Earnings Call Transcript - FOLD Q3 2025

Operator, Operator

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Third Quarter 2025 Financial Results Conference Call and webcast. 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.

Andrew Faughnan, Vice President of Investor Relations

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; Sebastien 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 2 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 of 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's my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer. Bradley?

Bradley Campbell, CEO

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 are 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 in 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. And 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. And 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 Sebastien to review the commercial business in more detail. Sebastien?

Sebastien Martel, Chief Business Officer

Thank you, Bradley, and good morning to everyone. So let's start with Galafold on Slide 5. You see that revenue reached $138.3 million, up 12% at constant exchange rates and up 15% in reported 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 6. 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. And 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 the diagnosed and treated population, including shortening the pathway to diagnosis; second, expanding Galafold into new markets and extending 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. And fourth, sustaining compliance and adherence rates above 90% so that patients who go on Galafold predominantly stay on Galafold. On Slide 5, 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 8, 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. So the new Finding Fabry campaign in the U.S. aims to help health care professionals recognize these diverse symptoms and prevent misdiagnosis. So to wrap up 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 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 has 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 ten countries thus far in 2025 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 proportionately 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. In 2025, we have observed many positive lead indicators that support the growing launch momentum. Globally, the number of avalglucosidase alfa patients that have switched to Pombiliti and Opfolda has actually doubled in the first nine months of 2025 as compared to the entirety of 2024. Similarly, naive prescriptions ex-U.S. have also doubled in the first nine months as compared to the total of 2024. Given these indicators, we're reiterating our full year 2025 revenue growth guidance for Pombiliti and Opfolda of 50% to 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 multiyear 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 ten new countries in 2025; fourth, differentiating our therapy through evidence generation and real-world evidence; and fifth, 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 for 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 Opfolda. With that, I'll now hand the call over to Jeff to highlight the work we do to further differentiate Pombiliti and Opfolda.

Jeffrey Castelli, Chief Development Officer

Thank you, Sebastien, and good morning, everyone. Moving on to Slide 12, we showcase examples of our rapidly growing and diverse evidence supporting the unique aspects of Pombiliti and Opfolda in Pompe disease. In September, we shared new four-year data from the PROPEL open-label extension at the International Congress of Inborn Errors of Metabolism. This analysis showed that patients in the ERT experience group exhibited lasting improvements or stability in muscle function, muscle strength, and biomarkers over four years. On Slide 13, also presented at ICIEM, we would like to point out a presentation from an independent group in the U.K. that observed 28 patients who switched from Myozyme to Pombiliti and Opfolda, with 13 on Myozyme to Pombiliti and 15 on Myozyme to Nexviazyme, reporting enhancements in motor function for those who transitioned to Pombiliti and Opfolda. We anticipate this evidence base to continue growing, reinforcing the case for Pombiliti and Opfolda as valuable treatment options in Pompe disease. Now moving to Slide 15 and DMX-200. As previously announced, we made significant progress in our strategy to enhance our portfolio through a successful U.S. licensing agreement with Dimerix to commercialize DMX-200, a groundbreaking treatment in late-stage development for FSGS, a rare and potentially life-threatening kidney disease. With significant market potential, we are very optimistic about the data we have collected so far and believe this asset offers immediate strategic value to Amicus and will benefit patients and shareholders in the future. Moving on to Slide 16, we are impressed by the strong progress Dimerix has made and the increasing evidence backing the transformative potential of DMX-200. The pivotal Phase III ACTION3 trial is advancing well, with over 90% of patients enrolled and on track for full enrollment by year-end. This study is well-designed and has been strongly powered, with several successful interim analyses already completed. Notably, FDA alignment has been achieved on proteinuria as the primary endpoint for approval. In October, Dimerix updated the PARASOL data analysis, which consistently supported proteinuria as an endpoint for standard approval, in line with previous analyses. We plan to request another meeting with the FDA in the first quarter to further discuss the next interim analysis from the ACTION3 study and the future steps for DMX-200 development. With that, I will now hand the call over to Simon to review our financial results and outlook.

Simon Nicolas Harford, CFO

Thank you, Jeff. Our financial summary begins on Slide 18 with our income statement for the third quarter ending September 30, 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 expense as research and development and SG&A expenses, excluding stock-based compensation expense, loss on impairment of 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 30, 2025, compared to $249.9 million as of December 31, 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% to 22%. Galafold revenue growth of 10% to 15%. Pombiliti and Opfolda revenue growth of 50% to 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 approximately 83% to 87% and will likely be at the top end of that range. As a reminder, 2025 is a hybrid year for Pombiliti Opfolda COGS as we have worked through previously expensed inventory during the first three quarters of 2025. As a result, Pombiliti Opfolda COGS will be expensed through Q4 '25. Non-GAAP operating expense guidance remains $380 million to $400 million. However, we anticipate being at the high end of the guidance range. And finally, we anticipate positive GAAP net income for the second half of 2025. And with that, let me turn the call back over to Bradley for our closing remarks.

Bradley Campbell, CEO

Great. Thank you, Simon, Jeff, Sebastien. 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 III 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.

Operator, Operator

Our first question comes from Joe Schwartz of Leerink Partners.

Joseph Schwartz, Analyst

Congrats on the strong performance. Now that we're into the second full year of the Pombiliti and Opfolda launch, I was wondering if you could talk a little bit about the overall reception to both the label for Pombiliti and Opfolda, 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 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 and Opfolda nowadays?

Bradley Campbell, CEO

Joe, thanks a lot for the question. I like the multipart 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. So 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 a growing 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. And 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 Opfolda. So please look out for continued highlights there in the 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.

Jeffrey Castelli, Chief Development Officer

Yes. Thanks, Brad, and thanks, Joe, for the question. From our perspective, like the four-year data we just reported at ICIEM, 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. And 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 Opfolda versus Nexviazyme, and we were very pleased to see one of the most robust indirect comparisons come out at ICIEM, which we highlighted in the slides from a large group in the U.K. that switched from either Myozyme to Pombiliti and Opfolda or Myozyme to Nexviazyme. And lastly, 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 Opfolda and having quite good experiences. And 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. And in terms of endpoints, of course, it's always critical what do you look in trials versus in following patients in the real world. And usually, you don't do quite the same comparisons, and 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.

Operator, Operator

Our next question comes from Dennis Ding of Jefferies.

Yuchen Ding, Analyst

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 as they continue to go up relative to some of the commentary you made earlier this year for April and May? And then 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? And expanding your sales force is something you're considering, particularly in the U.S.?

Bradley Campbell, CEO

Thanks, Dennis, for the questions. I think you were talking about 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 on 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, which helps with the margins as well. And we're observing very strong adherence and compliance rates as well. So really excited about the U.S., but that's not just here in the States. As Sebastien highlighted on the call, all of our launch markets 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 2026. What do we do to continue to support that momentum growth? Part of it for sure is just experience, and 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 and 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 Sebastien 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 that we're launching in Q4 will have a significant contribution. Another one that we didn't highlight on 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 Pombiliti and Opfolda. 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 as more and more people have experience, and as more and more real-world evidence comes out, that fuels the momentum that we're seeing.

Operator, Operator

Our next question comes from Anupam Rama of JPMorgan.

Anupam Rama, Analyst

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?

Bradley Campbell, CEO

Yes. Thanks, Anupam. Sebastien, do you want to take that one?

Sebastien Martel, Chief Business Officer

Yes. So 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 is a significant underlying growth potential simply because we continue to see that Fabry is unfortunately really underdiagnosed. And so 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. And we continue to see, again, demand that is stronger than what we anticipated right before launch.

Operator, Operator

Maxwell Skor from Morgan Stanley.

Maxwell Skor, Analyst

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? And any thoughts on FILSPARI, the FDA no longer requiring an advisory committee meeting for FILSPARI?

Bradley Campbell, CEO

Maybe I'll take the second one, and 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, and 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.

Jeffrey Castelli, Chief Development Officer

Yes. Thanks for the question. So briefly, MCP-1 is the monocyte chemoattractant protein. That is the chemokine that binds the CCL2 receptor and leads to the monocyte-driven inflammation. So DMX-200 is interrupting that signaling. In Phase II, we did see a nice effect on MCP-1 levels from DMX-200. And we actually saw the patients with the highest MCP-1 and the highest proteinuria showed the most robust responses on proteinuria in that Phase II. For the Phase III 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 II 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. So we certainly will continue to learn more, and that is one of the key biomarker endpoints in the Phase III.

Operator, Operator

Our next question comes from Ritu Baral of TD Cowen.

Joshua Fleishman, Analyst

This is Joshua Fleishman on the line for Ritu. Congrats on the quarter. So what impact may BIOSECURE 2.0 have on the usability of the Ireland plant PomOp 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 from when docs feel comfortable to switch patients to Pombiliti and Opfolda?

Bradley Campbell, CEO

Thank you for the questions. We received one about BIOSECURE 2.0 and another regarding the ongoing feedback on Pombiliti and Opfolda. Regarding BIOSECURE, we continue to emphasize the importance of U.S. biotech manufacturing for our economy. The transition to Dundalk is crucial, and as you may have noted, we recently received approval from Europe for that facility. We are looking forward to the U.S. approval as well, which helps ensure that we have supply from a friend-shored location in Ireland. We believe we can maintain a secure supply, and based on the progress we've seen with BIOSECURE from last year to this year, we are increasingly confident in a stable supply from Ireland for the long term. Therefore, we are not worried about the evolution of that legislation. Concerning the experience feedback, many are curious and asking the right questions. When we launched, we committed to providing ongoing experience and evidence to physicians and patients so they can grasp the benefits of Pombiliti and Opfolda. As we gather more evidence, we are confident that we will show Pombiliti and Opfolda to be the preferred therapies for patients. I encourage everyone to continue reviewing the posters, presentations, and publications that have been released, as the evidence will only strengthen. Additionally, as Jeff mentioned, with the availability of multiple therapies, we are addressing what physicians should consider in real-world applications. This includes not only mobility and breathing but also a range of other subtle, patient-driven endpoints that will influence treatment decisions. We will keep highlighting these aspects as we assist the community in their development.

Operator, Operator

Our next question comes from Kristen Kluska of Cantor Fitzgerald.

Rick Miller, Analyst

This is Rick Miller on for Kristen. 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?

Bradley Campbell, CEO

Great question. Maybe I'll frame, but then, Jeff, you can answer the specifics. So clearly, the biggest unmet need, the most fragile population within Pompe disease is the infantile onset Pompe patients, and 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 and Opfolda today are the pediatric late-onset Pompe patients, so 12 to 17 and then 1 to 12. And so those are also a priority for us, and we've made great progress there. And 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.

Jeffrey Castelli, Chief Development Officer

Yes. Thanks for the questions. So in terms of the first cohort of the 12- to 17-year-old late-onset patients as adolescent patients, we anticipate having a submission shortly and would look to an expansion of the label sort of mid next year. That will be the first pediatric expansion. We're completing enrollment in that younger LOPD group below the age of 12. So 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. So a couple of years probably until that group gets added to the label. And then similarly for infantile onset Pompe disease, 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 the time for submission. So 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.

Operator, Operator

Our last question comes from Salveen Richter of Goldman Sachs.

Salveen Richter, Analyst

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 and Opfolda 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, CEO

Yes. Thanks, Salveen. As I said earlier, we're very confident in the growth as we come to the end of the year here and expect continued momentum into next year. A little early to give specifics on guidance, but we are confident it will 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 percent 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. And so 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 $1 billion plus at peak potential. So we're very confident that 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. So more to come.

Operator, Operator

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, CEO

Great. Thank you all.