It's worth starting, obviously, lots of interest. Phase III readouts are coming up. Just remind us, give you a quick question, where do you find those scores and what we got coming up maybe focusing on?
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 DARZALEX, but importantly also by EPKINLY. 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 EPKINLY frontline study in DLBCL, where we combine EPKINLY with R-CHOP versus R-CHOP, where we guided that the readout will be in Q4, and it's based on a pre-specified interim. We also made it clear that we're going to have the Rina-S phase III trial readout in Q4, which is Rina-S in second-line plus platinum-resistant ovarian cancer.
This is actually also very exciting in the sense that it's a phase III trial that has been brought forward, so reading out now in Q4 this year. Which, of course, puts us in a position to potentially become first in class among the next generation of folate receptor alpha ADCs in ovarian cancer. So that's why that's very important. Then finally, we have the frontline metastatic head and neck cancer opportunity with petosemtamab plus KEYTRUDA versus KEYTRUDA, 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 III compared to our competitors.
The same goes for the next generation of folate receptor alpha ADCs with Rina-S and for petosemtamab, also in frontline head and neck cancer.
Got it. That is very clear. Petosemtamab and Rina-S both acquired through acquisition recently. I think both got broader programs. Remind us where we are on the broader programs for that and any sort of rough timelines on data for that and if we can expect more phase III starts this year for both.
Sure. Starting with Rina-S, this came through the acquisition of ProfoundBio in 2024. To provide context as to how, you say, rapid the development and broad the development program is, we are now up at five active phase IIIs, with the first reading out as guided here in Q4. Again, this speaks to the breadth and the depth of the program. We have guided for the second-line plus PROC opportunity to read out in Q4, but remember, we also have second-line endometrial cancer phase III well on the way. We have a platinum-sensitive maintenance phase III well on the way. Then we announced a platinum-sensitive replacement phase III this year, and we also announced the frontline endometrial cancer phase III this year. So five phase IIIs, with the potential to be first in second-line PROC in Q4 with Rina-S.
So broad and aggressive development plan, also showing our confidence in the value proposition of Rina-S in the GYN onc space. In addition to that, we have also gone beyond that and started some signal-seeking studies in lung cancer. So we have started a phase II signal-seeking trial with Rina-S, as well as we have gone into GI solid tumors with Rina-S, also signal-seeking. So a lot going on with Rina-S since we acquired it in 2024. Going over to petosemtamab, where we completed the acquisition of Merus in December 2025. There, we inherited two phase III trials, one in the frontline metastatic head and neck cancer, and the second line metastatic head and neck cancer. Oh, maybe taking a step back.
While doing the due diligence and the acquisition, we decided to amend the trial designs, not the trial design, but the size of the trials, by adding an additional 200 patients to the frontline phase III trial, and add an additional 100 patients to the second line phase III trial. We kept the co-primary endpoints unchanged for the frontline head and neck phase III 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 Merus and the acquisition of petosemtamab. In addition to that, we just recently announced here at Q2 that we are starting two phase III 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 IIIs in locally advanced head and neck, and we are still committed to that. But we felt that the, you could say, underlying data in CRC was compelling enough to start these two phase III trials as well.
Got it. Very clear. Then I think worth jumping into full course of what we have got coming up. I think, you have got Rina-S second line phase II, phase III, petosemtamab first line, EPKINLY frontline, and then some ESMO data. So have you given any commentary on the rough sort of sequence of the trials that we are coming reading out in terms of phase IIIs or sort of what we could expect first or any-
No. So we have not 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 have confirmed is that we are going to have the petosemtamab data in colorectal cancer at ESMO. So that is, 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 III trials, both in front line and second-line colorectal cancer. That we have provided you, and that will take place on October 23rd to October 27th. But other than that, you kind of have to wait for Q4 to figure out when you will get the phase III data in Rina-S, phase III data in EPKINLY, and as well as the phase III on petosemtamab.
Very clear. Then on the petosemtamab frontline, I think for us and for many people, this is obviously an anchor asset for you, given the size of the deal. The data to date looks very impressive. So remind me, what will we get in fourth quarter, and if there are filing strategy timelines on that, I think you could potentially launch by the end of 2027. So what are we getting, and what is the sort of path post that as you get that?
Sure. For petosemtamab, the way the trial is designed, and this was something that Merus has agreed upon with the FDA, is that there are two co-primary endpoints with an interim look. One being ORR and duration of response, and then the other co-primary endpoint is OS. What we are guiding for to read out in Q4 is going to be ORR. Remember, it is petosemtamab plus pembrolizumab versus pembrolizumab. That is essentially what you should somewhat anticipate we 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 have been disclosing our previous phase III trials across EPKINLY, it has 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. Just a reminder, if there are any questions, feel free to raise your hand. I would say the biggest question I get in on petosemtamab is obviously, you are now six, nine months ahead of potential competitor with Bicara data coming out soon. So your phase II looks fairly differentiated in terms of response rate data. How do you compare the two? Do you think there is a risk of a large dilution in terms of overall efficacy? Is there anything on safety you would flag as we look to your data and then we will look ahead to the competitor coming in, I think, mid-2027?
No, but broadly speaking, we are rather confident in the strength of the data on petosemtamab. Remember, we have done a thorough due diligence since we initiated the proposal to acquire Merus, starting, I think it goes back to September last year. Then, of course, as we now formally took over the assets and the development starting in December, we have become more familiar with the data. Irrespective of how you kind of cut or compare the data to competition, whether it is Bicara's asset or whether it is Johnson & Johnson's asset, which is RYBREVANT, we feel rather confident in the profile of petosemtamab and how it performs across this heterogeneous patient population that head and neck cancer is. With all the inherent flaws of doing cross-trial comparisons, we feel that petosemtamab, whether you look at efficacy or across safety, compares favorably across our competitors.
Got it. Then I guess another big question is the HPV positives and negatives in your trial. I know some of the others are just going for a negative strategy. You can obviously potentially address both straight up, but the risk is that the, I guess, the patient numbers in today's HPV positive are not obviously as robust as the negative. So is there enough confidence that you have, A, got enough patients with both in the trial, and B, you can show sort of consistent enough activity across the two?
Again, based on the data that's in the public domain, this is more specifically the phase II 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, more specifically 50% ORR. We believe that signal is rather robust. So we remain confident in the potential to address both HPV negative and positive. Remember that the trial design, 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 positive versus negative, and the various types of tumor types that exist within head and neck cancer.
That's very clear. On your second/third line strategy, obviously J&J out there earlier this year, that they have filed on their data, I think sort of not what everyone had expected. So 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, 1, 2 next year.
Yeah.
What's your relative position? How can you compete there?
With regards to the second-line opportunity, here we are in also in a rather good position in the sense that we will have a formal phase III readout based on a hard endpoint, which is overall survival in Q1 next year. We are fully aware that Johnson & Johnson 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. 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 petosemtamab in that opportunity competes fairly.
To your point, Charlie, we will have a formal global randomized phase III with a hard endpoint in OS reading out essentially three months after they have a potential readout. We still feel that the petosemtamab will be competitive compared to that asset, or RYBREVANT more specifically, in the second-line opportunity.
Got it. That's clear. 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 head and neck, colorectal, anything else. You've obviously seen enough data to gauge a phase III start. You're presenting it at ESMO. For the patients, longer duration, what can we expect for ESMO? I guess within that, your timelines are behind Johnson & Johnson versus many other indications. Clearly, I think to gauge your phase III, is it fair to assume competitive versus what we've seen from their data to date?
Yes. To provide some context, when we did the acquisition, Merus 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. As most of you also concluded, it looked encouraging, but it was rather limited. 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 all these patients and we've added more patients. We now have a, you could say, larger data set with longer follow-up.
While we've been following this data, what you can infer, given the fact that we've made this important decision to pursue phase IIIs 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 last year in November.
Got it. The last of the ones, the locally advanced, I think [inaudible] is a very significant op, but a lot of assets have failed in this space, and you don't necessarily have the locally advanced data. So confidence to go into a phase III there, is that just which could be huge but risky? Or is there enough confidence that there's a decent probability of that trial being successful?
The confidence remains unchanged with regards to locally advanced head and neck. Taking a step back to your previous question, when we announced the deal, we came out and said that we see petosemtamab as a next-generation EGFR bispecific that is going to be anchored in head and neck. 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. Already back in December or September when we announced the deal, we already provided guidance as to, you could say, our appetite to pursue late-stage development in locally advanced head and neck, and essentially guided that we would start a phase III trial in locally advanced head and neck before end of this year.
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 front-line 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. On, I guess, peak to financials, if you look unrisk-adjusted, if you have a rough rank order or rough sizing of the potential peak ops that you've announced so far, if you go into say first line, second, third line, colorectal, locally advanced.
We've provided kind of the addressable patient population sizes in our materials. I think what you can see from the announcement of the colorectal cancer trials that we did at Q2, where we also provided updated numbers, is that the colorectal cancer patient opportunity is a significant opportunity. Taking a step back, the locally advanced head and neck opportunity is as big as front line and second line head and neck put together. It's essentially a doubling. The metastatic head and neck cancer opportunity is around 60,000- 70,000, and then you essentially double it by going into locally advanced. Then by the announcement we made in Q2 by pursuing colorectal cancer, we are of course, adding to that, and that is a significant addition of patients essentially larger than head and neck put together.
Got it. I think you currently guide to multi-billion peak sales consensus of DKK 3.5 billion . Is there any sort of appetite to update that to give more concrete numbers? If we see positive data coming out, could we see further incrementals?
For now we are comfortable with the multi-billion dollar peak sales potential. We think it's appropriate, and it appropriately reflects the opportunity set which initially was the statistical front line and second line head and neck. Now we have just started the colorectal cancer opportunity. But we have yet to see any clinical evidence or late-stage evidence for that. 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 it. But I think the multi-billion peak sales potential is appropriate given. We provided the patient populations. We have phase III in 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 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. Any questions on petosemtamab before I move on to Rina-S? No. Rina-S then. Also got. Phase II and phase III data coming up fourth quarter. I think it's not that we see it sort of fairly underappreciated, I think almost given the deal size, but it could be very significant to you. Again, same setup. Remind us what we've got coming, phase II, phase III. How much for you will the phase II de-risk your phase III in terms of data coming, and what should we expect coming in the fourth quarter?
Yeah. So for fourth quarter on Rina-S, we've guided that we will have the phase II data from the Arm C expansion cohort, which is 100 patients, Rina-S, in second-line plus platinum-resistant ovarian cancer. As I said, what is of course, increasingly positive is that the phase III was brought forward also to read out in Q4, where the phase III is a formal global study with a primary endpoint of PFS that will allow us to engage with global health authorities. Hence, that has become, you could say, the most important data set.
From how we're going to disseminate the data, you should assume that the phase III data readout will be top-lined and press released, whereas the phase II data, which is now more, you can view this as a more robust phase II data set, will ideally be presented at a medical conference or potentially press released. But that is still to be determined. But what you can rest assured is that we provided guidance as to you will have some insights into these two data sets in Q4 of this year.
Okay. In terms of still to be determined for the phase II, what will dictate whether you press release it, whether you look to present at a conference? Because I guess if it's at a conference after your phase III, it wouldn't be seen as that material for Genmab as a whole. I guess, how are you feeling about the phasing of that?
Look, within oncology or drug development, data is currency, so I wouldn't entirely dismiss the phase II data being irrelevant after the phase III reads out. To put it in perspective, you will only get the top-line results from the phase III data, and then we would prefer to present the underlying data at a medical conference. 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 Rina-S performs in that setting. That's where the phase II data becomes highly relevant, because so far you've seen highly encouraging phase II data in second-line platinum, but it has been in a patient population of around 20 patients.
Now you have the opportunity to actually look at a more robust data set of 100 patients. It's more figuring out as to how can we get the most out of this data, this phase II data. Yes, as I said, that's still to be determined when or where or how it's going to be disseminated. But the phase III should be clear. That will be press release in a top-line manner and then phase II TBD.
Got it. Confidence, obviously, we know ELAHERE is on the market. This is a program set to agnostic trial, I guess confidence in showing efficacy across the broad expression. Your phase I, II, you've obviously presented data about some expressions, but I know some competitors have given broader efficacy by expression.
Yeah.
Do you think you're in line with that? How do you feel you sit versus those in confidence in the broader label or broader opportunity?
Yeah. Referring back to the phase II data that was presented at SGO, so it's a while ago. Nevertheless, there we showed by expression cutoff above 75% and below 75%. What you can infer from the data that's 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 vary. You could sit and do the math and count the bars in the waterfall plot, which also shows that we also had responses in patients who are post-ELAHERE. So that's also another point to remember.
What we also want to make clear is that we're not sitting here claiming that it works, you could say equally well across folate 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 ELAHERE if you're above the 75% expression. However, getting back to your question, given that the limited size of the patient, we chose to disclose it above 75% and below 75% because that's also kind of where the cutoff is based on ELAHERE.
Whether we will have the opportunity to disseminate the data as to where you want it, which is of course, according to these buckets, time will tell. But our confidence with regards to working across folate receptor alpha expression remains unchanged. High.
Got it. That is very clear. I think the main debate we get in terms of the opportunity here in second-line platinum and [inaudible], it is getting competitive. You have two alpha competitors, B7-H4s. Gilead has now got an asset in this space. How do you frame the competitive market? Since you have done the deal, it has evolved somewhat materially. How do you view the competitive risk coming into the space and your competitive rebuttal?
No, we fully acknowledge that the space has become highly competitive, but we have also ensured that we remain competitive. We continue to firmly believe that Rina-S has the potential to become first in class. Think about it. We acquired Rina-S or ProfoundBio in 2024. Fast-forward, we have five active phase IIIs, the first one reading out in Q4. Putting that into context versus our competitors, whether it be Eli Lilly, AstraZeneca, GSK, Gilead, they are all just recently entering the market. What I am trying to get at is that given that we already have the first phase III reading out, that should also tell you that we are well on the way with some of the other phase IIIs, 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.
Remember, the thesis or the value proposition is that we want to establish Rina-S within the GYN onc space, so across ovarian cancer, as well as PROC or PSOC, as well as endometrial cancer, front line and second line. We are well on track to delivering that shortly after you can say an acquisition that was made in 2024. Whereas our competitors, they are essentially just getting into the market late last year or this year.
Very clear. Do you see more hypothetically over time, I do not believe that it has alpha expression is correlated with some of the other mechanisms of B7-H4 with [FRα]. Is there a chance that you actually can have better penetration of the highs versus competitors that might look to come into your [folate receptor alpha] low population because they are not quite as biomarker correlated to those? Is that not a scenario you see playing out?
No, in simple terms, I think what we are seeing right now is more as to who can come in first and go broadest. The reason for that is that across all those, at least those from big pharma that you mentioned there, we are using essentially the same Topo1 payload. The question is, of course, is there a risk or a potential of patients becoming resistant or refractory to this payload? So here, that is why it is critically important for us to have all these phase IIIs up and running well ahead of our competitors to potentially be in the GYN onc space first and broadest, in the event that this should be a situation that plays out where there will be patients that essentially becomes refractory to the payload rather than necessarily the target.
Got it. Last one on Rina-S for me. Assuming positive data, assuming you are launching, our feedback is because ELAHERE has formed the market very nicely, that you have potential to come in with better data, broader label, that this could be a really strong launch. I know, petosemtamab you framed as a billion dollars by 2029. So you would have two essentially very fast launching oncology assets. Is that sort of how you looked at it internally as well in terms of launch trajectory, excitement from physicians around this data as well?
Yeah, I think it goes across our three assets. So remember, EPKINLY, there we are just taking them one by one. EPKINLY, what we are 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 petosemtamab, where that being the only asset where we have provided kind of a stick as to how the uptake or the launch should look like. 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. Whereas for EPKINLY or Rina-S, we have not provided specific guidance to how the uptake is.
However, what I am trying to get at is that all three put together puts us in a really good position where we are 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 is all about what will the data look like in Q4.
Got it. You have alluded to it already, obviously EPKINLY, you are getting the first-line data, but starting on your second line, DLBCL combo, which was very strong PFS hazard ratio. I guess, what is your confidence in that data? I know you have talked with the other assets, you have done lots of internal modeling expectations. How did that 0.4 hazard ratio look relative to what you had modeled internally?
Yeah, I think what has been positive so far with EPKINLY, and also why we have been somewhat consistent in our way of guiding is that if you take a step back and look at the phase III readouts, with the exception of one, they have essentially one-to-one mirrored the phase II data. If we go back to the phase III 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 II data that we have 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 II data that we have been presenting at ASH. When we presented an asset, so what are your expectations for the frontline data? What does it look like? Again, we are not in a position to guide on hazard ratios or what the bias, but we have been pointing back to the R-CHOP EPKINLY phase II data that we just recently at ASH presented, where we even showed you the and this was the 36 months follow-up, where you have the PFS curves and you have even the response rates across cell of origin and even risk type, whether the IPI status.
That has kind of been informing our, you could say, excitement or conviction going into this readout. Back to your original question, we would say that the phase II data and second line DLBCL read out as expected, based on that hypothesis that we put out there.
Very clear. Going to the frontline trial, obviously, it is a partnered asset, but I guess just reaffirm your confidence on that trial. 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 is later than expected, but you have confirmed it is the interim coming in fourth quarter. What is your read of sort of the delay based on anything you can see, from the AbbVie side, et cetera, any sort of blindly prep, et cetera, and confidence?
Look, our confidence is unchanged high with regards to this readout. What we have been guiding and reiterating is that we are going to have this readout in 2026. What has essentially changed is that now we have been more specific when in 2026 it is going to take place, where we said it is going to take place in Q4, and that is based on a pre-specified interim. Other than that, nothing has really changed. We gave this guidance many months ago. As everyone is aware in the room, phase III trials, event-driven 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. Do you expect to present data for the IPI 3-5 and 2-5?
Again, the premise and the framework is that we top-line results only based on the primary endpoint. The primary endpoint is IPI 3-5. The 2-5 is a secondary endpoint.
Very clear. Any more on that Rina-S? You sort of alluded to it already, but obviously wrapping this all together, I think the big picture stories for Genmab, DARZALEX LOE, these are really sort of gating opportunities, but both with Rina-S, petosemtamab, EPKINLY, but both with much broader phase IIIs. How from where you sit today, if we come out fourth quarter with positive data, how would you feel about the shape of your sales margin curves, like through the DARZALEX LOE, just remind us how that looks and how you feel about growth through that.
Sure. Rather than sit here and try to do DARZALEX 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 late-stage assets, while at the same time we retain our royalty portfolio. We're in a unique position where we've been privileged to have a really strong royalty portfolio that has got us this far.
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 Genmab 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 our excitement level around Rina-S and phase extension of where we have the potential to go broader than just the initial indications. That's highly promising for the future ahead.
At the same time, we also shouldn't dismiss our early innovation, which is still going on, but it's more, you could say, from a disclosure perspective of how much we talk about it has been put to kind of work in silence, in secrecy. 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. 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. One of the questions I get is obviously, you've enlarged your royalty revenue business today to EPKINLY. You're a bit more in the middle, but your confidence and ability to commercialize your wholly owned assets, what steps you need to take, what have you got so far already in place, how's launch progress, et cetera, for all of this?
Yeah. We've come really far with regards to forward integrating and becoming this mature, established business. It's been a stepwise approach where I think we tend to forget the journey of Genmab, but it all started with essentially us commercializing TIVDAK, which is a tissue factor ADC for the treatment of late-stage cervical cancer. We started that journey with Seagen, now Pfizer. We built upon that with EPKINLY together with AbbVie. But where the difference was that we retained more rights or more responsibility, from a commercial perspective. So 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 petosemtamab, for launching these next year.
Part of the journey that we've also been sharing with you is that, for example, we'll be utilizing TIVDAK, acquiring back the rights for TIVDAK 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 are thinking. The same, you should also think about petosemtamab going into next year. So we feel that we are ready. Of course, there are still some additional investments that needs to be put in place next year, but that are already also put in place this year.
Got it. Rina-S and petosemtamab, I guess some of the launch timelines you've suggested can happen in 2027.
Yes.
Will that be without any sort of priority review, et cetera? Or how have you sort of framed the consensus to launch those by the end of 2027?
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 this 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, one of us going to ask, but in terms of consensus 2027-
Yeah.
wonder if it's something you've looked at. Obviously, lots going on in terms of cost lines, bits on the tax side of things.
Yeah.
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. 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. To put it in perspective, this year we've added two more new phase III 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. What I'm trying to get at is that it's more about having a consensus catch up on that fact that, r emember that we just added two CRC trials on top of the already guided locally advanced trials.
This is something that, of course, consensus has to adjust to and appropriately reflect going into next year. That is one example from an R&D perspective. Then with regards to SG&A, there we've been rather explicit that, yes, there are some additional investments that have to be made as we get closer to launch. 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 petosemtamab and Rina-S, and remembering to carry that into next year's estimates, essentially.
Got it. One very last final one.
Sure.
Real amortization.
Yes.
Do you think that's being well reflected there?
No, 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 DKK 7 billion on petosemtamab, and DKK 1 point something billion on Rina-S. 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 I'll continue to remind them. I'll set it here so everyone in this room knows it.
Perfect. Well, we are slightly over time, but very much appreciate the time. Thank you for joining me today.
Thank you for having me.
It's awesome. Cheers, man.
Thank you.