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: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Brad, to start here, can you give us a snapshot of your business today and your strategy on commercial execution in the second half of the year?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: You've guided to achieving a full year of non-GAAP profitability in 2024. Can you describe what is baked into that guidance and your expectations
on the operating expense side and over the course of the year?
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JUNE 11, 2024 / 8:00PM, FOLD.OQ - Amicus Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: You've really been, at this point, a commercial stage company with limited pipeline. Maybe speak to us about how you'll bring in a future growth
lever via R&D.
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: What do you think with regard to the full story is underappreciated by the Street? And what are you most excited about over the next year?
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JUNE 11, 2024 / 8:00PM, FOLD.OQ - Amicus Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Let's start on the PomOp launch. How is the launch that's currently underway in the US and UK and Germany progressing? I think you've mentioned
as you just did about $1 billion in peak sales opportunity. Could you speak to the assumptions baked into this guidance and when you expect to
get to the peak sales number?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Are there any other dynamics there playing out with regard to use of the competitor drug and how recently they may have gone on that drug with
regard to understanding then the time before you would switch over?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: And how do you think about the US versus ex-US split?
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JUNE 11, 2024 / 8:00PM, FOLD.OQ - Amicus Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: How is the frontline market playing out in terms of the various players right now?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Meaning if a patient were naive and being put on drug for the first time, what proportion are coming on to your drug versus the others?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Could you speak to the path to get naive patients included in the US label?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Can you speak to the reimbursement dynamic in the US? I think you've spoken to a lag that was playing out with regard to referral forms to time
to infusion. How long does it take for that to be shortened?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Can you speak to the Myozyme switch dynamics? Have they all mostly gone to Nexviazyme? Or are you seeing some switch over to your drug?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: You touched on the Biosecure bill. Maybe help us understand the plan here as you look to opening another second WuXi plant about the move
elsewhere with regard to manufacturing?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
:
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Maybe turning over to Galafold, help us understand what's baked into the assumptions around your guidance there.
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: How are you thinking about emerging competitors that are taking different -- using different modalities such as the substrate reduction therapies
or gene therapy?
Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst
: Brad, thank you so much. Really appreciate the discussion. Thank you.
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