Genmab A/S

Hello and welcome to the GenMAP first half 2025 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GenMav is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that GenMav may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on GenMav going forward. Please refer to our website for more information on GenMav and our privacy policy. I would now like to hand the conference over to our first speaker today, Jan van der Winkel. Please go ahead.

Hello, and welcome to our financial results call for the first nine months of 2025. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Taya Mahdi. And for the Q&A, we will be joined by our Chief Development Officer, Judith Klimowski. As noted, we will be making forward-looking statements, so please keep that in mind. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. As we near the end of 2025, I would like to remind you of the commitments that we made at the beginning of the year. We said that we would accelerate the development of a high-impact late-stage pipeline that we would maximize the potential of our commercialized medicines, and that we would deliver on our capital allocation priorities. I'm pleased to say that we are following through on these commitments, supporting our continued growth and long-term value creation. Over the past nine months, our total revenue grew by 21%, fueled by increased recurring revenue. and we have invested fully in line with our capital allocation priorities. Importantly, we have grown operating profit by 52% even while making these strategic investments. We ended the first half with around $3.4 billion in cash. Our strong financial foundation has given us the flexibility for continued growth and expansion through investment in our high-impact late-stage programs. Abkinli and Rina S have both progressed rapidly over the course of this year with extremely encouraging data sets. And for Rina S, we have initiated additional phase three clinical trials. As part of our disciplined investment into the highest potential programs, together with BioNTech, we have agreed that the current data in frontline head and neck cancer for Gen 1042 did not meet our high bar for continued development. As part of our capital allocation priorities was our promise to explore focused M&A opportunities. We have delivered on this commitment with the potentially transformative proposed acquisition of Meris. So let's briefly review the highlights. The proposed acquisition of Meris is an exceptional opportunity that advances our evolution into a global biotech leader. It accelerates our shift towards a 100% owned model It expands and diversifies our revenue, and it brings us closer to achieving our 2030 vision to improve the lives of patients. With this proposed acquisition, we will add PaetoSymptomUp, or Paeto, to our already compelling portfolio. High-potential assets like Paeto, which has received two breakthrough therapy designations, are truly rare. The totality of data we have seen for PATO underscores the potential as a best-in-class EGFR bispecific across head and neck cancer indications, as well as in other EGFR-expressing tumors. And with data anticipated in 2026 from one or both of the ongoing Phase III trials, we expect PATO will also be first-in-class, with an initial launch expected in 2027. We are confident that our expertise and leadership in antibody-based innovation, as well as our swift and broad clinical development of both APKinley and RENAS, demonstrate our ability to fully realize PETOS potential. We will also see real promise for it to join APKinley and RENAS as multi-billion dollar program. We expect to close the acquisition by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions. And combined with our disciplined capital allocation, strong financial foundation, and proven commercial execution, this transaction sets us up for durable long-term growth into the next decade. Now let's turn to some of the recent advancements for our late-stage programs. Beginning with Upkinley. We eagerly await its potential approval in second-line follicular lymphoma later this month. In addition to the unprecedented phase 3 second-line follicular lymphoma data we discussed during our second quarter call, recently we announced updated results for abcaritumab in the outpatient setting. These data evaluated the feasibility of treating and monitoring patients with relapsed or refractory diffuse large piece of lymphoma in this setting. Data from both the Phase III second line and outpatient studies are included in more than 20 EPCOR abstracts that have been accepted for presentation at this year's ASH meeting end of the year. Excitingly, the second line follicular lymphoma data will be one of seven oral presentations for EPCOR at ASH. These abstracts highlight advances that expand abcaritumab's clinical profile, supporting use in earlier lines of therapy, and across additional B-cell malignancies. So now let's turn to RENA-S. Last month at ASMO, we presented an update of the data for single-agent RENA-S in patients with advanced endometrial cancer. Today, Ty will provide a brief overview of this data, which further supports the encouraging results that we showed at ASCO. This progress reflects our vision to accelerate our innovative late-stage pipeline and shows additional momentum behind the possibilities of RINA-S. Our confidence in the potential of RINA-S in endometrial cancer is reinforced by the Breakthrough Therapy designation granted by the US FDA. As a reminder, this indicates that the FDA considers RINA-S to have the potential to significantly improve patient outcomes compared with existing therapies. The data we have seen, and the recognition from the FDA, both support our development plans for RENAS. And I am pleased to tell you that we have initiated a phase three trial in endometrial cancer. So our rapid development of RENAS continues. And we are also preparing for potential commercialization. TifTac is now available for prescribing in Germany, our first European market. And the foundation that we are building in the European Guyana community with TIFTAC will set us up for future success with RINA-S. Now over to Thay and the updated RINA-S data from ESMO. Thay, go ahead.

Thank you, Jan. At ASCO, we presented the first results for single-agent RINA-S in patients with advanced endometrial cancer from the ongoing Phase I-II Rainfall-01 study. And at ESMO, just a few weeks ago, We provide an update on that data with four additional months of follow-up. What we saw was that at a median follow-up of around a year, reNA-S dose at 100 mg per meter squared showed deep and durable responses regardless of foliar receptor alpha expression. The disease control rate at that dose continuing to be at 100% and a confirmed ORR remaining at 50%, including two complete responders. and with seven out of the 11 confirmed responses still ongoing at that data cutoff. This compares to the standard-of-care chemotherapy, which delivers approximately a 15% OR and a limited durability roughly around six months. In addition to the durable efficacy, reNA-S continues to have a manageable safety profile. There are still no signals of ocular toxicity, interstitial lung disease, or neuropathy across the entire program. So in summary, the data we have seen for vena S, both in endometrial cancer and the data we've presented on clock, reinforce our conviction that vena S is best in class ADC across efficacy, safety, and durability across the entire spectrum of folate receptor alpha expression. And we are maximizing its potential with an accelerated and extremely comprehensive development plan that includes Now, three ongoing Phase 3s, if you follow today's disclosure on clinicaltrials.gov, and two Phase 3s that are intended for potential registration under the accelerated approval pathway in the United States, one in PARCC and one in second line endometrial cancer. And we expect a first launch in 2027, and we also are generating data beyond Gynonc with signal-seeking Phase 2 trial in non-small cell lung cancer. And now over to Brad for a review of the recent commercial performance for Epkinley and Tiftac.

Thank you, Ty. Q3 marked another strong quarter for our proprietary portfolio. Our commercialized medicines are contributing positively to our overall revenue growth, driven by the strong performance in our established markets, as well as now the early success in new markets. This gives us further confidence in our growth potential as we advance our portfolio and prepare to bring our medicines to even more patients around the world. Take a closer look now at performance overall. McKinley & Tibdak sales through the third quarter of 2025 were up 54% year-over-year. This accounted for 25% of our total revenue growth. And as we've said before, we expect our proprietary portfolio to increasingly contribute to our overall revenue growth over time. During the quarter, we continue to scale our operations across markets in a disciplined fashion, accelerate the adoption of our medicines, and meet patients' needs. And as you just heard from Jan, the proposed Damaris transaction provides us with the unique potential to double down on our shift to a 100% owned model and maximize our long-term growth. With Epkinley, Rina S., Ecosulamab, and potentially Pitocentamab, we have the pieces in place to deliver several multi-billion dollar opportunities in the coming years. Let's turn now to Epkinley's performance. Epkinley posted $333 million through Q3, which represents a 64% year-over-year increase. We're highly encouraged by Epkinley's performance and steady growth globally as the clear leader in the third-line setting across diffuse large B-cell lymphoma and follicular lymphoma. In the U.S., performance continues to demonstrate the value of Epkinley as the only dual-indication option in DLBCL and FL. We're seeing increases in adoption across sites of care and new patient starts, reinforcing both the clinical and operational differentiation that McKinley brings to the market. Indications, further growing utilization within ordering accounts and expanding more broadly into the community setting. As we prepare to enter earlier lines of therapy with the anticipated launch in second line FL later this year, we'll build on this positive momentum to bring up the Kenley to even more patients. Now looking in Japan, we're seeing an encouraging start at Kenley's launch in third line plus follicular lymphoma. Our teams are building on the traction we've seen in large B cell lymphoma and continue to drive account activation while also preparing for future potential launches. To that end, Today, we filed a supplemental J&DA for Epkinley in second-line FL, marking another important milestone to potentially bring Epkinley to earlier lines of therapy in this priority market. Across all other markets, through our partner AbbVie, we saw solid sales for Epkinley in the quarter as an increasing number of countries gained access and reimbursement and saw rapid uptake. Globally, Epkinley has received the most regulatory approvals for a buy-specific in DLBCL and FL with approvals in more than 65 countries worldwide, including more than 50 countries now with the dual indication. As we look ahead to the remainder of the year and into 2026, we're focused on increasing utilization across sites of care and delivering Epkendley to patients in earlier disease settings where we may have the opportunity to transform outcomes. With its strong performance to date and accelerating development program, we're confident in Epkendley's growth potential to reach peak cells of more than $3 billion in the future. Now let's look at TIBDAC. TIBDAC is well recognized as the global standard of care in recurrent or metastatic cervical cancer. Our year-to-date sales for TIBDAC totaled $120 million with performance in both new and established markets, highlighting the clear need for women with advanced cervical cancer across geographies. In the US, we continue to see strong, stable performance across sites of care. And in Japan, we saw continued early launch success, further reinforcing the patient need, the strength of our launch strategy, and impactful execution by our field teams. Broadening our reach across markets, in September, TIVDAC officially launched in Germany. This marks the first medicine we've launched in Europe independently. We've seen encouraging early uptake in Germany, providing positive momentum as we look ahead to expand to additional countries. With our focus on TIBDAC, we've made important progress establishing our operations to support our current and future portfolio in Europe. This strong foundation will ensure we're equipped to broaden our impact with the gynecologic cancer community and deliver our medicines to more patients around the world. The work we've done to transform our business has positioned us well now for sustained growth and profitability. We remain focused on expanding the utilization of our medicines and bringing them to as many patients as possible. The proposed acquisition of Meris and the potential addition of pedosymptomab could strengthen the opportunities ahead for our proprietary portfolio of antibody-based medicines. We look forward to closing out the fiscal year with continued strong performance. And with that, I'll hand the call over to Anthony to discuss our financials.

Thanks, Brad. We continue to deliver solid revenue growth throughout the first nine months of 2025. driven by sustained recurring revenues and the solid market performance of our products. We've also strengthened our long-term growth potential as we continue to generate encouraging clinical data for both Eprutimab and RENA-S. And our financials remain strong. We grew total revenues by 21%, with recurring revenue up 26%. This was driven by royalties from Darzelex and Cosinta, and importantly, this growth was also supported by product sales from McKinley and Tibdak, which together represented 25% of our total revenue growth. Looking at Darzelex, we continue to see extremely strong growth. Overall, net sales grew by nearly 22%. That's $10.4 billion for the first nine months of the year, which translates to over $1.7 billion in royalty revenue for us. This growth was driven by continued share gains and solid performance in the frontline setting. So you can see that the quality of our revenue profile continues to improve. In fact, in the first nine months of this year, recurring revenues represented 96% of our revenues And that's up from 92% in the same period of last year, a clear sign of increasing visibility and durability of our revenues. What's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off. This sets us up well as we prepare for potential expansion into earlier lines for FKinley, including second line FL and the anticipated launch of Marina S and contingent on the successful close of the transaction, the launch of PETA. And we continue to take a disciplined approach to these investments. Total OpEx in the first nine months of 2025 was slightly less than $1.5 billion, up 7% over the same period last year, excluding the impact of the profound bio acquisition. And we're managing our investments strategically, prioritizing our high impact phase three programs and focused investments in our commercialization capabilities. Our operational discipline contributed to our operating profit growth of an impressive 52% in the first nine months of the year. So here you can see that we're really continuing to deliver on our commitments. Next, looking at our net financial items. Here we have a net gain of $142 million. Then moving on to tax, we have tax expense of $217 million, which equates to an effective tax rate of 18.9 percent. Taken together, our net profit amounts to $932 million. So, as you can see, continued strong underlying financial performance. With that, Let's move to our 2025 financial guidance. We remain on track to achieve our existing financial guidance with projected double-digit revenue and double-digit profit growth. We expect our revenue to be in the range of around $3.5 to $3.7 billion, delivering a robust 15% growth at the midpoint. And it's our recurring revenues from Royalty Medicines and from Epkinley and Tibdak that's been driving that growth in 2025. In total for the year, we expect our recurring revenues to grow by 22%. For operating expenses, due to our continued focused and disciplined approach to our investments, we still expect to be in a range of around $2.1 to $2.2 billion. Putting all this together, we're planning for operating profit in a range between around $1.1 to $1.4 billion, with the midpoint of our guidance amounting to over $1.2 billion of operating profit and strong year-over-year growth of 26%. Our guidance highlights our continued strategic discipline, targeted investments, and operational efficiency, all while advancing our pipeline and enhancing shareholder value. Now, to give you just a bit more color on FX, every 10-point move in the exchange rate relative to our guidance rate of the US dollar to the Danish kroner of 7.20 is worth just around a million dollars in operating profit or loss at the midpoint. Now, finally, before I conclude, I would like to take a minute to look ahead to 2026. While, of course, Our guidance will be given in February next year. As I stand here today, 2026 consensus expectation for GMMAP standalone investments appear to be in a reasonable place, capturing our investment priorities. And as I take a look at consensus expectations for MARIS investments, they also appear to be in a reasonable place. Importantly, we remain confident that GENMAB will deliver significant profitability in 2026 and meaningful EBITDA growth in 2027. Our performance in the first nine months of 2025 underscores our ability to produce solid, high-quality revenue growth, advance key pipeline assets, deliver on our capital allocation commitments with the proposed acquisition of Meris, and maintain strong profitability through disciplined execution. So in summary, our very strong financial foundation, sustained profitability, and disciplined capital allocation strategy positions GEMMAP for growth, creating value for both shareholders and for patients. And on that note, I'm going to hand the call back over to Jan.

Thank you, Anthony. Let's move on to our final slide. We have strengthened the foundations of our business in the first nine months of 2025. We have expanded the reach of both Upkinley and Tiffdeck to more patients. For Rinaas, we have presented additional support of clinical data showing its potential beyond ovarian cancer. and we are prepared to accelerate and maximize the potential with additional Phase III clinical trials. And we continue to anticipate further Acrosunimab data this year, and they will be presented at ESMO I.O. in December in London. Beyond our commitment to our existing pipeline priorities, we further delivered on our capital allocation strategy with the proposed acquisition of Meris. an extraordinary opportunity that will advance our evolution into a global biotech leader and position us for sustainable long-term growth and value creation. Before we move to the Q&A, I'm pleased to announce that we will hold our annual R&D updates and data review on December the 11th. And to ensure that this event is accessible to as many people as possible, this year's presentation will once again be fully virtual. Details will be available on our website, and we look forward to a lively event. That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.

Thank you. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. We kindly ask analysts to limit themselves to one question per person. We will now take the first question. From the line of Jonathan Chang from Learing, please go ahead.

Hi, guys. Thanks for taking my question. Now, coming out of ESMO, there's been a lot of discussion around the competitive landscape of PETO and RENA-S. What are your thoughts on how these drugs are positioned in the competitive landscape, and what gives you confidence in the potential for these two programs to be key drivers of growth? Thank you.

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

Thank you, Jonathan, for the question. And so let me start with this. There was really nothing that in any shape or form was a surprise to us. Our conviction in PETO and RINA being the best and first-in-class asset in the respective indications of head and neck and gynecology has not changed. Peto, if you look at the totality of data, Jan said this in a prepared remark, in our mind, has all the attributes of the best-in-class second-generation EGFR by specific. There are two phase threes already ongoing in head and neck, in second line, in monotype, for which it has a BTD, and in combination with PEMBO in front line, where it has BTD, so it's also on track to be the first-in-class. Nothing really changed on that. As it relates to RHNA, there's, of course, a couple of photoreceptor alpha ADCs in development by AZ and Eli Lilly. Again, this is not news. We are, generally speaking, operating in a very competitive landscape. None of the data in any way, shape, or form are changing our assumption that RHNA has, based on the data in PROC and endometrial, both in response and long-term follow-up and durability and long-term safety. has the profile to be best in class. I mentioned this in my comments. There are now two phase twos that are ongoing for some time, and we expect a launch, at least one of these indications, in 27, and three phase threes that are actively involving. So I think we have a good position here also to be the first class topo ADC in Gynong space, and we're expanding already into other indications. So in totality, we feel very comfortable about the profile of the assets. We feel extremely comfortable about where we are positioned in the competitive landscape, and we feel very confident in our ability to accelerate the development of Petro once we are having control of this asset, hopefully, and on Binance. So there's more to come on both of these assets. That's probably all there is to say at this point.

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

No. Beautifully said. Nothing to add. Thank you.

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

Thank you. We will now take the next question from the line of Michael Schmidt from Guggenheim Partners. Please go ahead.

Hey, thanks for taking my questions and congrats on all the progress. I had a question on Ebb Keenly and I was just wondering if you could comment on the commercial dynamics. You know, I'm just curious in terms of What are you seeing in terms of use in the approved indications between follicular and DLBCL? And then how should we think about the near-term growth opportunity in second-line follicular in the U.S. and Japan in your markets? What is the magnitude of that near-term growth opportunity? Thanks so much.

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

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

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

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

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

Thank you. We will now take the next question from the line of Shan Deng from UBS. Please go ahead.

Hi, thank you very much. Thank you for taking my questions. Sorry, if I may just say, I wonder if I could maybe push a little bit more sort of the near-term performance, I mean, this quarter, we did see kind of a miss in Ab Kingley. Just wondering, is there anything, you know, you would flag in terms of this quarter's performance? And also, just wondering for second-line follicular lymphoma, just wondering, how should we think about the launch trajectory? Do you think this is actually going to be a bit more gradual, given the I don't know, follicular lymphoma, is it mainly community setting, or do you think this actually will be a pretty fast uptake? Thank you very much.

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

Yeah, we're actually seeing right now the observed consistent and continued uptake across sites of care in the U.S., and we do see, to your latter part of the question, that second-line FL allows this acceleration in the community setting where FL patients are actually treated, as you stated. And we do see that as a consistent uptake over time as we continue to get operationalization, if you will, and buy specifics in the community setting. As it relates to the performance, we're extremely encouraged by what we're seeing year-to-date with the performance, both in the U.S. as well as Japan and through our partner, AbbVie, globally. And again, feel like, as we've said, all along the earlier lines of therapy, or where the value of Epkinley will be. And the second line FL is really that first step taking us into this next phase. So hopefully that answered your question.

Thanks. Thanks, Brad. And definitely, Sian, we definitely hope to move forward to the front line and second line diffuse-slash-bisoneform also very rapidly from here with readouts hopefully soon of the phase three trials. So we're very encouraged by Epkinley and really look forward to a very, very good future there. Let us move to the next question.

Thank you. We will now take the next question from the line of key sitting from Rothschild & Co. Please go ahead.

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

Thanks, Kiezer, for the question. I think I can start there and then maybe Judith can step in there. So what we determined together with our part of BioNTech is that basically the data of 1042 in combination with chemo and PEMBRO in frontline head and neck cancer didn't meet the high bar we have internally for continued development. So we stopped the development there. And that's where I want to leave it at. Jure, do you want to add anything there?

Yeah, no. Just to add that this was the most relevant data set and the initial proof of concept. And based on that, we decided to stop the development in combination with PEMBRO and chemo.

Thanks. Thanks, Jure. Thanks, Kisa, for the question.

Thank you. We will now take the next question from the line of Rajen Sharma from Goldman Sachs. Please go ahead.

Hi. Thanks for taking my question. I just wanted to get your thoughts ahead of the Epkin-Lee-Purduefa in November. There's obviously been a bit more of a focus, seemingly, on US representation in clinical trials. So I just wanted to get your confidence going into that approval, into that potential approval. And if you could just confirm the efficacy in the EPCOR FL1 trial is consistent across both U.S. and non-U.S. patients. Thank you.

Thanks, Rajan, for the questions. Ty, can you give some color on the U.S.-non-U.S.?

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

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

Thank you.

Next question.

We will now take the next question from the line of Jaron Werber from TD Securities. Please go ahead.

Great. Thanks so much. Anthony, I got a couple of questions for you more about 2026 and then 2027. So you mentioned for next year, the numbers, standalone OpEx for MIRIS and GenMAP are reasonable. For MIRIS, they're sort of in the 450 range in terms of, you know, OpEx, let's call it, you know, 450, maybe some even have as high as 500. I think we're imagining there's going to be some synergies as you bring that company in. And I know you can't give guidance, but can you give us a little bit of a sense, are we thinking about this correctly? And then secondly, when you're talking about significant profitability next year, there could be as much as like $430 million change between interest income net to now interest expense net, you know, because of the debt liability. So we're thinking about that correctly because it would impact profitability next year. Thank you.

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

Thanks. So, you know, I can really start off by thinking, as you all now know and appreciate, we have a very disciplined and focused approach to our investments. We've outlined for the markets starting at the overall capital allocation framework, a very clear framework of where and how we're going to invest on the one hand, and as we do that, do that in the most prioritized and productive manner possible. That's how we were able to deliver on our 2024 actual financial results. And also, you know, what our overall guide was for 2025 and where the year-to-date performance is. Moving forward, that same approach in terms of very clear investment priorities remains as well as that approach to being super focused and disciplined now to reiterate what i said is i kind of look at overall standalone consensus for genmap that is in a reasonable place likewise for maris now here i'm looking at the consensus number is in a reasonable place we also have to appreciate where we are at in the overall process here as it relates to being on track to closing the transaction in early Q1 2026. Today, I thought it was important to provide that market, the market, the commentary similar to what I did last year, but I think the overall investments are in a reasonable place. Of course, we will look for opportunities to prioritize, to remain disciplined, and ultimately, we'll provide our guidance when we get to February of 2026. Now, my comment as it relates to Significant profitability, just to be super clear, here I am referring to EBIT. So I'm referring to our EBIT figure, our operating profit, consistent with historical practice. We are guiding on the EBIT line. So overall, if I think we sort of step back, we think about the overall setup here, what you should expect here on this continued investment in line with our capital allocation framework, lots of focus and discipline by the team, and continue to deliver on our overall commitments, both operationally and financially.

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

Thank you. We will now take the next question from the line of Ashtika Kunewartane from Truist. Please go ahead.

Hey, guys, thanks for taking my questions. I want also to say congrats on all the growth that you guys have shown this quarter. It's impressive. Jan, when the MERS acquisition was announced, you mentioned that head and neck cancer was the main driving factor for that interest there. And you said you'll talk a little bit more about colorectal when that data is presented. The data in CRC at the triple meeting was, I would say, perhaps a little better than what even Bill telegraphed. So how do you view that colorectal opportunity? And then importantly, that as well as head and neck, do you feel that you need a subcutaneous formulation to be competitive with their emerging competition from right event? Thanks.

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

Yeah, thank you, Ashnikar, and thank you for all the hard questions. I tried to manage this. I think as Jan said, early data, limited data, encouraging and we should leave it at that until we have control of the asset and it's really us to speak about the data. But I think that's kind of the top line and broadly speaking I think we even talked about this in the prepared remarks when we announced the acquisition. We do think of PETRO as a best-in-class, second-generation EDGFR, SPICE-specific, and that obviously includes also opportunities outside of head and neck. But the focus is where it is right now, two phase threes ongoing in head and neck, and there we have a significant head start over any form of competition. Subcutaneous administration is something that we are very familiar with, that we have some deep understanding of prior capacity. And it's obviously something that we are looking at as part of a life cycle management. But our focus right now is execution on the studies that are already ongoing. And then we can talk more about what GemUp is going to plan in due time.

Thanks, Thijs. So confirming that the sub-Q development is an integral part of our strategy for PAYTO, but more to come after the finalization of the transaction. Let's move on to the next question, operator.

Thank you. We will now take the next question from the line of Matthew Phipps from William Blair. Please go ahead.

Hi, thanks for taking my question. I've had a lot of investor interest recently on the first line DLBCL trial with Deb Kenley reading out next year. I'm wondering if you can give us any sense where you think that's a first half or second half readout, and then what level of PFS benefit do you think you need to really out-compete the PILVR chip regimen that has gained some traction there? Thanks.

Thanks, Matthew, for the question. Ty, can you give a bit of color on the frontline diffuse large B cell lymphoma trial and the potential need for the type of data to give us an angle, a differentiated angle of other therapies?

Well, I'll take it again. We have guided that we expect the readout to happen in 2026, and we should probably leave it at this right now. This is obviously an event-driven study, and we'll update in the appropriate setting when we have a little bit more clarity. But clearly, the study was more or less fully accrued in the summer of last year. As it relates to what it has to do in order to be competitive in the competitive landscape, I don't think it makes sense to go into some kind of discussion about hazard ratio and what it has to show. I think we are very confident that when the study reads out, that there will be a significant improvement over the standard of care. And in that regard, also, that is partially underwritten by the data that's going to be represented now with a longer follow-up at ASH, where you have a Phase II data set that in these high-risk patients, IPI 3 to 5, shows an incredible high CR rate with an incredible high durability. And what we've seen over and over again is... that these very robust Phase II studies that we ran, and then the data we generated on them, more or less one-to-one translates into the Phase III. And so we anticipate the same to be true for the frontline diffuse HPSA study.

Thanks, Thijs. So in addition to efficacy, also think about the convenience of the sub-Q dosing, and the safety pattern may be very different from other studies. other combination therapies, Matthew. So we are very excited about the potential to see the readout, hopefully soon, from the front line, diffuse lines, piece and form. It's a potential game changer, we feel, for Afghani. Let's move to the next question.

Thank you. The next question comes from the line of Victor Flood from BNP Paribas. Please go ahead.

Yes, thank you very much for taking my question, Victor Flood from BNP Paribas. Maybe just a small housekeeping question on data readout timing. So thank you for the comment on the first-hand VLBCL. But you used to have an anticipated readout column on the slide seven. So I just wanted to ask you whether you can confirm that all the phase three trials that are on those slides All the timings are consistent with what you've discussed last time for the second quarter update. Thanks so much.

Ty, can you comment on the timings there?

Nothing has changed.

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

Thank you. The next question is from Zion Abraham from JP Morgan. Please go ahead.

Hi, everyone. Thanks for taking my question. I've got one clarification question for Anthony, just on the OPEX for 26 in terms of when you say both the standalone investments for mirrors and for general via a reasonable place, I think is how you characterized it. Does that include the potential for indication expansion that you outlined for locally advanced head and neck for PEPSO and maybe other indications that we might hear about more in Q1 was my first question. And the second question is just on, if you can remind us on the filing strategy for winner S in CROC next year. I know you just said everything's on track, but in terms of recruitment, how that's progressing for the phase three and when we can expect to see more duration and response data from the phase two trial. Thanks a lot.

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

So, yes, the short answer is yes. So, I think about, again, just reiterating, as we think about looking forward to 2026, what was important to condition the market, thinking about overall investment levels, again, to reiterate, expect, as I look at consensus today for both GEMMAP standalone as well as MARIS, you know, look to be in a reasonable place, also reflective of our investment priorities. Of course, we're notified ultimately our guidance to the market in February of 26, but to put a finer point on it, Zain, yes, as I said here today, it does include what we think about it from overall portfolio development, including your specific question around inclusion of investment in the locally advanced.

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

Thank you. Next question is from the line of Charlie Haywood from Bank of America. Please go ahead.

Hi, Charlie Haywood, Bank of America. Thanks for taking the questions. The first one was on just how you're looking at the first line head and neck cancer landscape, specifically, I guess, the option to have a triplet versus a doublet strategy, how you think those segments of the markets differ versus the Keytruda mono or combo arms that you have as part of the trials and then the second one being in rena s your endometrial data i think optically looked like better responses in the folate receptor grace than 25 and a bigger delta than you'd seen in proc so i guess confidence in efficacy across broad folate receptor alpha expresses thank you thanks charlie for the questions ty can you start and then maybe you that you can step in there let's first start with the frontline head and neck cancer landscape sure i mean i wouldn't say

The way I would answer your question is that, broadly speaking, in the current landscape, as you were alluding to, there is a pembo-mono strategy and then a pembo-chemo strategy, and at times physicians make that choice based on maybe a slightly higher response rate for the chemo-pembo combination and a faster time-to-response, and that's a lot to do with location of the tumor and size of the tumor. That all becomes essentially irrelevant if the data in the phase two with PETO and PEMBO is essentially double, twice the reported response rate for chemo PEMBO. Because at that point, you basically have a higher, twice as high, response rate without the significant toxicities of chemotherapy chemotherapy too well. So this is what we like about the profile of PETO in particular, also in the data in PEMBO-PETO, because it really, in the combination, provides an opportunity where you have a high response rate, a rapid time to response without any of the quite significant toxicities that go along with combination chemotherapy in this patient setting. That's the head and neck story. On the EC, on the vena S, and the meteor cancer, I mean, there are nuances here and there. It's not that we have ever said that folate receptor alpha expression is irrelevant to the response. That's not the case. What we said is that vena S has a profile that allows us to generate meaningful responses across the entire spectrum of folate receptor alpha expression. and thus does not require a biomarker selection. And that's a strategy that has allowed us to go into these indications, and the mitral is generally considered to be a lower folate receptor alpha-expressing tumor than PROC. And it's also what is undervaluing the confidence in going to other indications such as, for example, EGFR, non-small cell lung cancer. And so this is one of the differentiating aspects of VNAS, that it... is able to generate meaningful and stable response rates across the entire spectrum. That doesn't mean that the higher don't even have higher responses. That just means that even at the low end, the responses are meaningful and doable.

Thanks, Tai. Let's move on to the next question. Thanks, Charlie. Thank you. Next question, please.

There are no further questions at this time. I would now like to turn the conference back to Jan Vattenwinkel for closing remarks.

So thank you for calling in today. If you have additional questions, please reach out to our investor relations team. We very much look forward to speaking with you all again soon.

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