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Wells Fargo 20th Annual Healthcare Conference 2025

Sep 4, 2025

Derek Archila
Analyst, Wells Fargo

... All right, good morning, everyone. I think we'll get started here with the first Fireside of the day. My name is Derek Archila. I'm one of the Senior Biotech Analysts here at Wells. I'm very excited to have argenx, you know, leading us off today. From the company, we have Tim Van Hauwermeiren, CEO and co-founder, as well as the CFO, Karl Gubitz. Gentlemen, thank you so much for joining us, and looking forward to the discussion.

Karl Gubitz
CFO, argenx

Thanks for having us, Derek. It's a pleasure.

Derek Archila
Analyst, Wells Fargo

Excellent. Well, you know, maybe just to start with a very high-level question, you know, there's been a lot of change, you know, with argenx over the last couple of years, and a lot of growth, you know, with that change. So really wanna understand, you know, over the last couple of years, how you've kind of seen, you know, the opportunity set kind of evolve with VYVGART and kind of where we're headed in the next five years.

Tim Van Hauwermeiren
CEO, argenx

I think that's a real great opening question, and when you go back in time and you reflect on, you know, the steps we have been taking, we always realized the FcRn space is a huge universe, and then the question is, with very limited means and a tiny organization, how do you unpack such an opportunity? You remember the beachhead strategy, you know, where we basically planted a seed in the neurology space with MG, a seed in the skin space with pemphigus, and then a seed in the heme space with ITP, and today we are actually selling in two of these three beachhead indications, ITP and MG, and basically, the ball has been rolling from there on. We're now in 15 indications ourselves. We're in five investigator-initiated trials, and that list is growing.

So I think that the dream, that vision of building a true pipeline and a product is actually unfolding in front of our eyes, and it's a very exciting exercise.

Derek Archila
Analyst, Wells Fargo

Yeah. I mean, I guess as you think about the class as a whole, I mean, obviously you're not the only FcRn, but you're the leading. You know, so I guess, how do you think about that evolving and, you know, we've always kind of comped this to maybe the TNFs. Is, is that still a good comp, or are we kind of actually looking at this maybe even as being better than the TNFs over time?

Tim Van Hauwermeiren
CEO, argenx

Derek, we, we're tracking them. I mean, we, we're obsessed with history, so we're actually tracking our launch with, you know, the TNF alpha launches, Humira and Enbrel. Today, we're beating them. I mean, we're in good company, but I think we're slightly beating them. We're actually tracking closer to Dupixent ramp, which I think is a hell of a pipeline and a product. But the only way to stay there, you know, in such a good company, is to continue to launch indications, and that's why I think it's so important that, you know, we look in front of us at these 15 indications, because that's what it will take to continue to track with these pipeline and product launches, which, you know, are deep pipelines and the products of our industry.

They're remarkable examples to study, and I think we are well on the way to actually become one of them.

Derek Archila
Analyst, Wells Fargo

Gotcha. So maybe let's start with the lead indication, MG. I obviously, you know, looking back, I think the opportunity has just been a lot larger than, you know, what we thought and maybe even you thought initially. So I guess, what's kind of driven that and, you know, what's kind of surprised you with kind of the launch with VYVGART and also kind of your strategy here with multiple presentations?

Tim Van Hauwermeiren
CEO, argenx

I think there are a few lessons learned. The first lesson I personally learned is when you do your market research, not just call the KOLs, which we all call all the time.

We are always calling on the same folks, and they have an opinion which is often wrong, because they cannot predict the future. So we heard so many times, "My patient is doing fine. My patient is just fine. I don't need such an expensive innovation. Maybe I'll use it in 5%-10% of my patients." Today, they speak totally differently, and the thing which we forgot to do in the initial market research was actually to phone the patients. I would encourage all of us in this business to reach out to patients earlier and actually ask them, you know, to compare and contrast the opinion of the KOLs, because patients would violently disagree with the statement that they're doing fine. And then I think the miracle happens, which you often see in high unmet need spaces.

Once an innovation comes in, the opportunity turns out to be bigger than what people thought initially. We're not unique. I mean, that is a pattern in our industry. If you have a transformational medication in a high unmet need space, the opportunity which you can build, which you can shape, turns out to be way bigger than what the initial calculations predicted.

Derek Archila
Analyst, Wells Fargo

I guess, as you think about, you know, the MG market as it stands today, so obviously I think you initially had really focused or was seeing use in more refractory population. Over the last, you know, maybe year, two years, you really looked to push earlier. So I guess, where do you think we are in that journey? And I guess, you know, with the addition of now seronegative, which you just had positive data in, future ocular next year, like, how big do you think MG can be?

Tim Van Hauwermeiren
CEO, argenx

We're on a journey. So when we launched, and I was traveling the field, the typical question you would get from physicians is, "What patients should I use VYVGART on?" You know, that was the key question. And they were really looking for the, you know, the worst of the worst patients, to try the drug. Today, when I travel in the marketplace, the question is no longer that question. The question is, "How early should I use VYVGART?" And there, I think we always like to draw the analogy with the MS markets, but I think innovation today in MS is used first line, where the mantra is, "Time is nerve. We need to treat these patients as fast as we can with the best possible medication we have." The result in MS is transformational.

The number of patients in wheelchairs went down dramatically. I think the MG space is going there, and we're somewhere on that journey. We're not there yet, but our ambition is to go faster than the 10 years it took in the MS space to get there, so there's a ton of work to do, but I think we're well on the way to bring VYVGART close to first-line therapy, with, I think, remarkable outcomes for patients.

Derek Archila
Analyst, Wells Fargo

How does the PFS kind of fit into that?

Tim Van Hauwermeiren
CEO, argenx

Karl, do you want to comment briefly on the PFS setting?

Karl Gubitz
CFO, argenx

Yeah, the PFS, we launched that in April. The PFS is self-administration, so it provide that independence to patients, and it really is helping to expand the patient population. It also expand the prescriber population. Just in terms of prescribers, we always give a data point. We've got 1,000 prescribers on PFS. 150 of them are new to VYVGART, i.e., never gave us a VYVGART script before, so clearly expanding the prescribers. But for the patients, this is transformational. You have independence, you can take it out of the fridge, you can put it in your bag, you can travel with it for 30 days, and that is gonna help us reach the patients. Think of a younger patients, more active, who doesn't want to sign up to the logistics of infusion, scheduling infusions.

We're gonna get more into the community, patients who have to travel long distances to infusion centers or physician offices. So I think it is. It's really a key growth driver for us.

Derek Archila
Analyst, Wells Fargo

Karl, was there anything unique of those new 150 prescribers that just, again, they weren't using VYVGART before, but, you know, have since with PFS launch?

Karl Gubitz
CFO, argenx

I think the way to look at that is to say what we are. We are mostly in the community, so we are expanding into the community.

Derek Archila
Analyst, Wells Fargo

Gotcha. Okay.

Tim Van Hauwermeiren
CEO, argenx

I'd like to add on what Karl said, because, look, we don't have a cure for MG yet. But in absence of a cure, the best thing you can give to an MG patient is living a life without being constantly reminded of your disease. From an efficacy point of view, more than 50% of VYVGART patients live a life with no symptoms. From a safety tolerability point of view, the safety profile is pristine. I mean, there are no real side effects associated with this drug, unlike the immunosuppressants they used to be on. And then the third point is independence. So I think PFS gives them the independence to live a full life.

Derek Archila
Analyst, Wells Fargo

Yeah. I mean, obviously, with the explosion of, like, the growth in terms of revenues for VYVGART and some of these other drugs in MG, you know, people always, you know, ask me about the competitive intensity, other competitive threats, CAR-T, CD19, all these sorts of things. So I guess, I know you've used the MS analogy also in terms of competitive intensity. Maybe walk us through, again, maybe how you see that evolving with new, you know, either targeted therapies, CAR-T, and other things coming into the MG market.

Tim Van Hauwermeiren
CEO, argenx

I think you're spot on. I think the MG space is becoming a very exciting place. If you're a neuromuscular specialist or even a generalist neurologist, it's an exciting time, you know, to see this innovation come into your space. It's outstanding news for patients because finally, they have options, and what we learned from the MS space is that more innovation builds markets. So it would be a bad dynamic if it would be all fighting for the same refractory patient, but that's not true. Jointly, we're growing this market. I think we're growing faster than competition, and I think the way the treatment paradigm is crystallizing today is that FcRns are used first.

They're safe, they're fast-acting, easy to use, and I think C5s come next because you have, of course, the barrier of entry with the vaccination, the safety concerns, I think, you know, the fact that you only address one of the three modes of action of these pathogenic IgGs. And then really last line, refractory, I think you will see some B-cell depleting agents, maybe some CAR-Ts, but I think they will be reserved, you know, for the more refractory patients. That's exactly where we do not want to play. We want to move upstream as early as we can, and that's what we're doing. So today, you see more and more physicians, which would use VYVGART as the first-line therapy after Mestinon, and that's where we want to play.

Derek Archila
Analyst, Wells Fargo

Like, where do you think FcRn penetration right now is, like, again, as a class within MG?

Karl Gubitz
CFO, argenx

If we look at all the novel biologics, it's around 10% of the market. VYVGART is clearly the biggest. We've got the biggest market share. But with all the novel biologics coming in, we are growing that pie. You'll see all of us are growing. IVIG is probably also growing, but that 10%, I don't know where the share of biologics will be in a few years, but it should be multiples of 10%, which is why we're saying, "Yes, we are three years into the launch of MG, but it's still the early innings. There's a lot of growth ahead of us.

Derek Archila
Analyst, Wells Fargo

So clearly a big lever just in terms of more biologic penetration, but also levers in terms of you're adding seronegative as well as ocular. So maybe you can walk us through maybe some of the data that we just saw and how that impacts, you know, maybe the growth prospects for VYVGART and MG.

Tim Van Hauwermeiren
CEO, argenx

It's an important stepping stone to that 60,000 total addressable market, which we presented during the R&D day last year in July. There are three important stepping stones to get there. Two stepping stones have to do with label expansion. I think the seronegative patients are in high unmet need. We have a long-standing commitment to them, and I'm personally very proud of the fact that now we can honor that commitment. So that's the first addition of a meaningful set of patients to the label, hopefully soon. The next stepping stone will be ocular myasthenia. That's another 15% of your total addressable market, and then, of course, the innovations like the pre-filled syringe, the auto-injector, that will help drive, you know, earlier and earlier line use. So these stepping stones together should lift us into the 60,000 TAM.

Derek Archila
Analyst, Wells Fargo

Gotcha. I mean, I guess as you think about, you know, the neuromuscular space, obviously, we'll talk about CIDP in a second, but I guess, you know, right now is awareness of kind of maybe FcRn or VYVGART, like, where do you think we are in, you know... like what inning? Is it still a lot of unreachable docs that have just not, you know, kind of converted to using these therapies, and is that because they're neuros and they don't like change? Or is that really started to... You guys have broken down barriers now with, like, through DTC and, and, you know, physician education.

Tim Van Hauwermeiren
CEO, argenx

We're working very hard to educate the community and to shape the space. I think as a pioneer, that's our duty to elevate the entire community, but Derek, the job is not done, and there is still so much work to do. We're on our way, but there's a ton of work in front of us.

Derek Archila
Analyst, Wells Fargo

Yeah, I was gonna ask, like, some of the physicians who are not using VYVGART right now, what's... I mean, I don't know, is there a pushback, or is it just lack of awareness or lack of education?

Tim Van Hauwermeiren
CEO, argenx

It's education. I call it inertia. People are stuck in their habits, and you cannot blame them. If you have been treating patients 20, 30, 40 years with the limited toolbox you had, you like to believe you were doing a good job, and you like to believe your patients are stable and are just doing fine, and you're proud of the fact that you keep them out of the hospital. So we need to move that goalpost mentally in terms of it's not good enough to keep a patient out of the emergency room. You need to give that patient his or her life back, and that's why we're doubling down on mobilizing the patient. It's the patient who needs to stand up and, you know, ask for better and demand their life back. So patient education is as important as physician education.

Derek Archila
Analyst, Wells Fargo

Gotcha. And then just in terms of what we're seeing for trends with PFS, there's obviously the recent launch. So, you know, I guess, first off, the comment on the quarterly call in terms of seeing all the presentations grow, you know, maybe that caught some of us by surprise just 'cause we thought PFS would be, you know, taking more share. But I guess, like, you know, how do you kind of think about PFS long term in terms of the overall share dynamics, you know, within the presentations and for... specifically for MG, but also, you know, long term, I guess, again, this should be the predominant, you know, share across all indications. Is that fair to say?

Karl Gubitz
CFO, argenx

Yeah, I think that's fair to say. On Q2, yes, all presentations, on both indications, all markets grew. I think it's—we're very proud of it, but to your point, longer term, PFS will be the key growth driver for VYVGART. I think over time, outside the U.S., very quickly, I think PFS, once it's launched, will be the predominant presentation. In the U.S. also, it will be the biggest of the three. However, IV and Hytrulo will always be important presentations in the U.S. because the way the healthcare system works.

Derek Archila
Analyst, Wells Fargo

Yeah.

Karl Gubitz
CFO, argenx

But PFS is the growth driver.

Derek Archila
Analyst, Wells Fargo

Got it. Maybe just last question on MG. Just kind of ex-U.S., like, you know, obviously, we've seen a lot of great growth in the U.S. market. You know, how should we be kind of thinking about regions like Japan as well as the E.U.?

Karl Gubitz
CFO, argenx

Yeah, Japan is our second-most important market, really impressive growth. If you look at the history of Japan, quarter after quarter, they continue to deliver for us. In the last two quarters, they've been added by the CIDP launch, which was really quick out of the blocks, and strong performance there. Also wanna give a shout-out for ITP. On the global basis, maybe ITP is not that material for ... but in Japan, it is material, and ITP is doing really well also in Japan, and I think that is something which we're looking forward to if we can get the study in the U.S. approved. For the rest of the world, for Europe and for Canada, you see that consistent growth.

It just takes longer to get the pricing and reimbursement done in these countries, and we've also aimed to be disciplined in terms of pricing, so we did not sacrifice speed to market by accepting lower prices. We really wanted to focus on the value proposition of VYVGART, so it took time, but I think you can look forward to growth in these regions every quarter now.

Derek Archila
Analyst, Wells Fargo

Got it. So yeah, maybe shifting gears to CIDP, a more recent launch for you guys. You're ultimately really going head-to-head to IVIG, you know, pretty hard there. So I guess, you know, in that dynamic and based on some of the commentary of, you know, the neuros and the inertia that you see, like, how do you kind of feel like that launch is doing, and how do you think that will ultimately, you know, kind of the trajectory relative to MG?

Tim Van Hauwermeiren
CEO, argenx

I think we're in the early stage of the launch. I mean, typically, you land in that last line patients, you know, the refractory patients, which are not doing well on IVIG. Not doing well could mean that they weaken in between the cycles, or they still progress whilst they're being on IVIG, or frankly speaking, there are significant safety and tolerability issues because do not underestimate the burden of therapy if you're on IVIG. So I think we're in that initial phase where people, you know, are building their experience curve, just like we have seen in MG, and my expectation is that if their experience is positive, that they will start to use the drug more and more often and will also start to consider, you know, early-in-line patients. But, you know, we are where we are currently.

I think it's going really well, and what I personally take great pride in is the regain of function, which happens in the real world. Remember, in the ADHERE trial, you know, 60% of patients regained function. About 30% of patients had a spectacular regain of function, like, you know, leaving the wheelchair by the end of the trial. These anecdotes are also reaching us from the real world. I mean, it is impressive how many people who used to be on IVIG can now walk again long distances, can play golf again, can go back to work, can start to travel to see their family. That is quite transformational. And again, we need to double down on patient education. Patients start to talk about it. They need to understand this option, and they need to stand up and ask for it.

Derek Archila
Analyst, Wells Fargo

Yeah. I mean, I guess, do you think there's challenges with moving people from IVIG to VYVGART? And I guess I know you have a trial ongoing, but, like, you know, in the real world, how has that kind of been playing out, and what some of the key learnings you've seen, you know, in the early launch there?

Tim Van Hauwermeiren
CEO, argenx

Good question. The ADHERE trial answered many questions... but it did not answer the question, how do you optimally switch from IVIG to VYVGART? So physicians are experimenting with it. They typically take the approach, how they would switch an IVIG patient to an SCIG patient. That means one week or the latest two weeks after the last IVIG, you put them on VYVGART, and that typically gives you good results when you look at, you know, the real-world experience. We're running a small, phase IV clinical trial to generate some data to inform physicians. Neurologists like some guidance. They like some hand-holding, and therefore we're generating this type of data. The trial design is indeed, you switch patients over from IVIG to VYVGART one week after the last dose, which makes scientific sense here.

Derek Archila
Analyst, Wells Fargo

Gotcha. I guess, how do you think about this opportunity versus MG? And I know you guys have said in the past, like, you know, the value of a CIDP patient is double given, you know, the dosing frequency. So, you know, again, smaller numbers, but yes, what's the potential here?

Karl Gubitz
CFO, argenx

Yeah. The contribution to us is double, but the patient population is smaller. For total addressable market for MG, we talk about 60,000. For CIDP today, we talk about 12,000. That 12,000 is the bottom of a patient funnel. You start the patient funnel with this is U.S. numbers, at around 42,000 diagnosed CIDP patients in the U.S. 24,000 of them are being treated, and the bottom 12,000 of those are the patients which we believe are not adequately treated with standard of care. That is the total addressable patient population for us today. That's the patients we are focusing on. As Tim said earlier, typically, when you launch, you get that more refractory patient.

That is how you start a launch, and then you build from that. But if you go quarters into the launch, that's where we focus today.

Derek Archila
Analyst, Wells Fargo

Gotcha. Like, what do you think needs to happen for people to start using it earlier or, you know, maybe even first-line before IVIG? Is that just, you know, more data or just more experience? What do you think actually needs to happen?

Karl Gubitz
CFO, argenx

I think, I mean, the experience needs to build with the patients and the physicians. The physicians need to receive a positive experience from the patient. I think the patient activation strategies which we have should also help to get there. Also need to point out that there is a payer hurdle, so there's more work to do with the payers if we wanna get it front line, because at the moment, most of the payer policies, not all of them, do require a step through IVIG or IG, I should say. Those restrictions, by the way, is not too restrictive, in that it doesn't require a specific time period.

And it's not really an issue today because most patients do have IG experience. But longer term, I think there's potential, but it will take time, and it will take us to work with the payers.

Derek Archila
Analyst, Wells Fargo

Gotcha. And then maybe last question, because I want to focus on the pipeline next, but just in terms of, like, competitive dynamics, you know, not as, you know, competitive maybe as an MG, but, you know, there are certain, you know, complement inhibitors that are looking at, and also yourself, you're looking with Empasiprubart, you know, in, in CIDP. So I guess, where do you kind of think this will all shake out in terms of FcRn and maybe complement in, in CIDP, also with IVIG kind of being, you know, still standard of care?

Tim Van Hauwermeiren
CEO, argenx

It's a bit of a typical argenx story. When we ventured into CIDP, people thought it could not be done, and now that we did it, they're all gonna follow. So... But again, let's not be intimidated by that or scared by that. I think CIDP is a desert from an innovation point of view.

These patients badly need options, and I think, you know, you will see a similar dynamic as the MG marketplace. More innovation will come in. That innovation will build that market, will transform that market, and I think CIDP patients in the future will have totally different outcomes compared to where they are today.

Derek Archila
Analyst, Wells Fargo

Gotcha. So, you know, obviously, this year has been, you know, largely commercial story. Next year, you have multiple, you know, phase III readouts for VYVGART. So maybe just talk us through, you know, how you think this really starts to stack the indications and I guess your confidence level in some of these readouts that we'll see for VYVGART.

Tim Van Hauwermeiren
CEO, argenx

I think you're making a good point. I mean, there is an avalanche of data coming. We still have a couple of important data points this year, in addition to the PFS approval and of course, the seronegative trial. We have the data point in delayed graft function for EMPA, and we have the lupus nephritis data point for efgartigimod. But then when you turn the page into next year, you will see the ocular MG study data readout. We will, we will see data in a number of phase III clinical trials. The first one, I think, will be myositis. So there's a lot of phase III data coming our way. Guys, expect some level of attrition.

We're not magicians. I think we like to do our homework based on the biology. I think we design solid clinical trials, but you will have attrition. It still remains a clinical experiment. But even if you take normal attrition into account, what's coming is gonna be big-

... because each of these phase III data cards, which we will turn, represent intrinsic opportunity in the same ballpark number as MG. So this is gonna be a big product, and these phase III wins, if they're positive, will be very significant additions to the potential, the future potential of the drug. They all come with their own specific clinical execution risk, but I think they're all marching on a very solid biology rationale, and they all carry the potential to really be transformative to the therapeutic areas where we're gonna land. For example, if you take the case of myositis, it's a very bad disease. These patients are pretty desperate for effective therapy. The toolbox is as much as almost empty-

...last except for, you know, an IVIG approval in dermatomyositis, but we know how to fight IVIG.... so I think these are all meaningful opportunities to shape treatment paradigms.

Derek Archila
Analyst, Wells Fargo

Gotcha. I mean, I guess, what do you like about myositis specifically in terms of, like, that market? And I guess, how do you think about, you know, these, when we think about some of these new indications in 2026, in these phase III readouts, I mean, these are all, you know, could be quite large. But, you know, realistically, again, are these gonna be areas kind of like MG, kind of maybe slow adoption, neuros, inertia, things like that? Or would you expect, you know, different types of launch trajectories in these indications?

Tim Van Hauwermeiren
CEO, argenx

Honestly, too early to tell. We're doing a ton of preparatory work in the marketplace. In myositis, you have an interface with neurology because, for example, IMNM is an indication often treated by neurologists, so maybe you get the halo effect of VYVGART. We need to see. But it's also our door into rheumatology, and frankly speaking, rheumatologists don't know FcRn, so there's a lot of education to do, and that's also true in endocrinology and the kidney space. So let's see. I think you need strong data in order to really make a splash in these spaces, and that's what we're now set to do. Myositis specifically is a very interesting space, too, because the world is starting to accept that this is an IgG-driven disease.

The diagnosis, the classification actually happens based on your unique pattern of autoantibodies. And guess what? VYVGART is removing these autoantibodies. So I think there's a very solid reason to believe if you walk into the myositis space.

Derek Archila
Analyst, Wells Fargo

Gotcha. And I guess in the context of some of the larger indications, like TED, as well as you, you mentioned lupus nephritis, which is more of a proof of concept, but, you know, I guess, how do you start to think about positioning VYVGART there, you know, and is it kind of just finding specific populations within the broader population, or, you know, can you go there with a, a price point where you're at right now with VYVGART in a, in a larger, you know, hundred thousand patient market?

Tim Van Hauwermeiren
CEO, argenx

Look, in TED specifically, of course, we have Tepezza, which is a transformational drug.

I mean, it reminds me of the situation in MG, where Soliris was already in the marketplace with pretty spectacular data in refractory patients, and then it became a payer-to-payer competition. We were convinced in MG that, you know, IgGs drive the disease-

And I think we have now proven that, you know, unequivocally. In TED, the jury is out. I mean, are we getting closer to the heart of the biology compared to with Tepezza? That is the key question, and that will allow you to differentiate on efficacy. Let's not forget that, you know, there's a unique safety profile associated with VYVGART, which will be distinctly different from Tepezza. So let the data speak. I think these are markets which, you know, can all support multiple innovation products, but this is a pathway-to-pathway competition.

Derek Archila
Analyst, Wells Fargo

Gotcha. And just remind us, so a lot of the phase IIIs that are ongoing, they're all using PFS?

Tim Van Hauwermeiren
CEO, argenx

Absolutely.

Derek Archila
Analyst, Wells Fargo

Okay. Gotcha. So maybe let's talk about kind of the longer-term strategy just with the FcRn franchise that you guys have built. So like I said, you've got these multiple franchises. I'm sorry, multiple presentations of VYVGART, but that's not. You're not stopping there. You're continuing to kind of innovate to really drive long tail value of FcRn. So maybe you can kind of talk about that and, you know, ultimately, when we could, you know, kind of get some updates from some of these programs.

Tim Van Hauwermeiren
CEO, argenx

It's a great question because the way we look at the FcRn space, that's how we started the conversation, it is such a universe of opportunity that it's too big for one molecule. So there is a certain, you know, lifetime to a molecule. It can be an IRA life, a patent life, what have you. There's more work than we can do with one molecule, and that's why we started to invest in next-generation molecules, trying to build a leadership position in the FcRn space for the long term. So if we can bring longevity to the franchise, the way, for example, Vertex did in the CF franchise, then I think this will be a pillar for long-term growth. We are developing multiple next gens. We already spoke in the R&D day last year about ARGX-213.

That molecule is dose-escalating in phase I. Based on the PK and the PD data and everything we know about FcRn, we will soon know what we have in our hands. So this is probably an update you can expect for next year.

Derek Archila
Analyst, Wells Fargo

Gotcha. And then anything else in terms of, like, presentation? I know you've looked at, you know, maybe lower volume via Elektrofi. Like, is that another thing that's kind of, you know, part of this whole kind of franchise longevity?

Tim Van Hauwermeiren
CEO, argenx

Absolutely. I think we need to continue to try and develop product presentations which can delight patients. The Halozyme technology is an incredible technology. We have the exclusive license-

For FcRn, regardless of the molecule we use, and that is doing a phenomenal job in today's product. The other way to go about delivering bigger volumes or bigger amounts of protein under the skin is the Elektrofi technology. I mean, you can hyper-concentrate the proteins. You can achieve 400-500 milligram per milliliter concentrations easily. So that is, again, opening the door into a totally different patient experience. So we're developing multiple options. The auto-injector is on track. We get that question often. There is a unique auto-injector on its way to markets by 2027. So the bottom line, I think, is we continue to innovate in these spaces.

Derek Archila
Analyst, Wells Fargo

Got it. So now just a couple of minutes on, you know, the ex-VYVGART pipeline. I want to give your EMPA team a little credit here in 119. So maybe just as you think about, you know, again, using all the resources that you're gaining from VYVGART and kind of how you want to apply them to, you know, some of these other pipeline agents. I mean, EMPA, we've got data. You're in a phase III trial in MMN. So maybe just kind of think about how those really start to frame out a larger portfolio of, you know, programs here versus just kind of, you know, the indication expansion that we see with VYVGART.

Tim Van Hauwermeiren
CEO, argenx

Yeah, I'm glad you asked the question, and EMPA, it's about time for EMPA to come out of the shadow of of efgartigimod. It's the argenx innovation playbook, because EMPA is going after a unique novel target in the complement cascade. It comes with unique features from a safety and efficacy point of view. It's a very well-designed molecule. I think you would be hard-pressed to make a better molecule against C2, and then it's a pipeline and a product, because if you just follow the biology, the C2 biology takes you squarely into the indications which we're developing. So MMN, the phase II data were transformational. You know, I saw, you know, the similar picture as we have seen for VYVGART in CIDP, transformational regain of function.

So we now head-to-head in the phase III trial against IVIG. Based on, I think, the phase II data we have seen, we have a reasonable chance to show superiority over IVIG and take the MMN market, which we think is, you know, a virgin territory, which we can completely shape and build. delayed graft function is in phase II for this year. That's again, you know, an indication with very high unmet need, clear involvement of C2, if you look at the kidney biopsies and you stain for the complement factors in play. We're in phase III in CIDP. Based on, you know, some data we have seen from competition, our own translational data, we are really investing a lot in unpacking the biology of CIDP, and we think there is space for EMPA.

And then we have dermatomyositis as a fourth indication, where again, I think we are marching based on solid biology. What I want this audience to know is that there is more coming. We are already in four indications. There are more indications coming for EMPA, and therefore, we think it's gonna be a big product.

Derek Archila
Analyst, Wells Fargo

Yeah. And in terms of, you have an event coming up for ARGX-119, so I guess maybe walk us through that molecule and what you're gonna showcase and I guess, again, your excitement around some of the indications you're pursuing there.

Tim Van Hauwermeiren
CEO, argenx

This is a cool program. We're working with, you know, the world experts on the neuromuscular junction. We're trying to bring Steve Burden to a meeting, by the way. He's the walking encyclopedia on the neuromuscular junction. This guy has unraveled that biology. He understands the junction, and he guided us to, you know, the activation of MuSK as an interesting therapeutic target, which represents potential in all these indications, where, you know, your neuromuscular junction is not firing the way it should be firing. Congenital myasthenic syndrome, we have a very interesting proof of biology in phase I- B. The ALS data point is around the corner. CMS is coming, but more indications are coming. Think about the ability to rejuvenate nerves.

I think that's a very interesting area of opportunity, which we're going to unpack in that mini R&D event two weeks from now. So I hereby invite all of you to join us in the office. Steve will be there, the scientists will be there. I think it's going to be a very cool event.

Derek Archila
Analyst, Wells Fargo

Got it. And maybe just with the last two minutes, so, you know, obviously, your execution has been very good. You know, revenues have ramped, stock has worked. We always get the questions like, "Stock's expensive." Like, what would you tell investors, like, again, right now, like, what you still think is unappreciated about the story right today? And I guess, again, going back to the initial question, like, five years from now, what does argenx look like?

Tim Van Hauwermeiren
CEO, argenx

Let's go back to the start of the conversation. If you go back in the history of the TNF alphas, the history of Dupixent, in all these earnings calls, the CEOs were explaining that these pipelines and the products were actually way bigger than the analysts could see. And they were right. I mean, again and again, pipelines and the product turned out to be way bigger than what people thought. When we look at the analyst models today, not yours, people are only giving attention to one or two extra indications. They're just not modeling everything which is coming, and that is just fine. So let us generate the data, let us unpack that opportunity, and then I think the models will follow, the valuation will follow. So let's continue to execute.

Derek Archila
Analyst, Wells Fargo

Sounds good. Well, we'll leave it there. Tim, Karl, great to see you. Thank you so much.

Tim Van Hauwermeiren
CEO, argenx

Thank you.

Derek Archila
Analyst, Wells Fargo

Okay, thank you so much.

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