argenx SE

Good morning. My name is Leila, and I will 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 DelGiaco, Vice President of Corporate Affairs. You may now begin your call.

Thank you. A press release was issued earlier today with our second quarter 2026 financial results and business updates. 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 developments, 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. ArgenX is not under any obligation to update statements regarding the future or to perform those statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Sandrine Perret-Girard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A. I'll now send the call over to Karen.

Thank you, Beth, and welcome, everyone. I'll begin on slide three. The team delivered one of our strongest quarters yet, marking our 18th consecutive quarter of growth. This momentum reflects the value Vivga continues to deliver for patients, the continued expansion of both MG and CIDP markets, and our ability to unlock new opportunities for growth, most recently with the zero-negative MG approval. The progress we're seeing across the business brings us closer to realizing Vision 2030, our roadmap for delivering near, medium, and long-term growth. Looking ahead, we have two registrational readouts before year end, which support our goal of achieving 10 labeled indications. Together with our differentiated immunology pipeline, these programs position us to extend our growth well beyond 2030. Our success today creates the opportunity to reinvest in the best science we can find, wherever we can find it, during the next phase of our genetics growth. Slide four. VivGuard continues to change what is possible for patients with MG and CIDC, and we see strong growth across both indications and all regions. We're reaching more patients than ever before, driven by our commitment to bring meaningful innovation to the treatment experience. Last year, we introduced our pre-filled syringe, expanding our prescriber base and supporting our goal to reach patients earlier in their treatment journey. This year, we reached another important milestone with the approval of VivGuard for seronegative GMG, Vivgard is now the first and only treatment approved across all serotypes of GMG, including for triple seronegative patients who previously had no approved treatment option. This is transformational for patients and physicians, removing the need for testing. With OcularMG ahead, we are moving forward in our ambition to make Vivgard the treatment of choice across all MG patients.

Slide five.

We have two important readouts ahead that represent the next chapter of our growth strategy. Broadening our leadership in urology with Intarsal VibGuard and extending the impact of FCRM into new therapeutic areas, starting with rheumatology. VibGuard has the potential to have a similar impact in rheumatology as it has had in urology. Autoimmune myositis is our entry point. It represents both a near-term label expansion opportunity and the foundation for long-term leadership. What continues to motivate us is the urgent patient need. In IM&M, patients can progress from their first symptoms to needing a wheelchair within a matter of months. We heard this at R&D day, and there are no approved treatments today. This sense of urgency to deliver for patients is what is driving our filing strategy, based on the benefit-risk of each subtype on its own. We saw a clear signal in both IM&M and DM in the phase two, and we're on track for a readout this quarter. Myositis is just the beginning. We believe First-in-class launching myositis can establish the foundation for broader leadership in rheumatology, with assurance data expected in the second half of 2027. Slide six. Impulse Approval remains on track to become our second pipeline of products, with our first registration or readout in MMN expected later this year. MMN represents one of the clearest unmet needs in neurology. Impulse Approval has the potential to offer a differentiated approach, supported by the efficacy, Durability and safety profile observed in the Phase 2 ARDA study. We continue to see growing enthusiasm from the neurology community, particularly around the safety profile and the sustained improvements in drip strength observed in the open-label extensions. These are outcomes that matter in patients' daily lives. Our ambition extends well beyond M&M. The unique biology of C2 inhibition has the potential to benefit a broader range of patients. from our ongoing phase three program in CIDP to our combination study in MG. We are focused on unlocking the full potential of this mechanism for patients. Slide seven. It's an incredibly exciting time to be building a company around scientific innovation. The pace of discovery is accelerating and our job is to find the most promising science that can change outcomes for patients. Our goal is to advance five late stage molecules by 2030 to fuel long-term growth. and we are pursuing this through two pathways. We're extending our leadership in FCRM and we're broadening our immunology pipeline. We are already delivering against this strategy. Our future FCRM molecules, Argenix 213 and Argenix 124, as well as our IgA sweeper, Argenix 121, are progressing towards late stage development. And Argenix 118, Argenix 125, and TSP 101, now in phase one, each represent new pipeline and product opportunities. Together, these investments reflect a disciplined capital allocation strategy focusing on delivering durable growth over the long term. And with that, I'll turn the call over to Karl.

Thank you, Karen. Slide eight. I am pleased to present the second quarter 2026 financial results in this morning's press release. We continue to increase the number of patients that we treat. resulting in growing revenues. Product net sales for the second quarter were $1.5 billion, representing 60% year-over-year growth and 17% quarter-over-quarter growth. By region, product net sales were $1.3 billion in the US, $102 million in Japan, $136 million across the rest of the world and five million dollars related to product supply to Xilab in China. Our US market grew by 15% quarter over quarter with a growth to net and net pricing similar to prior quarters. In Japan, quarter over quarter net product sales growth is 55% of $35 million. Reported sales include a one of benefit of approximately $25 million due to a change in our distribution model. Next slide, slide nine. Total operating expenses in the second quarter were $1 billion, representing an increase of $129 million compared to the first quarter. We have set up our combined R&D and SG&A investment to $903 million in the quarter. This increase is deliberate and reflects disciplined investment in multiple mid and late stage clinical development programs and commercialization capabilities to support our growing multi-product portfolio. Operating profit in the second quarter is $494 million, an increase of 146% year over year. Tax for the quarter is 11% of profit before tax. We ended the quarter with a cash balance of $5.2 billion, including cash, cash equivalents, and current financial assets, an increase of more than $744 million from the beginning of the year. Our capital allocation priority continues to be building durable long-term revenue growth. At the same time, we are well on track to deliver a financial profile that includes increasing operating margins, sustained earnings growth, and a significant cash generation. I now turn the call over to Sandrine, who will provide details on the commercial front.

Thank you, Karl. I'll begin on slide 10. What continues to set Argenix apart is our ability to translate the patient-first approach into execution across the entire treatment journey. From educating healthcare providers to supporting patients through ongoing care, we are focused on removing friction at every step. And this is an approach that continues to deliver results. More HCPs are choosing to prescribe VidGuard as a preferred biologic for MG and CIDP. More patients are requesting VidGuard, and as a result, getting on treatment earlier. Patients are remaining on treatment because this guard continues to make a meaningful difference in how they feel and function in their daily lives. Today, we have patients who started in our very first quarter of launch and remain on therapy 18 quarters later. These strong fundamentals are reflected in our performance this quarter and they continue to position us well for future growth. Slide 11. This quarter, we continue to see growth driven by both MG and CIDP across all regions, with new patient demand remaining at a consistently higher level. The pre-filled syringe continues to be an important driver of this demand across both MG and CIDP. Its convenience and flexibility are supporting broader adoption of this GARD. In the second quarter, approximately 80% of pre-filled syringe patients in the US have been new to this GARD. We also see increasing breadth and depth of prescriptions for VidGuard. Physician confidence in VidGuard is reflected in a repeat prescriber base of more than 5,000 neurologists and increasing use earlier in the treatment journey. While early into launch, we also saw a contribution to growth from our seronegative expansion in GMG. VidGuard is now the first and only biologic approved across all serotypes of generalized MG, significantly expanding our addressable market in MG by 11,000 patients.

Slide 12.

Our recent approval across all therotypes of GMG, musk positive, triple theronegative, and LRP4 positive, strengthens safeguard leadership in MG and advances our goal of reaching the broadest patient population. We are pleased with the early response to the liberal expansion with extremely positive and ACP Feedback. We have established relationships with more than 80% of seronegative MG treaters and see the recent safeguard label expansion having a halo effect on all GMG prescriptions, also driving increased uptake by prescribers in the seropositive population. On the payer side, we leverage the credibility and relationship we have built to secure policies covering approximately 55% of U.S. commercial life. all within 10 weeks since launch. Most plans are removing the serology testing requirement, making it simpler for physicians to prescribe VisGuard as the go-to option in the MG. There is also tremendous excitement and hope among patients, particularly triple-seronegative patients who previously had no approved therapies available. One of these patients, Zach, shared, I sat at my computer and cried. Hope, this is finally real hope for the seronegative community. As we look ahead in MG, we see significant opportunity to reach patients earlier in the treatment journey and pending approval expand into popular MG. These patients continue to face a meaningful burden of disease, underscoring the need for additional treatment options and reinforcing our commitment to serving the full MG community.

Slide 13. Let's move to the opportunity in CIDP.

Within our initial 12,000 patients addressable population in the U.S., we are driving further adoption through physician education and continued evidence generation. At the same time, we are laying out the groundwork to expand beyond this. Today, approximately 24,000 patients are being treated for CIDP in the U.S., and roughly half are considered well-managed on the current therapy. What we consistently hear is that many have learned to live around their disease, often without realizing how much function they have lost. And this is exactly why generating data that shows meaningful functional improvement matters. Our GRIPS-trained results demonstrate the impact GATE-Guard can have on outcomes that are important in patients' daily life and meaningful to the physicians treating them. Similarly, we have generated evidence that helps physicians navigate practical treatment decisions. including transitioning appropriate patients from IVIG to safeguard. We presented recently at PNS the results of a phase four switch study showing that 87% of patients on IVIG switched successfully to safeguard, helping address the question, how do I switch from IVIG to safeguard? Finally, we continue to explore the opportunity to reach patients earlier in the ADD journey. We see significant potential among the large population of untreated patients where our data suggests that treatment-naive patients may derive meaningful benefits from earlier treatment. Slide 14. Looking ahead, we are preparing the organization for the next wave of growth. We view autoimmune myositis as a strategic entry point into rheumatology with the potential for WISGARD to establish early leadership as the first FCRN. We are augmenting our best-in-class launch playbook in MG and CIDP to be launch ready for myositis. We are already engaging with 650 CROs treating autoimmune myocytes, advancing disease-safe education, engaging patient communities, and getting ready to expand our field force footprint. With that, let me turn the call back to Karen for closing remarks.

Thank you, Sandrine. As you heard today, we continue to see strong momentum across the business. with significant opportunities ahead for VivGuard and a pipeline position to sustain growth well into the future. And while there is much to be proud of in the first half of the year, there is even more ahead. We enter the second half of 2026 with multiple opportunities to advance innovation and further our mission of transforming the lives of people living with autoimmune disease. I want to thank our team, patients, and strategic partners for their continued commitment as we continue this commission together.

And with that operator, we'll open the call for questions. If you would like to ask a question, please press star five on your telephone keypad.

You may remove yourself at any time by pressing star five again. We would like to remind callers to please limit to one question. And we'll pause just a moment. Our first question will come from Miles Minter. Your line is now open. Please go ahead.

Thanks very much and congrats on the quarter. Looking forward to the myositis data in the third quarter here as well. I'll keep it to one on the commercial business. You've delivered quarter over quarter sort of mid-teens percentage growth if you take out the first quarter seasonality. I just had a question on whether that sort of future growth trajectory might change with the launch in the seronegative population here and whether there's any sort of tailwinds that we should think about from the broader population now that most plants are not requiring the serology testing for that population. Thanks very much.

Thanks for the question, Miles. And I would agree with you. It is incredible, 18 quarters in, that we're still delivering consistent growth quarter over quarter. And what I would say related to the quarterly trends is You know, of course, every quarter has its own dynamics. And after Q1 seasonality, we generally see some rebound in Q2. But we expect the shape of the curve for the remainder of the year to look pretty consistent to what you've seen it in prior years. We're off to a strong start, of course, with zero negatives. But we've had the same dynamic in prior years with the launch of the PFS and that type of thing. So I would expect it to continue to grow and to look similar to prior years. Thanks for the question, Mal.

Our next question will come from Derek Archila with Wells Fargo.

Hey, good morning, and congrats on the quarter here. Excellent results. I just want to understand, so where do things stand with the Ocular MG filing? And I guess, you know, maybe going to more tailwinds, but, you know, assuming approval, I guess, how do you think Thank you for joining us.

Yeah, thanks for the question. We're moving forward with urgency on ocular MG filing. I mean, there's a big patient unmet need in ocular MG. Of course, there's no advanced therapies approved in this patient population. So we will be the first and only approved treatment in this population. So we're on track with the filing. We'll update you when we have a PDUFA date. But maybe Sandrine, you could comment a little bit on how you see the outlook if we do have an ocular approval.

Thank you, Karen, and Derek for the question. So I see the OcularMG potential approval as another way to continue and to support a growth momentum. Over the last five years, we basically have had five launches when you think about that. So this would give us another launch to continue that growth momentum. We are well positioned because many of these patients are being treated by neurologists, and this is already a population of providers that we visit and that have experience with the drug. So I'm very confident that this will be adding another leg to our world for the long term.

Our next question will come from Tazine Ahmad with B of A.

Hi, good morning. Thanks for taking my question. So Karen and maybe Sandrine, I wanted to get your thoughts about the competitive landscape. So you're right, your 18 quarter is in and you have commanding share, but there continue to be new launches and upcoming launches. And some of the competitors that are talking about what advantages their products might have include comments such as efficacy may not necessarily be where it needs to be with SDRNs in general. and that patients might be dropping off therapy due to safety observations. So can you maybe share with us your feedback from the field about what, you know, doctor's satisfaction is these are either patient commentary on both efficacy and can you talk to us about dropouts as a result of any safety concerns? Thanks.

Thank you, Tazine, for the question. Let me just comment broadly on competition, and then I'll hand it over to Sandrine. But we've had this question a lot. I would say we launched in MG, and I like to say that Argenix put MG on the map, and there's been a lot of competition that has followed us into the space. And throughout that, we've maintained our leadership in the market. And you can see, for example, four out of five physicians continue to say that they choose VivGuard. before any other biologic. But Sandrine, maybe you want to comment on specifically the efficacy advantage and any other dynamics you see in the market.

Yes, so Vivgard, I mean, like you said, Karen, is being seen and is being used today earlier than the others. You know, the others are used more in refractory populations and it's being used in earlier lines. And the reason is that the label supports it and the data supports it. And when you look at the data, I wonder if anybody else can demonstrate an MSC that we have. We have 60% of patients that have reached minimal symptom expression and then that MSC is sustained over time. So I haven't seen until now other competitors being able to demonstrate MSC or even speak about MSC. And so that's really surprising. What stands out when you speak about the efficacy of IFGARD? And then if you combine that with its safety over more than 25,000 patient years, I mean, this is a very strong combination of a safety and efficacy profile that puts us in a position to being used earlier lines. And that's why until now, we haven't really seen a meaningful impact on our growth trajectory.

Our next question will come from Alex Thompson with Stifel.

Hey, great. Thanks for taking our question. Maybe for Karen, could you walk us through sort of what we should expect to see now at the top line for myositis in terms of both primary endpoint clinical data as well as the potential path to filing, particularly in DM? Thanks.

Yeah, thanks, Alex. We're really looking forward to the readout in Q3, and we're on track. Just to set the stage, what we see as success for myositis is positive readout on the primary endpoint in one or more subsets. And that's the data that we'll share. So you'll remember from our myositis day that we shared that we see both of these indications on their own as potential blockbuster indications. They both have significant unmet need, and they're both actually strategically important to us if we proceed with an approval. This will be important because it will be the first in class FCRN approval in rheumatology. So we'll be looking for positive data on the primary endpoint in one or more subsets. But maybe, Beth, you want to share a little bit more about what they can expect to see at top line results.

Yeah, I mean, we're still working out the specific details of what the communication will look like, but what we know is that this is an important event with positive data for our genics. It's our entry into rheumatology, and we'll want to capture that in our communication, and we'll also want to capture the primary endpoint analysis in IMNM and in DM. So the details are still to come, but you can assume that those are the key topics of the communication.

Our next question will come from Akash Tiwari with Jefferies.

Hey, thanks so much. Can you give a little more color on your stat plan from my side? Based on your public comments, it seems like there is no alpha split. Basically, DM and IMM are now being run independently as two separate trials. Is that the correct read here? And then if the effect size in DM for your Phase II trials was replicated in Phase III, would the trial hit stat sig or not? And if not, what are some reasons that efficacy could improve from Phase II to Phase III? Thank you.

Yeah, thanks for the questions, Akash. We have Luc here, so ask him to comment.

Yeah, and thanks, Akash. So, you are correct. So, the way we now approach the analysis of the phase three is that we will independently analyze the subsets, so each has their own chance to win. As you also know from the research there, of course, the enrollment differed between subsets, so that will affect the intrinsic power. Nevertheless, the analysis plans are completely in parallel. With respect to your question on effect size, if we see effect size in phase three in the end, that's what we have observed in phase two, you could make the assumption that because it's twice as long and twice as big, that that would increase the chance for a statistics difference, which is certainly true, but not a guarantee. We just still have to turn the data cards, see what we have, and then determine our path forward. But whether stat sick or stat negative, we are working on a plan forward in the end.

Our next question will come from Rajan Sharma with Goldman Sachs.

Hi, thanks for taking my question. I've actually got one on Empathy Prevot. Could you just provide a little more colour on the DGF update, please? So it seems like you're progressing development, but not in DGF itself. So can you maybe help us understand what the forward path is here in terms of indications and when you may be in a position to move through a pivotal trial and what it was that you saw in the 52-week data that gives you confidence to move forward? And I'm just wondering if there's any additional reassurance into MMN based on what you've seen in the DGF trial. Thank you.

Yeah, happy to have Luke comment on this. Just a reminder, this is a phase two proof of concept study and what we wanted to do was use it to explore and learn about the use of EMPA in the transplant setting broadly with a focus on DGF in the particular study. But Luke, maybe you can talk about what we saw in the past four weeks.

Yeah, thanks, Cameron. Thanks for the question. So as already said, this was a relatively small trial, basically evaluating a hypothesis whether we could influence reperfusion injury with this mechanism. And the transplant situation lends itself to this. And we had chosen as a target DGF, which is a relatively short-term goal. So when we saw the data at 24 weeks, We found an intriguing signal which made us decide let's continue the exploration of the study up to 52 weeks, which more or less confirmed that there is something in the renal parameters here that is affected, which gives us an interesting perspective on exploring the transplant. However, it does not support DGF, which as I said is a short-term readout to be continued as an indication.

And maybe just to comment on the second part of your question around MMN read-through, I don't think I would take any read-through for MMN other than we did see some effect of the drug, but in particular for MMN with the readout in Q4, I think the most important data point to look at there was our positive phase two study, where on the endpoint of grip strength, both in the initial phase part A as well as the open label extension, we saw positive results. Thanks for the question.

Our next question will come from Yatin Saneja with Guggenheim.

Hey, guys. Thank you for taking my question. Again, excellent results. So congrats again. So quick one on the pipeline, specifically on ARGX121, the IGN program. Could you maybe talk a little bit about the profile that you have seen in Phase 1 that is enabling you to move into Phase 2 What level of IGA reduction you saw? How should we think about frequency? All of that. Thank you.

Yeah, thanks for the question about IGENIX 121. We're really excited about 121 and broadening our pipeline with the IGA sweeper. And we had shared data specifically from Phase 1 and with the profile that showed that Argenix 121 reduces IgA by about 90% within a matter of days. And that reduction is maintained all the way out till day 28 with one single dose. So very impressive data. And we're moving very quickly with urgency into IGAM. And perhaps, Luc, you could share your thoughts on the IGAM program, clinical development program.

Well, with such a signal in phase one, we are already excited to keep this really moving fast. When we showed those later key opinion leaders, they were also very enthusiastic. And this speed and depth really puts it aside from, as we all know, again, has quite some efforts going on. But our signature of the drug here really sets us apart and is really offering us great hopes for... The Phase 2 and the Phase 3 that we can bring a meaningful drug to patients.

Our next question will come from Jeroen Werber with Cowen.

Great. Thanks so much. Congrats on that really nice quarter. Just a question for you on MMN, and thanks for putting that slide into the deck that shows the grip strength change from baseline. What we hear from clinicians is that eight points is clinically meaningful, and I believe the primary is not inferiority, and then you have superiority. Can you maybe just talk about that phase three trial design, maybe a little bit of the powering or whatever you can share as to what do you expect from baseline? Thank you.

Yeah, maybe Luca can talk about the study design.

Yes, and very thanks for the question because it allows us to talk through what are we really trying to achieve at Argenix. So, with the Phase 2 data, as you remember, we had like an 81% reduction in the need for rescue with IVIG based for those that received empathetic rebars. This to the point where we said if every rescue we need to take forward as on IVIG, we might as well do IVIG head-to-head, which would also provide the most meaningful data for prescribers. So we designed this trial where after stabilization on IVIG and optimizing, that we initiate either a continuation of the IVIG regimen or a switch to empathy for BART. The endpoint here is indeed grip strength, which we picked in conversation with actually the agencies, because there were quite meaningful data available, which allowed us to define a non-inferiority margin. And the non-inferiority margin is set, I think, pretty relevantly, but we also have the opportunity to go to superiority. And I think based on the Phase 2 data and what we learned on IVIG, that there is, in my opinion, a great chance that we could show that. But the non-inferiority at least gives us the ability to at least provide that information.

Yeah, thanks, Luc. And just to wrap it up, what I would say is what we see as success is a positive readout on the primary endpoint, non-inferiority, and obviously upside would be superiority. But when we speak to KOLs and prescribers, we certainly hear excitement about the fact that we have a head to head versus IVIG. And certainly with our experience in CIDP, we have some experience competing in that space as well. So I think we're set up for success, assuming a positive readout towards the end of the year with MMN.

Our next question will come from Danielle Brill with Truist.

Hey guys, this is Alex for Danielle. Thanks for the question and congrats on the quarter. Just a question on CIDP as it pertains to the current commercial dynamics as well as the ongoing EMPA trials. As far as it relates to the commercial read-through to the CIDP launch, in the regions where VivGuard is available, who are the types of patients who are enrolling in the EMPA CIDP trials instead of trialing VivGuard? Thanks.

Hi, yeah, so maybe to start just to lay out our strategy with CIDP. So we see that CIDP is a heterogeneous disease and there is significant unmet need. Until VivGuard launched, there hadn't been innovation in the space for 30 years. And we've seen the strong uptake of VivGuard in CIDP. What we know is with the disease heterogeneity, that there is also IgMs driving the disease. And so that's why we have the study with impasse prubat, where we think we have strong biology rationale. So our hypothesis is that there are some patients that we have a 70% response rate with VivGuard. So those patients that don't respond to VivGuard might have more IgM-driven disease. And so we think that there's an opportunity there. for impasto-prubat in those patients. There also might be patients where they have sort of multiple drivers of the disease and so an overlap that might be eligible for both Vivgard and impasto-prubat. So our strategy here is to study impasto-prubat and we're enrolling impasto-prubat in a broad patient population so we can understand the impact of impasto-prubat on the disease And then once we have the data readout, we can analyze that data as well as the VivGuard data and really understand what is driving the best outcome for patients and move forward with the commercial strategy from there. Thanks for the question.

Our next question will come from Thomas Smith with Lyric Partners.

Hey, guys. Good morning. Thanks for taking our questions, and let me add my congrats on the really strong quarter here. On the pipeline, could you just provide some updated thoughts on how you're thinking about advancement between your next-gen FCRN candidates, 213 and 124? Any additional color on the target profile you're aiming for with 124 with respect to IgG lowering or dosing interval or other potential differentiation? And how do you think about indication selection between lifecycle management and potential expansion opportunities across those candidates? Thanks so much.

Yeah, thanks for the question. Our goal with FCRN is to maintain our leadership and even advance our leadership for decades to come. And we have a few pieces or parts to that strategy. Next generation molecules, 213 and 124 that you refer to. 213 is, we call it phase three ready. and 124, we're in phase one at the moment and by the end of the year, we'll be in a position to move it into late stage clinical development. So at the moment, we're working with our teams based on that data to assess the two molecules. Of course, Argenix 213, we know has a Q4 weekly dosing schedule. Argenix 124, we're further categorizing the advantages that it will bring over VivDart at the moment. and then we'll be in a position where we can lay out what the strategy is for the full portfolio between VivGuard 213 and 124. The other component of our strategy that's really exciting is that we are in development of an oral FCRN and that program also moves forward quickly at the moment. Thanks for the question.

Our next question will come from Sean Lauman with Morgan Stanley.

Good morning Karen and team, hope everyone's well. Karen, just going back to the seronegative GMG impact, what specific early prescribing trends have most exceeded your expectations and how should investors think about the revenue contribution from seronegative patients over the next 12 to 24 months?

Thanks for the question, and I'll hand it over to Sandrine in a moment, but I'd be remiss if I didn't just say, first of all, that I'm really proud to see Zero Negative launch. It really is the Argenix playbook in action. We made a commitment to this patient population many years ago when we launched VivGuard that we would bring this innovation forward. to seronegative patients, and to see that happening in the market and being so positively responded to is really exciting. But Sandrine, maybe you could comment a little bit more on the dynamics you're seeing with the launch.

Thank you, Karen, and thank you for asking a question on seronegatives, because for me this is a big event in the second quarter, so it's great to have someone asking that question. So I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers, Thank you very much. A lot of hope, a lot of enthusiasm for the patient side. Some of them were calling the physician to make sure that they had access to the product as soon as possible. On the provider side, what is interesting is that When you look at what the provider are saying is that they consider now that the fact that we add seronegative to the label is that we now have a fully loaded GMG label and that adds simplicity in decision making, streamlining decision making. They quote, I consider now VisGuard as the go-to option for all my GMGs. And so one of the things we have observed over the first few weeks is that it has really a strong halo effect beyond the seronegative patient onto the positive serotype patient. And that was something that we were expecting, but it's great to see come from. What we are also very, very happy about is that the payers have been approving quite quickly and endorsing the policy with guarding seronegative, where we have roughly 55% of the covered lives yet already, less than three months after launch. And I have said that it would take three to six months to get to roughly 90% and we are well on track to get there. And so what is also very important is not just the quantity of coverage but also the quality and seeing that the majority of the plants are removing the testing requirements for the serotype is also making the life of the providers easy. So if I would summarize, it's all about leadership in MG with that approval but also simplicity of decision making for the providers. So great feedback. Thank you.

Our next question will come from Samantha Semenkow with Citi.

Hi, good morning, and thanks very much for taking the question. Just one on CIDP for me. You outlined in your slides market expansion opportunity. I'm wondering, you know, what you're seeing in the data about treatment-naive patients utilizing VivGuard as a first line. Are you seeing a shift towards these patients being are treated more frequently, and if so, how should we think about the progression of the launch in that segment going forward? Thanks very much.

Yeah, thanks for the CIDP question. Sandrine, maybe you can comment?

Yeah, so it's indeed a very big opportunity for us to really make sure that this guard is used as early as possible because still the majority of the patients start with IVIG when they start the treatment for CIDP. We published data and we are generating more and more evidence to show that if you are prescribing VisGuard for treatment-naive patients, actually you see clinical benefits. And we presented a study at AEN where we showed that 87.5% of the patients that were treatment-naive benefited from a clinical response. And we are using data to encourage physicians to try VisGuard in patients. Earlier line patients, and they are seeing good results. Now it's taking time. It's taking time because you have to change entrenched habits, and you have also to make sure that payers are supporting that because the majority of them are requiring some kind of experience with IVIG. So that's what we are working on, but you see more and more traction in the treatment-naive population as well as in the patients that are seen as well-managed but need some more functional improvements.

Our next question will come from Gavin Clark Gartner with Evercore ISI.

Hey, thanks for taking the question. Just following the recent RLPRBART update, are you considering any changes to your CIDP development plans for EMPA? And I guess on this point, did this outcome change what you think the likelihood of EMPA meeting superiority versus IVIG is in either CIDP or MNN? Thank you.

Thanks for the question, Gavin. As a reminder, before I hand it over to Luc, our clinical development program for CIDP for impasse of Proubat has two studies. One is the head-to-head versus IVIG, and the other is a placebo-controlled study. And so I think it's around the placebo-controlled study that you're particularly asking for, but also maybe some comments, Luc, on your confidence in the IVIG study as well.

Yeah, and what is important to CIDP, and we used the term already, is a heterogeneous disease also. And therefore, your selection of patients matters. We took particular care in that HEAR study to install, for example, that clinical education committee, which now has become the standard. But we continue to exclude possible CIDP patients, for example, as one of the differences. And then if you then, on top of that, go with very refractory patients, You may come in a situation where the disease has burned out more or less, and then what's your ability to change? We, of course, want to learn, and we will be looking more closely at these data and evaluate is there anything we need to do to optimize our studies, but we are continuing with our plans to continue both.

And maybe just one more comment on that that it's made me reflect on is that it's very clear from this that it's not easy to run successful clinical trials in CIDP. And one advantage that we have is that we do have the VivGuard experience and we've been able to demonstrate that ability. So that gives me additional confidence as well.

Our next question will come from Sophia Graf with J.P. Morgan.

Good afternoon. Thanks for taking my question.

One on the upcoming myositis trial. You commented that you currently no longer see a path forward for polymyositis patients. But given the strong evidence that ACEs is autoantibody driven, would there be scope to run an ACEs specific trial in future or is this population still a bit too small to target?

Yeah, thank you for that question. We of course want to reach as many patients as we can. Just from a technical point of view in this trial with the enrollment numbers, we just can't get there, but we will learn. And so ACES is not just confined to PM and polymyositis itself is heterogeneous and has been a bit kind of being more and more allocated to the other subsets as we get to know more. So we will definitely look at the data as they come and determine a plan forward for ACES.

Thank you. Our next question will come from Victor Floch with BNPP.

Hey, thanks so much for taking our question. So maybe just one on the PFS. I've noticed in your slide that the proportion of PFS patients new to VidGuard actually increased to 80% from 68% in Q1, which is quite impressive. So I was just wondering whether it makes you incrementally more bullish about the autoinjector opportunity and whether there's any chance you can share more details on the remaining development milestone for the autoinjector and the expected Thank you very much.

Yeah, so thanks for the question on PFS. I'll hand it over to Sandrine in a moment. But just to confirm, auto-injector is on target or on schedule for 2027 launch. But maybe some of the dynamics you're seeing with pre-filled syringe in the market, Sandrine?

Thank you for your question, Victor. So indeed, I wrote on the slide 80% of the patients that are on PFS in the second quarter in the US are new to VidGuard. So it's true expansion for us. And you compare it to last time where we said 68%. Last time, 68% was launched today. So these were the patients since the launch. This time, we should actually just focus to, if you look at launch today, to compare apples with apples, we would be at 70%. So it's a slight increase, but it's not 80%. 80% is really Thank you for the question.

Our next question will come from Andy Chen with Wolf.

Hi, thank you for taking my question. This is Jason taking it for Andy. I just wanted to ask a question in terms of seronegative approval and what its effect on this quarter's earnings has. Also, I wanted to ask in terms of the launch curve of seronegative and ocular, would they be similar or what might there be in terms of subtle differences and anything to think about when we're looking at the uptake of ocular? Thank you.

Yes, thanks for the question. Karl, maybe you can comment on the dynamics of the quarter.

Thank you, Karen, and thank you, Jason, for the question. Yeah, Sandrine already mentioned in the prepared remarks, the quarter was driven by strong fundamentals and PFS was the key driver of growth. However, zero negative, of course, is also a contributor, in particular the triple negative patients where we see the huge unmet need and also the halo effect the zero negative had on the broader GMG market. So I think what, and of course we expect that to also flow into Q3O. In terms of Ocular, I think as we always said, you need continued innovation to maintain the growth and regular new launches, of course, is what we need. And I think we are very excited that we're going to continue to deliver that for patients. Thank you for the questions.

Your next question will come from Luca Issy with RBC Capital Markets.

Oh, great. Thanks so much for the question, and congrats on another great quarter. Maybe, Luc, I just want to circle back on a prior question. So my side is you mentioned that IM&M and DM are independent analysis. Each of them has its own chance, I think, the stats. But did the FDA still ask you to split the alpha between the two trials, given that this was originally structured as an all-comma trial that enrolled both populations together? or are each trial at this point completely independent from one another and there's absolutely no crosstalk between the two trials? I guess the other way to ask the question, are these trials successful if the p-value is below 0.05 or do you need to hit p-value below 0.025? Because again, you're splitting the alpha between the two trials. Any call there, much appreciated. Thank you.

Yeah, so I want to stay consistent with how we answered that at the R&D day, which is we're not going to comment on a specific alpha value. Because even in these rare diseases, even with alphas that are in between 0.05 and 0.1 even, you can have a conversation. It's not that we go in there, but I'm just saying we're not going to disclose the actual alpha value. And yeah, the data card is to be turned soon.

Yeah, and maybe just to give you some additional insight and color on the strategy and the filing strategy. So as Luke shared earlier, the analysis plan is independent of each other. So IM&M and then DM separately. So they are two separate analysis plans. And our filing strategy and path forward is in IM&M, Recall that there are no approved treatments in IM&M, and so we have breakthrough designation with the FDA and have had those communications based on that with the FDA. In DM, what we'll be looking for, of course, is statistical significance. And once we have that data, we'll be able to continue discussions with the FDA on what the path forward is there. But what I want to come back to is that with this myositis study, what we've given ourselves the opportunity to do is have two opportunities for label expansion. both or each of them individually as potential blockbuster indications, IM&M and DM. So we're on track for Q3. We'll turn the data card and we'll determine the path forward from there.

Got it. Thanks so much.

Our next question will come from Sebastian van der Soot with Kempen.

Hi guys, congrats on the excellent quarter and thanks for taking the question. Can you maybe share your latest thinking on your ambitions regarding business development M&A? What should or should we not expect in this aspect for the next 12 to 24 months? And can you maybe describe the profile of assets that you will be looking for to add to your pipeline? Thank you.

Yep, thanks for the question. So our overall capital allocation strategy is very much focused on delivering growth, growth in the short, mid, and long term. And in line with that, our capital allocation strategy focuses on, number one, fueling safeguard growth. Number two, funding and accelerating our internal pipeline that includes our FCRN assets that I was talking about earlier, but also beyond FCRN. And then, of course, with the strength of our balance sheet, we also have the opportunity to look at business development. Now, looking at business development opportunities in order to identify potential new assets is not a new strategy for us. In all ways, the approach that Argenix has taken has been to partner to look for novel biology, new mechanisms of action where there's significant unmet patient needs. and in the past, we partnered with academic institutions in order to identify that biology and build those molecules. With the strength of our balance sheet and our continued profitability, we can now widen the lens and also look at biotech companies that are pursuing, but we use the same bar for those business development opportunities as we do for our internal pipeline. And that bar is that it has to be novel biology and it has to be in areas where there is significant unmet patient need. So we hold the bar high, but I can tell you when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them and continue to build our pipeline. Thanks for the question.

Our next question will come from Douglas Thao with HC Wainwright.

Hi, good morning. Thanks for taking the questions. I'm curious in terms of the CIDP opportunity and the slides where you indicate the number of patients who are diagnosed but not treated, and I'm just curious if your sense is those patients aren't being treated just given the sort of tolerability issues related to IVIG, and is DivGard sort of Thanks for the question, Douglas.

And I think what you can see from that slide that I find exciting is that it's clear we're just at the beginning of the growth curve for CIDC, and there's a lot of opportunity for continued growth. But maybe, Sandrine, you can share what you're seeing in the market around those patients. Thank you, Karen.

So indeed, CIDP, lots of opportunities for further growth within the addressable market we started with at launch, but also way beyond that. And so what I noticed when I discussed CIDP with patients, but most importantly with providers, is that it's a disease which is not well understood and where there is not really a true dialogue between the patients and the providers, where actually the unmet need is underestimated. And even when a patient is being treated and is thought as being well-managed, Actually, this is not the case because there is not this dialogue. And I often use examples like you would ask somebody, are you doing okay? Can you brush your hair in the morning? And the person says, yes, I can. And then when you ask, oh, do you do that? They say, I'm lying on my bed to brush my hair, which shows that there is really a muscle weakness there and that we must show the physician and the provider that you can make a difference by putting them on treatment like Vivgard. And this is the same happening for patients who are not on treatment. and that have been diagnosed because they kind of underestimate their level of functional, how they function every day. They have accommodated their life, they have moved from a house to an apartment, they don't drive anymore, they have just lowered the bar of what their life should look like, what the quality of life should look like and what we are trying to do is generate data to show that you can get your life back if you really take that seriously. This takes time, this takes a lot of data generation and it takes also patience to go and and have the discussion with their providers. So that's what we are trying to do.

Our next question will come from Keezy Ding with Redburn.

Hi, thanks for taking my question. Can I just ask a quick follow-up question on the BD? Are you interested in the assets within the same therapy areas that could further strengthen your existing portfolio, or are you looking for complementary assets that could broaden your portfolio? Thank you so much.

Yeah, thanks for the question. So when we build our pipeline, whether it's with internal assets or through business development, We're focused on immunology assets, but we are focused on diversifying our pipeline beyond FCRN. And so you can see that within our internal pipeline. Of course, we have mParsifrubat, we have Argenix 121. We also have molecules in earlier stage development that are very exciting. When we look at internal and external molecules, we set the bar as what we're looking for is novel biology. And we need to have clarity on how we can de-risk that novel biology to move into patients. And we keep the bar high on that, as well as these areas of high unmet patient need, where we could be bringing the first in class or the best in class assets forward for patients. And so that's the strategy that we have for both our internal pipeline as well as business development.

Our next question will come from Jian Deng with UBS.

Hi, thank you for taking my question. One on DM, please. So just wondering, there are some studies or evidence kind of suggesting DM is more sort of interferon-1-driven disease, and the role of autoantibodies is not as clear as that in IMNM. So just wondering, for your DM study, but I think on the other hand, especially in DM, Some autoantibodies have very strong predictive power to prognosis and symptoms, etc., etc. So just wondering, do you see some sero-subtypes of DM that potentially have a better response, and are you enriching those for the study? Thank you.

Thanks for the question. Maybe I can just start by sharing at a high level what we shared at R&D Day, which is we see a clear biology rationale for both IMNM and DM. They are both autoantibody-driven diseases. But maybe, Luc, you can provide a little more detail.

Again, the theme of these diseases are not driven by just one mechanism, which is why we thought that multiple motions of action are moving forward. The Dianthus molecule clearly is more in the Interferon-1 pathway, as you indicate, which we feel is clearly a demonstrated driver mostly in skin pathophysiology, but some in muscle. We feel that given the demonstrated level of antibodies present in these diseases and their targets, that addressing primarily the outer antibodies has a role to play and in that sense of phase two subset data demonstrate that there was a signal in the end which could not be driven by interferon one so Yeah, there's place for more than one approaching.

Yes, and that was what I was going to just close out with. I think that's important, Luc. I mean, there's been really very limited innovation in the myocytes space for many, many years. And so I think if you zoom out, there is room for more than one mechanism of action in DM. and in particular what I think is going to be important is to look at the muscle involvement and the impact of these mechanisms of action on the muscle because that is the defining feature of this disease and that's something that we'll be looking for in our phase three readout. Thanks for the question.

And our final question will come from Niall Alexander with Deutsche Bank.

Hi, good afternoon. This is Neil Alexander from Deutsche Bank. Thanks for taking my questions. So just one on VivGuard pricing and channel mix. It'd be helpful seeing if you can provide the actual realized list price per average subcutaneous patient at present. Any color you can give on gross to net pricing and discount. And in addition, it'd be great to get a sense of the channel split for VivGuard sales right now. Thank you.

Thank you. Yeah, of course, I mean, the list price in the U.S. is public information, and you can also reach out to us if you need help with that. I think what is important is that the growth to net and the net price per patient will continue to be stable. It's the same in Q2 as it was in prior quarters. Over time, you'll see a slight increase in growth to net quarter over quarter. and that is because PFS, prefold syringe for self-injection, do have a slightly higher growth to net than the other presentations, but that of course is offset by higher adherence. So I think what we can say is that the net prices per patient continues to be stable and there's nothing really new to say. So thank you for the question.

There are no further questions. This concludes our conference for today. Thank you for participating. You may now disconnect.