Amicus Therapeutics Inc Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Ritu Baral - TD Cowen - Analyst : I wanted to ask about your Pombiliti prescribing trends that you mentioned. You mentioned that you had improving trends on both sites and prescribers. Could you go into that a little bit and describe a little more what you're seeing now about US -- like the point at which US prescribers and patients elect to switch specifically what the patients are experiencing? And then could you help us just quantify the Japanese market opportunity in Pompe since that's coming up?

Question: Anupam Rama - JPMorgan - Analyst : I just wanted to dig in a little bit on the previously untreated patients that are now on Galafold. I think the slide says around 60%. Can you speak to like what you're seeing about these previously untreated patients in some of your core regions or more legacy regions versus some of the emerging market regions? That's my one question.

Question: Tazeen Ahmad - BofA Global Research - Analyst : On Galafold, as it relates to IP, are there any filers still left on that front? Is there a chance, I'm wondering, if you could get any better outcome than the one that you've just announced the settlement with? And then just a point of clarification as it relates to dropout rates for Galafold, can you tell us if those rates have remained the same or changed much at all recently?

Question: Eliana Merle - UBS Equities - Analyst : In terms of thinking about your pipeline, I guess, what's your focus as you think about building out your clinical pipeline from here? Are you more focused on internal development work? Or are you looking externally with business development? And then I guess as you think about business development, are there specific modalities or stages of development where you're most focused? And just how you're thinking about that strategy overall? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 1:30PM, FOLD.OQ - Q3 2024 Amicus Therapeutics Inc Earnings Call

Question: Joseph Schwartz - Leerink Partners - Analyst : It looks like around 17 patients were added from the end of July to the end of October versus around 30% in prior quarters. So I'm wondering what is driving this and how things are trending in the fourth quarter? And how should we be thinking about the cadence of new patient adds as we get into '25? Have you started to think about expectations for '25? It looks like the Street assumes sales of around $145 million, and that's about a doubling of sales year over year. So what do you make of the activity in terms of patient demand this quarter and going forward? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 1:30PM, FOLD.OQ - Q3 2024 Amicus Therapeutics Inc Earnings Call

Question: Dae Gon Ha - Stifel Nicolaus and Company, Incorporated - Analyst : And congrats on the progress. I wanted to circle back on the BD side of the story. Now that we're done with the election, there's a lot of chatter around STC and who might come up next. So on the BD front, when you think about these late-stage pre-commercial assets, I guess what's the driver here ultimately? Are you more focused on getting to GAAP profitability and a significant cash flow before pulling the trigger? Or is there something that's on your radar already that you might think about pulling the trigger once you get over the hurdle of the non-GAAP profitability? And just a clarification for Jeff. On the pipeline, these genetic approaches, are these the same ones that you guys had for Caritas that you guys are retaining? Or are these evolved versions that are separate from what we have seen from Caritas?

Question: Dennis Ding - Jefferies - Analyst : I had a question around Pompe. And your new 2024 guidance assumes Q4 would be generally flattish for Pombiliti. I just wondering how much conservatism is baked into this guidance and if there's anything normal worth calling out in terms of inventory or timing of drug shipments that may have benefited Q3?

Question: Dennis Ding - Jefferies - Analyst : Got it. And maybe as a follow-up, as you think about the trajectory of the Pompe launch, this -- like is the messaging more around steady study and linear growth? Or do you see any point of acceleration in terms of new patient adds? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 1:30PM, FOLD.OQ - Q3 2024 Amicus Therapeutics Inc Earnings Call

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Congrats on a great quarter, not just from the revenue side, but from all the operational updates as well. I was hoping you can comment more on some of these main drivers that have led to some of the tightening of the operating expense guidance you're providing today?

Question: Michael RIad - Morgan Stanley & Co. LLC - Analyst : This is Michael Riad on for Jeff. Congrats on the strong quarter. How far into 2025 -- for like the Pombiliti and Opfolda previously expensed inventory, how far would that like that inventory be able to carry for next year? And like, can you provide any commentary on the potential for next-gen manufacturing? When would you expect that could start to impact gross margins?

Question: Gil Blum - Needham & Company LLC - Analyst : So as it relates to genetic medicine and Fabry, recent feedback from the FDA regarding potential for accelerated approval was pretty interesting. I just wonder what you guys think and whether current dynamics could push a program for genetic medicine in Fabry a little faster than expected.

Question: Salveen Richter - Goldman Sachs Research - Analyst : Just would it be possible to give us some further commentary on the competitive dynamics versus Nexviazyme in the US and ex US, just given the appreciable growth in the ex-US share for that asset for Sanofi's last earnings.