Genmab Q4 2025 Earnings Call - 2026 lined up for multiple registrational readouts that could enable 2027 launches

Conference Operator: Hello, and welcome to the Genmab full year 2025 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipate, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note, Genmab may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would like to hand the conference over to our first speaker today, Jan van de Winkel.

Please go ahead.

Jan van de Winkel, CEO, Genmab: Hello, and welcome to our financial results call for 2025. With me today is our Chief Financial Officer, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahamtan Ahmadi, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. As we reflect on 2025, I would like to remind you of the commitments that we made at the beginning of the year. We said that we would accelerate the development of our high-impact late-stage pipeline, that we would maximize the potential of our commercialized medicines, and that we would deliver on our capital allocation priorities.

I’m pleased to say that we have delivered on these commitments, and we begin 2026 with a diversified, high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the 2030s. In 2025, we grew total revenue by 19%, fueled by both our royalty portfolio and sales from our own medicines. We also invested fully aligned with our capital allocation priorities. Importantly, we have also grown operating profit, even while making these strategic investments. 2025 was marked by some significant milestones in our mission to deliver innovative medicines to patients. Highlights include positive momentum for Epkinly, as it continues to demonstrate the potential to become a core therapy in B-cell lymphomas. Its FDA approval in second-line follicular lymphoma in combination with R², as well as the unprecedented data in this indication, are key milestones.

Taken together, these move treatment into earlier lines of, of therapy and expand our impact for people living with follicular lymphoma. We also built on our commitment to the gynonc community. In addition to the availability of Tivdak in both Japan and Europe, we expanded the development of Rina-S, ending the year with three phase 3 trials across PROC, endometrial cancer, and PSOC. Finally, a pivotal step on our journey to sustainable, diversified growth was our acquisition of Merus, which enhanced our late-stage portfolio with petosemtamab. Petosemtamab, with petosemtamab joining Epkinly and Rina-S, we have a strong pipeline of late-stage assets that will provide us with multiple value-creating catalysts in 2026 and in the future. Now, let’s take a look at the strength of these three programs on the next slide.

With our five combined breakthrough therapy designations, these three programs have multi-billion dollar potential, and they firmly underpin our long-term growth. Epkinly is currently the only bispecific antibody with a dual indication across B-cell malignancies in the U.S., Europe, and Japan. Following unprecedented data, Epkinly plus R-squared is well positioned to become a best-in-class option in second-line plus follicular lymphoma. Rina-S is a folate receptor alpha-targeted ADC, designed to broaden eligibility beyond high expressers. Based on current expression distributions, this could expand the addressable PROC population by as much as three times versus approved medicines that are restricted to high folate receptor alpha expression. Finally, petosemtamab, a potentially transformative EGFR LGR5 bispecific antibody with compelling data in both first-line and later-line recurrence and 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 3 times higher than the 19% that has been observed at the standard of care. 2026 will be a defining year for all three of these programs, as we will see on the next slide. We expect up to 6 potentially 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 2 data for Rina-S in platinum-resistant ovarian cancer. We also anticipate that one or both phase 3 trials for petosemtamab in first- and second-line or third-line head and neck cancer will deliver top-line data in the second half.

While we anticipate around 25,000 potential patients for later lines of therapy, in first line head and neck cancer, this increases to an additional 41,000 patients. For Epkinly, we anticipate data from two Phase III trials in diffuse large B-cell lymphoma. The indication with the largest addressable patient population, around 70,000 people, is, of course, frontline diffuse large B-cell lymphoma, and we are looking forward to data in this indication in combination with R-CHOP this year. We are also looking forward to data in the first half of the year in second-line plus diffuse large B-cell lymphoma in combination with lenalidomide. Now, as you are aware, in January, we announced top-line results from the Phase III EPCORE DLBCL-1 trial of Epkinly monotherapy.

The results showed an improvement in progression-free survival, as well as improvements in complete response rates, duration of response, and time to next treatments. And in fact, this is the first phase III study to demonstrate an improvement in progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma who are treated with a CD3/CD20 T-cell engaging bispecific monotherapy. Overall survival did not reach statistical significance, and further analysis of the data is ongoing, including the potential impact of a variety of factors, including COVID-19 and the increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting, and we will engage with global regulatory authorities on next steps. The monotherapy results do not change our expectations for our other phase III trials.

We are very confident that these studies continue to have the potential to move Epkinly earlier in the treatment paradigm and significantly increase its, its addressable population from approximately 27,000 patients today to almost 150,000 patients by early in the next decade. The data presented across Epkinly, Rina-S, and petosemtamab in 2025 strengthened our our conviction in these programs. Now, in 2026, it is the meaningful registrational readouts that will be the catalyst that allow us to potentially bring these antibodies to to patients in 2027. I’m pleased to now hand you over to Brad for a review of the recent commercial performance for Epkinly and Tivdak.

Brad Bailey, Chief Commercial Officer, Genmab: Thanks, Jan. 2025 marked another successful year for our commercialization team. We maintained leading positions for our proprietary brands globally, and we made important progress evolving into a wholly owned model, fueling our long-term growth engine. In the past year, we successfully executed 4 key launches across our portfolio, 2 of which were led entirely by Genmab, demonstrating the strength of the commercialization model we’ve built in the U.S., Japan, and now in Europe. We expanded our footprint to 3 additional markets, opening business operations in Germany, the U.K., and France, and we delivered on our commitment to bringing our antibody-based medicines to patients in area of high need. To this end, Tivdak became the first ADC approved in recurrent or metastatic cervical cancer in the E.U., U.K., and Japan, providing a much-needed option for patients whose disease progresses after initial therapy and where outcomes have historically been poor.

With its approval in the US in relapsed or refractory follicular lymphoma, Epkinly became the first bispecific antibody approved in any form of non-Hodgkin’s lymphoma in the second-line setting, and the first bispecific combination therapy approved in the lymphoma space. These milestones represent progress for patients, and they set the foundation for our growth trajectory in gynecologic cancers, along with Rina-S in the future, and further into B-cell malignancies. Through our efforts in 2025, sales of our proprietary medicines totaled $632 million. This is up 54% year over year and accounting for approximately 28% of our total revenue growth. We expect this growth trajectory to continue in 2026, grounded in the strong foundation we’ve built as we deliver our own medicines to an increasing number of patients around the world.

Now let’s take a closer look at Epkinly. We closed out 2025 with solid performance, achieving $468 million in sales for the year, which represents a 67% year-over-year increase. This performance was driven by continued growth for the brand across geographies as the first and only bispecific, with approved dual indication in diffuse large B-cell lymphoma and FL in Europe, Japan, and the U.S. In fact, Epkinly closed 2025 with regulatory approvals in more than 65 countries, nearly all of which feature the dual indication. We continue to be encouraged by Epkinly’s strong momentum and the positive feedback we hear from physicians across geographies regarding Epkinly’s differentiated clinical profile, powerful efficacy, and proven safety, and the value of having a single dual indication option across DLBCL and FL.

In the U.S., this momentum’s translated to continued growth for Epkinly across sites of care, with an acceleration in new sites ordering, including in the community and the majority of health systems now ordering from multiple sites. As expected, following the launch of Epkinly in second-line FL in November, we’re seeing increased uptake, suggesting that this approval will be a growth driver for the brand. In Japan, we continue to see Epkinly’s launch in third-line plus FL build on the brand’s success in large B-cell lymphoma. This is driven in large part by Epkinly’s dual indication differentiation and execution by our field teams to activate sites. ... Across all other markets, we continue to increase our presence through our partner, AbbVie, and its global footprint.

We closed out the year with yet another quarter of solid sales of Epkinly in these markets as we continue to see rapid uptake in countries gaining access and reimbursement. Looking ahead, 2026 will be a pivotal year for Epkinly as we advance our position in early lines of therapy and anticipate key data readouts supporting Epkinly’s versatility and status as the core therapy in B-cell malignancies. Our focus is on delivering Epkinly to as many patients as possible, particularly in early lines of therapy, where we see the market opportunity, and critically, where we may have the opportunity to truly transform the trajectory of these diseases for patients. To that end, we’re maximizing our first-mover advantage in second-line FL in the U.S., and we expect to build on this opportunity across markets with anticipated approvals in this setting in Europe and Japan later this year.

With this traction in earlier lines of FL, we’re looking towards key readouts in 2026 in first and second-line DLBCL with fixed duration, Epkinly combination therapies to further strengthen Epkinly’s position in DLBCL. Together with a robust development program for Epkinly and strong execution by our teams, we see a clear opportunity for Epkinly to achieve blockbuster status over the next few years. Moving now to Tivdak. Tivdak continues to be recognized as the go-global standard of care in recurrent or metastatic cervical cancer. In 2025, Tivdak generated $164 million in sales, representing a 26% year-over-year increase. Tivdak continues to form well across both new and established markets, highlighting the clear need for treatments that improve survival for women with advanced cervical cancer across geographies. In the U.S., notably, Tivdak posted its fourth consecutive year-over-year growth, underscoring its continued market leadership.

This strong, stable performance continues to be driven by the depth and breadth of sites of care using Tivdak. In Japan, Tivdak demonstrated another strong quarter of continued performance, underscoring the traction it’s gaining in the second-line setting and the high patient need in recurrent and metastatic cervical cancer in the country. This trend continued in Europe, where the launch in Germany continues to be off to an encouraging start, with strong, consistent uptake and positive physician feedback. As the first medicine we’ve launched in Europe independently, our efforts in recent months have demonstrated our ability to strategically build infrastructure and scale in new markets. We received MHRA approval in December in the U.K. and are now working towards reimbursement, reimbursement to bring Tivdak to more patients as soon as possible.

As we look ahead to the new fiscal year, we have the foundation in place to continue this momentum and bring Tivdak to additional markets. Infrastructure and operations are well underway in new markets, with our teams executing in preparation for exciting launches on the horizon. We expect to see continued positive performance across markets as we strengthen and scale our presence and broaden our impact within the gynecologic cancer community. Wrapping up, 2025 was a critical year in our company’s evolution. We built on our proven launch expertise and scientific strength and achieved key milestones to solidify our commercialization model and business operations that will unlock our ability to deliver on the significant growth opportunities ahead of us.

Our proven ability to evolve our model in the U.S. and Japan, coupled with the early traction we are seeing in Europe, gives us the confidence that we have the pieces in place today to drive future growth and expansion. With this strong foundation, 2026 is shaping up to be another meaningful year for Genmab. We will grow the impact of our proprietary portfolio, expand our footprint, and sharpen our capabilities as we look toward entering new and larger market opportunities and delivering on the blockbuster potential of Epkinly, Rina-S, and petosemtamab in the coming years. With that, I’ll hand the call over to Anthony to discuss our financials.

Anthony Pagano, Chief Financial Officer, Genmab: Thanks, Brad. 2025 was a year of strong execution for Genmab, with solid revenue growth, expanding profitability, and disciplined investment. Looking ahead, our 2026 guidance reflects the same framework we outlined at Q3 and at the time of the Merus acquisition. It also reflects our continued commitment to funding growth while maintaining substantial profitability. Now, before diving into the numbers, please note that the results and guidance I will, I will review exclude the impact of acquisition-related expenses, including amortization. A reconciliation to our reported results is included in the appendix. In 2025, total revenue increased 19% to $3.7 billion, reflecting strong execution across our royalty portfolio, as well as continued progress for our commercialized medicines. We also continued to improve the quality of our revenue profile with a higher contribution from our own medicines, especially Epkinly, further diversifying our revenue base.

In addition, we strengthened our long-term growth potential with the addition of petosemtamab to our late-stage pipeline. Alongside the Merus acquisition, we made targeted strategic investments during the year, with operating expenses up 13%.... The investments we made in building our commercialization capabilities are already delivering for us today, and importantly, they are positioning us to support expansion into earlier lines for Epkinly and the potential launches of Rina-S and petosemtamab in 2027. And even with these investments, we expanded operating profit to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales. Overall, 2025 demonstrates the strength and quality of Genmab’s underlying financial performance. Turning to our 2026 guidance, our framework is straightforward. Revenue growth enables strategic investment, which supports long-term value creation.

At the midpoint, we expect 14% total revenue growth, driven by continued momentum in Epkinly and our royalty portfolio, further enhancing revenue quality. More specifically, we expect DARZALEX net sales in the range of $15.6 billion-$16.4 billion. As discussed previously, expectations for operating expenses were in a reasonable place. For 2026, the increase in operating expenses reflects planned investments to advance late-stage development for petosemtamab and Rina-S, as well as launch readiness activities to support multiple potential product launches. Even with the strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026. With that, now I would like to provide some context for how revenue growth supports a deliberate increase in investments while delivering $1.15 billion of operating profit at the midpoint for 2026.

You can see this on the chart on the right. What really stands out is the strength of our underlying business, demonstrated by strong organic operating profit growth before our planned investments in pitocentimab. Here, we are choosing to reinvest part of the operating leverage now to strengthen future growth drivers, while continuing to manage costs actively and maintain profitability discipline. This balance, reinvesting to support growth while driving substantial profitability, is a core feature of our operating model. Taken together, our 2025 results and 2026 guidance demonstrate consistent delivery against our financial commitments. Our capital allocation framework remains fully aligned with our strategy to drive sustainable growth well into the 2030s. First, we will continue to invest to accelerate our late-stage pipeline and maximize the success of our commercialized medicines, including launch readiness.

These investments are intended to generate meaningful revenue for us in the future. Second, we will continue the rapid integration of Merus to accelerate value capture while maintaining focus and prioritization. Third, we remain committed to deleveraging, targeting gross leverage below 3x by the end of 2027, maintaining balance sheet strength and flexibility. In summary, our performance in 2025 underscores our ability to deliver revenue growth, our ability to advance key pipeline assets, and our ability to maintain strong profitability through disciplined execution. Looking ahead to 2026, we are building on this momentum through disciplined prioritization of our investments, continued operating discipline, and expansion of market opportunities. This positions us for sustained growth and long-term value creation. On that note, I’m going to hand you back over to Jan.

Jan van de Winkel, CEO, Genmab: Thank you, Anthony. Our confidence in our ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 come from our track records. We have proven that we are excellent evaluators of innovation and that we deliver on our promises. 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 are committed to delivering profitable growth. Genmab is a skilled oncology biotech business with strong momentum, an increasingly diversified growth profile, and multiple catalysts ahead. As we begin 2026, our focus remains on translating our antibody science and development expertise into meaningful breakthroughs for patients and long-term value for shareholders. That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.

Conference Operator: Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star, one, one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star, one, and one again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question. Thank you so much for your understanding.... Please stand by. We’ll compile the Q&A to you. This will take a few moments. Now we’re going to take our first question. It comes to the line of Jonathan Chang from Leerink. Your line is open. Please ask your question.

Speaker 6: Hi, guys. Thanks for taking my questions. Can you discuss what the next steps are for Epkinly, following the results of the EPCORE DLBCL-1 study? Can you still get the second line plus label with the EPCORE DLBCL-4 combination study? And what was the rationale, I guess, behind using the monotherapy DLBCL-1 study as the confirmatory study in the first place? Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Jonathan, for the questions. I will hand it over to Tai to explain in further detail what the next steps are for the regulatory part for 05. Tai?

Tai, Executive (likely Chief Medical Officer or similar), Genmab: Yeah. Thank you, Jan, and thank you, Jonathan, for the question. Yes, so as we had already indicated in the press release, I mean, the 05 study is positive by PFS as a single agent beating a chemoimmunotherapy regimen on progression-free survival, but it missed the overall survival, confounded by key aspects that are already discussed in the community. One is being COVID. The study was involved heavily during the Omicron wave, and the other one is the emergence of access to bispecifics, of which we are an important part as well. So we’ll have this discussion with the agencies.

They have pre-specified analysis in the protocol that were already agreed prior to the readout on these two major biases, and so we’ll have this conversation both with the FDA and, of course, with the European health authorities and the overall health authorities on the data set. We’re also gonna have this conversation with you guys, once it is in the public domain. As it relates on the rationale for, which was your third question, on the rationale for why this is the confirmatory study, it’s important to put yourself back into the situation where we were when this Epkinly program started.

This was the first phase 3 to be initiated, and and hence it was the confirmatory study, because the requirement for an accelerated approval is that you have a confirmatory study initiated and really actually well underway by the time you file for for for the accelerated approval, which is why this was initially, why it was for a long time, the only diffuse large B-cell study, the confirmatory study. Discussions are ongoing with the agencies about all the other, phase 3 studies that we have, ongoing, 2, specifically, for which we both are already guided, that we will have a readout this year.

There is absolutely from our end and no indication from any of the health authority interactions, any readouts to the viability of the other study that has been conducted and that we already guided, will read out in the first half of this year, which is the combination with Len Epco in second line, third line. This is a separate study that was set up separately. This was started and initiated after the Omicron wave. It is testing a combination regimen with lenalidomide, with a fixed duration, as Brad was alluding to earlier. So it’s a different study with different opportunities, and we’ll be looking forward to have this data in our hand and to also, like, communicate them to the community and then to engage with health authorities as appropriate.

Jan van de Winkel, CEO, Genmab: Thanks, Tai. Jonathan, I think that answers your question then, yes?

Speaker 6: Understood. Thank you very much.

Conference Operator: Thank you.

Jan van de Winkel, CEO, Genmab: Thank you.

Conference Operator: Now we’re going to-

Jan van de Winkel, CEO, Genmab: Let’s move to the ne-

Conference Operator: Oh, yes, of course. The next question comes from the line of Astika Gunewardene from Truist. Your line is open. Please ask a question.

Speaker 1: Hey, guys. Thanks for taking my question. So you presented Epco outpatient data late last year. Just want to get an update from you on how this data has been adapted to change in the practice in the US. I guess, given, maybe you can give us an idea of what proportion of community clinics that are still sending DLBCL patients to a large center to get that step-up dose monitoring. And then just maybe to tag on to Jonathan’s question, could you put us at ease and just tell us what you think is the likelihood that you’ll be able to convince the regulatory agencies to consider one of the many other Epco phase three study readouts that are coming this year as a confirmatory study? Thanks.

Jan van de Winkel, CEO, Genmab: Thanks, Astika, for the questions. I will first hand it over to Tai, and then also Brad will definitely be able to comment on the commercial use of Epkinly, I believe. But, Tai, why don’t you start with the first question?

Tai, Executive (likely Chief Medical Officer or similar), Genmab: Yeah, I mean, thank you. I should go with this question. So I’m gonna reiterate to the degree, but, reaffirm what I said earlier. We have, at this point, 3 phase 3s in diffuse large B-cell, 1 that we already announced the results, and then 2 that we already announced we’re gonna have the results this year, 1 in the first half at least, and the other one we have not committed to it. So, we are extremely comfortable, to a degree also by, by the precedent already set on the, on the glofitamab program, but also generally speaking, that, this is, this is really not a concern on our end, in terms of the confirmation trial.

We have two major phase 3s that are reading out in addition to a study that was positive on PFS, but confounded on OS. So this is. As much as I can say at this point, we are not concerned about this, and don’t see a reason to be concerned also, if you look at the precedent that was set by R-squared. On the outpatient, I’ll leave it to Brad to talk about the pattern of prescription, but what I would say to the outpatient study is that that was an important strategy for a variety of reasons. One is, of course, what Brad talked about, practice patterns in the community, but it’s also an incredibly important component for our overall regulatory strategy to modify the label.

and to have label language that then also facilitates administration of Epkinly in the community, and then Brad, you can take it from here.

Speaker 12: Yeah, no, Ty, just dovetailing off that, you’re absolutely correct. And we do see this as certainly an enabler, if you will, and as we continue to evolve and receive physician feedback, specifically moving into even earlier, more early lines of therapy, see this as a potential, a great opportunity for us.

Jan van de Winkel, CEO, Genmab: Thanks, Brad. Thanks, Tai. Let’s move on to the next question. Thank you, Astika.

Conference Operator: Thank you. Now we’re going to take our next question, and it comes from the line of Xian Deng from UBS. Your line is open. Please ask a question.

Speaker 17: Yeah. Hi, Xian from UBS. Thank you very much for taking my question. So, I have one on Rina-S, please. So given the pivotal phase two that’s due to come out this year, and given this is kind of a pivotal phase two, and it’s not a formal phase three. So just wondering, what determines when you can decide you are going to have a readout? You know, what is the definition of this? Because I guess here you don’t have to have a, you know, the formal PFS here, and it’s an open label trial. So that’s the first question. And then, sorry, the second one, so just a very quick yes or no question, please.

For Epkinly frontline DLBCL trial, just wondering, can you confirm whether you have passed the interim, please? Thank you.

Jan van de Winkel, CEO, Genmab: Well, thanks, Xian, for the questions. The first one I will ask Judit to address, and then Ty can give a very short answer on the second question. Judit, why don’t you start on the phase 2 data for Rina-S?

Judith Klimovsky, Chief Development Officer, Genmab: Yeah, thank you for the question. So the study was designed or the pivotal arm, with a potential outcome of being supportive of accelerated approval. An accelerated approval is a path that the FDA has for drugs when the results support with the substantial benefit over current standard of care, with endpoints that can predict substantial benefit. So the way the phase two design is for ORR and duration of response, which is our validated endpoint as surrogate for clinical benefit. Now, the accelerated approval is also dependent on having phase threes with clinical endpoint. As you know, we have O-two study ongoing, which is a phase three with PFS as always as a primary endpoint.

Jan van de Winkel, CEO, Genmab: Thank you. Thank you, Judith. Then maybe, Tai, can you give some color on the frontline, the first-line follicular lymphoma study?

Tai, Executive (likely Chief Medical Officer or similar), Genmab: Yeah, thank you for the question, and I appreciate the attempt of a yes or no question, but we’re just going to reiterate what we’ve been saying publicly since J.P. Morgan, that we expect the readout for the study to happen in 2026.

Jan van de Winkel, CEO, Genmab: Thanks, Tai. Thanks, Xian, for the questions.

Conference Operator: Thank you. Now we’re going to take our next question. The question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask a question.

Speaker 12: Hi, thanks for taking my question. So just, same with Epkinly. Could you just discuss your expectations into the EPCORE DLBCL 4 trial? What do you think is a clinically meaningful outcome here, especially relative to Lunsumio and Polivy? Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Rajan, for the question. Ty, can you handle the address, the DLBCL four question?

Tai, Executive (likely Chief Medical Officer or similar), Genmab: Well, I mean, the anticipation is that it will actually be a trial that will get registered, which is the first differentiation to these studies that you mentioned. That’s, I think, the intent. It’s a study that has a combination with lenalidomide that was involved exclusively after the immunotherapy wave, which was a significant confounder for a lot of the studies that were run with these bispecifics in the diffuse large B-cell space, not only the diffuse large B-cell, but relevant to this conversation. We’re really excited and looking forward to this data set, which will also have a larger portion of second-line patient. So the expectation is that this is a trial that will be positive and then will lead to registration in second-line and third-line.

Jan van de Winkel, CEO, Genmab: Thanks, Ty. Thanks, Rajan, for the question. Let’s move on to the next one.

Conference Operator: Thank you so much. Now we’re going to take our next question from Judah Frommer, from Morgan Stanley. Your line is open. Please ask a question.

Speaker 12: Yeah, hi, thanks for taking the question, guys. Just curious on your thoughts on the pembro approval in PROC recently and kind of implications for Rina-S, and then, maybe just more high level, we appreciate the guidance on DARZALEX, but I guess just kind of given positive data in combo with bispecific at ASH, just curious if you have any kind of high-level thoughts on the DARZALEX trajectory over the coming years, maybe versus where your expectations were, you know, 6, 12 months ago for that drug. Thanks.

Jan van de Winkel, CEO, Genmab: Thanks, Judah. Judith, can you start, and then maybe Tai can chip in?

Judith Klimovsky, Chief Development Officer, Genmab: Yeah, thank you. Thank you for the question. So we, you know, we were aware of the data and the approval. I think it’s a good potential option for patients. However, two things, and not to underestimate, first, that the approval is in PD-L1 positive CPS1 above 1%, and this encompasses around 70% of the population. And B, the combination includes weekly taxol, which is not minor for patients. So on the one hand, it is great that patients have another option. On the other hand, you know, we believe that Rina-S can be more transformative and serve the full broad population.

Jan van de Winkel, CEO, Genmab: ... Thanks, thanks, Judith. I think that addresses your question, Julian-Judith. So, let’s move on to the next one.

Conference Operator: Thank you. The next question comes from the line of James Gordon from Barclays. Your line is open, please ask your question.

Speaker 4: Hello, James Gordon from Barclays. Also a question on Epkinly and first line DLBCL. So, my question was, what are you hoping to see when the trial reports in terms of the OS benefit? Would you hope to see a strong OS benefit, even though it is a first line trial, and some other agents like Polivy had struggled to do that, and then that related to the lack of OS benefit? And then sort of connected to it, what is the efficacy bar? Are you just hoping to be static, or do you need to be materially better than Polivy, given that Roche are doing a CD3, CD20 on top of Polivy? And maybe also thoughts on the JUPITER front line trial as well, in terms of whether that sets any sort of bar.

Jan van de Winkel, CEO, Genmab: Thank you, James, for the questions. This is definitely Tai questions and very exciting questions. So let’s see what Tai answers them.

Tai, Executive (likely Chief Medical Officer or similar), Genmab: All right. Let’s try my best to answer your questions in sequence. I think the first part that I think we’ve been very clear for a while is that the primary endpoint is PFS. The expectation on our end, the anticipation and the excitement is that we believe that Epkinly in combination with R-CHOP will be transformative. Of course, the data will have to show it. We’ve been arguing for a while that the robust phase 2 data sets have been quite informative in our development. On the second line for the confirmatory, just to remind everybody again, the phase 3 mimicked almost to a point the efficacy that we had seen in the second line data set in combination with len square, R square in second line fully confirmatory.

If you then go back and revisit the data that’s in the public domain on R-squared combination with Epkinly and IPI 3-5, and particularly pay attention to the CR, which is the most relevant data point. So, there is a reason, and this is where the excitement, the enthusiasm, the expectation comes from our end, to believe that the study will be quite positive. Now I’m not going to speculate on what positive really, really means, but certainly on a compound by compound, we anticipate that it’s going to exceed the currently reported phase 3 data sets that are positive.

As it relates to OS, you’re absolutely right, in the few such pieces, OS is an endpoint that lags to a degree also by a change on, practice, but also because of the impact on PFS. So I think this is a discussion we can have once we have the data set, and we can have a conversation on the scale of, improvement in PFS and how that translates to us.

Jan van de Winkel, CEO, Genmab: Thanks, thanks, Ty. I think we have to leave it at that, but that was very good answer. Thanks, thanks, James, for the question. Let’s move on to the next question.

Conference Operator: Thank you so much. The next question comes from the line of Zain Abrahim from JP Morgan. Your line is open, please ask a question.

Speaker 19: Zain Abrahim, J.P. Morgan. Thanks for taking my question. Quick clarification question on Epkinly, just in the first line, the DLBCL trial, in terms of the events tracking, how those are tracking relative to your expectations, given reiteration of this 2026, as opposed to sort of narrowing it down to the first half? And then my actual question was on the Merus acquisition. So following the acquisition completion, have you spoken to the FDA about the trial design for the ongoing phase 3 trials? And based on those conversations, how confident you are that objective response rate is sufficient as a regulatory endpoint?

Jan van de Winkel, CEO, Genmab: Thanks, Zain, for the question. So I’ll ask Ty to talk a bit about events tracking, if we can, and then Judith can potentially address the PITO question on trial design in head and neck cancer. Ty, why don’t you start?

Tai, Executive (likely Chief Medical Officer or similar), Genmab: On events tracking, I don’t necessarily think this is what we do in calls like this, that we give a commentary on events tracking.

Jan van de Winkel, CEO, Genmab: We cannot comment.

Tai, Executive (likely Chief Medical Officer or similar), Genmab: This is not something that we can do right now, but we obviously do track them.

Jan van de Winkel, CEO, Genmab: All right, thanks. Then let’s move on to Judith, and then maybe some feedback on the design of the head and neck pivotal trials for petosemtamab.

Judith Klimovsky, Chief Development Officer, Genmab: Yeah. Yeah, no, thank you for the question. As we all know, I mean, the two phase 3 studies have a dual endpoint, ORR and OS, which I would say, as you know, the Origami 5, recently published, has as well, ORR and PFS. So it’s quite the standard that in areas of unmet medical need, the FDA, and even other health authorities, can be prone to an earlier endpoint that can be good surrogates or associated with more overall survival. So we feel good with the dual endpoint that both studies have. And of course, you know, as part of the integration, we are digging into the operational characteristics of the studies, but we are pleased with the design as is, initially, and, yeah, and with the dual endpoint.

Jan van de Winkel, CEO, Genmab: Thank you, Judith. Thanks, Zain, for the, for the questions. Let’s move on to the next one.

Conference Operator: Thank you so much. The next question comes from the line of Suzanne Barber, who is in from Van Lanschot Kempen. Your line is open, please ask your question.

Speaker 14: Hi, team, this is Suzanne from Kempen. Thanks for taking my question. I was wondering for petosemtamab, whether we should be expecting a phase 1/2 data update in head and neck cancer during this year at a medical conference?

Speaker 8: Considering especially the frontline data set, the mature data since ASCO last year, this could be very insightful for the market ahead of the phase three readouts. If there is a data update, could you elaborate what you believe the expectations should be on duration, metrics, and survival, for example? Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Suzanne, for the questions. I will ask Judith to comment on that. Suzanne, as you know, we hope to see one or both of the phase three data this year, but you asked specifically about the phase one, two data. Judith?

Judith Klimovsky, Chief Development Officer, Genmab: Yeah, no, thank you for the question. But I, I want to reinforce that the last read was, last readout for the, Tivdak pembro combination was with, around 15 months follow-up, which allowed to see 79% of patients, at 12 months landmark overall survival. So of course there is censoring, but the censoring happened, after the 12-16 months, which, what is what you expect from the control arm. So what I’m trying to say is that the last, ASCO 2025, presentation from Merus, is very informative in terms of the probability of success of the phase 3, and, you can, take advantage of that presentation already.

Jan van de Winkel, CEO, Genmab: Thank you, Judith. Thanks, Suzanne, for the question. Let’s move on to the next one.

Conference Operator: Thank you. Our next question comes to line of Yaron Werber from TD Securities. Your line is open, please ask your question.

Speaker 18: Great. Thank you so much. So quick question, just as a natural follow-up. Oh, the Origami-five study, as you mentioned, uses Keytruda and chemo as a combo, presumably in patients with more bulky, aggressive disease in frontline. Would you consider doing the same sort of trial design with Pito? Thank you.

Jan van de Winkel, CEO, Genmab: Judith, can you address that question from Yaron-

Judith Klimovsky, Chief Development Officer, Genmab: Yeah

Jan van de Winkel, CEO, Genmab: on Origami five?

Judith Klimovsky, Chief Development Officer, Genmab: Yeah. Yeah, no, thank you for the question. So first, let me note that we stand behind the original strategy, which is combining petosemtamab with pembro. And the reason is that the 65% ORR, furthermore, with 6 CRs, is unprecedented, even in the context of what we know for pembro chemo. So we are very pleased that, you know, Merus put in place a strategy that could offer a chemo-free option for patients. You know, having said that, given the data that you have seen and we have seen on petosemtamab, we believe that the CDP potentially could be expanded in many different directions. This could be one, but we are very, we think that the chemo-free combination for patients that can offer almost double what the chemo can offer is a very good value proposition for patients.

Jan van de Winkel, CEO, Genmab: Thanks, Judith. Thanks, Yaron, for the questions. More to come.

Conference Operator: Thank you. And our next question comes from the line of Keza Ding from Rothschild & Co. Your line is open. Please ask your question.

Speaker 11: Hi, guys. Thanks for taking my question. So I noticed that the petosemtamab is at phase 2 stage for combining pembrolizumab in first-line non-small cell lung cancer. Just wanted to clarify, is this a new trial that was started in Q4 2025? If so, could you please share your high-level thoughts and expectation behind this study? Thanks.

Jan van de Winkel, CEO, Genmab: Thanks, Keza, for the question. Judith, can you comment on the lung cancer trial for Pito?

Judith Klimovsky, Chief Development Officer, Genmab: Yeah, yeah, I can. Thank you. As we all know, you know, EGFR is a good target for lung cancer. The study was planned as a signal-seeking in the indications where Cetuximab showed the maximum benefit, and in combination with Pembro, given that what we know, which is the synergy between Pito and Pembro. It’s a signal-seeking study, and we will update you when we have data.

Jan van de Winkel, CEO, Genmab: Thanks. Thanks, Judith. Thanks, Keza, for the questions, question. Let’s move on to the next one.

Conference Operator: Thank you. The next question comes from the line of Matthew Phipps from William Blair. Your line is open. Please ask a question.

Speaker 8: Thank you for taking my question. Just to confirm, you list an additional phase 3 for Pito in 2026. Is that the locally advanced trial that you have already talked about or something else? And do you anticipate providing any update from the colorectal cancer cohorts that we saw in the fall, or maybe thoughts on the development plan there? Thank you.

Jan van de Winkel, CEO, Genmab: Thank you, Matt, for the question. So, Judith, maybe you can address both of them.

Judith Klimovsky, Chief Development Officer, Genmab: Yeah. Thank you. Thank you for the question. So yeah, the data that Merus presented in December on colorectal was very encouraging, although a limited number of patients. As it was shown publicly, each one of the cohorts is to enroll 40, 40, and 60. So this data set is growing, and as the data is growing, we plan to inform the medical community and we have not decided when, but the data set is growing. And in terms of future phase 3s, we already mentioned the locally advanced head and neck, and we are actively working on a comprehensive clinical development plan.

Jan van de Winkel, CEO, Genmab: Thanks. Thanks, Judith. Thanks, Matt, for the question.

Conference Operator: Thank you. And now we’re going to take our next question, and it comes from the line of Victor Floc’h from BNP Paribas. Your line is open. Please ask your question.

Speaker 16: Hi, thanks so much for taking my question, Victor Floc’h, BNP Paribas. So maybe a quick one on the pipeline, and I mean, more specifically, your early stage pipeline, which has been, you know, significantly streamlined over the last 12 months, and to my knowledge, only contains now two clinical stage bispecific. So I just wanted to, you know, hear your thoughts and maybe whether you can discuss your priorities moving forward in terms of platform, technologies and therapeutic areas. Because I can’t really like see any ADCs. So maybe it’s I mean whether you can discuss like what are the technologies behind the two recent INDs you’ve done.

But so, you know, moving forward, whether you can discuss whether you believe you have enough candidates in-house, or should we expect also some early-stage M&A, at some point? Thanks so much.

Jan van de Winkel, CEO, Genmab: Victor, let me, let me start off here, and then Tai can definitely chip in. We have recently actually had three IND filings, one for a bispecific antibody, one for an ADC, making use of the linker and payload technology which we acquired via ProfoundBio. And one which is a bispecific, also including the HexaBody technology. So when you look at our whole pipeline overall, 45% is ADC right now, 50% is DuoBody-based, so bispecific-based, and 5% HexaBody-based, Victor. But we are right now integrating both the Merus pipeline and the Genmab pipeline, and only prioritize the high-impact ones, basically, for further development. So we have a very, I think, diversified pipeline, all based on next-generation antibody technologies.

But I will stop here and maybe Ty can give you a bit more color on the organic pipeline, which is still a key priority for the company to actually fill the pipeline with candidates, which can then be promoted to mid and late stage programs in due time. Ty?

Tai, Executive (likely Chief Medical Officer or similar), Genmab: Yeah, yeah. And I mean, you kind of like framed this already, right? So as you said, when we have three ideas that we file towards the end of the year with, you know, that are all expecting dosing this month. More to come on this end, in this year as well. And our focuses are, and now particularly also after the integration of the Merus and the capabilities that came through that integration, continue to be in antibodies. And they fall into these categories of next-generation ADC platforms, which is increased interest of our research in Suzhou, and next-generation bispecific and trispecific platforms. There is obviously a focus on our research capabilities in Utrecht, and that’s what we’re going to continue to do.

There is, of course, a change now with a very heavily focused late-stage landscape within Genmab, with petosemtamab being positioned in head and neck and maybe we’ll see in the future also opportunities in colorectal with Rina-S being positioned in the gynonc space and ovarian and endometrial, but also maybe possibly based on data, also opportunities in other receptor alpha tumor space. Very clearly also a change on how we think internally about where our focuses should be, right? So it’s not completely a disease area focus, but without a doubt, we’re starting to get into a space where we’re also starting to think about combinatorial strategies for our internal assets. But generally speaking, you should expect more to come from our internal capabilities.

That in of itself does not preclude that we will not continue to look for external innovation, because that’s what we’re going to do.

Jan van de Winkel, CEO, Genmab: Thanks. Thanks, Ty. I think Victor will leave it at that. Thanks, Victor.

Speaker 16: Yeah, thanks so much.

Conference Operator: Thank you. Now we’re going to take our next question, and the question comes line of Matthias Hagbaum from Handelsbanken. Your line is open. Please ask your question.

Speaker 9: Thanks so much. This is Matthias from Handelsbanken. I had one on petosemtamab, an asset which you now own. Help me think about what you need in terms of additional information from ongoing or future clinical trials to specify your current peak sales potential from multibillion-dollar to an actual number like you have for Epkinly and Rina-S. Thanks so much.

Jan van de Winkel, CEO, Genmab: Thanks, Matthias, for the question, and I will hand it over with pleasure to Anthony Pagano to see what he’s willing to say about the, multibillion-dollar potential of these molecules.

Anthony Pagano, Chief Financial Officer, Genmab: Yeah. Thanks, Matthias. So as you’ve heard from us since the time of the acquisition, we’re highly encouraged by the data we’ve seen so far for petosemtamab. Highly encouraged by the excitement and recognition from the FDA in terms of the breakthrough therapy designations, and really looking forward here to one or more data readouts, pivotal readouts, during the course of 2026. And equally, looking forward to potentially expanding into earlier lines in terms of starting a first phase III in locally advanced head and neck cancer. So if we look at this overall, petosemtamab has the characteristics of potentially being best in class, first in class, and we’re really focused on expanding, accelerating it to also make it broadest in class, starting of course in head and neck cancer.

For now, we’re gonna remain with our guidance in terms of multi-billion blockbuster potential. As we continue to review the opportunity, refine our CDP, see more data, we’ll look for the right time to update that. So I’m not gonna front-run this, Matthias, in terms of guiding to when we’re gonna potentially update guidance, but the key takeaway here really is that we’re very happy owners of petosemtamab, and we look forward to seeing the data later in 2026 and continue to expand and accelerate the CDP. Thanks so much.

Jan van de Winkel, CEO, Genmab: Thanks, Anthony. We will leave it to this, Matthias, but thank you for the question.

Conference Operator: Thank you. Now we’re going to take our next question, and it comes from the line of Sarah B from Guggenheim Partners. Your line is open. Please ask your question.

Speaker 13: Hi, this is Sarah on for Michael Schmidt from Guggenheim. Thanks for taking my question. I wanted to quickly circle back to Rina-S, if you could comment on the size of the opportunities for Rina-S, both in and outside of gynonc, including in lung. You have the ongoing phase 2. And then separately, super quickly, if you could clarify the terms of the debt offering announced late last year. Thank you.

Jan van de Winkel, CEO, Genmab: Thank you, Sarah. Anthony, can you address both questions, the size of the opportunity for Rina-S and also the debt offering terms?

Anthony Pagano, Chief Financial Officer, Genmab: Sure, happy to do so. First of all, everything I’ve just said about pitocentimab, I would echo for Rina-S. Very happy owners of Rina-S, and the team is really here looking for any and all opportunities to expand and accelerate the opportunity. Again, looking forward to the first potentially pivotal and registrational data here during the course of 2026, initially in the platinum-resistant ovarian cancer setting. Today, I can reiterate our overall guidance of $2 billion plus for Rina-S. That’s really underpinned by second line plus PROC, second line plus endometrial, second line plus PSOC, and then also moving forward, the frontline endometrial opportunity. What’s important to note for those first three indications that I’ve mentioned, second line PROC, second line endometrial, and second line PSOC, we’ve already initiated phase three trials.

So very excited about the opportunity, very excited about what we’re seeing in terms of the data so far, both in PROC and endometrial cancer. So that takeaway, as we continue to reiterate our PPR sales guidance of $2 billion+, and a very significant amount of clinical development work is ongoing to underpin that investment, that PPR sales guidance, excuse me. In terms of the overall debt offering, first of all, we’re very pleased with the demand for the offering, both in quantum, in terms of also the high-quality nature of the investors that ultimately subscribed to the deal. Again, it’s $5.5 billion, with roughly $2.5 billion of it being fixed. Another $3 billion is floating rate debt based upon a spread over three months SOFR.

Now, what we have done in top for the $3 billion that is floating, around $1.6 billion of that, we’ve hedged back to make it fixed. So net, $4.1 billion is now fixed, as well as the remaining being floating. One thing I would leave you with is that we’ve committed and remain committed to getting below 3x gross leverage by the end of 2027. And one maybe other data point to kinda help you sort of think this through would be if you look at the kind of weighted average, you know, based upon current market conditions, the weighted average sort of effective interest rate of the debt is around 6.6%. So that’s what I can help you guys for now.

Jan van de Winkel, CEO, Genmab: Thanks, Anthony. Thanks, Sarah, for the questions. Let’s see whether there’s any further questions. Operator?

Conference Operator: Now we’re going to take our last question for today, and it comes from the line of Benjamin Jackson from Jefferies. Your line is open. Please ask your question.

Speaker 2: Brilliant. Thank you. Conscious of the time, so just one from me. I guess longer term, are you able to comment on how you’re thinking about the level of sales and marketing investments needing to be made ahead of any potential launches, given that you’re now starting to get into the later stages a lot of this pivotal data? So how comfortable are you with how big and how where the team is located today, and how much more scale needs to be achieved with in terms of feet on the floor? Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Ben, for the question, and I will ask Brad to give you a short feedback here. Brad?

Brad Bailey, Chief Commercial Officer, Genmab: Yeah, thank you for the question, and we continue to be disciplined on OpEx as guided, and certainly we’ll invest strategically to strengthen the development and commercialization to bring our medicines to as many patients as possible. We’re strong with where we are today, both US and Japan, and the early signs in Europe are encouraging, and look forward to sharing more in the not-too-distant future.

Jan van de Winkel, CEO, Genmab: Thanks. Thanks, Brad. So more to come, Ben, in the future. Thank you.

Conference Operator: Thank you, Benjamin. There are no further questions for today. I would now like to hand the conference over to a speaker, Johan Zwinkels, for any closing remarks.

Jan van de Winkel, CEO, Genmab: So thank you for calling in today. If you have additional questions, please reach out to our investor relations team. We very much look forward to speaking with you, you again, soon.

Conference Operator: This concludes today’s conference call. Thank you for participating. You may now all disconnect. Have a nice day.