Thank you. A press release was issued earlier today with our half year 2020 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on Slide 2 that forward-looking statements may be presented during this call. This may include statements about our future expectations, clinical development, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. Our genus 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 am joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer; Keith Woods, Chief Operating Officer; and Eric Castaldi, Chief Financial Officer. On Slide 3, you can see our agenda. Tim will be highlighting recent milestones including the positive Phase III ADAPT data we reported in May, and the progress we've made in our ongoing efgartigimod programs and additional indications. We announced a change in our development plan for cusatuzumab this morning, and Tim will update you on the reason for that shift in strategy. And he will close with an update on our earlier-stage programs, including those that are wholly owned and partnered. Keith will then provide an update on our commercial preparation, and Eric will share our financial results. We will then close with a Q&A session. I will now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. We appreciate you joining the call today. We are now almost six months into what we can only continue to describe as unprecedented times. I hope you and your families are staying safe and healthy. At argenx, we have been opening our organic offices on a restricted basis as we watch the data on the number of coronavirus cases in Belgium. We continue to keep our work-from-home mandate in the U.S. and Japan. Throughout this virtual work environment, our team has kept to its high work standards to minimize disruptions to our business as best as possible. For this, I must share my gratitude to the entire team in navigating this new normal. On Slide 4, I would like to highlight some of the significant milestones we have achieved virtually as a team, all of which will be covered in more detail later in the call. We executed a key Phase III data disclosure with the top-line readout of our ADAPT trial, including a subsequent financing to support our first commercial launch and the advancement of our differentiated pipeline. The data from ADAPT showed that efgartigimod has a promising therapeutic profile with robust efficacy and tolerability and the potential to offer individualized dosing to patients. These results, along with our having enrolled ADAPT ahead of pace, have further strengthened our leadership position among SGRM antagonists. We have also worked hard to stay on track with the filing of our BLA to the FDA expected by the end of the year, and our filing in Japan in early 2021. That, plus our long-term open-label extension study has had a high retention rate and continues to provide us the safety data we need for our regulatory filings. Our clinical operations team has been able to open…

Thank you, Tim, and good morning, everyone. Please see Slide 16. Today, I want to give you an update on some of the ways in which we are preparing for a successful launch of efgartigimod in the U.S. in 2021 and in Japan, following the U.S. launch. We've been providing you updates on our commercial preparation for over a year now. But following the positive Phase III data readout, we have felt a dynamic shift in the work we are doing to get efgartigimod to patients as quickly as possible. I can tell you today that all commercial preparation activities are on track across each of the key work streams. As a first step, we are right on track with our BLA filing to the FDA and with our JMAA filing to the PMDA in Japan. The BLA will be filed by the end of 2020 and the JMAA in the first half of 2021. This will be a rolling submission allowing for us to include longer-term safety data from the ADAPT Plus trial as we have it. We additionally are planning to meet with the FDA in the fourth quarter of this year to talk about our subcutaneous formulation of efgartigimod and how we can initiate a bridging strategy to get it into MG patients as soon as possible. This is a top corporate priority. We are right where we need to be in terms of supply chain preparation. We have a long-established alliance with Lonza and manufacturing for efgartigimod is currently out of two different locations, one in the U.K. and one in Singapore. We will be ready with our commercial inventory in time for both our U.S. and our Japan launches. We also have the scale-up potential to expand our manufacturing capacity to a third location in…

Thank you, Keith. Slide 19 covers our half year 2020 operating results, which are detailed in today's press release and regulatory filings. Total operating income for the six months ended June 30, 2020 was EUR31.1 million, a decrease of EUR20.2 million from the same period in 2019 due to a milestone payments we received last year under the AbbVie collaboration agreement, and partially offset by the revenue recognition of the transaction price related to the Janssen collaboration and an increase in other income driven by higher payroll tax rebates. R&D expenses for the six months ended June 30, 2020 were EUR171.7 million, compared to EUR78.3 million for the same period in 2019. Selling, general and administrative expenses were EUR61.6 million for the six months ended June 30, 2020, compared to 27.5% - sorry, EUR27.5 million for the same period in 2019. These increases in R&D and SG&A expenditures over the prior year have been driven by the progress made within our late-stage pipeline, including higher consulting and personnel expenses, higher clinical trial costs and manufacturing expenses and also the recruitment of additional employees to support ongoing activities. We expect operating expenses to continue to increase this year, as we further advance our pipeline and prepare for future commercialization. For the six months ended June 30, 2020, financial expenses, which primarily relates to interest received and changes in fair value of current financial assets amounted to EUR2.2 million, compared to a financial income of EUR7.2 million for the same period in 2019. Exchange gains totaled EUR0.2 million for the six months period ended June 30, 2020, compared to EUR2.5 million for the same period in 2019. The total net loss for the six months ended June 30, 2020, was EUR205.6 million, compared to a net loss of EUR45.1 million and an operating loss of EUR54.5 million for the same period in 2019. We ended the first half of 2020 with EUR1.9 billion in cash, cash equivalents and current assets, compared to EUR1.3 billion on December 31, 2019. The increase was primarily due to the closing of a global offering including the U.S. offering and a European private placement resulting in the receipt of EUR730.7 million net proceeds in June 2020. I will now turn the call back to Tim.

Thank you, Eric. Before we open up the call for questions, I would like to turn to Slide 20. We are very excited by what is ahead of argenx. We are focused across the company on the filing of our first BLA and the launch of our first drug in the United States. As we shift to be a commercial organization, we are committed to further building out our differentiated pipeline of antibody therapies, both by advancing our ongoing clinical trials as quickly as possible and by identifying new value creation opportunities through our immunology innovation program. With a cash position of EUR1.9 billion and a strong and rapidly expanding team, we know we are in pole position to execute our business plan to generate value for our shareholders in the long-term. We continue to be inspired by the resilience and hope of our patients and believe we are closer than ever to reaching them through our commitment to immunology innovation. With that, I will now ask the operator to open the call for your questions.

[Operator Instructions] First question, it's from the line of Derek Archila from Stifel. You may ask your question.

Hi, Bill on for Derek. Thanks for the update and taking the questions. So just on cusatuzumab, can you just remind us whether or not the update has any impacts on the terms of the deal with J&J? And then, sort of on the Phase Ib, can you talk a little bit about how in the evolving landscape of AML, you sort of think the bar will be in the combination study with Aza and venetoclax? Thanks.

Thanks for the question and thank you for being with us today. So, the strategy change, which we announced today is not affecting by any means the terms of the deal. Actually, the way you have to look at the global development plan, which is an intrinsic part of the contract is that there is nothing else than a decision tree, which we can navigate based on data. So with this new data point from VIALE-A coming in, we know that in our strategy, we have to give a priority to the Phase Ib study where we combine with what is now likely going to be the future standard-of-care. So where is the bar? Well, we know that VIALE-A had a 37% CR rate and a 15-month overall survival, which is a benefit of about five months compared to Vidaza alone. And while venetoclax Vidaza has shown strong data to induce CRs, the question remains how you can keep people in a stable remission. So, the bar to be beaten will not just be in terms of CR rates, but also in the durability of these CRs and the safety of the combination.

That makes sense. Thanks.

Thank you.

Next question is from the line of Yaron Werber from Cowen. You may ask the question.

Thanks for taking the question. So, maybe a couple of questions on the subcu bridging study and the strategy. I mean, as you noted, you are going to be meeting with FDA in Q4 and both to advance it sort of in ITP, but also importantly, obviously, in MG, and the MG landscape is, as expected it's going to be a big market. There is a few competitors coming in, talking about subcu dosing. In those cases, some potentially are going to be looking at sort of fixed interval subcu doses chronically. So thoughts about that and how do you bridge from your intermittent dosing to subcu? And is there a chance that subcu is going to be fixed or is that going to be intermittent? Thank you.

Thank you, Yaron. Thank you for being with us today. Keith, would you like to take this question, please?

Sure. Thank you. As we noted, that we will go meet with the FDA and discuss the bridging strategy for MG. We also are bringing subcu forward in ITT. And additionally, it's the preferred in CIDP route of administration. In regard to the exact treatment regimen that we will use in MG, we'll comment more on this after we have had our meeting with the FDA. But as you know, from the ADAPT study, we do have individualized dosing and it varies among our various patients. So, I do see the possibility with our subcu of not only being able to use it on an individualized treatment basis, but some might be on a more fixed dose.

And do you have a sense yet on the MG strategy what the FDA might require. Is - obviously, they are going be to looking at PK, but they are going to want to look at some PD efficacy. Is it possible to do a bridging study that's got a primary endpoint at eight weeks? And maybe run a 24-week study and that's sufficient for approval? Thanks so much.

Yes, I still think it's too early for us to comment on exactly what they are going to require. But I think it's fair to say that we will need some exposure in MG patients. But let's wait and see until we hear back from the FDA.

Great, thank you.

Thank you. The next question is from the line of Yatin Suneja from Guggenheim.

Congrats on all the progress. Just on the CIDP trial, number one, could you just comment on your expectation, given that, I think the data might be coming, hopefully, sometime next year. How much disclosure will you make, when you make the decision to expand it? And then, also, if you can comment on the relative size of CIDP in the current use of IVIg in MG versus CIDP, just to give a sense of how big that opportunity might be. Thanks.

Okay, thank you, Yatin. Thanks for being with us today. So we realized that the go or no go decision point to expand the Phase II study into a registrational study is a very significant data point for our shareholders and investors. So we plan to make that decision public. And also give some view on the data. We now guide this data point is going to come in, in 2021. This study is enrolling and actually, we are opening sites at a pretty high pace, but it's a demanding protocol. And in terms of relative size, we think that CIDP is likely representing one of the bigger markets for efgartigimod. If we simply look at the chronic nature of the disease and the lifelong nature of the disease and the reliance mainly on IVIG, CIDP is basically a lifelong sentence to IVIg, then we think that this is going to be one of the more substantial markets. Remember that the IVIg sales in CIP, just in the United States, on an annual basis is exceeding EUR1.5 billion.

Okay. And just maybe quickly on the financial side. Can you just help us with the spend going forward? I saw the R&D coming down a little bit in the quarter? Just help us understand how should we model the expenses G&A is picking off. Thank you.

Eric, would you like to take this question, please?

Sure, absolutely. Yes. So indeed, there is a significant increase in our operating cost, as I said. And basically, we are not giving any guidelines on the cash burn, but what we can say is that we expect, as we continue to advance our late-stage pipeline that the costs continue to go up quarter-over-quarter.

Thank you.

Okay. Your next question is from Jason Butler from JMP Securities.

Hi. Thanks for taking the question. Just had another one on cusa. Can you maybe talk about the - any of the safety data you have from CULMINATE? And I guess, that in addition to from a mechanistic perspective, how you think about the safety and tolerability in context of a triple combo with venetoclax? And then, again, in terms of CULMINATE, is there enough data there to look at molecular subgroups or other biomarkers? Or do biomarkers play into your strategy at all at this point? Thanks.

Okay. Thank you, Jason. These are two great questions. So, on the safety side, what we say today is that, what we're going to disclose, of course, more detailed data early 2021. And we can say that the safety profile we observed in CULMINATE is consistent and in line with the earlier safety data. So the safety profile of cusa continues to look very promising. And this is important, because, you're absolutely right. The veneto combination comes with some toxicity. And while it's very important inducing CRs, the question is, how do you keep patients in CRs. So safety is going to be a key aspect in any future combination going forward with what we think could be the future standard-of-care, which is venetoclax file data. And with regards subs analysis, it's too early to comment on it, but it is possible. Of course, within AML, we have a very clear view on risk classification, cytogenetics, some biomarkers. So, we will, for sure, try to further stratify the data sets coming out of CULMINATE, but we will have to be a little bit patient here because these data are, of course, still maturing.

Okay, great. That's helpful. Thanks for taking the questions.

Thanks, Jason.

Thank you. Our next question is from Akash Tewari from Wolfe Research.

First, efgartigimod. Just had a question there. Would the FDA allow you to run a basket trial for indications that are predominantly driven by pathogenic IgG, but may have low prevalence, for example, myelodysplastic syndrome or good pass through syndrome and could you possibly do this in larger indications, as well? Thank you.

Hey. This is a good question, and it's a question which we entertain internally in the company. We believe that after having proven the concept a number of times in the current indications where we are playing, we will be in a position to turn around and have that conversation with the FDA, I think, especially for indications, which are very high unmet need clearly mediated by pathogenic IgGs and probably too small or unethical to do a placebo-controlled or controlled randomized study. So, this is something which we have on our regulatory to-do list. But we believe that the time is only right to do that even when we have established proof-of-concept a number of times.

Great. Thank you.

Thank you.

Thank you. Next question would be Matthew Harrison from Morgan Stanley.

Hi. This is Max Skor on for Matthew Harrison. Just a quick question regarding the CIDP delay. Do you view this primarily as related to COVID 19? Or are a lot of these patients hesitant to complete a wash-out period? And also, could you talk about how you are thinking about the timing around the European application for efgartigimod? Thank you very much.

I will take the first question on CIDP, and then I will hand over to Keith on the European registration. But this is a good question, Max. Thank you. The CIDP timeline is totally driven by COVID-19. So, the level of enthusiasm we see for the drug candidates, its mode of action and for the protocol remains high. We do not see any issues in getting site enthusiastic about the clinical trial or physicians. And I think the sites which are open, actually are successful in identifying and screening patients. So that does not seem to be the problem. I think the protocol is a workable protocol. It's mainly the COVID-19 situation, which is in play in the delay. Keith, would you mind addressing the European registration path question?

Sure, happy to, Tim. Well, first of all, our priority, as you know, is the U.S. and then Japan. We currently are in the process in the final stages of hiring a European GM and we are outlining our strategy in Europe. This will likely be a staged approach as we determine the process of approaching the EU big 5, but also how we will expand beyond there. We have the opportunity to expand our supply chain to accommodate the additional geographies. The bottom-line is, internally, we are working forward – we are working towards an EMA submission.

Great. Thank you.

Thank you. Our next question is from the line of Joon Lee from SunTrust.

If so, when can we expect an update there? And I have a follow-up.

Hey, Joon, could we repeat the question, because we missed the first part of the question? You were probably still on mute.

Okay. So cusatuzumab, CD70 is becoming a very popular target and others are targeting CD70 for solid tumors and T-cell malignancies. So, do you or J&J have plans to expand beyond AML? And if so, when can we expect an update there?

Yes, I think you are absolutely right in the fact that CD70 is on the radar screen. And in solid tumors, we do know that CD70 is often heavily overexpressed, but we don't understand the disease biology, which is involved in that. That is the big difference with the leukemias, which called out because there, thanks to the work of Professor Ochsenbein from the Bern University Hospital, we do understand the involvement of the CD70, CD27 pathway in the survival and proliferation of leukemic stem cells. Remember that we also ventured into T-cell lymphoma at the start of the program and we did dose escalation in Phase I. We did see some pretty spectacular responses in T-cell lymphoma and we did do an expansion cohort in T-cell lymphoma. We achieved about a 30% overall response rate. We saw very long responses in T-cell lymphoma. But basically, we were judging at that point in time that this was insufficient to take the molecule forward in T-cell lymphoma. In general, lymphomas are part of the Janssen’s global development plan, but they will clearly follow in sequence after and the work we plan to do in AML and high risk MDS. So these two indications are prioritized in the global development plan, okay?

But, so your indications outside of lymphoma and AML are years to control?

We have not been specific on that in the global development plan. I think what we said in public is, first is AML and high-risk MDS, then is the potential to venture into lymphomas and other indications, but we have not said anything specific about solid tumors.

Great. Okay. So, just another question, for your 117 study in COVID-19, how many patients do you need to treat to get comfortable around efficacy, because others have treated as little as 10 patients with COVID-19 Rs and got sufficient conviction to move into a pivotal trial. So what's your bar for advancing in COVID-19 Rs?

Remember that this is a Phase I study. So we have never been in human subjects with 117 before. So actually, we need to do two things in this Phase 1. The first thing we need to do is dose escalate and establish the right dose, that means that those which is completely knocking out C2, and then we need to establish signs of efficacy. So, think of a number of patients, which would be typical for a classical dose escalation. Although the regulator allows us to dose escalate in somewhat bigger steps given the urgency of the situation. But then you are right, I mean, in order to establish activity or an evidence of activity, you are talking about a similar number of patients, around 10.

Okay. Thank you.

Thank you.

Thank you. Our next question is from the line of Tazeen Ahmad. You may ask your question.

And that's already have been asked. Just let me know, Tim, maybe on pricing for MG, can you just adjust a general range of what payers are – I am saying that they would be receptive to, at this stage. You've always said that you would be very competitive with the current market and how you want to price efgartigimod for MG? And as a point of comparison, can you give us an idea of how much annually at cost per patient in the U.S. to take IVIg? And then I have a follow-up on CIDP. Thanks.

Thank you. Keith, why don't you go ahead and you take a question on pricing and the annualized cost of IVIg and MG, and then I will probably take on the next question, okay?

Okay. That sounds good. As you know, we are doing the homework on two fronts. First of all, is the current market dynamics, and also the value that efgartigimod can bring to the MG patients. You know that at the high-end of the spectrum in U.S., we have Soliris with a price tag of about $700,000 a year. We've learned from chronic IVIg patients that the annual therapy for them is around $140,000 a year. So, there is a lot of flexibility in pricing with MG, but we also want to make sure that we are responsible as efgartigimod being a pipeline and a product.

Tazeen, did you have a second question, please?

Oh, I am sorry. I wanted to just also ask you about CIDP. How is this indication potentially different in terms of the heterogeneity of the patient population, let's say, relative to MG? And how does that make the challenge of determining if it's worth moving forward in this indication viable or not? And then, secondly, let's say, another company is able to get some market before you for CIDP, if you do choose to move forward, how much is where you would be in the competitive landscape in terms of when you would enter the market going to be a decision in deciding whether to move forward in that indication or not?

Well, you know Tazeen that CIDP is a big indication with very limited tools in the therapeutic toolkit. So, a CIDP patient today would be mainly treated with steroids and IVIg. There is not much other optionality out there. So, even if there would be a couple of players entering this space, I think the space is pretty much wide open. You are right in pointing out the heterogeneity for CIDP, which is true by the way for so many autoimmune indications and I think some of the confusion comes from the fact that certain people, which are labeled as CIDP patients and of being prescribed IVIg as being CIDP patients or maybe not CIDP patients after all. That's something which we learned from the homework we did when we were designing the Phase III trial and that's why we also bought out the concept of having an independent board of CIDP specialists, which validates the diagnosis CIDP before the patient can actually enroll to the trial. So we need to read out non-CIDP patients from the trial to make sure that we are effectively treating CIDP. And then indeed, you see that within CIDP, there are different subsets of patients, if you would try to classify them based on the nature and identity of the autoantibody. Now, we believe that all these true CIDP patients do have auto antibodies of the IgG type as was evidenced in the R&D Day by means of the plasma exchange and more importantly, the immunoabsorption data. And that is the beauty of efgartigimod. It does not matter where your autoantibody binds or what it does as long as it is an IgG molecule, we will clear it with efgart’s mode of action. So, I think with the 30 patients go, no go decision point, we will have a pretty clear handle on what is the likely subset of patients in which we can play and whether this heterogeneity is playing a role at all if you try to treat them with efgartigimod.

And then in general, Tim, is there anything that makes it difficult to enroll CIDP patients? It does seem that, for example, your competitor UCB did also said their trial has been delayed. Is it COVID-related or are there other issues too?

Well, we cannot speak for somebody else's trial, but what we experience is it's really COVID. We try to enroll patients in Japan, Europe and United States. This is already global from the get-go. And what you see is that really on a country-by-country and even site-by-site basis, COVID has kept the medical community very busy. So, I think we are now really ramping up a number of sites, which we are opening and as I said before in the call, those sites which are open, actually don't find it difficult to identify patients and screen patients. So we are pretty optimistic that if COVID remains under control, that's a big if, and these sites which we are opening will be successfully enrolling the trial.

Okay. Thank you.

Thank you. Our next question is from the line of Graig Suvannavejh.

Great. Good morning and good afternoon. Can you hear me okay?

Yes, we can.

Okay. Great. I have got two questions, please, and they are all around efgartigimod. Just first, in the myasthenia gravis Phase III study, you talked about 40% minimal symptom expression. I just wanted to ask a question about that. We've done some work with KOLs who said in their personal opinion, while 40% is good, they might have been hoping that for maybe 50% or 60% would be perhaps something that would be better. So can you put the 40% MSC in context? So just wanted to get some color on that. And then, the second question I have is with the Phase III data behind you and as we look at next efgartigimod data events, given COVID-19, are you able to provide us with at least current expected timelines on your various readouts, whether they’d be next data sets and ITP, pemphigus and CIDP? Thank you.

Okay. Thank you for these two great questions. I will give the first question to Keith in a minute to contextualize the 40% minimum symptom expression because, of course, we have been very busy learning about our data from the community. But on your second question, no matter how much I would like it, it is not possible yet to give you clear guidance on when exactly these studies are going to read out for the simple fact that COVID is not gone. I think we're still battling COVID big time in the United States. Let's touchwood, but for the moment, in Japan and big parts of Europe, it seems to be under control. But now, we are looking at a second wave of COVID, which is approaching us. So, it's pretty difficult to give you any reliable forecast on when exactly these studies would read out. But I hope you agree with me that today, just like we did in the Q1 call, we tried to give you a fully transparent look on the studies and where we are. And actually, we will continue to do that in the next quarters. So that we can keep you closely abreast of the COVID situation. With that being said, Keith, would you mind contextualizing the 40% minimum symptom expression, please?

Sure, happy to. Actually, when we've shared this data with our investigators and with other physicians in market research, they've been impressed with the 40% and found it quite compelling, because this is so meaningful to patients. I also want to remind you that this was a measurement after one cycle. So this was four doses of efgartigimod, and we obtained that 40% MSC. We will continue to look at it in subsequent cycles and see where the numbers go from there. But, we were quite encouraged that after only four doses to have that type of a MSC number.

Okay. Thanks, Keith. And just one follow-up, Tim. Just on your comments, I appreciate that it's very difficult to give guidance on the timing of the readouts. But, maybe given your visibility into where your studies are, is there perhaps one of those studies that is closer to being fully enrolled, where that might give an indication of kind of what could be next, even though you might not be able to provide exact timing?

No. We are not in a position to give any comment on that. And I also don't think it would be appropriate. I think we need to continue to work hard on enrolling the trials. And then look for reasonable updates in the next quarters to come.

Okay. Alright. Thank you very much.

Thank you.

Our next question is from the line of Sandra Cauwenberghs from KBC Securities.

Hi, thanks for the update. I still have one small question left. It's more around - it's for clarification with regard to the cusatuzumab follow-up trial. So what I understood is that you will do a triple combination, but I want to understand will you be able to generate some data on a double combination of cusa and venetoclax in terms of safety data, adverse events popping up on the combination of these two instructions in particular?

You're right, Sandra. There are two studies going on right. I mean, one is cusa with venetoclax, the couplet or the doublet as people call it. And then, we have the triplet. So these two studies are running in parallel. So we will actually be able to pick up any differences between the two treatment regimens if they would exist.

Okay. Thanks.

Thank you.