Genmab investor call efter årsregnskab med analytiker Q&A

Hello, and welcome to the Genmab Full Year 2025 Financial Results Conference Call.

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, Tahi 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. And we also invested fully [ in line ] 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 therapy and expand our impact for people living with follicular lymphoma. We also built on our commitment to the GynOc community. In addition to the availability of TIVDAK in both Japan and Europe, we expanded the development of Rina-S, ending the year with 3 Phase III 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 3 programs on the next slide.

With the 5 combined breakthrough therapy designations, these 3 programs have multibillion-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. And following unprecedented data, EPKINLY plus R2 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 population by as much as 3x versus approved medicines that are restricted to high folate receptor alpha expression. And finally, petosemtamab, a potentially transformative EGFR LGR5 bispecific antibody with compelling data in both first-line and later-line recurrent 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 3x higher than the 19% that has been observed with the standard of care.

2026 will be a defining year for all 3 of these programs, as we will see on the next slide. We expect up to 6 potential — 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 II data for Rina-S in platinum-resistant ovarian cancer. We also anticipate that one or both Phase III trials for petosemtamab in first and second line or third line head and neck cancer will deliver top line data in the second half. And 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 2 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 treatment. 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 the 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. And we are very confident that these studies continue to have the potential 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. The data presented across EPKINLY, Rina-S and petosemtamab in 2025 strengthened our conviction in these programs. Now in 2026, it is the meaningful registrational readouts that will be the catalysts that allow us to potentially bring these antibodies 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.

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 an area of high need. To this end, TIVDAK became the first ADC approved in recurrent or metastatic cervical cancer in the EU, U.K. and Japan, providing a much needed option for patients whose disease progresses after initial therapy and where outcomes have historically been poor. Additionally, when its approval in the U.S. — with its approval in the U.S. 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 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 for 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 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 perform 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 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.

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. And 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 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 continue 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’ve 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 to $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. And 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 petosemtamab. 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. And 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. And on that note, I’m going to hand you back over to Jan.

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 record. 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 scaled 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.

[Operator Instructions]. And now we’re going to take our first question, and it comes from the line of Jonathan Chang from Leerink.

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?

Thanks, Jonathan, for the questions. I will hand it over to Tahi to explain in further detail what the next steps are for the regulatory part for [ 05 ] Tahi?

Yes. Thank you, Jan, and thank you, Jonathan, for the question. Yes, as we already indicated in the press release, I mean, the [ 05 ] study is positive by PFS as a single agent beating a chemo-immuno 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, which we are an important part as well. So we will have this discussion with the agencies. They are prespecified analysis in the protocol that were already agreed prior to the readout on these 2 major biases.

And so we’ll have this conversation both with the FDA and of course, with the European health authorities and global health authorities on the data set. And we’re also going to 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 [ kidney ] program started. This was the first Phase III to be initiated. And hence, it was a confirmatory study because the requirement for an accelerated approval is that you have a confirmatory study initiated and really actually well on enrolled by the time you file for the accelerated approval, which is why this was initially — 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 III studies that we have ongoing to specifically for which we both 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 readout to the fail ability of the other study that is being conducted and that we already guided will read out in the first half of this year, which is the combination with [ EPCORE ] 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 will 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.

Thanks Tahi. Jonathan, I think that answered your question?

Understood. Thank you very much.

The next question comes from the line of Asthika Goonewardene from Truist.

So you presented EPCORE outpatient data late last year. I just want to get an update from you on how this data has been adapted to change in the practice in the U.S. I guess given maybe you can give us an idea of what proportion of community clinics that are still sending patients to 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 EPCORE Phase III study readouts that are coming this year as the confirmatory study?

Thanks, Asthika, for the questions. I will first hand it over to Tahi and then also Brad will definitely be able to comment on the community center use of EPCORE, I believe. But Tahi, why don’t you start with the first question?

Yes. I mean thank you, Asthika, for this question. So I’m going to reiterate the green, but reaffirm what I said earlier. We have, at this point, 3 Phase IIIs in diffuse large B-cell, one that we already announced the results and then 2 that we already announced we’re going to have the results this year, one in the first half at least, and the other one we have not committed to when. So we are extremely comfortable to a degree also by the precedent already set on the [ glofi ] program, but also generally speaking, that this is really not a concern on our end in terms of the confirmation trial.

We have 2 major Phase IIIs that are reading out in addition to a study that was positive on PFS, but confounded on OS. So this is — I can — 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 [ Russia ]. 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 talk 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 Brad, you can take it from here.

Yes. No, Tahi, 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 great opportunity for us.

Now we’re going to take our next question. And it comes from the line of Xian Deng from UBS.

So I have one on Rina-S, please. So given the pivotal Phase II that’s due to come out this year, and given this is kind of pivotal Phase II and there — it’s not a formal Phase III. So just wondering what determines when you can decide you are going to have a readout? What is the definition of this? Because I guess here, you don’t have to have the formal PFS here and it’s an open-label trial.

So that’s the first question. And then sorry, the second one, sorry, just a very quick yes and no question, please. So for EPKINLY frontline DLBCL trial, just wondering, can you confirm whether you have passed the interim, please?

Thanks, Xian, for the questions. The first one, I will ask Judith to address and then Tahi can give a very short answer on the second question. Judith, why don’t you start on the Phase II data for Rina?

Yes. Thank you for the question. So the study was designed or the pivotal arm with a potential outcome of being supportive of accelerated approval and 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 II design is, is for ORR and duration of response, which is our validated endpoint to [ slate ] for clinical benefit. Now the accelerated approval is also dependent on having Phase IIIs with clinical endpoint. As you know, we have [ O2 ] study ongoing, which is a Phase III with PFS as a primary endpoint.

Thank you, Judith. And then maybe Tahi, can you give some color on the frontline diffuse large B-cell lymphoma study?

Thank you for the question, and I appreciate the attempt of yes, no question. But we’re just going to reiterate what we’ve been saying publicly since JPMorgan that we expect the readout for the study to happen in ’26.

Now we are going to take our next question and the question comes from the line of Rajan Sharma from Goldman Sachs.

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?

Thanks, Rajan, for the question. Tahi, can you handle the — address the DLBCL-4 question?

Well, I mean, the anticipation is that it will actually be a trial that will be registered, which is the first differentiation to the studies that you mentioned. That’s, I think, the intent as a study that has a — as I said, combination with lenalidomide that was enrolled exclusively after the Omicron 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.

And we’re really excited and looking forward to this data set, which will also have a larger portion of second-line patients. And 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.

Thanks, Tahi. Thanks for the question. Let’s move on to the next one.

And now we’re going to take our next question from Judah Frommer from Morgan Stanley.

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 6, 12 months ago for that drug?

Thanks, Judah. Judith, can you start and then maybe Tahi can chip in.

Yes. Thank you for the question. So we are aware of the data and the approval. I think it’s a good potential option for patients. However, 2 things not to underestimate. First, that the approval is in PD-L1 positive CPS 1 above 1% and this encompass around 70% of the population; and b, the combination includes [ wekitaxel ], which is not minor for patients.

So on the one hand, it is great that patients have another option. On the other hand, we believe that Rina can be more transformative and serve the full broad population.

Thanks, I think that addresses your question, Judah. So let’s move on to the next one.

The next question comes from the line of James Gordon from Barclays.

James Gordon from Barclays. Also a question on EPKINLY in 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 has struggled to do that?

I know that related to lack of OS benefit. And then connected to it, just what is the efficacy bar? Are you just hoping to be start? Would you need to be materially better than POLIVY [indiscernible] given that Roche are doing a CD3 CD20 on top of POLIVY? And maybe also just thoughts on MONJUVI frontline trial as well in terms of whether that sets any sort of bar.

Thank you, James, for the questions. This is definitely Tahi questions and very exciting questions. So let’s see what Tahi answers.

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 kidney in combination with [indiscernible] will be transformative. Of course, the data will have to show. We’ve been arguing for a while that the robust Phase II data sets have been quite informative in our development on the second-line follicular lymphoma, just to remind everybody again, the Phase III mimic almost to a point the efficacy that we had seen in the second-line data set in combination with R2 in second-line follicular lymphoma.

And if you then go back and revisit the data that’s in the public domain on R-CHOP combination with the kidney and IPI-325 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 and the enthusiasm and the expectation comes from our end to believe that the study will be quite positive. 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 current reported Phase III data sets that are positive.

As it relates to OS, you’re absolutely right. In diffuse large B-cell OS is an endpoint that lags to a degree also by a change on factors, 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.

Thanks, Tahi. I think we have to leave it with that, but that was a very good answer. Thanks, James, for the question. Let’s move on to the next question.

And the next question comes from the line of Zain Ebrahim from JPMorgan.

A quick clarification question on EPKINLY, just in the first-line DLBCL trial in terms of the events tracking, how they are tracking relative to your expectations and given reiterate 2026 to [indiscernible] narrowing it down to the first — 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 III trials? And based on those conversations, how confident you are that the response rate is sufficient as a regulatory endpoint?

Thanks, Zain, for the question. So I’ll ask Tahi to talk a bit about events tracking if we can, and then Judith can potentially address the peto question on trial design in head and neck cancer. Tahi, why don’t you start?

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. But we cannot comment. So this is not something that we can do right now. But we obviously do track.

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 peto.

Yes. No, thank you for the question. As we all know, I mean, the 2 Phase III studies have dual endpoints, ORR and OS which I would say, as you know, the OrigAMI-5 recently published as well ORR and PFS. So it’s quite a standard that in areas of unmet medical need, the FDA and even other health authorities can be prone to earlier endpoints that can be good surrogates or good associated with more overall survival.

So we feel good with the dual endpoints that both studies have. And of course, 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 yes, and with the dual endpoint.

Thank Judith. Thanks Zain, for the questions. Let’s move on to the next one.

And the next question comes from the line from Suzanne van Voorthuizen from Van Lanschot Kempen.

This is Suzanne from Kempen. I was wondering for peto, whether we should be expecting a Phase I/II data update in head and neck cancer during this year at a medical conference, considering especially the frontline data set further matured since ASCO last year, this could be very insightful for the market ahead of the Phase III readout.

And if there is a data update, could you elaborate what you believe the expectations should be on duration metrics and survival, for example?

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 III data this year, but you asked specifically about the Phase I/II data, Judith?

Yes. No, thank you for the question. But I want to reinforce that the last readout for the peto-pembro combination was with around 15 months follow-up, which allowed to see 79% of patients at 12 months landmark overall survival. And so of course, there is sensoring, but the sensoring happened after the 12, 16 months, 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 III, and you can take advantage of that presentation already.

Let’s move on to the next one.

And our next question comes from the line of Yaron Werber from TD Securities.

So quick question, just as a natural follow-up. The OrigAMI-5 study, as you mentioned, uses KEYTRUDA and chemo as a combo, presumably in patients with more bulky aggressive disease in front line. Would you consider doing the same sort of trial design with peto?

Judith, can you address that question from Yaron on OrigAMI-5?

Yes. No, thank you for the question. So first, let me tell you that we are stand behind the original strategy, which is combining peto 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 [indiscernible] put in place a strategy that could offer a chemo-free option for patients. Having said that, given the data that you have seen and we have seen on peto, we believe that the CDP potentially could be expanded on 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.

So more to come.

And our next question comes from the line of Qize Ding from Rothschild & Co.

So I noticed that petosemtamab is at Phase II 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, Qize, for the question. Judith, can you comment on the lung cancer trial for peto?

Yes, yes, I can. Thank you. So as we all 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 peto and pembro. So it’s a signal-seeking study, and we will update you when we have data.

Thanks, Judith. Thanks Qize for the questions — question. Let’s move on to the next one.

And the next question comes from the line of Matthew Phipps from William Blair.

Just to confirm, you listed an additional Phase III for peto in 2026. Is that the locally advanced trial that you’ve 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, Matt, for the question. So Judith, maybe you can address both of them.

Yes. Thank you for the question. So yes, the data that Merus presented in December on colorectal was very encouraging, albeit 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 IIIs, we already mentioned the locally advanced head and neck, and we are actively working on a comprehensive clinical development plan.

Thanks Judith. Thanks Matt for the question.

And now we’re going to take our next question, and it comes from the line of Victor Floch from BNP Paribas.

So maybe a quick one on the pipeline and I mean, more specifically your early-stage pipeline, which has been significantly streamlined over the last 12 months. And to my knowledge, only contains now 2 clinical stage bispecifics. So I just wanted to 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 see any ADCs. So maybe it’s — I mean, whether you can discuss like what are the technologies behind the 2 recent INDs you’ve done. But so 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?

Victor, let me start off here and then Tahi, can definitely chip in. We have recently actually had 3 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 or bispecific based and 5% HexaBody-based, Victor.

But right now, we are 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 Tahi 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. Tahi?

Yes. I mean you kind of like framed this already, right. So as you said, we have 3 INDs that we filed towards the end of the year with — that are expecting dosing this month. More to come on this end in this year as well. And our focuses are now particularly also after the integration of [indiscernible] And the capabilities that came to that integration continue to be in antibodies and then they fall into these categories of next-generation ADC platforms, which is an increased interest of our research in [indiscernible] and next-generation bispecific and trispecific platforms that 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 [indiscernible] with peto being positioned in head and neck and maybe we’ll see in the future also opportunities in colorectal with Rina being positioned in the GynOc space in ovarian and endometrial, but also maybe possibly based on data, also opportunities in other folate receptor alpha tumors, there is very clearly also a change on how we think internally about where our focus 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. And that in and of itself does not preclude that we will not continue to look for external innovation because that’s what we’re going to do.

Now we’re going to take our next question. And the question comes from the line of Mattias Haggblom from Handelsbanken.

I had one on peto, 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, Mattias, 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.

Yes. Thanks, Mattias. 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 outside 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 and accelerating it to also make it broadest in class, starting, of course, in head and neck cancer. For now, we’re going to remain with our guidance in terms of multibillion 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 going to front run this, Mattias, in terms of guiding to when we’re going to 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, Anthony. We will leave it with this, Mattias, but thank you for the question.

And now we’ll take our next question, and it comes from the line of [ Sarah B ] from Guggenheim Partners.

This is [ Sarah ] on for Michael Schmidt from Guggenheim. 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 [indiscernible], including in the ongoing Phase II? And then separately, super quickly, if you could clarify the terms of the debt offering announced late last year.

Thank you, [ Sarah ]. Anthony, can you address both questions, the size of the opportunity for Rina and also the debt offering terms?

Sure. Happy to do so. First of all, everything I’ve just said about petosemtamab, 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 on those first 3 indications that I’ve mentioned, second-line PROC, second-line endometrial, second-line PSOC, we’ve already initiated Phase III 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 is we continue to reiterate our peak year sales guidance of $2 billion plus and a very significant amount of clinical development work is ongoing to underpin that investment — that peak year 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 3-month [ SOFR ]. Now what we have done and 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 that kind of help you sort of think this through would be, if you look at the kind of weighted average based on current market conditions, the weighted average sort of effective interest rate of the debt is around 6.6%. So that’s what can help for now.

Thanks, Anthony. Thanks, [ Sarah ], for the questions. Let’s see whether there’s any further questions. Operator?

Now we’re going to take our last question for today. And it comes from the line of Benjamin Jackson from Jefferies.

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

Thanks, Ben, for the question. And I will ask Brad to give you — give a short feedback here. Brad?

Yes. 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 U.S. and Japan and early signs in Europe are encouraging and look forward to sharing more in the not-too-distant future.

So more to come, Ben, in the future.

There are no further questions for today. I would now like to hand the conference over to your speaker, Jan van de Winkel, for any closing remarks.

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 again soon.

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