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
: Hi, guys. Good morning. Thanks for taking my question. Brad, I wanted to ask about PomOp. As you go through the launch and as we look at, let's
say, the switch patient population, on average, how long are doctors keeping their patients on, let's say, the first or second-gen [fantasy ERTs]
before moving patients over to amicus?
Because we've done checks, which indicate there's excitement about the third option being available for patients who have undermet needs. But
there's also been talk about keeping patients on the first two gen drugs as long as possible. So I wanted to get a sense of what you're hearing from
your sales force on that. Thanks.
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FEBRUARY 19, 2025 / 1:30PM, FOLD.OQ - Q4 2024 Amicus Therapeutics Inc Earnings Call
Question: Ellie Merle - UBS Securities LLC - Analyst
: Hey, guys, thanks so much for taking the question. You mentioned that there's a high prevalence of Pompe in the Netherlands. Can you elaborate
a little bit more on the number of patients there and specifically a bit more on the timing for when you expect to start dosing and recognizing
revenues from that region?
And then just generally, I know you mentioned that there are a lot of countries where you expect the first commercial patients to begin in the first
half of the year. Can you maybe give us just a little bit more detail on the country-by-country timing for the revenues for PomOp and your expectations
there, particularly as we think about the quarterly cadence of revenues throughout the year? Thanks.
Question: Ellie Merle - UBS Securities LLC - Analyst
: Great, thanks.
Question: Dennis Ding - Jefferies LLC - Analyst
: Hi, good morning. Thanks for taking our questions. I just had one specifically on FX. Can you elaborate a little bit more on FX and where do you
see that going this year, especially with this whole macro narrative around interest rates being higher for longer? Does Amicus have any hedging
programs designed to mitigate FX volatility, and maybe also comment how impactful those were historically? Thank you.
Question: Dennis Ding - Jefferies LLC - Analyst
: Perfect. Thank you.
Question: Joe Schwartz - Leerink Partners LLC - Analyst
: Great. Thanks very much for taking my question. I was wondering if you could update us on your progress towards establishing second-source
manufacturing for PomOp. And is there any risk or exposure regarding tariffs in the importation of PomOp from China currently?
Question: Joe Schwartz - Leerink Partners LLC - Analyst
: Excellent. Thank you.
Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst
: Hi. Good morning, everybody. You talked about the proportion of patients that may be considering switching to PomOp from NEXVIAZYME based
on being on therapy for up to two years and some of the effects starting to wear off. But I wanted to ask, on the flip side of that, for those patients
that were treated with PomOp perhaps before that other option, are you seeing something similar? Or are you seeing that physicians want to keep
their patients on PomOp for longer as the effects are still persistent?
Question: Malcolm Kuno - JPMorgan Securities LLC - Analyst
: Hi. Thank you for taking the question. For the EU countries coming online during the first half of 2025, with regard to -- specifically the EAP patients,
how many should we be expecting to transition to commercial therapy?
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FEBRUARY 19, 2025 / 1:30PM, FOLD.OQ - Q4 2024 Amicus Therapeutics Inc Earnings Call
Question: Malcolm Kuno - JPMorgan Securities LLC - Analyst
: Great, thank you.
Question: Gil Blum - Needham & Co. LLC - Analyst
: Good morning, everyone, and thanks for the updates. Maybe a question on the AI aspect here. So what regulatory or logistical burden, if any, do
you anticipate to be required to roll out something like OM1? Thanks.
Question: Jeff Hung - Morgan Stanley & Co. LLC - Analyst
: Thanks for taking my question. Maybe a follow-up on the AI collaboration with OM1 and Penn. Have any of the high-potential patients begun to
be seen by physicians and been formally diagnosed with Fabry? And I think you said that it will take about six months to do the testing phase. I
was just curious if you'll provide a formal update when this phase is completed and the outcomes of that, whether in terms of families that additional
patients that you guys identify. Thanks.
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FEBRUARY 19, 2025 / 1:30PM, FOLD.OQ - Q4 2024 Amicus Therapeutics Inc Earnings Call
Question: Jeff Hung - Morgan Stanley & Co. LLC - Analyst
: Thanks.
Question: Joshua Fleischman - TD Cowen - Analyst
: Hi, this is Joshua Fleischman on the line for Ritu. Thanks for taking the question. How has the commercial competitive dynamic evolved for PomOp?
Our team attended World, and we noticed that Sanofi and Genzyme are doing less with NEXVIAZYME. Is this something you guys have noticed in
the field? Also, can you please give us an update on the LOPD label expansion and enrollment and timing for the IOPD study? And lastly, what
technologies or features are you looking at for business development candidates? Thank you.
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