Genmab A/S (GMAB) Earnings Call Transcript & Summary

[Audio Gap] Charlie Haywood from Bank of America [indiscernible] Andrew Carlsen, Head of Investor Relations at Genmab with us today. Welcome. Thank you for joining us. We're starting, obviously, lots of interest, people thoughts are coming up. So just remind us [indiscernible] coming up that we'll be 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. 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 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 prespecified interim. Then 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. And this is actually also very exciting in a sense that it's a Phase III trial that has been brought forward. So reading out now in Q4 this year and which, of course, puts us in a position to potentially become 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 metastatic head and neck cancer opportunity with petosemtamab plus Keytruda versus Keytruda, where we will have this readout guide for it to come out in Q4. So across all 3 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 folate receptor alpha ADCs with Rina-S and for petosemtamab also in frontline head and neck cancer.

Got it. That's very clear. And obviously, peto 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, any sort of rough time lines on data for that and when we -- if we can expect more Phase III starts this year for both.

So starting with Rina-S, this came through the acquisition of ProfoundBio in 2024 and to provide context as to how you say, rapid development and broad development program is. We are now up at 5 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've guided for the second line-plus PROC opportunities to read out in Q4. But remember, we also have second-line endometrial cancer Phase III well underway. We have platinum-sensitive maintenance Phase III well underway. And then we announced a platinum-sensitive replacement Phase III this year. And we also announced the frontline endometrial cancer Phase III this year. So 5 Phase IIIs with the potential to be first in second-line PROC in Q4 with Rina-S. So a broad and aggressive development plan also showing our confidence in the value proposition for Rina-S in the GynOc 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 II signal seeking trial with Rina-S as well as we've 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 2 Phase III 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 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. And in addition to that, we just recently announced here at Q2 that we are starting 2 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 a somewhat ahead of what we initially guided for because when we did the acquisition, we guided for the fact that we would pursue Phase IIIs 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 to start these 2 Phase III trials as well.

Got it. Very clear. And then I think worth jumping into fourth quarter, what we've got coming up. I think you've got your second Phase II, Phase III, peto first-line EPKINLY frontline and then some ESMO data. So is there any -- have you given any comment on the sort of sequence of the trials that we're coming reading out in terms of histories or sort of what we could expect first or any?

No. So we haven't provided any sequence or timing with regards to any of these important readouts, we, of course, appreciate the question and I want to understand that. But what we've confirmed is that we're going to have the petosemtamab 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 III trials, both in frontline and second-line colorectal cancer that we have provided you -- that will take place in October 23 to October 27. But other than that, you kind of have to wait for Q4 to figure out whether you will get the Phase III data in Rina-S, Phase III in EPKINLY and as well as Phase III in petosemtamab.

Very clear. And then on the peto frontline, I think, for us and for any 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 sort of filing strategy time line that I think you could potentially launch by 2027. So what are we getting? And what's the sort of path post that as you get that?

So for petosemtamab, the way the trial is designed, and this was something that Merus has agreed upon with the FDA is that there are 2 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. And remember, petosemtamab plus pembrolizumab versus pembrolizumab and that's essentially what you should anticipate will be top lining in a press release. We get a lot of questions as to what will this press release contain and I sit here and preempt that. But if you look at how we've been disclosing our previous Phase III trials, across EPKINLY, 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. Just a reminder, if there are any questions, feel free to raise your hand. I'd say the biggest question I get in on peto is obviously, you're now 6 to 9 months ahead of potential competitor data coming out soon. So your Phase II looks fairly differentiated in terms of response rate data. How do you compare the 2? Like do you think is there a 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, we are rather confident in the strength of the data on petosemtamab. Remember, we have done a thorough diligence during -- since we initiated the proposal to acquire Merus starting. I think it goes back to September last year. And then, of course, as we now formally took over the asset and the development starting in December, we have become more familiar with the data. And irrespective of how you kind of cut or compare the data to competition, whether it's Bicara's asset or whether it's J&J asset, which is RYBREVANT. We feel rather confident in the profile of petosemtamab and how it performed 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 petosemtamab, whether you look at efficacy or across safety compares favorably across our competitors.

Got it. And 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. So actually, you can obviously potentially address both straight up, but the risk is that -- I guess, the patient numbers seem to date in HPV positive as obviously as robust as the negative. So is there confident -- enough confidence that you've got enough patients, a, both in the trial and b, you can show sort of consistent efficacy across the 2?

Again, based to the data that's based -- that's in the public domain, and this is more specifically the Phase II 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 still 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 some potential imbalances and dilution that you're referring to, the trial design designed to take into account or to reflect the real world of graphics of head and neck cancer, metastatic and 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. And then on your second and 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 ahead in terms of timing on the front line, how do you feel about second line? You've got your 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 III 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 petosemtamab in that opportunity competes fairly. And to your point, Charlie, we will have a formal global randomized Phase III with a hard endpoint in OS reading out essentially 3 months after they have a potential readout that we still feel that petosemtamab will be competitive compared to that asset of RYBREVANT 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 having the colorectal anything else. You've obviously seen enough data to gate a Phase III start you're presenting at ESMO. What can we -- is this further patients longer duration? What can we expect at ESMO? And I guess, within that your time lines are behind J&J versus many other indications. So clearly, I think to gate your Phase III, is it fair to assume competitive versus what we've seen from their data to date?

Yes. And to provide some context, when we did the acquisition, Merus did have some early data in colorectal cancer. We were -- 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 would 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 is an important decision to pursue Phase IIIs in frontline 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 would view it as a very significant up, 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 III there. Is that just which could be huge, but risky? Or is there enough confidence that a decent probability of that trial being successful?

The confidence 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 petosemtamab 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 frontline 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 when -- or September when we announced the deal, we already provided guidance as to -- you can 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. 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 reckon sizing of the potential peto ops that you've announced so far, could go into say first line, second, third line colorectal locally advances?

So we've provided kind of the addressable patient population sizes in our materials. And I think what you can see from the announcement of the colorectal cancer trials that we did in 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 as 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 put together.

Got it. And then I think you currently guide to multibillion peak sales consensus at $3.5 billion. Is there any sort of appetite to update that to give more concrete numbers if we see positive data coming up, could we see sort of further incrementals?

So for now, we are comfortable with the multibillion dollar peak sales potential. We think it's appropriate. And it appropriately reflects the opportunity set, which initially was metastatic frontline and second-line head and neck. Now we have adjusted the colorectal cancer opportunity, but you have yet to see any clinical evidence or late-stage 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 it. But I think the multibillion peak sales potential is appropriate, given we provided the patient populations. We have Phase IIIs in metastatic frontline 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 advance will read out. So before we have that clinical data, you just have to kind of patiently wait to figure out what these multibillion means.

Very clear. Any questions on peto before I move on to Rina-S? Also got -- well, Phase II and Phase III data coming up fourth quarter, I think it's not that we see a sort of fairly underappreciated, I think, always given the deal size, but it could be very significant to you. So again, same set up, remind us what we've got coming, Phase II, Phase III, will you -- how much for you will the Phase II derisk your Phase III in terms of data coming? And what should we expect coming in the fourth quarter?

Yes. So for fourth quarter and Rina-S, we've guided that we will have the Phase II data from the [ RMC ] expansion cohort, which is 100 patients Rina-S in second line plus platinum-resistant ovarian cancer. And 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. And hence, that has become, you could say, the most important data set. So from a -- how we're going to disseminate the data, you should assume that the Phase III data readout will be top line and press release, 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 a press release, 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 2 data sets in Q4 this year.

Okay. And on the -- 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 the 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. So I guess how are you feeling about the phasing of that?

Look, I think -- so 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. So 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. 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 Rina-S performs in that setting, and that's where the Phase II data becomes highly relevant because that -- so far, you've seen highly encouraging Phase II 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 how can we get the most out of this data, this Phase II 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 III should be clear, that will be press released in a top line manner and then Phase II [indiscernible].