argenx SE (ARGX) Earnings Call Transcript & Summary

June 10, 2020

Euronext Brussels BE Health Care Biotechnology conference_presentation 39 min

Earnings Call Speaker Segments

Graig Suvannavejh

analyst
#1

Great. Well good morning, everyone. Thanks to everyone for joining us this morning. My name is Graig Suvannavejh, and I am a U.S. and European biopharma analyst at Goldman Sachs. With me today are Tim Hauwermeiren -- Van Hauwermeiren. Sorry if I butchered your name, Tim. Everyone butchers my name, so my apologies for that -- CEO of the company; and Keith Woods, who is Chief Operating Officer of the company. And so today, we're going to have a discussion on argenx. And with that said, obviously, we want to lead maybe straight off with talking with Tim, just about the successes that argenx has had. Tim cofounded the company back in 2008. We're now in 2020.

Graig Suvannavejh

analyst
#2

So maybe if we could just start with maybe a high-level brief perspective of kind of the vision you saw for argenx 12 years ago. And maybe walk us through the journey of where you are today. And maybe what some of those key factors have been towards the company's success.

Tim Van Hauwermeiren

executive
#3

Thank you, Graig. And the readout of the ADAPT data, of course, was a big day for the company. It's a big day for MG patients because I think we established we have a potential drug, which can change the treatment landscape and paradigm in MG, but it was also, of course, an important day for the molecule because it's showing that we have a true pipeline in the product and a big day for the company because I think we're now formally and officially transitioning into a precommercial stage company. And if you reflect on the journey until today, the start of the company seems like yesterday. I mean time has been flying. But a couple of elements which I think underpin the success of the company in its journey to become an independent, sustainable biotech company. As we all know, Graig, it starts with the people. I do not believe in individual stars or water walkers or rainmakers, none of us actually is in this company. But I think the collective power of the team is a recurrent success factor throughout our history. The other thing, which I believe in strongly is the power of collaboration. And argenx, we believe that the future belongs to the collaborating people, those who know how to collaborate. And for example, efgartigimod is borne out of collaboration with Sally Ward at Texas University. So extremely grateful for all these fruitful collaborations we managed to build and which actually yielded our pipeline and assets. We had also obsessed, Graig, there are many biotech companies sitting on good plans, great technology, great molecules. But often, the devil is in the detail. And I think you have a team here which is obsessed with execution. This is a company which likes to say what it's going to do, and then we also do it. And then last but not least, the funding. I think the reason we are here today is to be with our investor base. We could not have done what we have been doing so far if you would not have had that loyal, long-standing support from these blue-chip sophisticated life science investors. So this is just a mix, I think, of some of the success factors, which have been building this company.

Graig Suvannavejh

analyst
#4

Great. Thanks for that perspective. Obviously, we're fresh off of the positive Phase III data for efgartigimod. Maybe before we drill into perhaps some of the highlights of that Phase III data, my perspective is there's been an incredible amount of investor interest in this new class of agents, the FcRns or those agents that target the FcRn. And maybe for those who might be newer to the story, maybe could you just talk about what makes the FcRn class attractive as a class of agents to target this mechanism and where the utility could be before we go right into the Phase III data.

Tim Van Hauwermeiren

executive
#5

Look, the way we look at the autoimmune space is that this is a space which is start for innovation and really needs precision medicine the way we have been developing them for cancer. If you look at the oncology space, say, 15 years ago, we only had a few blunt instruments, right, like chemotherapy. And not much more today, your tumor is biopsied. We will take a look at the molecular pathways in play, and then we will basically carefully select precision medication, intervening with these pathways. Today, autoimmunity, to a large extent, reminds us of cancer 15 years ago. Aside from some broad blunt tools like high dose of steroids and these broad immunosuppressants like azathioprine or mycophenolate or cyclosporine, there isn't much precision intervention possible in autoimmunity. And that, I think, is the beauty of the FcRn pathway, which was pioneered by Sally Ward. This pathway allows you to intervene in a highly precise manner with a very specific compartment of the immune system being the IgG antibodies. Most often IgG antibodies, which are the most dominant class of antibodies protecting the body are playing, of course, a beneficial role. And in a number of autoimmune diseases, however, these IgGs are pathogenic IgGs, and they will turn against itself for reasons we often do not know. So the FcRn pathway -- or blocking the pathway is a tool to selectively eliminate IgGs, including pathogenic IgGs. And that explains the excitement because it's so precise, but it also should have broad applicability to so many autoimmune diseases, severe autoimmune diseases, which we know happen to be driven by pathogenic IgGs. So I think this is an important pathway for the future. And I think it has the potential to change the way we treat autoimmunity in the future.

Graig Suvannavejh

analyst
#6

Great. I appreciate that perspective. So clearly, the big news for the company, again, was a positive Phase III data in myasthenia gravis. And certainly great news for patients and investors as well as the company. Can you walk us through what you think are the key strengths of that data set? And why it's so important, not only for the company, but for patients?

Tim Van Hauwermeiren

executive
#7

So just as a reminder, you know that we designed this trial in close partnership with patients and physicians. So what you need to know about myasthenia gravis is that each patient is experiencing his or her disease in a highly unique individualized manner. I mean there are no 2 MG patients the same. And therefore, we heard loud and clear the voice of the patient that they were looking for an individualized approach to treating their MG. So that's exactly what we try to capture in the ADAPT trial, adapting to the individual needs of the patients. So we were thrilled to see that not only we had a very high efficacy score for what was a pretty tough primary end point to meet. I mean 5 subsequent measurements in 4 weekly visits, that's a tall bar to meet an improvement of 2 points or more on an ADL score. I think I've got -- taking method bar easily compared to placebo. We also saw a very fast and deep action of the molecule. And then I think on the risk side, from a safety point of view, what is exciting to see is a safety profile, which is not only consistent with the past data points in the healthy volunteer studies, in the smaller Phase II proof-of-concept studies. Actually, we saw a safety profile which is comparable to placebo. So the risk benefits profile of this drug starts to look very attractive. And then, of course, the minimum symptom expression, which is so important for MG patients. What do you buy as a patient with a delta of 2, 3 or 4 points of score, you want to be able to live a normal life and you want to be basically with no or almost no symptoms. That is exactly what is the minimum symptom expression is trying to capture. Now within the first treatment cycle, 40% of the patients achieving minimum symptom expression, I think that is very promising for the MG patient population.

Graig Suvannavejh

analyst
#8

Certainly, there are some other assets that are also going into MG. Given the strength of the Phase III profile, not only relative to perhaps other competitors in MG, but how do you see the drug overall being positioned in what is likely to be part of this future treatment paradigm?

Tim Van Hauwermeiren

executive
#9

A question I would like to pass over to my colleague, Keith Woods.

R. Woods

executive
#10

Yes. Thank you, Tim. So, Graig, following the ADAPT readout, we believe we have a highly differentiated proposition. As Tim said, strong efficacy, safety that's comparable to placebo and potentially a new standard in dosing MG patients. Now that we have the Phase III data in hand, we can shift to directly serving the patient population the best that we can and focus on our strategy. We believe when it comes to competition, we like the fact that we have the first-mover advantage, obviously, within this class, but we also believe that we've set the bar very high. From an efficacy point of view, I think Tim just highlighted very well the 67% response rate in ADL, backed up by our QMG score, not just in having a clinically meaningful response, but also having one that had a duration of at least 5 consecutive measurements. But remember, you had greater than half the patients had a response of greater than 8 weeks and more than 1/3 with a response greater than 12 weeks. In speaking with several of the key opinion leaders across the U.S., one thing that they continue to highlight is that 40% minimal symptom expression. Right now, this is the highest that's been shown in a trial. But think about what that really means to patients. You're taking someone with this rare debilitating disease and putting them to a state where they can have practically no symptoms or no symptoms at all when they achieve an ADL score of 0 or 1. If you look at it from a safety point of view, the safety profile was consistent with what we've seen in our Phase IIs. But now you go to a large global Phase III, the largest MG trial ever conducted and a safety profile, it's basically comparable to placebo. And we've already heard that this has the potential from our KOLs to be a big differentiator. And finally, the last element is convenience. I believe that we have convenience not only from our innovative trial design, which set up the prove individualized dosing can and should be used in MG patients, and we hit that bar. That, combined with the fact that we're looking at our subcu bridging study and bringing a simple, single injection could be self administered into a subcu delivery of efgartigimod for MG patients means we've set the bar in convenience. So overall, our competitive positioning is that where we can serve the patients, their location, their need and on their schedule, I feel, puts us in a good position to change how MG patients are treated.

Graig Suvannavejh

analyst
#11

Okay. Maybe if I could just piggyback on the subcutaneous formulation that you just mentioned. Can you just remind us what kind of profile you're hoping to achieve? And in terms of that bridging work that needs to be done, when is your current best guess as to when that kind of product might be available relative to the original IV formulation that you're developing?

R. Woods

executive
#12

Yes. So we've said that we will launch the IV in 2021. We've also shared with you that we're meeting with the regulatory authorities to discuss the exact bridging strategy that will be needed to bring efgartigimod subcu to MG patients. And as soon as we have the clear path forward, then we'll share what pathway is, but we'll also be able to give you a better time line. Right now, it would be a projection until after we have this successful meeting with the regulatory bodies.

Graig Suvannavejh

analyst
#13

Okay. Great. Appreciate that. I know the company has done extensive work engaging prescribers and payers on what the profile you had going into the Phase III data might have looked like. Now you've got the Phase III data in hand. And I'm just curious, I know it's very early days, but have you gotten a good sense? And can you share with us any initial feedback, whether it is from the prescriber or the payer side? Or is it just still too early to tell?

R. Woods

executive
#14

So you're right. We have done a great deal of market research, and we had done it with the prescribers. We've done it with the payers. We've also done it with the patients. I don't want to leave the patient group out of this because they were instrumental in creating the ADAPT design. Since we have had the results -- the top line results of the Phase III clinical trial, we have spoken with several KOLs across the globe, all of our investigators that participated in the trial as well as additional cohorts of neuromuscular specialists throughout the U.S. Again, the feedback has been very positive for one of the minimal symptom expression. It is jumping out to them. I mean our response rate, as we've pointed out, it is the highest that's ever been seen in a global Phase III clinical trial. So they're pleased with that. But when you count that at minimal symptom expression combined with that safety profile and the fact that we're building in some flexibility around the dosing schedule, the feedback has been quite promising. When we have not been able to conduct market research with payers at this point in the last 2 weeks since we've had the top line data, but we have, in fact, shared the top line data with the patient advocacy groups, and they were very pleased to hear, not only did we have this positive response in this safe profile, but we also had a high response rate in seronegative patients that were treated with efgartigimod, and that meant a lot to the patients in particular.

Graig Suvannavejh

analyst
#15

Okay. What's impressed me a lot, in addition to the asset itself, is just the amount of work as a company argenx is doing in terms of the precommercialization efforts in trying to map out what that strategy looks like in ADVANCE, the potential launch. Maybe if you could, and I'll ask you, Keith, perhaps to comment, tell us some of the things that argenx is doing that you think are really key critical components from a pre-commercialization perspective in terms of getting the company ready for actually commercializing the drug. It's not just about trying to find a price that makes sense, and there's a lot more than that. There's market access. There's reimbursement work. It's engaging to stakeholders. So could you give the audience perhaps a better sense of how argenx is approaching things that really should set up the company well for commercial success?

R. Woods

executive
#16

Sure. Well Graig, the first thing I think about is it's about the people. It's -- our success comes down to the people that we hire and the people that have joined the team. I like the vision that Tim had in adding commercial people early in this strategy, playing a part in how we set up our approach even towards our Phase III study by bringing these folks on early, and we were able to get out and listen, and I think that's absolutely key. Tim mentioned that the foundation of the company is collaboration. I think we've done the same with the patients, with the health care providers and even speaking with the payers in working with them. So that's absolutely been key. The team that we're building, I hear well, argenx has never launched a product commercially. No, argenx hasn't, but the people that we've hired have launched many, many products in their career. We've been able to attract talent from top companies, Biogen, Alexion, Takeda, Shire. So we have a very experienced team. Now we take this Phase III data forward, and we take it with this innovative trial design. And we think we can continue to build with innovation between the molecule, between the trial design, but now even in some of the ways that we're approaching our customers. A lot of folks are asking how are things going to change with COVID and working from home. And I would just tell you that this team has very rapidly turned on a dime and then able to continue to engage in digital and virtual matters. So I'm very pleased with how we've been able to engage with the entire community, and I feel that we're going to be in a strong position at launch.

Graig Suvannavejh

analyst
#17

Okay. With the Phase III data in hand, I would be remiss if I didn't ask about how you see now the commercial revenue dollar opportunity. So any initial thoughts on how investors should think about this? Obviously, we've got drugs that are approved on the market, but myasthenia gravis has been, relatively speaking, an unmet medical need. And so you have an opportunity to kind of really to be a first drug that could be very meaningful for patients. And I'm wondering what -- how the company is thinking about whether it's pricing, whether it's what kind of market share you think you can get? Any kind of high-level thoughts on the commercial opportunity?

R. Woods

executive
#18

Well I would tell you, first of all, the commercial opportunity with the literature shows, there's about 65,000 patients suffering from MG in the U.S.; 20,000 in Japan, and that's the first 2 markets that we're going to. When looking at the data in the U.S. in particular, we believe we're targeting a market that's roughly 20,000 MG patients with efgartigimod. When you think about the price, it's not actually about the cost. It's about the value that we are bringing to patients. And if you look at the data that just came out in the last 2 weeks, I think that we're providing substantial value to patients, whether it's in the overall efficacy, the magnitude of the response, the safety and the convenience. That's a lot of value for these patients that are suffering from MG. So we've always said that we will price -- we will be transparent and that we will price responsible. And what does that mean when you say price responsible? As you know, efgartigimod has the potential to be a pipeline and a product. And so we have multiple indications that we're currently studying. We're going to announce the fifth indication later this year. So there's a lot of factors that we take into consideration when we go and set price.

Graig Suvannavejh

analyst
#19

Okay. Great. At this point in time, I'm going to transition away from MG because clearly, efgartigimod has potential in other indications. So it's been a strategy that's been clearly delineated and initiated by the company. But maybe if I'll turn it back over to Tim, can you maybe, at a high level, in the interest of time, walk us through your excitement about its potential in other indications besides MG?

Tim Van Hauwermeiren

executive
#20

Sure. So we think the opportunity is vast. There is actually a long list of indications where we know that pathogenic IgGs drive the disease. And we explicitly explained in the past, Graig, how we go about mining that opportunity, right? So we adopted the beachhead strategy. MG is just the beachhead in neuromuscular, but ITP is the beachhead indication in heme. And then [indiscernible] is the beachhead indication and the idea is that based on successful and expand from that landing base into indications which are equally attractive. That's exactly what we're going to do for MG, right? So on the back of these positive data, we are already into CIDP, but there are more neuromuscular indications, which we are currently assessing. I mean ITP for Phase II, we show basically pretty exciting proof-of-concept data, which remind us of the performance of the TPO-receptor agonists, but now in TPO refractory patients. In pemphigus, we very recently announced a Phase II data, which frankly speaking, remind us now of the ADAPT data, very high response rates, very fast and deep responses. 70% of the patients going into fast CR once you use the optimized dosing regimen and then tremendous potential to taper off these high levels of steroids. So we are equally excited about the other beachhead indications and the potential to expand into adjacent indications. So in total, we think this molecule, efgartigimod, truly represents a pipeline of new products and the MG data have, to a certain extent, derisked, I think, the other indications, which have been chosen based on similar biology thinking.

Graig Suvannavejh

analyst
#21

Keith did reference the company's intent to announce a fifth indication later this year. And while I wouldn't expect you to announce it here today, but what are the thoughts around that fifth indication? And is this perhaps a second indication in the beachhead strategy? Is it expanding into a different therapeutic area? And then maybe beyond that, I mean, is it realistic for us to be thinking that argenx could be interested in a sixth, seventh and eighth indication down the line in the autoimmune space?

Tim Van Hauwermeiren

executive
#22

Well, first of all, talking about conviction level, we have another 5 to 10 high conviction indications for efgar. So the question is not if you're going to play them, the question is, how and in what sequence we're going to play them. And there, I think we need to be loyal to the strategy we use so far. It needs to be based on a solid biology rationale. You're not going to get lured into an indication because it would be the biggest market opportunity and then basically fail to succeed based on a biology rationale which was not solid. And we also want to stay within the orphan space, where it is possible to execute clinical trials. We want a clear clinical and registration end points. And of course, the commercial opportunity needs to be viable and ideally needs to fit in one of our commercial franchise. Investing in commercial infrastructure is expensive, and therefore, we will want to leverage that infrastructure across different indications and in the future across different molecules. So expect the fifth indication to follow the same pattern. We will explain you why we think there's a solid biology rationale, why we think it's feasible to perform clinical trials in that disease and how it would fit actually in one of the existing commercial franchises.

Graig Suvannavejh

analyst
#23

Appreciate that. I think the company is more than just efgartigimod. And with that said, I believe we've got about 15 minutes left on our call today. But with that said, I think the next pipeline asset that most investors focus on is cusatuzumab, which obviously, you've shared exciting data on that program, but it's been some time since we've heard about that program. So perhaps it's a sleepy asset at this stage, but perhaps we can use this opportunity to kind of revisit your excitement around cusatuzumab. Maybe we could just start off at a high level. What is the asset? What's novel about it? And if we then can perhaps talk about the data that at least has been shown thus far that gave one of your partners, J&J, the confidence to do a large global deal around it.

Tim Van Hauwermeiren

executive
#24

Yes. So I think cusa is a real argenx asset because it was borne out of collaboration. And this is a totally novel pathway, the CD70, CD27 pathway, a collaboration in this case with Dr. Ochsenbein out of the University Hospital in Bern, Switzerland. And what this academic group has been able to do is to show convincingly that this pathway is important for leukemic stem cell biology. So leukemic stem cells apparently proliferate and survive, thanks to this pathway. And we have shown in our collaboration and also in the Phase I dose-escalation study that when you block the CD70, CD27 pathway with cusatuzumab, you basically restore the normal myeloid differentiation of the stem cells in the bone marrow. So we have convincingly shown in AML patients and before, by the way, in CML, that leukemic -- the stem cells, again, start to divide and differentiate in a normal way. So you see, again, nicely differentiated cells producing platelets, red blood cells, white blood cells and the likes. This mode of action, by the way, is very attractive in AML because most of the current therapies out there are trying to kill the malignant blasts. So this is a highly complementary, if not synergistic, mode of action with some of the standard-of-care molecules, which we have again shown in case of aza or venetoclax. It's not a sleeping beauty. It's actually a very active program. And in the Janssen collaboration, we already started 4 studies, a study where we combined with the current standard of care, Vidaza, in the unfit elderly first-line AML population. We also started a combination study with venetoclax, which we believe is tomorrow's standard of care in that patient population. We also prepared a trial in high-risk MDS patients, and we're running a Phase I study in Japanese healthy volunteers. Due to COVID-19, as we announced in our Q1 earnings call, these studies have been passed, with the exception of the healthy volunteer study in Japan, because we do not want to put AML patients at an increased risk of infection, waiting for the global pandemic to cool off and to resume recruitment in these trials. So we're very excited about the global development plan, about the partnership with Janssen. And for sure, you're going to hear more about this program in the future, but that will be based on more mature data and typically at one of the big clinical conferences.

Graig Suvannavejh

analyst
#25

I'm sure there was a lot of interest in cusatuzumab as the data were being shown. And perhaps, can you walk us through why you felt Janssen was the right partner? Clearly, the economics of the deal, the structure of the deal, but if you could walk us through how you came to decide that it was Janssen that was the right partner.

Tim Van Hauwermeiren

executive
#26

Two elements. We always said that we selected the partner based on the ambition of the global development plan and that is true. Janssen committed to a global development plan, which is an intrinsic part of the contract. So we need to look beyond financials and really look at the ambition level and the commitment that the organization was willing to give in that pre-agreed global development plan. The other thing, Graig, is they are willing to treat us as an equal commercialization partner in the United Kingdom, something which we think is going to be very important in our corporate development, and [indiscernible] that's an independent sustainable biotech company. So being able to participate in commercialization, being able to co-generate these revenues, we will build our company from was for us very important and decisive factor in the deal made.

Graig Suvannavejh

analyst
#27

Okay. If I take a step back just for a moment and look at the commercialization efforts around efgartigimod, and that's going to be a fairly important commercial build for the company, you just talked about oncology and the potential of commercializing in oncology as well. In terms of your future ambition for the company, where else, if anywhere else would you think makes sense, if at all, for argenx to commercially expand into? These are fairly concentrated areas. But in terms of the ambition of the company, just curious as to how you're thinking about it from a commercial perspective.

Tim Van Hauwermeiren

executive
#28

Keith, do you want to talk about it?

R. Woods

executive
#29

Sure. So, Graig, from the commercial perspective, what we've set up is our various franchises. So the franchises just aren't in the development area and in the beachheads. It's also how we set up commercial. So we are already building out our neuromuscular commercial team in the U.S. and in Japan. We have already started to build out some of our hem/onc team, and in particular, the medical affairs side of it. We have medical research liaisons for hematology/oncology already out in the field in the U.S. If and when we go to a third franchise, whether that would be potentially blistering skin disorders or we've said publicly, it could be something in renal, we would then go with a new franchise. But one of the rules of thumb that Tim and I have talked about is we will not build a franchise or a commercial team unless you can put either multiple products or multiple indications into that franchise.

Graig Suvannavejh

analyst
#30

That's helpful. You had an R&D Day last year, and you introduced 2 new assets to us. Perhaps in a few words, can you highlight some of the other pipeline opportunities that you find most exciting, whether it may be partnered or proprietary?

Tim Van Hauwermeiren

executive
#31

So very briefly, of course, our C2 antibody, ARGX-117, is a high priority asset. We incurred a delay in the start of the Phase I healthy volunteer study due to COVID-19. We were on track to start at end of March, but we are doing everything we can to get that molecule back on track. This molecule has the same phenotype, we believe, as efgartigimod. It's an exciting novel target where we can be first. And it is a pipeline and a product opportunity because there is a whole host of indications mediated by the classical and lectin pathway of complements. These are indications which actually would nicely fit into the commercial franchises Keith has been speaking about. So I think we are highly excited about the C2 molecule. Just like we are about some of the other molecules in preclinical or discovery, you know that we're going to announce ARGX-119 later this year. Don't forget about that other pharma assets with AbbVie in ARGX-115. I know that the [indiscernible] has had successes and failures. But I think if there's anything clear that is that the TGF-beta pathway is an important pathway to be used in conjunction with the PD-1 PD-L1 pathway. And I think with the anti-GARP antibody, we have a unique approach to modulating TGF-beta biology in the tumor microenvironment. So AbbVie has launched into a very ambitious Phase I program. And we've been keen to learn about the data, which will come out of these studies.

Graig Suvannavejh

analyst
#32

Maybe just switching to kind of parts of the business that are away from assets. But obviously, on the positive Phase III data, you were able to go to the markets and raise a fairly substantial amount of capital. So congratulations on that raise. What do you plan to do with that? And what's the priority in terms of that spend? Is it mainly to support the existing programs? Is it more on the R&D side? Is it really for supporting the launch of efgartigimod? If you just give us a sense of kind of how you intend to use that capital.

Tim Van Hauwermeiren

executive
#33

Look, it's all of that. This is, for us, a critically important launch. I mean it's not just about launching efgartigimod in MG, it's about launching argenx as a commercial company. So this launch for us is a make or break launch, and we will do everything we can to set us and Keith's team up for success. Part of that is not only equipping the team with a highly differentiated molecule, but also making sure that we lay a very solid foundation, preparing for launch and then launching from a position of strength. So that's what this capital raise allows us to do. In addition, we can continue to execute, what I would call a very ambitious business plan. We aren't adding indications to efgartigimod. We are adding pipeline assets, including 119 later this year. And we believe that ARGX-117 by itself is, again, a pipeline in a product opportunity. So executing on that business plan will require substantial amounts of cash. But in return, I think we can give our shareholders a disproportional shareholder value. So we feel very good about the business plan. We feel very good about the cash position, and now we can focus again on execution. You know that, that's so important in our shop.

Graig Suvannavejh

analyst
#34

And I know that the company doesn't really give much detail around financial guidance for 2020 or beyond, but it clearly looks like, from an OpEx perspective and given the raise that you've done, that over the next several years, we should continue from a modeling perspective at least to think about substantial investment into R&D and SG&A. Is that fair to assume?

Tim Van Hauwermeiren

executive
#35

I think that's very fair to assume. Expect this company to try and excel in commercialization, while not forgetting about building a deep and rich R&D pipeline. So that's the only way to build a sustainable, long-term successful company.

Graig Suvannavejh

analyst
#36

Okay. I've got two questions left in the remaining few minutes that we have. And maybe the first one is really about, over the next 6 to 12 months, obviously, with the Phase III data and myasthenia gravis behind us, investors are asking what's next for the company. So if you could lay that out, that would be great.

Tim Van Hauwermeiren

executive
#37

Sure. The Phase III data were an incredibly important milestone, but the job is not done. So expect now a linear path through pre-BLA meeting, BLA submission, hopefully, fast approval and then launch. So these are all dissipated, well-understood stepping stones to launch, but nevertheless, very important. In addition, the subcu product presentation continues to be a high priority for the company. So we wanted to go fast-to-market with the IV product, which is going to serve a substantial amount of patients but we do want to flank the IV products where we think is going to be best-in-class subcu execution. So that is also a top priority for the company. Expect some further updates along the lines Keith painted to us earlier in the call. And then you will continue to see how the pipeline will grow and expand. So this company will not be short of news flow in the coming quarters.

Graig Suvannavejh

analyst
#38

Okay. Great. And then with my last question, obviously, with the Phase III data, derisking the assets, I'm sure interest in the asset itself is quite high. So a lot of questions I get from investors is M&A, business development and obviously, people look at argenx as a potential attractive acquisition target. But with that said, you've had, had experience with M&A with your former company, Ablynx. So perhaps, could you remind us kind of your overall perspectives and thoughts on the ambitions of the company, whether it's independent or a not independent company?

Tim Van Hauwermeiren

executive
#39

I think the ambition level of the company is clear throughout this fireside chat, right? I think we have a very ambitious business plan, building a sustainable, hopefully long-term successful company. And that has also been part of the agenda with the last raise. Not only did we substantially strengthened the cash position of the company, but we have also been gathering -- or continue to gather, I should say, the stellar shareholder base supporting this company in its ambition to become long-term independent and successful. So as I think we execute on such an ambitious plan and continue to create substantial shareholder value, I think we will be in a good position.

Graig Suvannavejh

analyst
#40

Okay. Great. And with that said, I think our time is up. But, Tim and Keith, I just want to thank you so much for joining us on our fireside chat today. Best on success and look forward to hearing next events from the company, so thank you.

Tim Van Hauwermeiren

executive
#41

Graig, thanks for hosting us.

R. Woods

executive
#42

Thank you, Graig. Appreciate it. Take care, everyone. Bye-bye.

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