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: Jeff Hung - Morgan Stanley - Analyst
: Great. Let's start with Galafold. You raised revenue guidance for the year. Can you just talk more about what is driving growth and what aspects
of those dynamics might change as you go out beyond this year?
Question: Jeff Hung - Morgan Stanley - Analyst
: And you talked about 80%, but can you just clarify what proportion of the newly diagnosed patients are being put on Galafold as the very first line
of treatment? And then how fast do you expect it to change?
Question: Jeff Hung - Morgan Stanley - Analyst
: And so then how much more room do you think that there is given that a fairly high percentage as it is for new patients?
Question: Jeff Hung - Morgan Stanley - Analyst
: If I'm not mistaken, I think Galafold has about 60% of the global market now --
Question: Jeff Hung - Morgan Stanley - Analyst
: And so, what gives you confidence that you can reach 85% to 90% market share? And can you just talk a little about what's required to achieve
those levels and how long you think that might take?
Question: Jeff Hung - Morgan Stanley - Analyst
: Great. Maybe let's shift the Pombiliti and Opfolda. You said that the global Pompeii disease market growth continues to be driven by diagnosing
new patients. How long do you expect this trend to continue? And do you expect that to be driven more by specific geographies?
Question: Jeff Hung - Morgan Stanley - Analyst
: You've launched in Spain and are in active reimbursement discussions with additional EU countries. Can you just talk about the launch trajectory
in the recently launched countries and how those have fared relative to your expectations?
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SEPTEMBER 05, 2024 / 2:00PM, FOLD.OQ - Amicus Therapeutics Inc at Morgan Stanley Global Healthcare
Conference
Question: Jeff Hung - Morgan Stanley - Analyst
: So you indicated expectations for the overall time from prescription to infusion to improve from 65 down to 30 to 45 days by the end of the year.
Can you just talk a little bit more about that trajectory where you are in that process?
Question: Jeff Hung - Morgan Stanley - Analyst
: And what proportion of growth is being driven by deepening with repeat prescriptions versus broadening with more sites? What have you seen
in terms of net patient adds?
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SEPTEMBER 05, 2024 / 2:00PM, FOLD.OQ - Amicus Therapeutics Inc at Morgan Stanley Global Healthcare
Conference
Question: Jeff Hung - Morgan Stanley - Analyst
: And what factors have been encouraging patients and physicians to switch to Pombiliti Opfolda?
Question: Jeff Hung - Morgan Stanley - Analyst
: And over time, where do you see the proportion of switch patients, naive patients trending in US and EU?
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SEPTEMBER 05, 2024 / 2:00PM, FOLD.OQ - Amicus Therapeutics Inc at Morgan Stanley Global Healthcare
Conference
Question: Jeff Hung - Morgan Stanley - Analyst
: And does that do splits differ across different insurance coverage or are they fairly comparable across --
Question: Jeff Hung - Morgan Stanley - Analyst
: And you've noted that one of your goals is to achieve 30% to 35% market share within three years for each market launch which you've seen in
UK. And then you've observed that the launches in Germany, US, Spain are kind of on that pathway. Are there any regional dynamics, though that
are worth noting?
Question: Jeff Hung - Morgan Stanley - Analyst
: And how do you think beyond that beyond the 30% to 35% and moving on to higher levels like say, 50% pathway? Like what factors would further
help accelerate?
Question: Jeff Hung - Morgan Stanley - Analyst
: And you touched upon this some a little bit ago, but in the US, like how do you see the treatment naive segment playing into the market share?
And how much data you collected so far? And how do you think about what's needed for potential label expansion?
Question: Jeff Hung - Morgan Stanley - Analyst
: Can you just talk a little bit about your manufacturing plans or any updates there? Especially on your second gen manufacturing process?
Question: Jeff Hung - Morgan Stanley - Analyst
: Great. Can you just talk about the latest update on your early-stage pipeline and when might we expect to hear additional updates on these
programs?
Question: Jeff Hung - Morgan Stanley - Analyst
: And your response kind of address the next question, but what are your thoughts about licensing or acquiring external assets? And if you were to
consider that, what would be the ideal profile?
Question: Jeff Hung - Morgan Stanley - Analyst
: Okay. Maybe one last question in the last couple of minutes on one of your key priorities for the years achieving full year non-GAAP profitability
and you achieved that in 2Q. Any additional thoughts on that for the year and your expectations for what could drive acceleration in the second
half?
Question: Jeff Hung - Morgan Stanley - Analyst
: Great. Thanks for your time.
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