Genmab A/S (GMAB) Earnings Call Transcript & Summary
January 13, 2026
Earnings Call Speaker Segments
Zain Ebrahim
AnalystsGood afternoon, everyone, and welcome to the Genmab presentation here at the 2026 JPMorgan Healthcare Conference. My name is Zain Ebrahim. I'm European pharma 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, Tahi Ahmadi and CFO, Anthony Pagano. Jan, over to you.
Jan van de Winkel
ExecutivesThank 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 base and our 3 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 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 have 9 medicines on the market, generating revenue for the company. That includes 2 co-owned products EPKINLY and TIVDAK and together, they provide a durable and diversified source of growing revenue from royalties and product sales. EPKINLY is 1 of 3 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. And financially, we are significantly profitable, and we continue to invest with discipline priority programs with clear 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 slide. Here, we have our 3 late-stage programs, which together have 5 breakthrough therapy designations. These programs with a multibillion-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 slide. 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 R2 is the first CD3/CD20 bispecific to demonstrate Phase III superiority of standalone care in follicular lymphoma. With this unprecedented data EPKINLY plus R2 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. And based on the current expression distributions, this could expand the addressable population by up to approximately 3x versus approved medicines that are restricted to high folate receptor alpha expression levels. We have seen encouraging antitumor activity and durability in both ovarian and endometrial cancer, supporting rapid late-stage development now -- into now 3 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. And as a reminder, in the first line setting petosemtamab in combination with pembro achieved a 63% response rate and that is more than 3x higher than the 19% that has been observed with the standard of care. And 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 slide. In 2025, last year, there were 7 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 form 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 first -- and the first look at promising data last year in metastatic colorectal cancer. These readouts not only derisk 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 6 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 3 Phase III trials in diffuse large B-cell lymphoma, frontline diffuse large B-cell lymphoma with R-CHOP and will be in 2026. And then in the first half of this year, 2 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 are now '26, it is the meaningful registrational 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 out-licensing 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's also increasingly diversified. Our confidence and our ability to execute our key -- on key data readouts in '26 and the subsequent high-impact launches in '27 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 3 high-impact late-stage assets, all with key clinical data, 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.
Zain Ebrahim
AnalystsThank you, Jan, for a great presentation. [Operator Instructions] Whilst we wait for hands to potentially be raised. There's one over there. Whilst we wait for the microphone to go over there, I will...
Unknown Analyst
AnalystsYes, are you intending to use a biomarker-driven strategy for your Rina-S Phase III?
Jan van de Winkel
ExecutivesSorry, say that again.
Unknown Analyst
AnalystsAre you intending to use a biomarker-driven strategy for your Rina-S?
Jan van de Winkel
ExecutivesI will hand it over to Tahi Ahmadi, we definitely stratify for folate receptor alpha expression, Tahi.
Tahamtan Ahmadi
ExecutivesYes. 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 is in endometrial. In endometrial, the expression is, generally speaking, a little bit lower and ovarian is almost miniscule 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. And when I say it has a meaningful efficacy that is not to say that it behaves the exact same way that folate receptor alpha expression does not have an impact on or even possibly on duration of response. It just means that it cost of spectrum of folate receptor alpha expression in the data that we have had both in ovarian and endometrial, we see a meaningful signal, meaningful means above what is currently a standard of care. And that kind of observation is also important because that is driving the ambition and the opportunity space for Rina-S even outside of the gyn-onc space. We always say that we view it as a best-in-class ADC in gyn-onc. That's our ambition. That's what we have to own. That's why we have very aggressively developed it so far with 2 Phase IIs. We guided that one of them is going to read out actually this year and then 3 Phase IIIs 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 disability, the hydrophilic of the linker and then the payload exatecan and then, of course, open spaces also in other folate receptor alpha expression tumors, not in the kind of space.
Jan van de Winkel
ExecutivesThank you for the question. Let's see whether it's another one or more.
Zain Ebrahim
AnalystsWe'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 you take a decision of Acasunlimab over Christmas. So any further consolidation to come?
Jan van de Winkel
ExecutivesYes, that's a very good question. So we're 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 2 Phase III trials but you will see more Phase III trials coming from for peto this year. All the other programs, you are going to try to rank all of 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, let's see, in December, deprioritized and actually stopped developing. In the context of only wanted 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 landscape, therapeutic landscape and 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. It 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 8 partnerships with different partners. Some of these partnership, 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.
Zain Ebrahim
AnalystsAnd maybe just to broaden the question on Merus, can you remind us on the strategic rationale for Merus? And we're seeing a lot of interesting mechanisms in the head and neck space, including some that have been talked about this week. So 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?
Jan van de Winkel
ExecutivesAbsolutely. Let me first put it in a broader context with Merus in general, we know the company for like 22 years. They technically enabled our R&D center in the Netherlands. And we are very impressed by the technology. They are very exciting technology. capable of making very, very good antibodies, they already created BIZENGRI, which is on the market now for a smaller indication with a fantastic complementary technology base, which together with our expertise in 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 are an even stronger multispecific antibody company going forward. Then zooming in to petosemtamab, let me first ask Tahi to give his perspective on the relative strength of petosemtamab versus other approaches and head and neck cancer and then I can potentially add to that.
Tahamtan Ahmadi
ExecutivesYes. I would start with first that part of the strategic imperative was that we were looking for an asset that we could integrate into a pipeline that would have a broad potential, significant commercial opportunity and would launch in '27 and peto, in our mind is within this emerging class or second-generation EGFR bispecifics. The one that in our mind, at least has potentially to be the best-in-class in that space. certainly underwritten by some of the data that is already in the public domain that then led to 2 BTDs, both in monotherapy and as well as in combination, both on a development point of view, it's also like already relatively well established with 2 Phase IIIs that Merus initiated some time ago that are well underway enrolled. And when we announced the acquisition, we already kind of like positioned ourselves in a way that for us, peto has to be the drug in the neck. So this is a space where we continue to go and to invest and further develop the drug. But in and of itself, also kind of underwritten some of the data that Jan was alluding to earlier that was presented at the end of the year in colorectal, it has beyond head and neck, of course, also other opportunities that we will then pursue. So that's kind of like what we're excited about it. There are not that many drugs that fit that profile. So we were fortunate, we were able to execute the execution and we're very excited to have peto in our pipeline.
Jan van de Winkel
ExecutivesYes. And on top of that, I mean, we understand bispecifics really, really well, literally 50% of our pipeline is bispecific. There now several DuoBody-based products already on the market for, of the 8 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 clinical. 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 cancers first and then also this year make progress in other areas based on data.
Zain Ebrahim
AnalystsAnd whilst 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?
Tahamtan Ahmadi
ExecutivesSo I mean the data that you referred to is like a 60-plus percent response rate in combination with pembro, where pembro has a mid-teens monotherapy response. And so it's 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, 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 on all the way down to a single patient level. So we are very convinced to have very good understanding about the capabilities of peto and the efficacy signal. Head and neck is somewhat heterogeneous disease. So understanding that space and being aware of that heterogeneity is important. So we clearly have also an understanding of this disease space because we have been in the head and neck space for a while, the 1042 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 the drug has beyond these 2 Phase IIIs. 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. You already touched on the colorectal data, which, again, very small data, but as a data point in terms of combination with chemotherapy in frontline and second line, again, interestingly strong signal.
Zain Ebrahim
AnalystsAnd we've got a question over here.
Jan van de Winkel
ExecutivesSo keep you fit today, keep you on top condition.
Unknown Analyst
AnalystsGreat. 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 and 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?
Jan van de Winkel
ExecutivesYes, very good questions. I think I'll let Tahi take a bite on both, and then Anthony can definitely talk about the commercial, how we are going to deal with 100 milligram per meter square versus 120 for the 2 indications. But Tahi, why don't you take the second question first?
Tahamtan Ahmadi
ExecutivesSure. Thanks for the question. First, the dose yes, so the dose with the Phase II dose and endometrial is 100 milligrams per meter square, in ovarian is a 120. We dosed by meter square. Endometrial women -- women with endometrial cancer tend to have a larger body mass. If you actually look at the 3 exatecan levels, 100-milligram per meter square in endometrial is exactly equal to 120 in PROC. 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 PROC right now, 75 and above. In the original Phase II patients are required to have ELAHERE 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 PROC regardless of folate receptor alpha expression, so 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 OR. 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 in 75 and above. So we'll have a little bit more robust data to support that. But clearly, what's out there in the public domain, the signal even in the 75 is significantly higher than it is ELAHERE. Duration of responses is 12 months, we still have not reached the duration of response. ELAHERE's duration of response was, I think, 6.5 months or 7 months. We do not have the liabilities of eye toxicity on neurotoxicity. And so I think in totality, this is just the second generation folate receptor alpha ADC with a completely different profile, a different opportunity. And it's expressed in the fact that you just acknowledge that there are already 3 Phase III running, which are 2 more than ELAHERE has.
Anthony Pagano
ExecutivesMaybe just to add on, if you 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 PROC 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, Tahi 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 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 or at post launch.
Zain Ebrahim
AnalystsAnd I think in terms of duration of 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? And how is the Phase III tracking in terms of recruitment that you need to have fully recruited for the support regulatory filing?
Tahamtan Ahmadi
ExecutivesWell, so I would say like the next data that we're going to see on PROC is the Phase II pivotal data set. I think it doesn't make sense to update the Phase II data 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, and that is going to give us the -- we'll describe the duration. I don't know whether duration response is going to land because I don't know. But we were very intrigued by the fact that we have a very long duration of treatment. I think this is in part to underscore again. Main toxicities of Rina-S is neutropenia, which is manageable with appropriate GCSF support. And so then women can stay on this drug for quite a long time. And if they stay on 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.
Zain Ebrahim
AnalystsThat's very clear. And I think you've said H2 '26 for the timing of the Phase II pivotal readout?
Jan van de Winkel
ExecutivesYes. That's what we project now.
Zain Ebrahim
AnalystsAnd 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, the likes of Astra, Lilly. So what are your perspectives on the data, they've shared so far and how Rina-S is differentiated?
Tahamtan Ahmadi
ExecutivesWell, I mean, this is a general truism in oncology now that's becoming increasingly more competitive and so 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 II dose. And we have 2 Phase IIs that are internal 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 through 3 Phase IIIs 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 was true for peto as well.
Zain Ebrahim
AnalystsAnd another thing that's emerging in gynecology is the B7H4 ADC strategy, and you're familiar with B7H4 as well as the target. So can you explain to us why folate receptor alpha is potentially a better target than B7H4?
Jan van de Winkel
ExecutivesTahi, do you want to start with that?
Tahamtan Ahmadi
ExecutivesSure. 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 expressly 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 gyn-onc, folate receptor alpha is expressed both in ovarian endometrial it's also actually express in cervical. But these are the 2 major indications. And so having ADC in your pipeline that has potential to change the treatment in both of these major indications. I think there's a significant strategic advantage as you think about dual indications. Something that we learned on 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 1 drug in follicular lymphoma, broadly speaking and the other one diffuse large B-cell. So folate receptor alpha is a fantastic target in gyn-onc. And because of its potential in other disease areas, we think Rina-S has the potential to become a really big drug. We anchor it, in gyn-onc but as said we are already generating data in other folate receptor alpha disease, and I'm excited about that, too.
Zain Ebrahim
AnalystsAny questions? If no, can I 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 past or whether we're still waiting for the interim?
Jan van de Winkel
ExecutivesNot the first line, the diffuse large B-cell lymphoma trial will be 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 clear in time, it's an event-driven anlysis. And once we know and 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 coming time for sure.
Tahamtan Ahmadi
ExecutivesAnd the only thing to add to that is, again, like to the theme of like 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 the data reads out speed into these frontline indications, these large indications, frontline diffuse large B-cell is actually half of the entire valuation for the space, the lymphoma space are important and are differentiating aspects.
Zain Ebrahim
AnalystsAnd 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 DLBCL trials versus what we've just seen with the CD19?
Tahamtan Ahmadi
ExecutivesWell, the first thing I would say, back on I'm a lymphoma doctor, so this is the second Phase III in the few such piece and 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 2 drugs, lenalidomide 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 enrolls IPI 2-5. So broadly speaking, the entire spectrum, except for the very low risk, but the primary readout is initially in IPI 3-5 and in 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 the hazard ratio of 0.2 and which is really without precedence in lymphoma, that data almost to the decimal point mimic the relatively robust 100 patients that we had involved prior to that in the combination with R2 in follicular lymphoma. And so there is some belief system that the Phase III in frontline diffuse large B-cell ought to also, to a degree, mimic the pretty impressive, I think, data that we have generated with R-CHOP, Epcor and IPI 3-5. And if that were to be the case, I think this is going to be a very positive trial.
Zain Ebrahim
AnalystsAnd on overall survival, what can we expect to see there? Could it -- should we be looking for a trend or is it too early?
Jan van de Winkel
ExecutivesTahi?
Tahamtan Ahmadi
ExecutivesWell, I mean, we're speculating right now, we shall see what it is. I mean the 2 trials that we talked about Incyte tafa-len, R-CHOP combination and 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 and if it is going to have a significant impact, and it probably will also translate into an earlier OS signal the way diffuse large B-cell usually behaves.
Zain Ebrahim
AnalystsAnd within your $3 billion peak sales target for EPKINLY, what have you assumed for share in first-line DLBCL versus the competitors where you've said you've got a time-to-market advantage. We're already hearing of other mechanisms, again, as fast followers in DLBCL, CD19, CD3 as an example. So your perspective on share there and how you differentiate it?
Jan van de Winkel
ExecutivesAnthony?
Anthony Pagano
ExecutivesSo I think maybe a good place to start with that is the progress we've made in the 2-plus years since launch. I mean particularly when we build 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 in 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 like 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, this 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 on a limb to say that a major, major driver is going to be the front line 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 front line DLBCL. It's worth reiterating what Jan covered in his presentation. In addition to the front line DLBCL readout in 2026, we're going to have 2 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. So 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.
Zain Ebrahim
AnalystsAnd Tahi, you mentioned the difference in trial design where there was a focus on ABC in one of the competitor trials. And so 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. How do you see -- do you expect to see a difference for EPKINLY or in terms of benefit across the 2 subgroups and maybe bigger picture. What does that represent as a percentage of DLBCL patients?
Tahamtan Ahmadi
ExecutivesWell, so first off, I can think of reason -- I believe the reason that Incyte designed the trial the way they designed to this because they were essentially following a presence that was established by Celgene, which had kind of generated data that was suggested that lenalidomide 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 understood difference how it behaves in ABC versus GCB, which has actually led to more of an adaptation in this ABC cell of origin subset in the general population. For a CD3 T-cell redirector, 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.
Zain Ebrahim
AnalystsThat's very fair. And we've got a couple of minutes. So Anthony, 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 were talking about adding trials to petosemtamab. So how should we think about the P&L into 2026 and maybe broadly with the trials that could be reading out this year, how are you feeling about the shape of Genmab through to 2030 on both revenues and operating profit?
Anthony Pagano
ExecutivesYes. 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 to date now sort of underpinning that, I think, are 2 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 peto, particularly for Rina-S and peto, particularly from financial planning purposes, I see 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 '25 and get into '26 and beyond, we're in a fundamentally different size and scale, which means we'll be 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 and sort of good old-fashioned like 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 IIIs, that number, as you can see, is increasingly going up. So we're going through that together with Tahi 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 we'll continue to do that in '26 and beyond, and that's going to free up capital for some of the expansion opportunities for Rina and peto and potentially other programs as well.
Zain Ebrahim
AnalystsI think that's brought us to time. So thanks, Jan, thanks, Tahi and thanks, Anthony. Thanks, everyone, for being here.
Jan van de Winkel
ExecutivesThank you.
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