argenx SE (ARGX) Earnings Call Transcript & Summary

All right. Hi, everyone.

[ Good morning, everybody ].

All right. Hello, everyone. I think we're going to get started. Welcome to the last session of the day before we have drinks on the terrace on the 6th floor. Thank you for being here. It's my pleasure to have Karl Gubitz, CFO of argenx and Beth actually...

DelGiacco.

DelGiacco.

[indiscernible]

[indiscernible]. Thank you for being here with us today. Yes. So maybe, Karl, you want to just kick it off for us. I know, most people are probably familiar with the company, but maybe you could just give us some short introductory remarks.

Thank you, and thank you for allowing us to be here. We had a really good day. So it's good to meet everybody. I won't say a lot, I will just like you're back to the beginning of the year when we laid out what we will deliver for our shareholders this year. And I just want to emphasize that we have done what we said we would do. And as a reminder, we talked about getting approval and launching subcu second formulation in the U.S., and we have done, but we talked about the CIDP, which is the second indication for us, getting approval. We -- [ that data ] came in July. I'm sure people noticed, and we are very happy with the data we believe we hit the bull case in that scenario. We also talked about 117, our second asset. We went through the go/no-go decision in, I think it was the end of July. Again, we delivered for our shareholders. In terms of geographical expansion, we talked about approval in China, we got that. We've already shipped inventory into China. Commercial sales will start soon. We talked about getting European markets pricing and reimbursement agreed in the European markets. We are -- we now have agreement on a German price, but price will be public in, I think, a week or 2. We will have pricing and reimbursement in Italy. We don't have patients yet in Italy, but we have it now after the summer holiday, we're going to start selling in Italy. So you see that we also -- and the Canadian approval is still up -- is still on schedule to hopefully be approved by the end of this year. So in terms of geographical expansion, again, we delivered what we said we would do. We are on track to do that. And in terms of the commercial execution, you would have seen the Q2 revenue numbers $269 million. Again, consistent gradual growth, continue to deliver for our shareholders. So very proud of the company. I'm very proud that we can say that we made certain promises, we were able to keep that. And looking forward, again, we can talk about what commitments we are making, and we have all the intent to again deliver for you. I'll stop now and then we can do Q&A.

Excellent. So maybe let's start with Pemphigus, which is another trial that you've guided and committed to. So we'll have that data next quarter from the Phase III ADDRESS trial. Just wondering, could you just provide an overview of Pemphigus Vulgaris and Pemphigus Foliaceus, and maybe just walk us through at a high level of the Phase III trial design?

Yes. So Pemphigus is our first indication in skin autoimmune blistering diseases. It's a very well-characterized autoimmune disease. It's driven by auto antibodies against DSG-1 and DSG-3, which are skin adhesion proteins. So patients experience lesions that emerge on their skin and in their mucosal layers. They suffer from -- it can actually be life-threatening because of the risk of infection from the loss of connectivity in the skin cells, and they suffer from a lot of pain. Patients are mostly treated with high-dose corticosteroids and then also rituximab is approved in Pemphigus.

Okay. And can you just talk about the opportunity in this disease? Like what will the opportunity look like for a drug like Efgartigimod?

If we look at the U.S. and we look at claims data, so which is the data patients currently being treated for Pemphigus the U.S., it's 19,000 patients. So if we can be successful in the study and deliver again on that Efgartigimod signature, fast speed of onset, safety profile, which is well established, we believe that we can get a sizable share of that 19,000 patients in the U.S., and that, again, is the [ claims ] data. The total amount of patients, of course, is bigger. We are doing market research. And what we've seen over and over again, once new innovation enters into a market, the size of a pie -- the size of the market tends to grow. So really excited about the skin blistering diseases. And of course, just after Pemphigus, we have Bullous Pemphigoid, which is very similar, of course, much bigger patient population, where we talk between 50,000 and 60,000 patients. We're going to get the go/no-go, of course, beginning of next year in that and then hopefully, approval after that. The point is we're going to build a skin blistering franchise, Pemphigus will be first. And I think that's something which is underappreciated by the market at the moment.

Got it. And maybe we can just dig into that deeper by looking at the trial, how it's designed, what the primary endpoint is, what would be win on that primary endpoint? And I know that you're enrolling a mix of Pemphigus Vulgaris and Pemphigus Foliaceus patients. Just any details you could provide on what that mix looks like?

Yes. So the primary endpoint is based on the Pemphigus Vulgaris patients. So while we do include both the Pemphigus Foliaceus patients are capped, but we haven't been specific on what that breakdown is. These patients are newly diagnosed and also relapsing. They're moderate to severe patients with Pemphigus. So they have a PDAI score of 15 or more. And all patients are dosed -- it's randomized 1:1, and they're dosed weekly on top of a low dose of corticosteroids, so 0.5 mg per kg per day. And from the weekly dosing, our goal is to put patients into complete remission, a sustained complete remission of 8 consecutive weeks and to do this on a minimal dose of steroids. So being able to taper patients down to a steroid dose of less than 10 mgs per day. Those are kind of the 3 components of success of the primary endpoint of getting to complete remission in a sustained -- showing durability and then also reaching that the minimal dose of steroids. From a success perspective, it's -- we want to hit the primary endpoint. It's a difficult primary endpoint. It's one that we aligned on with the regulators. So it's really going to be about that delta between treated and placebo. We're hopeful that this will bring the placebo to close to 0 because it is a high bar to meet.

And what's the actual definition of complete response? I understand the steroid tapering component, but what's the complete response definition?

So complete remission means no lesions. So it's a PDAI score of 0.

Okay. Got it. And if you have a score of 0, would you even need minimal steroids in some patients? Or is the expectation that you would also need that minimal steroid dose carried forward?

Well, I mean, for the purpose of this trial, we're -- we'd be really happy for the patients to get to that minimal dose, and that's where we'll -- to be a responder, you just have to be on less than 10 mgs per day.

Got it. Have you talked at all about the criteria for tapering, like what do you need to meet to have that tapering algorithm triggered?

So it's -- from the Phase II, actually, we showed that kind of physicians could taper, as they felt comfortable. In Phase III, we have a very set protocol for tapering, and it starts once patients achieve either a complete remission or they achieve a sustained end of consolidation. So basically, you dose weekly until they hit that complete remission or sustained end of consolidation. And then at that point, you can start to taper steroids down, and there is a set protocol for it, but we're not specific on what that looks like.

Got it. And have you also disclosed the powering for the study?

No, we have not.

Okay. Understood. Okay. So then when you were designing the trial, obviously, you have your Phase II proof-of-concept data to lean on, but there's also some data in the literature. I'm curious on your thoughts about the placebo response and how that worked into your trial design?

Well in terms of the placebo response, I think that we've managed that pretty well just given that high bar that we've set with the primary endpoint. So like I said, we do expect that to be close to 0. It's very difficult for a patient on just steroids alone to achieve a sustained CR and be able to taper down on steroids.

Okay. And maybe could you just for the audience recap what you actually showed in the Phase II open label?

Yes. So the Phase II was an adaptive Phase II. We had 4 different cohorts. You'll remember that in the beginning, we actually dosed patients with monotherapy and then throughout the 4 cohorts, we did experiment with different doses of corticosteroids. And we -- what we saw even with monotherapy, as we were able to drive fast -- patients fast into disease control that the majority of patients achieved disease control after just 1 or 2 infusions. And then, we were able to show that on top of a low dose of steroids, we were able to drive patients to remission, and there was initial evidence of tapering. But because it wasn't a set protocol, that was just kind of early signs. Another important thing that we saw in the Phase II was the ability to drive sustained remissions actually. So patients -- we had a few, who are -- showed durable CRs. So we went in and actually looked at what was happening with those patients. We looked at the autoreactive B cells. So the B cells that are producing the auto antibodies, and we saw that they were actually reduced in those patients with durable remissions. So that leads us to believe that actually Efgart could have the potential for disease-modifying benefits.

Got it. Okay. And so I would say this is probably your next big catalyst before the end of the year, I think investors are starting to pay attention to this one. The primary endpoint you stated is designed to read out that placebo response. How should we think about what the actual responder rate on drug would be?

We're not going to give what the bar looks like there. So I think it's really just saying that we would focus on really what that delta looks like between treated and placebo. But we're not going to put a bar out there yet.

Okay. Understood. So what should investors be looking for then when you report the data other than that delta? Are there any other secondary endpoints that are important?

Yes. The secondary show the overall population, so that includes PF and PV. So we want to see the responder rate there. We're also going to look at the cumulative steroid dose throughout the trial between treated and placebo and then speed of onset, so time to disease control and time to complete remission. Got it.

Okay. And Karl, you mentioned this, I think, in the beginning, this would be your first skin blistering, dermatology indication, you're going to build a franchise there. How does that -- when you're thinking about building that, how does that differ from what you've built in neurology and how do you think about the similarities and how you [ built ] that on?

So I think, first of all, in terms of where Pemphigus are treated, it's very, very concentrated. The dermatologists will generally refer them to the big academic centers. So you will definitely need less resources to get to those prescribing physicians. Ultimately, what we've built is our over support levels, so that doesn't need to be replicated. In terms of field force, we are debating, whether it should be a specialized field force or whether it should be a VYVGART field force. And there, we're going to look to Japan actually because in Japan, as you know, MG is launched, but you only need 1 ITP study in Japan, while in the U.S. you need 2, so we filed for ITP already in Japan, and we hopefully get approval there next year, and we're going to use one field force, a VYVGART field force for both franchises, if you like, MG and ITP, and we can see how that works, and then we can make decisions later on for the U.S. whether it's going to be a separate field force or integrated field force. But what I do know is that you would need less, perhaps less, we call them territory business managers for the [ gMG ] just because there's less prescribing physicians, it's more concentrated.

And that remains true even if you add on Bullous Pemphigoid?

Yes. We think it's...

Same -- same touch points.

Same touch points, yes.

Got it. Okay. And so you also touched on the unmet need. What proportion based on your market research of Pemphigus patients would you consider not well served by standard of care corticosteroids?

So I think we need to see the data. We need to do more market research. We have some market research, but we kicking off more detailed market research now. But I look at that [ claims ] data of 19,000 and make assumptions on terms of market share of about 19,000. And I think we're fairly bullish on what we can get.

Okay. And these patients, you touched on this as well, but diagnosis, is it fairly straightforward, they present to the dermatologist or is there some uncertainty as to what disease they have?

Yes. So I think the call it, the advantage, which we have is that we don't need to build the market, we need to go and find the patients, but dermatologists would know the patients. They already treat them. We need to go. There will still be a lot of education in terms of a new mode of action, new drug in a therapeutic area, but the patient is identified. That will not be the problem.

Got it. All right. And then, I guess, I'll put you on the spot a little bit on the market opportunity for Pemphigus. How large or would you say it is in relation to what you've seen so far for gMG and your expectations? Or what's the ITP could be, if you could rank them?

I mean, first of all, when I -- I'm the CFO when I look at it, I look at all the different indications, and we look at various scenarios and what I get excited about is not necessarily indication a, b or c, it's the totality of opportunity. As you know, we are currently in 13 -- [ 1-3 ] indications. We're going to add more indications. We're now discussing it, and we will announce that later. If you add the total addressable patient populations of all this indication, even if you allow for attrition because sometimes clinical studies, of course, don't work, you get to a really exciting opportunity. I mean, that is why we talk about Efgart, as a product in a portfolio. That's why we're talking about VYVGART, as a type of asset, which build companies. We've got a unique opportunity here following the CIDP data, where we think we hit the bull case. Our conviction level, of course, just increased, our ambition level just increased. That's why we did the financing [ in a ] way to make sure that we have a capital to fully go for this opportunity. But since you've put me on the spot in terms of -- I still think that gMG is going to be our biggest opportunity. I think the opportunity is even bigger even as what we thought. I think there's a lot of opportunity moving into those earlier treatment lines for MG. CIDP ultimately, the patient population base, call it similar to MG, a little bit smaller, I actually think. But after with the data hitting the bull case, we can take on the IVIg companies, and we can go for first line. In terms of the derm franchise, very excited about that. I mean, I think that those patients are waiting for innovation. If we can deliver a drug [ with ] safety profile, I mean, if we can establish the VYVGART signature, again, fast speed of onset, safe drug and be able to taper off steroids, I think we can again transform that and the derm franchise is also going to be very exciting.

Yes, looking forward to seeing that data in just a few short months. So I want to also ask about the second catalyst you have in the fourth quarter, it's for ITP, you're going to have the ADVANCE subcu trial readout. You already have positive data from the IV ADVANCE trial. So are there any differences between the study other than the formulation that we should be looking for as we compare the data?

No. The study is exactly the same, of course, a different formulation. What we have done is, we've increased the patient's -- patient numbers. As you would remember, for IV, we hit the primary endpoint, but was not by a big margin. So therefore, we wanted to just increase the powering, increasing the number of patients. That's what we've done, and that's why the study was delayed a little bit. But we will get this result now in the fourth quarter.

Got it. Okay. So good data would be hitting and maybe with a wider margin.

I mean, I think it would be the primary endpoint we will be happy.

Got it. Okay. So in the ITP landscape, it's a bit more crowded than say, Pemphigus or CIDP or even gMG. What's the unmet need there? And what could VYVGART address?

So I think that if you -- the way it's treated, I mean, everybody knows the TPOs, I think we have 3 TPOs on the market. We are under TPOs work, [indiscernible]. We are not going to be in front of a TPOs. People look at the Rigel drug, which were less successful. But I don't think we should compare ourselves with the Rigel drug. In terms of TPOs, what typically -- a patient still relapse from a TPO and then they go to the second TPO and the third TPO, where we see ourselves is after that first TPO. By the way, by the time we launch the first TPO will be generic. So the payers will force us into that position in any case. But after the first TPO, different mode of action, again, with our signature, fast speed of onset, safety profile, I mean, which we've illustrated again in the IV study already, we think that we have a really good chance to make this a significant opportunity.

Got it. And I guess, a similar commercial infrastructure question, it would be your first hematology indication. How do you build that on similar?

Yes. So the launch platforms, of course, will be established, things like medical affairs, patient support programs [ or in this ] case managers, all of those platforms are in place, you would need a small marketing team and then -- then it's about the field force. And as I said earlier, in Japan, we're going to use one field force, VYVGART field force, both franchises. We'll look at that. We'll learn from that, and we will see whether we can replicate that in the U.S. or whether we need a dedicated field force. But I will say that, as a company, we are very disciplined when we look at the commercial infrastructure, very careful how we built it, KPIs, metrics, profitability, all of those things are, of course, really important. And so, we will pay a lot of attention to that.

You could theoretically be launching 3 new indications around roughly the same time. Taking that on, how do you think about your resource allocation is similar is what you were saying just now?

Yes. I mean, we are starting to plan for that now. We're going to build this launch platform, multiple indications, but for now we're going to assume success, as we start planning for that. Yes, it's a lot. But it's still orphan/rare indications. In terms of -- if you look at MG and MG would probably be the biggest and MG and CIDP can definitely be combined, of course, it's 76 reps currently in the U.S. And with 76 reps, we had a really successful VYVGART launch in the U.S. I hope people agree with it. The derm franchise will be significantly smaller than that if it's a dedicated, if you don't make it the same and for ITP also. So yes, it's a lot of indications, a lot of expertise and knowledge we have [ devote ]. But it is, I think we've proven that we can bring the talent into argenx. And now that we are, I would say, a more established name, the company is derisk to some level. It's actually, we find it easier to get the talent into argenx. I think argenx is a place people want to work. We are known, people actively apply, actively reached out. So I think we are very confident that we can build that -- we can build that, and we can build that on a stand-alone basis, of course. If I go to Europe, Germany's biggest market. Currently, we have 8 reps in Germany. We call them key account managers. But with 8 reps in a country like Germany, you can launch MG, and we think we're launching it very successfully. My point is, we are not talking about massive infrastructure. You can't compare us with the big pharma companies out there.

Got it. That's very helpful. So looking forward to both those readouts in the fourth quarter, but you have many more along the way once you get into 2024. So I want to talk about the post-COVID POTS for a bit. You've guided a Phase II proof-of-concept data in the ALPHA Trial. So just can you remind us what the rationale for VYVGART working in this education was and what clinical or preclinical data support the role for blocking FcRn?

Yes. So this is actually an indication that was brought to us by physicians that they had recognized that immunoadsorption, IVIg was working in their patients and they thought this would also be a good VYVGART indication. Additionally, in this post-COVID environment, there was an uptick in cases, so that more awareness, more opportunity. So it was one that was presented to us. But when you look also into the literature, you do find additional support on that biology rationale. We know what the auto antibodies are and where they are generally. They're usually against the G-protein-coupled receptors in the autonomic nervous system. So that was one set of support. Additionally, there's preclinical models that support the biology. And then third, there's publications on immunoadsorption and Flex, which, of course, specifically target IgGs and serum protein, so that gave us good reason to look at this indication.

So what's the endpoint in this trial? And what would you consider a good proof-of-concept results that would encourage you to move forward?

So this is a true Phase II. I mean, I think that -- that's important to remember that we really don't have -- that we're really going to be looking for a signal. We do have primary endpoints that are established or endpoints that are established in POTS, and it's -- the compass score, the MAP score and those kind of capture different components of the POTS is pretty multifactorial. But really, we just want to see the safety and the signal in this indication that would give us a good reason to move forward into a Phase III trial.

Okay. And is VYVGART intended to be curative here? As in like you dosed for a while and then you're able to go off treatment? Or are we thinking this would be a chronic treatment for long COVID?

That's something that we don't know yet, and that the trial is dosed weekly. So we won't necessarily learn that in the Phase II. But it's something that we are not sure in POTS of whether this should be something, where you would receive a couple of treatment cycles and then go off or if it would be more chronic.

Got it. Okay. What's the current estimate for the number of patients that have COVID POTS. Do we have a feel for how many of them are out there at this point?

I think that we shouldn't really answer that question. If you look on our slide, where we put -- which is public, of course, we say more than [ 0.5 million ] and that is -- it depends, where you look, you could get to [ 1 million ] if you want to -- I'm talking about U.S. numbers here. So I think it is potentially a really big indication, but let's not get ahead of ourselves. It might only be acute and let's see if it works in all segments and everything else. But it's easy to get to really big numbers for us.

Right. Okay. Yes. It seems like there's more work to be done, figuring out again, that need there. So what -- if you had positive data in the ALPHA study, could this be applicable to other forms of POTS, not just for COVID? And how would you think about that?

Yes. I think that's exactly right. That I mean, in the study, we're looking at a specific post-COVID POTS. And so, these -- patients have to confirm that they have a positive PCR test of COVID within a certain time period and that the symptoms emerged after that. But from a biology perspective, there'd be no reason to believe that this wouldn't work in the broader POTS population.

Okay. Good to know. And I mean, we're seeing some COVID cases increase recently. I mean, as you think about COVID becoming endemic and potential long COVID cases being replenished, is that increase your excitement for this opportunity potentially as well?

No. I mean, with rather COVID just go away, I [ don't think that only got ] excites us. So I think it's really because this could be used in the broader population. This is really used as a way to establish a signal of -- that this biology makes sense in POTS, but again, it could be more broad.

What are the requirements inclusion, exclusion for getting and rolling into this trial?

Yes. So like I said, that you actually have to have shown a positive PCR test and that proof that the symptoms of POTS, which the one that we're most interested in is actually that increased heart rate has emerged after the positive test.

Okay. Got it. Okay. So also in the first quarter, you're going to have that go/no-go readout that you mentioned, Karl, for Bullous Pemphigoid. What -- can you give us a high level overview of that disease and what's the level of support for VYVGART working here as well if you build out that dermatology?

Yes. Bullous Pemphigoid, I mean, it's similar in biology to Pemphigus. And actually, this is one of the indications, where the -- a positive readout in Pemphigus does have some readout to Bullous Pemphigoid. So instead of the DSG-1 and DSG-3 auto antibodies against DSG-1 and DSG-3, we have those against BP-180 and BP-230. So very similar biology. It's checking cells and the basement membranes are a little bit lower. Importantly, patients though are more frail. They tend to be an elderly population. So this is a bigger population. It would -- when we were looking at going into autoimmune skin blistering diseases, we are obviously very excited about Bullous Pemphigoid, but we first went into Pemphigus because we wanted to understand the safety of the disease before going into a more elderly population. Once we had those positive data, it was again, the community that came to us and was encouraging us to look at Bullous Pemphigoid given the significant unmet need. These patients only have steroids and given that market opportunity.

Do you think the bar is higher or the same between the 2 Bullous Pemphigoid and Pemphigus?

So the BALLAD study, I can remember what it was called for a minute, the BALLAD study does have a similar endpoint, but it's a little bit different. It's -- the patients actually have to be off steroids. And so I mean, I think it's an equally as high bar. And yes, so...

What's the reason for them being completely off in that endpoint versus minimal steroid, I guess?

It's really about [ precedents ]. That's typically how -- that you work with the FDA and establishing a regulatory, an approvable endpoint and looking at precedent trials.

And do you think it will be easier for these patients to achieve no steroid use than, say, for the Pemphigus population? Or is it the bar slightly raised just because there's no steroids on the endpoint?

No. I mean, I think they're both -- they're both high bars.

Okay. All right. And so assuming a go decision, how does that influence the remainder of the study to increase enrollment to the endpoints and powering shift? What would be the next step if you hit there?

Yes. So this is an operationally seamless trial. So we will not stop enrollment for that go/no-go. We'll look at the first 40 patients. We likely won't communicate on what the data are. We'll look again more it's kind of the framework of how we made that decision, but enrollment just keeps on going. We can make small adjustments to the trial, if necessary, based on what we see, but things like sample size estimations or the ordering of secondary endpoints, not major changes to the trial.

Okay. So should we expect a similar disclosure to how you communicated this ADHERE go/no-go decision, whereas you just said it was positive, you sort of walked us through what you were looking for, say, you've met that requirement. Will it be similar?

Yes. I think that's fair.

Okay. Got it. Also speaking of CIDP, I did want to spend a few minutes on it. Since the top line data was reported, can you just characterize the level of excitement you're seeing from physicians that you've spoken with? And what is your current expectation of how it be used, Karl, I think you said you're going to go for first line?

Yes. So I think what we hear from physicians, I mean consistent with what we heard after the study, the first thing is the study has proven, but it's an IgG-mediated disease. So I think that's surprised a few people, and so that's the first thing, where I would say. The second thing is a lot of discussion on the study. We've set the gold standard now how to do a CIDP study. I think that is -- and that people will have to follow that. And then, the third comment I would make, this is a game changer. The data was really the bull case. I mean, we have planned for it, of course, and we have all the different scenarios, and for us, it was a bull case scenario. It was the best case, which we could imagine. And if I look at -- I mean, sell-side analysts are now all doing not all, but some are doing surveys, phoning docs, and when I read it, it is extremely positive actually. I mean, they talk about [ large ] percentages, which are market share. I also agree that we can be -- VYVGART can be used first line, but it's going to compete with IG. I think we need to -- I -- ultimately, I think in terms of the potential, I think we agree with that, just need to be a little bit cautious in terms of the speed in getting there. I don't see the ramp being similar to MG. IG is on label for CIDP, while in MG, it is not on label. So while it was easier to get the foothold in MG going afterwards more refractory patients, the doctors got experience and now we're hoping to move into the earlier lines. In CIDP, I think it will take a little bit longer. It will be a little bit more competition from the IgG companies will be a little bit more -- will be more competition. But ultimately, I think that yes, we are really bullish and very grateful to our development organization to give us [ hopefully VYVGART ] subject to approval, of course, to the commercial organization, and we are very excited to start promoting it.

Have you had the chance to speak with the FDA on the data yet? And do you have any timing to offer on when we could see you put the sBLA in?

So ultimately, we said that we would be ready to file by December, by the end of this year. We will be going to speak to the FDA. That meeting is in the diary. It's -- we know when we go in. I don't see us making any comments on that meeting, of course. But we will be ready for that meeting, and hopefully, ready to file by the end of this year, and that discussion will happen sooner.

Okay. Great. When can we see -- expect to see the full data for ADHERE, which like is that a 2024 or we see it before?

Yes. So really, our biggest priority there is to find the right meeting because I think that these data deserve a big audience and a big stage to really get the CIDP physicians excited about these data or a broad base of the CIDP physicians. So we're going to prioritize that. But we haven't committed to what that conference is, yes.

Got it. Helpful. So you have a PRV as well in your hands. How are you thinking about utilizing that now that you have a positive registrational study, like we see, you potentially use that for CIDP or one of your upcoming indications?

How do we think about it? I think carefully is the word, sorry, for those of you, who don't know, we use the PRV for the subcu. And then, of course, we've got the extension from the FDA. So for CIDP, I think, yes, we have a PRV. We can potentially use it. But I think we want to go and speak to the FDA and get a read from them and then we'll make decisions later.

Got it. Okay. And I think we've already...

I think there's a question there.

[Technical Difficulty] Thank you [indiscernible] Citi. Thanks, Sam. Can you just talk about further studies you want to do in CIDP. And the reason for the question is, I think, you want to -- you only enroll patients with very high IgG levels that have very active disease. So is that truly representative of that sort of broad very heterogeneous CIDP populations. Just are you going to do more studies in this -- in the setting in a [ Phase IV ] program? Thank you.

So for -- the point you're making on patients with only high IgG levels, that is -- I mean, we enrolled patients, who are newly diagnosed and patients, who were also coming on -- currently on IVIg and steroids. So we really enrolled patients across the treatment paradigm. What you're referencing is that it's a safety consideration. It's actually in all of our trials that patients have to have a baseline level of IgGs because by mechanism of action, we're lowering the IgG. So that is not related at all to the severity or where the patient is positioned in the treatment paradigm, it's just related to the mechanism of action and it's across every study.

Did you have another question today?

Just more study? Any other studies you're willing to do?

No. I mean, at this point, obviously, we're going to have a conversation with the FDA, but this study was the largest CIDP study of its kind. It was designed to be registrational. So our current plan is to file on these data.

Great. Okay. So in our last few minutes, I'll just -- I'll touch on MG. So you've launched subcu, it's been available for a couple of months now. As we come up towards the end of the third quarter, how should we think about expectations for revenue for the subcu product versus IV?

The subcu, as we said, will be slow out of the blocks because you need to get pricing and you [ need to get ] agreements with the payers. We saw the same thing with IV. It took a couple of quarters to get that. I think what we see now is, if you don't have an agreement with a payer and you get prescribed VYVGART, if you want subcu, the doctor will have to go, and advocate jump a lot of hoops and to get the subcu, while the IV is available. You just go to IV [indiscernible] wait. We do have patients, of course, we do sell subcu. My point is that the revenue numbers will be -- we will share it, probably not in the -- I won't put it in the financials, but I'll share it as part of the earnings call and will be available in our website. It will not be large numbers. We are -- we have made progress in the payer agreements. The ones, which have signed is basically copy and paste of IV for those payers. We are making progress, but it's low progress because urgency also from the payers is probably not there because VYVGART is available. But we're still confident that in 2 quarters, 3 quarters, we will get the majority of it signed on, and we're expecting similar conditions.

Okay. Great. And so [ IV ] VYVGART, I mean you continue to beat expectations quarter-over-quarter, and you've spoken about how penetrating earlier lines of therapy is needed to sort of sustain that growth? How -- what are the leading indicators of that? And what should investors be watching, as you work to move to earlier lines?

Yes. I mean, I think the story hasn't changed now. Most of our patients -- around 50% of the patients, last line of treatment is IVIg. We have 50% [ IV ] earlier or later. And every quarter, you see a slight increase in the earlier patient lines. Now of subcu, although, we need to sort out the access. I think that can help to move into those earlier lines because all number of sites of cares are increasing, you can -- any physicians offers you, of course, can get the subcu. We are making progress. But I mean, there's nothing new to say other than that and we will give you an update at the earnings call in a few weeks, a month or 2.

Yes. Looking forward to. I guess, just last question about other geographies, as they're coming online, we just had China, you're making progress in Germany, you mentioned we'll get the price public next week. I know you've guided this in the past, but how should we think about the rest of 2023 and into 2024 for some of these geographies in terms of the general ramp?

Yes. So Canada, as I said, we have to get approval in -- later this year, revenues only really next year, and I think we're going to get -- see revenues in Canada. In terms of Germany, as I said, we have a pricing agreement. It will be public. What I can say today is that the price will be higher than the U.S., both gross and net. The Italy prices agreed. We're not going to be public there on the price. But we're hoping to sign more pricing agreements in the -- with European governments, which will really -- we see that really kicking off in '24 in terms of revenues from Europe.

Great. Okay. And just last question. We talked about a lot of your near-term quarter catalysts over the next 2 quarters, what else can we look forward to over the next 6 months to 12 months from argenx?

I think the way we look at it is in terms of growth, geographical expansion, I think we just talked about that indication expansion, we talked about that. Hopefully, we get by the end of next year CIDP approved, and then, ITP and PV on top of that. In the formulation expansion, yes, we've got the subcu approved in the U.S., Europe and Japan to come next year. And of course, we're working on the prefilled syringe. We're public on that too. So in terms of growth, many, many growth drivers across different fronts. And as I started the meeting, we make commitments, and we really like to keep those commitments, and we'll be working hard for you to try to deliver that.

We do appreciate you keeping them as well. Well, thank you so much for taking the time. It's been a pleasure.

Thank you very much for the time.