Argenx SE (ARGX) September 2026 Conference Transcript

I think we're good to go. Welcome, everyone. I'm Sean Larmond, the head of SMIDCAP Biotech Equity Research here at Morgan Stanley, and welcome to our global healthcare conference. For important disclosures before we begin, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com forward slash research disclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative. With that, we welcome Carl Govitz, CFO from Argenics, and Anne Vanderbosch, Head of Development. Thank you both for joining us today. Thank you. Thank you, Sean. It's great to be here. Maybe just to kick off, we've got some more broader questions thematically. How is the rise of China innovation changing your competitive position, if at all, in your R&D and business development playbook?

What's happening in China, I think, is exciting. It's exciting for patients. It's exciting for the ecosystem. It creates a lot of new avenues to find biology. I think for us at Argenix, it doesn't really change because I think the mode which we have built is around innovative biology. It's a way we find new indications, and we build those indications in our commercial engine. So the way we think about China is it gives us another avenue to explore biology, to find that next molecule. And what we're doing as a company is we're investing in China. We've opened an office for this purpose where we have got a small team to help us hunt for business development opportunities. So no change in strategy. It is just augmenting or adding a geography where we are finding targets for our IIP, our immunology innovation platform. Thanks, Carl.

And moving on to AI, so another hot topic in drug development more broadly, but are you able to give us a sense of how Argenix is thinking about the adoption of AI and impact on your business?

I think all pharma companies, and I think all companies actually, are investing in AI. It's clearly a hot topic, and so is for us, too. Where we are today, I think it's a journey. Most of our AI initiatives are pilots, proof of concepts, and informing our strategy. We've got a clear AI strategy because AI needs to be part of our business. It's not a strategy which stands alone. I think if you want to be a biology innovator, you also need to innovate on the side of data. And our strategy is built around pillars. We've got a strategy for discovery, helping us find molecules. We've got a strategy around research, how we want to use that to help do the clinical studies earlier, finding patients, site selection, so forth. We've got a strategy on tech ops. We've got a strategy on commercial, all about patient interaction. And then very importantly, scaling the Argenix way, which is so close to our heart now we're operating as a company, building AI into our ways of working. So different strategies, but it's a big focus point for us as a company.

And last macro-type question before we delve into the heart of Argenix, but, you know, which policy variable, if any, is it? FDA, Medicare negotiations, MFN, global pricing, what matters most to your economics and what have you changed, if anything, because of it?

I think, I mean, all of those are super important and as a company we continue to focus on it and spend a lot of time on it, maybe just quickly on the FDA. Our interaction with the FDA has been positive. we didn't feel or see any disruption on any of our interactions with them and in terms of MFN, Globe, Guard, all of those I will put it all under pricing if you like pricing of course is not going to go away this administration, next administration it will continue to be an important factor for all drug development, biotechs, pharma and the only way to address this long term is to innovate. Society will only pay for innovation and that is core to our strategy of how we select drugs, what are we trying to do, novel biology, find those white space indications where we can have a disproportionate impact on patients and once you're there, you continue to innovate with adding indications, presentations and that's how you deal with it. On top of that, we do, of course, a lot of scenario play to make sure that we are ready for any change because I think it's a fluid situation.

Sure, thank you. Now to move on to the heart of the issue, which is company-specific. And I want to structure these questions to really get across the growth message. So maybe, and I promise that I'll ask some different questions to breakfast, I'll try to at least anyway, but you saw 17% sequential growth in Q2 on Q1, and just to give investors a flavor, how much of that would you attribute to the seronegative label, and how do you think about that as a contributor going forward?

Our key growth driver, of course, continues to be an MG and CIDP. In MG specifically, the growth is driven by biologic expansion. 80% of MG patients are still not on a biologic. So that is where the growth is. And by the way, if you ask five docs, four of them will tell you you start with VivGuard. So I think expansion and growing the biologic patient share is the key growth driver. PFS is super critical in that because that's a clear differentiator for us. It helps us to get into the community. And seronegative, which we got the label expansion in May, I should say, is an important contributor to that. It gives us the broadest possible label. Nobody else has a label as broad as we do. The triple negative, which is a subsection of a seronegative, around half of it, had no other treatment options. So that is where most of our seronegative patients are coming from. And it's an important growth driver. The growth since launch, 18 quarters, has been exceptional, and to maintain that growth, you need new innovation. The new innovation which we have now is zero negative, so it's an important contributor.

Sure, thank you. On my estimates, at least, I think generally consensus, just north of $6 billion revenue for the year is what's being expected, but then I think about some of the opportunities that lay in front of you. we looked at the myoscius data going on from the R&D date into the actual release of the phase 3 top line. In my view, it probably couldn't have read out better than what it actually did. But if you look at the IM&M indication, you've got 20,000 patients in the US, which is the epidemiology. My estimates are 6,000 to 7,000 patients seeking treatment for what is a severe disease. So in terms of what we should expect as investors from here in terms of the regulatory path, just on focusing on the IM&M side, focusing on the regulatory path from here? And how should investors think about the launch giving some of those dynamics?

And do you want to comment on the regulatory path and comment on the commercial?

Yeah, so as you have seen in our, and as we read out in the call, when we reported the results, we have strong results in IM&M and DM. They're really consistent. We're stat sick in IM&M and borderline in DM. And that puts us forward in a path forward to have the conversation with FDA on DM. And for IM&M, of course, we will use the data to go forward in that conversation. But it will be a matter of review and discussion with the regulator.

And from a commercial point of view, as you said, 20,000 patients in the U.S. It's a prototype Argenix indication, completely white space, no treatment options, severe, the libertating disease. So the opportunity for patients and for us as a company, of course, is clear. How quickly we can ramp that launch, of course, we're looking at different scenarios. But what I will say is that if you look at our history and how we get ready for a launch, how we prepare the market, and ultimately the resources we apply to that, I mean, we're going to play to win, and I think those patients are waiting, and we hope to make significant inroads into that patient population once we launch. A big element, of course, will be the payer work, which we need to do. It will take a while to get all the payers signed up here, but the value proposition of WebCard is well understood, well appreciated. We've done it a few times now with MG and all the label expansions with CIDP, So I think we know how to do it. We have relationships. So I think we are bullish on the long-term opportunity here. In the beginning, of course, we will have to work for all those factors.

And on the DM side, so I think it's double the number of patients, epidemiology is about 40,000. But if you go back to IM&M, you look at the TIS score, clinically meaningful, STAT-SIG. Clinically meaningful on DM, but not STAT-SIG. but then also in comparison to maybe some of the competitive products out there on DM, how should investors frame the opportunity given the data that you've seen on DM?

I think, I mean, of course, Brepo will launch before us. I think they're basically already launched. That's a Jack tick too. It's an oral, of course, but it comes with advantages. But I mean, Jack, of course, also have some safety issues which I'm sure the street will be aware of. But in terms of DM, It's a heterogeneous disease. It's a big patient population. I think it will take more than one or even more than two innovators to develop that space. And I think each drug will find its place. Andy, anything you want to comment on how a drug compares?

Well, what we have seen, repeating the results in the data, we have seen quite consistent results between IMNM and DM in Phase 2 and Phase 3. and we will let the data tell where each patient can play.

And thinking about the catalyst that we've got coming up, so we've got a pretty catalyst-rich next 18 months, but this year you've got the Q3 results, we've got the celiac results, but also just to focus a little bit on M-PASI-Pruvart and MMM, how are you thinking about translation of the Phase 2 results into Phase 3? how should investors think about the bar for success and how should we think about the commercial opportunity?

I'll let Anne talk about answering your question directly, but if I can just quickly add how important MPa and MNN is for us as a company. With Vivgard, of course, we all know it's a generational drug, once-in-a-decade type of drug which builds companies, but that playbook, novel biology, first-in-class, product in the pipeline, continue to innovate with presentations, continue to raise the bar, building the markets. That is the playbook. That is what made Argenix successful. And we believe we can replicate that playbook with our C2, with EMPA. And MMN is, of course, the first indication on deck. And we will get that phase three data later this year.

Yes. And to continue on your questions from the phase 2 learnings versus phase 3. What we have seen in the phase 2 trials is actually when you switch patients from IVIG to placebo, several return back to IVIG. And that is what led us to set up the trial in the way we did, as a head-to-head comparison versus IVIG. If you take the treatment burden into account, how long these patients are in the chair when they take IVIG, and what we know from EMPA, we believe that when we demonstrate that we're non-NCF versus IVIG, this is considered a win and success in the trial.

Sure, sure. Next question is a bit of an algorithm, at least it is for me, that you presented some data back at AAN in treatment-naïve patients, CRDP patients that were treatment-naïve, so hadn't had immunoglobulin. There is a bit of a conception that maybe Vivgard has mandated second-line therapy here in the U.S., but it's not. It's just that the payers require the step-through. But how do you anticipate getting more, moving to frontline over time, given the bolus of patients is so much greater on immunoglobulin than what R&B have got? So a long, a lot of runway to growth. So that part of the question. Second part is when we look to the Empathy Proof-Art data head-to-head against IgE in CIDP, how important that is to the story and how much growth that could unlock.

Now, expanding VivGuard in CIDP beyond refractory patients, I think that will happen over time. Remember when we launched in MG, we talked about 17,000 patients being the refractory patient population. That is where most of our competitors are today. VivGuard has moved beyond into the earlier lines. I think that playbook, of course, is not unique to VivGuard and MG. You see that in rare diseases. You typically start with your more refractory patients because that's where the unmet need is, and then hopefully you expand if you have a drug for it. We believe the same thing is going to play out in CIDP. Today, most of our patients are the refractory patients, IgA refractory patients. Only around 15% of patients are naive patients. As you said, that's not how the study was done. The study included naive patients. We've got the label. It is the payers who are pushing us there at the moment. I think as physicians, as patients get more experience, physicians will be more willing to add patients and also to move up earlier line. To help support that, we need data, and that is some of the data which you've referenced. We will create and publish more data, and over time I think you will see VivGuard also moving up a treatment paradigm in CIDP. Sure, thank you.

And as we talked Q3 a little bit, we talked Emperin, MNN, but what about the Forte acquisition and the data come up in Celiac? How would you frame it to investors and what to expect, what you think the bar for success is and how you think about the commercial opportunity relative to the rest of your business?

Maybe just quickly, and then Anne can comment on the data itself, which we are expecting, Forte, again, fits our playbook. Novel biology, first-in-class, product in a pipeline, and gives us the opportunity to replicate the WebCard playbook. I think when we did the Forte acquisition, it didn't stand on one indication. We don't think of it as we bought an indication. We think we bought a product, which we can put in many indications. And, of course, we were looking forward to the Phase 2 data, and then we'll look at the data and we'll try to get into phase three as quickly as possible because we do understand it's a competitive race. But what we do as a company at Argenix is execution. We think that we can execute really well and we will continue to do that also with FB102. Anything specific on the data?

Yes, so Forte had already done a phase one study in Celiac which read out positive and which created excitement. Of course, we will be reading out the Phase II data set later this year. And this is a learning study, so we will look at the data to learn more about the inflammation histology but also about the symptoms and, based on that, determine what the appropriate next steps are.

Wonderful. Thank you. Just on the competitive dynamics. So, you know, we have some other complement inhibitors sort of coming down the pike. We've got Umabi. We've got Alzheimer's. There's a couple of drugs out there. On the other hand, you've got a very broad label in MG, you've got CIDP, you've established market position. How do you think about the risk of competition, or how do you think about the competitive dynamic moving forward with all those pieces moving?

First of all, competition, of course, is good for patients. Competition helps to build the market, so of course we welcome all competition. In terms of how it impacts us and how we've been able to successfully position VivGuard as the first biologic in MG, of course it means that when competition comes in, it doesn't really impact us. It actually helps to grow the market. We are the market leaders. We get most of the new patients in terms of biologic patients. So that is one of the success stories, one of the reasons VivGuard is so successful in MG. And that is also why we should continue to be able to drive growth. I mean, it's amazing that we sit here today. VivGuard was launched 18 quarters ago. And we say, well, it's still the early stages of the launch because only 20% of patients is on a biologic. We are leading that biologic expansion, or VivGuard is leading that biologic expansion. And based on our efficacy where we talk about MSC, minimum symptom expression, our safety and tolerability where we have 20,000 patient years and on the patient convenience side where PFS for self-injection is clearly leading with an auto-injector to come, we believe that we will continue to see that growth. The competition comes in, we get four out of five patients, the rest of the competition is basically very competitive to get the rest, and of course you also hear competitors say that they get Vivcard refractory patients, but of course it's true. VivGuard does not work for all patients. Around four out of five patients respond to VivGuard. One of them don't. And that is the VivGuard refractory patients, and that is also where some of our competition is getting patients from. But if we look at our data, it's very consistent in terms of hanging on to the patients we believe we should be able to keep, and that is playing out in the real world.

Sure, sure. The top-line growth is often discussed. A lot of debate around that, not so much debate. Everyone recognises that the growth is there, but I think what is maybe underappreciated in your story, and you do have to invest for growth, is you've seen well over 1,000 basis point expansion in operating margin over the last year, and we look at some benchmarking. You're probably looking at operating margin across larger-cap biopharma, somewhere in the 40%, 40% range. So how would you contextualise the balance of investment in the business to sustain the top-line growth versus an expanding margin profile? Thank you, Sean. I love that question.

I think in terms of our capital allocation, how we make decisions, we always lead with the science. The science lead. We are a biotech company working for patients and investing in science. That is how we make decisions. We then want to, we also, in terms of giving guidance and talking about margins and putting ourselves in a box, we're going to be very hesitant to do that because we love the flexibility. If we see science to invest in, we want to invest in that science, like we just did in Forte. And, and it's not a but, it's an and, and we can give you a margin expansion. I think that is a unique position. It speaks to the strength of VivGuard, the VivGuard launch, and the financial structure of a company. We've got a very flexible operating structure. I keep on reminding the street that we're a $60 billion market company. We've got 2,000 colleagues only. We outsource a lot. We're working with partners. We collaborate. That is our DNA. That is how we work. And, of course, that allows us to be a little bit more flexible. but ultimately over time we're going to continue to expand that margin but following the science.

Sure, thank you. And I guess the myocytes data takes you into rheumatology. So again, related question, how do you think about the build-out of any commercial infrastructure associated with that TA entry?

Yeah, of course we've got strong neurocapabilities and if you think about myositis including DM and we've talked about what we need to do to get DM on label, It's not if, it's when. But for myositis, we will need neurocapabilities, which we already have, strong neurocapabilities. We will need room, and we might need a bit of derm, but that's very small. In terms of rheumatology capabilities, we will need to go and build a field force. We will need to put those customer-facing organizations in place. We've done that before. I think we know how to do it, and the platforms already exist, and we can just build on that. But in terms of size, we don't want to talk size now, but, I mean, typical orphan disease. I mean, I think most organizations will talk about reps of around 100. But, I mean, I'm not saying we're going to hire 100, but just in terms of giving you a sense of scale. But we will build that, and most of that resources will come online next year. We might start adding a little bit of resources now. And in Q3, the earnings call, which we will have in October, I will talk a little bit about expenses for this year because we don't guide as a company, but we gave a rough idea of where expenses will be in 2026. But now with a Forte acquisition and with my site is reading out successfully, we need to augment that. And so I'll give you revised guidance at that date.

Sure, sure. So our increased cost at the moment with Forte going vitiligo, celiac and alopecia. So we've got our incremental costs associated with that. Okay, thank you. Thinking about the next wave of FCRN and the pipeline bred, so ARGX213, Phase 3 ready for monthly dosing, does it extend the franchise or cannibalise VivGart?

And how do you sequence the two? at the moment people think of look at Argenix as a VivGuard company we need to change that to being an FCRN company VivGuard has got a very long patent life the matter of composition patent is until 2036 and we are adding patents on top of that by the way but eventually VivGuard will run into its LOE we are starting to think about how you build an FCRN capability and we've got two second-generation FCRNs. One is 2-1-3, which is once a monthly dosing. It's ready. It's ready now. We can start phase three studies. But we have a bit of time because the LOE is so far out, but we will get there. But we first want to see the profile of 1-2-4, our second-generation FCRN. That is currently in phase one and first in human studies. We will get that data soon enough, and then we can determine which compound will be used for lifecycle planning, which compound will be used for possibly broader indications, possibly at a different price point. That should also be augmented with our combo strategy. We have ADAPT Forward where we put VivGuard and our C2 together, and it's currently in an MG study, and, of course, we also have our oral program. All of that is designed to build on your current FCRN leadership and to make sure that we maintain and expand that leadership while and throughout the next decade.

Sure, thank you. Thinking longer term, we wrote quite a large report on your company I think two weeks or so ago, and thinking longer term, like if you're doing this year, just call it say $6.5 billion of revenue, whatever it turns out to be, and we're forecasting, I think, $13 billion, so basically a doubling of revenue by 2030. So therefore, if you held the current price-to-sales multiple, then you're looking at a doubling in market cap over that time. And while you don't have control over the price-to-sales multiple, at least the price component, you do have some control over the sales component. So if I think about not extra indications beyond what you have today in the broad CIMG label, throw in CIDP, that $6.5 billion revenue and compound it whatever you want to do at 5% to 10%, you're probably landing somewhere around $8.5, $9 billion, something like that. So to get to the $13, you've got another $3 to $4 billion of revenue to add, which may come from your entry into rheumatology. You can get there by mapping it out on 20,000 IM&M patients at $400,000 a pop is $8 billion, and then throw in whatever contribution from DM. So am I thinking about it the right way? What's your confidence in those? Well, I'm not asking you necessarily to give long-term guidance, but it's just your confidence in those kinds of aspirations.

So, Sean, first of all, thank you for that report. I've read it and read it again in detail and circulated with my team and we're studying it, see what we can learn. So it's a good read, everybody. Please go there. In terms of 2030, 2030, I think our strategy is very clear. We want to reach 50,000 patients. We want to have 10 on-label indications, and we want to have five late-stage programs. That is our vision for 2030. We believe we're going to execute on that, and we are working hard to achieve that. And I think if we can do that, that will, of course, translate into the market cap implications, and I'm sure we'll be rewarded for that. But in terms of that focus on patients, focus on Vision 2030, and doing it by our GenX way, by being very disciplined in terms of how we invest money, but still let the science lead, we believe that is how you build biotech for the future, and we're going to continue to execute on that strategy.

Wonderful. If I could go all the way back. Thank you, Carl, and thanks for the compliments. But if I could go all the way back to the Empathy-Provart study in CIDP, so maybe just sort of frame the treatment burden for patients on immunoglobulin that have CIDP versus what would happen if Empathy-Provart did improve on superiority. Then if you did prove superiority on IVIG, how do you think that melds into the conversation with payers around the different price points?

In CIDP or MMM?

Sorry, moving forward to next year, the CIDP study.

So moving forward to next year's CIDP study, as we know from IVIG, the burden is long in the chair. There is a safety label. And that is something where, of course, we don't have phase two data in CIDP, but we have phase two data in MMM. and we don't expect it in the same way. So that is an element to take into account for that study. And we will have to see how the data turn out at that moment in time. But here, too, we believe that setting up the experiment in a direct head-to-head comparison versus IVIG was the right way to do and we'll learn once we have seen the data. And, Carl, maybe you want to comment further.

Yeah, I think on the commercial opportunity, The VivCard, of course, is growing, is doing really well in CIDP, but we are not able to help all patients. From the ad-eared data, 70% of patients responded with VivCard in CIDP, so 30% did not. In the real world, by the way, we are not... I think our response rate is slightly better than that. Probably over time we might get to the 30%. We don't know. We'll see. But there is a segment of patients which are not being helped, and maybe IgM plays a role there. I think we need to do the experiment and let the science speak. But if a date of cards falls our way, having two drugs next to each other, we can talk about co-positioning at that date, but that will give us a very strong commercial footprint or foundation, I should say, to have continued success in CITP. Sure.

And moving forward, another catalyst we're keenly anticipating that next year is in Sjogren's. So again, a standard question, how do you frame the competitive framework and the competitive benchmarks? How do you think about what the bar for success is and how do you think about the commercial opportunity?

Sjogren's, of course, large indication. I see a lot of data points out there. Our data points suggest around over 300,000 patients in the U.S. And, of course, there are other drugs. Competition is coming in. Some of them are even launching before us. But in terms of FCRN and specifically around VivGuard, we believe that the VivGuard signature can be very successful in Sjogren's. Think of rapid response, deep and sustained. I think that, and with our safety and tolerability, where we already have over 20,000 patient years of safety data can give us a really strong position to compete in such a large, heterogeneous disease where multiple players will have to work together to build that market. I think longer term, if a data card falls our way, super excited about what we can do for patients here.

We've talked Forte, we've talked in Passive Prova, but we've talked further expansions for VivGuard. But what in the pipeline that maybe you don't get asked a lot about excites you the most?

I don't know. Anne, do you want to talk about the pipeline? Maybe you want to talk about IGE?

That's one option. I was going to actually respond. What you called out is already quite exciting, right, especially the forte acquisition in that regard and how we then expand our portfolio and pipeline. Of course, the data will have to tell and guide us in that regard. But when you look further down the pipeline, there is, of course, pioneering novel biology with Adi Manibar, although that's in phase three, but further down the pipeline, I would say the IGA 121. I believe also if you show how rapid and how deep we can inhibit the IGA, I believe that's also an exciting molecule to us.

And short, if you can add, what makes me excited is not necessarily one specific program. It is the opportunity we have at Argenix. We have the short-term growth drivers. We believe we do have the medium-term growth drivers. Think of Srogan's, think of FB102, all the other programs in your program. And then with our financial structure, the strength of our balance sheet, our focus on execution and the way we make capital allocation decisions, let the science lead. Let's focus on novel biology. Let's find those white spaces. Let's develop them. I think we're building a type of biotech here which will be durable and provide long-term revenue growth. I think the opportunity set we have here is what I'm very excited about.

I think I had you at about $6 billion on cash on a balance sheet, down to maybe $4-ish post-forte. But then thinking about what we... Correct the numbers, but thinking about what we've just discussed on the pipeline, do you think BD is more organic or inorganic?

So we had $5.2 billion at the end of the previous quarter when we used around $2 billion, and $2.2 billion on Forte, but still a very strong balance sheet. I've talked about how we make decisions in terms of what we spend the capital on, capital allocation for what. Of course, FCRN is a very important pillar, and we talked about next-gen combos, peptide, all of that. Next to it is the rest of our pipeline. We've talked about Empire and how important that is, but there's also a number of other programs in there which we're very excited about, like the IGE and all the other programs. And then the third pillar of growth is business development. We've done Forte. You can expect us to do more. You can expect us to look more at earlier stage because the way I describe it is what problem are we trying to solve? We do have a growth driver in the medium and the long term. But if you look forward well into the next decade, Vivgard and FCRN should be a really large franchise, which should generate a lot of revenue. To maintain a good revenue CAGR on that, you will need a number of other successful franchises. And what do we need to do today to build those franchises which gives us revenues early in the next decade to maintain the forward-looking CAGR we want? And that is where our business development efforts is focused on, and you can look forward to us hopefully executing more. but it will follow the same playbook novel biology look for those white spaces where we can be first in class and where we can build product and pipeline opportunities Wonderful, well we're right at time is there anything that I didn't ask that I should have asked? No, I just want to say thank you to you for inviting us and thank you to our investors who are supporting us on our journey, thank you Thank you everyone