Genmab A/S (GMAB) September 2026 Conference Transcript

Next session here, I'm Tony Hayward from the Bank of America, English Farmer Research Team. I'm here to speak to Andrew Carlson, Head of Investigation to GenLab, with us today. Welcome, thank you for joining us. I think we're starting, obviously, lots of interest, big thoughts are coming up. So just a reminder, a few big picture questions. Where do you find thoughts, thoughts, and what have you got coming up? Sure.

Maybe taking a step back and then looking at 2026. So far, so good. A strong first half, as you saw at our Q2 results, both operationally and financially, where we upped our guidance, especially the top line, where it was driven primarily by DASLEX, but importantly also by Epkinney. And getting to your question, we also provided, you could say, more specific guidance as to these important readouts that everyone has been waiting for to take place in 2026. the first one being the epkidney frontline study in dlbcl where we combine epkidney with rchop versus rchop where we guided that the the readout will be in q4 and it's based on a pre-specified interim then we also made it clear that we're going to have the rena s phase three trial readout in q4 which is rena s in second line plus platinum resistant ovarian cancer and this is actually also very exciting in the sense that it's a phase three trial that has been brought forward so reading out now in q4 this year and which of course puts us in the position to potentially become uh first in class among the next generation folate receptor alpha adcs in ovarian cancer so that's why that's very important and then finally we have the frontline uh header neck metastatic head and neck cancer an opportunity with pitocentamab plus Ktruda versus Ktruda, where we will have this readout guided for to come out in Q4. So across all three late-stage assets, we actually have the potential to be first in class, meaning that we will be the first bispecific in frontline DLBCL reading out phase 3 compared to our competitors. The same goes for the next generation folate receptor alpha ADCs with Rhina-S and for pitocentumab also in front line head and neck cancer.

Got it that's very clear and obviously PITO and Rhina-S both acquired through acquisitions recently I think both got broader programs. Remind us where we are on the broader programs for that any sort of you know rough timelines on data for that and when we if we can expect more phase three starts this year for both.

Sure so starting with Rhina-S this came through the acquisition of profound bio in 2024 and to provide context as to how you say rapid the development and broad the development program is we're now up at five active phase threes with the first reading out as guided here in Q4 again this speaks to the breadth and the depth of the program we've guided for the second line plus proc opportunity to read out in Q4 but remember we also have We have second-line intermedial cancer phase three well on the way. We have platinum-sensitive maintenance phase three well on the way. And then we announced a platinum-sensitive replacement phase three this year. And we also announced the frontline intermedial cancer phase three this year. So five phase threes with the potential to be first in second-line proc in Q4 with rena-S. So a broad and aggressive development plan, also showing our confidence in the value proposition of ARENA-S in the Gynon space. But in addition to that, we've also gone beyond that and started some signal-seeking studies in lung cancer. So we've started a phase 2 signal-seeking trial with ARENA-S, as well as we've gone into GI solid tumors with ARENA-S, also signal-seeking. So a lot going on with ARENA-S since we acquired it in 2024. Going over to pitocemptimab, where we completed the acquisition of MERIS in December 2025. There we inherited two phase 3 trials, one in the frontline metastatic head and neck cancer, and the second line metastatic head and neck cancer. Since then, or maybe taking a step back, while doing the due diligence and the acquisition, we decided to amend the trial design, not the trial design, but the size of the trials, by adding an additional 200 patients to the frontline phase 3 trial and add an additional 100 patients to the second-line phase 3 trial. We kept the co-primary endpoints unchanged for the frontline head and neck phase 3 trial, while in the second-line head and neck trial, we made it to a sole primary endpoint of overall survival. So those were changes that we decided and made during the due diligence of MARIS and the acquisition of pitocentumab. And in addition to that, we just recently announced here at Q2 that we are starting two phase 3 trials in colorectal cancer, in frontline colorectal cancer, and in second-line colorectal cancer. So again, as you can hear from this, a lot going on. The colorectal cancer trials are something that I just recently announced, but are somewhat ahead of what we initially guided for. because when we did the acquisition we also guided for the fact that we would pursue phase threes in locally advanced head and neck and we're still committed to that but we felt that the you say underlying data in crc was compelling enough to start these two phase three trials as well got it very clear and then i think worth jumping into fourth quarter what we've got coming up i I think you've got RENA-S, second line, phase two, phase three, PITO, first line, Kinley, front line, and then some ESMO data.

So have you given any comments on the rough sequence of the trials that we're coming reading out in terms of phase threes or what we could expect first or any?

So we haven't provided any sequence or timing with regards to any of these important readouts. We, of course, appreciate the question and why people want to understand that. but what we've confirmed is that we're going to have the pitocentumab data in colorectal cancer at ESMO. So that's of course something to look forward to. Essentially you will see the data that has been part of the that has kind of informed the decision to start the phase three trials both in frontline and second-line colorectal cancer that we have provided you and that will take place in October 23rd to October 27th.

But other than that you kind of have to wait for Q4 to to figure out when you will get the phase 3 data and rena s phase 3 in the kinley and as well as the phase 3 on peto septum app very clear um and then on the peto front line i think for you know for us and for many people this obviously an anchor asset for you given the size of the deal the data to date looks you know very impressive so remind me what will we get in fourth quarter any sort of filing strategy timelines on that um i think you could potentially launch by ender 27 so what are we getting and what's the sort of path post that as you get that sure so for pizza symptom map the way the trial is designed and this was something that

Maris has agreed upon with the with the FDA is that there are two co-primary endpoints with an interim look one being or our and duration of response and then the other co-primary endpoint is OS what we are guiding for to read out in Q4 is It's going to be ORR. And remember, it's pisosemtumab plus pembrolizumab versus pembrolizumab. And that's essentially what you should somewhat anticipate will be top lining in a press release. We get a lot of questions as to what will this press release contain. I cannot sit here and preempt that.

But if you look at how we've been disclosing our previous phase three trials across Epkinli, it's been anchored around the primary endpoint. and only that whereas all other secondary endpoints or data will be disseminated preferably at a medical conference very clear uh just a reminder if there are any questions feel free to to raise your hand um but i'd say the biggest biggest question i get in on pito is obviously you know you're now six to nine months ahead of central compressor with by cara data coming out soon so your phase two looks fairly differentiated in terms of response rate data how do you compare the two like do you think is there risk of a large dilution in terms of overall

efficacy is there anything on safety you'd flag as we look to your data and then we'll look ahead to the competitor coming i think mid-27 no but broadly speaking uh we are you know rather confident in the strength of the data uh on pizosemptimab uh remember we had we have done a thorough due diligence uh during uh since we initiated the the proposal to acquire maris uh starting i think it goes back to to uh to september last year um and then of course as we now formally took over the the asset and the development uh starting in december we've become more familiar with the data and irrespective of how you kind of cut or compare the data to competition whether it's a bicarous acid or whether it's J&J's acid, which is riboment, we feel rather confident in the profile of pitocentumab and how it performs across this heterogeneous patient population that head and neck cancer is. And with all the inherent flaws of doing cross-trial comparisons, we feel that pitocentumab, whether you look at efficacy or across safety, compares favorable across our competitors.

Got it, and then I guess another big question is the HPV positives and negatives in your I know some of the others are just going for a negative strategy. You can obviously essentially address both straight up, but the risk is that I guess the patient numbers seem to date in HPV positives aren't obviously as robust as the negatives. So, you know, is there enough confidence that you've A, got enough patients that are both in the trial, and B, can show sort of consistent enough efficacy across the two?

Again, based on the data that's in the public domain, and this is more specifically the Phase 2 data that was presented at ASCO last year, where we saw, yes, it was a smaller number compared to the HPV negatives, but we did see highly encouraging signal activity and more respective 50% ORR. We believe that signal is rather robust. So we remain confident in the potential to address both HPV negative and positive. And then remember that the trial design, and this is to address also a question we've been getting a lot as to potential imbalances and dilution that you're referring to, the trial design is designed to take into account or to reflect the real world demographics of head and neck cancer, metastatic head and neck cancer patients. So that, of course, you can all do your literature search, kind of inform you as to what proportion of patients will be HPV positives versus negatives, and the various types of tumor types that exist within head and neck cancer.

Well, that's very clear. And then on your second, third line strategy, obviously, J&J out earlier this year, that they have filed on their data, I think sort of not what everyone had expected. So, you know, you're ahead in terms of timing on the front line. How do you feel about second line? You've got your OS data coming, I think, 1Q next year. So what's your relative position? How can you compete there?

With regards to the second line opportunity, here we are also in a rather good position in the sense that we will have a formal phase 3 readout based on a hard endpoint, which is overall survival in Q1 next year. We are fully aware that J&J has pursued an accelerated approval path in the U.S. based on overall response rate and duration of response. That data was presented at ASCO. It looked highly encouraging. We also acknowledge that. But when you compare the data, again, with the data that we presented in that same opportunity, taking into account of patient demographics which could be for example the proportion of patients that are asian the proportion of where the primary tumor was located prior lines of therapy accounting for all that we still feel that pittosemptimab in that opportunity competes fairly and to your point charlie we will have a formal global randomized phase three with a heart endpoint in os reading out essentially three months after they have a potential weed out that we still feel that the

pitocentable will be competitive compared to that asset or to riprovent more specifically in the second line opportunity got it that's clear and then on your colorectal opportunity i think obviously at the time of the deal it was a reasonable focus of how much of your deal value was heading there colorectal anything else um you've obviously seen enough data to gate a phase 3 start, you're presenting it at ESMO, what can we, is this further patients, longer duration, what can we expect at ESMO, and I guess within that, your timelines are behind J&J versus many other indications, so clearly, I think to gate your phase 3, is it fair to assume competitive versus what we've seen from their data state?

Yes, and to provide some context, when we did the acquisition, MARIS did have some early data in colorectal cancer. We had the opportunity to go through that data as part of our due diligence. That data was later presented at a medical conference in November. And as most of you also concluded, it looked encouraging, but it was rather limited. So it was a small patient number, as well as it was a very short follow-up. What has changed since then is that we have followed, of course, these patients, and we've added more patients. So we now have a, you could say, larger data set with longer follow-up. And while we've been following this data, what you can infer, given the fact that we've made this important decision to pursue phase threes in front line and second line, seems to indicate that we continue to be encouraged about the signal we saw, the early signal we saw in last year in November.

Got it. And then the last of the ones, the locally advanced, I think I'd view it as a very significant op, but a lot of assets have failed in the space and you don't necessarily have the locally advanced data. So confidence to go into a phase three there, is that just, you know, which could be huge but risky? Or is there enough confidence that there's a decent probability of that trial being successful?

The competence remains unchanged with regards to locally advanced head and neck. And taking a step back to your previous question, where when we announced the deal, we came out and said that we see pitocemptumab as a next-generation EGFR bispecific that is going to be anchored in head and neck. And by that, we meant, first of all, in metastatic front-line and second-line head and neck, but also in locally advanced head and neck where you have the resectable and unresectable. So already back in December or September when we announced the deal, we already provided guidance as to, you would say, our appetite to pursue late stage development in locally advanced head and neck and essentially guided that we would start a phase three trial in locally advanced head and neck before end of this year. And that confidence remains unchanged. And that's also still something we'll pursue. It's based, of course, on, you could say, the early clinical data we've seen in frontline head and neck, which we believe in some way or manner should translate to something meaningful for patients in locally advanced head and neck.

Got it. And then on, I guess, peto-financials, if you look on risk-adjusted, do you have a rough rank order or a rough sizing of the potential peto-ops that you've announced so far it could go into? so first line, second, third line, colorectal, likely advanced?

So we've provided kind of the addressable patient population sizes in our materials. And I think what you can see from the announcements of the colorectal cancer trials that we did a Q2 where we also provided updated numbers is that the colorectal cancer patient opportunity is a significant opportunity. So taking a step back, locally advanced is – the locally advanced head and neck opportunities as big as frontline and second line head and neck put together. So it's essentially a doubling. So the metastatic head and neck cancer opportunities around 60,000 to 70,000, and then you essentially double it by going into locally advanced. And then by the announcement we made in Q2 by pursuing colorectal cancer, we're of course adding to that. And that is a significant addition of patients essentially larger than head and neck. uh put together got it and then i think you currently go to multi-billion peak sales consensus that uh three and a half billion is there any sort of appetite to update that to give more concrete numbers you know if we see positive data coming up could we see sort of further incrementals so for now we we're comfortable with the multi-billion uh dollar peak sales potential uh we think it's appropriate and and it appropriately reflects the opportunity set which initially was metastatic front line and second line head and neck now we have just started the corrective cancer opportunity but you have yet to see any clinical evidence or late chase evidence for that so to your point charlie once we have you could say more data to inform and also provide a credible set of underlying assumptions we'll be more comfortable to update but I think the multi-billion peak sales potential is appropriate given we've provided the patient populations, we have phase threes in the metastatic front line and second line head and neck that will read out Q4 and Q1, and then it will take some time before the colorectal cancer opportunity will read out. It will also take some time before the locally advanced will read out.

So before we have that clinical data, you just have to kind of patiently wait to figure out what this multi-billion means very clear um any questions on pso before i move on to rena s no rena s then uh also got well phase two and phase three data coming up fourth quarter i think it's an asset we see is sort of you know fairly under underappreciated i think almost given the deal size but it could be you know very significant to you so again you know same setup remind us what we've got coming phase two phase three will you you know how much for you will the phase two de-risk your phase three in terms of data coming and what should we expect coming in the fourth quarter?

Yeah so for fourth quarter and RNA-S we've guided that we will have the phase two data from the RMC expansion cohort which is 100 patients RNA-S in second line plus platinum-resistant ovarian cancer and as I said what is of course increasingly positive is that the phase three was brought forward also to readout in Q4, where the phase 3 is a formal global study with a primary endpoint of PFS that will allow us to engage with global health authorities. And hence, that has become, you could say, the most important data set. So from how we're going to disseminate the data, you should assume that the phase 3 data readout will be top-lined and press-released, Whereas the phase two data, which is now more, you can view this as a more robust phase two data set, will ideally be presented at a medical conference or potentially press release. But that is still to be determined.

But what you can rest assured is that we provide a guidance as to you will have some insights into these two data sets in Q4 this year. okay and on the in terms of still to be determined for the phase two what will dictate whether you press release it whether you look to present at the conference because i i guess if it's at a conference after your phase three it wouldn't be seen as that material for gem as a whole to you know so i guess how are you feeling about the phasing of that look i think all so within In oncology or drug development, data is currency, so I wouldn't entirely dismiss the phase two data being irrelevant after the phase three reads out.

So to put it in perspective, you will only get the top line results from the phase three data, and then we would prefer to present the underlying data at a medical conference. So I think there are a lot of physicians and prescribers, but also investors who would like to see some more granular data as to how in a larger data set as to how we nas performs in that setting and that's where the phase two data becomes highly relevant because that so far you've seen highly encouraging phase two data in second line proc but it has been around in a patient population of around 20 patients and now you have the opportunity to actually look at it at a more robust data set of 100 patients so it's more figuring out as to how can we get the most out this data this phase two data and yes as i said that's still to be determined when or where or

how it's going to be disseminated but the phase three should be clear that will be press released in a top line manner and then phase two to be d got it and then confidence obviously this is you know we know earlier here is on the market this is a photo receptor agnostic um trial i guess confidence in showing efficacy across the broad expression your face sorry your phase one two you've obviously presented data by some expressions but I know some competitors have given broader efficacy by expression. Do you think you're in line with that? How do you feel you see it versus those and confidence in the broader label or broader opportunity?

Yeah so referring back to the phase two data that was presented at SGO so it's a while ago but nevertheless there we showed by expression cut off above 75 and below 75 and what you can infer from the data that you know Looking at the overall response rate, which was above 50% or 56% more precisely, but also taking into account that this is only 20 patients, from what you can infer is that, yes, there is encouraging overall response rate across folate receptor alpha expression, but it does You could sit and do the math and count the bars in the waterfall platform, which also shows that we also had responses in patients who are post-ELA here. So that's also another point to remember. But what we also want to make clear is that we're not sitting here claiming that it works, you could say, equally well across foliar receptor alpha expression, but more that it works well in the sense that high expressions will potentially have high responses, whereas if you have lower expressions, the responses will be equivalently lower. but it's better than what you could say the alternative today which is chemo if you're below 75 expression or ella here if you're above 75 expression um however getting back to your to your question given that the the limited size of the the patient we chose to disclose it above 75 and below 75 because that's also kind of where the cutoff is based on ella here um whether we will have the opportunity to disseminate the data as the way you want it which is of course according to these buckets time will tell um but our confidence with regards to working across folio receptor alpha expression remains unchanged uh hi got it that's very clear and then i think the main debate we get in terms of the opportunity here in second line proc and endometrial obviously it's getting competitive you've got two folio receptor alpha competitors b7 h4s gilead's now got an asset in the space so how do you frame the competitive market you know since you've done the deals evolved sort of somewhat materially so how how do you view sort of the competitive risk coming into the space um and your sort of competitive rebuttal no we we fully acknowledge that that the space has become highly competitive uh but we have also ensured that we remain competitive we continue to firmly believe that rena s has the potential to become first in class so think about it we acquired rena s or profound bio in 2024 fast forward we have five active Phase 3s, the first one reading out in Q4, putting that into context versus our competitors, whether it be Eli Lilly, AstraZeneca, GSK, Gilead, they're all just recently entering the market. What I'm trying to get at is that given that we already have the first Phase 3 reading out, that should also tell you that we're well on the way with some of the other Phase 3s, and we also have the broadest development program compared to our competitors. Not all of our competitors are, for example, pursuing endometrial cancer, which is also a differentiating factor. And remember the thesis of the value proposition is that we want to establish RINA-S within the Gynon space, so across ovarian cancer, whether it's PROC or PSOC, as well as endometrial cancer, frontline, and second line.

And we are well on track to delivering that shortly after, you could say, an acquisition that was made in 2024, whereas our competitors, they're essentially just getting into the market late last year or this year very clear and then do you see more sort of hypothetically over time i don't believe folic receptor alpha expression is sort of correlated with some of the other mechanisms the b7 h4s the f2b is there a chance that you actually can have you know better penetration of the highs versus competitors that might look to come into your folic receptor low population because they're not quite as biomarker correlated to those or is that not you know a scenario you see playing out no I think in simple terms I think what we're seeing right now is more as

to who can come in first and go broadest and the reason for that is that across all those come at least those from big pharma that that you mentioned there we're using essentially the same super one payload and then the question is of course is there a risk or a potential of patients becoming resistant or refractory to this payload so here that's why it's critically important for us to have this all these phase threes up and running well ahead of our competitors to potentially be in the guy non space first and broadest in the event that this should be a situation that that plays out where there will be patients that essentially becomes refractory to to the payload rather necessarily that the target

got it and then uh last one really asked for me um in terms of potential obviously you know assuming positive data assuming you're launching our k-world feedback is because l here has formed the market very nicely but you have potential to come in with better data broader label that this could be a really strong launch and i know you know pito you've you framed as a billion dollars by 29 so you could have two potentially very fast launching oncology assets is that sort of how you look at it internally as well in terms of launch trajectory, sort of excitement from physicians around this data as well.

Yeah, and I think it goes across our three assets. So remember Epkinly, there we're just taking them one by one. Epkinly, what we're looking into is the frontline opportunity, which is essentially half of the addressable patient population. There, assuming we have positive data in Q4, that will also allow for launch next year, together with, to your point, RINA-S in second-line PROC, as well as frontline P2-symptomab, where that being the only asset where we've provided kind of a stick as to how the uptake or the launch should look like. And you correctly remember that we said greater than 1 billion by 2029. So that essentially gives you an opportunity to draw a line from launch in late 2027 up to 2029. design, whereas for Epkinli or RIN-S, we haven't provided specific guidance to how the uptake However, what I'm trying to get at is that all three put together puts us in a really good position where we're going into meaningful opportunities and with hopefully strong clinical data will allow us to successfully launch these medicines and bring to as many patients as possible. So it's all about what will the data look like in Q4.

Very clear. And then you've alluded to it already. Obviously, Epkinly, you're getting the first line data, but starting on your second line DLBCL combo, which was very strong PFS hazard ratio. I guess what's your confidence in that data? And then how, I know you've talked with the other assets, you've done a lot of internal modeling expectations. How did that 0.4 hazard ratio look relative to what you've modeled internally?

Yeah, I think what has been positive so far with Epkinney is that, and also why we've been somewhat consistent in our way of guiding, is that if you take a step back and look at the phase three readouts, with the exception of one, they have essentially one-to-one mirrored the phase two data. So if we go back to the phase three readout in second-line follicular lymphoma last year, in combination with R squared, where we had a hazard ratio of 0.21, that highly encouraging data, when we now retrospectively look at it, somewhat mirrors actually the phase 2 data that we've been presenting at ASH a couple of years ago. The same can be said for this second-line DLBCL readout that we had earlier this year in combination with lenalidomide, where essentially this hazard ratio of 0.4 or 0.44 resembles the phase 2 data that we have been presenting at ASH. Now when we've then been asked, so what are your expectations for the frontline data. What does good look like? Again, we're not in a position to guide on hazard ratios or what the bar is, but we have been pointing back to the RCHOP at Kinney Phase 2 data that we just recently at ASH presented, where we even showed you the, and this was a 36-month follow-up, where you have the PFS curves and you have even the response rates across cell of origin and even risk type uh whether the ipi and sorry ipi status and that has kind of been informing our you could say excitement or conviction going into this readouts uh so to to back to your original question we would say that the the phase two data and second line dlb cell read out as expected based on that hypothesis that we we put out there very clear and then going to the frontline trial

obviously you know it's a partnered asset but i guess just reframe your confidence on that trial While prior looking at the control arm, prior data should have suggested, and I think many investors were expecting it to come earlier, at some point earlier this year, it's later than expected, but you've confirmed it's the interim coming in fourth quarter, so what's your read of the delay based on anything you can see from the ABV side, et cetera, any sort of blinded curves, et cetera, and confidence?

Look, our confidence is unchanged high with regards to this readout. what we've been guiding and reiterating is that we were we're going to have this readout in 2026 and what has essentially changed is that now we've been more specific when in 2026 it's going to take place where we said it's going to take place in q4 and then it's based on a pre-specified interim um other than that nothing has really changed um we we gave this guidance many months ago and as everyone is aware in the room uh you know phase three trials event drivens and all that comes with these blinded trials. We have now increased our conviction and confidence as to the timing, and that has been narrowed down to Q4. So unchanged, excited, and looking forward to the data readout in Q4.

Got it. And do you expect to present data for the IPI 3 to 5 and 2 to 5?

So again, the premise and the framework is that we top-line result only based on the primary endpoint.

And the primary endpoint is IPI 3 to 5. the two to five is a secondary endpoint very clear and then any more on that can you or in your s you sort of alluded to it already but obviously wrapping this all together I think the big picture story for gen map does like Eloy these are really sort of gating opportunities but both with you know Reno SP toe at Kinley but both with much broader phase three so how you know from where you sit today if we come out fourth quarter with positive data how do you feel about the shape of your sales, margin curve, like, you know, through the Darsalex, Eloi, just remind us how that looks and how you feel about growth through that.

Sure. So rather than sit here and try to do Darsalex replacement math, I would rather frame, or the value proposition that you should think about is that we're essentially building a standalone growth oncology franchise with these three LHJ's assets, while at the same time we'll retain our royalty portfolio. So we're in a unique position where we've been privileged to have a really strong royalty portfolio that has got us this far. And now we have, within a very short time frame, established a proprietary oncology portfolio that will hopefully read out positively in Q4 this year and allow us to launch in 2027 and put us in a place where we essentially have, you could say, a business within the business where you have still cash flow coming in from the royalty business and then you have this wonderful growth business consisting of three highly differentiated potentially best and first-in-class assets that will ensure that Genmap will continue to be this growth and profitable growth business well into the next decade that's kind of how I see it also given you see our segment level around rena s and and pito symptom where we have the potential to go broader than just the initial indications that's highly promising for for the future ahead and then at the same time we'd also shouldn't dismiss our early innovation which is still going on but it's more you could say from a disclosure perspective how much we talk about it has been put to kind of work in silence in secrecy and then as that matures and becomes more tangible well then we will start unlocking what that could potentially bring for the future but for now it's all focused about this late stage portfolio and that business in itself together with the royalty business and then later on we'll hopefully also have our own proprietary pipeline become

sufficiently mature that that will also add on top of the growth got it and then one of the questions i get is obviously you know you've been largely royalty revenue business data kindly you're sort of a bit more in the middle but your confidence and ability to commercialize your wholly owned assets, you know, what steps do you need to take? What have you got so far already in place? How's launch progress, et cetera, for all of these?

Yeah, and we've come really far with regards to Ford integrating and becoming this mature, established business. It's been a stepwise approach where I think we tend to kind of forget the journey of GenMap that it all started with essentially us commercializing TIFDAC, which is a tissue factor ADC for the treatment of late-stage cervical cancer we started that journey with cgen now fight sir we built upon that with uh ep kinley together with abby but where the difference was that we retained more rights or more responsibility from a commercial perspective so we were or we are commercial lead in the u.s and japan and that of course entailed more investments and more investment in capabilities and function which essentially has put us in a place that we're now ready for the 100% wholly owned proprietary medicines, which is RINA-S and Pitocentumab, for launching these next year. Part of the journey that we've also been sharing with you is that, for example, we've been utilizing TIFDAC, acquiring back the rights for TIFDAC in Europe and Japan to establish, you could say, a launch platform for eventually when RINA-S comes to market. So that's another good example as to how we are thinking, how strategic we're thinking. And the same, you should also think about PITO-Semtomab going into next year. So we feel that we are ready. Of course, there are still some additional investments that need to be put in place next year, but that are already also put in place this year.

Got it. And then RINUS and PITO, and I guess somewhat at Cleanly Launch Timelines, you've suggested can happen in 27. Will that be with extra, any sort of priority review, et cetera? How have you sort of framed the potential to launch those by the end of 27?

So we've left it at that we anticipate to launch all three in 2027. And then depending on, it's hard right now without having the data as to how quickly the reviews and approvals can come. But I think we remain rather confident that we'll be able to launch at some point in 2027 across all three assets.

Got it. That's clear. And then And one I was going to ask, but in terms of consensus 2027, I wonder if it's something you've looked at, obviously, you know, lots going on in terms of the cost lines, bits on the tax side of things, like, you know, anything you'd comment on in terms of 2027 building blocks, I guess, underlying royalties going well, costs well reflected, how are you feeling about current consensus as we sit?

Look, I feel that it's kind of the same grind every year, I have to remind people as to what we're doing. And the reason why I say it that way is, of course, that it is a rapidly evolving business in the sense that we are investing in growth. So to put it in perspective, this year we've added two more new phase three trials, which were kind of not guided or reflected to the market, in addition to trials that have yet to start, for example, in locally advanced head and neck. So what I'm trying to get at is that, you know, it's more about having consensus catch up on that fact that remember that we just added two CSC trials on top of the already guided locally advanced trials and this is something that of course consensus has to adjust to and appropriately reflect going into next year so that is one example from an R&D perspective and then with regards to SG&A there we've been rather explicit that yes there are some additional investments that have to be made with regards to as we get closer to launch And that is more about fine-tuning. But I think the delta or where the catching up still remains is around the fact that we are continuing to broaden the development for both KIT2-Centumab and RINA-S and remembering to carry that into next year's estimates, essentially.

Got it. One very last final one. Real amortization. Do you think that's being well-reflected yet?

No, and that is something that will be articulated clearly soon. That is something that the market and consensus has to take into account. As soon as we hopefully launch or get approvals on these medicines, we will start amortizing essentially the close to 7 billion on PETO and 1 point something billion on RINA-S. And it's a straight line amortization journey. so it's simple math but people haven't yet started doing that and that's something that will continue to remind them and now set it here so everyone this room knows it perfect well we are slightly over time but very much appreciate the time thank you for joining us today thank you