Genmab A/S Aktie

Hello, and welcome to the Genmab 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 believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

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I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

Hello, and 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, Tahi Ahmadi, and our Chief Development Officer, Judith Klimovsky.

As noted, we will be making forward-looking statements, so please keep that the lines. Let's move to the first quarter highlights. In Q1 2026, we continue 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. And importantly, we continue to invest with discipline in our medicines in our pipeline and on 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 or removed from the third line plus relapse or refractory diffuse a B-cell lymphoma label. And we are on track with the indication of mirrors. And we are approaching this with the same focus and discipline that we brought to perform bio.

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 slide. We anticipate starting two new Phase III trials for renal in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers. This includes a Phase III chemo replacement trial in platinum-sensitive ovarian cancer and the first frontline trial for rent and endometrial cancer.

As we continue to explore new opportunities Forina outside canecological oncology, with a Phase II trial seeking Phase II signal-seeking basket trial in advanced gastrointestinal cancers. Finally, I'm pleased to share an update on the ongoing Phase III trial in second line plus platinum-resistant ovarian cancer on the next slide because recruitment has been much faster than expected, the Phase III RAINFALL 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 to significant unmet medical needs in this indication and the strength of our execution on one of our highest priority late-stage programs. So 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. So the key takeaway is that 2026 continues to be a very catalyst-rich 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, John. Our proprietary portfolio is off to a strong start here in 2026. I 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, and this growth reinforces uptimes value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems. The recent approval of fixed duration EPKINLY plus R square in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter.

The recent approval of in the quarter. We're seeing physicians increasingly use this chemophi 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. And in March, the FDA revised the label for EPKINLY in third line plus neoBCL to remove the recommendation for 24-hour hospitalization following the first full dose.

Now the label advises physicians to assess whether outpatient monitoring for hospitalization is appropriate following the first full dose. We do expect this will further broaden news 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 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 approval in this setting in Europe and Japan later this year. and in early lines of DLBCL in the future. As we look ahead, our priority is to accelerate development, including in combination in across early lines of therapy, to continue to build on the already strong clinical data demonstrating EPKINLY versatility and ultimately establish Epkinly as Vcore therapy and 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 $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 that has held since launch nearly 5 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, and 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 to make for more patients as additional markets gain approval and reimbursement. And 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 three potential blockbuster assets with EPKINLY, Rina-S and petosemtamab and our proven ability to scale commercialization and successfully launch in market, 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 and our remarks exclude the impact of acquisition-related expenses, including amortization. A 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. Revenue grew by 25%, driven by strong royalties from DARZALEX and [indiscernible]. And importantly, this growth was also driven by product sales from our own medicines especially at EPKINLY, continuing to diversify our revenue base.

Our investments remain fully in line with our capital allocation priorities, including significant investments for EPKINLY, Rina-S and petosemtamab. And 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%. And 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. So 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 to 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 oral portfolio, further enhancing revenue quality.

For operating expenses, we expect to be in a range of around $2.7 billion to $2.9 billion. reflecting planned investments to advance late-stage development for petosemtamab and arenas as well as launch readiness activities to support multiple potential product launches. And 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. Advanced 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.

And on that note, I'm going to 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 loan readiness for future opportunities. And as we further move into 2026, we also remain focused on integrating mirrors so that we can capture the full value of petosemtamab.

Lastly, we remain committed to deleveraging targeting gross leverage below 3x 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 I have, and our focus remains clear. to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable long-term value for shareholders. So that answers our formal presentation. Thank you for listening. Operator, please open the call now 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.

On the frontline petosemtamab 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?

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

Thank you, Jan. Thank you, Jonathan. Yes, so indeed, we increased the size of the frontline study. I think we had 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, details, I don't think are the ones that we want to discuss in the 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 time lines and staffs with our guidance that one or both of the peto studies will read out this year, and we'll provide data this year.

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

Yes, of course. Now we're going to take our next question. It comes from the line of Zain Ebrahim from JPMorgan.

We've got two questions. Zain Ebrahim, JPMorgan. First question is just a follow-up on the previous one. And it's helpful that you just said you don't expect the increased size of the first-line trial to impact the timing. But just to understand in more detail why that is given that you're increasing the trial from 500 patients to 700. So 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 in DLBCL. You've guided for the readout this year and haven't narrowed out further. So is that the final analysis? Or are we still waiting on the.

Thanks, Zain, for the question. I think, Tahi can handle both of the rest next question and then the [indiscernible] trial.

Yes, Zain, sorry, 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, and this will not impact the time lines and the what patient populations, it does impact the timing or the status of a core. 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.

So two things. It will not change the time lines of what we have 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 the fee such Visa, again, I think there, we have also been very disciplined, and I will try to be continuously disciplined today. We've guided at the front line, if such [indiscernible] will readouts this year. And we have not commented on interim or final or any of these questions. But we stay with the statement that the fact B-cell study will have a readout this year.

Thanks, Tahi. Let's move on.

And next James Gordon from Barclays.

James Gordon for Barclays. Two quick ones. One was rent. So there's 011 and 02 coming into H2 this year. So I just wanted to confirm, with the two trials reporting so closely together, so Phase II and Phase III. Would you definitely report them as separate results and 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? Or might they say, well if they so close together, let's see both. And the other 1 was just more girl, we see more data from [indiscernible] in gynecological cancers. How do you think that stacks up versus pro there seems to be a few people go for this approach is a different target in

Thanks, James, for the questions. I will ask Judith to address both the Phase II and Phase III PK trial unit and then the B7-H4 versus 4 receptor for ADCs.

Thanks for the question. So for the first part, as we highlighted the Phase III accrued ahead of projections that means that we will have these 2 data sets this year given the change in landscape in Prague, the potential for the Phase III submission and approval becomes more relevant. This is the plan. So we stay behind our guidance that Rina-S will be launched in Prague in 2027 with these two data sets a supportive, but the main data set for filing the Phase III that will allow for global submissions. Part one. With regard to the competitive landscape, of course, we are very aware of the B7-H4, the 2 in investigation, the [indiscernible] as we said several times, we know that this is a hypercompetitive space we stand behind the strength of the data offering in terms of efficacy, safety durability of the efficacy and clinical development plan and speed to market. So more competitors makes it more competitive that 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. So it comes down to effective execution, James. And we moved in basically 2 years from 0 Phase IIIs to now 5 Phase IIIs with the news of today.

And the question comes line of Xian Deng from UBS.

Xian Deng from UBS. So I got a few EPKINLY frontline BCL trials, please. Just wondering, given the typical PFS curve tend to pretty much almost start to plateau after, let's say, 18 months or so in a typical, let's say, frontline DLBCL, like color just purely hypothetically, right doesn't have to be anything to do with aptly. Just purely from a statistical point of view, do you expect a big change in hazard ratio when -- during the last 25% of events, just assuming sort of a typical, let's say, frontline DLBCL trial, PFS curve? That's the first question.

And the second one is kind of also on that one is your study is capped at 30% of IPI Stage 2 patients. So just wondering if you could give any color on whether you've reached this number or your IPI II patients is actually below this. I'm just wondering what impact could you have in terms of powering and timing for the primary end point?

Thank you, so I was always teached never to answer hypothetical questions. But we'll see -- we'll test if Tahi is willing to do that. Then move into the second [indiscernible] over to you.

So yes. So what I can say is you're absolutely, right, classical historic of the usage pizza all, by the way, not on Polaris. Frontline studies tend to plateau around month 18 to 20. And I think that's my only comment on that question. I am particularly speculating what I expect. I don't think it's helpful because I actually don't know how these costs are going to behave on this trial until we see the data. The cap is also correct. It's a 30% cap. 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 IPI 3 to 5 passes certain statistics than able read out 2 to 5. And so I think these are my comments on the questions can.

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

Yes, of course. And now we're going to take our next question. And the question comes on of Rajan Sharma from Goldman Sachs.

So first one on EPKINLY just kind of following on the theme there. But what do you think is sort of the relevant benchmark for AC-DC. That's the second line trial, just in the context of the competitive landscape and some of the potential advantages that EPKINLY has. And then secondly, just on the new Rina-S trial that you announced, RAINFALL 08,-- is that likely to be a KEYTRUDA combination trial?

Thanks, for the questions. Tahi, why didn't you take the first one and then maybe Judith can go onto the new Rina-S, one of the new Rina-S.

Yes. So this is a question about the second line is such [indiscernible]? And so I think there's a couple of things to be said about the 128 study. First, it is again a randomization against [indiscernible], that's what the study is going to be compared and everything else is then a cost study comparison. They are obviously a little bit problematic. But what is the excitement on our end for this particular regimen is that this is a regimen comprised of an oral medication analithomide and subcutaneous administration.

That hopefully, will show positive data and meaningful positive data for patients and then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination with [indiscernible] but also improved in efficacy vis-a-vis monotherapy and it's really perfectly suited for the outpatient setting or the community setting. And that's what this trial was intended to do to generate a regimen that is patient-friendly with increased CR rates that then is appropriate and suitable for the community setting. And so we'll see what the data is, but that's the intent of the trial.

And then maybe red on the combination for Rina-S?

The question, can you repeat the question, the combination with Bev? Did you ask? Yes. The data that we present. Okay. we -- in terms of combination, the combination with Web was presented at SGO. And as you can appreciate, if you are there, the safety was very well operated this study was meant only for safety. But in terms of efficacy, we are very pleased with the median number of cycles of 10 million and even the fact that 15 of the patients who were refractory, 85% of the patients got more than 6 cycles. So this in terms of November, we had 2 cohorts ongoing in different settings, and we will communicate the date when the data is a little bit mature and enrolled. So it's actively at all.

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

And the question comes line of Mike Schmidt from Guggenheim Partners.

I had another one on EPCOR DLBCL 2. Maybe just in terms of the enrollment of the study, Tahi, could you just comment on how enrollment has been relative to your expectations when starting the trial? And secondly, I know in the Phase II study, you've valued, I believe, a continuous treatment paradigm versus the fixed duration treatment in the Phase III study? And maybe speak to your confidence level that the fixed duration paradigm can replicate the Phase II data.

Thanks, Michael.

Yes, generally speaking, I think true for 128, which is the second such BSA trial as for the front anti trials that these trials include significantly faster than they were initially objected. And 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 pimontherapy after HP for the full year and the design of the trial, the Phase III trial, where it's [indiscernible] cycles plus pine followed by 2 monotherapy cycles of EPKINLY.

When we started to generate this data, cash, 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 as also discussed with health authority became very clear, partially also because of the data that was presented by voucher and MRD negativity that actually need to expose these patients to continue therapy. Keep in mind, significant portion of these patients are cured already with CHOP. And so that's why we ended up with the design. We feel extremely confident that, if you will, shorten 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 in the public domain and [indiscernible] and we have a reason as I've discussed many times, to be confident because we've seen this now in a number of [indiscernible] that the Phase III starts tend to mimic the original first 2 data just because the mechanism is very predictable for PMA.

Thanks, Michael.

And now we're going to take our next question. And the question comes on of Benjamin Jackson from Jefferies.

It 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. So when you're speaking to physicians, are you hearing that there is a preference for bispecifics upfront just naturally because of the order that those drugs can come in. So any thoughts that could be a tailwind there would be useful.

Thanks, Ben, for the question. This one is again for you.

Well, I think -- I'll try to answer Benjamin and maybe Brad add something he may add some too. But from the way I think about this, at least means and I think this is also how physicians that we work with and obviously engage. I think about this. The sequencing of drugs generally speaking, is a function of efficacy and safety. And in particular, in the Fuse frontline where use a decent amount of patients. I think the anticipation just has to be that 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. And if it does, then we'll need to natural adoption because office goal in diffuse B-cell is to avoid the relapse a factory setting where things would come generally speaking, a little bit higher to merge?

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

I think maybe the only thing to add, to said it well is we do hear from physicians that -- and we've said quite a while all along that the value of bispecifics are certainly in the earlier lines of therapy where patients are actually treated because of their home. We're starting to see this really come to fruition with the advent of the second line launch just late last year, and that's been a key growth driver. The feedback from physicians, hospitals and hospitals and health systems has been extremely positive with not only the unprecedented data as [indiscernible] and also the convenience and being able to realize the value closer to the patient's home.

Thanks, Brad. And then we are super excited about the potential to see both the online and the second-line diffuse B-cell lymphoma data pretty soon for EPKINLY. So exciting times.

And the question comes down of Charlie Haywood from Bank of America.

Charlie here with Bank of America. I have 2, please. First is on your peto Phase 2 OS rates. Just wondered if you've taken a 2-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 1? Or could you actually see similar to what your competitor saw with faster first 12-month curve decline and then stabilize more thereafter? Then will that data be presented any time? And then second one is just on Rina-S second-line endometrial. Could you just remind us on time lines of that data and then frame your excitement in that up relative to the more imminent second-line processing, I think, potential smaller patient number there, but possibly higher unmet need given lack of limited ADC presence to date.

Thanks, Charlie, for the question. Tahi, why don't you take the first one on peto and then Judith can handle the question on Rina and then [indiscernible] second line.

So 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? In frontline? Well, I mean, probably at some point going to update that curve presented in the data, but I think the meaning regattas going to be the actual study. So we said 1 or 2 of them will read out this year. And so that is probably the more meaningful data set and relevant to the brand and to the company.

And then did maybe something more on the time line for second line plus endometrial and arena?

Yes. Thank you for the question. And as you know, the Phase III is actively enrolling we haven't guided the [indiscernible] community about readouts. But what I can say is the activation and enrollment is going very well. Just something to add to is first question on the first-line Epitopembro combination. I think that it's very apparent what we already presented with 17 months follow-up, which is not negligible. And at this time point, around 30% was sensor and a live and this gives you a kind of magnitude of duration. And as Tahi alluded, now we are fixated on the Phase III which are much more relevant. But I think that the data presented at ASCO is a very good representation of the durability of the effect.

And it comes from line of Eva Fortea from Wells Fargo.

One from us on PD as it relates to CRC development, how should we be thinking about timing for any announcements for this tumor type? And are you exploring other mechanisms that would make sense to combine with beyond chemo?

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

Yes. So look, we've answered this question a couple of times. We obviously, if you look at the CLC data, we have generated more CRC data. We liked what we saw early on in the diligence. We continue to like what we see. And we will update you a little bit closer to -- similar to what we did with MENA when these studies then go into the public domain. -- on our next steps. So there will be more to come at some point. As it relates to combination with other mechanisms as a number of interesting things that are happening in this space and the subset of patients and obviously, we are aware of that, and there is a good rationale to combine with peto. So more to come on that end as well.

Thanks, T. So we keep the cards close to our just Eva because it's a very exciting area and also a very competitive area. So we want to be first and hopefully best here.

Thank you. Now we're going to take our next question. And the question comes from line of Matthew Phipps from William Blair.

I'm going to harp on the petosemtamab enrollment as well. There are some rumors on whether or not to increase the 20 patients would focus exclusively on HD-negative patients. So can you maybe just remind us on your thought on the breakdown of patients by that based on characteristic. And then as the number of patients needed to conduct the ORR analysis changed? Or is this really just patients for the OS analysis?

Thanks, Matt. For the questions, Tahi, can you address both of these questions and give some perspective.

Matt, I'm going to ask answer your questions. Good question. I will not go into the specifics I was stating that I used before, that the increase in the end of the study was intended to increase the overall tolerability of success study as we see it based on what we understood in the diligence with decisions made already back then and that we continue to understand about peto and that none of the things that we're doing right now has any impact on the time lines for the readouts that we anticipate.

Thanks, Matt, for the questions.

And now we're going to take our next question. The next question comes on of Yaron Weber from TD Securities.

Great. I'm just kind of maybe another question on the Lager program, maybe a little bit broader. Would you plan on filing with both studies? Or would you file presumably on second line potentially first? And then frontline. And when you do release the data by year-end, do you think it's going to be -- let's assume it's going to be in second line first because you're not continuing to -- you're not over enroll in that study. Would you have kind of at least the interim OS and would it even be mature OS at that time?

That's another shot on.

A very good question. Unfortunately, my answer will be the same as 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. And I want to comment on which 1 first or second together all these permutations that make is.

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

This is [indiscernible] on for Suzanne. One on EPKINLY. So looking ahead to the Phase III readout in first line, we recently did a survey, which found that doctors are projecting EPKINLY even before same 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?

Thanks very much for referring to that very nice [indiscernible]. We like the data, of course, and I will ask Tahi to sum up basically what the key parameters are here for why EPKINLY is so in the first-line setting according to the [indiscernible].

Yes. So I mean this is like if you step back, this is also something that we talked a bit from the very beginning when we engaged on the development program with EPKINLY that the CD320 mechanism of action of EPKINLY is a unique and very powerful seen agent mechanism that comes with a safety profile that one is infusion-related reactions. And then otherwise, it's extremely well tolerated. And because of subcutaneous administration also convenience and administration that makes it easy for the patient and also for the for the providers.

And so if you start combining EPKINLY in 320 with chemotherapy, we have 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. And so that's, I think, what's driving the enthusiasm of the front line in terms of what the expectation is around data. And then what drives Kidney specifically, of course, and the observation at a in very high likelihood will be the first study to read out in front line if such we saw at a significant time advantage.

And b, it is the one that comes with a subcutaneous administration. And as Brad was saying earlier, in frontline diffuse such cell, the vast majority of these patients are actually treated in the community setting. And so the fact that there is now a potential readout on a drug that is available for these patients -- for these physicians and these patients in this particular setting in the U.S. health care system. That is label, the only one that is labeled without restrictions on where it can be provided to the patients. I think that is what's driving the entire enthusiasm on that particular study. And I think why we had, I don't know questions from you guys on the study.

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

Yes, of course. We're going to take our next question, and it comes from the line of Victor Floch from BNP Pariba.

Just one on EPKINLY. So I mean [indiscernible] reported a decent Q1 performance. I was just wondering whether -- this is driven by the recent label change in the U.S. So I mean, any color on -- I mean, I was just wondering if you've seen 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?

Absolutely, Victor. So good question. So Brad, you can handle both of these.

Yes. 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 looked at as the only bispecific of the dual indication and the proven efficacy piece is certainly extremely important as well as the subcutaneous administrations, which is what Tahi mentioned well. Now as it relates to the moving forward into earlier areas, the ability to, again, have all of these ingredients in place, moving quickly into earlier lines, featuring a combination as well as fixed dose options is extremely important. But then also, as you mentioned, as it relates to the performance second line FL we're seeing as a key part of this driver of performance. And then the hospital removal of potential hospitalization data has been very well received. And again, looking to prove just additional barriers to be able to treat patients closer to where they live in the ways that you're seeing with this extremely important profile from an efficacy, safety and feet durable responses along with subcutaneous administration.

Now we're going to take our next question. And the question comes line of Kalpit Patel from Wolf Research.

For EPKINLY, the EPCOR 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. And then do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in the first line?

Thanks for the questions, Tahi. You can address part of these.

Yes. So on this question, unlike what hazard ratio we are expecting has come up a lot. And essentially, it doesn't make me sense to speculate. What we have said is that based on the public data that is available in Phase II, there is, of course -- and you heard this in the other question earlier, expectation and enthusiasm of what the possible read of that study. So Phase III have in the past on a tended to mimic close Phase II data, as I said, it's a mechanism of action that's very predictable. And so we are excitingly as you awaiting the readout and of course, are very enthusiastic of how positive this try would be, but we will see what it is when we have it.

As it really relates to OS now, we all know from the order that the FDA will approve frontline diffuse regimens even without was benefit. I said in the past, the ability of showing NS benefit, of course, is becoming a little bit more challenging defies general because of the increasing available or very effective salvage therapies for particularly worse patients refractory FX to cards and 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 from PFS, meaning the larger the PFS has a ratio benefit becomes the largely the opportunity to show an OS benefit. That's kind of like broadly speaking, how we think about that.

Yes, of course. And now we're going to take our last question for today. And it comes line of Judah Frommer from Morgan Stanley.

Just a follow-up on the peto trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial will be adding any investigation side. 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, Judah the question. Tahi, can you address the recruitment and the setting for the peto trial.

Yes. What I will answer, Judah, is that this amendment that increases trend had no impact on additional sites or a need for any additional sizes. Study is enrolling extremely well. So that's why it won't have an impact on anything.

Thanks, tahi. And that's -- I think address is the last question of today. So thank you all for calling in today. And 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. And it's a 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.

Good afternoon, everyone. Thanks for joining. I'm James Gordon, Barclay's European pharma and biotech analyst. And it's my pleasure this afternoon to host a fireside with Genmab and we've got two for the price of one because we've got Anthony Pagano, who is the Chief Financial Officer; and Brad Bailey, who's the Chief Commercial Officer. And we've got a little over 20 minutes, so we're going to discuss some of the exciting pipeline, readouts that come out this year. Maybe a bit on the longer-term outlook and maybe hopefully when these work, what's the commercial outlook for these products as well, that would be interesting as well.

So thanks a lot, both of you for joining. And well, maybe just to start off, so it's a big year of readouts. What is it that's coming out this year? And how excited about them are you? And where should we focus, do you think? What should investors be looking at?

Yes. Well, first of all, James, thank you so much for having us, seeing you back here this year. Pleasure to be here with you. You're right, 2026 is really set up to be a very important year for Genmab and our late-stage pipeline. And really, it's about the collection of the three brands EPKINLY, Rina-S and petosemtamab. And what's really appealing for me is you look across these 3 brands, each of them have FDA breakthrough therapy designation. Each of them had in 2025, meaningful data that served to increase our conviction in the prospects of these assets moving forward. I'll bring it specifically to your question, each of them in 2026 have at least one potentially registrational readout. In the case of EPKINLY, this could represent material line extensions into earlier line DLBCL. And then both for petosemtamab as well as Rina-S the chance to have the first potential registrational data leading to a launch of these brands in 2027. So I think individually, each of them are important but really looking at the collection of the data we're going to see during the course of 2026 to increase our conviction into sort of the shorter term, medium term and even longer-term prospects for these brands though I'm sure we'll dive into the specifics of each of them, but a lot to be excited about during the course of 2026.

Great. That's a lovely intro. If we could start with EPKINLY. So I believe we've got two things coming out this year. We've got data that, in the first half, that could convert your current conditional approval in refractory DLBCL into a full approval. And then we've also, at some point this year, got a frontline DLBCL readout. If we could start with second-line. So you had one trial, which was a mono trial that wasn't successful in terms of fitting its primary endpoint on overall survival. Does that have any read to the other second-line trial we're going to get this year? How confident are you in that other trial we've still got to read out?

So as a starting point, our confidence in these two additional readouts during the course of 2026 remains very high and unchanged. We see absolutely no read across from the monotherapy trial that you're speaking about. I think it's important to highlight that, that monotherapy trial in second-line plus DLBCL it was monotherapy. It did hit on PFS. As you noted, it did not reach the endpoint and overall survival and as we highlighted at the time of the announcement, that OS outcome was confounded by really two factors, one being, the impact of COVID, particularly on the EPKINLY arm; and then secondly, the impact of crossover to novel therapies in the control arm.

So if we kind of step back here, the point is it did hit on PFS as well as we see zero read across to the other two trials. And that's really a function of the totality of the data that we see in EPKINLY in combination with other therapies in particular, the Phase II data that we've seen EPKINLY plus R-CHOP in frontline and EPKINLY plus len in second-line plus DLBCL. We have been engaging with some thought leaders in this area post the readout of that trial.

Maybe Brad, do you want to add some of that feedback we've had?

Yes. No. Especially in this type of a patient population at the timing, the thought leaders, both academic as well as out in the community and some of the top global thought leaders in this space actually were quite impressed with the PFS in general is monotherapy. And I think that's the -- to keep that in mind. And then also just looking ahead with the breadth of the readouts that are coming this year feel like encouraged by this initial feedback, and that was also on the heels of having second-line FL approval in combination for the first time and where we had unprecedented hazard ratio and incredible data. So it's exciting moving forward.

And in the trials you're going to report this year for EPKINLY, do you need to show overall survival benefits in there? I don't believe that's the primary endpoint. What do you need to show for these two trials to be successful?

Yes. So the primary endpoint, as you just highlighted, for each of the trials is PFS. That is agreed regulatory endpoint, agreed with the regulators. And -- but of course, when you submit the data, the regulators will look at the totality of the data, but we believe the PFS is the regular -- I'm sorry, the important endpoint here for each of these trials.

Makes sense. And then for first-line, so whereas for the second-line trial, you said we're going to get a readout in the first half. For the first-line trial, it's uncertain when it is this year. Why is that? Because I think there is a paper that says that there's an interim setup at [ 0.75 ] as in 3/4 of the way through, there's an interim. So what do we know about that? Could there already been an interim? Or is that something that might still happen? So tomorrow morning, we could get an update or could it be any time?

So I think the -- you're correct, just to restate what you said. We are expecting the second-line DLBCL trial readout in the first half of the year. the Epco frontline, Epco plus R-CHOP and DLBCL is for 2026. This is an event-driven trial. And our view is that we're going to have data during the course of 2026, that should be registrational in nature.

So if I [indiscernible] which is understandable. You haven't said yet whether an interim has or hasn't happened. There could be one, but it's also the timing is a bit uncertain. because it depends how quickly the events occur?

Yes. I think our keeping to 2026 is primarily a function of just seeing the events occur.

And if this trial does work, what does this mean for the commercial potential of EPKINLY?

Yes. It further states kind of what we've been very consistent all along in saying that the value, specifically the value of EPKINLY is -- as we move into earlier lines of therapy. And this does a couple of things. One, it brings the medicine into the community setting more closer where the patients live; and two, obviously, the patient population numbers. You're looking between second-line and frontline DLBCL as we've talked about with readouts this year and follow on hopefully with approval upwards of around 90,000 to 100,000 more patients than what we have today.

And so if we price that up at where EPKINLY is, what sort of multiplier is that is the frontline opportunity versus the refractory one?

Yes. Frontline is about half the value of the brand.

And I think just maybe on that trial. I mean, we're really excited about the data that we've seen so far in the Phase II setting. Really looking forward to seeing these frontline readouts. And I think Brad started to touch on it, the importance of the second-line follicular lymphoma readout we saw last year, very strong data getting that approved in Q4 of last year. As a reminder, that's a smaller opportunity in terms of the patients, but it has been an important vehicle, if you like, to start talking about EPKINLY in combination therapy. Of course, in this case, second-line FL in combination with R2, but also importantly, starting to get outside those pure academic centers.

And maybe Brad, [indiscernible] we can add on a little bit more color?

Yes. No, the initial phase, and this has been basically all bispecifics, not just in lymphoma, bispecifics, the challenge of being sort of stuck in these major academic centers. And we're starting to see, as Anthony just mentioned, with the second-line FL, broader use in sites of care that are outside of sort of the mothership of these centers. And as a matter fact, out of our key accounts that we had set up where almost 80% of our total business was there, the one site ordering was where we were getting the business now multiple sites are ordering at least two, most of them have three sites, which means that the medicine is being administered close to where the patients live.

A final one on EPKINLY would be in first-line, what does a good result look like? Do you just need to be [indiscernible] just, but just clinically meaningful and statistically significant? Or do you need to be like very, very clinically meaningful because there could be some other things coming on in the future? So for instance, combining, say, Polivy with CD3, CD20 that Roche are doing, do you need to be much more than just like the minimum clinically meaningful to be confident it's going to be an attractive therapy for many years to come, seeing is there some other therapies coming along as well?

I'll start, Brad, and then you can add on. Let's start with the -- again, the Phase II data that we've seen adding EPKINLY to R-CHOP. We feel that, that combination, what we've seen in that Phase II setting is very strong regardless of the competition. In addition, we know the experience over the last several decades, two decades in this setting is R-CHOP. We know that, that is also used very heavily and is the standard of care and is using very predominantly in the community setting where the vast majority of these patients are. So we feel that adding on a very convenient subcutaneous EPKINLY on top of a widely used and accepted over multiple decades, therapy like R-CHOP is the right approach in this frontline setting.

Yes. No, I agree. And moving earlier combination in certain cases, chemo-free is what the market's asking for out of bispecifics and specifically with EPKINLY, we feel like we're well positioned there as well.

Thank you. I could ask a lot more on EPKINLY but I'm going to move on to the other pipeline because I know there's a lot going on this year. So we've also got for Rina-S, so your folate-targeting ADC the RAINFOL-01 study data, so that's second-line plus ovarian cancer. And so in the second half, we're going to get the readout there?

Correct.

So what do you need to show there? Because this is -- we've already got some ORR data, as in overall response rate data. It was more than 50% before. Do you just need to do that again? And is there any reason you wouldn't do that again? Is there something different about the population at all that you're looking at now versus what you've already reported that looks so good?

So first of all, we're very encouraged with the data that we've seen with Rina-S in platinum-resistant ovarian cancer. And again, we remind everyone, we've seen robust efficacy in terms of response rate and duration of response regardless of expression level of this target. Again, we've seen this in platinum-resistant ovarian cancer. We've also seen it in endometrial cancer, second-line plus endometrial cancer, which, in general, has a lower expression level. So looking at the totality of that data, we have a lot of confidence going into this Phase II potentially registrational readout.

Now similar to my comments for EPKINLY, I would say, really be focused on what we've shown so far in that sort of proof-of-concept setting. And we think that this next-generation full receptor alpha ADC is really a step change in the treatment of gynecological oncology indications. Again, here I remind everybody, we have the second-line plus product readout this year in H2. We have the companion, if you like, Phase III trial that has been now recruited, fully recruited, and we're following the same strategy in endometrial cancer and having that essentially accelerated to market Phase II and the companion Phase III and both of these are also well underway.

I think it's really exciting times to see what we can do with Rina-S. And really, again, bridging to broad a little bit, having a potential single option across these two indications could be important as we go to market.

I think opportunity-wise, you're talking between the two ovarian and endometrial, around 120,000 patients roughly split 55, 45 or so, ovarian endometrial. And we've learned this through EPKINLY as we were indicated for both DLBCL and FL as you're operationalizing the new modality outside of the key academic centers, it's a big convenience factor. The feedback from thought leaders and physicians has been very positive being able to operationalize one, and we're seeing this as well. As you see ovarian and endometrial competitive landscapes are a little bit different. And so we like the opportunity there as well with the dual indication.

And is it all or nothing, either works in everyone across all folate expression levels? Or could there be a scenario where actually, you look at a subpopulation. When we find out -- when we see the headlines in the details, is that going to be important how it works in different subpopulations?

So as we think about potential top line results. I mean, we've not yet decided what that will look like. But I would imagine it's going to be top line results. We're not going to get into too much subgroup analysis now both the Phase II and the Phase III. Obviously, there are post-hoc analysis, in some cases, prespecified analyses looking at various cuts of the data. But generally speaking, top line results is kind of focused on the top line.

And I've also been asked about competition because you're not the only company with a folate receptor targeting ADC, [ does it look ] like a promising approach? One thing is time to market. But there are some other companies who are also going across folate expression levels. What do you see is the key differentiation for your assets?

When I think about evaluating any asset, I guess here, we're referring to Rina-S, there's kind of three parts of the framework. One is, what is your product profile? Can it be best-in-class? Second element is looking at it, can it be first in class? And then what does the CDP look like, i.e., Can it be broadest in class? As I think about Rina-S, it checks all of those boxes. Looking at the clinical profile, I think at this stage, we have the most amount of data, particularly when you look at it across indications, we have a chance to be at or above, I think, the majority of the competition first-in-class. We kind of talked about where we're at in terms of having the potential first pivotal readout in the second half of this year and having the Phase III in that [ prox ] setting already fully recruited. We talked about where we're at with endometrial.

And then we're not stopping there. We also started the Phase III in platinum sensitive ovarian cancer, and we're not going to stop there. That speaks to the breadth of the CDP. So we're looking to compete against all of these dimensions best first and broadest because this is the reality in oncology, there is going to be big competition.

Interest of time, I should move on to another -- the third interesting late-stage readout this year, which will be peto, so your bispecific EGFR and LGR5. And so my understanding is we're going to get data from one or even two head and neck cancer trials this year. So what do we actually need to see in there? What's the cutoff for the threshold? I believe again, we're talking about overall response rate data. What does a good result look like?

Yes, you're right, James. So again, just to confirm for everybody, this is unchanged. We're expecting one or both of the ongoing Phase IIIs to read out in the second half of the year. As a reminder, we have a frontline trial, frontline head and neck cancer. It is petosemtamab plus pembro in that frontline setting. And then we have the second-line plus head and neck cancer trial.

Again, I'd point back to the data that we saw during 2025. Now it was part of my opening remarks for each of the brands, including petosemtamab, we saw significant data that increased our conviction during 2025.

Now for petosemtamab to put a finer point on that. What we saw in the data that was presented at ASCO last year in that frontline setting, an overall response rate of around 63% in the combination, pembro plus petosemtamab that compares favorably to monotherapy pembro of around 19%. We see it nearly tripling when you add on petosemtamab, which, to me, is very significant. Also, if you look there at the overall survival data, the 12-month overall survival data, peto plus pembro came in at about 79% at 12 months which compares very favorably, in fact, to historical pembro controls. So we think that setup is very nice if we were to see that replicated as we move into the potential readout here in the second half of the year for one or both of the Phase IIIs. So it's really looking at the totality of the data.

The other thing that stands out for petosemtamab, if you look at the data is the rapidity of the response. You see the vast majority of the responders already responding at the first scan which I think is another important attribute as you think back about going into even earlier lines which we have firm plans to do. And here, we're going to start the first Phase III in locally advanced head and neck cancer by the end of this year.

But going back to my framework of first -- or sorry, best first and broadest, we're applying that same methodology, that same thought process to petosemtamab as well.

Makes sense. And a fireside I was just hosting, the company talked about the phenomenon where when you go from Phase I to Phase II to Phase III, you often get a bit less efficacy because you don't enroll the patients quite as tightly. Then this isn't exactly a Phase II to a Phase III, it is a Phase II. Would you expect any dilution because you're looking at more patients? Or is there any other reason to be a bit cautious?

Well I think what we look at the totality of the data for petosemtamab, we're very encouraged with what we saw in Phase II. I'm certainly not going to use a crystal ball and predict about what the Phase III is going to do. But based upon everything we've seen, we're not expecting in advance any kind of dilution to the effect. I mean, we're very encouraged with this product concept the modality. In our view, this is the best-in-class next-generation eGFR-based bispecific.

Thank you. So we've talked about three drugs. We've talked about EPKINLY, Rina-S and peto, and it's going to be a big year for readouts. But if they all readout, maybe a question for Brad, how do you go about maximizing the value for those because Genmab is doing some distribution of products at the moment, EPKINLY and Tivdak and some partnerships as well. But are you going to build a global distribution network for all of these? And would that be a huge OpEx? How are you thinking about that already now?

Yes. We'll take the OpEx questions towards the end, but we've been quite busy in the last several years putting building businesses for both EPKINLY and Tivdak in partnership. But just as a quick level set in U.S. and Japan, we built the full complement of the business running the business booking sales, market access, everything, pricing reimbursement as well. And so feel very strongly in those two markets where the majority of the revenue comes from with both brands. We've now moved into with Tivdak as we've taken over the market authorization ownership rights from Pfizer for rest of world outside of China, where we're building our European business. So we have a launch in Germany that just took place. So we're showing success in scaling our business and opportunities also in U.K. and France and soon to be Italy and Spain. And so in these select key markets, we will certainly independently go to market. And then in the other markets, we'll look at either distributor ships or some type of partnership.

Because if you see -- I think Anthony mentioned upfront with EPKINLY, we've stated $3 billion plus, Rina-S, $2 billion. And then with petosemtamab in the multibillion range, it will using our proven launch engine, EPKINLY is now well on its way to become into core therapy in B-cell lymphomas, and Tivdak is the global standard of care in cervical. We really do like this [indiscernible] oncology space as it moves -- as we move from Tivdak as our foothold, if you will, into Rina-S. It's been very beneficial for us from both a development perspective. as. Well as we're bringing our medicines to patients ourselves. And from an OpEx perspective, everything that we've stated at this point from a guidance perspective is exactly what it is and feel confident that that's where we'll be.

Well we've got two minutes left, although I've been asking R&D questions, you are the CFO. So maybe I need to ask you a slightly more numbers-y question to me if I'm doing my job properly. So if everything works this year, if all the readouts work, what is the financial outlook for the company? You've also got the royalties from J&J on DARZALEX around the end of the decade go away. But is the company then positioned for growth even through that? What's the overall growth outlook if everything works?

The growth outlook for Genmab is very strong. Brad has articulated the peak year sales estimates for the three brands. That's EPKINLY, $3 billion plus, Rina-S, $2 billion plus and then petosemtamab as multibillion dollars. Just think about that, what that looks like as a stand-alone oncology business, very, very strong.

Importantly, what's underpinning those peak year sales estimates is, for the most part, particularly zooming in on EPKINLY and Rina-S is the known clinical development plans. Of course, both for Rina-S as well as petosemtamab, there are potential expansion opportunities. And those -- we're in the process of doing some early clinical proof-of-concept work.

And then let's not forget our proven research and discovery engine. I can't tell you which product, James, but I'm fully confident as we get into '27, '28, and '29, there should be an internal program that should move from early to late-stage development. That's just based upon our true proven track record. So you have that strong foundation of the royalty business. Of course, as you're right, DARZALEX will go away, but the rest of that portfolio of royalty products as a portfolio has nice growth prospects through that DARZALEX loss of royalty, then you think about stacking on the proprietary business, EPKINLY, Rina-S, petosemtamab expansion opportunities there, plus again, as I mentioned, a pretty good probability on other product from our early stage pipeline to flow through. So overall, the growth prospects, particularly when you get into the 2030s are very strong here at Genmab.

Great. Well, with that, we're out of time. So thank you very much for joining us today.

Yes. Absolutely. Our pleasure. Thank you.

Thanks for joining us. My name is Jonathan Chang. I'm part of the Leerink Partners Equity Research team. It's my pleasure to host the management team of Genmab. We have with us today, CFO, Anthony Pagano; and Chief Commercial Officer, Brad Bailey. Thank you guys very much for joining us today.

Yes, it's a pleasure to be here, Jonathan. Thank you so much for having us.

Would you like to take a few minutes to briefly introduce the company?

Sure. I can kick things off, and then we can dive into your questions. So 2025 for Genmab was another very strong year, and that's both from a financial perspective as well as the progress we've made with our late-stage pipeline. Financially, we saw another year of very strong revenue growth, disciplined OpEx management and really having that profit flow through to the bottom line. As we exit 2025 from a pipeline perspective, what's important to highlight is we have 3 late-stage programs, EPKINLY, Rina-S and petosemtamab. And in 2025, for each of these programs, we saw meaningful clinical data that served to increase our conviction around the prospects and growth opportunities for these programs. And these 2 key themes that I just highlighted in 2025 in terms of the strong financials and the clinical progress carry over into 2026.

For each of these programs, both EPKINLY, Rina-S and petosemtamab, we expect registrational trial readouts during the course of the year, which could carry forward in terms of the potential launches in 2027. So really, what you have here at Genmab is a very strong foundation across the entire business, the financials, the technologies and now most importantly, these 3 late-stage programs with the meaningful data in 2026, leading to potential launches in 2027, which really set us up very well as we get into the back part of this decade, Jonathan. So with that, maybe we should dive into your questions.

Sure. So of course, you mentioned 2026 is an important year for Genmab, where there are several key readouts expected across the late-stage pipeline, including from EPKINLY, Rina-S, petosemtamab. How do you view the commercial opportunities for each of these programs?

Sure. I don't know, Brad, did you want to sort of maybe kick things off?

I'll kick it off. And then we view -- certainly, as we've said quite a bit with EPKINLY, we view this as a blockbuster medicine with the $3 billion-plus potential. And we've also said all along the value proposition of EPKINLY is one that is extremely well suited as we move into earlier lines of therapy. And I think that's critical. We're very encouraged at this point with our performance to date and have made meaningful progress launching second-line FL most recently and starting to see not only our core sites where uptake has been robust in the initial phase in the later lines of therapy in DLBCL and second-line FL where patients are treated a little bit more closely to where they live, the value proposition of EPKINLY with both durable efficacy, but most importantly, that dual indication operationalizing a bispecific in the community is becoming meaningful. And so overall, moving into these earlier lines of therapy, we feel we're very well positioned from an EPKINLY perspective.

Yes. Maybe in terms of bringing the asset that fits into the kind of set the stage. Rina-S, think about the progress we've made in the last 18 months from a pre-proof-of-concept asset to exiting 2025 with 3 ongoing Phase III trials going to have the first potential registrational readout here in 2026 in the second-line plus PROC setting. Here, what really is encouraged with Rina-S is the overall profile of the asset in terms of its differentiated efficacy, we think differentiated safety, ultimately leading to very long potentially duration of therapy or duration of response.

Here, Jonathan, for Rina-S, we've pegged the peak opportunity of being $2 billion plus. And this is really underwritten by 4, let's call it, subsegments of the GYN/ONC space. Of course, we have the second line plus PROC. You also have platinum-sensitive ovarian cancer and then frontline and second-line endometrial cancer. And the good news is that out of those 4 sort of subsegments, the Phase III trials are already well underway. So it's really the combination of the product profile in terms of potential to be best-in-class, first-in-class and it's also broadest in class gives us confidence in that $2 billion-plus number for Rina-S.

Then in terms of petosemtamab, again, here to remind you, this is a program that we acquired at the end of 2025. It has two breakthrough therapy designations, two ongoing Phase III trials, one in frontline head and neck cancer, the other in second-line plus head and neck cancer. These Phase III trials are underway. And here, we expect one or both of these Phase III trials to read out during the course of 2026. Here for petosemtamab, we've pegged the peak opportunity as a multibillion-dollar opportunity. As I mentioned, we have the 2 ongoing Phase IIIs. We have very clear plans to start a next Phase III in the earlier line of head and neck, locally advanced head and neck cancer during the course of 2026.

And ultimately, if you sort of then think about Rina-S and petosemtamab that kind of round out the conversation, there are these, let's call it, initial core indications, Gyn/Onc for Rina-S, and head and neck cancer petosemtamab, for each of these programs, we have earlier-stage clinical work ongoing to potentially expand the clinical reach of these 2 programs. So a lot to be excited about. Obviously, the end-market performance for EPKINLY, the expansion opportunities there, but also what I just covered for Rina-S and petosemtamab. So really exciting time here at Genmab.

Great. Thank you. So we discussed what the peak numbers might look like. Can you help us understand what the time lines of these programs and commercial launch plans look like relative to the DARZALEX royalty stream.

Maybe I can kick start. I think if we take it program by program, we can obviously do that, Jonathan. But maybe the place to start is just look at the totality of what we just explained. Obviously, we're all aware of DARZALEX. I'm not going to get into the DARZALEX math here and trying to get into the replace -- exact precise replacement math. But look at the totality of what we just talked about, EPKINLY at $3 billion plus, Rina-S at $2 billion plus and then petosemtamab is a multibillion-dollar opportunity.

And again, think about the expansion opportunities for both Rina-S and petosemtamab. And let's not forget the robustness of our earlier-stage pipeline and our research and discovery engine. So there is a very strong stand-alone oncology business apart from DARZALEX and our other royalty streams.

Now let's go through product by product. EPKINLY, as we know, is competing very well in the third line plus settings where we're approved today in DLBCL and follicular lymphoma. We have this next expansion opportunity into second-line follicular lymphoma that came online last year. Just to remind ourselves, this is a smaller opportunity in terms of patient size initially, where it's approved in the United States, maybe around 4,000 patients. Brad may comment in a few minutes about why that's important, not only financially, but maybe more operationally, so we can come back to that.

But the real trajectory, Jonathan, towards that $3 billion-plus number for EPKINLY is going to come from getting into earlier lines initially here into DLBCL. Here, again, we have readouts for EPKINLY, both in frontline DLBCL and second-line DLBCL during the course of 2026. So that is going to be really the springboard to start seeing on that trajectory towards that $3 billion-plus number. As a reminder, we also still have for EPKINLY, the frontline follicular lymphoma trial, which will read out here. We've not yet provided guidance on timing. So it's really going to be these 2 trials, seeing that data during the course of 2026, go through the regulatory process back half of '26 into '27 to sort of drive us towards that $3 billion-plus number.

For Rina-S, it's earlier days, of course, this product is not yet on the market. Here, we have the $2 billion-plus number. Initially, it's going into second-line PROC, which will have that data here in '26 and a launch into 2027. We've not yet broken down that number, but those 4 sub-indications that I went through earlier that are driving that $2 billion-plus number. We look -- we're very excited about what we're seeing in terms of the differentiated efficacy, differentiated safety profile, which ultimately together lead to a very robust duration of response, particularly in platinum-resistant ovarian cancer.

And then maybe last but not least, petosemtamab here, again, we're expecting data in '26, potential launch in '27. Here, we have been a little bit more granular. We said that based upon the robust clinical profile, we're expecting petosemtamab to do $1 billion by 2029, ultimately driving us towards that multibillion-dollar plus potential. So a lot to unpack there, Jonathan. We can happy to maybe dive into anywhere you'd like to go from here.

Great. Thank you. From a commercial standpoint, can you talk about your ability to market Rina-S and petosemtamab yourselves?

Yes. No, it's a great question. Thank you. And we're very encouraged to date, and we've been sort of building for this for the last several years actually, and very strategic and deliberate in our footprint, building businesses in both the U.S. and Japan, where we're booking sales and now also building businesses in Europe, where we're launching TIVDAK on our own as well independently, just like we did in Japan.

And I think it's a very important point to make, launching TIVDAK globally puts us in a position from a Gyn/Onc perspective to be uniquely qualified and excited around the potential opportunity for the launch of Rina-S. So we have the infrastructure in place. It's building -- being built, especially based on the core markets where we know we will need to succeed and do well. And we're feeling very confident as it relates to the Rina-S launch opportunity.

And petosemtamab?

Yes. And petosemtamab, likewise, you're putting the synergies between building businesses in both U.S., Japan and now in Europe. You have all of your core capabilities that you need from the launch perspective, and then we'll build certainly our build teams as we get close to launch, which we have a little more time outside of U.S. and Japan, but U.S. and Japan, we're extremely confident as well.

I think here, what's important to highlight under Brad's leadership, really, we've -- he and the team have started to build out and have built out really strong road maps and playbooks in advance of the launch. We've done it with TIVDAK initially, done it rather successfully with EPKINLY, both in the U.S. and Japan. And these same playbooks are now being applied to the potential launches for both Rina-S and petosemtamab in 2027. We talked a lot about the investments that we've been making over, let's call it, the last 4 or 5 years in terms of this commercialization readiness and capabilities. This is why we've done it. We knew eventually we would get into earlier lines for EPKINLY, and we knew that we have additional launch opportunities.

I didn't know the time it was going to be for Rina-S and petosemtamab, but this is why we've made the very strategic forward-thinking investments we've been making over the last a number of years. So the team is really looking forward over the next 12 months or so to get ready for these launches and then post approval to really hit the ground running.

And maybe just to add one other topic on that. The track record of success of sort of U.S. and Japan, now also in launching TIVDAK in Europe has been very strong, and we're very encouraged by what's been delivered to date. And these are -- now TIVDAK is the standard of care in second-line cervical cancer globally. EPKINLY is leading globally and this, as we know, is a highly competitive marketplace. And so we're, again, very encouraged with the past performance, dictating the future success as well.

Great. So let's double-click on exactly that for EPKINLY. What are the reasons for confidence in the ability to maximize the commercial opportunity for EPKINLY? So of course, this includes being able to penetrate earlier lines of treatment, get more adoption in community settings and take share versus other CD20 bispecific players?

Yes. Great question, and I'll try to take that holistically and then drill into each one of those. And back to the comment around the success and how we've been encouraged to date with our success. This starts really with the value proposition of the product profile. The efficacy, both in DLBCL and FL, I mean the hazard ratio of second-line FL is unprecedented. And you have a dual indication and operationalizing bispecifics in the community is a topic across the industry, how to really do this well. And we feel uniquely positioned and it's starting to show out with the second-line FL launch uniquely positioned to bring EPKINLY closer to patients in the community.

We have out of our core sites, the key sites that have been ordering EPKINLY from the very beginning, which, for the most part, began with all the CD3, CD20s in these CAR-T centers, if we call them. Each of those key accounts with where we were focused initially, over -- just over 80% of those key accounts have now put themselves in a position where they have at least 3 sites ordering, not just at the main hub. And so you're seeing the operationalization of bispecifics become more relevant. And certainly, with the dual indication, the safety profile, the subcutaneous -- seamless subcutaneous administration at this point for DLBCL and FL, again, putting us in a position to not only perform in these key academic centers, but also in the community.

Got it. How should we be thinking about the impact of the results of the Phase III EPCORE DLBCL-1 study of EPKINLY monotherapy?

Yes. So this is the trial that read out earlier this year. This is the Phase III monotherapy trial you're referring to. Here, we had, obviously, the positive signal and positive readout in progression-free survival and really not the same case for overall survival. As we sit here today, we're obviously further analyzing the results. We believe the results were confounded due to COVID, as we highlighted, also confounded due to use of novel therapies subsequently in the control arm.

We look forward to presenting and going through that data in more detail in the future. Again, the highlight here is that a monotherapy EPKINLY versus the control arm, which was multiple products, including novel therapies, did beat on PFS. We think that is clinically relevant. And also as we sort of think about moving forward, 0 read across to the ongoing combination trials, EPCORE plus R-CHOP in frontline DLBCL and EPCORE plus lenalidomide in second-line DLBCL. So 0 read across there.

And here, we're very -- our confidence remains strong because of what we've seen EPKINLY can do in combination more broadly, but also the Phase II trial results that we've been publishing at ASH and other conferences at the last number of years in the same exact combos, same exact setting. So it's something that we have to work through. But as we sit here today, it's something we're just going to work through and haven't seen any significant impact to commercial performance as a result of this.

And maybe just to add on that, too quickly, from a thought leader perspective, given the circumstances, obviously, the timing of the trial with COVID, but also back to Anthony's point on the monotherapy, encouraged actually, and it was much more as expected as opposed to not.

Got it. Maybe switching over to RINA-S. What do you see as the key areas of differentiation versus approved FR alpha Elahere and also the growing list of ADCs in development in the ovarian cancer landscape.

So Brad, I'll start. It goes back to this framework, Jonathan, maybe it's too simple for some. I think about best-in-class, first-in-class, broadest in class. Against existing competition, what we're seeing from Rina-S is efficacy across the full spectrum of folate receptor alpha expression levels. We've seen this not only in platinum-resistant ovarian cancer, but also in endometrial cancer, where we're seeing robust activity, again, regardless of expression level.

We're also seeing in terms of that best-in-class profile relative to existing competition, potentially differentiated safety profile, which again means that patients can stay on drug longer, which then drives that duration of response. So we're seeing differentiated response rates across that expression level, differentiated safety, but ultimately better outcomes for patients because they stay on drug longer. So that duration of response is longer. So that's in terms of best-in-class. That's really relative to existing competition. Now relative to future competition, that's where first-in-class and broadest in-class comes into play. I mentioned the progress and highlight the progress we've made since acquiring the program, the robustness of our clinical development program, we're really looking to own the gynecological oncology space. So we have thought about the existing Phase IIIs.

I can't highlight today what else is to come, but there is definitely more to come in terms of Phase III development for Rina-S and Gyn/Onc. Really then leveraging that first-in-class position as well as being broadest in class. So we like where we're at relative to existing competition and really going to keep our foot on the gas pedal to really try to distance ourselves from future competition. And that's also then where the handover to commercialization is super important. It's not just about the clinical development, it's making sure that if and when the product is approved, our commercialization teams are going to be in place to really then effectuate a very strong launch.

How much of a time line advantage do you think Rina-S has over other ADCs in looking to address this all-comers population in platinum-resistant ovarian cancer?

So I think it's probably not helpful for me to speculate. I know what we can do. I know what our time lines are. Again, we're going to have our data in second-line PROC, the Phase II trial this year has been also communicated, the Phase III kind of confirmatory trial in a similar patient setting is also now fully recruited. We also have the second-line endometrial Phase II and Phase III, also very well underway. So we are focused on what we can do and control as it relates to the conduct of our trials and then regulatory readiness and launch readiness. We're doing everything we can every single day to maintain that leading position. We're, of course, very mindful of the competition. That's why we want to keep our foot again on that gas pedal.

Understood. And how do you guys see the endometrial opportunity relative to ovarian cancer?

Yes. It's -- if you look at the patient populations, looking at frontline and second line, you start to see comparable numbers of patients. And so we see this as -- Anthony started with the 4, sort of 4 components in both PROC BSOC and with endometrial. I think it's a very equitable opportunity, if you will, overall.

How about from a competitive landscape consideration? How do you see endometrial comparing to ovarian?

Yes. I think in general, certainly some different players there. And -- but back to Anthony's point on where we are with endometrial and the development perspective, but then also the agnostic with the FR alpha expression, we feel confident there as well.

Yes. I think this kind of brings back to some maybe similarities in terms of the approach and the mindset going back to EPKINLY, having a single option across follicular lymphoma and diffuse large B-cell lymphoma, similar principle here, same physicians are treating not only cervical cancer with TIVDAK, but here for Rina-S both ovarian cancer and endometrial cancer, having a single option, we think is also going to potentially be a really key differentiator when we go to market. So we're really focused on having these 2 options or the single option for these 2 indications available as quickly as possible for patients.

Got it. Maybe we will switch over to petosemtamab. How do you guys see this program positioned in the head and neck cancer landscape?

I can start. And the starting point really is looking at the clinical data that we've seen so far. As a reminder, both in frontline as well as second-line plus head and neck cancer, petosemtamab has been awarded FDA breakthrough therapy designation, really keying in on that frontline data that was released last year for petosemtamab, thinking about the additive benefit on top of pembro where you saw nearly a -- or more than a tripling of the response rate.

So we're seeing very strong response rate. We're also seeing a rather quick clinical response. A lot of the response is coming at the first scan. So not only a robust signal, but a very fast signal as well. And the collection of those 2 is carrying through to what we've seen in terms of the 12-month progression-free survival or overall survival, excuse me, in the high 70%, I think, 79%. So the overall profile of petosemtamab, particularly in combination with pembro is rather strong, which then gives us the confidence to go into the earlier lines locally advanced here with the first Phase III slated to start in 2029 -- I'm sorry, at the end of 2026.

Again, here, there's going to be competition in oncology is a given. So we're really focused on maximizing that clinical profile, go broad and go fast. This is really the principle, particularly as it relates to being first. We think, again, here relative to other eGFR-based bispecifics, we have the chance to be first in head and neck cancer, clear line of sight actually to doing that. So we're super focused on really seeing the first trial readout here in 2026 and get the market in '27.

Got it. And what can we expect in the top line second half '26 disclosure or disclosures from the 2 Phase III studies? There's the frontline study and then there's the second and third-line study.

Yes. So again, to remind everybody, there are 2 ongoing Phase IIIs, one in frontline and one in second line plus head and neck cancer. What we said is that one or both of the trials will read out this year. And that's probably where we have to leave it. Jonathan, if I start kind of telling you what the data endpoints could be that we're looking forward to, then you start by trying to guess or infer which of the trials are going to read out. I think what's important to note is that the clinical profile that we were able to highlight last year at medical conferences is super strong.

We remain convinced that this has best-in-class properties in terms of next-generation eGFR-based bispecifics. And this is only the beginning of the development of this product. So I'd say stay tuned to seeing the top line readouts in the back half of '26.

Got it. How about opportunities beyond head and neck cancer for this program? What's your latest thinking on that?

Yes. Obviously, this has been a topic of conversation. It goes back to that really profile of the program in terms of petosemtamab. And as you all know, in the back half of '25, we released some early but very encouraging data in colorectal cancer. We're in the process of collecting some more data in this indication and look forward to sharing some incremental data in colorectal cancer in the back half of 2026.

Also, you would have seen we have started a proof-of-concept trial in non-small cell lung cancer, unsurprisingly, perhaps for petosemtamab. So I'd say, right now, really focused on this lead core indication of head and neck cancer and then looking really thoughtfully at potential expansion opportunities.

Understood. Let me just check and see if there are any questions from the audience. Is it fair to assume that Genmab at this point is done with -- for the time being on the M&A front?

So for a capital allocation perspective, right now, we're focused on investing back in the business along our strategic and investment priorities, which is really around both R&D and commercialization launch preparedness and execution across these 3 brands. That's absolutely the focus from a financial perspective, but also from an operational perspective, given the very significant opportunities that are right in front of us.

From then further from a capital allocation perspective, we're focused on deleveraging. In terms of acquiring Merus, we took on $5.5 billion of debt. And we said we want to get at or below 3x gross leverage by the end of 2027. So excess capital really will be deployed in that deleveraging plan between now and the end of 2027. Beyond that, let's just see where we're at, at that point in time. It doesn't mean we're not going to do smaller technology deals, really tool and component type deals to plug into our research and discovery engine, but these will be rather small by definition.

Understood. Maybe just in our last minute here, can you just remind us what the milestones and catalysts for the company are for 2026?

No, absolutely. I mean -- and this is really where I think we're really excited and all of you should be equally excited. For EPKINLY, we have the 2 Phase III readouts in frontline and second-line DLBCL. Second-line DLBCL will be in H1 and then the frontline trial will be during the course of 2026. And in particular, the frontline DLBCL is around half of the total addressable patient population for EPKINLY.

Then we have the second line plus PROC data. First, registrational data we'll see for Rina-S, fueling the launch of the brand, hopefully in 2027. And then the same for petosemtamab, where we're going to have the first registrational data here in 2026 in the back half of the year, leading to the potential launch of that brand as well in 2027. So if you think about it, really having material significant line extension opportunities for EPKINLY and then launching 2 blockbuster brands in Rina-S and petosemtamab in terms of the clinical data in 2026 and then the launch opportunity in 2027.

Great. Thank you very much for taking the time.

Thank you.

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.

Good afternoon, everyone, and welcome to the Genmab presentation here at the 2026 J.P. Morgan Healthcare Conference. My name is Zain Ebrahim. I'm your biotech analyst here at JPMorgan covering Genmab and from Genmab, it's my great pleasure to welcome the CEO, Jan van de Winkel, who will lead the presentation and joining him for the Q&A session is Chief Medical Officer, Tahi Ahmadi and CFO, Anthony Pagano. Jan, over to you.

Thank you, Zain for the very nice introduction. It's a pleasure to join you all here once again at the JPMorgan Healthcare Conference as we kick off 2026. Over the past decade, we've taken Genmab from a royalty-based company to a fully integrated innovation-driven biotech with a growing portfolio of proprietary medicines and a powerful late-stage pipeline. Today, I will walk you through how our diversified revenue base and 3 high impact late-stage programs position Genmab for the next decade of sustainable long-term growth. So let's get started.

As a reminder, this presentation may contain forward-looking statements and as such may contain certain risks and uncertainties. With that context in mind, I would like to turn to how we are setting a for durable long-term growth. So move to the next slide. We begin 2026 with a diversified high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the 2030s. With the acquisition of Merus, we have 9 medicines on the market, generating revenue for the company. That includes 2 co-owned products EPKINLY and TIVDAK and together, they provide a durable and diversified source of growing revenue from royalties and product sales.

EPKINLY is 1 of 3 high-impact assets, along with Rina-S epitusatamab for which we are anticipated critical data this year, data that could enable important commercial launches beginning in 2027. And financially, we are significantly profitable, and we continue to invest with discipline priority programs with clear strategic and financial impacts and with the highest potential to make a difference for patients. So the key takeaway is, we have a robust foundation with multiple near-term growth drivers on the horizon, and you can see that clearly on the next slide. Here, we have our 3 late-stage programs, which together have 5 breakthrough therapy designations. These programs with a multibillion-dollar potential underpin our long-term growth. 2026 will be a defining year for the company. We will deliver key clinical data readouts. And importantly, we will also broaden the potential reach of Rina and pitusantomab with new Phase III trials.

Now let me briefly touch on some of the key highlights for each of the programs on the next slide. EPKINLY is currently the only bispecific antibody with a dual indication across key B-cell malignancies in the U.S. Europe and Japan, uptake and approved indications have been strong, and recent data at the 2025 ASH conference reinforced EPKINLY's potential as a core therapy capable of redefining care across B-cell lymphomas. At Kids R square is the first CD3/CD20 bispecific to demonstrate Phase III superiority of standalone care in follicular lymphoma. With this unprecedented data EPKINLY plus R square is well positioned to become a best-in-class option in second line plus follicular lymphoma.

Let's move to Rina-S, it's a folate receptor alpha-targeted ADC designed to broaden eligibility beyond the high expressors. And based on the current expression distributions, this could expand the addressable population by up to approximately 3x versus approved medicines that are restricted to high folicular receptor alpha expression levels. We have seen encouraging antitumor activity and durability in both ovarian and endometrial cancer, supporting rapid late-stage development now into now 3 ongoing Phase III trials. Then the latest addition to our pipeline on the right, following the acquisition of Merus is ptusentomab, a potentially transformative each of our LGR5 bispecific with compelling data in both first line and later line recurrent or metastatic head and neck cancer.

And as a reminder, in the first line setting pitusantamop in combination with Pembro achieved a 63% response rate and that is more than 3x higher than the 19% that has been observed with the standard of care. And again, this benefit is not limited to response rate, but is also reflected in improvements in the event endpoints such as progression-free survival and overall survival.

Let's move to the next slide. In 2025, last year, there were 7 key data readouts that validated the potential of EPKINLY, Rina-S and Petosemtamab. These are the programs that will define our next phase of growth. foraging,the Phase III ABCA1 study in second-line follicular lymphoma delivered unprecedented data. and form the basis for regulatory submissions. We also showed that our patient administration is feasible, which is important for broader adoption. For Rina-S, we presented updated data in platinum-resistant ovarian cancer and initial and updated data in second-line plus endometrial cancer. highlighting deep and durable responses across the spectrum of folate receptor alpha expression.

For Petosemtamab, there was an update in the first-line head and neck cancer data set that underpinned an FDA Braket therapy designation and first -- and the first look at promising data last year in metastatic colorectal cancer. These readouts not only derisk the individual assets, they collectively support our confidence that this powerful late-stage oncology portfolio can deliver multiple transformative launches over the next several years and have a positive impact on patients. Looking ahead, you can see on the next slide that 2026 will truly be a catalyst-rich year for Genmab. We expect up to 6 potential registrational data readouts that could set the stage for multiple important product launches and line extensions in 2027.

In the second half of the year, we expect Phase II data for arenas and platinum-resistant ovarian cancer. We also anticipate that 1 or both of the Phase III trials for pitusentamob in the first- and second-line head and neck cancer setting will deliver top line data in the second half. For Akili, we anticipate data now for 3 Phase III trials in diffuse large B-cell lymphoma frontline diffuse lots, B-cell lymphoma with a bit job and will be in 2026. And then in the first half of this year, 2 trials in the second line plus a cell lymphoma setting, one with epcoritamab monotherapy and 1 in combination with ledarlidamides.

And together, these studies are designed to move up kind earlier in the treatment paradigm and significantly increase its addressable population from approximately 27,000 patients today to almost 150,000 patients by early in the next decade. So importantly, data during 2025 strengthened our conviction in these programs are now -- it is the meaningful registration of readouts that will be catalysts that will allow us to potentially bring these antibodies to patients in 2027.

Let's move to the next slide. It's also important to remember the strength of our royalty portfolio as evidenced by the consistent quarter-over-quarter growth of our royalty revenue. Investment in our priority assets is possible in part because of the growing revenue streams from the approved partner of medicines. This slide brings together both our royalty portfolio and our own medicines. The combination of a durable royalty base and a rapidly maturing proprietary portfolio creates a balanced business model. It reduces our dependence on any single product or revenue stream and improves the quality of our earnings. Strategically, this is exactly the shift we set out to make a decade ago.

From primarily discovery and out-licensing towards being a fully integrated biotech that discovers, develops and commercializes its own medicines at scale. The takeaway is that our revenue growth is not only strong, but it's also increasingly diversified. Our confidence and our ability to execute our key -- on key data readouts in '26 and the subsequent high-impact launches in '27 come from our strong track records. We have proven that we are excellent evaluators of innovation and that we deliver on our promises.

We over delivered on the financial and operational commitments we made at the time of the Perform Bio, and we rapidly accelerated the development of Rina-S, you have all proven that we are disciplined in our execution against our capital allocation framework and in the prioritization of our investments, and we continue to be committed to delivering profitable growth. We intend to apply the same disciplined approach to the rapid integration of mirrors and the focused and strategic development of Petosemtamab. So to conclude, 2026 will truly be a transformational year for Genmab.

We will have many significant catalysts -- we have 3 high-impact late-stage assets, all with key clinical data, data readouts this year, and we have the capabilities in place to support multiple potential launches in 2027. And we have a growing set of wholly owned assets in clinical development. Put together, Genmab is a scaled oncology biotech business with strong momentum and increasingly diversified growth profile with multiple clinical catalysts ahead. And our focus remains on translating our antibody science and development expertise into meaningful breakthroughs for patients as well as long-term value for stakeholders.

Thank you very much. Let's move into the Q&A now.

Thank you on for a great presentation. [Operator Instructions] Whilst we wait for the microphone to go over there I will.

Yes, are you intending to use a biomarker-driven strategy for your Rina-S Phase III?

Sorry, say it again.

Are you intending to use a biomarker-driven strategy for your Rina-S.

I will hand it over to Tahi Ahmadi, we definitely stratify for [indiscernible].

Yes. Thank you for the question. So I think we've been very consistent on this. our thought, our position on Rina-S is it has efficacy across the entire spectrum of whether we sell the alpha expression. Now we have to be a little bit more specific, that is a little bit different in ovarian than this in endometrial and then the mutual the expression is, generally speaking, a little bit lower and ovarian is almost miniscule number of patients who are really truly negative.

But that's our position based on the data that we have had. On the other hand, we are still, of course, stratifying by the fleet alpha expression. And when I say it has a meaningful efficacy that is not to say that it behaves the exact same way that fully deception does not have an impact on or even possibly on duration of response. It just means that it cost of spectrum of further expression and the data that we have had both in the way and endometrial, we see a meaningful signal, meaningful means. -- above what is currently a standard of care. And that kind of observation is also important because that is driving the ambition and the opportunity space for VNS even outside of the gyno space. We always say we view it as a best-in-class ADC in Ghana. That's our ambition. That's what we have to own. That's why we have very aggressively developed so far with 2 Phase IIs.

We guided that one of them is going to read out actually this year and then 3 Phase IIIs and more to come. But the observation that the efficacy is preserved to a degree regardless of teeth expression speaks to the unique profile as it relates to the antibody disability, the higher policy of the linker and then the payload exatecan -- and then, of course, open spaces also in other [indiscernible] space.

Thank you for the question. Let's see, it's another 1 or more.

We've got 1 in the portal, which is with the Merus acquisition, how should we think about the impact on Genmab's R&D pipeline, do you expect to see any consolidation? I think we saw you take a decision of acaciamab over Christmas. So any further consolidation to come?

Yes, that's a very good question. So we're definitely in a rank ordering all of our programs and actually try to merge our pipeline with that of mirrors beyond Petosemtamab. I mean, Petosemtamab Centimeter going to actually make broader and accelerate in the come time I already said publicly that we are going to add a lot of technical operations and manufacturing expertise to the team executing on the 2 Phase III trials but you will see more Phase III trials coming from for Peto this year.

All the other programs, you are going to try to rank all of them with our own programs and focus only on the highest impact ones, and you're right. I mean just as we did with metacasulimab. Let's see, in December, deprioritized and actually stopped developing. In the context of only want to focus on the highest impact, potential impact programs for patients and for stakeholders. -- and make them broader rather than to focus on programs with in the context of an evolving landscape, therapeutic landscape and more competition, which we saw in the second-line lung setting probably not be that competitive. I think it's better to actually prioritize on other programs. It can make a much bigger impact for patients, and the same will be for the rest of the Merus pipeline.

On top of that, Merus has partnerships with different partners some of these partners if we will critically evaluate to really see whether we want to continue because, of course, for us, that may not have the same type of level of priority as for Merus. So yes, you will see some further actions over the coming time. We will do this very carefully, but then also the size of related [indiscernible].

And maybe just brought in the question on Merus, can you remind us on the strategic rationale for Merus we're seeing a lot of interesting mechanisms in the head of next space, including some that have been talked about this week. So what particularly attracted you about GFR and can you contextualize how that's differentiated from some of the other mechanisms that we've seen?

Absolutely. Let me first put it in a broader context with Merus in general, we know the company for like 22 years. They technically enabled to R&D center in the Netherlands. And we are very impressed by the technology. They are very exciting technology. capable of making very, very good antibodies, they already created Pangay which is on the market now for a smaller indication with a fantastic complementary technology base, which together with our expertise in DuoBody bispecific antibody space, which is now taking care of 50% of our pipeline is a completely complementary technology base.

So we really were attracted to put them together so that we are an even stronger multispecific antibody company going forward. Then zooming in to Petosemtamab, let me first ask Tahi to give his perspective on the relative strength of Petosemtamab versus other, apologies and Anthony can potentially add to that. .

Yes. I would start with first that part of the strategic imperative was that we were looking for an asset that we could integrate into a pipeline that would have a broad potential, significant commercial opportunity and would launch in -- and Peter, in our mind is within this emerging class or second-generation EGFR bispecifics. The 1 that in our mind, at least has potentially to be the best-in-class in that space. certainly underwritten by some of the data that is already in the public domain that then led to 2 BTDs both monotherapy and as well as in combination both on a development point of view. It's also like already relatively well established with 2 Phase IIIs that we also initiated some time ago that are well underway enrolled.

And when we announced the acquisition, we already kind of like positioned ourselves in a way that for us, Peto has to drug in the neck. So this is a space where we continue to go and to invest and further develop the drug. But in and of itself, also kind of on the witness some of the data that Jan was alluding to earlier that was presented at the end of the year in colorectal, it has beyond head and neck, of course, also other alternatives that we will then pursue -- so that's kind of like what we're excited about it. There are not that many drugs that fit that profile. So we were forced, we were able to execute the execution and we're very excited to have Peto in our pipeline.

Yes. And on top of that, I mean, we understand bispecifics really, really well. literally 50% of our pipeline is bispecific. There now several duoBody-based products already on the market for of the products which are based on our technology duobody-based, bispecific antibody based. So we understand really well how to work with those molecules. And the profile is just fantastic of Petosemtamab preclinically and clinical. So we think it's a much, much bigger drug than just a medicine for head and neck cancer, but we're going to consolidate our base and head and neck cancer move into other areas, of head and neck cancers first and then also this year make in other areas based on data. .

And whilst we wait for further questions in the audience. Thinking about the first-line data that you've seen so far. So I think you've shown really strong data at ASCO last year, could you remind us what we saw with parsatuzumab there in terms of ORR rates and how that compares with KEYTRUDA monotherapy?

So I mean the data that you referred to is like a 60-plus percent response rate in combination with Pemble, where pembro has a mid-teens small help response. And so it's whatever way you want to look at it, less tripling, if not even more of the response rate. It's not only the response rate Jan touched on it, it's also the durability of the response. And then also the or survival. Of course, this was Phase II data this needs to be replicated in the Phase III, but as part of the diligence, we, of course, had a view on all the way down to a single patient level.

So we are very convinced to have very good understanding about the capabilities of Peto and the efficacy signal, and makes it somewhat heterogeneous disease. So understanding that space and being -- we have that heterogeneity is important. So we clearly have also an understanding of this disease space because we have been in the head and neck space for a while, the 102 and Tiv -- and so we had an appreciation for the data that Merus had generated. And so we are very confident and excited about this data and the potential that RAC has beyond these 2 Phase IIIs.

We already said we're going to go into the local regional space. That is, of course, part of this strategy to anchor the drug in head and neck. You already touched on the colorectal data, which, again, very small data, but as a data point in terms of combination with chemotherapy in frontline and second line, again, a strong signal.

And we've got a question over here.

So keep you in fit today -- keep you on top condition.

Great. Thank you. First of all, congratulations on the rapid execution of Rina-S. I think that really is a pretty good testament. My question is thinking about from what little I know, and maybe I have this wrong, but the doses you're using for Rina-S as an ovarian and endometrial perhaps may not be the same. How are you going to tease this out when you launch? Question number one. Question number two, what about Ella here and the subset? I know [indiscernible] receptor positive, but that is already out there and how are you going to stratify or differentiate that Rina-S truly differentiates those.

Yes, very good questions. I think I'll let Tahi take a bite on both, and then Anthony can definitely talk about the commercial, how we are going to deal with [indiscernible] versus for the 2 indications. But Tahi, why don't you take the second first.

Sure. Thanks for the question. First, the dose yes. So the dose the Phase II dose and endometrial is 100 milligrams per meter square in ovarian is 120. We dosed by meter square. Endometrial women -- women with endometrial cancer tend to have a larger body mass. If you actually look at the exit levels 100-milligram per meter square in endometrial is exactly equal to 120 in [indiscernible] . So that's kind of like the rationale for the dosing. .

As it relates to the whole strategic positioning is la -- as you know, LA has approved in part right now, 75 and above. In the original Phase I patients are required to have LAA when they are meeting this criteria because that's the unmet medical need, but bringing this also to the first question. our trial enrolls all patients with Fog regardless of it, we have to offer expression. So that's the first meaningful differentiation. If you just look at the profile of the data, I think it's probably fair to say that the efficacy signal is stronger in OR. We will end the Phase III actually have that opportunity to describe this a little bit better because in the Phase III, we also will have patients who are naive and 75 and above. So we'll have a little bit more robust data to support that.

But clearly, what's out there in the public domain, the signal even in the 75% is significantly higher than the duration of responses 12 months, we still have not reached the duration of response. And I had a situation of responses, I think, 6.5 months or 7 months. We do not have the liabilities of eye toxicity on neurotoxicity. And so I think in totality, this is just the second generation or for Alpha ADC with a completely different profile, a different opportunity. And it's expressed in the fact that you just acknowledge that there are already 3 factories wanting which at all more than has.

Maybe just to add on, if you sort of think about the overall commercial opportunity. As we highlighted in the presentation, when we announced the acquisition, ProFound Bio and Rina-S as we initially had put the peak sales estimate at $1 billion. Now since that, we've upgraded it to $2 billion, and that's really a function of the emerging data we're seeing, in PROC in endometrial cancer, but also as we think about expanding and the progress we've made on the clinical development program, that's a function of the overall, again, the target product profile in absolute terms but also in relative terms Tahi just very eloquently outlined some of the differentiating factors relative to the existing competition.

Now moving forward, we're not just looking at the existing competition. We're really focused moving forward also around making sure that we can have in-class folate-receptor alpha product, a first-in-class where we can be first, but also broadest in class. So we stand fully behind our $2 billion sales estimate. We have the CDP in place to realize that. Now specifically to your question around the nuances around pricing, we're just going to leave those nuances for a later date closer to or add post launch.

And I think in terms of duration of response just to build on that because can you give us a view on what we should expect to see later this year? Is it going to be the median duration response in the Phase II? And how is the Phase III tracking in terms of recruitment that you need to have fully recruited for the support regulatory filing?

Well, so I would say like the next data that we're going to see on PROC is the Phase II pivotal data set. I think it doesn't make sense to update the Phase II data set actually have 100-plus patients, that's going to be the data that is going to be informative for the filing in the United States, and that is going to give us the -- well, this quite duration. I don't know whether duration response is going to land. -- because I don't know. But we were very intrigued by the fact that we have a very long duration of treatment. I think this is a port to underscore again, main toxicities of Mina-S neutropenia, which is manageable with appropriate GCSF support.

And so then women can stay on this drug for quite a long time. And if they stay on drug for quite a long time, that seems to be translating to the long duration of response. As it relates to the Phase III, I'm not going to give you an exact update, but I can tell you that we are extremely well accrued on the relevant confirmatory Phase III in PROC. So no issues there.

That's very clear. And I think you've said H2 '26 for the timing of the Phase II pivotal readout?

Yes. That's what we project now.

And we've also heard at this conference and also over the course of last year, some of the [indiscernible] followers that are coming the likes of Astra, Lilly. So what are your perspectives on the data share so far and how Rina-Sis differentiated?

Well, I mean, this is a general in oncology now that's becoming ore competitive into your Neverland loan. So part of the differentiation is also the speed by which you execute your development plans I do think that the AZ folli receptor offer ADC and the not say made equal. I think Ellie's Lilly's ADC does look by the data that's been shared the most closest to what we have publicly put out for Rina.

Having said all of that, it's really about execution. We're sitting here, what is it months after the acquisition of ProfoundBio at the time, we didn't have the recement Phase II dose. And we have 2 Phase IIs that are intend of registration, 1 that we already discussed is going to be presented -- we'll have the top line results presented in the in the second half of this year and through 3 Phase IIIs that are enrolling.

And so I think that's going to be part of the differentiation is to push the drug along the lines of therapies into earlier lines to benefit women -- and a lot of this is going to be execution. By the way, the same was true for Peto as well.

And another thing that's emerging in gynecology is the B7-H4 ADC strategy, and you're familiar with B7-H4 as well as the target. So -- can you explain to us why folate receptor alpha is potentially a better target than B7-H4?

Tahi, do you want to start with that?

Sure. I mean look, there's no shortage of targets. What we did like about Rina-S is, a, the whole package, folate receptor alpha is a tumor target that is especially actually in a variety of tumors. And once you have a package that allows you to illicit response in patients who have or in tumors that have lower expression levels of folate receptor alpha, it's actually a relatively broad space. .

Two, as it relates to gyn-onc, folate receptor alpha is expressed both in ovarian endometrial it's also actually express and cervical. But these are the 2 major indications. And so having in your pipeline that has potential to change the treatment in both of these major indications. I think there's a significant strategic advantage as you think about dual indications. Something that we learned on the kidney just to bring that up. where having an indication both in diffuse such B-cell and in follicular lymphoma has given us a competitive advantage against the competition where it's 1 drug and for the conformity speaking and the other 1. So folate receptor alpha is a fantastic target in gyn-onc.

And because of its potential in other disease areas, we think Rina-S has the potential to become a really big drug. We anchor it gyn-onc but as said we are already generating data and other 2 set up for the so excited about that, too.

Any questions? If no, can I ask about EPKINLY which you just mentioned. So what's the latest on timing of first BCL and I think you mentioned previously that we could be protecting an interim. So just to check whether that's past or whether we're still waiting for the interim?

Not the first line, the diffuse label lymphoma trial will be out this year for sure. We just don't know whether it will fall in the first half or in the second half. That will get clear in time, it's an event-driven as -- and once we know and we will definitely make that public because we want to be very open and transparent like for the other trials, and you will hear that in going time for sure.

And the only thing to add to that is, again, like to the theme of like acceleration of drug development -- we started the fascia frontline study about a year before the competition. And so that time advantage is going to be important. This data we saw. -- speed into these frontline indications, these large indications on that disease is actually half of the entire valuation for the space, the lymphoma space are important and are differentiating aspects. .

And you mentioned competition. There was recently a first-line BCL trial that showed a 25% PFS benefit for the CD19. So how has that changed your view and confidence level heading into your data and could you contrast what you'd expect to see with your first in retail trials versus what we've just seen with the CD19?

Well, the first thing I would say back on I'm a lymphoma doctor, this is the second Phase III in the few such piece and the last 26 or 27 years that's positive, so congratulations to inside. It's good for patients. There are some differences. This was a trial that was in a biomarker-selected population. ABC with the addition of 2 drugs in Inwit and TAF, as you said, with a hazard ratio of 0.75. We will see what our trial is going to show. It's a trial that actually enrolls IPI 25.

So broadly speaking, the entire spectrum, except for the very low risk, but the primary readout is initially in IPI 325 and a higher-risk population. -- we shall see. It's hard to speculate. Having said all of that, where we take our confidence and excitement is when you look at the second-line follicular lymphoma study, that just recently read out right after Tofas well, by the way, with the hazard ratio of 0.2% and which is really without present lymphoma, that data almost to the decimal point mimic the relatively robust 100 patients that we had involved prior to that in the combination with R-square in follic lymphoma.

And so there is some belief system that the Phase III in frontline defease to also, to a degree, mimic the pretty impressive, I think, data that we have generated with RCHOP, EPCO and IPI 3 5. And if that were to be the case, I think this is going to be a very positive trial.

And on overall survival, what can we expect to see there? Could it -- should we be looking for a trend or is it too early?

Tahi?

When we're speculating right now, we shall see what it is. I mean the 2 trials that we talked about inside tafa-len shop combination and a positive PFS, but there's almost a separation on because that usually trails significantly by time. I think it's completely speculative and not really helpful. Principally speaking, we've been very clear and bullish that we believe this trial is going to be having a significant impact and if it is going to have a significant impact, and it probably will also translate into an earlier OS signal the way the fabs usually is. .

And within your $3 billion peak sales target for pine, what have you assumed for Charmaine BC versus the competitors where you've said you've got a time-to-market advantage -- we're already hearing of other mechanisms, again, as fast followers in DLBCL, CD19, CD3 as an example. So your perspective on share there and how you differentiate it?

Anthony?

So I think maybe a good place to start with that is the progress we've made in the 2-plus years since launch. I mean particularly when we build out our commercialization capabilities in the United States and Japan. We've performed very, very well and probably ahead of, let's call it, your expectations, Zain, we're very happy with the foundation that has been built in the third line plus settings for DLBCL in third line plus follicular lymphoma. We now have to look forward to the second-line FL sort of uptake in 2026. And just to be like thoughtful about that. It's not going to be a hockey stick in 2026 in terms of the sales figures there.

The total addressable market for the second line FL this won't support that. But it is meaningful more from a qualitative perspective to be out there in the marketplace, speaking more about and this additional opportunity. In terms of the $3 billion peak year sales estimate, we've not broken that down. But I think I'm not going to lie to say that a major, major driver is going to be the front line DLBCL setting. From a total addressable patient population, this represents around half of that total opportunity for pine -- since we've been talking about data readouts, we've talked about the frontline DLBCL. It's worth reiterating what Jan covered in his presentation.

In addition to the frontline DLBCL readout in 2026, we're going to have 2 additional data readouts in the DLBCL setting. One of those was on your radar screen for some time, which is the second-line DLBCL monotherapy. What's new and I'd say, more relevant is going to be the second-line DLBCL combination therapy with Revlimid. Now both of those are slated for H1 of 2026. So really, the summary is Zain. We have a very good foundation we've built out in the later lines. We have a number of readouts in 2026 and really look forward to seeing those readouts and then hopefully, the successful launches subsequent to that.

And you mentioned the difference in trial design where it was focused on ABC in the common the competitor trials. And so thinking about what we saw with the Polarix regimen where there was GCB and ABC I think GCP there was very limited benefit. ABC was more of a benefit. How do you see -- do you expect to see a difference for EPKINLY or in terms of benefit of cross the subgroups and maybe bigger picture. What does that represent as a percentage of DLBCL patients?

Well, so first off, I can that I believe the reason that Incyte designed the trial the way they designed to this because they were essentially following a presence that was established by Celgene, which had kind of generated data that was suggested that lenalidomide actually only works in ABC. And so that's where they had done their original work where they're barely missed. And I think that was the reason why Inside went with that strategy. .

But you're right that in the politics side is a somewhat bizarre still understood difference how it behaves in ABC versus GCB, which has actually led to more of an allocation in this ABC cell of origin subset in the general population. -- for a CD3 T-cell director, I don't, at this point, have any biological reason to believe that cell of origin matters. It's not something that we've seen in any of our data sets ever. So certainly something that will be described in the demographics, but it's not something that we anticipate.

That's very fair. And we've got a couple of minutes. So Anthony, to ask you about R&D and thinking about -- you've mentioned before about census R&D being in about the right place. Since then, we've seen acasillimab discontinuation, but you were talking about adding trials to petasemtimab. So how should we think about the P&L into 2026 and maybe broadly with the trials that could be reading out this year, how are you feeling about the shape of Genmab through to 2030 on both revenues and operating profit?

Yes. So for 2026, first of all, maybe at the macro level, everything I said at Q3 in terms of consensus being in a reasonable place how we stand fully behind to date now sort of underpinning that, I think, are 2 key themes. One, our investment priorities at Genmab are super clear. We have a number of ongoing high conviction, high priority Phase IIIs across EPKINLY, Rina-S and Peto, particularly for Rina-S and Peto, particularly from financial planning purposes, I see clear line of sight and have left space for some additional expansion opportunities. So number one, investment priorities are super clear. On the other hand, at the same time, we're very focused on driving operational efficiencies and operational savings. Think about Genmab where it is now as we exit '25 and get into '26 and beyond, we're in a fundamentally different size and scale, which means we be super focused on driving those scale benefits whether it be from a bargaining power perspective or just sort of leveraging more fixed costs. That's one side of it.

The other side in terms of the operational efficiencies and sort of good old-fashioned like industrial logic, and us being super disciplined and specifically attacking our largest US driver, which are the Phase III trials. A couple of years ago, we're running a handful of Phase IIIs, -- that number, as you can see, is increasingly going up. So we're going through that together with Tahi and Judith really in a bottom-up fashion and really focused without sacrificing speed or quality, bringing down our per unit cost. We've made meaningful progress in 2025, and we'll continue to do that and beyond, and that's going to free up capital for some of the expansion opportunities for Rina and Peto and potentially other programs as well.

I think that's for us to time. So thanks, Jan, thanks, Tahi and thanks, Anthony. Thanks, everyone, for being here.

Thank you.

Hello, and welcome to Genmab's ASH 2025 update. As a reminder, this webcast is being recorded. During this webcast, 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 it is required by law.

Please also note that Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab moving forward. Please refer our website for more information on Genmab and privacy policy, I would now like to hand over to your first speaker today, Jan Van de Winkel. Please go ahead.

Hello, and welcome to Genmab's 2025 R&D update and ASH data review. I'm Jan Van de Winkel, President and CEO of Genmab. I'm delighted to share with you some of the highlights for Genmab in 2025 as well as exciting EPKINLY data from this year's ASH meeting.

Next slide, please. As a reminder, this presentation may contain looking statements and as such, may contain certain risks and uncertainties. So let's move to Slide 3. We will begin with a review of the focus we made this year as we advance toward our 2030 vision. Next, we will review some of the encouraging epcoritamab data presented at this year's ASH meeting. And for this, we are pleased to have Dr. Lorenzo Falchi. Then looking ahead, I will provide a brief overview of some of the key events we are anticipating for 2026. To conclude, I will open the floor for a lively Q&A session. And for this, Dr. Falchi and I will be joined by Genmab's Chief Medical Officer, Dr. Tahi Ahmadi; and our Chief Development Officer, Dr. Judith Klimovsky.

But first, let's explore some of the highlights from the past year. Next slide, please. I'm pleased to say that we have successfully delivered on the commitments that we made at the beginning of the year. With the proposed acquisition of Merus and the addition of petosemtamab to our portfolio, we saw an opportunity that will position us for sustained growth and long-term value creation. And our other commitments this year support our conviction that we will be able to rapidly maximize petosemtamab's full potential. We significantly accelerated the development of Rina-S. And together with our partners, we expanded the reach of both EPKINLY and TIVDAK. These strategic investments, in addition to our high-quality recurring revenue have set us up for success in 2026 and beyond.

So let's look at some of the specific progress we have made this year on the next slide. Since 2013, we have been executing a strategic shift from our royalty depending earnings to a diversified fully integrated 100% owned model. The addition of petosemtamab to our already compelling late-stage pipeline significantly accelerates the shifts. The totality of data that we have seen from petosemtamab underscores its potential as a best-in-class EGFR directed bispecific across head and neck cancer indications as well as other EGFR expressing tumors.

We anticipate the transaction will close by early in the first quarter of next year, and the integration of Merus will be a key priority for us in 2026. For Rina-S, we have presented compelling data in both second line endometrial cancer. Rina-S also received breakthrough therapy designation as well as in platinum-resistant ovarian cancer or PROC. What emerges from these data sets is a highly compelling product profile across efficacy, durability, safety and through the whole spectrum of poly receptor alpha expression. And we are investing to maximize the potential we see in Rina-S with an accelerated and comprehensive development plan. We are ending this year with 3 Phase III trials and 2 Phase II potentially registrational trials.

For acasunlimab, hopefully you have seen the updated data presented at ESMO IO just yesterday, showing promising overall survival and durable benefit with manageable safety. Turning to our already commercialized medicines, TIVDAK was approved in both Japan and Europe, providing us with the opportunity for the first independent product launches in Genmab's history. With these launches, we are building a foundation in the gyno community that will set us up for future success with the potential future launch of Rina-S.

EPKINLY expanded with additional approvals including the approval from the FDA just last month in combination with R2 in second-line follicular lymphoma. The unprecedented Phase III data in this indication was simultaneously published in the prestigious journal, The Lancet, and highlighted during an oral presentation at ASH. One of 7 oral presentations and over 30 total accepted abstracts for EPCORE this year. Now let's review this data along with 2 other key data sets presented this year -- at this year's ASH annual meeting.

Let's move to the next slide. To present this exciting data, I'm delighted to introduce to you Dr. Lorenzo Falchi of the Memorial Sloan Kettering Cancer Center in New York. Lorenzo is a medical oncologist and hematologist and an expert in the treatment of lymphoma. As an investigator, he is still intimately involved in the development of epcoritamab. Lorenzo, please go ahead.

Thank you. Thank you so much, and it's a great pleasure to be here with you and to share some of the exciting reports that Genmab has presented at this year's ASH, and I was very honored to be part of several of those. I'll begin with this slide, which is an overview of the accomplishments that have been made at this year's ASH through epcoritamab with 31 abstracts accepted and 7 of them being an oral presentation, and you see them highlighted here in 3 particular disease domains. Follicular lymphoma, diffuse large B-cell lymphoma and Richter's transformation, which is a specific complication of chronic lymphocytic leukemia and a very severe one.

For follicular lymphoma, you can see 3 abstracts were presented in the frontline setting, the first EPCORE NHL-2 Arm 6/7 were presented combined in 1 oral presentation with a 3-year follow-up update of this triplet combination of epcoritamab plus rituximab and lenalidomide or R2. EPCORE NHL-2 arm 3 was also presented as a 3-year update in this particular study.

Epcoritamab was combined with a chemoimmunotherapy standard bendamustine and rituximab. And then finally, in an academic study from the Dana-Farber group, epcoritamab, combined with rituximab was also tested for patients with newly diagnosed follicular lymphoma and presented as an oral talk. In the relapsed/refractory setting is where we really were happy to share for the first time the primary analysis of the randomized controlled Phase III trial named EPCORE FL-1 which tested rituximab and lenalidomide with or without epcoritamab. And I'll talk a little bit more about the study that I was honored to be presenting at this meeting.

As a corollary to that study, we also presented in the form of a poster patient-reported outcomes from the same study showing how the addition of epcoritamab really preserve the patient's quality of life while improving the results, as I mentioned. In diffuse large B-cell lymphoma in the frontline setting, 3 studies were presented, 2 of them is an oral talk, the first is the Arm 1 of EPCORE NHL-2. This is the flagship study, if you will, for patients who are fit to receive full dose chemotherapy.

And in the study, patients received R-CHOP plus epcoritamab. Here, we gave an updated 3-year follow-up or longer than 3-year follow-up. And we showed really encouraging results, and I'll talk about this in a subsequent slide. The Arm 8 of the same study, EPCORE NHL-2, looking at dose reduced chemotherapy for patients who are a little bit more elderly and cannot receive a full dose chemotherapy.

And then EPCORE DLBCL-3, which is looking at epcoritamab monotherapy, meaning epcoritamab given alone, for patients who are really more frail or very elderly and really cannot take any chemotherapy at all, and this is really going to fill a really important unmet need in that space. In the relapsed/refractory setting, a 4-year update of the EPCORE NHL-1 study, the original trial that led to the approval of epcoritamab for recurrent large cell lymphoma. This 4-year update gives essentially the longest update for a bispecific in diffuse large B-cell lymphoma in the market. And these data were also very exciting and very confirmatory in a good way.

EPCORE NHL-6 study was looking at epcoritamab in the same indication that it's approved for but including a diversity cohort in the U.S., including Puerto Rico and kind of testing epcoritamab a little bit more in the real world. And then NHL-2 Arm 5 study, also was presented as a 2-year update in this particular trial epcoritamab was combined with GemOx.

Also exciting news from the Richter's transformation space, as I mentioned, both epcoritamab as monotherapy and in combination with either lenalidomide or R-CHOP were tested and reported both as oral presentations. Of note, the epcoritamab monotherapy study eventually led to the NCCN recognition and so this treatment, this drug is now included in the NCCN compendium for patients with a recurrent chronic lymphocytic leukemia.

And so you see here how you have a Phase III readout, you have first reveal of data in a niche, a very important disease such as Richter's transformation. And you have a lot of long-term updates, in particular for the frontline follicular lymphoma and large cell lymphoma setting in combination, but also in the relapse setting as epcoritamab monotherapy.

So a little bit more about the EPCORE FL-1 study. This has been really our pride, and certainly has been my honor and my pride to present this study on behalf of all our co-authors. This was a randomized Phase III trial comparing in a one-to-one fashion, epcoritamab plus R2 versus R2 alone. You can see a large study, 488 patients equally distributed in the 2 arms.

These were patients with follicular lymphoma who have received at least 1 systemic therapy, including chemotherapy and in need of subsequent treatment. The study was designed to demonstrate the dual primary endpoints of overall response rate and progression-free survival, and it was conducted at 189 sites across the globe. We presented in this particular analysis with a median follow-up of 14.8 months. This was the second interim analysis, where we were able to analyze both primary endpoints.

Here is a look at the patient's characteristics at baseline by treatment arm. Obviously, this being a randomized controlled trial, the characteristics were well balanced in general. But I invite you to look at the bottom part of the chart where you can see the treatment history of these patients. And although just over half of the patients had received 1 line of therapy only prior to entering the study, there were a large number of patients with heavily pretreated disease, but more importantly, patients with high-risk features, including POD24, which means an earlier relapse after frontline chemotherapy and also patients that were refractory to the first-line therapy, meaning they never achieved the satisfactory response or patients who are double refractory, meaning that neither rituximab or chemotherapy has succeeded, so a particularly difficult to treat patient subgroup.

So here's the study first co-primary endpoint. The addition of epcoritamab to R2 led to a massive 79% risk reduction in the risk of progression or death. And this was with a hazard ratio of 0.21, which at least in my experience is unprecedented. I don't recall seeing a hazard ratio that's favorable, obviously, highly statistically significant.

But it's important to emphasize also that when we did the subgroup analysis of progression-free survival. What we found is that the benefit in terms of progression-free survival was preserved across patient subsets, including the higher risk but also the lower rice patients across ages, obviously, sex, regions of the world, et cetera. So this really demonstrates that the benefits of adding epcoritamab to R2 are really maintained across a broad population of patients with recurrent follicular lymphoma.

And here is the second co-primary endpoint, which is overall response rate. This is -- this was an earlier endpoint that we looked at. This was also met. The overall response rate was 95% for epcoritamab R2 and 79% for R2 alone and the complete response rate, perhaps even more compellingly, was 83% for epcoritamab R2 and 50% for R2 alone. So it's a large difference. And we know that the value of complete response is very significant in follicular lymphoma, where the complete response really translates almost one-to-one fashion into better progression-free survival and eventually better outcomes.

We also looked at a number of secondary endpoints. Perhaps an important one is a duration of response. That is how long the response that is achieved can last. And here again, we saw a very large difference with a very significant improvement in the duration of response with the addition of epcoritamab to R2. Again, here, an incredibly favorable hazard ratio of 0.19, highly statistically significant, really suggesting that once that response is achieved it tends to be maintained for a long time.

This was true for epcoritamab alone, and it's even more pronounced with the addition of epcoritamab and R2. We also took an early look at overall survival. Now I don't want you to overinterpret this curve because the follow-up of the study, as I mentioned, is too short, and this is, as we know, follicular lymphoma, where overall survival analysis can take a long time.

But with this very early time point, we started to see a little separation in those curves with a hazard ratio of 0.38 and a significant p-value. This does not mean that epcoritamab R2 results in a longer progression overall survival than R2 but it's possible that with longer follow-up, we may be able to see that difference. This would be, I would say, unprecedented that new treatment improves overall survival over an established real second-line therapy like R2 that it's an internationally accepted standard of care.

And then finally, we looked at safety because obviously, we were very happy to see the efficacy result, but we didn't want to neglect safety. And obviously, we want to make sure that this is not only an effective treatment and a superior treatment, but it's also well tolerated with adverse events that are manageable. This was indeed the case. Obviously, adding a drug that's very powerful is not going to go without any side effects.

There were a little bit more adverse events in the patients treated with epcoritamab plus R2. But these were not adverse events that were unexpected. In other words, it's what we call in jargon, there was no safety signal. We didn't see anything surprising. There was no strange toxicity coming out of the combination by putting together these 2 components. So certainly nothing that we were not able to manage.

CRS or cytokine release syndrome has been a major theme in terms of adverse events when talking about bispecific antibodies with the addition of rituximab with the particularly modified step-up dosing schedule during the first month of therapy, we were able to bring down not only the incidence of CRS but also the severity. There were no cases of severe CRS no patient was hospitalized for this treatment. So this treatment really is a fully outpatient therapy that can be applicable even in community settings across the country and beyond the U.S.

One brief comment about infections. Obviously, epcoritamab is an immunosuppressive therapy, and it's not surprising that these patients had a little bit of an excess in infections. But I would note and most of these infections were mild respiratory infections that we were able to monitor in an outpatient setting. Sometimes patients had to be admitted for infections, but this was in part true also for the control arm of the R2.

Clearly, this data point towards an attention that needs to be paid to prophylaxis and proactive management of infections. We don't want to start patients on this treatment without adequate antibiotic prophylaxis and adequate monitoring. But I think after a brief learning curve, what we've learned ourselves is that it's really easy to do that frequent monitoring and just really treating proactively this infections, ultimately, at least in our center, we didn't have to hospitalize anyone.

And so here, you really have an essentially practice-changing study that shows that the addition of a highly potent bispecific antibody like epcoritamab in patients with relapsed follicular lymphoma leads to a massive reduction in the risk of progression or death has a positive trend in overall survival. It is chemotherapy-free. It is fixed duration. I should mention this. You might remember in the epcoritamab monotherapy cohort treatment was given into progression. So indefinite here, we've fixed the duration to 12 months or 12 cycles. So this was really a transformative treatment in a transformative study.

This was recognized by prestigious journal like The Lancet that we were honored to be accepted in. But it also importantly was recognized by health care authorities, in particular the FDA, that, as you know, on November 18 granted approval to this combination for the treatment of patients with follicular lymphoma after at least 1 line of therapy and it also secured traditional approval for epcoritamab monotherapy in its present indication in follicular lymphoma. Other regulatory submissions are ongoing globally, and I would expect them to be positively received.

Now moving on to other follicular lymphoma settings, as I mentioned, in the frontline space, things are moving. Here's 3 studies that were presented. Arm 6 of EPCORE NHL-2 study, classic frontline study, patients with high burn disease in need of therapy, 2 years of treatment with epcoritamab, rituximab and lenalidomide same combination as in EPCORE FL-1 but given for a little bit longer, very impressive overall and complete response rates, 95% and 88%, respectively, and at 33 months, a pretty impressive 90% of patients remain progression-free. These data, if confirmed, would compare favorably with what we typically see with chemotherapy.

Similarly impressive a smaller study, epcoritamab combined with classic chemo immunotherapy BR same patient population. Almost every patient here had a complete response, and these were also preserved at 3 years, another very powerful combination. And I would note the study led by my good friend and colleague, Dr. Reid Merryman at Dana-Farber, this was an investigator-initiated study looking at chemo-free but also lenalidomide-free combination of epcoritamab and rituximab. Very impressive overall response rate, 97% complete response rate, 91%. It's a little bit early. The follow-up is still short but certainly very promising results.

So you can see how epcoritamab-based combinations are really bringing a serious challenge to standard chemotherapy for the first-line treatment of follicular lymphoma. So moving on to diffuse large B-cell lymphoma, particularly talking about the frontline setting. There's 3 studies that I'm going to briefly cover the Arm 1 of EPCORE NHL-2, Arm 8 of the same study and then EPCORE DLBCL-3.

The first study, Arm 1 of EPCORE NHL-2. It was dedicated to patients fit for full dose chemotherapy and with high-risk diffuse large B-cell lymphoma, with R-CHOP given for 6 cycles and epcoritamab extended to a 1 year. In these patients, we saw an impressive overall response rate of 98% and a complete response rate of 85% and at this 3-year follow-up update. We also observed that 83% of patients remained alive and 74% in complete response.

If we think about a comparator for this, for example, the control arm of the POLARIX study, that 3-year mark has a probably lower progression-free survival, and it makes us have high hopes for this particular combination in this setting. In Arm 8, we tested lower dose of chemo immunotherapy with epcoritumab. And again, here, there was a 3-year follow-up of data that was presented. This is for patients who are not able to tolerate full dose chemotherapy. But look at the responses, again, high overall response rate, 93% and 86% complete response rate, very similar to patients who had a full dose chemoimmunotherapy. And at 2 years, which is the update presented here, 82% of the patients remained alive and 79% in response.

And then finally, EPCORE DLBCL-3 looking at epcoritamab monotherapy that is epcoritamab alone in patients who are elderly or very frail and unable to tolerate any chemotherapy. These patients are really a highly unmet need because they would not be treated other than palliatively and they don't really have viable options. So having a chemo-free treatment that results in a very encouraging 73% overall response rate and 62% complete response rate with the vast majority of patients completing treatment remaining in remission is certainly is very encouraging news for these patients who will really have very few, if any, options.

The collection of this data really strongly supports the versatility of epcoritamab and the ongoing Phase III registration-directed EPCORE DLBCL-2 trial comparing epcoritamab plus R-CHOP versus R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma. And the study will read out in 2026. So I'm very eager to really discover the results of that study, and I'm very hopeful to celebrate those results as well.

So in summary, we dedicated a little more time to the EPCORE FL-1 study because it really is a transformative study. It really exemplifies the power of epcoritamab and how we can really reshape treatment paradigms just really displaced current treatment standards, really unprecedented progression-free survival and, more importantly, massive reduction of the risk of progression or death, almost 80%.

There certainly is momentum for the drug. There is -- this is the first positive Phase III study, not for just eccritumab for any bispecific in follicular lymphoma. In fact, it's the only randomized trial published for bispecifics in follicular lymphoma. Got FDA approved, we got published in a highly resonant journal. Basically, we have the trifecta here.

I couldn't be prouder of the team, and I couldn't be more grateful to be part of this project, really. But more importantly, I couldn't be happier for our patients and now have a really substantial improvement in their outcomes when treated with this combination. In large cell lymphoma, I think we continue to build momentum around epcoritamab based combinations and really support very strongly the Phase III study that's ongoing comparing or R-CHOP plus epcoritamab versus our R-CHOP alone.

And I think the collection of this data, including the ones in Richter's and some others that I didn't have time to mention or they were unpresented this year, ASH, really speak collectively to really the broad versatility of epcoritamab as a combination partner and as a drug that can really make a big dent in many disease settings in B-cell and Hodgkin lymphoma because it's administered subcutaneously.

It doesn't have really significant share time, doesn't have overlapping toxicity with most treatments that we commonly use for B-cell and Hodgkin lymphoma. It really has its position in the best way to really make a difference in every existing treatment paradigm for these patients. So really, all the data that I went over really support epcoritamab as almost shifting the narrative as a backbone therapy as opposed to considering chemotherapy as the backbone for patients with B-cell non-Hodgkin lymphoma.

So very excited to look forward to 2026 when more data will read out and just really going to be there and watch as the data unfold and probably and hopefully at least to celebrate many of these data. I'm just really thankful to be a part of several of these efforts. It's been so rewarding to use this drug in the clinic and see really the patients' outcomes under our eyes improved so significantly. And I really -- and thank you all for your attention. I'm happy to take any questions you might have.

Thank you, Lorenzo, for that inspirational presentation. So now let's move to some of the key pipeline events that we are anticipating in 2026. Next slide.

Yes. 2026 will be a year of important catalysts for Genmab. A key focus will be the rapid integration of mirrors following the close of the proposed acquisition. As a reminder, we integrated ProfoundBio in less than a year, and we are confident that we will replicate this success with Merus.

As part of this integration, we will keep a laser sharp focus on our investments in order to position the company for optimal growth. This includes investments to maximize the potential of our commercialized medicines, and a promising late-stage portfolio. In 2026, we expect multiple potentially registrational data sets for EPCORE, Rina-S and petosemtamab. If successful, we envision a 2027 with 4 KYSO products on the market, half of it will be entirely Genmab owned.

So in summary, in 2025, we significantly strengthened the foundation of our business. With that is through targeted M&A and strategic investments in the expansion of our key late-stage and commercial programs. In 2026, we will take the next difficult steps in our shift into a diversified, fully integrated 100% owned model, advancing our evolution into a global biotech leader and positioning us for durable growth. So let's move to the next slide.

Yes. Now it's time for our Q&A session. And I'm pleased to note that in addition to Lorenzo and I, we also have members of our executive committee to answer your questions. our Chief Development Officer, Judith Klimovsky; and our Chief Medical Officer, Tahi Ahmadi. And before we begin, a quick note that, as Lorenzo is very busy with the important work of caring for patients in New York, we will not be able to join us for the entire Q&A. So please now open the line for questions.

[Operator Instructions]. Our first question comes from Jonathan Chang with Leerink Partners.

Congrats on the data. On EPKINLY, what is the strategy for increasing adoption in community settings for both FL and DLBCL?

Thanks, Jonathan, for that question. I'll hand it over to Tahi to give you a perspective.

Yes. Again, John, ,thanks for the question. Well, generally speaking, just to go back a little bit. I mean from the very beginning, we've been very clear that we thought a key component of the differentiated profile of epcoritamab was the subcu administration. Efficacy, the safety and the convenience that comes with that, and that has translated into the relatively low Grade 2 CRS data, which we have further been able to improve in follicular lymphoma with 3-step-up dosing in diffuse large B-cell with a modified steroid regimen that we have already presented to help to it.

So to come to your question, I think a, the subcu administration in and of itself is an important differentiator as we enter the community, which is where a lot of these patients, particularly in follicular lymphoma are going to be are being treated today, but also in diffuse large B-cell, particularly if we get into front line.

The documented safety and the ease of administration, together with clinical trials that we are conducting and have been conducting to generate data that this is actually -- the community physicians are able to administer EPKINLY alone or in combination safely and confidently, that's an added differentiator.

And so also the updated label that comes with this particular study and that we also are looking forward to the B-cell, all of these components change in the label, subcu administration, safety, experience in the community that then gets communicated are components of our strategy to increase adoption in the community where most of these patients are being treated. And so we're looking forward to seeing this '26 play out.

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

Our next question comes from Matt Phipps with William Blair.

For Dr. Falchi, how do you think about the infection risk for EPKINLY and bispecifics? Is there any additional prophylaxis that needs to be done, particularly as these move into those community settings, making sure they're familiar with that? And if I can just ask the company on the acasunlimab update, the OS did median, OS did come down to about 12 months in the 6-week dosing regimen. How do you think about OS's success there when some docetaxel arms have shown maybe an 11- to 12-month median OS in recent Phase III studies?

Thanks, Matt, for the questions. I think I don't know whether Dr. Falchi is already on the line. Otherwise, Tahi can answer the first question and Judith can definitely handle the acasunlimab question, Matt. But let's wait for a second, Dr. Falchi is on board. Otherwise, he may join later on that, I will ask Tahi to address the first question on prophylaxis.

Well, I mean, I'm going to try to do my best to answer the question of Lorenzo. Thanks, Matt, for the question. From our point of view, and then obviously, you want to hear the external point of view.

With the instructions in the protocol it and also translated into the naval instructions, which is guidance on general guidance on using G-CSF when appropriate, but not mandating it we don't think there is a OE need to include antibiotic prophylaxis. I think what's going to happen is, generally speaking, that physicians and the community will get increasingly more sophisticated in individualizing this a little bit.

I would remind everybody that this is kind of like an interesting phenomenon. The more you deplete B cells, the more you end up with neutropenia, but there was really infectious neutropenia, neutropenic fever or the likes of was really not an issue on the study. You mentioned that the most -- actually all of the patients were managed really in the outpatient setting.

So from my point of view, from the company's point of view, we feel like we have given the community sufficient instructions to administer EPKINLY very safely. And I'm pretty sure that as a community, they are going to continue to fine-tune this, individualize this a little bit. There might be patients where there are higher risk we may get some prophylaxis. That's just the way it's an always been handled in oncology and also chemotherapies.

Thanks, Tahi. Judith, maybe you can address the new data, the updated data, I would say, on acasunlimab.

Yes, of course. Thank you for the questions. And we were delighted to have this data in the public domain. So I want to call to your attention that the subset Phase III eligible is the one that matters for the comparison and this encompasses patients that PD-L1 positive as per central and all of them exhausted PD-1 inhibitor and chemotherapy.

In that subset, which is numerically 32 patients, the median OS is 14 months. But what I want to call to your attention is that the median overall survival is not predictive as much as milestone survival analysis. And here for the ITT population, the 12 months is 51%, which is considerably higher than the docetaxel even if you go to ITT and the population of interest, which is the 32 patients that were used the subset that's Phase III eligible. The 12 months is 64%.

And when you compare with docetaxel, you see that the delta is meaningful. And most importantly, this study has follow-up to really see detail. And you see the 24 months which is 30% with some sensoring. So the tail is real, and this is totally different with the curve of docetaxel. So we are pretty confident that these results support the strategy that is being implemented in ABBIL1TY 06.

Thanks, Judith. Thanks, Matt, for the questions. Let's move on to the next question.

Our next question comes from Judah Frommer with Morgan Stanley.

Maybe I'm not sure if Dr. Falchi's on, but maybe one just high level on CAR-T versus bispecific. So maybe just high-level thoughts on sequencing CAR-Ts versus bispecifics in lymphoma, where we sit after rash, certainly it was a big debate in multiple myeloma, but curious how you're thinking about sequencing in lymphoma? And then just on DLBCL, specifically, with POLIVY approved in the front line, but not seeing necessarily an OS benefit over R-CHOP, how do we think about predicting OS and the benefit there in first-line DLBCL for other assets?

Please go ahead, Lorenzo.

Yes. So in terms of the sequencing, that's a very different question in the setting of follicular lymphoma in large cell lymphoma. I think in large cell lymphoma, it's a little less straight -- a little more straightforward because at least at the moment outside of the context of a clinical trial, you don't really have a label conflict because CAR-T cell therapies are approved in the second line and EPCORE monotherapy approved in the third line.

However, particularly in the United States, some of these boundaries that can be pushed through compendium indications and through just by virtue, by sheer fact that third-party payer system sometimes allows for earlier use of bispecific based therapies in the second line. What I will say is that there's data for both the bispecific to CAR sequence and the CAR to bispecific sequence.

And I would say the overall take away is that in the first case, there's not a clear evidence that the performance of CAR-T cell therapy is affected by prior bispecifics. In the second case, as we know from the pivotal trial, the complete response rates remain high or higher than pretty much any other alternative for bispecifics after CAR-T cell therapy. And so I think that bispecifics do remain the go-to therapy after CAR-T.

But I think that bispecifics pre-CAR-T is a more important question in 2025 because as I said, more and more people are using them. And so some of the questions are, if you use bispecific therapy as a holding therapy, meaning before CAR-T cell collection does that affect the collection. We're actually trying to answer that question here as we speak. And we presented also data as the bispecifics consortium had this ASH showing that really, the performance of CAR-T doesn't seem to be affected whether you use bispecifics as holding or bridging therapy.

In follicular lymphoma, the question is a lot more nuanced because when the goal of remission versus rather than cure, it comes down a lot more to patients' preference and to the specific context where that patient is being treated. If you focus for a second on bispecific monotherapy, the clear advantage of bispecifics over CAR-T is they're off-the-shelf nature and ability to be accessed outside centers that practice CAR-T cell therapy.

Let's not forget that out of 6,000 health care facilities in the United States, 5,100 are community hospitals. And out of those 6,000 facilities, only 300 offer CAR-T cell therapy. So when you scale this discourse up nationwide, you immediately see how having an off-the-shelf therapy that has excellent tolerance or tolerability and good, if not very good, long-term outcomes is a huge value.

The longest lasting bispecific study in that space shows that if you have a response, you have an about 40% chance of being disease 3 or 5 years. I mean that's not something we've ever seen before this era. So I don't think that the sequencing matters too much in terms of efficacy. I also don't think the sequencing matters too much in terms of burning bridges, so to speak.

The whole discussion that I had about whether CAR-T cell could be affected by prior bispecifics. I think here is a little less relevant in follicular lymphoma, where you always have more time before between one treatment and another with a few exceptions. So that ability of T cells to regain their fitness is much more likely in the setting of follicular lymphoma.

But I would say now with the results of EPCORE FL-1, this whole discussion acquires a whole new different light because when you're looking at patients in the second line -- first of all, there's an additional indication that CAR-T currently doesn't have, which is second line. Secondly, when you look at that performance, which is the same in second and third line, you're looking at complete response rate in the mid -- mid-80s percent that are deep and durable when you achieve that response, a duration, we don't even know what it is yet because it wasn't reached, but I wouldn't be surprised if it's in the overall years.

Progression-free survival that are very long and more impressively, the time to next lymphoma therapy being essentially 93% next lymphoma therapy free 16 months with no sign of the curve dropping, I think that's pretty impressive. Anything that makes a strong case to prefer treatment like R2 in follicular lymphoma after frontline treatment and lead CAR-T cell therapy as a third line.

With regard to your DLBCL question, I think that's very important. And the short answer is we don't really have great tools to predict overall survival during chemotherapy, but I think we're starting to have great tools to predict long-term survival after induction chemotherapy. R-CHP polatuzumab is the best treatment for non-GCB large cell lymphoma. And I think not using that treatment for non-GCB large cell lymphoma patients is -- I'm not afraid to say it's an error.

For GCB, large selling lymphoma, I think it's much less clear. I don't think that polatuzumab -- what it adds in non-GCB. But in either case, the measurement of minimal residual disease at the end of induction therapy, seems to currently be the most powerful predictor of cure, not just remission or progression-free survival. We know that if you have a clearance of MRD regardless of the results of PET, granted than most of those patients are PET negative, you have an almost 100% chance of being cured.

So I think we're getting to a point where we're very, very precise in predicting overall survival after induction therapy. Before the induction therapy that is at baseline, we don't have that ability at the moment. And I think that we're really all very eager to await the results of studies like EPCORE DLBCL-2 that if positive, may have an advantage and may have an advantage not only in progression-free survival because the results that we had seen in the Phase II experience were just so good in patients who were otherwise higher risk.

So I think to answer your question, I think that right now, there are tools to predict survival, none of which is readily applicable in clinical practice and we're waiting to see the results of these randomized trials chiefly to EPCORE DLBCL-2 to see if we can improve overall survival across the board, perhaps not even need too many tools to predict overall survival after induction is done.

Thanks, Lorenzo. So thanks, Judah, for the questions. Let's move on to the next question.

Our next question comes from Jaena Han with TD Cowen.

Yes, another question for Dr. Falchi also on kind of the first-line DLBCL opportunity. So EPCORE DLBCL-2 is versus R-CHOP and we know that's COLUMBA versus Pola-R-CHP. I was curious for you and for your colleagues, what degree of PFS benefit do you want to see with the TCO combination over R-CHOP to drive the usage of this regimen over both our job and also over Pola-R-CHP. And also if you could give us some context about kind of the current uptake of Pola-R-CHP in the real-world setting.

Yes, thank you. You couldn't have picked a more difficult question to answer, but I'll do my best. I think that -- it's important to understand there's a big distinction that's important to understand, and that speaks to both of your questions. One thing is what the FDA is asking of a clinical trial. And one thing is what the community is going to do with those results. What the FDA is asking is a progression-free survival advantage that is statistically significant per the study design. If that happens, the study is positive.

Now obviously, there's a Phase 4 where you have to see what happens when the community if and when the community picks up the new standard. I think if there is even a strong suggestion of overall survival advantage, there's no question, that's going to just become the new standard across the board. If there is a progression-free survival only advantage it's not going to be at 2%, right? If it is an advantage, it's probably going to be more substantial.

As you know, POLARIX had a 6%, 7% advantage in progression-free survival, that was enough to give it at whatever it is, 30%, I believe, uptake in the community. And as always happens, then you do the people do the -- well not be the investigators, they present usually subgroup analysis that have the limitations that they have, but then people interpret those subgroup analysis. And if there are subgroups that have big advantage.

It's possible that colleagues in the community might be more attracted towards using the combination in one subset versus another. But I would say again, the study is designed to answer a question in patients, IPI 2 to 5 and in particular, 3 to 5, all comers. And if the study is positive, and you're empowered as a physician to use epcoritamab in association with R-CHOP for those patients. In patients with non-GCB large cell lymphoma, where R-CHP polatuzumab really is delivering very good results.

It's going to come down to the always unwarranted practice of cross-trial comparison and frankly, familiarity of the specific position with one regimen or another. That's very hard to control, certainly, even harder to predict now. But I would wait and see. It's not just about the progression-free survival advantage the magnitude of it. Obviously, if you have a 10%, 12% advantage, that's plenty. And if possible, frankly, based on the EPCORE NHL-2 results. But if the advantage is a little bit thinner, then it depends on the specific estimate of progression-free survival in that particular non-GCB population.

Thanks, Lorenzo. So thanks, Jaena, for the questions. Let's move on to the next one.

The next question comes from [ Alec ] from UBS.

Great. Two, please. First, on EPKINLY and R-CHOP in first-line DLBCL. So it's nice to see sustained high PFS and OS rate at the 3-year follow-up. I'm just wondering if the duration data are similar in the GCB and ABC subtypes and if the duration curves are largely driven by one subtype.

And second question on Rina-S on ovarian cancer. I was just wondering if you could share anything on the potential filing strategy there. Do you think you can file based on pivotal Phase II data? Or will you have to wait for the confirmatory Phase III trial?

Thanks, Alex, for the questions. I think Dr. Falchi can probably best address the first one and then Judith can address the second part.

Yes. Thank you. Yes, we -- I don't believe we have curves by subtype, the response rates are very similar, and the representation of those patients in the clinical trial is fairly similar to real life with about 60-40, GCB, non-GCB. It's perhaps not surprising because bispecific antibodies were never really shown to work differently in GCB, non-GCB.

And so again, you might have that in high-risk patients that is IPI3 and above. With non-GCB, you may have excellent survival curves. And I always recommend caution in comparing and in doing cross-trial comparison. But what we have seen in our experience is really sustained responses at 3 years plus, which is more -- plenty of follow-up for large lymphoma in all patients that we treated.

Thanks, Lorenzo. Judith, why don't you go on, on the registration strategy for Rina. Very exciting.

Yes, super exciting. And as you know, we have R&C, which is designed as a potential pivotal arm more than 100 patients and could potentially make subpart accelerated approval requirements. And in addition, we have the 2 study actively enrolling. So the regulatory strategy is including both the potential pivotal for accelerated approval and a Phase III for full approval.

Thanks, Judith. Thanks, [ Alec ]. You should watch out for next year. Very exciting year. Let's move on to the next question.

Our next question comes from [ Sarah ] with Guggenheim Securities.

This is Sarah on for Michael. Just a really quick one for you. I was wondering if you could speak to the rationale for choosing a core plus square to move into frontline follicular over EPCORE plus bendamustine and rituximab given that now we've seen positive data for both.

I think Tahi can probably best address this, and Lorenzo can chip in there as well, but you're very actively involved Tahi.

Yes, sure. I mean thanks for the question. And so I think you have to just give a little bit back and look at the data that also Lorenzo talked about, which if you start thinking about when we start to make our decision, the ambition that we articulated for opinion was truly going to change follicular lymphoma and really challenge these paradigms that existed in follicular lymphoma where it's an incurable disease. And eventually, with every kind of relapse the duration of response to the PFS shorten.

So if you just look at the second-line data in combination with R2, I think it's probably reasonable to say it's at least a reasonable or even one could make that these assumptions in the past are being challenged as we speak with the data in front of us. And they're being challenged essentially with what is a regimen of tough 2 CD20-directed antibodies, a bispecific and native antibody in the pill, which has enormous amount of convenience, but also safety implications. And so I think it's probably fair to say and Lorenzo can add his perspective as a treating physician to that.

Generally speaking, the toxicity of R2 even in frontline will probably not be comparable to a region that includes any form of chemotherapy may be bendamustine or more historical cyclophosphamide combination regimens that have been used in front line follicular lymphoma. So the idea was to come up with a regimen that can challenge the current fundamentally change the outcomes for patients in frontline follicular lymphoma to meet these criteria for intensive care, which is criteria historically and provide an option that can be easily administered in the community, and that is patient-friendly and better tolerated. That's broadly speaking, the idea, the ambition of the frontline study and our general strategy in follicular lymphoma was.

Thanks, Tahi. Lorenzo, any further perspective from your side?

Yes, I echo the sentiments and articulation of the rationale. I think having been part of both trials as well as the relapse refractory trial, which -- with EPCORE is clear. I can tell you, when we first discussed the state, this is maybe late 2020. And then the Genmab team presented all the 5 arms we were discussing. And I pretty much after they went through the list, I was like, that's the one that I want to be part of. And I was the R2 EPCORE just because mechanistically and biologically makes just so much sense.

You may be aware, but just to simplify lenalidomide, one of the things it does. It reinvigorates your immune response against the lymphoma. So it just kind of made so much sense to say, okay, well, on the one hand, you're reinvigorating the T cells. And then on the other, just hitting them with a drug that just literally grabs them and brings them in proximity to the target lymphoma cell.

So that was just the kind of a theoretical rationale then you have to prove it. And what happened in the first few patients in Arm 2, which is the relapse setting was that everybody responded. At our side, everybody responded we just got so excited overnight. And so the hope was that it was going to go further and continue like that and lo and behold, it did. And you can find it published in blood earlier this year, over 100 patients in that arm 2 had an 88% complete response rate.

Then the other arm, which is Arm 6, which is a frontline arm, which has a very similar design, has pretty much the same results. So you're seeing something that has the same very powerful effect in second line plus or first line almost doesn't matter what line of therapy you are. That's one element.

The other element is let's not forget that now you have 108 patients in the second line for Arm 2. 243 additional patients in second line for ARM 2 and 40-odd patients in frontline. That's why like 400 patients treated with R2 EPCORE. The data for the efficacy and the follow-up are among the most solid in the space, I might say. For bendamustine, rituximab epcoritamab, we really have a very low number of patients. And yes, it's powerful, perhaps to no surprise.

But there are several reasons to not prefer, at least from my point of view, I'm happy to discuss. But bendamustine is a very immunosuppressive drug, and it tends to kill several of your T cells, some of the ones that you need for epcoritamab to work. That's not to say that epcoritamab didn't add to bendamustine, rituximab, but it just doesn't add as much.

And on the other hand, you really are compromising the immune system quite severely. We've had a number of pretty severe infections in that arm. And there really is no appetite, I think, in the community to use chemo immunotherapy as a backbone. If you take a look across the landscape, all the randomized controlled trials in frontline follicular lymphoma, are against chemo without chemo. So that's really where the field is going.

Again, that's not to say that chemotherapy is not working. But we're now in a place when I think Tahi mentioned this, where bispecific antibodies, we're flipping the paradigm. It's not that there's a backbone and then you add bispecific antibodies to them. There's bispecific antibodies, which you really can do without and then you choose the treatment to add on.

So I think of R2, for example, as an add-on to EPCORE, not the other way around. If you look at PCRF2, the difference between the curve is so huge, and that's all core that you can't help but think, okay, well, that's core that's driving everything are square is decorating it, but it's really -- the core therapy is really the bispecific.

So if that's true, then in my physician researcher mind, like why would I add chemotherapy to that? I think you do more harm than good to the EPCORE. So to me, it's really the chemo-free rationally conceived therapy that's going to have the better hand. And that's why I think EPCORE FL-2 is designed the way that it is.

Thank you, Lorenzo. So I think, Sarah, that's an answer. You can go backward to Michael. So really clear.

Our next question comes from Qize Ding from Rothschild & Co Redburn.

One question from me on EPKINLY. So I remember, I remember you previously talked about the potential indication expansion for EPKINLY in COL. So after seeing the latest data presentation at ASH this year, can you just talk about your latest thoughts on this potential indication expansion opportunity?

I definitely can, but I have a much better colleague to answer that question, that's Tahi.

Yes. Thank you for the question. Lorenzo touched on this in the beginning. The data we presented is in a specific complication of chronic lymphocytic leukemia, essentially a transformation that has been named Richter's transformation, so MYC transformed large cell lymphoma. That's why we presented the data.

It's something that we've had conversations with the health authorities in the past and continue to think about what our strategy is in that particular subset. Equally in CLL, I mean this has been a topic where we are continuously thinking. I think it's probably fair to say that the CLL field is fluid right now with multiple changes. And so I think there's a little bit of work to be done on our end to establish the most perfect place for cane to be positioned in that space and we'll continue doing that.

Thank you, Qize, for the question. Let's move on to with the next one.

Our last question comes from Asthika Goonewardene from Truist.

It's on -- so maybe something quick to Dr. Falchi apologies if something similar been asked already. But in the context -- so there are multiple studies in frontline DLBCL. But besides T-cell engages that also include BTKs, we saw so much with [indiscernible], et cetera. All these do have some pretty high CR rates.

So maybe to Dr. Falchi here in the context of having all these options in the future, how would you pick the right therapy? And what do you want to see a T cell engager plus R-CHOP show to rationalize using this over the other modalities? And maybe related to that, can T cell engagers be given in the community as easily as CLAs and BTKs to treat frontline DLBCL?

Yes. Because the topic would be too huge to address here, but there's something like 7 or 8 randomized controlled trials going on now. And when we presented the EPCORE R-CHOP data, I think it was last year at ASH, that session was stellar. Like everybody has 100% CR rate. So clearly, CR is an early good surrogate, but you need a time to event analysis. And that's what we presented this year with job at 3 years with very reassuring and encouraging PFS curves in patients who -- let's not forget, have high-risk disease, many of whom have double or triple hit lymphoma.

You -- obviously, you may have a situation where 1 or 2 trials largely stand out from the crowd with progression-free survival advantages that are more sizable in more subgroups. It's going to be a slicing and dicing of data. But there's a few factors that are going to help navigate and the landscape, right? One is very simply, who reads out first, right? Because if you read out early, usually, that's a good sign.

But you also have more time to penetrate the market and the community. And we know that familiarity with a certain drug or a certain regimen is key. I'm very good at using Ascot, for example, or EPCORE R-CHOP, my neighbor that's never used, they may be less familiar. So that's one other factor.

But if you do see a delta that's large enough, frankly, I hope so, from bispecific R-CHOP or polatuzumab, then I think if there is a bispecific that's easy to combine with chemoimmunotherapy, that top core and there's multiple reasons for that. One is that it's subcutaneous. Let's not forget, logistics are very important. Some of the other intravenous bispecific, you can't give them the same day. as R-CHOP or polazutumab, that means patients have to come another day.

Secondly, because your peak of CRS incidence is in cycle 1, day 15 you have given R-CHOP 2 weeks prior, you have debulking enough to dampen some of the CRS. The CRS rates in EPCORE NHL-2 were quite good. But even more importantly than that, perhaps, the idea that you have a subcutaneously administered bispecific that is "gentler" or it gets eased a little bit more smoothly into the patient allows you to start that bispecific in cycle 1, day 1, and that's critical for me.

Because most of the resistance that you see, even in patients who end up having a complete response is born in cycle 1 in second one. And so having the ability to potentially rescue those patients who are destined to fail later starting from cycle 1 may be a structural advantage of EPCORE-based platforms as opposed to others. Again, you're going to have to see the data. You're going to have to compare to the best of your ability to data.

But at least in principle, as of now, the reason that I'm more excited about following those developments with EPCORE DLBCL-2 because of these very plausible advantages that it has over the landscape.

One quick one to you here. The [indiscernible] data at ASH looked really interesting in the unfit frail population. I was just wondering if that is encouraging Genmab to also consider something like that with an ADC with a chemo preoption and if you could tell us a little bit more about your thinking.

Thanks, Asthika. That's probably question for Tahi.

Yes. I mean thanks, Asthika. Generally speaking, I would say this in our strategy on the elderly frail has been to essentially establish an anchor and plan. And hopefully, the study will read out in the anchor registration, which would be frontline R-CHOP and then provide additional data that informs factors within that anchor in R-CHOP, where you basically just can dose-reduce anthracycline or even in monotherapy where you can basically just drop the chemotherapy if the patient is really not tolerant.

That's kind of like how we're starting to think about this and I would say there's a lot of -- there was a lot of debate at ASH actually to who is really fair and how far has been defined on these trials. And so there's a little bit of a discussion on each of these trials. So rather failed patients are something to think about.

So we don't really -- actually at this point, concretely have any plans to combine with [indiscernible]. It is probably for Medicare first point, an interesting strategy. It's not necessarily clear to me why we would engage in that end. But anyway, we'll see. More to come on that end. We feel very happy with where we are with the data that we're generating in elderly, in fair, and we're really enthusiastically expecting the readout of our front line for the next year.

Thank you Tahi. I think that's a good closing remark. So thank you, Asthika, and thank you all for the very good questions and sight for questions today.

Next slide, please. Thank you all for joining us today, and a special note of thanks goes to Dr. Lorenzo Falchi for his contribution to this year's event. We're very thankful for that. And from all of us at Genmab, we wish you all happy holidays and the healthy, happy and truly wonderful '26. Looking forward to speak with you next year. Thank you.

And welcome to the next session. So it's sticking with -- we've got a European pharma afternoon, in fact, pharma biotech afternoon. So we have with Genmab and Anthony Pagano, who is the CFO. Anthony, I don't know if you wanted to make some sort of opening remarks, there's been obviously a lot going on for Genmab the last 6, 12 months, maybe just run through some key points, and then we'll get into some Q&A.

Yes. Thanks, Graham. And again, thanks for having us at the conference back here again. It's a pleasure to be here and have a chance to engage with all of our investors. As we start to get in the process of exiting 2025, I find it really useful to reflect on the progress that we've made here at Genmab during the course of the year. And I think it's really interesting to kind of tell the story through the lens of 3 of our late-stage programs, now assuming that the peto and Merus transaction closes, but to really tell that story through the lens of these 3 assets. And that's EPKINLEY, Rina-S and peto. And what you have across all 3 assets is each of them have at least 1 FDA breakthrough therapy designation. During the course of 2025, each of them have had really significant clinical data that has only served to increase our conviction in the programs, and you look forward to 2026, each of them also have meaningful registrational data that could set up some very important potential launches in 2027.

So if you step back, you really have is a very strong set of late-stage programs between EPKINLEY, Rina-S and peto and not forget about acasunlimab as well. And you look forward to '26, again, a number of important readouts and then potential launches in 2027. And this is underpinned by continued very strong financial performance. Through the first 9 months of this year, total revenue growth has been 21% and recurring revenue growth of 26%. And what you've seen as well is continued focus on running the business in a very financially disciplined way. As you can see a lot of that revenue growth really coming through to the bottom line.

So as we kind of really now sort of step back for a minute and think about Genmab, really, you have is a very strong existing oncology business that we're building with a set of very nice growth prospects here moving forward, and we'll continue to run this business in a very operationally and financially disciplined manner and really zooming out, thinking about continuing to sort of translate this antibody science, knowledge expertise into meaningful breakthrough therapies for patients and ultimately delivering value for patients and shareholders. So that's some opening remarks to set the context, Graham and now maybe let's get into some questions.

Yes. Great. Maybe sort of a question on strategy, sort of bigger picture of obviously Genmab inception, it was really a technology company, then came an out-licensing company, and now you're a company that has own assets that are growing. So perhaps you can just talk to over the midterm, what the strategy is to continue with that growth of your own products being marketed.

Yes. So for a number of years, I mean, really want to go back in time, it's really to 2013, we were very clear that new products going into the clinic that originated from Genmab but the absolute base case was for us to own those assets at least 50%, and it's really start to forward integrate around those products. that strategy really started to come to life as we got into that 2019, 2020 time frame when we started seeing some encouraging mid-stage clinical data for both at EPKINLEY and Tivdak. So at that point, we really started building out the development, late-stage development and commercialization capabilities particularly in the United States and Japan to really be very good owners of those programs.

But as importantly, to set the stage for where we are today to really now see the expansion of EPKINLEY, and really now looking forward see execution and expansion both around Rina-S and Peto moving forward. So overall, this has been a very sort of thoughtful, well thought out, stepwise plan to get us where we are today, which is having a very strong platform and foundation to allow us, as we have these readouts that I explained across the 3 programs to really harvest that clinical data, take it to regulators and then being very well positioned to market the program.

So we're very excited about what's been built up here over the last number of years, but very -- even more excited about the next couple of years, particularly 2026 with a number of very important clinical readouts.

Got it. Okay. And obviously, part of that strategy now has got M&A in there as well with the Merus acquisition. So perhaps you can just talk through the deal rationale for Merus or you think it brings to plate and why go external?

Yes. So it goes back to this capability build. So these are not just generic capabilities and expertise we've been building. Our focus, as everyone knows, at Genmab has antibodies in oncology. We have a very nice platform, and we're looking for opportunities to further leverage that platform and of course, we look for internal growth opportunities.

But of course, our job is also to survey the landscape and look for external opportunities and ultimately, we landed on the Merus potential acquisition of Merus. Here again, going to this concept of natural ownership in the first order, how can you be a very good evaluator of Merus or particularly in peto. Again, it starts with antibodies in oncology, then deep understanding of a bispecific, an EGFR bispecific and then the therapeutic area being head and neck cancer.

These are all areas where we've invested quite a bit over the last couple of decades in areas we know very, very well. So ultimately, we're in a position to evaluate this opportunity and then really think about post deal close, how can we add substantial value. And here, as we all know, peto has 2 ongoing Phase III trials, 1 or both of them will likely read out in 2026. We said, how can we add on to this? And what we said here is that we plan to start another Phase III trial in locally advanced head and neck cancer already in 2026.

And I think it's a natural evolution of the Genmab business, thinking about how we can further fuel the overall growth profile of the business. Again, very excited about the prospects of peto. We can maybe dive a bit deeper into the product profile in a minute Graham. But overall, it makes sense with that overall, again, forward integration of our business and really setting us up on a very nice growth trajectory here as we exit this decade and get into the early part of the next decade.

Okay. As you highlight, you've got 2 Phase IIIs running, 1 potentially reading out next year. The -- I guess what is it in the data perhaps discuss the earlier data on peto to sort of explain what gives you the confidence that this is going to be a successful asset in Phase III?

Yes. So again, we start off with building off what you just said. We have super high conviction in the program. A couple of things that really stand out for me is, of course, the external validation via the each of these indications, both in second line, third line, but also in frontline, having breakthrough therapy designation from the FDA. If you actually kind of dig into the data, particularly in front line in the data set we're looking at, you can see when you add peto to pembro or Keytruda, you get to a response rate of north of 60%. So 60 out of.

Every 100 patients are potentially going to benefit from this combination therapy. And what's important to think about that is what does pembro do or Keytruda do by itself, which is around 19% or 20%. So you have a tripling of the potential benefit. And you see, as you look at duration of response or PFS and the overall survival preliminarily, of course, you see, again, a pretty significant amount of headroom between the combo of peto and Keytruda versus Keytruda alone. So that headroom, that powerful efficacy gives us a lot of confidence here moving forward. And it's this profile as well that gave us the confidence to already commit to starting a Phase III in locally advanced head and neck cancer.

Got it. Okay. Perhaps you can talk through how it compares to the competition. So in particular, J&J's RYBREVANT?

Of course, I think all of us would acknowledge in biopharma, generally speaking, competition is a reality. There's not a lot of white space or very little white space really at all. So competition is a reality -- then the question is, if that's a given, how are you going to operate within that reality? You want to have high conviction programs like peto, like Rina-S like EPKINLEY that really have super strong target product profiles that could lead to a best-in-class profile as a starting point. We think peto ticks those boxes versus existing competition as well as potential future competition.

So first is best-in-class, then you have first-in-class. We think we have a real shot here to be first-in-class relative to competition. And then you can't take your foot off the gas pedal, it's about how can you be potentially broadest in class. And here, I go back to what I've said now maybe for the third time, is we already have very clear plans to expand beyond the existing 2 Phase IIIs, and we're going to start that first Phase III in locally advanced head and neck cancer.

And this is maybe a point around the data that we're seeing, you don't only see the strong efficacy and combo that I alluded to in terms of the response rate, but what we're also highly encouraged by is what seems to be a rapid response. We're seeing a fair number of responses already show up in that first scan. So it's really the combination of having a very competitive product profile in terms of best-in-class, be first-in-class where you can and then go as broad as you can.

And we feel very comfortable that we have the theme in place both from a development perspective, but also a commercialization perspective that we can compete. And I think we've demonstrated that with what we've been able to do with EPKINLEY. EPKINLEY is also obviously operating in a hypercompetitive environment. And I'd say the battle is not over yet, but we're more than holding our own as we sit here today.

Got it. And then with peto, there was some earlier data in colorectal cancer results when you talk about broadening. Is that an indication that type on the list of places to expand.

So as we think about peto, where the most amount of data very clearly is in head and neck cancer. There's 2 ongoing Phase IIIs. We're going to start another Phase III. That's what we publicly kind of -- is out there and we've committed to. So as you think about the rationale and the logic for the deal, it was really primarily around head and neck cancer. But of course, with any drug, when you see activity and a very strong activity, to be clear, and a particular tumor type, you're always going to look for expansion opportunities right now where we've seen some data, it's early and encouraging is in colorectal cancer.

I think for now, that's what we're going to say on the topic. That's the data that's out there. And we're ready to sort of talk about more broadly about peto, we'll kind of save that for a later day. But what I would say again is that we're encouraged by the data, it's early and more to come.

Okay. So perhaps you can just help us with just the cadence that you're expecting the data readouts for what's in development at the moment or any other way points we should look to, to give the market the confidence in the multibillion peak sales that you've communicated that you think that this can be.

So for peto, where we're at right now, again, just to summarize for everyone, there's the 2 ongoing Phase IIIs. We expect 1 or both of those to read out next year. And that's where we would kind of anchor everybody for now is 1 or both of those readout next year. And again, that's what's important, and obviously, the development side of things is important, -- of course, to see that clinical data. The next step is a potential launch. There, we've said that we expect the first commercial launch to be in 2027. We've also, based upon the product profile, I think it could be a very nice launch curve. And here, we've indicated we expect peto to exceed $1 billion of sales by 2029. So we're pretty confident in what we're seeing so far.

Okay, good. Any other questions on Merus in the room? Okay. So I might shift gears to EPKINLEY. the CD20/CD3 bispecific T cell engager. You've got, I guess, a broad indication strategy for that product as well. So maybe just talk through initially how you think about positioning across follicular lymphoma DLBCL across first and second line, just the broader strategy for the asset before we dive into any data.

So to remind everyone, at present broadly speaking, EPKINLEY is approved in third line plus DLBCL and third line plus follicular lymphoma. It was originally in the market, the first approval in May of 2023, and we've kind of added it on the FL indication in different countries and so forth and so on over the last number of years. As a starting point, we're very pleased with the launch to date. Again, we are launching into a competitive environment with entrenched competition and at EPKINLEY has performed very well.

Again, that's underwritten by very compelling product profile, and in some cases, us being first to market in particular markets like, for example, in Japan, overall, the existing base business, if you like, of third line plus FL and DLBCL is a really nice business and very strong data. We all know that ultimately, if EPKINLEY is going to hit its $3 billion peak year sales target, which we put out there and really have a lot of confidence in, it's going to be around getting into earlier lines of therapy.

And that's where we had the ongoing 5 Phase IIIs to really take it from a later line product to an earlier line product. And here, we had the first positive Phase III among those 5 read out earlier this year. This is the second line follicular lymphoma in combination with rituximab and Revlimid right out earlier this year, filed and was approved just a couple of weeks ago. So this will be the first of the 5 Phase IIIs to read out. And then next year, we look forward to 2 additional Phase III readouts, second-line DLBCL monotherapy as well as importantly, the frontline diffuse large DLBCL readout. This will be at EPKINLEY plus R-CHOP, and this represents a meaningful part of that $3 billion peak year sales forecast.

Got it. Okay. As you're launching in the second line follicular lymphoma to a recent approval there, just help us understand uptake, a sort of change in trajectory versus the existing indication as you sort of exit this year and go into '26.

Yes. So look, it's too early to get into launch dynamics. It's literally been less than 2 weeks. But I think what's important to maybe sort of think about as we think about the data, a couple of things. The data in the second line follicular lymphoma, we presented at ASH next week, just unbelievably strong data really show the combination power of adding EPKINLEY to existing standard of care. This remarkable efficacy. Now what's going to be important for this -- everyone to understand is the total addressable market in this indication. It's around 9,000 patients across the 3 major markets the U.S., Europe and Japan.

And that 9,000 is out of that total addressable market for EPKINLEY around 146,000. So it's important for the brand, I think, qualitatively in that it shows how -- what EPKINLEY can do in combination. It's something now for us to be out there in the marketplace promoting now in the United States to show that power of that combination therapy, financially, it's not going to be a hockey stick for us, certainly not in 2025 nor in 2026 really, as we think about the growth profile of EPKINLEY, it's going to be the accumulation of the broadening more generally, getting into earlier lines but most notably, that frontline diffuse large B-cell lymphoma readout, that represents around almost half around 70,000 out of the 146,000 of the total addressable market. So we're -- the data are super.

I encourage everybody to listen into the post ASH conference call, we'll be hosting very compelling data. But financially, it's just not going to be the major driver towards the peak year sales target.

So first-line DLBCL readout still expected 2026 for that and perhaps any more specifics you can add to that?

No. So here, our guidance remains unchanged. It's 2026. We have 2 Phase III trials we expect to read out in 2026. It's the second-line DLBCL EPCO monotherapy and then the frontline DLBCL, EPCO plus R-CHOP. Again, here, there will be some additional data for the -- for you all to sort of consider. We've done a fair amount of Phase II work of looking at EPKINLEY in lots of different settings, lots of different combinations. And among those is the EPKINLEY plus R-CHOP in frontline DLBCL, some Phase II data, and some of that will be profiled at ASH next week.

And you said first-line DLBCL, about half of the total opportunity. Then you're also running the, as you said, pointed out the second line study. So maybe just talk through the strategy of why run second line as well as first line or patients eventually not once they're treated, then would there be an opportunity in second line. So over the long term, do you -- how big do you see the opportunity for the second line trials?

So maybe sort of like level up and zoom out I don't think there are any products that have 100% share in frontline. So even if you assume very high shares, market share calls in frontline. Not every customer is going to -- or every patient, excuse me, is going to get your drug or even the class. So even the class share CD3/C20 bispecific is never going to be 100% in front line. That's just the reality of the marketplace.

So there's always going to be space for your product to be used in a later line. We think it's important for as people are -- there's also a timing element here as people transition from front line to second line or to third line vis-a-vis when these products are approved. So it is important to really cover all of your bases as it relates to different lines and also in either Phase IIs or Phase IIIs, different combination therapy. So that's what -- that was the initial kind of concept as we thought about the CDP is essentially covering first line, second line, third line DLBCL and in the same front line, second line, third line follicular lymphoma, and that's exactly what we're doing.

Got it. Perhaps just talk to what differentiation you see versus the Roche bispecific, Columvi Lunsumio and what do you need to see out of that first-line DLBCL readout to feel that you've got a competitive asset there?

So first of all, we're absolutely mindful of the competition. I kind of said that earlier on. There's going to be competition out there. It goes back to that framework of best-in-class, first-in-class and then broadest. And we think we're competing effectively, depending on a particular indication and setting very effectively vis-a-vis the competition.

If we look at the product profile for EPKINLEY, we think about a single option across both DLBCL and FL that distinguishes us from the competition today a,s we know they have 2 different options depending on the setting. So it's 1 product option regardless of disease. Secondly, we have the subcutaneous delivery, which we think is additive in terms of the overall customer experience, both from the physician as well as the patient. We think this is also a distinguishing characteristic.

And we think overall, if you think about EPKINLEY, we think relative to the 2 different products that are out there from the competition, we look at the efficacy, very strong efficacy we see as well as a very manageable safety profile. We think that stacks up very nicely relative to the competition. There will be some areas where the competition will be ahead of us. We have to acknowledge that and compete effectively. There'll be other areas like second-line follicular lymphoma, where very clearly, it looks like we are ahead, and we'll look to continue to look for opportunities to do that.

And then perhaps depending on timing of various trial readouts we could have the potential to be ahead in frontline DLBCL as well. I think that kind of brings back to your other question was around that product profile in frontline DLBCL. The existing standard of care is R-CHOP. We're adding on to R-CHOP. Of course, we have to see our Phase III data, but we've seen so far in the Phase II data is highly compelling. We think it's going to be additive to the existing standard of care R-CHOP, and we think it's going to be competitive to other things that are out there in the marketplace.

Okay. Just from a practical standpoint, as you go earlier lines, you're going to be -- the patients that are going to be increasingly treated in the community setting, just perhaps talk through your commercial capabilities in community versus in academic centers?

So yes, increasingly, ultimately, in any product scenario, you want to meet the customer where they are, in this case, the patient. And we know that in the earlier lines, particularly in DLBCL and follicular lymphoma, they are treated in the community. So what have we been doing here to effectuate that. So get us closer to the customer. So we have been really being thoughtful about the overall commercialization build. Now, we go back to the overall mindset of how we resource EPKINLEY from day 1. Remind everybody, this product was approved in May of 2023 in third-line DLBCL.

As we thought about the go-to-market plan, particularly where Genmab is sort of the lead commercialization party in the United States and Japan, as we thought about that, we were not resourcing at EPKINLEY for a late-line therapy. We are resourcing it that it was going to be competitive or is competitive, and ultimately, this could be a multibillion-dollar blockbuster or $3 billion-plus product, and we've resourced it accordingly.

So really, the resource is there. It's in place. Of course, you always revisit your brand plans on an annual basis, but there's a very significant investment behind the brand already that we think positions us well together with AbbVie to get into the earlier lines, particularly also to increase the reach out into the community setting.

So of course, it's something that's top of mind. But as we sit here today, we feel confident in our ability together with AbbVie in the U.S., in particular, to hit those key accounts in the community.

And I might move on to Rina-S, and the folate receptor ADC. I think you guided $2 billion peak on that one. And you're in Phase III for platinum-resistant ovarian cancer and endometrial cancer, I think you started Phase III or are starting Phase III. So perhaps just talk through the development plans and commercial opportunity across the different indications to start off with.

So to ground everybody, maybe where were we in H1 of 2024, where are we today? So H1 of 2024, there's roughly 50 patients worth of clinical data. As we exit 2025, we're going to have 2 ongoing registrational -- potentially registrational Phase IIs and 3 Phase IIIs. So there's been a material expansion and acceleration of the program. As we think about 2026, we expect to have the first potentially registrational Phase II data in platinum-resistant ovarian cancer.

So let's maybe sort of think about that platinum-resistant ovarian cancer opportunity for a moment. Here, what we've seen is, again, highly compelling data so far, both from a safety and efficacy perspective. And the safety is a key part here because safety is driving the efficacy. So let's unpack that efficacy just a little bit. What we've seen so far in the emerging, let's call it, Phase I/II data that we published is a response rate of around 50%. And that response rate is across all levels of folate receptor alpha expression, whereas the existing approved therapy is only looking at the high expressers, which is around 30% or 33% of the patient population.

So we're seeing a highly compelling response rate regardless of expression level, so we can treat in theory many, many more patients. I highlighted safety. Safety is a key part of this because what we think is and what we're seeing is that people are -- patients are staying on the therapy for much longer, which is then ultimately driving the duration of response the most publicly reported data at a medical conference is, we still have not reached the median duration of response at 11 months and that's still ongoing.

So we think we're going to have a very compelling efficacy profile in terms of number of patients we're able to help as well as for how long we're able to help them. So we'll see hopefully now the registrational Phase II data in 2026. And then ultimately, first potential launch in 2027, and that's obviously an important part for the brand and is going to be a first important stepping stone to hitting that $2 billion peak year sales potential. So in addition to that Phase II trial in PROC, we also have an ongoing Phase III trial in that same indication.

Sticking within ovarian cancer, we've also initiated a trial in platinum-sensitive ovarian cancer. So we feel very comfortable and confident with what we're doing in ovarian cancer today, probably with more to come here. Now in terms of endometrial cancer, we're seeing a consistent theme of very strong efficacy and duration with a nice safety profile. For those of you that don't know, endometrial cancer is a cancer where the folate receptor alpha expression levels are generally lower.

So here, what we -- that's why we're very encouraged about the activity we're seeing, again, regardless of expression level, we're seeing again around a 50% response rate with very nice durability and on the endometrial cancer side in terms of the CDP, we also have an ongoing potentially registrational Phase II and then a corresponding Phase III trial. So overall, what you've seen here, Graham, is really since the beginning of 2024, a material expansion and acceleration of the program with more to come, I think, in terms of the clinical development, I wouldn't be surprised at all if we start some more Phase IIIs in the gynecological oncology space as we move forward.

Got it. And -- so the 2 of the folate receptors, are in similar stage of development for Lilly and Astra. Perhaps compare and contrast the data, I think the Phase 1 data that Lilly put out in the summer, had numerically very similar sort of overall response rate. So are there any other differentiating point in features you'd point out between Rina-S and those 2 assets?

Look, it goes back to the same framework that I highlighted around best, first, broadest and there's going to be competition. So we want to look to be best. I think right now, if you look at the totality of the data, we're certainly in that conversation, we think that we have the best profile. And certainly, if you look at the totality of the data, we have the most data in terms of the next-generation ADC folate receptor alpha products. Unquestionably, we have the most amount of data.

And right now, we have the most advanced clinical development program and as I indicated, we're going to add on to that moving forward. Competition is a reality. Our job is to leverage the capabilities in place. As I highlighted those earlier, both from a development and a commercialization perspective. Again, here, one thing I would probably highlight for everyone is focus, right? We have 4 late-stage programs. These programs at Genmab, EPKINLEY, Rina-S, now peto as well as acasunlimab are getting the absolute focus, attention and resources of the organization.

And I think on the margin, this does make an important difference as we think about competing more effectively. But overall, whether it be EPKINLEY, Rina-S, peto, we really like our products and are very happy owners of those products.

I think you started the Phase II or planning state sort of Phase II non-small cell lung cancer trials. So I'll just talk quickly through the rationale and how you think that fits into the paradigm there.

Yes. I think this comes back to just investing generally, we see a product that is working, talking here about Rina-S, very, very well based upon the emerging clinical data in both platinum-resistant ovarian cancer as well as in endometrial cancer. We have very clear line of sight to expand that even further in the GYN space. So we see very clear activity and a nice safety profile.

Then the next question is, okay, where else can I take this product?" And the team did a lot of work. And I think Tahi did a wonderful job of outlining the different areas we could go into. And we decided the first area or the next area we would go into would be non-small cell lung cancer. We think there's a clear rationale here in terms of doing a signal-seeking study. So let's not get ahead of ourselves. It's a signal-seeking study.

This is an investment, I think you should be asking the opposite question, Graham, is if we're not making this investment, why we weren't making this investment. I think I'd kind of turn it around and look at it that way. It's a very clear and obvious thing we want to be doing. We're starting the trial as we speak, and we look forward to when we have data to us the first order evaluating it and then taking it and sharing it at a medical conference. And the same approach is sort of come back to the kind of the question in colorectal cancer or other opportunities for peto, it's the same thing.

You see very strong activity and very strong efficacy, manageable safety. You have to sort of think about doing other exploratory work or signal seeking work. I think if we weren't doing that, you should be asking us the question, why aren't you doing those.

Sticking with non-small cell lung cancer, the other asset you mentioned actually there about being very happy owners of his acasunlimab, the PD-L1, 4-1BB. Just I think just perhaps an update on the Phase III progress and timing of that readout, how important do you think that is again to the sort of materiality for the business?

So acasunlimab is a product where we saw very encouraging data that was presented at ASCO in 2024. Based upon that strong signal, we decided to start the Phase III. The Phase III is progressing well. There'll be some updated data that's presented here in a week or so at ESMO, IO. So look forward to sharing that data. We remain encouraged with what we're seeing.

I think just in terms of the context, it's a -- right now, we've pegged it being around $1 billion opportunity. So it is at least in the first order smaller. And right now, we have 1 Phase III here versus all of the other programs, as I've already articulated at length over the last half an hour or so, there's multiple Phase IIIs that are ongoing with a very clear intention to start more Phase IIIs moving forward.

So I think it's an important potentially an important product in the second-line non-small cell lung cancer setting, saw some strong overall survival data. And yes, the Phase III is progressing well.

Great. And maybe given you're CFO, we should ask some financial questions as well.

It's a novel concept, right?

But -- so I guess, post Merus, perhaps just talk to gearing, capacity, capital allocation how do you think about growing the business from a capital point of view?

So if I think about the business right now, and this is where we spent the bulk of the time talking today, we have 4 late-stage programs with ongoing Phase IIIs. And I highlighted at length EPKINLEY, Rina-S and peto, all having breakthrough therapy designation, all with meaningful readouts in '26 as well as potential launches in 2027. So when you look at across the entire portfolio, you really have a very nice oncology platform today with a very nice growth profile moving forward.

If you think about from a capital allocation perspective, priority #1 is investing back into those programs, both from a development and a commercialization perspective. That brings us to your question around kind of leverage. As we thought about funding the acquisition, as you all know, we're using a $5.5 billion of debt, we did not go into this decision lightly. We went into this eyes wide open. And here, I bring it back to what I just said from an R&D and a commercialization investment perspective, we thought about the overall financial profile of the business moving forward, we fully baked in all of the required investments to unleash the full potential of that late-stage portfolio on the investment side, particularly what we said from a leverage perspective, we said we hit -- we plan to be below 3x gross leverage within 24 months of deal close.

So particularly in 2027, I did not over-index on all of these launches that I just alluded to. I did not stretch out our next too much and think relying on those 2027 launches to drive that deleveraging profile, really looked at the strength of that existing base business, whether it be the existing royalty business, which have a very nice growth profile or the existing base business of EPKINLEY and Tivdak. So capital allocation perspective, invest back in the business. And then obviously hit our deleveraging target, which we feel comfortable we can hit within 24 months of deal close.

Got it. And then do you still see then that M&A would be part of the strategy going forward from there?

Look, I think as I just articulated right now, the focus is on being very good owners of the late-stage programs that we have. We also have a lot of innovation going on here at Genmab in terms of research and discovery preclinical Phase I, Phase II. I'm confident that 1 or more programs will move forward to late stage. And of course, as we get into -- beyond this deleveraging point, we can, of course, see where we're at and think about what opportunities we want to pursue, whether it be internal or external.

And then last question for me, just on operating leverage. So obviously, you've been displaying some as you've gone through this year just if you think about sort of your OpEx outlook into next year with, I guess, more launches, R&D as well. Just can you keep a cap on that? Or is that -- or how do you keep the capital on that?

So 2 things we're going to do. We're going to invest where there's very clear return opportunities. Sounds simple, but that we're going to allocate the resources to in a very thoughtful way. We're not going to spread the peanut butter evenly across the bread. We're going to think about opportunities where we can very clearly invest. We're not going to shy away from those investments.

At the same time, we're going to do those -- make those investments in the most productive and efficient way possible. We're looking across our entire business and being very thoughtful about realizing these scale benefits, whether it be in development or in commercialization.

And here, we're looking for every -- in detail, looking at our Phase III trial costs, bringing down the per patient costs in a very thoughtful, diligent way. And likewise, from a commercialization, we're looking for any and all opportunities to leverage the investments we've made in that commercialization capability, particularly at the kind of the foundation level where our investments in commercialization, particularly in the United States and Japan are going to be more of the brand, brand level. The foundation is there.

And then finally, we said on Q3 in terms of operating costs or investments that we thought that consensus both from a Genmab perspective, as well as Merus perspective are in a reasonable place. So ultimately, we feel like we're doing -- making the right investments in a productive and efficient manner.

Great. I think the clock we're up on time, but I really appreciate the time today Anthony, thanks for coming, and thanks, everybody, for listening in. Thank you.

Yes. Thank you, Graham. Thanks for having me. Thank you.

Good to see you all here. Welcome to day 3 of the Jefferies London Healthcare Conference. My name is Ben Jackson. I'm one of the analysts here on the European biopharma team. It's a pleasure today to be joined by the team from Genmab. We've got both CEO, Jan van de Winkel and also Anthony Pagano, who is CFO. Look, we're going to jump straight into the Q&A.

I guess, if you could just set the scene for us a little bit. There's been a lot going on with the development of products. But if you could put the layer of the land out there, what drugs are we focusing on at the moment and what are the opportunities and then we'll dig into the individual assets.

Absolutely. I'm delighted. So good to see you all. I'm delighted to be here. We're really focusing on the late-stage programs now. EPKINLY, Rina-S, Acasunlimab and also hopefully soon petosemtamab or Peto, which we intend to bring in via the acquisition of Merus. That is the late-stage development medicines. And of course, also, we have Tivdak as a commercial molecule, which we are now rolling out commercially in different European key countries in order to create a foothold for the Rina-S launch 1.5 years from now in the future in the GyNOc area.

Perfect. So let's start with Peto then because I think that's probably what's been debated most as of late. So could you give us a little bit of an overview, what attracted you towards the asset? And why did you make that move?

Absolutely. Peto is a fantastic EGFR-targeted bispecific antibody with a unique profile. We've never seen that with any other EGFR-targeted antibody up to now. It actually removes the epidermic growth factor receptor, which is a key target from the surface of cancer cells, and it actually allows this molecule to shrink tumors like very, very quickly, and that is also what is seen in the clinical trials. The data from Merus is absolutely impressive in both the frontline head and neck cancer setting where they see more than a tripling of the responses versus the benchmark with pembrolizumab and also in the second, third-line setting, unprecedented data with only petosemtamab. So we believe it has a unique profile. And we actually have a lot of experience at Genmab in EGFR targeting.

We actually worked on a naked EGFR targeting antibody many, many years ago, also in the head and neck cancer setting. And we worked actually on creating -- we helped J&J create amivantamab also by giving them access to an EGFR antibody and a c-Met antibody with our bispecific technology. We know exactly what these molecules need to look at. And we think petosemtamab is uniquely positioned there. On top of that, Genmab has a lot of knowledge on head and neck cancer. We had actually 2 molecules in clinical development in head and neck cancer. So we knew exactly what to look for in petosemtamab and what to focus on.

One of the molecules in head and neck cancer was Tivdak, our product for cervical cancer, second, third-line cervical cancer. It created very good data in head and neck cancer, I can assure you all. And despite that, we decided not to progress it to Phase III development because of the evolving landscape. And I even mentioned -- publicly mentioned petosemtamab as one of the molecules now really shaping and reshaping the second, third-line setting in a very dramatic way.

And another molecule we had in development until recently in head and neck cancer is 1042. It's a 4-1BB targeted bispecific antibody we created together with BioNTech, which we were testing together with pembrolizumab and chemo in the frontline head and neck cancer setting. And we actually realized that, that molecule was not potent enough to really deal with the evolving landscape in head and neck. So we feel that we are the appropriate owners of petosemtamab, we actually screened the landscape really, really carefully. And we think it's an ideal molecule, not only for treatment of head and neck cancer and bring really progress that to the absolute new level, but also in other EGFR-positive tumors. So we think the potential is actually a lot bigger for petosemtamab. I should stop there probably. I can go on for like half an hour.

So look, perhaps can you reference some of the recent data you've seen that's got you particularly excited about the biology?

Yes, absolutely. I mean the data in the biology, I need to be careful here because I need to only be speaking about the publicly available data because we have done deep due diligence on petosemtamab. And I think I need -- it's probably better for me to stick with the clinical data here than with the preclinical data because I'm not sure that all of that is in the public domain. And given that we still need antitrust clearance from the relevant authorities, we need to be very, very careful in talking only about what is in the public domain and not what we have seen under due diligence. But what I can tell you that in the frontline head and neck cancer setting, we see -- Merus has seen a 63% overall response rate combining petosemtamab with pembrolizumab and that is roughly 3x higher than what you see only with pembrolizumab in the frontline head and neck cancer setting.

And the median overall survival has not been reached even with very, very good indicators that this will be a very long median overall survival. In the second-line setting, with monotherapy of petosemtamab, they have seen a 36% overall response rate, whereas the benchmark is between 6% and 19%, depending on whether you look at chemo or an antibody targeting EGFR cetuximab, a first-generation EGFR targeting antibody. And they're with very, very impressive median progression-free survival and overall survival of 11.4 months, which is hugely impressive. So I think I better stick with the clinically available data in head and neck cancer. And Peto has actually set a new bar there, which I think will be a focus point, I think, for other companies to focus on in the coming time.

That makes sense on efficacy, but we also have to probably touch on safety and tolerability as well. One of the things that we debate often with the EGFR targeting drugs is often the severe rash. So what can you tell us about that within the context of the profile? And is there anything that's been done to mitigate that, that you've seen?

Absolutely. Merus has tested a new schedule for dosing with Peto. And since the implementation of that new schedule, the infusion-related reactions were far diminished versus the original schedule. On top of that, what Merus announced this week is that they have agreed with Halozyme to actually create a subcutaneous version and many times subcutaneous applications of antibodies also against EGFR actually really help to mitigate infusion-related reactions. So as life cycle management, that is also what we have already confirmed a week ago in our conference call, we said, well, subcu development is an integral part of our proposed development for petosemtamab, and that will likely further improve infusion-related reactions, but it's already very well under control with the new administration regimen, very much better than the original regimen.

Very clear. And I guess not only is the drug being studied in head and neck cancer, but there's also, as you referenced, some interest in other cancers as well. One of those is colorectal cancer. So perhaps could you add some additional color about where else this could be of interest and what you've seen so far?

The answer is yes, I can, but I will not do that because of several reasons. One is that we need to be very careful with what I can say at this moment about our plans for Peto because we still need to finalize the transaction. Second reason is competition. I mean there's other molecules -- other companies moving into this area, and we don't want to give them good ideas. We want to keep the good ideas for ourselves actually. So after we finalize the transaction, then I'm happy to speak about it much more openly, but we see a lot of potential.

That's very fair. And Anthony, perhaps one for you on financials. What are the key considerations that we need to be thinking about as this deal progresses? What have you pointed to in terms of accretion in the long term?

Yes. So thanks for the question, Ben. Maybe sort of start off and think about our investment priorities are super clear at Genmab. We're going to be investing in our late-stage pipeline, particularly Rina-S, EPKINLY, Acasunlimab and now moving forward, Peto. This is not only in late-stage development, but it's also important investments in commercialization capabilities to prepare for EPKINLY line extensions as well as upcoming launches for both Peto and Rina-S, hopefully, in 2027. Now to reiterate some of the guidance we provided when we announced the deal and more recently reaffirmed on our Q3 earnings call for everybody, 2026 invariably is going to be an investment year, but these are important investments that are 100% in line with our investment priorities, but are also going to be driving a number of important registration trial readouts in 2026 as well as some important launches here in 2027.

So in 2026, it will be an investment year. Now we did say on our call -- Q3 call, that we feel that consensus both from a Genmab investment level perspective as well as a Merus investment level perspective is in a reasonable place. The other thing you should be thinking about Genmab, investment priorities are clear. I just highlighted that. On the other side of the coin, if you like, we're absolutely focused on realizing scale benefits as we move forward. Our business is fundamentally in a different place now in terms of the size and scale of our operations. That means we can be very focused now on realizing these productivity measures and scale benefits. This is a large -- a major driver for how we landed 2024 in terms of the overall financial performance and also our year-to-date financial performance in terms of, let's call it, OpEx management. So 2026 investment year, 2026 consensus from an OpEx perspective in a reasonable place.

For 2027, we expect to return to meaningful growth on the EBITDA line. Now you might be asking why are you talking about EBITDA? Here, it's important to note, assuming successful launches or launches of both Peto and Rina-S in 2027, we will start to see some purchase price amortization in 2027. However, we expect meaningful growth on the EBITDA line in 2027. Looking at the Merus transaction, we expect to be approaching breakeven on the EBITDA line. And then in 2029, having the transaction being highly accretive, again, on that EBITDA line funded or fueled in part by what we expect to be a pretty significant ramp for Peto. And here, we've guided to around $1 billion or more than $1 billion of sales already in 2029. So what you have in the Genmab team really is very clear investment priorities, super focused on driving productivity measures and a really nice growth profile, both from the existing in-line business as well as new potential launches starting in '27.

Super clear. So if we park Peto then and we move on to EPKINLY, I want to chat a little bit on this. Perhaps set the scene, could you just touch on the commercial differentiation in the landscape that we see with Roche's bispecifics as well? And maybe if you could reference the recent outpatient study as well and how that helps the profile.

Anthony?

Yes. So overall, we're very pleased with the EPKINLY launch performance. And then think about where we're at, overall, we've set the scene for EPKINLY potentially being a $3 billion-plus global brand. Right now, the brand has been performing very well since its launch in May of 2023 in the U.S. The initial approval today is in the late-line setting in both third-line DLBCL and third-line FL. Now we think about the recent positive data in second-line follicular lymphoma and very encouraged by the approval by the U.S. FDA. Now it's mindful -- it's important to note that the second-line FL opportunity is an important one for the brand. It's the first positive Phase III for EPKINLY, now also in combination. So it's an important sort of, let's call it, qualitative aspect for the brand to get into earlier lines to get earlier into -- out further into towards of the community.

Now at the same time, we should be mindful that this will not be a hockey stick in terms of the sales performance in 2026, given the size of the total addressable market in second-line follicular lymphoma. It's around 9,000 patients across the U.S., EU5 and Japan. So we're very encouraged with what we've seen. We have a nice stepping stone here with the second-line FL, and we're very much looking forward to the frontline diffuse large B-cell lymphoma readout in 2026. Now if I think about the brand overall, when we think about the target product profile, what continues to stand out, number one, is EPKINLY being a single option across FL and DLBCL.

Number two, the subcu delivery and really uncompromising balance of safety and efficacy. It's really that combination that really sets it up for having a very strong competitive target product profile. And then moving forward, it's going to be important for us to continue to compete from a development perspective. Let's try to get those trials read out and on to market as quickly as possible, but also leverage the investments we've made commercially to continue to drive commercial performance. So overall, we're pleased with the performance and look forward to some -- the potential launch here in second-line FL and then the frontline DLBCL data next year.

And if we stick on the last point then, to what extent does the later line studies read across to the earlier line studies in terms of the profile that we should be expecting? Is it fairly derisking? Or is there still more to learn?

I can take that. What is very, very good for EPKINLY is that actually the Phase II data actually translate really, really well to the Phase III data. That's what we have seen now with the second-line follicular lymphoma data. The data is just stunning in second-line follicular lymphoma, a hazard ratio of 0.21 means a 79% decrease in the presence of EPKINLY and R-square in risk reduction -- risk for disease progression. That is a hazard ratio, which has simply never been seen before with any other combination of medicines in that setting. So -- but it was already preluded by data presented last year at ASH in the Phase II setting. So it translated really well from Phase II to Phase III. And that is what antibodies tend to do. They tend to be very predictable.

We have very sizable Phase II studies also in the frontline setting, the very important study Anthony referred to, where we combine EPKINLY with R-CHOP. We have very strong Phase II data last year already at ASH. And also this year at ASH, we have over 20 presentations, 7 oral presentations and some of them are frontline combining with R-CHOP. So we believe that there is a very good likelihood that these data will translate well into robust Phase III data. But of course, you never know for sure until you have seen the data. So we very much look forward to hopefully see these data and share them with all of you next year.

And we look forward to it, too. Moving on to Rina-S then. And if we take a step back and think a little bit more about ADCs in general, what's important around ADCs in terms of the payload, the linker, the target, which are the most important in terms of delivering a better efficacy and tolerability profile? And how does that read across to what you're developing?

Yes. What is super important with an ADC is that they actually -- while you attach a toxic payload, which is what happens in an ADC to an antibody molecule that you don't really change the half-life and the pharmacodynamics of the molecule. And that is what is absolutely unique with Rina-S is they -- what ProfoundBio, the company which we acquired last year in May did with Rina-S is they combined a very good antibody with an hydrophilic linker, allowing them to attach up to 8 toxin molecules per antibody molecule and then have an antibody which really had a very good half-life and very good PK/PD characteristics. And what it does translate to with that molecule is it actually gives you very, very good data in the clinic efficacy-wise, but also safety-wise.

It is a very clean safety profile, no ocular toxicity, no interstitial lung disease observed with Rina-S. And the net-net is that you can actually treat patients for a very prolonged period of time because patients can actually tolerate that medicine for a much longer time, leading to deeper and more long-lasting responses. So it's actually a unique molecule with perfect characteristics. And I think that is, I think, leading to Rina-S becoming a potential best-in-class and very likely also first-in-class in a much broader group of patients and tumors than the first generation of folate receptor alpha ADCs, Elahere, have been able to demonstrate.

Another aspect of Rina-S is that it has a very good what is called bystander killing activity. When it is near a tumor and the payloads are cleaved off from the antibody, they can kill bystander cells with antigen negative. And that is super important because tumors tend to be heterogeneous. They are never 100% homogeneous and you want to kill all the cells from the cancer locally with a toxic molecule. And that is what Rina-S also does really, really well. And this combination is very difficult to get actually in an ADC. And that is also what I think we should really all be keenly aware of is, yes, there is competition building up, several other molecules now targeting folate receptor alpha with a toxin and a linker, but they have all very different characteristics from what Rina-S is showing already at this time.

And that is, I think, something to be aware of that they will not all be the same. There will be different categories for sure. And I think time will tell which molecule will be the dominant medicine in a category of cancer. But I think Rina-S has a very good chance now. We already have a breakthrough therapy designation in endometrial cancer, which we got this year from the U.S. FDA, that is a type of cancer which has too low expression of folate receptor alpha. So it cannot be hit by the first generation of folate receptor alpha ADCs. And I think up to now, the data is just unparalleled with Rina-S. What is important for the company then is that we actually keep the momentum that we keep executing and keep in the forefront basically of this development because other competitors are potentially moving in. But I think it's too early to really categorize them in different categories at this moment.

That's very fair. And perhaps, Anthony, one for you as well. You've provided some peak sales guidance for the asset. How do you see that in terms of the balance between endometrial and ovarian? And what are the key signposts we should be watching for to derisk that and unlock that potential?

Yes. So I guess maybe sort of starting point for Rina-S, we're very excited about the brand, what we've seen so far and the prospects here moving forward. To just remind everybody, when we announced the deal in April of 2024, we provided kind of 2 pieces of guidance relevant to your question, Ben. One was that we expect a launch in 2027, and number two, that we expect peak year sales of north of $1 billion. Now as we fast forward to today, we stand behind the 2027 potential launch date, number one. But secondly, earlier this year, in January, we've upgraded that peak year sales guidance to $2 billion. That's underwritten by the data we've seen, but also underwritten by the rapid progress and expansion of the clinical data development program. Here, when we essentially bought the program, we had around 50 patients worth of data. We're going to exit 2025 with 2 registrational Phase IIs and 3 registrational Phase IIIs.

Now what is that $2 billion underwritten by? It's really underwritten by sort of 4 subsegments or 4 sub-indications. That's going to be the PRC indication. That's going to be the PSOC or platinum-sensitive ovarian indication, and that's going to be frontline and second-line endometrial cancer. Now in terms of major events, we'd be looking forward to 2026, where we have potentially the first Phase II registrational readout in the PRC indication. So that's what you should really be focusing on. Obviously, it will derisk that particular opportunity. But also, I think it will be nice to see the data in a registrational setting and see the activity across folate receptor alpha expression levels. So certainly looking forward to that in 2026.

Got it. And if we move on to acasunlimab as well then near term, we've got some additional data. Could you perhaps outline what we could expect to see in terms of types of data, obviously, not the data itself, and how that could help build confidence in the program?

Absolutely with pleasure. So last year at ASCO, we've seen very, very good data at the every 6-week dosing cohort of acasunlimab plus pembrolizumab in the second-line plus lung cancer setting. You will see more follow-up from that data to see how robust that overall survival difference, which was observed there is actually at this moment with longer follow-up. And we added an extra 20 patients. So you get a much bigger cohort also at every 6-week dosing. And this is the exact same dosing regimen, which is used in the ongoing Phase III. So that will hopefully give more confidence and reassurance to the market and believing that acasunlimab is a very competitive potential medicine for the second-line plus lung cancer setting, which is a very important setting.

There's a real need for medicines there. We have actually guided for a peak sales of around $1 billion. And I get the question many times, Ben, why is it so low? Because lung cancer has so many patients, and this will be a much bigger setting. And the reason is we want to really give realistic peak sales guidance to the market because there's so much competition there with the new very fancy VEGF, PD-L1 type bispecifics. There are several ADCs in development in that setting. And I cannot really figure out right now or anticipate what the exact distribution will be of the different medicines if they would be approved for that setting. So I think it's better to be conservative and realistic at that point than to give fancy projections, which everybody will look at with shiny eyes, but we cannot really understand.

Very clear. And look, one of the questions that we always have to ask, you've clearly got your hands full at the moment, lots going on in oncology, but we always have to ask about the wider thoughts about pipeline and potentially some movement into immunology and inflammation, given the potential applicability of EPKINLY, maybe something developing from the argenx collaboration. So what's your thinking around this in the therapeutic area? And is it something you'd like to invest more in?

We have a lot of activity in the preclinical setting in the I&I area. We think that our antibody technologies are very well of use in I&I, but it takes a longer time. I mean, to develop clinical candidates from scratch preclinically, you need a lot more safety data before you can actually allow to go to the clinic in the I&I setting than in cancer. So oncology is a lot faster. Reality is that Genmab's activities are for over 90% in oncology that will remain in oncology because that's where we have most expertise, most track records, most momentum. And we probably need to make choices, rigorous choices in rank ordering these programs in the coming time because we have actually a wealth of late-stage programs, which can attribute to most value in the shortest possible time frame, which is, I think, more important now for Genmab. But we are progressing. We have a partnership with argenx, which we're really excited about in the I&I setting, but it's all preclinical. It will -- we will report on progress for sure, Ben, but it is actually going to be very minimal compared to what we do in oncology.

Perfect. That makes sense. And I guess beyond that then, final 30 seconds, is there anything else in the portfolio that you think is worth having a look at? Or are we covering the main focus areas here?

I think we're covering the main focus areas. We have a very strong organic pipeline, which is also important not to forget because we have now done 2 acquisitions, 1 acquisition, 1 proposed acquisition 2 years in a row, bringing in fantastic molecules. Hopefully, Rina-S is just sensational ADC, which we are very, very impressed by. It does everything which we hoped it would do and more. Then Peto when we can bring the Merus transaction over the finish line is also a sensational molecule, we think very differentiated from other EGFR targeted antibody molecules. But we actually think that we also need to pay attention to our own organic pipeline between now and the end of the year.

We're going to move at least 2 more bispecifics from our own organic pipeline into the clinic and 1 ADC, which is a combination of a Genmab antibody and a legacy Profound payload and linker technology in a new molecule. So we believe that we are also very, very capable of generating -- organically generating the next winners, therapeutic winners. And I think that is probably where we should end up with, I see a flashing sign now that means that we need to get out of the room and make place for the next company.

Exciting stuff. Lots going on. Thank you so much for your time. I appreciate both of you, and thank you all for coming.

Thank you.

Hello, and welcome to the Genmab First Half 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 that Genmab may hold your personal data as indicated by you as part of our Investor Relations upreach activities in order to update you on Genmab going forward. Please refer to our website for more information on general and our privacy policy.

I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

Hello, and welcome to our financial results call for the first 9 months of 2025. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey; and our Chief Medical Officer, Tahi ahmadi. And for the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky.

As noted, we will be making forward-looking statements, so please keep that in mind. During today's presentation, we will reference products being developed under some of our strategic collaborations. And this slide acknowledges those relationships. As we near the end of 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 are following through on these commitments supporting our continued growth and long-term value creation.

Over the past 9 months, our total revenue grew by 21%, fueled by increased recurring revenue, and we have invested fully in line with our capital allocation priorities. Importantly, we have grown operating profit by 52%, even while making these strategic investments. We ended the first half with around $3.4 billion in cash. Our strong financial foundation has given us the flexibility for continued growth and expansion through investment in our high-impact late-stage programs. [indiscernible] have both progressed rapidly over the course of this year with extremely encouraging data sets. And for arenas, we have initiated additional Phase III clinical trials. As part of our disciplined investment into the highest potential programs, together with BioNTech, we have agreed that the current data in frontline head and neck cancer for GEN1042 did not meet or high bar for continued development.

As part of our capital allocation priorities, was our promise to explore focused M&A opportunities. We have delivered on this commitment with the potentially transformative proposed acquisition of Merus. So let's briefly review the highlights. The proposed acquisition of Merus is an exceptional opportunity that advances our evolution into a global biotech leader. It accelerates our shift towards a 100% owned model. It expands and diversifies our revenue and it brings us closer to achieving our 2030 vision to improve the lives of patients. With this proposed acquisition, we will add petosemtamab, or Peto to our already compelling portfolio. High potential assets like Peto, which has received 2 breakthrough therapy designations are truly rare.

The totality of data we have seen for Peto underscores the potential as a best-in-class EGFR bispecific across head and neck cancer indications as well as in other EGFR expressing tumors. And with data anticipated in 2026 from one or both of the ongoing Phase III trials, we expect Peto will also be first-in-class with an initial launch expected in 2027. We are confident that our expertise and leadership in antibody-based innovation as well as our swift and broad clinical development of both up [indiscernible] demonstrate our ability to fully realize Peto's potential. We will also see real promise for it to join [indiscernible] a multibillion-dollar program. We expect to close the acquisition by early in the first quarter of 2026, and subject to the satisfaction of customary closing conditions.

And combined with our disciplined capital allocation, strong financial foundation and proven commercial execution, this transaction sets us up for durable long-term growth into the next decade. Now let's turn to some of the recent advancements for our late-stage programs. Beginning with EPKINLY. We eagerly await the potential its potential approval in second-line follicular lymphoma later this month. In addition to the unprecedented Phase III second-line follicular lymphoma data we discussed during our second quarter call. Recently, we announced updated results of epcoritamab in the outpatient setting. These data evaluated the feasibility of treating and monitoring patients with relapsed or refractory diffuse large B-cell lymphoma in this setting. Data from both the Phase III second line and outpatient studies are included in more than 20 Apco abstracts that have been accepted for presentation at this year's as meeting end of the year.

Excitingly, the second-line follicular lymphoma data will be 1 of 7 oral presentations for EPCORE at ASH. These upstracts highlight advances that expand epcoritimab clinical profile, supporting use in earlier lines of therapy and across additional B-cell malignancies. So now let's turn to [indiscernible]. Last month at ESMO, we presented an update of the data for single-agent rides in patients with advanced endometrial cancer. Today, Tahi will provide a brief overview of this data, which further supports the encouraging results that we showed at ASCO. This progress reflects our vision to accelerate our innovative late-stage pipeline and shows additional momentum behind the possibilities of Rina-S. Our confidence in the potential of Rina-S as an endometrial cancer is reinforced by the breakthrough therapy designation granted by the U.S. FDA. As a reminder, this indicates that the FDA considers in has to have the potential to significantly improve patient outcomes compared with existing therapies. The data we have seen and the recognition from the FDA, both support our development plans for Rina-S.

And I'm pleased to tell you that we have initiated a Phase III trial in endometrial cancer. So our rapid development of Arena as continues, and we are also preparing for potential commercialization. [indiscernible] is now available for prescribing in Germany, our first European markets. And the foundation that we are building in the European dynamic community with [indiscernible] will set us up for future success with Rina-S. Now over to Tahi and the updated Rina-S data from ESMO.

Thank you, Jan. At ASCO, we presented the first results for single-agent Rina-S in patients with advanced endometrial cancer from the ongoing Phase I/II RAN-401 study. And at ESMO just a few weeks ago, we provided an update on that data with 4 additional months of follow-up. What we saw was that as a median follow-up of around a year, Rina-S dose at 100-milligram per meter square showed deep and durable responses regardless for receptor alpha expression. The disease control rate at that dose continuing to be at 100% and a confirmed or remaining at 50%, including 2 complete responders. And with 7 out of the 11 confirmed responses still ongoing at that data cutoff.

This compares to the standard of care chemotherapy, which delivers approximately a 15% ORR and a limited durability roughly around 6 months. In addition to the durable efficacy, Rina-S continues to have a manageable safety profile, there are still no signals of ocular toxicity, interstitial lung disease or neuropathy across the entire program. So in summary, the data we have seen in for mines, both in endometrial cancer and the data we've presented on [indiscernible] reinforce our conviction that Rina-S is best-in-class ADC across efficacy, safety and durability across the entire spectrum of folate receptor alpha expression. And we are maximizing its potential with an accelerated and extremely comprehensive development plan that includes now 3 ongoing Phase IIIs.

If you follow today's disclosure on clinical trials of [indiscernible] and 2 Phase IIIs that are intended for potential registration on the accelerated approval pathway in the United States, one in [indiscernible] and one in [ second line ] endometrial cancer. And we expect a first launch in 2027, and we also are generating data beyond [indiscernible] with sickle seeking Phase II trial in non-small cell lung cancer.

And now over to Brad for a review of the recent commercial performance for EPKINLY and [indiscernible].

Yes. Thank you, Tahi. Q3 marked another strong quarter for our proprietary portfolio. Our commercialized medicines are contributing positively to our overall revenue growth, driven by the strong performance in our established markets as well as now the early success in new markets. This gives us further confidence in our growth potential as we advance our portfolio and prepare to bring our medicines to even more patients around the world. Take a closer look now at performance overall.

EPKINLY [indiscernible] sales through the third quarter of 2025 were up 54% year-over-year. This accounted for 25% of our total revenue growth. And as we've said before, we expect our proprietary portfolio to increasingly contribute to our overall revenue growth over time. During the quarter, we continue to scale our operations across markets in a disciplined fashion, accelerate the adoption of our medicines and meet patients' needs. And as you just heard from Jan, the proposed [indiscernible] transaction provides us with the unique potential to double down on our shift to a 100% owned model and maximize our long-term growth. With pembro, Rina-S, acasunlimab and potentially petosemtamab, we have the pieces in place to deliver several multibillion-dollar opportunities in the coming years.

Let's turn now to our EPKINLY's performance. EPKINLY posted $333 million through Q3, which represents a 64% year-over-year increase. We're highly encouraged by EPKINLY performance and steady growth globally as the clear leader in the third-line setting across diffuse large B-cell lymphoma and follicular lymphoma. In the U.S., performance continues to demonstrate the value of EPKINLY as the only dual indication option in DLBCL and FL. We're seeing increases in adoption across sites of care and new patient starts. Reinforcing both the clinical and operational differentiation that EPKINLY brings to the market dedications further growing utilization within order and accounts and expanding more broadly into the community setting.

As we prepare to enter earlier lines of therapy with the anticipated launch in second-line FL later this year, we'll build on this positive momentum to bring up EPKINLY to even more patients. Now looking in Japan, we're seeing an encouraging start at EPKINLY's launch in third line plus follicular lymphoma. Our teams are building on the traction we've seen in large B-cell lymphoma and continue to drive account activation while also preparing for future potential launches. To that end, today, we filed a supplemental JNDA for EPKINLY in second-line FL. Marking another important milestone to potentially bring up EPKINLY to earlier lines of therapy in this priority market. Across all other markets through our partner, AbbVie, we saw solid sales EPKINLY in the quarter as an increasing number of countries gain access to reimbursement and so rapid uptake.

Globally, EPKINLY has received the most regulatory approvals for a bispecific in DLBCL and FL with approvals in more than 65 countries worldwide, including more than 50 countries now with the dual indication. As we look ahead to the remainder of the year and into 2026, we're focused on increasing utilization across sites of care and deliver epti patients in earlier disease settings where we may have the opportunity to transform outcomes. With its strong performance to date and accelerating development program, we're confident in EPKINLY's growth potential to reach peak sales of more than $3 billion in the future.

Now let's look at TIVDAK. TIVDAK is well recognized as the global standard of care in recurrent or metastatic cervical cancer. Our year-to-date sales for TIVDAK totaled $120 million with performance in both new and established markets highlighting the clear need for women with advanced solvable cancer across geographies. In the U.S., we continue to see strong, stable performance across sites of care. And in Japan, we saw continued early launch success, further reinforcing the patient need the strength of our launch strategy and impactful execution by our field teams. [indiscernible] our reach across markets in September, TIVDAK officially launched in Germany. This marks the first medicine we've launched in Europe independently. We've seen encouraging early uptake in Germany, providing positive momentum as we look ahead to expand to additional countries.

With our focus on TIVDAK, we've made important progress establishing our operations to support our current and future portfolio in Europe. The strong foundation will ensure we are equipped to broaden our impact with the gynecologic cancer community and deliver our medicines to more patients around the world. The work we've done to transform our business has positioned us well now for sustained growth and profitability. We remain focused on expanding the utilization of our medicines and bring them to as many patients as possible. The proposed acquisition of Merus and the potential addition of petosemtamab could strengthen the opportunities ahead for our proprietary portfolio of antibody-based medicines. We look forward to closing out the fiscal year with continued strong performance. And with that, I'll hand the call over to Anthony to discuss our financials.

Thanks, Brad. We continue to deliver solid revenue growth throughout the first 9 months of 2025, driven by sustained recurring revenues and the solid market performance of our products. We've also strengthened our long-term growth potential as we continue to generate encouraging clinical data for both epritumab and Rina-S. And our financials remain strong. We grew total revenues by 21% with recurring revenue up 26%. This was driven by royalties from DARZALEX and [indiscernible]. And importantly, this growth was also supported by product sales from EPKINLY and TIVDAK, which together represented 25% of our total revenue growth.

Looking at DARZALEX. We continue to see extremely strong growth. Overall, net sales grew by nearly 22%. That's $10.4 billion for the first 9 months of the year, which translates to over $1.7 billion in royalty revenue for us. This growth was driven by continued share gains and solid performance in the frontline setting. So you can see that the quality of our revenue profile continues to improve. In fact, in the first 9 months of this year, recurring revenues represented 96% of our revenues, and that's up from 92% in the same period of last year, a clear sign of increasing visibility and durability of our revenues. What's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off.

This sets us up well as we prepare for potential expansion into earlier lines for EPKINLY including second-line FL and the anticipated launch of arenas and contingent on the successful close of the transaction, the launch of [indiscernible]. And we continue to take a disciplined approach to these investments. Total OpEx in the first 9 months of 2025 was slightly less than $1.5 billion, up over the same period last year, excluding the impact of the Profound Bio acquisition. And we're managing our investments strategically. Prioritizing our high-impact Phase III programs and focused investments in our commercialization capabilities. Our operational discipline contributed to our operating profit growth of an impressive 52% in the first 9 months of the year. So here, you can see that we're really continuing to deliver on our commitments.

Next, looking at our net financial items. Here, we have a net gain of $142 million. Then moving on to tax. We have a tax expense of $217 million, which equates to an effective tax rate of 18.9%. Taken together, our net profit amounts to $932 million. So as you can see, continued strong underlying financial performance. With that, let's move to our 2025 financial guidance. We remain on track to achieve our existing financial guidance with projected double-digit revenue and double-digit profit growth. We expect our revenue to be in the range of around $3.5 billion to $3.7 billion, delivering a robust 15% growth at the midpoint. And it's our recurring revenues from royalty medicines and from EPKINLY and TIVDAK that's been driving that growth in 2025. In total for the year, we expect our recurring revenues to grow by 22%. For operating expenses, due to our continued focused and disciplined approach to our investments, we still expect to be in a range of around $2.1 billion to $2.2 billion.

Putting all this together, we're planning for operating profit in a range between around $1.1 billion to $1.4 billion, with the midpoint of our guidance amounting to over $1.2 billion of operating profit and strong year-over-year growth of 26%. Our guidance highlights our continued strategic discipline, targeted investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value. Now to give you just a bit more color on FX, every 10-point move in the exchange rate relative to our guidance rate of the U.S. dollar to the Danish kroner of 7.20 is worth just around $1 million in operating profit or loss at the midpoint. Now finally, before I conclude, I would like to take a minute to look ahead to 2026.

While, of course, our guidance will be given in February next year, as I stand here today, 2026 consensus expectation for Genmab stand-alone investments appear to be in a reasonable place, capturing our investment priorities. And as I take a look at consensus expectations for Merus investments, they also appear to be in a reasonable place. Importantly, we remain confident that Genmab will deliver significant profitability in 2026 and meaningful EBITDA growth in 2027. Our performance in the first 9 months of 2025 underscores our ability to produce solid high-quality revenue growth. advanced key pipeline assets, deliver on our capital allocation commitments with the proposed acquisition of Merus and maintain strong profitability through disciplined execution.

So in summary, our very strong financial foundation, sustained profitability and disciplined capital allocation strategy positions Genmab for growth, creating value for both shareholders and for patients. And on that note, I'm going to hand the call back over to Jan.

Thank you, Anthony. Let's move on to our final slide. We have strengthened the foundations of our business in the first 9 months of 2025. We have expanded the reach of both up EPKINLY and TIVDAK to more patients. For Rina-S, we have presented additional support of clinical data showing its potential beyond ovarian cancer, and we are prepared to accelerate and maximize the potential with additional Phase III clinical trials. And we continue to anticipate further acasunlimab data this year, and they will be presented at ESMO I-O in December in London.

Beyond our commitments, to our existing pipeline priorities, we further delivered on our capital allocation strategy with the proposed acquisition of Merus. An extraordinary opportunity that will advance our evolution into a global biotech leader and position us for sustainable long-term growth and value creation. Before we move to the Q&A, I'm pleased to announce that we will hold our annual R&D updates and a data review, on December 11 and to ensure that this event is accessible to as many people as possible, this year's presentation will once again be fully virtual Details will be available on our website, and we look forward to a lively event. That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.

[Operator Instructions]. We will now take the first question from the line of Jonathan Chang from Leerink.

Now coming out of ESMO, there's been a lot of discussion around the competitive landscape of Peto and Rina-S. What are your latest thoughts on how these drugs are positioned in the competitive landscape. And what gives you confidence in the potential for these 2 programs to be key drivers of growth

Thanks, Jonathan. Very good question. So let me ask Tahi to start off, giving you our thinking on the positioning of Peto as the best and first-in-class molecule and the same for Rina-S, and I'm sure that Judith will then also add to that. Tahi, why don't you get going?

Thank you, Jonathan, for the question. And so let me start this. There was really nothing that in any shape or form was surprised us. Our conviction in Peto and Rina-S being the best and first-in-class asset in the respective indications of head and neck and [indiscernible] has not changed. Peto, if you look at totality of data, Jan said this in the prepared remarks in our mind, has all the attributes of the best-in-class second-generation EGFR bispecific. They are to Phase IIIs already ongoing in head neck and second line, the Monotype has and in combination with pembro in frontline, where it has BTD.So it's also on track to be the first in class, nothing really changed on that. As it relates to Rina, there's, of course, a couple of fully receptor alpha ADCs in development by AZ and [indiscernible], again. This is not news. We are, generally speaking, operating in a very competitive landscape.

None of the data in any way, shape or form are changing our assumption that Rina-S based on the data in Pro and endometrial both in response and long-term follow-up and durability and long-term safety has the profile to be best-in-class. I mentioned this in my comments, there are now 2 Phase IIs that are ongoing for some time. And we expect to launch at least one of these indications '27 and 3 Phase IIIs that are actively involving. So I think we have a good position here also to be the first class [indiscernible] space, and we're expanding already into other indications. So in totality, we feel very comfortable about the profile of the assets. We feel extremely comfortable over where we are positioned in the competitive landscape, and we feel very confident in our ability to accelerate the development of petro once we are having control of this asset, hopefully and on VNAND, so there's more to come on both of these assets.

That's probably all that to say at this point.

Thanks, T. Judy, do you want to add anything to Dan?

No, beautifully said, [indiscernible].

Thanks, Jonathan, for the question. Let's go to the next question.

We will now take the next question from the line of Michael Schmidt from Guggenheim Partners.

Congrats on all the progress. I had a question on EPKINLY I was just wondering if you could comment on the commercial dynamics. I'm just curious in terms of sales, what are you seeing in terms of use in the approved indications between follicular and DLBCL. And then how should we think about the near-term growth opportunity in second line follicular in the U.S. and Japan in your markets? What is the magnitude of that near-term growth opportunity?

Thanks, Michael, for the questions. And I think these are perfect questions for Brad to handle. Brad?

Thank you for the question. We actually are extremely encouraged and pleased with our progress to date in the performance. We don't actually split out by indication, and that's actually part of the benefit, and we're hearing from customers and planning around their feedback that the dual indication from an operationalization perspective is extremely beneficial along with the seamless subcu administration. And as we move into the earlier lines of therapy, I see this as a tremendous opportunity to bring treatment close to where patients live and see this as an opportunity, again, moving forward with where we are. So I'm extremely encouraged with our performance to date. And as we know the value is in earlier lines of therapy, and I look forward to seeing that success in the future as well.

Thanks, Brad. Do you want to say a bit about the size of the market in second line of [indiscernible] lymphoma.

Yes. The second line [indiscernible] previously stated, we really feel the value of these medicines are much broader and much greater in the earlier lines, approximately 9,000 patients in second line FL and it's really our first step into this larger opportunity. And so we would expect that this enabling treatment in earlier lines will open up additional opportunities for us in the not-too-distant future as well.

Thanks, Brad. Thanks, Michael, for the question.

Thank you. We will now take the next question from the line of Xian Deng from UBS.

Sorry, if I may just stay on key a bit. I wonder if I could maybe push a little bit more on sort of the near-term performance given I mean in this quarter, we did see kind of a miss EPKINLY. Just wondering if there's anything you would flag in terms of this quarter's performance. And also just wondering for second follicular lymphoma. Just wondering how should we think about the launch trajectory? Do you think this is actually going to be a bit more gradual given I don't know, follicular lymphoma. Is that mainly community setting? Or do you think this actually will be a pretty fast uptake?

Thanks, Xian, for the questions. I'm going to hand them over to Brad. Brad, please comment.

Yes. We're actually seeing right now the observed consistent and continued uptake across sites of care in the U.S., and we do see to your latter part of the question that second line allows this acceleration in the community setting where FL patients are actually treated as you stated. And we do see that as a consistent uptake over time as we continue to get operationalization, if you will, bispecifics in the community setting. And as it relates to the performance, we're extremely encouraged by what we're seeing year-to-date with the performance. Both in the U.S. as well as Japan and through our partner [indiscernible] globally.

And again, feel like as we said all along, the earlier lines of therapy or where the value of kidney will be and the second line FL is really that first step taking us into this next phase. So hopefully, that answers your question.

Thanks, Brad. And definitely, Xian, we definitely hope to move forward to frontline and second-line diffuse labs for also very rapidly from here. with readouts hopefully soon of the Phase III trial. So we're very encouraged by EPKINLY and really look forward to a very, very good future there. Let us move to the next question.

We will now take the next question from the line of Qize Ding from Rothschild.

One, if I may. So can you elaborate a little bit more on your decision to terminate the clinical development of 1042 in first-line anti cancer. And also, what is the implication to the future development of this drug in first-line lung cancer and first-line melanoma?

Thanks, Qize, for the question. I think I can start there and then maybe Judith can step in there. So what we determined together with our part of Biotech basically the data of 142 in combination with chemo and pembro, and frontline head and neck cancer didn't meet the high [indiscernible] of internally for continued development. So we stopped the development there. And that's where I want to leave at that. Judith, do you want to add anything there?

Yes. No, just to add that this was the most relevant data set and the initial proof of concept. And based on that, we decided to stop the development in combination with pembro and chemo.

Thank you. We will now take the next question from the line of Rajan Sharma from Goldman Sachs.

Just wanted to get your thoughts that had the Apine PDUFA in November, there's obviously been a bit more of a focus seemingly on U.S. representation in clinical trials. So I just wanted to get your confidence into that potential approval. And if you could just confirm the efficacy in the ATCO FL1 trial is consistent across both U.S. and non-U.S. patients?

Thanks, Raj, for the question. Tahi, can you get some color on the U.S., non-U.S.

Yes. I mean, basically, the way I'm going to respond to that without getting into the minutia of the data is that there's absolutely nothing at this point that would indicate that it will not be approved in the next few weeks or days. in United States.

All right. I think. So we're highly confident, Rajan. So let's wait and see the coming weeks.

Thank you. We will now take the next question from the line of Yaron Werber from TD Securities.

Anthony, I got a couple of questions for you more about 2026 and then 27%. So you mentioned for next year, the numbers -- the stand-alone OpEx for Merus and Genmab are reasonable. For Merus, they're sort of in the 450 range in terms of OpEx, let's call it, 450, maybe some you're going to have as high as 500. I think we were imagining there's going to be some synergies as you bring that company in. And I know you're not -- you can't give guidance, but can you give us any -- a little bit of a sense, are we thinking about this correctly? And then secondly, when you're talking about significant profitability next year, there could be as much as like $430 million change between interest income net to noninterest expense net because of the debt liability. So we're thinking about that correctly because it would impact profitability next year.

Thanks, Jan, for the questions. Anthony, I think it's good that you also got a chance to answer some questions here.

Thanks. So I can really start off by thinking as you all know, I know would appreciate we have a very disciplined and focused approach to our investments we've outlined for the market starting the overall capital allocation framework, a very clear framework of where and how we're going to invest on the one hand and as we do that in the most prioritized and productive manner as possible. That's how we were able to deliver on our 2024 actual financial results and also what our overall guide was for 2025 and where the year-to-date performance is. Moving forward, that same approach in terms of very clear investment priorities remains as well as that approach to being super focused and disciplined. Now to reiterate what I said is I kind of look at overall stand-alone consensus for Genmab, that is in a reasonable place.

Likewise, for Merus here, I'm looking at the consensus number is in a reasonable place. We also have to appreciate where we are at in the overall process here as it relates to being on track to closing the transaction in early Q1 2026. Today, I thought it was important to provide that market -- the market the commentary similar to it did last year, but I think the overall investments are in a reasonable place. Of course, we will look for opportunities to prioritize, to remain disciplined and ultimately, we'll provide our guidance when we get to February of 2026.

Now my comment as it relates to significant profitability, just to be super clear here, I am referring to EBIT. So I'm referring to our EBIT figure, our operating profit consistent with historical practice, we are guiding on the EBIT line. So overall, if I think you sort of step back, we think about the overall setup here, what you should expect here on is continued investment in line with our capital allocation framework, lots of focus and discipline by the team and continue to deliver on our overall commitments, both operationally and financially.

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

Thank you. We will now take the next question from the line of Asthika Goonewardene from Truist.

I want to also say congrats on all the growth that you guys have shown this quarter is impressive. Jan, when the Merus acquisition was announced, you mentioned that head-neck cancer was the main driving factor for that your interest there. And you said you'll talk a little bit more about colorectal when that data is presented. To get at in CRC at the Triple meeting was, I would say, perhaps a little better than what even Bill telegraphed. So how do you view that colorectal opportunity? And then importantly, that as well as a net, do you feel that you need a subcutaneous formulation to be competitive with their emerging competition from Rina.

Thanks very much for the questions. And we said about the fall was primarily determined by head-neck and we want to expand [indiscernible], as you know, into locally advanced and potentially other settings fairly soon. And we would say that the data, the early data in colorectal cancer is very exciting, but very early data. And we believe that the risk potential in other each of our positive tumors also outside of head and neck, but there's simply no or limited data there. I will ask Tahi to maybe give a bit more color there on our thinking.

Yes. Thank you, Ashtika, thank you for always the hard questions. So I try to manage this. I think as Jan said, early data, limited data, encouraging and we should leave it at that until we have control of the asset, and it's really used to speak about the data. But I think that's kind of the top line. And broadly speaking, I think we even talked about this in the prepared remarks when we announced the acquisition. We do think of Peto as a best-in-class second-generation EGFR spispecific, and that obviously includes also opportunities outside of head and neck.

But the focus is where it is right now. 2 Phase IIIs ongoing in head and neck. And there we have a significant head start over any form of competition. Subcutaneous administration is something that we are very familiar with that we have some deep understanding in prior past. And it's obviously something that we are looking at as part of a life cycle management, but our focus right now is execution on the studies that are already ongoing. And then we can talk more about what Genmab is going to plan in due time.

Thanks, TahI. So confirming that the subcu development is an integral part of our strategy for Peto, but more to come after the finalization of the transaction. Let's move on to the next question, operator.

Thank you. We will now take the next question from the line of Matthew Phipps from William Baird.

I've had a lot of investor interest recently on the first-line DLBCL trial with EPKINLY reading out next year. I'm wondering if you can give us any sense of where you think that's a first half or second half readout. And then what level of PFS benefit do you think you need to really outcompete the PVR CHP regimen that has gained some traction there?

Thanks, Matthew, for the question. Tahi, can you give a bit of color on the frontline, the Fuse label trial and the potential need for the type of data to give us an angle, a differentiated angle of other therapies.

Well, thank you, Jan. I think we have guided that we expect the readout to happen in 2026, and we should probably leave it at this now. It's obviously an event-driven study, and we will update in the appropriate setting when we have a little bit more clarity. But clearly, the study was more or less fully accrued in the summer of last year. So as it relates to what it has to do in order to be competitive in the competitive landscape vis-a-vis put I don't know -- I don't think it makes sense to go into some kind of like discussion about how that ratio and what it has to show. I think we are very confident that if the study -- when the study reads out, then there will be a significant improvement over the standard of care.

And in that regard, also significantly differentiated from the [indiscernible] study. That is partially underwritten by the data that's going to be represented now with a longer follow-up at ASH, where you have a Phase II data set that in these high-risk patients shows a incredible high CR rates with an incredible high durability and on -- what we've seen over and over again is that these very robust Phase II studies that we win and then the data we generated on them more or less one-to-one translates into the Phase III. And so we anticipate the same to be true for the frontline diffuse BIS study.

Thanks, Tahi. So in addition to efficacy, I also think about the convenience of the subcu dosing and the safety pattern may be very different from other combination therapies metro. So we are very excited about the potential to see the readout, hopefully, soon from the frontline diffuse [indiscernible] potential game changer we feel for EPKINLY. Let's move to the next question.

The next question comes from the of Victor Floch from BNP Pariba.

Maybe just a keeping question on data readout timing. So taken for the comments on the first [indiscernible]. But you used to have an anticipated readout column on the Slide 7. So I just wanted to ask you whether you can confirm that all the Phase III trials that are on that slide. on the timings are consistent with what we -- what you've discussed last time for the second quarter update.

Tahi, cna you comments on the timing there?

Nothing has changed.

So we have confirmed the signal.Thanks. Let's move to the next one.

Thank you. The next question is from the line of Zain Ebrahim from JPMorgan.

Got one clarification question for just on the OpEx for '26 in terms of when you say both the time alone investments from Merus [indiscernible], reasonable pace, I think is how you characterized it. Does that include the potential for indication expansion that you outlined for locally advanced head and neck for Peto and maybe other indications that we might hear about more in Q1 was my first question. And the second question is just on -- can you remind us of the filing strategy for [indiscernible] next year? I know you just said everything is on track. But in terms of recruitment, how that's progressing for the Phase III and when we can expect to see more duration of response data from the Phase II trial

Thanks, Zain, for the questions. I will leave the first one to Anthony, of course, to give you further clarity there. The second one I can take for RIAs filing strategy. The initial filing will likely be based on the Phase II potentially registrational trial for [indiscernible]. That trial is completely recruited and also in parallel to Phase III is recruiting very rapidly. So we are fully on track there to have a readout next year potentially a filing and an approval, hopefully, in '27. Anthony, can you give a bit more color on the inclusion of the locally advanced head and neck for the GEN MOP trials as projected for 2026.

So yes, the short answer is yes. So I think about, again, just reiterating, as we think looking about forward to 2026, it was important to condition the market thinking about overall investment levels, again, to reiterate, expect as I look at consensus today for both Genmab stand-alone as well as Merus, look to be in a reasonable place, also reflective of our investment priorities. Of course, we're going to provide ultimately our guidance to the market in February of 26%. But to put a finer point on it, Zain, yes.

As I say today does include what we think about it from an overall portfolio development, including your specific question around inclusion of investment in the locally advanced.

Thanks, Anthony. So thanks, Zain, for the questions. Let's move on to the next one.

Next question is from the line of Charlie Howard Bank of America.

Charlie Howard Bank of America. First one was on just how to look -- how you're looking at the first-line head and neck cancer landscape, specifically, I guess, the option to have a triplet versus a doublet strategy. How you think those segments of the markets differ versus the KEYTRUDA mono or combo arms that you have as part trials? And then the second one being in Rina-S endometrial data I think optically looked like better responses in the file receptor greater than 25% and a bigger delta than you've seen in [indiscernible], I guess, confidence in efficacy across broad flareceptor alpha expresses.

Thanks, Charlie, for the question. Tahi, can you start and then Judith maybe you can step in there. The first start with the form line had a cancer landscape.

The way I would answer your question is that, broadly speaking, in the current landscape, as you were alluding to, there is a pembro mono strategy and then a pembro chemo strategy and at times physicians make that choice based on maybe a slightly higher response rate for the chemo pembro combination in a faster time to response, and that's had a lot to do with location of the tumor and the size of the tumor. That all becomes essentially irrelevant if the data in the Phase II with Petro and pembro is essentially double twice the report response rate for chemo. Pembro because at that point, you basically have a higher to response rate without the significant toxicities of chemotherapy and these patients don't necessarily tolerate chemotherapy too well.

So this is what we like about the profile of pet, in particular, also in the data and people in the combination provides an opportunity where you have a high response rate, a rapid time to response without any of the quite significant toxicities that go along with combination chemotherapy in this patient setting. That's the head and neck story. On the EC and the Rina-S the [indiscernible] cancer, I mean the nuances here and there it's not that we have ever said that fully receptor alpha expression is [indiscernible] the response? That's not the case. What we said is that Rina has a profile that allows us to generate meaningful responses across the entire spectrum of 4 receptor alpha expression and that does not require a biomarker selection.

And that's a strategy that has allowed us to go into these indications in the mitral generally considered to be a lower folateceptor alpha-expressing tumors than Prog. And it's also what is underwriting the confidence in going to other indications such as, for example, EGFR non-small cell lung cancer. And so this is one the differentiating aspects of Rina-S as that it was able to generate meaningful and stable real response rates across the entire spectrum. That doesn't mean that the higher don't even have higher responses that just means that even at the low end, the responses are meaningful and durable.

There are no further questions at this time. I would now like to turn the conference back to Jan van de Winkel for 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 all again soon.

This concludes today's conference call. Thank you for participating. You may now disconnect.

Hello to Genmab's conference call regarding its proposed acquisition of Merus. 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 that Genmab may hold your personal data as indicated by you as 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 your first speaker today, Jan van de Winkel. Please go ahead.

Hello, and thank you for joining us. Today, we are sharing a transformative step for Genmab, our planned acquisition of Merus. With me today to present this exciting news is our Chief Medical Officer, Tahi Ahmadi, who will tell you about Merus' exciting program, petosemtamab or peto; and our Chief Financial Officer, Anthony Pagano, who will walk you through the details of the proposed transaction.

For the Q&A, we will be joined by Genmab's Chief Development Officer, Judith Klimovsky; and Chief Commercial Officer, Brad Bailey. Before we continue, just a reminder, we will be making forward-looking statements, so please keep that in mind as we go through the rest of this call. And here is some important information on where you will be able to read more about today's news.

The proposed acquisition of Merus marks a pivotal moment for our company. It clears Genmab's very high bar for innovation and aligns with our financial commitment of driving profitable and disciplined growth. Since 2010, we have been successfully building an integrated biotech, the Genmab way, having an impact on thousands of patients. We are on track to achieve our 2030 vision and improve the lives of more patients with our wholly owned medicines. With this proposed acquisition, we will further strengthen our foundation as we add peto to our already compelling late-stage product pipeline. High potential assets like peto, which has received 2 breakthrough therapy designations are truly unique and rare.

And our expertise and leadership in antibody-based innovations as well as our rapid and broad clinical development of both EPKINLY and Rina-S are a testament to our ability to unlock peto's full potential. We believe there is a clear path to market in multiple head and neck indications for peto, and we anticipate its initial launch could take place in 2027. And we are confident that peto has multibillion-dollar peak sales potential. The addition of revenue from peto, once approved, will give us the flexibility to invest in the next [ winners ] from our innovative R&D pipeline.

Genmab has delivered robust performance year-over-year. Our long-term strategy has been to shift the company from a dependence on royalties into an end-to-end biotech, one that fully owns, develops and commercializes our own medicines. peto provides us with a unique opportunity to both advance that shift to a 100% owned model and maximize our long-term growth. Altogether, Genmab is on course to achieve sustainable growth and profitability into the next decade and beyond. Here, you can see how the addition of peto change enhances our late-stage pipeline.

These programs represent the future of Genmab. We will have 3 products with 5 breakthrough therapy designations between them. That means that the FDA believes each of these therapies has the potential to substantially improve outcomes for patients over existing therapies. Importantly, Rina-S, acasunlimab and peto will be 100% owned assets, positioning Genmab as an antibody-focused biotech powerhouse. And together with EPKINLY, they underpin our sustainable long-term growths. We are confident in our late-stage pipeline. And excitingly, we anticipate a number of significant catalysts in the next 12 to 24 months.

As Merus has stated, we expect top line interim readout of one or both of the Phase III peto trials in 2026. For EPKINLY, we are anticipating the potential approval in second-line follicular lymphoma in November. And in 2026, we expect data in frontline diffuse large B-cell lymphoma. Also next year, we expect potentially registrational data in platinum-resistant ovarian cancer for Rina-S. And following these significant readouts, we anticipate critical launches and indication expansions across EPKINLY, Rina-S and peto in 2027. So with this exciting news, I will ask Tahi to provide you with the details of why we are so very enthusiastic about peto. Tahi, the floor is yours.

Thank you, Jan. Similar to EPKINLY and Rina-S, we view peto as one of these truly rare assets that are a pipeline within a product. But to start with the basics, peto is an EGFR LGR5 bispecific antibody with the potential to become the first and best-in-class therapy for head and neck. We've seen meaningful clinical benefit in both first and later line head and neck cancer settings. And this has been recognized by the FDA, which granted breakthrough therapy designation for both the first-line PD-L1 positive and second-line plus recurrent or metastatic head and neck cancer.

There are 2 Phase III trials ongoing, one in first-line and one in second-line head and neck. And as Jan just noted, we anticipate potential top line data for one or both of these trials already in 2026. And as Merus has publicly indicated, there is a clear path for accelerated approval under Project frontrunner agreed with the FDA in both indications. Importantly, as we have been doing with Rina and are doing with Rina-S, there are multiple significant opportunities for expansion beyond the ongoing Phase III trials.

There remains a significant need for innovative treatments in head and neck cancer with current standard of care delivering modest progression-free survival and overall survival in frontline disease and active and well-tolerated bispecific could materially change outcomes for patients. In addition to first and second line, peto's emerging profile supports a strategy to expand development into locally advanced head and neck cancer. So this is our first planned next step with our goal to initiate the first Phase III trial in this indication in 2026.

And we will provide you with more specific details in terms of both timing and trial design next year. So now let's take a look at some of the data behind our confidence and our enthusiasm for peto. The data to date are highly compelling in both first-line head and neck in combination with standard of care and in second-line plus head and neck as a single agent, peto has demonstrated a meaningful clinical benefit. In the second and third-line setting, standard of care typically achieves objective response rates around 6% to 19%.

By contrast, peto demonstrated a 36% response rate with improvement also observed in both progression-free survival and overall survival. Equally, the data in the first-line setting are also highly encouraging. peto here in combination with pembro achieved a 63% response rate that is more than 3x higher than the 19% that have been observed with the standard of care. And again, this benefit is not limited to response rate, but it's also reflected in improvements in event endpoints such as progression-free survival and overall survival.

It is this data on which the FDA based its granting of 2 PDDs breakthrough designations for peto. This recognition underscores our confidence in peto's potential to meaningfully improve outcomes for patients with head and neck. Importantly, these results support moving the combination into earlier setting, locally advanced disease where the treatment opportunity and medical need is even greater.

Now turning to safety. In addition to its efficacy, peto has been shown to be well tolerated with a manageable safety profile. Infusion-related reactions were generally confined to the first cycle with a mitigation plan in place. And overall, the risk benefit supports advancement across lines and combination. So in summary, we believe that our expertise in both clinical development and commercial execution will allow us to maximize the potential of peto, giving us another opportunity to rapidly advance innovation into the clinic and ultimately to patients. And I would now like to hand it over to Anthony to take you through the financial details of this transaction. Anthony?

Thanks, Tahi. I'd like to begin by reiterating how enthusiastic we are about Merus and what this acquisition means for the future of Genmab. This proposed transaction will have a substantial and positive impact on Genmab's growth trajectory. Under the terms of the transaction, Genmab will acquire Merus at an offer price of $97 per share in cash, which equates to around $8 billion. We will fund the transaction with a mix of existing cash and new debt, and we expect to achieve a strong non-investment-grade rating.

We anticipate that the transaction will close by early in the first quarter of 2026, subject to the receipt of regulatory clearances. Now I'd like to take a moment to frame the financial considerations. We are confident that peto has the potential to meaningfully improve outcomes for patients with head and neck cancer. But in order to unlock this potential, we'll need to invest. So as you'd expect, there will be a step-up over the near to medium term in R&D and commercialization expenses as we invest in peto as well as our existing late-stage programs. Even with this investment, we will maintain significant profitability in 2026.

And we'll expect meaningful growth in 2027 as launch revenues build and our spending normalizes. We anticipate we will be approaching breakeven on the transaction in 2028, and the transaction will be accretive to EBITDA a year later as we believe peto has the potential to reach at least $1 billion in revenue by 2029. Further, we are committed to rapidly deleveraging and our robust financial foundation will allow us to pay down this debt significantly within 2 years after the closing of the proposed transaction, giving us low leverage by the end of the decade.

So we are planning for sustained growth and profitability into the next decade as we unlock meaningful value from our late-stage assets and maximize the potential of our commercialized medicines. Now I want to take a moment to look more closely at just how the addition of peto to our pipeline will help us achieve this sustained growth. Adding peto to our portfolio not only increases our scale, it significantly advances our strategy to reduce dependence on royalties by diversifying our sources of revenue, which will address our path to growth and profitability by the end of the decade and beyond.

As you can appreciate, there are essentially 2 parts of our business. We have the royalty products, which include 6 out-licensed therapies. And then we have our co-owned and wholly owned assets. Let's remember, in addition to DARZALEX, we also have 5 other royalty products with the potential for more to come and all of which have significant potential for growth into the next decade. Together, these will continue to serve as a solid foundation of recurring revenue for Genmab well into the future. But what's really exciting for us at Genmab is the potential of our proprietary products.

These are the promising late-stage programs that we are investing in today that provide us with significant growth prospects moving forward. we believe that the data we are anticipating next year will serve as proof points for our conviction that EPKINLY, Rina-S and now peto all have multibillion-dollar potential. In summary, we have multiple streams of growing recurring revenue. These have laid the groundwork for our success. And now with the addition of peto to our high potential late-stage portfolio, we will be well positioned to move into Genmab's next phase of growth. Our confidence in our projected growth comes from our track record.

We have proven that we are excellent evaluators of innovation and that we can deliver on our promises. We overdelivered on our financial commitments made at the time of the ProfoundBio acquisition, and we rapidly accelerated the development of Rina-F. We had roughly 40 patients worth of data when we acquired ProfoundBio, and we're going to exit this year with 3 ongoing Phase III trials and 2 potentially registrational Phase IIs for Rina-S. We have also proven that we are disciplined in our execution against our capital allocation framework and prioritization of our investments, and we continue to be committed to delivering profitable growth.

The addition of peto will be absolutely key to achieving this. So in summary, our differentiated approach to building a fully integrated biotech company started in the 2010s, has continued here into the 2020s and now we have high conviction that we have the building blocks in place to continue this strong track record through the 2030s. The proposed acquisition of Merus and the addition of peto to our pipeline is firmly on strategy and has the potential to bring another breakthrough therapy to patients and help drive long-term sustainable growth for Genmab. So with that, I'm going to hand you back over to Jan.

Thank you, Anthony. So let me summarize. The proposed acquisition of Merus is an exceptional opportunity that advances our evolution into a global biotech leader. It accelerates our shift towards a 100% owned model. It expands and diversifies our revenue, and it brings us closer to achieving our 2030 vision to improve the lives of patients. The first peto launch is anticipated in 2027, with real potential for it to join EPKINLY and Rina-S as multibillion-dollar program.

Combined with our disciplined capital allocation, strong financial foundation and proven commercial execution, this transaction sets us up for durable long-term growth into the next decade. We are pleased to answer any questions you may have. So I will now turn the call back to the operator and open the call for questions.

[Operator Instructions] Our first question comes from the line of Jonathan Chang from Leerink.

Congrats on the proposed acquisition. How much does the CRC opportunity contribute to your decision and price of the acquisition? And when could we see data on CRC? And what could we see in that update?

Thanks, Jonathan, for that question. I think I will take this one myself. CRC data will come in the coming months and will be released by Merus. And we have based our whole model only on the head and neck cancer data.

Our next question comes from the line of Michael Schmidt from Guggenheim Partners.

Congrats from me as well on the proposed deal. Could you talk a bit about the timing of the acquisition? You're obviously taking on some clinical risk and talk about your comfort level in stepping in with the proposed deal prior to the Phase III data reading out next year. And then I also had a question on the investment that may be necessary to maximize the potential of [ teclistamab ] globally. Can you talk about that as well?

Thank you, Michael, for the question. I will take the first one, and then Anthony can take the second one. We think that the timing is perfect here. We have done very deep due diligence, and we understand better really, really well, Michael. So we have, I think, went through 56,000 files, I think, in due diligence. And we are very, very confident that this is a potential game-changing -- potentially transformational bispecific antibody. We understand bispecifics really well as well as head and neck cancer. Remember that we had a number of programs active with Tivdak and also with 1042 in head and neck.

So we could really value the strength of the data I think, better than other companies potentially can do. And we believe that this is perfect timing for us to actually first approach Merus and now come to an agreement with them because it will be the exact building block we need to very convincingly grow into -- or profit into the next decade together with molecules like Rina-S, EPKINLY and acasunlimab. So we think the timing is just perfect. The confidence level is super high. I want to leave it with that and then hand it over to Anthony to maybe talk a bit more about the investment levels needed to optimally and broadly maximize the potential for peto.

Yes. Thanks, Michael. I mean, as a starting point, if we think about the opportunity for peto, from my perspective, that very clearly clears our high bar for innovation. And at the same time, Michael, clears that high bar we have here at Genmab for investment. Now moving forward, you're going to see the same focus and disciplined approach to how we run this business and how we invest back into our business. Further, peto in this overall deal is fully in line with our capital allocation framework.

And peto, again, is that opportunity, that potential breakthrough therapy asset where we want to prioritize investment and that's fully in line with our capital allocation framework. Again, this is a late-stage program with important data readouts in 2026 and has the potential to launch again in 2027. So absolutely, we will be investing accordingly. We will resource peto to unlock its full potential, both from an R&D and commercialization perspective. From a commercialization perspective, we have a very strong foundation that we've built out here, particularly in the United States and Japan, and we'll be looking to leverage that investment.

And as you know, we've started to build out in Europe. So we feel very comfortable that we have a very strong foundation that we can leverage. At the same time, Michael, we're not going to shy away from making the necessary investments. To just very quickly then reiterate what I covered in my prepared remarks. As we get into 2026, again, we fully expect to retain significant profitability in 2026. have meaningful growth in 2027, and we expect this transaction to be approaching breakeven in 2028 and to be accretive in 2029.

So overall, we really like the setup here from an overall financial profile perspective. And as a reminder, again, we not only delivered but overdelivered on the financial commitments we made to the market the last time we did an acquisition and acquired Rina-S from ProfoundBio. So overall, Michael, you should expect the same focus and disciplined approach from the Genmab management team here.

Thank you, Anthony. Let's hand back to the operator.

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

Congrats on the deal. So it's good to see that you already have plans to commence the trial in locally advanced head and neck cancer. But to Jonathan's question earlier, you could potentially see some sufficient data in colorectal cancer expansion cohorts that might illustrate a potential path to market in CRC as well in the near term. So I just want to get an idea from you, how would you prioritize that?

If you do see a signal in CRC, how would you prioritize that versus expanding into locally advanced head and neck? And then if I can just tag on something extra here. I just want to get your comments on what you think about the LGR5 mechanism of action, specifically relating to head and neck and colorectal, which one makes more sense to you?

Thanks, Asthika, for the questions. Why don't we ask Tahi to first give your perspective on the prioritization of colorectal versus locally advanced head and neck and then also talk a bit about the mechanism of action of the peto. This is what you referred to. And then let me see whether Judith can then add to that. Tahi, why don't you start?

Yes. Thank you, Asthika, for the question. And I would start with what is in the public data, and this is, of course, what we at this point can talk with confidence in the public space is the head and neck data, right? We've obviously done a lot of diligence on all the data that Merus has. But the focus right now is to talk about our plans in head and neck. Merus did a fantastic job in starting a very broad focused development with 2 Phase IIIs that will read out in '26.

And this is the area where you have a signal in the public domain, single-agent activity, good combinability, good safety profile with high response rates that then allows us to talk about the first of many plans, which is to move into the local regional space, head and neck. I think it's premature for us to have a conversation about colorectal until Merus has publicly released the data. And at that point, we would be very happy to discuss what our thoughts that we, of course, have on colorectals are.

As it relates to the mechanism of action of the asset, I think Merus itself spoke about that there are looking into trying to further elucidate the biology. But broadly speaking, what it does, it deintegrates and basically binds to EGFR, internalizes it and don't really see a reason why it would play out differently in one EGFR-positive disease over the other. I haven't seen any reasons to believe that. We like the profile. We like the potential of the drug, and we are really excited. And as we said in the beginning, we view this as a potential pipeline within the drug.

Thanks, Tahi. Judith, do you want to add anything to that?

Yes. Only 2 things that there are strong preclinical data on different models of organoids to support LGR5 in different settings, among them colorectal. And I want to echo Anthony on our commitment to unleash the full value of peto as data provides signals to your question on potential prioritization. That's it.

Thanks, Judith. Let me hand back to the operator and see whether there are any additional questions. Thanks Asthika.

Our next question comes from the line of Judah Frommer from Morgan Stanley.

Congrats on the announcement. Maybe just one on your assumptions around peak market share potential in head and neck, first line specifically. Can you share with us any thoughts around peak market share in HPV-positive versus HPV-negative head and neck and the competitive landscape within those 2 subsets?

Thanks, Judah, for the questions. Anthony, why don't you give this a go and then I can ask Tahi to add to that.

Yes. I'll start off to kind of characterize the opportunity and then Tahi can maybe address the emerging target product profile. Again, I think if we sort of think about peto, it has all of the characteristics that we like in terms of wanting to invest into a product. Again, it clears our very high bar for innovation and our high bar for investment here at Genmab. We think about the opportunities we stated, we think this has multi-blockbuster potential moving forward.

And importantly, as we think about the financial profile of Genmab, we've said that we expect at least $1 billion of sales from the opportunity by the end of the decade or, in fact, by 2029. So we like the overall setup in terms of adding this potential multibillion-dollar product to our pipeline, which now includes 3 products with that multibillion-dollar potential EPKINLY, Rina-S and now potentially peto moving forward. So we like the overall setup in terms of the -- as well as the financial profile. In terms of sort of further characterizing that, we're not going to get into that right now.

The last thing I'd leave you with before handing over to Tahi is really just sort of thinking about where we're at in terms of the clinical development. We have the 2 ongoing Phase IIIs in frontline and second line, expect at least one of the readouts next year and a launch in 2027. So I think not only the multibillion-dollar peak sales potential is very important here. It's also the launch timing being near term as well as clear line of sight to a very appealing and highly compelling growth trajectory as we get in the back half of this decade. But perhaps, Tahi, now you want to sort of further characterize the target product profile?

Yes. Thank you, Anthony, and thank you for the question. What I would say is I start with this is peto has 2 breakthrough therapy designation, one as monotherapy in second line and one in combination with pembro in frontline. And what that usually means is -- what it actually means is that the FDA has come to the conclusion that this data set, if true in a Phase III is really transformational for that particular space. And so we underscored that conviction.

That's also what we have seen based on our diligence. The opportunity space that we go in, the patient right now is there is really no drug available in second line and not much transformation or innovation has happened in frontline beyond the integration of pembro into that space. And so I think that kind of gives you the idea of the potential, as Jan said, to really transform head and neck that peto has and that we are excited about to be part of.

Thanks, Tahi. I think Judah we'll leave it with that and then look forward to further discussions in the very near future. Let me hand the floor back to the operator.

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

Congrats on getting what we believe is a great asset. Do you think there's any need to develop a subcutaneous formulation to try to reduce those initial infusion reactions, particularly maybe if you move into the locally advanced setting? And I assume there you would look to kind of build on the KEYNOTE-689 data given what we've seen as good combinability with pembro generally.

Thanks for the questions, Matt. I'll hand over the formulation question to Judith. Judith, maybe you can give some color on that?

Yes. Thank you for the question. So at this point, the target product profile is based on the current formulation. So we are not -- it's very early to speculate on future potential subcutaneous.

Our next question comes from the line of Qize Ding from Redburn Atlantic.

Congrats on the proposed deal. I have one on my side. So given you have the 1042 ongoing for the head and neck cancer, so how does this proposed deal change your view and the future development for GEN1042 in head and neck cancer?

Thanks, Qize for the question. Judith, can you handle this one?

Yes. Thank you, Jan, and thank you for the question. So as we already communicated, we expect more mature data for 1042 by the end of the year. As we usually do, at that time, we will put that data in line of other data sets in our own pipeline and competitive landscape, and we will make the best decision for the compound and for Genmab and for patients. So for now, things as planned with readout for GEN1042 by the end of the year.

Thank Judith, very clear. Thanks Qize for the question.

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

This is [ Jana ] on for Yaron. Congrats on the deal. Obviously, as you say, it's pretty early to speculate on the CRC opportunity. But just because we're going to see data at Merus later this year, can you give us a sense of what you'd like to see to be convinced that you could get another kind of blockbuster potential in CRC as well as head and neck? And then secondly, do you see any issues potentially with RYBREVANT given that you receive royalties on that drug while it competes with peto?

Thanks, [ Jana, ] for the questions. I will hand them over to Tahi. Tahi, maybe you can give your thinking on CRC and RYBREVANT potentially interfering.

Yes. And I appreciate the question, and I have to bring it back to that we are somewhat limited at this point on what we can disclose and what we can discuss based on Merus not yet having shared any data in CRC. And so broadly speaking, I think we -- I went in the earlier question through why we believe it has really the potential to transform head and neck single-agent activity, great combinability, fantastic combination data in terms of ORR, PFS and OS. In colorectal, this is even more obvious because there's a pretty substantial data to support the idea that ORR does indeed translate into event-driven endpoints such as PFS and OS, maybe more so than in other disease areas.

And so I think what we would be looking for is particularly in the combination setting where actually also the larger patient population is in frontline and second line, an ORR that would really promise a transformational effect. But we will have this conversation when the data is in the public domain. As it relates to amivantamab or RYBREVANT, this is a Janssen drug that we are fortunate to receive royalties because it came out of the Genmab discovery engine. And that's basically all there is to say, not much to say. I don't know, Jan, if you want to add anything to that? No.

No. I think that's what we can say here. We will -- the strength of the data, [ Jana, ] speak for itself. Let's look forward to the data and then we will position peto further -- for further development in different settings if the data actually underlying there is potential there, and then we'll just go for hopefully differentiated data.

Our next question comes from the line of Rajan Sharma from Goldman Sachs.

Just wanted to understand the extent to which this is an acquisition of a platform rather than just a single asset in peto. Could you potentially just discuss Merus' bispecific technology platform and how that differs from Genmab's in-house capabilities and post closure of the deal, how would you think about sort of prioritization of assets as they come through both of the individual platforms?

Absolutely, Rajan. Thank you for the question. I will definitely let Tahi speak with you more about the details, but they have Merus has a completely different platform based on the Merus mouse than Genmab has. And they are very, very good in making excellent bispecifics like peto, but also trispecifics in different settings in a different way than Genmab now has in their suite of technologies. But I will pause here, Tahi, and let you give further color on the Merus platform and the complementarity to our suite of technologies at Genmab.

Yes. Thank you for the question. Thank you, Jan. It is exactly as Jan said. I mean, obviously, we know our colleagues at Merus very well. They are our friends and literally neighbors. And so we understand their point of view, their pipeline, their technologies. They are very complementary to what we are doing. So it essentially expands our toolbox, gives us another edge and angle and looking at certain scientific problems through a different lens of a more wider toolbox.

As it comes to prioritization, if and when this transaction were to close, we are one company, so then each asset gets looked at its own merits and there's no Merus or Genmab pipeline anymore. It's one pipeline. And I think that's all that is to say. But we are very excited to have a group of fantastic scientists also within the same ecosystem, culturally, very good fit to join the company.

Thanks, Tahi. I think probably nothing further to add, Rajan, but a good question for sure.

Our next question comes from the line of Sebastiaan Van der Schoot from Lanschot Kempen.

Congrats on this acquisition of this great asset. I was wondering whether you can expand on your understanding of the mode of action of petosemtamab that actually drives the therapy in head and neck. And then I'm just wondering whether you see opportunity to create other new bispecifics that can combine the LGR5 arm with potentially other cancer therapies.

Thank you, Sebastian, for the questions. I think Tahi already addressed it a bit, but I will ask Tahi to elaborate a bit further what the unique aspects are of peto, which is basically combining a very good EGFR binding arm with an LGR5 binding arm and the resulting mechanism of action for that molecule. We have a pretty good understanding of that at this moment. But Tahi, why don't you describe that and then see whether we can potentially use the LGR5 arm also in other combinations later on if we would close this transaction, hopefully at the beginning of next year at the latest. Tahi?

Yes. Thank you for the question again. And I would start with that first, of course, the mechanism of action is one thing and the other one is clinical data. The clinical data for peto is, as we said many times now, truly impressive, transformational, very well tolerated with a low discontinuation rate due to AEs, single-agent activity, combinability, high response rate in combination with pembro in the frontline setting.

So this is what we're seeing. If you -- to the degree I have to be [indiscernible] within the frame of what is in the public domain as it has been communicated by Merus itself, Merus itself has spoken to, that they are further diving into the mechanism of action and what really is the contribution of both of these arms.

It is without a doubt, a very good EGFR arm. And without a doubt, the mechanism leads to the internalization and degradation of EGFR, which is, to some degree, a differentiating aspect of this bispecific that then translates into the clinical profile as it's been seen, as it relates to future plans on other bispecific combination on the LGR5. I think this is too premature to discuss at this point.

There are no further questions at this time. So I'll hand the call back to Jan for closing remarks.

So thank you for calling in today to discuss this exciting step in Genmab's evolution. If you have any additional questions, please reach out to our Investor Relations team. We very much look forward to speaking with you again soon.

Thank you so much for joining. My pleasure to be hosting Anthony Pagano, CFO of Genmab. We have 40 minutes. I think, Anthony will make some introductory comments, and then we'll get into questions. Anthony, with pleasure, over to you.

Great. Thank you. Pleasure to be back at the conference today, Sachin. Pleasure to have a chance to catch up with you and all of the investors today.

As we sit here in September of 2025, and just reflecting on the progress in the first 8-plus months of the year, I think we've been off to a remarkable start. If we think about our -- 2 of our late-stage programs, EPKINLY and Rina-S, we're very excited about the emerging target product profiles that we see, the prospects moving forward, in particular, for each of these programs, we've seen some pretty meaningful and important and exciting data so far this year. With Rina-S, we saw some very strong, let's call it, proof-of-concept data, both in endometrial -- second-line endometrial cancer, as well as platinum-resistant ovarian cancer. And some more data sets, at least one more data set in endometrial here at ESMO moving forward.

I think what's emerging is a highly compelling product profile along multiple dimensions, whether it's activity across different expression levels, response rate, duration of response as well as the safety profile. I think moving forward with Rina-S, there's a lot to be excited about, particularly as we look forward to 2026, we see clear line of sight to the first registration -- potentially registrational data with the Phase II trial in platinum-resistant ovarian cancer. So a strong start to the year for Rina-S.

Likewise, for EPKINLY, both here, it's not only the development, but also the commercialization has gone rather well with the strong H1 performance, continuing to compete very effectively in the market. And excitingly, from a development perspective for EPKINLY, we saw the first positive Phase III of EPKINLY in combination. Here, it was in second-line follicular lymphoma, very exciting data that we saw with a hazard ratio of 0.21 or 79% risk reduction in terms of PFS. So what again appears to be emerging is a very strong product profile for EPKINLY. I look forward to sharing that data, hopefully, at ASH. We've submitted for presentation there.

And moving forward for EPKINLY, I think about further, let's call it, derisking or value creation could come next year when we expect the next Phase III in terms of the frontline DLBCL readout. So from a product perspective, very strong start our first 8 months of the year. On the financials, again, continue to execute here as well, very strong H1 results from a top line perspective as well as on the bottom line. That resulted in a guidance upgrade of about $100 million at the midpoint for our guidance. So very strong start to 2025, looking forward to some additional positive momentum at the balance of the year. And I think we're set up very well as we move forward into 2026 and beyond.

So maybe with that, we could just sort of see where we want to go, Sachin.

Yes. Perfect. I'm going to start really big picture for me. So we were just talking about it, but you've started this year in providing sort of a roadmap with peak sales for the various assets and sort of the indication breakdown. Perhaps you could just kick off with what you've said on Rina-S, what you said on EPKINLY, what you said on acasunlimab, and how that sort of bridges the world post DARZALEX?

Yes. So if you think about our business and our capital allocation framework, a key part of that in terms of priority #1 is investing back into our business. And we've been doing that not only in 2025, but over the last number of years. And what that's resulted in here is clear line of sight in our minds for very meaningful opportunities for EPKINLY, Rina-S and acasunlimab.

Now let's take it -- go one by one. For EPKINLY, we put out their peak year sales guidance of $3 billion. Now initially here so far in H1 to kind of say where we are today, we did around $211 million. So where is this going to come from in terms of getting to that $3 billion peak year sales target? It's going to come from the 5 ongoing Phase IIIs for EPKINLY with 3 of those expected to read out between now and the end of 2026. The first one just happened with follicular lymphoma. Again, we talked about the spectacular data there. The PDUFA date with the FDA is November 30. So that will be a nice big sort of step forward in terms of showing the utility of EPKINLY.

The next big one for EPKINLY would be the frontline DLBCL. This is EPKINLY in combination with R-CHOP. Rough order of magnitude in terms of the total addressable patient population, the frontline DLBCL represents around 70,000 patients, which is broadly speaking, around half of the total addressable market for EPKINLY. So a very important data set to come out sometime between now and the end of 2026.

And then beyond the second-line follicular lymphoma, frontline DLBCL, there's a number of trials that will read out in 2026 and beyond, that will further provide the evidence towards that $3 billion peak year sales guidance. So I think so far, if we kind of step back for EPKINLY, what we're seeing is very, very strong execution from a development perspective, we started several years behind the competition. We ultimately got from first patient, first dose of EPKINLY in July of 2018, to first approval in May of 2023. That's less than 5 years. It's rather fast. We're able through focused development together with our partner, AbbVie, really accelerate the second-line FL. And right now, we like the overall trajectory of the frontline DLBCL.

On the commercialization side, again, we think we're -- how we're competing today against the competition sets us up very well as these additional indications come online. So EPKINLY, $3 billion, very strong progress from a development and commercialization perspective.

Rina-S. There, we put out peak year sales guidance of $2 billion. Now let's compare and contrast to what we said at the time we announced the deal, we said $1 billion. So we've been able to upgrade that or double that since the time of the acquisition. And this is a function of 2 things. One, the emerging target product profile is highly, highly compelling. What we're seeing across efficacy, utility across expression levels, duration safety, that coupled with the speed and the breadth of the development program allowed us to take that peak year sales number from $1 billion to $2 billion.

Again, if you think about the speed of development, I think there's a reasonable chance going back to that 5-year number, first patient, first dose for EPKINLY, I think there's a reasonable chance, we'll be able to be in that kind of same range for Rina-S. And again, this doesn't happened by accident. This is really having a -- really compelling product profile but then focused execution. So speed is, I think, a key factor here.

In terms of that $2 billion peak year sales number, really, that is in the gynecological oncology space, particularly second-line PROC, second-line endometrial, second-line platinum-sensitive ovarian cancer, and frontline endometrial. We think there's a potential to do more in the gynecological oncology space. And again, for that, the first derisker from a pivotal trial readout perspective will come hopefully in 2026, where you're going to have the second-line PROC data.

Maybe briefly to profile Rina-S for you just a bit more. When we started the program, Sachin, we acquired it from ProfoundBio. At that time, we had roughly speaking, 40 patients worth of data. We're going to exit this year with 3 ongoing Phase IIIs, and 2 potentially registrational Phase IIs. And I think more to come in GynOnc in terms of additional Phase IIIs as we get into 2026 and beyond.

Last but not least, we have acasunlimab. There, we put up the $1 billion sales target. Here, we have the ongoing Phase III in the second-line plus non-small cell lung cancer. We'll have additional data in the back half of this year around that program. So I think we step back, we have 3 exciting programs really focused on executing there from a development and setting up the commercialization efforts as well.

Perfect. So I'll do them in order of peak sales size then. So EPKINLY, just again, right back to [indiscernible]. So you said half of the opportunity, $3 billion was for the frontline DLBCL. If you could just remind us what percentage is the existing launch indication to third-line FL and like how much second-line FL is adding? I'm trying to get a sense of -- perhaps you don't get enough focus on kidney because it's initially niche indications, but the big one is around the corner. So I'm trying to get a sense of...

Yes. I mean, back of the envelope rough math here in the major markets, U.S., major markets in Europe and Japan, the total addressable patient population is around 146,000, 150,000. Existing indications are around 18,000. Second-line FL, 9,000, so smaller. Frontline DLBCL represents around 70,000 patients. So this could be, if successful, a bit of a step change for the product. To kind of level set expectations, the second-line FL data that we've announced the top line results, I mean, highly, highly exciting and interesting, right? You don't often see a risk reduction of 79% in PFS. It's really unprecedented in this setting. We have to be mindful, though, that this is only 9,000 patients. So you should not be expecting a hockey stick as you get into 2026. Of course, it should be additive if it's approved. But hopefully, the big step change would come from frontline DLBCL.

And then on to frontline DLBCL, what have you said on timing of that Phase III?

So at the beginning of the year, we outlined this framework, we said we expected 3 Phase IIIs which frontline DLBCL is part of that to read out between now and the end of 2026. So if they want to get to a point where we can refine that guidance, we'll do so. But for now, we should take it between now and the end of 2026.

So I'm not asking you to do this in third quarter or full year, but roughly, when are you thinking about giving the market better visibility on the timing of that data set?

What I think -- maybe this is useful to kind of just sort of spend a second and talk about this in terms of providing information to the market, whether it be this or anything else, the way I really think about it, when we provide the information, can we fully stand behind it? And is it going to be useful to the market. So when we feel like we can do that for this particular data point, we'll do it. I'm not going to sort of provide guidance, I don't know when I'm going to provide guidance. But if we get to a point when we can fully stand behind it, we think it's useful, we're going to do it. And of course, we have every incentive in the world for -- to accelerate that, but we're at a phase in the trial where the recruitment is done. We're waiting for events. And we know how that event rates can go, that can kind of change over time. So when we're at a point together with our partner, AbbVie, to provide this color for the market, if and when we're there, we'll do it.

And then could you talk to the competitive landscape in frontline DLBCL at the time of launch?

So I think in the first order, what we've been able to do with EPKINLY, now as I mentioned, we started several years behind the competition, we were able to catch up in certain markets and certain indications, particularly in third-line DLBCL. We started several years behind, and we're able to come to market first there. We think right now, where we're seeing second-line FL, again, we were potentially, if approved, we could be first there. There could be certain indications where the competition could be ahead of us, but we think there's many indications, including third-line DLBCL, second-line FL, where we can be ahead.

I think it's too early to call frontline DLBCL. But from a market order of entry perspective, we think there's the potential where we could be at or ahead of the competition. So we think that's an important place to start. It kind of speaks to the leverage of the AbbVie machine, but also the overall Genmab team and capabilities has set us up well from a development perspective.

Look, from our perspective, we think that the R-CHOP combination is the standard of care. We're adding on EPKINLY to that. We think what's also really interesting is to look at the very strong Phase II data that we've presented EPKINLY in combination with R-CHOP. And this has been presented, I think, a couple of times at different medical conferences. That data is really pretty strong. And if that were to pull through into the Phase III, that would set us up pretty nicely in terms of the competitive profile.

I check -- my apologies, I would look to the competitive programs in detail, but the point on your combo with R-CHOP is that different for the other players out there?

Yes. So I think the other player is looking at combinations with POLIVY. Of course, we have our own Phase II trial with POLIVY, which could be sort of thought about moving forward in terms of guidelines and so forth. And there, our data also look very good. From our perspective, standard of care is R-CHOP, and we're adding on EPKINLY. The Phase II data we presented so far, super strong and look forward to seeing the Phase III results next year.

And if you could just talk to existing share dynamics, the pros and cons of your product versus the competitor and whether that translates beyond the data and the trial backbones into the other settings?

Yes. I mean I think overall, if we kind of zoom out, the CD3, CD20 bispecific class is a highly compelling class, providing a lot of benefit for patients, a needed benefit for patients. We know the kind of the advance of CAR-Ts and so forth. We think this class as a general starting point, provides a lot of value in absolute and relative terms. We think within that class, EPKINLY further distinguishes itself along multiple dimensions. We think the overall balance of safety and efficacy, we have that right balance. We have the absolute unquestionable high efficacy, not compromising anything there with a very nice safety profile.

Further, we do have the subcu delivery. And we know that some of the competition has multiple products to go after different segments of the population. We have a single product offering. So I think it's the totality of, let's call it, the efficacy and safety subcu and a single product option that is resonating today and should set us up well moving forward. Of course, look, ultimately, the Phase III trial results will be important and the overall, call it, the equation in terms of the competitive profile moving forward. But as a starting point, the fundamentals of the product are rather strong.

Can I go back to the backbone? So will you have data with POLIVY at the time of launch just to cover that segment of the market? What would you...

We've already presented some data. So that's already out in the public domain. I forget the exact end, but this was a meaningful end that was presented, and we think that's a good place to start. That's already out in the public domain. I think that's -- one thing that's often overlooked in the EPKINLY CDP is that we have a very significant Phase I, Phase II multi-combo trial. I mean it must be over 10 arms, must be each arm, roughly speaking, 40, 50 patients. And just looking at the quality of that data as it's been unveiled over the last couple of years, what you see is a very consistent pattern is EPKINLY is highly efficacious alone, but what you see is -- EPKINLY is highly combinable and highly additive to whatever it's added to. And particularly, what you see -- now looking at the second-line FL data, if you kind of go back and look at the Phase II data and the consistency from the Phase II into the actual Phase III data, highly consistent. So that gives us a lot of confidence moving forward in terms of that investment in the Phase II proof-of-concept work or that multi-combo work was investment well spent, but also gives us a lot of confidence into the Phase IIIs moving forward.

Very clear. Could you just talk to the AbbVie collaboration and where you are from an SG&A perspective ahead of frontline DLBCL?

If we think about EPKINLY and what it meant for the brand and what it meant for Genmab as we thought about launching the product in 2023, and the thinking of this and the investment for this didn't start in 2023. I mean this probably goes back. I don't have our P&L in front of us, but probably even in 2021. And as we sat down with, obviously, our internal team at Genmab as well as with AbbVie, we thought about this as being a super important launch. We thought about it along multiple dimensions. Now maybe starting at the overall Genmab level, of course, we had already kind of started to commercialize Tivdak. But as we thought about the EPKINLY launch, this was really in the United States and Japan, the opportunity to launch Genmab more broadly into the commercial marketplace. So we took that into consideration.

Secondly, when we were thinking about launching EPKINLY, there was 2 things in my mind. One, and it goes to what you said, this was not going to be a third-line plus product forever. And ultimately, this did have multibillion-dollar peak year sales potential, ultimately, which we're calling $3 billion. So we resourced it accordingly for that. We also resourced it according to -- there's an incumbent and it was going to be competitive. So we did resource it together with AbbVie with these sort of different things in mind from day 1. And we've seen the pull-through there in terms of how we're competing in the marketplace today.

Now getting to your question, we think this does set us up well nicely moving forward. We're going to look for any and all opportunities to leverage the historical investment. At the same time, we're going to be very thoughtful in terms of brand planning, field forcing, field-facing resource numbers with our partner. And if it makes sense to add field force, we're going to do that, whether it be in the U.S. or Japan. But I would say, overall, there is a nice foundation of investment and resources that we can leverage based upon the initial approvals we can leverage moving forward. But to be clear, there's going to have to be additional investment in the brand.

Okay. Any more on EPKINLY before we move on?

And Rina-S, we're going to start. So perhaps we do the $2 billion, how do you think about the split ovarian versus endometrial?