Q3 2025 Amicus Therapeutics Inc Earnings Call

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics third quarter. 20125 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.

In 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 fahnen, 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, Sebastian, Martell Chief business officer, Dr. Jeff castelli. Chief development officer and Simon Harford to financial officer joining for Q&A 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 and speak only as of the call’s original date. We undertake no obligation to update or revise any of the statements. Additionally, I caution you not to place undue reliance on any forward-looking statements.

At this time, this is my pleasure to turn the call over to Bradley Campbell president and chief executive officer Bradley.

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 Gap, 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 fabre and Pompei Core Business, a trend, we expect to sustain into the years ahead.

Gal, delivered 13% year-over-year, patient growth. This quarter driven by record demand and robust new patient starts for pond building up folda, 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 pond building up solda.

Both products are on track to meet current consensus of sales estimates for the full year.

Third. We continue to emphasize the growing body of evidence, and differentiation of pality in that folder through scientific Publications and Congress presentations. In fact, recently at ICM in September, we shared new 4-year data from the Propel ongoing extension study demonstrating, stability, or Improvement in Ken points of muscle function and strength and the RT experience patients, which Jeff will review in more detail later on the call along, with some exciting new real world, evidence supporting pality and upov,

Forth. We reaffirm our confidence that our 2 commercial products each with Blockbuster potential are on track to deliver combined sales of 1 billion dollars in 2028.

Galafold, strong growth trajectory supported by improving diagnostic rates, and patient access coupled with meaningful contribution. We expect from paucity and up, fold up to our long-term performance reinforces our confidence in this milestone.

Fifth alongside our partners. At Dierks, we continue to advance the development of DMX 200. A first-in-class therapy in late stage phase 3 development for fsgs, a rare life-threatening kidney disease.

The action 3, pivot study is over, 90% enrolled and remains on track to complete enrollment by the end of the year.

And our work with DMX 2000 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 Gap profitability and a growing cash position in the third quarter and remain very confident in achieving Gap Gap, n, 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 Sebastian to review the commercial business in more detail, Sebastian.

Thank you. Brandy and good morning to everyone. So let's start with galap. Hold on. Slide 5. 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 patients 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 fabric patients with amenable mutations.

Gap is clearly positioned as the treatment of choice, for amenable patients among prescribers. And there's still many more patients eligible for our therapy.

Turning to slide 6, our leading markets continue to be the biggest driver of the strong, patient demand for Galafold. We saw record high demand in Q3, as Brad just mentioned, and on a year-to-date basis, new patient starts have reached their highest levels since launch.

a global mix of patients on galapo 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 Gafford 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 patients. Start. This year will 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, our first finding new patient and penetrating into the dinos and treated population, including shortening, the pathway to diagnosis second expanding galapo, into new markets and extended the label

Third driving, Galafold, share of treated minimal patients. We're actually seeing that in most mature markets, we can reach 85% to 90% share. So, we know that there's the potential to reach those levels globally.

And forth sustaining compliance and adherence rates above 90%. So that patients who go on? Galafold predominantly stay on. Galafold.

See, the significant unmet need in public disease today.

So, over 12,000 people receive the February treatment worldwide, while about 6,000 patients remain untreated.

The literature suggests actual prevalence May exceed.

100,000 patients, indicating meaningfully larger and diagnosed populations and substantial Market opportunity for the Apple.

We're highly confident that a small molecule is a compelling treatment options for the untreated and undiagnosed populations as indicated. By the increase in naive new patient starts

Lay-on set probably makes up a growing percentage of the newly diagnosed and treated population, which is enriched for amenability to Gap.

On slide 8. We just provide a great example of our own going efforts to enhance fabri disease, awareness and support improved diagnosis.

The diagnosis of fabri disease is unfortunately often delayed for up to a decade or more due to the Rarity of the D of the disease.

High variability of presentation. And seems that are quite often non-specific and resemble the use of other diseases.

So the the new finding fabric campaign in the US aims to help Healthcare professionals recognize that these diverse symptoms and prevent misdiagnosis.

So, to wrap up on our February section with excellent. Momentum the sizable and treated population, and our strong IP protection. Galafold has a long Runway well into the next decade and a clear path to surpassing 1 billion dollars in Revenue.

turning on now, to pompei's on flight 10,

We outline our Global launch programs with, um, pity and up fall down.

Third quarter Revenue, reached 30.7 million up 42% at constant, change rates, and up, 45% in reporting terms.

Your mobility of folder has grown 59% at Crescent and 61% in reported revenue.

The majority of sales came from our initial 5, launch countries. The US UK Germany, Spain Austria, although, as I highlighted in the moment, we've actually, uh, secured reimbursement in an additional 10 countries thus far in 2025, with 4 new markets since the end of Q2,

Namely, Japan. Belgium, Ireland, and Luxembourg.

For the Quattro, the US represented, approximately 43% of Revenue while xus 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 editions. We're also seeing a growing number of patients, exploring alternative treatment options and actually advocating for their own decisions to switch special in the US.

With 2025, we have observed, many positively indicators that support the green, the growing launch momentum.

Globally. The number of events. We could Alpha patients that have switched to pump up. Has actually doubled in the first 9 months of 2025 as compared to the entirety of 2024.

See you in a lean night prescriptions. X us have also doubled in the first 9 months as compared to the total of over 2024.

Even these indicators.

Will reiterating our full year 2025 Revenue, growth guidance for mobility and a folder of 50 to 65% at constant exchange rate.

Trending in line with the current full-year consensus sales estimate.

We expect mobility and a folder to be a major contributor to multi-year growth parameters.

Based on Tiko fibers, 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 2025 for

Differentiating our therapy through evidence generation and real world evidence.

And 5 maintaining over 90% compliance in the urine rates.

Moving to slide 11, looking at the geographic expansion of probability and of folder.

As I mentioned today, we're now reimbursed in 15 countries and continue to observe strong execution in the newer launch markets.

Notably 5 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, uh, the the EU.

It's a bit of a unique Market at the end of Q3. We saw the first commercial patients in Japan. Majority of uh patients in Japan. Have actually been on next year's time for 2 to 3 years and that represents a strong Market opportunity for us.

I hope that commercial overview, provide a strong sense of the continued execution and growth in Ghana for, and the building momentum in the launch of PA with that. And now hand the call over to Jeff to highlight the work. We do to further differentiate Mobility can afford that.

Yeah.

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 Pam building up for in pompe disease across clinical trials. Mechanistic studies real world data and case studies.

In September, we presented new 4 year data from the Propel open label extension. This new analysis, presented at the international Congress of inborn, Arizona metabolism, showed patience within the ERT experience group demonstrated, durable, improvements or stability on measures of muscle function, muscle strength and biomarkers out to 4 years.

On-site 13 and also presented at icim. We'd like to highlight a presentation by an independent group in the UK that followed 28 patients. Switched from Maisie to Palm up, which is an end of 13, or Maisie to next vazyme, which was an N of 15

and that analysis reported improvements in motor function for the patients that switched from Maisie to Palm Florida.

We expect this body of evidence to continue expanding over time, strengthening the case for building of Florida, as a compelling treatment option in Pompei 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 us licensing agreement with DMX 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, Durk says built and the growing body of evidence supporting this transformative potential DMX 200

The pivotal phase 3 action trial. Sorry, action. 3 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, enteral cities are already completed.

Importantly, there is FDA alignment on proteinuria as the primary endpoint for approval.

In October DMX, provided an update on parasols 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 action 3 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.

Thank you, Jeff.

Uh, Financial summary begins on, slide 18 with our income statement. For the third quarter, ending September, the 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 US.

Cost of goods sold as a percentage of net sales was 12% for Q3 cam compared to 9% in the same period last year.

The total Gap 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%.

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, research and development and sgna 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 Gap, 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 18 cents per share compared to non-gaap net, income of 30.8 million, or 10 cents per share in the third quarter of last year.

Cash Cash equivalents and marketable securities with 263.8 million, as of September, the 30th 2025 compared to 249.9% of December, the 31st 2024

This is a 32.8 million increase during the third quarter versus the prior quarter. So we are importantly generating cash also. Uh, 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%, perillity in Oxford or Revenue, growth of 50 to 65%.

All growth rates are at constant exchange rates.

Based on our performance for the 9 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 rather investors portion of our website.

Gross margin is expected to be in the mid 80s which we Define as 83 to 87% approximately and will likely be at the top end of that range as a reminder, 2025, as a hybrid year for probability op folder cogs. As we have worked through previously expensed inventory. During the first 3 quarters of 2025, as a result, pulley art folder cogs will be expensed through q425 non-gaap operating expense. Guidance remains 380 to 400, 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.

Great. Thanks, Simon Jeff Sebastian. As we come to the end of our presentation, let me just remind you of our strategic priorities for the year.

And in closing, I just want to reiterate how encouraged we are, by the growing impact of our therapies, plus the very promising phase 3 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.

Thank you, ladies and gentlemen, if you have a question, please press star, 1 1, 1 on your touchtone telephone to withdraw your question. Please press star 1, 1 1 again, at this time we request that you only ask 1 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.

Question comes from Joe, Schwarz of lying Partners, your line is now open.

Great. Thanks. Very much. And congrats on the strong performance. Um, now that we're into the, uh, Second full year of the Palm up launch. I was wondering if you could talk a little bit about, um, the overall reception to both the label for Palm up, especially in the US, um, and the, uh, real world evidence. Um, that you seem to be um, layering in now and how that's driving prescription patterns and whether the conversations vary across treatment centers. Um, do any, um,

Uh, certain types of Physicians or or patients seem to appreciate 1 set of data, more than others, what are you? Finding is uh encouraging. Um, the most patients to switch to Palm up nowadays.

Joe, thanks a lot for the question. Um,

I like that. I like the multi-part question there, but we'll do our best to, uh, to get to all of those pieces. I heard some labeling, uh, questions as well as real world evidence, and how that's influencing or impacting, uh, the prescriber base. And then finally, is there a particular data set that 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, um, with late onset pompe disease,

And infantile onset patients as well as Jeff. Highlighted we have ongoing studies there. So uh and those should support label expansion globally. So I think we continue to look to wait for ways to expand that population.

And we should start seeing the benefit of that sometime next year. Um, in terms of real world evidence, for sure, that is an growing and important part of the conversation with Physicians. Um, I can tell you, I've had the privilege of attending a number of launch uh meetings around the world and uh as that body of evidence grows, Jeff highlighted 1. We've talked about some case studies previously, we will continue to support those Publications that will only be, uh, more and more supportive. We think of the use of publicity upfold. So, please look out for continued highlights there and, and a medical congresses, uh, 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. Um,

Yeah. Thanks Brian. And thanks. Joe for the question, you know, from our like the the 4-year data, we just reported at icim. I think the long-term data is of particular Interest really across the population that's always been 1 of the challenges with early Pompei treatments is sort of a lack of their 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. You know, the switch experience was something that our trials, it was very strong and we continue to see that in various real world settings. Um, what is lacking of course, is, you know, indirect comparisons of pump up index via zy. And we were very pleased to see 1 of the most robust. Indirect comparisons come out at icim, which we highlighted in the slides, a large group in the UK that switched from either Maisie to Palm up or Maisie to next.

And, you know, lastly, I would just say, you know, individual case studies are always very important. You can always learn a ton even from Individual patients who might have unique background. You've seen some really interesting case, studies of people on, you know, 4 times the dose of my and, and not doing well and switching to Palm up and having quite 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, you know, actually expanding the labeling here in the US hopefully mid next year for adolescent patients. Um and in terms of end points, of course it's always critical. What do you look? You know in Trials versus in in following patients in the real world and usually you don't do quite the same comparisons and um we're really helping work with key stakeholders about what is the right sort of cadence of monitoring patients? What are the key end points to look at especially as Physicians try to make decisions on Switching.

Very helpful. Thank you. Thanks, Jeff. Thanks Joe.

Thank you.

Our next question comes from Dennis, ding of Jeffreys, your line is now open.

To, as we think about 2026 consensus, seems to expect the big inflection in on pay Revenue. Can you talk about things that you can actively do to accelerate that Revenue trajectory relative to 2025 and is expanding? Your Salesforce is something you're considering particularly in the US

Thanks, Dennis for the question.

Further color on.

Uh, progress in the us and our other markets in Q3 and then also kind of looking forward to the, to the Future. How can we continue to drive that that building momentum? So yes, Q3 as I said in the call was the largest ever. Um net commercial demand for possibility of fold up, which is really exciting and that the US was a huge contributor to to that growth. Um and we are seeing you know, significant increases in breadth and depth of prescriptions in the United States. We've actually improved our time to reimbursement and you know, every day helps so that's I think that helps with the margins as well, and we're seeing very strong, um, uh, adherence and compliance rates as well. So really excited about the us, but that's not just here at the states. It says, Sebastian highlighted in the call, you know, all of our launch markets we think are progressing really. Well, as we head into the next year, of course, it's a little bit too soon to, to give guidance, but I think the moment we're building in Q4 gives us

Confidence to see continued to momentum going into 2026. Um, 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, you know, I've literally been in meetings where some of those those data points are presented for the first time and the excitement. Um, as people are seeing new data and new populations, I think is a key part of, um, of seeing that translate then into to wanting to use the product in a new or different way. So I think that's part of it, for sure. As Sebastian mentioned, we have a whole host of new countries contributing to uh, to the demand. You know, this quarter, those new markets like Japan as an example. Um will be you know modest in contribution from a revenue perspective but of course going into next year the the countries are launching in Q4. We'll have a significant contribution another 1 that we didn't highlight on the call but is definitely going on the background is the experience and the Netherlands we talked before about um about the expectation.

There that we'll see, 70% of patients. Uh, switch over to laid out or excuse me, switch over to to Palm up that will continue to be a significant contributor as well. And we've made great progress over Q3 uh and into Q4 in switching those patients. So I hope that gives you some flavor for the places that we're focused. Um, but again, I think it as more more than anything as more and more people have experienced as more and more. Real world evidence comes out that fuels the momentum that that we're seeing.

Great. Thank you.

Thank you.

Our next question comes from a new pom Rama of JP Morgan. Your line is open.

Hey guys, thanks so much for taking the question. Single question, Single part from me, um, for galafold in particular, you talked about the strongest patient ads uh since launch on the 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.

Yeah, thanks Anna Palm um Sebastian do you want to take that 1?

Yes.

Um, so and if I'm, as I mentioned, you know, the the key countries continue to grow and, and this is, uh, for the most part driven by, you know, naive patients being diagnosed and us, having overtime established Gap in those markets. Now, as the standard of care, for, newly diagnosed, patients with, uh, amenable mutations. Um, we continue to see some degree of switches in those markets where, um, you know, we've launched in in the more, uh, recent past if you want. Um, but I I as I highlighted, you know, there's a significant um, underlying growth potential simply because we continue to see that.

Um, from the years and, you know, unfortunately, uh, really under diagnosed. And so, you know, we've talked in the past about the fact that, um,

Today, the number of diagnosed patients, as far exceeded what we had, uh, projected right before we launched and we continue to see, again the man that is uh, stronger than uh, what we anticipated. Uh, you know, right before launch

Excellent, thank you.

1 moment for our next question.

Maxwell, score from Morgan Stanley, your line is now open.

Great, thank you very much for taking my question. Uh just 1 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 Phil spari, um, the FDA no longer, requiring an advisory committee meeting for Phil spari. Thank you.

Maybe, I'll take the second 1 and then Jeff, you could talk about, um, the mCP 1 levels, which we do believe are correlated, uh, with the potential for that, that product. So it's a great question, you know, from from as relates to the, the Adcom for Phil spari. What I'll just say is, you know, we are eagerly anticipating the progress there. We're, we're hopeful for them and and um, we think uh,

We think it's a good sign, in fact, that that they are no longer requiring an Adcom, uh, and we're wishing them well. Um, as relates to the, uh, relationship of mCP, 1 and proteinuria, Jeff. Maybe you can respond there.

Yeah, thanks for the question. So, you know, briefly mCP, 1 is the minus A chemoattractant protein, that is the chemo. Kind that binds the ccr2 receptor and leads to the monocytes of an inflammation. So, DMX 200 is interrupting that signaling in Phase 2. We did see a nice effect on mCP, 1 levels, um, from DMX 200. And we actually saw the patients at the highest mCP 1 and the highest protein area, showed the most robust responses on Parrilla uh in that Phase 2.

For the phase 3 study. We did not have any sort of Entry criteria in mCP 1. We are measuring mCP 1 uh, 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 2 that people with higher, mcp-1 are likely to have more inflammation and therefore, are likely going to show even more of an impact of DMX 200. Um, so we've certainly will continue to learn more and that is 1 of the key biomarker end points in the phase 3.

Great. Thank you.

Thank you.

Our next question comes from Ratu Berol of TD Cohen. Your line is now open.

Hi Brad. This is Joshua fleshman on the line for a 2 congratulation. So what impact May biocure? 2.0 have on the usability of Ireland. Plant comma product in the US and how has physician feedback changed over the last quarter on the competitive dynamic in Pompei?

Are the goalposts changing for when docs feel comfortable to switch patients to Palm up. Thanks.

Thanks Joshua for the questions. We had 1 on biocure 2.0 and 1 on um uh the continued incentive and around uh

Around experience with pond building up folda. So, on the first 1 with, with biocure, look, you know, we've continued to believe that, uh, we do think highlighting the importance of uf's. Biotech manufacturing is critical, uh, for our economy, um, going forward. However,

The move to Dundalk and you might have seen on the call the approval. Now, from Europe, uh, of that facility. And we're eagerly anticipating the approval of the United States as well. I think, is, is a great way to ensure that we have Supply coming from a, you know, French or uh, location in Ireland. We are confident that we will be able to maintain security of supply. And at least, you know, the way that based secure has been evolving from last year into this year, I think gives us even more confidence that, uh, that we'll have a stable Supply coming out of Ireland. And, uh, for the, for the long time to come.

The availability of multiple therapies. What should Physicians use in a real world setting? Um,

To understand that better. And I think we're helping the community answer that question as well. Yes. It's going to be, you know, mobility and breathing. But I think there'll be a number of other subtle, uh, more subtle end points or more patient driven end points that will drive that as well. And so, we'll continue to highlight those as we're able to uh, support the community and developing them.

Great. Thank you.

Thank you.

Our next question comes from Kristen kluska of Cantor Fitzgerald, your line is now open.

Hi. This is Rick Miller on for Kristen, thanks for taking our questions, just 1 for us on Pompei. How should we be thinking about when you could potentially receive infantile onset pump a disease, label expansion. And will this be solely contingent on the Rosella trial? Thank you.

Great question. Maybe I'll I'll frame but then Jeff you can you can answer the specifics. So clearly the biggest biggest time I need the most fragile population within Pompei disease is you know, the tail, onset Pompei patients and it's critical for us to be able to

Be able to serve those patients. Jeff can talk about the timing. There I would say, though, the largest portion of, uh, remaining patients who don't have access to Palm up today are the

Pediatric late-onset Pompe patients, aged 12 to 17 and then 1 to 12, are also a priority for us, and we've made great progress there. In fact, those would probably become earlier label expansion opportunities than in the case of late-onset. So maybe, Jeff, just remind us of the rough timing on the...

Pediatric laid out at Pompei and then to the specific question, uh, 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 as adolescent patients, uh we anticipate having uh submission shortly and would look to an expansion of the label sort of mid next year. That'll be the first pediatric expansion. Uh, 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, follow up and then time for submissions. So a couple of years probably till that group, gets added to the label. And then similarly for OPD, um we have 2 cohorts of patients, those that are switch patients and those that are naive patients, um we're making great progress. Um, on the switch patient enrollment, uh, that's nearly completed start.

To make good progress in the naive. Um, and again that will be, you know, a year plus study and then time for submissions. So that would be, you know, probably even coming shortly after that uh younger lgpd group. But as Brad said, you know, with the newborn screening in the US and 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.

Thank you.

Our last question comes from saline. Richard of Goldman, Sachs your line is now open.

Good morning. Thanks for taking my question. Um, as we look to 2026 here um with the switches from next size, I'm expected in the US and and more xus countries coming along. How should we think about the commercial trajectory of of palm up versus what we've seen this year? And, you know, I I guess as you think forward to kind of a steady state, how are you thinking about market share for this asset?

Yeah. Thanks Alvin, as I said earlier, we're very confident in the growth. Uh, as we come to the end of the year here, expect continued to 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. Um in terms of market share. Look uh you know what? We've seen in countries like the UK as an example where we were

Uh, we're still on that journey, of course. Uh, but we're, we're starting to see signs uh, that that, uh, we can get to those those shares after a period of time. So uh, more to come

Thank you.

Thanks.

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

Great. Thank you all.