argenx (NASDAQ:ARGX) released second-quarter financial results and hosted an earnings call on Thursday. Read the complete transcript below.

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The full earnings call is available at https://argenx-2q26-update.open-exchange.net/registration

Summary

argenx SE reported strong financial performance with Q2 2026 revenues of $1.5 billion, a 60% YoY growth driven by Vyvgart sales, particularly in the U.S. and Japan.

The company is focusing on expanding its Vyvgart indications, including seronegative MG approval, and sees significant opportunity in CIDP and upcoming myositis data.

argenx SE is advancing its immunology pipeline with a goal of launching five late-stage molecules by 2030, including empasiprubart and future FcRn candidates.

Operational highlights include the successful launch of Vyvgart for seronegative gMG and strategic efforts to extend leadership in neurology and rheumatology.

Management emphasized disciplined capital allocation and the potential for significant growth opportunities beyond 2030, leveraging a strong balance sheet for future investments.

Full Transcript

Layla, Conference Operator

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

Beth Del Joco, Vice President of Corporate Affairs

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 2, 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 SE is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer; and Karl G., Chief Financial Officer.

Layla, Conference Operator

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

Beth Del Joco, Vice President of Corporate Affairs

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 2, 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 SE is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer; Karl G., Chief Financial Officer; and Sandrine Piret-Gerard, Chief Commercialization Officer. Luke Troyan, Chief Medical Officer, will be available during the Q and A. I'll now turn the call over to Karen.

Karen Massey, Chief Executive Officer

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 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'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 argenx growth. Slide 4. Vyvgart continues to change what is possible for patients with MG and CIDP 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 Vyvgart for seronegative gMG. Vyvgart is now the first and only treatment approved across all serotypes, 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 5. 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 and 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 IMNM and DM in the phase 2, and 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 assurance data expected in the second half of 2027. Slide 6.

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 2 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 3 program in CIDP to our combination study in MG, we are focused on unlocking the full potential of this mechanism for patients. Slide 7. 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 shape 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 FcRn and we're broadening our immunology pipeline. We are already delivering against this strategy. Our future FcRn molecules, argenx 213 and argenx 124, as well as our IgA sweeper, argenx 121, are progressing towards late stage development, and argenx 118, argenx 125 and TSP101, now in phase one, each represent new pipeline-in-a-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.

Karl G., Chief Financial Officer

Thank you, Karen. Slide 8. 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. Slide 9. 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 and 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 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

Thank you, Karl. I'll begin on slide 10. What continues to set argenx SE 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 VYVGART as a preferred biologic 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 the 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 VYVGART. In the second quarter, approximately 80% of pre-filled 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 approval for 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 AChR-positive population. On the payer side, we leveraged the credibility and relationships 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 requirements, 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 sat at my colleague’s 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 recurrent 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. And this is exactly why generating data that shows meaningful functional improvement matters. Our grip strength 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 a Phase 4 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?" Finally, 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 our data suggest 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 SQ RM. 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 HCPs 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

Thank you, Sandrine. As you've 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. And while there is much to be proud of in the first half of the year, there is even more ahead. We entered 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. And with that, operator, we'll open the call for questions.

Layla, Conference Operator

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.

Miles Minter, Analyst

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 know, you've delivered quarter-over-quarter, sort of mid-teens percentage growth if you take out the first quarter seasonality. 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 plans are not requiring the serology testing for that population.

Thanks very much.

Sandrine Piret-Gerard, Chief Commercialization Officer

Yes, 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: of course every quarter has its own dynamic, 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 in prior years.

We're off to a strong start, of course, with seronegative, 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 to continue to look to grow and to look similar to prior years. Thanks for the question, Miles.

Layla, Conference Operator

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

Derek Archila, Analyst at Wells Fargo

Hey, good morning and congrats on the quarter here. Excellent results. I just want to understand, where do things stand with the ocular MG filing? And I guess, maybe going to more tailwinds, but assuming approval, how do you think ocular could be a growth driver, and does that really materially change VYVGART's revenue trajectory? Thanks.

Karen Massey, Chief Executive Officer

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.

Sandrine Piret-Gerard, Chief Commercialization Officer

Thank you, Karen, and Derek for the question. So I see the ocular MG potential approval as another way to continue and to support our growth momentum. For 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, and 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.

So I'm very confident that this will be another leg to our growth for the long term.

Layla, Conference Operator

Our next question will come from Tazina Maad with B of A.

Tazina Maad, Analyst at BofA Securities

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, you're 18 quarters in and you've had commanding share, but there continue to be new launches and upcoming launches, and some of the competitors are talking about what advantages their products might have, including 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.

So can you maybe share with us your feedback from the field about what, you know, doctors’ satisfaction is vis-à-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

Yeah, thank you, Tazina, for the question. Let me just comment broadly on competition and then I'll hand it over to Sandrine. But, you know, we've had this question a lot. I would say we launched in MG, and I like to say that argenx SE 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 VYVGART 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.

Sandrine Piret-Gerard, Chief Commercialization Officer

Yes. So VYVGART, I mean, 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 been used in earlier lines. And the reason is that the label supports it and the data support it. And 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.

So I haven't seen, until now, other competitors being able to demonstrate MSE or even speak about MSE. And so that's really what stands out when you speak about the efficacy of VYVGART. And then if you combine that with its safety over more than 25— I mean, this is a very strong combination of a safety and efficacy profile that puts us in a position to be used earlier. And that's why, until now, we haven't really seen a meaningful impact on our growth trajectory.

Layla, Conference Operator

Our next question will come from Alex Thompson with Stifel.

Alex Thompson, Analyst at Stifel

Hey, great. Thanks for taking our question. Maybe for Karen, could you walk us through 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

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 a positive readout on the primary endpoint in one or more subsets, and 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. 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?

Beth Del Joco, Vice President of Corporate Affairs

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 argenx SE. 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.

Layla, Conference Operator

Our next question will come from Akash Tiwari with Jefferies.

Akash Tiwari, Analyst at Jefferies

Hey, 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. Basically, DM and IMNM are now being run independent as two separate trials. Is that the correct read here? And then if the effect size in DM for your phase 2 trials was replicated in phase 3, would the trial hit stat sig or not? And if not, what are some reasons that efficacy could improve from phase two to phase three?

Thank you.

Karen Massey, Chief Executive Officer

Yeah, thanks for the questions, Akash. We have Luke here, so I'll ask him to comment.

Luke

Yeah, and thanks, Akash. So you are correct. The way we now approach the analysis is that we will independently analyze the subsets, 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 3 in the end that's what we have observed in phase 2.

You could make the assumption that because it's twice as long and twice as big that that would increase the chance for a statistical difference, which is certainly true, but not a guarantee. We just will have to turn the data card, see what we have, and then determine our path forward. But whether stat signal or stat negative, we are working on a plan forward in the end.

Layla, Conference Operator

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

Rajan Sharma, Analyst at 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? 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.

Cameron

Yeah, happy to have Luke comment on this. Just a reminder, this was a phase 2 proof-of-concept study, and what we wanted to do was use it to explore and learn about the use of empasiprubart in the transplant setting broadly, with a focus on DGF in the particular study. But Luke, maybe you can talk about what we saw and the path forward.

Luke

Yeah, thanks, Cameron, thanks for the question. So as I 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. We had chosen as a target DGF, which is a relatively short 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.

Karen Massey, Chief Executive Officer

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 2 study where, on the endpoint of grip strength, both in the initial part A as well as the open-label extension, we saw positive results.

Thanks for the question.

Layla, Conference Operator

Our next question will come from Yatin Suneja with Guggenheim.

Yatin Suneja, Analyst at Guggenheim

Hey guys, thank you for taking my question. Again, excellent results, so congrats again. So quick one on the pipeline, specifically on ARGX One2One, the IgAN 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.

Karen Massey, Chief Executive Officer

Yeah, thanks for the question about argenx One2One. We're really excited about One2One and broadening our pipeline with the IgA sweeper. We had shared data specifically from the phase 1 profile that showed that argenx One2One reduces IgA by about 90% within a matter of days, and that reduction is maintained all the way out to day 28 with one single dose. So very impressive data, and we're moving very quickly with urgency into IgAN. Perhaps, Luke, you could share your thoughts on the IgAN development program.

Luke

Well, with such a signaling phase 1, we are all 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 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.

Layla, Conference Operator

Our next question will come from Yaron Werber with Cowen.

Yaron Werber, Analyst at 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 8 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 3 trial design, maybe a little bit of the powering or whatever you can share as to what you expect from baseline?

Thank you.

Karen Massey, Chief Executive Officer

Yeah, maybe Luke, I can pass it over to you to talk about the study design.

Luke

Yes, and thanks for the question, because it allows us to talk through what are we really trying to achieve. So with the phase 2 data, as you remember, we had like an 81% reduction in the need for rescue with IVIG for those that received empasiprubart—this 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. 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 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. 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.

Karen Massey, Chief Executive Officer

Yeah, thanks, Luke. And just to wrap it up, what I would say is what we see as successful 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.

Layla, Conference Operator

Our next question will come from Danielle Brill with Truist.

Alex, Analyst at Truist (for Danielle Brill)

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 empasiprubart trials. As far as it relates to the commercial read-through to the CIDP launch in the regions where VYVGART is available, who are the types of patients who are enrolling in the empasiprubart CIDP trials instead of trialing VYVGART?

Sandrine Piret-Gerard, Chief Commercialization Officer

Thanks. Hi. Yeah, so 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 biologic rationale.

So our hypothesis is that we have a 70% response rate with VYVGART, so 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 multiple drivers of the disease and so an overlap that might be eligible for both VYVGART and empasiprubart. So 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.

And then 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

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

Thomas Smith, Analyst at Leerink 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 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?

Karen Massey, Chief Executive Officer

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, ARGX-213 we know has a Q4 weekly dosing schedule. ARGX-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

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

Sean Lahmann, Analyst at 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?

Karen Massey, Chief Executive Officer

Yeah, 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 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. 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.

Sandrine Piret-Gerard, Chief Commercialization Officer

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. So I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers, but also from patients. And although we are only 10 weeks in, so it's still very early, the feedback is overwhelmingly positive. I mean, you saw the quote 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. And so a lot of hope, a lot of enthusiasm from 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 providers are saying, 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. 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 confirmed. What we are also very, very happy about is that the payers have been approving quite quickly and endorsing the policy regarding seronegative, where we have roughly 55% of the covered lives yet already, less than three months after launch.

And 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. 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 plans 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.

Layla, Conference Operator

Our next question will come from Samantha Semenkow with Citi.

Samantha Semenkow, Analyst at 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 and 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

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

Sandrine Piret-Gerard, Chief Commercialization Officer

Yeah, so 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 the treatment for CIDP. So we published 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. And we presented a study at AAN 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 VYVGART in 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 improvement.

Layla, Conference Operator

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

Gavin Clark Gartner, Analyst at Evercore ISI

Hey, thanks for taking the question. Just following the recent riliprubart 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 MMN? Thank you.

Karen Massey, Chief Executive Officer

Yeah, thanks for the question, Gavin. As a reminder before I hand it over to Luke, our clinical development program for CIDP for empa 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, Luke, on your confidence in the IVIG study as well.

Luke

Yeah, and what is important to realize, 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 study to establish, for example, that clinical adjudication committee, which now has become the standard. But we continue to exclude possible CIDP patients, for example — this is 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 if there is 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 VYVGART experience and we've been able to demonstrate that ability.

So that gives me additional confidence as well.

Layla, Conference Operator

Our next question will come from Sophia Graust with JP Morgan.

Sophia Graust, Analyst at JP Morgan

Good afternoon. Thanks for taking my question — one on the upcoming myositis trial. You've 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?

Luke

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 path forward for ACES.

Sophia Graust, Analyst at JP Morgan

Thank you.

Layla, Conference Operator

Our next question will come from Victor Flock with BNP Paribas.

Victor Flock, Analyst at BNP Paribas

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 VYVGART 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 milestones for the autoinjector and the expected launch timing.

Thank you very much.

Karen Massey, Chief Executive Officer

Yes. So thanks for the question on PFS. I'll hand it over to Sandrine in a moment. But just to confirm, autoinjector — that 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.

Sandrine Piret-Gerard, Chief Commercialization Officer

Yeah. So 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 VYVGART. So it's true expansion for us. And you compare to last time where we said 68%. Last time, 68% was launch to date — so these were the patients since the launch. This time, actually just if you look at launch to date, to compare apples with apples, we would be at 70%. So 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 — start on PFS, sorry — are new to VYVGART. So thank you for the question.

Layla, Conference Operator

Our next question will come from Andy Chen with Wolfe.

Jason, Analyst at Wolfe Research (for Andy Chen)

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. And 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 like subtle differences and anything to think about when looking at the uptake of ocular. Thank you.

Karen Massey, Chief Executive Officer

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

Karl G., Chief Financial Officer

Thank you, Karen. And thank you, Jason, for the question. Yeah, as 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 US huge unmet need, and also the halo effect the seronegative had on the broader GMG market. So I think — and 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, 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 for patients. Thank you for the question.

Layla, Conference Operator

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

UNKNOWN Analyst

Oh great. Thanks so much for taking a question and congrats on another great quarter. Maybe, Luke, just want to circle back on a prior question. So my side is you mentioned that IMNM and DM are independent analyses. Each of them has its own chance of hitting 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-comer trial, 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 a P-value below 0.025 because, again, you're splitting the alpha between the two trials?

Luke

Yeah, so I want to stay consistent with how we answer that at the R&D day, which is we will not 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.

Karen Massey, Chief Executive Officer

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 plans are independent of each other — so IMNM and then DM separately. So they are two separate analysis plans. And our filing strategy and path forward is in IMNM. Recall that there are no approved treatments in IMNM and so we have breakthrough designation with the FDA and have had significant 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 — IMNM and DM. So we're on track for Q3, we'll turn the data card, and we'll determine the path forward from there.

UNKNOWN Analyst

Got it. Thanks so much.

Layla, Conference Operator

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

Sebastian van der Sot, Analyst at 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 the 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.

Karen Massey, Chief Executive Officer

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 VYVGART 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. As always, 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. 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 capacity — 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.

Layla, Conference Operator

Our next question will come from Douglas Stile with H.C. Wainwright.

Douglas Stile, Analyst at H.C. Wainwright

Hi, good morning. Thanks for taking the questions. Just 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. 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 VYVGART's 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

Yeah, 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 CIDP 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.

Sandrine Piret-Gerard, Chief Commercialization Officer

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 notice when I discuss CIDP with patients, but most importantly with providers, is that it's a disease which is not well understood. And when there is not really a true dialogue between the patients and the providers, actually the unmet need is underestimated. And even when a patient is being treated and is thought as being well managed, actually not the case, because there is not this true dialogue.

And I often use an example: 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 them to 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 providers that you can make a difference by putting them on treatment like VYVGART. 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 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 just generate data to show that you can get your life back if you really take that seriously. This takes time. It takes a lot of data generation and it takes also patience to go and have the discussion with their providers.

So that's what we are trying to do.

Layla, Conference Operator

Our next question will come from Kezi Ding with Redburn.

Kezi Ding, Analyst at Redburn

Hi, thanks for taking my question. Can I just ask a quick follow-up question on the BD? Are you interested in 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

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 Empatha Prova, we have argenx 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 are 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.

Layla, Conference Operator

Our next question will come from Xiandeng with UBS.

Xiandeng, Analyst at UBS

Hi, thank you for taking that question. One on DM, please. So just wondering, there's 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, et cetera, et cetera. So just wondering, do you see some sero-subconscious types of DM that potentially have better response, and are you enriching those for the study?

Thank you.

Karen Massey, Chief Executive Officer

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, but maybe you can provide a little more detail.

Luke

Again, the theme of these diseases are not really driven by just one mechanism, which is why we thought that multiple modes of action are moving forward. The anti-something 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 the muscle. We feel that, given the demonstrated level of autoantibodies present in these diseases and their targets, addressing primarily the autoantibodies has a role to play.

And in that sense our Phase 2 subset data demonstrate that there was a signal in DM which could not be driven by interferon-1. So yeah, there's a place for more than one approach here.

Karen Massey, Chief Executive Officer

Yes, and that was what I was going to close out with. I think that's important. I mean, there's been really very limited innovation in the myositis 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 forward to in our Phase 3 readout. Thanks for the question.

Layla, Conference Operator

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

Niall Alexander, Analyst at Deutsche Bank

Hi, good afternoon. It's Niall Alexander from Deutsche Bank. Thanks for taking my questions. So 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. And in addition, it would be great to get a sense of the channel split for VYVGART sales right now. Thank you.

Karl G., Chief Financial Officer

Thank you. Yeah, of course, I mean the list price in the US 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 gross-to-net and the net price per patient 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 gross-to-net quarter over quarter, and that is because PFS — prefilled syringe for self-injection — does have a slightly higher gross-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 continue to be stable and the business is good, and there's nothing really new to say. So thank you for the question.

Layla, Conference Operator

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

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