argenx SE (ARGX) Earnings Call Transcript & Summary

December 3, 2024

Euronext Brussels BE Health Care Biotechnology conference_presentation 36 min

Earnings Call Speaker Segments

Samantha Lynn Semenkow

analyst
#1

Thank you for joining. My name is Sam Semenkow. I'm one of the Biotech Analysts here at Citi. And it's my pleasure to be hosting argenx at Citi's Global Healthcare Conference here in Miami. I'm joined on the stage by Karen Massey, Chief Operating Officer at Argenx. Karen, thank you so much for being here.

Karen Massey

executive
#2

Thanks for having us, Sam.

Samantha Lynn Semenkow

analyst
#3

Yes. So how about we just start off, you can just set the stage a little bit by recapping a lot of what argenx has done in a very busy 2024 and maybe thinking about what we should look forward to in the future, and then we'll be able to dive into each individual program that you have from there?

Karen Massey

executive
#4

Yes, that sounds great. As you say, it's been a really busy year, 2024, and I would say a really good year for argenx. When I reflect on the year, I mean, I think Argenx is known for 3 things. One of them is breakthrough science. Another one is really our innovative approach that we take to developing medicines and bringing them to patients and then just this relentless focus on execution and delivering. And I think in 2024, we sort of -- we hit across all 3 of those. So if I think about the execution point in -- from a commercial perspective, we continue to drive growth in MG over 2 years, since approval and since launch, which doesn't just happen. That requires a lot of hard work and focused strategy. And we continue to grow with a successful CIDP launch, which again takes a lot of effort by the team. We had over 300 patients in the first quarter of the CIDP launch, which was incredible and something to be really proud of. If I think about the -- on the innovation front, -- we had 2 really exciting data readouts, helping us moving VYVGART into Phase III for Sjogren's as well as myositis most recently. And again, 2 really good examples of the innovative approach that we like to take to development. So I think of Sjogren's, we did a small Phase II study. We were able to go deep and leverage that data alongside the competitors' data that did a much larger Phase II to be able to quickly get the insights we need to be able to move fast into Phase III. And then myositis, obviously, the seamless Phase II into Phase III, I think, was a really innovative approach. And then in terms of the breakthrough science, there's a lot going on behind the scenes that many people outside of argenx don't see necessarily, although we brought some of that to the forefront with our successful R&D Day in the mid part of the year. But all the work going on behind the scenes means that we're looking to 4 INDs in the next year, which is just incredible. So continuing with that breakthrough science. So 2024 has been a really strong year. I think 2025, what you can expect, we'll share more at JPMorgan about the specifics, but I would say you can expect the argenx way, which is some bold plans, big ambitions and really making significant and meaningful progress towards our Vision 2030, which is what we laid out at R&D Day.

Samantha Lynn Semenkow

analyst
#5

Yes, absolutely. All right. So maybe we'll start with the CIDP launch and how that's going. So the first 4 quarter our performance was quite strong, as you noted. Has that early momentum really continued thus far into the fourth quarter, 2 months out of the 3 so far into the holidays? So just curious if there's anything you can share on how that's going?

Karen Massey

executive
#6

Yes. We're really pleased with where we're at, at the end of the first quarter of the CIDP launch. And I would say we are continuing to see that momentum across those KPIs into the fourth quarter. So what's important that we look at the underlying KPIs that we laid out, payer policies, we said we're 54% of lives, covered with favorable policies at the end of Q3. We're on track with what we had said, which is we want to get to within 6 months, the majority or 90% of patients with favorable payer policies. That's progressing really well. And that's a really important foundation of launch because we need to get those payer policies in place in a favorable way because that sets us up for success over the long term. Our access team has just been doing a fantastic job building on the credibility, the strength of relationships that we built with the MG launch to really bring that forward with the CIDP launch as well. In terms of what we're seeing out with prescriptions, we are seeing that sort of continued momentum of prescribers starting new patients. And you start to see patients coming back to their prescribers at this point, back to their neurologists and the neurologists are getting the positive reinforcement of the patients having a positive experience with VYVGART. So that helps to contribute to the continued momentum in CIDP. So we're seeing great patient outcomes as well as, I would say, strong prescriber support.

Samantha Lynn Semenkow

analyst
#7

When you get those first couple of patients treated back to the physician, are you seeing in your data that those physicians are expanding their utilization within their patient population?

Karen Massey

executive
#8

Yes. I mean what I would say is that we continue to see sort of slow and steady expansion in 2 directions. One is more prescribers, writing or starting patients. And then as you say, we do have also prescribers that are starting multiple patients.

Samantha Lynn Semenkow

analyst
#9

So breadth and depth, but you're seeing both this early in the launch. Yes, that's great. So how should we think then about the shape of the launch curve for CIDP? I know it's a little bit hard to tease out for MG because you report them together. But is CIDP itself, is it linear? Is it more S shaped, where as they get more experience, you'll start to see more of an uptick in utilization? What do you think?

Karen Massey

executive
#10

I would think of it more as more of a linear curve, definitely. Look, we're really pleased with the 300 patients we got -- we had started in Q3. it's fair to say that there were some patients that were sort of, let's say, eagerly awaiting VYVGART. And so those patients getting started, those having a positive experience has been a good signal. And I would expect that, that -- again, that continued growth, that linear momentum to continue as we progress through the launch.

Samantha Lynn Semenkow

analyst
#11

Got it. And it's still pretty early, but are you able to share anything anecdotally about discontinuation rates? Like are there patients that really -- or how long are physicians giving them on the drug before they're saying, okay, this isn't working for you. Curious on those dynamics and how they're shaping up?

Karen Massey

executive
#12

Yes. I mean, as you say, it's a little bit too early to tell. What we're not seeing any significant sort of trends around discontinuations, anything that would be unexpected. What we're seeing is that doctors are prescribing, as you would expect. This is maintenance therapy. So they're just prescribing it for the long term, they're having patients come back in. Most of -- the majority of the patient feedback has been really positive about the efficacy as well the safety and the convenience. So yes, I think we're right on track with that and nothing surprising. I mean the -- what we would expect in the clinical trials, let's say, about a 70% response rate. So you would expect that in the real world, there are patients that are not going to respond to VYVGART, and we will start to see that, but we haven't heard significant yet.

Samantha Lynn Semenkow

analyst
#13

Got it. Okay. And then you've shared that you have those new physicians to CIDP prescribing that have not prescribed for MG. I'm just curious what type of physician is this where the first time they're experiencing VYVGART is through CIDP? Do they tend to treat less gMG or did they just resistant before? And I guess what is the reason why they now are prescribing for CIDP and seeing the value in MG, why not before?

Karen Massey

executive
#14

Yes. It's a great question. So in -- so I'd say there's 2 categories of these prescribers. 1, which is those -- the prescribers that don't treat MG and really only treat CIDP. And so we're definitely seeing growth in prescribers from that perspective. But there is this other cohort of prescribers, particularly out in the community that have MG patients, but for whatever reason, as you said, have not tried VYVGART yet. And there could be a few different reasons for that. One of them is they might only have a few MG patients, not a lot. And so when we built our target list who we were going to focus on when we did the MG launch, they might not have made -- we might not have been out already calling on those prescribers in the community. With the CIDP launch, which is treated more in the community or with CIDP treated more in the community, we went back and looked at the overlap and we redid our prescriber list, and there was a significant increase in the number of prescribers, and that's why we expanded the field teams as well. So now when we can go out and call on these prescribers, both for CIDP and MG, this might be -- they're willing to -- they're hearing about VYVGART maybe for the first time in some cases or trying VYVGART for the first time. So I think it really reinforces the strategy that we implemented, which is expanding the field force being able to focus on those community neurologists that we hadn't been able to focus on before that have both CIDP and MG patients.

Samantha Lynn Semenkow

analyst
#15

Yes, definitely a tailwind for the MG launch as well.

Karen Massey

executive
#16

Absolutely.

Samantha Lynn Semenkow

analyst
#17

Just before I turn to MG, though, you mentioned you're tracking towards that 90% covered payer lives. In the policies, you mentioned they're all pretty favorable. Are you seeing a lot of step-through for IVIg? And I think you've talked about this before, but does it really matter?

Karen Massey

executive
#18

Yes. So we are seeing a lot of -- the majority of the policies do require some experience with IVIg. Now it doesn't really matter because most of the patients have been on IVIg, most CIDP patients have had some trial of IVIg, whether that's partly because it's part of the diagnosis or at some point in their -- it's been the only treatment available. The other thing that's positive and why we call these favorable policies is that the policies are not written in such a way that the patients have to be on IVIg for a certain period of time and that there's a demonstrated sort of failure of IVIg on a scale or anything like that, that needs to be documented. What it is, is the neurologist attestation that they've tried IVIg and for whatever reason, efficacy, tolerability, whatever the reason might be, that they're not able to stay on IVIg. And so therefore, they can start VYVGART. So it's not an onerous step through. It really is just some trial and failure with IVIg. And that's why -- I mean, we're seeing that 85% to 95% of the patients that we're getting are coming from IVIg. And that's exactly what we expected. And that's how we define the TAM, the addressable market of 12,000 as most of those 12,000 have been on IVIg and have residual symptoms. Some of them are also just on corticosteroids and have residual symptoms or can't tolerate.

Samantha Lynn Semenkow

analyst
#19

Got it. Before I move on, anything else on CIDP that you want to highlight as we go into the new year?

Karen Massey

executive
#20

No. I mean I think we're just -- we're very pleased with where we're at with the launch. It's exactly where we had thought we would be. And I think we're executing across all those KPIs and looking for a strong close to the year.

Samantha Lynn Semenkow

analyst
#21

Got it. Okay. And so then the -- for MG, that growth has been quite steady as well. Should we really expect it to be the double-digit 20% quarter-over-quarter? There's going to be some fluctuation, but is that the general trend that we should really expect, especially as we go into the PFS approval potentially in April?

Karen Massey

executive
#22

Yes. Look, what I would -- I think we're over 2 years from the MG launch at this point. And so I think we're at the point where we should -- where we can't look at the individual quarter-on-quarter growth rates, but rather look at what's the CAGR, what's the consistent growth rate over time. And I would say that, yes, we should look with that lens that over time, we will continue to have steady momentum and steady growth. And what that growth is being driven by is this expansion into earlier line with earlier line patients, broadening of the prescriber base, and that's being enabled by, for example, us bringing Hytrulo to market, so having the -- launching subcutaneous. And as you rightly mentioned, hopefully, in April, getting an approval for self-administration. That will help us to be able to continue to sustain, I would say, continued momentum or growth. And it gets harder and harder the further you get out from launch. So you need some of these sort of catalysts just to keep that momentum going. And that's how I think about it.

Samantha Lynn Semenkow

analyst
#23

Okay. Yes. I think that's very helpful. And so then you didn't mention this, but you're also expanding the TAM for MG. So first, I guess what I wanted to -- so seronegative and ocular MG, just to say it. But I'd love to hear your thoughts on what the patient journey is specifically for the ocular because I think the seronegative makes sense to me, but ocular is a lot earlier. So when do they come in and become a potential candidate for VYVGART? And how would -- is it a different prescribing physician? Like do you need to go to ophthalmologists? Like just any kind of thoughts around what that looks like?

Karen Massey

executive
#24

Yes. So about 85% of MG patients first present with ocular symptoms and the majority of those progress to generalized MG. So it's an important part of our strategy to move earlier line for our earlier line treatment. Certainly being the first and only to have that ocular MG sort of indication helps us with that strategy. What the patients look like when they come in, they may present to someone and their general practitioner, their ophthalmologist, whatever it is with the ocular symptoms. But quite rapidly, they are referred to a neurologist. So generally, the neurologist is the treating physician. And what gives us confidence in the fact that once they get to the neurologist that the neurologists, the neurologist will be comfortable with VYVGART is that when you look at the VYVGART studies from MG and you look at the domains within the MG-ADL, VYVGART performed quite well on the ocular domains. So we have reason to believe that treating early and treating being -- when they have ocular MG, VYVGART should have a positive impact and potentially even delay generalization of the disease.

Samantha Lynn Semenkow

analyst
#25

Right. And so you're just capturing them earlier and earlier. Would these patients not even have seen steroids then in some cases?

Karen Massey

executive
#26

In some cases, generally, they -- generally, ocular MG is treated with mestinon or steroids. And then -- and the sort of steroid dose continues to increase as their symptoms get worse. So again, it's more around treating them earlier with VYVGART.

Samantha Lynn Semenkow

analyst
#27

That makes sense. Okay. And should we expect both the data from the Phase IIIs for seronegative and ocular? Is it likely we'll see both of those top line in '25?

Karen Massey

executive
#28

So we will, at JPMorgan, provide an update on all of the sort of 12- to 18-month outlook of dates for all of the phase. All of those.

Samantha Lynn Semenkow

analyst
#29

Stay tuned. Okay. So yes, so then we touched a little bit on the PFS already, but looking forward for both MG and CIDP, we're going to have maybe that 1 to 2 quarters of payer policies getting in place. That is the same for PFS as well, similar to, say, Hytrulo.

Karen Massey

executive
#30

Yes, it's similar that it takes 1 to 2 quarters. It's a little bit of a different dynamic. So you'll recall with Hytrulo, when we launched, it was HCP administration. So we needed to wait for a J-code, which takes about 2 quarters. And so we got that on January 1. Then with CIDP, we need -- it's a new indication still under Medicare Part B, still under Hytrulo, but we needed the payers to get policies in place for that indication, and that takes 1 to 2 quarters as well. In the case of prefilled syringe, it's -- we're actually -- if we get self-administration, it will actually be Part D, so a different part of the benefit. So we will have to negotiate new payer policies, which again takes 1 to 2 quarters. And often with Part D or medicines in the commercial space, at least when they're through specialty pharmacies, there's these new-to-market blocks that the payers put on these -- so that for the first 6 months, you can't write the prescription until you get the payer policy in place. So it will take us 1 to 2 quarters to get those payer policies in place.

Samantha Lynn Semenkow

analyst
#31

So you can't break like -- or is there like an exception route that physicians could go down?

Karen Massey

executive
#32

So there's an exception route for Medicare patients, but for commercial, they put these new-to-market blocks in and it's very hard to get around them. Now you can have the new-to-market blocks removed by getting the payer policy in place, but...

Samantha Lynn Semenkow

analyst
#33

So that's the strategy. The faster you can get them in, the faster you can get that prescription.

Karen Massey

executive
#34

That's exactly right.

Samantha Lynn Semenkow

analyst
#35

Okay. And then being on Part B and -- sorry, Part D and Part D redesign, how should we think about reimbursement and gross to net and how that will affect VYVGART pricing?

Karen Massey

executive
#36

Yes. Yes, it's something that we spend a significant amount of time on thinking about all of these dynamics because what we -- the strategy that we've pursued is making sure that we have optionality and that we're able to take advantage of all of the different components and ways to get the medicines to patients. So we have the IV, VYVGART IV that will always be Part B. And so the pricing dynamics won't change for that. For Hytrulo, we'll have Part B, which is the current Butterfly execution. And then if we get approval for self-administration, we'll have Part D, which, as you say, has very different implications in terms of the rebating and the catastrophic coverage and that type of thing. We have the opportunity to reprice when we -- with the prefilled syringe. So the work that we're doing and that we're not ready to share yet, but we will be closer to getting the approval is how do we want to price so that we can maintain the value and retain value for the overall VYVGART franchise so that the gross to net is not significantly impacted, but at the same time, ensure access for patients because -- so that we can start to expand the patient population. And so it's very much a balancing act, I would say, but we'll have more to share on that when we get closer to the approval.

Samantha Lynn Semenkow

analyst
#37

Got it. Okay. That makes sense. And then so just wrapping up the commercial piece of the business. With all of the positive tailwinds that we have going for both CIDP and MG, I think maybe like -- I think you mentioned there might be a headwind or 2, but they're minor. But the takeaway, and correct me, if I'm wrong, is that linear growth is really the expectation for VYVGART definitely through '25.

Karen Massey

executive
#38

I think the -- I don't know if I would say the headwinds are minor. I would say we do have some headwinds and in particular, on the competitive front in both MG and CIDP. But yes, I do think we are well positioned for both MG and CIDP, and we'll continue to execute. And the goal is that we continue to deliver that steady momentum and growth.

Samantha Lynn Semenkow

analyst
#39

Got it. Okay. Great. So then maybe we can switch to the pipeline. Perhaps let's start with myositis since that was the most recent positive announcement. You're advancing all 3 subtypes, which is great. When should we think about when that Phase III is reading out? I know maybe this is in the JPMorgan release as well, but is that a '25, '26? Like how long does it take to run that kind of study?

Karen Massey

executive
#40

It is a JPMorgan update. So I won't be -- I won't hypothesize on the date right here. But what I will say is that I'm pleased, I'd say we're pleased with how we're executing the study and how it enrolls. So we talked a little bit about the fact that it's a Phase II into a phase -- direct seamless Phase III. So we had 90 patients in the -- that we were recruiting for Phase II. As soon as the 90th patient was recruited, we stopped that cohort and the 91st went straight into Phase III. And so we've been enrolling for the Phase III study for a period of time ongoing. And look, what's clear in myositis, we have the 3 subgroups, IMNM, ASUS and DM. And it's very clear particularly in IMNM, but across the board that there is a high unmet need in these patients, limited treatment options. And if we look at how fast the study was enrolling, I think you can see the unmet need there.

Samantha Lynn Semenkow

analyst
#41

Got it. And do you think this positive proof-of-concept Phase II release that you put out -- have you seen that reflected in the clinical enrollment thus far? Are you seeing an increase?

Karen Massey

executive
#42

I haven't seen the latest numbers specifically tied to that. But what I will say is that I've had a chance to connect with rheumatologists and I was at ACR. And I would say rheumatologists are excited about the data in general and recognize the unmet need.

Samantha Lynn Semenkow

analyst
#43

Yes, absolutely. So what does that market opportunity actually look like? Because when you add it up across all 3 subtypes, it seems quite collectively large and attractive. So how does that look like from a commercial aspect if you can look into the future and DM has IVIg, but the other 2 indications don't have anything. So what does that look like in terms of things that are, I guess, challenges to go into that? And what's also maybe a little bit easier given your first to market for the most part?

Karen Massey

executive
#44

Yes. So I think I'm really excited from a commercial perspective, mostly because, as you said, the unmet need is huge for these patients. So the unmet need is highest with IMNM. There's nothing available for these patients, and there's about 7,000 patients in that -- from a prevalence perspective. ACES is about 11,000 patients and really limited options as well. And so it's all off-label. And then DM is a little bit of a different story. That's the larger prevalent population, 70,000 patients, but their IVIg is approved for DM. And it's a lot more heterogeneous, I would say, patient population. In fact, we're also studying Empasiprubart, our complement blocker in that patient population because it is quite heterogeneous. So the work that we need to do now and that we will do from a commercial perspective is really deeply understand each of those different patient populations, the patient journey, the prescriber perspectives so that we can get to a real accurate addressable market by the time we get to launch based on the data and based on the market insights. And I would think about it in a similar way as when you think of MG, which was 70,000 patient population and then at launch around 17,000 TAM based on where is the unmet need and what's the value that we're bringing. But over time, we've seen that in MG, that addressable market has certainly expanded. I won't be surprised if we see something similar with myositis. So we have to do the work up, but I think there is a lot of opportunity to transform patients' lives in this space, assuming the data reads out positive.

Samantha Lynn Semenkow

analyst
#45

And do you think that the DM opportunity, given IVIg is on label is kind of analogous to CIDP in a way? Will it be the patients that fail that and that aren't tolerating it well?

Karen Massey

executive
#46

It could be. It could be. I mean we have to unpack that a little bit more, but you can imagine that it's similar. Also similar in terms of the heterogeneity as well.

Samantha Lynn Semenkow

analyst
#47

Got it. Okay. Yes. So that's a lot to look forward to. And if I'm thinking about competition, obviously, you said you're doing empa as well in there. So -- and there's some other -- I think there's at least one other DM drug, brepocitinib, I believe. And then, of course, they have the CAR-T and you have the bispecifics. Where do you think FcRn sort of falls in the treatment paradigm, if you could, I don't know, look into the future because we don't quite know yet, but where -- if you could speculate?

Karen Massey

executive
#48

I think without speculating, as you say, because it's -- we like to be data-driven, and it's hard to speculate. But I will say, in general, what we see where FcRn as a mechanism brings the most value for patients is earlier on in the disease before the damage starts accumulating from whatever the autoantibodies damage is causing. So you could hypothesize that it will be similar within DM. But let's let the data speak and see what that's sort of.

Samantha Lynn Semenkow

analyst
#49

I'll look forward to it. So you're also initiating a Phase III trial for Sjogren's and for empa as well in MMN. I guess, can you just frame both those opportunities, too? Because I think MMN might be on the smaller side, but Sjogren's is definitely a much larger opportunity. So any color you want to add there?

Karen Massey

executive
#50

Yes, certainly. Sjogren's -- when you combine Sjogren's and myositis, it's exciting because it's really our expansion into rheumatology with VYVGART. So combined, they're really exciting. And certainly, Sjogren's, I mean, it's another disease that -- or indication that currently has no approved treatments. Now it's competitive. There's a lot that's under development, but we're really pleased with what we saw in our Phase II data, combined with the competitor data that really demonstrated the sort of the proof of concept for FcRn. See Sjogren's, I mean there's 300,000 patients with Sjogren's. And when you look at the data, I think we've broken down about 100,000 that are in the more severe systemic types of Sjogren's patient population. So large patient population, huge unmet need. And as I said, I was recently at ACR in Washington, D.C. And when you speak to rheumatologists, they're really excited about the fact that there's multiple MOAs potentially coming for this patient. So that's an exciting place, certainly for VYVGART. MMN is also really exciting for, I would say, for a different reason. And for me, that reason is that it could be the first indication for our second molecule for Empasiprubart. And we're starting the -- moving into Phase III. We know the Phase II data was really strong, moving rapidly into Phase III, and we could be launching that before the end of the decade. That's part of our Vision 2030 goal. So MMN, it is a smaller patient population, maybe around 10,000 patients and treated by neurologists and it's basically muscle weakness is so different to CIDP where you might have the numbness, -- this is about muscle -- progressive muscle weakness, and it generally starts in your arms and hands and progresses over time. These patients -- I mean, it's a devastating diagnosis. They often are misdiagnosed as ALS. The symptoms overlap with early ALS. So you can imagine they get that diagnosis, which is devastating and then sort of go through further testing and find the relief of being diagnosed with MMN and then find out that there's not really anything available other than IVIg, which isn't particularly helping them with their symptoms over the long term. So I think there's a huge unmet need. And I think what we'll find in MMN is similar to some of these other rare diseases that we've seen, which is once you have a treatment available, a targeted treatment available, I think we'll start to see that market grow and the diagnosis rates increase as well.

Samantha Lynn Semenkow

analyst
#51

Yes. We see that a lot in many of these rare diseases, many that you're involved in as well. So maybe we could just take a moment then to just talk about empa development of empa, your second molecule and how -- you have a couple of indications already in Phase IIs as well MMN moving to Phase III. I'm sure you probably have other ideas as well. Does it look just like VYVGART in the early days? And how do you think about the total market opportunity in comparison to VYVGART? Does it reach the same amount? Is it a little bit smaller given the mechanism is a little bit narrower? I don't know, anything to help us think about that?

Karen Massey

executive
#52

Yes. I think holding anything to the bar of VYVGART is a high bar. So -- but I think -- but I'm really excited about Empasiprubart as a molecule. And certainly, the fact that it's exciting for us to be able to -- well, again, fingers crossed, but we're certainly planning for success to bring a second molecule to market as a biotech. That's really exciting. And the molecule itself is very exciting. I think it's a great example of our innovation playbook and how we like to develop molecules. And similar to how we developed VYVGART for Empasiprubart, partnering with an academic center, in this case, at Utrecht University to really identify the best target and a meaningful target and unpack the biology of that target. In this case, it's C2. And really, we believe that C2 is the best place to, I guess, intervene in the complement cascade. Certainly, it leaves the alternative pathway to be able to fight infection. And it's -- so -- but we have the classic and lectin pathway addressed. And what's exciting with Empasiprubart with the antibody engineering that we brought to the table after understanding the C2 target is the mechanism of action as a sweeping antibody. So it's really cool science being able to sort of go mop up the C2 that's circulating and then for the molecule to be able to go back into circulation and continue to mop up that C2, which really extends the half-life significantly. So another example, again, similar to VYVGART with the fragment, Empasiprubart with the sweeping mechanism of just the world-class antibody engineering that argenx is built on. And then, of course, it's a pipeline in a product, which is what we like. It's part of the reason we choose these targets is being able to identify these products that -- where we can have multiple opportunities to transform patients' lives. So as you said, we have already a robust list of indications that we're exploring. So first up, MMN, which we already talked about. We also have DGF delayed graft function, which we're hoping will read out in the coming 12 to 18 months, we believe, which could open up some important on the transplant front in the transplant setting. We have CIDP, which we talked about and also DM. And as you said, more ideas to come as well. So it's a really exciting molecule and certainly for argenx, exciting to bring -- hopefully bring our second molecule to market.

Samantha Lynn Semenkow

analyst
#53

Yes. I think this is a good time to ask about capacity because we have VYVGART with, I think, what, 10 Phase IIIs or something going on next year. You have at least one for empa with a bunch of Phase IIs. You have 119, we haven't discussed about, a couple of Phase IIs and then 4 INDs or CTAs going into being filed next year. So at what point -- is there a maximum that you can handle at one time? Or how do you consider the growth of the organization to be able to handle that volume of clinical studies?

Karen Massey

executive
#54

Yes. Well, our Chief Medical Officer would be happy that you're asking this question because it's something that he's passionate about and talks a lot about. I think maybe just to take a step back when we think about one of the pillars of Vision 2030 for argenx is this idea of disciplined scaling and being really thoughtful about how we scale. And it goes to what I was talking about at the beginning of our conversation around this real focus on execution and being able to prioritize and not overcommit. And I think that's -- and that's what we're committed to. This year, in 2024, for the first time last quarter, we had a breakeven point. And I think if you look to the future, we can start to think about argenx as a financially sustainable independently financial -- financially sustainable company. And what that enables us to do is be able to take that revenue and reinvest it into innovation. And what reinvesting in innovation means is really scaling our organization so that we can invest in 10 Phase IIIs and 4 INDs and do it in a disciplined way. But certainly, we have the flexibility with our financials to be able to make those investments and allocate the capital to bring as much innovation to patients as quickly as possible.

Samantha Lynn Semenkow

analyst
#55

Yes. No, it's a huge undertaking.

Karen Massey

executive
#56

It is a huge undertaking. It's really exciting. We spend a lot of time as a senior management team talking particularly about how do we make sure we're scaling the organization in a way that retains the unique argenx culture and that culture being a real focus on innovation and execution, and that's something that we're committed to.

Samantha Lynn Semenkow

analyst
#57

Yes, absolutely. So in the couple of minutes we have left, I do want to touch on ARGX-213, your next-gen FcRn. I guess that's coming into the clinic or an IND at least next year. What's the strategy around that? I know it's a half-life extension. Are you considering both IV and subcu formulations? What are you disclosing at this moment about how you're thinking about using that molecule?

Karen Massey

executive
#58

Yes. So it is moving into IND next year, as you mentioned. And at R&D Day, hopefully, everyone has seen the really exciting overview of how we developed. And again, antibody engineering on display. I mean, it's incredible when you hear Karen Slance review how the team worked on that. So the way that I think about it is, look, -- what we're seeing with the development of VYVGART and the other FcRns is there is -- there are so many potential applications of FcRn mechanism of action. The list is almost too long to take on with one molecule with VYVGART, certainly, partly because of IRA and LOE and development time lines, but also because of the different sizes of the patient population. You have rare disease, you have large sort of larger patient populations. You have different specialties as well. So we're exploring how do we make sure that we can maximize having the optionality of a second FcRn to really explore all of the different avenues that you can consider and think about. We haven't been public beyond that other than we're excited to be able to continue to lead the space. We see ourselves as the leaders in FcRn, and this means that we continue to be ahead of the curve.

Samantha Lynn Semenkow

analyst
#59

Yes. I look forward to seeing that into the clinic and hearing more about that strategy. So I think I'll just turn it back to you, Karen, for any closing remarks that you might have.

Karen Massey

executive
#60

Yes. Thank you. Thanks for the opportunity to be here. And I would just say closing remarks being how excited we are to be able to be working towards Vision 2030 with argenx. I mean we shared it at R&D Day by the end of the decade, trying to get to 5 molecules in late-stage development, 10 approved indications, which includes the approved indications for VYVGART for Empasiprubart and potentially even ARGX-119, which we didn't speak about and getting our medicines into the hands of 50,000 patients and transforming their lives, transforming the lives of those patients and their families. And so it's just a really exciting time for our company, a really exciting time to be part of it. And we look forward to being able to share more details for 2025 at JPMorgan.

Samantha Lynn Semenkow

analyst
#61

Absolutely. We'll look forward to that, too. Thank you so much for the time. Really appreciate you having here.

Karen Massey

executive
#62

Thank you.

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