Good morning. My name is Ryan and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. Thank you. I'd like to introduce Beth DelGiaco, Vice President of Corporate Affairs. You may now begin your call.

Thank you. A press release was issued earlier today with our 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 developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. ArgenX is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Sandrine Perret-Girard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A. I'll now turn the call to Karen.

Thank you, Beth, and welcome everyone. This has been another outstanding quarter for Argenix. Nearly five years into launch, we're still early in realizing VivGuard's potential across MG and CIDP. And on the heels of positive phase three Alkivia results, we're seeking to bring VivGuard into rheumatology for the first time, with the goal of reaching an entirely new group of patients and prescribers. Beyond VivGuard, we're building what comes next for Argenix. We're advancing in Passapruva towards its first Phase 3 readout in MMN. And we had positive Phase 2 results for FB102 in celiac disease, just months after the Forte acquisition, giving us another Phase 3 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 innovated our genics. 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 Argenix, expanding the opportunity for VivGuard 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 Argenix, with five potential launches across our portfolio. Together, they would mark significant progress towards Vision 2030. In MG, our ambition is for VivGuard 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 Vivgard beyond generalized MG for the first time. In the second half of 2027, we also expect to introduce the Vivgard Hytrulo autoinjector, continuing to elevate the treatment experience across approved indications. Autoimmune myositis is positioned to be the next major area of growth for Vivgard. 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 impulsoprubat and MMN, where we are approaching the expected readout of the impassioned 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 impasse-prubat 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 and Pastor Proubart 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 Impassion, our phase three 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 impasse-approved art 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 impasse-prubat. 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 impasse-prubat, 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 three. 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. Filiac is the most advanced opportunity and the consistency of the phase two results across efficacy measures including symptoms together with this favorable safety profile reinforce the potential we see in the molecule. In 2027, we plan to share more about how we will further unlock the broader pipeline in a product potential of FB102. More broadly, our pipeline is becoming both deeper and more mature. Adam Manabat is advancing to phase three in CMS. Argenix 121 is in phase two 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 supply to Xilab in China. US product net sales grew 16% quarter over quarter with net pricing broadly consistent with prior quarters. Close 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 one-time 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 additional 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 a 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 four-day 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 Vivcar 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. DivGuard 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 this guard 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 VidGuard 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 VidGuard 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 disclosure. Our access teams have done an outstanding job securing coverage for approximately 96% of covered life, and most payers have removed serotype testing from their VivGuard policies, making it simpler to prescribe VivGuard for GMG patients. Importantly, the launch is driving both breadth and depth. Approximately 10% of seronegative prescribers are new to VidGuard, 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 VivGuard 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 VivGuard 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 VidGuard, more patients are experiencing the difference treatment can make in their daily lives, and the pre-filled 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 CADP 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 ZipGuard 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's meant getting your 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 ADHER and ADHER+, we have now followed patients for more than five years, building the most extensive long-term data set in CIDP. At AMEM, we show that nearly 40% of patients who initially responded through VivGuard reached an in-cap score of 0 or 1 during the OPAL label extension, reflecting little to no functional disability. We also continue to see evidence that patients can benefit from VisGuard early in their disease journey, as seen in our treatment-naive dataset, while our Phase 4 switch study data support the feasibility of a one-week transition from IVIG. Together, this data and growing real-world evidence continue to build confidence in VisGuard and support adoption across the CIDP community. Autoimmune myositis is where we plan to take the VidGuard 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 three to six months. Despite the severity of the disease, the approximately 20,000 patients living with IMNM in the US today have no approved treatment options. The combination of profound unmet needs 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. This is 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 VidGuard's profile meets the mark. Our medical team, including MSLs, is already in place. Spatial conversations are underway, and we are expanding on sales teams. We look forward to connecting with the rheumatology community at ACR in November, where the phase three Alkivia results will be presented during an oral session. To conclude, 2027 could bring up to five launches in a single year in the US. 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. Argenics 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 VivGuard 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.

At this time, we will open the floor to 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. And we'll pause for just a moment.

Okay, our first question will come from Tezeen Ahmad with Bank of America.

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Hey guys, good morning. This is Daniel for Tizien. Congrats on all the updates. We have a question on Alkivia. What additional data should we expect to see at the ACR presentation? And, you know, 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, you know, 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?

Thanks for the question and the interest in DM. I'll start with your third question related to the DM trial. So we had the NSVLA meeting recently and it gave us the clarity that we were looking for. So as you pull out, it confirms actually the base case that we'd 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.

Yeah, thanks, Karen. And we will, again, use Arjen's playbook because we have significant data in phase two and three that we will build upon that will inform this next phase NextDesign to make it the most efficient possible and to speed the path to patients with DM. And as you asked for, the Alkevia 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.

Great. Thanks for the question.

Thank you.

Our next question will come from Derek Archila with Wells Fargo. Your line is now muted.

Hey, good morning and congrats on the progress. Thanks for taking the questions. 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 ultimately for that MG-based business, how should we think about the impact on that current growth trajectory with ocular MG, pediatric MG, and auto-injector launches in 27. Thanks.

Yeah, Derek, thanks for the question. I think it's incredible, isn't it, that five 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 from the quarter.

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 questions 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 hurdles 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 VidGuard, but also on all the seropositive patients. And it's mostly driven by simplicity. If you put yourself in the shoes of a physician, if a patient with GMG coming into your practice, it's very easy to just have to remember about Vivgard. 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 OcularMG, positioning VivGuard 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 this broad halo effect.

Thanks, Eric.

Our next question will come from Victor Flock with BNPP.

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Thank you very much for taking our question and congratulations for another strong quarter. My question is for Karl. If I may, 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 application cost, the OPEX related to Forte, and the recently announced Phase 3 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 review expectation next year given that pediatric GMG, OMG, IMNM, and potentially MMN could all start contributing by mid-year at the latest. Thank you very much.

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 a 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, of course, brings you to an operating margin of 28%. If you exclude the forte transaction cost, the 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 queue three, 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 the increase includes some commercial cost for Sandrine following the successful Alkevia results as we're going to start to ramp up our IM&M 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 build those inventory and get that already. So that gets you to a four billion. If you compare it to 2025, that translate to a 45% increase year over year, from 25 to 26. For 27, I think JP Morgan will provide better guidance, but please do not assume another 45% increase into 2027. Thank you very much.

Our next question will come from Gavin Clark Gartner with Evercore. Your line is now unmuted.

Hey, guys. Thanks for taking the question. Just on impassion 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 IBIG-RM performance are? Thank you.

Hi, 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 VivGuard. So it's an important moment for us. And before we get into discussing the 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.

Yeah, thank you, Karen. And just we are not public on the actual margin, but I can clearly explain why we've chosen on inferiority design. This was based on the learnings from Arda and thinking about how can we best define the potential of Empathy Brevard. So the head-to-head here against IVIG is based on the fact that in the phase two, 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 to go straight into it. 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, two 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.

Thanks, Luc.

Our next question will come from Akash Tiwari with Jefferies.

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Hey, thanks so much. So how confident is your team that you can deliver on Vision 2030 post the Sjogren-Smith and the DM update today? Our math suggests if you have consistent patient ads for CIDP and GMG, you'll approach around 40K patients on those two indications. But that would mean IMNM would represent the bulk of the additional patient ads you would have. Is that the right way to think about it, that those three indications alone could push you past the 50K patient target? Thanks.

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 get 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, IMM also potentially if we get an MMN approval and any other approvals before 2030 will contribute, but the majority would be MG and CIDC. 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 five 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 five molecules in phase three 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 SB102 that's ready for phase three. 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 Jaron Werber with TD Cohen. Your line is now unmuted.

Great. Thanks so much. Maybe a quick kind of two 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 they're low and they're much lower than C5. Can you discuss the biology of that? And then secondly, just on superiority, maybe for Luc, our understanding is that it's a three-day moving average, whereas non-inferiority is a 28-day moving average. Why is there a difference? It almost seems that the three-day is sort of, in a good way, is a tailwind for superiority. Thank you.

Yeah, thanks for that question. And you are correct that given the selection of our molecule, the target C2, was pretty... purposefully aimed at maximizing our opportunity to have effects 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 four-week moving average selected was based on the conversations with the FDA to ensure that it's a solid evaluation over that month. The three-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.

Thanks, Luc.

Our next question will come from Yatin Suneha from Guggenheim.

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Hey guys, thank you for taking my question. Maybe just a few on FBE 102. Could you just talk about the competitiveness of the data that you have generated internally in CTIAC relative to the other approaches? And then for celiac, it seems like you are definitely moving into phase three. 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? Thank you.

Yeah, thanks for the interest in SB102. Maybe I'll take the first question, and Luke, if you want to comment on the clinical development. But yeah, in terms of the competitiveness, I think here, based on the Phase 2 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 SB102. So the Phase 2 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. Two 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 three plan that we will move forward with as fast as we can. Well, Vitelligo, 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 that JPMorgan or early part of next year to be able to provide a more holistic or more detailed update. Thanks for the question.

Our next question will come from Alex Thompson with Stifel. Your line is now unmuted.

Great. Congrats on the quarter and thanks for taking our question. I guess ours is on futility analyses. I guess you've now had futility analyses that have discontinued programs and Sjogren's and TED. I guess looking forward, should we assume that all your pivotals have built-in futility analyses as we think about data next year in CIDP for Mpacip or BART and potentially later for FGAR-Tigamot and Graves? Thanks.

Yeah, thanks for the question, Alex. It's an important one. As we pursue our strategy, which is novel biology and exploring 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 analyses in our study so that we can make disciplined choices at the right moment. And you saw that with Sjogren'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 discipline investments without reducing the calculated risks that we're taking on the biology. Thanks for the question.

Our next question will come from Danielle Brill with Truist. Your line is now unmuted.

Hi guys, good morning. Thanks so much for the question. Karen, you mentioned up to five 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 and 27 launch? Thank you.

Yeah, thanks for the question. So yes, the five potential launches in the U.S. does include MMN once we get the data readout And assuming positive data, then our plan would be to apply for priority review for impossible in MMN. And we believe that we meet the criteria or that it would meet the criteria. Let's see the data and have the data card turnover. But based on the unmet need 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 five launches. Thank you.

Our next question will come from Miles Minter with William and Blair. Your line is now unmuted.

Thanks, everyone, and congrats on the quarter. Just on FB102 and the Phase 3 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, you know, where are you on moving from IV to a sub-Q formulation for that product? Thanks very much.

Yeah, 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 VivGuard playbook that we're applying, and it's now part of the Argenix playbook, both for MPAS approval 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 or would start treating. So we have to design our development plan so that we can cater 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. Your line is now unmuted.

Hi, thanks for taking my question. Maybe one for Carla 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 the 2027 and beyond, given that you've got multiple launches, label expansions, Carl, do you want to comment? Yeah, I mean, I think we will talk about it at J.P. Morgan 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 in 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 understand 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 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 we'll continue.

Our next question will come from Samantha Semenkow with Citi. Your line is now unmuted.

Hi, this is Jingyang for SEM. and congratulations on the strong quarter and thanks for taking my questions. My question is mostly also on the celiac. Can you share at the high level your expectations for phase three design and the challenging trial being considered? Or if so, how should we think about the retention of the placebo pacitipant? And also for broadly, What gives you the confidence that FD102 can become a major growth pillar beyond VSCAR? Thank you.

Yeah, thanks for the question. So in terms of your second question, I think SB102 or 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 needs 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 they've got In terms of the celiac design and the phase three study, maybe I'll just comment. I mean, you're asking specifically about the placebo retention rate. And I think you call that something really important, which is how you design the gluten challenge in these studies is going to be really important. Because, you know, 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 Luke 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 4T 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 Lamin with Morgan Stanley. Your line is now unmuted.

Good morning, Karen and team. Hope everyone's well. I've got an input question. With the impassioned 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 VivGuard? Do you see them as competing products, patient segmentation, sequencing or combination? Thank you.

Yeah, 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've said there hasn't been innovation for decades. And obviously, with VivGuard, we brought that innovation. And you can see the impact and the growth that VivGuard is having. At the same time, we saw that in the ADHERE study, there were some non-respondents to Vivgard. We had the highest response rate that has been seen, but there are some non-respondents. 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 mPasipruvit 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 impasse-approval. 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 Advanced Understanding of the Biology by having both of these mechanisms in CIDP. And I think it'll 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 impasse-approved ART if the study reads out positively. Thanks, Erin.

Thanks, Sean, for the great question. So noninferiority versus IVIG in our MMN trial, we see that as a success. And the superiority would be an add-on, an upside. And why do I say that? It's because when you look at MMN, it has the highest surge of IVIG across all indication and disease. Patients can spend up to two 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 provides this Convenient, starting with an IV once a month, you know, one or two hours and then moving to subcutaneous and another injector long term. This is really a plus and it's clinically meaningful for patients. Actually, at ANEM, I had the opportunity to have dinners with MMM patients and I was sitting for a few hours between two MMM patients and they were describing their life, what it is to live with MMM and having to plan your life around your infusion that are super burdensome. They're extremely excited. by the opportunity that MPAC would offer in MMN. And we are also very excited. So non-inferiority versus IVIG is a bold already 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. Thanks.

Our next question will come from Sophia Graf with J.P. Morgan. Your line is now unmuted.

Good afternoon, thanks for taking my question. 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 the syndication? You've referred to the high degree of unmet need there today, or could it be less so given the more limited overlap with your existing prescriber base?

Yeah, 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, 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 take about two quarters after approval to be able to get payer policies in place. So 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 IM&M 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.

Yeah, 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. It could even be bigger because we feel that a lot might be misdiagnosed or not diagnosed well. So given that I am in 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 at 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 prescriptions will come from neurologists and they're We already have a foot in the door since five years, and this should be even easier than with rheumatology. 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 it's important. So thank you for the question. Thank you.

Our next question will come from Luca Isi with Royal Bank of Canada. Your line is now unmuted.

Oh great, thanks so much for taking my question and 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 LTEVIA data despite, you know, very impressive 15 points improvement in TIFs, if I recall it correctly, and obviously in the context of the drug, it was 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 Roy Vann took exactly four years from the time the PIVL trial was actually posted on clinicaltrial.gov for the actual approval for brepacitinib. Is that the right comp for us to think about, Ed, or do you think you can beat that? Thanks so much.

Yeah, 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 IMM and very consistent, it was felt that this was a really great hypothesis generating data, but 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 affect appreciation and so forth.

Yeah, 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 Au with HC Wainwright. Your line is now unmuted.

Hi, good morning. Thanks for taking the questions. Maybe I would just be curious to hear from Sandrine, from her perspective, coming back from Anam, 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

Thank you for your question. So indeed, I was at ANEM and the feedback, I must say, has been extremely positive. We've seen 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. and as you have finished, since you have looked at ANEM, 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 PAD.

Our last question will come from Alison Bratzel with Piper Sandler. Your line is now unmuted.

Hey, good morning and thanks for fitting me in. Just going back to the unity futility decision, I guess, could you talk to, you know, do you have a sense of whether that outcome was specific to Sjogren'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 Sjogren's with other mechanisms or other assets in the Argenyx pipeline? Thank you.

Yeah, thanks for the question. So after this utility 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 that 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 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 plans. We're looking to be a leader in immunology and Sjogren's is obviously an area with high unmet needs. 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 development, developability, and also the patient, unmet patient needs. So we're looking forward to the scleroderma phase two 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.