[Call Starts Abruptly] This might explain why patients consistently switch between treatments. Finally, there is a considerable market opportunity with approximately 16,000 to 17,000 addressable patients in the U.S. alone. We are continuing to enroll patients in the ADVANCE SUBCU, ADHERE, and ADDRESS trials for ITP, CIDP, and Vulgaris, respectively, which are shown on Slide 7, 8, and 9. As we approach enrollment completion, we will be able to provide more granular standing for these results. We recently shared the full results from the Phase 2 Pemphigus study in the British Journal of Dermatology. We would encourage you to read its manuscript with data to support our latest understanding of how Efgartigimod could fit into the treatment paradigm in Pemphigus given the observed fast onset of action, favorable tolerability profile, and potential to use lower initial doses of corticosteroids and start early steroid tapering. With our newest indications, we are in the final preparation stages to initiate registrational trials. The Bullous Pemphigoid trial is on track to start by the end of this year, and Myositis is expected to start during the first quarter of 2022, now that we have wrapped up our FDA consultations, and these are depicted on Slides 10 and 11. Through our collaboration with Zai Lab, we are also planning to launch proof-of-concept trials in additional indications. We aren't ready to be public on the plan yet, but in the meantime, Zai is preparing to start enrollment of Chinese patients into our ongoing global clinical trials. I'm going to quickly talk about 2 other important programs in our pipeline, starting with ARGX-117, our first-in-class C2 inhibitor. We shared Phase 1 data from ARGX-117 during our R&D Day when we explain the reasons why we believe that C2 is an ideal point of intervention within the complement…

Thanks, Tim. Slide 15 covers our 2021 financial results for the 9 months ended September 30, 2021. I will summarize them here, but they are covered in more detail in today's press release. Total operating income increased to $494.6 million compared to $47.7 million during the same period in 2020. The significant increase was primarily due to the recognition of $315.1 million as a consequences of a termination of a collaboration agreement with Janssen. Additionally, the closing of a strategic collaboration with Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue. R&D expenses increased to $413.3 million compared to $276.4 million in 2020. The increase resulted primarily from higher external research and development expenses, mainly for our efgartigimod programs. SG&A expenses totaled $210.2 million for the first 9 months for 2021 compared to $113.2 million in 2020. The increase resulted primarily from higher personnel expenses. The change in fair value on non-current financial assets totaled $11.2 million so far this year, which is the result of the closing of a Series B financing round of AgomAb Therapeutics in which we have a profit share. Finally, cash, cash equivalents, and current financial assets totaled $2.53 billion as of the end of September compared to $2 billion on December 31, 2020. I'd now like to turn the call over to Keith Woods to provide an update on our commercial launch preparation. Keith?

Thanks, Karl. Slide 16, please. We are on track with our preparations for the global launch of efgartigimod in MG. Based on our December '17 PDUFA date in the U.S., we anticipate an effective launch date in January 2022. In Japan, we anticipate an approval in the first quarter of 2022, followed by a commercial launch 3 months later once we have price set. In Europe, we expect to have an approval in the second half of 2022, and then we will negotiate price and reimbursement on a country-by-country basis, and this is a process that can take anywhere from 12 to 36 months. Slide 17, please. We are also excited to announce that as of today, our U.S. and Japan field teams are fully on board. We are currently conducting training and account profiling to ensure that we are prepared to reach patients, providers, payers, and other stakeholders upon approval. We have 70 territory business managers in the U.S. and 24 in Japan, but our full field force in the U.S. will be a team of 146 people. In addition to the territory business managers, the team also includes the Regional Business Directors, Nurse Case Managers, case coordinators, medical research liaisons, thought leader liaisons, field reimbursement managers, Regional Account Managers, and National Account Directors. We continue to be impressed with the level of talent, experience, and enthusiasm the new team members bring, and we see their shared commitment towards the patient. We know that the investments we are making in our team and our other infrastructure now will benefit us for the long term because we will recognize economies of scale as we expand to each commercial franchise across new indications and with new assets. While we feel we have assembled a best-in-class team that is equipped to handle…

Thank you. I'd first like to echo what Keith said. We are on the precipice of an important moment for argenx, our first opportunity to bring in new medicine to people living with MG, and those suffering from a multitude of other serious autoimmune diseases. This is what motivates us every day. To summarize, we are excited and ready for the global launch of efgartigimod for the treatment of myasthenia gravis, first in the U.S., then Japan, then Europe. In order to maximize long-term value, we are efficiently developing multiple indications in parallel and working with partners such as Zai and Medicine to accelerate and expand the development and reach of its first and potentially best-in-class assets. As we grow into a fully integrated global immunology organization, we have not lost sight of our strong scientific foundation and commitments to translate immunology breakthroughs into groundbreaking treatments for patients in needs. This is why we are simultaneously progressing other assets, such as ARGX-117 and ARGX-119, and fueling our long-term growth by continually adding new assets to our powerful discovery engine, the Immunology Innovation Program. We believe this will provide long-term sustainable growth for all stakeholders. With that, I will open up the call now to your questions. Operator?

[Operator Instructions] Our first question comes from Akash Tewari with Jefferies.

Have any of your sites from Vetter, Lander, or Cardinal been inspected, either in-person or remotely by the FDA heading into your December PDUFA decision on efgartigimod? And just if I can take this in, what's the rationale for you initiating trials that are exploring other dosing regimens in gMG? Was that a decision based on doctor feedback or agency feedback?

Thank you, Akash. Thanks for the question. So first question, the manufacturing sites are currently being inspected by the FDA remotely. And remember, these are sites which are very well-known to the FDA. These are sites which have been expected in the past on numerous occasions and notable products are being manufactured there, which are FDA approved. So that is ongoing, and we think we're on track. You see on clinicaltrials.gov one of hopefully many Phase 4 studies, we'll continuing to efgartigimod in some of our indications. So I would say there's nothing more, nothing less to say than this is one of the Phase 4 studies, which we're currently rolling out.

Our next question comes from James Gordon with JP Morgan.

One question was on efgart pricing. So just -- what is your latest thinking, assuming U.S. approval about how the product could be priced? Is it a product which you think is being priced similar price to what it would cost to give sort of immunoglobulin so not much more than $100,000 or could this be more like a $200,000 per patient per year product depending quite how many doses a patient were to get? And if I just squeeze in a follow-up question. Just ASCO round but I noted some of the comments about needing a J Code and the time taken to get a J Code and also to build awareness of a new mode of action, all makes total sense. In light of those comments, I think Bloomberg consensus has revenues of $193 million for next year for the group overall. Could that be a little bit higher given just some of the things we need to bear in mind for the ASCO round?

Keith, would you mind taking the first question on pricing, please? Thank you.

Happy to do so, Tim. So, James, we've been doing homework for quite a while on pricing. And we've also been looking at IVIg and if you look at it with the recent price increases that they've taken over the last couple of years, the cost of -- the average cost of chronic IVIg treatment for an MG patient is about $190,000 per year. And I want to call, that's the average. Some patients are much more expensive. We believe that we offer a premium value proposition based on our efficacy, our rapid onset of response, and our depth of response over that of IVIg. In addition, we think we provide greater convenience and overall safety and tolerability with our individualized dosing schedule. So that's kind of where we are on this with our pricing thoughts. And this should be the last earnings call before we can actually disclose price.

Maybe Karl, you want to comment on the second question, please?

Thank you, James. So I'm just going to comment on -- you said that consensus is under the $193 million. When I look at the consensus, I see for product revenues, it's around $140 million. So that's what I see for consensus for product sales. I think some analysts still have revenue assumptions in there for closure, which, of course, has now all been recognized in this year. So I think that's something which analysts will look at as they refine their models. Thank you.

Our next question comes from Danielle Brill with Raymond James.

Tim, I was wondering if you could provide some color on the topics of focus and maybe the types of questions posed by the agency during your late-cycle review meeting. And then also curious, given the proximity to the PDUFA date as labeling discussions have begun yet?

Danielle, thanks for being with us today. So there's not too much, of course, we can publically discuss about the ongoing dialogue with the FDA, but we can confirm that the late-cycle review meeting is behind us. I would say it was a meeting in line with our expectations, and we believe that based on the short discussion, this company is on track with the review of the file. We got confirmation again on -- no need for another 5-day panel. We did explicitly ask the question to the FDA that we are on track from their point, the review on the file, which is something we can confirm. And therefore, based on that discussion, we believe we're on track for the PDUFA date of December 17. But thank you for the question.

Our next question comes from Yatin Suneja with Guggenheim.

Another question on the launch dynamic. So I understand, I think the revenue is likely a function of price and how many cycle a patient can receive. So can you just talk about how many -- how should we think about cycles per patient per year? And then maybe just moving away from revenue, if we look at Soliris, I think they added about 750 to 800 patients in the first year of launch. And obviously, you are going after a much bigger TAM. So just trying to get a sense that is Soliris a good -- or sort of a reasonable base to build a case and then sort of more upside as you expand in other geographies.

Yatin, thanks for being with us today, and these are 2 great questions. I'm going to give the floor to Keith who's in the best place to address those. Keith?

Yes. Thank you for the question, Yatin. So when it comes to cycles per patient per year, what we're seeing from the data is a distribution curve. So you're going to have about 50% of patients that are going to be able to take advantage of a substantial period of time off therapy and experience few cycles per year, where we also have part of the population that is going to require closer to chronic dosing. So I think what the -- how we are discussing this with the payers is they're taking a look at where on that distribution curve? Do they feel a typical patient will fall, realizing that with some of their patients, it's going to be relatively low expense for them. And with others, it will be more of a chronic dosing, and therefore, it would be a higher revenue patient for us. As far as the read-through from the Soliris launch, it's really give a read-through because it's not a pure apples-to-apples comparison. They do have a broad label, but they're restricted to acetylcholine receptor-positive patients. But the real thing is a lot of the payers have limited them to the severe relapsed refractory. And as you know, we are targeting a broader audience. So it's difficult to use that as a direct read-through.

Just one clarification question. The 20,000 addressable patients that you talk about, that's a U.S. number, correct?, in gMG?

That's correct. That is the U.S.

Our next question comes from Joon Lee with Truist.

Thanks for the update. ICER recently published a report giving eculizumab B + and efgartigimod a C+. Plus, also, they concluded that the quality-adjusted life years was less than that of -- less than half of that of eculizumab. Obviously, they made several assumptions, including placeholder for price and not accounting for the differences in frequency of dosing and other convenience factors. But would love to hear your comments on their findings and where you differ from them on the value prop at efgartigimod. Thank you.

Joon, thank you for the question. I think that review done by ICER was a great opportunity for us to really take a deep dive into our own data and develop the fullest understanding of our own data, and then we continue to be very excited about this data. And I think if you look at the track record and history of ICER, you can see that typically the conclusions there report on were never really aligning well for rare disease drugs from a pricing point of view. So it looks like their models are not really in queue with modeling a rare disease drug like efgartigimod for treatment of MG. We did agree with some of their relative conclusions, however, in terms of positioning vis-à-vis some of the other medications, including eculizumab. And one of the things which really separate us from the data is that if you would look at the subset of patients in the ADAPT study, which would need to regain criteria, you would basically see that the data in the regain light population was in line and as strong as it was in the overall population. And that also gives me the opportunity to relate back to some of the latest data disclosures, which we have given at the EMEM conference, for which we won't give any upcoming reasons during the scientific session of the MGFA. Very excitingly, you see that in the ADAPT study, the effect of efgartigimod was as potent regardless the number of lines of background therapy given patient was on. So even in the most refractory patients, we have an equally strong effect, but also across the different muscle domains. So regardless when we talk about ocular, boulder, respiratory, or limb and growth multifunction, you see that the effect of efgartigimod is consistent and strong across the different subsets of muscles. So I thought a great further data analysis continuing to underpin the strength of our data. Thanks for the question.

The next question comes from Tazeen Ahmad with Bank of America.

Tim, just a quick question. I'm sorry if it's already been asked. I joined just a tad bit late. But how are discussions with FDA going regarding the application for efgartigimod and MG and have labeling discussions started yet?

Tazeen, yes, we did cover the FDA topic very briefly based on the status of our reality inspections, the review of the file, and how the late-cycle of each region has been growing. We think that we are on track vis-à-vis the PDUFA date of December 17. And from a labeling discussion point of view, we have to refrain from answering this question. We will talk about labeling discussions hopefully on a later occasion. But so far, we think everything's on track. Ultimately, of course, this remains an FDA decision and only FDA will decide. Thank you.

Okay. And then just a follow-up on how you think of the market opportunity, just not including the products that are on the market now, but ones that might be coming on for MG in the future. So for example, I think that Regeneron is working on bringing a product into the clinic for MG. Where do you think the biggest point of differentiation will be for efgartigimod versus anything else that you potentially foresee entering the market? Thank you.

Well, 2 stuff answered to the question, which is a great question. If you look beyond the FcRn class to, for example, complement inhibitors, I think we now have an understanding of the biology such that we do know that the pathogenic autoantibody is acting upstream of complement. So it's actually having multiple pathogenic modes of action on the junction. Complement recruitment is one of them. And I think it is fair to see that -- or to say that the ADAPT data show the strength of -- the power of removing the pathogenic autoantibodies, a part of which probably goes above and beyond what the complement blocker can do. Now within these FcRn class, I think we've put the bar very high. If you look at the safety profile of our drug, where by far we have the biggest and the largest safety data set of all across healthy volunteers and multiple indications. It's fair to say that the safety profile of efgartigimod is emerging as a potential differentiator. I think we've also put the bar very high when it comes to the efficacy. I mean an 80% response rate over the first 2 cycles, achieving almost a 60% minimum symptom expression and then the durability of the effect that, that is a very tall bar for other people to come and even try too much. And then on the convenience angle, we do continue to believe that the exclusive Halozyme license and therefore, the very convenient subcu dosing that enables an immediate setting a whole new standard in the space of MG. So municipality, safety, efficacy, convenience, I think we're really setting at tall bar. Thanks for the question.

Our next question comes from Rosie Turner with Barclays.

So just 2 very quick ones from me. In terms of the 15 indications and your targeting being in by 2025, is that in -- were those Zai Labs indications be in addition to that or is that including those Zai Lab indications? And then just thinking about the at-home infusion network you mentioned. Just wondering kind of how that will work and is that going to be corresponded by yourself or something that you can pass on to the insurers and just thinking about what that will have an impact on margins?

These are 2 great questions. Keith, I will hand over question 2 to you in a minute on the infusion network and how that would work. On the 15 indications, the simple answer is that it does include the strategic alliance with Zai Lab. So this is a totality indication bringing into play, pursuing our own indications but also indications pursued by our partners. Keith?

Yes. Thank you. As far as the infusion network goes, we are working with a number of providers across the U.S., and how this is designed is there are certain insurance companies that have preferred home infusion providers, and we will be working with them. We also have targeted the home infusion centers that currently treat a great deal of neurology patients at home. So it is a broad network because our overall concept here, especially in a COVID environment is as we launch, we want to be able to meet the patient demand where it needs to be met. And what I mean by that is we will offer through specialty pharmacy, we will offer home infusion, we will offer in office treatment, we will offer infusion centers where patients can go be treated. So the idea is to make it as convenient as possible.

Our next question comes from Jason Butler with JMP Securities. Jason, you might be muted?

Just one on Japan and the reimbursement process there. Can you just talk to us at a high level, how you think about price dynamics versus the U.S.? And also the reimbursement process relative to any reference -- relevant reference in Japan? Thanks.

Jason, Thanks for being with us today. Keith, this is a question for you, right?

Yes. Thanks, Tim, and, Jason, thanks for the question. So as far as the process for reimbursement in Japan is, the first thing that we need to do is negotiate price with Japan. That's an ongoing process that takes some time. Ideally, our pricing strategy is to have as close of a tight pricing band across the globe, but we will continue to work with Japan. And after we have regulatory approval in Japan, it is typically 3 months later that you get your NHI price from them. So we will continue through in the negotiation of that process with them.

The next question comes from Joel Beatty with Citi.

For the subcutaneous trials underway, such as in MG and ITP, what are your expectations for showing comparable data versus opportunities to show some type of benefit compared to the IMP formulation?

Great question. In the -- at this situation, we believe that 1,000 milligram for a dose of subcu has an almost identical PD effect as the 70 milligrams IV. So we're actually going from non-inferiorities, and that will be measured in the primary endpoint based on percentage IgG reduction and in the secondary endpoints based on the improvement of clinical symptoms. We've been expecting equivalents at safety and efficacy. Of course, we're aiming for a different product presentation, which could be appealing from a convenience point of view to a subset of patients. Again, for ITP, we've many queue registration trials for submission. We've chosen to do one with the IV product and one with the subcu product, but again, identical to vitro. So we expect that the total data sets will be consistent between both studies. Thank you for the question.

The next question comes from Yanan Zhu with Wells Fargo.

I have 2 quick ones. Is it reasonable to assume that the antibody-negative patient population might be one of the topics of labeling discussion? And also, more broadly, are you -- do you contemplate any head-to-head studies with IVIg in some of the indications that you're pursuing, where IVIg is approved treatment?

Thank you for the question. Keith, you want to take the seronegative question, please?

Yes, happy to do so. If we take a look at the seronegative population, I just want to call out that they were not a part of our Phase 2 study, but we honored our commitment to the MG patient community by including the seronegative in our Phase 3 trial. We did this because of the belief of the impact that efgartigimod has on specifically IgG-4. We did in the Phase 3 study, see in the data that there was a treatment benefit in using efgartigimod, but I want to call out that the response to placebo was nearly equivalent. So the data we saw are not statistically significant. We continue to look at this group even further by not just looking at ADL but also QMG, we've shared some information on both MG-ADL and QMG as well as those who achieved MSE. So we have provided all of this data to the FDA. But ultimately, this is going to be a decision by the agency.

Thank you, Keith. And then on the second question, the -- look, for the current studies, none of the studies are going head-to-head, of course, against IVIg. As a reminder, in myasthenia gravis IVIg is not an approved product. In ITP, we're aiming for the chronic setting and not for the acute setting with IVIgs in play. For CIDP in myositis, there was no need or no requirement by the FDA to do such a head-to-head study vis-à-vis IVIg. And again, in Pemphigus vulgaris, Pemphigus IVIg is not really a place. So for the current announced trials, there's no head-to-head comparison required or warrants us. And of course, we cannot comment yet on future clinical trials. But thank you for the question.

Our next question comes from Douglas Tsao with H. C. Wainwright.

I'm just curious if you have a sense for providers, are they going to be treated? Since you have so many patients, you do to treat sort of minimally, symptom expression. Are they going dosing to that level? And then just I'm curious, do you see in the data, patients who achieve MSE, do they achieve the same level of durability of response or is when they start to -- the disease starts to manifest again, is it sort of slow progression or do symptoms come on fairly quickly?

It's a great question. Keith if you're comfortable to ask about -- to answer the question, whether we think physicians who dose onto MSE?

Sure. Ultimately, we believe not only physicians are going to want to treat their patients to achieve MSE because until there's a cure, there's really nothing more powerful than being able to walk around with no symptoms and not having to deal with adverse events that are associated with many of the current off-label treatment for MG. We've also met with physicians, most recently at AANEM, where we got to meet with them live. And ideally, they want to put their patient into MSE and be able to maintain them there. By the way, payers feel the same way because a patient that is not experiencing symptoms at substantially lower opportunity for wind up being hospitalized for MG and therefore incurring higher costs. So ultimately, the ADAPT trial, you did see MSE. But as you know, in the dosing cycles, because of how we needed to learn from the trial, we did allow patients to lift back up out of MSE before redosing. I think real world, you're going to see them -- those patients achieve MSE and then attempt to be maintained there.

Thank you, Keith, and then on durability of the effects. Of course, now we have data from 2 open-label expansions or expansion studies taking patients 2 to 3 years on study drug. And what we said earlier in the call is that the ICER was an opportunity for us to really take a deep dive into the totality of our data, and we continue to be excited about the strength of the drug through that data review. The only thing we have publicly said is that in the second treatment cycle, we continue to see an equally strong and not stronger MCE effect in our patients. We will be talking about interim data looks in the open-label expansion studies going forward, but that is data to be expected at conferences, most likely next year, okay?

Our next question comes from Charles Pitman with Redburn.

I just have two, if I may. Firstly, we've seen a number of delayed PDUFA decisions due to COVID-related manufacturing inspection issues due to regulators' inability to visit manufacturing facilities. I was just wondering if you could talk to whether or not this is at risk for the 17 PDUFA date? And then secondly, just on your partnerships, could you give us an indication on the potential approval time lines for Zai Lab in China in Medicine in Israel? And just to clarify, for the Medicine partnership, does this have potential to extend other indications beyond marginal prowess? Thanks.

Thank you. Keith, I will -- want to give you the second question on likely approval or approval process for Zai and Medicine. And on the first question, what we said publicly is that clinical site inspections have been successfully concluded by the FDA in-person. The selected manufacturing sites are being inspected currently remotely. These are facilities which are known to the FDA. They have had numerous FDA inspections before with the group track records. And therefore, there's a good likelihood that the manufacturing site inspection will basically happen completely remotely. So at this moment, I'll just repeat what I said before in this call, we cannot see any risk associated with manufacturing site inspection when it comes to a potential delay of the PDUFA date of December '17. Thank you. Keith?

So let's take Zai first. So in regard to Zai and the time lines, we expect that we will make submission in China that will occur after we have approval here in the U.S. and after we've made that submission, we expect to review time line to be approximately 1 year. As for the Medicine agreement, the process in Israel can actually start once we have approval in the U.S. And we've done this; Medicine has been selected on the basis of their reputation and their track record. It's part of a business case on whether to partner Israel, and we just believed in their capabilities, we've seen their track record of success there, and being able to get patients started. Just so to give you some reference, in Israel, from the literature that we can see, there's about 1,500 diagnosed MG patients there. So this is -- we expect this to be the first of several distribution agreements that we will be providing throughout the world. It's too early to give definitive regions on whether we will be argenx by ourselves or with a distributor partnership, but this is just the first example of one.

Next call comes from Emmanuel Papadakis with Deutsche Bank.

Essentially, I wanted to ask how important will subcu be in accelerating MG uptake in 2023 once it is approved. And secondly, what are the expectations for ITP data next year relative to the current standard of care and its likely clinical positioning?

Thanks for these 2 excellent questions. Keith, why don't you go ahead and you talk about how you look at the imports of the subcu products relatively compared to the IV products for penetrating our engine market, and then I will take the second question, okay?

Sure. I'd like to first call out that IV efgartigimod for MG patients is meeting a substantial unmet medical need. And patients that are experiencing efgartigimod, that I've had the opportunity to meet with, are extremely happy with their experience. So I think that because if you think of some of the steps that I quoted in the prepared statements of 51% of people not being able to go to work, you will gladly go sit down and have an IV if you're going to be able to improve your quality of life and overall, what you're able to do by taking efgartigimod IV. We do believe that one subcu is available that there will be -- where the market will get slightly bigger. And that is because you do have some patients that just from a convenience point of view or how far they are from a possible infusion site might not go on to therapy, while its IV, whereas with subcu, we expect that they are going to be able to self inject at home. So I think you will see the overall size of the buy grow once we have the subcu available for MG. At the end of the day, it's about optionality for the patients. It's about optionality for the health care professionals. And even when subcu is available, we still expect up to 30% of the patients will remain on IV.

Thank you, Keith. And then with regards to the ITP question, I would like to refer to the Phase 2 results. When we studied the Phase 2 trial, which we published, you can see that we had quite an effective patient population on study. So refractory to splenectomy, corticosteroids, TPOS, one or more. And we had a response rate of 46%. So our expectations for the readout of the Phase 3 trials when it comes to the patient population, you will be able to enroll and a likely response rate which we could see, our expectations are comparable to the Phase 2. From a product positioning point of view, we're thinking about the positioning right after filing the first TPO instead of then cycling the patient to the next -- in the next TPO, which will be equally unsuccessful. And it is not unlikely that in such a line, you will see an improved efficacy compared to the quite refractory patient population we're expecting in the Phase 3. Thanks for the questions.

This concludes the question-and-answer session. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.