Genmab A/S (GMAB) Earnings Call Transcript & Summary

Thanks for joining us. My name is Jonathan Chang. I'm part of the Leerink Partners Equity Research team. It's my pleasure to host the management team of Genmab. We have with us today, CFO, Anthony Pagano; and Chief Commercial Officer, Brad Bailey. Thank you guys very much for joining us today.

Yes, it's a pleasure to be here, Jonathan. Thank you so much for having us.

Would you like to take a few minutes to briefly introduce the company?

Sure. I can kick things off, and then we can dive into your questions. So 2025 for Genmab was another very strong year, and that's both from a financial perspective as well as the progress we've made with our late-stage pipeline. Financially, we saw another year of very strong revenue growth, disciplined OpEx management and really having that profit flow through to the bottom line. As we exit 2025 from a pipeline perspective, what's important to highlight is we have 3 late-stage programs, EPKINLY, Rina-S and petosemtamab. And in 2025, for each of these programs, we saw meaningful clinical data that served to increase our conviction around the prospects and growth opportunities for these programs. And these 2 key themes that I just highlighted in 2025 in terms of the strong financials and the clinical progress carry over into 2026. For each of these programs, both EPKINLY, Rina-S and petosemtamab, we expect registrational trial readouts during the course of the year, which could carry forward in terms of the potential launches in 2027. So really, what you have here at Genmab is a very strong foundation across the entire business, the financials, the technologies and now most importantly, these 3 late-stage programs with the meaningful data in 2026, leading to potential launches in 2027, which really set us up very well as we get into the back part of this decade, Jonathan. So with that, maybe we should dive into your questions.

Sure. So of course, you mentioned 2026 is an important year for Genmab, where there are several key readouts expected across the late-stage pipeline, including from EPKINLY, Rina-S, petosemtamab. How do you view the commercial opportunities for each of these programs?

Sure. I don't know, Brad, did you want to sort of maybe kick things off?

I'll kick it off. And then we view -- certainly, as we've said quite a bit with EPKINLY, we view this as a blockbuster medicine with the $3 billion-plus potential. And we've also said all along the value proposition of EPKINLY is one that is extremely well suited as we move into earlier lines of therapy. And I think that's critical. We're very encouraged at this point with our performance to date and have made meaningful progress launching second-line FL most recently and starting to see not only our core sites where uptake has been robust in the initial phase in the later lines of therapy in DLBCL and second-line FL where patients are treated a little bit more closely to where they live, the value proposition of EPKINLY with both durable efficacy, but most importantly, that dual indication operationalizing a bispecific in the community is becoming meaningful. And so overall, moving into these earlier lines of therapy, we feel we're very well positioned from an EPKINLY perspective.

Yes. Maybe in terms of bringing the asset that fits into the kind of set the stage. Rina-S, think about the progress we've made in the last 18 months from a pre-proof-of-concept asset to exiting 2025 with 3 ongoing Phase III trials going to have the first potential registrational readout here in 2026 in the second-line plus PROC setting. Here, what really is encouraged with Rina-S is the overall profile of the asset in terms of its differentiated efficacy, we think differentiated safety, ultimately leading to very long potentially duration of therapy or duration of response. Here, Jonathan, for Rina-S, we've pegged the peak opportunity of being $2 billion plus. And this is really underwritten by 4, let's call it, subsegments of the GYN/ONC space. Of course, we have the second line plus PROC. You also have platinum-sensitive ovarian cancer and then frontline and second-line endometrial cancer. And the good news is that out of those 4 sort of subsegments, the Phase III trials are already well underway. So it's really the combination of the product profile in terms of potential to be best-in-class, first-in-class and it's also broadest in class gives us confidence in that $2 billion-plus number for Rina-S. Then in terms of petosemtamab, again, here to remind you, this is a program that we acquired at the end of 2025. It has two breakthrough therapy designations, two ongoing Phase III trials, one in frontline head and neck cancer, the other in second-line plus head and neck cancer. These Phase III trials are underway. And here, we expect one or both of these Phase III trials to read out during the course of 2026. Here for petosemtamab, we've pegged the peak opportunity as a multibillion-dollar opportunity. As I mentioned, we have the 2 ongoing Phase IIIs. We have very clear plans to start a next Phase III in the earlier line of head and neck, locally advanced head and neck cancer during the course of 2026. And ultimately, if you sort of then think about Rina-S and petosemtamab that kind of round out the conversation, there are these, let's call it, initial core indications, Gyn/Onc for Rina-S, and head and neck cancer petosemtamab, for each of these programs, we have earlier-stage clinical work ongoing to potentially expand the clinical reach of these 2 programs. So a lot to be excited about. Obviously, the end-market performance for EPKINLY, the expansion opportunities there, but also what I just covered for Rina-S and petosemtamab. So really exciting time here at Genmab.

Great. Thank you. So we discussed what the peak numbers might look like. Can you help us understand what the time lines of these programs and commercial launch plans look like relative to the DARZALEX royalty stream.

Maybe I can kick start. I think if we take it program by program, we can obviously do that, Jonathan. But maybe the place to start is just look at the totality of what we just explained. Obviously, we're all aware of DARZALEX. I'm not going to get into the DARZALEX math here and trying to get into the replace -- exact precise replacement math. But look at the totality of what we just talked about, EPKINLY at $3 billion plus, Rina-S at $2 billion plus and then petosemtamab is a multibillion-dollar opportunity. And again, think about the expansion opportunities for both Rina-S and petosemtamab. And let's not forget the robustness of our earlier-stage pipeline and our research and discovery engine. So there is a very strong stand-alone oncology business apart from DARZALEX and our other royalty streams. Now let's go through product by product. EPKINLY, as we know, is competing very well in the third line plus settings where we're approved today in DLBCL and follicular lymphoma. We have this next expansion opportunity into second-line follicular lymphoma that came online last year. Just to remind ourselves, this is a smaller opportunity in terms of patient size initially, where it's approved in the United States, maybe around 4,000 patients. Brad may comment in a few minutes about why that's important, not only financially, but maybe more operationally, so we can come back to that. But the real trajectory, Jonathan, towards that $3 billion-plus number for EPKINLY is going to come from getting into earlier lines initially here into DLBCL. Here, again, we have readouts for EPKINLY, both in frontline DLBCL and second-line DLBCL during the course of 2026. So that is going to be really the springboard to start seeing on that trajectory towards that $3 billion-plus number. As a reminder, we also still have for EPKINLY, the frontline follicular lymphoma trial, which will read out here. We've not yet provided guidance on timing. So it's really going to be these 2 trials, seeing that data during the course of 2026, go through the regulatory process back half of '26 into '27 to sort of drive us towards that $3 billion-plus number. For Rina-S, it's earlier days, of course, this product is not yet on the market. Here, we have the $2 billion-plus number. Initially, it's going into second-line PROC, which will have that data here in '26 and a launch into 2027. We've not yet broken down that number, but those 4 sub-indications that I went through earlier that are driving that $2 billion-plus number. We look -- we're very excited about what we're seeing in terms of the differentiated efficacy, differentiated safety profile, which ultimately together lead to a very robust duration of response, particularly in platinum-resistant ovarian cancer. And then maybe last but not least, petosemtamab here, again, we're expecting data in '26, potential launch in '27. Here, we have been a little bit more granular. We said that based upon the robust clinical profile, we're expecting petosemtamab to do $1 billion by 2029, ultimately driving us towards that multibillion-dollar plus potential. So a lot to unpack there, Jonathan. We can happy to maybe dive into anywhere you'd like to go from here.

Great. Thank you. From a commercial standpoint, can you talk about your ability to market Rina-S and petosemtamab yourselves?

Yes. No, it's a great question. Thank you. And we're very encouraged to date, and we've been sort of building for this for the last several years actually, and very strategic and deliberate in our footprint, building businesses in both the U.S. and Japan, where we're booking sales and now also building businesses in Europe, where we're launching TIVDAK on our own as well independently, just like we did in Japan. And I think it's a very important point to make, launching TIVDAK globally puts us in a position from a Gyn/Onc perspective to be uniquely qualified and excited around the potential opportunity for the launch of Rina-S. So we have the infrastructure in place. It's building -- being built, especially based on the core markets where we know we will need to succeed and do well. And we're feeling very confident as it relates to the Rina-S launch opportunity.

And petosemtamab?

Yes. And petosemtamab, likewise, you're putting the synergies between building businesses in both U.S., Japan and now in Europe. You have all of your core capabilities that you need from the launch perspective, and then we'll build certainly our build teams as we get close to launch, which we have a little more time outside of U.S. and Japan, but U.S. and Japan, we're extremely confident as well.

I think here, what's important to highlight under Brad's leadership, really, we've -- he and the team have started to build out and have built out really strong road maps and playbooks in advance of the launch. We've done it with TIVDAK initially, done it rather successfully with EPKINLY, both in the U.S. and Japan. And these same playbooks are now being applied to the potential launches for both Rina-S and petosemtamab in 2027. We talked a lot about the investments that we've been making over, let's call it, the last 4 or 5 years in terms of this commercialization readiness and capabilities. This is why we've done it. We knew eventually we would get into earlier lines for EPKINLY, and we knew that we have additional launch opportunities. I didn't know the time it was going to be for Rina-S and petosemtamab, but this is why we've made the very strategic forward-thinking investments we've been making over the last a number of years. So the team is really looking forward over the next 12 months or so to get ready for these launches and then post approval to really hit the ground running.

And maybe just to add one other topic on that. The track record of success of sort of U.S. and Japan, now also in launching TIVDAK in Europe has been very strong, and we're very encouraged by what's been delivered to date. And these are -- now TIVDAK is the standard of care in second-line cervical cancer globally. EPKINLY is leading globally and this, as we know, is a highly competitive marketplace. And so we're, again, very encouraged with the past performance, dictating the future success as well.

Great. So let's double-click on exactly that for EPKINLY. What are the reasons for confidence in the ability to maximize the commercial opportunity for EPKINLY? So of course, this includes being able to penetrate earlier lines of treatment, get more adoption in community settings and take share versus other CD20 bispecific players?

Yes. Great question, and I'll try to take that holistically and then drill into each one of those. And back to the comment around the success and how we've been encouraged to date with our success. This starts really with the value proposition of the product profile. The efficacy, both in DLBCL and FL, I mean the hazard ratio of second-line FL is unprecedented. And you have a dual indication and operationalizing bispecifics in the community is a topic across the industry, how to really do this well. And we feel uniquely positioned and it's starting to show out with the second-line FL launch uniquely positioned to bring EPKINLY closer to patients in the community. We have out of our core sites, the key sites that have been ordering EPKINLY from the very beginning, which, for the most part, began with all the CD3, CD20s in these CAR-T centers, if we call them. Each of those key accounts with where we were focused initially, over -- just over 80% of those key accounts have now put themselves in a position where they have at least 3 sites ordering, not just at the main hub. And so you're seeing the operationalization of bispecifics become more relevant. And certainly, with the dual indication, the safety profile, the subcutaneous -- seamless subcutaneous administration at this point for DLBCL and FL, again, putting us in a position to not only perform in these key academic centers, but also in the community.

Got it. How should we be thinking about the impact of the results of the Phase III EPCORE DLBCL-1 study of EPKINLY monotherapy?

Yes. So this is the trial that read out earlier this year. This is the Phase III monotherapy trial you're referring to. Here, we had, obviously, the positive signal and positive readout in progression-free survival and really not the same case for overall survival. As we sit here today, we're obviously further analyzing the results. We believe the results were confounded due to COVID, as we highlighted, also confounded due to use of novel therapies subsequently in the control arm. We look forward to presenting and going through that data in more detail in the future. Again, the highlight here is that a monotherapy EPKINLY versus the control arm, which was multiple products, including novel therapies, did beat on PFS. We think that is clinically relevant. And also as we sort of think about moving forward, 0 read across to the ongoing combination trials, EPCORE plus R-CHOP in frontline DLBCL and EPCORE plus lenalidomide in second-line DLBCL. So 0 read across there. And here, we're very -- our confidence remains strong because of what we've seen EPKINLY can do in combination more broadly, but also the Phase II trial results that we've been publishing at ASH and other conferences at the last number of years in the same exact combos, same exact setting. So it's something that we have to work through. But as we sit here today, it's something we're just going to work through and haven't seen any significant impact to commercial performance as a result of this.

And maybe just to add on that, too quickly, from a thought leader perspective, given the circumstances, obviously, the timing of the trial with COVID, but also back to Anthony's point on the monotherapy, encouraged actually, and it was much more as expected as opposed to not.

Got it. Maybe switching over to RINA-S. What do you see as the key areas of differentiation versus approved FR alpha Elahere and also the growing list of ADCs in development in the ovarian cancer landscape.

So Brad, I'll start. It goes back to this framework, Jonathan, maybe it's too simple for some. I think about best-in-class, first-in-class, broadest in class. Against existing competition, what we're seeing from Rina-S is efficacy across the full spectrum of folate receptor alpha expression levels. We've seen this not only in platinum-resistant ovarian cancer, but also in endometrial cancer, where we're seeing robust activity, again, regardless of expression level. We're also seeing in terms of that best-in-class profile relative to existing competition, potentially differentiated safety profile, which again means that patients can stay on drug longer, which then drives that duration of response. So we're seeing differentiated response rates across that expression level, differentiated safety, but ultimately better outcomes for patients because they stay on drug longer. So that duration of response is longer. So that's in terms of best-in-class. That's really relative to existing competition. Now relative to future competition, that's where first-in-class and broadest in-class comes into play. I mentioned the progress and highlight the progress we've made since acquiring the program, the robustness of our clinical development program, we're really looking to own the gynecological oncology space. So we have thought about the existing Phase IIIs. I can't highlight today what else is to come, but there is definitely more to come in terms of Phase III development for Rina-S and Gyn/Onc. Really then leveraging that first-in-class position as well as being broadest in class. So we like where we're at relative to existing competition and really going to keep our foot on the gas pedal to really try to distance ourselves from future competition. And that's also then where the handover to commercialization is super important. It's not just about the clinical development, it's making sure that if and when the product is approved, our commercialization teams are going to be in place to really then effectuate a very strong launch.

How much of a time line advantage do you think Rina-S has over other ADCs in looking to address this all-comers population in platinum-resistant ovarian cancer?

So I think it's probably not helpful for me to speculate. I know what we can do. I know what our time lines are. Again, we're going to have our data in second-line PROC, the Phase II trial this year has been also communicated, the Phase III kind of confirmatory trial in a similar patient setting is also now fully recruited. We also have the second-line endometrial Phase II and Phase III, also very well underway. So we are focused on what we can do and control as it relates to the conduct of our trials and then regulatory readiness and launch readiness. We're doing everything we can every single day to maintain that leading position. We're, of course, very mindful of the competition. That's why we want to keep our foot again on that gas pedal.

Understood. And how do you guys see the endometrial opportunity relative to ovarian cancer?

Yes. It's -- if you look at the patient populations, looking at frontline and second line, you start to see comparable numbers of patients. And so we see this as -- Anthony started with the 4, sort of 4 components in both PROC BSOC and with endometrial. I think it's a very equitable opportunity, if you will, overall.

How about from a competitive landscape consideration? How do you see endometrial comparing to ovarian?

Yes. I think in general, certainly some different players there. And -- but back to Anthony's point on where we are with endometrial and the development perspective, but then also the agnostic with the FR alpha expression, we feel confident there as well.

Yes. I think this kind of brings back to some maybe similarities in terms of the approach and the mindset going back to EPKINLY, having a single option across follicular lymphoma and diffuse large B-cell lymphoma, similar principle here, same physicians are treating not only cervical cancer with TIVDAK, but here for Rina-S both ovarian cancer and endometrial cancer, having a single option, we think is also going to potentially be a really key differentiator when we go to market. So we're really focused on having these 2 options or the single option for these 2 indications available as quickly as possible for patients.

Got it. Maybe we will switch over to petosemtamab. How do you guys see this program positioned in the head and neck cancer landscape?

I can start. And the starting point really is looking at the clinical data that we've seen so far. As a reminder, both in frontline as well as second-line plus head and neck cancer, petosemtamab has been awarded FDA breakthrough therapy designation, really keying in on that frontline data that was released last year for petosemtamab, thinking about the additive benefit on top of pembro where you saw nearly a -- or more than a tripling of the response rate. So we're seeing very strong response rate. We're also seeing a rather quick clinical response. A lot of the response is coming at the first scan. So not only a robust signal, but a very fast signal as well. And the collection of those 2 is carrying through to what we've seen in terms of the 12-month progression-free survival or overall survival, excuse me, in the high 70%, I think, 79%. So the overall profile of petosemtamab, particularly in combination with pembro is rather strong, which then gives us the confidence to go into the earlier lines locally advanced here with the first Phase III slated to start in 2029 -- I'm sorry, at the end of 2026. Again, here, there's going to be competition in oncology is a given. So we're really focused on maximizing that clinical profile, go broad and go fast. This is really the principle, particularly as it relates to being first. We think, again, here relative to other eGFR-based bispecifics, we have the chance to be first in head and neck cancer, clear line of sight actually to doing that. So we're super focused on really seeing the first trial readout here in 2026 and get the market in '27.

Got it. And what can we expect in the top line second half '26 disclosure or disclosures from the 2 Phase III studies? There's the frontline study and then there's the second and third-line study.

Yes. So again, to remind everybody, there are 2 ongoing Phase IIIs, one in frontline and one in second line plus head and neck cancer. What we said is that one or both of the trials will read out this year. And that's probably where we have to leave it. Jonathan, if I start kind of telling you what the data endpoints could be that we're looking forward to, then you start by trying to guess or infer which of the trials are going to read out. I think what's important to note is that the clinical profile that we were able to highlight last year at medical conferences is super strong. We remain convinced that this has best-in-class properties in terms of next-generation eGFR-based bispecifics. And this is only the beginning of the development of this product. So I'd say stay tuned to seeing the top line readouts in the back half of '26.

Got it. How about opportunities beyond head and neck cancer for this program? What's your latest thinking on that?

Yes. Obviously, this has been a topic of conversation. It goes back to that really profile of the program in terms of petosemtamab. And as you all know, in the back half of '25, we released some early but very encouraging data in colorectal cancer. We're in the process of collecting some more data in this indication and look forward to sharing some incremental data in colorectal cancer in the back half of 2026. Also, you would have seen we have started a proof-of-concept trial in non-small cell lung cancer, unsurprisingly, perhaps for petosemtamab. So I'd say, right now, really focused on this lead core indication of head and neck cancer and then looking really thoughtfully at potential expansion opportunities.

Understood. Let me just check and see if there are any questions from the audience. Is it fair to assume that Genmab at this point is done with -- for the time being on the M&A front?

So for a capital allocation perspective, right now, we're focused on investing back in the business along our strategic and investment priorities, which is really around both R&D and commercialization launch preparedness and execution across these 3 brands. That's absolutely the focus from a financial perspective, but also from an operational perspective, given the very significant opportunities that are right in front of us. From then further from a capital allocation perspective, we're focused on deleveraging. In terms of acquiring Merus, we took on $5.5 billion of debt. And we said we want to get at or below 3x gross leverage by the end of 2027. So excess capital really will be deployed in that deleveraging plan between now and the end of 2027. Beyond that, let's just see where we're at, at that point in time. It doesn't mean we're not going to do smaller technology deals, really tool and component type deals to plug into our research and discovery engine, but these will be rather small by definition.

Understood. Maybe just in our last minute here, can you just remind us what the milestones and catalysts for the company are for 2026?

No, absolutely. I mean -- and this is really where I think we're really excited and all of you should be equally excited. For EPKINLY, we have the 2 Phase III readouts in frontline and second-line DLBCL. Second-line DLBCL will be in H1 and then the frontline trial will be during the course of 2026. And in particular, the frontline DLBCL is around half of the total addressable patient population for EPKINLY. Then we have the second line plus PROC data. First, registrational data we'll see for Rina-S, fueling the launch of the brand, hopefully in 2027. And then the same for petosemtamab, where we're going to have the first registrational data here in 2026 in the back half of the year, leading to the potential launch of that brand as well in 2027. So if you think about it, really having material significant line extension opportunities for EPKINLY and then launching 2 blockbuster brands in Rina-S and petosemtamab in terms of the clinical data in 2026 and then the launch opportunity in 2027.

Great. Thank you very much for taking the time.

Thank you.