Good afternoon, everyone, and welcome to the Genmab presentation here at the 2026 JPMorgan Healthcare Conference. My name is Zain Ebrahim . I'm a European pharma and biotech analyst here at JPMorgan covering Genmab. And from Genmab, it's my great pleasure to welcome the CEO, Jan van de Winkel, who will lead the presentation. And joining him for the Q&A session is Chief Medical Officer, Tahamtan Ahmadi, and CFO, Anthony Pagano. Jan, over to you.
Thank you, Zain, for the very nice introduction. It's a pleasure to join you all here once again at the JPMorgan Healthcare Conference as we kick off 2026. Over the past decade, we've taken Genmab from a royalty-based company to a fully integrated, innovation-driven biotech with a growing portfolio of proprietary medicines and a powerful late-stage pipeline. Today, I will walk you through how our diversified revenue-based and three high-impact late-stage programs position Genmab for the next decade of sustainable long-term growth. So let's get started. As a reminder, this presentation may contain forward-looking statements, and as such may contain certain risks and uncertainties. With that context in mind, I would like to turn to how we are setting up Genmab for a durable long-term growth. So move to the next slide.
We begin 2026 with a diversified, high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the 2030s. With the acquisition of Merus, we now have nine medicines on the market generating revenue for the company. That includes two co-owned products, Epkinly and Tivdak. Together, they provide a durable and diversified source of growing revenue from royalties and product sales. Epkinly is one of three high-impact assets, along with Rina-S and Petosemtamab, for which we are anticipating critical data this year, data that could enable important commercial launches beginning in 2027. Financially, we are significantly profitable, and we continue to invest with discipline, priority programs with the clearest strategic and financial impacts, and with the highest potential to make a difference for patients.
So the key takeaway is we have a robust foundation with multiple near-term growth drivers on the horizon, and you can see that clearly on the next slides. Here we have our three late-stage programs, which together have five breakthrough therapy designations. These programs, with a multi-billion-dollar potential, underpin our long-term growth. 2026 will be a defining year for the company. We will deliver key clinical data readouts, and importantly, we will also broaden the potential reach of Rina-S and petosemtamab with new phase III trials. Now, let me briefly touch on some of the key highlights for each of the programs on the next slides. Epkinly is currently the only bispecific antibody with a dual indication across key B-cell malignancies in the U.S., Europe, and Japan.
Uptake and approved indications have been strong, and recent data at the 2025 ASH conference reinforced Epkinly's potential as a core therapy capable of redefining care across B-cell lymphomas. Epkinly plus R-squared is the first CD3/CD20 bispecific to demonstrate phase III superiority over standard of care in follicular lymphoma. With this unprecedented data, Epkinly plus R-squared is well positioned to become a best-in-class option in second-line plus follicular lymphoma. Let's move to Rina-S . It's a folate receptor alpha-targeted ADC designed to broaden eligibility beyond the high expressors. Based on the current expression distributions, this could expand the addressable FRα population by up to approximately three times versus approved medicines that are restricted to high folate receptor alpha expression levels. We have seen encouraging anti-tumor activity and durability in both ovarian and endometrial cancers, supporting rapid late-stage development now into three ongoing phase III trials.
Then the latest addition to our pipeline on the right, following the acquisition of Merus, is petosemtamab, a potentially transformative EGFR LGR5 bispecific with compelling data in both first-line and later-line recurrent or metastatic head and neck cancer. As a reminder, in the first-line setting petosemtamab in combination with Pembro achieved a 63% response rate, and that is more than three times higher than the 19% that has been observed with the standard of care. Again, this benefit is not limited to response rate, but is also reflected in improvements in the event endpoints, such as progression-free survival and overall survival. Let's move to the next slides. In 2025, last year, there were seven key data readouts that validated the potential of Epkinly, Rina-S , and petosemtamab. These are the programs that will define our next phase of growth.
For Epkinly, the phase III EPCORE FL-1 study in second-line follicular lymphoma delivered unprecedented data and formed the basis for regulatory submissions. We also showed that outpatient administration is feasible, which is important for broader adoption. For Rina-S , we presented updated data in platinum-resistant ovarian cancer and initial and updated data in second-line plus endometrial cancer, highlighting deep and durable responses across the spectrum of folate receptor alpha expression. For petosemtamab, there was an update in the first-line head and neck cancer data set that underpinned an FDA breakthrough therapy designation and the first look at promising data last year in metastatic colorectal cancer. These readouts not only de-risk the individual assets, they collectively support our confidence that this powerful late-stage oncology portfolio can deliver multiple transformative launches over the next several years and have a positive impact on patients.
Looking ahead, you can see on the next slide that 2026 will truly be a catalyst-rich year for Genmab. We expect up to six potential registrational data readouts that could set the stage for multiple important product launches and line extensions in 2027. In the second half of the year, we expect phase II data for Rina-S and platinum-resistant ovarian cancer. We also anticipate that one or both of the phase III trials for petosemtamab in the first- and second-line head and neck cancer setting will deliver top-line data in the second half. For Epkinly, we anticipate data now for three phase III trials in diffuse large B-cell lymphoma.
Front-line diffuse large B-cell lymphoma with R-CHOP will be in 2026, and then in the first half of this year, two trials in the second-line plus diffuse large B-cell lymphoma setting, one with Epcoritamab monotherapy, and one for Epcoritamab in combination with lenalidomide, and together, these studies are designed to move Epkinly earlier in the treatment paradigm and significantly increase its addressable population from approximately 27,000 patients today to almost 150,000 patients by early in the next decade, so importantly, data during 2025 strengthened our conviction in these programs, and now in 2026, it is the meaningful registration or readouts that will be catalysts that will allow us to potentially bring these antibodies to patients in 2027. Let's move to the next slide. It's also important to remember the strength of our royalty portfolio, as evidenced by the consistent quarter-over-quarter growth of our royalty revenue.
Investment in our priority assets is possible in part because of the growing revenue streams from the approved partnered medicines. This slide brings together both our royalty portfolio and our owned medicines. The combination of a durable royalty base and a rapidly maturing proprietary portfolio creates a balanced business model. It reduces our dependence on any single product or revenue stream and improves the quality of our earnings. Strategically, this is exactly the shift we set out to make a decade ago, from primarily discovery and outlicensing towards being a fully integrated biotech that discovers, develops, and commercializes its own medicines at scale. The takeaway is that our revenue growth is not only strong, but it is also increasingly diversified. Our confidence in our ability to execute on key data readouts in 2026 and the subsequent high-impact launches in 2027 come from our strong track records.
We have proven that we are excellent evaluators of innovation and that we deliver on our promises. We over-delivered on the financial and operational commitments we made at the time of the acquisition of ProfoundBio, and we rapidly accelerated the development of Rina-S . We have also proven that we are disciplined in our execution against our capital allocation framework and in the prioritization of our investments, and we continue to be committed to delivering profitable growth. We intend to apply the same disciplined approach to the rapid integration of Merus and the focused and strategic development of petosemtamab, so to conclude, 2026 will truly be a transformational year for Genmab. We will have many significant catalysts. We have three high-impact late-stage assets, all with key clinical data readouts this year, and we have the capabilities in place to support multiple potential launches in 2027.
And we have a growing set of wholly owned assets in clinical development. Put together, Genmab is a scaled oncology biotech business with strong momentum and increasingly diversified growth profile with multiple clinical catalysts ahead. And our focus remains on translating our antibody science and development expertise into meaningful breakthroughs for patients, as well as long-term value for stakeholders. Thank you very much. Let's move into the Q&A now.
Thank you, Jan, for a great presentation. And if you'd like to ask a question, please raise your hand and we'll get a microphone across to you. While we wait for hands to potentially be raised, there's one over there.
There's a hand there.
While we wait for the microphones.
Microphone is coming.
To go over there, I will.
Yeah, are you intending to use a biomarker-driven strategy for your Rina-S phase III ?
Sorry, say that again.
Are you intending to use a biomarker-driven strategy for your?
I will hand it over to Tai Ahmadi. We definitely stratify for folate receptor alpha expression, Tai.
Yeah, thank you for the question. So I think we've been very consistent on this. Our thought, our position on Rina-S is that it has efficacy across the entire spectrum of folate receptor alpha expression. Now, we have to be a little bit more specific. That is a little bit different in ovarian than it is in endometrial. In endometrial, the expression is, generally speaking, a little bit lower. In ovarian, there's an almost minuscule number of patients who are really, truly negative. But that's our position based on the data that we have had. On the other hand, we are still, of course, stratifying by the folate receptor alpha expression.
When I say it has a meaningful efficacy, that is not to say that it behaves the exact same way and that folate receptor alpha expression does not have an impact on ORR or even possibly on duration of response. It just means that across the spectrum of folate receptor alpha expression in the data that we have had, both in ovarian and in endometrial, we see a meaningful signal. Meaningful means above what is currently standard of care. That kind of observation is also important because that is driving the ambition and the opportunity space for Rina-S even outside of the guideline space. We always say we view it as a best-in-class ADC in guideline. That's our ambition. That's what we have to own. That's why we have very aggressively developed it so far with two phase IIs.
We got it that one of them is going to read out actually this year, and then three phase III s and more to come. But the observation that the efficacy is preserved to a degree regardless of folate receptor alpha expression speaks to the unique profile as it relates to the antibody stability, the hydrophilicity of the linker, and then the payload exatecan. And that, of course, opens spaces also in other folate receptor alpha expressing tumors, not in the guideline space.
Thank you for the question. Let's see whether there's another one or more.
We've got one in the portal, which is with the Merus acquisition, how should we think about the impact on Genmab's R&D pipeline? Do you expect to see any consolidation? I think we saw we take a decision over Acasunlimab over Christmas. So any further consolidation to come?
Yeah, that's a very good question. So we are definitely now rank ordering all of our programs and actually try to merge our pipeline with that of Merus beyond petosemtamab. I mean, petosemtamab, we're going to actually make broader and accelerate in the coming time. I already said publicly that we are going to add a lot of technical operations and manufacturing expertise to the team executing on the two phase III trials. But you will see more phase III trials coming from petosemtamab this year. All the other programs, we are going to try to rank order them with our own programs and focus only on the highest impact ones. And you're right.
I mean, just as we did with Acasunlimab, which we in December deprioritized and actually stopped developing in the context of only wanting to focus on the highest impact, potential impact programs for patients and for stakeholders and make them broader rather than to focus on programs which in the context of an evolving therapeutic landscape with more competition, which we saw in the second-line lung setting, probably not be that competitive. I think it's better to actually prioritize on other programs which can make a much bigger impact for patients. And the same will be for the rest of the Merus pipeline. On top of that, Merus has eight partnerships with different partners. And some of these partnerships we will critically evaluate to really see whether we want to continue. Because, of course, for us, that may not have the same type of level of priority as for Merus.
So yes, you will see some further actions over the coming time. We will do this very carefully, but then also decisively, like we did with Acasunlimab.
Maybe just to broaden the question on Merus, could you remind us on the strategic rationale for Merus? We're seeing a lot of interesting mechanisms in the head and neck space, including some that have been talked about this week. What particularly attracted you about LGR5, EGFR, and can you contextualize how that's differentiated from some of the other mechanisms that we've seen?
Absolutely. Let me first put it in a broader context with Merus in general. We know the company for like 22 years. They're the technical enablers to R&D center in the Netherlands, and we are very impressed by the technology. They have very exciting technology capable of making very, very good antibodies. They already created Pzenkry, which is on the market now for a smaller indication. But they have a fantastic complementary technology base which, together with our expertise in the DuoBody bispecific antibody space, which is now taking care of 50% of our pipeline, is a completely complementary technology base, so we really were attracted to put them together so that we have an even stronger multi-specific antibody company going forward.
Then zooming into petosemtamab, let me first ask Tai to give his perspective on the relative strength of petosemtamab versus other approaches in head and neck cancer. And then I can potentially add to that.
Yeah, I would start with first that part of the strategic imperative was that we were looking for an asset that we could integrate into our pipeline that would have a broad potential, significant commercial opportunity, and would launch in 2027. P2, in our mind, is within this emerging class of second-generation EGFR bispecifics, the one that, in our mind, at least has the potential to be the best in class in that space. That's certainly underwritten by some of the data that is already in the public domain that then led to two BTDs, both in monotherapy and as well as in combination. Both from a development point of view, it's also already relatively well established with two phase III s that Merus initiated some time ago that are well underway and enrolled.
And when we announced the acquisition, we already kind of positioned ourselves in a way that, for us, P2 has to be the drug in head and neck. So this is a space where we continue to invest and further develop the drug. But in and of itself, also kind of underwritten by some of the data that Jan was alluding to earlier that was presented at the end of the year and collaborated, it has beyond head and neck, of course, also other opportunities that we will then pursue. So that's kind of like why we're excited about it. There are not that many drugs that fit that profile. So we were fortunate that we were able to execute the execution. We're very excited to have P2 in our pipeline.
Yeah, and on top of that, I mean, we understand bispecifics really, really well. Literally, 50% of our pipeline is bispecifics. There are now several DuoBody-based products already on the market, four of the eight products which are based on our technology, DuoBody-based, bispecific, antibody-based. So we understand really well how to work with those molecules. And the profile is just fantastic of petosemtamab preclinically and clinically. So we think it's a much, much bigger drug than just a medicine for head and neck cancer. But we're going to consolidate our base in head and neck cancer, move into other areas of head and neck cancer first, and then also this year make progress in other areas based on data.
While we wait for further questions in the audience, thinking about the first-line data that you've seen so far, so I think you've shown really strong data at ASCO last year. Could you remind us what we saw with Petosemtamab there in terms of ORR rates and how that compares with Keytruda monotherapy?
I mean, the data that you referred to is like a 60-plus% response rate in combination with Pembo, where Pembo has a mid-teens monotherapy response. And so whatever way you want to look at it, at least a tripling, if not even more of the response rate. It's not only the response rate Jan touched on, it's also the durability of the response, and then also the overall survival. Of course, this was phase II data. This needs to be replicated in the phase III . But as part of the diligence, we, of course, had a view all the way down to a single patient level. So we are very convinced to have very good understanding about the capabilities of P2 and the efficacy signal. Head and neck is a somewhat heterogeneous disease. So understanding that space and being aware of that heterogeneity is important.
And so we clearly have also an understanding of this disease space because we have been in the head and neck space for a while with GEN1042 and Tivdak. And so we had an appreciation for the data that Merus had generated. And so we are very confident and excited about this data and the potential that the drug has beyond these two phase III s. We already said we're going to go into the local regional space. That is, of course, part of this strategy to anchor the drug in head and neck. And we already touched on the colorectal data, which, again, very small data, but as a data point in terms of combination with chemotherapy in front line and second line, again, intriguingly strong signal.
And we've got a question over here.
So keeping you fit today. Keep you in top condition.
Great, thank you. First of all, congratulations on the rapid execution of Rina-S . I think that really is a pretty good testament. My question is thinking about from what little I know, and maybe I have this wrong, but the doses you're using for Rina-S in ovarian and endometrial perhaps may not be the same. How are you going to tease this out when you launch? Question number one. Question number two, what about Elahere and the subset? I know Elahere is folate receptor positive, but that is already out there. And how are you going to stratify or differentiate that Rina-S truly differentiates those?
Yeah, very good questions. I think I'll let Tai take a bite on both. And then Anthony can definitely talk about the commercial, how we are going to deal with 100 milligrams per square meter versus 120 for the two indications. But Tai, why don't you take the second question?
Sure, thanks for the question. First, the dose, yes. So the dose recommended phase II dose in endometrial is 100 milligrams per square meter. In ovarian, it's 120. We dose by square meter. Endometrial women with endometrial cancer tend to have a larger body mass. If you actually look at the free exatecan levels, 100 milligrams per square meter in endometrial is exactly equal to 120 in ovarian. So that's kind of like the rationale for the dosing. As it relates to the whole strategic positioning versus Elahere, as you know, Elahere is approved in ovarian right now, 75 and above. In the original phase II, patients are required to have FRα when they are meeting this criteria because that's the unmet medical need. But bringing this also to the first question, our trial enrolls all patients with ovarian, regardless of folate receptor alpha expression.
That's the first meaningful differentiation. If you just look at the profile of the data, I think it's probably fair to say that the efficacy signal is stronger in ORR. We will, in the phase III , actually have that opportunity to describe this a little bit better because in the phase III , we also will have patients who are Elahere naive and 75 and above. We'll have a little bit more robust data to support that. But clearly, what is out there in the public domain, the signal, even in 75, is significantly higher than it is with Elahere. The duration of response is 12 months. We still have not reached the duration of response. Elahere's duration of response was, I think, six and a half months or seven months. We do not have the liabilities of eye toxicity or neurotoxicity.
I think in totality, this is just a second-generation folate receptor alpha ADC with a completely different profile and a different opportunity. It is expressed in the fact, as you just acknowledged, that there are already three phase III s running, which are two more than Elahere has.
Thanks, Tai.
Maybe just to add on, if we sort of think about the overall commercial opportunity, as we highlighted in the presentation when we announced the acquisition of ProfoundBio and Rina-S , we initially had put the peak sales estimate at $1 billion. Now, since that, we've upgraded it to $2 billion. And that's really a function of the emerging data we're seeing in ovarian as well as in endometrial cancer. But also, as we think about expanding and the progress we've made on the clinical development program, that's a function of the overall, again, the target product profile in absolute terms, but also in relative terms. Tai just very eloquently outlined some of the differentiating factors relative to the existing competition. Now, moving forward, we're not just looking at the existing competition.
We're really focused moving forward also around making sure that we can have a best-in-class folate receptor alpha product, a first-in-class where we can be first, but also broadest in class. So we stand fully behind our $2 billion peak year sales estimate. We have the CDP in place to realize that. Now, specifically to your question around the nuances around pricing, we're just going to leave those nuances for a later date, closer to our post-launch.
Thanks, Anthony.
I think in terms of duration and response, just to build on that, can you give us a view on what we should expect to see later this year? Is it going to be the median duration response in the phase II? How is the phase III tracking in terms of recruitment that you need to have fully recruited to support regulatory filing?
So I would say that the next data that we're going to see on Rina-S is the phase II pivotal data set. I think it doesn't make sense to update a phase II data set when you actually have 100-plus patients. That's going to be the data that is going to be informative for the filing in the United States. That is going to give us that will describe the duration. I don't know where the duration response is going to land because I don't know. We were very intrigued by the fact that we have a very long duration of treatment. I think this is important to underscore again. Main toxicities of Rina-S is neutropenia, which is manageable with the appropriate G-CSF support. Women can stay on this drug for quite a long time.
And if they stay on the drug for quite a long time, that seems to be translating to the long duration of response. As it relates to the phase IIIs, I'm not going to give you an exact update, but I can tell you that we are extremely well accrued on the relevant confirmatory phase III in PROC. So no issues there.
That's very clear, and I think you've said H226 for the timing of the phase II pivotal readout.
Yes, that's what we project now. Yeah.
And we've also heard at this conference, and also over the course of last year, some of the folate receptor alpha followers that are coming, like Elahere, Lilly. So what are your perspectives on the data they've shared so far and how Rina-S is differentiated?
Well, I mean, this is a general truism in oncology now that's becoming increasingly more competitive and too, you're never alone. So part of the differentiation is also the speed by which you execute your development plans. I do think that the AZ folate receptor alpha ADC and the Eli Lilly are not necessarily made equal. I think Eli Lilly's ADC does look by the data that's been shared the most closest to what we have publicly put out for Rina. Having said all of that, it's really about execution. We're sitting here, what is it, 18 months after the acquisition of ProfoundBio at the time. We didn't have the recommended phase III dose. And we have phase IIs that are intended for registration. One that we already discussed is going to be presented.
We'll have the top line results presented in the second half of this year and three phase III s that are enrolling, and so I think that's going to be part of the differentiation, is to push the drug along the lines of therapies into earlier lines to benefit women, and a lot of this is going to be execution. By the way, the same is true in P2 as well.
Another thing that's emerging in gynecology is the B7-H4 ADC strategy. You're familiar with B7-H4 as well as a target. Can you explain to us why folate receptor alpha is potentially a better target than B7-H4?
Tai, do you want to start with that?
Sure. I mean, look, there's no shortage of targets. What we did like about Rina-S is, A, the whole package. Folate receptor alpha is a tumor target that is expressed actually in a variety of tumors. And once you have a package that allows you to elicit response in patients who have or in tumors that have lower expression levels of folate receptor alpha, it's actually a relatively broad space. Two, as it relates to gyne-onc, folate receptor alpha is expressed both in ovarian, endometrial. It's also actually expressed in cervical. But these are the two major indications. And so having an ADC in your pipeline that has the potential to change the treatment in both of these major indications, I think is a significant strategic advantage as you think about dual indications.
Something that we learned on the Epkinly, just to bring that up, where having an indication both in diffuse large B-cell and in follicular lymphoma has given us a competitive advantage against the competition where it's one drug in follicular lymphoma, broadly speaking, and the other one in diffuse large B-cell. So folate receptor alpha is a fantastic target in ovarian. And because of its potential in other disease areas, we think Rina-S has the potential to become a really, really big drug. We anchor it in ovarian. But as I said, we're already generating data in other folate receptor alpha disease areas, and I'm excited about that too.
Any questions? If not, I can ask about Epkinly, which you just mentioned. So what's the latest on timing of first line DLBCL? And I think you mentioned previously that we could be potentially seeing an interim. So just to check whether that's passed or whether we're still waiting for the interim.
No, the first line, the diffuse large B-cell lymphoma trial will read out this year for sure. We just don't know whether it will fall in the first half or in the second half. That will get clearer in time. It's an event-driven analysis. And once we know, we will definitely make that public because we want to be very open and transparent like for the other trials. And you will hear that in the coming time for sure.
Yeah, and the only thing to add to that is, again, to this theme of acceleration of drug development. We started the diffuse large B-cell frontline study about a year before the competition. And so that time advantage is going to be important as this data reads out. Speed into these frontline indications, these larger indications, frontline diffuse large B-cell is actually half of the entire valuation for the space, for the oncology space, are important and are differentiating aspects.
And you mentioned competition. There was recently a first-line BCL trial that showed a 25% PFS benefit for the CD19. So how has that changed your view and confidence level heading into your data? And could you contrast what you'd expect to see with your first-line BCL trial versus what we've just seen with the CD19?
The first thing I would say, by background, I'm an oncologist. So this is the second phase III in diffuse large B-cell in the last 26 or 27 years. That's positive. So congratulations to Incyte. It's good for patients. There are some differences. This was a trial that was in a biomarker-selected population, ABC, with the addition of two drugs, Revlimid and Tafa, as you said, with a hazard ratio of 0.75. We will see what our trial is going to show. It's a trial that actually involves IPI 2 to 5. So broadly speaking, the entire spectrum except for the very low risk. But the primary readout is initially in IPI 3 to 5 in the higher risk population. We shall see. It's hard to speculate.
Having said all of that, where we take our confidence and excitement is when you look at the second-line follicular lymphoma study that just recently read out right after Tafa as well, by the way, with a hazard ratio of 0.2, which is really without precedence in lymphoma. That data almost to the decimal point mimicked the relatively robust 100 patients that we had enrolled prior to that in combination with R-squared in follicular lymphoma. And so there is some belief system that the phase III in frontline diffuse large B-cell lymphoma ought to also to a degree mimic the pretty impressive, I think, data that we have generated with R-CHOP, ABC, and IPI 3-5. And if that were to be the case, I think this is going to be a very positive trial.
On overall survival, what can we expect to see there? Should we be looking for a trend or is it too early?
I mean, we're speculating right now. We shall see what it is. I mean, the two trials that we talked about, the Incyte, Tafa, and R-CHOP combination, had a positive PFS, but there's almost no separation on OS because that usually trails significantly by time. I think it's completely speculative and not really helpful. Principally speaking, we've been very clear and bullish that we believe this trial is going to be having a significant impact. If it is going to have a significant impact, then it probably will also translate into an earlier OS signal. That's the way diffuse large B-cell usually behaves.
Within your $3 billion peak sales target for Epkinly, what have you assumed for share in first-line DLBCL versus the competitor where you've said you've got a time-to-market advantage? We were also hearing of other mechanisms, again, as fast followers in DLBCL, CD19, CD3 as an example. So your perspective on share there and how you're differentiated?
Anthony?
I think maybe a good place to start with that is the progress we've made in the two-plus years since launch. I mean, particularly where we've built out our commercialization capabilities in the United States and Japan, we've performed very, very well and probably ahead of, let's call it your expectations, Zain. We're very happy with the foundation that has been built in the third-line plus settings for DLBCL and third-line plus follicular lymphoma. We now have to look forward to the second-line FL sort of uptake in 2026. And just to be thoughtful about that, it's not going to be a hockey stick in 2026 in terms of the sales figures there. The total addressable market for the second-line FL just won't support that.
But it is meaningful more from a qualitative perspective to be out there in the marketplace speaking more about the brand and this additional opportunity. In terms of the $3 billion peak year sales estimate, we've not broken that down. But I think I'm not going out on a limb to say that a major, major driver is going to be the frontline DLBCL setting. From a total addressable patient population, this represents around half of that total opportunity for Epkinly. Since we've been talking about data readouts, we've talked about the frontline DLBCL. It's worth reiterating what Jan covered in his presentation. In addition to the frontline DLBCL readout in 2026, we're going to have two additional data readouts in the DLBCL setting. One of those was on your radar screen for some time, which is the second-line DLBCL monotherapy.
What's new, and I'd say more relevant, is going to be the second-line DLBCL combination therapy with Revlimid. Now, both of those are slated for H1 of 2026. Really, the summary is, Zain, we have a very good foundation we've built out in the later lines. We have a number of important readouts in 2026 and really look forward to seeing those readouts and then hopefully the successful launches subsequent to that.
Tai mentioned the difference in trial design where it was focused on ABC in one of the competitor trials. Thinking about what we saw with the POLARIX regimen where there was GCB and ABC, I think GCB, there was very limited benefit. ABC was more of a benefit. Do you expect to see a difference for Epkinly in terms of benefit across the two subgroups?
Maybe bigger picture, what does that represent as a percentage of DLBCL patients?
So first off, the reason that I believe Incyte designed the trial the way they designed it is because they were essentially following a precedent that was established by Celgene, which had kind of generated data that was suggestive that Revlimid actually only works in ABC. And so that's where they had done their original work, where they barely missed. And I think that was the reason why Incyte went with that strategy. But you're right that in the POLARIX trial, there is a somewhat bizarre, poorly understood difference in how it behaves in ABC versus GCB, which has actually led to more of an adaptation in this ABC cell of origin subtype than in the general population. For a CD3 bispecific antibody, I don't at this point have any biological reason to believe that cell of origin matters.
It's not something that we've seen in any of our data sets ever. So it's certainly something that will be described in the demographics, but it's not something that we anticipate.
That's very clear. And we've got a couple of minutes. So Anthony, I want to ask you about R&D and thinking about you've mentioned before about consensus R&D being in about the right place. Since then, we've seen Acasunlimab discontinuation, but you're talking about adding trials for petosemtamab. So how should we think about the P&L in 2026? And maybe broadly, with the trials that could be running out this year, how are you feeling about the shape of Genmab through to 2030 on both revenues and operating profit?
Yeah, so for 2026, first of all, maybe at the macro level, everything I said at Q3 in terms of consensus being in a reasonable place, we stand fully behind today. Now, sort of underpinning that, I think are two key themes. One, our investment priorities at Genmab are super clear. We have a number of ongoing high conviction, high priority phase IIIs across Epkinly, Rina-S , and now Pito. Particularly for Rina-S and Pito, particularly for financial planning purposes, I see a clear line of sight and have left space for some additional expansion opportunities. So number one, investment priorities are super clear. On the other hand, at the same time, we're very focused on driving operational efficiencies and operational savings. Think about Genmab where it is now as we exit 2025 and get into 2026 and beyond.
We're at a fundamentally different size and scale, which means we're being super focused on driving those scale benefits, whether it be from a bargaining power perspective or just sort of leveraging more fixed costs. That's one side of it. The other side in terms of the operational efficiencies is sort of good old-fashioned industrial logic and this being super disciplined and specifically attacking our largest cost driver, which are the phase III trials. A couple of years ago, we're running a handful of phase III . That number, as you can see, is increasingly going up. So we're going through that together with Tai and Judith, really in a bottom-up fashion and really focused without sacrificing speed or quality, bringing down our per unit cost. We've made meaningful progress in 2025 and will continue to do that in 2026 and beyond.
That's going to free up capital for some of the expansion opportunities for Rina and Pito and potentially other programs as well.
I think that's brought us to time. Thanks, Jan.
Thank you.
Thanks, Tai, and thanks, Anthony. Thanks, everyone, for being here.
Thank you.