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GMAB

Genmab A/SC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-26
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Earnings documents stored for GMAB.

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Investor releaseQuarter not tagged2026-08-26

Could Genmab (GMAB) Stock Win as Royalty Growth Fuels a New Earnings Cycle?

Insider Monkey
Genmab A/S (NASDAQ:GMAB) boosted its full-year 2026 revenue guidance to a range of $4.325 billion to $4.525 billion, up from its previous outlook of $4.065 billion to $4.395 billion. The upward revision underscores the strong commercial momentum across the company's royalty streams and proprietary portfolio. For the first half of 2026, GMAB reported total revenue of $2,051 million, representing a 25% year-over-year growth. Royalty revenue increased 24% to $1,708 million, heavily supported by $8,171 million in net sales of DARZALEX by Johnson & Johnson. Meanwhile, global net sales of EPKINLY/TEPKINLY surged 48% to $312 million. Operating profit came in at $555 million, while adjusted operating profit rose 18% to $656 million. Following the robust print, Guggenheim analyst Michael Schmidt raised the firm’s price target on Genmab to $42 from $40 while maintaining a Buy rating on August 7. This brings up a key question: Does this guidance raise reflect a permanent, high-margin inflection for Genmab A/S (NASDAQ:GMAB)’s pipeline, or will rising operating expenses eventually weigh on its bottom line? Genmab's broad-based top-line expansion, driven equally by DARZALEX royalties and EPKINLY net sales, demonstrates a diversified, partner-plus-proprietary revenue model. This setup reduces reliance on any single product, securing predictable royalties that fund ongoing commercial rollouts. Furthermore, a Phase III PFS win for epcoritamab in B-cell malignancies strengthens its clinical proof, expanding label potential and long-term royalty streams across geographies. Additionally, Genmab's high cash conversion and strong balance sheet provide ample organic financing to fund late-stage programs without risking shareholder dilution. Conversely, leverage levels remain a consideration, limiting overall financial flexibility. Should interest or refinancing costs shift, capital allocation toward expensive confirmatory trials could face pressure. Margin compression also poses a near-term risk as adjusted operating expenses climbed 28% to $1,270 million in H1 2026 due to pipeline investments like Rina-S and petosemtamab. Lastly, competitive landscapes in key indications and regulatory hurdles surrounding overall survival data could slow peak adoption and shorten royalty durations for new assets. Hedge fund sentiment around Genmab has turned noticeably positive. According to Insi…Read full document

Genmab A/S (NASDAQ:GMAB) boosted its full-year 2026 revenue guidance to a range of $4.325 billion to $4.525 billion, up from its previous outlook of $4.065 billion to $4.395 billion. The upward revision underscores the strong commercial momentum across the company's royalty streams and proprietary portfolio. For the first half of 2026, GMAB reported total revenue of $2,051 million, representing a 25% year-over-year growth. Royalty revenue increased 24% to $1,708 million, heavily supported by $8,171 million in net sales of DARZALEX by Johnson & Johnson. Meanwhile, global net sales of EPKINLY/TEPKINLY surged 48% to $312 million. Operating profit came in at $555 million, while adjusted operating profit rose 18% to $656 million. Following the robust print, Guggenheim analyst Michael Schmidt raised the firm’s price target on Genmab to $42 from $40 while maintaining a Buy rating on August 7. This brings up a key question: Does this guidance raise reflect a permanent, high-margin inflection for Genmab A/S (NASDAQ:GMAB)’s pipeline, or will rising operating expenses eventually weigh on its bottom line? Genmab's broad-based top-line expansion, driven equally by DARZALEX royalties and EPKINLY net sales, demonstrates a diversified, partner-plus-proprietary revenue model. This setup reduces reliance on any single product, securing predictable royalties that fund ongoing commercial rollouts. Furthermore, a Phase III PFS win for epcoritamab in B-cell malignancies strengthens its clinical proof, expanding label potential and long-term royalty streams across geographies. Additionally, Genmab's high cash conversion and strong balance sheet provide ample organic financing to fund late-stage programs without risking shareholder dilution. Conversely, leverage levels remain a consideration, limiting overall financial flexibility. Should interest or refinancing costs shift, capital allocation toward expensive confirmatory trials could face pressure. Margin compression also poses a near-term risk as adjusted operating expenses climbed 28% to $1,270 million in H1 2026 due to pipeline investments like Rina-S and petosemtamab. Lastly, competitive landscapes in key indications and regulatory hurdles surrounding overall survival data could slow peak adoption and shorten royalty durations for new assets. Hedge fund sentiment around Genmab has turned noticeably positive. According to Insider Monkey’s database, 30 hedge funds held positions in Genmab in Q1 2026, up from 24 funds in Q4 2025. Major institutional holders include Paradigm Biocapital Advisors with 13,133,131 shares valued at $360.77 million (representing a 65% increase in position) and Orbis Investment Management with 11,368,161 shares valued at $312.28 million. Investors should keep a close eye on whether Genmab A/S (NASDAQ:GMAB) can sustain its 20%+ royalty growth rate through the second half of 2026 without letting R&D and integration expenses erode operating margins. Additionally, key regulatory updates regarding epcoritamab's expanded indications and early pipeline updates for Rina-S will be vital in determining whether the stock can meet Wall Street's higher price targets. While we acknowledge the potential of GMAB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

Investor releaseQuarter not tagged2026-08-07

Genmab (GMAB) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 12:00 p.m. ET Chief Executive Officer - Jan van de Winkel Chief Financial Officer - Anthony Pagano Chief Commercial Officer - Brad Bailey Chief Medical Officer - Tahamtan Ahmadi Chief Development Officer - Judith V. Klimovsky Need a quote from a Motley Fool analyst? Email [email protected] Operator: 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. Jan van de Winkel: 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…Read full document

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 12:00 p.m. ET Chief Executive Officer - Jan van de Winkel Chief Financial Officer - Anthony Pagano Chief Commercial Officer - Brad Bailey Chief Medical Officer - Tahamtan Ahmadi Chief Development Officer - Judith V. Klimovsky Need a quote from a Motley Fool analyst? Email [email protected] Operator: 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. Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Brad Bailey: 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. Anthony Pagano: 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. Jan van de Winkel: 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. Operator: 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. Zain Ebrahim: 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? Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Jan van de Winkel: Let's hand the question back to the operator, and then see whether there is another 1. Operator: 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. Michael Schmidt: 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. Jan van de Winkel: Thanks, Michael, for the question. Tahi, can you address this 1? Tahamtan Ahmadi: 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. Jan van de Winkel: Thanks, Michael, for the question. Operator: 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. James Gordon: 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. Jan van de Winkel: 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? Tahamtan Ahmadi: 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. Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Jan van de Winkel: Thanks. Thank you. Thanks, James. Operator: 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. Analyst: 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. Jan van de Winkel: Thanks, Gregory, for the question. Tahi, can you take this 1? Tahamtan Ahmadi: 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. Jan van de Winkel: Thanks, Asthika. Let's move on to the next 1. Operator: Thank you. And the next question comes from the line of Xian Deng from UBS. Your line is open. Please ask your question. Xian Deng: 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. Jan van de Winkel: Thanks, Xian. I think I am going to pass them over again to you, Tahi. Thank you. Tahamtan Ahmadi: 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. Jan van de Winkel: I think very clear. Thank you. Thanks, Xian, for the questions. Let's move on to the next 1. Operator: 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. Rajan Sharma: 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. Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Jan van de Winkel: Judith, are you back online? Apparently, not. So maybe Tahi, you can dive a bit into the endometrial cancer, and that is okay. Tahamtan Ahmadi: 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. Jan van de Winkel: Let's move on to the next question. Operator: 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. Eva Fortea-Verdejo: 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. Jan van de Winkel: 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? Tahamtan Ahmadi: 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. Jan van de Winkel: 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. Operator: 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. Suzanne van Voorthuizen: 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. Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Jan van de Winkel: Thank you, Tahi. Thanks, Suzanne, for the questions. Let's move on. Operator: 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. Charlie Haywood: 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? Jan van de Winkel: Thanks, Charlie, for the questions. Tahi, can you address both of them. Tahamtan Ahmadi: 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. Jan van de Winkel: 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. 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. Yaron Werber: 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. Jan van de Winkel: Thanks, Yaron. Tahi, can you address both of the questions? Tahamtan Ahmadi: 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. Jan van de Winkel: I think that is clear. Thanks, Yaron, for the questions. Let's see whether there are further questions. Operator: 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. Benjamin Jackson: 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. Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Jan van de Winkel: 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? Operator: 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. Judah Frommer: 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. Jan van de Winkel: Thanks, Judah. Tahamtan Ahmadi: 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. Jan van de Winkel: Thanks. Thanks, Tahi. I think we keep it to that, Judah, at this time. Thank you. Operator: 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. Victor Floch: 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. Jan van de Winkel: 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. Brad Bailey: 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. Jan van de Winkel: 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? Tahamtan Ahmadi: 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. Jan van de Winkel: Okay. Thanks, Tahi. I think Victor, we keep it to that for now. Great. Thank you very much. Thanks. Operator: Any further questions? We have. Would you like to take Yes. Jan van de Winkel: 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. Operator: 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. Kalpit Patel: 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. Jan van de Winkel: 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. Operator: 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. Matthew Phipps: 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. Jan van de Winkel: 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. Tahamtan Ahmadi: 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. Jan van de Winkel: 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. Operator: Thank you for participating. You may now all disconnect. Have a nice day. Thank you. Before you buy stock in Genmab A/s, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Genmab A/s wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Genmab A/s. The Motley Fool has a disclosure policy. Genmab (GMAB) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-06

Genmab Announces Financial Results for the First Half of 2026

GlobeNewswire
August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million Genmab 2026 financial guidance updated “The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S® (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2026 Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties and higher EPKINLY® net product sales. Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY® were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%. Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales. Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six…Read full document

August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million Genmab 2026 financial guidance updated “The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S® (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2026 Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties and higher EPKINLY® net product sales. Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY® were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%. Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales. Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches. Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026. Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform. Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025. OutlookGenmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY. 2026 FULL YEAR OUTLOOK 1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak® ex-U.S. net product sales plus Genmab's share of U.S. gross profits.2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million.3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million. Non-IFRS Financial MeasuresOur Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Conference CallGenmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register-conf.media-server.com/register/BId9cf2ff8aa3c489ca2ad2007d64a1964. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations. ContactMarisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: [email protected] Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: [email protected] The Interim Report contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect®; KYSO®, RAINFOL™, ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Biclonics® and BIZENGRI® are registered trademarks of Merus N.V. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, RYBREVANT FASPRO™,TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Half of 2026 on attachment or at www.genmab.com/investor-relations CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 060826_CA34_Genmab Interim Report H1 2026

Investor releaseQuarter not tagged2026-08-06

Genmab A/S Q2 Earnings Call Highlights

MarketBeat
Interested in Genmab A/S Sponsored ADR? Here are five stocks we like better. Genmab raised its 2026 outlook, now forecasting revenue of DKK 4.3 billion–DKK 4.5 billion and operating profit of DKK 1.1 billion–DKK 1.4 billion, supported by strong DARZALEX and EPKINLY growth. EPKINLY sales rose 48% year over year to DKK 312 million, driven by increased U.S. patient starts, broader site adoption and international approvals; TIVDAK sales also increased. Genmab expanded petosemtamab development with two planned Phase III colorectal cancer trials and expects multiple late-stage readouts in the second half of 2026, including studies of Rina-S, petosemtamab and EPKINLY. Genmab A/S (NASDAQ:GMAB) reported first-half 2026 revenue growth of 25% year over year and raised its full-year financial outlook, citing continued momentum from DARZALEX, EPKINLY and the broader portfolio. The company also outlined upcoming late-stage trial readouts and announced two new Phase III studies of petosemtamab in colorectal cancer. President and CEO Jan van de Winkel said the company grew revenue while increasing investments in late-stage development, launch readiness and the integration of Merus. Adjusted operating profit rose 18% in the first half, according to Chief Financial Officer Anthony Pagano. → 3 Drone Stocks That Should Soar After the Summer Slump Genmab now expects 2026 revenue of DKK 4.3 billion to DKK 4.5 billion, representing 19% year-over-year growth at the midpoint. The new outlook is 5% higher than the company’s previous revenue guidance, with the DKK 195 million midpoint increase split approximately equally between DARZALEX and EPKINLY, Pagano said. The company raised its operating-expense outlook by 2%, to a midpoint of DKK 2.88 billion, reflecting further investment in development programs including the newly announced petosemtamab colorectal cancer trials. Genmab expects operating profit of DKK 1.1 billion to DKK 1.4 billion, 7% above its prior guidance. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Pagano said approximately half of the company’s first-half revenue growth came from DARZALEX, which increased 21% year over year. Worldwide EPKINLY net product sales increased 48%, while the remainder of the portfolio grew 35%. Genmab reported an effective tax rate of 3.6% for the first half, equivalent to DKK 13 million in tax expense. Pagano attribut…Read full document

Interested in Genmab A/S Sponsored ADR? Here are five stocks we like better. Genmab raised its 2026 outlook, now forecasting revenue of DKK 4.3 billion–DKK 4.5 billion and operating profit of DKK 1.1 billion–DKK 1.4 billion, supported by strong DARZALEX and EPKINLY growth. EPKINLY sales rose 48% year over year to DKK 312 million, driven by increased U.S. patient starts, broader site adoption and international approvals; TIVDAK sales also increased. Genmab expanded petosemtamab development with two planned Phase III colorectal cancer trials and expects multiple late-stage readouts in the second half of 2026, including studies of Rina-S, petosemtamab and EPKINLY. Genmab A/S (NASDAQ:GMAB) reported first-half 2026 revenue growth of 25% year over year and raised its full-year financial outlook, citing continued momentum from DARZALEX, EPKINLY and the broader portfolio. The company also outlined upcoming late-stage trial readouts and announced two new Phase III studies of petosemtamab in colorectal cancer. President and CEO Jan van de Winkel said the company grew revenue while increasing investments in late-stage development, launch readiness and the integration of Merus. Adjusted operating profit rose 18% in the first half, according to Chief Financial Officer Anthony Pagano. → 3 Drone Stocks That Should Soar After the Summer Slump Genmab now expects 2026 revenue of DKK 4.3 billion to DKK 4.5 billion, representing 19% year-over-year growth at the midpoint. The new outlook is 5% higher than the company’s previous revenue guidance, with the DKK 195 million midpoint increase split approximately equally between DARZALEX and EPKINLY, Pagano said. The company raised its operating-expense outlook by 2%, to a midpoint of DKK 2.88 billion, reflecting further investment in development programs including the newly announced petosemtamab colorectal cancer trials. Genmab expects operating profit of DKK 1.1 billion to DKK 1.4 billion, 7% above its prior guidance. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Pagano said approximately half of the company’s first-half revenue growth came from DARZALEX, which increased 21% year over year. Worldwide EPKINLY net product sales increased 48%, while the remainder of the portfolio grew 35%. Genmab reported an effective tax rate of 3.6% for the first half, equivalent to DKK 13 million in tax expense. Pagano attributed the rate primarily to the Merus integration and the recognition and use of deferred tax assets, adding that the rate may fluctuate during integration and is expected to normalize over the next 12 to 18 months. → Jersey Mike's Serves Fresh Gains After IPO Stumble Chief Commercial Officer Brad Bailey said proprietary-product sales totaled DKK 396 million in the first half, up 37% from a year earlier. EPKINLY sales reached DKK 312 million, rising 48% year over year and 28% from the prior quarter, while TIVDAK sales totaled DKK 84 million. Bailey said EPKINLY’s U.S. performance benefited from higher new-patient starts and site activations. The chemotherapy-free, fixed-duration EPKINLY-plus-lenalidomide-and-rituximab regimen in second-line follicular lymphoma has seen rapid uptake, he said. More than 90% of key customers are now ordering EPKINLY for two or more sites, with a majority of new site activations coming from community practices. Outside the U.S., Bailey cited continued EPKINLY growth in Japan, where it is approved in diffuse large B-cell lymphoma and follicular lymphoma. Through partner AbbVie, EPKINLY recently received approvals in Europe and China for use with lenalidomide and rituximab in second-line follicular lymphoma. TIVDAK growth was driven by the U.S. and launch markets in Japan and Europe. Genmab also secured reimbursement for TIVDAK in the U.K. and said discussions are continuing in additional markets. Genmab expects several important clinical updates in the second half of 2026. Van de Winkel said both Phase II and Phase III datasets for Rina-S in platinum-resistant ovarian cancer are expected in the fourth quarter. For petosemtamab in head and neck cancer, the company expects the frontline study to report in the fourth quarter and the second- or third-line study to report in the first quarter of 2027. Genmab said the frontline interim analysis is expected to support a filing, though management did not provide further details on the data expected in the top-line update. EPKINLY’s frontline EPCORE DLBCL-2 trial is also expected to produce top-line interim-analysis data in the fourth quarter. The company previously reported positive top-line findings from EPCORE DLBCL-4, which showed a statistically significant and clinically meaningful improvement in progression-free survival. Chief Medical Officer Tahi Ahmadi said overall-survival data from that study were immature. Ahmadi said Genmab remains in discussions with the U.S. Food and Drug Administration over whether the frontline or second-line EPKINLY trial will serve as the confirmatory study for an existing indication. Genmab announced it has initiated a global, randomized, open-label Phase III trial of petosemtamab plus investigator-choice chemotherapy in first-line unresectable or metastatic left-sided colorectal cancer with RAS/RAF wild-type disease. The trial will compare the regimen with cetuximab plus chemotherapy. A second global Phase III study is planned in second-line RAS/RAF wild-type unresectable or metastatic colorectal cancer. It will compare petosemtamab plus modified FOLFOX6 or FOLFIRI against cetuximab or bevacizumab plus chemotherapy. Ahmadi said petosemtamab is an EGFR-LGR5 bispecific antibody, with LGR5 serving as a marker of cancer stem cells in colorectal cancer. The company plans to present updated colorectal cancer data for the therapy at the European Society for Medical Oncology meeting in October. Management said petosemtamab has the potential to become a multi-indication asset, alongside ongoing Phase III studies in head and neck cancer and planned expansion into locally advanced head and neck disease. Genmab A/S is a Denmark-based biotechnology company specializing in the discovery and development of antibody therapeutics for the treatment of cancer. Since its founding in 1999 and with headquarters in Copenhagen, Genmab has built a robust research platform focused on harnessing novel antibody engineering technologies to create next-generation therapies. The company's work centers on identifying targets in hematologic malignancies and solid tumors, advancing its proprietary molecules from early discovery through clinical development. Genmab's portfolio includes products developed in collaboration with leading global pharmaceutical partners. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Genmab A/S Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-06

Genmab AS (GMAB) (Q2 2026) Earnings Call Highlights: Strong Revenue Growth and Strategic ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue Growth: Increased 25% year-over-year in the first half of 2026. Proprietary Portfolio Sales: Totaled DKK396 million, a 37% increase compared to the same period last year. EPKINLY Sales: Grew to DKK312 million in the first half, representing a 48% increase year-over-year and a 28% increase in the quarter. TIVDAK Sales: Totaled DKK84 million during the first half of the year. DARZALEX Revenue Growth: Increased 21% year-over-year. Adjusted Operating Profit Growth: Increased by 18%. Effective Tax Rate: 3.6% for the first half, equating to a tax expense of DKK13 million. 2026 Revenue Guidance: Updated to a range of DKK4.3 billion-DKK4.5 billion, representing 19% year-over-year growth at the midpoint. 2026 Operating Expense Guidance: Updated to a new midpoint of DKK2.88 billion. 2026 Operating Profit Guidance: Expected to be in the range of DKK1.1 billion-DKK1.4 billion. Warning! GuruFocus has detected 5 Warning Signs with GMAB. Is GMAB fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total revenue grew 25% year-over-year, driven by strong performance across the portfolio, including a 48% increase in EPKINLY sales. Positive phase III EPCORE DLBCL-2 results showed statistically significant improvement in progression-free survival, supporting epcoritamab's versatility. European approval of EPKINLY plus lenalidomide and rituximab for second-line follicular lymphoma makes it the first bispecific-based therapy approved in Europe for this indication. Expansion of petosemtamab into colorectal cancer with two new phase III trials, leveraging promising early data and a differentiated mechanism targeting EGFR and LGR5. Updated 2026 guidance raised revenue expectations by 5% and operating profit by 7%, while increasing investment by only 2%, demonstrating strong operating leverage. EPKINLY's rapid uptake in the U.S. community setting, with over 90% of key customers ordering for multiple sites, indicates growing physician confidence and market leadership. Multiple late-stage pipeline catalysts are on track for the second half of 2026, including phase III readouts for Rina-S, petosemtamab, and EPKINLY in frontline DLBCL. Petosemtamab's second-line head and neck cancer trial readou…Read full document

This article first appeared on GuruFocus. Total Revenue Growth: Increased 25% year-over-year in the first half of 2026. Proprietary Portfolio Sales: Totaled DKK396 million, a 37% increase compared to the same period last year. EPKINLY Sales: Grew to DKK312 million in the first half, representing a 48% increase year-over-year and a 28% increase in the quarter. TIVDAK Sales: Totaled DKK84 million during the first half of the year. DARZALEX Revenue Growth: Increased 21% year-over-year. Adjusted Operating Profit Growth: Increased by 18%. Effective Tax Rate: 3.6% for the first half, equating to a tax expense of DKK13 million. 2026 Revenue Guidance: Updated to a range of DKK4.3 billion-DKK4.5 billion, representing 19% year-over-year growth at the midpoint. 2026 Operating Expense Guidance: Updated to a new midpoint of DKK2.88 billion. 2026 Operating Profit Guidance: Expected to be in the range of DKK1.1 billion-DKK1.4 billion. Warning! GuruFocus has detected 5 Warning Signs with GMAB. Is GMAB fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total revenue grew 25% year-over-year, driven by strong performance across the portfolio, including a 48% increase in EPKINLY sales. Positive phase III EPCORE DLBCL-2 results showed statistically significant improvement in progression-free survival, supporting epcoritamab's versatility. European approval of EPKINLY plus lenalidomide and rituximab for second-line follicular lymphoma makes it the first bispecific-based therapy approved in Europe for this indication. Expansion of petosemtamab into colorectal cancer with two new phase III trials, leveraging promising early data and a differentiated mechanism targeting EGFR and LGR5. Updated 2026 guidance raised revenue expectations by 5% and operating profit by 7%, while increasing investment by only 2%, demonstrating strong operating leverage. EPKINLY's rapid uptake in the U.S. community setting, with over 90% of key customers ordering for multiple sites, indicates growing physician confidence and market leadership. Multiple late-stage pipeline catalysts are on track for the second half of 2026, including phase III readouts for Rina-S, petosemtamab, and EPKINLY in frontline DLBCL. Petosemtamab's second-line head and neck cancer trial readout was delayed to Q1 2027, attributed to the event-driven overall survival endpoint. The timing of the EPCORE DLBCL-2 interim analysis in Q4 2026 appears delayed by about a year compared to analyst expectations, raising questions about event accrual. Management declined to provide clarity on whether the frontline DLBCL trial will meet statistical significance at the interim, leaving uncertainty about potential approval timelines. The effective tax rate is currently low (3.6%) due to Merus integration, but is expected to normalize over the next 12-18 months, which could impact future profitability. Competitive pressure in head and neck cancer from J&J's amivantamab, which is pursuing accelerated approval, may challenge petosemtamab's market positioning despite claims of best-in-class profile. Management was vague on the potential for EPKINLY's IP protection beyond mid-2030s, with no clear commitment to extended patent life, which could affect long-term revenue. The company's strategy for Rina-S in non-small cell lung cancer remains undisclosed, with data presentation deferred until next steps are ready, indicating potential competitive challenges. Q: What is driving the slight delay in the petosemtamab second/third-line head and neck cancer trial readout to Q1 2027, and what is the latest feedback from the FDA on whether the second-line or first-line trial could serve as the confirmatory trial for EPKINLY?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) explained that the second-line trial uses overall survival (OS) as the primary endpoint, making it an event-driven projection for data availability. The timeline update reflects the company's current visibility on when the top-line results will be ready. Regarding the FDA confirmatory trial for EPKINLY, he noted that Genmab is in active engagement with the agency, and the decision on whether the frontline or second-line trial will serve as the confirmatory trial is an ongoing discussion that will partly depend on the results of the frontline trial. Q: Can you explain the timing of the EPCORE DLBCL-2 interim analysis in Q4 2026, given that it seems delayed compared to initial expectations?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) stated that the company is very excited about the upcoming readout, which is the most important study in the epcoritamab franchise. He referenced exciting Phase II data presented at ASH showing unprecedented complete response rates for the epcoritamab plus R-CHOP combination. He confirmed the interim analysis will be top-lined next quarter but declined to provide further details on the timing, preferring to discuss the data once it is available. Q: For the petosemtamab frontline trial reading out in Q4, how mature will the interim OS data be, and what happens if the trial doesn't hit its interim endpoint? Also, will the Rina-S Phase II and Phase III PROC data be released together?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) stated that the company expects to present the interim data from the frontline trial next quarter, which they believe will be the basis for filing. He declined to speculate on the maturity of the OS data or the likelihood of success, stating that having an OS benefit is always a high bar, but they have high confidence in petosemtamab. Regarding Rina-S, he confirmed that both the Phase II and Phase III data sets in platinum-resistant ovarian cancer will be made available when top-line results are ready in Q4. Q: With competitors advancing in the second/third-line head and neck setting, what efficacy and durability profile does petosemtamab need to show to remain competitive?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) emphasized that Genmab's Phase III data with an OS benefit is a completely different and more comprehensive dataset compared to a competitor's accelerated approval based on ORR and duration of response. He reiterated confidence in petosemtamab as a best-in-class, second-generation EGFR bispecific, citing the totality of data across head and neck and other indications. The company is pursuing a frontline indication with pembrolizumab and a Phase III OS readout in the second-line setting, which they believe provides a compelling and comprehensive dataset. Q: Given the interim analysis for the EPKINLY frontline trial has not yet passed, does this suggest events are happening slower than expected? Also, what is the rationale for the chemo-free design of the petosemtamab frontline trial?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) stated that the company has no visibility into how the R-CHOP control arm is performing, but noted that R-CHOP has historically had robust performance across trials. He expressed excitement about the upcoming data based on the predictability of EPKINLY's efficacy and safety from Phase II to Phase III. For the petosemtamab frontline trial, he explained that head and neck patients are a fragile population, and the decision to use a chemo-free pembrolizumab combination was based on the Phase II data showing double the response rate and durability compared to chemotherapy combinations. The trial design reflects the need for tolerable treatment options in this patient population. Q: Was the EPKINLY second-line trial data better than expected, and does this increase confidence in the frontline trial? Also, how does the emerging TROP2-ADC data in endometrial cancer impact the Rina-S opportunity?A: Jan van de Winkel (President and CEO) expressed excitement about the frontline study based on Phase II data presented at ASH, noting that the second-line data was fantastic but unrelated to the frontline setting. He highlighted the rapid recruitment and the fact that R-CHOP has been the gold standard for over 20 years, suggesting that if Phase II data translates to Phase III, the results could be sensational. Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) added that the competitor's TROP2-ADC data has little bearing on Rina-S strategy, as folate receptor alpha is expressed in endometrial cancer, and Rina-S has shown efficacy across a spectrum of expression levels. The company has initiated two Phase III trials in endometrial cancer. Q: How is Genmab's newly disclosed colorectal cancer strategy differentiated from competing EGFR bispecifics like amivantamab, and would a combination with RAS-directed therapies be viable?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) stated that petosemtamab has consistently shown higher response rates and a better safety profile than amivantamab across multiple datasets, including monotherapy and combination settings. He attributed this to the different secondary arms of the antibodies, which may have a biological mechanistic role in differentiating efficacy and safety. Regarding RAS-directed therapies, he acknowledged the exciting field and confirmed that Genmab is actively engaging in discussions to embark on novel combinations, with more details to come in the near future. Q: How has the competitive development of amivantamab in head and neck changed Genmab's filing or commercial strategy for petosemtamab, and what underpins the confidence in its best-in-class profile?A: Tahi Ahmadi (CMO, EVP Head of Experimental Medicine) reiterated that Genmab's strategy remains unchanged, with a frontline top-line result expected this year and an OS readout for the monotherapy in Q1 2027. He noted that this is a more comprehensive dataset than the competitor's accelerated approval approach. On the best-in-class profile, he cited cross-study comparisons showing petosemtamab outperforming amivantamab on efficacy across four datasets (monotherapy and combination in head and neck, and colorectal), with a differentiated safety profile, particularly regarding skin-related toxic For the complete transcript of the earnings call, please refer to the full earnings call transcript.

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 144 paragraphs
Operator

Hello, welcome to the Genmab first half 2026 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipate, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. 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, not to rely on any single financial measure.

Operator

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

Jan Van de Winkel

Hello, everyone, welcome to our financial results call for the first half of 2026. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahi Ahmadi . For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As the operator said, we will be making forward-looking statements, 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, stay disciplined with our capital. That is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio.

Jan Van de Winkel

Even as we have made focused and strategic investments in our late-stage programs, in launch readiness, in the integration of Merus. We did all this while growing operating profit. To me, that says a lot about the quality of our business. Beyond financial performance, I'm enthusiastic about our recent pipeline progress. Let me walk you through the highlights. In June, we announced positive top-line results from the phase III EPCORE DLBCL-2 trial, which showed statistically significant, clinically meaningful improvement in progression-free survival. What is important about these results is what they demonstrate about epcoritamab 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 EPKINLY plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second line setting.

Jan Van de Winkel

This makes EPKINLY the first and only bispecific-based therapy approved in Europe for this indication. Our presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. 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 two new phase III studies in colorectal cancer. Tahi will share more detail on them in just a moment. 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.

Jan Van de Winkel

For Rina-S, we anticipate both phase II and phase III platinum-resistant ovarian cancer datasets will be available in the fourth quarter. For petosemtamab, we are eagerly awaiting the readouts for both studies. With better visibility, we can now say that the full line study is expected to readout in the fourth quarter, while the second or third line study is anticipated to readout in the first quarter of 2027. Finally, for EPKINLY, we anticipate that top-line data from the frontline 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. Potential approvals and launches in 2027. This is what we have been building towards, and it reflects our focused execution. Exciting times ahead.

Jan Van de Winkel

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.

Tahi Ahmadi

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. As you know, petosemtamab is a EGFR LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. LGR5 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 RAS/RAF wild-type colorectal cancer. The early clinical data have been very encouraging. We will be able to show more on this at ESMO in October.

Tahi Ahmadi

Based on this promising data, we are initiating two phase III studies, one in front line and one in second-line colorectal cancer. For front line, we have already initiated a phase III randomized trial, open label, a global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator choice chemotherapy of either mFOLFOX6 or FOLFIRI. A first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS/RAF wild type. It will thus be versus the standard of care, namely 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 FOLFOX6 or FOLFIRI as a second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS/RAF wild type.

Tahi Ahmadi

Here the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy. Taken together with our two ongoing phase III 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 rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients. With that, I'm pleased to hand over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

Brad Bailey

Thanks, Tahi. Our proprietary portfolio performed incredibly well in the first half of the year. Sales totaled DKK 396 million, representing 37% growth compared to the same time last year. These results demonstrate the strength of 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 2026 reflects growth for both EPKINLY and TIVDAK globally. We're very pleased with how EPKINLY is performing. In fact, EPKINLY grew to DKK 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 U.S., 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 in second-line FL has been going extremely well with rapid uptake across sites.

Brad Bailey

This contributed positively to our growth in the first half of the year and suggests that EPKINLY is becoming a preferred regimen in this setting. We've 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 two 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.

Brad Bailey

The uptake we're seeing in the community, with more physicians gaining experience using EPKINLY at 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, EPKINLY 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're really pleased with EPKINLY's growth globally, and particularly in the U.S. and Japan, where 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.

Brad Bailey

As we look towards the back half of 2026, we're focused on continuing to grow EPKINLY and strengthening our leadership in the market by maximizing our first-mover advantage in second-line FL and preparing for anticipated launches in early lines of DLBCL in the future. Turning briefly to TIVDAK. TIVDAK totaled DKK 84 million in sales during the first half of the year, driven by continued performance in the U.S. as well as in our launch markets in Japan and Europe. In markets where TIVDAK 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.

Brad Bailey

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 2026, we're 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 2026 and into 2027 and beyond. With that, I'll turn it over to Anthony to walk us through the financials.

Anthony Pagano

Thanks, Brad. The first half of 2026 demonstrated the continued strength of our business with revenue growing 25% year-over-year. Beyond the headline 25% revenue growth, I'd highlight two characteristics of our performance. First, high growth, and second, broad-based growth. 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 two brands, the remainder of our portfolio increased 35% year-over-year. Turning to broad-based growth. Approximately half of our year-over-year revenue growth came from DARZALEX. Impressively, the other half was generated by EPKINLY 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.

Anthony Pagano

The strength of our business also provides the financial flexibility to continue investing behind our highest value growth opportunities, including 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 while continuing 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 DKK 13 million. Now, as we've 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.

Anthony Pagano

We expect our effective tax rate will normalize over the next 12-18 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 by 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 DKK 4.3 billion-DKK 4.5 billion, representing 19% year-over-year growth at the midpoint. This compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both DARZALEX and EPKINLY, with the DKK 195 million increase at the midpoint being approximately equally split between DARZALEX and EPKINLY. Now turning to operating expenses.

Anthony Pagano

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 two new phase III 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 DKK 2.88 billion. Finally, operating profit is now expected to be in the range of DKK 1.1 billion-DKK 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.

Anthony Pagano

In summary, our first-half performance provides further evidence of the strength of our business. We 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.

Anthony Pagano

Now on that note, I'm going to hand you back over to Jan.

Jan Van de Winkel

Thank you, Anthony. Let's now move to our final slide. Looking at the first half overall, we've had a strong six months, both scientifically and financially. 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, and what is still to come in the coming months, I'm super excited. That now ends our formal presentation, and thank you for listening. Operator, please open the call for questions.

Operator

Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A roster. This will take a few moments. Now we're going to take our first question. It comes line of Zain Ebrahim.

Zain Ebrahim

Hello.

Operator

Your line is open. Please ask your question.

Zain Ebrahim

Hi, everyone. Thanks for taking the question. Zain Ebrahim, JPMorgan. First question is on the petosemtamab second line trial, which way you're now guiding for the readout in Q1 in 2027. Just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint variable survival? Is it the upsizing of the trial? How is recruitment progressing for the second line trial relative to your expectations? I think the slide suggests it's still recruiting. Just any updates there would be helpful. My second question is on EPCORE DLBCL-2. Quite a strong PFS outcome, but just any sense of what you've seen so far on overall survival, or was it just too immature to see a trend at this point?

Zain Ebrahim

What's the latest feedback you've had from the FDA on whether the second-line trial or the first-line trial could be used as a confirmatory trial?

Jan Van de Winkel

Thank you, Zain, for the questions. I think I will hand them both over to Tahi. Maybe start, Tahi, with the second line trial for petosemtamab and head and neck cancer then move on to DLBCL-4 to address some of the points raised here.

Tahi Ahmadi

Yeah, thank you for the question. Let's take the petosemtamab first. As you correctly noted, the endpoint is overall survival, this is an event-driven projection for when we have the data and the trial is fully enrolled. That was to that question. We're 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 lin epcor combination, you noted 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's the most meaningful kind of data point. We are really excited about the data.

Tahi Ahmadi

The OS, of course, at that point, is totally immature, which is why it's not yet been reported. The data will be presented in an upcoming conference. We'll have a chance to look at it in a little bit more granular detail. As it relates to the part of your question, for the confirmation of the indication that is already approved, we are of course in very active engagement with the agency on all kinds of fronts. Whether the frontline or the second line trial is going to be the confirmatory trial, I think that's an ongoing discussion right now, to a degree, also depends on how are the results of the frontline trial are going to be. This is all there is to say at this point. We have an active process, active engagement, and it'll be one of the two.

Jan Van de Winkel

Thanks, Tahi. Let's hand the question back to the operator, and then see whether there's another one.

Operator

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

Michael Schmidt

Hey, thanks for taking my questions. I had one on EPCORE DLBCL-2, and I'm 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 one-year delay, essentially, of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

Jan Van de Winkel

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

Tahi Ahmadi

Let's start first. We are very excited about the results of this trial, as they be going to read out next quarter. This is the most important study, I think it is fair to say, within the epcoritamab franchise. There is exciting phase II data that is in the public domain. Last year and the year before presented at ASH around the combination of epcor with R-CHOP that showed really unprecedented CR rates, which is driving the excitement for the results of this trial. 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-lined next quarter. I think we should probably leave it at this point. Once we have the data in our hands, we can have a good conversation about all of these other questions that may arise.

Tahi Ahmadi

For now, next quarter, looking forward to it.

Jan Van de Winkel

Thanks, Tahi. Thanks, Michael, for the question.

Operator

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

James Gordon

Hello, James Gordon from Barclays. A question, a couple of clarifications, please. One question was on petosemtamab. 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. For the first-line trial that I think we're going to get in Q4, how mature will the interim OS be when you report it that you plan to file? Do you think the first line or refractory is a higher bar in terms of being successful? It was just two clarifications. One was for EPKINLY and where we're going to get the interim in the first-line trial in Q4.

James Gordon

If it doesn't work at interim, will you tell us that and say that the trial is going to continue on to the final data, or it's just we won't hear anything, and if we don't hear anything by the end of the year, we'll have to assume that it didn't work interim, how that works, please. The other clarification was just, for Rina-S and PROC, the 01 and 02 trials, they're both in Q4, phase II and a phase III. Are we going to get two different readouts, or it's the phase III that's material because that's what you're filing, we'll just get all the data together?

Jan Van de Winkel

Thanks, James, for the questions and the clarification requests. The first two I'm going to hand over again to Tahi, Judith can deal with the phase II and phase III data for PROC for Rina-S. Tahi, why don't you start with petosemtamab and the frontline trial?

Tahi Ahmadi

It was actually, I think, I don't know, I stopped counting at three, I'll try to address all of the points that were made and asked. The first thing is, on the petosemtamab trial, right, we've from the beginning stuck to the guidance that had come from us, one 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 obviously the one indication that has a 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, we don't have any visibility to this, so this would be all speculation.

Tahi Ahmadi

I don't think this makes any sense. We'll have that discussion when we have the interim results in our hands. 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 petosemtamab trial. I think you asked about whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this, to be honest. I think having an OS benefit is always a high bar, and we have a very high confidence in petosemtamab being able to provide an overall survival benefit for patients in frontline and in second line.

Tahi Ahmadi

This is underwritten to a degree by these two BTD indications, the data sets in a public domain, 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, in these two studies that are already operationalized. In colorectal, where we are today announcing that we're going to start two phase III and any future trials. It's a very exciting drug. We're really looking forward to the data in frontline, we can have a more detailed discussion on what actually the data will be.

Jan Van de Winkel

There was a question, Tahi, on epcoritamab, in the frontline study, when we wouldn't hit the interim, what would happen then with the petosemtamab trial?

Tahi Ahmadi

I think we should stick with what we just said. What we expect to present the interim data next quarter.

Jan Van de Winkel

All right. Very good. Let's stay with that. Judith, maybe the phase II and phase III data sets for Rina-S and PROC, a bit more color there. Judith, are you there?

Tahi Ahmadi

If she's unmuted, I can take that too.

Jan Van de Winkel

Okay. Why don't you take it, Tahi?

Tahi Ahmadi

There will be indeed, as you said, there's a phase II in PROC, and then we already talked about that there's also a phase III. Both of these data sets, of course, will be made available at the time that we get them and then have the top-line results.

Jan Van de Winkel

I think that should do it for now, Tahi Thanks.

James Gordon

Thank you.

Jan Van de Winkel

Thanks, James.

Operator

Thank you. Now we're going to take our next question. The question comes from the line of Gregory Renza from Truist. Your line is open, please ask-

Speaker 8

Hi. Thanks so much for taking our question. This is support line for Greg. I have one for petosemtamab in head and neck. With competitors advancing quickly in the second-line third-line setting ahead of your action to read out in the first quarter of next year, what efficacy and durability profile would petosemtamab need to show to remain competitive? Thanks so much.

Jan Van de Winkel

Thanks, Greg, for the question. Tahi, can you take this one?

Tahi Ahmadi

Sure. I think you're alluding to the J&J filing. I think one thing to say is that we just had a conversation about this and that the second-line data set will be a phase III with an overall survival benefit, and that is a, of course, completely significantly different data set, as a OR duration of response data set that may form the basis of accelerated approval, as it is for amivantamab. We remain very steadfast in our statement that we believe petosemtamab 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.

Tahi Ahmadi

The totality of our data, the fact that we will have a front-line indication with pembrolizumab, that we are seeking with the phase III readout next quarter, then a overall survival phase III readout in the first quarter of next year. I think this is a very compelling and comprehensive dataset across these two studies, monotherapy, second-line, third-line, combination with pembrolizumab front-line. That is going to really underwrite our ambition in head and neck. We're very comfortable with our position and where we are. The expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Jan Van de Winkel

Thank you, Tahi. Thanks, Greg. Let's move on to the next one.

Operator

Thank you. The next question comes line of Xian Deng from UBS. Your line is open, please ask your question.

Xian Deng

Hi. Thank you for taking my question. I guess I'll just try my luck a little bit on the EPKINLY frontline trial. Given the interim two has not passed, this really suggests that events are happening really a lot slower than expected. Just wondering, is there any reason that you could think of that you can suspect that your R-CHOP arm would perform differently from the one from Monjuvi phase III trial or the POLARIX phase III trial, at least in the IPI 3 to 5 group? That's the first question. The second one, just wondering for petosemtamab in frontline. Your trial design is chemo-free, so it's with pembrolizumab combo only, whereas [inaudible] is pembrolizumab plus chemo. Just wondering if you could elaborate a bit of rationale in that trial design to go without chemo, please. Thank you.

Jan Van de Winkel

Thanks, Xian. I think I'm going to pass them over again to you, Tahi.

Tahi Ahmadi

Thank you. On the frontline diffuse large B-cell, I think first things first. I think it's best if we 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 II data sets have been, not only in the second-line follicular lymphoma trial, but also now in the second, third-line diffuse large B-cell trial, in the combination with lenalidomide. The phase III trial is almost point to point replicated what had been described in the phase II data set. There's a lot of anticipation that we have, and I'm sure you too, for that trial. There's a lot of excitement about the results that are going to be then reported next quarter.

Tahi Ahmadi

As it relates to the performance of R-CHOP, 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's probably fair to say that R-CHOP in the past, as you pointed out yourself, has had a very robust performance. It kind of behaves the way R-CHOP behaves across multiple trials. Generally speaking, cross-trial comparisons on the control arm are always a little bit flawed because they are informed by regions and patients and all of these things. We don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP. On petosemtamab frontline, the question was what the reason was for the combination of pembrolizumab. A lot of these discussions happened a long time ago when this was still in the hands of Merus.

Tahi Ahmadi

I think, generally speaking, head and neck patients are known to be a fragile population. Locality of the disease, status of the patient play a significant role in the tolerability of the treatment. Even today, if you look at the paradigm, there are patients who get treated with pembrolizumab chemo, and there are patients who get treated only with pembrolizumab. That is not only a decision made by the CPS score, but it's probably even larger informed by the patient that sits in front of the physician and their status. The data that is out there in the phase II for the combination for pembrolizumab, petosemtamab, though, is dramatically different. It's twice a high response rate and durability than has been described even for chemotherapy pembrolizumab.

Tahi Ahmadi

In that regard, our anticipation is that petosemtamab and pembrolizumab is going to provide a truly very significant and important data set for patients with head and neck because it will have, hopefully, if it replicates the data in the phase II, a very significant OR and duration of response improvement even over chemotherapy combinations. We roughly range in the 30% range of response. We'll have a conversation about the comparison to what the JNJ strategy may or may not be when we have the data in our hands.

Jan Van de Winkel

Thanks, Tahi. I think very clear.

Xian Deng

Thank you.

Jan Van de Winkel

Thanks, Xian, for the questions. Let's move on to the next one.

Operator

Yes, of course. Now we're 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.

Rajan Sharma

Hi. Thanks for taking my questions. Firstly, just on EPKINLY and just on that first-line trial again. 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? I'm just wondering if, maybe I'm stretching here, but is that giving you increased confidence that the frontline trial could read out at the interim? Could you maybe just discuss your latest perspectives on the endometrial cancer treatment landscape? Merck have said that they've hit PFS and OS from the interim of their TROP2-ADC trial. Does that, in your mind, when the data come, will that set a bar for Rina-S? Could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and folate receptor alpha in endometrial? Thank you.

Jan Van de Winkel

Thanks, Rajan, for the questions. Before Tahi starts, I think for the frontline study, I could tell you we are super excited based on the phase II studies, the data released last year at ASH, the year before at ASH, Rajan. We believe that this data will be very, very good in the frontline setting. Of course, the second-line data was also fantastic data, but it's unrelated, I feel, to the frontline data because it's in a different setting with different patients, with different levels of illness. I think we are excited about both settings. The frontline setting, I think the enthusiasm comes from rapid recruitment and also running against the gold standard. Our shop has been for over 20 years the gold standard in diffuse large B-cell lymphoma.

Jan Van de Winkel

The phase II data actually show if that will translate to phase III, this will be sensational data. Let's hope for good data in the fourth quarter. Tahi, do you want to add anything to that? Then maybe Judith can go into the landscape for endometrial cancer.

Tahi Ahmadi

Yeah, sure. The only thing I would add is I tried to make that point earlier. I think Jan touched on that. The len epco phase III actually reported out the way we were anticipating and hoping, and this is like a pattern that we've seen. The efficacy and safety of EPKINLY is very predictable. We have seen now multiple times that phase II combination data approximates very closely to what then the phase III describes in a larger data set, and this is also just to underscore the point that Jan was making. One 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, never changing, never stopping landscape in endometrial and anywhere else.

Jan Van de Winkel

Thanks, Tahi. Judith, are you back online? Apparently not, maybe Tahi, you can dive a bit into the endometrial cancer landscape.

Tahi Ahmadi

I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a TOP1-ADC with a TROP2 target. That has really very little bearing on our strategy because I think from the very beginning, we were aware that this was going to read out before the data sets for Rina-S are going to be available. We continue to be very excited about Rina-S, not only in PROC, where we already guided we're going to have some data this year, but also in endometrial. Folate receptor alpha is expressed maybe on a lower level than on PROC, but it is expressed. One of the things that we have routinely and repeatedly described with Rina-S is this phenomenon of efficacy across a spectrum of folate receptor alpha expression. Endometrial is an exciting second indication.

Tahi Ahmadi

We initiated two phase III in that indication, we look very much forward to have that discussion when we have the data, I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Jan Van de Winkel

Absolutely. We have a Breakthrough Therapy Designation, of course, in one of the settings in endometrial cancer. It's super important. Let's move on to the next question.

Operator

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

Speaker 11

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

Jan Van de Winkel

Thanks, Eva, for the questions. We like those questions because we are super excited about the potential differentiation of petosemtamab. I will ask Tahi to give you a bit more color on why we are so excited. We will present more data from the phase II setting in colorectal cancer at the-

Tahi Ahmadi

Yeah.

Jan Van de Winkel

At ESMO conference. Also the combinations is also an area we are pursuing. Tahi, why don't you give a bit more color to Eva?

Tahi Ahmadi

Yes, please. Thank you. First things first, I think, colorectal as this new indication that we are embarking on with petosemtamab. 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 data set that had been shared, but that numerically showed very impressive OR data. Of course, this data set has grown both in numbers of patients and durability, and Jan already pointed out that we will share that. Our enthusiasm has continuously remained very high for what we see in this data set and underscores our conviction that petosemtamab is not only the really in every data set, colorectal, head and neck monotherapy, combination, continuously to show that on point estimates and cost study comparisons are difficult.

Tahi Ahmadi

It appears to have higher response rate and a better safety profile than, for example, amivantamab. This is what underscores the conviction that we really with petosemtamab have the best-in-class second-generation EGFR bispecific, and that will also translate into meaningful data sets in the phase III settings for both frontline and second-line colorectal, which is why we started these two trials now, even though, as you kind of like alluded to, JNJ already has started these trials. That's the colorectal part. The RAS field, of course, is super exciting. I worked on RAS inhibitor 12 years ago when it didn't work.

Tahi Ahmadi

It's a super fascinating field to watch, we are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal, we are actively engaging in discussions to really embark on these novel combinations. There will be more to come in the near future.

Jan Van de Winkel

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

Operator

Yes, of course. Now we'll go and take our next question. The question comes then of Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open, please ask your question.

Suzanne van Voorthuizen

Hi, this is Suzanne. Thanks for taking my questions. Also on petosemtamab, with your competitor or partner, J&J, going for accelerated approval with amivantamab in head and neck. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with petosemtamab at this point in time. Could you comment on that? Secondly, you mentioned a couple of times the high confidence in the best-in-class profile for petosemtamab compared to AMI. Could you elaborate on what is underpinning that confidence, the higher response, better safety in the datasets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action? Thank you.

Jan Van de Winkel

Suzanne, thank you very much for these questions. I'm going to hand them over in a sec to Tahi, I can tell you that you'll definitely have to wait for the ESMO dataset for the phase II data, which will give you a bit of further color why we are so enthusiastic. As it relates to the strategy, we think that we will have a differentiated drug, actually, based on everything we know. I'll pause here and let Tahi give you a bit more color, Suzanne, on the head and neck setting and frontline, second line accelerated approval versus potentially approval based on phase III.

Tahi Ahmadi

Yeah. Thank you. I'm going to reiterate what I tried to point out earlier. I think that if we step back on head and neck, where we are is we're going to have a top-line result in frontline in next quarter this year. Then AOS readout for the monotherapy in the first quarter of next year. I think this is completely different in terms of comprehensiveness, but also by capturing patient population profile than the accelerated profile now that J&J is pursuing with amivantamab in head and neck. We feel very comfortable, particularly because the larger population is in frontline. Our position where we are, and we're, of course, doing everything to accelerate these filings and these launches to the degree that is possible. Nothing changed on our end. We obviously did this, there's some partnership on amivantamab with J&J, some visibility to their plans.

Tahi Ahmadi

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. Your second question was around what again, sorry?

Jan Van de Winkel

Best-in-class criteria. Why do we say that?

Tahi Ahmadi

Why do we say this? Why do we say this? Cross-study comparisons are difficult, but if you just cross-compare monotherapy in second-line head and neck, the small dataset that were presented in combination with pembrolizumab in frontline for both trials, for both drugs. The colorectal combination with chemotherapy datasets that exist for both drugs. In all four of these datasets, actually, petosemtamab outperforms amivantamab on the efficacy. In totality, it does have a differentiated safety profile. It doesn't have the same challenges, to the degree, at least, with skin-related toxicities. I think it's a little bit speculative to figure out why that is, but they're clearly different antibodies with different secondary arms. It's not unreasonable to speculate that the difference in the second arm may have a biological mechanistic role that differentiates both on efficacy and safety.

Tahi Ahmadi

As is, and I think there's now a larger dataset, I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety. This is where we come with this conviction that we have a best-in-class asset in our hand.

Jan Van de Winkel

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

Operator

Thank you. Now we're going to take our next question. Now we're taking the question from Charlie Haywood from Bank of America. Your line is open, please ask your question.

Charlie Haywood

Hey, Charlie Haywood, Bank of America. Thanks for taking my questions. I have two, please. This first one is just, well, both actually, on Rina-S. First is on the second-line progression-free survival data you've got coming in fourth quarter. Both phase II, phase III in fourth quarter. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts, anything to consider as we sort of read across between the two? Secondly, we've seen limited phase II PFS data for the folate receptor class in general. Could you frame any target PFS profile or PFS delta versus control arm you'd expect to see to be clinically meaningful for that phase III readout? Thank you.

Jan Van de Winkel

Thanks, Charlie, for the questions. Tahi, can you address both of them, differences between the phase II and phase III, and then the profile as it relates to folate receptor alpha expression levels?

Tahi Ahmadi

Yeah. By inclusion, exclusion criteria, they're very much more or less the same patient population. There is a readout for sure based on the phase II data to the phase III data, the only difference is, of course, a phase II data set has always its own dynamics, vis-a-vis a phase III trial. There's obviously a larger footprint for a phase III trial as it relates to a phase II trial. These are 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. That's the difference between these two data sets, probably all to say to that. As it relates to speculating on the readout, I don't think I want to do that.

Tahi Ahmadi

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, 50%+, which is probably even more important, a very long durability of response. This duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AE, it then allows a long continuation of treatment, which then drives the duration of response. If you put these things together, you can already get a sense of the direction of the PFS, which I think will be without a doubt not only significant but also meaningful for patients. I think that's where we should leave it, then we can have this conversation when the data is in the public domain.

Jan Van de Winkel

Thanks, Tahi. On top of that, Charlie, you will get that we are like a year, one and a half years ahead of some of the potential competitors. I think we're in good shape here.

Charlie Haywood

Thank you.

Jan Van de Winkel

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

Operator

Yes, of course. Now we're going to take our next question. This question comes to line of Yaron Werber from TD Securities. Your line is open, please ask your question.

Yaron Werber

Great. Thank you so much. Quick question on petosemtamab. For the first-line study, can you just give us a sense when you upsized this study, can you confirm that you didn't change the powering assumption, and that you're enrolling the random distribution of HPV negative and positives that are in the market, you're not enriching specifically for only one subtype? Secondly, you're going to show us the second-line recurrent head and neck data at ESMO with or without pembrolizumab. Is there a chance that you might want to move to phase III in that study with pembrolizumab to complement your monotherapy second-line data, which is coming Q1 next year? Thank you.

Jan Van de Winkel

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

Tahi Ahmadi

Let's take the first one first. This is I think we said multiple times we changed this trial to increase the probability of success, and this was not in any particular shape or form driven by anything that really 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 one of the first things that we actually executed, and 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. I think that's all there is to say about this. The rest is not necessarily part of our thought process or anything that we have spoken about.

Tahi Ahmadi

The second question that you had was around other strategies for petosemtamab, and I would say this, we've been very clear there's going to be more to come on petosemtamab and head and neck. We will present these trials in the granularity and at a time similar to what we just did with colorectal when they are literally dosing patients. That is so in some near future, we'll have more conversation about more activities or what trials in head and neck, if that's fair.

Jan Van de Winkel

Thanks, Tahi. I think that's clear. Thanks, Yaron, for the questions.

Operator

Yes, of course. Now we're going to take our next question. The question comes line of Ben Jackson. Your line is open. Please ask the question.

Speaker 15

Brilliant. Thank you for the question. I've got two, please. The first one on Rina-S. We've seen a couple of other companies make moves into drugs that look to overcome TOP1 resistance. The aim for Rina-S is to come first to 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? Secondly, not a focus topic today, lots of other stuff going on, but obviously any updated thoughts on the EpCAM potential in I&I diseases where B-cell pathology is key. There's obviously a few competitors making noises in this area with similar drugs. It'd be interesting to hear your thoughts there. Thank you.

Jan Van de Winkel

Thanks, Ben, for the question. With Rina-S, we of course hope to be first to the market and we are going to read out already a phase III in Q4. Tahi, do you want to comment on TOP1 resistance and strategy for Rina-S?

Tahi Ahmadi

Well, I mean, you said the 1st one, the most important part is there are already three phase IIIs actively enrolling patients in ovarian cancer. One in PARP and two in PSOC, one maintenance and one in the platinum replacement strategy. We are constantly and actively working on moving essentially the entry point for Rina-S into earlier lines. We have already talked about that there's more to come also in the ovarian cancer space with Rina-S. That's basically the reality. You have to develop these drugs, just try to move into earlier lines as efficiently and as effectively as data allows and operation allows.

Tahi Ahmadi

That's the first, partly also the only thing to say about this emerging idea of TOPO resistance, because if Rina-S, which we have very confidence will be the 1st TOPO payload ADC in PARP, this is more a post-Rina-S problem, to be honest.

Jan Van de Winkel

Exactly. I&I and epcoritamab, right now the focus is on cancer, multiple cancers, and we will have exciting data readout in Q4. Let's discuss I&I in more detail in the future. Cancer is clearly the priority for us by now. Operator, can we move to the next question?

Operator

Yes, of course. Now we're going to take our next question. The question comes line of Judah Frommer from Morgan Stanley. Your line is open. Please ask the question.

Judah Frommer

Hi, thanks for taking the question. Maybe just a follow-up on petosemtamab in frontline. Can you help us with thoughts on the nature of the update in Q4? It'll be a top line, can you give us any direction on whether you'll press release in line with some of the top lines we've seen for EPKINLY, or could we potentially see subgroup data perhaps by HPV status? If not, do you have a sense for when we would see responses by HPV negative versus positive patients? Thanks.

Jan Van de Winkel

Thanks, Judah. Tahi, can you give a bit of color on the top line results that we intend to present in the Q4 timeframe?

Tahi Ahmadi

Well, I think the accurate response to that question is top-line results in Genmab historically focus on the primary endpoint. I think that's what's going to be happening for petosemtamab as well. 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 conference.

Jan Van de Winkel

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

Operator

Thank you. Now we're going to take another question. Now the question comes to line of Victor Floc'h from BNP Paribas. Your line is open. Please ask your question.

Victor Floc'h

Hi. Thanks so much for taking my questions. Actually two questions on EPKINLY. First one, very impressive momentum lately, obviously you've mentioned the accelerated uptake in the community setting. Just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling the remainder of the year for EPKINLY? My second question, still on EPKINLY, but on IP. There is a report from Bloomberg arguing that EPKINLY's formulation patent family could extend beyond the combination of matter patents and could potentially add five years, potentially in the U.S., six years in Europe. Just wondering whether you can discuss your IP strategy and your current assumption for EPKINLY in terms of IP. Thanks so much.

Jan Van de Winkel

Thanks, Victor, for the questions. The first one can be handled by Brad, the second one, I think I will ask Tahi to give some color on the length of time for the patents. Brad, why don't you start on the stocking question?

Brad Bailey

Yeah, no, thank you for the question. Just briefly on the community, we are encouraged, as you mentioned, with the momentum there, it's due to the dual indications, the only bispecific with the dual indications, and it's really been received extremely well by physicians as well as health systems. As it relates specifically to stocking, no stocking issue or no stocking at this point in time to be discussed.

Jan Van de Winkel

Thanks, Brad. Tahi, do you want to add to address the IP and the length of time we have patent protection, or don't you want to do that right now?

Tahi Ahmadi

Yeah, I would say this, discussing our patent and IP strategy on calls like this in the nuance details is probably not appropriate. Right now, I would stick to mid-30s is where we are. Then, of course, there's always an IP strategy to try to generate additional intellectual protection, property protection that helpfully extends some of that protection.

Jan Van de Winkel

Okay, thanks, Tahi. I think, Victor, we keep it to that for now.

Victor Floc'h

Great. Thank you very much.

Jan Van de Winkel

Thanks.

Operator

Thank you.

Jan Van de Winkel

Any further questions?

Operator

We have. Would you like to take?

Jan Van de Winkel

Yes. Why don't we take one or two more, and then we probably have to end the call and follow it up one-on-one.

Operator

Yes, of course. Of course, not a problem. Now we're going to take our next question then. The question comes from line of Kalpit Patel. Your line is open. Please ask your question.

Speaker 18

Yeah, hey, thanks for taking the question. One 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 so in line with what you guys originally modeled when you first started the study? Then when you completed the enrollment, I believe in 2024, did that estimate, the timing estimate of the readout materially shift? 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.

Jan Van de Winkel

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're not going to address any further timing and timeline issues here. Look forward to the data.

Operator

Thank you. Now we're going to take our final question for today. Just give us a moment. The question comes line of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Matthew Phipps

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

Jan Van de Winkel

Thanks, Matt, 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-S?

Tahi Ahmadi

It is fair to assume that we will also explore, if it is opportune, Project FrontRunner opportunities for colorectal for both trials. I think that is a fair assumption. On the lung cancer Rina-S trial, once we have a data set 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. I have said this many times, we are working in a super competitive environment. There are multiple folate receptor ADCs from very large competitors that are coming left and right. I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. We will present that data at the time when we also have the next steps ready.

Jan Van de Winkel

Thanks, Tahi. Thanks, Matt. Thank you all for joining us today, and thank you for that lively and invigorating Q&A. With three super important phase III studies reading out in the coming months, we are well on track to deliver sustainable growth well into the next decades. We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. As always, if you have questions for now, please reach out to our IR team.

Operator

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

Tahi Ahmadi

Thank you

Investor releaseQuarter not tagged2026-08-05

Earnings To Watch: Genmab AS (GMAB) Q2 2026 -- GF Value Sees 47% Upside

GuruFocus.com

This article first appeared on GuruFocus. Genmab AS (NASDAQ:GMAB) is set to release its Q2 2026 earnings on Aug 6, 2026. The consensus estimate for Q2 2026 revenue is 1112.13 million, and the earnings are expected to come in at 0.33 per share. The full year 2026's revenue is expected to be $4364.12 million and the earnings are expected to be $1.13 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 5 Warning Signs with GMAB. Is GMAB fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for Genmab AS (NASDAQ:GMAB) have increased from $4314.69 million to $4364.12 million for the full year 2026 and increased from $5168.42 million to $5216.59 million for 2027 over the past 90 days. Earnings estimates for Genmab AS (NASDAQ:GMAB) have declined from $1.22 per share to $1.13 per share for the full year 2026 and declined from $1.94 per share to $1.71 per share for 2027 over the past 90 days. In the previous quarter of 2026-03-31, Genmab AS's (NASDAQ:GMAB) actual revenue was $896 million, which missed analysts' revenue expectations of $911.599 million by -1.71%. Genmab AS's (NASDAQ:GMAB) actual earnings were $0.08 per share, which missed analysts' earnings expectations of $0.327 per share by -74.62%. After releasing the results, Genmab AS (NASDAQ:GMAB) was down by -2.98% in one day. Based on the one-year price targets offered by 13 analysts, the average target price for Genmab AS (NASDAQ:GMAB) is $39.38 with a high estimate of $48 and a low estimate of $32. The average target implies an upside of 35.76% from the current price of $29.01. Based on GuruFocus estimates, the estimated GF Value for Genmab AS (NASDAQ:GMAB) in one year is $42.52, suggesting an upside of 46.57% from the current price of $29.01. Based on the consensus recommendation from 14 brokerage firms, Genmab AS's (NASDAQ:GMAB) average brokerage recommendation is currently 1.6, indicating a "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-15

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Second Quarter of 2026

GlobeNewswire
Company Announcement Net sales of DARZALEX® in the second quarter of 2026 totaled USD 4,207 million Genmab receives royalties on worldwide net sales from Johnson & Johnson (J&J, legal entity Janssen Biotech, Inc.) COPENHAGEN, Denmark; July 15, 2026 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by J&J were USD 4,207 million in the second quarter of 2026. Net trade sales were USD 2,435 million in the U.S. and USD 1,772 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Contact:        Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: [email protected] Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: [email protected] This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ m…Read full document

Company Announcement Net sales of DARZALEX® in the second quarter of 2026 totaled USD 4,207 million Genmab receives royalties on worldwide net sales from Johnson & Johnson (J&J, legal entity Janssen Biotech, Inc.) COPENHAGEN, Denmark; July 15, 2026 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by J&J were USD 4,207 million in the second quarter of 2026. Net trade sales were USD 2,435 million in the U.S. and USD 1,772 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Contact:        Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: [email protected] Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: [email protected] This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson. Company Announcement no. 33CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 150726_CA33_DARZALEX Q2 2026 sales

Investor releaseQuarter not tagged2026-07-08

Is Genmab A/S (GMAB) Stock Undervalued After Positive Epkinly DLBCL Trial Results?

Insider Monkey
We recently compiled a list of the 10 Best Innovative Healthcare Stocks to Buy Now. Genmab A/S (NASDAQ:GMAB) is one of the best healthcare stocks on our list. TheFly reported on July 2 that H.C. Wainwright analyst Raghuram Selvaraju increased the price target on GMAB to $40 from $38 while reaffirming a Buy rating on the shares. The revision followed the company’s announcement that the EPCORE DLBCL-4 trial achieved its primary endpoint. Based on the trial outcome, the firm raised its estimated likelihood of regulatory approval for Epkinly to 70% in the first-line setting and 95% in the second-line setting. In a major secondary development on July 6, Genmab A/S (NASDAQ:GMAB) announced that the European Commission approved marketing authorization for TEPKINLY in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. The approval was supported by findings from the Phase 3 EPCORE FL-1 trial, which evaluated a fixed-duration TEPKINLY plus R2 regimen against the standard R2 treatment. GMAB highlighted that the results demonstrated the therapy’s potential to deliver durable responses through a chemotherapy-free approach for patients with limited treatment options. Epcoritamab is being jointly developed with AbbVie (ABBV) through their oncology partnership, with both companies sharing commercial responsibilities in the U.S. and Japan, while AbbVie manages additional global commercialization. Genmab A/S (NASDAQ:GMAB) is a global biotechnology company headquartered in Copenhagen, Denmark, focused on developing innovative antibody-based therapies for cancer and other serious diseases. The company uses advanced AI, computational science, and proprietary platforms to create next-generation medicines, including DuoBody bispecific antibodies, HexaBody immune-enhancing technology, and ADC platforms expanded through its acquisition of ProfoundBio. While we acknowledge the potential of GMAB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monke…Read full document

We recently compiled a list of the 10 Best Innovative Healthcare Stocks to Buy Now. Genmab A/S (NASDAQ:GMAB) is one of the best healthcare stocks on our list. TheFly reported on July 2 that H.C. Wainwright analyst Raghuram Selvaraju increased the price target on GMAB to $40 from $38 while reaffirming a Buy rating on the shares. The revision followed the company’s announcement that the EPCORE DLBCL-4 trial achieved its primary endpoint. Based on the trial outcome, the firm raised its estimated likelihood of regulatory approval for Epkinly to 70% in the first-line setting and 95% in the second-line setting. In a major secondary development on July 6, Genmab A/S (NASDAQ:GMAB) announced that the European Commission approved marketing authorization for TEPKINLY in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. The approval was supported by findings from the Phase 3 EPCORE FL-1 trial, which evaluated a fixed-duration TEPKINLY plus R2 regimen against the standard R2 treatment. GMAB highlighted that the results demonstrated the therapy’s potential to deliver durable responses through a chemotherapy-free approach for patients with limited treatment options. Epcoritamab is being jointly developed with AbbVie (ABBV) through their oncology partnership, with both companies sharing commercial responsibilities in the U.S. and Japan, while AbbVie manages additional global commercialization. Genmab A/S (NASDAQ:GMAB) is a global biotechnology company headquartered in Copenhagen, Denmark, focused on developing innovative antibody-based therapies for cancer and other serious diseases. The company uses advanced AI, computational science, and proprietary platforms to create next-generation medicines, including DuoBody bispecific antibodies, HexaBody immune-enhancing technology, and ADC platforms expanded through its acquisition of ProfoundBio. While we acknowledge the potential of GMAB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

Investor releaseQuarter not tagged2026-06-29

Genmab Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Demonstrating Statistically Significant Improvement in Progression-Free Survival

Business Wire
Company Announcement Topline results from Phase 3 EPCORE® DLBCL-4 evaluating epcoritamab in combination with lenalidomide demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) EPCORE DLBCL-4 demonstrated improved PFS with a chemotherapy-free combination treatment regimen in patients with R/R DLBCL COPENHAGEN, Denmark, June 29, 2026--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of fixed duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, and lenalidomide, compared to standard-of-care, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of treatment. Based on topline results, the trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p value < 0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p value < 0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively. The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the previously reported safety profiles of the individual agents (epcoritamab or lenalidomide). "These topline results add to the growing evidence supporting the versatility of epcoritamab-based combinations, including fixed-duration epcoritamab, across lines of therapy for patients with relapsed or refractory large B-cell lymphoma who received at least one prior treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "With each new combination and treatment setting, we are building on our vision for epcoritamab as a core therapy across B-cell malignancies. We look forward to engaging with regulatory authorities as we continue to advance this program." Genmab and AbbVie will engage global regulatory authorities. Data will be submitted for presentation at a future medical meeting. About the EPCORE® DLBCL-4 TrialEPCORE DLBCL-4 (NCT06508658) is a global Phase 3 open label, multi-ce…Read full document

Company Announcement Topline results from Phase 3 EPCORE® DLBCL-4 evaluating epcoritamab in combination with lenalidomide demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) EPCORE DLBCL-4 demonstrated improved PFS with a chemotherapy-free combination treatment regimen in patients with R/R DLBCL COPENHAGEN, Denmark, June 29, 2026--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of fixed duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, and lenalidomide, compared to standard-of-care, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of treatment. Based on topline results, the trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p value < 0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p value < 0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively. The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the previously reported safety profiles of the individual agents (epcoritamab or lenalidomide). "These topline results add to the growing evidence supporting the versatility of epcoritamab-based combinations, including fixed-duration epcoritamab, across lines of therapy for patients with relapsed or refractory large B-cell lymphoma who received at least one prior treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "With each new combination and treatment setting, we are building on our vision for epcoritamab as a core therapy across B-cell malignancies. We look forward to engaging with regulatory authorities as we continue to advance this program." Genmab and AbbVie will engage global regulatory authorities. Data will be submitted for presentation at a future medical meeting. About the EPCORE® DLBCL-4 TrialEPCORE DLBCL-4 (NCT06508658) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) in combination with lenalidomide compared to chemoimmunotherapy, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including patients with diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC and B-cell /lymphoma 2 (BCL2) and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B), T-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr Virus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). Patients in the trial were previously treated with at least one line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy, and failed or relapsed after, or were not a candidate for autologous stem cell transplantation (ASCT) and ineligible for or unable to receive CAR-T since DLBCL diagnosis. The trial started on August 13, 2024, and is ongoing. More information on this trial can be found at https://clinicaltrials.gov/study/NCT06508658 (NCT: NCT06508658). About Diffuse Large B-Cell LymphomaDiffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.i,ii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.iii DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.iv,v DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,vi About EpcoritamabEpcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vii Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976) and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab have not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. Please see local country prescribing information for all labeled indication and safety information. What is EPKINLY?EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATIONImportant Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Medication Guide, including Important Warnings. About GenmabGenmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. This Company Announcement contains forward looking statements. The words "believe," "expect," "anticipate," "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO™. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. View source version on businesswire.com: https://www.businesswire.com/news/home/20260629433290/en/ Contacts Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: [email protected] Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: [email protected]

Investor releaseQuarter not tagged2026-06-11

Genmab Presents EPCORE® FL-1 Subgroup Data Demonstrating Consistent Efficacy and Safety Results for Epcoritamab in Combination with Rituximab and Lenalidomide (R2) Across Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Patients

GlobeNewswire
Media Release COPENHAGEN, Denmark; June 11, 2026 Findings from a post-hoc subgroup analysis of the Phase 3 EPCORE® FL-1 trial reinforce fixed-duration epcoritamab in combination with rituximab and lenalidomide (R2 ) data across subgroups in this trial of relapsed or refractory (R/R) follicular lymphoma (FL) patients treated in the second-line or later setting Epcoritamab in combination with R2 demonstrated sustained efficacy with manageable safety, regardless of baseline risk factors, including those traditionally associated with higher- or lower-risk disease factors Data were presented during an oral presentation at the 2026 European Hematology Association (EHA) Congress Genmab A/S (Nasdaq: GMAB) today announced new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE® FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), which showed that epcoritamab + R2 delivered consistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score). These results were presented during an oral presentation (abstract S229) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11 -14, 2026. “The EPCORE FL-1 trial, bolstered by this subgroup analysis, established fixed-duration epcoritamab in combination with R2 for relapsed or refractory follicular lymphoma,” said Benoit Tessoulin, M.D., Ph.D., Nantes University School of Medicine & University Hospital. “It delivers consistent efficacy and a manageable safety profile, regardless of comorbidity burden.” The EPCORE FL-1 trial randomized a total of 481 patients, with 243 receiving epcoritamab + R2 and 238 receiving R2 alone. The subgroup analysis of the Phase 3 EPCORE FL-1 trial was performed to assess the benefit and tolerability of epcoritamab + R2 across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared with standard of care R2. The data demonstrated that progression-…Read full document

Media Release COPENHAGEN, Denmark; June 11, 2026 Findings from a post-hoc subgroup analysis of the Phase 3 EPCORE® FL-1 trial reinforce fixed-duration epcoritamab in combination with rituximab and lenalidomide (R2 ) data across subgroups in this trial of relapsed or refractory (R/R) follicular lymphoma (FL) patients treated in the second-line or later setting Epcoritamab in combination with R2 demonstrated sustained efficacy with manageable safety, regardless of baseline risk factors, including those traditionally associated with higher- or lower-risk disease factors Data were presented during an oral presentation at the 2026 European Hematology Association (EHA) Congress Genmab A/S (Nasdaq: GMAB) today announced new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE® FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), which showed that epcoritamab + R2 delivered consistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score). These results were presented during an oral presentation (abstract S229) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11 -14, 2026. “The EPCORE FL-1 trial, bolstered by this subgroup analysis, established fixed-duration epcoritamab in combination with R2 for relapsed or refractory follicular lymphoma,” said Benoit Tessoulin, M.D., Ph.D., Nantes University School of Medicine & University Hospital. “It delivers consistent efficacy and a manageable safety profile, regardless of comorbidity burden.” The EPCORE FL-1 trial randomized a total of 481 patients, with 243 receiving epcoritamab + R2 and 238 receiving R2 alone. The subgroup analysis of the Phase 3 EPCORE FL-1 trial was performed to assess the benefit and tolerability of epcoritamab + R2 across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared with standard of care R2. The data demonstrated that progression-free survival (PFS) benefits continued to favor epcoritamab + R2, with hazard ratios (HR) consistently below 0.3 across FLIPI 0–2 (0.18 [0.10–0.33]) and FLIPI 3–5 (0.25 [0.15–0.42]), POD24 (HR 0.22 [95% CI 0.13–0.37]), and non-Hodgkin lymphoma 5 (NHL-5) subgroups (low: HR 0.27 [0.17–0.42]; H+I, high and intermediate: HR 0.14 [0.06–0.29]), indicating a substantially reduced risk of disease progression or death. Additionally, overall response rates (ORR) were higher with the combination of epcoritamab and R² compared to R² alone across different FLIPI risk groups. For patients with FLIPI scores of 0–2, the ORR was 96.5% with the combination versus 84.8% for R2 alone. In patients with FLIPI scores of 3–5, the ORR was 93.0% with the combination compared to 72.6% with R2 alone. Moreover, complete response rates (CRR) were consistently higher with epcoritamab and R² across all analyzed subgroups. In patients with lower FLIPI scores (0–2), the CRR was 86.6% with the combination, compared to 62.1% for R2 alone. Among those with higher FLIPI scores (3–5), the CRR was 77.0% for the combination versus 35.4% for R² alone. Similar improvements in CRR were noted among non-POD24 patients (85.5% vs. 57.6%) and across various patient fitness categories, including NHL-5 low-risk patients (81.3% vs. 50.3%) and H+I patients (85.7% vs. 49.0%). The safety profile of epcoritamab + R2 was manageable across all patient subgroups and consistent with that observed in the overall trial population, with no new safety signals identified. Although adverse events such as neutropenia and infections were more frequent among patients receiving lower lenalidomide doses, the consistent and sustained efficacy of epcoritamab + R2 compared with R² alone was maintained in this subgroup. These findings are consistent with standard clinical practice, in which lenalidomide dose reductions are routinely implemented to manage adverse events while preserving treatment benefit in combination with epcoritamab. “The EPCORE FL-1 subgroup analysis demonstrated consistent and deep responses with a manageable safety profile across all patient characteristics, including varying risk profiles and lenalidomide dosing schedule, which validate the potential of the combination therapy,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “These data strongly reinforce our belief that epcoritamab, combined with rituximab and lenalidomide, is poised to transform the treatment paradigm, offering a highly effective and broadly accessible option for relapsed or refractory follicular lymphoma.” About the EPCORE® FL-1 TrialEPCORE® FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). More information on this trial can be found at www.clinicaltrials.gov/. About Follicular Lymphoma (FL)Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases.i  FL is considered incurable.ii Patients often relapse, and with each relapse the remission and time to next treatment shorten.iii Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.iii,ivAbout Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Contact:        David Freundel, Senior Director, Global Communications & Corporate AffairsT: +1 609 613 0504; E: [email protected] Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: [email protected] Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. i Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed May 2026.ii Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421iii Rivas‐Delgado, A., Magnano, L., Moreno‐Velázquez, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708iv Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6. PMID: 18838711.v Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. Media Release no. 07CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 061126_MR_07_EHA FL-1 Subanalysis

Investor releaseQuarter not tagged2026-06-11

Genmab Presents EPCORE® FL-1 Subgroup Data Demonstrating Consistent Efficacy and Safety Results for Epcoritamab in Combination with Rituximab and Lenalidomide (R2) Across Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Patients

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Findings from a post-hoc subgroup analysis of the Phase 3 EPCORE® FL-1 trial reinforce fixed-duration epcoritamab in combination with rituximab and lenalidomide (R2 ) data across subgroups in this trial of relapsed or refractory (R/R) follicular lymphoma (FL) patients treated in the second-line or later setting Epcoritamab in combination with R2 demonstrated sustained efficacy with manageable safety, regardless of baseline risk factors, including those traditionally associated with higher- or lower-risk disease factors Data were presented during an oral presentation at the 2026 European Hematology Association (EHA) Congress COPENHAGEN, Denmark, June 11, 2026--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE® FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), which showed that epcoritamab + R2 delivered consistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score). These results were presented during an oral presentation (abstract S229) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11 -14, 2026. "The EPCORE FL-1 trial, bolstered by this subgroup analysis, established fixed-duration epcoritamab in combination with R2 for relapsed or refractory follicular lymphoma," said Benoit Tessoulin, M.D., Ph.D., Nantes University School of Medicine & University Hospital. "It delivers consistent efficacy and a manageable safety profile, regardless of comorbidity burden." The EPCORE FL-1 trial randomized a total of 481 patients, with 243 receiving epcoritamab + R2 and 238 receiving R2 alone. The subgroup analysis of the Phase 3 EPCORE FL-1 trial was performed to assess the benefit and tolerability of epcoritamab + R2 across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared with standard of care R2. The data demonstrated that progress…Read full document

Findings from a post-hoc subgroup analysis of the Phase 3 EPCORE® FL-1 trial reinforce fixed-duration epcoritamab in combination with rituximab and lenalidomide (R2 ) data across subgroups in this trial of relapsed or refractory (R/R) follicular lymphoma (FL) patients treated in the second-line or later setting Epcoritamab in combination with R2 demonstrated sustained efficacy with manageable safety, regardless of baseline risk factors, including those traditionally associated with higher- or lower-risk disease factors Data were presented during an oral presentation at the 2026 European Hematology Association (EHA) Congress COPENHAGEN, Denmark, June 11, 2026--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE® FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), which showed that epcoritamab + R2 delivered consistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score). These results were presented during an oral presentation (abstract S229) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11 -14, 2026. "The EPCORE FL-1 trial, bolstered by this subgroup analysis, established fixed-duration epcoritamab in combination with R2 for relapsed or refractory follicular lymphoma," said Benoit Tessoulin, M.D., Ph.D., Nantes University School of Medicine & University Hospital. "It delivers consistent efficacy and a manageable safety profile, regardless of comorbidity burden." The EPCORE FL-1 trial randomized a total of 481 patients, with 243 receiving epcoritamab + R2 and 238 receiving R2 alone. The subgroup analysis of the Phase 3 EPCORE FL-1 trial was performed to assess the benefit and tolerability of epcoritamab + R2 across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared with standard of care R2. The data demonstrated that progression-free survival (PFS) benefits continued to favor epcoritamab + R2, with hazard ratios (HR) consistently below 0.3 across FLIPI 0–2 (0.18 [0.10–0.33]) and FLIPI 3–5 (0.25 [0.15–0.42]), POD24 (HR 0.22 [95% CI 0.13–0.37]), and non-Hodgkin lymphoma 5 (NHL-5) subgroups (low: HR 0.27 [0.17–0.42]; H+I, high and intermediate: HR 0.14 [0.06–0.29]), indicating a substantially reduced risk of disease progression or death. Additionally, overall response rates (ORR) were higher with the combination of epcoritamab and R² compared to R² alone across different FLIPI risk groups. For patients with FLIPI scores of 0–2, the ORR was 96.5% with the combination versus 84.8% for R2 alone. In patients with FLIPI scores of 3–5, the ORR was 93.0% with the combination compared to 72.6% with R2 alone. Moreover, complete response rates (CRR) were consistently higher with epcoritamab and R² across all analyzed subgroups. In patients with lower FLIPI scores (0–2), the CRR was 86.6% with the combination, compared to 62.1% for R2 alone. Among those with higher FLIPI scores (3–5), the CRR was 77.0% for the combination versus 35.4% for R² alone. Similar improvements in CRR were noted among non-POD24 patients (85.5% vs. 57.6%) and across various patient fitness categories, including NHL-5 low-risk patients (81.3% vs. 50.3%) and H+I patients (85.7% vs. 49.0%). The safety profile of epcoritamab + R2 was manageable across all patient subgroups and consistent with that observed in the overall trial population, with no new safety signals identified. Although adverse events such as neutropenia and infections were more frequent among patients receiving lower lenalidomide doses, the consistent and sustained efficacy of epcoritamab + R2 compared with R² alone was maintained in this subgroup. These findings are consistent with standard clinical practice, in which lenalidomide dose reductions are routinely implemented to manage adverse events while preserving treatment benefit in combination with epcoritamab. "The EPCORE FL-1 subgroup analysis demonstrated consistent and deep responses with a manageable safety profile across all patient characteristics, including varying risk profiles and lenalidomide dosing schedule, which validate the potential of the combination therapy," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "These data strongly reinforce our belief that epcoritamab, combined with rituximab and lenalidomide, is poised to transform the treatment paradigm, offering a highly effective and broadly accessible option for relapsed or refractory follicular lymphoma." About the EPCORE® FL-1 TrialEPCORE® FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). More information on this trial can be found at www.clinicaltrials.gov/. About Follicular Lymphoma (FL)Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases.i FL is considered incurable.ii Patients often relapse, and with each relapse the remission and time to next treatment shorten.iii Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.iii,iv About EpcoritamabEpcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. What is EPKINLY?EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATIONImportant Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Medication Guide, including Important Warnings. About GenmabGenmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. This Media Release contains forward looking statements. The words "believe," "expect," "anticipate," "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. View source version on businesswire.com: https://www.businesswire.com/news/home/20260610500156/en/ Contacts David Freundel, Senior Director, Global Communications & Corporate AffairsT: +1 609 613 0504; E: [email protected] Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: [email protected]

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