My name is Peter Welford. I'm one of the European pharma and biotech analysts at Jefferies in London. With me on stage, we have the CEO of Genmab, Jan van de Winkel, and we also have at the end there the CFO, Anthony Pagano. If anyone in the audience has any questions, by all means, do raise your hand, and we can try and get a mic out to you. We will take questions if anyone has them. Please just wave at me. With that, let's get started. Perhaps first of all, we should talk about epcoritamab or Epkinly. Obviously, you recently launched in collaboration with your partner, AbbVie. Perhaps can you just talk a little bit about the early feedback you've had for EPKINLY, you know, and how you're positioning yourself in the lymphoma market? Thanks, Peter. Thank you for having us here. Let me start off here with EPKINLY. I mean, epcoritamab has been very well received in the market. We only had a first full quarter at very... I think, a very encouraging sales number of $22 million, which actually was very, very, I think, very exciting. The feedback has been very, very good. I mean, it's a drug which can be easily dosed. It's a two-second injection, which is a real advantage over other IV-applied T-cell engagers. So doctors and patients are very, very enthusiastic. We initially got very ill patients, third line plus, diffuse large B-cell lymphoma patients, but now we also see less heavily pretreated and less ill patients coming to be treated with epcoritamab. Feedback has been very, very good. It's still early days, Peter. We're also very excited about the upcoming launch in Japan. I mean, in Japan, we got an approval in September, but we are allowed to actually speak with hematologists and position the drug prior to the launch, in an effective way, and the interest level has been sky high. We think that that's meaningful because the Japanese market initially will be very similar to the U.S. market, in number of patients, and actually, safety is a very, very big item in Japan. We have a very good label with very, very limited requirements for hospitalization, for epcoritamab, so we think that that will actually position us really, really well. Also in Japan, we will have a head start over competitors, which is much, much longer than in the United States. So we are very excited about the initial reception. It's still early days, so let's wait on another few quarters, Peter, before we are going to draw further conclusions. What I can say is that we will, at the post-ASH update from Genmab on December the twelfth, actually give you a very good insight into the whole development plan. Because we have multiple phase 2s and phase 3s upcoming. One of the key advantages of EPKINLY is that not only is it subQ, but it's also very easily combinable with other medicines, and that is, I think, a key advantage over some other competing products. We will actually use that optimally in the future, and we will actually really build up a very, very comprehensive development plan together with AbbVie over the coming months, and we will give you insight on that in December. That's very clear. So, perhaps you can just talk a little bit about how you do think about expanding the, the indications for EPKINLY. I appreciate, obviously, details to come, in December, but just talk more broadly about the sort of indications you're looking at and, and lines of therapy, particularly, and, perhaps some of the timelines, if you can, for some of those. The timelines will come in in December, Peter, and because we want to align that everybody gets information at the same time. But right now, we already have a frontline study together with R-CHOP and diffuse large B-cell lymphoma. We have a second-line study in follicular lymphoma, in relapsed refractory follicular lymphoma, where we combine epcoritamab with R², and we will actually go to frontline follicular lymphoma pretty quickly. We go also to second-line diffuse large B-cell lymphoma with multiple studies and multiple combinations. And we also actually broaden the program towards CLL, Richter syndrome, and some other B-cell cancers. But again, details will follow in December, so keep the suspense high, I think, here for everybody. And we're very excited about the clinical data. I think that there will be a number of studies presented at ASH, where we see new combination data, as well as the follicular lymphoma monotherapy data, where you only have seen the top-line data of in June. That will be featured, and we are very excited about filing for follicular lymphoma at least one jurisdiction, if not more, this year. So we are also progressing with the filings for epcoritamab. It's still early days for epcoritamab, but we feel that this is a blockbuster in the making. Okay. Let's move on then to some of the other pipeline assets. Let's start off, I guess, with maybe 1046. Perhaps you can just, first of all, I guess, just describe for us what 1046 is and the thinking behind that. And then, you know, talk about some of the initial early data that you've seen so far. Yes. GEN1046 is a bispecific antibody. It's targeting 4-1BB with one arm of the antibody and PD-L1 with the other arm of the antibody. It's a unique antibody. What I think I should describe here is that we generated over 5,000 candidates and actually selected this antibody from the 5,000 as the optimal antibody, only activating T cells and NK cell, and NK cells in a conditional way when both arms of the antibodies are bound. We had good monotherapy data, but the data also told us that it was not very strongly sustained responses at that time in monotherapy and lung cancer. This was the second-line lung cancer setting. So we now started adding a PD-1, PD-L1 axis blocker like Keytruda to GEN1046, and then I got great data. We actually now have the data in hand in the second-line lung cancer setting after chemo and after checkpoint inhibitor, where there's very limited options for patients. We have actually exciting data in hand, and we already decided together with BioNTech that we will move this forward towards pivotal studies, and we will do that in the coming time. We have already scheduled meetings with the regulators so that we get feedback on the proposed dosing schedules and the combinations, et cetera. And we think that actually we can actually further expand into other lines of treatment also with GEN1046. So it's a very exciting antibody. We are becoming experts in targeting 4-1BB, because we also have two other bispecifics targeting 4-1BB. One is called GEN1042. It's, it's binding to 4-1BB on one arm, and with the other arm to CD40, a molecule on dendritic cells, on antigen presenting cells near the tumor. We have some very, very exciting data in multiple cancers now obtained. We're doing a bit more dosing information, Peter, because also in the context of the Project Optimus program from the FDA, you really need more dosing information before you can get a okay on combination studies going forward. And we're going to collect that data as we speak, but we are very encouraged about the data, and we believe that we can actually, in the coming months, make a decision on moving to next stage of development for that molecule. And to top it off, we have a third bispecific, believe it or not, targeting 4-1BB, with one arm and the other arm with EpCAM, to actually target a completely different set of tumors than we could actually target with GEN1046 and GEN1042. And that molecule will also go into the clinic next year. And again, it's based on excellent preclinical data, and we have collected that preclinical data together with BioNTech. They all three are 50/50s with BioNTech, and we believe that that's a very productive partnership. In the foreseeable future, Peter, we will have, I think, 6 clinical programs together with BioNTech, all 50/50s, and 3 of them are going to be 4-1BB targeted. Okay, there's a lot you covered there. Let's just back up a minute and let's just... So, let's start off with 1046 again, I mean, just in terms of the strategy. So obviously more visibility to come at ASH, the event you're hosting there in December, but can you just give us some orientation? So, what we think about- is this gonna be studied in combination with the PD-1 drugs? And perhaps you can talk a little bit about, you know, what sort of indications do you think are the most likely, or how do you think about, you know, which indications could be most likely to pursue with this approach? So, Peter, we have actually a very comprehensive program already with GEN1046. We have 12 expansion cohorts, and you've only seen data from 1 or 2 of these expansion cohorts now. We think that lung cancer is definitely a very, very attractive indication. We are going to start in second-line lung cancer, but we also believe that we can move to other lines of therapy in lung cancer. We are collecting data as we speak, so it's a bit early days, Peter, without the data to make a decision on which lines of treatment we're going to move forward to. But there's no theoretical reason why it wouldn't work in frontline, basically, when it works so well in second line settings. Then there are a number of other cancers where we are now testing, exploring, 1046. One of them is endometrial cancer. That is a tumor which came up also on the investor call, I think, two weeks ago. And also in that setting, we believe there's a lot of 4-1BB expressing cells in the tumor vicinity, so we believe that that's an excellent tumor also to really explore this concept. But we are in the process, Peter, of testing out that tumor as well as a number of other cancers. I think it's still early days to decide on which tumor to pursue, because we're very much data-driven company, and we actually let the data speak for itself. And, what we really want the, the data to, to be showing us, is that it is really very strongly differentiated further versus other competitors in that, setting. Otherwise, we will kill it. We are not shy away from killing programs, and we have done that, with one of the programs, the CD37 program, in, in, Q3, timeframe. Not because of lack of efficacy, I can assure you, and you will see the data in the future or toxicity, but simply it, actually was comparing less favorably versus other, candidates in the pipeline. Because, Genmab gets a more and more robust, clinical stage, differentiated, pipeline now. So we are going to only focus on the right ones, Peter, and if you allow me to say a bit more about it, the next year will be about the phase IIIs. We will have at least five phase IIIs and at least three indications for at least three molecules, three products, if not more, in the new year. So the next year, we're going to rank order all the programs, and we're going to probably, at the expense of some of the earlier stage programs, we're going to massively expand in the phase III setting in the new year, based on data, based on very solid data. That's exactly what you would want us to do, to build more value basically for the company and to actually bring products closer to cancer patients, 'cause that's what we are going to do in the new year. So just to be clear, that's five phase IIIs for three different programs. Does that... Sorry, does that include EPKINLY or is this, is this- That includes EPKINLY, and as I said, at least a handful, so it's probably more. Then we will take those decisions, Peter, based on the data. Yeah. In the coming months, we will give you further clarity because we are moving towards February the fourteenth. Anthony can speak more about it when we give guidance for- Yeah ... 2024. We will actually make that quite explicit, so that it's clear to investors what, what we're going to do in the new year. And, and I'm thrilled, I'm super excited, as you can potentially see here in London, about the pipeline. I think we have never had a better pipeline than we have right now. The best is yet to come, so hold, hold on. Hold steady here. Right. We'll come to Anthony later for how this is all gonna be paid for, but let's stick with the pipeline for a minute and 1042. So can you just... You mentioned 1042 is obviously the CD40 ligand with 4-1BB, so another bispecific. Perhaps talk a little bit about the data you've seen from that, and I guess how that is positioned or so the early data positions it relative to your excitement for 1046? ... Yeah, GEN1042 is, had a cleaner safety profile from the beginning. We, we thought that was actually a bit easier to manage. Now we know that both bispecifics can actually quite easily be dosed to patients. We saw some monotherapy data in a number of tumors in three or four cancer patients in the early days, already, two years ago, Peter, which we didn't expect because this is a program targeting CD40 and 4-1BB, with very strong preclinical data and activating T-cells. But we knew it would not block the PD-1, PD-L1 axis, which is so dominant in immuno-oncology. So we knew from the beginning that we needed to combine that with a PD-1 axis blocker. And despite that, we saw monotherapy data, which in contrast to GEN1046, Peter, was very long-lasting in some of the patients, which was very, very encouraging. What we have done then is we have actually tested it in lung cancer, in head and neck cancer, and a number of other cancers. We shared some head and neck cancer data last year at ESMO IO, but that was only four patients, but all four basically responded, like, really, really well to GEN1042 plus pembrolizumab at that time. So what we're doing right now is we're now testing further combinations of either 1042 plus pembro or 1046 plus pembro plus chemo, depending on which is the standard of care in four frontline tumors: melanoma, lung cancer, head and neck cancer, and pancreatic cancer. And what I can tell you right now, without sharing further data, is that we have seen in multiple cancers very, very encouraging signals with 1042. We're now doing a bit more dose titration to really get a better feeling for how to approach the regulator in the context of Project Optimus, basically, before we can actually ask for a permission to go forward with late-stage clinical trials. What you can hear from me is, we are very, very excited about the data, and we are eager to share that, and that will come in 2024, Peter. We will share the data at medical conferences for different cohorts of tumors in 2024. So it sounds as though 1046 is a little bit ahead of 1042. 1046, it sounds as though we, you know, we might get some more clarity on phase III plans in December, whereas 1042, you know, it's fair to say that we're gonna have to wait till later in 2024. Is that a fair assessment? No, for 1046, we are definitely... You get some further color- Yeah. Basically on how to develop it. We have already taken the decision together with BioNTech. Yeah, yeah. Remember, it's a 50/50. Yeah. For GEN1042, in the coming months, we'll take the decision. Yeah. We will flag that up to the market, whether it will be in a conference call or whether it will be in a quarterly report, and then you will see the data in 2024. But I think it can be a bit more optimistic about the timing. You said later in 2024, I think it will probably be in the first half of 2024. All right. Very clear. Let's move on to then HexaBody-CD38. Obviously, potentially a, a super Darzalex, if you wanna call it that. Can you talk a little bit about what you've seen so far for that asset, and I guess how we should think about the, the eagerly awaited decision, I guess, from J&J? Yeah. The HexaBody-CD38 has shown some phenomenal data. I mean, we have seen the dose escalation data last year. It's very difficult to draw conclusions on that because many of the patients were underdosed, because it's a dose escalation where you're trying to test out the dose. But still, we have seen some very good responses and also deep responses there. The more meaningful data will be presented this year at ASH, in San Diego in December, where we have actually seen in seven patients, which received at least one cycle of treatment. They were very heavily beaten up patients, at least four lines of prior treatment. They had not seen a CD38 antibody because that was a requirement there. We see 71% response rate on a very low number of patients, but we have seen 14% of the patients with complete responses, so much, much deeper response that you tend to see with daratumumab early on. But the problem is that the daratumumab monotherapy data were, like, more than 10 years ago, and these patients were far less heavily pretreated than the current ones. So what you really want to see, Peter, is the head-to-head data, because then you have basically the same type of patients stratified over either subcu dara or HexaBody-CD38. But the data is, actually very encouraging, and we are excited about that. And, we think that actually Janssen will, take a decision in 2024. The question which comes up in every single investor meeting is: When is Janssen going to have enough data to make that call? Technically, they can wait on all the head-to-head data. I don't know whether Janssen is going to do that. It's up to them to take that decision. But what I hear from them is that CD38 antibodies are going to be the backbone therapy in the foreseeable future for multiple myeloma, combined with literally all the new moieties, the bispecifics, the CAR Ts, the new IMiDs, et cetera, will always be combined with the CD38. What I also know is that Janssen says publicly that in May 2034, they're going to lose the income basically on subcu dara because of either IRA or the patents running out basically at that time, or a combination of those two. So I think when you really believe that CD38 antibody is the backbone therapy for all the combinations, you better switch as quickly as you are convinced that you have a clinically differentiated next generation CD38. You do that as quickly as possible. So I think that they will probably, at some point conclude, Peter, that they have enough data to make a call, basically on yes or no. And but I think the best thing which I could imagine from a Janssen perspective is, that as soon as you're convinced that this is a clinically differentiated molecule versus daratumumab, that you start combining it with all of the new moieties, all of the new molecules as quickly as possible, so you can make it actually the standard of care for the coming years. But that's a call which Janssen needs to make. It will be made in 2024. The timing, I think, depends very much on what they have seen and how many data they want to actually look at, contractually. They have to make that call at some point after we give them all the data, and we are confident now we are on schedule with the recruitment of the head-to-heads, that we can deliver all that data to Janssen in 2024. ... Perhaps then, let's shift to some of the sort of more, I guess, to some extent, financial topics, perhaps starting off, though, with Darzalex. Can we just talk a little bit about... obviously, you know, you get the royalties from J&J on Darzalex. Can we talk a little bit about how Darzalex in terms of the multiple myeloma market, you know, how it's doing in there, in the markets in terms of the penetration in the various different settings, and what's really sort of driving Darzalex growth? Absolutely. I'll let Anthony step in here. Yeah. I mean, as Jan said, we continue to believe that together with Janssen, that Darzalex is absolutely here to stay as a backbone therapy in multiple myeloma. We can see continued growth year-over-year in Q3, around 22%. Continued progression in the sales trajectory, driven by overall market shares, particularly in the front line setting. There, increasingly, we expect Darzalex to be used in the front and second line setting. And there, Peter, we continue to see very strong momentum, as we also see continued development by Janssen, including, as Jan highlighted, with the new modalities, but also with existing standard of care. As you might recall, there are two ongoing phase 3s looking to basically define a quadruplet in front-line multiple myeloma, the so-called Perseus and Cepheus trials. I think Dara is very well positioned today, but moving forward, well positioned to further entrench itself, both with existing standards of care, but also potentially moving forward with these new modalities. And then could you just talk a little bit about how we should think about that royalty income potentially ending or decreasing over time? I guess there's been a lot of debate about this, and it's a focus for investors in terms of, you know, the pipeline developing. So could you elaborate a bit looking forward, how we should think about that royalty towards the end of the decade? Well, Peter, I mean, this is exactly why we've been investing to build out our business over the last number of years, and that starts with what are our core competencies in terms of antibody science, antibody technologies. We made a conscious decision back in 2017 to really double down on that. We looked at our discovery engine and concluded it was an underutilized asset. We've materially scaled up that discovery engine. You can see that now already in terms of the number and maintaining a very high quality of clinical candidates, as well as INDs. We expect that to continue to progress here as we move forward to the middle part of this decade and the end of the decade. You can already see now the transition of our pipeline from being early stage... Think about where we were in 2019, and what the composition of our pipeline was then relative to now, really no mid, late stage programs. Now we have epcoritamab, of course, potentially Tivdak now moving to a new indication, head and neck, late stage development, and GEN1046, and many more to come. So I think we're making important investments, starting with doubling down on our core competence discovery and building out the capabilities to really usher through those programs to mid to late-stage development. And at the same time, importantly, we've made the structural investments in our two core markets, the United States and Japan, meaning that such when those, those products are ready to come to market, we're very well positioned to execute. You can see the early progress we've made, as Jan alluded, with how we've positioned epcoritamab in what is obviously a very competitive market, and we're very pleased with the early returns there in the U.S. Also, we made the decision, Peter, in 2019, and maybe it wasn't a normal decision or usual decision, if you like, to also invest in building out Japan. And think about the timing there in terms of when we're bringing this important therapy epcoritamab to market in Japan relative to the U.S. and Europe. We've really contracted that timeline. So I think we step back, we're building out the team, the capabilities, and importantly, the pipeline, to make sure we're very well positioned when we confront what you referred to in terms of the end of the decade. Okay, and then I guess if we think about the shape of the P&L then next year, and I appreciate, you know, you're obviously not going to tell us, or you... well, you could do- Well, I was, Peter. Now you've said I don't have to, then I'm not going to. Okay. All right. But I guess, you know, just more broadly, I mean, how do you think about in terms of the, the shape of the Genmab P&L, particularly, I guess, R&D spend and, and, you know, how should we think about that evolving over the next few years? Yeah. So let's break R&D down into the two components, R and D. As I've highlighted, research, or let's call it discovery, we've maturely scaled that up over the last number of years. And we're talking, you know, multiples, again, to set us up well here for the middle to the end part of the decade. Moving into 2024, we do expect that investment to moderate a fair amount. You can already see it moderating a little bit in 2023. We expect that investment to further moderate in 2024. For development, here, the swing factor is really gonna be the phase 3s. Here again, the three programs you should be thinking about, EPKINLY. There, we do intend to highlight our more comprehensive CDP. Secondly, GEN1046, potentially moving into a registrational trial, and Tivdak, also potentially moving into a late-stage trial. So there, those are the three that will be the swing factors, but particularly for, for these three programs, you should think about that very much as revenue-generating, potentially, if they're successful trials. This is very clear, defined business cases, and they have cleared, in our minds, a very, very high bar. So that's from R&D. If you, if you let me real quickly on SG&A, and if we break that again into the sales and marketing and then G&A, G&A is absolutely starting to get into a place where that's reaching scale, so we can effectively manage this business and the size and complexity of our business. Sales and marketing, again, we've invested heavily in 2023 to build out the U.S. and Japanese markets. Next year, what you're gonna see is a little bit of the annualization impact based upon the timing of the launches. Epcoritamab launch in the U.S. was in May, so we're gonna have an annualization impact during 2024. Potentially, the epkinly launch in Japan will come here in November or December, so a little bit more of an annualization impact in 2024. But, and then the final point I would be make is around that increased prioritization. As we move forward, we're really are gonna prioritize late stage development and ensure that anything we move forward is absolutely clearing a very high bar. Perhaps then in the minute or so left, you, Jan, just bigger picture, I think the other thing that's happened this year for Genmab is you've moved beyond oncology. You've done a deal, you know, with argenx, and you talked about, you know, immunology. Could you just talk a little bit about the sort of way we should think about this for Genmab's evolving future? Absolutely. It's our second focus area. We are super excited about that. We know that immunology and inflammation is an area where antibody therapies have made a big difference already, and where we feel that with our new platforms, with our next-generation platforms, we can actually build much better differentiated therapies. We're already working on a number of programs internally, Peter, and on top of that, we now added several programs with argenx. I can tell you that originally we started on two programs. We've now added another program in that collaboration. That's, again, 50/50. We believe in this concept to work with very strong partners and actually bring in your own expertise. Argenx can actually get access to our technology suite of technologies. We can access, actually get access to their suite of technologies to really work on programs, but they all will be 50/50 partners. So this will be definitely, I think, very, very impactful for the future. We're super excited about that interaction, so as we are excited about the BioNTech interaction already set. Well, very soon we have six programs in the clinic with BioNTech. The argenx ones will be lagging a bit behind that, but are making very, very good momentum as we speak, Peter. And we think combining the qualities of very strong players with different levels of expertise is a really, really smart, I think, plan for the future to create better medicines and bring them to patients more effectively. That's great. With that, we've run out of time. Thank you very much, Jan and Anthony. Thank you all for attending. We'll close the session here.