GENMAB A/S(GMAB)Q2 2026 法說會逐字稿

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

Hello, everyone, and welcome to our financial results call for the first half of 2026. With me today are our Chief Financial Officer, Anthony Pagano; our Chief Commercial Officer, Brad Bailey; and our Chief Medical Officer, Tahamtan Ahmadi. For the Q&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. 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 a 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. This makes EPKINLY 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 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, and Tahamtan 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. 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 III platinum-resistant ovarian cancer datasets will be available in the fourth quarter. For petosemtamab, we are eagerly awaiting the readouts for both head and neck studies. 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 2027. Finally, for EPKINLY, we anticipate that top-line data from the front-line 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 Tahamtan to walk you through the details of the Phase III colorectal studies. Tahamtan, the floor is yours.

Thank you, Jan. We are pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing Phase III trials in head and neck cancer. There are a significant number of patients impacted by these diseases. As you know, petosemtamab is an EGFR-LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care, and LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has been 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, and we will be able to show more on this at ESMO in October. Based on this promising data, we are initiating two Phase III studies: one in frontline and one in second-line colorectal cancer. For frontline, we have already initiated a Phase III randomized, open-label, global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator-choice chemotherapy of either modified FOLFOXIRI or FOLFIRI as first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS/RAF wild-type. This trial will be versus the standard of care, cetuximab plus chemotherapy. For the second-line colorectal cancer patients, the Phase III trial will be similarly randomized, open-label, and global. This trial is designed to assess the efficacy and safety of petosemtamab plus investigator-choice therapy of either modified FOLFIRI as a second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS wild-type. The comparator will be standard of care, which will be cetuximab 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 multi-indication asset with the potential to reach a significant number of patients. With that, I am pleased to hand over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

Thanks, Tahamtan. Our proprietary portfolio performed incredibly well in the first half of the year. Sales 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 2026 reflects growth for both EPKINLY and TIVDAK globally. We are very pleased with how EPKINLY 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 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 follicular lymphoma 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 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 follicular lymphoma, 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 follicular lymphoma. 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, EPKINLY continues to build on its compelling position in the market with approvals in both DLBCL and follicular lymphoma. We expect the second-line follicular lymphoma 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 follicular lymphoma in Europe and China. Overall, we are really pleased with EPKINLY's growth globally and particularly in the U.S. and Japan. 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 2026, we are focused on continuing to grow EPKINLY and strengthening our leadership in the market by maximizing our first-mover advantage in second-line follicular lymphoma and preparing for anticipated launches in early lines of DLBCL in the future. Turning briefly to TIVDAK, TIVDAK totaled $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 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 2026, 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 2026 and into 2027 and beyond. With that, I will turn it over to Anthony to walk us through the financials.

Thanks, Brad. The first half of 2026 demonstrated the continued strength of our business, with revenue growing 25% year-over-year. Beyond the headline 25% revenue growth, I would 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. Now turning to broad-based growth: approximately half of our year-over-year revenue growth came from DARZALEX, with the other half 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. 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 expanding 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. As 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 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 $4.3 to $4.5 billion, representing 19% year-over-year growth at the midpoint, compared 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 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 $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. 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. Now, on that note, I am going to hand it back over to Jan.

Thank you, Anthony. Looking at the first half overall, we have 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 and our versatile and promising product pipeline — I am very excited about what is still to come in the coming months. That now ends our formal presentation, and thank you for listening. Operator, please open the call for questions.

Thank you so much. Dear participants, to ask a 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. We will now take our first question, which comes from the line of Zain Ebrahim. Your line is open. Please ask your question.

Everyone, thanks for taking the questions. This is Zain Ebrahim from JPMorgan. First question is on the petosemtamab second-line trial, which you are now guiding for the readout in Q1 2027. I wanted to understand what is driving the slight delay to the readout in Q1 — is it the change in the primary endpoint to overall 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 any updates there would be helpful. My second question is on DLBCL-4. It is quite a strong PFS outcome, but 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 frontline trial could be used as a confirmatory trial?

Thank you, Zain, for the questions. I will hand both of them over to Tahamtan. Tahamtan, can you start with the second-line petosemtamab trial and then move on to DLBCL to address the points raised?

Thank you for the question. On petosemtamab, as you correctly noted, the endpoint is overall survival, so this is an event-driven projection for when we will have the data and the trials are fully enrolled. We are updating based on what we see and now expect top-line results in the first quarter of next year. Regarding the EPCORE DLBCL-4 trial, this is a very exciting PFS benefit for patients for what is a chemo-free regimen — an oral pill with a subcutaneous injection — and with a really impressive CR rate for patients. That CR rate is one of the most meaningful data points, and we are very excited about the results. Overall survival is still immature at this point, which is why it has not yet been reported; the data will be presented at upcoming conferences and will allow us to examine it in more granular detail. On the confirmatory trial question, we are actively engaging with the agency on all fronts. Whether frontline or the second-line trial will be used as the confirmatory trial is an ongoing discussion and will depend in part on the frontline results. We are in active engagement with the agency and will provide more information as those discussions progress. Thank you.

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

We will now take our next question, which comes from the line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

I have one on EPCORE DLBCL-2, and I'm 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 of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

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

We are very excited about the results of this trial, which will 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 in the public domain presented at ASH over the last two years on the combination of epcoritamab with R-CHOP that showed unprecedented CR rates, which is driving the excitement for this Phase III trial. All I can say now is that the interim analysis will be reported next quarter as top-line data. Once we have the data in our hands, we'll have a detailed conversation about the questions that may arise. For now, we look forward to next quarter. Thanks.

Thanks, Michael, for the question.

We will now take our next question from the line of James Gordon from Barclays. Your line is open. Please ask your question.

Hello, it's James Gordon from Barclays. A couple of clarifications please. First, on the frontline trial versus the refractory trial: the frontline trial is now going to report before the refractory trial, presumably because the frontline has an ORR primary with an interim OS, whereas the refractory trial is more mature OS. For the frontline trial that you plan to report in Q4, how mature will the interim OS be when you report it that you plan to file? Which trial do you think is a higher bar in terms of being successful? Then two clarifications: for EPKINLY, if the interim in the frontline trial does not cross the boundary, will you tell us that and say that the trial will continue to the final data, or will you not say anything and we should assume it did not work? And regarding Rina-S and PROC, there are both a Phase II and a Phase III in Q4; are we going to get two different readouts, or will it be the Phase III that is material because that's what you are filing? Will we get all the data together?

Thanks, James, for the questions and the clarification requests. I'll hand the first two to Tahamtan, and Judith can provide color on the Phase II and Phase III datasets for Rina-S in PROC, although Judith may not be available immediately. Tahamtan, please start.

Regarding petosemtamab and the frontline trial: we have been precise now that we will have the top-line results for the frontline indication next quarter. Frontline is a larger population and, if positive, has a significantly larger impact on patients. On whether it will meet statistical significance, it would be speculative to answer now; we will discuss that when we have the interim results in hand. As to whether OS in one indication is a higher bar than the other, generally speaking, demonstrating an OS benefit is always a higher bar. We have high confidence in petosemtamab's potential to provide an overall survival benefit in frontline and in second line, which is underpinned by Breakthrough Therapy Designation datasets in the public domain and our growing confidence in the drug across indications. On the EPKINLY frontline interim, our expectation is that we will present the interim data next quarter. If the interim does not meet the boundary, we will provide appropriate disclosure consistent with our historical approach when we have the data. For Rina-S in PROC, there will indeed be both a Phase II and a Phase III; both datasets will be made available when we have top-line results, and both will inform our decisions and communications. Once we have the data, we'll provide full details. Thank you.

Thanks. Judith, are you available to add anything on the Phase II and Phase III datasets for PROC?

Judith is unmuted but appears not to be speaking at this time. I'll reiterate: both datasets will be made available when we have top-line results. That should cover the clarification for now.

Thanks, James.

We will now take our next question from the line of Gregory Renza from Truist. Your line is open. Please ask your question.

Hi, thanks so much for taking our question. This is Asthika on for Gregory. One for petosemtamab in head and neck: with competitors advancing quickly in the second- and third-line setting ahead of your expected readout in Q1 next year, what efficacy and durability profile would petosemtamab need to show to remain competitive?

Thanks, Gregory. Tahamtan, can you take this one?

You are alluding to competitor filings, and one thing to say is that our second-line dataset will be a Phase III with an overall survival endpoint, which is a different type of dataset than one geared toward accelerated approval. We remain steadfast in our belief that petosemtamab is best-in-class among second-generation EGFR bispecifics based on the data in head and neck and outside of head and neck. The totality of our data — including frontline and second-line monotherapy and combinations — provides a comprehensive dataset that underwrites our ambition in head and neck. We are comfortable with our position and expect these trials to provide significant data that can have meaningful impact for patients.

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

We will now take our next question from the line of Xian Deng from UBS. Your line is open. Please ask your question.

Hi. Thank you for taking my question. I'll try my luck on the EPKINLY frontline trial. Given the interim still has not passed, this suggests events are happening much slower than expected. Is there any reason the R-CHOP arm could perform differently from historical trials such as POLARIX, at least in the IPI 3-5 group? Second, on petosemtamab frontline: your trial design is chemo-free with pembrolizumab, whereas a competitor's design includes pembrolizumab plus chemotherapy. Can you elaborate on the rationale for going without chemotherapy?

Thanks, Xian. Tahamtan, can you respond to both?

On frontline DLBCL: we are excited and looking forward to the data next quarter. Phase II data has been predictive, and the Phase III trial replicates the Phase II combination closely. Cross-trial comparisons for control arms can be unreliable because of regional and patient population differences, so we have no visibility to how R-CHOP behaved in external trials versus how it behaves here; we'll find out when we have the data. Regarding petosemtamab frontline: many discussions about trial design occurred prior to the acquisition. Head and neck patients can be a fragile population, and treatment tolerability is influenced by disease location and patient condition. In practice, some patients receive pembrolizumab plus chemotherapy and some receive pembrolizumab alone. The Phase II data for petosemtamab plus pembrolizumab show dramatically higher response rates and durability compared with pembrolizumab plus chemotherapy in historical comparisons. Our anticipation is that petosemtamab plus pembrolizumab will provide a very significant dataset in frontline head and neck, with a strong ORR and improved duration of response. We'll discuss comparison to other strategies further when the data are public.

Thank you. Let's move on to the next question.

We will now take our next question from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Firstly, on EPKINLY frontline: was the data you saw in the second-line trial better than you were expecting internally, and does that give you increased confidence that the frontline trial could read out at the interim? Second, could you discuss your latest thoughts on the endometrial cancer treatment landscape? Merck has said they have hit PFS and OS in an interim of a Trop-2 ADC trial. When that data comes, will that set a bar for Rina-S, and can you discuss areas of differentiation and potential relative expression of Trop-2 and folate receptor alpha in endometrial cancer?

Thanks, Rajan. On frontline, we are very excited based on the Phase II studies and prior ASH data. The Phase II data suggested that if translated to Phase III, the results could be transformational. Tahamtan, do you want to add and then address the endometrial question?

The lenalidomide-EPKINLY Phase III outcomes have approximated our Phase II expectations, which underscores the predictability of EPKINLY's efficacy and safety. That pattern provides confidence for the frontline readout next quarter. Regarding endometrial cancer and the Trop-2 ADC data: Merck's announcement of PFS and OS in a Trop-2 ADC trial does not materially change our strategy. We were aware their readout would occur before Rina-S datasets. We remain excited about Rina-S, not only in PROC where we will have data this year, but also in endometrial cancer. Folate receptor alpha expression can be lower in endometrial than in ovarian cancer, but Rina-S has shown efficacy across a spectrum of alpha expression levels. Endometrial is an exciting second indication; we have initiated two Phase III trials in that indication and look forward to presenting data when available. Rina-S has Breakthrough Therapy Designation in one endometrial setting, which is important.

Let's move on to the next question.

We will now take our next question from the line of Eva Fortea-Verdejo. Your line is open. Please ask your question.

Hi, team. Thanks for taking our questions. On colorectal cancer, as the landscape becomes increasingly crowded with EGFR bispecifics, how is your newly disclosed strategy differentiated from competing assets in the space, particularly compared to amivantamab? Given the growing focus on RAS-directed therapies in colorectal cancer, would a combination strategy with petosemtamab be viable and what's your current thinking on a development path for such a combination?

Thanks, Eva. Tahamtan, could you give more color on differentiation and on combinations with RAS-directed therapies?

Colorectal is a new indication for petosemtamab that we have pursued because early datasets showed very impressive ORR and durability. Our conviction has remained high as patient numbers have increased and durability signals have strengthened. Comparing cross-study results is challenging, but in the monotherapy second-line head and neck data and colorectal combinations, petosemtamab appears to have higher response rates and a better safety profile versus amivantamab in the datasets that exist today. This supports our belief that petosemtamab is best-in-class among second-generation EGFR bispecifics. The RAS field is indeed exciting, and we are aware of the novel RAS-directed drugs. We are actively engaging in discussions about potential combinations. Combinations with RAS-directed therapies could be viable, and we will provide more detail on combination strategies in the near future as plans are finalized.

Thank you, Eva. Let's move to the next question.

We will now take our next question from the line of Suzanne van Voorthuizen from Kempen & Co. Your line is open. Please ask your question.

Thanks for taking my questions. Also on petosemtamab: a competitor or partner is pursuing accelerated approval in head and neck. Has that competitive development changed your filing or commercial strategy? And you mentioned high confidence in best-in-class profile versus amivantamab. Could you elaborate on what underpins that confidence — efficacy, safety, mechanism, molecule differences?

Suzanne, thank you. Tahamtan, could you address the impact of competitor accelerated approval efforts and the basis for your best-in-class conviction?

On competitive filings: we will have top-line frontline results next quarter and OS readout for monotherapy in Q1 next year. Having frontline data in particular delivers a comprehensive dataset that captures a larger population than an accelerated approval in the second-line setting. We are comfortable with our head and neck strategy and are executing to accelerate findings and launches where possible. Regarding best-in-class confidence: cross-study comparisons are imperfect, but in monotherapy second-line head and neck and in combination datasets, petosemtamab has shown higher efficacy in available comparisons and a differentiated safety profile with fewer skin toxicity challenges. These differences likely reflect distinct antibody constructs and secondary arms that may influence both efficacy and safety. Taken together, these data support our conviction that petosemtamab is best-in-class.

Thanks, Suzanne. Let's move on.

We will now take our next question from the line of Charlie Haywood from Bank of America. Your line is open. Please ask your question.

Hi, Charlie Haywood from Bank of America. Two questions please. First, on the second-line PROC data in Q4: can you remind us of differences between the Phase II and Phase III trials in terms of recruitment and patient cohorts — anything relevant to read across between the two? Second, for folate receptor–targeted agents in general, we have seen limited Phase II PFS data; could you frame any target PFS profile or delta versus PLD you would expect to be clinically meaningful for the Phase III readout?

Thanks, Charlie. Tahamtan, please respond.

The Phase II and Phase III inclusion/exclusion criteria are broadly similar, so the patient populations are comparable. The primary differences are the dynamics of Phase II versus Phase III and the larger footprint and scale of the Phase III trial. Regarding PFS expectations, I don't want to speculate on exact numbers. What we can say is that Rina-S has demonstrated a very high response rate — over 50% in public datasets — and long durability of response driven by a favorable safety profile with low discontinuation rates due to adverse events. That combination supports a meaningful PFS benefit versus the comparator. We'll present the data when it is in the public domain and discuss clinical meaningfulness then.

Thanks, Charlie. Let's take the next question.

We will now take our next question from the line of Yaron Werber from TD Cowen. Your line is open. Please ask your question.

Thank you. Quick question on petosemtamab frontline: when you upsized the study, can you confirm you did not change the powering assumptions? Are you enrolling a representative distribution of HPV-negative and HPV-positive patients, or are you enriching for a subtype? Second, will you show second-line recurrent head and neck data at ESMO with or without pembrolizumab, and is there a chance you'll move to a Phase III with pembrolizumab to complement monotherapy second-line data coming in Q1?

Thanks, Yaron. Tahamtan, please address powering and enrichment and talk about future strategies.

We increased the sample size to ensure proper power for subgroup analyses important for global filings. That decision was made during diligence and executed early; it was not driven by post-acquisition changes. The trial is designed to support the needed subgroup analyses, and we are enrolling broadly rather than enriching for a single subtype. On future strategies for petosemtamab in head and neck, there will be additional studies and more to come; we will announce trials as they begin dosing patients in the near future. We are considering multiple development paths, including combinations, and will provide further details when those plans are ready to be shared.

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

We will now take our next question from the line of Benjamin Jackson. Your line is open. Please ask your question.

Thank you. Two quick ones on Rina-S. We've seen companies pursue drugs to overcome topoisomerase I resistance. The aim for Rina-S is to come to market first; are there implications if resistance mechanisms emerge when thinking about Rina-S's commercial opportunity once competition comes to market? Second, any updated thoughts on EPKINLY's potential in inflammatory and immune-mediated diseases, where B-cell pathology is key?

Thanks, Benjamin. Tahamtan, do you want to comment on topo I resistance implications and on EPKINLY in immunology?

On topoisomerase I resistance: several competitors have agents aiming to overcome topo I resistance. Our strategy for Rina-S is to continue executing our development plan to move Rina-S into earlier lines as data supports it. If we are first to market as an anti-folate receptor alpha ADC with a topo I payload in certain settings, subsequent resistance mechanisms in later lines would be a future consideration for the field, but our priority is to bring Rina-S to patients and expand earlier as supported by data. Regarding EPKINLY and inflammatory and immune-mediated diseases, our current primary focus is oncology across multiple cancers with several important Phase III readouts coming in Q4. We will discuss potential opportunities in immunology at an appropriate time, but cancer remains the priority for the near term.

Thank you. Let's move to the next question.

We will now take our next question from the line of Judah Frommer from Morgan Stanley. Your line is open. Please ask your question.

A follow-up on petosemtamab frontline. Can you help with thoughts on the nature of the Q4 update? Will it be top-line only, and might you provide subgroup data, perhaps by HPV status? If not, when would we see subgroup responses by HPV negative versus positive patients?

Thanks, Judah. Tahamtan, can you provide guidance on what the Q4 update will include?

Historically, Genmab's top-line results focus on the primary endpoint, and we expect the Q4 update will be top-line results focused on the primary endpoint as well. Once we have the top-line results, we will communicate timing for a more granular discussion and likely present subgroup and other detailed data at a scientific conference in a public presentation.

Thank you, Judah. Let's take another question.

We will now take our next question from the line of Victor Floch from BNP Paribas. Your line is open. Please ask your question.

Hi, thanks for taking my questions. Two on EPKINLY. First, momentum looks strong with accelerated uptake in the community setting. From a modeling perspective, is there any stocking we should be aware of for modeling the remainder of the year for EPKINLY? Second, there are reports about a formulation patent potentially extending exclusivity; can you discuss your IP strategy and current assumptions about patent protection duration?

Thanks, Victor. Brad, can you address stocking? Tahamtan, can you comment on IP questions as appropriate?

Thanks for the question. Regarding community momentum and stocking: we are encouraged by the momentum in the community driven by the dual indications and physician uptake. At this point, there are no stocking issues to report for modeling the remainder of the year.

Tahamtan, on IP strategy?

Discussing detailed patent and IP strategy on a public call is nuanced; I would say our base assumption is protection into the mid-2030s, and we continue to pursue additional intellectual property to potentially extend protection where appropriate.

Thanks, Victor. We'll take one or two more questions.

We will now take our next question from the line of Kalpit Patel. Your line is open. Please ask your question.

Hi, thanks for taking the question. Regarding the frontline DLBCL study: when the protocol was designed, was the expected timing of the readout in Q4 more or less in line with your original modeling? After enrollment completed in 2024, did the estimated timing materially shift? The start-to-finish timeline looks roughly in line with POLARIX; any color on model assumptions would be useful.

Kalpit, we are excited about the frontline readout in Q4. We believe the data will be excellent based on Phase II, and we are not going to provide further timing detail beyond what we have said today. We look forward to sharing the results next quarter.

We will now take our final question for today from the line of Matthew from William Blair. Your line is open. Please ask your question.

Hi, thanks for squeezing me in. Comparing the frontline colorectal trial with petosemtamab to the OrigAMI-2 trial, designs look similar except your trial includes an ORR primary endpoint. Is it reasonable to assume you will explore a Project FrontRunner regulatory pathway in that frontline trial? Also, any updated thoughts on Rina-S in non-small cell lung cancer — is there an ongoing Phase II trial and when might we see data?

Thanks, Matthew. Tahamtan, can you address both the FrontRunner exploration and the NSCLC Rina-S trial status?

Yes, it is fair to assume we will explore Project FrontRunner opportunities in the frontline colorectal trial when appropriate. Regarding Rina-S in NSCLC: we have an ongoing Phase II, and once we have a dataset that allows a robust discussion of next steps, we will present it and discuss subsequent plans. We are in a competitive environment with several folate receptor ADCs in development, and we aim to present data when we are ready and have next steps aligned.

Thank you, Matthew. Thank you all for joining us today and for the lively Q&A. With three important Phase III studies reading out in the coming months, we are well on track to deliver sustainable growth into the next decade. We look forward to sharing more updates as the year progresses. As always, if you have follow-up questions, please reach out to our investor relations team. This concludes today's conference call.

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