GMAB

Hello, welcome to the Genmab's first quarter 2026 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 beliefs, anticipates, 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 that 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.

Hello, welcome to our financial results call for the first quarter of 2026. 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, Taj Amari, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind.

Let's move to the first quarter highlights. In Q1 2026, we continued to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. Importantly, we continue to invest with discipline in our medicines, in our pipeline and in our future growth, fully aligned with our capital allocation priorities. Even with these strategic investments, we grew operating profits.

The quarter was also marked by progress in our mission to bring innovative medicines to patients. There are a few highlights I would like to mention. EPKINLY continued to build positive momentum. We were very pleased to see the hospitalization recommendation removed from the third line plus relapsed or refractory diffuse large B-cell lymphoma label. We are on track with the integration of Merus. We are approaching this with the same focus and discipline that we brought to ProfoundBio.

Finally, the breadth, depth and potential of Rina-S continues to increase. The data we presented at SGO in April further support the promise of Rina-S, including in combination with the standard of care therapies such as bevacizumab. We are also making significant progress with our development plan, as you can see on the next slides.We anticipate starting 2 new phase III trials for Rina-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers.

These include a phase III chemo replacement trial in platinum-sensitive ovarian cancer and the first frontline trial for Rina-S in endometrial cancer. We continue to explore new opportunities for Rina-S outside gynecological oncology with a phase II signal-seeking basket trial in advanced gastrointestinal cancers. I'm pleased to share an update on the ongoing phase III trial in second-line plus platinum-resistant ovarian cancer on the next slides.

Recruitment has been much faster than expected, the phase III RAINFOL-02 trial has now completed enrollment. This important milestone brings forward the pivotal phase III data for Rina-S in platinum-resistant cancer into 2026.This reflects strong investigator engagement, the significant unmet medical needs in this indication, and the strength of our execution on one of our highest priority late-stage programs.

We can now look forward to two data sets in the second half of this year for Rina-S in platinum-resistant ovarian cancer and the opportunity for broader global regulatory filings earlier than anticipated. For both petosemtamab and EPKINLY, we are maintaining our guidance on the timing of data, as you see here.

The key takeaway is that 2026 continues to be a very catalyst-rich year for Genmab, with readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients.With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for Epkinly and TIVDAK. Brad.

Thanks, Jan. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for TIVDAK and EPKINLY reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake, and ultimately reach more patients.

This performance, combined with our work this year to advance our portfolio and expand our footprint to reach patients in more markets, positions us well to deliver on our growth ambitions in 2026 and beyond. In the quarter, EPKINLY continued to gain notable traction as the only bispecific approved in DLBCL and FL indications.Looking globally, EPKINLY grew 52% year over year, reaching $137 million in sales. In the U.S., EPKINLY continued to expand across both academic and community settings.

This growth reinforces EPKINLY's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems. The recent approval of fixed duration of EPKINLY plus R² in 2nd-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter.

In the quarter, we're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy and proven safety with seamless subcutaneous administration. Looking ahead, we expect adoption in the community to continue to expand across both FL and DLBCL, bringing EPKINLY-based therapies closer to where patients live.

In March, the FDA revised the label for EPKINLY in third-line plus DLBCL to remove the recommendation for 24-hour hospitalization following the first full dose. Now, the label advises physicians to assess whether outpatient monitoring or hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting. Beyond the U.S., performance remains strong.

In Japan, EPKINLY continues to stand out as the only bispecific approved in both third-line plus LBCL and FL, with continued year-over-year growth. The FL launch is building positively on the brand success in large B-cell lymphoma, supported by strong field execution and ongoing site activation. In other markets, through our partner, AbbVie, EPKINLY continues to grow with approvals in more than 65 countries, which most have dual indications.

For the remainder of 2026, we're focused on maximizing our first-mover advantage in second-line FL in the U.S. while preparing for expected approvals in this setting in Europe and Japan later this year, and in early lines of DLBCL in the future. We look ahead, our priority is to accelerate development, including in combination and across early lines of therapy, to continue to build on the already strong clinical data demonstrating EPKINLY's versatility and ultimately establish EPKINLY as the core therapy in B-cell malignancies.

Turning now to TIVDAK, which is the global standard of care in recurrent or metastatic cervical cancer. TIVDAK grew 18% year-over-year, reaching DKK 39 million in sales in the quarter. This reflects both the significant need for therapies that improve survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets.In the U.S., the brand delivered steady performance and continues to lead the market, a position it has held since launch nearly five years ago.

Outside the U.S., we're seeing encouraging progress in newer launch markets. In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the U.K., TIVDAK launched in February through private prescribing and payer channels.We're actively engaging NICE and SMC to secure broader availability.

At the same time, building upon our work in the U.K. and our established presence in Germany, we're actively preparing for additional launches, with infrastructure and teams being established across key European markets, including France, Italy, and Spain.Given the significant unmet need in advanced cervical cancer, we look forward to the impact TIVDAK can make for more patients as additional markets gain approval and reimbursement.

More broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact over time, particularly with Rina-S in the future. To wrap up, our Q1 performance positions us well to sustain momentum in 2026.

With continued performance and expanding portfolio, we're well-positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including 3 potential blockbuster assets with EPKINLY, Rina-S, and petosemtamab, and our proven ability to scale commercialization and successfully launch in markets where we can drive the greatest impact for patients.Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for Genmab.With that, I'll turn it over to Anthony to walk through the financials.

Thanks, Brad. Before diving into the numbers, as we highlighted last quarter, please note that these results and guidance in our remarks exclude the impact of acquisition-related expenses, including amortization. The reconciliation to our reported results is included in the appendix. In Q1 2026, we delivered growth driven by sustained revenues and the solid market performance of our portfolio.

Importantly, this growth was also driven by product sales from our own medicines, especially EPKINLY, continuing to diversify our revenue base. Revenue grew by 25%, driven by strong royalties from DARZALEX and Kesimpta. Our investments remained fully in line with our capital allocation priorities, including significant investments for EPKINLY, Rina-S, and petosemtamab. We made these important investments while growing operating profit by 23%. Moving to tax.

As you can see in the appendix of this presentation, we have tax expense of around $21 million, which equates to an effective tax rate of 28.9%. Here, I do want to pause for a moment and note that we are currently evaluating the integration of Merus operations from a tax perspective. Our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12-18 months.

Overall, the first quarter of 2026 demonstrates the continued strength and quality of Genmab's underlying financial performance. With that, let's move to our 2026 financial guidance. We remain on track to achieve our existing financial guidance, with revenue growth that enables strategic investment supporting 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.

For operating expenses, we expect to be in a range of around $2.7 billion-$2.9 billion, reflecting planned investments to advance late-stage development for acoziborole 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.

In summary, our performance in the first quarter of 2026 underscores our ability to deliver revenue growth, advance key pipeline assets, and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2026, we will continue to build on our 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 gonna hand you back over to Jan.

Thank you, Anthony. Let's move on to our final slide. In the first quarter of 2026, our financial performance reinforced the strength of our foundation and the durability of our growth trajectory. That strength supports a disciplined capital allocation strategy focused on the areas with the greatest potential to create long-term value, accelerating our late-stage pipeline, maximizing the success of our commercialized medicines, and ensuring strong launch readiness for future opportunities.

As we further move into 2026, we also remain focused on integrating Merus so that we can capture the full value of acoziborole. Lastly, we remain committed to deleveraging, targeting gross leverage below 3 times by the end of 2027, while maintaining balance sheet strength and flexibility. Taken together, Genmab is very well positioned. We have a growing and increasingly diversified revenue base, a powerful late-stage pipeline, and multiple catalysts ahead.

Our focus remains clear, to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable long-term value for shareholders. That ends our formal pre-presentation. Thank you for listening. Operator, please open the call now for questions.

Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for a name to be announced. To withdraw a 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.

Please stand by while we compile the Q&A queues. This will take a few moments. Now we're going to take our first question, it comes line of Jonathan Chang from Leerink. Your line is open. Please ask your question.

Hi, guys. Thanks for taking my question. On the frontline acoziborole head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes? Thank you.

Thanks, Jonathan, for the question. Tai, why don't you take the first question by Jonathan?

Yeah. Thank you, Jan, and thank you, Jonathan. Yes, indeed, we increased the size of the frontline study. I think we had in the past indicated that there were thoughts that we had, as it relates to the studies, that we want to ensure that they have the highest probability of success. The details, I don't think are the ones that we want to discuss in a public space, but these trials are being increased based on our insight that we generated during due diligence to ensure that they have the highest probability to our standards.

We do not have any anticipation that these changes have any impact on the timelines and on step first stay with our guidance that one or both of the beta studies will read out this year and will provide data this year.

Thanks, Tai. Let's move on to the next question.

Yes, of course. Now we're going to take our next question. It comes line of Zain Abrahim from JP Morgan. Your line is open. Please ask your question.

Thanks a lot. I've got two questions. Zain Abrahim, JP Morgan. First question is just to follow up on the previous one. It's helpful that you just said you don't expect the increased size of the first line trial to impact the timing. Just to understand in more detail why that is, given that you're increasing the trial from 500 patients to 700. Have you already completed enrollment of the initial patient population that you're looking to enroll, and how is enrollment progressing?

I suppose and, I guess tied to that, whether the increases for HPV-negative patients, that will be helpful to understand as well. Second question is just on EPKINLY first-line DLBCL. You've guided for the readout this year and haven't narrowed it up further. Is that the final analysis, or are we still waiting on the interim?

Thanks, Zain, for the questions. I think, Kai, you can handle both of them yourself, at least the next question, and then the EPCORE first-line trial.

Yeah. Zain, I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. This was indeed to ensure that this trial has the appropriate data that we need for our probability of success, how we feel about the program and what we understand about the program. This will not impact the timelines and what patient populations it does impact or the timing or the status of EPCORE.

I hope you will appreciate that in the context of a very competitive landscape, we are trying to be a little bit more disciplined on what we're sharing, when we're sharing it. 2 things.It will not change the timelines of what we've guided before, and we continue to stay with the statement that one or both of these studies will read out this year. As it relates to diffuse large B-cell, again, I think there we have also been very disciplined, and I will try to be continuously disciplined today.

We've guided that the frontline diffuse large B-cell will read out this year, and we have not comment on interim or final or any of these questions. We stay with the statement that the diffuse large B-cell study will have a readout this year.

Thanks, Zain.

All right. Thanks very much.

Thanks, Zain. Let's move on.

Thank you. Now we're going to take our next question, and it comes line of James Gordon from Barclays. Your line is open. Please ask your question.

Hello. James Gordon from Barclays. Thanks for taking the question or two quick ones. One was Rina-S. There's 1 and 2 coming in H2 this year. Just wanted to confirm, with the two trials reporting so closely together, phase II and a phase III, will you definitely report them as separate results? If the phase II is positive, you'll file it and not wait for the phase III, or have you discussed that plan with FDA? Might they say, "Well, if they're so close together, let's see both." The other one was just more generally that we've seen more data from B7H4 ADCs in gynecological cancers. How do you think that stacks up versus folate ADCs? There seems to be a few people going for this approach. Is it the different target, gyne?

Thanks, James, for the questions. I will ask Judit to address both the phase II and phase III PROC trials, Judit, and then the B7H4 versus folate receptor alpha ADCs.

Yeah. No, thank you for the question. For the first part, as we highlighted, the phase III accrued ahead of projections, that means that we will have these two datasets this year. Given the change in landscape in PROC, the potential for the phase III submission and approval becomes more relevant. This is the plan. We stay behind our guidance that Rina-S will be launched in PROC in 2027, with these two dataset as supportive, but the main dataset for filing the phase III that will allow for global submissions.

Part one, with regard to the competitive landscape, of course, you know, we are very aware of the B7H4, the two in investigation, the GSK and . As we said, several times, we know that this is an hypercompetitive space.

We stand behind the strength of the data of Rina-S in terms of efficacy, safety, durability of the efficacy, and a clinical development plan and speed to market. More competitors makes it, you know, more competitive, but doesn't preclude the fact that we could be not just first in class, but best in class, given the data so far.

Thanks. Thanks, Judith. It comes down to effective execution, James. We moved basically 2 years from 0 phase III to now 5 phase III, with the news of today.

Thank you. Now we're going to take our next question. The question comes line of Xian Deng from UBS. Your line is open. Please ask your question.

Hi, Xian from UBS. Thank you for taking my question. I got a few EPKINLY frontline DLBCL trials, please. Just wondering, given, you know, the typical PFS curve tend to pretty much, you know, almost start to plateau after, let's say, 18 months or so in a typical, let's say, what frontline DLBCL trial like POLARIX. Just purely hypothetically, right? It doesn't have to be, you know, anything to do with EPKINLY.

Just purely from a statistical point of view, do you expect a big change in hazard ratio, when, you know, during the last 25% of events, just assuming sort of a typical, let's say, frontline DLBCL trial, you know, PFS curve? That's the first question.

The second one is kind of, you know, also on that one, your study is capped at 30% of IPI stage 2 patients. Just wondering if you could give any colors on whether, you know, you've reached this number or your IPI 2 patients is actually below this. Just wondering what impact could it have in terms of powering and timing or for the primary endpoint. Thank you.

Thank you, Siyan. I was always teach never to answer hypothetical questions. I will see. We'll test out whether Tai is willing to do that for your first question and then move into the second part as well. Tai, over to you.

Yes, Siyan. Thank you. Yeah. What I can say is you're absolutely right. Classical historical diffuse large B-cell, oh, by the way, not only POLARIX. Frontline studies tend to plateau around month 18 to 20, and I think that's my only comment on that question. Particularly speculating what I expect, I don't think is helpful because I actually don't know how these curves are gonna behave on this trial until we see the data. The cap is also correct. There's a 30% cap.

You know, again, I don't think it's appropriate at this point to talk about what the actual demographics of the study are.The only other point that I think is important to understand, the primary endpoint is actually IPI 3 to 5, and if IPI 3 to 5 passes, you know, certain statistics, then it will read out 2 to 5. I think these are my comments on your questions.

Thanks. Thanks, Tai

-very again.

Thank you.

Well, I tried.

Thank you.

Yes, absolutely. Thank you. On to the next one, operator.

Yes, of course. Now we're going to take our next question. The question comes then of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Hi. thanks for taking the question. First one on EPKINLY, just kind of following on the theme there, but what do you think is sort of the relevant benchmark for EPCORE DLBCL-4? That's a 2nd-line trial, just in the context of the competitive landscape and some of the potential advantages that EPKINLY has. Secondly, just on the new Rina-S trial that you announced, RAINFOL-02, is that likely to be a KEYTRUDA combination trial? Thanks.

Thanks, Rajan, for the questions. Tai, why don't you take the first one, and then maybe Judith can go onto the new Rina-S trial, one of the new Rina-S trials. Tai.

Yes. This is a question about the second-line diffuse large B-cell, right? I think there's a couple of things to be said about the BMC128 study. First, it is again a randomization against our GemOx. In the end, that's what the study is gonna be compared, and everything else is then a cross-study comparison. They're obviously a little bit problematic.

What is the excitement on our end for this particular regimen is that this is a regimen comprised of all medication and lenalidomide in a subcutaneous administration that hopefully will show positive data and meaningful positive data for patients. Also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination, so GemOx, but also improved in efficacy vis-a-vis monotherapy.

It's really perfectly suited for the outpatient setting or the community setting, that's what this trial was intended to do, to generate a regimen that is patient-friendly with increased CR rate, that then is appropriate and suitable for the community setting. We'll see what the data is, but that's the intent of the trial.

Thanks, Tai. Maybe Judith on the combination for RINA.

Okay. The question, can you repeat the question? The combination with Bev-

Yeah

Did you ask? Oh, yeah.

No.

The data that we present. In terms of combination, the combination with bevacizumab was presented at SGO. As you can appreciate, if you were there, you know, the safety was a very well tolerated. The study was meant only for safety, but in terms of efficacy, we are very pleased with the median number of cycles of 10. Even the fact that 15 of the patients were refractory, 85% of the patients got more than 6 cycles.

This is with bevacizumab. In terms of pembrolizumab, we have 2 cohorts ongoing in different settings, and we will communicate the data when the data is a little bit mature and enrolled. It's actively enrolling.

Thanks, Judith. I think that answers your questions, Rajan. Let's move on to the next question.

Yes, of course. Now we're going to take our next question. The question comes then of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Hey. Thanks for taking my questions. I had another one on EPCORE DLBCL-2. Maybe just in terms of the enrollment of this study, Tai, could you just comment on how enrollment has been relative to your expectations when starting the trial? Secondly, I know in the phase II study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed duration treatment in the phase III study. Can you speak to your confidence level that the fixed duration paradigm can replicate the phase II data? Thanks.

Thanks, Michael. Tai.

Yeah. Generally speaking, I think, true for 1 to 8, which is the second-line diffuse large B-cell trial. The front-end diffuse large B-cell trials, these trials accrued significantly faster than they were initially projected. I think that's a statement that we've made multiple times. As it relates to the original phase II data in frontline where, we continued epcoritamab monotherapy after R-CHOP for the full year, the design of the trial, the phase III trial, where it's R-CHOP for 6 cycles, plus EPKINLY, followed by 2 monotherapy cycles of EPKINLY.

You know, when we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to.As we generated the data and had the opportunity to see this and also discuss with health authority, it became very clear, partially also because of the data that was presented by Faucher and MRD negativity, that you don't actually need to expose these patients to continued therapy. Keep in mind, significant of the portion of these patients are cured already with R-CHOP.

That's why we ended up with the design. We feel extremely confident that the, if you will, shortened observation of EPKINLY, as you framed it, doesn't have any impact on the ability of this combination regimen to achieve CR and even MRD negativity at really very high rates, as they have been in the public domain and shared.

We have a reason, as I've discussed many times, to be confident because we've seen this now in a number of trials with EPKINLY, that the phase III trials tend to mimic the original first 2 data just because the mechanism is very predictable for EPKINLY.

Thank you.

Thanks, Tai. Thanks, Michael.

Thank you. Now we're going to take our next question. The question comes now of Benjamin Jackson from Jefferies. Your line is open. Please ask your question.

Brilliant. Thank you for the question. I guess just another one, thinking about sequencing of drugs through the lines of therapies in DLBCL. We've heard from some docs that perhaps POLIVY is a very strong salvage option. When you're speaking to physicians, are you hearing that there is a preference for bispecifics up front just naturally because of the order that those drugs can come in? Any thoughts that could be a tailwind that would be useful. Thank you.

Thanks, Ben, for the question. Tai, this one is again for you.

Well, I think, yeah, I'll try to answer Benjamin and maybe Brad has to add something. He may add something to do. From the way I think about this, at least, I mean, this is, I think this is also how physicians that we work with and obviously engage think about this. The sequencing of drugs, generally speaking, is a function of efficacy and safety.

In particular, in diffuse large B-cell frontline, where R-CHOP cures a decent amount of patients, I think the anticipation just has to be that, you know, this trial, the trial that reads out is going to generate data that is going to have a significant impact on the outcomes for patients.

If it does, then that will lead to natural adoption because the obvious goal in diffuse large B-cell is to avoid the relapsed refractory setting where things become, generally speaking, a little bit harder to manage.

Thanks, Ty. Brad, do you want to add anything to this, to sequencing of the medicines?

I think maybe the only thing to add, Tai said it well, is we do hear from physicians that, you know, we've said quite a while or all along that the value of bispecifics are certainly in the earlier lines of therapy where patients are actually treated closer to their home. We're starting to see this really come to fruition with the advent of the second-line FL launch just late last year, and that's been a key growth driver.

The feedback from physicians, hospitals and health systems has been extremely positive with the, not only the unprecedented data, as Tai referenced, but also the convenience in being able to realize the value closer to the patient's home.

Thanks. Thanks, Brad. Ben, we are super excited about the potential to see both the frontline and the second line diffuse large B-cell lymphoma data, pretty soon, for Epcalis or epcoritamab, so, exciting times.

Thank you. Now we're going to take our next question. The question comes now of Charlie Heywood from Bank of America. Your line is open. Please ask your question.

Hi, Charlie Heywood, Bank of America. Thanks for taking the question. I have two, please. First is on your peto phase II OS rates. Just wondered if you've taken a two-year OS cut, and any directional comment on how that OS curve has trended relative to the first 12-month data that we've seen. Would it be fair to think a similar trajectory to what you've seen at year one, or could you actually see similar to what your competitors saw with faster first 12-month curve decline and then stabilize more thereafter?

Will that data be presented any time? Second one is just on Rina-S in second line and endometrial. Could you just remind us on timelines of that data? Frame your excitement in that op relative to, you know, the more imminent second line PROC setting.I think potential smaller patient number there, but possibly higher unmet need given lack of, you know, limited ADC presence to date. Thank you.

Thanks, Charlie, for the questions. Ty, why don't you take the 1st one on peto, and then Judith can handle the question on Rena, and then endometrial cancer for 2nd line.

If I understood your question correctly, you were asking if we are intending to update the phase II data set for peto in second line or in front line?

In front line, yes.

Front line. Well, I mean, we'll probably at some point we're going to update that curve presented in the data, but I think the more meaning we got is gonna be the actual study. You know, we said one or two of them will be out this year. That is probably the more meaningful data set, and relevant to the brand and to the company.

Thanks. Thanks, Tai. Judith, maybe the something more on the timeline for second-line plus endometrial and Rina.

Yeah. No, thank you for the question. As you know, the phase III is actively enrolling. We haven't guided the business community about read out, but what I can say is the activation and enrollment is going very well.

Thanks. Thanks, Judith.

Just something to add to Tai's first question on the first-line pito pembro combination. I think that it's very apparent what we already presented with 17 months follow-up, which is not negligible. At this time point, around 30% were censored and alive. This gives you a kind of magnitude of duration. As Tai alluded, now we are fixated on the phase III, which are much more relevant. I think that the data presented at ASCO is a very good representation of the durability of the effect.

Thanks. Thanks, Judith. Thanks, Charlie, for the questions.

Thank you.

Let's move on to the next question.

Yes, of course. Now we're going to take our next question, it comes from line of Eva Fortea-Verdejo from Wells Fargo. Your line is open. Please ask your question.

Hi, team. Thanks for taking our question. A quick one from us on Pito as it relates to CRC development. How should we be thinking about timing for any announcements for this tumor type? Are you exploring other mechanisms that would make sense to combine with beyond chemo? Thanks.

Thanks, Eva, for the question. I think probably Tai can handle this one, CRC updates for Pito in the second half.

Yeah. Look, we've answered this question a couple of times. We obviously have looked at the CRC data. We have generated more CRC data. We liked what we saw early on in the diligence. We continue to like what we see. We will update you a little bit closer to similar to what we did with Mina, to when these studies then go into the public domain on our next steps. There will be more to come at some point.

As it relates to combination with other mechanisms, there's a number of interesting things that are happening in this space in the subset of patients. Obviously, we are aware of that, and there is a good rationale to combine with Pito. More to come on that end as well.

Thanks, Tai. We keep the cards close to our chest, Eva, because it's very exciting area and also a very competitive area. We want to be first and hopefully best here.

Got it. Thanks.

Thank you. Now we're going to take our next question. The question comes in of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Hello. Thanks for taking my question. I'm going to harp on the pito symptom of enrollment as well. You know, there are some rumors on whether or not the increase to 200 patients would focus exclusively on HPV-negative patients. can maybe just remind us on your thought on the breakdown of patients by that baseline characteristic. then has the number of patients needed to conduct the ORR analysis changed, or is this really just patients for the OS analysis? Thank you.

Thanks, Matt, for the question. Tai, can you address both of these questions and give some perspective?

Matt, I'm gonna ask you to answer your questions. Good question. I will not go into the specifics. I will stick with the line that I used before, that, you know, the increase in the N of the study was intended to increase the overall probability of success of the study as we see it, based on what we understood in the diligences were decisions made already back then, and that we continue to understand about pito, and that none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

Thanks, Tai. Thanks, Matt, for the questions.

Thank you. Now we're going to take our next question. The next question comes in of Yaron Werber from TD Securities. Your line is open. Please ask your question.

Great. Thank you so much. Tai, I'm just gonna maybe ask another question on the LiGeR program, maybe a little bit broader. Do you plan on filing with both studies, or would you file presumably on second line, potentially first and then front line? When you do release the data by year-end, do you think it's gonna be, let's assume it's gonna be in second line first because you're not continuing to over-enrolling that study? Would you have, you know, at least the interim OS, and would it even be mature OS at that time? Thank you.

Thanks, Yaron. Tai, that's another sharp one.

A very good question. Unfortunately, my answer will be the same that I did before. Right now, all we guide, and, have been consistently guiding that we indeed expect one or more of these studies to read out this year. I will not comment on which one first or second and together all these permutations that may exist.

Thanks. Thanks, Tai. More to come later, Yaron Werber.

Thank you. Now we're going to take our next question. Just give us a moment. The question comes to line of Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question.

Hi, team. This is Romy on for Suzanne. One on EPKINLY. Looking ahead to the phase III readouts in first line, we recently did a survey which found that doctors are projecting EPKINLY even before seeing this data to be the most dominant first line option. I just want to know your thoughts on what you see as the most important features of EPKINLY specifically that drives this enthusiasm. Thank you.

Thanks very much for referring to that very nice survey. We like the data, of course, and then we'll ask Tai to sum up basically what the key parameters are here before for why EPKINLY is so advantageous in the first line setting according to the survey.

Yeah. I mean, this is like, you know, if you step back, this is also something that we talked about from the very beginning, when we engaged on the development program with EPKINLY, that the CD3xCD20 mechanism of action of EPKINLY is a unique and very powerful CN agent mechanism that comes with a safety profile that predominantly is infusion-related reactions and then otherwise it's extremely well-tolerated.

Because of subcutaneous administration, also a convenience administration that makes it easy for the patient and also for the providers. If you start combining EPKINLY and CD3xCD20 with chemotherapy, we've already seen this in all kinds of phase II studies or phase III studies, that tends to be a mechanism that is very well combined with chemotherapy and at least additive.

That's, I think, what's driving the enthusiasm about frontline in terms of what the expectation is around data. What drives EPKINLY specifically, of course, is then the observation that, A, in very high likelihood will be the first study to read out in frontline diffuse large B-cell with a significant time advantage. B, it is the one that comes with a subcutaneous administration. As Brad was saying earlier, in frontline diffuse large B-cell, the vast majority of these patients are actually treated in the community setting.

The fact that there is now a potential readout on a drug that is available for these physicians and these patients in this particular setting, particularly in the U.S. healthcare system, that is labeled, it's the only one that is labeled without restrictions on where it can be provided to the patients. I think that is what driving the entire enthusiasm on that particular study, and I think why we had, I don't know, six or seven questions from you guys on this study.

Great. Thank you.

Thanks, Tai, for the answer. Let's move on to the next question.

Yes, of course. Now we're going to take our next question, and it comes to line of Victor Floc'h from BNP Paribas.

Thanks for taking my question. Just one on EPKINLY. I mean, EPKINLY has reported a decent Q1 performance. I was just wondering whether this is driven by the recent label change in the U.S. I mean, in equal or, I mean, I was just wondering if you've seen like a material uplift in the academic setting and whether you can comment on the key orders that you need to clear to further drive penetration in this setting. Thank you very much.

Absolutely, Victor Floc'h. Good question. Brad Bailey, you can handle both of these, huh?

Yeah. No, I think, first of all, thanks for the question and the strong start to the year is certainly evident by the profile being appreciated by physicians as well as health systems. Primarily being, you know, looked at as the only bispecific with the dual indication. The proven efficacy piece is certainly extremely important as well as the subcutaneous administrations, which is what Tai had mentioned well.

Now, as it relates to moving forward into earlier areas, the ability to again, have all of these ingredients in place, moving quickly into earlier lines, featuring combinations as well as fixed-dose options is extremely important.Also, as you mentioned, as it relates to the performance second-line FL, we're seeing as a key part of this driver performance. The hospital removal of potential hospitalization data has been very well-received.

Again, looking to remove just additional barriers to be able to treat patients closer to where they live in the ways, you know, that you're seeing with this extremely important profile from an efficacy, safety, and deep durable responses along with subcutaneous administration.

Thanks, Brad. Thanks, Victor, for the question.

Thank you. Now we're going to take our next question. The question comes line of Kalpit Patel from Wolfe Research. Your line is open. Please ask your question.

Thanks for taking the question. For EPKINLY, the EPCORE DLBCL-2 trial in frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind POLARIX study? Do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in the first line?

Thanks for the questions. Tai, you can address both of these, huh?

On this question on like what hazard ratio we are expecting has come up a lot, and essentially it doesn't make much sense to speculate. What we've said is that based on the public data that is available in phase II, there's of course, and you heard this in the other question earlier, expectation and enthusiasm of what the possible readout of that study. Phase IIIs have in the past on a kidney tended to mimic close phase II data, as I said, because it's a mechanism of action that's very predictable.

We're excitingly, as you, awaiting the readout and of course are very enthusiastic of how positive this trial could be, but we will see what it is when we have it.As it really relates to OS now, we all know from the ODAC that, you know, the FDA will approve frontline diffuse large B-cell regimens even without OS benefit.

I've said in the past, the ability of showing an OS benefit, of course, is becoming a little bit more challenging, diffuse large B-cell general because of the increasing available of very effective salvage therapies for particularly the worst patients with primary refractory, they have access to CAR T. The bispecifics that are also now penetrating second line and are already very much available in third line.

Having said all of that, it's also a function of the effect size that you have on PFS, meaning the larger the PFS hazard ratio benefit becomes, the larger the opportunity to show an OS benefit.That's kind of like broadly speaking how we think about it.

Thanks. Thanks, Tai. Let's move on to the next question.

Yes, of course. Now we're going to take our last question for today. It comes line of Judah Frommer from Morgan Stanley. Your line is open. Please ask your question.

Hi, thanks for squeezing us in here. Just to follow up on the pito trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial? Will you be adding any investigation sites? I'm just curious if you are, if any other EGFR bispecifics might be being studied at those sites and what reception might be. Thanks.

Thanks, Judah, for the question. Tai, can you address the recruitment and the setting for the pito trial?

Yes. What I will answer, Judah, is that this amendment that increases the N had no impact on additional sites or need for any additional sites since the study's enrolling extremely well. That's why it won't have an impact on anything.

Thanks. Thanks, Tai. That, I think addresses the last question of today. Thank you all for calling in today. If you have any additional questions, please reach out to the investor relations team of Genmab. We very much look forward to speaking with all of you soon in this super exciting year for the company. Thank you.

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

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, anticipates, 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 now like to hand the conference over to our first speaker today, Jan van de Winkel. Please go ahead.

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.