"argenx" Q2 2026 Earnings Call - VYVGART Sales Hit $1.5B as Seronegative Expansion and Pipeline Catalysts Accelerate

Layla, Conference Operator, argenx: Good morning. My name is Layla, 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 would like to introduce Beth DelGiacco, Vice President of Corporate Affairs. You may now begin your call.

Beth DelGiacco, Vice President of Corporate Affairs, argenx: Thank you. A press release was issued earlier today with our second quarter 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 would 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 conform those statements in relation to actual results unless required by law. I am joined on the call today by Karen Massey, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Sandrine Piret-Gerard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A.

I will now turn the call over to Karen.

Layla, Conference Operator, argenx: Thank you, Beth, and welcome everyone. I will 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 VYVGART 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 seronegative MG approval. The progress we are 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, fueling the next phase of argenx growth. Slide four.

VYVGART continues to change what is possible for patients with MG and CIDP, and we see strong growth across both indications in 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 prefilled 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 VYVGART for seronegative gMG. VYVGART 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 ocular MG ahead, we are moving forward in our ambition to make VYVGART 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 neurology with empasiprubart and extending the impact of FCRN into new therapeutic areas, starting with rheumatology. VYVGART has the potential to have a similar impact in rheumatology as it has had in neurology. 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 IMNM, patients can progress from their first symptoms to needing a wheelchair within a matter of months. We heard this at R&D Day. 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 IMNM and DM in the phase II, we’re on track for a readout this quarter. Myositis is just the beginning. We believe a first-in-class launch in myositis can establish the foundation for broader leadership in rheumatology with data expected in the second half of 2027. Slide six. empasiprubart remains on track to become our second pipeline in a product with our first registrational readout in MMN expected later this year. MMN represents one of the clearest unmet needs in neurology. empasiprubart has the potential to offer a differentiated approach supported by the efficacy, durability, and safety profile observed in the phase II ARDA study. We continue to see growing enthusiasm from the neurology community, particularly around the safety profile and the sustained improvements in grip strength observed in the open label extension. These are outcomes that matter in patients’ daily lives.

Our ambition extends well beyond MMN. The unique biology of C2 inhibition has the potential to benefit a broader range of patients. From our ongoing phase III 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, 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, we are pursuing this through two pathways. We’re extending our leadership in FCRN, we’re broadening our immunology pipeline. We are already delivering against this strategy. Our future FCRN molecules, ARGX-213 and ARGX-124, as well as our IgA sweeper, ARGX-121, are progressing towards late-stage development

Karen Massey, Chief Executive Officer, argenx: ARGX-118, ARGX-125, and TSP-101, now in phase I, 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. With that, I’ll turn the call over to Karl.

Karl Gubitz, Chief Financial Officer, argenx: 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 U.S., $102 million in Japan, $136 million across the rest of the world, and $5 million related to product supply to Zai Lab in China. Our U.S. market grew by 15% quarter-over-quarter, with a gross-to-net and net pricing similar to prior quarters. In Japan, quarter-over-quarter net product sales growth is 55% or $35 million. Reported sales include a one-off benefit of approximately $25 million due to a change in our distribution model. Next 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 stepped 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 multiproduct 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 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.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Thank you, Karl. I’ll begin on slide 10. What continues to set argenx 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. This is an approach that continues to deliver results. More HCPs are choosing to prescribe Vyvgart as their preferred biologics for MG and CIDP. More patients are requesting Vyvgart, and as a result, getting on treatment earlier. Patients are remaining on treatment because Vyvgart 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 high level. The prefilled syringe continues to be an important driver of this demand across both MG and CIDP. Its convenience and flexibility are supporting broader adoption of Vyvgart. In the second quarter, approximately 80% of prefilled syringe patients in the U.S. have been new to Vyvgart. We also see increasing breadth and depth of prescriptions for Vyvgart. Physician confidence in Vyvgart 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. Vyvgart 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 serotypes of gMG, MuSK positive, triple seronegative, and LRP4 positive, strengthens Vyvgart’s leadership in MG and advances our goal of reaching the broadest patient population. We are pleased with the early response to the label expansion, with extremely positive patient and HCP feedback. We have established relationships with more than 80% of seronegative MG treaters and see the recent Vyvgart 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 lives, all within 10 weeks since launch. Most plans are removing the serology testing requirement, making it simpler for physicians to prescribe VYVGART as the go-to option in 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 shut off 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 ocular 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-patient 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 their current therapy. Yet, what we consistently hear is that many have learned to live around their disease, often without realizing how much function they have lost. This is exactly why generating data that shows meaningful functional improvement matters. Our GRIT-strong results demonstrate the impact VYVGART 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 VYVGART. We presented recently at PNS the results of our phase IV switch study showing that 87% of patients on IVIG switched successfully to VYVGART, helping address the question, how do I switch from IVIG to VYVGART?

We continue to explore the opportunity to reach patients earlier in their disease journey. We see significant potential among the large population of untreated patients, where all 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 VYVGART to establish early leadership as the first sSARM. 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 KOL treating autoimmune myositis, advancing disease state 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.

Karen Massey, Chief Executive Officer, argenx: Thank you, Sandrine. As you heard today, we continue to see strong momentum across the business, with significant opportunities ahead for VYVGART and a pipeline positioned to sustain growth well into the future. 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 mission together. With that, operator, we’ll open the call for questions.

Layla, Conference Operator, argenx: 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. We’ll pause just a moment. Our first question will come from Myles Minter. Your line is now open. Please go ahead.

Myles Minter, Analyst: Thanks very much. 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 % 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, whether there’s any sort of tailwinds that we should think about from the broader population now that most plans are not requiring the serology testing for that population. Thanks very much.

Karen Massey, Chief Executive Officer, argenx: Thanks for the question, Myles. I would agree with you. It is incredible, 18 quarters in, that we’re still delivering consistent growth quarter-over-quarter. What I would say related to the quarterly trends, of course, every quarter has its own dynamics. 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 seronegative. We’ve had the same dynamic in prior years with the launch of the PFS and that type of thing. I would expect it to continue to look to grow and to look similar to prior years. Thanks for the question, Myles.

Layla, Conference Operator, argenx: Our next question will come from Derek Archila with Wells Fargo.

Derek Archila, Analyst, Wells Fargo: Hey, good morning. Congrats on the quarter here. Excellent results. I just wanted to understand, where do things stand with the ocular MG filing? I guess, maybe going to more tailwinds, assuming approval, I guess how do you think Ocular could be a growth driver, does that really materially change VYVGART’s revenue trajectory? Thanks.

Karen Massey, Chief Executive Officer, argenx: Yeah, thanks for the question. We’re moving forward with urgency on Ocular MG filing. There’s a big patient unmet need in Ocular MG. Of course, there’s no advanced therapies approved in this patient population. We will be the first and only approved treatment in this population. We’ll update you when we have a PDUFA date. Maybe, Sandrine, you could comment a little bit on how you see the outlook if we do have an ocular approval.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Thanks, Karen, and Derek for the question. I see the Ocular MG potential approval as another way to continue and to support our growth momentum. Over the last five years, we basically have had five launches when you think about that. This would give us another launch to continue that growth momentum. We’re 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. I’m very confident that this will be adding another leg to our growth for the long term.

Layla, Conference Operator, argenx: Our next question will come from Tazeen Ahmad with BofA.

Tazeen Ahmad, Analyst, Bank of America: Hi. Good morning. Thanks for taking my question. Karen, and maybe Sandrine, I wanted to get your thoughts about the competitive landscape. You’re right, your 18 quarter is in and you’ve had commanding share. 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 FcRns in general, and that patients might be dropping off therapy due to safety observations. Can you maybe share with us your feedback from the field about what doctors’ satisfaction is vis-a-vis their patient commentary on both efficacy, and can you talk to us about dropouts as a result of any safety concerns? Thanks.

Karen Massey, Chief Executive Officer, argenx: Yeah. Thank you, Tazeen, for the question. Let me just comment broadly on competition, then I’ll hand it over to Sandrine. We’ve had this question a lot. I would say we launched in MG, and I like to say that argenx put MG on the map, and there’s been a lot of competition that has followed us into the space. Throughout that, we’ve maintained our leadership in the market. You can see, for example, four out of five physicians continue to say that they choose VYVGART before any other biologic. Sandrine, maybe you want to comment on specifically the efficacy advantage and any other dynamics you see in the market.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Yes. VYVGART, like you said, Karen, is being seen and is being used today earlier than the others. The others are used more in refractory populations, and it’s being used in earlier lines. The reason is that the label supports it and the data support it. When you look at the data, I wonder if anybody else can demonstrate an MSE that we have. We have 60% of patients that have reached minimal symptom expression, and then that MSE is sustained over time. I haven’t seen, until now, other competitors being able to demonstrate MSE or even speak about MSE. That’s really what stands out when you speak about the efficacy of VYVGART.

If you combine that with its safety over more than 25,000 patient years, this is a very strong combination of safety and efficacy profiles that puts us in a position to be used earlier lines. That’s why, until now, we haven’t really seen a meaningful impact on our growth trajectory.

Layla, Conference Operator, argenx: Our next question will come from Alex Thompson with Stifel.

Alex Thompson, Analyst, Stifel: Great. Thanks for taking our question. 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.

Karen Massey, Chief Executive Officer, argenx: 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. That’s the data that we’ll share. 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’ll be the first-in-class FcRn approval in rheumatology. We’ll be looking for positive data on the primary endpoint in one or more subsets. Beth, you want to share a little bit more about what they can expect to see at top-line results?

Beth DelGiacco, Vice President of Corporate Affairs, argenx: We’re still working out the specific details of what the communication will look like. What we know is that this is an important event with positive data for argenx. 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. The details are still to come, but you can assume that those are the key topics of the communication.

Layla, Conference Operator, argenx: Our next question will come from Akash Tewari with Jefferies.

Akash Tewari, Analyst, Jefferies: Thanks so much. Can you give a little more color on your stat plan for myositis? Based on your public comments, it seems like there is no alpha split. DM and IMNM are now being run independently as two separate trials. Is that the correct read here? If the effect size in DM for your phase II trials was replicated in phase III, would the trial hit stat sig or not? If not, what are some reasons that efficacy could improve from phase II to phase III? Thank you.

Karen Massey, Chief Executive Officer, argenx: Thanks for the questions, Akash. We have Luuk here, so I’ll ask him to comment.

Luc Truyen, Chief Medical Officer, argenx: Thanks, Akash. You are correct. The way we now approach the analysis of the phase III is that we will independently analyze the subset, so each has their own chance to win. As you also know from the research day, 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 III, in the end, that will be observed in phase II. 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.

Whether stat sig or stat negative, we are working on a plan forward in the end.

Layla, Conference Operator, argenx: Our next question will come from Rajan Sharma with Goldman Sachs.

Rajan Sharma, Analyst, Goldman Sachs: Hi. Thanks for taking my question. I’ve actually got one on empasiprubart. Could you just provide a little more color on the DGF update, please? It seems like you’re progressing development, but not in DGF itself. 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 to a pivotal trial and what it was that you saw in the 52-week data that gives you confidence to move forward? I’m just wondering if there’s any additional reassurance into MMN based on what you’ve seen in the DGF trial. Thank you.

Karen Massey, Chief Executive Officer, argenx: Yeah. Happy to have Luuk comment on this. Just a reminder, this was a phase II proof of concept study. 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. Luuk, maybe you can talk about what we saw and the path forward.

Luc Truyen, Chief Medical Officer, argenx: Yeah. Thanks, Cameron. Thanks for the question. As already said, this was a relatively small trial, basically evaluating a hypothesis whether we could influence reperfusion injury with this mechanism. The transplant situation lends itself to this. We had chosen as a target DGF, which is a relatively short-term goal. 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.

Karen Massey, Chief Executive Officer, argenx: 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. In particular for MMN with the readout in Q4, I think the most important data point to look at there was our positive phase II 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.

Layla, Conference Operator, argenx: Our next question will come from Yatin Soneja with Guggenheim.

Yatin Soneja, Analyst, Guggenheim: Hey, guys. Thank you for taking my question. Again, excellent results, congrats again. Quick one on the pipeline, specifically on ARGX-121, the IgAN program. Could you maybe talk a little bit about the profile that you have seen in phase I that is enabling you to move into phase II? What level of IgA reduction you saw, how should we think about frequency, all of that? Thank you.

Karen Massey, Chief Executive Officer, argenx: Thanks for the question about ARGX-121. We’re really excited about ARGX-121 and broadening our pipeline with the IgA sweeper. We had shared data specifically from phase I and with the profile that showed that ARGX-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. Very impressive data, and we’re moving very quickly with urgency into IgAN. Perhaps, Luuk, you could share your thoughts on the IgAN program, clinical development program.

Luc Truyen, Chief Medical Officer, argenx: With such a signal in phase I, we are very excited to keep this really moving fast. When we showed those data to key opinion leaders, they were also very enthusiastic, and this speed and depth really puts it aside from, as we all know, IgAN has quite some efforts going on, but our signature of the drug here really set us apart and is really offering us great hopes for the phase II and the phase III that we can bring a meaningful drug to patients.

Layla, Conference Operator, argenx: Our next question will come from Yaron Werber with Cowen.

Yaron Werber, Analyst, Cowen: Great. Thanks so much. Congrats on a 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 non-inferiority, and then you have superiority. Can you maybe just talk about that phase III trial design, maybe a little bit of the powering or whatever you can share as to what do you expect from baseline? Thank you.

Karen Massey, Chief Executive Officer, argenx: Maybe Luke has a particular view. Talk about the study design.

Luc Truyen, Chief Medical Officer, argenx: Zeynep, thanks for the question because it allows us to talk to what are we really trying to achieve at argenx. With the phase II data, as you remember, we had an 81% reduction in the need for rescue with IVIG for those that received empasiprubart. To the point where we said, if every rescue we need to take forward is on IVIG, we might as well do IVIG head-to-head, which would also provide the most meaningful data for prescribers. 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 empasiprubart. The endpoint here is indeed grip strength, which we picked in conversation with the agencies because there were quite meaningful data available, which allowed us to define a non-inferiority margin.

The non-inferiority margin is set, pretty relevantly, but we also have the opportunity to go to superiority. Based on the phase II 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 the best information.

Karen Massey, Chief Executive Officer, argenx: Thanks, Luke. 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. When we speak to KOLs and prescribers, we certainly hear excitement about the fact that we have a head-to-head versus IVIG. Certainly with our experience in CIDP, we have some experience competing in that space as well. I think we’re set up for success, assuming a positive readout towards the end of the year with MMN.

Layla, Conference Operator, argenx: Our next question will come from Danielle Brill with Truist.

Alex (for Danielle Brill), Analyst, Truist: Hey, guys. This is Alex on 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 of the CIDP launch, in the regions where VYVGART is available, who are the types of patients who are enrolling in the EMPA CIDP trials instead of trialing VYVGART? Thanks.

Karen Massey, Chief Executive Officer, argenx: Hi. Yeah. Maybe to start, just to lay out our strategy with CIDP. We see that CIDP is a heterogeneous disease and there is significant unmet need. Until VYVGART launched, there hadn’t been innovation in the space for 30 years, and we’ve seen the strong uptake of VYVGART in CIDP. What we know is with the disease heterogeneity, that there is also IgM driving the disease, and so that’s why we have the study with empasiprubart where we think we have strong biology rationale. Our hypothesis is that there are some patients. We have a 70% response rate with VYVGART. Those patients that don’t respond to VYVGART might have more IgM-driven disease, and so we think that there’s an opportunity for empasiprubart 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 VYVGART and empasiprubart. Our strategy here is to study empasiprubart, and we’re enrolling empasiprubart in a broad patient population so we can understand the impact of empasiprubart on the disease. Once we have the data readout, we can analyze that data as well as the VYVGART data and really understand what is driving the best outcome for patients and move forward with a commercial strategy from there. Thanks for the question.

Layla, Conference Operator, argenx: Our next question will come from Thomas Smith with Leerink Partners.

Thomas Smith, Analyst, Leerink Partners: Hey, guys. Good morning. Thanks for taking our questions, 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 ARGX-213 and ARGX-124? Any additional color on the target profile you’re aiming for with ARGX-124 with respect to IgG lowering or dosing interval or other potential differentiation? How do you think about indication selection between life cycle management and potential expansion opportunities across those candidates? Thanks so much.

Karen Massey, Chief Executive Officer, argenx: 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. Our next-generation molecules, 213 and 124 that you referred to, 213 is we call it phase III-ready, and 124, we’re in phase I at the moment, and by the end of the year, we’ll be in a position to move it into late-stage clinical development. At the moment, we’re working with our teams based on that data to assess the two molecules. Of course, Argenx 213 we know has a Q4W dosing schedule.

Argenx 124, we’re further categorizing the advantages that it will bring over VYVGART 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 VYVGART, 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.

Layla, Conference Operator, argenx: Our next question will come from Sean Bauman with Morgan Stanley.

Sean Bauman, Analyst, Morgan Stanley: Good morning, Karen and team. Hope everyone’s well. Karen, just going back to the seronegative gMG impact. What specifically 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?

Karen Massey, Chief Executive Officer, argenx: Thanks for the question. 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 seronegative launch. It really is the argenx playbook in action. We made a commitment to this patient population many years ago when we launched VYVGART, that we would bring this innovation to seronegative patients. To see that happening in the market and being so positively responded to is really exciting. Sandrine, maybe you could comment a little bit more on the dynamics you’re seeing with the launch.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Thank you, Karen, and thank you for asking a question on seronegative, because for me, this is a big event in the second quarter, so it’s great to have someone asking that question. I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers, but also from patients. Although we are only 10 weeks in, so it’s still very early, the feedback is overwhelmingly positive. You saw the quotes I had in the presentation from the patients. Many were actually waiting for solutions because they had been excluded from clinical trials, especially the triple seronegative patients, and they were really waiting for an option. 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 VYVGART as the go-to option for all my gMG." One of the things we have observed over the first few weeks is that it has really a strong halo effect beyond the seronegative patients onto the positive serotype patient, and that was something that we were expecting, but it’s great to see confirmed.

What we are also very happy about is that the payers have been approving quite quickly and endorsing their policy VYVGART in seronegative, where we have roughly 55% of the covered lives yet already less than three months after launch. I had said that it would take three to six months to get to roughly 90%, and we are well on track to get there. What is also very important is not just the quantity of coverage, but also the quality. Seeing that the majority of the plans are removing the testing requirements for the serotype is also making the life of the providers easy. If I would summarize, it’s all about leadership in MG with that approval, but also simplicity of decision-making for the providers. Great feedback until now.

Sean Bauman, Analyst, Morgan Stanley: Thank you.

Layla, Conference Operator, argenx: Our next question will come from Samantha Samenko with Citi.

Samantha Samenko, Analyst, 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 what you’re seeing in the data about treatment-naive patients utilizing VYVGART as a first-line. Are you seeing a shift towards these patients being treated more frequently? If so, how should we think about the progression of the launch in that segment going forward? Thanks very much.

Karen Massey, Chief Executive Officer, argenx: Thanks for the CIDP question. Sandrine, maybe you can comment.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: It’s indeed a very big opportunity for us to really make sure that VYVGART is used as early as possible because still the majority of the patients start with IVIG when they start a treatment for CIDP. We publish data, and we are generating more and more evidence to show that if you are prescribing VYVGART for treatment-naive patients, actually you see clinical benefits. We presented a study at AAN where we show that 87.5% of the patients that were treatment-naive benefited from a clinical response. We are using data to encourage physicians to try VYVGART in earlier line patients, and they are seeing good results. 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 still the majority of them are requiring some kind of experience with IVIG. That’s what we are working on. 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 improvement.

Layla, Conference Operator, argenx: Our next question will come from Gavin Clark-Gartner with Evercore ISI.

Gavin Clark-Gartner, Analyst, Evercore ISI: Hey, thanks for taking the question. Just following the recent ralipracimat update, are you considering any changes to your CIDP development plans for EMPA? 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 MMN? Thank you.

Karen Massey, Chief Executive Officer, argenx: Yeah. Thanks for the question, Gavin. As a reminder, before I hand it over to Luke, our clinical development program for CIDP for empasiprubart has two studies. One is the head-to-head versus IVIG, and the other is a placebo-controlled study. I think it’s around the placebo-controlled study that you’re particularly asking for, but also maybe some comments, Luke, on your confidence in the IVIG study as well.

Luc Truyen, Chief Medical Officer, argenx: Yeah. What is important to realize, CIDP, we used the term already, is a heterogeneous disease also. Therefore, your selection of patients matters. We took particular care in that HERE study to install, for example, that clinical education committee, which now has become the standard. We continue to exclude possible CIDP patients, for example, as one of the differences. 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. What’s your ability to change? We, of course, want to learn, we will be looking more closely at these data and evaluate is there anything we need to do to optimize our studies, we are continuing with our plans to continue both.

Karen Massey, Chief Executive Officer, argenx: Yeah. Maybe just one more comment on that has made me reflect on is that it’s very clear from this that it’s not easy to run successful clinical trials in CIDP. One advantage that we have is that we do have the VYVGART experience, and we’ve been able to demonstrate that ability. That gives me additional confidence as well.

Layla, Conference Operator, argenx: Our next question will come from Sophia Graf with JP Morgan.

Sophia Graf, Analyst, JP 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. Given the strong evidence that ASIS is autoantibody driven, would there be scope to run an ASIS specific trial in future or is this population still a bit too small to target?

Luc Truyen, Chief Medical Officer, argenx: 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. ASIS 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. We will definitely look at the data as they come and determine a path forward for ASIS.

Sophia Graf, Analyst, JP Morgan: Thank you.

Layla, Conference Operator, argenx: Our next question will come from Viktor Floch with BNPP.

Viktor Floch, Analyst, BNPP: Hey, thanks so much for taking our question. Maybe just one on the PFS. I’ve noticed in your slide that the proportion of PFS patients new to VYVGART actually increased to 80% from 68% in Q1, which is quite impressive. I was just wondering whether it makes you incrementally more bullish about the auto-injector opportunity and whether there’s any chance you can share more details on the remaining development milestone for the auto-injector and the expected launch timing. Thank you very much.

Karen Massey, Chief Executive Officer, argenx: Yeah. Thanks for the question on PFS. I’ll hand over to Sandrine in a moment. Just to confirm, auto-injector is on target or on schedule for 2027 launch. Maybe some of the dynamics you’re seeing with prefilled syringe in the market, Sandrine.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Yeah. Thank you for your question, Viktor. Indeed, I wrote on the slide 80% of the patients that are on PFS in the second quarter in the U.S. are new to VYVGART. It’s true expansion for us. You compare to last time where we said 68%. Last time, 68% was launched today. These were the patients since the launch. This time, we should actually just for Q2. If you look at launch to date, to compare apples with apples, we would be at 70%. It’s a slight increase, but it’s not 80%. 80% is really the last quarter, and it shows that actually more and more of the patients that start on VYVGART actually are truly new or start on PFS, sorry, are new to VYVGART. Thank you for the question.

Layla, Conference Operator, argenx: Our next question will come from Andy Chen with Wolfe.

Jason (for Andy Chen), Analyst, Wolfe: 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, will 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.

Karen Massey, Chief Executive Officer, argenx: Yes, thanks for the question. Karl, maybe you can comment on the dynamics of the quarter.

Karl Gubitz, Chief Financial Officer, argenx: Thank you, Karen, and thank you Jason for the question. Sandrine already mentioned in the prepared remarks, the quarter was driven by strong fundamentals and PFS was the key driver of growth. However, seronegative 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 seronegative had on the broader gMG market. Of course, we expect that to also flow into Q3. In terms of ocular, I think as we always said, you need continued innovation to maintain the growth. 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 question.

Layla, Conference Operator, argenx: Your next question will come from Luca Issi with RBC Capital Markets.

Luca Issi, Analyst, RBC Capital Markets: Oh, great. Thanks so much for taking the question, and congrats on another great quarter. Maybe Luke, just want to circle back on a prior question. Myositis, you mentioned that IMNM and DM are independent analyses. Each of them has its own chance to hit the stats. Did the FDA still ask you to split the alpha between the two trials, given that this was originally structured as an all-comer trial that enrolled both populations together? 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?

Do you need to hit P value below 0.025? Again, you’re splitting the alpha between the two trials. Any color there much appreciated. Thank you.

Luc Truyen, Chief Medical Officer, argenx: Yeah. 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. 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 can go in there, but I’m just saying we’re not going to disclose the actual alpha value. Yeah, the data card is to be turned soon.

Karen Massey, Chief Executive Officer, argenx: Yeah. Maybe just to give you some additional insight and color on the strategy and the filing strategy. As Luke shared earlier, the analysis plan is independent of each other. IMNM and then DM separately. They are two separate analysis plans. Our filing strategy and path forward is in IMNM. Recall that there are no approved treatments in IMNM, we have breakthrough designation with the FDA and have had those communications based on that with the FDA. In DM, what we will be looking for, of course, is statistical significance, and once we have that data, we will be able to continue discussions with the FDA on what the path forward is there.

What I want to come back to is that with this myositis study, what we have given ourselves the opportunity to do is have two opportunities for label expansion, both or each of them individually as potential blockbuster indication, IMNM and DM. We are on track for Q3. We will turn the data card, and we will determine the path forward from there.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Got it. Thanks so much.

Layla, Conference Operator, argenx: Our next question will come from Sebastiaan van de Sype with Kempen.

Sebastiaan van de Sype, Analyst, 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 and M&A? What should or should we not expect in this aspect for the next 12 to 24 months? Can you maybe describe the profile of assets that you’ll be looking for to add to your pipeline? Thank you.

Karen Massey, Chief Executive Officer, argenx: Yeah. Thanks for the question. Our overall capital allocation strategy is very much focused on delivering growth, both in the short, mid, and long term. In line with that, our capital allocation strategy focuses on, number 1, fueling VYVGART growth, number 2, funding and accelerating our internal pipeline. That includes our FCRN assets that I was talking about earlier, but also beyond FCRN. 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 argenx has taken has been to partner to look for novel biology, new mechanisms of action, where there’s significant unmet patient need.

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. That bar is that it has to be novel biology, and it has to be in areas where there is significant unmet patient need. 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.

Layla, Conference Operator, argenx: Our next question will come from Douglas Tsao with H.C. Wainwright.

Douglas Tsao, Analyst, H.C. Wainwright: Hi, good morning. Thanks for taking the questions. I’m curious in terms of the CIDP opportunity and the slide where you indicate the number of patients who are diagnosed but not treated. I’m just curious if your sense is, if those patients aren’t being treated, just given the sort of tolerability issues related to IVIG, and is VYVGART’s sort of tolerability become an attractive sort of attribute that you are going to sort of try to sell to clinicians in terms of bringing those patients back into treatment?

Karen Massey, Chief Executive Officer, argenx: Yeah. Thanks for the question, Douglas. 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 CIDP, and there’s a lot of opportunity for continued growth. Maybe, Sandrine, you can share what you’re seeing in the market around those patients.

Sandrine Piret-Gerard, Chief Commercialization Officer, argenx: Yes. Thank you, Karen. Indeed, CIDP, lots of opportunities for further growth within the addressable market we started with at launch, but also way beyond that. 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. 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 true dialogue. I often use the example like, you would ask somebody, "Are you doing okay?

Can you brush your hair in the morning?" The person say, "Yes, I can." Then when you ask how they will 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 to this patient and this provider that you can make a difference by putting them on treatment like VYVGART.

This is the same happening for patients who are not on treatment, and that have been diagnosed because they underestimate their level of 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 their quality of life should look like. What we’re 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 have the discussion with their providers. That’s what we are trying to do.

Layla, Conference Operator, argenx: Our next question will come from K.C. Ting with Redburn.

K.C. Ting, Analyst, 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.

Karen Massey, Chief Executive Officer, argenx: Yeah. Thanks for the question. 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. You can see that within our internal pipeline. Of course, we have empasiprubart, we have ARGX-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. 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.

That’s the strategy that we have for both our internal pipeline as well as business development.

Layla, Conference Operator, argenx: Our next question will come from Jian Deng with UBS.

Jian Deng, Analyst, UBS: Hi, thank you for taking my question. One on DM, please. Just wondering, there are some studies or evidence suggesting DM is more sort of interferon 1-driven disease, and the role of autoantibodies is not as clear as that in IMNM. 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, et cetera. Just wondering, do you see some several subtypes of DM that potentially have better response and are you enriching those for the study? Thank you.

Karen Massey, Chief Executive Officer, argenx: Yeah, 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. Maybe Luuk, you can provide a little more detail.

Luc Truyen, Chief Medical Officer, argenx: Yeah. Again, the theme of these diseases are not driven by just one mechanism, which is why we thought that multiple modes of action are moving forward. The DM is more clearly is more in the Interferon one pathway, as you indicate, which we feel is clearly a demonstrated driver, mostly in skin pathophysiology, but some in the muscle. We feel that given the demonstrated level of autoantibodies presence in these diseases and their targets, that addressing primarily the autoantibodies has a role to play. In that sense, our Phase II subsid data demonstrate that there was a signal in DM, which could not be driven by Interferon one. Yeah, there’s place for more than one approach here.

Karen Massey, Chief Executive Officer, argenx: Yes. That was what I was going to just close out with. I think that’s important, Luuk. There’s been really very limited innovation in the myositis space for many, many years. I think if you zoom out, there is room for more than one mechanism of action in DM. 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 III readout. Thanks for the question.

Layla, Conference Operator, argenx: Our final question will come from Niall Alexander with Deutsche Bank.

Niall Alexander, Analyst, Deutsche Bank: Hi, good afternoon. It’s Niall Alexander from Deutsche Bank. Thanks for taking my questions. Just one on VYVGART 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. In addition, it’d be great to get a sense of the channel split for VYVGART sales right now. Thank you.

Karl Gubitz, Chief Financial Officer, argenx: Thank you. Yeah, of course. The list prices in the U.S. is public information, and you can also reach out to us if you need help with it. I think what is important is that the gross to net and the net price per patients have continued to be stable. It’s the same in Q2 as it was in prior quarters. Over time, you’ll see a slight increase in gross to net quarter-over-quarter, and that is because PFS, prefilled syringe for self-injection, do have a slightly higher gross to net than the other presentations, but that of course, is offset by higher adherence. 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. Thank you for the question.

Layla, Conference Operator, argenx: There are no further questions. This concludes our conference for today. Thank you for participating. You may now disconnect.