Genmab A/S (GMAB) Earnings Call Transcript & Summary
June 9, 2025
Earnings Call Speaker Segments
Rajan Sharma
analystOkay. Good morning, everyone. Thank you for joining day 1 session of the conference this year. Pleased to have Anthony Pagano from Genmab with us. Anthony, thank you for joining.
Anthony Pagano
executiveYes. Great. Great to be here today, Rajan. Thanks for having us back at the conference here today and look forward to having a great discussion with you.
Rajan Sharma
analystYes, sure. So do you want to maybe just kick off by making a few introductory remarks?
Anthony Pagano
executiveYes, that would be great. And I appreciate the opportunity to kind of set the stage and then dive into your questions. As I kind of reflect on Genmab at the moment, really what stands out for me is us coming off a very strong Q1 and a very strong ASCO. And then you sort of think about what's driving that positive momentum and that strength in the ASCO in the Q1. For me, it really starts with the super strong foundation that we've built out over the last number of years, and that's really across our entire business. And it starts with the team. Think about the team that we've built and how they've been both executing and delivering. Think about on the development side, how we've been really been able to put our foot on the gas pedal around epcoritamab, and how we're very well poised to do that again for Rina-S. And you're looking at potential first-in-human potential approval at record speed. So that development team is really executing. Likewise, from a commercial perspective, look at how that team is executing and in many cases, winning in the marketplace against very fierce competition. So the strong foundation starts with the team. Of course, it extends through to the technologies. Of course, you all know HexaBody and DuoBody. We've added on to that with the acquisition of ProfoundBio and the ADC platform. So super strong technology pipeline, 10 assets in the clinic. I'm sure we're going to do a deeper dive there across a number of those. And of course, the financials, very strong start to the year, 19% revenue growth, 62% operating income growth. And it's really that super strong foundation that creates our future growth opportunities. So that foundation allows us to execute today and create those strong growth opportunities moving forward. And really at the beginning of the year, in more concrete terms, we outlined for all of you what those growth opportunities look like moving forward, particularly around at EPKINLY, Rina-S and acasunlimab. We outlined how we're going to create value for patients and also drive revenues moving forward. And think about the progress that we've made so far this year. At the beginning of the year, for EPKINLY, where we outlined the potential $3 billion peak sales opportunity, we outlined the 5 Phase III trials that are going to drive that revenue in the future. And we also outlined that 3 of those 5 Phase IIIs will read out between now and the end of 2026. And excitingly, in May, we had the first Phase III readout in second-line FL and have already filed that. It goes back to us outlining that framework and then actually delivering on that promise and then executing very quickly in terms of getting that filing done. So more to come for EPKINLY. Rina-S, again, made substantial progress. At the beginning of the year, we outlined that this is a potential $2 billion-plus peak sales opportunity. And we outlined the building blocks there. And look at where we're at today and where we're going to be at by the end of 2025. We have an ongoing Phase III and second-line plus PROC. We have then 2 additional Phase IIIs that are planned to start by the end of 2025 in terms of second-line plus endometrial and the PSOC trial as well. And as a reminder, in addition to the Phase IIIs, there are 2 potential accelerated approval opportunities, one in PROC and one in endometrial. And then last but not least, in terms of acasunlimab, very excited there about the potential -- of that potential product and sharing more data in the later part of this year. So if we start to step back and just look again at that very strong foundation that allows us not only to execute and deliver today, but that strong foundation is really the engine that will create these future growth opportunities moving forward. And when those growth opportunities emerge, allow us to actually realize their full potential. So I think Genmab is in a super strong foundation -- a super strong position and a great start to the year with the Q1 results as well as a very strong ASCO, where we rarely there at ASCO to really round things out. We're able to present some very exciting data, particularly in second-line plus endometrial cancer. With that, maybe we dive into your questions.
Rajan Sharma
analystYes, sure. And we'll get into the pipeline and the micro as we talked about that. But just maybe just kind of starting out on a -- from a sector perspective and a macro where there's been a lot of focus recently. Can you just maybe talk about potential implications of tariffs on the sector if they are applied and sort of how you're thinking about mitigating any potential effect?
Anthony Pagano
executiveYes. So I think as you kind of enter in any discussions along these lines, Rajan, I think it's important to always remind ourselves why we are here at Genmab or why we are here as an industry, and that's to help patients. That is our first and foremost goal. And our job is to make sure that we have all of the tools in place to do just that, and that's what we stay laser sharp focused on every day as we make up making sure we're really going as fast as possible to bring important medicines to patients. And that's what we have to be grounded in. There's always going to be potential risks out there, whether it be the things that you're talking about or others that may emerge. And our job as an industry and people that are running a business like Genmab is to evaluate those risks, look for potential opportunities to mitigate them and then think about how we exactly want to do that. And that's what we're focused on here at Genmab is really applying all of the tools that we have to deliver breakthrough therapies to patients. And then as potential risks emerge, think about how we can potentially mitigate those. As a matter of just sort of maybe more directly answer your question now, we're not going to get into speculation. There's -- until some -- we have actually a real firm policy out there, we're not going to get into speculation what this may or may not mean for our business. But rest assured, we have a team in place that's evaluating all the potential risks for our business including these and coming up with potential mitigation strategies.
Rajan Sharma
analystOkay. So maybe we'll switch gears then to EPKINLY. So obviously, you talked about it's been a pretty encouraging start. How would you kind of characterize the success of the launch relative to your initial internal expectation?
Anthony Pagano
executiveSo I think as you think about EPKINLY or more broadly, our journey or evolution from a, let's call it, a development sort of stage biotech to a company that's actually commercializing its own medicines, this didn't happen overnight. We actually started thinking about this more than a decade ago and then really started in earnest planning and building out the team as we got into the 2019, 2020 time frame. And we started making important investments then that are now paying a dividend. This was building out the U.S. market in the first instance and building out our Japanese market and being very thoughtful about what kind of resources and what level of resources we wanted to deploy. As we started thinking more particularly about building out the team and the resources and everything that you need to launch a product for EPKINLY, we had an eye towards this not being a third-line plus product. We have an eye that this is a product that can make a meaningful difference for patients, ultimately get into second line, ultimately get into frontline and also acknowledging that there was fierce competition. So again, this was a thoughtful multiyear build, and we can see it now paying dividends. So I think the success that we're enjoying today, of course, it starts with the product characteristics that EPKINLY enjoys, and we can dive into those. But it really is also a function of the team and the overall resources we put in place over a number of years to make sure that we were positioned for success when EPKINLY was launched.
Rajan Sharma
analystOkay. And then you kind of talked about laying at the top of the session, you kind of talked about earlier in the year, how you laid out the opportunity for EPKINLY. Can you maybe just sort of build the blocks as to how this gets to where your guidance is, how this becomes a multibillion product? What are the key trials that we should be focusing on?
Anthony Pagano
executiveYes. So right now, EPKINLY, as everyone knows, is in the market and approved in many countries for third-line plus DLBCL and third-line plus follicular lymphoma. And that's driving the business that we see today, helping those patients and driving the revenues today. In addition to that, there are 5 ongoing Phase III trials that will read out between -- well, 3 of those 5 will read out between now and the end of 2026. Of course, the major building block there is the frontline DLBCL trial. Again, that fits within that time frame. And we look very much to seeing that. We also have the second-line plus follicular lymphoma. Again, that read out earlier this year and remind everybody that data has already been filed with the FDA. So those are the major building blocks I would highlight.
Rajan Sharma
analystAnd you pointed out that the second-line follicular trial read out earlier than expected. Is there any possibility that the DLBCL trials could be earlier than expectations?
Anthony Pagano
executiveYes. Well, we're going to stick to our guidance, Rajan. We said between now and the end of 2026, when I'm in a position or Genmab's in a position to provide more refined thinking around time lines, if at all, that's when we would do that. As everyone knows, this is an event driven trial. So we are dependent upon the events occurring.
Rajan Sharma
analystOkay. And then there was obviously your competitor at Roche, they had a negative ODAC opinion. Could you maybe just talk about EPKINLY's potential approval in the same setting and how confident you are there?
Anthony Pagano
executiveWell, look, we've built out the overall development program for EPKINLY thoughtfully with our partner over the number of years. These trials, these 5 Phase IIIs are now in a very good position to start reading out as I've highlighted. And all I can say is those trials were thought out carefully. Obviously, in any trial, there's inherent risk, but those trials were thought out carefully, and we look forward to seeing the data when they're ultimately released. And I'm not going to get into commenting on Roche's ODAC.
Rajan Sharma
analystOkay. Okay, cool. Maybe we'll come back to EPKINLY, but also I need to touch on Rina-S just given the recency of the ASCO data. So again, could you -- I know when you sort of talked into the event, we talked about a bar for the data on response rates of around 10% to 15%. You obviously came in much stronger than that. How does that change perception of Rina-S and what the potential of the asset is?
Anthony Pagano
executiveSo when we looked at potentially acquiring Rina-S, our hypothesis was that this is a Phase III-ready asset. And this product had the potential to treat patients regardless of folate receptor alpha expression levels. And so far, that hypothesis is really proving out. Still early days, but we've been able to demonstrate and put our foot in the gas pedal by starting these Phase IIIs, planning more as well as the data we're seeing, both in PROC, platinum-resistant ovarian cancer as well as second-line plus endometrial cancer, we're seeing this hypothesis prove out there as well. We're able to treat patients and help patients, again, early days, small patient numbers regardless of folate receptor alpha expression levels and doing that while maintaining a very -- relatively speaking, very high response rate in both tumor settings. So on one hand, this is very encouraging and maybe to the market a bit of an upside surprise. But for us, it's delivering on what we thought we were getting when we bought -- basically, our hypothesis is being proven out as we move forward. And I think we shouldn't forget obviously, response rate in terms of the number of patients you can help is very, very important. However, what's even maybe as important or more important is that duration of response. And there, the data we've been able to present so far, particularly in PROC is very encouraging, what we're seeing in terms of the duration of response. So not only are you helping more patients at a higher rate, you're also then helping them for longer. So there's actually 3 potential tiers to the benefit -- or the relative benefit that Rina-S is able to provide for patients. And for me, that's super exciting as potentially delivering on all the promise and hope when we acquired the product only over 1 year ago.
Rajan Sharma
analystAnd then could you just remind us on timing then. So as you said, the 2 Phase IIIs are ongoing. When should we be looking at Phase III data and first launch?
Anthony Pagano
executiveSo again, I think -- the other thing about the evolution of Genmab is it goes back to the team and the execution. When we acquired Rina-S, we said that we're potentially going to get this to market, first approval in 2027, and that remains the case here today. We're absolutely on track to do that whether it be through the Phase II accelerated approval or the Phase III. Both potentially could drive that result in terms of the first approval in 2027. So absolutely remain on track to deliver just that, and that would come from PROC.
Rajan Sharma
analystYes. And then if you go down the accelerated approval path, do you have alignment with the FDA and what kind of response rate will be required?
Anthony Pagano
executiveOverall, it's going to be data dependent. I mean there are -- it's going to be data dependent. Certainly, we've had discussions with the FDA, but it's actually going to be data dependent that will be a function of response rate and duration.
Rajan Sharma
analystOkay. Okay. And then in terms of next data updates, what should -- when should we expect that from a presentation perspective?
Anthony Pagano
executiveSo we maybe to set the scene here a little bit. We presented some really nice response rate data for PROC at the back half of last year, provided the duration data earlier this year, and we're looking for a potential update to that data, whether it be in the back half of this year or early next year.
Rajan Sharma
analystOkay. And that would be -- would that be more patients or just longer exposure?
Anthony Pagano
executiveLonger exposure. Really the idea was to put our foot on the gas pedal here, really finish out that -- of course, we did the dose expansion work that's sort of now locked in terms of patient numbers. Now the idea is putting all the patients into the potentially pivotal Phase II.
Rajan Sharma
analystYes. And then maybe if we just kind of think about the competitive landscape in the folate receptor alpha space, there's a few other ADCs in development, one approved. How do you think about the differentiation of Rina-S from a technological perspective? Is there something different on the -- in the ADC that means it's differentiated relative to ELAHERE, for example, or we saw some data from [ Lilly ] at ASCO as well.
Anthony Pagano
executiveSo I think about -- we've talked about our product and Rina-S. And we -- again, one of our hypothesis when we bought the product was this a potential best-in-class. And now a year plus later, we think in our minds, that is proving out that, that potential is there and where our job is to actually realize that potential. Now what's driving that? And really, you think about ultimately what is an ADC drug trying to do is trying to deliver chemo to the tumor. So that's a function of really how much chemo you can deliver and what's the strength of that chemo? And we think with the characteristics of Rina-S in particular, we're able to deliver a lot of chemo, the DAR of 8 and a super strong chemo. So I think that is ultimately one of the reasons we're seeing this very nice effect and benefit for patients. Now what is that benefit? I spoke about it earlier. Relative to existing competition, we're able to help potentially write more patients. We're able to help them at a higher rate, higher response rate. And then third, we're able to potentially drive a duration of response that is significantly longer. So there are, again, 3 tiers to that potential benefit of Rina-S relative to existing competition. Now in terms of future competition, I think we are ahead in many respects. And then our job, again, is to put the foot on the gas pedal to go as fast and as broad as we can. And that brings me back to what I said earlier, having the right team in place to do adjust that. So I think we have a product with the characteristics to potentially be best-in-class, and we absolutely have the right team to exploit that product characteristics.
Rajan Sharma
analystOkay. And then there's obviously -- you've talked about potential of Rina-S and opportunities outside of ovarian cancer, outside of endometrial cancer. We've seen some of the data where it looks like there's good levels of folate receptor expression. Can you maybe just talk to some of the other indications where the asset may have some utility?
Anthony Pagano
executiveYes. So I think, again, it goes back to the product characteristics of Rina-S. And given the very -- the way we're able to deliver the chemo to the tumor via this product, it means that, ultimately, we're able to help patients with lower levels of folate receptor alpha expression levels, which then potentially opens up the field for future indications. So in our first order, we're super focused in ovarian cancer and endometrial cancer. And there, we already have ongoing Phase III work. And there's probably more to come there as we move forward. Now given the product characteristics, it's absolutely incumbent upon us to look for expansion opportunities. So that's exactly what we're doing. And we're starting off with non-small cell lung cancer. And of course, we keep our eye open for additional opportunities moving forward. In the first order, this expansion work or this work, this Phase II trial that we announced over a week ago is a signal-seeking study. And the idea here is to really get Rina-S in the non-small cell lung cancer setting into the appropriate centers of care and sites, really specialists to really do the proper evaluation of the product in that setting.
Rajan Sharma
analystYes. And then obviously, it's relatively recently since you announced or at least disclosed the Phase II trial in non-small cell lung cancer. So can we just kind of run through a few details there? Is that going to be enriched for folate receptor expression?
Anthony Pagano
executiveI think the idea initially is that this is going to be an all-comers trial.
Rajan Sharma
analystOkay. And it won't be in any specific driver mutation?
Anthony Pagano
executiveNo. For the start-up -- well, I think initially, it's going to be in the EGFR mutated.
Rajan Sharma
analystOkay. Okay. And then maybe just in that setting, again, there's a competitive development space that exists in second-line non-small cell lung cancer, including in the EGFR, you've got the TROP-2 ADCs, for example. How do you think Rina-S could compare there?
Anthony Pagano
executiveWell, look, I think that's why we're going to do the trial. I mean you could have said the same thing about Rina-S potentially in ovarian cancer. You could have said the same thing about Rina-S in endometrial cancer. So far, we've shown a product that is really standing out. The reception at ASCO was very, very strong for Rina-S in endometrial. There was probably some maybe some skepticism from some going into that about what the actual product would look like. And I think we've demonstrated, at least in endometrial that it's, at least for now, really separating itself from the potential competition. No promise there that we can do the same in non-small cell lung cancer. But given the product characteristics, this is an investment that Genmab should absolutely be making to see if we can expand the opportunity, and that's exactly what we're going to do. So more to come, but I think so far, Rina-S is demonstrating some very encouraging activity across the board. Again, why is that? It goes back to the linker enabling us to deliver a lot of chemo and a very strong chemo.
Rajan Sharma
analystOkay. And the Phase I data to support the initiation of the Phase II that's from the basket trial, right?
Anthony Pagano
executiveYes. So I think the logic for us going into this trial is a function of the totality of the data we've seen regardless of tumor type. So it's not just the small number of patients in that basket trial. It's really looking at the totality of patients that we've dosed so far with Rina-S and how they're responding to the drug. Now again, part of drug development is really making -- you're setting up your drug for success. And that's a function of many things, but it also includes running the exact proper trial. And that's why the team is focused on running this Phase II trial, stand-alone Phase II trial, and that's going to be focused on really getting the right sites up proper sites to evaluate Rina-S in that setting.
Rajan Sharma
analystOkay. And when will we see the Phase I data from basket trial?
Anthony Pagano
executiveI don't think we've committed yet. We'll have to wait and see. I wouldn't take a lot from that trial. It's going to be a very, very small number of patients, dose escalation. I think really what you're going to be doing is waiting for the Phase II data from this new trial that just to be initiated.
Rajan Sharma
analystYes. And then the -- we'll talk acasunlimab in a moment as well, but obviously, that's second-line non-small cell lung cancer. So there's an overlapping patient population here. Is that fair? And could both of these assets actually coexist?
Anthony Pagano
executiveWell, I think for 1046. I still call it 1046 or DuoBody-PD-L1x4-1BB, acasunlimab, probably in order of ease of saying the names, that's a nondriver mutated. So I think these are 2 potential shots on goal to help patients in second-line plus lung cancer, still a very, very underserved patient population. And as -- look, I mean, if we're not going to go after this with an ADC approach, we know that others are. So I think you kind of get this overlapping question once in a while. To me, if you have a product that potentially works in a setting, you should at least do some clinical work to evaluate if it's really going to provide a benefit for patients because if you don't do it, I'm pretty sure that somebody else will. [indiscernible] coming back to the competition you see in the space at the moment.
Rajan Sharma
analystAnd you talked about the strength of the efficacy dates around ASCO. I guess one of the very small niggles that came out was potentially the neutropenia profile of Rina-S. How confident are you there? And what's been the feedback from physicians and PIs on the trial?
Anthony Pagano
executiveOverall, we feel that it's very manageable. And the feedback, whether it be in ad boards or from people exactly on the trial has been positive. And overall, this is manageable and no real concerns as we think about putting this now into the Phase III setting. Overall, I think that the kind of the risk benefit profile is very clear in terms of the benefit of this product, and that's both in endometrial as well as in PROC. Of course, any safety considerations are important. And the team looks for ways to try to mitigate this.
Rajan Sharma
analystOkay. And then just to wrap on Rina-S. So you have guidance of $2 billion as a potential opportunity. Can you just kind of walk us through the building blocks of that? Is that ovarian and endometrial and anything beyond that would be upside?
Anthony Pagano
executiveCorrect. So right now, the $2 billion is a peak sales estimate. Again, you should think about the context of that $2 billion when we acquired Rina-S. Initially, we said $1 billion. And based upon the strength of the data and us executing against the development plan in one short year, we've upgraded that guidance to $2 billion. But you're correct, that's a function of ovarian cancer as well as endometrial cancer. So anything on top of that would be potential upside, but I think let's not get the cart in front of the horse. Let's get the actual signal from indications outside of the gynecological oncology space, and then we can reevaluate potential forecasts.
Rajan Sharma
analystSounds good. And maybe just staying with lung cancer, and we could touch on acasunlimab. And I think on this one, most investors that we see seem to think of this as kind of a high-risk trials, high-risk development path and have potentially have limited value for it in the model. Is that the right way of thinking about it?
Anthony Pagano
executiveWell, I mean, obviously, we're running the Phase III trial. So if I said, yes, I would be sort of talking against my own -- our own strategy. So look, we're very encouraged with the data that we saw last year at ASCO. At that point, we showed -- I think 174, 17.5 months of overall survival benefit. That compares very well to existing standard of care, which is kind of in the 10-, 11-, 12-month range. So a significant improvement. We'll have additional data later this year. And if that signal were to hold up in that ballpark, we think this is a potential meaningful product for patients in that second-line plus lung cancer setting, which again is a very underserved patient population. So ultimately, this is -- the data will speak for itself. We think so far the data we presented is quite compelling. We hear and understand some of the pushback and feedback. And again, we'll have more data in the second half of this year.
Rajan Sharma
analystOkay. And then just in terms of evolving standard of care in the front line if, for example, the PD-L1 or PD-1 VEGF bispecifics were to become a new standard of care in first-line non-small cell lung cancer, do you think that this trial that's set up for acasunlimab is insulated that they could -- it still could be used in a second-line setting?
Anthony Pagano
executiveWell, I think first of all, that has also to be proven out, but we think this is a different mechanism of action. The 1046 program or acasunlimab is really meant to enhance and unleash the power of 4-1BB. So we think that this could still have a role in second-line plus setting regardless of what standard of care in frontline.
Rajan Sharma
analystOkay. And then on the 4-1BB topic, maybe that's a segue to 1042. When can we expect the update there? Because that's sort of been one of these areas where we've been expecting an update on a development path. And is that still coming this year?
Anthony Pagano
executiveYes. That's absolutely what we're focused on doing with 1042. That acknowledge has taken a little bit longer, but sometimes that's how it is in drug development. There are certain products, whether it be EPKINLY, Rina-S, there you're dealing more with direct cell kill broadly speaking. You kind of get an answer quicker. And there, we've been able to put our foot on the gas pedal. With 1042, we've taken more of a step-wise approach. And that's what we continue to do, and we'll provide an update in the second half of this year.
Rajan Sharma
analystOkay. And what is it exactly that you're looking for in terms of making that decision on a go or no-go basis?
Anthony Pagano
executiveI think it's -- there's nothing unique there for 1042 when you're looking to -- an important point in drug development is transitioning from, let's call it, early or mid-stage to late stage. As you make that transition, there are important [ consent ] release around the financial investment that is required. You're starting potentially then a later-stage trial. You're really been unleashing significant manufacturing investments. So that's a very important decision, not just for 1042 or for any product. So when you do that, you're going to look at the actual product, the potential risk benefit, what benefits can provide for patients. You're going to look at it compared to your own pipeline. And different trade-off decisions you may or may not want to make and then you're going to look at the external environment. So the thought process around 1042 won't be any different as for any product that we want to put forward into late-stage development. It's a very important decision, and it's a decision that we don't take lightly at all. As to remind everybody in terms of Genmab really being focused on prioritization as part of our Q3 earnings last year would have been in November, we had some pretty compelling data for Tivdak in head and neck cancer, second-line plus setting and made a decision not to move forward. And it was the same thought process that I just outlined there. Now there should be no read across to 1042. I'm just trying to walk everybody through the thought process around how you make that decision to potentially make a significant investment in a late-stage program.
Rajan Sharma
analystOkay. And maybe on that topic of investments, can we talk about BD M&A.? It's obviously an area that you've had some success with Rina-S and Profound. It's an area of focus as you've outlined in your capital priorities. Could you just outline what your -- what the focus would be from a Genmab perspective?
Anthony Pagano
executiveYes. I mean if we think about our capital allocation framework, number one is investing back into our business, and we've outlined how we're doing that, particularly around Rina-S, EPKINLY and acasunlimab and also continuing to invest in our commercial capabilities to drive revenues today and set us up for tomorrow. Now moving forward in terms of future growth opportunities from that earlier stage pipeline, I'm fully confident that there will be more products that get into that late-stage category. I'm also confident in terms of Rina-S and EPKINLY in particular, that there'll be more Phase III trials moving forward. So that first platform in terms of investing back in our business will be a function of more for Rina-S, more for EPKINLY and another product transitioning from earlier mid- to late-stage development. The second priority in terms of capital allocation is looking at external opportunities. Now you're right, Rajan, we've done -- I think the team did an excellent job in terms of identifying ProfoundBio, particularly Rina-S, evaluating, transacting, and now really being very good owners of that asset, Rina-S, in particular. Now moving forward, we're looking for assets along the same lines of Rina-S, to be very clear. These are potential either Phase III or Phase III-ready assets and/or later stage than that and really looking for something that is -- that where we can be very, very good evaluators of it and then ultimately very good owner. So the way to sort of headline the way to think about it is something that looks very similar to Rina-S. We can be very good evaluators and ultimately very good owners and drive benefit for patients and then of course, for all of our stakeholders.
Rajan Sharma
analystOkay. And then in terms of modality, is there a focus here in terms of specific -- I think oncology is clearly the place and you've talked about that, Jan talked about that in the past as well. But from a modality perspective, are you agnostic?
Anthony Pagano
executiveAgain, I think the overall framework is being very good evaluators. Okay, that's simple evaluators. What does that mean? Also, what are your capabilities? Our capabilities right now are obviously in antibodies. No one's going to question that in oncology. And there in oncology, you could look at where we built up expertise in the gynecological oncology space, in certain blood cancers as well. So obviously, we have a bias towards antibodies. But for the right opportunity, I think we could probably open up the aperture a bit.
Rajan Sharma
analystOkay. And then in the last couple of minutes, I just want you to kind of talk about long-term trajectory. So obviously, you have the LOE for DARZALEX coming that we will know before the end of the decade. How do you think about profitability through that period? Is there a scenario in which you could grow or keep EBIT flat?
Anthony Pagano
executiveGreat question, Rajan. So where do profits come from? Profits come from revenue, right? Of course, we all know that we are going to lose DARZALEX. This is not a surprise. We've been planning for this some time. This is one of the reasons we started to scale up our research and discovery engine a number of years ago to build out the pipeline further. Think about it now, we have 10 products in clinical development. So again, first thing to think about, this is not new, we've been planning for this. Second [indiscernible] made in my comments, where the profits come from, they come from revenues. We've outlined our overall revenue projections for the 3 lead assets, $3 billion plus for EPKINLY $2 billion plus for Rina-S and $1 billion for acasunlimab. Now for those 3 programs, particularly Rina-S and EPKINLY, I think we can do more, more Phase IIIs to drive that revenue hopefully up higher. You gave the example of potentially getting outside of the gynecological oncology space for Rina-S as being one idea, for EPKINLY, one idea could be getting into, say, CLL for example. So I think we can do a lot more with those 3 assets. We can also do more in terms of putting our own products into late-stage development, and we'll do that. So the first order is the revenue being there, revenue looks very, very strong from the Genmab pipeline. Transitioning to revenue also in terms of the royalty medicines, we don't just have DARZALEX, right? There are 6 royalty medicines today, meaning there's another 5 products that we currently are enjoying revenue from. Those are going to be growing as we exit this period based upon most projections. And there are 2 additional programs that are either in Phase III. These are royalty medicines or already with the FDA or be at the FDA soon for potential review and approval. So that royalty business can also help us grow. Now as we think about the revenues being there, nice profile for there, both from our products as well as royalty medicines. And ultimately, your question on profitability, I think what we've demonstrated more recently is us delivering on our financial commitments, increasingly focused on prioritization and increasingly focused on realizing the important scale benefits that are in front of us. So I'm not going to give you revenue guidance today like beyond what I've already done or profitability guidance. But rest assured, we are focused on driving this business the right way in terms of driving revenues. And then secondly, we do have an eye towards how we're actually running the business in terms of profitability as well.
Rajan Sharma
analystPerfect. I think we're out of time. So thank you very much, Anthony.
Anthony Pagano
executiveThank you very much. Pleasure to be here with you today. Thank you again.
This call discussed
For developers and AI pipelines
Programmatic access to Genmab A/S earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.