Good afternoon, everyone. Thanks for joining. I'm James Gordon, Barclays European Pharma and Biotech Analyst, and it's my pleasure this afternoon to host a fireside with Genmab. We've got two for the price of one because we've got Anthony Pagano, who's the Chief Financial Officer, and Brad Bailey, who's the Chief Commercial Officer. We've got a little over 20 minutes, so we're going to discuss some of the exciting pipeline readouts that are coming out this year, maybe a bit on the longer-term outlook or maybe hopefully when these work, what's the commercial outlook for these products as well. That would be interesting as well. Thanks a lot, both of you, for joining. 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?
Yeah, well, you know, first of all, James, thank you so much for having us, you know, 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. Really it's about the collection of the three brands, EPKINLY, Rina-S, and petosemtamab. What's really appealing for me is you look across these three 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. To 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.
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. 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 in the sort of the shorter-term, medium-term, and even longer-term prospects for these brands. You know, 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. Well, that's a lovely intro. If we could start with EPKINLY. I believe we've got two things coming up 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. Then we've also at some point this year got a frontline DLBCL readout. If we could start with second line. You had one trial, which was a mono trial that wasn't successful in terms of hitting its primary endpoint on overall survival. Does that have any read-through 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?
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 monotherapy trial in second-line plus DLBCL, it was monotherapy. It did hit on PFS. As you noted, it did not reach the endpoint in overall survival. As we highlighted at the time of the announcement, that OS outcome was confounded by, you know, 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. 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.
That's really a function of the totality of the data that we've seen 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 lenalidomide in second line, plus, you know, DLBCL. You know, 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?
Yeah, no, especially in this type of a patient population at the time, I mean, 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 as monotherapy. To keep that in mind and then also just looking ahead with the breadth of the readouts that are coming this year, feel like you know 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. It's exciting moving forward.
Thank you. In the trials that are going to report this year for EPKINLY, do you need to show overall survival benefits in them? I don't believe that's the primary endpoint. What do you need to show for these two trials to be successful?
Yes. The primary endpoint, as you just highlighted, for each of the trials is PFS. That is agreed regulatory endpoint, agreed with the regulators. Of course, when you submit the data, the regulators will look at the totality of the data, but we believe the PFS is the important endpoint here for each of these trials.
Makes sense. Then for first line, 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 set up at 0.75, as in, three-quarters of the way through, there's an interim. What do we know about that? Could there already been an interim, or is that something that might still happen? Tomorrow morning, we could get an update, or could it be any time?
I think you're correct. Just to restate what you said, we are expecting the second-line DLBCL trial to read out in the first half of the year. EPCORE frontline, EPCORE plus R-CHOP in 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.
If I follow correctly, you have, 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.
Yeah. I'd say our keeping to 2026 is primarily a function of just seeing the events occur.
Thank you. If this trial does work, what does this mean for the commercial potential of EPKINLY?
Yeah. It, you know, further states kind of what we've been very consistent all along in saying that the value of bispecifics, specifically the value of EPKINLY, is as we move into earlier lines of therapy. This does a couple of things. One, it brings the medicine into the community setting more close to where the patients live. Two, obviously the patient population numbers, and 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 90-100 thousand more patients than what we have today.
If we price that up at where EPKINLY is, what sort of multiplier is that, is the frontline opportunity versus the refractory one?
Yeah. Frontline is about half of the value of the brand.
Thank you.
I think this may be on that trial. I mean, we're really excited about the data that we've seen so far in the Phase II setting. You know, really looking forward to seeing these frontline readouts. I think Brad started to touch on it, the importance of the second-line follicular lymphoma readout we saw last year. You know, 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 R squared, but also importantly starting to get outside those pure academic centers. Maybe, Brad, we can add on a little bit more color.
Yeah. No. The initial phase. This has been basically all bispecifics, not just in lymphoma, bispecifics, the challenge of being sort of stuck in these major academic centers. 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. As a matter of 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's being administered close to where the patients live.
Thank you. A final one on EPKINLY would be in first line. What does a good result look like? Do you just need to achieve 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 along in the future? 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 as there's some other therapies coming along as well?
I'll start, Brad, and then you can add on. Let's start with again, the phase II data that we've seen, adding EPKINLY to R-CHOP. We feel 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 is also used very heavily and is the standard of care and is used very predominantly in the community setting where the vast majority of these patients are. 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.
I agree. The move in 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. Well, I could ask a lot more on EPKINLY, but I'm going to move on to some of the other pipeline because I know there's a lot going on this year. 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. In the second half, we're going to get the readout there?
Correct.
What do you need to show there? Because this is. You'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? 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?
Yes. First of all, we're very encouraged with the data that we've seen with Rina-S in platinum-resistant ovarian cancer. Again, 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. Looking at the totality of that data, we have a lot of confidence going into this phase II, potentially registrational, readout. 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 folate receptor alpha ADC is really a step change in the treatment of gynecological oncology, indications.
Again, here to remind everybody, we have the second-line plus PROC 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. Really again, you know, bridging the broad a little bit, having a potential single option across these two indications could be important as we go to market. You know, I think, opportunity-wise, you're talking between the two, ovarian and endometrial, around 120,000 patients, roughly split 55-45 or so ovarian to endometrial.
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 we like the opportunity there as well with the dual indication.
Is it all or nothing? It 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 and the details, is that going to be important how it works in different subpopulations?
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, you know, obviously there are post-hoc analyses, in some cases pre-specified analyses, looking at various cuts of the data. But generally speaking, top-line results is kind of focused on the top line.
I've also been asked about competition there 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 as the key differentiation for your asset?
When I think about evaluating, you know, any asset, and 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? You know, 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 cross indication. 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 PROC setting already fully recruited. We talked about where we're at with endometrial, and then we're not stopping there. We also have started a phase III in platinum-sensitive ovarian cancer, and we're not going to stop there. That speaks to the breadth of the CDP. 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 the competition.
Makes sense. Thank you. In the interest of time, I should move on to another. The third interesting late-stage readout this year, which would be petosemtamab, so your bispecific for EGFR and LGR5. My understanding is we're going to get data from one or even two head and neck cancer trials this year. What do we actually need to see in there? What's the cutoff or the threshold? I believe, again, we're talking about overall response rate data. What does a good result look like?
Yeah, you're right, James. 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 pembrolizumab 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.
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, pembrolizumab plus petosemtamab. That compares favorably to monotherapy pembrolizumab of around 19%. We see nearly a tripling when you add on petosemtamab, which to me is very significant. Also, if you look at the overall survival data, the twelve-month overall survival data, petosemtamab plus pembrolizumab came in at about 79% at twelve months, which compares favorably, very favorably, in fact, to historical pembrolizumab controls.
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. It's really looking at the totality of the data. The other thing that stands out for petosemtamab, we 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 about going into even earlier lines, which we have firm plans to do. Here we're going to start the first phase III in locally advanced head and neck cancer by the end of this year. Going back to my framework of best, first and broadest.
We're applying that same methodology, that same thought process to petosemtamab as well.
Makes sense. 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. This isn't exactly a phase II to a phase three. It is a phase II. Would you expect any dilution because you're looking at more patients, or there's any other reason to be a bit cautious?
Well, I think when 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. We've talked about three drugs. We've talked about EPKINLY, Rina-S and petosemtamab, and it's going to be a big year for readouts. If they all read out, maybe a question for Brad. How do you go about maximizing the value for those? Because Genmab's doing some distribution of products at the moment, like EPKINLY and TIVDAK and some partnerships as well. Are you going to build a global distribution network for all of these, and would that be huge OpEx? How are you thinking about that already now?
We'll take the OpEx question towards the end, but we've been quite busy in the last several years, building businesses for both EPKINLY and TIVDAK in partnership. Just as a quick level set in U.S. and Japan, we've built the full complement of the business, running the business, booking sales, market access, everything. Pricing reimbursement as well. 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 U.S., world outside of China, where we're building our European business. We have a launch in Germany that just took place, so we're showing success in scaling our business and opportunities.
Also in UK and France and soon to be Italy and Spain. In these select key markets, we will certainly independently go to market. In the other markets, we'll look at either distributorships or some type of partnership. Because if you see, you know, as I think Anthony mentioned up front with EPKINLY, we've stated $3 billion+ Rina-S $2 billion, and then with petosemtamab in the multi-billion range, it will you know, using our proven launch engine, EPKINLY's now well on its way to becoming the core therapy in B-cell lymphomas. TIVDAK is the global standard of care in cervical. We really do like this gynecological 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. From an OpEx perspective, everything that we've stated at this point is from a guidance perspective, is exactly what it is, and feel confident that that's where we'll be.
I'm aware 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 numbersy 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 is 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+, Rina-S, $2 billion+, and then petosemtamab as multi-billion dollars. Just think about that, what that looks like as a standalone 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. Then let's not forget our proven research and discovery engine.
Can't tell you which product, James, but I'm fully confident as we get into 2027, 2028, 2029, there should be an internal program that should move from early to late-stage development. That's just based upon our truly proven track record. You have that strong foundation of the royalty business. Of course, as you're right, DARZALEX royalties 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. You think about stacking on the proprietary business, EPKINLY, Rina-S, petosemtamab, expansion opportunities there. Plus, you know, again, as I mentioned, a pretty good probability another product from our early stage pipeline to flow through. Overall, the growth prospects, particularly when you get into the 2030s, are very strong here at Genmab.
Right. Well, with that, we're out of time. Thank you very much for joining us today.
Yeah. Absolutely. Our pleasure. Thank you.