Earnings call transcript: Amicus Therapeutics beats Q3 2025 earnings expectations

Amicus Therapeutics reported its third-quarter 2025 earnings, surpassing analyst expectations with an EPS of $0.06, doubling the forecast of $0.03. The company also exceeded revenue projections, reporting $169.1 million against the expected $165.4 million. This positive performance contributed to a pre-market stock increase of 1.02%, with shares trading at $8.95. The company’s strong performance was driven by robust sales of its key products, Galafold and Pombiliti/Opfolda, and strategic market expansion efforts.

Key Takeaways

• Amicus Therapeutics’ Q3 2025 EPS was $0.06, beating the forecast by 100%.
• Revenue reached $169.1 million, a 19% year-over-year increase.
• Pre-market stock price rose 1.02% following the earnings announcement.
• Galafold sales grew 12% at constant exchange rates, maintaining a 69% market share.
• Pombiliti/Opfolda revenue surged 42% with successful international market entries.

Company Performance

Amicus Therapeutics demonstrated strong financial and operational performance in Q3 2025. The company reported its first quarter of GAAP net income, achieving $17.3 million. Non-GAAP net income was significantly higher at $54.2 million. The company’s strategic focus on expanding its geographic footprint and improving reimbursement timelines contributed to its robust performance, particularly in its international markets.

Financial Highlights

• Revenue: $169.1 million, up 19% YoY
• GAAP Net Income: $17.3 million
• Non-GAAP Net Income: $54.2 million
• Cash and Equivalents: $263.8 million, up $32.8 million from the prior quarter

Earnings vs. Forecast

Amicus Therapeutics reported an EPS of $0.06, surpassing the forecasted $0.03 by 100%. Revenue was also above expectations, coming in at $169.1 million compared to the projected $165.4 million. This earnings beat reflects the company’s effective execution of its growth strategy and strong product demand.

Market Reaction

Following the earnings announcement, Amicus Therapeutics’ stock experienced a pre-market increase of 1.02%, reaching $8.95. This positive market reaction is indicative of investor confidence in the company’s financial health and growth prospects. The stock remains within its 52-week range, with a low of $5.51 and a high of $12.65.

Outlook & Guidance

Looking forward, Amicus Therapeutics anticipates total revenue growth of 15%-22% for 2025. The company projects Galafold revenue to grow by 10%-15% and Pombiliti/Opfolda revenue by 50%-65%. Amicus is also pursuing label expansions for its products, aiming for a significant market share in the Fabry and Pompe disease treatment markets.

Executive Commentary

"We are confident that our two commercial products, each with blockbuster potential, are on track to deliver combined sales of $1 billion in 2028," said Bradley Campbell, CEO. Sébastien Martel, Chief Business Officer, noted the underdiagnosis of Fabry disease, highlighting the company’s focus on expanding patient reach. Campbell also emphasized the differentiation of Pombiliti and Opfolda through real-world evidence and clinical data.

Risks and Challenges

• Market Saturation: Increased competition in the Fabry and Pompe disease markets could impact market share.
• Regulatory Challenges: Pursuing label expansions involves regulatory hurdles that could delay product launches.
• Economic Pressures: Macroeconomic factors may affect healthcare budgets and reimbursement processes.
• Supply Chain Issues: Potential disruptions could impact product availability and sales.

Q&A

During the earnings call, analysts showed strong interest in the real-world evidence for Pombiliti and the company’s plans to expand patient populations. The management also addressed questions about the development of DMX-200 for treating FSGS, expressing confidence in their growth momentum and strategic initiatives.

Full transcript - Amicus Therapeutics Inc (FOLD) Q3 2025:

Andrew Faughnan, Vice President of Investor Relations, Amicus Therapeutics: Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics third quarter 2024 financial results conference call and webcast. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Vice President of Investor Relations. You may begin.

Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics third quarter 2025 financial results and corporate highlights. Leading today’s call, we have Bradley Campbell, President and Chief Executive Officer; Sébastien Martel, Chief Business Officer; Dr. Jeff Castelli, Chief Development Officer; and Simon Harford, Chief Financial Officer. Joining for Q&A, we have Ellen Rosenberg, Chief Legal Officer. As referenced on slide two of the presentation, I would like to remind you that we will be making forward-looking statements on today’s call. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on the IR portion of our corporate website. Forward-looking statements are subject to substantial risks and uncertainties, speak only as the call’s original date, and we undertake no obligation to update or revise any of the statements.

Additionally, you are cautioned not to place undue reliance on any forward-looking statements. At this time, it is my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer. Bradley.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Great. Thank you, Andrew, and welcome everyone to our third quarter conference call. I’m very pleased to report another great quarter for Amicus, highlighted by strong revenue growth, GAAP profitability, and continued confidence in our positive outlook going forward. Let me go through a few highlights before I turn it over to the team to go through in more detail. First, we delivered another quarter of double-digit revenue growth in our Fabry and Pompe core business, a trend we expect to sustain into the years ahead. Second, we remain firmly confident in our growth trajectory as we approach year-end. Galafold delivered 13% year-over-year patient growth this quarter, driven by record demand and robust new patient starts. For Pombiliti and Opfolda, Q3 represented another strong quarter marked by significant momentum in both our established and newly launched markets, underpinned by growing commercial demand and increasing new patient starts.

In fact, this was the strongest quarter ever for new commercial demand for both Galafold and Pombiliti and Opfolda. Both products were on track to meet current consensus sales estimates for the full year. Third, we continue to emphasize the growing body of evidence and differentiation of Pombiliti and Opfolda through scientific publications and congress presentations. In fact, recently at ICIEM in September, we shared new four-year data from the PROPEL ongoing extension study demonstrating stability or improvement in key endpoints of muscle function and strength in ERT experienced patients, which Jeff will review in more detail later on the call, along with some exciting new real-world evidence supporting Pombiliti and Opfolda. Fourth, we reaffirm our confidence that our two commercial products, each with blockbuster potential, are on track to deliver combined sales of $1 billion in 2028.

Galafold’s strong growth trajectory, supported by improving diagnostic rates and patient access, coupled with meaningful contribution we expect from Pombiliti and Opfolda to our long-term performance, reinforces our confidence in this milestone. Fifth, alongside our partners at Dimerix, we continue to advance the development of DMX-200, a first-in-class therapy in late-stage phase III development for FSGS, a rare life-threatening kidney disease. The ACTION3 pivotal study is over 90% enrolled and remains on track to complete enrollment by the end of the year. Our work with DMX-200 and the potential to address the considerable unmet need in FSGS represents an important and growing part of the Amicus story. Finally, as we continue to maintain our financial discipline, we are pleased to deliver GAAP profitability and a growing cash position in the third quarter and remain very confident in achieving GAAP net income for the second half of the year.

Altogether, we are proud of our achievements this quarter and believe Amicus is well positioned to continue to create significant shareholder value while fulfilling our mission for patients in the years ahead. With that, let me now hand the call over to Sébastien to review the commercial business in more detail. Sébastien.

Sébastien Martel, Chief Business Officer, Amicus Therapeutics: Thank you, Bradley, and good morning to everyone. So let’s start with Galafold on slide five. You see that revenue reached $138.3 million, up 12% at constant exchange rates and up 15% in reporting terms. The underlying growth of this product remains very positive and is driven by the number of new patient starts globally. Year over year, the underlying growth in patient demand increased by 13%. We ended the quarter with approximately 69% of the global market share of treated Fabry patients with amenable mutations. Galafold is clearly positioned as the treatment of choice for amenable patients among prescribers, and there are still many more patients eligible for our therapy. Turning to slide six, our leading market continues to be the biggest driver of the strong patient demand for Galafold.

We saw record high demand in Q3, as Bradley just mentioned, and on a year-to-date basis, new patient starts have reached their highest level since launch. The global mix of patients on Galafold today is about 65% naive and 35% switch. This compares with 60% and 40% respectively in 2024. So clearly, we’re seeing stronger uptake in naive populations. While we continue to achieve high market shares in countries where we’ve been approved the longest, there’s still plenty of opportunity to switch patients over to Galafold and to keep growing the market as we penetrate the diagnosed, untreated, and newly diagnosed segments. Given the sustained growth in patient demand and our projection of a record level of new patient starts this year, we remain highly confident in our full year 2025 growth guidance for Galafold, trending in line with current full year consensus estimates.

Key drivers behind the robust demand for Galafold, which we expect to continue well beyond 2025, are first, finding new patients and penetrating into the diagnosed and treated population, including shortening the pathway to diagnosis. Second, expanding Galafold into new markets and extended the label. Third, driving Galafold’s share of treated amenable patients. We’re actually seeing that in most mature markets, we can reach 85%, 90% share. So we know that there’s the potential to reach those levels globally. Fourth, sustaining compliance and adherence rates above 90% so that patients who go on Galafold predominantly stay on Galafold. On slide seven, you can see the significant unmet need in Fabry disease today. So over 12,000 people receive Fabry treatment worldwide, while about 6,000 diagnosed patients remain untreated. The literature suggests actual prevalence may exceed 100,000 patients, indicating meaningfully larger undiagnosed populations and substantial market opportunity for Galafold.

We’re highly confident that a small molecule is a compelling treatment option for the untreated and undiagnosed populations, as indicated by the increase in naive new patient starts. Late-onset Fabry makes up a growing percentage of the newly diagnosed and treated population, which is enriched for amenability to Galafold. On slide eight, we just provide a great example of our ongoing efforts to enhance Fabry disease awareness and support improved diagnosis. The diagnosis of Fabry disease is, unfortunately, often delayed for up to a decade or more due to the rarity of the disease, high variability of presentation, and symptoms that are quite often nonspecific and resemble those of other diseases. The new Finding Fabry campaign in the U.S. aims to help healthcare professionals recognize Fabry’s diverse symptoms and prevent misdiagnosis.

To wrap up on our Fabry section, with excellent momentum, the sizable untreated population, and our strong IP protection, Galafold has a long runway well into the next decade and a clear path to surpassing $1 billion in revenue. Turning now to Pompe disease on slide 10. We outline our global launch progress with Pombiliti and Opfolda. Third quarter revenue reached $30.7 million, up 42% at constant exchange rates and up 45% in reporting terms. Year to date, Pombiliti and Opfolda have grown 59% at CER and 61% in reported revenue. The majority of sales came from our initial five launch countries: the U.S., U.K., Germany, Spain, Austria, although, as I’ll highlight in a moment, we’ve actually secured reimbursement in an additional 10 countries thus far in 2024, with four new markets since the end of Q2, namely Japan, Belgium, Ireland, and Luxembourg. For the quarter, the U.S.

represented approximately 43% of revenue, while ex-U.S. represented 57% of sales. Q3 showed strong sales growth and a high level of patient demand. We continue to see patients switching proportionally based on market share, as well as a broadening and deepening of prescriptions, with more sites coming online and multiple new prescriptions from physicians. We’re also seeing a growing number of patients exploring alternative treatment options and actually advocating for their own decisions to switch, especially in the U.S. With 2024, we have observed many positive lead indicators that support the growing launch momentum. Globally, the number of avalglucosidase alfa patients that have switched to Pompe has actually doubled in the first nine months of 2024 as compared to the entirety of 2023. Similarly, naive prescriptions ex-U.S. have also doubled in the first nine months as compared to the total of 2023.

Given these indicators, we’re reiterating our full year 2024 revenue growth guidance for Pombiliti and Opfolda of 50%-65% at constant exchange rates. Trending in line with the current full year consensus sales estimates. We expect Pombiliti and Opfolda to be a major contributor to multi-year growth for Amicus based on key growth drivers, namely: first, continuing to increase the number of net new patients; second, increasing the depth and breadth of prescribers; third, launching in up to 10 new countries in 2024; fourth, differentiating our therapy through evidence generation and real-world evidence; and five, maintaining over 90% compliance and adherence rates. Moving to slide 11, looking at the geographic expansion of Pombiliti and Opfolda. As I mentioned, today, we’re now reimbursed in 15 countries and continue to observe strong execution in the newer launch markets.

Notably, five of the countries launched during the second quarter generated revenue in Q3: Switzerland, Italy, the Czech Republic, Portugal, and the Netherlands. As mentioned, we recently reached pricing and reimbursement agreements in Japan, Belgium, Ireland, and Luxembourg. We also continue our work to secure broad access to patients through the EU. A little more color on Japan, as it’s a bit of a unique market. At the end of Q3, we saw the first commercial patients in Japan. The majority of patients in Japan have actually been on Nexviazyme for two to three years, and that represents a strong market opportunity for us. I hope that commercial overview provides a strong sense of the continued execution and growth in Galafold and the building momentum in the launch of Pombiliti and Apfolda.

With that, I’ll now hand the call over to Jeff to highlight the work we do to further differentiate Pombiliti and Apfolda. Jeff?

Dr. Jeff Castelli, Chief Development Officer, Amicus Therapeutics: Thank you, Sébastien, and good morning, everyone. Moving on to slide 12, we highlight a few examples of our rapidly expanding and diverse body of evidence supporting the differentiation of Pombiliti and Apfolda in Pompe disease across clinical trials, mechanistic studies, real-world data, and case studies. In September, we presented new four-year data from the PROPEL open-label extension. This new analysis, presented at the International Congress of Inborn Errors in Metabolism, showed patients within the ERT experience group demonstrated durable improvements or stability on measures of muscle function, muscle strength, and biomarkers out to four years. On slide 13, and also presented at ICIEM, we’d like to highlight a presentation by an independent group in the U.K. that followed 28 patients switched from Myozyme to Pombiliti, which was an N of 13, or Myozyme to Nexviazyme, which was an N of 15.

That analysis reported improvements in motor function for the patients that switched from Myozyme to Pombiliti and Apfolda. We expect this body of evidence to continue expanding over time, strengthening the case for Pombiliti and Apfolda as a compelling treatment option in Pompe disease. Now, moving to slide 15 and DMX-200, as previously announced, we took a major step forward in our strategy to strengthen our portfolio through a successful U.S. licensing agreement with Dimerix to commercialize DMX-200, a first-in-class treatment in late-stage development for FSGS, a rare and potentially fatal kidney disease. With blockbuster market potential, we remain highly encouraged by the data seen to date and believe this asset brings immediate strategic value to Amicus today and will create value for patients and shareholders moving forward.

Moving on to slide 16, we are impressed by the strong momentum Dimerix has built and the growing body of evidence supporting this transformative potential of DMX-200. The pivotal phase three ACTION3 trial is progressing well, with more than 90% of patients now enrolled and remains on track for full enrollment by year-end. This study is robustly designed and strongly powered, with several successful interim analyses already completed. Importantly, there is FDA alignment on proteinuria as the primary endpoint for approval. In October, Dimerix provided an update on PARASOL’s data analysis that showed a consistent result in line with the prior analyses, supporting again proteinuria as an endpoint for standard approval. We anticipate requesting an additional meeting with the FDA in the first quarter to further discuss the next interim analysis from the ACTION3 study and the next steps for DMX-200 development.

With that, let me now hand the call over to Simon to review our financial results and outlook. Simon.

Simon Harford, Chief Financial Officer, Amicus Therapeutics: Thank you, Jeff. Our financial summary begins on slide 18 with our income statement for the third quarter ending September 30th, 2025. For Q3, we achieved total revenue of $169.1 million, which is a 19% increase over the same period in 2024. At constant exchange rates, revenue grew 17%. The global geographic breakdown of total revenue in the quarter consisted of $98.8 million, or 58% of revenue generated outside the United States, and the remaining $70.3 million, or 42%, coming from within the U.S. Cost of goods sold as a percentage of net sales was 12% for Q3. Compared to 9% in the same period last year. The total GAAP operating expenses increased to $115.3 million for the third quarter of 2025, as compared to $106.6 million in the third quarter of 2024, an increase of 8%.

On a non-GAAP basis, total operating expenses increased to $95.4 million for the third quarter of 2025, as compared to $82.6 million in the third quarter of 2024, an increase of 15%. We define non-GAAP operating expenses as research and development and SG&A expenses, excluding stock-based compensation expense, loss on impermanent assets, changes in fair value of contingent consideration, restructuring charges, and finally, depreciation and amortization. On a GAAP basis, net income in the third quarter of 2025 was $17.3 million, or $0.06 per share, compared to a net loss of $6.7 million, or $0.02 per share, for the third quarter of 2024. This was the first quarter of 2025 that Amicus delivered positive GAAP net income, consistent with our guidance to have positive GAAP net income during the second half of 2025.

While we are pleased with the positive Q3 GAAP net income results, let me remind you that in the early stages of turning profitable, GAAP profitability may not be linear quarter to quarter. We do, however, anticipate having positive GAAP net income for the second half of 2025. In Q3 2025, non-GAAP net income was $54.2 million, or $0.18 per share, compared to non-GAAP net income of $30.8 million, or $0.10 per share, in the third quarter of last year. Cash, cash equivalents, and marketable securities were $263.8 million as of September 30th, 2025, compared to $249.9 million as of December 31st, 2024. This is a $32.8 million increase during the third quarter versus the prior quarter. So we are importantly generating cash also this quarter. On slide 19, we are reiterating our full year financial guidance for 2025 as follows: total revenue growth of 15%-22%.

Galafold revenue growth of 10%-15%. Pombiliti and Opfolda revenue growth of 50%-65%. All growth rates are at constant exchange rates. Based on our performance for the nine months and our clearer line of sight for the fourth quarter, including the anticipated FX impact, we are confident that total and product revenues for the full year are trending in line with full year consensus numbers, which you can find via the investors’ portion of our website. Gross margin is expected to be in the mid-80s, which we define as 83%-87% approximately, and will likely be at the top end of that range. As a reminder, 2025 is a hybrid year for Pombiliti and Apfolda COGS, as we have worked through previously expensed inventory during the first three quarters of 2025. As a result, Pombiliti and Apfolda COGS will be expensed through Q4 2025. Non-GAAP operating expense guidance remains $380-$400 million.

However, we anticipate being at the high end of the guidance range. Finally, we anticipate positive GAAP net income for the second half of 2025. With that, let me turn the call back over to Bradley for our closing remarks.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Great. Thank you, Simon, Jeff, Sébastien. As we come to the end of our presentation, let me just remind you of our strategic priorities for the year. In closing, I just want to reiterate how encouraged we are by the growing impact of our therapies, plus the very promising phase three asset that we’ve added to our pipeline for FSGS. Our expertise in rare diseases and proven track record of commercial execution support our ongoing commitment to our mission and sustaining long-term growth in 2025 and beyond. I’m confident we can continue to develop and deliver transformative treatments and create enduring value for patients and shareholders alike. With that, operator, we can now open the call to questions.

Conference Call Operator: Thank you. Ladies and gentlemen, if you have a question, please press star one one on your touchstone telephone. To withdraw your question, please press star one one again. At this time, we request that you only ask one question. If you have any additional questions, please enter back in the queue. Thank you. Please stand by as I compile the Q&A roster. Our first question comes from Joe Schwartz of Leerink Partners. Your line is now open.

Great. Thanks very much, and congrats on the strong performance. Now that we’re into the second full year of the Pombiliti launch, I was wondering if you could talk a little bit about the overall reception to both the label for Pombiliti, especially in the U.S. and the real-world evidence that you seem to be layering in now, and how that’s driving prescription patterns, and whether the conversations vary across treatment centers. Do any certain types of physicians or patients seem to appreciate one set of data more than others? What are you finding is encouraging the most patients to switch to Pombiliti nowadays?

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Joe, thanks a lot for the question. I like the multi-part question there, but we’ll do our best to get to all of those pieces. I heard some labeling questions as well as real-world evidence and how that’s influencing or impacting the prescriber base. And then finally, is there a particular data set that is more compelling or not? So from a label perspective, I think it’s largely been well received, although clearly in the United States, we hope to continue to look for ways to expand that label in particular down to pediatric patients with late-onset Pompe disease and infantile-onset patients, as well as Jeff highlighted, we have ongoing studies there. And those should support label expansion globally. So I think we continue to look for ways to expand that population. And we should start seeing the benefit of that sometime next year.

In terms of real-world evidence, for sure, that is an ingrowing and important part of the conversation with physicians. I can tell you I’ve had the privilege of attending a number of launch meetings around the world. As that body of evidence grows, Jeff highlighted one, we’ve talked about some case studies previously, we will continue to support those publications. That will only be more and more supportive, we think, of the use of Pombiliti and Apfolda. So please look out for continued highlights there and in medical congresses throughout this year and into next year. And then maybe, Jeff, from your perspective, just talk a little bit about some of the different types of data that we think are so important for physicians, and maybe also about quickly the importance of finding the right endpoints for patients as well as physicians.

Dr. Jeff Castelli, Chief Development Officer, Amicus Therapeutics: Yeah, thanks, Brad, and thanks, Joe, for the question. From the four-year data we just reported at ICIM, I think the long-term data is of particular interest, really, across the populations. That’s always been one of the challenges with early Pompe treatments, is sort of a lack of durability. We’ve been quite pleased, and physicians and stakeholders have been quite pleased with the durability we’ve seen across trials. In terms of the real-world data, the switch experience was something in our trials that was very strong, and we continue to see that in various real-world settings. What is lacking, of course, is indirect comparisons of Pombiliti and Nexviazyme, and we were very pleased to see one of the most robust indirect comparisons come out at ICIM, which we highlight in the slides from a large group in the U.K. that switched from either Myozyme to Pombiliti or Myozyme to Nexviazyme.

I would just say individual case studies are always very important. You can always learn a ton, even from individual patients who might have a unique background. We’ve seen some really interesting case studies of people on four times the dose of Myozyme and not doing well and switching to Pombiliti and having quite good experiences. Of course, pediatrics is important. We’ve had some really compelling pediatric case studies. We continue to really invest in our pediatric trials and look forward to actually expanding the labeling here in the U.S., hopefully mid-next year, for adolescent patients. In terms of endpoints, of course, it’s always critical, what do you look in trials versus in following patients in the real world? Usually, you don’t do quite the same comparisons.

We’re really helping work with key stakeholders about what is the right sort of cadence of monitoring patients, what are the key endpoints to look at, especially as physicians try to make decisions on switching.

Very helpful. Thank you.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Thanks, Jeff. Thanks, Joe.

Conference Call Operator: Thank you. Our next question comes from Dennis Ding of Jefferies. Your line is now open.

Hi, good morning. Thanks for taking our questions. We have two on Pompe, if we may. Number one, congrats on the progress, but talk about the U.S. new patient starts in Q3. If they continue to go up relative to some of the commentary you’ve made earlier this year for April and May. Number two, as we think about 2026. Consensus seems to expect a big inflection in Pompe revenue. Can you talk about things that you can actively do to accelerate that revenue trajectory relative to 2025? If expanding your sales force is something you’re considering, particularly in the U.S.? Thanks.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Thanks, Dennis, for the questions. I think you were talking about kind of further color on progress in the U.S. and our other markets in Q3, and then also kind of looking forward to the future, how can we continue to drive that building momentum? So yes, Q3, as I said in the call, was the largest ever net commercial demand for Pombiliti and Opfolda, which is really exciting. The U.S. was a huge contributor to that growth. We are seeing significant increases in breadth and depth of prescriptions in the United States. We’ve actually improved our time to reimbursement, and every day helps. So I think that helps with the margins as well. We’re seeing very strong adherence and compliance rates as well. So really excited about the U.S., but that’s not just here, the States.

It’s, as Sébastien highlighted in the call, all of our launch markets, we think, are progressing really well. As we head into next year, of course, it’s a little bit too soon to give guidance, but I think the momentum we’re building in Q4 gives us confidence to see continued momentum going into 2025. What do we do to continue to support that momentum growth? Part of it, for sure, is just experience. I think Jeff’s point around that real-world evidence, I’ve literally been in meetings where some of those data points are presented for the first time. The excitement as people are seeing new data and new populations, I think, is a key part of seeing that translate then into wanting to use the product in a new or different way. So I think that’s part of it, for sure.

As Sébastien mentioned, we have a whole host of new countries contributing to the demand. This quarter, those new markets, like Japan, as an example, will be modest in contribution from a revenue perspective. But of course, going into next year, the countries launching in Q4 will have a significant contribution. Another one that we didn’t highlight in the call, but is definitely going on in the background, is the experience in the Netherlands. We talked before about the expectation there that we’ll see 70% of patients switch over to late-onset or, excuse me, switch over to Pompe. That will continue to be a significant contributor as well. We’ve made great progress over Q3 and into Q4 in switching those patients. So I hope that gives you some flavor for the places that we’re focused.

But again, I think more than anything, as more and more people have experience, as more and more real-world evidence comes out, that fuels the momentum that we’re seeing.

Great. Thank you.

Conference Call Operator: Thank you. Our next question comes from Anupam Rama of J.P. Morgan. Your line is open.

Hey, guys. Thanks so much for taking the question, single question, single part from me. For Galafold in particular, you talked about the strongest patient adds since launch on a year-to-date basis. Can you expand a little bit on if that’s coming from core countries, or is that being more driven by emerging countries? Thanks so much.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Yeah, thanks, Anupam. Sébastien, do you want to take that one?

Yes. Anupam, as I mentioned, the key countries continue to grow, and this is for the most part driven by naive patients being diagnosed and us having over time established Galafold in those markets now as the standard of care for newly diagnosed naive patients with amenable mutations. We continue to see some degree of switches in those markets where we’ve launched in the more recent past, if you want. But as I highlighted, there’s a significant underlying growth potential simply because we continue to see that Fabry is, unfortunately, really underdiagnosed. We’ve talked in the past about the fact that today, the number of diagnosed patients has far exceeded what we had projected right before we launched. We continue to see, again, demand that is stronger than what we anticipated right before launch.

Excellent. Thank you.

Conference Call Operator: One moment for our next question. Maxwell Score from Morgan Stanley, your line is now open.

Great. Thank you very much for taking my question. Just one on DMX-200. Is there a defined threshold for MCP-1 levels or other inflammatory markers that would make patients particularly good candidates for DMX-200? Any thoughts on Filspari, the FDA no longer requiring an advisory committee meeting for Filspari? Thank you.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Maybe I’ll take the second one. Then, Jeff, you can talk about the MCP-1 levels, which we do believe are correlated with the potential for that product. So it’s a great question. As it relates to the adcom for Filspari, what I’ll just say is we are eagerly anticipating the progress there. We’re hopeful for them. We think it’s a good sign, in fact, that they are no longer requiring an adcom, and we’re wishing them well. As it relates to the relationship of MCP-1 and proteinuria, Jeff, maybe you can respond there.

Yeah, thanks for the question. So briefly, MCP-1 is a monocyte chemoattractant protein. That is the chemo kind that binds a CCR2 receptor and leads to the monocyte-driven inflammation. So DMX-200 is interrupting that signaling. In phase two, we did see a nice effect on MCP-1 levels from DMX-200. We actually saw the patients with the highest MCP-1 and the highest proteinuria showed the most robust responses on proteinuria in that phase two. For the phase three study, we did not have any sort of entry criteria in MCP-1. We are measuring MCP-1 throughout the study, and we do intend to sort of analyze the results based on different MCP-1 levels. We do anticipate, again, like we saw in the phase two, that people with higher MCP-1 are likely to have more inflammation and therefore are likely to show even more of an impact of DMX-200.

We certainly will continue to learn more, and that is one of the key biomarker endpoints in the phase three.

Great. Thank you.

Conference Call Operator: Thank you. Our next question comes from Ritu Barral of TD Cohen. Your line is now open.

Andrew Faughnan, Vice President of Investor Relations, Amicus Therapeutics: Hi, Brad. This is Joshua Fleischman. I’m on the line for Ritu. Congrats on the quarter, and thanks for taking our question. So what impact may Biosecure 2.0 have on the usability of Ireland-plant Pombiliti product in the U.S.? And how has physician feedback changed over the last quarter on the competitive dynamic in Pompe? Are the goalposts changing for when docs feel comfortable to switch patients to Pombiliti? Thanks.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Thanks, Joshua, for the questions. We had one on Biosecure 2.0 and one on the continued sentiment around experience with Pombiliti and Apfolda. So on the first one with Biosecure, look, we’ve continued to believe that we do think highlighting the importance of U.S. biotech manufacturing is critical for our economy going forward. However, the move to Dundalk, and you might have seen on the call, the approval now from Europe of that facility, and we’re eagerly anticipating the approval of the United States as well, I think, is a great way to ensure that we have supply coming from a friend-shored location in Ireland. We are confident that we will be able to maintain security of supply.

At least the way that Biosecure has been evolving from last year into this year, I think, gives us even more confidence that we’ll have a stable supply coming out of Ireland for the long time to come. So we’re not concerned about the evolution of that legislation. As it relates to the experience, I think everybody, I think, is eagerly anticipating or eagerly asking those questions. It is exactly the right question. You may remember that when we launched, we said that part of our goal is to continue to provide experience and evidence to the physician and patient populations so they can understand the opportunity with Pombiliti and Apfolda. As that evidence mounts, we are convinced that we will demonstrate that Pombiliti and Apfolda is the right therapy for patients.

I think I would encourage folks to continue to look at the posters and presentations as well as the publications that have come out. I think that evidence will only grow. As Jeff said, part of it also is with now the availability of multiple therapies, what should physicians use in a real-world setting to understand that better? I think we’re helping the community answer that question as well. Yes, it’s going to be mobility and breathing, but I think there’ll be a number of other more subtle endpoints or more patient-driven endpoints that will drive that as well. We’ll continue to highlight those as we’re able to support the community in developing them.

Great. Thank you.

Conference Call Operator: Thank you.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Thanks, Joshua.

Conference Call Operator: Our next question comes from Kristen Kluska of Cantor Fitzgerald. Your line is now open.

Dr. Jeff Castelli, Chief Development Officer, Amicus Therapeutics: Hi, this is Rick Miller on for Kristen. Thanks for taking our question. Just one for us on Pompe. How should we be thinking about when you could potentially receive infantile onset Pompe disease label expansion? And will this be solely contingent on the ROSELLA trial? Thank you.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Great question. Maybe I’ll frame, but then, Jeff, you can answer the specifics. So clearly, the biggest—I’m going to need the most fragile population within Pompe disease is the infantile onset Pompe patients. It’s critical for us to be able to serve those patients. Jeff can talk about the timing there. I would say, though, the largest portion of remaining patients who don’t have access to Pombiliti today are the pediatric late-onset Pompe patients, so 12 to 17 and then one to 12. Those are also a priority for us, and we’ve made great progress there. In fact, those would probably become earlier label expansion opportunities than infantile onset. So maybe, Jeff, just remind us the rough timing on the pediatric late-onset Pompe and then to the specific question from Rick, the infantile onset timing.

Yeah, thanks for the questions. So in terms of the first cohort of the 12 to 17-year-old late-onset patients, adolescent patients, we anticipate having a submission shortly and would look to an expansion of the label sort of mid-next year. That would be the first pediatric expansion. We’re completing enrollment in that younger LOPD group below the age of 12. With enrollment completing here probably by the end of the year, you’re looking at a year or so of follow-up and then time for submission. A couple of years probably till that group gets added to the label. And then similarly for IOPD. We have two cohorts of patients, those that are switch patients and those that are naive patients. We’re making great progress on the switch patient enrollment. That’s nearly completed, starting to make good progress in the naives.

And again, that will be a year-plus study and then time for submission. That would be probably even coming shortly after that younger LOPD group. But as Brad said, with the newborn screening in the U.S. and how much more patients are followed earlier, in particular LOPD, we’re very excited to hopefully have an updated labeling into that adolescent group mid-next year.

Conference Call Operator: Thank you. Our last question comes from Salveen Richer of Goldman Sachs. Your line is now open.

Dr. Jeff Castelli, Chief Development Officer, Amicus Therapeutics: Good morning. Thanks for taking my question. As we look to 2026 here with the switches from Nexviazyme expected in the U.S. and more ex-U.S. countries coming along, how should we think about the commercial trajectory of Pombiliti versus what we’ve seen this year? And I guess as you think forward to kind of a steady state, how are you thinking about market share for this asset?

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Yeah, thanks, Salveen. As I said earlier, we’re very confident in the growth as we come to the end of the year here. Expect continued momentum into next year. A little early to give specifics on guidance, but we’re confident it’ll be a strong growth year next year as well. In terms of market share, look. What we’ve seen in countries like the U.K., as an example, where we were available through that EAMS program for a number of years prior to launch, we’re now getting to market shares in the 40%-plus after, call it, three or four years on the market, probably four years in the market there. Our strong belief is that we can establish this product as the leading product for treating Pompe patients. For me, that means over a 50% market share at peak.

I think if you look at where the market is headed from a growth perspective, that’s how we get to a billion dollars plus at peak potential. We’re very confident in the end this will be the leading prescribed product for people living with Pompe disease. We’re still on that journey, of course, but we’re starting to see signs that we can get to those shares after a period of time. More to come.

Dr. Jeff Castelli, Chief Development Officer, Amicus Therapeutics: Thank you.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Thanks, Salveen.

Conference Call Operator: Thank you. That was our last question. This does conclude today’s conference call. We hope you have a great day, and you may now disconnect.

Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics: Great. Thank you all.

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