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 DelGiacco, Vice President of Corporate Affairs. You may now begin your call.
Thanks, Layla, and welcome to everyone on the call. Earlier today, we issued a press release summarizing positive top-line results from the phase III ALKIVIA study of VYVGART Hytrulo in autoimmune myositis. The press release and the presentation for today's webcast are available on our website. Before we begin on slide two, I'd like to remind you that forward-looking statements may be presented during this call.
These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. argenx is not under any obligation to update statements regarding the future or to confirm these statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer, and Luc Truyen, Chief Medical Officer. I will now turn the call over to Karen.
Thank you, Beth, and welcome everyone. Let's go to slide three. Today is an important day for patients living with autoimmune myositis, and an important day for FcRn science, an exciting day for the rheumatology community, and it is a proud day for argenx. Based on the strength and consistency of the ALKIVIA data that we shared this morning, I can say that I am personally committed to securing a VYVGART label for patients living with both IMNM and DM.
In IMNM, we have breakthrough therapy designation, and we will move with urgency towards submission. In DM, the data establish a path forward, and we'll move with the same urgency to engage regulators on next steps. This is where the data lead us, and more importantly, it's what patients deserve. For too long, patients with IMNM and dermatomyositis have lived with serious progressive diseases and too few treatment options.
For those living with IMNM, the consequences are particularly severe. IMNM progresses quickly, sometimes in a matter of months, leading to irreversible muscle damage, yet no approved therapies exist. In DM, the burden extends beyond severe muscle weakness. Patients live with debilitating skin manifestations of the disease, and many continue to struggle despite available therapies. The ALKIVIA data start to change that picture.
Today is also an exciting day for science. Six years ago, we shared the ADAPT data in gMG, the first registrational study ever for an FcRn. It established VYVGART and the FcRn class as a meaningful new approach in autoimmunity. At the same time, it was a breakthrough for patients and its impact continues today. Since then, each successful VYVGART study has strengthened our understanding of where pathogenic IgGs are not just bystanders of disease, but rather they are driving it.
ALKIVIA is now our sixth positive first-in-class phase III data set with VYVGART, and it validates that autoimmune myositis is IgG-mediated. It is also an exciting day for the rheumatology community. For years, rheumatologists have cared for IMNM and DM patients without the right tools. This is our first phase III data set for VYVGART in rheumatology, and if approved, it will be the first opportunity to integrate an FcRn into their practice of medicine.
And because of all of this, it is also a very proud day for argenx. For us, it is not simply about introducing a new medicine. It is about advancing science and changing what patients can expect from their treatment. Slide four. With that, let us dive into the results. What stands out most to me is the consistency of the data.
We met the primary endpoint in the overall population with VYVGART demonstrating a statistically significant and clinically meaningful improvement in mean total improvement score versus placebo. What is particularly compelling is that this benefit was not confined to one subgroup or one aspect of the disease. We saw a similar magnitude of treatment effect in both IMNM and DM. Consistent improvement across all six core set measures that make up the tests, including MMT-8, and we saw benefits across both muscle and skin manifestations of the disease.
We also saw the profile that has become a hallmark of VYVGART, rapid separation from placebo, deep treatment effect, and benefit sustained through 52 weeks. Importantly, all of this was achieved while maintaining the signature safety and tolerability profile of VYVGART. Slide five. These results are particularly meaningful when you consider the burden these patients face every day.
There is a real urgency to intervene early. Patients can experience severe and rapidly progressive muscle weakness. We heard at R&D Day from Dr. Aggarwal that IMNM patients can go from diagnosis to a wheelchair in a matter of months. Hospitalization is common. Irreversible muscle damage can occur if it is not brought under control. Despite the seriousness of the disease, autoimmune myositis has remained largely overlooked by the industry.
And that is why these results matter. VYVGART is the first and only therapy to demonstrate clinically meaningful improvements across both IMNM and DM, with benefits that span muscle strength, physical function, and other aspects of the disease that directly affect patients' daily lives. In the study, patients maintain their benefit from VYVGART while tapering corticosteroids, which remains an important treatment goal for many patients and physicians. Early KOL feedback has been positive.
They see these results as a meaningful step forward for patients who have historically had far too treatment options. Slide six. ALKIVIA reflects the playbook that has guided us from the beginning, following biology to areas where we believe we can have transformative impact for patients. Along the way, we have translated FcRn science into meaningful advances for patients with several firsts.
We delivered the first major innovation in CIDP in nearly 30 years, and now we have achieved the first positive phase III results in IMNM ever. VYVGART continues its leadership as the only FcRn medicine approved in more than one indication, and now we have the data to support seven. The potential for FcRn is expansive, with an opportunity to transform the treatment paradigm in many more autoimmune diseases, and in the process, reshape treatment outcomes for patients. Slide seven.
With these data, we have the opportunity to build on the foundation we have established in neurology and expand FcRn into rheumatology. If approved, VYVGART will be the first FcRn to reach rheumatologists, with whom we have a tremendous opportunity to make a difference for patients. As we have engaged with rheumatologists, we have heard many of the same challenges we encountered in our early conversations with neurologists.
A need for therapies that work quickly, deliver durable benefit, reduce steroid burden, and improve patients' daily lives. We are also seeing a growing recognition of the role pathogenic IgG autoantibodies play across a number of rheumatic diseases, creating increasing interest in the potential of VYVGART. While our immediate focus is on IMNM and DM, this is just the beginning.
Our next major rheumatology milestone is the Sjögren's phase III readout expected in the second half of 2027, and our phase II study in systemic sclerosis remains ongoing. With that, I will turn the call over to Luc to take you through the ALKIVIA study results. Luc?
Thank you, Karen. Slide eight. I really want to echo your comments. It is an exciting day for the autoimmune myositis community, who have waited a long time for meaningful innovation and targeted treatment options. I want to sincerely thank the patients who enrolled in ALKIVIA, the investigators and advocacy leaders who partnered with us, and the argenx team, whose scientific rigor made this moment possible. Slide nine.
We designed ALKIVIA to reflect what the biology was telling us. Myositis presents differently across subtypes, but IgG autoantibodies are a common driver, and muscle weakness is a hallmark clinical feature. That gave us a scientific basis to study IMNM, DM, and PM within a single, operationally seamless phase II, III basket trial with mean total improvement score, or TIS, as our primary endpoint to measure muscle strength, physical function, and broader disease activity.
We included a specific skin measure for DM as well. We made the decision to continue enrolling all subtype patients in the phase III portion of the study based on the phase II results. 175 patients ended phase III, and all patients had to demonstrate active muscle weakness to enroll. The phase III duration was 52 weeks, allowing us to evaluate the response over a longer time period.
We also introduced a mandatory corticosteroid taper from weeks 16- 44. It is a core part of the design to pressure test the robustness of the treatment effect. This is especially important as it would provide confidence to taper in real life. With that context, let me take you to the data. Slide 10.
As you see on the left chart, the study met its primary endpoint of mean total improvement score, TIS, at week 52 in a combined study population of IMNM and DM with a p- value of 0.0011. You can see a clear, rapid separation of the active versus placebo arm, sustained over the 52-week period and consistent with VYVGART's profile.
We saw a consistent treatment effect across both IMNM and DM across all core TIS measures, which was consistent with the phase II data, as you can see on slide 11. From the baseline chart on the left side here, you can also see that consistent with phase II, we did not have a balanced randomization by subtype. This led to a larger percentage of IMNM patients enrolled in the study.
Looking in the pre-specified subtype analysis for IMNM, efgartigimod met the primary endpoint with a p- value of 0.0048. At week 52, mean TIS was 45.05 in the active treatment arm compared with 30.24 in the placebo arm, resulting in a 14.81 treatment difference. I want to pause here to reiterate, this is the first phase III data set in IMNM, a milestone for the field.
In IMNM, where progressive muscle weakness creates real urgency and long-term steroid exposure remains significant concern, these results are exactly what we aim for. These data form a clear path towards bringing a new treatment to these patients as soon as possible. Moving to dermatomyositis. Patients treated with efgartigimod showed a clear clinical benefit, with an identical magnitude of effect to what we have seen in IMNM.
The mean TIS was 51.51 in the active arm versus 36.96 in placebo, demonstrating 14.52 points of improvement. However, the DM subgroup did not reach statistical significance on the primary endpoint. This is a reflection of the smaller sample size rather than absolute treatment effect. In addition to muscle, we also saw a clear impact on skin disease in DM. The strength of these data compel us to engage with the FDA with urgency on the path forward.
Altogether, we have a rich and compelling data set from ALKIVIA, which we will look forward to sharing with you at a future medical congress. Slide 12. The safety and tolerability profile observed in ALKIVIA is consistent with the established safety profile of VYVGART Hytrulo, as well as from previous clinical trials. The strength and consistency of the efficacy data, combined with a favorable tolerability profile, creates a compelling benefit-to-risk proposition. This strengthens our conviction in bringing this medicine to patients who urgently need better treatment options. I will now turn the call back to Karen.
Slide 13. Thank you, Luc. We are ready to move forward with urgency to bring VYVGART to patients living with autoimmune myositis. Based on the phase II and phase III data and the consistency of treatment effect we observed across both IMNM and DM, we believe we have a compelling regulatory package.
In IMNM, where we have breakthrough therapy designation, we intend to move rapidly towards submission. In DM, we have strong conviction in these data and what they mean for patients, and will engage with the regulators on a path forward. Today's announcement reflect the top-line results. Our next step is to share the full data set with the medical community at an upcoming congress.
We look forward to presenting the depth and consistency of effect across endpoints, including both muscle and skin measures of disease, and to engaging the rheumatology community with a data set that has the potential to change clinical practice. Finally, we are not waiting to prepare for the future. We are advancing our plans for a launch in one or both subtypes, and we continue to invest in the rheumatology capabilities that will support long-term leadership.
This reflects our commitment to the myositis community and our ambition to build a lasting presence in rheumatology. Slide 14. We set a bold ambition to reach 50,000 patients with our medicines, secure 10 labeled indications, and advance five new late-stage molecules by 2030. Today, the ALKIVIA results strengthen our confidence that we are well on track to achieve that vision. What today's data reinforce is that our strategy is working.
We continue to follow biology, we invest in areas of high unmet need, and generate evidence that can change how diseases are treated. ALKIVIA is the latest example of this approach in action. As we look ahead, we are building on a strong foundation, continued expansion of VYVGART, a growing late-stage pipeline, and an innovation model designed to create lasting impact for patients. Slide 15. We continue to unlock the full potential of VYVGART.
Today, we have data supporting seven potential labeled indications for VYVGART and a growing opportunity to reach many more patients. Empasiprubart continues to advance through late-stage development, with our first phase III readout in MMN expected later this year. We are also progressing adimanebart and ARGX-121, and looking forward to adding FB102 to our late-stage pipeline following the close of the Forte transaction.
What you see on this slide is that our growth story does not begin or end with any single molecule. We are broadening the reach of VYVGART today while building the next generation of medicines that can shape the future of argenx.
This is why I am more confident than ever in our ability to continue to bring meaningful innovation to patients and create long-term impact in immunology. I want to say thank you again to the patients, investigators, physicians, and Argonauts who helped make today's milestone possible. We will now open the line for questions.
At this time, we will open the floor for questions. If you would like to ask a question, please press star five on your telephone keypad. You may remove yourself at any time by pressing star five again. We would like to remind callers to please limit themselves to one question so we can accommodate as many participants as possible. We will pause just a moment. Our first question will come from Tazeen Ahmad with Bank of America. Your line is now open. Please go ahead.
Hi, guys. Good morning. Thanks for taking my questions, and congratulations on the positive update this morning. I was wondering if you could provide a little bit more detail on the steroid tapering benefit that you saw. This has been something that you have pointed to as a potential benefit. It looks like you did see that. How do you think it is going to compare relative to how physicians would want to see benefit? Is it simply lowering the amount of steroid, or is there a minimal amount that they wanted to see? Do you plan on showing this and other level of data at upcoming medical meetings as well? Thanks.
Yeah, Tazeen, thank you for the question. In terms of comparing across the different data sets, what I think is actually most compelling about this data set is the consistency of data, even with the steroid taper. Maybe, Luc, I can hand it over to you to talk through that steroid taper.
Yeah. Thank you, Karen, and thank you, Tazeen, for the question. The steroid tapering was a real construct within the trial, where as of week 16, patients were, depending on their level of steroid use coming in, were tapered until week 44 with a target of 5 mg or less of steroids. The reason that we wanted to do this in the trial was to see if indeed the treatment effect would be maintained under those conditions.
And we achieved that, as the robust endpoints show. There is observation that, in fact, placebo patients, several of them had to use rescue. The main goal for us was to make sure that indeed treatment effect is robust. And as I said in the remarks, hopefully for the field, this will give some confidence that you can taper a patient that is benefiting off VYVGART.
Then, Tazeen, on your last question around medical congress, you can absolutely expect that we will be very transparent and share all of the data in the argenx way at an upcoming congress, and it certainly is a robust data set. Thanks, Tazeen.
Our next question will come from Derek Archila with Wells Fargo. Your line is open. Please go ahead.
Hey, good morning, and let me add my congrats on the data. Just one question from us. I was wondering if you could better characterize some of the benefits you are seeing on the secondary endpoints in DM and understanding the caveats of cross-trial comparisons, but how might those compare to brepocitinib? Any that you could see VYVGART where they could be differentiated? Thanks.
Yeah. Absolutely. I think this is top-line results. We've shared with you what I think the primary endpoint and tried to qualitatively sort of outline for you what we see in the secondary results. What is important there is the consistency across all of the core set measures that we see. When we look at those six measures within the TIS, and when we look at other secondary endpoints that measure also things like impact on skin in DM, then we really see consistent treatment effect. That consistency is across both IMNM and DM. I would say we are very pleased with that consistency of the data set. Thanks, Derek.
Our next question will come from Akash Tewari with Jefferies.
Hey, thanks so much. By our math, if you group the phase II and phase III data sets in DM, VYVGART would have a stat sig data package. Can you confirm that is true? Did you disclose bundling both trials when the FDA modified your original trial design earlier this year? If I could sneak in one more, I suspect an effect size approaching 15 on TIS would have been stat sig in phase II. What led to the miss in phase III despite the larger N? It seems like there was a lot of underlying variability here or perhaps steroid rescue imputation. Thank you.
Yeah. Thanks, Akash. Great questions. Let me zoom out for a second. I think what you see, what is clear from the data is that we have a medicine that works across IMNM and DM. We see that there is, as you call out very well, consistency in the improvements that we see between phase III and phase II. Now, obviously, there are some differences in the design between phase III and phase II, so pooling those would not make sense.
But I think you are really focused on the right thing, which is when you look at the primary endpoints for phase II and phase III for IMNM and DM, it is clear that we have a medicine that works, and it is the first time a medicine has demonstrated positive benefit for both of these patient populations, and I think we have a strong regulatory package to take forward. Thanks, Akash.
Our next question will come from Danielle Brill with Truist.
Hi, guys. I'll also add my congrats, and thanks so much for the question. Maybe a follow-up on some of the secondary efficacy endpoint measures. I wanted to ask about the TIS 20, 40, 60 thresholds specifically. I know many physicians view these as important measures of clinical relevance. Can you comment directionally on how efgartigimod performed across these response thresholds and whether the effect was consistent across IMNM and DM? Thank you.
Yeah. Thanks for the question. Maybe, Luc, you can comment on-
Well, we don't want to give too much detail away given upcoming presentations. What I can say is that we were very pleased with the rates of response to those yards milestones you state. TIS 40 in particular is recognized as an important one, and we had a very robust result there.
Your next question will come from Alex Thompson with Stifel.
Hey, great. Congrats on the data, and thanks for taking our question. I wonder if you could talk through your next steps in DM in particular. Do you plan to seek regulatory alignment before filing, or do you expect to file directly with these data? Thanks.
Yeah, I'll hand it over to Luc to comment on the pathways. What I want to reiterate is where I started the call today, which is we do see that we have a medicine that works in both, and we are committed to getting a label expansion in both IMNM and DM. As you point out, the paths do look different. So maybe, Luc, you want to talk to that?
Yeah. From the data set, it should be clear that the path to submission and consideration by the FDA is pretty clear, compelling data set, very robustly significant. So that's very clear. On the DM side, while we are very pleased with the result and the magnitude of the effect size, this has to be a discussion as to what they would require to see to be able to grant approval. And it's too early to speculate what that could be. We will engage in the dialogue as soon as we can.
Your next question will come from Samantha Semenkow with Citi.
Hi, good morning. Thanks very much for taking the question, and let me also add my congratulations on the great result this morning. I have a question on DM. Just given the heterogeneity of this disease, are there any early signals that you can pull out that some autoantibody profiles responded better than others, or are you seeing a pretty broad magnitude of benefit across patients enrolled? Thanks very much.
Yeah, I think we've all used that word heterogeneous nature of DM. I think what we see is that there is one common feature, and that's that autoantibodies are driving this disease, and IgG autoantibodies. And so we see consistent impact across secondary endpoints, across patient populations, and I think it really reinforces the value of VYVGART in that population.
Your next question will come from Sarah Cai with TD Cowen.
Hi, team. Congrats on the amazing data, and thanks so much for taking our question. This is Sarah on for Yaron. The data seems to support filing in DM, as you had noted earlier, but just curious if the conversation with FDA maybe doesn't completely support filing in DM. Would you then choose to run a smaller phase III to have a confirmatory effect in DM?
And separately, are you thinking about maybe expanding into other subtypes of myositis? We've heard inclusion body myositis, IBM, mentioned as an interesting subtype of myositis that maybe VYVGART could also have an effect in. Just curious to hear your thoughts there as well. Thank you.
Yeah. Thanks for the question. I would agree with you, these are amazing data that we're seeing. Yes, in terms of the path forward on DM, as Luc said, we will very urgently have a discussion with the FDA to be able to share what we see as a very compelling data package.
Then I think that we can see that there are a few paths forward, either that we're able to move forward for a label expansion based on the strength of this phase II and phase III data package, or we can think about the example of what we did with SERON and the seronegative in MG. The agreement we came to with the FDA was to do a small follow-on study to be able to really demonstrate the benefit in that patient population.
We have that as a path forward as well. Certainly, from my perspective, what I want to impress is that we are working with urgency on this, and we see a real need to get to patients as quickly as possible. They have really limited treatment options today, and this is a severe disease that progresses quickly. So our goal is the fastest path to patients possible. Then maybe, Luc, I could hand over to you to talk about our thinking on the other subtypes.
Yeah. You mentioned IBM in particular. There, the biology is somewhat more unclear, but you can rest assured that we are very committed with VYVGART or any of our other assets to make an impact for this community with our innovation benefiting their unmet needs. This is just in our mission.
Your next question will come from Thomas Smith with Leerink Partners.
Hey, good morning. Let me add my congrats on these data, and thanks for taking our questions. I know these are just top-line results, but anything in the ALKIVIA data that makes you more confident on the opportunities for VYVGART in Sjögren's versus systemic sclerosis? Thanks so much.
Yeah, it's certainly exciting that we are able to establish ourselves in rheumatology through this data before the Sjögren's readout. But maybe, Luc, you want to talk about your-
Yeah
thoughts on.
Well, I think I would say other than our commitment to rheumatology, there is not an immediate read-through of these results to Sjögren's. For Sjögren's, we did our own small study, giving us confidence that there is a consistency in the biology that we can follow. But I wouldn't say that these data would further support that.
Your next question will come from Rajan Sharma with Goldman Sachs.
Hi. Thanks for taking my questions. Maybe thinking ahead a little bit, but just on the potential commercial launch, assuming there is an approval, I think in the past you've always talked about two or three quarters to get sufficient coverage for VYVGART when there's been new indications. Just given the unmet need in IMNM and potentially even DM, is there any reason that that could be a faster launch than you may have experienced in other indications? Thank you.
Yeah. Great question. We'll certainly be working to get patient access as quickly as possible. I think what we'll do is take the same approach that we've taken in neurology, so it likely will, to your specific question, take a couple of quarters to get that access in place. We don't see that access will be a major barrier for IMNM or DM. Thanks for the question.
Your next question will come from Gavin Clark-Gartner with Evercore ISI.
Hi, this is Yizhong for Gavin. Congrats on the data. Just a question on the phase III eligibility. Can you remind us, it looks like muscle weakness was required for each patient, but for the active skin involvement is not mandatory. It only need to meet one of the five criteria. Based on this criteria, can you remind us how the resulting mix is going to compare with the real-world DM patients presented in the practice? Thank you.
I can answer this. Yes. From the paradigm of a basket trial, we were looking for a dimension that was really common to all so that we can have a common measure of it. As I've indicated, we included in DM a specific skin measure, the CDASI, but we didn't really require a specific level of activity on that. Nevertheless, what I will say about the CDASI result is that I find them very compelling for a treatment effect.
Thank you, Luc.
Your next question will come from Sean Laaman with Morgan Stanley.
Good morning, Karen and team. Congrats on the results, and hope everyone's well. Just wondering with competition, why should physicians choose FcRn over JAK inhibition, and is there particular physician segments or patient profiles where FcRn might emerge as the preferred approach? Thank you.
Yeah. Thanks for the question. Look, I think if we zoom out, we can think of neurology as a good sort of playbook of what we can expect in rheumatology here. What you see in neurology is that VYVGART was the first-in-class FcRn, and that argenx was able to establish ourselves as a trusted partner to neurologists.
As a result of those things, along with the fact that VYVGART has rapid, significant, sustained efficacy, a clear safety profile with, I think it's now 25,000 patient years of safety that gives those neurologists real comfort, and also, of course, the prefilled syringe. So, the convenience factor of a prefilled syringe. That's established VYVGART as the number one branded biologic in MG, and I think what you'll see in rheumatology is exactly the same. We'll be the first, if approved, to launch in rheumatology.
It's the first FcRn in the hands of rheumatologists. I think we have a package of data today that you can see in autoimmune myositis that shows rapid, sustained, significant efficacy with a safety profile consistent of that with what we see in the real world, and obviously the convenience of a prefilled syringe. I think you'll see some similar uptake and similar impact in rheumatology that you have in neurology.
Thank you, Karen.
Your next question will come from Matt Phipps with William Blair.
Thanks for my question, and congrats on great data here. You've talked up a lot the IMNM commercial market opportunity, really CIDP-like in the number of patients. But now with the DM data in hand, how do you see this total myositis opportunity? Could it be as large as MG, given now maybe 60,000 patients with these two subtypes? Thank you.
Yeah. It's a great question. What we shared at R&D Day is that we see both of these indications as blockbuster indications on their own. Obviously the dynamics are a little bit different. In IMNM, with about 20,000 patients, we estimate, but no treatment options, so very high unmet need. In DM, about 40,000 patients, there is an approved therapy. But what we hear from patients and rheumatologists, that there is significant unmet need remaining. As you say, I think that this will be a substantial commercial opportunity. Thanks for the question.
Your next question will come from Suzanne van Voorthuizen with Kempen.
Hi, this is Suzanne. Congrats again on the data. Thanks for taking my question. A lot of the regulatory route focuses on the U.S. and the FDA, but I'm wondering about the ex-U.S. filing strategy. Can you expand a bit on what feedback you've gotten from other health agencies? I think IMNM is clear, but basically for DM, should we expect that the global path to market resembles whatever the route will be in the U.S., or do you see more flexibility already up front in certain other territories? Thank you.
I'm glad you asked, because it is important for us that we are able to bring VYVGART to patients around the world, not just in the U.S. Maybe, Luc, you can talk to that.
Well, given the nature of this data set, of this whole program, in fact, first to phase II and now to phase III, with the treatment impact that we have shown, we will most certainly engage with regulators and present them with this data package, and discuss the route to approval for both IMNM and DM.
Your next question will come from Leland Gershell with Oppenheimer.
Congrats on the data as well. Thanks for taking my question. Just quickly, following on to a previous question on the data differences between DM and IMNM. It looks like from the consistency of the data and the effect size, you have missed that sig on DM by literally just a couple of, or handful of patients. If those patients had produced the same data, could you comment on that? Thank you.
Yeah, absolutely. Look, I do not think I have ever sat in any top-line results where we have not looked at one piece of data and said, "If only," or "What could have been?" I think what is really important is the strength and consistency of the data that we see across IMNM, DM, and that we have a path forward for label indications, for potential label expansion, I should say, in both of those indications. Thank you.
Thanks. Also, just wanted to ask, as you move into this new area of rheumatology, just wonder if you see any differences in getting uptake amongst this new group of physicians, relative to your penetration into the neurologic community. Thank you.
Yeah. Thanks for the follow-up question. Look, I think just like when we started out in neurology, it is about establishing argenx as credible and as a partner in providing care to their patients. I think we are on that journey with rheumatologists. We will be investing to become that partner just like we are in neurology. I think it will take some time, but we will be able to apply that same playbook that I think has been successful in the past.
Okay.
Your next question will come from Victor Floc'h with BNP Paribas.
Hi. Thank you so much for taking my question, and congrats for this great milestone. Maybe first one, a quick follow-up to Rajan's question on the launch. Just like if we let access on the side for one second, considering the very unmet need that you have discussed many times during the call, should it be fair to assume that the launch could be even faster than what we have seen for MG at the time?
A very quick follow-up on modeling and some maybe like a question for Karen, if I may. In terms of launch readiness and preparations, should we expect like a significant step-up in term of SG&A? I think consensus has 3.6 billion in OpEx excluding COGS for this year, 4.2 billion for next year. Does it look fair to you in the context of the IMNM and then launch later this year or maybe more likely later next year? Thank you very much.
Yeah, thanks for both of those questions. I can take both of those. As you said, with our launch, what you can expect, and we have a lot more work and we will have a lot more opportunity to share this with you, is we will go about getting access as soon as possible. That always takes a couple of quarters. But I do think that as you are calling out, there is significant unmet need. I do think that patients and rheumatologists will be excited about the opportunity to start using VYVGART in their practice.
We look forward to a successful launch, that is for sure. In terms of launch readiness, we are already working on it. But any step-up in SG&A that you can expect because of the expansion into rheumatology would come through in next year's financials. We will be able to share more detail with you at an upcoming meeting. Thank you.
Thank you very much.
Your next question will come from Luca Issi with RBC.
Oh, great. Yeah, thanks so much for taking my question. Congrats on the great data. Maybe, Luc, can you comment on what you're seeing in polymyositis? I know that was obviously just a small number of patients enrolled, and you obviously deprioritized that, but how does the p- value look like in the overall trial if you also include polymyositis? I guess what I'm trying to ask is, how does the p- value look like in the ITT population as the way the trial was originally designed in case the FDA ultimately decides to do that sensitivity analysis as part of the review process?
Yeah, it's a good question. Luc, do you want to-
Yeah. As we are indicating during the R&D day already, we had actually modified our primary analysis already to only focus on the IMNM plus DM population, given the very low numbers. In fact, we don't have the analysis and are not planning to do it as it would not really contribute to our overall effort. But it's an interesting observation how few we actually got, which again, reflects maybe how that disease picture is moving.
Got it.
Your next question will come from Douglas Tsao with H.C. Wainwright.
Hi. Good morning. Thanks for taking the questions and congratulations. I'm just curious, Luc, we saw in terms of IM NM , almost all the patients enrolled in the study were MSA positive. But we did see a lower proportion in DM, and I'm just curious if you saw any difference in results between those who are MSA positive and those who were not.
Well, thanks for that question, which we of course are also looking in with interest, but it wasn't part of our top line. We are in the process of analyzing that. But again, look at the overall result. Very robust.
Okay, great. Thank you very much.
Your next question will come from Xian Deng with UBS.
Hi. Thank you for taking my question. Maybe I just ask a broader pipeline question, if I may. You mentioned this IMNM could actually be VYVGART's first step into rheumatology. Just wondering, in your broader pipeline, of course, you have Sjögren's coming up next year, but other than that, just wondering what are the other non-VYVGART assets that you think could potentially leverage this rheumatology infrastructure that you will be building. Thank you very much.
Yeah, thanks for the question. First of all, let's start with VYVGART. As you mentioned, we're excited that we also have Sjögren's data that we'll be reading out towards the end of next year, and we have a phase II study ongoing in systemic sclerosis. So already, within our development plans for VYVGART, we have quite a rheumatology footprint.
In fact, we also have seen that there is biological rationale for the use of FcRn in other diseases treated by rheumatologists as well. I think this is just the beginning. Secondly, as you said, if you take a step further back, we are building an immunology innovation company. Many of the therapies that we're developing, as pipeline in a product assets, will have indications that will cross over and be treated by rheumatologists.
I think over time, what you'll see is argenx becoming a real leader in the space and transforming outcomes for patients treated by rheumatologists across a number of different diseases. Thanks for the question.
Your next question will come from Andy Chen with Wolfe Research.
Hey, thank you for taking the question. Can you talk about whether your previous decision to separate the two trial types or the two subtypes would have any impact on how the FDA views DM versus an alternative scenario, assuming you never separated the subtypes? Based on the data today, it sounds like argenx really never had to separate the subtypes and you're likely to obtain approval regardless of whether DM is static. Thank you.
Yeah, I will let Luc comment, but before he does, what I do want to say is this basket trial, I think, has delivered exactly what we wanted it to. That is that it allowed us to generate data in multiple different subtypes as well as the total population.
As a result of that, we have the opportunity to pursue a label expansion in both IMNM as well as DM. So I think if you take a step back and are asking the question, "Was this the right clinical trial design?" My answer to that would be absolutely, and it has put us in a position where we can bring VYVGART to patients across both IMNM and DM.
To come further, so we actually did this in dialogue with the FDA to look at the individual risk-benefit, in each subtype. It was actually already planned in the overall trial, but the hierarchy was different. So they just wanted to have the hierarchy focused on the subset rather than the total. But, yeah. So it was not just an invention of ours. This was in dialogue.
Thank you.
Your next question will come from Qize Ding with Rothschild & Co Redburn.
Hi, guys. Thanks for taking my question. I have one follow-up question about the potential for other pipeline assets for the DM subtype. If you look at the ARGX-217, this molecule has a similar mechanism of action to VYVGART. Based on the data and learnings from VYVGART in the DM subtype, do you have any thoughts about the potential future clinical development plans for ARGX-213 in the DM subtype? Thank you.
Yeah. I think you're referring to ARGX-213, which is one of our next-gen FcRn assets, alongside ARGX-124. What you're calling out is something very important, which is that the space and the biology that we're unraveling with FcRn is very broad. With this data set, this is the sixth positive phase III registrational data set for VYVGART.
There's more to come. So when we look at our FcRn strategy with ARGX-213 and ARGX-124, I think there's opportunity to continue to broaden that indication landscape as well as deepen our leadership within indications as well. So you'll certainly see that in our FcRn strategy moving forward. Thanks for the question.
Your next question will come from Jack Allen with Baird.
Good morning. Thanks for taking my question, and congrats on the update. This is Chris on for Jack. Just a safety question. Can you provide just a little more color on the infection and immunoglobulin reduction profile in these subtypes versus what you've seen in gMG and CIDP given the sustained 52-week dosing? Then just along those lines, do you plan on providing subtype-specific safety data at some point? Thank you.
Yeah, I'm glad you're focusing on safety. It's certainly one of the strengths of VYVGART as well. But Luc, maybe you want to provide some color?
To start with your last question, yes, of course, we will be providing at some point the data by subtype. So far, we don't see any differentiation there on terms of the safety and you talk about infections. The first thing we have to talk about is the population we're in today in these diseases is heavily pre-treated with steroids and immunosuppressants.
That's the background on which this trial is run. If you look at that and take that into account, it is very consistent with what we've seen before. On the one hand, there is a slight increase in infections. On the other hand, there is no consistent pattern. We don't think that this is changing the view on the risk side. Let's not forget, with VYVGART, we have already 25,000 patient years in the real world.
So far for us, not a real case for concern. Of course, we continue to evaluate. But for me, the main thing is the benefit we've shown really makes for a real robust benefit-risk in this population that's needing new options.
Our final question will come from Mathijs Geerts Danau with KBC Securities.
Hi, and thanks for taking my question and congrats on the results. A final question on the IMNM commercialization. Do you actually plan on relying on the existing sales force, or will you need to hire additional people? Thanks.
Yeah. Thanks for the question. Maybe to put the reason why you are asking that question, IMNM is often diagnosed by neurologists and treated by rheumatologists. So it is a really important bridge for us to be able to leverage our strength in neurology into rheumatology.
We will be able to leverage a lot of the infrastructure that we have in commercial to, for example, our patient support and that type of thing where we will provide the same sort of quality and level of support that we do in neurology. But we do foresee an expansion into rheumatology so that we can reach all of the prescribers that we need to. Thanks for the question.
There are no further questions at this time. This concludes our conference call for today. Thank you for participating. You may now disconnect.