Conference Transcript - ARGX 2026-06-03

Myles Minter, Analyst — William Blair

All right, I think we'll get started. Welcome back to the 46th William Blair Annual Growth Stock Conference. My name is Myles Minter. I'm a senior biotech analyst here at the firm. I'm joined here with Matt Phibbs, who's the head of biotech research as well. We cover our genetics together. And with that, I need to point you to important disclosures that are available to everyone in this room and listening online at williamblair.com. It's my absolute pleasure to introduce Carl Gubitz, the chief financial officer of our Argenics as well and sitting in the audience we have Alexander Roy who are Senior Director of IR.

Karl Gubitz, CFO

With that I'll pass it over to Carl. Thank you. Good afternoon everybody. Pleasure to be here. Thank you Miles, thank you Matt. Yeah I've been with Argenics now for just over five years. I joined Argenics when it was an essentially an R&D centre in Belgium. Today we are a fully integrated global company um built on the success of Vivcard our lead asset I'll talk about that a little bit more market cap of around 50 billion dollars and growing um growing a lot up until now and a lot of future growth I'll take you through the deck I'll show you a few slides but if I if you can if I can leave you with two things about Argenics. One is growth. Yes, we've grown a lot. 17 quarters of consecutive growth, typically about 100 percent year-over-year growth. The last quarter was a little bit lower at 63 percent, but there's still a lot of growth in the short term, in the medium term and the long term in terms of revenues and there's also growth in terms of profitability the scale of a company the scale of revenues now allows you see that profitability increase is falling through to the profit line and you see it falling through to the cash generation line. Growth is the one thing I want to please want you to remember and the second one is execution. We get the question a lot about what makes Argenix different. We can talk about the focus on the patient, entrepreneurial science, innovation, the way we scale as a company, the way we think about scaling. I truly believe it's unique. We're a 50 billion dollar market company, we've got less than 2 000 colleagues. It really makes is unique but why does it matter for you it matters for you because execution as a company we are super focused on execution we I mean we had a few setbacks like all biotechs it's part of the industry but we haven't missed the beat in terms of execution and that focus on execution will continue so if you have to if you remember two things from today I my talk here would have been successful growth execution thank you so okay I can stop now we set ourselves a really big ambition which is our ambition for 2030 we want to have 50,000 patients on treatment the last time we gave you a patient number was at At the end of last year, we had 19,000 patients, one nine, on treatment. We're going to get to that 50,000. There are multiple paths getting there. Currently, we only have two indications. Well, three if you count ITP in Japan, but that's very small. And we are working our way to adding multiple indications. We can all do the math. And you can also, just with the two indications which we already have, we're going to get close to 50,000 patients in any case. So very ambitious but achievable target for patients and I know there's some accountants, I remember I'm the CFO in the room, in terms of dollar per patient MG is around 225, CIDP our second indication is around 450,000 dollars per patient. You can all do the math on where this is going to get you. The second target for vision 2030 is 10 labeled indications we have two at the moment we want to have 10 and that's our plan and I can show you how we're going to get there by the end of this decade and then in terms of driving that future growth long-term sustainable growth well into the next decade five new molecules in phase three that's over and above what we currently have in phase three that is our vision it is ambitious but we believe we can get there what are we doing this year the priorities for 2026 impact more patients with VivGuard that is revenue growth now and I'll talk about it later on how we're going to get there what are the growth drivers we have today I'll get into those a little bit later. The second thing we do is this company is built on Vivcard. Vivcard is an FCRN. The FCRN class, we believe is going to be very sizable. And how do we ensure that we continue to build the class and we play a leadership role in this class while into the next decade. And that's why we have our second generation um fcrns we have our combo strategy we have our aurels i'll talk about all of that and a lot of our focus is make is is pulling that through and then the last uh on the right hand side is call it other innovation we also as i said this company is built on with card once in a decade drug but we want to show you but it's our model our technology is repeatable and scalable we've got other assets which we believe are a product and a pipeline but what we're doing with VivGuard we can do again and again and we're pulling that through that is our objectives for 2026. usually we keep the finances until the end but since you Miles got the CFO to be up here today we're going to start with our finances that's the revenue curve there 17 quarters in a row growing growing growing always growing very very impressive and to maintain that growth curve you need new innovation and I'm going to talk about that new innovation because we have it in hand you'll see on the top there we typically prepare review revenues versus the consecutive quarters because year over year is quite high. I'll go to the P&L and this is where you already start seeing the scale of a P&L falling through to profitability. On the top line growth of 63%, operating profit growing at 183%, 400 million in the quarter and that by the way also fell through to the cash generation slide where we ended the quarter at 4.9 billion dollars this is just me trying to illustrate that we're gonna be very disciplined in how we scale the company how we build capabilities the fact that we have cash today the fact that you can buy things doesn't mean you should be buying them. The days of biotechs and pharma owning everything, manufacturing all through the value chain, we believe those days are gone. It is a disadvantage. You need to focus on what you're really good at and then you need to build capabilities outside the company. You have a flexible P&L, you can toggle it up and down as you want and you can get true expertise in those areas if you do it right and that is what we're doing as a company and with all the new indications and new products we believe we can keep that revenue line growing which will then give you that profitability I was referencing. Just some of our data points which we talk about today. MG stands for Myasthenia Gravis, that's our first indication. CIDP is our second indication. Those are the two indications which we've launched in the U.S. Those two indications drives that 1.3 billion revenues in Q1 which I showed to you and that is across all the different presentations. We have an IV, we have a physician-administered sub-q we call it itrulo and we have a pfs a pre-filled syringe for self-injection which is which is a 20 second injection really important because the pfs for self-injection is the key differentiator from the competition typically you go to infusion center you get infused takes hours or you can literally walk to your fridge you can take out the injection inject yourself you can take the injection on a holiday it doesn't you can throw it in your bag for 30 days it we've we've d we've democratized the treatment of mg and cidp with pfs our competitors cannot get there because we have exclusivity on the halazime technology which allows you to do the the self-injection. On the top in the in the quarter we gave you that data point in the last quarterly earnings a few weeks ago. New patient starts amongst the highest quarters since the start. That is just a short way of saying that the growth is not stopping. MG and CIDP we will have continued growth in those indications even after 17 quarters and even before you add the new indications and label expansions I will reference. 5,000 prescribers in the US, it's going really well. Early online use, so important because in MG 80% of the patients are not yet on a biologic. Vivcard, of course, is a biologic. All the new innovations are biologics. You add all of them together, it's around 20% of the market. 80% is still out there to be captured. You're not going to capture 100% of it, but the share of biologic will be substantially higher than 20% in a few years. And Vivcard is getting that first line patient in terms of biologic. Four out of five by physicians will start you with VivGuard today. There's a lot of competition out there, they're all typically behind VivGuard. And as I already said, PFS, refilled syringe for self-injection, is what's driving the growth. In terms of where are we now with Myasthenia Gravis, when we launched we talked about 17,000 patients in the US, these are US numbers. the 25,000 there on the right, that is the patients which we believe are the subset of those earlier patient lines which we can capture for VivGuard, which will be VivGuard patients, because patients will always start with mestanone and steroids, but many of them should be converted to VivGuard patients. That is where we're going to get the growth from and that is being driven by PFS. Seronegative is a label expansion. It is acetylcholine positive patients, was our original ADAPT study, got approved through the ADAPT study. Now we're at seronegative, which basically expand the label. We've got the broadest label out there. What this means in the physician office, you walk in, you present yourself as a GMG patient. The patient, the physician, they needs to do your test to see are you acetylcholine positive are you mask or what are you before the payer will approve with guard and only with guard you don't need to do that test anymore because we've got all of gmg generalized myasthenia gravis the next one is ocular that's 7 000 patients Ocular, think of ocular as even before you go, before you're generalized into generalized myasthenia gravis, you have ocular. It's those even earlier patient lines. 85% of those patients generalized into a GMG. We've got the, we've got the study result. We're going to file. Hopefully next year we're going to launch. Then we're going to add another 7,000 patients and that will help us strengthen ourselves as at first line biologic because only us will have ocular on the label. Long way of saying plenty of growth in GMG. I've talked about the broadest label, I'm not going to talk about the, I can just say ADAP was the original study acetylcholine positive, then we've got zero negative and then last one is ocular, very similar efficacy across the three subsets. The next one is CIDP. 42,000 patients in the U.S. 24,000 patients are being treated. 12,000 of them are not adequately treated. We get our patients currently in that 12,000 patients and over time we can move up earlier. What's driving that moving up earlier is continued experience, feedback from patients, physicians, and also arming them with data. And some of the data, which we shared at the recent medical conference, says that nearly 90% of patients or naive patients showed the treatment effect with VivGuard, which is really important because you don't have to step through anything else. If you have a naive patient, just put them on VivGuard. And the other one was sustained benefit after 96 weeks. What is important when we speak to docs is that Vivcard is not just a more convenient IG because IG, IVIG is the main is what most patients start on that is again infusion, takes time, side effects with Vivcard 20 second injection so much easier but it's not just more convenient we also have a regain of function data from the study from that year study half of the patients which entered the study in a wheelchair walked out of a study and this is what's so encouraging working at the company we open our company meetings with patients simple things patients can't wash their hair can't walk to the mailbox you hear stories about I am playing golf now I can go on holidays as the impact on patient is so motivating and this is why we're doing what we do at the Biotech Lycargenics. Behind that we the next readout in Q3 we're going to have myositis. Myositis is a basket study three set three different myositis types. We're going to get that phase three data in Q3. If you add all three together it's around 70,000 patients in the U.S. Really sizable opportunity. This is a prototype VivGuard indication or a GenX indication. Huge unmet need. IMM in particular for example 20,000 patients with basically no treatment options. If we get that data in a few weeks, a few months in Q3, we can transform those patient lives. On the right hand side is Sjogren's, we're also in phase three, we're going to get that data next year, over 300,000 patients. I mean we can all do the math of what that could mean if these studies read out positively and I remind you these are all IgG mediated diseases this is what MG is this is what CIDP is this is what we believe these are I mean there are always a risk but saying these studies are going to work might might not work but it is a de-risk asset which we have in VivGuard this is how we build the FCRN franchise remember we have got VivGuard, VivGuard like Trula I talked about the different presentations we've got an auto injector coming next year nobody can get to an auto injector because we've got the exclusivity on alazime technology we also got the exclusivity on the electrified technology which is another way of concentrating the drug for fcra nobody can copy that so we've got the combo studies the auto injector and the next gens are really important because how do you sustain your fcrn into the next decade you do life cycle planning we already have two one three we've got this dosed depending on the indication either every second week or every week we've got a longer acting uh version of that now two one three it's phase three ready so we can roll off we can take all our existing indications and move them to this more convenient dosing similar to Solaris Ultimares of AZ and then we've got one to four which is still in phase one we will be able to pull that through this year and then we if we have two next gens we can play with lifecycle management versus going into broader indications at a different price point which in the long term I think will be very beneficial we also have a with an unnatural products oral program which we're working on I will just maybe over here is our pipeline on the left about 25 IIP programs this is the heart of our GenX this is how we get innovation in our discovery organization is actually quite small we build antibodies how we get the novel biology in is collaborating with typically academic institutions all our innovation is sourced like that you can come and visit us in Ghent. Our labs are actually relatively small for the size of a company because we believe you can hire hundreds and thousands of scientists. You're not going to copy the knowledge out there in these academic centers and if you can tap into that successfully and build an operating model, this is what we have done and we've done it multiple times. and then on the right hand side maybe on the registration of those are all phase three assets which are going to read out in the next year or two and on the proof of concept I mean we also have all the other assets which I won't get into now these are the assets which we're going to have this year myositis as I said shortly Sjogren's later this year ITP next year we haven't talked about impasse probart mmn we will also have this here as i said this company is built on vivcard but we want to show you whether we can do it again and again the first one on deck is empire it's our second asset it's a c2 blocker and we have a multi-focal motor neuropathy data the phase two data was spectacular we've backed that up with open label extension data which we showed earlier this year in January, we showed that to the investor community. If we can replicate the phase two in the phase three study, we do it head-to-head with IVIG, because MMN patients are typically, well, are all on IG. The primary endpoint is to show non-inferiority and with a secondary showing superiority, because we believe we can get there, but let's see what the data says and then that will be the first indication of your second asset which we believe will also be a product in a pipeline. So attractive DRS profile of phase 3 studies, I won't go into that now. So basically I hope that you as I started growing this year MG CIDP driven by PFS in In the short term, in the medium term, myositis, Sjogren's, ITP, MMN for our second asset. In the long term, changing from VivGuard to an FCRN strategy with multiple next-gens, combos, orals, and the rest of a pipeline. All of that in a company where we're already profitable, where we already have operating leverage which we can pull through, we stand on our own legs. And then we can also use the cash which we are generating to think about business development longer term, to make sure that we augment our very exciting pipeline. And over that I'll stop.

Myles Minter, Analyst — William Blair

Sounds good. Thanks very much, Carl. We can take questions from the room as well, but perhaps I'll start in the seven and a half minutes we have left. um i think i got the message i think it was growth and execution thank you um i previously i've heard karen describe the growth potential for the company from the vivgart franchise as potentially linear in nature um you've just got approval in seronegative patients i think you're going to get approval in ocular given the data that you've shown you're moving to early alliance of therapy in mg alone the biologics class is growing and has massive potential to grow that almost seems exponential to me maybe you can help quantify for us i know you don't guide but maybe you can help quantify for us what you see the growth potential to be in 2026 and then 2027 as more of those factors come into

Karl Gubitz, CFO

play for fifth guard yeah as a company we do not guide um two reasons for that one is i think we're we're happy with the broad alignment in the street where the street puts us and also because we've got these binary events which makes a big difference i mean i can show you i won't show you but internally we have of course our different scenarios and one is there and the other one is we here and and everything in between because it depends I mean if Sjogrens the Sjogrens read out positively 300 000 patients at the prices we're talking about I mean we can all do the math so yeah we're not going to guide but to your point I think what we need to do as a company is to explain these significant and multiple growth drivers we have to explain that Vivcar to some extent has been de-risked although of course there's every study there's always clinical risk and I think as a company we will continue to grow and we're not going to talk about inflection point and I think as a company we will say that our growth has been fairly consistent To continue that, you need new innovation because we hold on to our patients. An MG patient should be an MG patient basically for a very, very long time. But you do lose patients for whatever reasons. And as your base business grow, you lose small percentages of that. Small percentages starts to add up to a lot of patients and you need to continue to feed the funnel at the top. And that's why you need the new innovation. So all of this innovation, I think, is going to help us maintain that, call it linear growth.

Myles Minter, Analyst — William Blair

We get a lot of questions considering you're a global organization with the net prices that you described earlier in the presentation. We get a lot of questions on the risk of most favored nations and pricing there long term. I mean, how do you see that playing out for Igenix currently?

Karl Gubitz, CFO

Yeah I think international reference pricing has always been an issue for pharma companies but the U.S. was always excluded from that I think what happened with a new administration is that the U.S. is now really part of international reference pricing and that we we don't think that will change I mean the current administration will come and go but I will the impact on pricing will probably stay how does it impact Argenix we are a fairly new company we've been fairly disciplined in that pricing in a narrow band so our exposure is I would say less than most companies and we're not going to unlikely but we're going to enter into a voluntary agreement because I think we can manage on the way we are now looking forward I think it'll be interesting to see how it plays out i think there will probably be a little bit of a reset maybe u.s prices come down a little bit the rest of the world comes up a little bit because companies will be forced to price within a narrow price band you will not expose your u.s business by pricing at a substantially lower xus going forward i don't think anybody will do that gal you mentioned uh life cycle management with

Speaker 2

213 and 124. I guess do you need to see more data from 124 before making that determination of which one is new indications, which ones you know kind of follow-on or are there any external data points that you're also evaluating when

Karl Gubitz, CFO

in trying to make those decisions? Yeah so our patent life on WebGuard runs to till 2036 at the moment. We keep on filing patents to extend that but currently 2036 so if in terms of life cycle planning if you look at analogues you probably need your your next gen on the market in early in the next decade call it 2031 32 so we've got time but we need to start moving soon but we want to see the one two four data that's the second second generation fcrn we've got 213 which is one a month dose once a month dosing is ready we can start with it today but we want to see one to four the second asset we want to compare the two firstly do we really have two because I mean maybe we don't we think we will have two and if we have two which one is best suited for life cycle management and which one is best suited for broader indications at a different price point and we will have our data this year so in a few months or by the end of this year we will be able to talk about that and when we're going to make

Myles Minter, Analyst — William Blair

those decisions and then we're going to start. Beautiful well it's fantastic to see the growth story evolve at Argenix it really is a unicorn in the biotech industry I think and with that we will conclude here. The breakout session is upstairs it will be in room Jenny A. We'll see you up there in 10 minutes. Thanks.