you with this product for last because sure make sure that we can keep the patient on this
for as long as we can. So just curious on what you're hearing on that.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Right.
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MAY 15, 2024 / 8:40PM, FOLD.OQ - Amicus Therapeutics Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. So in Europe where you're not, you're not label restricted to split, why would a patient go on somebody first, for example?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. So for the guidance that you've given for the year, is there a sense on what proportion of that is going to be US sales versus ex-US just because
of that?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Yes, on the on the price point in general, on what kind of discount should we expect to see in Europe of our US?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: And as you move forward, do you think you'll have any type of exposure to things like IRA, for example.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. Maybe let's just talk about manufacturing and down, whereas the product manufactured.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Yes, I did want to go into a little bit of detail on the biosecurity and what exactly that means because, yes, you will be having a manufacturing site
not located in China, but is still owned and by machine, right. And as far as sourcing your API would that still be coming from China, at least for the
time being?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. And I guess based on what you know about your API needs, do if the API. can be sourced to others idea.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. What was it about Rishi, in particular that made Amica's all those years ago choose Rishi as the partner and what is it that you might need to
particularly pay attention to if you're looking for a replacement.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. That's good to know. And would that pay come out? And in terms of your OpEx, how would that impact the investments that you would
need to make?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. I'm now going back to the launch metrics for a couple of more minutes. You talked about over time you expect US to be up 40% of the
contribution that you got from from Pompeii sales, does that assume that it stays as a switch market only in the US and what potentially could be
an advantage of trying to also have a treatment-naive segment.
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MAY 15, 2024 / 8:40PM, FOLD.OQ - Amicus Therapeutics Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. And then you also talked about the time from mining a script, the patient getting an infusion. The early assumption was 90 days and I went
to 17 days, it's now a 30 to 45-ish days.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. So that would be the your idea estate? Yes, ideas a lot of time to turnaround and for, I guess for doctors who have not yet written script,
what's the main reason here sign?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: And just remind us how big of a marketing organization you've created for this particular launch.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. So assuming that, your sales force is now detailing both Fabry and Pompe turning concern that the momentum for fabric could be impacted
as and some sales reps need to start building out those other relationships.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: So I don't want to be Dallas pulled out of the conversation altogether. So as you think about this as a mature launch for Amicus now and maybe
it's more mature in Europe because you launched there. First, how are you thinking about what's what is left for you in terms of market opportunity
when you're talking about Europe? And then also the US?
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MAY 15, 2024 / 8:40PM, FOLD.OQ - Amicus Therapeutics Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Ones that are diagnosed but not treated with the reason?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: And have you had to use any discounting to get on formulary or stay on formularies since you launched?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. And we're almost at the end, but I did want to ask you about how you're thinking about biz dev because, yes, you're now a company that's
just purely focused on two commercial launches. And in the past, Amica's did have a pipeline.
I mean, you've made some changes to the company. How are you thinking about where the company is now and whether or not you think investing
in a pipeline again might make sense?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Okay. Perfect.
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: But we're out of time. So thanks, everybody, for joining us. Thank you, Brad, for playing out this year, hope everybody has a great rest of the session.
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