argenx SE (ARGX) Earnings Call Transcript & Summary

Good morning. My name is Adra, and I will be your conference operator today. At this time, I would like to welcome everyone to the Argenx Second Quarter 2024 Financial Results Conference Call. Today's conference is being recorded. [Operator Instructions]. At this time, I would like to turn the conference over to Investor Relations, Beth DelGiacco. Please go ahead.

Thank you. A press release was issued earlier today with our half year 2024 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I would like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Timothy Van Hauwermeiren, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. I'll begin on Slide 3. Last week, many of you joined us for our R&D Day, where we laid out an ambitious vision 2030 and shared a comprehensive overview of the growth opportunities ahead in our -- to achieve this vision. We are in a very strong position today to generate substantial value across our business, investing in our internal innovation engine, executing on our differentiated multi-asset pipeline and building on the commercial success we have achieved in our first 10 quarters of launch. This is a team that delivers on our innovation mission time and time again, all towards our goal to transform autoimmunity and reach 50,000 patients globally. Given the recency of this update, we will aim to keep our prepared remarks brief and focus primarily on the second quarter dynamics. But first, I'd like to highlight key themes that emerged from the R&D Day in the context of our 2030 vision. Slide 4, the first theme is around how we innovate, centered on a model of co-creation. This model has been core to our growth since our founding and still exists in the most obvious form today with our immunology innovation program. We have a strong track record of success in building out our differentiated pipeline, including 8 out of 12 molecules that demonstrated human proof of concept and 9 that are first-in-class targets. We have no shortage of opportunity with identifying novel targets and believe our overall approach sets us up to drive continued pipeline expansion for years to come. The second thing is the new standard we're studying with VYVGART in MG. We are currently de-reading advanced biologic in MG and have delivered 10 consistent quarters of growth since our initial launch. We are making excellent progress across all key indicators and are exactly in line with our internal long-term thinking of the MG marketplace. We think this is a big opportunity, and we have a strategic plan to reach more patients as we move into earlier lines of treatment and broaden to new populations through label-enabling studies in seronegative and ocular MG patients. We will use the same playbook for CIDP and are happy with the early days of the launch. We've got the best possible label, which puts us in a strong position for continued growth as we work to get the access piece in place. Third, we laid out our next wave of indications and expect to initiate 4 new registrational trials this year across VYVGART and Empasiprubart. We set the bar high with a medicine like VYVGART, which we introduced to use the R&D day to put Empasiprubart more in the spotlight. This is a second pipeline in a product opportunity and we were able to show phenomenal patient data in MMN, which we see as the first of many indications where we hope to drive transformational impact. Slide 5. The progress we have made across our business over the quarter moves us another step closer towards achieving our 2030 vision to bring 5 molecules to Phase III, advance our late-stage pipeline to 10 labeled indications across our molecules and to ultimately have 50,000 patients on an argenx medicine by 2030. One ambitious, we believe we are well positioned to deliver on this goal with a continuum of innovation from discovery all the way to commercial, underpinning our incredible success to date is the strong financial health of our business, which will enable us to continue delivering on our innovation mission, ultimately driving value for our patients and our shareholders. With that, I would like to turn over the call to Karl.

Slide 6. Thank you, Tim. The second quarter 2024 financial results are detailed in the press release of this morning. Total operating income in the second quarter is $489 million. This reflects $478 million in product net sales and $12 million in other operating income. In the second quarter, a $478 million in product net sales is attributed solely to MG patients. We received the CIDP approval on June 21, and our teams were immediately in action the next day. It takes time at the start of a launch to get patients through the funnel from script to injection. So the first CIDP revenue will be a third quarter event. Product net sales of $478 million represents 20% growth quarter-over-quarter compared to Q1 '24, which we know with a biologic is typically a more challenging quarter due to insurance reverification and loss of shipping days with [ weather ] and holidays. The product revenue breaks down by region to $407 million in the U.S., $20 million in Japan, $35 million in EMEA and $14 million from products supplied to Zai Lab in China. Operating expenses in Q2 of $535 million, an increase of $29 million compared with Q1 2024. SG&A expenses are $256 million in Q2 which is an increase of $20 million compared to Q1. The increase reflects a full quarter impact of the expansion of a customer-facing organization in the U.S. as well as incremental expenses to prepare for a CIDP launch. R&D expenses on the continued investment in our pipeline of $225 million in the second quarter, broadly in line with the previous quarter. The operating loss of the quarter of $45 million is offset by financial income of $30 million and a tax benefit of $44 million. The tax benefit is a result of a deferred tax asset recognized in our U.S. legal entity due to intra-group inventory movements. It is a temporary timing difference and will reverse in future quarters. Overall, we saw a net profit for the quarter of $29 million and earnings per share of $0.49. It is an important distinction, but the net profit was primarily driven by the recognition of a deferred tax asset and we still had an operating loss for the quarter of $45 million. We are on a clear path to profitability, but we are not there yet. We continue to have a strong balance sheet with $3.1 billion in cash. Based on our year-to-date cash burn of $77 million, we are updating our 2024 cash burn guidance from approximately $500 million to less than $500 million. Our guidance on expenses remains unchanged. This puts us in a strong position to invest in innovation across our business. And we have many opportunities to do so. There's a sizable opportunity in our current markets in new markets with our VYVGART franchise with our current pipeline and through our immunology innovation program to expand our pipeline. This is how we will set ourselves up for a sustainable future where we continue to generate significant value for our shareholders. I will now turn the call over to Karen, who will provide details on the commercial front.

Thank you, Karl. Slide 8. I'm very excited by our Vision 2030, especially the ambition we have set for ourselves to impact the lives of 50,000 patients globally and their caregivers. To reach this goal, we will need to expand in a multidimensional way, getting more medicines approved across many indications, product presentations and geographies. We have a strong commercial playbook in place that delivered in MG, and we'll be leveraging that same approach for CIDP, focusing on evidence generation that matters most to physicians and patients, empowering patients to demand more from their treatment, and last, the need to execute on our strategies with speed and urgency. We know that patients are waiting, and we also know that every day counts in building out our first-in-class leadership position. Slide 9. Starting with MG, I'm extremely proud of the team who worked really hard to expand our reach into new patients for our tenth consecutive quarter of revenue growth. We said this in Q1 and can reiterate it today that all key indicators of growth are performing well, and the fundamentals to the commercial business are strong. Focusing on the key drivers of growth this quarter. We saw the seasonality impact in Q1 normalized in Q2 with the impressive 17% quarter-over-quarter growth. Within the U.S., Hytrulo continues to attract both new patients and prescribers to the VYVGART franchise. This is important for a few reasons. First, over 50% of new Hytrulo patients are coming from orals and 60% are brand new to VYVGART, which is consistent with our goal to reach early aligned patients and to expand new patients with Hytrulo. Second, we continue to expand our prescriber base for MG, many of whom have the potential to be CIDP's prescribers. This will serve us well in our early conversations with physicians who have grown accustomed to the favorable safety and efficacy profile of VYVGART-Hytrulo. Slide 10. We continue to gain traction outside the U.S. as well, where we are focused on securing broad access. We have strong momentum in EMEA and VYVGART is now available in countries representing 82% of the gMG population in the region. We also continue to see strong growth in Japan, including positive early indicators on the launch of ITP. This launch rolled out rapidly and 74% of HCPs were made aware of VYVGART in the weeks post approval. It is clear that there is a need for innovation in ITP, which is why we are also launching an efficient label-enabling study with VYVGART IV in the U.S. after discussions with the FDA. Lastly, in China, we continue to be very impressed by patient adds each quarter, and now subcutaneous is also available following the approval earlier this month. Slide 11. Even with our strong performance to date, we believe that we're still at the front end of the opportunity in MG. We are seeing the MG market expand, the dynamics that we have seen play out in other rare disease markets when innovation enters the space. We believe that earlier use of advanced biologics will expand the addressable market significantly and that we can reach broader populations of MG patients with our label expansion studies in seronegative and ocular MG, each of which represents 15% of the total MG population. Based on these evolving dynamics, we have updated our addressable market in MG to 60,000 patients. Slide 12. Following our approval in June, we recognize that all eyes are on CIDP, and we share your excitement. We are thrilled with the broad label that we got, which will support use across the treatment paradigm. Now we're leveraging our MG launch playbook to maximize our impact in CIDP, driving rapid adoption with neurologists based on the strength of our data, empowering patients and working diligently with payers to put the necessary policies in place to secure access as quickly as possible. Reception has been incredibly positive with physicians, particularly on the strength of the data and improvement in function. We've already reached 25% of our key targets within 14 days of launch and 20% of the prescriptions we are receiving are from new prescribers to VYVGART. Many of the prescribers are studying multiple patients. Right now, our priority is to bring as many patients into the top of the funnel as possible. Once an enrollment comes in, payer approval at this stage takes a few weeks, after which patients can be scheduled for their first injection. This shows the importance of getting payer policies in place quickly. And as this happens, the time from script to injection gets shorter. Based on where we are today, we're making good progress with payers, and we're tracking to plan. Slide 13. Looking forward, we have an ambitious plan to successfully execute multiple launches across our pipeline in order to reach 50,000 patients in 2030. We're on track to start multiple Phase III studies before the end of the year. And each of these brings us a step closer to reaching new autoimmune indications where there is a high unmet need. The TED registrational study has already started, and we see an opportunity here to provide a differentiated and targeted therapy with favorable safety. We look forward to initiating a Phase III study in Sjogren's before year-end, following the positive signal we saw in our Phase II proof-of-concept study. There are no approved treatments for Sjogren's patients, and we know the disease goes well beyond sicker symptoms and can affect patients' ability to work and complete daily tasks, particularly the fatigue. This is a sizable opportunity. And while data will drive the specific target population, we know that there are 100,000 moderate-to-severe Sjogren's patients in the U.S. And last, we also look forward to decisions in myositis and BP on whether to advance the Phase III later this year. Finally, before year-end, we will start a Phase III trial with our second molecule, empasiprubart in MMN. This is an indication that fits perfectly into our neuromuscular focus, and it is another indication where the unmet need is high and IVIg is the only approved treatment. The data we generated in Phase II were tremendous and very meaningful to patients. We demonstrated consistent improvement in grip strength and in cohort 1, 94% of patients felt better on empasiprubart than they did compared to their peak with IVIg. Similar to MG and CIDP, we believe this is an underdeveloped market likely to grow over time as more innovation enters. Overall, this is an exciting time for the company. We have seen phenomenal growth to date, and we're eager to continue with this momentum as we enter into the second half of this year, applying innovation to every aspect of our business to reach even more patients. I'll turn it back to you, Tim.

Thanks, Karen. Slide 14. I'm proud of the argenx team and their tireless commitment to changing the lives of patients through our science. We are perfectly positioned with the right team and the right approach to execute on the broad opportunity ahead of us. We will continue to lead with the strength of our data and deep knowledge to address the sizable MG opportunity ahead and will apply the same rigor with CIDP. And this is just the beginning. We are eager to raise the bar for how autoimmune diseases are treated as we continue to expand our horizons, embarking on new paths to create long-term value for patients and shareholders. Thank you for your time today. I would now like to open the call to your questions.

[Operator Instructions]. We'll take our first question from James Gordon at JPMorgan.

James Gordon, JPMorgan. Two questions, please. First question was on VYVGART performance in Q2 and the extent to which we can extrapolate that to Q3. So sales were up $79 million, which was a strong performance. But how much, if any, would you say was one-off phasing that we should sort of take out if we're thinking about what the underlying performance would be. And if we're thinking about doing our Q3 modeling, how careful do we need to be about any reversals or seasonality? Or can we make quite a strong extrapolation from how well VYVGART has done today? That's the first question, please. The second question was Phase III initiation for ITP, and I saw a comment or heard a comment about this being an efficient trial. So how might this trial differ from the previous 2 Phase III in ITP. Can you expedite it if it's an efficient trial? And would it be going to like a smaller patient population in some way or a similar size population just a different design.

Thank you, James. Thank you for asking these 2 questions. I would like to hand over to Karen to comment on the underlying dynamics of the business and how to see the overall trends in our VYVGART MG business first. And then I will take the question on the ITP study in Phase III. Karen, why don't you go ahead with question 1.

Thanks, Tim. And thanks for the question and for recognizing, I think, like you, I'm really pleased with the results of the quarter -- this quarter. The way that I would think about it is that when you look at the first half of the year in totality, what you see is that we maintain that consistent momentum that we've had since launch. So we've had 10 quarters of consistent growth -- pretty consistent growth. I would take that longer-term view as I will look into the future, if I was you. And I'm confident that we will continue that consistent momentum. The underlying dynamics are strong. We continue to get early aligned patients. The majority are coming directly from the orals. We're growing both VYVGART and Hytrulo and we are broadening that prescriber base, which also serves us well for the CIDP launch. So I would say, think about consistent momentum and growth as we've seen over the last 10 quarters. I'll hand it back to you, Tim.

So thank you, Karen. And let me briefly comment on the ITP study. First of all, I would like to take a step back and remind the audience about the ADVANCE IV study but I think we had a very impressive efficacy with an IWG score of more than 50% in a PIT refractory patient population and a physician community, which is excited also about the very clean safety profile. We observed the patients in our open-label extension study, they continue to do actually very well on ITP and also the Japan launch of ITP is actually going according to plan. So the task we gave to the team was sit down with the FDA, go through all the data and propose a smaller confirmatory study in order to push the ITP indication over the finish line. And I think they succeeded in doing that. So by leveraging all the insights and the know-how we have on the disease by actually proposing an alternative primary endpoints, which allows for a small confirmatory study, we think we are on track to start a small ITP trial before the end of the year but I think we will be able to push the product over the finish line in that refractory patient population, we have been studying all the way. Thanks for the questions.

[Operator Instructions]. We'll go next to Tazeen Ahmad at Bank of America.

Here's my 1 question. I just was curious about the PFS filing. I know you've talked about already having applied officially. But given that there's no PDUFA, we're just curious about how we should expect to think about communication from your team on what part of the application is in process and what back and forth there might be? And do you have an idea of when you would be able to get that [ salon ] approval, given that doctors in particular, seem to be excited about having that as an option for patients.

Thanks, Tazeen, thanks for being with us this morning. [indiscernible] question, simple answer the filing has been submitted -- is accepted and under [ PDUFA ] with the FDA. And I think we will have a better sense of approval timing when the process unfolds. So stay tuned. We will keep you updated on the progress we make. Thank you.

Next, we'll move to Allison Bratzel at Piper Sandler.

Maybe just a follow-up from the R&D Day. Could you help us understand just the scope of the data required by FDA that will be needed for filing in seronegative and ocular MG patients. I think you described an ability to leverage existing trial data and real-world data at least for seronegative patients, but I've just been getting a bunch of questions on this. So any more color there would be helpful.

Yes. Thank you for the question, Allison. So remember that we printed strong results in seronegative MG patients. And as we already have an approval in Japan, but actually in the real world, the product is doing very well in seronegative patients. And we have impressive case reports out of Europe where people have been successfully using the drug in seronegative patients. So we made a commitment to the patient community, we would not give up and we have been entertaining the dialogue with the FDA on seronegative patients in the background. I think where we could land with the FDA is a pretty and fast elegant study in seronegative patients, which, as Luc called during the R&D day is somewhat relaxed P value. So I think the FDA is taking the existing evidence into account and is allowing us to run such a trial. So we think there's a high demand. This is an elegant study, and we will do everything we can to enroll that study as fast as we can. Thanks for the question.

We'll move next to Rajan Sharma at Goldman Sachs.

I just wanted to discuss kind of competitive landscape in myasthenia gravis and how you see VYVGART kind of continuing to differentiate that. There's obviously a busy pipeline. We've got [ iptacopan ] in a Phase III, [indiscernible] is also in a Phase III. So could you just kind of discuss how you think VYVGART differentiates relative to those mechanisms. And then longer term, what gives you confidence that VYVGART and the FcRn class more broadly remains kind of the preferred treatment option in early aligned patients.

Thank you for the question. And I will first hand over to Karen to comment on how you see the overall dynamics of this market and how we're building it together. Maybe can you go first, and then I will briefly comment on your differentiation question. Thank you.

Sounds great. Yes, thanks for the question. And look, I think building on what we shared at R&D Day last week. We believe that innovation coming to the MG market is good because it grows the impact that we can have for patients, expands the market, expands the number of patients we treated with advanced biologics earlier as well. So we believe innovation is great for patients. And I think we're seeing that and we believe we're very well positioned to continue to lead in that growing market. And I think there's a few things that maybe I'll -- since you asked about the differentiation that I'll touch on. One is around where first-in-class FcRn and it's clear that FcRn and certainly VYVGART are being used early line, I said earlier, over 50% of our patients are coming directly from the orals. So that's where the growth is, and we're positioned well there. I think we compete really well on our -- we have rapid efficacy, but also deep and sustained efficacy, and we have it across cyclical and biweekly dosing regimes. So I think that's a really strong position to be competing from. And don't forget about our real-world safety, the length of that real-world safety, the number of patients as the first mover advantage. And of course, we have the treatment -- low treatment burden. So we have both IV and subcutaneous, we have PFS plan. So overall I think the dynamics in MG are positive, if the market is growing, and we're well positioned to maintain and even advance our leadership. I'll hand it back to you, Tim.

Yes. Thank you, Karen. I much appreciate it. If you just look at the biology of the disease, it is crystal clear that MG is an IgG mediated disease. Remember the team -- most of [ action ] of these patogenic antibodies, complement recruitment, just being one of them. And that nicely translates into the clinical data, right. So let me remind you that 80% of VYVGART patients achieved in an ADL lower than 5, which is a threshold for entering a clinical trial and that 50% to 55% of VYVGART patients achieve minimal symptom expression. So, there's always the need that the most effective line for alternative methods of action because the drug only works in 80% of patients. But it's difficult to go into more detail in absence of data. So let's look at the data to then further understand how the biology really plays. Thanks for the question.

We'll move next to Derek Archila at Wells Fargo.

So just -- can you discuss maybe how the time from payer approval to injection that you're currently seeing during the early part of the CIDP launch compares to what you saw in the early part of the MG launch. Is that similar? Or is it different? And maybe a little color on why?

Karen, would you mind taking this question, please?

Yes. Happy to take the question. Thanks -- first of all, just to start with saying, we're really pleased with the strong and positive response we're having in CIDP. And to answer your specific question, as enrollments come in, it does take a while for patients to get approved by their payers. And it's that period of time, they can take a few weeks before they get injected. And that's standard for any launch. It's the reason that we're so focused on getting payer policy in place because once the payer policy is in place, that process from script to injection can go more quickly. I would say we're exactly on track where we thought we would be, both in terms of that process as well as most importantly, the discussions that we're having with payers around getting those policies in place. We're really pleased with the progress and the team is acting with urgency, and I think we're right on track and pleased with where we're at. I'll hand it back to you, Tim.

Yes. Thank you, Karen. We would like to ask a little bit patience, Derek, because remember what we did for MG rights. I mean, it took us 2 quarters to install broad and favorable policies. That was our commitment to the patient community, and that is fast guys. I mean 2 quarters is really outstanding and outstanding job done by the team and we will seek to replicate that for CIDP.

Next, we'll take a question from Akash Tewari at Jefferies.

So kind of on that point on CIDP, you mentioned in the past you're clearly seeing strong demand from doctors, but you wanted to see how that actually translated to patient impaired demand given the label, the overlap in the prescriber base and the amount of IVIg experienced patients here, would it be fair to say the CIDP launch it at least be half as good as gMG out to the first year. And maybe to that point, do you think we will see this kind of inflection after 2 quarters with CIDP like we saw with gMG? I just wanted to double-click on that point like that would say.

Yes, Akash and thank you for the question. Thanks for being with us today. It is tempting right to draw analogies between an MG launch and a CIDP launch. But what we're trying to say and explain is that the 2 distinctly different markets with their own dynamics, launch dynamics. And maybe, Karen, do you want to dig in a bit deeper into this question, right?

Yes, I think that's right. It's very hard to draw parallels. They each have their own dynamics. One thing that I would say around the inflection point that you mentioned after 2 quarters, I wouldn't think about an inflection point. The payer policies will come in sort of one by one over the 2 quarters. And what we like to think about is that sort of by the time you get to the end of 2 quarters, you might have -- you have sort of that critical mass where neurologists really can start to get confident that favorable payer policies are in place. So we do believe that there will be uptake, the same that we saw in MG, and we think that they'll -- it will be consistent over the period of time. But the dynamics between the 2 launches are very different for the reasons that you pointed out.

We'll go next to Alex Thompson at Stifel.

I guess I wanted to ask about OpEx trajectory over the next couple of years, how you're thinking about that as it relates to expansion into additional Phase III programs as well as thinking about commercial expansion beyond neurology.

Thank you, Alex. It's Karl, I'll take that question. In terms of SG&A, our infrastructure is now largely in place. As you will remember, we put that expansion in the U.S. in Q1. For the rest of the world, we have infrastructure in most of the markets with a few big markets still outstanding in Europe. I would expect SG&A from here forward to grow, but if we grow will be muted, and you will see the rapid expansion. In terms of R&D, again, I think that will grow quarter-over-quarter as we invest in all the new science, which we talked about last week. I think we have a unique opportunity to invest in ourselves here to set us up for a long sustainable future. That's what we're going to do. Thank you for your question, Alex.

We'll move next to Thomas Smith at Leerink Partners.

For VYVGART in MG, can you just remind us on the data that's being generated that could support chronic dosing in addition to the current cycle-based dosing? And whether you expect to get chronic dosing explicitly added into the label? Or how important do you think it is for prescribers to have that chronic dosing flexibility and the label to facilitate access and reimbursement.

Yes. Thank you for the question. And it's [indiscernible] simple. We have chronic dosing in the label. The label is basically describing the use of VYVGART for the treatment of statistically with plentifully postive gMG patients. So we have cyclical dosing, but it is, of course, chronic use. And we're the only company which has already such a long time line of chronic dosing of patients. But I think it is important to call out that the safety profile of the drug maintains consistent and that we see a consistent minimum symptom expression over multiple years now in 50% to 55% of the patients. What we did do is we run an ADAPT NXT study which was filling a data gap for those patients, which, for example, are coming from chronic plasma exchange for chronic IVIg patients, which we really did not study in the ADAPT trial because these patients cannot stand, of course, cyclical dosing, if you're on a weekly plasma exchange, you would need to feel intense chronic therapy. Every ADAPT NXT study, we have actually shown that every alternate dosing with VYVGART is as powerful as the cyclical dosing, both from an efficacy and a safety point of view. So in summary, I think we're the only company really with chronic dosing data and we're the only company which can offer such a diverse sets of dosing schedules. Thanks for the question.

Next, we'll move to Yaron Werber at TD Cowen.

A quick question. Just on Europe and Japan. I know Europe is very tough these days, and Japan usually got lumpiness as you noted, and obviously changes in the pricing, but just any sense kind of what should we expect there in terms of acceleration of sales?

Yaron, that's a great question, and thank you for assuming out on the global aspirations of the company. This is a question I would like to hand over to Karen.

Yes, happy to take this. And thanks for the question. So maybe I'll break them out and talk about Europe first and then Japan. I would say in Europe, we're on track. As you know, it takes a little longer, as you already called out in Europe to get pricing and reimbursement in place across all of the different countries. We're pleased with the progress that we've made. And certainly, in 3 of the big 5 markets, Germany, Spain and Italy, we have good reimbursement. We have strong clinical advocacy, and we're really seeing that consistent uptake with what we're seeing in the U.S. And what I mean by that is that we see a broader prescriber base, not just in the academic centers, at broader potential and really pushing towards earlier line use. So I think we're seeing consistent trends there. And as we open up new markets with pricing and reimbursement, then I think you'll start to see that consistent growth as well. So we're pleased where we are in Europe. We're on track. We take it step-by-step. It takes a little bit longer. In Japan, I just want to applaud the team. I think they've done a phenomenal job. I mean if you look back quarter-over-quarter, it's just so incredibly consistent with the growth in Japan, and we see that again this quarter. I would imagine that you can see -- you can imagine that outlook being consistent moving forward. We just recently launched VYVDURA, which is the name for subcutaneous in Japan and that, like in other market we're seeing that really expand the patient population that is open to VYVGART with, again, opening up those earlier lines of treatment. So again, I would say, consistent growth, as you've seen for the last 10 quarters from Japan, that we can expect in the future. Thanks for the question.

We'll move next to Matt Phipps at William Blair.

Congrats on the progress. Quickly, you mentioned a different end points in the next ITP trial. Is that just looking at a different time frame for sustained [ platelet ] response? Or can you use something like IWG responders as the primary endpoint? And then maybe just quickly on the launch of ITP in Japan. Any sense yet on where VYVGART is being used in the treatment paradigm for ITP patients. Is it after multiple [indiscernible] can you saw it earlier in that treatment paradigm?

Two great questions. Thank you, Phipps. I will hand over question 2 to Karen. On the ITP trial, I think the reason why we can go with a significantly smaller study in a confirmatory mindset is, a, because we can work with an endpoint, which is looking for extent of disease control and b, we can really leave us to know-how and the expertise we have developed in running ITP clinical trials. So I think this is going to be, roughly speaking, a trial, less than half the size of the global Phase III trials, which we have done so far. And we think it's a responsible investment to make for a significant patient unmet need waiting on the other line. Karen, would you mind discussing the Japan question, please?

Yes. Happy to take that. I would start by saying the ITP launch in Japan is going really well. We've applied sort of the same launch playbook that we have in other launches, and we're seeing the same strong early performance. And what I would say is that it's clear that there's an unmet need in these ITP patients. So far, what we're seeing, to your specific question is that the early experience is in later lines of therapy, and that's exactly what you would expect in any of these launches. The doctors want to try to get experience, maybe in those refractory patients in those later-line patients get experience under their belt and then start to move earlier line. But what we're seeing that I'm really pleased with is that there's a strong belief in the MOA in the mechanism of action of FcRn, the neurologist -- sorry, the hematologists are responding that they believe in the MOA and therefore, that they believe in the reason to try this get. So I would say strong early results exactly where we would expect them and really important learnings that we're going to be able to take away from this Japan launch as we think about the U.S. and potentially other launches with the second study that we're planning.

We'll go next to Suzanne van Voorthuizen at Kempen.

This is Suzanne at Kempen. I just have a small follow-up to last week's R&D day regarding argenx-121, the IgA degraded that was revealed. Can you give some context to the indications where such molecule would fit well and how many indications do you see? And also how you compare the opportunity in terms of size? Is there a potential for this to be an opportunity of VYVGART size? Or do you see more parallel to a drug like [indiscernible] looking at the commercial opportunity? Any thoughts or direction here would be appreciated.