Good evening. My name is Brent, and I will be your conference operator today. At this time, I would like to welcome everyone to the call. 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 at that time, simply press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, press the star one key again. Thank you. I'd like to introduce Beth DelGiacco, Vice President of Corporate Communications and Investor Relations. You may begin your conference. Thank you, Brent. We're very excited to be here today to discuss the FDA approval of efgartigimod, now with the easier-to-pronounce brand name VYVGART. The press release and corresponding presentation can be found on our website at argenx.com/investors. 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, the market for and market acceptance of our products, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. argenx is not under any obligation to update statements regarding the future or to confirm 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, Wim Parys, Chief Medical Officer, and Keith Woods, Chief Operating Officer. Hans de Haard, our Chief Scientific Officer, and Karl Gubitz, Chief Financial Officer, will be available for the question-and-answer portion. I'll now turn the call to Tim. Thank you, Beth. Let me begin by saying how thrilled we are to share this historic moment with you all, many who have been with us since the early days of developing what was known as ARGX-113. Today, VYVGART was approved by the FDA for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive, making this the first-ever FDA-approved FcRn blocker and the first approved drug for argenx. This scientific breakthrough has been the result of so much hard work, innovation, and collaboration from my colleagues over the last decade. I'm very proud to be here today with a new treatment modality for adults living with gMG. We have always said that our purpose sits at the intersection of the patient and the science, which you can see on slide five. This is where we can make a real impact in how we understand immunology and how we can potentially treat patients with autoimmune disease. Today, we are ready to take a major leap forward on this path as we prepare to launch VYVGART. We see the potential to truly transform the lives of adults with gMG who are in desperate need of more options. Slide six. VYVGART is indicated for the treatment of generalized MG in adult patients who are acetylcholine receptor antibody positive, accounting for approximately 85% of all gMG patients. The recommended dosing is in treatment cycles, 10 mg per kg administered as a 60-minute IV infusion once weekly for four weeks. Subsequent treatment cycles can be administered based on clinical evaluation from a healthcare provider. VYVGART has demonstrated safety in gMG. There are no contraindications. There are two warnings, one for infections to delay administration to patients with an active infection, and the second on hypersensitivity reactions. This is a great label, and we've been very pleased with our collaborative interactions with the FDA. We also believe this label enables us to bring significant value to adults living with gMG. Two quick comments before we move on. First, we are happy to see flexibility in the label that allows physicians to manage timing of treatment cycles depending on the patient's clinical response to VYVGART. This addresses the question on how physicians will dose VYVGART in the real-world setting. We're also happy to see breadth within acetylcholine receptor antibody-positive patients. In ADAPT, we enrolled patients who were not doing well on current therapies, including 20% who were on Mestinon alone. This is typical for those with early disease. We also enrolled more refractory patients, including 30% who are relapsed refractory with unresolved symptoms after having previously failed immunosuppressive treatment. You can see the outcome of our broad trial enrollment reflected in our label. Second, we included both acetylcholine receptor antibody positive and seronegative patients in ADAPT because we saw a significant unmet need that we hoped to address. We also know from a biology perspective that FcRn recycles all IgGs regardless of subtype. In ADAPT, we saw a high benefit, but also a high placebo response in the seronegative population. These patients are not in the VYVGART label, but as part of our long-term commitment to the gMG community, we will continue to follow the biology and work on behalf of these patients. When we started our work in myasthenia gravis, we knew that we needed to first listen to patients and their supporters and to partner closely with advocacy organizations like the Myasthenia Gravis Foundation of America. We integrated patient input in how we designed ADAPT, which Wim will walk through shortly. We also spent considerable time understanding the disease and treatment burden that patients continue to face even with currently available therapies. On slide seven, you can see what we learned. Neurologists told us that severe MG ranks second to only ALS as the most severe disease they treat. This was eye-opening to this still unmet need. We learned that the journey to diagnosis and treatment for all types of MG can be a long one, taking an average of 2.6 years from symptom expression to reach a definitive diagnosis. Even once diagnosed, the difficulty does not end there. In fact, over half of patients diagnosed with gMG have also been diagnosed with depression or anxiety. Symptoms can vary from patient to patient and day to day and even throughout the same day. This unpredictability contributes to the significant emotional burden of the disease. Despite taking an average of 2.3 treatments, 61% of patients have poor well-being, and 51% reported that they stopped working completely due to the impact of the disease. I look back at these early conversations with patients, and I'm so happy to be here today, having honored our commitment, offering hope with this new treatment option. Slide eight. We have long said that collaboration is at the heart of everything we do at argenx, and VYVGART is a perfect example of this. We owe a great deal of gratitude to Professor Sally Ward, our academic collaborator and a pioneer of FcRn, who identified the crucial role of the receptor in maintaining and distributing IgG antibodies. It is through her immunology breakthrough that we engineered VYVGART as an IgG one Fc fragment equipped with our proprietary ABDEG mutations. It was also through Sally that we recognized the broad potential of FcRn antagonism to address a multitude of severe IgG-mediated autoimmune diseases. VYVGART as a fragment is uniquely designed to block FcRn by outcompeting IgG antibodies and maintaining the pH-dependent binding associated with the interaction between FcRn and its natural ligand, endogenous IgG. In the graphic, you can see the now-familiar mechanism of action. VYVGART blocks FcRn, driving unbound IgGs into the lysosome for degradation while keeping FcRn in the recycling path, along with other bound serum proteins like albumin. Now let me turn the call to Wim, who will walk through the clinical data that we have collected in support of the BLA submission and approval. Wim? Thank you, Tim. Today is indeed a tremendous milestone for gMG patients, the argenx team, and all of our collaborators who made the approval of the first FcRn blocker possible. Slide 10. The clinical efficacy and safety data that supported the approval of VYVGART came from two studies, the global registrational ADAPT trial and the associated open-label extension study ADAPT+. The results of ADAPT were published earlier this year in The Lancet Neurology. Moving on to slide 11. As Tim said, we designed the ADAPT trial through listening to and learning from the gMG patient community. The number one takeaway is that no patient experiences this disease in the same way. As a result, we wanted to design a trial that reflected the individualized nature of gMG with a dosing approach that would be unique to each patient's individual response. Overall, in ADAPT, we saw significant response rates, a fast onset of response in the majority of patients, depth of response as measured by minimal symptom expression, and a safety profile comparable to placebo. Even with a stringent primary endpoint that had a durability component built in, we saw the highest response rate of any phase III trial in gMG today. 167 adult gMG patients were randomized one-to-one to receive 10 milligrams per kilogram of VYVGART or placebo in four weekly infusions dosed as treatment cycles over 26 weeks. The primary endpoint of the trial was defined as the percentage of responders on the myasthenia gravis activities of daily living, MG-ADL, scale among acetylcholine receptor antibody-positive patients during the first treatment cycle. To qualify as a responder, patients had to show a 2 or more point improvement on the MG-ADL scale for four consecutive weeks. The timing of a second treatment cycle was determined by the duration of clinically meaningful improvement. Slide 12. The ADAPT phase III trial demonstrated significant treatment benefit on both the MG- ADL and quantitative myasthenia gravis, QMG, disease course scales. 68% of patients were MG- ADL responders, compared to 30% in placebo. Efficacy was consistent on the more objective QMG scale, which was the first secondary endpoint. 63% of patients were QMG responders compared to 14% of placebo patients. Slide 13. Minimal symptom expression, or MSE, is an increasingly important data point for physicians and patients because it's a measure of symptom-free status. The opportunity to live with little to no symptoms could make a real difference in a patient's quality of life. In ADAPT, 40% of patients achieved MSE or an MG score of 0 or 1 at any time during cycle one. On the right side, you see another chart showing depth of response. Over half of patients treated with VYVGART experienced an improvement of 5 points or more on the MG- ADL scale by week four. Finally, slide 14 shows the summary of adverse events in ADAPT. The adverse events from VYVGART look comparable to placebo. Most of the treatment-emergent adverse events were mild or moderate in nature. The most frequent adverse events were headache, nasopharyngitis, GI symptoms, and upper respiratory tract infections. These safety data, combined with the efficacy data, show the favorable benefit- risk profile of VYVGART. I will now turn the call over to Keith to discuss our commercial launch plan. Keith? Thanks, Wim. I'd like to echo the earlier sentiments on what a critical milestone this is for argenx and the broader gMG community. I'm very grateful to everyone who has been a part of the VYVGART journey. It is a commitment and dedication of our teams that has brought us here today, and we are thrilled to be able to reach gMG patients who need more options. I'd like to start high level with our commercialization strategy on slide 16. Our goal is to capture the preferences of our key stakeholders, the patients, the physicians, and the payers. We have created a commercial infrastructure with optionality, so we can meet our stakeholders where they are. Our strategic imperatives for VYVGART launch are as follows: empower patients to demand better, provide best-in-class patient support, ensure rapid healthcare provider adoption of VYVGART, and enable appropriate access. Moving to slide 17. This is the number of adult gMG patients in the U.S. that we believe could benefit from VYVGART. This is also the opportunity before us and the motivation behind our efforts. We believe we are well-positioned to address the approximately 37% of acetylcholine receptor-positive patients in the U.S. This is 17,000 gMG patients who are intolerant to or showing inadequate response to commonly used therapies. These patients could be anywhere in the treatment paradigm because our label supports broad positioning. We believe VYVGART will initially be positioned as the first infusible therapy option. Though we have heard from neurologists who have had hands-on experience with VYVGART that they would potentially move it earlier into the treatment paradigm, including patients who are on broad immunosuppressive therapies like azathioprine or methotrexate, or on steroids where symptoms have returned with tapering. Slide 18. We have a very robust field team to reach the estimated 7,700 neurologists who treat approximately 97% of gMG patients. Our team is fully staffed and trained, and we expect drug to be in the channel in the next two weeks. We are ready to engage with the healthcare professionals and ultimately reach patients. The field team consists of 71 territory business managers, 10 thought leader liaisons, 16 medical research liaisons, 10 nurse case managers, 13 market access professionals, and 10 reimbursement managers. We were limited in the extent of our stakeholder engagement we could carry out prior to approval, focusing on identifying top priority targets, establishing relationships, and building a strategic go-forward plan that we will now put into action. Our teams have targeted and tiered neurologists based on several factors, including the number of gMG patients and frequency with which they treat them, the types of treatments that they currently prescribe, their willingness to adopt new therapies and their reach and level of influence with peer neurologists. Now with the VYVGART label in hand, we can confidently engage with stakeholders to ensure broad access for adult patients across all sites of care, underscoring the importance of our extensive network of infusion sites of care, home infusion nurses and national specialty pharmacies. Slide 19. We have spent considerable time with key opinion leaders in neurology, market research and various advisory boards. In these forums, we gathered input for an activation plan of how to increase physician experience with VYVGART following approval. We know that FcRn recycling is generally not taught in medical school. To address this, we need to be out there in a multi-channel approach. We will focus our educational efforts on the following, the role of FcRn in regulating IgG autoantibodies, the primary role of autoantibodies in driving gMG and VYVGART and its clinical profile. We expect interactions to mostly be in person, and we will consider in our planning the content that we have to share, the channel and the preference of each physician. We will also continue to use virtual interactions strategically where it makes sense. This is about meeting our customers where they want to be met. If you think about models of consumer adoption, we know that we need to build a foundation of awareness as a starting point to drive interest. Ultimately, we expect the physician experience with those first few patients to drive to their broader adoption. We already see a difference between neurologists who have had their hands-on experience with VYVGART and those who have not. This is one of the reasons, along with a great deal of uncertainty that's going on with the pandemic, that we continue to believe we will have a gradual launch. We expect to see steady, consistent growth among healthcare professionals as we launch our peer-to-peer speaker programs and broad marketing efforts. This brings me to slide 20. We are proud to launch My VYVGART Path to provide access and support and education. The physician prescribing VYVGART is just the first step of the process, but we believe we have created a best-in-class patient support program. With My VYVGART Path, we focused on personalized support to prioritize the needs of patients through our nurse case managers. Each patient will have a single point of contact that is delivering the white glove service and specialized attention that our patients need and deserve. Similar for the physician practices, each office will have a dedicated case coordinator for insurance needs throughout the process. The My VYVGART Path team will work with healthcare professionals to understand healthcare requirements for treatment initiation and for treatment continuation and to identify infusion fulfillment options. Overall, we feel this patient support program is unique to the needs of people on VYVGART and reflects our long-term commitment to the community of patients and their supporters. We want awareness and interest in VYVGART to flow not only from the physician to the patient, but also from the patient to the physician. This is part of our continued activation plan shown on slide 21. We are making a concerted effort to empower patients in their treatment decisions, both through our disease awareness campaign and our direct-to-consumer campaign. We want patients talking to each other and to their physicians about VYVGART. Slide 22. We are extremely excited to announce today that we have reached an agreement in principle with several national and regional payers to a structured value-based agreement. We believe these agreements will facilitate reimbursement for patients in participating plans. The VBAs were accomplished due to our early engagement and mutual alignment with payers on the importance of individualized dosing in gMG, where much variability exists between patients. The goal of the VBAs are clear, affordability, predictability and simplicity. We want to enable access to VYVGART for eligible patients. This requires an affordable, transparent pricing paradigm based on the value we can offer to patients. With individualized dosing, we see some patients who have a long duration of clinical benefit and some who may require more frequent dosing. This can mean a high degree of uncertainty on the cost of therapy. While the majority of patients will benefit from less frequent dosing, we implemented the VBAs to limit exposure to the payers for the high-frequency patients. We believe we landed on a fair price for VYVGART. The price captures the value we offer to patients in addressing the significant treatment and disease burden they continue to face despite the availability of current therapies. This is outlined on slide 23. We want to enable access to eligible patients who do not feel well managed on current treatments. These are patients who have changed their lives or given up on their passions because of gMG. VYVGART has the potential to transform the treatment paradigm and patient experience based on the significant efficacy response, demonstrated safety profile and individualized dosing schedule. The strong value proposition that VYVGART presents to patients is fairly reflected in the expected annual net price of $225,000 for a typical patient. This number is based on the treatment duration seen in the ADAPT and the ADAPT+ studies and the number of vials patients will receive per infusion, either two or three, depending on weight. Of course, this net price will vary based on the individual's dosing cycle and specific insurance coverage as well as mandatory government rebates and discounts. This brings me to slide 24. Today's approval in the U.S. is the first approval of a broader launch strategy to bring VYVGART to people living with gMG globally. Outside of the U.S., we expect an approval in Japan in the first quarter of 2022, and in the EU in the second half of 2022. These reviews are underway. Our partner, Zai Lab expects to file for approval in China by mid-2022, and Medison is on track to file for approval in Israel in the second quarter of 2022. We look forward to sharing updates on our regulatory and expansion progress next year. With that, I will turn the call back to Tim. Tim? Thank you, Keith. We started this company in 2008, driven by an entrepreneurial spirit to make an impact through scientific innovation. VYVGART has been a work of true collaboration. Before we turn the call to your questions, I would like to thank all of my partners in co-creation. First and foremost, patients and their families for participating in our trial, our advocacy partners who have built a community around MG, our physician partners whose dedication to their patients inspires us, our collaborators, specifically Sally Ward and her research teams who have guided us for over a decade to optimize the potential of FcRn blockade. Finally, my team of Argonauts, who collectively show up every day to turn an immunology breakthrough into a newfound hope for patients. We also want to thank you, our shareholders, for your continuous support. In many ways, this is a culmination of years of work, but the approval of VYVGART also marks just the beginning of what we believe will be a robust pipeline of indications for this novel new class of medicines. Slide 25. We are in six indications today that are all rooted in a strong biology rationale. We have shared our ambition to be in at least 15 indications by 2025 within our therapeutic franchises. We see a future of exponential growth for argenx by taking VYVGART into new indications and global markets and through our continuous commitment to drive innovation throughout the pipeline growth. With that, I would like to turn the call back to the operator to begin the questions. Operator? Thank you, sir. At this time, I would like to remind everyone, in order to ask a question, press star followed by the number one on your telephone keypad. In the interest of time, please limit yourself to one question. Your first question comes from the line of Yaron Werber with Cowen. Your line is open. Hi, guys. This is Brendan on for Yaron. Big congrats to the whole team on the news. Really great to hear. Yes, just one quick one for us. I know it's getting late in the day here. So I did want to see if you could maybe give us a little bit more color on your plans for the seronegative patients. I know you mentioned you'll continue to work on them. Are you planning maybe any additional studies there, or did you have something else in mind specifically for seronegative ones? Thanks very much. Yeah, you know that we included seronegatives in our ADAPT study as part of our long-term commitment to the community. As you remember from the ADAPT data, we did see a benefit- risk profile comparable to the total population, but we ran into an unexpectedly high placebo effect. Given the long-term commitment to the MG community and specifically to these seronegative patients, we are determined to continue to work on their behalf. Thank you for the question. Your next question comes from the line of Akash Tewari with Jefferies. Your line is open. Hey, guys. Thanks so much for the time and congrats on the approval. A couple if I can. We saw market drop-off in new patient starts for Soliris in MG during the pandemic. I think their last disclosed quarterly patient add was in the 50s, which was much lower than what they had previously. Kind of from a distance, how much are Soliris' issues related to the pandemic or sales force disruption versus some long-term issue with the gMG market? And do you have any updated thoughts on consensus estimates for gMG going into next year? And then, if I can sneak this in, when do you expect to hear back from the FDA on orphan drug exclusivity? Do you feel like that could block other FcRn players from entering the gMG market if granted? Thank you. Well, thank you, Akash. These are three good questions. Let me hand the floor to Keith to make a comment about, you know, how drug launches go in a semi-virtual world due to the COVID pandemic. Keith? Thank you, Tim. Appreciate the question, Akash. What we really believe is we've had the opportunity to put together a dual track, one that is both gonna be live and in-person, and we have been engaging with physicians live and in-person with our team out in the field, as well as with payers. But as we know, times change and this pandemic seems to waver, so we are completely prepared for virtual programs. I think that we all know the data shows that there are fewer patient visits live in the office than what we saw prior to the pandemic. I cannot comment on the Alexion's situation, but I can tell you that it's why we've taken the multi-channel approach to not just have the physician reaching out to the patient, but also the patient who's in need wanting to reach out to their physician. With regards to revenue, we don't provide our revenue guidance, but the analyst consensus for the U.S. is $99 million. Thank you, Karl. Akash, on your question on orphan exclusivity. Based on our understanding of the orphan exclusivity, we think that will mainly provide a protection against biosimilars. Thank you for the question. Thanks so much. Your next question comes from Tazeen Ahmad with Bank of America. Your line is open. Hi, guys. Good evening and congratulations on the well-deserved approval. A couple questions from me. Just looking at the label, specifically on the dosage and administration language. You know, after your first four weeks of dosing, it does say that the safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established. Can you give us more color on what that would mean in a real-world usage setting? Was that the language that you had proposed? Is it, you know, consequently the case that doctors are gonna be discouraged from redosing patients less than 50 days after they finish the first four-week cycle? Then secondly, can you give us an update on where you are with the bridging study for the subQ formulation? Thank you. Yeah, thank you, Tazeen. This is a great question on the label language. I'd suggest that Keith is going to take the first question, and then I will answer on the subQ bridging. Okay. Keith? Yeah. Thank you for the question, Tazeen. In the label, it is based off the ADAPT clinical trial. In the ADAPT clinical trial, we did have a timeframe between the end of the first cycle and the beginning of the second cycle. That time was about 48 days. That's where you see that language is in there. Do I think that this will change in the real world? I can tell you that we already see a change because after patients have been in our open-label extension for a year, they go into what is an OLE+, and at that point the patient can be dosed on cycles as the physician chooses. Now remember, in the ADAPT study, when we treated a patient, we had to allow them to begin to return to baseline before they were retreated. I n the real world, physicians, payers, and patients have told us they wanna reach their best level of response and be maintained there. The last comment that I will make here is not only in MG have we seen patients that were dosed less than 50 days apart, we also have other indications where the safety has been proven with continuous dosing. Okay. Thank you, Tazeen. Yes. This was the best possible outcome. I think we're super happy with such a broad label, and we have full degree of freedom on redosing and individualized dosing as actually studied in the ADAPT trial. Very happy with the broad label. Thank you. What was your question on subQ dosing, Tazeen? Could you remind me? Yeah, sure, Tim. Where are you on the bridging study, and when do you think we could potentially see data? We are making nice progress. I should say the teams are again making very nice progress. We announced publicly that we expect top-line data of the phase III study, first half next year. Remember, that's gonna be a non-inferiority trial where we go head-to-head with a 1,000 mg subQ dose, versus the 10 milligram per kilogram IV dose, for which we just got approval. The primary endpoint is all centered around percentage of IgG reduction. Of course, in the secondary endpoints, we're also studying clinical symptom improvement on the ADL and the QMG score. Okay. Thank you. Thanks for the question. Your next question comes from the line of Derek Archila with Wells Fargo. Your line is open. Great. Thanks for taking the question, guys, and congratulations on the approval. Just two quick questions from us. Just on the community neurologist, maybe you can kinda talk to the uptake you expect to see in that setting and whether you think there's gonna be a meaningful lag behind kind of academic medical centers. Also just on redosing, is there gonna be the requirement for reauthorization for redosing from the insurance and payer perspective? Thank you. Thank you, Derek. These are two great questions. Keith, why don't you make a start? Sure. What I can tell you, Derek, is that the community neurologists, at least in the launch of eculizumab, was actually where the predominant part of their business came from. I think that we will have the opportunity to potentially see that with our launch as well. Our team is not just targeting the academic centers, whereas remember, the reason why I guide to a gradual steady launch is even in the academic centers where they're familiar with VYVGART, they have to go through a P&T process to get access to it. We saw the uptake quicker in community. What are we gonna be doing? First of all, our team has already been out there meeting with these top community neurologists. They haven't been able to talk about VYVGART, but believe me, these community neurologists know a new product was coming out for gMG. We put together a number of educational programs that will be both virtual and in-person speaker programs so that we can educate the community neurologists as rapidly as possible. Your second question was on reauthorization for redosing. As you know, because of the VBAs that I mentioned in the prepared statements, we have already been working with the payers quite extensively, both national payers and regional payers. We do not expect you are going to have to do reauthorization on a cycle-by-cycle basis. What we believe you are going to see is probably a six-month or 12-month approval, and then it will have to be reauthorized. It's very similar to what you are seeing with eculizumab. Great. Thanks, guys, and congrats again. Thank you. Your next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open. Great. Good evening. Thanks for taking the question. I was just hoping you could go into a little bit more detail on some of the assumptions you made around the net price that you presented. Maybe you could just tell us how does the WAC compare to Soliris, and then what were the assumptions you guys made around discounts and rebates as well as the average number of cycles per patient to get to that $225 net? Thanks. Thank you, Matthew. Thanks for being with us tonight. We appreciate it. This is a question I'm going to hand over to Keith. Yeah. Matt, I mean, first of all, as we said, the price is based on the value to the patient. We took that annualized price, and we came to that really truly based on the data. All right. What the data shows is that 58% of patients that have been exposed to efgartigimod required five treatment cycles or fewer, okay. That means that you've got the majority of your patients that are really getting the benefit from this longer duration between cycles. The other things that were taken into consideration on this was we looked at the patient mix, not just of the ADAPT trial, but of the U.S. MG patient population. We looked at the gender mix as well as typical body weights because, as you know, VYVGART is dosed by weight. What the net price, the $225,000 that I commented on, is the typical patient. What this really means is the most commonly occurring patient based on the number of vials and the number of cycles per year. As far as the discounts and others that you take into consideration, we know that we're gonna have a payer mix, right? That payer mix is roughly 50/50 between commercial and public. We also know that we will have 340B mandatory discounts. You heard of the VBAs that we are going to be offering. We went with what was a typical net that you would see on most biologics. I will tell you that number that we are using is not applying the full 340B discount. Thank you, Keith. Thank you, Matthew, for the question. Your next question comes from Yatin Suneja with Guggenheim Partners. Your line is open. Hello. Thank you for taking my questions, and congratulations on the approval. So a couple questions from me. First is, on this redosing, can you just talk about what are the triggers for redosing, the physician's comfort around redosing? And then one clarification question. I think Keith made a point that, it's 50 days between cycles, so that would imply basically two months off and one month on, so only four cycles, but, per year. But the way we read the label, it says 50 days from the start of the previous cycle. So I just need some clarity, you know, when at the earliest the next cycle can be given. Thank you. Thank you, Yatin. Thank you for being with us tonight. We have the benefit of having our Chief Medical Officer on the phone, Wim. I'm going to hand the floor to him to discuss how, according to label, redosing is actually going to happen. Wim? Yeah, sure. I hope you can hear me. The label actually states what according to the protocol was the case. The minimum time between treatment cycles was 50 days. And the mean and median times for the second treatment cycle are also included in the label. To the earlier point that was made, how is redosing going to happen? I think if you look at the label that it is up to the patient and physician together to decide when a patient is ready. For the next cycle, based on the response that the previous response had occurred and the reemergence of symptoms. There is nothing specific in the label that dictates when that should happen. Thank you, Wim. Thank you, Yatin, for the question. Thank you. Your next question comes from the line of Yatin Suneja with Guggenheim Partners. Your line is open. Yatin just asked a question unless he's back in the queue. Your next question comes from David Nierengarten with Wedbush Securities. Your line is open. Hey, thanks for taking my question. I was holding out for Nierengarten as a brand name, but I guess it was taken. I know we've chatted about this before, a little bit, but you know, in your more recent, you know, market awareness, is there a demand from neurologists and patients for a drug, you know, to, you know, go on the drug without, you know, having worsening symptoms? Or, you know, do you anticipate the switch to VYVGART to be triggered by worsening symptoms in a patient, you know, and a desire for a new therapy or, you know, desire by the doctor for a new therapy? You know, has that dynamic changed or, you know, is it, you know, kind of how have you know, learned anything about that in your recent market awareness efforts? Thanks. Thank you, Dave. Thank you for being with us tonight. I think this is a question for Keith, right? Yeah. Thanks, David. Appreciate the question. What I will tell you is patients switching from their current therapy, regardless of what their current therapy is, we believe that if they're satisfied with the benefit, they're not gonna change therapy, at least not at the time of our launch. We are going to go the patients that are not satisfied with their current therapy, and they could be in a case of where they are worsening, right? That's still what the market research is showing us. Now, what I do believe is that with experience with VYVGART, and you have patients getting the benefit of it, and we see patients going into minimal symptom expression, and the physicians are seeing this. The physicians that are treating them. When the physicians are seeing it, I think that they will start to think about VYVGART for other patients and realize that, you know, maybe my patient that says they're doing okay, they're doing okay because they're living a new normal life. They don't get to have the activities that they used to like. If VYVGART can help them get there, then I think you're gonna see even some of the transition of those patients that are, you know, just getting by. That's gonna be over time. Okay. Just to double-check, you still anticipate, of course, a physician visit, you know, necessary for switching over to VYVGART therapy? You know, I would be surprised if somebody is going to prescribe a brand-new biologic over when they're seeing a patient, you know, when they're not seeing a patient in person. Yeah. I don't know the answer, but it would surprise me. Yeah, just double-checking. Thanks. Your next question comes from the line of Joel Beatty with Baird. Your line is open. Hi. Congratulations on the approval, and thanks for taking the questions. For the agreements in principle with payers, do those take the sub-Q formulation into consideration or will discussions on that be left to a later time? Then maybe another question related to these agreements. What do you anticipate payers will ask for before starting therapy on VYVGART for the first time? Yeah. First of all, the question on the VBAs and the subcutaneous. I just wanna remind you that the subcutaneous product is a combination product of efgartigimod with the ENHANZE enzyme. It will be a completely separate BLA and a completely separate product, which does allow us freedom to do completely individualized pricing from that of our IV therapy. To answer that question, no, the sub-Q therapy is not tied into these VBA agreements right now. And what was the second question in regard to payers? Well, any type of re-requests from payers before starting treatment for the very first time, you know, such as authorizations. Yeah. I think what we will definitely see is they're gonna wanna see the information that the patient actually has an MG-ADL score that's at least five or worse. The good news is we're not gonna be in a situation where there's any pre-vaccination or pre-medication that's required to begin therapy. I would expect to see payer policies in regard to get more detailed in the first half of 2022. Great. Thank you. Your next question comes from the line of Allison Bratzel with Piper Sandler. Your line is open. Hi. Good evening. Congratulations on the approval and, thanks for taking my question. First might be another one on price. Could you just help us understand how you consider pricing for other indications for efgartigimod that have different dosing frequencies like CIDP and ITP and deciding on this net price for MG? Yeah. Hi, Allison. Thanks for being with us tonight. It's really appreciated. Maybe this pricing question is one for Keith, right? I mean, we're a biotech company, and we made the decision on pricing efgartigimod, and we set the price based on MG, because this is our phase III that we have approved. We know that it has individualized dosing. I think in each of the other therapies, we already have subcutaneous product. The subcutaneous efgartigimod that is being studied in CIDP, it's being studied in pemphigus, it's also being studied in ITP and in MG. As I just mentioned, we do have another opportunity to price again. The last thing that I'm gonna say is when you look at some of these other indications, like ITP and PV, we believe that those patients will be treated into potential remission, and therefore not a 52-week-a-year patient. Yeah. Thank you, Keith. Allison, just to wrap it up, I think this is a fair price for MG patients, but it's not the type of price which is going to keep us out of any of the other indications which we're currently studying or planning to study. Thank you. Your next question comes from the line of Danielle Brill with Raymond James. Your line is open. Hey, guys. Good evening and I'll also extend my big congratulations on the approval. I just have a quick question about the open label extension plus. I'm curious how many patients are in that at this point, and how quickly you would expect those patients to transition over to reimbursed drugs. Thanks. Yeah. First of all, remember the open label extension after you completed a year of it, we gave patients more than one opportunity. They could go into the continued IV therapy in the open label extension plus, or we asked them if they wanted to participate in the subcutaneous study, because we've said several times, although we have the bridging study, we also have a commitment to a safety database with the FDA. As far as U.S. patients coming out of the original ADAPT study, there's not gonna be a bolus of patients that you're gonna see converting over to commercial. There are some, because not everybody elected to go into the subcutaneous study, but I wouldn't say it's a material amount. Okay, that's helpful. The ones, the few that did stay on IV would transition over fairly quickly to reimbursed product? They will. Our desire is to have those patients be some of the first ones into My VYVGART Path. Great. Thanks, Keith, and congrats again. Thank you. Your final question comes from the line of Jason Butler with JMP Securities. Your line is open. Hi. Thanks for taking the question, and I'll add my congratulations as well. Just, can you speak to the clinical data about retreatment and frequency of retreatment with earlier versus more refractory patients? Just how that ties into how we should think about the average annual net price earlier in the launch and then further out into the launch when you're getting more earlier stage patients. Thanks. Hi, Jason. Thank you so much for being with us tonight. It's a very special moment. We recently presented further data from the study at the scientific session of the MGFA conference where we actually could demonstrate that efgartigimod has an equally big impact on gMG patients regardless of the number of lines of therapy you're on. Whether your patient is more mild, more moderate, or more severe refractory, the impact of efgartigimod in terms of onset of action, magnitude of the benefits, and the durability of the benefits is the same. Maybe, Keith, you want to take the second question? Yeah. As far as the dosing and the duration that we saw in the clinical trial, one of the things that we've seen as the patients progress from the ADAPT to the ADAPT+, is when you take a look at their annual treatment, it usually takes physicians and patients a couple of three cycles to get dialed in into what that unique interval that patient requires. But once they've determined what that duration is between the cycles, we've seen consistency over time. If you wind up being on a every 10-week patient that needs a cycle, it remained consistent over time with every 10 weeks. The other thing that I will say to you is, as Tim remarked with the response rate all the way across, the variety of earlier second- line patients all the way to relapse refractory, it also didn't dictate how long their duration of response was from what bucket they came from. I don't see that, you know, later on when we're getting earlier treated patients that will necessarily mean less valuable patients. Great. Thanks again and congrats again. There are no further questions at this time. I will turn the call back over to the presenters for closing remarks. Well, dear shareholders, thank you again for your time today. We wish everyone a nice holiday season with your families and a Happy New Year. Thank you. Ladies and gentlemen, this concludes today's conference call.