Transcript fra Genmab Investor Call Q3: ‘We will deliver significant profitability in 2026’

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.