Good morning. My name is Rob, 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. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star one. Thank you. I'd like to introduce Beth DelGiacco, Vice President of Corporate Communications and Investor Relations. You may now begin your conference. Thanks, Rob. We're very excited to be here today to discuss the FDA approval of VYVGART Hytrulo, our subcutaneous injection for the treatment of generalized myasthenia gravis. The press release can be found on our website, along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two, 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 Tim Van Hauwermeiren, Chief Executive Officer, and Karen Massey, our Chief Operating Officer. Karl Gubitz, Chief Financial Officer, and Luc Truyen, Chief Medical Officer, will be available for the question-and-answer portion. I'll now turn the call to Tim. Thank you, Beth. Welcome, everyone. Slide three. I'm very excited to be here today to share that the subcutaneous efgartigimod, branded as VYVGART Hytrulo, was approved by the FDA for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. This approval marks the second innovation we are bringing to the gMG community just 18 months after receiving FDA approval for VYVGART, our first-in-class innovation. The feedback from our launch so far has been incredibly rewarding. We are hearing from patients and physicians that we are offering a new treatment standard for gMG. Patients can gain a significant efficacy benefit without having to compromise on safety and tolerability. This is transformative. Now with VYVGART Hytrulo, we can offer a consistent benefit, but with the power of a 30- 90-second subcutaneous push, creating flexibility on how and where patients can receive treatment. Three points I would like to make before getting into the details of the approval. First, I continue to be impressed by the hard work and dedication of our commercial and medical teams, who have built incredible launch momentum. We have reached thousands of patients and both a breadth and depth of prescribers in the first 18 months of launch. We believe that based on the VYVGART Hytrulo label, we will be able to maintain the current launch trajectory as we work to move into earlier patient lines. Second, with this approval, we continue to honor our long-term commitment to the gMG patient community, meeting patients where they are with a broad, individualized treatment offering. Our decision to bring a subcutaneous product combination to market so soon after IV was never a life cycle management decision. It was a strategy driven by the value we place on patient choice, so that we could provide the flexibility of IV or subcutaneous administration. Last, I want to bring up innovation. When we first explored a partnership with Halozyme, we were still several years from a commercial launch, but our team had the foresight to find a way to easily deliver a biologic and subcutaneous injection and to put our exclusive agreement in place. This proved to be a fortuitous decision, and now we are bringing together two great innovations in one bottle with the first FDA-approved subcutaneous injectable for gMG. Slide four. We often get asked about the factors that drove the success of the launch so far, the biggest is the significant unmet need that exists for gMG. 61% of patients report poor well-being, even though they are taking more than two therapies on average to treat their disease. Current non-targeted treatments can cause significant side effects, creating a scenario in which patients need to make the choice between enduring often debilitating symptoms or experiencing negative side effects. The unpredictable nature of the disease starts early with a difficult diagnosis journey and can ultimately contribute to emotional burden, including depression or anxiety. The impact on society is also felt. More than half of patients have to stop working, and one-third require a caretaker to help with daily activities. Slide five. The ultimate goal for patients is to live without a constant reminder of their disease and its impact on their quality of life. This is what we want to achieve in redefining what well-controlled means. It's no longer that you are controlled if you're out of the hospital. We want patients to be able to achieve effective symptom control and to regain control of their lives. With VYVGART Hytrulo, we believe we are one step closer to this, with the flexibility to receive treatment outside of an infusion setting. This gives patients time to do the activities they love. Slide six. This approval was based on innovative, patient-centric bridging strategy. We wanted to bring a subcutaneous option to patients as quickly as possible. This trial design enabled that. Most bridging studies are based on PK. Ours was based on PD, specifically autoantibody reduction, which in the ADAPT trial was established to correlate to efficacy. You can see the consistency across IV and subQ in both IgG reduction and correlating efficacy measures. Slide seven. These are the highlights of our VYVGART Hytrulo label, which closely mirrors the label for IV, based on the bridging strategy we used. This is a strong label with its safety profile, record across the gMG treatment paradigm, and the built-in flexibility for physicians to manage timing of treatment cycles depending on the patient's clinical response. As part of our long-standing commitment to the gMG community, we will continue to work towards inclusion of self-administration and seronegative patients into the label to make VYVGART the go-to choice for an even broader population of gMG patients, which is a perfect segue to Karen, who will talk more about this. Thanks, Tim. Slide eight. VYVGART is transformative for MG because of how it simplifies the treatment in a process that I like to call democratizing the treatment of MG. The diagnosis and treatment of gMG and many other autoimmune diseases can be really complex. There are a battery of tests to start treatment, often vaccine requirements. Current treatment options come with safety and tolerability challenges or are not convenient for patients, prescribers, or payers. The impact, for example, of high-dose steroids on patient lives is very well documented. It takes close management from a gMG specialist to get the right balance between symptom control and side effects. This is why patients are often referred to specialist centers for diseases like generalized MG. For community neurologists, like with anything, the less you do something, the less familiar you are with it and the less practiced you become. Slide nine. With both VYVGART and VYVGART Hytrulo approved, we believe that we can further simplify the treatment of gMG deeper into the community and in the process, transform outcomes for patients, redefining what well controlled means. We can build the confidence of neurologists to prescribe VYVGART with a demonstrated efficacy of a 78% response rate after two cycles in the ADAPT study. There is a predictability with the safety and tolerability profile now with real-world experience. There are no vaccine requirements, and through our PSP and payer policies, we've been able to achieve broad access. Patients are provided with flexibility and choice, not only in how they want to be treated with IV or subQ, but also where they want to be treated, whether at an infusion center, in a physician's office, or at home with nurse administration. Tim mentioned earlier that we continue to invest in the how patients want to be treated. The current vial and syringe presentation of VYVGART Hytrulo is our first-generation subQ injectable, and our prefilled syringe development is already underway. We're also looking ahead at other device options. This higher treatment dynamic, patients have the choice to significantly cut down on treatment time, if they prefer, and can spend more time doing the things they love. With prescribers, we think we can reach more of them and offer a simple, effective treatment for a very complex disease. Slide 10. We also hope to achieve simplicity of access with VYVGART Hytrulo, building on the successful strategy we deployed with the VYVGART launch. We engaged early with payers for the IV launch, focusing on the significant value VYVGART can bring to patients with its efficacy and safety. This strategy has led us to very broad access, including more than 90% of lives covered, with 80% of those policies considered as favorable. With VYVGART Hytrulo, we hope to achieve the same, and we want to make sure that patients, physicians, and payers are choosing between IV and subcut only based on preference and not on price. For this reason, we are taking a parity pricing approach so that the annual net price is consistent across IV and subQ. Slide 11. We'll be using the same patient support program for VYVGART Hytrulo as we did for the IV launch. My VYVGART Path will be available to provide patients with personalized support as they navigate their treatment journey and the insurance process. Through this program, patients are matched with a nurse case manager who can help identify the appropriate site of care for treatment, whether in an infusion center, a doctor's office, or through home administration. Slide 12. Lastly, before I turn the call back to Tim, I want to share the global view for our VYVGART launches, both with IV and subQ. Our VYVGART IV product is now approved in the U.S., in Japan, in Europe, the U.K., and Israel, and we're expecting approval in Canada and China by the end of. This is the first approval for VYVGART Hytrulo, we have already filed the Sub-Cut in Japan and Europe and expect both approvals by the first quarter of 2024. Having joined argenx just over three months ago, I continue to be amazed at the ability of this team and this company to innovate and to execute. Bringing Sub-Cut to market just 18 months after the IV and now preparing for parallel global launches is impressive and something you see very rarely. I'm proud to have joined a company that truly puts patients at the center in all they do. Tim? Thank you, Karen. We have really appreciated your contributions during your first three months as we think about scaling our commercial infrastructure to prepare for many launches in the future. You can see on slide 13 that gMG is the very beginning of our journey to transform autoimmunity. We have demonstrated proof of concept now in four indications, and are awaiting data readouts this year in CIDP, ITP, pemphigus, and POTS. All of this working towards our 13 current indications and the plan to be in 15 by 2025, and this is only for our first pipeline candidate. Slide 14. We also announced news this morning from empasiprubart, our first-in-class anti-C2 antibody and our second pipeline candidate. We had a planned review by an independent data monitoring committee after nine patients completed the full 16-week treatment period of the first cohort. We observed a favorable safety profile in the first dose cohort, as well as early efficacy signals, both of which support proof of concept of ENPA in MMN and continuation of the study. All nine of these patients have rolled over to the ADHERE+ open-label extension study. This interim look at ENPA data in MMN is a meaningful snapshot for us for many reasons. ENPA is a perfect example of our immunology innovation program, where we worked alongside Professor Erik Hack from Utrecht University to build a differentiated molecule targeting an upstream component of the complement cascade. These results provide further proof that our unique approach of co-creation works well. We have a strong track record of creating innovative molecules, which have shown success in the clinics. Adding ENPA brings us to eight in total. This has also been a program where we have been able to unravel novel biology insights on MMN and the role complement activation plays in driving disease. It is gratifying to see a strong signal for ENPA in its first indication because it provides further support for the body of translation work we have generated. With a very thoughtful decision to target C2 based on solid translation biology together with black belt antibody engineering, we hope to be able to bring a new therapy to MMN patients who continue to face significant unmet needs. We feel confident that ENPA can be another pipeline in the product assets, and that continued investment in our IIP will help to drive organic value from our pipeline, including at least one additional pipeline candidate, which will be nominated by year-end. Slide 15. Today is a very exciting day for argenx as we continue to demonstrate our ability to execute across the value chain from discovery work to commercial strategies. This includes the unique biology insights we generate, the successful outcomes of our R&D work, another win on the regulatory front based on an innovative trial design, and delivering on our commitment to transform how autoimmune disease is treated, bringing patients one step closer to living the life they want. Thank you all for the time today and your continued support. We will now open the call for your questions. At this time, I would like to remind everyone, in order to ask a question, press star, then one on your telephone keypad. Your first question comes from a line of Tazeen Ahmad from Bank of America. Your line is open. Hi, guys. Thanks for taking my questions. I have a few just for clarification purposes. Tim, just with this approval, when do you think you would actually have the Sub-Q available in the U.S.? Do you think that with the availability of the Sub-Q, that the pace of the launch will accelerate in the second half of the year? That's my first question. Secondly, with the label for acetylcholine receptor-positive patients only, what proportion of the MG community now would you not have access to, and what plans would you have in order to, over time, gain access to the receptor-negative patients as well? Thanks. Yeah, thank you, Tazeen, for these questions. I will hand the commercial questions in a second to Karen Massey on, you know, when the product will be available, and, you know, whether this will accelerate the launch. Let me first take on your question on the acetylcholine receptor antibody negative patients, which is a very important one for us. We have made a long-term commitment to the gMG community, we're not going to give up all the negative patients. You know that we have compelling evidence from other synergies on the efficacy and safety of the drug, we have our plan ready. This was step one in our plan. Now that we don't have it in this current label, we will revert to the second step in our strategy, and we will communicate about it later this year. Karen, would you mind taking on the first, two questions, please? Yes. Thanks, Tim. Thanks for the question. On the initial question of when it will be available, we expect it to be available in July. Similar to the IV launch, the team's been working hard to ensure quite quick access and in the channel. In terms of the second question around whether we expect this to accelerate the launch momentum, maybe I wouldn't think about acceleration. What I would think about is that since the launch of IV, what we've seen is continued momentum and continued growth quarter-over-quarter. We're now approaching 18 months after launch. What you could normally expect is that growth might slow. What I believe that we will see is not an acceleration, but indeed a continued momentum in terms of how we're delivering with VYVGART and now also with VYVGART Hytrulo. What we've seen, in market research and in conversations with patients and with prescribers, is that there's not a bolus of patients that are, that are being held back and not started on VYVGART because they're waiting for subcutaneous. We don't believe there'll be a bolus. We do believe that this provides an additional and an important option for a difference in how patients can be treated, and therefore will continue that steady momentum that we've seen. Okay. Got it, Karen. Should we assume that at least initially, most of the pickup for Hytrulo will be switches from IV, or do you think that the new patient starts will also drive it? Great question. We believe that it'll be both. We are not pursuing a switch strategy. There may be some patients, prescribers who prefer the subcutaneous option, but and w e also believe that there will be some new patients that come on board. The one thing that I will just note, that I should have noted earlier is don't forget, there could be new to market blocks, depending on individual payers through the second half of the year on the subcutaneous VYVGART, depending on when they decide to review their policy. That could have an impact as well. Your next question comes from a line of Derek Archila from Wells Fargo. Your line is open. Great, thanks. good morning, and congrats on the Hytrulo approval. just two questions from us. just first, you want to know, since Hytrulo was approved as a HCP administered product, does it remain Part B, or does that change? and then also just on the self-administered prefilled syringe and development, just maybe an update on the status there. Is that different from the high concentration formulation you've talked about in the past? Thank you. Thanks for the question. We have the benefit of having Luc with us, our Chief Medical Officer. Luc, would you mind addressing the question on HCP administration first, please? Yeah, thank you. For the question, with getting that discussion with the agency, the two main factors that were considered were the actual nature of the presentation with a butterfly and a vial. And the second, then, how would that interact with the actual disease condition? In other words, double size, waxing and waning strength. And in that discussion, it was felt that bringing the HCP in as the sole source of administration was probably the better choice. We have to remember that this was actually a formulation that was designed to bring the ability for the subcutaneous to patients as quick as we could and address that unmet need. I think, having that HCP administration actually provides us an opportunity to learn more about these conditions under which self-administration could occur, which would inform our prefilled syringe development. To your second question, Derek, we're working diligently towards the PFS, the prefilled syringe, which is the next generation. The high concentration, we already have high concentration, by the way. It's quite remarkable you can concentrate a biological to the concentration we have, you know, up to 200 milligrams per milliliter with no penalty on viscosity, unlike, you know, full-size monoclonal antibody. We are working above and beyond this formulation, also with Elektrofi on a very high concentrated formulation. That collaboration is progressing well. I would say stay tuned for further information, you know, in the coming periods. Thank you for the question. Your next question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Hey, thanks for the question. Just to follow up on the seronegative population, just if you could clarify that, is the base case that you'd need to do an additional trial in that setting to get an approval? Secondly, just in terms of to the extent that you've had any discussions with payers on the subcutaneous coverage to date, can you share any feedback from that? I guess, how fast do you expect to get to the IV level of coverage? Yeah, thank you, Rajan, for the question. I will hand over the question on payers to Karl in a minute, but maybe first, Luc, your comment on seronegative, please. Doing another trial is certainly not our first option that we would go for. As was already indicated, we have accumulated both in the real-world setting but also in the 2001 trial itself, additional data on how efgartigimod can provide efficacy to seronegatives. We will reach out to the agency to set up a meeting to discuss these data. Then in that discussion, hear what else could be needed. If there, from there, the option comes for an additional trial, we will evaluate that and look at what that could mean. Karl? Thank you, Rajan. Yes, we think that the discussions are ongoing with the payers. It will take time. We will see similar dynamics as with the IV. Think about it as a quarter or two, also taking into account the new market blocks. We are confident that we will get equal coverage and broad coverage over time. Okay, thank you. Your next question comes from a line of Yatin Suneja from Guggenheim Partners. Your line is open. Hey, thank you for taking my question. Two quick one for me. First one is on 117. Could you characterize the signal that you saw in the efficacy assessment? I think in the PR, you mentioned that it was based on 22 patients, but only nine completed the full 16-week treatment. I'm curious to understand, you know, how quickly you're seeing the signal, what exactly, if you can articulate for us, in terms of the signal that you're seeing. The question on the subcu, I mean, in terms of the adoption, do you think the patients who are already on IV are the first switchers, like they'll switch to subcu? Are there any restrictions or particular requirement if somebody wants to switch from an IV to a subcu? Thank you so much, and congrats on getting this approved. Thank you, Yatin. Thanks for joining us today. I will hand over the IV subcu question to Karen in a second, but maybe, Luc, you want to give some further color to where we are with 117? Yeah. First of all, this is quite exciting. This is the first time that we get a new intervention showing promise in MMN, where there was a lack of innovation. I will have to carefully answer your question because this is still a blinded trial, which ultimately will become part of a regulatory submission, so I cannot provide too much detail. With respect to the data quantity we looked at per protocol, once nine patients had achieved 16 weeks, we had a data cut made that was sent to an independent data monitoring committee, as well as an internal panel. From that, we learned that safety would not be an issue to proceed with the next cohort. The internal panel evaluated that across several measures, there was a consistent response that would allow us to proceed to the selection of a dose. I'm afraid I have to keep it at that, but just to say the consistent response gave us sufficient confidence that we could make that step. Thank you, Luc. Karen, you want to comment on the second question? Yeah, sure. Thanks, Tim. As I mentioned earlier, we're not pursuing a switch strategy for IV to subcutaneous, and that might be different from some of the strategies, but other companies pursue when they launch a subcutaneous. This is not a lifecycle management strategy for us. We're trying to put patients at the center, meet them where they are, and ensure that they have options for how they receive their treatment. That's not our strategy. Having said that, there's no restriction in the label. Patients can switch from IV to subcutaneous. What we'll be pursuing is a strategy where the patient, the provider, should have a conversation and have a shared decision, based on the, also on the patient's access, the patient's preferences, as well as the prescriber's decision on whether they should be either started or switched to subcutaneous. In the interest of time, we ask that you please limit yourself to one question in order to get through as many of our questions as possible. Your next question comes from the line of Samantha Semenkow from Citi. Your line is open. Good morning. Thank you for taking my question, and let me add my congratulations on the approval. I was hoping to follow up on a previous question on payer dynamics. You know, is there any potential for acceleration of achieving payer coverage, given the payers are already familiar with efgartigimod? Karl, do you want to take this one? Samantha, thank you for the question. I mean, I think there's a potential, but the flip side of that is that IV is already available, so maybe the payers won't be in a hurry to make it available to patients. I think the discussions are ongoing. We think it will take a quarter or two, and ultimately, we're positive that we will get similar and broad coverage. your next- Thanks, Samantha. Your next question comes from a line of Akash Tewari from Jefferies. Your line is open. Hi, this is Amy on for Akash. Thanks so much for taking our questions. Just three on our end, if we may. First, for your prefilled syringe, what additional confirmation do you need from the FDA to get this on market, and what are your expectations on timeline? Could this be kind of a human factor or bioequivalent study in order to be sufficient? On MMN, what was the safety committee looking at specifically in relation to lupus or infection risk? Can you make any sort of comments on considerations on dosing in cohort two and early thoughts on target thresholds for C2 suppression? Finally, early thoughts on CIDP pricing now that you have the subcu approved? Given CIDP patients on average seem to receive around three times more IVIG by volume compared to gMG, could we be looking at an annual price of around $300,000-$400,000 for efgartigimod and CIDP? Thanks so much. Thank you. I think we will start with the first few questions. Why don't we try to save the key questions till later? I think the dosing for cohort two, the general framework we need to keep in mind is that the ultimate goal for phase II is to populate a PK/PD model, which can then interpolate the dose for phase III. Luc, do you want to comment on the specific fields of interest being lupus and infection risks and the deliberations of the safety committee? Yes. The safety committee got all available data, both clinical, adverse events, and labs that were available to us at that time. With this mode of action, infections, and in particular, one could think about encapsulated bacteria, were, of course, of interest. No events were seen. With respect to the lupus, that was also evaluated, and no changes were seen, neither in respect to the autoantibodies and so forth. It was given a clean bill. Yeah, thanks, Luc. I want to call out again the target rationale for C2. If you look at the phenotype of the genetic knockouts, there is no increased risk of lupus really, compared to C1 knockouts or other complement factor knockouts. I think we're on a safe biology ground, and the initial clinical data seem to confirm the ongoing hypothesis. On the PFS, I think you gave us the answer in your question. Key building bricks of the dossier will be bioequivalence and human factor study, right, Luc? Correct. Thank you for the question. Your next question comes from a line of Danielle Brill from Raymond James. Your line is open. Hey, guys, this is Alex on for Danielle. Just want to circle back to the self-administration roadmap. Just you were mentioning, you know, taking some of the learnings from the subcutaneous. I just wanted to see if that's, you know, what formally is the FDA looking for into the potential roadmap to self-administration, and are we really just waiting for the prefilled syringe for those? Thanks. Yes. One of the obvious advantages of a prefilled syringe is the number of steps it takes to get to the administered form. I think the agency just looked at the first generation, felt there were too many steps, and that a PFS would be a natural, more likely to be self-administered formulation. That's more or less their positioning. What we can learn from in the interactions with this first generation is how the fluctuation does impact, how do we need to adapt our training programs using then the simplified administration, the PFS, and roll that in a human factor study, which again, is going to be a key part of that dossier, as Tim mentioned. Your next question comes from a line of Vikram Purohit from Morgan Stanley. Your line is open. Good morning. Hi, thanks for taking our question. We just had one on uptake for subcu VYVGART. How do you think the mix of eventual IV versus subcu use could differ between U.S. and ex-U.S., assuming you receive approval by early 2024 for subcu VYVGART in the ex-U.S. geography that you've mentioned you're looking towards in last night's release? Thanks. Thanks, Vikram. Karen, this is a question you could take, please? Absolutely. Thanks for the question. In terms of the uptake of IV versus subcut, U.S. versus ex-U.S., we do expect subcut, once approved or if approved, have a greater uptake ex-U.S., because of the dynamics around the infusion centers and the practice economics in the U.S. versus the preference for subcutaneous, in markets outside the U.S. Your next question comes from a line of Alex Thompson from Stifel. Your line is open. Hey, great, thanks for taking my question. Maybe just one on reporting. Maybe, Karl, could you talk a little about how you expect to report revenues, and if you expect to give us some understanding around patient adds for the subcu and maybe context around switching between IV and subcu moving forward? Thanks. Thank you for your question, Alex. I think reporting, we will, of course, report revenue separately for subcu and IV. In terms of patient adds and switches, at the moment, we're not planning to provide any specific detail on that in the quarterly earnings calls. Your next question comes from a line of Allison Bratzel from Piper Sandler. Your line is open. Hey, good morning, and congrats on the approval, and thank you for taking the question. Just curious, with the Hytrulo approval, is there any reason to think that this dosing format could affect the average treatment cycle length in gMG patients? It just seems to us like some docs are starting patients on a fixed dosing regimen just because it's easier to schedule infusion chair time that way. Just curious how you think that may change or evolve now with a more convenient, non-infused dosing format available. Thank you. Hi, Allison. Thanks for joining us. This is a great question. What we see in the real world, of course, given the breadth of the label, is that indeed, different physicians decide to use the drug differently. Our experience is that about, you know, 1/3 of the patients is really enjoying long periods in between cycles. 1/3 of patients is getting really, let's say, quarterly cycles. 1/3 of patients needs more frequent dosing. That's where you see, I think, most initiatives taken by physicians to kind of plan the next infusion. I think your instinct is also our instinct. Maybe the subcutaneous product is uncoupling the patient from the infusion chairs and from the capacity planning, and will basically represent one step further in the individualization of how we treat MG. Remember, this is what patients want. I mean, there are no two MG patients the same, and they really call out the need for individualized dosing. We hope, and let's see now in the marketplace, how it turns out, that subcu is a meaningful addition to that. Thank you. Your next question comes from the line of Yaron Werber from TD Cowen. Your line is open. Hi, guys. This is Brendan on for Yaron. Thanks for taking the questions, and congrats to the team. Most of our questions have been addressed, but I did want to ask specifically for MMN. I know we've touched on this a bit, but based on what you've seen so far, is there a degree or level of C2 inhibition that you're aiming for now based on the data that you have at hand that you think would provide meaningful improvement? Then maybe if you could just tell us exactly what to expect data-wise from the upcoming release. Thanks very much. Conceptually, when we think about the treatment of MMN through C2 blockade, the question we need to solve for is, you know, what is the level, the adequate level of C2 blockade to have a maximum clinical benefit? I think you can assume that for the two different doses and dosing regimens, there's one extreme where you go for maximum inhibition, and then there will be another data point, you know, which is distinctly different, separated from that complete inhibition. Both data points actually should be able to inform the PK, PD model, such as we can extrapolate to know what is that dose we need going forward. Luc, is there anything you want to add to that concept? The only one I want to add is that this particular antibody is also designed to have a long effect. One of the key features that patients have to deal with IVIG treatment is their fluctuations. Aside from just a level of improvement, it's also the duration of improvement in terms of either staying stable or as we hope, the system repairs, even improving over time. It's not just being able to treat, but also treat in a different way, where people do not have to have these worsening of treatment and then go and get another course of IVIG. Thanks, Luc. Your next question comes from the line of Joel Beatty from Baird. Your line is open. Great. Thanks. What do you anticipate will be the most likely administration setting for Hytrulo, such as a provider office or a patient's home? Karen? We believe it'll be a mix, between provider, office, and patient's home. Of course, patients receiving it in the home will mostly be commercial. We do see that already with some in, of our infusion patients. We believe that that opportunity will expand, with the more simple subcutaneous offering. We believe that, it, this will be, as a Part B medicine with both infusion and subcutaneous. There will be SC administration and some home infusion, or home administration, expanding from the amount of home administration that we have today. Your next question comes from a line of Jason Butler from JMP Securities. Your line is open. Hey, it's Ryan for Jason. Thanks for taking our question. A quick one. What are your expectations for early, sub versus the academic setting? Thank you. I think you broke up, Jason, but I think the question is, expectations in terms of uptake between community and academic centers for subcu. Is that correct? Correct. Yep. Yeah. Patients that are in the low risk- Hey, Karen, can you comment on that, please, now that you know the question? Absolutely. I mean, I think to start with, when we've spoken to physicians, whether they're in academic centers or in the community, generally there is excitement to have the opportunity or the option for an infusion and subcutaneous. I think it's gonna depend a little bit on the dynamics of the local market, what you'll see in terms of the uptake between those. I'll comment on two dynamics. One, I do think you'll see an expansion in community neurologists because of the shorter, you know, going to 90 seconds for an injection rather than the infusion. It also seems like less of a step going from, say, an oral to an injection like that. We'll definitely see some uptake in the community. In academic settings, there might be a different dynamic, where there's challenges with infusion capacity, or just general site of care challenges, in terms of cost, and payer dynamics. You might see some uptake there as well. I think the real benefit will be that depending on the patient's preference, the prescriber's unique situation, there is the option for either, and we'll be able to meet the patients where they are. Your next question comes from a line of Douglas Tsao from H.C. Wainwright. Your line is open. Hi, good morning. Thanks for taking the questions. One for me, just one one seven. I'm just curious, when do we expect to get the final readout from the phase II study? Can you just provide an update where you are in terms of enrollment? Thank you. Thank you, Douglas, for the question. Luc, we have the benefit of having you here. How do we talk about the readout for phase II and status? Yeah. Again, as this is for us, a learning study, there's going to be multiple additional readouts to inform what we're going to do in phase III. The first interim analysis will be when we have the full data for the first cohort, which we expect to have sometime in October. The second cohort, in fact, the dosing for that will start next Tuesday, and then we have a cadence of patients already lined up to fill up that cohort. But one of the drivers, and this is specifically the design, is for each patient, what is their IVIG cadence? Because we need to know that before being able to dose them, and that creates some uncertainty on the back end. Yeah, sometime early next year, I think we will have cohort two. Yeah. Thank you, Luke. Thank you, Douglas, for the question. Your next question comes from the line of Joon Lee from Truist Securities. Your line is open. Good morning. Thanks for taking the question. This is Aseman for Joon. Just wondering, you know, do you think there may be a bolus of patients waiting on the sidelines for subcutaneous VYVGART? Thank you. Yeah, thanks for joining, and thanks for the question. I believe Karen covered it, so I can quickly repeat it. No, we do not believe there has been a kind of warehousing of patients which are now waiting for subQ and refuse to get an IV. Think of the subQ product, you know, as a tool to maintain the loss trajectory and do not expect anything close to a bolus. Okay? Thanks for the question. Thank you. Your next question comes from a line of Myles Minter from William Blair. Your line is open. Hey, congrats on the approval. Just one from me. Do you have any clarity now that this product has been approved as to what triggered the major amendment during the BLA filing? Was it something to do with additional data on those, anti-acetylcholine receptor antibody negative patients, or the route of administration and the need for an HCP to administer it? Just trying to get some additional clarity over whether this was specific to the filing or something we should think more broadly about this SC product moving forward. Thanks. Yeah, thank you for the question. This is personal opinion. We, we do not believe that, you know, either the acetylcholine receptor, negative patients or the self-administration was the reason for the initial, delay, because these are topics which only popped up during the label, conversations or the label negotiations. It remains difficult for us to really, get our fingers behind the initial clock extension. Technically speaking, of course, people remind us of the fact that we still did receive a priority review because we're still arriving early at the finish line. Thanks for the question. Thank you. Your next question comes from a line of Xian Deng from UBS. Your line is open. Hi, thank you for taking my question. Just one, please. Start with a general question on 117. I think there might be some indication overlap with FcRn, I think, VYVGART. For example, dermatomyositis could also be part of myositis that you're running the trial with VYVGART. MMN also has anti-GM1 autoantibody involvement, one could argue that there could be a rationale to try VYVGART. Just wondering, you know, on a sort of broad level, just wondering, how do you select which drug to go for which indication? What is your general strategy for 117 together with VYVGART? Thank you. Thank you. Thank you for that question. The biology of dermatomyositis actually has both modes of action and operation, and we feel that we need to provide the evidence for both, for each of these separately. As, as you know, VYVGART is studying the myositis actually three subtypes, and for C2, the 117, or Empa, for short, we are looking at dermatomyositis specifically. From a disease, there is clearly an indication overlap, but from how these two assets might impact it, I think it's important to generate the data separately. Afterwards, we can always look based on data, whether there's usefulness in a, in either a regimen or a combination approach. Yeah. When you start from the biology, I think there are two distinctly different population slides. One where clearly complement is in the driver's seat with no detectable antibody in the biopsy. Whilst for the other subset, you clearly see an autoantibody depositing and then recruiting, effector function, including complement. That's correct, right, Luc, we will test both. We will test both. Yeah. Thank you. There are no further questions at this time. This does conclude today's conference call. We thank you for your participation, and you may now disconnect.