Genmab A/S (GMAB) Earnings Call Transcript & Summary
September 23, 2025
Earnings Call Speaker Segments
Sachin Jain
AnalystsThank you so much for joining. My pleasure to be hosting Anthony Pagano, CFO of Genmab. We have 40 minutes. I think, Anthony will make some introductory comments, and then we'll get into questions. Anthony, with pleasure, over to you.
Anthony Pagano
ExecutivesGreat. Thank you. Pleasure to be back at the conference today, Sachin. Pleasure to have a chance to catch up with you and all of the investors today. As we sit here in September of 2025, and just reflecting on the progress in the first 8-plus months of the year, I think we've been off to a remarkable start. If we think about our -- 2 of our late-stage programs, EPKINLY and Rina-S, we're very excited about the emerging target product profiles that we see, the prospects moving forward, in particular, for each of these programs, we've seen some pretty meaningful and important and exciting data so far this year. With Rina-S, we saw some very strong, let's call it, proof-of-concept data, both in endometrial -- second-line endometrial cancer, as well as platinum-resistant ovarian cancer. And some more data sets, at least one more data set in endometrial here at ESMO moving forward. I think what's emerging is a highly compelling product profile along multiple dimensions, whether it's activity across different expression levels, response rate, duration of response as well as the safety profile. I think moving forward with Rina-S, there's a lot to be excited about, particularly as we look forward to 2026, we see clear line of sight to the first registration -- potentially registrational data with the Phase II trial in platinum-resistant ovarian cancer. So a strong start to the year for Rina-S. Likewise, for EPKINLY, both here, it's not only the development, but also the commercialization has gone rather well with the strong H1 performance, continuing to compete very effectively in the market. And excitingly, from a development perspective for EPKINLY, we saw the first positive Phase III of EPKINLY in combination. Here, it was in second-line follicular lymphoma, very exciting data that we saw with a hazard ratio of 0.21 or 79% risk reduction in terms of PFS. So what again appears to be emerging is a very strong product profile for EPKINLY. I look forward to sharing that data, hopefully, at ASH. We've submitted for presentation there. And moving forward for EPKINLY, I think about further, let's call it, derisking or value creation could come next year when we expect the next Phase III in terms of the frontline DLBCL readout. So from a product perspective, very strong start our first 8 months of the year. On the financials, again, continue to execute here as well, very strong H1 results from a top line perspective as well as on the bottom line. That resulted in a guidance upgrade of about $100 million at the midpoint for our guidance. So very strong start to 2025, looking forward to some additional positive momentum at the balance of the year. And I think we're set up very well as we move forward into 2026 and beyond. So maybe with that, we could just sort of see where we want to go, Sachin.
Sachin Jain
AnalystsYes. Perfect. I'm going to start really big picture for me. So we were just talking about it, but you've started this year in providing sort of a roadmap with peak sales for the various assets and sort of the indication breakdown. Perhaps you could just kick off with what you've said on Rina-S, what you said on EPKINLY, what you said on acasunlimab, and how that sort of bridges the world post DARZALEX?
Anthony Pagano
ExecutivesYes. So if you think about our business and our capital allocation framework, a key part of that in terms of priority #1 is investing back into our business. And we've been doing that not only in 2025, but over the last number of years. And what that's resulted in here is clear line of sight in our minds for very meaningful opportunities for EPKINLY, Rina-S and acasunlimab. Now let's take it -- go one by one. For EPKINLY, we put out their peak year sales guidance of $3 billion. Now initially here so far in H1 to kind of say where we are today, we did around $211 million. So where is this going to come from in terms of getting to that $3 billion peak year sales target? It's going to come from the 5 ongoing Phase IIIs for EPKINLY with 3 of those expected to read out between now and the end of 2026. The first one just happened with follicular lymphoma. Again, we talked about the spectacular data there. The PDUFA date with the FDA is November 30. So that will be a nice big sort of step forward in terms of showing the utility of EPKINLY. The next big one for EPKINLY would be the frontline DLBCL. This is EPKINLY in combination with R-CHOP. Rough order of magnitude in terms of the total addressable patient population, the frontline DLBCL represents around 70,000 patients, which is broadly speaking, around half of the total addressable market for EPKINLY. So a very important data set to come out sometime between now and the end of 2026. And then beyond the second-line follicular lymphoma, frontline DLBCL, there's a number of trials that will read out in 2026 and beyond, that will further provide the evidence towards that $3 billion peak year sales guidance. So I think so far, if we kind of step back for EPKINLY, what we're seeing is very, very strong execution from a development perspective, we started several years behind the competition. We ultimately got from first patient, first dose of EPKINLY in July of 2018, to first approval in May of 2023. That's less than 5 years. It's rather fast. We're able through focused development together with our partner, AbbVie, really accelerate the second-line FL. And right now, we like the overall trajectory of the frontline DLBCL. On the commercialization side, again, we think we're -- how we're competing today against the competition sets us up very well as these additional indications come online. So EPKINLY, $3 billion, very strong progress from a development and commercialization perspective. Rina-S. There, we put out peak year sales guidance of $2 billion. Now let's compare and contrast to what we said at the time we announced the deal, we said $1 billion. So we've been able to upgrade that or double that since the time of the acquisition. And this is a function of 2 things. One, the emerging target product profile is highly, highly compelling. What we're seeing across efficacy, utility across expression levels, duration safety, that coupled with the speed and the breadth of the development program allowed us to take that peak year sales number from $1 billion to $2 billion. Again, if you think about the speed of development, I think there's a reasonable chance going back to that 5-year number, first patient, first dose for EPKINLY, I think there's a reasonable chance, we'll be able to be in that kind of same range for Rina-S. And again, this doesn't happened by accident. This is really having a -- really compelling product profile but then focused execution. So speed is, I think, a key factor here. In terms of that $2 billion peak year sales number, really, that is in the gynecological oncology space, particularly second-line PROC, second-line endometrial, second-line platinum-sensitive ovarian cancer, and frontline endometrial. We think there's a potential to do more in the gynecological oncology space. And again, for that, the first derisker from a pivotal trial readout perspective will come hopefully in 2026, where you're going to have the second-line PROC data. Maybe briefly to profile Rina-S for you just a bit more. When we started the program, Sachin, we acquired it from ProfoundBio. At that time, we had roughly speaking, 40 patients worth of data. We're going to exit this year with 3 ongoing Phase IIIs, and 2 potentially registrational Phase IIs. And I think more to come in GynOnc in terms of additional Phase IIIs as we get into 2026 and beyond. Last but not least, we have acasunlimab. There, we put up the $1 billion sales target. Here, we have the ongoing Phase III in the second-line plus non-small cell lung cancer. We'll have additional data in the back half of this year around that program. So I think we step back, we have 3 exciting programs really focused on executing there from a development and setting up the commercialization efforts as well.
Sachin Jain
AnalystsPerfect. So I'll do them in order of peak sales size then. So EPKINLY, just again, right back to [indiscernible]. So you said half of the opportunity, $3 billion was for the frontline DLBCL. If you could just remind us what percentage is the existing launch indication to third-line FL and like how much second-line FL is adding? I'm trying to get a sense of -- perhaps you don't get enough focus on kidney because it's initially niche indications, but the big one is around the corner. So I'm trying to get a sense of...
Anthony Pagano
ExecutivesYes. I mean, back of the envelope rough math here in the major markets, U.S., major markets in Europe and Japan, the total addressable patient population is around 146,000, 150,000. Existing indications are around 18,000. Second-line FL, 9,000, so smaller. Frontline DLBCL represents around 70,000 patients. So this could be, if successful, a bit of a step change for the product. To kind of level set expectations, the second-line FL data that we've announced the top line results, I mean, highly, highly exciting and interesting, right? You don't often see a risk reduction of 79% in PFS. It's really unprecedented in this setting. We have to be mindful, though, that this is only 9,000 patients. So you should not be expecting a hockey stick as you get into 2026. Of course, it should be additive if it's approved. But hopefully, the big step change would come from frontline DLBCL.
Sachin Jain
AnalystsAnd then on to frontline DLBCL, what have you said on timing of that Phase III?
Anthony Pagano
ExecutivesSo at the beginning of the year, we outlined this framework, we said we expected 3 Phase IIIs which frontline DLBCL is part of that to read out between now and the end of 2026. So if they want to get to a point where we can refine that guidance, we'll do so. But for now, we should take it between now and the end of 2026.
Sachin Jain
AnalystsSo I'm not asking you to do this in third quarter or full year, but roughly, when are you thinking about giving the market better visibility on the timing of that data set?
Anthony Pagano
ExecutivesWhat I think -- maybe this is useful to kind of just sort of spend a second and talk about this in terms of providing information to the market, whether it be this or anything else, the way I really think about it, when we provide the information, can we fully stand behind it? And is it going to be useful to the market. So when we feel like we can do that for this particular data point, we'll do it. I'm not going to sort of provide guidance, I don't know when I'm going to provide guidance. But if we get to a point when we can fully stand behind it, we think it's useful, we're going to do it. And of course, we have every incentive in the world for -- to accelerate that, but we're at a phase in the trial where the recruitment is done. We're waiting for events. And we know how that event rates can go, that can kind of change over time. So when we're at a point together with our partner, AbbVie, to provide this color for the market, if and when we're there, we'll do it.
Sachin Jain
AnalystsAnd then could you talk to the competitive landscape in frontline DLBCL at the time of launch?
Anthony Pagano
ExecutivesSo I think in the first order, what we've been able to do with EPKINLY, now as I mentioned, we started several years behind the competition, we were able to catch up in certain markets and certain indications, particularly in third-line DLBCL. We started several years behind, and we're able to come to market first there. We think right now, where we're seeing second-line FL, again, we were potentially, if approved, we could be first there. There could be certain indications where the competition could be ahead of us, but we think there's many indications, including third-line DLBCL, second-line FL, where we can be ahead. I think it's too early to call frontline DLBCL. But from a market order of entry perspective, we think there's the potential where we could be at or ahead of the competition. So we think that's an important place to start. It kind of speaks to the leverage of the AbbVie machine, but also the overall Genmab team and capabilities has set us up well from a development perspective. Look, from our perspective, we think that the R-CHOP combination is the standard of care. We're adding on EPKINLY to that. We think what's also really interesting is to look at the very strong Phase II data that we've presented EPKINLY in combination with R-CHOP. And this has been presented, I think, a couple of times at different medical conferences. That data is really pretty strong. And if that were to pull through into the Phase III, that would set us up pretty nicely in terms of the competitive profile.
Sachin Jain
AnalystsI check -- my apologies, I would look to the competitive programs in detail, but the point on your combo with R-CHOP is that different for the other players out there?
Anthony Pagano
ExecutivesYes. So I think the other player is looking at combinations with POLIVY. Of course, we have our own Phase II trial with POLIVY, which could be sort of thought about moving forward in terms of guidelines and so forth. And there, our data also look very good. From our perspective, standard of care is R-CHOP, and we're adding on EPKINLY. The Phase II data we presented so far, super strong and look forward to seeing the Phase III results next year.
Sachin Jain
AnalystsAnd if you could just talk to existing share dynamics, the pros and cons of your product versus the competitor and whether that translates beyond the data and the trial backbones into the other settings?
Anthony Pagano
ExecutivesYes. I mean I think overall, if we kind of zoom out, the CD3, CD20 bispecific class is a highly compelling class, providing a lot of benefit for patients, a needed benefit for patients. We know the kind of the advance of CAR-Ts and so forth. We think this class as a general starting point, provides a lot of value in absolute and relative terms. We think within that class, EPKINLY further distinguishes itself along multiple dimensions. We think the overall balance of safety and efficacy, we have that right balance. We have the absolute unquestionable high efficacy, not compromising anything there with a very nice safety profile. Further, we do have the subcu delivery. And we know that some of the competition has multiple products to go after different segments of the population. We have a single product offering. So I think it's the totality of, let's call it, the efficacy and safety subcu and a single product option that is resonating today and should set us up well moving forward. Of course, look, ultimately, the Phase III trial results will be important and the overall, call it, the equation in terms of the competitive profile moving forward. But as a starting point, the fundamentals of the product are rather strong.
Sachin Jain
AnalystsCan I go back to the backbone? So will you have data with POLIVY at the time of launch just to cover that segment of the market? What would you...
Anthony Pagano
ExecutivesWe've already presented some data. So that's already out in the public domain. I forget the exact end, but this was a meaningful end that was presented, and we think that's a good place to start. That's already out in the public domain. I think that's -- one thing that's often overlooked in the EPKINLY CDP is that we have a very significant Phase I, Phase II multi-combo trial. I mean it must be over 10 arms, must be each arm, roughly speaking, 40, 50 patients. And just looking at the quality of that data as it's been unveiled over the last couple of years, what you see is a very consistent pattern is EPKINLY is highly efficacious alone, but what you see is -- EPKINLY is highly combinable and highly additive to whatever it's added to. And particularly, what you see -- now looking at the second-line FL data, if you kind of go back and look at the Phase II data and the consistency from the Phase II into the actual Phase III data, highly consistent. So that gives us a lot of confidence moving forward in terms of that investment in the Phase II proof-of-concept work or that multi-combo work was investment well spent, but also gives us a lot of confidence into the Phase IIIs moving forward.
Sachin Jain
AnalystsVery clear. Could you just talk to the AbbVie collaboration and where you are from an SG&A perspective ahead of frontline DLBCL?
Anthony Pagano
ExecutivesIf we think about EPKINLY and what it meant for the brand and what it meant for Genmab as we thought about launching the product in 2023, and the thinking of this and the investment for this didn't start in 2023. I mean this probably goes back. I don't have our P&L in front of us, but probably even in 2021. And as we sat down with, obviously, our internal team at Genmab as well as with AbbVie, we thought about this as being a super important launch. We thought about it along multiple dimensions. Now maybe starting at the overall Genmab level, of course, we had already kind of started to commercialize Tivdak. But as we thought about the EPKINLY launch, this was really in the United States and Japan, the opportunity to launch Genmab more broadly into the commercial marketplace. So we took that into consideration. Secondly, when we were thinking about launching EPKINLY, there was 2 things in my mind. One, and it goes to what you said, this was not going to be a third-line plus product forever. And ultimately, this did have multibillion-dollar peak year sales potential, ultimately, which we're calling $3 billion. So we resourced it accordingly for that. We also resourced it according to -- there's an incumbent and it was going to be competitive. So we did resource it together with AbbVie with these sort of different things in mind from day 1. And we've seen the pull-through there in terms of how we're competing in the marketplace today. Now getting to your question, we think this does set us up well nicely moving forward. We're going to look for any and all opportunities to leverage the historical investment. At the same time, we're going to be very thoughtful in terms of brand planning, field forcing, field-facing resource numbers with our partner. And if it makes sense to add field force, we're going to do that, whether it be in the U.S. or Japan. But I would say, overall, there is a nice foundation of investment and resources that we can leverage based upon the initial approvals we can leverage moving forward. But to be clear, there's going to have to be additional investment in the brand.
Sachin Jain
AnalystsOkay. Any more on EPKINLY before we move on? And Rina-S, we're going to start. So perhaps we do the $2 billion, how do you think about the split ovarian versus endometrial?
Anthony Pagano
ExecutivesSo what we said, and this is directional, the way -- maybe it goes back to what you said about providing the guidance. So we thought it was useful to anchor the market in a number. We started at $1 billion based upon the profile execution from a clinical development perspective, we upgraded that to $2 billion. So that was a starting point. Let's provide a marker out there. And then secondly, once you have the marker in terms of the $2 billion peak sales number, provide a bit of a framework for how to think about it in terms of a clinical development perspective. So we did not absolutely and definitively break down the $2 billion. But directionally, what we said is that PROC, second-line PROC, second-line endometrial and PSOC was greater than $1 billion, and then you get to greater than $2 billion by adding in frontline endometrial. So importantly, what's not there in terms of that $2 billion peak year sales number is frontline ovarian and then anything else within the GynOnc space and then clearly, anything that's above and beyond or outside of the gynecological oncology space. And I guess maybe importantly, in terms of data readouts that will provide more information to the market in terms of how they should think about the $2 billion. Again, next year, we're going to have the second-line PROC data, the Phase II data. And then in 2027, we're going to have the second-line endometrial data.
Sachin Jain
AnalystsAnd time lines for frontline in both?
Anthony Pagano
ExecutivesWe've not yet really clarified that. So more to come. Again, looking at the CDP, we're just going to be starting those trials here in the not-too-distant future. So we obviously have to sort of go through the trial startup, site initiation, accrual. Again, it goes back to my framework, when we're in a position we can provide forward guidance that we can fully stand behind, we'll provide that to the market.
Sachin Jain
AnalystsAnd then remind me of where you are in the non-gynae tumors. I know you asked about lung probably the most.
Anthony Pagano
ExecutivesYes. So again, the way that sort of -- rather than sort of answering your question, but I think it's useful to sort of take people on the journey for how we think about it. Again, when we acquired Rina-S, we had about 40 patients or so worth of data. And this came out of like a basket trial, which was predominantly GynOnc. There was a smattering of other patients outside of GynOnc. So obviously, we evaluated that. But what's been emerging looking at now that basket trial and the work that we're doing is a product profile where we see activity regardless of folate receptor alpha expression level. So we're looking at the totality of the data set, whether it be in ovarian, whether it be in endometrial. That said, look, we have a really strong player here in gynecological oncology. We should accelerate that. We should expand that. We're going to do that. Okay? And we said, okay, what else can we, should we, must we do? And we came to the conclusion, we must do something else. And really, the next step for us is to do this and listen to these words here, signal-seeking study in non-small cell lung cancer. So we're going to -- we started a separate stand-alone Phase I, Phase II trial in non-small cell lung cancer, EGFR-mutated. We'll see if we can see a signal there. If we see a signal there, potentially, we can do more in that setting and then potentially further broaden beyond that. So that's how we've kind of done this in a thoughtful, I think, stepwise fashion, but certainly very clearly not taking our foot off the gas pedal. We're still doing this in the right -- but doing it in the right way.
Sachin Jain
AnalystsSo you're very clear. Second-line PROC next year, second line endometrial '27, frontline studies just starting. Any rough timing of non-gynae data sets coming to investors?
Anthony Pagano
ExecutivesI think that, again, also what we try to do in terms of helping investors, you'll see a nice clear chart in our investor materials each quarter, we've actually outlined this. And what we said being thoughtful here, I think we said -- I think we earmarked 2027. If it's sooner, it's sooner. But let's -- we'll see.
Sachin Jain
AnalystsVery clear. So competitive landscape, I think the investors I speak to, got fairly comfortable, you're differentiated from Elahere, which is whatever, $2 billion, $2.5 billion. I get more questions around the competitive landscape. And the 2 I'll mention and there may be others, but Aster had some data at ESMO, last year Eli Lilly had some data at ASCO just gone. Profiles, cross-trial comparison, small end, all the caveats, right, so we're super clear, looks comparable. So how do you think about, A, is that statement fair? B, how do you think about competing with 2 big players in oncology?
Anthony Pagano
ExecutivesI think there's a lot to unpack there. So maybe I'm going to start with the last part first. How we compete? And it sort of speaks generally, not just for Rina-S. Genmab is a highly, highly focused company. We're not trying to do everything. We're not working on 50 products. We're focused on predominantly antibodies in oncology. I think we kind of talked through the test case here, how we're competing in the CD3, CD20 bispecific class. I think both from a development perspective and a commercialization perspective, we have proven, are proving, we can compete and compete against a very strong company and an incumbent. So as a starting point, I understand there's competition. There's sometimes can be well entrenched competition. But generally speaking, in the area we're competing, I feel very confident in our team competing very effectively from a development and a commercialization perspective. Starting point. Now going to the front part of your question in terms of the target product profile for, say, Rina-S relative to existing competition and future competition. I think relative to existing competition in terms of marketed product, we have the potential based upon the proof-of-concept data to compete very effectively, whether this be activity against the folate receptor expression levels, we're seeing activity across that full suite relative to the existing product being -- for now, it seems to be working in the high expressers. We see a response rate being very competitive and north of where the existing product is approved. We see a potential duration of response, also that is highly competitive. Right now, at our last published data at 48 weeks, we have not yet reached the median duration of response. And this is coupled with what we think is a very competitive safety profile. And I think that safety profile that we're seeing feeds into the duration. So patients seem to be staying on drug, which then drives the duration. So I think relative to existing, Sachin, I think we're in a good place. Future competition, again, you kind of said it, the data is earlier. We think overall, our product profile still stacks up very well. Now it comes down to speed and execution. And again, I've already highlighted how we are competing and we'll continue to compete here. In particular, I'll come back to how we've accelerated and broadened this program. We're going to exit this year again with 3 ongoing Phase IIIs, 2 registrational Phase IIs, hopefully, and then more to come in 2026. So I think the combination of the target product profile with the very strong execution, I'm very, very pleased with where we're sitting today.
Sachin Jain
AnalystsSo just 2 follow-ons. So one, combination strategies. I'm less close to what Eli Lilly said, but actually talk about potential combos with some of their existing assets. So is that something you think about on competitive edge or not? And then two, biomarker strategy. Obviously, we'll wait and see how it works out for their lung asset, but they talk about potentially doing that. So are those aspects you think about as competitive risk or not?
Anthony Pagano
ExecutivesSo right now, what we're focused on is think about broadly speaking. And here, I think it's probably best if I talk about gynecological oncology for the reasons that I've already stated. What we're going with is an all-comer strategy. And then in terms of combination work, I think the starting point is combining with existing standards of care. This is sort of, I think, the first sort of order of entry, if you like, in terms of prosecuting our late-stage clinical development plan. I think, again, what we're seeing so far gives us confidence. We've not yet presented any PSOC data. But we think overall we have confidence in the combinability of Rina-S.
Sachin Jain
AnalystsOkay. If I can pivot to BD, if you could just reoutline framework, size of deals, focus? Do you have capacity to digest another bigger deal within the next 12 to 15 months?
Anthony Pagano
ExecutivesYes. I think, again, to answer this question, it is useful to start with our overall capital allocation framework and where M&A or external opportunities fit into that. Priority #1 is investing back in our business. There, the priority particularly in terms of growth and investment is absolutely focused in our late-stage pipeline, EPKINLY, Rina-S and acasunlimab. I think there, we have outlined our clinical development plans with a lot of detail, and we're super focused on execution. We'll see if there's more we can do in terms of the CDP for each of these products. So that's very clearly number one. Number two is making sure we have the right commercialization team and capabilities in place as those Phase IIIs read out. We've invested quite a bit over the number of years to build out those platforms and those capabilities. Now we're looking for any and all opportunities to leverage those investments. Now number one, investing back in our business, which I just covered. Number two is thinking about external opportunities. Of course, we've executed on the ProfoundBio deal, particularly Rina-S. We've talked about the very rapid acceleration and expansion of that program, where we're going to end 2025 and some of the key data readouts in 2026 and 2027. So from my perspective, post deal, job #1 was to successfully and thoughtfully integrate that into our business. As I sit here today, that is in very, very good shape. So in terms of considering external opportunities, if the right opportunity were to cross our desks, we would certainly consider it. To be clear, though, at the same time, Genmab is not in the business of chasing deals. We will take a very -- as always to any investment, whether it be internal or external, a very detailed bottom-up focused approach. And then look for opportunities, and this might sound kind of simple, Sachin, but really look for opportunities where we can be very good evaluators. Again, we know what we're looking for, right? Think about ProfoundBio, Rina-S, antibodies in oncology, ADC in GynOnc. We could be very good evaluators. So moving forward, continue this sort of framework of looking for opportunities where you can be very good evaluators. As we evaluate it, we're very looking what does the value add from Genmab and then how can we be very good owners. So we're looking for programs go through that framework, very thoughtful evaluation and then how can we really put our foot on the gas pedal for the right deal in terms of acceleration and expansion. Again, maybe the other parameter from my perspective is looking at something that is either Phase III or Phase III ready.
Sachin Jain
AnalystsOkay. And if we could spend the last 5 minutes just on the financial drivers. So DARZALEX obviously continues to deliver. You're very vocal in the sort of breadth of the royalty stream and the diversification of revenues. Perhaps you could just spend a couple of minutes on that. And I'm going to segue into the DARZALEX LoE, that's sort of where I'm going. But if we kick off with that, then we'll go there.
Anthony Pagano
ExecutivesMaybe to kind of like at the macro level kind of level set for everybody. I think everyone knows the story, but kind of just sort of think about the business. We have the royalty products and then we have, let's call it, the growth products and the proprietary products is the second bucket. The royalty business right now, we have the 6 products. Obviously, DARZALEX is one of those, and then there's 5 additional products. I think if you look at all of these products and looking at what the marketers have said, of them, these are all growth oriented. So we expect growth from all of these products here moving forward according to what the marketers have said. That existing royalty business is a very nice business. Obviously, you have DARZALEX, we're going to get to the dynamic that you articulated, but the other 5 in terms of the life should go beyond that DARZALEX period. So in addition to the 6 royalty products that are currently marketed, there's the potential for more to come. There's products with Lundbeck, with Novo. So I think you have those existing 6. We talked about the growth profile. There's the potential to add on to that. Now what's most exciting, though, for us is the proprietary business, really the growth assets that where we're investing behind from a development and commercialization perspective. And very clearly, here, we've outlined the peak year sales targets for EPKINLY Rina-S and acasunlimab, as well as the value drivers and the plans underpinning it. I think that's really important. These aren't just peak year sales numbers. We've outlined for all of you the building blocks and some of the time lines associated with building blocks of how we work towards achieving those peak year sales targets. And a reminder, it's $3 billion for EPKINLY, $2 billion for Rina-S, and $1 billion for acasunlimab. And look, Sachin, you haven't talked about today, but we do have the wonderful research and discovery engine as well. That is a wonderful platform, both from an early-stage research and discovery perspective as well as kind of a Phase I early-stage pipeline perspective. And I can't tell you which product, but I would be pretty sure with high confidence over time, one or more products from that research and discovery engine or early-stage pipeline should also transition into late-stage development to add a fourth or fifth product to that late-stage pipeline.
Sachin Jain
AnalystsSo I know we think from an NPV perspective, it's all very clear, but I also obviously get asked about the shape of the business through '29 when I think DARZALEX goes in the U.S. and then you have Japan, Europe thereafter. So I guess it's difficult for you at the moment knowing exactly what indications launch when and data, but how are you thinking about the shape of the business through that period from both the sales and I guess, more importantly, EBIT perspective with the DARZALEX would drop through?
Anthony Pagano
ExecutivesSo again, I think if we look at the building blocks that are in place today, I think collectively, from a revenue perspective, an investment perspective and capabilities, we're set up very nicely as we get to the -- where we are today, but also as we get into the back half of this decade and the early part of next decade. Okay. Well, that's nice to say, but what does that actually mean? Of course, look, DARZALEX is going to go away. But we have the building blocks in place, particularly as it relates to EPKINLY, Rina-S and acasunlimab, and clear line of sight to how we're going to discharge that risk over time. And I come back to, I think, 2 important trials, particularly next year, the frontline DLBCL and the second-line PROC. I think those are 2 important trials because they're going to give, I think, we already have a lot of confidence, but will increasingly give the market more confidence in terms of the read across and the overall confidence in the trajectory towards those peak year sales numbers. So I think between EPKINLY, Rina-S and acasunlimab, that's a nice setup combined with the [ ex-dara ] royalty business. Maybe to spend a minute, though, not directly on EBIT, but the other side of the coin, which is the investments. If you kind of go back to, say, 2019, 2020, I mean, effectively, excluding the royalty business, Genmab was kind of a Phase I company. Now compare and contrast to where we are today from a capabilities perspective, we're putting our foot in the gas pedal, prosecuting, competing, late-stage development, commercialization very effectively. That didn't happen by accident. That was all the investment that we had to make in 2020, '21, '22, '23, '24, '25. But where are we at now? I think if you look at 2024 and 2025, I hope you would all agree, we not only delivered but overdelivered on our financial commitments. And again, that didn't happen by accident because what we've done is now we scaled up the business, we've gotten to a size, scale, scope perspective where we can increasingly be focused on realizing the scale benefits. And what does that mean? What I'm super focused on is every incremental dollar of revenue has the potential to be potentially more profitable. Every incremental clinical trial could be cheaper without sacrificing speed or quality. And then even at a more granular level, every patient into a trial. Now obviously, the dynamics are different. But on average, every incremental patient in a trial could also be done more productively, again, without sacrificing speed or quality. And that's a large portion of how we've delivered the 2024 financial result as well as the H1 performance as well as the overall guide for 2025. So what you should take away from this is we're not going to shy away from investments, particularly late-stage Phase III investments that have the potential to drive revenue, but that will absolutely be done in the most productive, efficient manner possible, ultimately setting us up well from a revenue perspective, but also if successful, from a profit perspective. So I can't yet give you specifics, Sachin, but I think the overall setup is pretty strong here moving forward.
Sachin Jain
AnalystsVery clear. Any questions in the room? We'll run down to the last minute before I wrap the session. Okay. How was that good? With that, Anthony, thank you so much for joining.
Anthony Pagano
ExecutivesThank you, everybody.
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