argenx SE

Good morning. My name is Gavin. I'll be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. Thank you.

I'd like to introduce Beth Del Draco, Vice President of Corporate Affairs. You may now begin your call. Thank you.

A press release was issued earlier today with our first quarter of 2026 financial results and business update. This can be found on our website along with the presentation for today's webcast. Before we begin on slide two, I'd like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Our GenX is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm very excited to be joined on the call today by Karen Massey, our new Chief Executive Officer. Today is her first official day on the job, marking a very important milestone in the story of GenX. We're also joined by Carl Bubis, Chief Financial Officer, and Sandrine Perre-Girard, Chief Commercialization Officer. I will now send the call over to Kim. Thanks, Beth, and welcome, everyone.

I'll begin on slide three. I want to start by saying what a privilege it is to step into the CEO role at this point in our journey. I joined the company three years ago for the culture, the science, and the opportunity to help build a different kind of immunology innovation company alongside an exceptional team. one that scales innovation through collaboration, delivers meaningful impact for patients, and creates lasting value for all stakeholders. I'm excited to carry forward Vision 2030, our roadmap for growth and value creation, at a moment when we have so much opportunity across the near, medium, and long term. Near-term, we see continued growth with VISA across both MG and CIDC. While we see the typical effects of seasonality, the underlying demand trends remain very strong, and continue to appoint your business that is both growing and expanding. I'm particularly encouraged by our new patient demand. Q1 was amongst our highest quarters ever. Our leadership in neuromuscular was on display at AEM last month, where consistently strong efficacy and safety data reinforced by physicians to treat broadly and earlier with disregard in both MG and CIMT. Importantly, that growing confidence amongst neurologists positions VidGuard well for the next phase of growth, with potential expansions into seronegative, ocular, and pediatric MG populations, based on the strength of Adapt Serum, Oculus, and Junior. When I consider growth over the medium term, we see strong runway of launches ahead, reflecting the scale of our admissions and the depth of opportunity across our pipeline. We're advancing into rheumatology, with readouts in autoimmune myositis and Sjogren's. And we expect a first readout and potential launch of our second medicine, imposter prubat, in evermen. Lastly, we're investing in our future. We're building a pipeline by consulting novel biology relevant in diseases of high-eminent needs, positioning us to sustain long-term growth and reach thousands more patients. Slide four. Our strategy is ambitious, but it's one we know how to execute. Vision 2030 is built on a prudent immunology innovation model that has already delivered a strong foundation. Today, we have five clinical stage molecules that follow our model. First in class, against a novel immune target, and collectively addressing more than 15 distinct diseases. The class of Krupa is positioned to be the second medicine we bring to patients. Like Vizcar, we've built this molecule very intentionally to target T2. that reduce novel biology insights from leading experts in complement biology. Through in-path and robust development, we've also unraveled critical insights into MMM biology that have convinced us to fully transform the treatment paradigm. The phase 3 readout is expected in the fall period, bringing us closer to launching our second medicine. In MMM, we see a familiar opportunity. Build and lead the category, much as we did with VivGuard and MG, transforming the entire disease space. In CIDC, we have the same ambition. We continue to grow our market share with VivVap and are generating extensive real-world insights as patient experience increases. And now, by advancing a second targeted approach we can help improve us, we will deepen our understanding of the underlying biology, helping us learn which patients benefit most from which treatment and positioning us for secure leadership in CIDC. Slide five. Across this garden in Hofstra-Proveis, we're solidifying our leadership in neuromuscular diseases, and amongst the physician and patient communities. One of the most critical therapeutic area expansions for our dentists is into rheumatology, and this starts with an important phase three readout in autoimmune myositis in the third quarter. This is a disease with significant unmet needs, defined by progressive muscle weakness that makes basic daily activities really challenging, if not impossible. There are no approved treatments in necrotizing myocytes, and even metamyocytes, where serious symptoms can emerge in the muscle, in the skin, and in other organ systems, the complexity of the disease means more innovation is needed. This now has the potential to be the first truly targeted therapy in this indication, targeting autoantibodies against proteins that are highly expressed in the muscle. In the case of positive data, we plan to take an approach similar to what we've done with MG and CIDC, because the myocarditis opportunity has similar attributes. Overlapping physician communities, long-established conventional treatment patterns, and our goal is to transform patient outcomes and become the number one prescribed biology. Slide 6. We've significantly broadened the number of clinical candidates across our pipeline in the last 12 months, and you can expect to see this cadence continue. Adam Manabar is in phase 3 in CMS. Igenix 121 is in phase 2 development in IGAM, with more invitations to follow. And our long-term XCRA portfolio is taking shape, with Igenix 213 ready for phase 3 and Igenix 124 to follow. To expand our pipeline at a cadence that will sustain our long-term trajectory, we need to deliberately expand the ecosystem from which we source novel biology. will double down on collaborations and licensing agreements with academic institutions and biocarm companies, alongside acquisitions and strategic investments, giving us the flexibility to engage in whatever form accelerates innovation into our pipeline. The establishment of our China entity supports this strategy, building on the clinical and commercial strengths of our partnership with iLab and embedding us into the local ecosystem to effectively access emerging innovation, accelerate evidence generation, as part of our pipeline and product strategy, and ultimately expands our impact in this region. As I step into this new role, I'm reminded of our purpose as a company, our patients. When we launched GIFDAR five years ago, we made a commitment to continue raising the standards of care for people living with myasthenia grata. Today, with 17 consecutive quarters of growth, we continue to see that commitment translate into real-world impact in MG, in CIDC, and in IPC. This is what gives me confidence in the opportunity ahead. We're deeply committed to our purpose, we're disciplined in our execution, and we'll be flexible in how we source innovation. With that, I'll turn the call over to Carl to walk through our financial performance and outlook.

Thank you, Karen. Slide 7. Product net sales for the first quarter were $1.3 billion, representing 63% year-over-year growth by region, we generated $1.1 billion in the US, $67 million in Japan, $112 million in the rest of the world, and $12 million in product supply to Xilab in China. The 1% quarter-over-quarter growth reflects the impact of Q1 seasonality in the US and is aligned with our expectations. Growth to net adjustments and net pricing in the US remained consistent with the prior quarter. Next slide, please. Total operating expenses in the first quarter were $990 million, representing a decrease of $36 million compared to the fourth quarter of last year. Research and development expenses increased by $68 million quarter-over-quarter, principally driven by CMC investments to support the expected launch of a Viscard sub-Q auto-injector in 2027, continued development of FKTD mode across several indications, and advancing our pipeline assets. These strategic investments will deliver long-term growth through innovation in providing transformational outcomes to patients. SG&A decreased 17% quarter over quarter, reflecting higher discretionary expenses in the fourth quarter of last year. We delivered an operating profit of $394 million in the first quarter, an operating margin of 30%, representing 183% year-over-year growth. With revenue growth exceeding operating expense growth, we are on a clear path of continued margin expansion, demonstrating the operating leverage we are building as VidGuard scales and we advance our pipeline. Tax for the quarter is in line with We ended the quarter with a cash balance of $4.9 billion, including cash, cash equivalents, and current financial assets, an increase of more than $400 million from the beginning of the year. This strong financial position gives us significant flexibility as we deploy capital to fuel long-term growth. Our capital allocation priorities are clear. maximizing the safeguard commercial opportunity, advancing our pipeline, strengthening our supply chain, and pursuing business development opportunities to source the novel biology that will fuel our long-term growth. With our profitability profile, we are investing from a position of strength to deliver on Vision 2030. I will now turn the call over to Sandrine, who will provide details on the commercial front.

Thank you, Carol. I'll begin on slide nine. Over the past several months, I have spent a lot of time with our physicians and meeting with physicians and patients. What stood out to me is how organic transit differentiates science into execution in the market, from securing access to building physician confidence and safeguard in MG, CIBP, as well as in ITP in Japan, and to delivering wide-loved patient support designed to help patients start and stay on therapy. This level of discipline execution and building trust among our core stakeholders will be critical as we approach several important growth catalysts. Today, I'll focus on what's driving our performance and where we see the most meaningful opportunities to build from here under Vision 2030. Slide 10. We continue to deliver on our long-term growth strategy in 2026 with strong momentum across all indications and all regions. Our fundamentals are incredibly strong. Now four years into MG and two years into CIDP launch, we see no signs of diminished slowing. In the first quarter, new patients' scars were among the higher since launch, and we continue to have an expanding prescriber base, reflecting increasing confidence in this art. We now have over 5,000 neurologists prescribing this card in the US. Since launching in CIDP, We have effectively doubled our prescriber base, and each incremental physician meaningfully expands the number of patients we can reach. We are also seeing a change in prescribing behavior. Across both MG and CIBP, we are seeing a clear shift toward earlier use of this card, as physicians gain confidence in what it can offer patients. In the U.S., our market research now shows that 4 out of 5 ACPs prefer to start with safeguard as the first targeted biologic in GMG. New patient demand continues to build across both indications, driving consistent quarter-over-quarter patient growth. The pre-flow challenge has materially changed the demand of safeguard. By giving patient and physician more flexibility, it continues to drive earlier adoption across NG and CLP, with 68% of PFS patients being new to safeguard since launch.

Slide 11.

VIVGARD is the number one prescribed biologic in GMG, a market that continues to grow. We still believe the biggest opportunity is ahead of us, particularly given that nearly 80% of MG patients were not yet on a biologic. We know the VIVGARD profile is resonating with physicians in this population, and more than 70% of patients starting VIVGARD today come directly from oral therapies. This continues to be the focus of our strategy, to extend our leadership by reaching patients earlier in their treatment journey and expanding our reach to broader MG populations. The data we presented at AN served as an important driver of this strategy, and we were excited by the positive response from neurologists. This guide is delivering fast, deep, and sustained efficacy and safety across MG patients. She supports her ambition for VidGuard to be the targeted treatment of choice, simplifying decision-making for the HCP and underscoring VidGuard's growth potential. I want to share one patient story that underscores why this matters. Pam first presented with blurred vision and muscle weakness around her eye. But her ocular symptoms were not taken seriously and she was unable to accept appropriate treatment. As her disease progressed, she ultimately sterilized, suffered a serious fall, and was hospitalized. When Sam later started GriefGuard, the impact was meaningful, helping her regain both mobility and independence. Her experience is a powerful reminder that alkalinity is not a mild disease. It can be profoundly debilitating and disrupt independence in ways that are often underestimated. Our positive ocular MG data, which demonstrated consistent improvement in both solid and double vision, bring us closer to extending innovation to these patients. We are now three days away from our May 20 ZUFA date for seronegatives, so we are limited in what we can say at this point. A potential approval represents a meaningful opportunity to reach patients without detectable antipytoine receptor antibodies. up to 11,000 additional patients in the U.S. Many of them have been left out of studies or lack access to targeted innovation, and this commitment is what drives us every day. Slide 12. Turning to CIDP, we continue to see consistently strong patient ads quarter over quarter, with nearly 80% of new starts coming from direct pictures from IVIG. As neurologists gain real-world experience and diagnosis emerging data, they are becoming more thoughtful about when to introduce a targeted therapy like VidGuard, and are increasingly considering earlier use. Physicians are citing VidGuard's functional outcomes as a key differentiator, particularly of grid-frame data. When CIDP patients were followed from Adair to the open-level extension, mean grip strength continued to improve with basic treatments up to 96 weeks. One neurologist shared that it is rare to see patients regain function after deterioration, which makes an ulcer recovery in grip strength especially compelling. We remain focused on understanding how best to start the broader CIDP population, and how we can shape the market for earlier use of these cards. We are steadily expanding within our initial 12,000 patient addressable market and are seeing our strategies work increasingly beyond this. At AEN, we presented the post-hoc analysis of the Adair study showing 87.5% response among treatment-naive patients, which continue to support this effort. As we look ahead, we're focusing on repeating what has already proven successful. The commercialization playbook we built in MG and CIDP is repeatable, combining a patient-first access strategy, deep prescriber engagement, and disciplined execution. These positions as well as lead graph expand into new indications and as future medicines, including invasive pro-virus, move closer to launch. With that, I will now turn the call back over to Karen.

Thank you, Sandra. Slide 13. Putting patients first is how we define success at Argenix. I'm incredibly proud of what this team has accomplished, and I'm energized by what lies ahead. I'm grateful for the trust of our patients, our partners, and our shareholders as we continue this journey together. Thank you. And with that, Operator, we'll open the call up to questions.

Please press star 1 if you wish to ask a question. Your first session comes to an end. Your line is open.

Good morning, everyone. Thank you for taking my questions. First, congratulations to Karen on the CFO confirmation. Perhaps two questions from me. So we'd love to hear, Karen, we'd love to hear your perspective on the outlook of Argenix as you see it. Once you are fully settled in the role, do you anticipate or should we think about any sort of changes to the company's strategic direction? So that's one. And then the second one is more around VivGuard. You do have two significant label expansion opportunities ahead of you. you probably will have the broadest label for MG across various subsets. How does this change the growth outlook as we head into second half, and how do you expect this differentiation to play out from a competition standpoint? Thank you.

I appreciate the congratulations on the new role. I'm really excited to be taking on this role at this time for the company. We're in such a position of strength with a really strong quarter and strong momentum, and there's so much opportunity and momentum ahead. So in terms of the question around strategic priorities, as I step into the role, my priorities are very clear. I mean, I was very much involved with Vision 2030, and there won't be a change in that strategy. For us, Vision 2030 is not just an aspiration, but it's a growth strategy. And so when you look at what we've laid out for that strategy, by the end of the decade, we want to have two and a half more times patients, two and a half times patients on VIVGA. We want to have three times more indications approved, and five molecules in late-stage development. And those five molecules in late-stage development really set us up for the next decade of growth. So there's no change to the strategy, and I'm incredibly optimistic about our future. In terms of your second question on label expansion, we've laid out a strategy in MG for continued growth by bringing continued innovation to the market. So we have our producer date for seronegative in three days. Beyond that, we have ocular MG that we'll be filing quickly, and we're also looking at an expansion into the pediatric population in the future. So as you say, with this, we should in MG have the potential to have the broadest label and be able to reach the broadest set of patients. And we see this as a huge differentiator in the market. What we're already seeing today is that physicians are choosing VivDart four out of five times for their early-line patients as their first biologic. So we see really strong momentum already, and that growth strategy of expanding our label should continue that momentum through this year, but also into the future.

Thanks for your questions. Your next question comes line of Hussain Ahmed from Bank of America.

Your line is open.

Okay, great. Good morning. Thanks for taking my question. So, Karen, there's a big second half of the year upcoming for the company with several data readouts. I did want to focus my question on myositis in particular. Can you clarify your view of the likelihood for success for each of the three subtypes that you're studying? You know, in particular, do you feel like anyone is more likely to work? than the others. I think some people recently have interpreted comments you've made to indicate that you might be less bullish on DM.

Thanks. Thank you so much, Sabine, and I appreciate the pipeline question early on in the early call. Yeah, as you said, the second half of the year is exciting. My excited is our entry into rheumatology, and we should remember this is a first-in-class opportunity. This is a white space opportunity. and we have a very thoughtfully designed trial that really lets us explore and understand across three different subtypes. Each of those subtypes is grounded in a very strong biology rationale, and you'll recall that we had phase two data in these same three subtypes, and we did move forward into phase three. So what we see as a win is a positive study, meaning statistical significance on the primary endpoint. More broadly, I think what's important in myositis is that there's significant unmet need across myositis broadly. And we've been talking about IMNM quite a bit recently because we've had some learnings around IMNM. Specifically, as we've been learning about IMNM leading up to the readout and looking into the data in more detail, what you see is that because IMNM is, those patients have no treatments available, It is severely underdiagnosed and undertreated. So we see that the TAM opportunity in IMNM is bigger than we previously thought. It's around 20,000 patients. That's more similar in size to a CIVP opportunity and with similar dosing. So that's why we've been focused on IMNM. But, of course, the other subtypes, for example, DM, also have significant unmet need and with limited treatment options. IVIG is the only treatment option available there. DM is a little bit more heterogeneous, but we still think that there's plenty of room for multiple mechanisms of action, and we think that VivGuard has a good value proposition in DM.

So we're looking forward to the data readout in Q3. Your next question comes from Derek Ocellas from Wells Fargo. Your line is open.

Hey, good morning, and let me add, like, a draft, Karen, to, you know, stepping into the CEO role. Just two quick questions. So, first, just on 2Q26 ZipGuard step-up, like, in the last two years, we kind of see that move from 1Q growth to 2Q growth, and we see kind of a nice magnitude of step-up. So, I guess, can you characterize what we should expect this year? And then just a follow-up to Zine's question on myocytosis. So my understanding is that it's not powered for the individual subtypes, but will you give any qualitative information on how the subtypes performed in the Phase 3? Thanks.

Thanks, Derek. Yeah, let me hand it over first to Carl so that he can give you some comments on the momentum that we have heading into Q2, and then maybe, Beth, you can comment on the primary endpoint and communications.

Thank you, Derek. Nice to hear from you. Every quarter has its different dynamics, of course. I think we need to focus on the underlying dynamics, which, as Karen already said, and as we said earlier in the prepared remarks, which are very strong at the moment. Our full year expectations are unchanged, and you can look at the shape of the curve, which will be consistent with prior years. Thank you for the question, Derek.

And hi, Derek. I'm just on the question about what we're going to share on the myositis readout. I think at this point, you know the style in which we communicate. Our plan is, of course, to give the outcome of the primary endpoint. The primary endpoint of the study is the mean KISS score, and that is taken at week 52, but we also understand the importance of contextualizing that subtype performance. How we do that and what that looks like will still, you know, still to be seen. I think it's important to remember that because this is a new therapeutic space that we're entering, we will need to preserve some of that data for an upcoming medical meeting so that we can inform and generate enthusiasm among the rheumatology community.

Very helpful. Thank you.

Your next question comes from the line of James Gordon of Barclays. Your line is open.

Hello, James Gordon of Barclays. Thanks for taking the question. I have a question on competition in NG. So I've had some questions from investors about competitors in the U.S., such as Amazon has been talking about Ablizna, so CD19. They're talking about strong uptake in both Biome and Switch patients, even without step-throughs. So are you seeing Ablizna being used much in NG, and is it displacing in any patients that can use VivCard? And also, I think that's, as Angela said, they're taking it into a CLDP trial. So could that be a threat in addition to potentially C1s coming along? And then also from the competitive point of view, Regeneron, they've got some disarray, so also tipping C5, but also the potential MG approval later this year in Q4. Do you think that could impact Vivcar's fall in MG?

Yeah, thanks for the question, James. There's a lot in there. I'm actually going to hand it over to Sandrine. She's been spending a lot of time out in the field with customers and at AAN and I think has probably recent experience to talk from.

Thank you. Thank you, Karen. Thank you, James. So, indeed, competition has come. We have put MG on the map, so there are more and more players in there, and we see that as a good sign. It means there is a lot of potential in that market, but also more option and innovation for patients. which drives the size of the biologic markets, which benefit all of us, and especially VidGuard as four out of five providers really prefer VidGuard as the first biologic. Now going to your question specifically on some more recent entrants. So what is interesting to see is that most of the recent launches are really positioned towards the later lines, so more for refractory patients and after safeguard. So we see some use, but not really directly competing with us, because what we are trying to do is to go in earlier lines, because we know that 80% of the MG market is still not in the hands of biologics, and this is where we see a really big opportunity, and that's our strategy. So some use indeed, but more in later lines and refractory. So you also mentioned a recent competitor in CIDP. I mean, CIDP, as you know, we have been in the field for now two years. We have another product in development, Empathy Boulevard in development. So what we believe is that CIDP is a progressive disease, but very heterogeneous, and there is space for multiple mechanisms of action. And so with the current profile of VILDRIVE, we believe we have a very strong value proposition between the PFS, the efficacy, the safety, recent great strong data where we should sustain efficacy up to 96 weeks, and then we just presented the data at AN on earlier use, where we did a post-doc analysis, I don't know if you saw that one, where we showed that naive patients had a 87.5% clinical efficacy, so we are really trying to extend here the overall market for VidGuard, and this is very great for CLDP patients. So now for the C5 question, I think Karen wanted to say something, so I'll hand it over back to Karen.

Thank you, Sandrine. I think that's great. And I think you're exactly on point. As we see new competitors coming into the market, C5s and others, they're mostly being used in the refractory space. So thanks for the question.

Your next question comes from Alex Thompson from Stifel. Your line is open. Hey, great. Thanks for taking our questions. And again, congrats to Karen here.

I was wondering sort of to talk at a high level about your appetite for later stage, you know, business development and what you've done historically and maybe in the context of that, you know, how you're thinking about your forte equity investment.

Thank you.

Yeah, thanks for the question. Yeah, maybe to take a step back, we talked about our ambition earlier with Vision 2030, and over the long term, we want to become a leader in immunology. And what that means is that we're focused very much on building our pipeline. In the past, we've been focused on building our pipeline through partnerships with academic institutions. You all know our immunology innovation program. and where we source novel biology that can provide transformative outcomes for patients through those partnerships with academic institutions. As we've been developing a stronger cash balance and financial strength, what that allows us to do is broaden our lens a little bit and also look for other opportunities to source novel biology where we can provide transformative outcomes. So your example that you're calling out of Forte is one example of that, where we made a strategic investment in something that we see as novel biology, and similar to... what you also saw with Tensegrity earlier this year, where we're investing in options in novel biology. So you can expect to see more of this from us as we continue to build our pipeline and continue to leverage our balance sheet. We want to invest in our internal innovation pipeline and source novel biology from wherever we can find it. Thanks for the question.

Your next question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open.

Hi, thanks for taking my question. Maybe just on the topic of competition, we saw that J&J are running a head-to-head trial of Imavi versus Vivgot and Mycenia Gravis, which could read out next year. I was just wondering if you could provide your perspectives on the trial design and expectations here. To what extent is that a risk to or not conscious of the different formulation? And then a very quick follow-up for Carl. I heard your comments on operating leverage. Should we expect to see this incrementally quarter on quarter as well as on an annual basis? Thank you.

Yes, thank you. I'll take your question on competition and then I'll hand over to Carl for the question on operating leverage. I think Sandrine said it best. We put MG on the map, and many competitors are following us, especially as the first-in-class FCRN. And I think what you see is that we've set the standard for efficacy in terms of MSC in MG and have the strongest safety profile, and we have all of these innovations. We started with IV, we launched subcutaneous, and then we most recently brought PFS to market. And, in fact, PFS is driving the majority of our growth at the moment. And so when you think about that, I think the question to ask about some of these studies and these other competitors is what problem are they trying to solve? And I think what we're really focused on is how do we bring more value to more patients where there is unmet need? And for us, that's focusing on PFF, which is unmatched, as well as focusing on that strategy we were talking about earlier, which is broadening the population through seronegative, through ocular, and in the future through pediatrics. So with that being said on competition, maybe, Carl, you can talk about our operating margin.

Thank you. Thank you, Rajan, for the question. Yeah, I want to start off by reminding we are on an innovation mission. The patient is your North Star. We have a unique opportunity now. to invest in innovation and set the company up for the long run, to build a long-term sustainable company. That is the capital allocation priorities of the company. But that said, yes, you are right. A very successful launch allows us to build a P&L where we already have a very good margin structure. Our growth margin is around 90%. Our operating margin is around 30%. We added $400 million of cash this quarter, getting us to $4.9 billion. So, yeah, you can expect going forward to see margin expansion every quarter, year over year, and we're going to continue to build on that. But that, of course, is not the objective at the moment, but I think we can do both.

Thank you for the question. Your next question comes from Alison from . Your line is open.

Good morning. This is Ashley for Alison . Congrats on the quarter and all the progress. So, just for months, just curious to learn more about the go and no-go decision on the phase two trialing the gray in delayed graph function, which is expected mid-year. What specific clinical or biomarker signals are you looking to see to justify advancing clinical development? And just more broadly speaking, how are you viewing the commercial opportunity in delayed graft function? Thank you.

Hi, yeah, thanks for the question on DGF. As I said earlier, it's great to hear these questions on our pipeline. So DGF is an important indication for us for our second molecule, impasse-approved art, and we're able to pursue DGF as an indication because of impasse-approved art being a C2, so involved in both the classic and the lectin pathways in complement. So that's a differentiator for us. In terms of the study, it is a phase two study. So think about it as an exploratory study. And what we wanted to do was see the readout of the data for longer term. So we're following the data out to 52 weeks Because in this patient population and what we hear from those patients as well as healthcare systems and providers is what they care about is the long-term outcomes. So as soon as we have that data, we'll be able to analyze it and we'll have a go, no-go decision for phase three. Thanks for the question.

Your next question comes from Daniel Brill from Truist Securities. Your line is open.

Hey, guys. This is Alex. I'm for Daniel. Thanks for taking our question, and congrats on the quarter. Another question on myositis, on the placebo response, just curious if you could talk a little bit about what factors are known to drive the placebo response, and do you expect any difference in the three subgroups? And then alternately on the steroid taper, just curious what effects of the steroid tapering you're anticipating in the placebo response, and also do you have any thoughts on why really that steroid tapering did not yield any decrease in the overall TIL, TIS endpoint in its placebo arm in its DM trial. Thanks so much.

Yeah, thanks for the question. So, let me take them one by one. So, first, when you think about placebo response, whether across immunology, you see this pretty consistently. You know, we've seen it in MG. In CIDP, you see it in Sjogren's studies and similar in myositis. So I think this is a pretty common phenomenon. And when you're developing an immunology like we are, then you start to get sort of good learnings around how to make sure you're minimizing that placebo response in the trial. And that can include things like training the sites to make sure that they understand how best to use the tools and the measures for the primary endpoint and that type of thing. So in this case, as you said, it's TIS. So I don't think there's anything special across the different subtypes or in myositis there. In terms of the steroid paper, we think this is actually a benefit of the design of our study because what we've been able to do is build it in late enough in the trial so that you have a systemic steroid papering which should actually unmask any placebo response and help us to show a clear benefit on active disease. So we see that the way that we've designed it is very elegant and it should actually help us to uncover the benefit of this gut. In terms of RoiVan, I would encourage you to ask them. I'm not sure about the details on this paper. Thanks for the question.

Your next question comes from . The line is open.

Thanks so much, and congrats, Karen, again. A couple of sort of interrelated questions. One, can you just give us a little bit of a sense? We're kind of thinking that CIDP is around 40% of sales right now, maybe kind of 37%, I don't know if we're in the right ballpark. And then secondly, for the seronegative study, it was a very wide study with a p-value of 0.1 across all patients which you hit successfully. It looks like it was driven by the musk and LRP positive patients. In the seronegatives, technically, the endpoint wasn't met, but because at the end, there was a benefit throughout the period. Just trying to get your conviction that you can get a broad approval and not just in the autoantibody positive. Thank you.

Yeah, thanks for the questions. I'm going to hand it over to Carl. to talk about CIDP and how the mix of business is evolving. And then I'll turn over to Sandrine to talk about seronegative. I want to just make a point that's really important, though, related to the specific question you asked. We're three days from our to-do for date, and so we have to be very careful in how we talk about this. So we're going to keep the discussion very general, and what I want Sandrine to talk about is, in general, how you see the seronegative opportunity in the case of approval. so that we don't go into those details. But maybe we can talk about CIDP first.

Jeroen, thank you for the question. Yeah, both CIDP and MG continue to be growth drivers for us. And, of course, CIDP is mainly in the U.S. now, but also in Japan and Germany. Other markets we still have to launch. In terms of a percentage breakdown, I don't want to get into that, but I will say that MG is still the majority of our revenues and, of course, a majority of our of our patients, but both still have a lot of growth in them. Thank you for the question. I'm handing over to Samrin.

So thank you for the question on seronegative. So like Karen said, I will stay very general because we are only three days away from the PDUHA date. So if approved in seronegative, as you mentioned, I mean, there is a pool of patients which we assessed at 11,000 patients that would cover potentially, you know, these three subtypes. And so as we are only three days away from pedophilia, we are obviously ready to launch. And the good news is that we are already embedded into MG. There is a big overlap of the prescriber base with more than 80% of the target we already visited that we cover seronegative patients. So we don't need to add any field force. The prescribers know extremely well ViviGuard and they trust it. They have experience of ViviGuard. and its efficacy that is deep, fast, and sustained. And then you had a good presentation at AAN with lots of questions, so it shows that there is an interest, really, and that physicians and providers are really waiting for that. So I won't be able to go more into the details, but we should hear in the next few days.

Thank you. Your next question comes from Thomas Smith of Learing Partners. Your line is open.

Hey, guys. Good morning. Thanks for taking our questions.

And let me add my congrats to Karen on stepping into the CEO role here. It sounds like the BizArt auto injector continues to advance and you're guiding the launch in 27. Can you just provide an update on where you are with this formulation? What are the outstanding gating factors for bringing this to market? And how are you thinking about potential uptake in this form versus the pre-filled syringe? And then if I could, just a clinical follow-up on Epgar-Kijamani Graves disease. We saw the phase three design that you recently posted on clinicaltrophics.gov, and I was wondering if you could comment on some of the design considerations for this multi-part study, how are the patients being handled between part A and part B, and how are the background ATDs being managed?

And maybe just higher level, like what are your expectations with respect to the primary endpoint registrational path? Thank you so much.

Hi, yeah, let me start with the auto-injector question. We're moving into manufacturing stage at the moment, as you say, to get ready for auto-injector launch in 2027. The key ungating factors are really just moving through those different gates of making sure that we're ready for production and approval. In terms of the opportunity that we see with auto-injector, what we saw with pre-filled syringe is that it opened up a significantly larger patient population. And actually, and we said earlier, pre-filled syringe is driving the majority of the growth for us today. And so with auto-injector, I don't think it will be as much of a step forward as pre-filled syringe. You'll recall that in the U.S., pre-filled syringe moved us out of healthcare administration into at-home administration. But the auto-injector will be a step forward in terms of patient convenience and ease. So I think that's an important consideration for how we compete in MG. In terms of Graves disease, clinicaltrials.gov covers all of the details that we want to disclose publicly. But I'm going to hand over to Beth to talk about some of the additional details.

Yes, so we designed the GRADE study taking into account, of course, precedent studies, and that was aligned with, you know, what the regulators wanted. So it's actually going to be two studies. You're going to see some kind of similar attributes of this study where we're actually dosing on top of antithyroid drugs. We're looking at patients at the end of the study who are euthyroid off antithyroids. So you're going to see kind of a tapering off that. You know, I think beyond that, we'll get into more details at a later date. But, you know, we're really excited about taking this off. We're focused on, you know, moving enrollment along as quickly as possible.

And, yeah, more to come at a later date. Your next question comes from the line of Akash Tiwari from Jefferies.

Your line is open.

Hey, thanks so much for the questions, and Karen, congrats on your role. Very well deserved. Just on your Phase III myositis trial design, will the FDA allow you to file on pool data, or does each subset need to be statistically significant for broad approval? And additionally, can you go over the rationale of your ADAPT forward trials that look at these carbon and plant in combination in GMG? What type of signal would you want to see to move that forward in larger studies? Thank you.

Yeah, thanks for the question. So in terms of myositis, look, the label that we get, that will be a review decision, and we'll have to see how the data unfolds and let the data speak in each of the subtypes. So we look forward to that data in Q3. I'm glad you asked about ADAPT Forward because it's a key part of our combination strategy that I think we're uniquely positioned as Argenix to pursue in MG and also in some other of our indications like CIDP. So, ADAPT Forward is a platform study, and what we're looking at is, can we dramatically increase the efficacy and outcomes for patients in MG? So, what we're looking at is VivGuard as the backbone of therapy, and then looking at different combinations, for example, Intussifribate on top of VivGuard, and can we increase the number of patients reaching MSC? Over time, it's a platform trial, so we will be adding different arms to the trial to explore different combinations that we have in our pipeline so that we can explore which we would want to move forward in Phase 3. Thanks for the question.

Your next question comes from Sean Laman from Morgan Family. Your line is open.

Good morning, Karen and Carl and Dean. Hope everyone's welcome. Two questions. The first one is your recent data presented at AAM for VivGuard and treatment, i.e. CIDP patients. How do you see that evolving? Do you see VivGuard potentially moving up into the front line? I think there's a lot of focus on just the cost of drug, but considering you've got just a short injection with VivGuard versus all the palaver that goes on with IG administrations, just to give your view there and Second question is just on the IM&M opportunity, and I think Karen, you mentioned a CIDP-like opportunity, but just give us a bit more colour on the accessibility of that patient base. Are they readily diagnosed? What do you have to do there to get into that market? Thank you.

Yeah, thanks for the question. I'm going to hand over to Sandrine to talk about the CIDP data. She was at AAN, and then I'll come back to the question on IM&M.

Yes, so great question. And indeed, in my preparatory remark, I mentioned that post-work analysis, because I think it's data that we have never presented before, showing that VidGuard can indeed have an impact, a sustainable impact and fast impact and efficacy on naive patients, truly naive patients. So we are very excited by this data. A few analysts picked that up, and I think this is going to expand the possibilities for VidGuard. Because if you look at our label in the U.S., we actually – could be used first line. So there is actually, theoretically, no barriers to using. And so in practice, we see two barriers for broader usage in first line. The first one is indeed getting physicians comfortable using it when patients are doing okay. And for that, it's very important to come with convincing data like the one in the post-hocanalysis, but also data like we are showing with the grip strength, where we show really very good efficacy on a 15 basis at 96 weeks. And the second barrier we are seeing is indeed payers. And you mentioned that in your question. So having data like the one we had in the postdoc analysis allows us to go back to payers and have a discussion because ultimately this is better for patients. So we believe this kind of data will help us move the needle step-by-step into broadening the market in first line for research. So I'll hand it back to Karen for your other questions.

Thank you, Sandrine. Yeah, and in relation to your question on IM&M being a CIDP-like opportunity, So the way that we see it is we size the addressable market as around 20,000 patients. But when you first look at the treated population of IMNM in claims data, it looks more like it's around 6,000 to 7,000 patients. So we think that those are quite easily accessible because there's no treatment options available. at the moment. Beyond that, what we will need to invest in, in the case of positive data, is really disease state education to increase awareness and increase diagnosis of this patient population. But the opportunity that we have is that IMNM is frequently treated by neurologists, and there's quite a lot of overlap with those neurologists, with our MG and our CIDP prescribers. So we see the opportunity to build this market in the same way that we've built the CIDP market, we've built the EMG market, and I think we'll see, assuming positive data, the same outcome in IM&M. Thanks for your question.

Before we go to the next question, I would just like to ask if we could speak to one question per person, so we can take as many questions as time permits. Thank you. Your next question, it comes from the line of Gavin Clark-Garza of Evercore. Your line is open.

Hi, this is Yi Xiong for Gavin. Thanks for taking our question, and congrats on the front quarter. So, one question about the next Generation Model 213, we saw now it's become ready. Just wondering, can you share more details on the timeline and how you are thinking about indication selection And also for the phase three, will it be a non-injury study that you had against Riverguard, or is it going to be a standalone placebo-controlled study? Thank you.

Yeah, thanks for the question. The strategy that we're laying out for FCRN is to continue our leadership for decades to come. And so, as you mentioned, we have Argenix 213, which moves dosing to every four weeks. And we also have Argenix 124, another next generation asset in the FCRN space, as well as our program focused on developing an oral FCRN. So, we have a portfolio of options here for how we'll continue to build the FCRN space, explore the FCRN biology, and deliver value to patients. So, we aren't public on our clinical development plan for 213 yet, but it is phase three ready, and we'll be moving quickly. And we see a few different opportunities. One is to advance patient outcomes in the indications we already have approval for, with 213 being a more convenient option. And we have the opportunity to expand the indications that we have FDRN approval in. So continuing to expand the boundaries, if you will, of FDRN biology. So we're really excited about our full FDRN portfolio, and we think that it'll be able to deliver growth for many years to come. Thanks for the question.

Your next question comes from line of Samantha from Carlton City. Your line is open. Samantha, your line is open. Your next question comes in the line of Jacob Macau from KBC Securities.

Your line is open.

Hi there, and thanks for taking my question. I have one maybe further down the line on the oral adherence and collaboration with UMP. Maybe if you can share a bit more on how that's evolving and a follow-up on that. You know, we see other disease areas that if you introduce an oral, that could expand the market. So I'm keen to hear your view on the potential impact of an oral SCRN on the overall biogas market in MG and CRDPs. Could this lead to further market expansion or do you see it more as a tool to prevent the competition from taking existing share?

Yeah, thanks for the question on the oral. Our partnership with UMP is progressing incredibly well. They're great partners, and we're partnering with them on a number of targets, and SCRN being the first one. And exactly as you said, our strategy here is that we believe an oral SCRN can expand the market. You can imagine there are patients earlier in disease, that would prefer to have an oral option rather than an injectable, even if it is a PFS that we have with VivGuard. So the strategy here across all of our indications, and as I mentioned on the prior question, even potentially in new indications, is that we'll be able to bring more convenient options to patients that continue to deliver the same efficacy and safety standard that we've seen with VivGuard. Thanks for the questions.

Your next question comes from from BMP Paribus. Your line is open.

Hi. Thank you very much for taking my question. Maybe just a quick follow-up on 213 and, I mean, I was looking at the initiation of the great disease phase three, and I was just wondering how should we think in terms of additional phase three studies in new indication moving forward? Basically, should we assume that the great disease program will be for new indication, any promising signal from the ongoing concept studies will instead be with the due to IT configuration. So any comments on the there would be helpful. And maybe if I can just quiz one on the CDP. You've mentioned that the penetration of biologics in MG was around 20%. Can you share the same matrix for CDP? And can you discuss, like, the drivers that you have to further, like, penetrate the market there? Thank you so much.

Yeah, let me take the first question and I'll hand over the question on CIDC to Sandrine. For Graves disease, we're pursuing Graves as an indication for VisGuard. And I wouldn't assume that future indications that we name are going to 213 or 124 or any of our future pipelines. We still see that we have a lot of runway with VisGuard and a strong development program with VisGuard. So we continue to invest and we'll continue to grow VisGuard. And in parallel, we'll be developing 213, 124, and the oral as well. As I mentioned earlier, we see those molecules as a real expansion opportunity for FCRN. But let me hand it over to Sandrine to talk about the CIDP opportunity and market growth opportunity.

Yes, and I like that you picked that up under 80% in MG being still, you know, among orals where there is a huge market opportunity. We see something similar with CIDP. So the total number of diagnosed patients for CIDP in the U.S. is 42,000 patients. And 24,000 of these patients are treated. That means the remaining are not right now. They have been diagnosed, but they're not treated. Out of these 24,000 patients, 12,000 of them are on IVIG, but are not optimally treated. And these are the ones we have been focusing on when we started launching, because these are the ones that have a reason to switch to something better. And that's why we see that VidGuard is the answer. The other 12,000 that are treated and feel optimally treated with the IVIG could also potentially switch to VidGuard because it could benefit from efficacy like the great strength data where we showed strong efficacy. So you have to compare the 80 to 20 split of MG with what we see here in CIDP, which is out of the 42,000. Only 24,000 are treated. The others are not, so there is room there. And then 12,000 feel optimally treated, but there is an opportunity for us to expand the market beyond what we already see today. So still a big potential beyond what we have focused on until now.

Thank you, Sandrine. Your next question comes from Miles Minter from William Blair.

Your line is open. Hi, Dean. This is John on for Miles. Thanks so much for squeezing us in here. Wondering if you could talk a little bit about how you're viewing the evolving CIDP complement development landscape, especially as some of the early C1S inhibitor data has been suggestive of potentially best in class profile there. And as a follow-up, maybe if you could just talk a little bit about your views on knocking down both the lexan and classical pathway with C2 versus just knocking down the classical pathway.

Yeah, thanks for the question on impasse-approved art. It's exciting to be bringing our second medicine potentially to market with our first phase-three readout at the end of this year. Certainly from my perspective on the competitor data, I see this as a real confidence booster for why we're pursuing impasse-approved art in CIDP. It demonstrates that they're in CIDP. IgM is part of the driver of the disease, and complement is at play. And so that reinforces why we think impasse approved BART could have best-in-class potential in CIDP. And I think from a company perspective, Argenix is very well positioned in CIDP. You know, there hasn't been innovation in CIDP in 30 years. The first innovation was VivGuard. And now, as we develop that market, we also in parallel are developing impasse-approved art. So I think what you'll see is that we have the opportunity between VivGuard and impasse-approved art to really shape that market and transform the market. And I think it'll look very different in the future from where it looks today as we really raise expectations of patients of what they can get from their medicine. So we're excited for that. In terms of the CLASIC and the lectin pathway, the reason we chose C2 was very specific. And one of the reasons for that is because there are indications where the lectin pathway plays an important role. I was talking about DGS earlier. And so we think that it gives us better pipeline in a product opportunity. by targeting C2 to be able to get the efficacy benefit there, but also the safety benefit of leading the alternate pathway intact. Thanks for the question.

Your next question comes from Samantha Semenkal from Citi. Your line is open.

Hey, good morning. Thanks for taking the question. Apologies for the technical difficulties. I just wanted to follow up on a couple of the previous questions on combination strategy for both CIDP and MG. You know, how do you think about the market evolving? It seems combo therapies is growing theme within I&I. And as you start to see some of that data in the platform trials that you talked about, Karen, how do you see the market evolving there and your opportunity to continue being a leader in both indications? Thanks very much.

Yeah, thanks for the question, and we had some technical difficulties earlier today as well, so no problem. In terms of our combination strategy, as you said, you can see that this is emerging in INI in a way that is similar to how it did in oncology as well. So we're at the forefront of that, and we're driving innovation. And I think we're very clear on what we want to achieve. The value proposition for combination therapy has to be that it substantially raises efficacy outcomes for patients. I think that's the bar that we need to see in combination therapy. And you have to be able to deliver that efficacy benefit without a safety trade-off. So that's what we'll be looking for in the platform studies with the different approaches, the different combinations that we'll be testing. And as I said earlier, the reason we did a platform study is that that will allow us to test these quite quickly, and then when we see a signal, we'll be able to move quickly into phase three with the goal that we always have as a company of elevating outcomes for patients. Thanks for the question.

That's all the questions we have time for. I'd like to hand the call back over to Karen Massey for closing remarks.

Thank you, everyone, for the questions and the great discussion, and we'll see you next quarter.

That does conclude our conference for today. Thank you for participating.

You may now disconnect.