argenx SE (ARGX) Q3 2026 Earnings Report, Transcript and Summary

Good morning. My name is Ryan, and I will be your conference operator today. I would like to welcome everyone to the call. [Operator Instructions] Thank you. I'd like to introduce Beth DelGiacco, Vice President of Corporate Affairs. You may now begin your call.

Thank you. A press release was issued earlier today with our third 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, I'd like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Sandrine Piret-Gerard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A. I'll now turn the call to Karen.

Thank you, Beth, and welcome, everyone. This has been another outstanding quarter for argenx. Nearly 5 years into launch, we're still early in realizing VYVGART's potential across MG and CIDP. And on the heels of positive Phase III ALKIVIA results, we're seeking to bring VYVGART into rheumatology for the first time with the goal of reaching an entirely new group of patients and prescribers. Beyond VYVGART, we're building what comes next for argenx. We're advancing empasiprubart towards its first Phase III readout in MMN. And we had positive Phase II results for FB102 in celiac disease, just months after the Forte acquisition, giving us another Phase III-ready program. Across our broader pipeline, we expect to have 10 molecules in clinical development by the end of this year. This progress reflects something fundamental about how we innovate at argenx. We pursue novel foundational biology that has the potential to make a meaningful difference across multiple diseases of high unmet need. This boldness often has us leading the way, shaping new markets like we have in MG and CIDP and exploring the boundaries of where a target can have the greatest impact for patients. That's how we're building the next chapter of argenx, expanding the opportunity for VYVGART while creating new pillars of growth alongside it. It's what gives us confidence in our ability to deliver on Vision 2030 and sustain growth beyond that. As we look ahead, 2027 will be an important year in the evolution of argenx with 5 potential launches across our portfolio. Together, they would mark significant progress towards Vision 2030. In MG, our ambition is for VYVGART to become the treatment of choice across the spectrum of disease. We have a PDUFA date early next year for pediatric MG, and our recent filing in ocular MG could extend VYVGART beyond generalized MG for the first time. In the second half of 2027, we also expect to introduce the VYVGART Hytrulo auto-injector, continuing to elevate the treatment experience across approved indications. Autoimmune myositis is positioned to be the next major area of growth for VYVGART. ALKIVIA further validated the role of autoantibodies in myositis, demonstrating consistent and clinically meaningful results in both IMNM and DM patients. IMNM is where we have the immediate opportunity and has the greatest unmet need. Patients lose their independence within months, and there are no approved treatments today. We will file an sBLA in IMNM by year-end, for which we have breakthrough therapy designation. We remain committed to securing a label for people living with DM. And based on the strength of the ALKIVIA data, we are moving with urgency to start an additional registrational study. Now let me turn to empasiprubart and MMN, where we are approaching the expected readout of the EMPASSION study in December. MMN is a serious autoimmune disease that affects 12,000 patients across our key markets. Today, patients depend on IVIg, often spending hours in the infusion chair and many still experience worsening symptoms over time. We believe empasiprubart has the potential to offer a differentiated treatment option, both in the outcomes it could deliver for patients and in reducing treatment burden. We have good reasons for this conviction. We believe C2 is the right point in the complement pathway to intervene above where the damage in MMN starts. And empasiprubart was engineered as a sweeping antibody to efficiently remove C2 and achieve sustained C2 suppression. The Phase II ARDA data gave us meaningful clinical evidence to support this C2 targeting approach. We saw improvements in grip strength and function together with a substantial reduction in the need for IVIg retreatment. With longer-term treatment, these improvements in grip strength were sustained through 64 weeks. We took those learnings into EMPASSION, our Phase III head-to-head study against IVIg. It's a bold choice to go directly against the current standard of care, but it's one that is grounded in what we know of the biology, the molecule and the ARDA data. The study asks a very practical question, can empasiprubart deliver efficacy comparable to IVIg while reducing the treatment burden? If the answer is yes, that will be meaningful for patients. MMN is only the beginning for empasiprubart. We believe C2 inhibition has the potential to address a broad range of complement-driven diseases, creating another opportunity to build a pipeline in a product. Beyond our FcRn portfolio and empasiprubart, our pipeline continues to advance and FB102 is the latest example of that progress. The positive Phase II results in celiac reinforced our belief in CD122 as a target and gives us another asset ready to advance into Phase III. FB102 has many of the characteristics we look for in a medicine, novel biology, the opportunity to be first-in-class in a disease that has seen little innovation and the potential to address multiple autoimmune diseases. Celiac is the most advanced opportunity and the consistency of the Phase II results across efficacy measures, including symptoms, together with this favorable safety profile, reinforced the potential we see in the molecule. In 2027, we plan to share more about how we will further unlock the broader pipeline and a product potential of FB102. More broadly, our pipeline is becoming both deeper and more mature. Adimanebart is advancing to Phase III in CMS. ARGX-121 is in Phase II in IgA nephropathy and additional first-in-class molecules are advancing across new mechanisms and disease areas. This breadth is important to our strategy, giving us multiple opportunities to deliver on Vision 2030 while building the foundation for sustainable growth beyond it. With that, I'll turn the call over to Karl.

Thank you, Karen. Next slide. I am pleased to review our third quarter 2026 financial results detailed in this morning's press release. Growth in the number of patients we serve continues to drive strong revenue performance, giving us the capacity to invest across our portfolio from a position of financial strength and with a clear focus on long-term value creation. Product net sales were $1.7 billion, representing growth of 54% year-over-year and 13% quarter-over-quarter. By region, product net sales were $1.5 billion in the U.S., $81 million in Japan, $158 million across the Rest of the World and $11 million from product supplied to Zai Lab in China. U.S. product net sales grew 16% quarter-over-quarter with net pricing broadly consistent with prior quarters. Gross to net deductions were 22%, in line with our expectations. In Japan, sales grew 47% year-over-year. The quarter-over-quarter comparison is impacted by the onetime benefit of approximately $25 million in the second quarter associated with a change in our distribution model. The markets in the Rest of the World grew 70% year-over-year, reflecting strong underlying demand. Next slide. Our expenses this quarter reflects both the addition of Forte and the growing opportunity across our portfolio. Total operating expenses were $1.3 billion. Combined R&D and SG&A expenses were $1.1 billion, an increase of 22% quarter-over-quarter. These expenses included $150 million of transaction-related costs associated with the Forte acquisition. Excluding the transaction-related costs, the increase is 5%. Operating profit was $486 million, representing an operating margin of 28%. Adjusted for the Forte transaction-related cost, this is 37%. Revenue growth continues to outpace expense growth, demonstrating the operating leverage in our business while supporting investment for future growth. Our year-to-date effective tax rate was 10%. We ended the quarter with $3.7 billion in cash, cash equivalents and current financial assets after paying a net $2.1 billion for the Forte acquisition. Turning to our full year investment plans. These have evolved since we discussed expenses earlier in the year. We now expect combined R&D and SG&A expenses of approximately $4 billion for 2026. The increased investments include the transaction-related cost of Forte, investment into FB102 following the acquisition, continued progress across our pipeline and investment in our commercial infrastructure following the positive ALKIVIA result. We are making these investments from a position of financial strength, supporting the opportunities emerging from 10 assets in the clinic across our portfolio. We will continue to prioritize these investments with discipline. Our capital allocation priorities remain clear: strengthen the VYVGART franchise, advance a diversified pipeline for future growth and maintain the financial flexibility to execute our strategy as we deliver on Vision 2030. I will now turn the call over to Sandrine.

Thank you, Karl. It has been an incredible quarter with tremendous energy as we engage with HCPs and patients. And the feedback is remarkably consistent. VYVGART continues to set a high bar for what treatment can deliver, and we are seeing the impact it can have for patients. That impact is translating into impressive growth. This was among our strongest quarters of patient growth since launch. In MG, we are moving VYVGART into earlier lines of treatment, while our seronegative label expansion is lifting growth across all of MG. In CIDP, we continue to add new patients and new prescribers at a steady pace. As HCPs gain experience with VYVGART and see outcomes in their patients, the confidence grows, supporting continued adoption. Let me spend the next few slides discussing the drivers of performance in both MG and CIDP. In MG, our goal remains clear: to establish VYVGART as the treatment of choice for all MG patients. We aim to get there by broadening the label and reaching patients earlier in their treatment journey. Five months into the seronegative launch, we are off to a strong start. Seronegative was a key contributor of growth this quarter. Our Access teams have done an outstanding job securing coverage for approximately 96% of covered lives. And most payers have removed serotype testing from their VYVGART policies, making it simpler to prescribe VYVGART for gMG patients. Importantly, the launch is driving both breadth and depth. Approximately 10% of seronegative prescribers are new to VYVGART and growing physician experience in seronegative patients is driving increased prescribing in acetylcholine receptor antibody positive patients, creating a halo effect across MG. The biggest opportunity ahead is reaching patients earlier and the evidence keeps building. At MGFA, real-world data from more than 1,100 patients show that half of those who started VYVGART within a year of diagnosis reached minimal symptom expression. Potential label expansion into ocular and pediatric MG could further extend the opportunity to reach patients earlier. We have submitted supplemental BLA for both indications with a pediatric PDUFA date of February 2027. We are moving closer to a future where VYVGART may serve patients across the entire MG spectrum. In CIDP, we continue to see steady growth in new patients and prescribers quarter-over-quarter. More physicians are gaining experience with VYVGART. More patients are experiencing the difference treatment can make in their daily lives and the prefilled syringe is offering patients greater convenience and flexibility in how treatment is administered. I recently heard a patient story that captures exactly why our work matters. Gail is a woman whose CIDP had progressed to the point where she was receiving hospice care and was told that she was not expected to live more than a week. Her daughter had learned about VYVGART while she was in hospice care and asked Gail's HCP about it. After starting treatment, she returned to doing the things she loves, including using her hands to create artwork, and she even recently got her driver's license back. For Gail, regaining grip strength was more than just a clinical measure. It meant getting her life back. This is just one story that highlights the importance of reaching patients and family with information that can empower them to have meaningful conversations about treatment. Through ADHERE and ADHERE+, we have now followed patients for more than 5 years, building the most extensive long-term data set in CIDP. At AANEM, we showed that nearly 40% of patients who initially responded to VYVGART reached an INCAT score of 0 or 1 during the open-label extension, reflecting little to no functional disability. We also continue to see evidence that patients can benefit from VYVGART early in their disease journey as seen in our treatment-naïve data set. While our Phase IV switch study data support the feasibility of a 1-week transition from IVIg. Together, this data and growing real-world evidence continue to build confidence in VYVGART and support adoption across the CIDP community. Autoimmune myositis is where we plan to take the VYVGART playbook next, and IMNM is the perfect starting point. IMNM is one of the most urgent unmet needs as patients can rapidly decline from their initial symptoms to needing a wheelchair in 3 to 6 months. Despite the severity of the disease, the approximately 20,000 patients living with IMNM in the U.S. today have no approved treatment options. The combination of profound unmet need and its CIDP-like size makes IMNM a compelling growth opportunity for argenx starting in 2027. As we advance towards the sBLA filing, we are leveraging the same playbook that worked in MG and CIDP: disease education, deep physician engagement, strong patient support, broad access, evidence generation and best-in-class execution. We have been engaging with KOLs who treat autoimmune myositis and the feedback has been consistently strong. Patients need more safe and effective treatments, and we believe VYVGART's profile meets the mark. Our medical team, including MSLs, is already in place, payer conversations are underway, and we are expanding on sales team. We look forward to connecting with the rheumatology community at ACR in November, where the Phase III ALKIVIA results will be presented during an oral session. To conclude, 2027 could bring up to 5 launches in a single year in the U.S. Our teams are ready, and I could not be more excited about what is ahead. With that, let me turn the call back to Karen for closing remarks.

Thank you, Sandrine. Argenx continues to be defined by entrepreneurial science. We're developing medicines by pursuing bold biology, asking difficult scientific questions and challenging assumptions about what is possible for patients. There is so much to be proud of this year, and there is even more ahead as we approach 2027. From expanding the impact of VYVGART to advancing the next wave of innovation across our pipeline, we remain firmly on track towards Vision 2030. And with that, operator, we'll open the call for questions.

[Operator Instructions] Our first question will come from Tazeen Ahmad with Bank of America.

This is Daniel on for Tazeen. Congrats on all the updates. I had a question on ALKIVIA. What additional data should we expect to see at the ACR presentation? And can you maybe comment a little more on the feedback you've been getting from physicians? And then as you think about the DM trial, what are going to be the key considerations there? Do you think you'll just need a bigger trial? Or is there something else that will need to be changed from what you did before?

Yes. Thanks for the question and the interest in DM. So yes, on the -- related to -- I'll start with your third question related to the DM trial. So we had the sBLA meeting recently, and it gave us the clarity that we were looking for. So as you call out, it confirmed actually the base case that we've also been planning for. So we've been planning in parallel and designing what we think a DM trial will look like. The teams are working on that. You'll understand that until we finalize that and get further down the path, we won't be public on what that will look like. But perhaps, Luc, you could share some of the considerations that the team has been looking at as we think about that potential DM trial.

Yes. Thanks, Karen. And we will again use the argenx playbook because we have significant data in Phase II and III that we will build upon that will inform this next next design to make it the most efficient possible and to speed the path to patients with DM. And as you asked for, the ALKIVIA results that will be presented at ACR as an oral late-breaker will contain a significant amount of data on the efficacy profile across IMNM and DM.

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

Congrats on the progress. I was just wondering if you could provide some color on how both MG and CIDP revenues are growing. Is it about the same rate quarter-over-quarter? And then ultimately, for that MG base business, how should we think about the impact on that current growth trajectory with ocular MG, pediatric MG and auto-injector launches in '27?

Yes. Derek, thanks for the question. I think it's incredible, isn't it that 5 years since launch, we continue to see momentum and sustained growth. And I think it just shows what that strategy of consistent and steady cadence of innovation coming to the market, how that can contribute to growth. But maybe, Sandrine, you can comment on the MG and CIDP dynamics in the quarter.

Yes. Thank you, Karen. Thank you, Derek. So both indications have been growing really well. So we don't see a slowdown of CIDP or we don't see MG just being the driver of growth this quarter like the other quarters. So both continue to grow very nicely. As you mentioned, I mean, we have seen a great launch with seronegative. And one of your question is to say, what does it mean in terms of the trajectory, assuming we get approval for both pediatric MG and ocular MG. So we are very pleased about the seronegative launch because not only Access has been strong in removing some of the hurdle in terms of serotype testing that makes it very, very simple to prescribe. But what we have seen is the halo effect that seronegative MG has on the broader gMG population, both on the breadth of prescribers where we saw that 10% of the seronegative prescribers were completely new to VYVGART, but also on all the seropositive patients. And it's mostly driven by simplicity. If you put yourself in the shoes of a physician, you have a patient with gMG coming into your practice, it's very easy to just have to remember about VYVGART. You don't have to do the serotype testing. It's a one-stop shop. And what we believe is that this halo effect is probably going to also be seen and replicated for both pediatric MG and ocular MG, positioning VYVGART even earlier in the treatment paradigm and contributing to this halo effect. So we are very excited about that. And just to be honest, we were a bit surprised by the magnitude of that halo effect. We knew there would be some, but this confirms that it really has an impact beyond just the indication itself. It has a broader halo effect.

Our next question will come from Victor Floch with BNPP.

Congratulations for another strong quarter. My question is for Karl, if I may. Karl, would you mind help us quantify the different moving parts behind the increase in your OpEx guidance this year? Is that fair to assume that only a small part of the increase comes from additional investment in your platform, while most of it is actually driven by the Forte acquisition cost, the OpEx related to Forte and the recently announced Phase III trials? And looking at next year, could you give us a sense of where OpEx could land? Is that fair to say there is now some headroom to consensus revenue expectation next year given that pediatric gMG, oMG, IMNM and potentially MMN could all start contributing by midyear at the latest?

Victor, thank you for the question. I need to start with what Sandrine said, it's the strength of the revenue, 19 quarters in a row, and it's that revenue growth, which allows us to invest from a position of strength. If you look at this quarter, operating expenses of $1.3 billion, SG&A and R&D in there of around $1.1 billion in that number is $150 million of the Forte acquisition cost. That's basically the only Forte cost in the quarter and drove higher expenses from Q2 to Q3. On a full year basis, sorry, $1.3 billion, of course, brings you to an operating margin of 28%. If you exclude the Forte transaction cost, operating margin is 37%. I think that's really important because it shows you that we continue to invest. However, we also continue to drive margin expansion. That's really important. Looking to the full year, we now put the number out there of around $4 billion. The increase to what -- the Street was previously expecting can basically be attributed to Forte, Forte being around half of it. That breaks down to the $150 million, which is already in Q3, plus call it another $50 million, which is the FB102 operating cost for the rest of the year as we plan to invest in that opportunity. The rest of course includes -- rest of the increase includes some commercial cost for Sandrine to -- following the successful ALKIVIA results as we're going to start to ramp up our IMNM and rheumatology capabilities. And the remainder of those costs in '26 is largely driven by having 10 assets in the clinic. A lot of that driven by CMC type of work as we need to get those -- to build those inventory and get that already. So that gets you to the $4 billion. If you compare it to 2025, that translates to a 45% increase year-over-year from '25 to '26. For '27, I think at JPMorgan, we'll provide a better guidance, but please do not assume another 45% increase into 2027. Clearly, the base is already lower and also we won't see the same jump. Think of about half of that 45% if you need something for your models now, but we'll give more guidance at JPMorgan. I think what's important is that we were going to invest in our opportunities and we will continue to provide operating leverage going forward. Thank you for the question.

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

Just on EMPASSION for MMN, what is the non-inferiority margin that's specified in the study? And can you just remind us what your expectations for the IVIg arm performance are?

Gavin, thanks for the question. I'm really looking forward to the Phase III readout in December. This is potentially our second molecule and our next pillar of growth alongside VYVGART. So it's an important moment for us. And before we get into discussing the inferiority (sic) [ non-inferiority ] margins and all of those details, I think it's important that we take a step back and think about MMN and MMN patients. There's been no innovation in this space for decades actually. And I think it's important to say that even a placebo-controlled study would be groundbreaking for this market and for these patients. So the choice to go head-to-head, I think, is a bold one. I think we've set ourselves up for success with how we've designed the study. And obviously, we need to wait for the data to speak. But maybe, Luc, you could add some more color on how we thought about designing the head-to-head study.

Yes. Yes. Thank you, Karen. And just we are not public on the actual margin, but I can clearly explain why we chose a non-inferiority design. This was based on the learnings from ARDA and thinking about how can we best define the potential of empasiprubart. So the head-to-head here against IVIg is based on the fact that in the Phase II, we largely avoided the need for IVIg in the active arm, whereas untreated patients in almost all cases needed IVIg. So the better to describe the effect is go straight to head-to-head. And we think that the performance of IVIg will be as we've seen historically, both in ARDA in external data, but we will even have a check on that within the study itself. So each patient can be on their cycles, 2 cycles of them before they get into the randomized part. So we will know very well what IVIg will do. Based on our data in hand, the expectation is we can match that. And there is always opportunity to show superiority, but the data will ultimately tell that story.

Our next question will come from Akash Tewari with Jefferies.

So how confident is your team that you can deliver on Vision 2030 post the Sjögren’s miss and the DM update today? Our math suggests if you have consistent patient adds for CIDP and gMG, you'll approach around 40,000 patients on those 2 indications. But that would mean IMNM would represent the bulk of the additional patient adds you would have. Is that the right way to think about it that those 3 indications alone could push you past the 50,000 patient target?

Thanks for the question, Akash. I always like to talk about Vision 2030, and we're well on track, and I think I have strong conviction that we'll hit Vision 2030, and we have multiple paths to get there. So just to lay it out, as you said, the first part of Vision 2030 is 50,000 patients by the end of the decade. We've always said that the bulk of those patients will come from MG and CIDP, just given the timing of launch and the continued growth that we expect. And then obviously, the additional indications, IMNM also potentially if we get an MMN approval and any other approvals before 2030 will contribute, but the majority would be MG and CIDP. In terms of the other parts of Vision 2030 that are important for our future growth, 10 labeled indications, we're well on track with that and the 5 potential launches next year add obviously significantly towards that goal. So I'd say we're well on track for 10 labeled indications. And we want 5 molecules in Phase III development by the end of the decade. We're also well on track there. And Karl mentioned earlier, in fact, we'll have 10 clinical stage molecules by the end of this year, and those are all moving rapidly through into late-stage development, including FB102 that's ready for Phase III. So I have strong conviction that we're well on track for Vision 2030. And I think we're setting ourselves up for growth for the next decade beyond as well. Thanks for the question.

Our next question will come from Yaron Werber with TD Cowen.

Maybe a quick, kind of, 2 interrelated questions on empa. Number one, you've shown data that there's been obviously concerns about infections in the class, which really have not been an issue so far. But you've shown data that C2 and C1s are very similar on infection risk and low and they're much lower than C5. Can you discuss the biology of that? And then secondly, just on superiority, maybe for Luc, your -- our understanding is that it's a 3-day moving average, whereas non-inferiority is a 28-day moving average. Why is there a difference? It almost seems that the 3-day is, sort of, in a good way, is a tailwind for superiority.

Yes. Thanks for that question. And you are correct that given the selection of our molecule to target C2 was pretty purposefully aimed at maximizing our opportunity to have effect across diseases that were caused by both classical or lectin pathway while not affecting the alternate pathway. And that in studies we have conducted leads to our ability to kill encapsulated bacteria that, that is maintained. The C1s, as you point out, has still a similar capability, but then maybe not the same breadth of indications it could target. Hence, our selection of that part of the complement pathway. With respect to the superiority endpoint, the non-inferiority one where we have a 4-week moving average selected was based on the conversations with the FDA to ensure that it's a solid evaluation over that month. The 3-day moving average for the superiority was not further discussed, and we felt that, that was the appropriate way to continue to test this hypothesis of superiority. So we didn't change that.

Our next question will come from Yatin Suneja from Guggenheim.

Maybe just a few on FB102. Could you just talk about the competitiveness of the data that you have generated internally in celiac relative to the other approaches? And then for celiac, it seems like you are definitely moving into Phase III. What about vitiligo? You already have that data in hand. So what are the future plans? And anything you can share on the upcoming alopecia data coming up?

Yes. Thanks for the interest in FB102. Maybe I'll take the first question and Luc, if you want to comment on the clinical development. But yes, in terms of the competitiveness, I think here, once we -- based on the Phase II data, it, sort of, confirms our hypothesis that we had with the acquisition just a few months ago. I think we have a potential first-in-class and best-in-class asset with FB102. So the Phase II data was consistent with what we expected and was really exciting. I mean, seeing the efficacy effect on the histology and the symptom outcomes as well as maintaining that safety profile. So I think we have a great molecule here. And as you said, we have strong celiac data, but we also have the potential for additional indications, 2 of them you mentioned, vitiligo and alopecia. I'll have Luc comment on those. But we're also looking beyond those indications to really build this as a pipeline in a product. But Luc, perhaps you can comment on the status of those indications.

Well, so for celiac, we, of course, fully and very busy in developing a Phase III plan that we will move forward with as fast as we can. For vitiligo, again, with the data in hand, again, showing this biology at work, we're doing the same. What is the most efficient path to patients? And we will roll that out as we get confirmatory conversations with authorities that it's the appropriate plan.

And I think the last thing I'll say is we expect at JPMorgan or early part of next year to be able to provide a more holistic or more detailed update.

Our next question will come from Alex Thompson with Stifel.

Congrats on the quarter. I guess ours is on futility analysis. I guess you've now had futility analyses of discontinued programs in Sjögren’s and TED. I guess looking forward, should we assume that all your pivotals have built-in futility analysis as we think about data next year in CIDP for empasiprubart and potentially later for efgartigimod in Graves'?

Yes. Thanks for the question, Alex. It's an important one. As we pursue our strategy, which is novel biology and exploring the -- really the boundaries of that biology, we continue to make bold choices about where we're going to invest. And we want to try to develop our assets by moving early, moving fast and then also stopping early. So to your point, we're very disciplined about making sure we have measures like futility analysis in our studies so that we can make disciplined choices at the right moment. And you saw that with Sjögren’s when we heard that data. So yes, you can expect that in our development programs, we always have built-in mechanisms to make sure that we're making the right choice and making the right disciplined investments without reducing the calculated risk that we're taking on the biology. Thanks for the question.

Our next question will come from Danielle Brill with Truist.

So Karen, you mentioned up to 5 potential launches in 2027, which appears to include empa and MMN. Is that correct? And if so, what assumptions would support a priority review eligibility following the December readout? Would non-inferiority be sufficient? Or is superiority potentially gating to an expedited review in '27 launch?

Yes. Thanks for the question. So yes, the 5 potential launches in the U.S. does include MMN if we -- once we get the data readout. And assuming positive data, then our plan would be to apply for priority review for empasiprubart in MMN. And that we believe that we meet the criteria or that it would meet the criteria. Let's see the data and have the data card turn over. But based on the unmet need and in MMN, we will likely apply for priority review. So let's see the data at the end of the year, but we're planning for success with the potential of 5 launches.

Our next question will come from Myles Minter with William Blair.

Congrats on the quarter. Just on FB102 and the Phase III celiac trial design, can you comment a little bit more there? I mean, obviously, the length and particularly the type of gluten challenge appears to be a variable across trials here. And where are you on moving from IV to a sub-Q formulation for that product?

Yes. I can comment on your second question, Myles. We very much have a plan to move from IV to subcutaneous as quickly as possible. That's part of the VYVGART playbook that we're applying, and it's now part of the argenx playbook for both for empasiprubart as well as FB102. So you can expect that. And maybe, Luc, you want to comment a little bit on the gluten challenge question?

Well, I mean, the bigger question is which celiac patients do we want to affect. And given what we've seen confirming the biology at work, we feel there should not really be a limitation on which patient you start -- would start treating. So we have to design our development plan so that we can cater to the -- across the spectrum of celiac. And in that sense, also follow what we did in MG, which is leave no patient behind.

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

Maybe one for Karl, and I guess, Karen as well. There's obviously been a lot of discussion around OpEx. So I just wanted to check in on your latest thoughts for providing some kind of formal guidance for 2027 and beyond given that you've got multiple launches, label expansions, potentially a second asset as well as the acquisition to integrate. I guess is -- do you think the company is now at a point in time where the market would benefit from some form of formal guidance on the shape of the business on the forward?

Yes. Karl, do you want to comment?

Yes. I mean, I think we will talk about it at JPMorgan because I think that's where we -- beginning of next year. But where we are today is I think that we have broad alignment on the opportunities between us and the Street in terms of where the revenue number could go. There's also a lot of variables in terms of binary events. So I think that makes it a little bit difficult to give revenue guidance. But in terms of OpEx, we want to make sure that The Street understands the investment opportunities which we have and what we invest in. So I think we will probably look to provide better clarity or more clarity on the expense number, but probably not on the revenue number.

Thanks, Karl. And maybe just to -- I think that's a good summary. And just to reinforce the strategy here, which you mentioned earlier, which is we are investing for growth and innovation while also delivering on margin expansion. I think that's important and will continue.

Our next question will come from Samantha Semenkow with Citi.

This is Jing on for Sam. And congratulations on the strong quarter. My question is most on the -- also on the celiac. Can you share at a high level your expectations for Phase III design? Is the challenge trial being considered? Or if so, how should we think about the retention of the placebo participants? And also for broadly, so what gives you the confidence that FB102 can become a major growth pillar beyond VYVGART?

Yes. Thanks for the question. So in terms of your second question, I think FB102 or and specifically the target CD122, the reason for our interest in that is that we see pipeline in a product potential, so multiple indications. And we just talked through what some of those are. Celiac, vitiligo, we already have positive data, alopecia, and we think there's more indications beyond that, and we'll be ready to share that in the early part of the new year once we work those up. So when you start to put all of those indications together, where there's significant patient population, significant unmet need. And as I mentioned earlier, we think a potential first-in-class and best-in-class asset, then you can really see that this starts to become a growth driver and pillar alongside VYVGART. In terms of the celiac design in the Phase III study, maybe I'll just comment. I mean you're asking specifically about the placebo retention rates. And I think you called out something really important, which is how you design the gluten challenge in these studies is going to be really important because how intense of a gluten challenge do you want, how long should that gluten challenge be so that you can really see the impact on placebo. But to your point, you balance that with not having too many patients drop out. And I think what Luc was talking about earlier around that, that might look different depending on the symptomatic versus the non-symptomatic patients. That's all of the work that we're doing. We have experts on the team. We're consulting with KOLs. And I think the Forte team has had really productive discussions and input also from regulators over the past number of months and years. So we're well positioned. We're taking all of that into account, and we'll look forward to sharing the details of the design when they're ready. Thanks for the question.

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

I've got an empa question. So with the EMPASSION study reading out in December, beyond simply meeting the primary endpoint, what do you think you need to show to drive meaningful physician adoption? And if ultimately, empa also reads out well in CIDP, how do you position it against VYVGART? Do you see them as competing products, patient segmentation, sequencing or combination?

Yes. Thanks for the question. I'll hand it over to Sandrine to comment on how we compete in MMN. But maybe just briefly to comment on your question on CIDP. I mean this is another place where we said there hasn't been innovation for decades. And obviously, with VYVGART, we brought that innovation and you can see the impact and the growth that VYVGART is having. At the same time, we see that -- we saw that in the ADHERE study, there were some nonresponders to VYVGART. We had the highest response rate that has been seen, but there are some nonresponders. So it clearly is a heterogeneous disease, and there are multiple factors that are driving the disease. So our approach is that we believe that empasiprubart might be able to provide benefit to those patients. We've enrolled all comers, so we'll be able to see the true impact of empasiprubart. Once we get both of those data sets, we'll be able to analyze them, look at the biomarkers and really understand, I think, better than anyone else in the industry, what is really driving this disease and what's the most appropriate treatment for the different patient types. So we really hope to advance outcomes and advance understanding of the biology by having both of these mechanisms in CIDP. And I think it will allow us to really shape the market and certainly lead the market in CIDP. But maybe, Sandrine, you can also comment on the more near-term opportunity of MMN for empasiprubart if the study reads out positively.

Thanks, Karen, and thanks, Sean, for the great question. So non-inferiority versus IVIg in our MMN trial, we see that as a success. And the superiority would be an add-on and upside. And why do I say that is because when you look at MMN, it has the highest use of IVIg across all indications and disease. Patients can spend up to 2 days in a row with an infusion. I mean, just to give you an idea, this is really burdensome and absolutely not convenient and being able to come with something that is at least as good in terms of efficacy as IVIg, but provide this convenience starting with an IV once a month, 1 or 2 hours and then moving to subcutaneous and an auto-injector long term. This is really a plus and it is clinically meaningful for patients. Actually, at AANEM, I had the opportunity to have dinners with MMN patients, and I was sitting for a few hours between 2 MMN patients, and they were describing their life, what it is to actually live with MMN and having to plan your life around your infusion that are super burdensome. They're extremely excited by the opportunity that empa would offer in MMN, and we're also very excited. So non-inferiority versus IVIg is a bold R&D design, I would say, provide an amazing value proposition for prescribers, for providers and for patients. And then if we have superiority, this is really an upside.

Our next question will come from Sophia Graeff with JPMorgan.

You've referred to IMNM before being a CIDP-like opportunity. How are you thinking about the relative ramp compared to uptake in CIDP? Could it be relatively more rapid given the less entrenched position of IVIg in this indication? You referred to the high degree of unmet need there today, but -- or could it be less so given the more limited overlap with your existing prescriber base?

Yes. Maybe I can start and then hand over to Sandrine to talk a little bit about the preparation for IMNM launch and those prescribers. But from an IMNM perspective, I do -- we see it as a large opportunity, as you said. I think in terms of launch trajectory, one thing that's important to take into consideration that we always say, we will need to -- we will take about 2 quarters to -- once after approval to be able to get payer policies in place. So from a -- when you compare the launch uptake to something like a CIDP, I would take that into account. But I do think it's important to take into consideration once we have those payer policies in place, that IMNM has no other treatment options available. These patients are waiting. And so I think they will be -- both patients and prescribers will be excited. But maybe, Sandrine, you can comment on how we're preparing for that launch.

Yes, we are getting ready. I mean -- so we are all very, very excited, as you can imagine, we can help up to 20,000 patients actually. This is the size of the opportunity. And it could even be bigger because we feel that a lot might be misdiagnosed or not diagnosed well. So given that high unmet need, we think that the uptake and the adoption will be pretty fast. So we have been gearing up for success. And actually, we have set up already a medical team since a while. They have been in the field speaking about the disease itself and some of our data. So we already can leverage the amazing patient services that we have, patient support program, but also everything we have done with payers, and we are a known entity there. So this is something which we don't have to reinvent from scratch. And we are in the midst -- if you look on LinkedIn, I mean, we are in the midst of expanding our field force and sales team focusing on rheumatologists. So exciting time for us. And we know that some of the prescription will come from neurologists. And there, we already have a foot in the door since 5 years. And so -- and this should be even easier than with rheumatologists. So that's something we will leverage as well. So I would say we were gearing up for success. We are in the midst of the preparation. And now we just need to get the approval, which is not a detail, but important. So thank you for the question.

Our next question will come from Luca Issi with Royal Bank of Canada.

Congrats on the progress. Maybe, Luc, if I can circle back on a prior question for dermatomyositis. Can you just maybe talk about why the FDA told you that you couldn't file on the ALKIVIA data despite very impressive 15 points improvement in TIS, if I recall it correctly. And obviously, in the context of the drug that is already approved and we know it's very safe. And then maybe related to it, how long will it take to run this additional trial that the FDA is asking you? I think Roivant took exactly 4 years from the time the pivotal trial was actually posted on clinicaltrials.gov to the actual approval for brepocitinib. Is that the right comp for us to think about it? Or do you think you can beat that?

Yes. Thank you for that question. So it was actually first principles, I think, in interaction with the FDA for the DM discussion. As you recall from our disclosures earlier, we missed the primary endpoint. And even though the magnitude of the effect size was exactly as we had seen in IMNM and very consistent, it was felt that this was a really great hypothesis generating data, but that it needed confirmatory evidence. Now as we're still designing the program, I'm not going to speculate on duration. This will be a matter of agreement with the agency what it would take. The one thing I will say is we have already data in hand on DM, which would inform sizing and effect appreciation and so forth. So...

Yes. And I think it's fair to say that our goal is to go as fast as possible. I think we have a track record of being able to beat industry averages. So we'll be working hard. Thanks for the question.

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

Maybe I would just be curious to hear from Sandrine from her perspective from coming back from AANEM because at the conference, it was really striking how many of the podium presentations were focused on both seronegative as well as ocular. Obviously, you saw some strong momentum already with the seronegative, but I'm curious what feedback you might have gotten from clinicians.

Sandrine?

So yes, thank you for your question. So indeed, I was at AANEM and the feedback, I must say, has been extremely positive. We see in the numbers of seronegative that providers have jumped on the opportunity, especially for triple-seronegative patients, and they're all very excited about ocular MG. Actually, when you speak to them because the question I ask them is how do you see -- do you consider this as a mild disease because some physicians say that the majority say it's absolutely not mild. The symptoms you're having are fully debilitating. People cannot read, cannot drive. It's really impacting the quality of life. So they really look forward to having a solution and option to offer them. So the many interactions we had during the congress were very, very encouraging, and it was more a question of when we will be able to offer that as soon as we can because patients are really waiting. So -- and as you have seen since you have looked at AANEM, I mean, there are not many, many other options, and they are coming much later than us. So I think coming first there will be a key advantage, and we think it will have a halo effect like seronegative had.

Our last question will come from Allison Bratzel with Piper Sandler.

Just going back to the UNITY futility decision, I guess, could you talk to -- do you have a sense of whether that outcome was specific to Sjögren’s biology, its trial design, something else? And just does that change your confidence in pursuing other rheumatology indications like systemic sclerosis? And just lastly, could you just talk to the commitment to addressing Sjögren’s with other mechanisms or other assets in the argenx pipeline?

Yes. Thanks for the question. So after the futility analysis, we actually haven't seen the data yet. We're still going through the process of closing out that study so that we'll be able to get the data. It will be a rich data set. About 500 patients made it to week 24. So we'll have a very strong data set. So we'll be able to analyze and really understand what was driving the futility analysis. So more to come on that. But I think what what you can expect is that after we've done that analysis and really understood, we'll be able to define then and we'll share what's the path forward, either for FcRn if we maybe see a patient population or something like that, where it made a difference or certainly, we'll use those insights to inform our future pipeline programs for Sjögren’s. We're looking to be a leader in immunology, and Sjögren’s is obviously an area with high unmet need. So we'll continue to look and continue to invest, and we'll be able to leverage that data set to inform those decisions. I wouldn't assume that the futility analysis or the outcome for UNITY reads through to any other indications. Each indication that we select stands on its own in terms of the biology, the developability and also the patient -- unmet patient need. So we're looking forward to the scleroderma Phase II study reading out, and there shouldn't be any read-through, but we look forward to that data card turning over. Thanks for the question.

This concludes our conference for today. Thank you for participating. You may now disconnect.