All right. 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. Pleasure to be here.
Great. So Anthony, it has been an extraordinary stretch for Genmab this year. You have had three positive phase III trials in a very short period. When you look across these results, what surprised you the most? Let us start there.
Well, going into the readouts as we have highlighted, based upon the overall quality of the products and the assets, development plans behind them, we had high conviction going into these readouts. Over the last couple of years, we have 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 us just actually step back and reflect on the actual readouts themselves. You have all seen them, thinking about what was done for EPKINLY in frontline DLBCL, stacking on top of R-CHOP with a hazard ratio of 0.49. And then for both Rina-S and petosemtamab, the very strong results, notably also with showing an overall survival benefit.
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. As I mentioned, based upon the strong assets, the strong development plans, we had high conviction going into these readouts.
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?
Yeah, I mean, as I mentioned, we had very high conviction going into these readouts. Again, think about the products in turn, or really actually just look at them all. Going into these phase III readouts, in the particular indications, we had rather robust phase II data, whether it be for EPKINLY, Rina-S, and petosemtamab, 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 III data could be and gave us a better view in terms of what the ultimate target product profile could look like. 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 II data.
Something we've been talking quite a bit about, particularly as it relates to EPKINLY, really that translatability from the strong phase II data into the phase III results. For EPKINLY 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. Again, we had high conviction 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 a, I know the word gets thrown around quite a bit, but it was an unprecedented month we had here in October.
Yeah. Wonderful. I want to start with EPKINLY first. Internally, do you see the role of R-CHOP anymore for any group of patients in frontline DLBCL? Second, how do you see the Pola-R-CHP segment today and being shifted towards your EPKINLY plus R-CHOP?
Our view all along has been that the predominant number of patients get R-CHOP, that those patients get that treated in the community. That is why we chose the phase III path that we did to add on a subcutaneous product like EPKINLY on top of what is the market leader, R-CHOP. This is our view now, stacking on top of a very widely used regimen like R-CHOP, it has been now used widely for two decades. A rather nice subQ formulation like EPKINLY on top of that is, we think, the right approach moving forward. In terms of what physicians will actually do in terms of which patients would get what, we will save that for a later date. But we see that the phase III data that we have produced here certainly position as well as we think about potentially launching this in 2027.
As it relates to your question about some of the other competitive products, they have 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 us just call it ease of use, subQ lends itself very well to the community setting, and overall thinks the position as well moving forward.
You posted a 70,000 number for frontline DLBCL population across U.S., EU, and Japan. Does that exclude the IPI zero to one patients?
Yes.
Okay. Roche has this study ongoing right now with, it's called the SKYGLO study, that's glofitamab in combination with Pola-R-CHP. We have seen most of the benefit with Pola-R-CHP historically come from the ABC population, subpopulation, rather than the GCB population. Do you think that ultimately matters, as now physicians can decide between Pola-R-CHP and EPKINLY plus R-CHOP?
If we look at the overall profile of EPKINLY, going back now to some of the phase II data that we've reviewed previously, looking at EPKINLY plus R-CHOP, what you see is a very significant benefit, now with the phase II 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 III results as soon as we can, where we can get into actually looking at the phase III results along these same lines.
But again, going back to that phase II 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 EPKINLY. I think the other thing to think about EPKINLY, now this is more looking across other bispecifics, again, some of the product features, certainly around the subQ delivery, but also having a single option across both follicular lymphoma and across DLBCL. We think that makes it also a, let's call it a simpler option for physicians.
Does your current assumptions for EPKINLY's peak sales incorporate the potential success of SKYGLO study?
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 estimate, it does take into account any potential competitive dynamics.
How would a doctor, let's assume this regimen does make it to the finish line, how would a doctor choose between EPKINLY versus glofitamab in terms of safety, administration profile, efficacy potentially?
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 x 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 x CD20-based bispecific. 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'd 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 subQ delivery. We have a single option across FL and DLBCL, and we think ultimately a drug that is easier to administer.
Incyte also had good data earlier this year from their frontline study. Do you guys expect that to be a competitive threat to you guys in any sense, or do you see EPKINLY plus R-CHOP as the standard of care going forward?
Certainly more the latter than the former. We think that we've said this for some time, that the CD3 x CD20 class is a major step forward, and we think within that class that EPKINLY is positioned very well. 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 Genmab's product and EPKINLY. We're going to do everything we can to make that experience the optimal experience. Something that we've been doing is we've thought about building out Genmab's commercial presence, building out that commercial presence and efforts around EPKINLY, something that we've been investing for a number of years.
We always had a view as we were thinking about building out commercialization at Genmab 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.
Have you submitted a late breaker abstract, if you can comment on that, for ASH?
Yeah, I'm not going to comment on that. Again, we submitted our curtain raiser for ASH. We have, as 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. We look forward to, yeah, and 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.
One of the abstracts has the combo of EPKINLY plus Pola-R-CHP in frontline DLBCL. I guess, what's the game plan there for that combo? Would you ever consider a phase III with Pola-R-CHP?
Yeah, for right now, our phase III strategy, we have five phase IIIs for EPKINLY. Now, four of them have read out. The remaining phase III is in frontline follicular lymphoma. Right now, our focus is on those five phase IIIs. We look forward. This will not be the first cut of the EPKINLY plus POLIVY plus R-CHOP 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.
Got it. Okay. Maybe moving on to peto 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?
Yeah. I mean, first of all, just repeat what you said. We are very pleased with the results that we have 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 II data, which put out, I think, a pretty strong number in terms of overall survival. This weekend was the phase II data. Moving forward, we will continue to evaluate potential investment opportunities for petosemtamab broadly in head and neck cancer. As a reminder, we have the two phase III trials, one in frontline, one in second line. Frontline just shut out. Second line will come in Q1 of next year. We also said that we will start a trial in locally advanced head and neck cancer.
Your specific question about potentially peto with pembro and chemo, something that, of course, we will 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 are able to achieve with EGFR bispecific and pembro, something we are going to evaluate as we move forward, like anyone really should be doing.
Okay. Once, let's say you secure FDA approval for peto, 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?
Just to reiterate what we announced, we are very pleased with the results, of course, and what we saw was very broad activity. Other things that we are focused on, a 2027 launch. This is sort of what we have 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.
What about competition in this space? Many other players. There's Bicara, 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?
Yeah. Again, definitely 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 these next-generation EGFR bispecifics. You named, obviously, Genmab's petosemtamab. They're the other two competition. 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 III. So, I think we've set a very, very high bar, and I think, again, I like our chances to be best in class. The next that I mention is around first in class. Fully acknowledge that J&J did get to market in second-line based upon a single-arm trial. 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 then being first and broadest overall. If I look at the overall positioning of this next-generation EGFR bispecifics, I think we're setting a very, very high bar here for the class.
Okay. 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 rationale for that?
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 is 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 is not something that is I think it is just not what we are going to do.
Got it. Okay.
Again, I think we answered this question if you read the company announcement, right? We talked about the broad activity.
You have a second-line study ongoing for head and neck cancer.
Yep.
I guess one obvious question is, what's the purpose of that second-line study now that you have cleared the first-line, frontline broader population?
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, a particular product's 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 bispecific in frontline. We want to make sure that both the patients and the physicians have, based upon data, and also, again, here, randomized phase III data, including OS as the endpoint, they have that option.
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?
Mean duration of treatment?
Treatment.
I'd have to go back and study the ESMO presentation. What we did comment on, the data that was presented was the median overall survival, which was 28 months.
Maybe moving on to Rina-S. Congrats again there. Fantastic hazard ratios there as well. Do you guys see a role for ELAHERE in PROC now that you've beaten with a fantastic hazard ratio? Do you expect to be used after ELAHERE in that folate receptor high-expressing patient population?
I think I'd look at this in the context of what we think the value proposition of Rina-S is. Rina-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 II data has really shown. We think it's fundamentally a different and better value proposition relative to either existing, really focusing on existing competition. The data, I think, speak for themselves, the phase II data that we've presented, and then backed up now by the phase III 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.
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. We think our data, though, does stack up very well and does represent a step change relative to existing competition.
You did in this study have patients with prior ELAHERE exposure enrolled in this study. Have you commented on what percentage of patients might have received?
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.
Regardless of prior ELAHERE or?
Yeah, you saw a very consistent result and backed up both on the, particularly on the OS, very consistent results. I'd have to say wait for a future medical conference to see the results be presented in more detail.
There are several other folate receptor alpha ADCs in development. 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 Rina-S versus the others?
Yeah, 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 faster. Again, we have the most mature dataset. We have treated, I think right now it is safe to say, the most number of patients with the next-generation folate receptor alpha ADC. We have treated patients not only in ovarian cancer, but now also in endometrial. It goes back to that framework of, at least now talking about first and broadest, we think we are stacking up very well now. It is 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 will have to see when you get into larger numbers on their side as well.
We think our safety profile is looking pretty strong. Where that is 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. So far, we are seeing Rina-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.
From our inbounds, we hear a lot about Gilead's NaPi2b-targeting ADC. I know they are a little behind in development right now, but they do not need a biomarker. They are not folate receptor alpha-targeting ADC. Anything there you want to point out where you guys might have an edge against [inaudible]?
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 EPKINLY in follicular lymphoma and DLBCL. We're hopeful that we could, not only have 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 IIIs 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.
Okay. You've mentioned a $2 billion+ peak sales guidance for Rina-S that includes ovarian, that includes endometrial. Any comments on the split for that $2 billion+ ? We get questions on that. How much is PROC versus the platinum-sensitive and non-ovarian cancer indications?
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 III read out with an overall survival benefit, and then an additional five phase IIIs either ongoing or announced. So we had high conviction. When we bought the program, we put the peak year sales at $1 billion. We subsequently upgraded it to greater than $2 billion, and again, we stand behind that number. We're not going to further disaggregate it for now.
Got it. Some version of this question was asked before, but I want to try again.
Right. Let's see what you got written down there.
Yeah. I think that a lot of your investors were shocked with the hazard ratios that you've seen with all three studies.
Okay.
Your peak sales expectations have not changed. Ideally, we would think that if your expectation, let's say, for Rina-S was 0.65 and you got materially less than that, duration of treatment would be materially higher than your expectations. Why not raise the guidance for Rina-S, EPKINLY, and show the guidance for peto?
It starts with something, I think, at the very beginning of the conversation. Two things. One, said greater than $3 billion for EPKINLY, greater than $2 billion for Rina-S, and then the multi-billion for petosemtamab. 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 2025 to put out the numbers that we did for EPKINLY and Rina-S, and then obviously a lot of visibility and confidence to say multi-billion when we acquired petosemtamab.
As we sit here today, continue to stand behind these estimates we previously put out. Previous, I get the question, good try. Probably 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.
For peto, when you say multi-billion, are you just waiting for CRC data and then potentially give guidance, or what's the rationale there?
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 or 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.
Okay. One question on pricing. I know we still have to file for the BLAs. We're seeing pricing for oncology step up materially in recent times. We're seeing RevMed's drug at $40,000 a month, Corcept's drug at $38,000 a month. Should we expect your pricing to be different for peto and Rina-S?
I'm not going to comment on pricing. We'll comment on pricing when the products are launched. That's it. All I can tell you is that we have experience in pricing. We've let the pricing work for EPKINLY, 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.
I will stop there and maybe see if anyone has any questions from the audience. Okay, we're at time. Thank you, Anthony.
Great. Thank you so much. Pleasure to be here. Thank you.