Good to see you all here. Welcome to day 3 of the Jefferies London Healthcare Conference. My name is Ben Jackson. I’m one of the analysts here on the European biopharma team. It’s a pleasure today to be joined by the team from Genmab. We’ve got both CEO, Jan van de Winkel and also Anthony Pagano, who is CFO. Look, we’re going to jump straight into the Q&A.

I guess, if you could just set the scene for us a little bit. There’s been a lot going on with the development of products. But if you could put the layer of the land out there, what drugs are we focusing on at the moment and what are the opportunities and then we’ll dig into the individual assets.

Absolutely. I’m delighted. So good to see you all. I’m delighted to be here. We’re really focusing on the late-stage programs now. EPKINLY, Rina-S, Acasunlimab and also hopefully soon petosemtamab or Peto, which we intend to bring in via the acquisition of Merus. That is the late-stage development medicines. And of course, also, we have Tivdak as a commercial molecule, which we are now rolling out commercially in different European key countries in order to create a foothold for the Rina-S launch 1.5 years from now in the future in the GyNOc area.

Perfect. So let’s start with Peto then because I think that’s probably what’s been debated most as of late. So could you give us a little bit of an overview, what attracted you towards the asset? And why did you make that move?

Absolutely. Peto is a fantastic EGFR-targeted bispecific antibody with a unique profile. We’ve never seen that with any other EGFR-targeted antibody up to now. It actually removes the epidermic growth factor receptor, which is a key target from the surface of cancer cells, and it actually allows this molecule to shrink tumors like very, very quickly, and that is also what is seen in the clinical trials. The data from Merus is absolutely impressive in both the frontline head and neck cancer setting where they see more than a tripling of the responses versus the benchmark with pembrolizumab and also in the second, third-line setting, unprecedented data with only petosemtamab. So we believe it has a unique profile. And we actually have a lot of experience at Genmab in EGFR targeting.

We actually worked on a naked EGFR targeting antibody many, many years ago, also in the head and neck cancer setting. And we worked actually on creating — we helped J&J create amivantamab also by giving them access to an EGFR antibody and a c-Met antibody with our bispecific technology. We know exactly what these molecules need to look at. And we think petosemtamab is uniquely positioned there. On top of that, Genmab has a lot of knowledge on head and neck cancer. We had actually 2 molecules in clinical development in head and neck cancer. So we knew exactly what to look for in petosemtamab and what to focus on.

One of the molecules in head and neck cancer was Tivdak, our product for cervical cancer, second, third-line cervical cancer. It created very good data in head and neck cancer, I can assure you all. And despite that, we decided not to progress it to Phase III development because of the evolving landscape. And I even mentioned — publicly mentioned petosemtamab as one of the molecules now really shaping and reshaping the second, third-line setting in a very dramatic way.

And another molecule we had in development until recently in head and neck cancer is 1042. It’s a 4-1BB targeted bispecific antibody we created together with BioNTech, which we were testing together with pembrolizumab and chemo in the frontline head and neck cancer setting. And we actually realized that, that molecule was not potent enough to really deal with the evolving landscape in head and neck. So we feel that we are the appropriate owners of petosemtamab, we actually screened the landscape really, really carefully. And we think it’s an ideal molecule, not only for treatment of head and neck cancer and bring really progress that to the absolute new level, but also in other EGFR-positive tumors. So we think the potential is actually a lot bigger for petosemtamab. I should stop there probably. I can go on for like half an hour.

So look, perhaps can you reference some of the recent data you’ve seen that’s got you particularly excited about the biology?

Yes, absolutely. I mean the data in the biology, I need to be careful here because I need to only be speaking about the publicly available data because we have done deep due diligence on petosemtamab. And I think I need — it’s probably better for me to stick with the clinical data here than with the preclinical data because I’m not sure that all of that is in the public domain. And given that we still need antitrust clearance from the relevant authorities, we need to be very, very careful in talking only about what is in the public domain and not what we have seen under due diligence. But what I can tell you that in the frontline head and neck cancer setting, we see — Merus has seen a 63% overall response rate combining petosemtamab with pembrolizumab and that is roughly 3x higher than what you see only with pembrolizumab in the frontline head and neck cancer setting.

And the median overall survival has not been reached even with very, very good indicators that this will be a very long median overall survival. In the second-line setting, with monotherapy of petosemtamab, they have seen a 36% overall response rate, whereas the benchmark is between 6% and 19%, depending on whether you look at chemo or an antibody targeting EGFR cetuximab, a first-generation EGFR targeting antibody. And they’re with very, very impressive median progression-free survival and overall survival of 11.4 months, which is hugely impressive. So I think I better stick with the clinically available data in head and neck cancer. And Peto has actually set a new bar there, which I think will be a focus point, I think, for other companies to focus on in the coming time.

That makes sense on efficacy, but we also have to probably touch on safety and tolerability as well. One of the things that we debate often with the EGFR targeting drugs is often the severe rash. So what can you tell us about that within the context of the profile? And is there anything that’s been done to mitigate that, that you’ve seen?

Absolutely. Merus has tested a new schedule for dosing with Peto. And since the implementation of that new schedule, the infusion-related reactions were far diminished versus the original schedule. On top of that, what Merus announced this week is that they have agreed with Halozyme to actually create a subcutaneous version and many times subcutaneous applications of antibodies also against EGFR actually really help to mitigate infusion-related reactions. So as life cycle management, that is also what we have already confirmed a week ago in our conference call, we said, well, subcu development is an integral part of our proposed development for petosemtamab, and that will likely further improve infusion-related reactions, but it’s already very well under control with the new administration regimen, very much better than the original regimen.

Very clear. And I guess not only is the drug being studied in head and neck cancer, but there’s also, as you referenced, some interest in other cancers as well. One of those is colorectal cancer. So perhaps could you add some additional color about where else this could be of interest and what you’ve seen so far?

The answer is yes, I can, but I will not do that because of several reasons. One is that we need to be very careful with what I can say at this moment about our plans for Peto because we still need to finalize the transaction. Second reason is competition. I mean there’s other molecules — other companies moving into this area, and we don’t want to give them good ideas. We want to keep the good ideas for ourselves actually. So after we finalize the transaction, then I’m happy to speak about it much more openly, but we see a lot of potential.

That’s very fair. And Anthony, perhaps one for you on financials. What are the key considerations that we need to be thinking about as this deal progresses? What have you pointed to in terms of accretion in the long term?

Yes. So thanks for the question, Ben. Maybe sort of start off and think about our investment priorities are super clear at Genmab. We’re going to be investing in our late-stage pipeline, particularly Rina-S, EPKINLY, Acasunlimab and now moving forward, Peto. This is not only in late-stage development, but it’s also important investments in commercialization capabilities to prepare for EPKINLY line extensions as well as upcoming launches for both Peto and Rina-S, hopefully, in 2027. Now to reiterate some of the guidance we provided when we announced the deal and more recently reaffirmed on our Q3 earnings call for everybody, 2026 invariably is going to be an investment year, but these are important investments that are 100% in line with our investment priorities, but are also going to be driving a number of important registration trial readouts in 2026 as well as some important launches here in 2027.

So in 2026, it will be an investment year. Now we did say on our call — Q3 call, that we feel that consensus both from a Genmab investment level perspective as well as a Merus investment level perspective is in a reasonable place. The other thing you should be thinking about Genmab, investment priorities are clear. I just highlighted that. On the other side of the coin, if you like, we’re absolutely focused on realizing scale benefits as we move forward. Our business is fundamentally in a different place now in terms of the size and scale of our operations. That means we can be very focused now on realizing these productivity measures and scale benefits. This is a large — a major driver for how we landed 2024 in terms of the overall financial performance and also our year-to-date financial performance in terms of, let’s call it, OpEx management. So 2026 investment year, 2026 consensus from an OpEx perspective in a reasonable place.

For 2027, we expect to return to meaningful growth on the EBITDA line. Now you might be asking why are you talking about EBITDA? Here, it’s important to note, assuming successful launches or launches of both Peto and Rina-S in 2027, we will start to see some purchase price amortization in 2027. However, we expect meaningful growth on the EBITDA line in 2027. Looking at the Merus transaction, we expect to be approaching breakeven on the EBITDA line. And then in 2029, having the transaction being highly accretive, again, on that EBITDA line funded or fueled in part by what we expect to be a pretty significant ramp for Peto. And here, we’ve guided to around $1 billion or more than $1 billion of sales already in 2029. So what you have in the Genmab team really is very clear investment priorities, super focused on driving productivity measures and a really nice growth profile, both from the existing in-line business as well as new potential launches starting in ’27.

Super clear. So if we park Peto then and we move on to EPKINLY, I want to chat a little bit on this. Perhaps set the scene, could you just touch on the commercial differentiation in the landscape that we see with Roche’s bispecifics as well? And maybe if you could reference the recent outpatient study as well and how that helps the profile.

Anthony?

Yes. So overall, we’re very pleased with the EPKINLY launch performance. And then think about where we’re at, overall, we’ve set the scene for EPKINLY potentially being a $3 billion-plus global brand. Right now, the brand has been performing very well since its launch in May of 2023 in the U.S. The initial approval today is in the late-line setting in both third-line DLBCL and third-line FL. Now we think about the recent positive data in second-line follicular lymphoma and very encouraged by the approval by the U.S. FDA. Now it’s mindful — it’s important to note that the second-line FL opportunity is an important one for the brand. It’s the first positive Phase III for EPKINLY, now also in combination. So it’s an important sort of, let’s call it, qualitative aspect for the brand to get into earlier lines to get earlier into — out further into towards of the community.

Now at the same time, we should be mindful that this will not be a hockey stick in terms of the sales performance in 2026, given the size of the total addressable market in second-line follicular lymphoma. It’s around 9,000 patients across the U.S., EU5 and Japan. So we’re very encouraged with what we’ve seen. We have a nice stepping stone here with the second-line FL, and we’re very much looking forward to the frontline diffuse large B-cell lymphoma readout in 2026. Now if I think about the brand overall, when we think about the target product profile, what continues to stand out, number one, is EPKINLY being a single option across FL and DLBCL.

Number two, the subcu delivery and really uncompromising balance of safety and efficacy. It’s really that combination that really sets it up for having a very strong competitive target product profile. And then moving forward, it’s going to be important for us to continue to compete from a development perspective. Let’s try to get those trials read out and on to market as quickly as possible, but also leverage the investments we’ve made commercially to continue to drive commercial performance. So overall, we’re pleased with the performance and look forward to some — the potential launch here in second-line FL and then the frontline DLBCL data next year.

And if we stick on the last point then, to what extent does the later line studies read across to the earlier line studies in terms of the profile that we should be expecting? Is it fairly derisking? Or is there still more to learn?

I can take that. What is very, very good for EPKINLY is that actually the Phase II data actually translate really, really well to the Phase III data. That’s what we have seen now with the second-line follicular lymphoma data. The data is just stunning in second-line follicular lymphoma, a hazard ratio of 0.21 means a 79% decrease in the presence of EPKINLY and R-square in risk reduction — risk for disease progression. That is a hazard ratio, which has simply never been seen before with any other combination of medicines in that setting. So — but it was already preluded by data presented last year at ASH in the Phase II setting. So it translated really well from Phase II to Phase III. And that is what antibodies tend to do. They tend to be very predictable.

We have very sizable Phase II studies also in the frontline setting, the very important study Anthony referred to, where we combine EPKINLY with R-CHOP. We have very strong Phase II data last year already at ASH. And also this year at ASH, we have over 20 presentations, 7 oral presentations and some of them are frontline combining with R-CHOP. So we believe that there is a very good likelihood that these data will translate well into robust Phase III data. But of course, you never know for sure until you have seen the data. So we very much look forward to hopefully see these data and share them with all of you next year.

And we look forward to it, too. Moving on to Rina-S then. And if we take a step back and think a little bit more about ADCs in general, what’s important around ADCs in terms of the payload, the linker, the target, which are the most important in terms of delivering a better efficacy and tolerability profile? And how does that read across to what you’re developing?

Yes. What is super important with an ADC is that they actually — while you attach a toxic payload, which is what happens in an ADC to an antibody molecule that you don’t really change the half-life and the pharmacodynamics of the molecule. And that is what is absolutely unique with Rina-S is they — what ProfoundBio, the company which we acquired last year in May did with Rina-S is they combined a very good antibody with an hydrophilic linker, allowing them to attach up to 8 toxin molecules per antibody molecule and then have an antibody which really had a very good half-life and very good PK/PD characteristics. And what it does translate to with that molecule is it actually gives you very, very good data in the clinic efficacy-wise, but also safety-wise.

It is a very clean safety profile, no ocular toxicity, no interstitial lung disease observed with Rina-S. And the net-net is that you can actually treat patients for a very prolonged period of time because patients can actually tolerate that medicine for a much longer time, leading to deeper and more long-lasting responses. So it’s actually a unique molecule with perfect characteristics. And I think that is, I think, leading to Rina-S becoming a potential best-in-class and very likely also first-in-class in a much broader group of patients and tumors than the first generation of folate receptor alpha ADCs, Elahere, have been able to demonstrate.

Another aspect of Rina-S is that it has a very good what is called bystander killing activity. When it is near a tumor and the payloads are cleaved off from the antibody, they can kill bystander cells with antigen negative. And that is super important because tumors tend to be heterogeneous. They are never 100% homogeneous and you want to kill all the cells from the cancer locally with a toxic molecule. And that is what Rina-S also does really, really well. And this combination is very difficult to get actually in an ADC. And that is also what I think we should really all be keenly aware of is, yes, there is competition building up, several other molecules now targeting folate receptor alpha with a toxin and a linker, but they have all very different characteristics from what Rina-S is showing already at this time.

And that is, I think, something to be aware of that they will not all be the same. There will be different categories for sure. And I think time will tell which molecule will be the dominant medicine in a category of cancer. But I think Rina-S has a very good chance now. We already have a breakthrough therapy designation in endometrial cancer, which we got this year from the U.S. FDA, that is a type of cancer which has too low expression of folate receptor alpha. So it cannot be hit by the first generation of folate receptor alpha ADCs. And I think up to now, the data is just unparalleled with Rina-S. What is important for the company then is that we actually keep the momentum that we keep executing and keep in the forefront basically of this development because other competitors are potentially moving in. But I think it’s too early to really categorize them in different categories at this moment.

That’s very fair. And perhaps, Anthony, one for you as well. You’ve provided some peak sales guidance for the asset. How do you see that in terms of the balance between endometrial and ovarian? And what are the key signposts we should be watching for to derisk that and unlock that potential?

Yes. So I guess maybe sort of starting point for Rina-S, we’re very excited about the brand, what we’ve seen so far and the prospects here moving forward. To just remind everybody, when we announced the deal in April of 2024, we provided kind of 2 pieces of guidance relevant to your question, Ben. One was that we expect a launch in 2027, and number two, that we expect peak year sales of north of $1 billion. Now as we fast forward to today, we stand behind the 2027 potential launch date, number one. But secondly, earlier this year, in January, we’ve upgraded that peak year sales guidance to $2 billion. That’s underwritten by the data we’ve seen, but also underwritten by the rapid progress and expansion of the clinical data development program. Here, when we essentially bought the program, we had around 50 patients worth of data. We’re going to exit 2025 with 2 registrational Phase IIs and 3 registrational Phase IIIs.

Now what is that $2 billion underwritten by? It’s really underwritten by sort of 4 subsegments or 4 sub-indications. That’s going to be the PRC indication. That’s going to be the PSOC or platinum-sensitive ovarian indication, and that’s going to be frontline and second-line endometrial cancer. Now in terms of major events, we’d be looking forward to 2026, where we have potentially the first Phase II registrational readout in the PRC indication. So that’s what you should really be focusing on. Obviously, it will derisk that particular opportunity. But also, I think it will be nice to see the data in a registrational setting and see the activity across folate receptor alpha expression levels. So certainly looking forward to that in 2026.

Got it. And if we move on to acasunlimab as well then near term, we’ve got some additional data. Could you perhaps outline what we could expect to see in terms of types of data, obviously, not the data itself, and how that could help build confidence in the program?

Absolutely with pleasure. So last year at ASCO, we’ve seen very, very good data at the every 6-week dosing cohort of acasunlimab plus pembrolizumab in the second-line plus lung cancer setting. You will see more follow-up from that data to see how robust that overall survival difference, which was observed there is actually at this moment with longer follow-up. And we added an extra 20 patients. So you get a much bigger cohort also at every 6-week dosing. And this is the exact same dosing regimen, which is used in the ongoing Phase III. So that will hopefully give more confidence and reassurance to the market and believing that acasunlimab is a very competitive potential medicine for the second-line plus lung cancer setting, which is a very important setting.

There’s a real need for medicines there. We have actually guided for a peak sales of around $1 billion. And I get the question many times, Ben, why is it so low? Because lung cancer has so many patients, and this will be a much bigger setting. And the reason is we want to really give realistic peak sales guidance to the market because there’s so much competition there with the new very fancy VEGF, PD-L1 type bispecifics. There are several ADCs in development in that setting. And I cannot really figure out right now or anticipate what the exact distribution will be of the different medicines if they would be approved for that setting. So I think it’s better to be conservative and realistic at that point than to give fancy projections, which everybody will look at with shiny eyes, but we cannot really understand.

Very clear. And look, one of the questions that we always have to ask, you’ve clearly got your hands full at the moment, lots going on in oncology, but we always have to ask about the wider thoughts about pipeline and potentially some movement into immunology and inflammation, given the potential applicability of EPKINLY, maybe something developing from the argenx collaboration. So what’s your thinking around this in the therapeutic area? And is it something you’d like to invest more in?

We have a lot of activity in the preclinical setting in the I&I area. We think that our antibody technologies are very well of use in I&I, but it takes a longer time. I mean, to develop clinical candidates from scratch preclinically, you need a lot more safety data before you can actually allow to go to the clinic in the I&I setting than in cancer. So oncology is a lot faster. Reality is that Genmab’s activities are for over 90% in oncology that will remain in oncology because that’s where we have most expertise, most track records, most momentum. And we probably need to make choices, rigorous choices in rank ordering these programs in the coming time because we have actually a wealth of late-stage programs, which can attribute to most value in the shortest possible time frame, which is, I think, more important now for Genmab. But we are progressing. We have a partnership with argenx, which we’re really excited about in the I&I setting, but it’s all preclinical. It will — we will report on progress for sure, Ben, but it is actually going to be very minimal compared to what we do in oncology.

Perfect. That makes sense. And I guess beyond that then, final 30 seconds, is there anything else in the portfolio that you think is worth having a look at? Or are we covering the main focus areas here?

I think we’re covering the main focus areas. We have a very strong organic pipeline, which is also important not to forget because we have now done 2 acquisitions, 1 acquisition, 1 proposed acquisition 2 years in a row, bringing in fantastic molecules. Hopefully, Rina-S is just sensational ADC, which we are very, very impressed by. It does everything which we hoped it would do and more. Then Peto when we can bring the Merus transaction over the finish line is also a sensational molecule, we think very differentiated from other EGFR targeted antibody molecules. But we actually think that we also need to pay attention to our own organic pipeline between now and the end of the year.

We’re going to move at least 2 more bispecifics from our own organic pipeline into the clinic and 1 ADC, which is a combination of a Genmab antibody and a legacy Profound payload and linker technology in a new molecule. So we believe that we are also very, very capable of generating — organically generating the next winners, therapeutic winners. And I think that is probably where we should end up with, I see a flashing sign now that means that we need to get out of the room and make place for the next company.

Exciting stuff. Lots going on. Thank you so much for your time. I appreciate both of you, and thank you all for coming.

Thank you.