Conference Transcript - GMAB 2026-11-10

Operator

Welcome, everyone. Our next fireside chat for today is GenMab. With me, I have the CFO, Anthony Pagano. Anthony, welcome. Thank you for joining us. Thank you so much.

Anthony Pagano, CFO

Pleasure to be here.

Operator

Great. So, Anthony, it's been an extraordinary stretch for GenMab this year. You've had three positive phase three trials in a very short period. When you look across these results, what surprised you the most? Let's start there.

Anthony Pagano, CFO

Well, going in to the readouts, as we've highlighted, based upon the overall quality of the products and the assets, development plans behind them, we had a high conviction going into these readouts over the last couple of years. We've done everything we can to maximize the development of these, accelerate development paths. So not a lot actually surprised us because we were so confident and had high conviction going into the readouts. Now, of course, having said that, let's just actually step back and reflect on the actual readouts themselves. You've all seen them thinking about what was done for Epkinlee and frontline DLBCL, stacking on top of our CHOP with the hazard ratio of 0.49. And then for both RENA and Pitocentumab, very strong results, notably also showing an overall survival benefit. So that's the one thing I would probably highlight is perhaps that overall survival benefit that was shown at this maybe from the market's perspective earlier stage for both of those assets. But as I mentioned, based upon the strong assets, the strong development plans, a bit high conviction going into these readouts.

Operator

So with that said, would you characterize this as you beat your own expectations for the hazard ratios that you've seen, or were they in line with your expectations?

Anthony Pagano, CFO

Yeah, I mean, as I mentioned, we had very high conviction, you know, going into these readouts. Again, think about the products in turn, or really actually just look at them all. Going into these phase three readouts, in the particular indications, we had rather robust phase two data, whether it be for at Kinley, RENA-S, and Pitocentumab, and all of this data was presented somewhat recently. So that really gave us a better view in terms of what the ultimate resulting phase three data could be and gave us a better view in terms of what the ultimate target product profile could look like. So again, it wasn't just hope and belief in terms of this conviction. It was really backed up over the last period of time based upon this strong phase two data. Something we've been talking quite a bit about, particularly as it relates to Epikinley, really that translatability from the strong phase two data into the phase three results. For Epikinley now, this is the third time we've seen it. We saw it in second line follicular lymphoma. We've seen it in second line diffuse large B-cell lymphoma, and now we've seen it with the frontline results. So again, we had high conviction, you know, going into the readouts. Of course, you never know until you know. And of course, we were very pleased when we actually saw the results here during the month of October. It was certainly, in other words, it gets thrown around quite a bit, but it was an unprecedented month we had here in October.

Operator

Wonderful. I want to start with Epkinle first. Do you see internally, do you see the role of RCHOP anymore for any group of patients in frontline DLBCL? And second, how do you see the Pola RCHIP segment today and being shifted towards your Epkinle plus RCHOP?

Anthony Pagano, CFO

So our view all along has been that the predominant number of patients get our CHOP, that those patients get that treated in the community. That's why we chose the phase three path that we did to add on a subcutaneous product like of Kinley on top of what is the market leader, our CHOP. And this is our view. Now, stacking on top of a very widely used regimen like R-TOP has been now used widely for two decades. A rather nice sub-Q formulation like Epkinlee on top of that is we think the right approach, you know, moving forward in terms of what physicians will actually do in terms of which patients would get what. We'll save that for a later date, but we see that the phase three data that we've produced here certainly position as well as we think about potentially launching this in 2027. As it relates to your question about, you know, some of the other competitive products, they've now been approved for a while. What we see, those products are gaining some traction and some share, largely in the academic setting. We think that this really significant benefit we saw here with this hazard ratio of 0.49 potentially put us in a different league in terms of benefit. Coming back also then to this, let's just call it ease of use, sub-Q lends itself very well to the community setting and overall things to position as well moving forward.

Operator

You posted a 70,000 number for frontline DLVCL population across U.S., EU, and Japan. Does that exclude the IPI 0 to 1 patients? Okay, and Roche has this study ongoing right now with, it's called the SkyGlo study. That's Glofitimab in combination with PolarChip. We have seen most of the benefit with polar R-chip historically come from the ABC population, subpopulation, rather than the GCB population. Do you think that ultimately matters as now physicians can decide between polar R-chip and Epkinli plus R-chop?

Anthony Pagano, CFO

If we look at the overall profile of Epkinle, going back now to some of the phase two data that we've reviewed previously, looking at Epkinle plus RCHOP, what you see is a very significant benefit, nothing but the phase two data, regardless of patient subtype. So again, it's that easier, simpler option essentially can be used for the appropriate frontline DLBCL patients without having to think about anything along the lines that you were ultimately describing. Of course, we look forward to providing the full phase three results as soon as we can, where we can get into actually looking at the phase three results along these same lines. But again, going back to that phase two data, what we've seen is a very consistent efficacy signal, regardless of how you cut the data, which I think is going to bode well as we think about adoption moving forward for Epkinlee. I think the other thing to think about at Kinley, now this is more looking across other biospecifics. Again, some of the product features, you know, certainly around sub-Q delivery, but also having a single option across both follicular lymphoma and across DLBCL. We think that makes it also, let's call it a simpler option for physicians.

Operator

Does your current assumptions for Epkin Lease Peak Sales incorporate the potential success of SkyGlow study?

Anthony Pagano, CFO

Yeah, so look, we put out our peak year sales estimate of greater than $3 billion at the beginning of 2025. That was a function of the high conviction we had going into this result. And of course, when we put out our estimates, it sort of does take into account any potential competitive dynamics.

Operator

How would a doctor, you know, let's assume this regimen does make it to the finish line. How would a doctor choose between Epkinle versus Glofitimab in terms of safety, administration profile, efficacy, potentially?

Anthony Pagano, CFO

Well, I think we can see how this has played out so far looking at the areas where we are competing against the other CD3, CD20 bispecifics. If you look across third-line DLBCL, third-line follicular lymphoma across many markets, and second-line follicular lymphoma, we are competing today. Physicians are making those choices, and if you look at the data, we are the number one prescribed CD3, CD20-based by specific. We will do everything we can to maximize the target product profile. We've put our data out there. We're going to put the resources behind our finishing off that development work and then behind the commercialization efforts to really position Epkinly as strongly as possible moving forward. But again, I point to what we've done from an execution perspective, both from a development angle and a commercialization angle. It's going to be up to us to continue to execute and put us in the best possible light in front of physicians. I would come back to some of the target product profile attributes. We have a sub-Q delivery. We have a single option across FL and DLBCL. And we think ultimately a drug that is easier to administer.

Operator

Insight also had good data earlier this year from their front-line study. Do you guys expect that to be a competitive threat to you guys in any sense, or do you see Epcot and Lee Plus Archop as the standard of care going forward?

Anthony Pagano, CFO

Certainly more the latter than the former. We think that the, we've said this for some time, that the CD3, CD20 class is a major step forward, and we think within that class that F. Kindley is positioned very well. Now, at the same time, we do take competition very seriously. We're going to do everything we can to make sure that when physicians think about treating the appropriate DLBCL or follicular lymphoma patients that are on label, that they're going to be thinking about GemMap's product and AbbVie's product at Kinley, and we're going to do everything we can to make that experience the optimal experience. And some something that we've been doing is we've thought about. Building out the GemMap's commercial presence, building out that commercial presence and efforts around Epkinly, something that we've been investing for for a number of years. We always had a view as we were thinking about building out commercialization at GemMap and for Epkinly that Epkinly could be this potentially $3 billion brand and that we would have more products beyond Epkinly. So we've been investing now for a number of years for this moment that we find ourselves in.

Operator

Have you submitted a lead breaker abstract if you can comment on that for Ash?

Anthony Pagano, CFO

Yeah, I'm not going to comment on that. Again, we submitted our curtain raiser for ASH. We have, I believe, six oral presentations, including one summarizing the DLBCL-4 trial, which is the second line, EPCO plus LEN in DLBCL with a number of other additional abstracts, and we look forward to submitting those. Of course, we'll do everything we can to think about what's the appropriate venue to share that very exciting frontline data.

Operator

One of the abstracts has the combo of a Kindly plus Polar chip and frontline, DLBCL. I guess, what's the game plan there for that combo? Would you ever consider a phase three with Polar chip?

Anthony Pagano, CFO

For right now, our phase three strategy, we have five phase threes for Epkinlee. Now, four of them have read out. The remaining phase three is in frontline follicular lymphoma. Right now, our focus is on those five phase threes. We look forward. This will not be the first cut of the Epkinlee plus PolyV plus our chip data. We've presented some very encouraging data over the years. We look forward to sharing some more data in a couple of, maybe about a month or so.

Operator

Maybe moving on to Pito here, fantastic hazard ratio there as well. Congrats with the 0.5. Any role for Pembro plus chemo today? I know your trial tested against Pembro monotherapy, but Pembro plus chemo also gets used in head and neck cancer. How do you see that regimen in the landscape going forward?

Anthony Pagano, CFO

I mean, first of all, I'll just repeat what you said. We're very pleased with the results that we've seen. Obviously, we were able to present top-line results in terms of the OS hazard ratio and the odds ratio for response rate. Very, very compelling. As a reminder, we did also have the updated Phase 2 data, which put out, I think, a pretty strong number in terms of overall survival. This, again, was the phase two data. Moving forward, we'll continue to evaluate potential investment opportunities for pedocentumab broadly in head and neck cancer. As a reminder, we have the two phase three trials, one in frontline, one in second line. Frontline just read out. Second line will come in Q1 of next year. We also said that we'll start a trial in locally advanced head and neck cancer. Your specific question about potentially PDO with Pembro and chemo is something that, of course, we'll evaluate. There was data from one of our competitors at ESMO. I think that data needs to be further evaluated about what is the actual added benefit of chemo relative to what you're able to achieve with an EGFR by specific in Pembro, something we're going to evaluate as we move forward. Like anyone should be doing.

Operator

And once, you know, let's say you secure FDA for a PDO, you guys get into the NCCN guidelines, any specific positioning you want to comment on potentially for NCCN across CPS positive patients as well as maybe by HPV status?

Anthony Pagano, CFO

Just to reiterate what we announced, we're very pleased with the results, of course, and what we saw was very broad activity. Other things that were focused on a 2027 launch, this is sort of what we've continued to communicate. Again, pleased with the results and just reiterating what we said in the top line results company announcement, we saw activity regardless of HPV status.

Operator

What about competition in this space? Many other players, there's Bikara, there's J&J. Do you sort of see this market as being fragmented over time, or do you see PETO as the ultimate leader because of the activity in both HPV positive and negative patients?

Anthony Pagano, CFO

Yeah, again, definitely the, I like the way you're asking these questions, definitely the latter. I always think about evaluating a product around best, first, and broadest. We look at the next, like, These next-generation EGFR bispecifics, you named, obviously, GenMaps, Pedocentimab. They're the other two competition. We look at, I think if you objectively look at the data, our data stacks up very well so far. Obviously, this involves cross-trial comparisons right now. We're the one that actually has a randomized phase three. So I think we've set a very, very high bar. And I think, again, I like our chances to be, you know, best in class. The next that I mentioned is around, you know, first in class, fully acknowledge that J&J did get to market in second line based upon a single arm trail. That is what it is. We're going to put our foot on the gas pedal now in terms of taking this first line data that we have, including an overall survival benefit to regulators as soon as we can, and we will be ready to launch as soon as we get that approval. So that speaks to first. We're also putting our foot on the gas pedal as it relates to further development. I mentioned the locally advanced and also announcing the two trials in colorectal cancer. So that speaks to them being first and brought us overall. If I look at the overall positioning of this next generation EGFR by specifics, I think we're setting a very, very high bar here for the class.

Operator

And one of the more common questions we get, as you probably do as well, is why not just sort of disclose the hazard ratios between HPV positive and HPV negative patients? Is that mainly for preserving the data for a medical conference, or what's the rational for that?

Anthony Pagano, CFO

So I think part of this is just sort of. Very straightforward. We focus on, in these company announcements, like a lot of companies do, on what is the primary endpoint. Primary endpoint was looking at the data across the entire population. It's as simple as that. I think when you start getting into selectively disclosing secondary endpoints like this and cutting the data in a TLR, it's not something that is. Um, I think it's just not what we're gonna do. Okay, and we I think we we answered this question. If you read the company announcement, right? We talked about the broad activity.

Operator

You have a second-line study ongoing for head and neck cancer. I guess one obvious question is, what's the purpose of that second-line study now that you have cleared the first-line, front-line, broader population?

Anthony Pagano, CFO

So, look, I mean, this is biopharma, and generally, you look at any class of drug in a particular disease area, that class is not going to get 100%. Just very rarely, if ever, going to happen. Likewise, within a class of particular products, you're not going to get 100% share. So by definition, even if you have a very strong position in Frontline, which we believe we are based upon our data, there are going to be some patients, for whatever reason, are not going to get an EGFR based by specific in Frontline. We want to make sure that both the patients and the physicians have, based upon data, and also, again, here. Randomized Phase 3 data, including OS as the endpoint, they have that option.

Operator

Have you commented on the median, or sorry, mean duration of treatment for PETO in first-line head and neck cancer from your prior study?

Anthony Pagano, CFO

Mean duration of treatment? I'd have to go back and study the ESMO presentation. What we did comment on, the data was presented, was the median overall survival, which was 28 months.

Operator

Maybe moving on to Rina, congrats again. There's fantastic hazard ratios there as well. Do you guys see a role for Elahir in PROC now that you've beaten with a fantastic hazard ratio? Do you expect to be used after Elahir in that folate receptor high expressing patient population?

Anthony Pagano, CFO

So, again, I think I'd look at this in the context of what we think the value proposition of RHNA-S is. RHNA-S is, we believe, a product that can help, not talking about PROC in particular, PROC patients, regardless of folate receptor alpha expression. At a higher rate and for a longer, potentially a longer period of time. This is what the phase two data has really shown. We think it's fundamentally a different. And better value proposition relative to either existing, really focusing on existing, you know, competition. The data, I think, speak for themselves, the phase two data that we've presented, and then backed up now by the phase three data. We think this is a step change for physicians and for patients. Now, assuming we get approved, of course, but we think this is a step change and going to position us very well. Now, having said that, competition is there. You have to be mindful that we cannot take the market for granted. We have to go as fast as we can, and we have to have our commercialization team execute very, very well. I mean, the competition is not going to hand over the market to us. So we think our data, though, does stack up very well and does represent a step change relative to existing competition.

Operator

You did, in this study, have patients with prior LHR exposure enrolled in this study. Have you commented on what percentage of patients might have received?

Anthony Pagano, CFO

No, we've not broken it down. I mean, you can look at the details of the press release. You can look at the PAS versus the ITT and kind of look at the deltas there. But beyond that, we've not broken down. We saw a very consistent result regardless of that. We've not broken down the patients.

Operator

Regardless of prior LA here?

Anthony Pagano, CFO

Yeah, you saw a very consistent result and backed up both on the, particularly on the OS, very consistent results. So I have to say wait for a future medical conference to see the results be presented in more detail.

Operator

There's several other folate receptor alpha ADCs in development. You know, I guess aside from having an edge in time to development, you guys are first in line. Anything else you want to point out that stands out to differentiate? Green ass versus the others.

Anthony Pagano, CFO

Yeah, so I think if you think about it right now, the time does matter. We get to set the bar. We get to hopefully get to market, you know, faster. Again, we have the most mature data set we've treated. I think right now it's safe to say the most number of patients with the next generation fully receptor alpha ADC. We've treated patients not only in ovarian cancer, but now also in endometrial. So it goes back to that framework of at least now talking about first and broadest. We think we're stacking up very well now. It's hard to do cross-trial comparisons, but we think we also have a chance to be best, certainly as it relates to existing competition. If you look at other competitors are going after the space, we'll have to see when you get into larger numbers on their side as well. But we think our safety profile is looking pretty strong. And where that's relevant is patients being able to stay on therapy. This is a big part of delivering efficacy, particularly with ADCs, is keeping the patients on therapy. And so far, we're seeing RENA-S have a very nice profile as it relates to very low discontinuation rates that then speaks to them staying on therapy and then the duration as well.

Operator

From our inbounds, we hear a lot about Gilead's NAPI-2B targeting ADC. I know they're a little behind in development right now, but they don't need a biomarker. They're not folate receptor alpha targeting ADC. Anything there you want to point out where you guys might have an edge against Gilead?

Anthony Pagano, CFO

Sure. Well, maybe not about them in particular, but just talking about our product. In platinum-resistant ovarian cancer, we don't have a biomarker either. This is not an issue, particularly as it relates to PROC. I think another thing, I talked about the dual indication for Epkinlee and follicular lymphoma and DLBCL. You know, we're hopeful that we could, not really a dual indication, but that broad development plan and having a single option for various types of ovarian cancer, whether it be frontline ovarian cancer, platinum-sensitive ovarian cancer, PROC. Or frontline endometrial or second-line endometrial, having potentially, if we're able to successfully complete all these phase threes and get them approved, a single option across this broad set of patients could also be very attractive for, I would imagine, for potential prescribers.

Operator

You mentioned a $2 billion-plus peak sales guidance for renos that includes ovarian, that includes endometrial. Any comments on the split for that $2 billion-plus? We get questions on that. How much is PROC versus platinum-sensitive and non-ovarian cancer indications?

Anthony Pagano, CFO

Yeah, we have high, again, reiterate what we said previously, high conviction in the number. Remind everybody, when we acquired... I think it's just useful to think about what we've done since we acquired the program. April of 2024, there was probably 50 patients. We're sitting now here two and a half years later with the phase three read out with an overall survival benefit, and then an additional five phase threes, either ongoing or announced. So we had high conviction. When we bought the program, we put the peak year sales at a billion. We subsequently upgraded it to greater than two billion. And again, we stand behind that number. We're not going to further disaggregate it for now.

Operator

Some version of this question was asked before, but I'm going to try again.

Anthony Pagano, CFO

Right. Let's see what you got written down there.

Operator

Yeah, I think a lot of your investors were shocked with the hazard ratios that you've seen with all three studies. And your peak sales expectations have not changed. Ideally, we would think that if your expectation, let's say for RENAS, was 0.65 and you got materially less than that, Duration of treatment would be materially higher than your expectations. So why not raise the guidance for Rhena S, Epkinli, and show the guidance for PETO?

Anthony Pagano, CFO

So it starts with something, I think, at the very beginning of the conversation. Two things. One said greater than $3 billion for Epkinli, greater than $2 billion for Rhena S, and then the multi-billion for pedocentumab. In addition, I highlighted very intentionally the robustness of the Phase II data. That we had access to and ultimately published. That gave us high conviction and high visibility already in January of 25 to put out the numbers that we did for Kenley and Rena S. And then obviously a lot of visibility and confidence to say multi-billion when we acquired pedocentumab. So as we sit here today, continue to stand behind these estimates we previously put out. I get the question, you know, good try. I've been asked this question 25 times in the last couple of days. But again, I think, look, really good assets, really good data. Now it's time to execute, get them filed and approved as quickly as possible, and then start the launch of the medicines.

Operator

And for PDO, when you say multi-billion, are you just waiting for CRC data and then potentially give guidance, or what's the rationale there?

Anthony Pagano, CFO

Yeah, so when we announced the deal in September of 2025, so a little over a year ago, we thought this was the appropriate guidance then. I kind of talked through it today a bit. We feel today this is still the appropriate guidance. I'm not going to provide guidance on when I'm going to provide guidance. I just don't think that would be useful. Again, we feel that these are the right estimates to have out there for the market at this time.

Operator

One question on pricing. I know we still have to file it for the BLAs. We're seeing pricing for oncology step up materially in recent times, like we're seeing RevMed's drug at $40,000 a month, CoreSup's drug at $38,000 a month. Should we expect your pricing to be different for Pito and Rina's?

Anthony Pagano, CFO

I'm not going to comment on pricing. We'll comment on pricing when the products are launched. That's it. What I can tell you is that we have experience in pricing. We've let the pricing work for Epkinlee, so we're well-positioned, taking into account everything to price these medicines appropriately. But we'll comment that only when the actual price is set.

Operator

I will stop there and maybe see if anyone has any questions from the audience. Thank you.

Anthony Pagano, CFO

Great. Thank you so much. Pleasure to be here. Thank you.