Genmab A/S ($GMAB)

Good afternoon, everyone. Thanks for joining. I'm James Gordon, Barclay's European pharma and biotech analyst. And it's my pleasure this afternoon to host a fireside with Genmab and we've got two for the price of one because we've got Anthony Pagano, who is the Chief Financial Officer; and Brad Bailey, who's the Chief Commercial Officer. And we've got a little over 20 minutes, so we're going to discuss some of the exciting pipeline, readouts that come out this year. Maybe a bit on the longer-term outlook and maybe hopefully when these work, what's the commercial outlook for these products as well, that would be interesting as well.

So thanks a lot, both of you for joining. And well, maybe just to start off, so it's a big year of readouts. What is it that's coming out this year? And how excited about them are you? And where should we focus, do you think? What should investors be looking at?

Yes. Well, first of all, James, thank you so much for having us, seeing you back here this year. Pleasure to be here with you. You're right, 2026 is really set up to be a very important year for Genmab and our late-stage pipeline. And really, it's about the collection of the three brands EPKINLY, Rina-S and petosemtamab. And what's really appealing for me is you look across these 3 brands, each of them have FDA breakthrough therapy designation. Each of them had in 2025, meaningful data that served to increase our conviction in the prospects of these assets moving forward. I'll bring it specifically to your question, each of them in 2026 have at least one potentially registrational readout. In the case of EPKINLY, this could represent material line extensions into earlier line DLBCL. And then both for petosemtamab as well as Rina-S the chance to have the first potential registrational data leading to a launch of these brands in 2027. So I think individually, each of them are important but really looking at the collection of the data we're going to see during the course of 2026 to increase our conviction into sort of the shorter term, medium term and even longer-term prospects for these brands though I'm sure we'll dive into the specifics of each of them, but a lot to be excited about during the course of 2026.

Great. That's a lovely intro. If we could start with EPKINLY. So I believe we've got two things coming out this year. We've got data that, in the first half, that could convert your current conditional approval in refractory DLBCL into a full approval. And then we've also, at some point this year, got a frontline DLBCL readout. If we could start with second-line. So you had one trial, which was a mono trial that wasn't successful in terms of fitting its primary endpoint on overall survival. Does that have any read to the other second-line trial we're going to get this year? How confident are you in that other trial we've still got to read out?

So as a starting point, our confidence in these two additional readouts during the course of 2026 remains very high and unchanged. We see absolutely no read across from the monotherapy trial that you're speaking about. I think it's important to highlight that, that monotherapy trial in second-line plus DLBCL it was monotherapy. It did hit on PFS. As you noted, it did not reach the endpoint and overall survival and as we highlighted at the time of the announcement, that OS outcome was confounded by really two factors, one being, the impact of COVID, particularly on the EPKINLY arm; and then secondly, the impact of crossover to novel therapies in the control arm. So if we kind of step back here, the point is it did hit on PFS as well as we see zero read across to the other two trials. And that's really a function of the totality of the data that we see in EPKINLY in combination with other therapies in particular, the Phase II data that we've seen EPKINLY plus R-CHOP in frontline and EPKINLY plus len in second-line plus DLBCL. We have been engaging with some thought leaders in this area post the readout of that trial. Maybe Brad, do you want to add some of that feedback we've had?

Yes. No. Especially in this type of a patient population at the timing, the thought leaders, both academic as well as out in the community and some of the top global thought leaders in this space actually were quite impressed with the PFS in general is monotherapy. And I think that's the -- to keep that in mind. And then also just looking ahead with the breadth of the readouts that are coming this year feel like encouraged by this initial feedback, and that was also on the heels of having second-line FL approval in combination for the first time and where we had unprecedented hazard ratio and incredible data. So it's exciting moving forward.

And in the trials you're going to report this year for EPKINLY, do you need to show overall survival benefits in there? I don't believe that's the primary endpoint. What do you need to show for these two trials to be successful?

Yes. So the primary endpoint, as you just highlighted, for each of the trials is PFS. That is agreed regulatory endpoint, agreed with the regulators. And -- but of course, when you submit the data, the regulators will look at the totality of the data, but we believe the PFS is the regular -- I'm sorry, the important endpoint here for each of these trials.

Makes sense. And then for first-line, so whereas for the second-line trial, you said we're going to get a readout in the first half. For the first-line trial, it's uncertain when it is this year. Why is that? Because I think there is a paper that says that there's an interim setup at [ 0.75 ] as in 3/4 of the way through, there's an interim. So what do we know about that? Could there already been an interim? Or is that something that might still happen? So tomorrow morning, we could get an update or could it be any time?

So I think the -- you're correct, just to restate what you said. We are expecting the second-line DLBCL trial readout in the first half of the year. the Epco frontline, Epco plus R-CHOP and DLBCL is for 2026. This is an event-driven trial. And our view is that we're going to have data during the course of 2026, that should be registrational in nature.

So if I [indiscernible] which is understandable. You haven't said yet whether an interim has or hasn't happened. There could be one, but it's also the timing is a bit uncertain. because it depends how quickly the events occur?

Yes. I think our keeping to 2026 is primarily a function of just seeing the events occur.

And if this trial does work, what does this mean for the commercial potential of EPKINLY?

Yes. It further states kind of what we've been very consistent all along in saying that the value, specifically the value of EPKINLY is -- as we move into earlier lines of therapy. And this does a couple of things. One, it brings the medicine into the community setting more closer where the patients live; and two, obviously, the patient population numbers. You're looking between second-line and frontline DLBCL as we've talked about with readouts this year and follow on hopefully with approval upwards of around 90,000 to 100,000 more patients than what we have today.

And so if we price that up at where EPKINLY is, what sort of multiplier is that is the frontline opportunity versus the refractory one?

Yes. Frontline is about half the value of the brand.

And I think just maybe on that trial. I mean, we're really excited about the data that we've seen so far in the Phase II setting. Really looking forward to seeing these frontline readouts. And I think Brad started to touch on it, the importance of the second-line follicular lymphoma readout we saw last year, very strong data getting that approved in Q4 of last year. As a reminder, that's a smaller opportunity in terms of the patients, but it has been an important vehicle, if you like, to start talking about EPKINLY in combination therapy. Of course, in this case, second-line FL in combination with R2, but also importantly, starting to get outside those pure academic centers. And maybe Brad, [indiscernible] we can add on a little bit more color?

Yes. No, the initial phase, and this has been basically all bispecifics, not just in lymphoma, bispecifics, the challenge of being sort of stuck in these major academic centers. And we're starting to see, as Anthony just mentioned, with the second-line FL, broader use in sites of care that are outside of sort of the mothership of these centers. And as a matter fact, out of our key accounts that we had set up where almost 80% of our total business was there, the one site ordering was where we were getting the business now multiple sites are ordering at least two, most of them have three sites, which means that the medicine is being administered close to where the patients live.

A final one on EPKINLY would be in first-line, what does a good result look like? Do you just need to be [indiscernible] just, but just clinically meaningful and statistically significant? Or do you need to be like very, very clinically meaningful because there could be some other things coming on in the future? So for instance, combining, say, Polivy with CD3, CD20 that Roche are doing, do you need to be much more than just like the minimum clinically meaningful to be confident it's going to be an attractive therapy for many years to come, seeing is there some other therapies coming along as well?

I'll start, Brad, and then you can add on. Let's start with the -- again, the Phase II data that we've seen adding EPKINLY to R-CHOP. We feel that, that combination, what we've seen in that Phase II setting is very strong regardless of the competition. In addition, we know the experience over the last several decades, two decades in this setting is R-CHOP. We know that, that is also used very heavily and is the standard of care and is using very predominantly in the community setting where the vast majority of these patients are. So we feel that adding on a very convenient subcutaneous EPKINLY on top of a widely used and accepted over multiple decades, therapy like R-CHOP is the right approach in this frontline setting.

Yes. No, I agree. And moving earlier combination in certain cases, chemo-free is what the market's asking for out of bispecifics and specifically with EPKINLY, we feel like we're well positioned there as well.

Thank you. I could ask a lot more on EPKINLY but I'm going to move on to the other pipeline because I know there's a lot going on this year. So we've also got for Rina-S, so your folate-targeting ADC the RAINFOL-01 study data, so that's second-line plus ovarian cancer. And so in the second half, we're going to get the readout there?

Correct.

So what do you need to show there? Because this is -- we've already got some ORR data, as in overall response rate data. It was more than 50% before. Do you just need to do that again? And is there any reason you wouldn't do that again? Is there something different about the population at all that you're looking at now versus what you've already reported that looks so good?

So first of all, we're very encouraged with the data that we've seen with Rina-S in platinum-resistant ovarian cancer. And again, we remind everyone, we've seen robust efficacy in terms of response rate and duration of response regardless of expression level of this target. Again, we've seen this in platinum-resistant ovarian cancer. We've also seen it in endometrial cancer, second-line plus endometrial cancer, which, in general, has a lower expression level. So looking at the totality of that data, we have a lot of confidence going into this Phase II potentially registrational readout. Now similar to my comments for EPKINLY, I would say, really be focused on what we've shown so far in that sort of proof-of-concept setting. And we think that this next-generation full receptor alpha ADC is really a step change in the treatment of gynecological oncology indications. Again, here I remind everybody, we have the second-line plus product readout this year in H2. We have the companion, if you like, Phase III trial that has been now recruited, fully recruited, and we're following the same strategy in endometrial cancer and having that essentially accelerated to market Phase II and the companion Phase III and both of these are also well underway. I think it's really exciting times to see what we can do with Rina-S. And really, again, bridging to broad a little bit, having a potential single option across these two indications could be important as we go to market.

I think opportunity-wise, you're talking between the two ovarian and endometrial, around 120,000 patients roughly split 55, 45 or so, ovarian endometrial. And we've learned this through EPKINLY as we were indicated for both DLBCL and FL as you're operationalizing the new modality outside of the key academic centers, it's a big convenience factor. The feedback from thought leaders and physicians has been very positive being able to operationalize one, and we're seeing this as well. As you see ovarian and endometrial competitive landscapes are a little bit different. And so we like the opportunity there as well with the dual indication.

And is it all or nothing, either works in everyone across all folate expression levels? Or could there be a scenario where actually, you look at a subpopulation. When we find out -- when we see the headlines in the details, is that going to be important how it works in different subpopulations?

So as we think about potential top line results. I mean, we've not yet decided what that will look like. But I would imagine it's going to be top line results. We're not going to get into too much subgroup analysis now both the Phase II and the Phase III. Obviously, there are post-hoc analysis, in some cases, prespecified analyses looking at various cuts of the data. But generally speaking, top line results is kind of focused on the top line.

And I've also been asked about competition because you're not the only company with a folate receptor targeting ADC, [ does it look ] like a promising approach? One thing is time to market. But there are some other companies who are also going across folate expression levels. What do you see is the key differentiation for your assets?

When I think about evaluating any asset, I guess here, we're referring to Rina-S, there's kind of three parts of the framework. One is, what is your product profile? Can it be best-in-class? Second element is looking at it, can it be first in class? And then what does the CDP look like, i.e., Can it be broadest in class? As I think about Rina-S, it checks all of those boxes. Looking at the clinical profile, I think at this stage, we have the most amount of data, particularly when you look at it across indications, we have a chance to be at or above, I think, the majority of the competition first-in-class. We kind of talked about where we're at in terms of having the potential first pivotal readout in the second half of this year and having the Phase III in that [ prox ] setting already fully recruited. We talked about where we're at with endometrial. And then we're not stopping there. We also started the Phase III in platinum sensitive ovarian cancer, and we're not going to stop there. That speaks to the breadth of the CDP. So we're looking to compete against all of these dimensions best first and broadest because this is the reality in oncology, there is going to be big competition.

Interest of time, I should move on to another -- the third interesting late-stage readout this year, which will be peto, so your bispecific EGFR and LGR5. And so my understanding is we're going to get data from one or even two head and neck cancer trials this year. So what do we actually need to see in there? What's the cutoff for the threshold? I believe again, we're talking about overall response rate data. What does a good result look like?

Yes, you're right, James. So again, just to confirm for everybody, this is unchanged. We're expecting one or both of the ongoing Phase IIIs to read out in the second half of the year. As a reminder, we have a frontline trial, frontline head and neck cancer. It is petosemtamab plus pembro in that frontline setting. And then we have the second-line plus head and neck cancer trial. Again, I'd point back to the data that we saw during 2025. Now it was part of my opening remarks for each of the brands, including petosemtamab, we saw significant data that increased our conviction during 2025. Now for petosemtamab to put a finer point on that. What we saw in the data that was presented at ASCO last year in that frontline setting, an overall response rate of around 63% in the combination, pembro plus petosemtamab that compares favorably to monotherapy pembro of around 19%. We see it nearly tripling when you add on petosemtamab, which, to me, is very significant. Also, if you look there at the overall survival data, the 12-month overall survival data, peto plus pembro came in at about 79% at 12 months which compares very favorably, in fact, to historical pembro controls. So we think that setup is very nice if we were to see that replicated as we move into the potential readout here in the second half of the year for one or both of the Phase IIIs. So it's really looking at the totality of the data. The other thing that stands out for petosemtamab, if you look at the data is the rapidity of the response. You see the vast majority of the responders already responding at the first scan which I think is another important attribute as you think back about going into even earlier lines which we have firm plans to do. And here, we're going to start the first Phase III in locally advanced head and neck cancer by the end of this year. But going back to my framework of first -- or sorry, best first and broadest, we're applying that same methodology, that same thought process to petosemtamab as well.

Makes sense. And a fireside I was just hosting, the company talked about the phenomenon where when you go from Phase I to Phase II to Phase III, you often get a bit less efficacy because you don't enroll the patients quite as tightly. Then this isn't exactly a Phase II to a Phase III, it is a Phase II. Would you expect any dilution because you're looking at more patients? Or is there any other reason to be a bit cautious?

Well I think what we look at the totality of the data for petosemtamab, we're very encouraged with what we saw in Phase II. I'm certainly not going to use a crystal ball and predict about what the Phase III is going to do. But based upon everything we've seen, we're not expecting in advance any kind of dilution to the effect. I mean, we're very encouraged with this product concept the modality. In our view, this is the best-in-class next-generation eGFR-based bispecific.

Thank you. So we've talked about three drugs. We've talked about EPKINLY, Rina-S and peto, and it's going to be a big year for readouts. But if they all readout, maybe a question for Brad, how do you go about maximizing the value for those because Genmab is doing some distribution of products at the moment, EPKINLY and Tivdak and some partnerships as well. But are you going to build a global distribution network for all of these? And would that be a huge OpEx? How are you thinking about that already now?

Yes. We'll take the OpEx questions towards the end, but we've been quite busy in the last several years putting building businesses for both EPKINLY and Tivdak in partnership. But just as a quick level set in U.S. and Japan, we built the full complement of the business running the business booking sales, market access, everything, pricing reimbursement as well. And so feel very strongly in those two markets where the majority of the revenue comes from with both brands. We've now moved into with Tivdak as we've taken over the market authorization ownership rights from Pfizer for rest of world outside of China, where we're building our European business. So we have a launch in Germany that just took place. So we're showing success in scaling our business and opportunities also in U.K. and France and soon to be Italy and Spain. And so in these select key markets, we will certainly independently go to market. And then in the other markets, we'll look at either distributor ships or some type of partnership. Because if you see -- I think Anthony mentioned upfront with EPKINLY, we've stated $3 billion plus, Rina-S, $2 billion. And then with petosemtamab in the multibillion range, it will using our proven launch engine, EPKINLY is now well on its way to become into core therapy in B-cell lymphomas, and Tivdak is the global standard of care in cervical. We really do like this [indiscernible] oncology space as it moves -- as we move from Tivdak as our foothold, if you will, into Rina-S. It's been very beneficial for us from both a development perspective. as. Well as we're bringing our medicines to patients ourselves. And from an OpEx perspective, everything that we've stated at this point from a guidance perspective is exactly what it is and feel confident that that's where we'll be.

Well we've got two minutes left, although I've been asking R&D questions, you are the CFO. So maybe I need to ask you a slightly more numbers-y question to me if I'm doing my job properly. So if everything works this year, if all the readouts work, what is the financial outlook for the company? You've also got the royalties from J&J on DARZALEX around the end of the decade go away. But is the company then positioned for growth even through that? What's the overall growth outlook if everything works?

The growth outlook for Genmab is very strong. Brad has articulated the peak year sales estimates for the three brands. That's EPKINLY, $3 billion plus, Rina-S, $2 billion plus and then petosemtamab as multibillion dollars. Just think about that, what that looks like as a stand-alone oncology business, very, very strong. Importantly, what's underpinning those peak year sales estimates is, for the most part, particularly zooming in on EPKINLY and Rina-S is the known clinical development plans. Of course, both for Rina-S as well as petosemtamab, there are potential expansion opportunities. And those -- we're in the process of doing some early clinical proof-of-concept work. And then let's not forget our proven research and discovery engine. I can't tell you which product, James, but I'm fully confident as we get into '27, '28, and '29, there should be an internal program that should move from early to late-stage development. That's just based upon our true proven track record. So you have that strong foundation of the royalty business. Of course, as you're right, DARZALEX will go away, but the rest of that portfolio of royalty products as a portfolio has nice growth prospects through that DARZALEX loss of royalty, then you think about stacking on the proprietary business, EPKINLY, Rina-S, petosemtamab expansion opportunities there, plus again, as I mentioned, a pretty good probability on other product from our early stage pipeline to flow through. So overall, the growth prospects, particularly when you get into the 2030s are very strong here at Genmab.

Great. Well, with that, we're out of time. So thank you very much for joining us today.

Yes. Absolutely. Our pleasure. Thank you.