Genmab A/S (GMAB) Q2 2026 Earnings Report, Transcript and Summary

Hello, and welcome to the Genmab First Half 26 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans or expects. Actual results may differ materially for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements in the future nor to confirm such statements in relation to actual results. Unless this is required by law. Today's presentation will also include comments on certain non-IFRS financial measures, which management uses to describe the company's baseline performance and which supplement but do not substitute for the comparable IFRS measures. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure. Please also note that our 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, everyone, and welcome to our financial results call for the first half of 26. With me today is our Chief Financial Officer, Anthony Pagano our Chief Commercial Officer, Brad Bailey our Chief Medical Officer, Tahamtan Ahmadi. For the Q and A, we will be joined by our Chief Development Officer, Judith V. Klimovsky. As the operator said, we will be making forward-looking statements, so please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do. Accelerate our late stage pipeline, maximize our commercialized medicines, and stay disciplined with our capital. And that is exactly what we have been doing. We grew total revenue by 25% driven by continued momentum across our portfolio. Even as we have made focused and strategic investments in our late stage programs, in launch readiness, and in the integration of Merus. And we did all this while growing operating profits. To me, that says a lot about the quality of our business. And beyond financial performance, I am enthusiastic about our recent pipeline progress, so let me walk you through the highlights. In June, we announced positive top line results from the Phase III EPCORE DLBCL-4 trial. Which shows statistically significant, clinically meaningful improvement in progression free survival. What is important about these results is what they demonstrate about the aperitamab more broadly. It is growing evidence of the versatility of epcoritamab based combinations across multiple lines of therapy. This data was followed by the European approval of TEPKINLY plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second line setting. This makes TEPKINLY the first and only bispecific based therapy approved in Europe for this indication. All presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. And we are looking forward to sharing with you petosemtamab data with updated results in colorectal cancer presented at ESMO in October. Based on this promising data, we are continuing to build momentum for petosemtamab. We are initiating 2 new Phase III studies in colorectal cancer. And Tahi will share more detail on them in just a moment. Now let's turn to the catalysts we continue to look forward to this year on the next slides. As we move into the second half of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts. For Rina-S, we anticipate both Phase II and Phase 3 platinum resistant ovarian cancer datasets will be available in the fourth quarter. For petosemtamab, we are eagerly awaiting the readouts for both studies. And with better visibility, we can now say that the frontline study is expected to read out in the fourth quarter while the second and third line study is anticipated to read out in the first quarter of 27. Finally, for EPKINLY, we anticipate that top line data from the front EPCORE DLBCL-2 study, which will be based on an interim analysis, will also be available in the fourth quarter. What this means is that for each of our late stage programs, we remain on track for Phase III readouts in the second half and then to potential approvals and launches in 2027. This is what we have been building towards and it reflects our focused execution. So exciting times ahead. Now I would like to hand you over to Tahi to walk you through the details of the Phase III colorectal studies. Tahi, the floor is yours.

Thank you, Jan. We are pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing Phase III trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. And as you know, Peto is an EGFR LGR 5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. And LGR 5 is a marker of cancer stem cells. In this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RASRAF wild type colorectal cancer. And the early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October. Based on this promising data, we are initiating 2 Phase III studies. 1 in front line and 1 in the second line colorectal cancer. For frontline, we have already initiated a phase 3 randomized trial open label, a global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator choice chemotherapy of either mFOLFIRINOX 6 or FOLFIRI. as a first-line therapy in patients with unresectable or metastatic left sided colorectal cancer, that is RAS, RAF, wild type. I will thus be with the standard of care named cetuximab plus chemotherapy. For the second line colorectal cancer patients, the Phase III trial will be similarly a randomized open label and global trial. This trial is designed to assess the efficacy and safety of petosemtamab plus investigator choice therapy of either modified FOLFIRI 6 or 3. as a second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS wild type And here, the trial will be versus the standard of care, which is cetuximab or tafasitamab plus chemotherapy. So taken together with our 2 ongoing phase 3 trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer and the encouraging data we continue to generate petosemtamab is a rapidly emerging as a generally multi indication asset with the potential to reach a significant number of patients. And with that, I am pleased to hand over to Brad for a review of the recent commercial performance for a EPKINLY and TIVDAK.

Thanks, Tahi. Our proprietary portfolio performed incredibly well in the first half of the year. James totaled $396 million representing 37% growth compared to the same time last year. These results demonstrate the strength of our antibody sciences as well as the strong execution by our teams to bring our medicines to patients. around the world. The performance we delivered in the first half of 26 reflects growth for both Epkenly and TIVDAC globally. We are very pleased with how Epkenly is performing. In fact, EPKINLY grew to $312 million in sales for the first half of the year representing a 48% increase year-over-year and a 28% increase in the quarter. In The US, we delivered accelerated growth with increases in both new patient starts and new site activations. The launch of chemo-free, fixed-duration EPKINLY plus R-squared and second line FL has been going extremely well. With rapid uptake across sites. This contributed positively to our growth in the first half of the year and suggests EPKINLY is becoming a preferred regimen in this setting. We have also seen increasing growth in the community this year. With the majority of new sites activated coming from community practices and now over 90% of our key customers are ordering for 2 or more sites. This is driven by EPKINLY's differentiated dual indication label without a recommendation for 24 hour hospitalization and broad adoption of EPKINLY plus R-squared in second line FL. Which is leading more sites to utilize EPKINLY across its approved indications. This performance reflects strong execution by our field teams, physician confidence in EPKINLY's differentiated clinical profile, and the value of using a single bispecific option across DLBCL and FL. The uptake we are seeing in the community with more physicians gaining experience using EPKINLY and sites of care closer to where patients live, is a positive indicator as we look ahead to potential launches in early lines of DLBCL. Outside the U.S., performance remains strong. In Japan, Epkenly continues to build on its compelling position in the market with approvals in both DLBCL and FL. We expect the second line FL launch anticipated later this year will serve as another growth driver for the brand. Through our partner AbbVie, EPKINLY's global footprint continues to expand including recent approvals for EPKINLY plus R-squared in second line FL, in Europe and China. Overall, we are really pleased with EPKINLY's growth globally and particularly in the U.S. and Japan, we book sales. The momentum we are seeing today reinforces our confidence in EPKINLY's long-term growth opportunities. Especially its potential in early lines of therapy. As we look towards the back half of 26, we are focused on continuing to grow EPKINLY, and strengthening our leadership in the market by maximizing our first mover advantage in second line of health and preparing for anticipated launches in early lines of DLBCL in the future. Turning briefly to TIVDAC. TIVDAK totaled $84 million in sales during the first half of the year, driven by continued performance in The US, as well as in our launch markets in Japan and Europe. In markets where TIVDAC is available, we saw expanding site activations underscoring the continued need for treatments that can improve survival for women with advanced cervical cancer. As part of our work to bring TIVDAK to more patients, we secured reimbursement for TIVDAK in the U.K. and the conversations continue to progress in additional markets. Looking ahead, we remain focused on continuing to scale our commercialization capabilities to support TIVDAK launches in new markets while building on that foundation to prepare for the anticipated launches of Rina-S and petosemtamab in the future. Heading into the second half of 26, we are extremely pleased with the performance across our portfolio. Our performance to date combined with meaningful momentum underway across the business to advance our pipeline and expand our commercialization footprint positions us well to grow adoption of our approved medicines to benefit more patients and successfully launch additional indications and new medicines as we look towards the end of 26 and into 2027, and beyond. With that, I will turn it over to Anthony to walk us through the financials.

Thanks, Brad. The first half of 26 demonstrated the continued strength of our business. With revenue growing 25% year-over-year. Beyond the headline 25% revenue growth, I would highlight 2 characteristics of our performance. First, high growth. And second, broad-based growth. Now, starting with the high growth. DARZALEX increased 21% year over year. While worldwide EPKINLY, net product sales increased 48%. Reflecting continued commercial momentum and strong execution. Beyond these 2 brands, the remainder of our portfolio increased 35% year over year. Now turning to broad-based growth. Approximately half of our year over year revenue growth came from DARZALEX. Impressively, the other half generated by Epkinley and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base. The strength of our business also provides the financial flexibility to continue investing behind our highest value growth opportunities. Including at EPKINLY, Rina-S, and petosemtamab. At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that Genmab can increase investment to expand profitability. Now before moving to our updated 2026 guidance, let me briefly comment on tax. Our effective tax rate for the first half was 3.6%. Primarily reflecting the ongoing integration of Merus and related recognition and utilization of deferred tax assets. As shown in the appendix to the presentation, this equates to tax expense of $13 million. Now, as we discussed previously, we continue to evaluate the integration of Merus from a tax perspective. As a result, our effective tax rate may continue to fluctuate as those integration activities progress. We expect our effective tax rate will normalize over the next 12 to 18 months. Now with that, let me turn to our updated 2026 financial guidance. The strength of our business and the financial flexibility it continues to create are reflected in our updated 2026 financial guidance. Compared with our previous guidance, we now expect to deliver 5% higher revenue and 7% higher operating profit. While increasing investment but only 2%. This demonstrates the operating leverage inherent in our business. Starting with revenue, we now expect full year revenue to be in the range of 4.3 to 4.5 billion. Representing 19% year over year growth at the midpoint. And this compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both DARZALEX and EPKINLY. With the $195 million increase at the midpoint, being approximately equally split between DARZALEX and EPKINLY. Now turning to operating expenses. We are continuing to invest behind our highest value growth opportunities. Our updated operating expense guidance includes additional investment to maximize the long term value of our portfolio. Including the 2 new Phase 3 petosemtamab studies we announced today. Even with these incremental investments, we are only increasing our OpEx guidance by 2%. Resulting in a new midpoint of $2.88 billion Finally, operating profit is now expected to be in the range of $1.1 to 1.4 billion Importantly, the majority of our revenue outperformance continues to translate into higher operating profit while preserving our ability to invest behind our highest value growth opportunities. In summary, our first half performance provides further evidence of the strength of our business. are delivering high growth, broadening our revenue base, investing behind our highest value opportunities and continuing to expand profitability. Together, this positions us well to deliver sustained growth and long term value creation. Now, on that note, I am going hand it back over to Jan.

Thank you, Anthony. Let's now move to our final slides. Looking at the first half overall, we have had a strong 6 months, both scientifically and financially. And our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long term value. When I look at where we are, the revenue base we have built, our versatile and promising product pipeline, but it is still to come in the coming months. I am super excited That now ends our formal presentation, and thank you for listening. And operator, please open the call for questions.

Thank you so much, dear participants. Question, please press 1 on your telephone keypad, and wait for your name to be announced. Please standby while we compile your Q&A. This will take a few moments. And now we are going to take our first question. And it comes from the line of Zain Ebrahim. Hello. Your line is open. Please ask your question.

Everyone. Thanks for taking the questions. Zain Ebrahim, JPMorgan. First question is on the petosemtamab second line trial. Which way you are now guiding for the readout in Q1 2027. Just wanted to understand what is driving the slight delay to the readout in Q1. Is it the change in the primary endpoint survival or is it the upsizing of the trial? And how is recruitment progressing for the second line trial? Relative to your expectations? I think the slide suggested it is still recruiting. So just any updates there would be helpful. And then my second question is on DLBCL 4. it is quite a strong PFS outcome. But just any sense of what you have seen so far in overall survival, or was it just too immature to see a trend at this point And what is the latest feedback you have had from the FDA on whether the second line trial or the first line trial could be used as a confirmatory trial?

Thank you, Zain, for the questions, and I think I will hand them both over to Tahi. Can you start, Thay, with the second line trial Peto in head and neck cancer and then move on to DLBCL for to address some of the points raised here.

Yeah. Thank you for the question. So, let's take the Peto first. As you correctly noted, the endpoint is over survival, so this is an event driven, projection. For when we have the data and the trials fully enrolled. So that was to that question. And so we are just updating based on what we see when we expect to have the top line results which is now in the first quarter of next year. As it relates to the second-line/third-line DLBCL-4, the EPCORE combination, You know that correctly that this is a very exciting PFS benefit for patients. For what is a chemo free regimen of a pill with a subcutaneous injection with a really impressive CR rate for patients that is the most meaningful kind of data point, and we are really excited about the data. The OS, of course, at that point, is totally immature, which is why it is not yet been reported, and the data will be presented in upcoming, conference. So we will have a chance to look at it a little bit more. Granular detail. I said, well, it is the part of your question, for the confirmation of the indication that is already approved, We are, of course, in the active engagement with the agency on all kinds of fronts. And so whether the frontline or the second trial is going to be the confirmatory trial. I think that is an ongoing discussion right now. To a degree also depends on how are the results of the frontline trial are gonna be. And so this is all there is to say at this point. We have an active process, active engagement, and it will be 1 of the 2. Thanks, Thay.

Let's hand the question back to the operator, and then see whether there is another 1.

Yes of course. And now we are going to take our next question. Just give us a moment. And the question comes from the line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

I had 1 on EPCORE DLBCL-2, and just trying to wrap my head around the timing of the interim analysis in the fourth quarter this year. Based on our work, we think this should have already occurred at some point last year. How do you explain this 1-year delay essentially of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe.

Thanks, Michael, for the question. Tahi, can you address this 1?

Well, let's start first. We are very excited what the results of this trial as they are going to read out next quarter. This is, the most important study. I think it is fair to say within the eprolizumab franchise. there is exciting phase 2 data that is in the public domain. Last year and the year before presented at ASH, on the combination of Epco with R CHOP that showed really unprecedented CR rates. Which is driving the excitement for the results of this trial. And so the only other thing to say is that, we have been now confirming that this is based on the interim and that it will be top-line quarter. And I think we should probably leave it at this at this point. Once we have the data in our hands, we can have a good conversation about all of these things. other questions that may arise. But for now, next quarter, looking forward to it. Thanks, Tahi.

Thanks, Michael, for the question.

Thank you. Now we are going to take our next question. And the question comes from line of James Gordon from Barclays. Your line is open. Please ask your question.

Hello. James Gordon from Barclays. A question, a couple of clarifications, please. 1 question was on. So the first line trial is now going to report before the refractory trial. presumably because the first line has an OR primary with interim OS, whereas the refractory trial is more mature OS. So for the first line trial that I think we are going to get in Q4, how mature will the interim OS be when you report it that you plan to file? And do you think the first line or refractory is a higher bar in terms of being successful? And then there was just 2 clarifications. 1 was for Epkinley and where we are going to get the interim in the first line trial in Q4. If it does not work in interim, will you tell us that and say that the trial is gonna continue onto the final data, or it is just we will not hear anything and do not hear anything by the end of the year, we will have to assume that it did not work at interim. How that works, please? And the other clarification was just For PROC, so the o 1 and o 2 trials, they are both in Q4. So a Phase II and a Phase III. Are we going to get 2 different readouts, or will you just it is the phase 3 that is material because that is what you are filing. We will just get all the data together.

Thanks, James, for the questions and the clarification requests. So the first 2, I am going to hand over again to Tahi, and then Judith can deal with the Phase II and Phase III data for PROC for Rina-S. But Tahi, why do not you start?

With P2? And the frontline trial? So it was actually I think, like, I do not know. I stopped counting at 3, but okay. I will try to address all of the points that were made, and asked. So the first thing is, on the PETRO trial, right, we have in the beginning, stuck to the guidance that had come from at least 1 or both going to read out this year. Now we are being more precise that we actually will have the top line results. On the frontline indication, which is very exciting because this is, the 1 indication that has significantly larger impact on patients, larger population, and we believe this is going to be very exciting data, when we have it, to present and discuss. As it relates to what will be meeting statistical significance, have any visibility to this, so this would be all speculation. So I do not think this makes any sense. But so we will have that discussion when we have the interim results in our hands. But what we are saying is we will have an interim data that we expect to be the basis for filing. In the next quarter on this frontline PETO trial. Then I think you asked about what whether we believe that OS in 1 indication or the other is, like, a higher bar. I really do not know how to answer this, to be honest. I think having a OS benefit is always a high bar, and then we have a very high confidence in Peto being able to provide an overall survival benefit for patients in frontline and in second line. This is underwritten to a degree by these 2 BTD indication datasets in a public domain, and then it is, of course, also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients in head and neck. And these 2 studies that are already operationalized, in colorectal. Where we are today announcing that we are going to start 2 phase threes and then on the future trials. it is a very exciting drug. We are really looking forward to the data in frontline, and then we can have a more detailed discussion on what actually the data will be.

And then there was a question, Ty, on EPKINLY in the frontline study, if we would not hit the interim, what would happen then? Would we say it is a trial-- I think we should stick with what we just said, what we expect to present the interim data. Next quarter. Alright. Very good. Let's let's stay with that. And then, Judith, maybe the Phase II and Phase III datasets for Rina-S in PROC, a bit more color there.

Judith, are you there? She's unmuted, I can take that too. Okay. Why do not you take it, Tahi? So we there will be indeed, as you said, there is a Phase II in PROC. And then we already talked about that there is also a phase 3. Both of these datasets, of course, will be made available at the time that we get them and then have the top line results. I think that should do it for now, Ty.

Thanks. Thank you. Thanks, James.

Thank you. Now we are going to take our next question. And the question comes from the line of Gregory Renza from Truist. Your line is open, please.

Hi, thanks so much for taking our question. This is Asthika on for Gregory. Have 1 for Peto in head and neck. With competitors advancing quickly in the second line, third line, setting ahead of your expected readout in the first quarter of next year. What efficacy and durability profile would Peto need to show to remain competitive? Thanks so much.

Thanks, Gregory, for the question. Tahi, can you take this 1?

Sure. I think you are alluding to the J&J filing I think, like, you know, 1 thing to say is that we just had a conversation about this, and that the second line dataset will be a phase 3 with an overall survival benefit, and let us say, of course, completely significantly different dataset as a or duration of response dataset that may form the basis of accelerated approval. As it is for amivantamab. So we remain very steadfast in our statement that we believe Peto is the best in class second generation EGFR bispecific based on all the data that we have seen in head and neck but also outside of head and neck. And, the totality of our data, The fact that we will have a frontline indication with Pembroke that we are seeking with the phase 3 readout, next quarter and then a over survival phase 3 readout, in the first quarter of next year. I think this is a very compelling and comprehensive dataset across these 2 studies, monotherapy, second line, third line, combination with pembro frontline. That is going to really underwrite our ambition in head and neck. And so we are very comfortable with our position where we are. And the expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck. Thank you, Tahi.

Thanks, Asthika. Let's move on to the next 1.

Thank you. And the next question comes from the line of Xian Deng from UBS. Your line is open. Please ask your question.

Hi. Thank you for taking my question. So I guess I will just try my luck a little bit on the EPKINLY frontline trial. So given the interim still has not passed, this really suggests the events are happening really, really a lot slower than expected. So just wondering is there any reason that you could think of that, you can suspect that the R12 arm would perform-- your R-CHOP arm would perform differently from, the 1 from Mount Jubilee history trial or the POLARIX Phase III trial, at least in the IPI 3-5 group. that is the first question. And the second 1, just wondering for Peto in frontline. So your trial design is, you know, chemo-free, so it is with pembro combo only, whereas Relevan is plus. Pembro plus chemo. So just wondering, you know, if you could elaborate a bit of rationale in that trial design to go without chemo, please. Thank you.

Thanks, Xian. I think I am going to pass them over again to you, Tahi. Thank you.

So on the frontline, this is DLBCL. I think first things first, I think it is best if you just stick to a few things first. We are very excited and really much looking forward to this trial based on everything we know. About how EPKINLY has behaved in the past and how predictive these phase 2 datasets have been, not only in the line follicular lymphoma trial, but also now in the second, third line diffuse large B-cell trial in the combination with lenalidomide. The phase 3 trial is almost point to point replicated what had been described in the phase II data set. And so there is a lot of anticipation that we have, and I will show you too, for that trial, and there is a lot of excitement about the results that are going to be then reported next quarter. As it relates to the performance of R-CHOP, I mean, we have no visibility to how R-CHOP has behaved on that trial. We will find out when we get the data I think it is probably fair to say that, R-CHOP in the past, as you pointed out yourself, has had a very robust performance kind of behaves the way R-CHOP behaves in across multiple trials. But generally speaking, cross trial comparisons on the control arm are always a little bit flat because they are informed by regions and patients and all of these things. So we do not have really any visibility, but it is probably not unreasonable. To assume that R-CHOP behaves like R-CHOP. On Peto frontline, the question was what the reason was for the combination with pembro. Like, a lot of these discussions happened a long time ago when this was still in the hands of Merus. But I think, generally speaking, head and neck patients are known to be a fragile population, location of the disease, status of the patient play, a significant role in the tolerability of the treatment. And even today, if you look at the paradigm, there are patients who get treated with Pembroke chemo, and there are patients who get treated only with chemo with pembro. That is not only a decision made by the CPS score, but it is probably even larger informed by the patient that sits in front of the physician and their status. So the data that is out there in the phase 2 for the combination of Peto-pembro is dramatically different. it is like twice as high a response rate and durability than has been described even for chemotherapy pembro. So in that regard, our anticipation is that Peto-pembro is going to provide a truly very significant and important dataset for patients with head and neck because it will have hopefully, if it replicates the data on phase 2, a very significant ORR and, duration of response improvement. Even over chemotherapy combinations, we roughly range in the 30 percent range of response. And then, you know, we will have a conversation about the comparison to what the J&J strategy may or may not be. When we have the data in our hands. Thanks, Tahi.

I think very clear. Thank you. Thanks, Xian, for the questions. Let's move on to the next 1.

Yes of course. And now we are going to take our next question. And it comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Firstly, just on EPKINLY and just on that first line trial again. So maybe could you just help us understand, was the data that you saw in the second line trial better than you were actually expecting internally. And I am just wondering if maybe I am stretching here, but is that giving you increased confidence that the frontline trial could read out at the interim? And then could you maybe just discuss your latest thoughts on the endometrial cancer treatment landscape? Merck have said that they have hit PFS and OS from the interim of the Trop 2 ADC trial. Does that in your mind, when the data come, will that set a bar for Rina-S? And could you maybe just talk about areas of differentiation there and potential relative expression of Trop 2 and photoreceptor alpha in endometrial. Thank you.

Thanks, Rajan, for the questions. So before Tahi starts, think for the frontline study, I could tell you we are super excited based on the phase 2 studies, the data released last year at ASH, the year before at ASH, Rajan, So we believe that this data will be very, very good at the frontline setting. And of course, the second line data was also fantastic data, but it is unrelated. I feel, to the frontline data because it is in a different setting with different patients with different levels of illness. But I think we are excited about both settings. But the full line setting, I think the enthusiasm comes from rapid recruitment, and also running at it again the gold standard. I mean, R-CHOP has been for over 20 years the gold standard in diffuse large B cell lymphoma. The Phase II data actually show that if that would translate to Phase III this will be sensational data. And let's hope for good data in the in the fourth quarter.

Tahi, do you want to add anything to that? And then maybe you can go into the landscape for endometrial cancer. Yeah. Sure. The only thing I would add is, like, you know, I tried to make that point earlier. I think Jan touched on that. The len-EPKINLY Phase III actually reported out the way we were. Anticipating and hoping, and this is kind of like a pattern that we have seen. The efficacy and safety of EPKINLY is very predictable. And so we have seen now multiple times that phase 2 combination data approximates very closely to what then the phase 3 describes in the larger dataset, and this is also just to underscore the point that Jan was making. Of the reasons why we are continuously excited, looking forward to that data next quarter in the frontline, and then Judith can talk about the emerging ever-changing, never-stopping landscape in endometrial and anywhere else. Thanks, Tahi.

Judith, are you back online? Apparently, not. So maybe Tahi, you can dive a bit into the endometrial cancer, and that is okay.

Then I will do this very shortly. Look. Yes. Merck has announced that they have hit the PFS on a TOPO I ADC with a Trop-2 target. And that has really very little bearing on our strategy because I think from the very beginning, we were aware that was gonna read out before the datasets for Rina are going to be available. We continue to be very excited about Rina not only in PROC, where we already got it. We are going to have some data this year. But, also, in endometrial, for the receptor alpha is expressed maybe on a lower level than on ovarian cancer. It is expressed in 1 of the things that we have routinely and repeatedly described with Rina is this phenomenon of efficacy across a spectrum of alpha expression. So endometrial is an exciting second indication We initiated, 2 phase threes in that indication, and so we will look very much forward to have that discussion when we have the data, and I think there is not much more to say about this. We are executing our strategy. And sticking to our plans. Absolutely. And we have a breakthrough therapy designation, of course, in 1 of the settings in endometrial cancer, it is super important.

Let's move on to the next question.

Yes. Of course. And now we are going to take our next question. And the question comes from the line of Eva Fortea-Verdejo. Your line is open. Please ask the question.

Hi, team. Thanks for taking our questions. On CRC, as landscape becomes increasingly crowded with EGFR bispecifics, how's your newly disclosed strategy differentiated? From the competing assets in the space, particularly compared to amivantamab And if I might just sneak in a given the growing focus on RAS directed therapies in CRC, would a combination strategy with petosemtamab be a viable approach and what is your current thinking on a potential development path for such a combination? Thanks so much.

Thanks, Efra, for the questions. We like those questions Those questions because we are super excited about the potential differentiation of petosemtamab. And I will ask Tahi to give you a bit more color why we are so excited. We will present more data from the Phase II setting in colorectal cancer. At the ESMO conference? And then also the combinations is also an area we are pursuing. Tahi, why do not you give a bit more color to Eva?

Yes, please. Thank you. So first things first, I think colorectal as this new indication that we are embarking on with Peto, if you recall, even when we start to talk about publicly the intended acquisition of Merus, there was already a lot of questions about colorectal, there was a relatively small dataset that had been shared, but that numerically showed very impressive, ORR data. And, of course, this dataset has grown with numbers. Of patients and durability, and Jan already pointed out that we will share that. And so our enthusiasm has continuously remained very high for what we see in this dataset and, underscores our conviction that Pito is not only the really in every dataset, colorectal, head and neck monotherapy, combination, continuously shows that on point estimates and cross study comparisons are difficult, it appears to have higher response rate and a better safety profile than, for example, amivantamab. And so this is what underscores the conviction that we really appear to have the best in class second generation EGFR bispecific, and that will also translate into meaningful datasets in the phase 3 settings for both frontline and second line colorectal. Which is why we started these 2 trials now even though, as you kind of, like, alluded to, and J&J already has started these trials. So that is the colorectal part. And the RAS field, of course, is, like, super exciting. I worked on RAS inhibitor years ago when it did not work. And so it is a super fascinating field to watch and so we are obviously very aware of the importance of that biology and the novel drugs that are out there, in colorectal, and we are actively engaging in discussions. Combinations there will be more to come in the near future. Thanks, Tahi.

So thank you, Eva, again for pointing out this super exciting area. and more to come this year, in the coming months. Let's move to the next question.

Yes, of course. Now we are going to take our next question. And the question comes from the line of Suzanne van Voorthuizen from Kempen & Co. Your line is open. Please ask your question. Hi, this is Suzanne.

Thanks for taking my questions. Also on Peto, which are competitor or partner, J&J going for accelerated approval at Head and Neck? Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with Peto at this point in time. Could you comment on that? And secondly, you mentioned a couple of times the high confidence in the best in class profile for Peto compared to amivantamab. Could you elaborate on what is underpinning that confidence, the high response better safety in the data sets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action? Thank you.

Susan, thank you very much for these questions. I am going to hand them over in a sec to Tahi, but I can tell you that you will definitely have to wait for the ESMO data set for the phase 2 data. Which will give you a bit of further color why we are so enthusiastic. And as it relates to the strategy, we think that we will have a differentiated drug, actually, based on everything we know But I will pause here and let Tahi give you a bit more color, Susan, on the head and neck setting and front line, second line accelerated approval versus potentially approval based on Phase III.

Yeah. Thank you. And I am going to reiterate what I, I tried to point out earlier. I think, like, if we step back on head and neck, where we are, is, we are going to have a top line results in frontline in next quarter this year. And then OS readout for the monotherapy in the first quarter of next year. I think this is a completely different in terms of comprehensiveness, but also by capturing patient population. Profile than, the accelerated approval for now. that J&J is pursuing with amivantamab for head and neck. So we feel very comfortable, particularly because the larger population is in frontline about our position where we are, and we, of course, doing everything to accelerate. These findings and these launches to the degree that they are that it is possible. So nothing changed on our end. We always knew. We have obviously-- there is some partnership on amivantamab, we have some visibility to their plans And so this is exciting for patients, more opportunities. We are very confident in our head and neck strategy, and there will also be additional studies. That we already announced that are going to be initiated in the very near future. And may just not be public to discuss because I think we changed a little bit our strategy some time ago, similar to the colorectal trials to publicly announce these trials more closer to when the first patient is dosed. And then your second question was around what again? Sorry. Best in class criteria. Why do we say that this Why do we say this? So, yeah, why do we say this? So and the cross-study comparisons are difficult. But if you just cost compare the monotherapy in second-line head and neck, The small dataset that were presented in combination with pembro in frontline. For both trials for both drugs. The colorectal combination with chemotherapy, datasets that exist for both drugs. In all 4 of these datasets, actually. Peto outperforms amivantamab. On the efficacy. And then in totality, it does have a differentiated safety profile. It does not have the same challenges to the degree, at least, with skin toxicities. And I think it is a little bit speculative to figure out why that is, but they are clearly different antibodies with different secondary arms. And it is not unreasonable to speculate that the difference in the second arm may have a biological or mechanistic role that differentiates both on efficacy and safety. But as is, and I think there is now a larger dataset, I think, yeah, all indicators are that it is slightly differentiated on efficacy, reasonably differentiated on safety. This is where we come with this conviction that we have a best in class asset in our hand.

Thank you, Tahi. Thanks, Suzanne, for the questions. Let's move on.

Thank you. Now we are going to take our next question. And now we are the question comes from the line of Charlie Haywood from Bank of America. Your line is open. Please ask your question.

Hi, Charlie Haywood, Bank of America. Thanks for taking the questions. I have 2, please. So the 1 is just, or both actually on Readiness. The first is on the second-line PROC data you have got coming in fourth quarter. So both Phase II and Phase III in fourth quarter. Can you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts? Anything together as we sort of read across between the 2. And secondly, we have just we have seen limited phase 2 PFS data for the folate receptor class in general. So could you frame any target PFS profile or PFS delta versus PLD you would expect to see to be clinically meaningful for that Phase III readout?

Thanks, Charlie, for the questions. Tahi, can you address both of them.

Differences between the Phase II and Phase III. And then the profile relates to folate receptor expression levels. Yeah. So by inclusion exclusion criteria, they are very much more or less the same patient population. So there is a readout for sure based on the Phase II data to the phase 3 data, and then the only difference is, of course, a phase 2 dataset has always its own dynamics vis-à-vis a phase 3 trial. And then there is obviously, like, a larger footprint for a phase 3 trial as it relates to phase trials. So these are kind of, like, the where the patients come on and the difference between having a choice or being forced to have a choice. Versus, not having a choice. And so, that is kind of the difference between these 2 datasets. Probably all to say to that. As it relates to speculating on the data, I do not think I want to do that. All I can say is that we are super excited about this data that if you look at what is already in the public domain for Rina-S, it shows a very high response rate of 50%, plus 50, which is probably more important a very long durability of response. And the duration of response is driven by a safety profile with a very low single digit discontinuation rate due to AEs, which then allows a long continuation of treatment, which drives duration of response. And if you put these things together, you can already get a sense of, like, the direction of the PFS which I think will be, without a doubt, not only significant, but also meaningful for patients. I think that is where we should leave it. Let me-- we can have this conversation when the data is in the public domain.

Thanks, Tahi. And on top of that, Charlie, you will get that will be like a year, 1.5 years ahead of some of the potential competitors. So I think we are in good shape here. Thank you. Thanks, Charlie. Let's move on to the next question, operator.

Yes, of course. Now we are going to take our next question. And this question comes from the line of Yaron Werber from TD Cowen. Your line is open. Please ask your question.

Great. Thank you so much. Quick question, on Peto. For the first line study, can you just give us a sense when you upsize the study? Can you confirm that you did not change the powering assumption? And that you are enrolling the random distribution of HPV negative and positives that are in the market, you are not enriching specifically for only 1 subtype. Then secondly, you are going to show us the second line recurrent head and neck data at ESMO. With or without pembro. Is there a chance that you might wanna move to phase 3 in that study with pembro to complement your monotherapy second line data, which is coming Q1 next year. Thank you.

Thanks, Yaron. Tahi, can you address both of the questions?

So let's take the first 1 first. This is I think we said, multiple times we changed this trial to in increase the probability of success. And this was not any particular shape or form, driven by anything that emerged after the acquisition. This was actually a decision that we at Genmab had made during the diligence process. And that got executed immediately. It was 1 of the first things that we actually executed. This was purely driven to ensure that we have the proper power for all kinds of subgroup analyses. That are going to be important for global filings. So I think that is all there is to say about this, the rest is not necessarily part of our thought process or anything that we have spoken about. And then the second question that you had was, around other strategies, for Peto, and I would say this. We feel very clear. there is gonna be more to come on Peto and head and neck. And we will we will present these trials in the grand granularity and at a time similar to what we suggested with colorectal. When they are literally dosing patients. And that is so some near future, we will have more conversation with more activities. So with what trials and head and neck is that-- Thanks, Tahi.

I think that is clear. Thanks, Yaron, for the questions. Let's see whether there are further questions.

Yes of course. Now we are going to take our next question. And the question comes from the line of Benjamin Jackson. Your line is open. Please ask your question.

Brilliant. Thank you for the question. I have got 2, please. The first 1 on Rina-S. Look, we have seen a couple of companies make moves into drugs that look to overcome TOPO1 resistance. So, look, the aim for Rina-S is to come first to the market but are there any implications to this? And thinking positively or negative, how this resistance could emerge for when thinking about the Rina-S commercial opportunity once the competition comes to market and then secondly, look. Not a focused topic today. Lots of other stuff going on, but, obviously, any updated thoughts on EPKINLY potential in I&I diseases where B cell pathology is key. there is obviously a few competitors making noises in this area with similar drugs, so it would be interesting to hear your thoughts there. Thank you.

Thanks, Benjamin, for the question. So with Rina, we, of course, hope to be first to the market, and we are going to read out already a Phase III in Q4.

But, Tahi, do you want to comment on topo I and strategy for Rina? Well, I mean, you said the first 1. The most important part is there are already 3 phase threes actively enrolling patients. In ovarian cancer. 1 in PROC and 2 in PSOC. 1 maintenance, 1 in the platinum replacement strategy. And so we are constantly actively working on moving essentially the entry point for Rina into earlier lines. And we have already talked about that there is more to come also in the ovarian cancer space with Rina. And that is basically the reality. You have to, like, develop these drugs and then just try to move into earlier lines as efficiently and as effectively. As data allows. and operations allow. that is the first, but it is also the only thing to say about this emerging idea of topo I resistance because if we now, which we are very confident will be the first topo I payload ADC in PROC then this is more a post-Rina problem. To be honest. Exactly.

On I&I, right now, the focus then is on cancer. Multiple cancers, and we will have exciting data readout in Q4 And then let's discuss let's discuss I&I in more detail in the future. But cancer is clearly the priority for us right now. Operator, can we move to the next question?

Yes, of course. And now we are going to take our next question. And the question comes from the line of Judah Frommer from Morgan Stanley. Your line is open. Please ask the question.

Just a follow-up on Peto in frontline. Can you help us with thoughts on the nature of the update in Q4? So it will be a top line but can you give us any direction on whether you will kind of press release in line with some of the top lines we have seen for Epkinley, could we potentially see subgroup data perhaps by HPV status? And if not, do you have a sense for when we would see responses by, HPV negative versus positive patients? Thanks.

Thanks, Judah.

Tahi, can you give a bit of color on the top line results that we intend to present in the Q4 time frame. Well, so I think the accurate response to that question is top line results in Genmab have historically focused on the primary endpoint. And I think that is what is going to be happening for Peto as well. And then obviously, once we have the top line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data. In a public presentation at a public presentation at a conference.

Thanks. Thanks, Tahi. I think we keep it to that, Judah, at this time. Thank you.

Now we are going to take another question. And now we are going-- the question comes from the line of Victor Floch From BNP Paribas. Your line is open. Please ask your question.

Hi. Thanks so much for taking my questions. Actually, 2 questions on EPKINLY. First 1, very impressive momentum lately, I mean, obviously, you have mentioned the accelerated uptake in the community setting. So just like from like a modeling perspective, is there any stocking we should be aware of when it comes to, like, modeling the remainder of the year for EPKINLY? And my second question still on EPKINLY, but on IP. There is a report from Bloomberg arguing that the EPKINLY formulation, patent 70, could extend beyond the completion of matter patents and could potentially add, like, 5 years potentially in The US, 6 years in Europe. So just wondering whether you can, you know, discuss your IP strategy and your current assumption for in terms of IP? Thanks so much.

Thanks, Victor, for the questions. The first 1 can be handled by Brad. And the second 1, I think I will ask Tahi to give some color on the length of time for the patents.

Perhaps, why do not you start on the on the stocking question? Yeah. No. Thank you for the question. And, just briefly on the community, we are encouraged as you mentioned, with the momentum there. And it is due to the dual indications. The only bispecific for the dual indication, then it is really been received extremely well by physicians as well as health systems. But as it relates specifically to stocking, no stocking issue or no stocking at this point in time to be discussed. Thanks.

Thanks, Brad. And, Ty, do you want to add to address the IP and the length of time we have patent protection, or do you not want to want to do that right now?

Yeah. I would say this. Like, discussing patent and IP strategy on a call like this in the nuanced details is probably not appropriate. Right now, I would stick to, like, mid thirties is where we are. And then, of course, there is always an IP strategy to try to generate, additional, intellectual property protection that, that hopefully, extend some of that protection.

Okay. Thanks, Tahi. I think Victor, we keep it to that for now. Great. Thank you very much. Thanks.

Any further questions? We have. Would you like to take Yes.

Why do not we take 1 or 2 more, and then we probably have to end the call and follow it up 1-on-1.

Yes. Of course of course. Not a problem. And now we are going to take our next question then. And the question comes from the line of Kalpit Patel. Your line is open. Please ask your question.

Yes. Hey, thanks for taking the question. 1 more on the first line DLBCL study. I guess, originally, when you guys designed that protocol, and had assumptions for that frontline study, Is the timing of the readout, fourth quarter, more or so in line with what you guys originally modeled when you first started the study. And then when you completed the enrollment, I believe, 2024, did that estimate the timing estimate of the readout materially shift? And the reason I ask is because the start to finish still looks roughly in line between when frontline and the POLARIX study started and they finished, any color on your model assumptions would be useful. Thank you.

Look, Kalpit, we are super excited about the frontline setting. The readout will be in Q4. We believe that the data will be excellent based on the Phase II data. We are not going to address any further timing and time line issues here. But look forward to the data. Thank you.

And now we are going to take our final question for today. Just give us a moment. And the question comes from the line of Matthew from William Blair. Your line is open. Please ask your question.

Hi, thanks for squeezing me in. Comparing the frontline CRC trial with Peto to the OrigAMI-2 trial, that was looking pretty similar in design except for the Peto trial does include an ORR primary endpoint. Is this safe to assume you will try to explore Project FrontRunner in that frontline trial And then just curious on Rina-S in non small cell lung cancer. I have had a trial ongoing there this year. Any updated thoughts on the potential there or when we might see data from that phase 2 trial? Thank you.

Thanks, Matthew, for the questions. Tahi, can you address both for the frontline CRC trial and also the non small cell lung cancer trial data for Rina.

Sure. Yeah. So it is fair to assume that we will also explore if it is opportune Project FrontRunner opportunities, Colorectal for both trials. I think that is a fair assumption. And on the lung cancer Rina-S trial, Once we have, like, I think, a dataset that allows a robust discussion on what the next steps are going to be, I think it is a proper and opportune time to present that data. You know, I have said this many times, we are working in a super competitive environment. there is multiple folate receptor ADCs from very large competitors that are coming left and right. And so I think presenting data without having already actioned on it may not necessarily be the smartest thing for us to do. So we will we will present that data at the time, and we also have the next steps ready. Thanks, Tahi.

Thanks, Matthew. So thank you all for joining us today. And thank you for that lively and invigorating Q and A. With 3 super important phase 3 studies reading out in the coming months. We are well on track to deliver sustainable growth well into the next decade. We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. And as always, if you have questions for now, please reach out to our IR team. This concludes today's conference call.

Thank you for participating. You may now all disconnect. Have a nice day. Thank you.