argenx SE (ARGX) Earnings Call Transcript & Summary

January 11, 2021

Euronext Brussels BE Health Care Biotechnology conference_presentation 40 min

Earnings Call Speaker Segments

James Gordon

analyst
#1

Great. Good morning, good afternoon. I'm James Gordon, JPMorgan European pharma and biotech analyst. And today, it gives me great pleasure to introduce Tim Van Hauwermeiren, CEO of argenx for this presentation. Timely, too, for argenx, give all the progress made since we last heard from the company a year ago and also recent updates last week. So today, we can have a 20-minute presentation from Tim, and then we'll have 20 minutes for questions. I will also have argenx COO, Keith Woods, join us for the Q&A. [Operator Instructions] So with that said, welcome, Tim, to the conference and looking forward to the presentation.

Tim Van Hauwermeiren

executive
#2

Thank you, James. Thank you very much for having us. And I would like to start with the first slide on the forward-looking statements, please, to draw your attention for 1 minute to these statements. Okay. So next slide, please Slide #3. Good morning, and thank you all for joining us today, and a big thank you, James, for hosting this conference and having us today. Our company name, argenx, refers to a story that has always inspired us. It's a story, probably the oldest one on record, about the power of a collective team trying to do the unthinkable. They were sailing out to the end of their worlds trying to conquer the golden fleece and bring it back home. Today, we find ourselves on a mission to bring efgartigimod to myasthenia gravis patients this year and, thereafter, to many more people living with autoimmune diseases. Next slide. I would really like to give kudos to the argenx team for having delivered an incredible progress against the key business objectives in 2020 despite being such a challenging year with the COVID-19 issues. So let's look at what we achieved. First of all, we submitted what we think is a high-quality BLA for efgartigimod in MG on the back of strong Phase III ADAPT data. We initiated an impressive clinical activity, and we'll soon have 7 global trials running for efgartigimod across 6 indications and in 2 product forms, the IV form and the subcu product form. We also progressed ARGX-117 into the clinic and added ARGX-119 to the pipeline. We strengthened our world-class antibody discovery and engineering platform by adding 2 powerful Fc engineering technologies. And last but not least, we've doubled our organization to about 450 people across 3 continents. Personally, I'm very excited by the addition of Anant Murthy to the team, who will lead the European commercialization activities as our EU GM. Next slide. This means we're ready to scale with confidence. We have been working hard and executing across the business to build an integrated immunology company. We have outlined the vision for 2021 to be the year where we are going to reach patients for the first time and solidify our FcRn leadership position. I think we can scale confidently by continuing to add indications with a solid biology rationale, thereby reaching more patients through our franchise model. We have growing offices in the U.S., in Japan, in Europe, which are our key clarity areas for building out commercial infrastructure. We are growing beyond these territories through strategic partnerships like the Zai partnership we announced recently. Next slide. We recognized that China will be a very important market for our global launch. We decided to address this market through a strategic partnership with Zai Lab. Partnering is in the DNA of our company, and we were looking for a partner in China with a strong cultural fit, an equal ambition level, an equal passion for patients and equal skill and expertise when it comes to product development. Through the strategic collaboration, we have the joint intent to bring efgartigimod to Chinese MG patients quickly; to accelerate our current and future Phase III global registration trials with Zai contributing patients from world-class Chinese medical centers; and finally, to expedite indication expansion to China-based proof-of-concept trials in additional efgartigimod indications. We're very proud to be moving forward with Zai Lab as our partner of choice in Greater China. On the next slide, you see that we are building a differentiated -- pipeline of differentiated therapeutic antibodies that is broad and deep. We are prioritizing candidates that can be evaluated across multiple indications. We do believe efgartigimod is a rare product opportunity. It's the type of assets which can build great companies. You see our clinical development work now across 6 indications for which we design thoughtful clinical trials. In addition, we're progressing cusatuzumab under our alliance with Janssen. We are progressing ARGX-117 in complement, ARGX-118 in airway inflammation, and we recently added ARGX-119 for which we said it fits squarely in our neuromuscular product franchise. Next slide. Here, we take a closer look at our molecule of efgartigimod, the genesis of it and why we are so excited by its broad potential. On the left hand, you see the groundbreaking work performed by Professor Sally Ward, leading to her seminal publication in Nature Biotech. She showed that the neonatal Fc receptor, FcRn, is responsible for the longer serum half-life of IgG antibodies through a pH-dependent recycling mechanism, rescue the antibodies from lysosomal degradation. On the right-hand of the slide, you see how we apply that knowledge to design our unique FcRn blockers. It is an Fc fragment, so the natural ligand of the receptors, and we engineered the molecule for enhanced FcRn affinity without compromising the characteristic pH-dependent binding. This allows efgartigimod to hijack the pathway without the system really noticing it. And as a result, IgGs can no longer recycle through FcRn and therefore, go down the lysosomal degradation path. It is thanks to the unique insights from Sally that we could come up with this design. This collaboration formula became the foundation of our immunology innovation program. Next slide. We believe that efgartigimod is not just a first-in-class but potentially also a best-in-class FcRn antagonist based on strong efficacy. We have shown fast, deep and lasting clinical benefit in MG in our Phase III global registration trial. We have also set the bar high in our Phase II trials for ITP and pemphigus. We have the largest safety database showing a promising and potentially differentiated safety and tolerability profile that is consistent across the different disease indications we are studying. And finally, we crafted a subcu product presentation, which is designed with the patient experience in mind. It is equipped with Halozyme's volume-enhancing technology, which allows us to dose our FcRn antagonist as one fast simple subcu injection. This product is getting very promising early feedback from clinical trials. Next slide. We have spent significant time interacting with myasthenia gravis patients worldwide, and we have heard firsthand about the significant unmet need that still exists in this serious disease. It's a true autoimmune disease. So next to severe muscle weakness, which can basically affect any voluntary muscle of the human body, it comes with severe fatigue, but also depression and anxiety. Neurologists ranked severe MG only second to ALS as the most serious disease they treat. The waxing and waning nature of the disease makes it highly unpredictable. It's severely affecting people's lives with good days being only 70% of what healthy people experience and bad days as low as 10%. MG's called a snowflake disease. That means every patient is experiencing the disease in his or her own unique way. Next slide. Our global Phase II registration trial for efgartigimod was the largest and broadest trial ever in myasthenia gravis. We enrolled 167 patients who had significant symptoms despite being on standard of care. We talked to patients when designing ADAPT and learns that a simple one-size-fits-all approach does not work well in MG. We, therefore, designed ADAPT such that physicians could adapt the cadence of the treatment cycles to the individual patient needs. Looking at the Phase III data in the totality, we showed a compelling value proposition for generalized myasthenia gravis patients. If you were receiving efgartigimod, you have an almost 80% chance of responding across the first 2 treatment cycles. Recall the definition of response was a pretty stringent one. 84% of the responders came within the first 2 weeks and responders had a 60% chance of basically eliminating disease symptoms. We also learned that about half of the patients would benefit from individualized dosing. Finally, generalized myasthenia gravis patients are typically on steroids and often on ISTs like mycophenolate or azathioprine, which can commit significant side effects. What we saw in ADAPT is that the safety and tolerability profile of efgartigimod looks comparable to placebo. Next slide. Next to the innovative ADAPT trial design, we also embarked on an innovative strategy to bridge from the IV efgartigimod product to the subcu efgartigimod product. From the ADAPT data, we demonstrated the linear correlation between IgG reduction on the one hand and ADL score improvement, on the other hand, thus showing the IgG reduction to be a reliable surrogate for clinical efficacy. We have also data from the Phase I healthy volunteer study to show equivalence of the 10-milligram per kilogram IV product from a PD point of view compared to the 1,000 milligram subcu product. While bridging on PK is simply not possible because the IV and subcu products have different profiles, we have argued it is possible using the PD parameters. Following FDA feedback, we are moving forward with a small, focused trial, enabling a faster path to registration and one where we believe we can achieve our ambition to be the first true subcu to market. Next slide. We have been busy preparing for the last 2 years for the potential launch of efgartigimod in generalized myasthenia gravis, which we expect to happen this year. We are building commercial infrastructure within our neuromuscular franchise, to reach the 20,000 addressable GMG patients in the United States who are treated by, roughly speaking, 16,000 neurologists. There's a lot that goes into a successful first launch but we've outlined some of our areas of focus. Physician education is one of -- on this new mechanism of action and on the foundational biology of FcRn and its role in autoimmune diseases, education is more important than ever given the fact we will likely launch in at least a partially virtual environment. We have a team of market access account managers that have been conducting pre-approval meetings with national and regional payers. We're planning for a sales force size of around 100 sales team members, plus an additional 90 team members, dedicated exclusively to supporting patients that suffer from MG. On the manufacturing side, we do all of our manufacturing out of Lonza, which provide us with site and geographic diversity. We have ramped up capacity and are making significant investments over the next 5 years to ensure commercial supply as we prepare for multiple launches. Next slide. Our teams are doing an incredible job connecting with MG patients. Connecting for us means listening, learning and giving a voice to these people suffering from this severe debilitating chronic autoimmune disease. MG United, an online platform that provides clear and credible information to people living with MG, now has 20,000 people who opted into this virtual community. Our docuseries, A Mystery to Me, has been watched over 2,000 times and was selected for the Chicago Film Festival. We surpassed our targets for My Real World MG with now close to 1,000 patients who downloaded the app on their smartphone and many of which are already entering real-world data into this app. Next slide. Through the foundational FcRn biology, we believe we can address a broad range of patients with autoimmune diseases. Pathogenic IgGs are known to drive many of these diseases, which are all equally debilitating and staffed for innovation and where we consistently hear feedback from patients on the unmet needs, the fact that facing significant disease and treatment burden with a high need to increase disease awareness. These are indications which select new, targeted and fast-acting therapies. We believe that through each of the trials, we are running in autoimmune diseases, we are working towards addressing very significant patient needs. And therefore, MG is just the beginning, and the list of high conviction indications is one. We're also expanding our immunology pipeline, next slide, beyond efgartigimod. IgG antibodies are a cornerstone of the adaptive immune system, and with efgartigimod, we are well-placed to intervene in that type of disease biology mediated by pathogenic IgGs. With ARGX-117, we are turning our attention to the complement system. A key component of the innate immune system. Complement plays an important role in host defense against pathogens, but also in cleaning protein debris. Over the past few years, we saw a real renaissance of the complement system as a therapeutic target, and we are rapidly learning more about its role in so many diseases, including autoimmune diseases, which are of high interest to our company. Next slide. ARGX-117 is a potential first-in-class opportunity, and we believe that targeting C2 carries tremendous potential as a therapeutic target. C2-deficient people have a rather benign phenotype when it comes to infection or the risk of developing lupus. In addition, C2 is uniquely situated at the nexus of the classical and the lectin pathway, enabling therapeutic intervention in diseases mediated by both pathways but without affecting the alternative pathway, which is so important in the fight against serious infection. We are developing both on IV and the subcu products. Our subcu product is, again, utilizing the Halozyme technology. We are in the midst of an ambitious Phase I healthy volunteer study, evaluating the safety, tolerability, and C2 elimination across multiple doses and dosing regimens. Based on this work, we are preparing to enter our first Phase II proof-of-concept indication multifocal motor neuropathy or MMN, an indication which squarely fits in our neuromuscular franchise. Indeed, physicians treating myasthenia gravis and CIDP are also typically treating MMN patients. Next slide. Now that we have reviewed our growing autoimmune pipeline, we can turn our attention to our strategic alliance with Janssen for the development of cusatuzumab. Recall, we announced earlier in 2020 that based on the maturing CULMINATE data, we decided to select the 20-milligram per kilogram dose going forward and to make a data-based decision to prioritize the triplet combination study of cusa with venetoclax and azacitidine. Here, we can see the interim CULMINATE data based on a December data cutoff. There are a couple of points I would like to make. The interim ITT results in 52 patients treated with the 20-milligram per kilogram dose show a CR and CCR rate of 27% and 40%, respectively. Compared to the historic data for aza, this outcome is below what we expected. It is possible that in this study, the patient population and treatment did not allow cusatuzumab to show its full potential, 46% of patients fell in the adverse risk classification according to the ELN criteria. And we also saw a very significant amount of infection. We now know that cusatuzumab needs some time to achieve its full activity and when we looked at patients who had received at least 2 cycles of cusa, in this study, we saw a CR and CCR rates going up to 42% and 64%. Next slide. While we are navigating development of efgartigimod, cusatuzumab and ARGX-117, we continue to build pipeline assets from our successful IIP formula. The key principles of IIP are simple, but the implementation of it requires special skill. Based on our powerful antibody discovery and engineering capabilities, we seek out top-notch translational biology labs working on pretty fundamental immunology principles. By seeding their research with our diverse antibody panels, we can enable their work but also identify leads with unique properties. By applying our state of the art antibody engineering skills, we can turn these leads into differentiated product candidates we can take forward in our own proprietary product pipeline. We aim to build drug candidates, which we can take forward on our own, fitting with our orphan disease strategy and growing commercial franchises. You can see that through the IIP, we have identified multiple assets for value creation. First, through wholly-owned pipeline candidates. We have also demonstrated a willingness to partner out assets, which may fall outside of our therapeutic focus. And finally, we have been spinning off argenx-built assets into stand-alone companies. Next slide. For us to be successful as the preferred antibody experts in our immunology innovation program, it is essential we continue to seek out complementary state-of-the-art antibody engineering technologies to build these pipeline candidates. And here, you can see how we have discovery and engineering technologies at both ends of the antibody molecule. Simple antibody provides us with unprecedented diversity of full human V regions, covering more and different epitopes compared to what can be achieved with mice, also excellent manufacturability compared to synthetic library technologies. We also have half-life extending and sweeping technologies enabling us to design appealing dosing regimens. All of this is further enhanced by our Halozyme collaboration, for which we have in total 6 slots, 2 of which are already taken by FcRn and C2. Moving on to my last slide and to wrap up, I would like to show our strategic priorities for 2021. First, we want to reach MG patients through the commercial launch of efgartigimod in the U.S. Second, we want to advance efgartigimod across a rapidly growing set of indications. Third, to continue to expand globally in Japan and the top 5 EU countries on our own and in China and rest of the world through partnerships. And finally, to continue to grow the pipeline with ARGX-119, and later on, promised ARGX-120. And with this, I would like to conclude this presentation and open the floor for questions and answers. Thank you.

James Gordon

analyst
#3

Great. Thanks for the presentation. And we'll now move on to the Q&A part. And so we're also joined by argenx's COO, Keith Woods, I think, we've also got on screen as well. And so we've -- I think we've got about 15 to 20 minutes for questions. [Operator Instructions] And maybe just to start, so a question I have had is about some of the disclosure from late last week from the company. And so you talked about the fact that for efgart, you have actually requested priority review with the FDA. So why would the FDA not give you priority review for MG?

Tim Van Hauwermeiren

executive
#4

I think that is an excellent question, James. And I think on the one hand, we are in a strong position with the data which we generated from the ADAPT trial. We believe there is significant unmet medical need in myasthenia gravis. We think these Phase III data are quite compelling, quite compelling proposition for patients living with gMG. And I think we have also a pretty unique safety profile. Now that being said, and I think we're facing extraordinary times with an FDA, which is probably going to be very busy with all the COVID dossiers on the desk. And there's also, I think, some further difficulty with FDA people being able to travel and inspect, for example, as part of the regular review process, clinical sites who participated to the study or the manufacturing plants where the products are being manufactured. So I think we are cautiously optimistic.

James Gordon

analyst
#5

Assuming you do get timely approval, and hopefully, with a priority review, how are you thinking about uptake? Is it going to be a fast launch, straight off the bat or are there other things that need to fall into place? I'm aware that this is a product that might require a J code.

R. Woods

executive
#6

Yes. So thanks for the question, James. Overall, we're expecting a gradual steady launch. And let me give you a few reasons why this is what we believe. First of all, this is a brand-new mechanism of action. So there's a great deal of health care professional education that's going to have to take place because of the 12,000 neurologists that are currently treating an MG patient in the U.S. It is a very, very small number that actually have hands-on experience with using an FcRn antagonist. So there's going to be a deal of education. And keep in mind, we are launching in a COVID or partially COVID environment, so you have the challenges that take place with that. Even when we get a physician comfortable where they are ready to prescribe the medication for a patient, you have to have a patient that's willing to take it. Many of the patients right now are being seen by telemedicine and to try a brand-new agent, when they haven't even visited face-to-face with their physician, may give them a bit of apprehension. But once we've cleared both of those hurdles, we now enter some of the challenges that could be present with payers. First of all, it's a brand-new product. And so we believe that some insurers will delay approval of it or even deny at first, and we'll have to go through a process, and this will take time so that we can get the product approved and paid for. Secondly, as you mentioned, no J code available at launch. So it will probably be a little over 6 months from the time that we launch to the point where we have a J code. What this actually means is that it slows the payment back to physicians, so it can be a deter for them to use the product upfront. What we have done though is we put together a team that is very well-equipped and experienced in these areas, so we will be able to overcome the obstacles that exist. It just may take a little bit more time. And so that's why I'm saying a consistent gradual launch.

James Gordon

analyst
#7

And how are you thinking about pricing for a product like this because there's much higher prices like Soliris or another reference price might be immuno-polypropylene. So this a $700,000 product? A $130,000 product? Where should we think about it launching?

R. Woods

executive
#8

Well, I mean, first of all, we will anchor our pricing based on the value that efgartigimod is going to provide for these patients that are suffering with MG, the value to the patient, the value to the system as a whole. You mentioned IVIg, one of the therapies, about $146,000 per year, and you've got Soliris that's substantially higher. We've already shared publicly. We do not anticipate pricing anywhere up there near Soliris. And the other thing is we look at this long-term. As you know, with efgartigimod, we're already studying this in 4 indications that everybody is aware of. But we'll also be enrolling patients in our fifth indication and our sixth indication here in 2021. So we're thinking about this big picture pricing.

James Gordon

analyst
#9

A message about further indications or a question. So the question was do you plan on applying anti-FcRn technology to autoimmune diseases with larger populations such as RA or IBD?

Tim Van Hauwermeiren

executive
#10

I think it's fair to say, James, that there is plenty of work for us to do following the orphan model. And also following the commercial franchises, which we are building. So we expect the company to continue to move forward with diseases of high unmet medical needs, which fits the orphan strategy and our franchise model.

James Gordon

analyst
#11

Maybe as a follow-up to that question. In terms of -- will this be a product that's going to be the same price per patient across all the diseases? Or based on the different formulations? Do you actually have some flexibility anyway?

Tim Van Hauwermeiren

executive
#12

So I don't think you're going to see the same price across all indications just simply based on the dosing cadence, right? Remember, we've got a very unique study model with ADAPT where you have individualized dosing. And patients that take advantage of this are actually going to be patients that are going to require fewer infusions per year. Whereas some of our other indications like CIDP, for example, this is going to be consistent, chronic dosing regularly scheduled on a year-round basis. But as far as price per vial, it will be the same for all indications.

James Gordon

analyst
#13

And maybe one other one on new indications. So for your sort of first indications, you followed a more classical model in terms of doing Phase II than a separate Phase III. Whereas, the CIDP, where were actually going to get an announcement imminently, I believe, your -- the Phase II could turn into a Phase III, and that could be fileable. So for these other indications, are they going to be a more protracted development or can you expedite it a lot and then speed things up?

Tim Van Hauwermeiren

executive
#14

I think that's a great question, James. I mean, obviously, when you have more and more experience with efgartigimod, I think you can confidently expand indications based on the cumulative knowledge you have, and I hope you see that we're building a track record of pretty innovative trial design. I think not only ADAPT was innovative, adapting to the individual needs of the patients. I think also our subcu bridging study from IV to subcu based on the PD readout, I think, is pretty innovative. And you're right, I mean, going forward in these orphan rare indications, you will see the company make an attempt to bring the product as fast as we can to these patients. So just continue to watch trial design. They will continue to be innovative and fast.

James Gordon

analyst
#15

We've also had some interest in the subcu formulation where you gave us some update late last week. So I mean in terms of time lines for bringing that forward, so my understanding is it's just PK data that you're going to need. But, I think, to, like, the bridging study, when could you have a subcu product on the market? And is this an area where you might think about deploying your PRV?

R. Woods

executive
#16

I mean as far as our trying to having the subcu available on the market, we're really pleased that -- in our agreement with the FDA that we're not having to do a full-blown global Phase III program, and this is going to be, as you mentioned, a bridging study with 50 patients in it with a PD as a primary endpoint, but we'll also have efficacy and safety data that will come out of that as well. To give you a time frame is a little bit more challenging because of a couple of components. One, we still are living in a COVID environment. And as you've seen across the industry, it's affected the pace at which people are able to enroll trials. So that makes it much more difficult to predict. I'd also call out that there are a number of MG trials taking place globally right now. So it still will be competitive enrollment. So we'll give you an update on a regular basis as we continue to enroll patients into the trial.

James Gordon

analyst
#17

And maybe just on that subcu formulation. So how competitive will it be versus the other FcRn inhibitors? I know that we don't know exactly what the otherwise are going to look like. But I've had interest in what Momenta has got, which could be part of Astra -- sorry, a part of J&J. Also Alexion Astra, yes, and there's a number of other companies with FcRn activities as well. So how do you think your subcutaneous is going to be differentiated because you are going to go up against some big companies now?

Tim Van Hauwermeiren

executive
#18

Yes. So, I guess, first of all, for the J&J -- Momenta J&J product, we haven't seen any subcu data from them yet. So I can't really comment on their availability to have a subcutaneous formulation. Same thing with the Alexion product or AstraZeneca in the future, the former Syntimmune product. We haven't seen any subcu data on that as well, so difficult to comment. What we have seen with FcRns is there's really 3 different presentations of what some are calling subcu, all right? One is what we've seen where it's a subcu infusion with a disposable pump. And with that agent from UCB, we've seen in studies where they've infused it over up to 90 minutes in some of their studies. Another subcu formulation that's available from Immunovant. What we've seen from their studies is to get the volume that's required, to get the response that they need, they have to give multiple injections on the same day. Why we're so pleased to be working with Halozyme is because of that technology. efgartigimod subcu is a single injection. It is a quick, simple push that a patient is going to be able to administer at home. And in fact, where we're already using this formulation in the CIDP study, yes, during the primary part of the study, the patients are coming in and being injected in the office, but when it gets to open-label, we're going to actually train the patients to be able to inject themselves at home, quick 30-second push.

James Gordon

analyst
#19

And how would that compare to a complement therapy as an alternative?

Tim Van Hauwermeiren

executive
#20

Right now the only complement subcu that we have seen in MG is zilucoplan and that is -- that's a daily subcu. So the patients will be injecting themselves 365 days a year on that. In our subcu bridging, we look at a weekly cadence, and we really believe that in the real world, you're going to see individualized dosing with our subcu product just as you see with our IV.

James Gordon

analyst
#21

I've also had a question about CIDP. So the question is CIDP go/no-go decision, what are the push and pull factors about how whether to go forward specifically in this indication?

Tim Van Hauwermeiren

executive
#22

Yes. So we are going to communicate about the first 30 patients go/no-go decision point. And people have been asking us, indeed, how would the disclosure look like. So on the one hand, you know, James, that we like to be transparent, and we also like to make database decisions, and we want to talk about this data to you and our audience. On the other hand, we should not forget that these initial 30 patients are an integral part, if it's a go, of a global registration trial. So therefore, we cannot be seen by regulators as biasing the study with a disclosure and thereby also jeopardizing the integrity of the study. So we will need to balance and the quality of information we can give you around the go/no-go. And on the other hand, of course, the preserving the integrity of the study. So expect a disclosure, which is going to talk about meeting a certain hurdle rate, which we have set from a statistical point of view. And some of the key underlying principles feeding into that statistical model are coming from the double blind, placebo-controlled IVIg studies in an indication like CIDP. I would like to refer to the ICE trial with a 53% response rate in the treated arm versus 21% response in the placebo arm. So we have started from a comparable response rate of profile to build some of the key statistical assumptions, okay?

James Gordon

analyst
#23

One other question I'll just comment is about cusa or cusatuzumab, so AML. And the question is how are you thinking about further development? What's the bar for triple combo to want to move forward with development? And what are the safety risks from combining with venetoclax?

Tim Van Hauwermeiren

executive
#24

I think that's a great question. So what we said publicly is that CULMINATE can no longer be that fast single-arm registration trial, right? Because frankly speaking, the data we see are comparable to the changing standard of care but are not basically outperforming it. So there is a great rationale to combine cusa with -- which is more slowly acting, pretty clean from a safety tolerability point of view and unique in its mode of action to combine it with a fast cytotoxic drug like venetoclax and also azacitidine. So I think there is room for improvement still on that response rate. We saw 66% CCR in VIALE and a 37% CR rate. The issue with the VEN+AZA combination today is that it's fast, it's effective, but it's pretty toxic to the bone marrow. And therefore, people are already trying to find ways to taper off or at least taper the dose of that toxic medication. And that's where we see, also, space for a drug like cusatuzumab. You're right. I mean, what is the safety profile of the triple combination remains to be seen. So really, the data from the ELEVATE trial, that's the triplet combination study, they will be getting any further global development under the agreement.

James Gordon

analyst
#25

Maybe we've got time for a final question, which would just be in a moment. I think many people think of the company as being just efgartigimod. But I've also been asked when does the rest of the pipeline become more visible? So is it this year that we'll see more? What will we actually see beyond efgart?

Tim Van Hauwermeiren

executive
#26

I'm glad you asked the question, James, because efgart is indeed getting or attracting a lot of attention and rightfully so because I think this is a company and a company, efgart. Now if you look at the track record of this company, which became operational in 2009, and we have basically built and launched 1 new differentiated antibody molecule every year since inception. So there's from ARGX-109 from 2009 and ARGX-110 from 2010 and so on until ARGX-119, which we launched last year. It's fair to say that most of these assets continue to make progress and create value either in our own hands or in the hands of our partners. And I think it's only ARGX-111 today, which is not making any further progress in the clinic. But our partners, AbbVie on ARGX-115, LEO Pharma on ARGX-112, Genor on 109, they continue to make nice progress with these molecules. We just don't have time to talk about them, given all the attention efgartigimod deserves.

James Gordon

analyst
#27

Great. Well, thank you very much. With that, I can say we're actually out of time. So thanks a lot to everyone from argenx for participating. And I hope you have a great rest of the conference.

Tim Van Hauwermeiren

executive
#28

Thank you, James.

R. Woods

executive
#29

Thanks, James.

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