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

September 9, 2025

US Health Care Biotechnology Company Conference Presentations 34 min

Earnings Call Speaker Segments

Judah Frommer

Analysts
#1

Good morning, everyone. Welcome to this session of the Morgan Stanley Global Healthcare Conference Day 2. Let me just read a quick disclosure before we get started with Genmab here. For important disclosures, please see the Morgan Stanley Research Disclosures website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So with that, I'm very excited to welcome the Genmab team. We have Jan and Anthony representing up here. Maybe just to start, as you know, I'm somewhat newer to the story, but for people who are less familiar with Genmab's history, maybe you can give a high-level overview of sort of the current sources of revenue and how you anticipate those sources could change over the coming years, if that's a good way to frame the high-level story.

Jan van de Winkel

Executives
#2

Absolutely. So over 25-year history, we focused on differentiated antibody therapeutics. We have a good track record, as you know, 8 FDA-approved antibody therapeutics that are based on our science on the market, 2 of them we commercialize ourselves TIVDAK and EPKINLY. And EPKINLY is a late-stage [indiscernible] multiple Phase III clinical trials add to that [indiscernible] also are moving into more and more late-stage clinical trails. We will actually make sure that they will grow into the future. And of course, we are also trying to look at the external roles or opportunities there like we did with ProfoundBio and also from our own pipeline. We actually intend to add more products to it actually drive sustainable growth for the coming decades.

Judah Frommer

Analysts
#3

Okay. Great. So maybe if we start with the ongoing Phase III trial for our CD3, CD20 bispecific EPKINLY in first-line DLBCL. So how has the trial been progressing? What do you see as the benchmarks or outcomes for a strong commercial launch in the frontline setting in DLBCL?

Jan van de Winkel

Executives
#4

Well, that trial is completely recruited actually very far ahead of self schedule, and we expect it to read out between now and the end of next year. So very near term. And I think that based on the data, this is, of course, a PFS endpoint. Based on the data, we think that this could actually add a lot of income for us via EPKINLY because this is essentially half of the market, frontline diffuse large B-cell lymphoma as you now look at the landscape. So we're very excited about the potential of that trial to read out quickly as that can turbo boost the income for EPKINLY and also improve our position. What you've seen is also we had a second-line follicular lymphoma trial recently moving to top line results. We submitted that data for ASH. The second-line follicular lymphoma trial has fantastic data, as you have seen, with a hazard ratio of 0.21, so a 79% lower risk of disease progression or that has simply never been seen. So EPKINLY is doing really, really well. And we actually moved to earlier and earlier lines of therapy. There's another second-line plus diffuse large B-cell lymphoma trial. This is also fully recruited, also expected to read out between now and end of next year. They are event-driven. So we cannot give you the exact timing, Judah. But we're very excited about the potential of EPKINLY and we're going to further broaden it -- we submitted nearly 30 abstracts to ASH this year, including the follicular lymphoma second-line pivotal data. And many of them are novel combinations, basically either tried by Genmab together with AbbVie in our collaboration or investigator-initiated studies because one of the real advantages of EPKINLY is it's not only super effective, that's a very clean safety profile. You don't need hospitalization, and it is easily combinable with other medicines. So -- and that is exactly what doctors want to see for the next phase of treatment of B-cell cancer. So we are very excited about EPKINLY. It's doing -- actually, it's better than what we anticipated actually.

Judah Frommer

Analysts
#5

Okay. So maybe moving just kind of a level higher up on the broader lymphoma space. I guess, how do you anticipate bispecific antibodies and ADCs will shift lymphoma standard of care more generally as they advance into earlier treatment lines? And I guess, specifically, how does EPKINLY fit within that?

Jan van de Winkel

Executives
#6

I mean, EPKINLY, it's optimally positioned as they're super, super potent. I mean -- and it gets better when you combine it with other agents actually multiple other agents that is actually not requiring hospitalization. And you can inject it in the 1, 2 second injection. So which is a real advantage if you think about combinations with small molecule drugs, which will certainly be positioned in the future to take over from chemotherapy because I think that's what really both patients and doctors want to get away from in the coming years. So EPKINLY has absolutely the potential to become the backbone therapy for new combinations and for B-cell cancers and potentially beyond when it moves into other areas.

Judah Frommer

Analysts
#7

Okay. Great. And maybe if we move to Rina-S, your ADC, how do you view competitive positioning in platinum-resistant ovarian cancer, endometrial cancer especially against ADC competitors that may be further advanced in development, kind of, I guess, Rina-S specifically, but then within the broader ADC landscape.

Jan van de Winkel

Executives
#8

I mean Rina-S has a unique linker technology and a DAR of 8, so 8 Payloads per antibody molecule, without change in the PK/PD. So the net-net is that you can actually get very potent killing even of cells with very low levels of expression of folate receptor-alpha, we see that both in ovarian cancer as well as in endometrial cancer in different settings. There will be another data download at ESMO in October in Berlin of the endometrial cancer second-line plus data. And it is differentiated because it actually can actually hit tumors with very low levels of expression of folate receptor alpha that for very durable responses. So it is absolutely differentiated from the first generation of folate receptor alpha ADCs, which needed a very high expression and would only work in like 30% of the patients. So it can broaden the market and move out into other markets. We believe that this is -- this molecule has the potential to be an all-comers type drug for multiple cancers. So we're going to move our next into a non-small cell lung cancer, and we will do it this year. We have already treated some patients with non-small cell lung cancer in an earlier trial, which we took over from ProfoundBio. And so we are very excited about the potential to move into other cancers because there's actually a lot of cancers, which have folate receptor alpha overexpression, lower than in ovarian cancer, but it may not be that relevant for Rina-S. So we believe it's all about differentiation. Not all of these folate receptor alpha targeted ADCs are similar, identical. And I think it comes down to differentiation and [indiscernible] comes down to flawless execution. I mean remember that we only acquired ProfoundBio in May last year. And then now, 1.5 years later, we have not only accelerated it from Phase I/II into 1 Phase III, we will add 2 more Phase IIIs there between now and the end of the year, and we're planning multiple Phase IIIs for the coming years. So we are -- I think it comes down to a combination of doing the right trials and do them flawlessly and very rapidly because it's all down to execution in the end.

Judah Frommer

Analysts
#9

Okay. Great. And then maybe just getting back to platinum-resistant ovarian cancer and endometrial cancer. How can an accelerated pathway come together for relapse in those conditions?

Jan van de Winkel

Executives
#10

I mean, we're doing a Phase II trial in both second-line plus refractory ovarian cancer and endometrial cancer also second-line plus. We do a Phase II trial. This could be the basis for an accelerated approval. Remember, we got the first breakthrough therapy designation recently for second-line plus endometrial cancer. But we're also running Phase III trials. The Phase III trial for POC is already running and is expected to complete recruitment in '27. That's why we think that based on the Phase II data, we can get the drug on the market for second-line plus platinum-resistant ovarian cancer. And then for endometrial is exactly the same, but lagging a little bit behind. And the strategies in place. We got already a breakthrough therapy designation for based on the endometrial cell cancer data. And I think we have all figured out how to optimally position it very rapidly for the market. And we still believe that we can get it on the market in '27 in the ovarian cancer setting.

Judah Frommer

Analysts
#11

Okay. Great. And maybe just specifically on platinum-sensitive ovarian cancer, how does that opportunity compare to platinum resistant? What does competition look like in platinum-sensitive and why might Rina-S be well suited there?

Jan van de Winkel

Executives
#12

It's a different landscape. What we are going to do is do a Phase III where we either run it against observation or against the bevacizumab. So it's either bevacizumab plus Rina-S or bevacizumab or we run it against other patients against observation. And we will start a Phase III between now and the end of the year, that will add competition-wise, another 25,000 patients potentially as a market for Rina-S. So we're very excited about that potential. We are actually planning an additional Phase III for next year also in that setting. So we actually are going in multiple settings in both platinum-resistant as platinum-sensitive ovarian cancer because we believe there is really good market share there and an unmet medical need, which is the most important in the end. What we want to do is to provide better treatments for patients because that in the end, so I think drive to the success of the company. And also I think that's where the company is aiming for.

Judah Frommer

Analysts
#13

Okay. Great. And then you touched on it with what you're doing in lung, but in terms of expanding Rin a-S beyond ovarian and endometrial cancers, lung. I think breast is an indication. You talked about. How are you thinking about expanding into additional indications?

Jan van de Winkel

Executives
#14

So we're going to do some basket trials in the future. We are going to start with lung cancer, second-line plus lung cancer pretty soon. We start with different cohorts. One is the EGFR-mutated cohort, where we know there's a decent level of folate receptor alpha expressed, but we also test multiple other cohorts. And the same holds for other cancers, we would prefer you that to keep the CARs to a chest for this moment because it's a very competitive area, as you said, because folate receptor alpha is now, I think, clinically validated target. More and more companies are becoming interested and we all know about innovation in China. I mean this all molecule was actually originated in Suzhou in China, very quickly for validated targets with multiple companies coming up now. The innovation landscape is changing dramatically over the coming years. So I think we want to keep the CARs a bit longer to close to a chest for other cancer, but we see actually multiple tumors with folate receptor alpha expression levels, which are not a different from some of the expression levels we have witnessed in both ovarian cancer and in endometrial cancer, especially endometrial cancer tends to have lower levels of folate receptor alpha expressed in ovarian cancer. So we believe that they may actually be optimal for Rina-S to provide help and opportunity for patients there.

Judah Frommer

Analysts
#15

Okay. So maybe just taking a step back, it does seem like you said that other folate receptor alpha targeted agents are going to broaden their indications, I guess, how is Rina-S kind of maybe uniquely positioned from a molecule design perspective versus what you think those competing molecules could do?

Jan van de Winkel

Executives
#16

I mean the unique characteristics for Rina-S is that it has a very hydrophilic linker -- and the net-net is that you can attach hydrophobic payloads because that's what you want. You want actually toxic molecules attached to the antibody. When you do that with a regular linker, which is not hydrophilic, you change the PK/PD characteristics of the antibody. You get very short half-life, you get very strange clearance characteristics. And that is why they become toxic and also you cannot dose escalate them fast enough. And what happens to be with the linker and payload combination in Rina-S, you get very good bystander killing. So you kill other cells, which antigen negative, it's a folate receptor negative. in the vicinity of folate receptor positive cells without toxicity. It has a very clean safety profile, no ocular toxicity, no interstitial lung disease, which is seen with other folate receptor alpha targeted ADCs or other ADCs in general. So I think it has unique characteristics to be very, very effective. And what I can tell you, one of the charms of the ProfoundBio acquisition last year, that was the very first acquisition in 25 years for the company, but we brought in technology from another company that we can actually use their payload and linker technology also for other programs. And there are actually a number of programs now in preclinical development, several of which are slotted to go to the clinic pretty soon between now and end of next year for sure, under our leadership. So we think that we can actually use that same technology base for other antibody-drug conjugates and combine that with immuno-oncology antibodies, we have [indiscernible] as a very potent immune activator and also others like 1042, also an immune activator, both targeting CD40. But we actually have other molecules in our preclinical pipeline, which we think could actually be added to ADCs and actually together with ADCs provide new treatment paradigms for the future.

Judah Frommer

Analysts
#17

Okay. Maybe just turning back to EPKINLY for a minute. Can you give us kind of the latest thinking on your strategy for developing epithelial immunology and inflammatory disease indications?

Jan van de Winkel

Executives
#18

I mean EPKINLY is a good candidate, I think, for treatment of immune-mediated diseases. The depletion of B cells is, I think, a known mechanism of action in different autoimmune disorders, and we are discussing a potential use in that direction together with our partner AbbVie, which is, of course, an autoimmune specialized company. But you have to balance that with what we can do in the cancer area. I mean, for Genmab, I can tell you, we have actually a number of I&I applications preclinically. Some we are working on a bit with argenx as our partner, these are like 50-50 partnerships and some we are doing 100% ourselves. But we are actually experiencing that it takes longer to develop the molecules for an I&I indication because you need more safety data, more extensive tox data. And we will definitely -- we definitely believe that some of these approaches will be valuable in the future for treatment of patients. But I think the majority of the activities for Genmab will for the coming years, be focused on cancer because we have a track record there despite knowing Judah that some of our molecules work really, really well. For example, [indiscernible]. You're aware of that molecule is a CD20 antibody, which we originally developed in the early 2000s and part of the GSK in 2006 for the treatment of CLL is actually a far better medicine for relapsing MS. I mean, Novartis is doing a fantastic job there. It's the fastest-growing drug for relapsing MS. And that actually in the last quarter had over $1 billion in sales for Novartis. So we believe that actually molecules, which are specifically targeted for cancer treatment can actually work really, really well in the right autoimmune disease. We have a second example, as you know, with TEPEZZA, which is now part of Amgen after the acquisition of Horizon Therapeutics. And that molecule was originally developed for in a Roche partnership in 2003, I was overseeing the preclinical development at that time for that molecule. And it works, I think I can tell you it works actually really well in some cancers. But despite that Roche, deprioritize it, hands it over to a group of venture capitalists. They do one trail in Graves' eye disease or thyroid eye disease. It's spectacular data and FDA breakthrough therapy designation on a New England Journal paper offer it back to Roche, this is all in the public domain. Roche says no, because they didn't believe that there was a good market for that molecule for the reason that there's never been a molecule developed in the United States, a medicine for treatment of thyroid eye disease. And guess what? The Horizon brings it to the market in the first year, which was not even a full year, $850 million sales next year, $1.6 billion. And the next one they didn't even make that because Amgen then bought Horizon for $28 billion. So yes, we know that our molecules can actually work very, very good, in other indications. But realistically, I think Genmab is a company with most of its expertise in oncology. So we will probably focus on that more in the future, but we will probably make available our technology for companies who can develop antibody-based medicines in other areas. Another good example is Mim8 for Novo Nordisk for hemophilia. That is a molecule Novo Nordisk created with our help and our technology, our DuoBody technology platform against Factor XI and XII. And that is for treatment of hemophilia. And we found one molecule out of over 30,000 molecules, which is 15-fold better than HEMLIBRA in their preclinical evaluation. And that has been, I think, filed this year also for regulatory approval. So that could be another molecule, which is based on the Genmab technology, which could actually work really well for treatment of another disease, which is an important disease hemophilia.

Judah Frommer

Analysts
#19

Okay. Now that's a good overview of kind of how you're thinking about strategically approaching the market. So I guess with the focus on oncology, specifically for EPKINLY. We do get questions on adoption in the community versus academic settings. I guess, given the advantage of no required hospitalization with EPKINLY. How are you thinking about commercialization across those settings?

Jan van de Winkel

Executives
#20

We are definitely very, very actively interested in moving out from the academic hospitals and from the cancer hospitals into the community health care centers because it's such an important area of treatment in this country, which is the biggest market, as we both know, for a molecule like EPKINLY. This has the unique characteristics. It is a very, very effective medicine. It has a very clean safety profile. It can easily be combined with other molecules. And of course, right now, it's only on the market in third line plus diffuse large B-cell lymphoma and follicular lymphoma, but it is one molecule for both of these indications, which is unique positive for smaller health care centers because they don't want to think, well, is this patient a follicular lymphoma patient or has it already -- has the tumor already changed into a more aggressive diffuse large B-cell lymphoma direction because then you need to use a different molecule for our company. So this is much more straightforward. That is a 2-second injection under the skin with patients like -- doctors like. So I think we get more and more visibility and traction now in the community health care centers. Our commercial teams have really set up a very good structure of engaging with these health care centers. And I think with now the molecule moving more to earlier lines of therapy because remember, that is how most of the patients want to be treated in community health care centers. It's very early after their diagnosis. They have a real preference of being treated in their community health care center close by their home and not travel like 3 hours to a cancer hospital with a plane or by CAR. And so I think we have a molecule uniquely positioned to do really, really well, especially in earlier lines of treatment. I mean we now have the Phase III data in second-line follicular lymphoma. We still have a front-line follicular lymphoma trial also together with [indiscernible] clear recruiting as we speak. So we cannot give you a time estimate there. But the most important, I think, is the front-line diffuse large B-cell lymphoma Phase III, which should read out between now and end of next year, hopefully sooner based on the event rate building up quickly. So I think that could be an ideal combination, I think, for -- when you have front-line diffuse large B-cell lymphoma, second-line, third-line plus, then it becomes really attractive, I think, to position EPKINY optimally in the community health care center. And I think it has all the characteristics of what I understand from our commercial team. The feedback is very, very positive and gets more and more momentum. I think upcoming ASH data will be important because of the nearly 30, I think, abstracts that we have submitted, we have not yet heard back. But what we know now over some years is that most of the abstracts submitted based on EPKINLY are selected for presentation by the hematology community. So we have good hopes that we have actually have a good exposure at ASH this year in December. But I think important is that we can actually get the label in the front-line and second-line setting.

Anthony Pagano

Executives
#21

Yes. Maybe just to add on a little bit as we think about the actual performance we've seen so far, and that provides a really strong foundation. I think about $211 million in global sales in H1 competing very effectively against the incumbent. And that didn't happen by accident that we had years of planning, that was years of investment. As we thought about approaching the launch of EPKINLY in May of 2023 in the United States and then subsequently in Japan, these are the markets where we're leading. We spent a lot of time thinking about this is the first time to really launch Genmab into the marketplace and a chance to launch EPKINLY. And as we did that, we had an eye that EPKINLY was not going to always be a late-line product. Ultimately, would get into earlier lines. This could be a multi-billion-dollar opportunity as well, we're competing against fierce competition. So this was resourced accordingly from day 1. And as you can see, so far, the execution has been rather strong, I would say. And I think it provides a really strong platform for additional launches for EPKINLY moving forward. But the overall, let's say, commercialization capabilities of that platform will also serve us very well for Rina-S. Now very specifically to your question around the community setting as this is more relevant as you get into earlier line, just to remind everybody, we did recently announce some data in the outpatient setting, very encouraging data showing that it could be -- the patients could be treated the first full dose on outside of the hospital. I think the results speak for themselves. And there importantly, a large part of that trial was actually conducted in the community. So I think that was another way to sort of demonstrate not only sort of in theory, can you do this in an academic center, but in practice, yes, you can give patients the first full dose in the community setting. So we're very pleased with, let's say, the overall performance so far, but also the prospects moving forward.

Judah Frommer

Analysts
#22

Okay. Great. Maybe that's a good way to kind of move into some sort of strategy and capital allocation question. So maybe can you just set the stage, I guess, from your perspective in terms of where the company sits from a strategy standpoint? How do you plan on allocating capital in the relative near term, maybe over the next couple of years? And how has that changed versus maybe 5 years ago?

Anthony Pagano

Executives
#23

So look, our capital allocation strategy is super clear and is 100% aligned with our strategy. Number 1 is investing back in our business, more specifically, prioritizing our late-stage programs, particularly EPKINLY, Rina-S and [indiscernible]. You're all aware of the Phase III work ongoing for those programs. I think if I think about those programs, they also have characteristics where we could potentially do more than the existing Phase III work. So certainly, we're looking to do more with those Phase III programs. As it relates to R&D, no one should take what I said that we we've stopped thinking about innovation. Innovation in our early-stage research and discovery preclinical Phase I/II work remains fully on track and is a big focus. And here, I think Jan and I and the team fully expect that one or more programs out of this research and discovery engine will progress to mid- to late stage here and hopefully not the not-too-distant future. So number one, that's sort of our priorities around R&D. Certainly, we're very excited about the prospects for our existing products and more to come. Likewise, in our commercialization capabilities, we're absolutely focused on realizing scale benefits based upon the investments we've made, but we're not going to shy away from investments that are going to generate incremental revenue, incremental profit. So we'll think very carefully as the market opportunities expand for EPKINLY as we bring Rina-S to market, we'll at the same time, be focused on realizing scale benefits, but we're not going to shy away from making the required investments to position our products for success. So that's in terms of number one, investing back into our business. Number two is looking outside the 4 walls of Genmab. Here, we've demonstrated that we can do this rather effectively. Post the ProfoundBio acquisition, the first priority was integrating that. I think we can all agree that's gone rather well. We're going to exit this year with 3 ongoing Phase IIIs and 2 registrational Phase IIs. Moving forward, of course, you would expect us to continue to look for opportunities. We're doing that. But you shouldn't think that we're going to be chasing deals. If the right deal crosses our desk, we'll certainly pursue it, but we'll have to kind of wait and see. Last but not least, really is if -- once you go through items #1 and 2, in terms of investing back in our business, considering external opportunities, we can think about potentially returning capital to shareholders. So that is #3 as we speak here. So that's, I think, very clearly our capital allocation strategy, and it sort of aligns with our overall business strategy.

Judah Frommer

Analysts
#24

When we think about potential external deals or business development externally, are there sizes that you've guided folks towards? Or is it a fairly wide array?

Anthony Pagano

Executives
#25

We're focused on looking at the right product where we can be very good evaluators, right? Can we apply the expertise and the capabilities that we've built up over time to really evaluate what it is we're looking at and then transition to if we execute, be very good owner. So that's the primary lens. Then you get into kind of a value and price discussion. That's a function of the product opportunity, where it is in development and the cash flow sort of profile. So for now, we've not gotten into discussion around size.

Judah Frommer

Analysts
#26

Got it. Okay. Super helpful. And then maybe just one last one company specific. Anything we didn't talk about that you'd want to highlight to investors or maybe folks that are newer to the story.

Jan van de Winkel

Executives
#27

I think we covered it quite nicely. I mean there's a big focus on the commercial programs. And also what we didn't cover yet is moving also into Europe with TIVDAK. I mean it has been approved in Japan and in Europe. And I can tell you this launch now in both territories, but we do this in a stepwise gradual way and also to make ourselves ready in '27 for launches of [indiscernible] following very closely the offer. So we're building more momentum, but we all do that in a strategic and very stepped-up type manner, which I think is the right way, Judah, to really build the company to the next level. We also hired in Rayne Waller a year ago with over 26 years of experience at Amgen for supply chain management and technical operations because we now need to think about how to actually produce these materials in different continents in the future. And we never had to do that because it was always the partner who actually took the heavy lifting, either AbbVie or Pfizer for the 2 commercial products. But I think they are also building up our expertise and stronghold to really be very effective. And of course, the world is changing. There's a lot of geopolitical dynamics factored in there. So I think it's important to have people like Rayne on board now to really set us up for success in the future. So we're building a stronger and stronger team. Coming back to the ProfoundBio acquisition, what Anthony already has summarized really, really nicely. We are very proud that over 90%, 9-0, of the team members associated with ProfoundBio are now integrated in Genmab. So we're actually quite good in integrating a new entity into the Genmab team. And that also, I think, bodes well for if we will do that again, I think the market can be assured that we will focus on that and then effectively execute and do this all in a very rational way.

Judah Frommer

Analysts
#28

Okay. Great. And I'm going to move now into sort of a mini survey that we're asking all of our management team. If anyone in the audience has a question, just raise your hand and we'll get your microphone. So biotech seems to be more exposed to external and macro factors of late. So we're asking each of our management teams 3 related questions. The first, and you touched on it a little bit, Jan. With China's rise in biotech innovation, how are you thinking about your competitive position here will this influence your R&D or business development strategy in any way?

Jan van de Winkel

Executives
#29

Very clearly, we think that the world is changing. Innovation ecosystems are changing. We are very pleased with having 2 sites actually, one in Suzhou and one in Shanghai, which both came in via the acquisition of ProfoundBio. So we have more or less a foothold in the Chinese innovation landscape. And when I read, I think some of your analyst reports that in 2040, 35% of the predicted FDA approvals come from China with science based on happening in China. I think it's very good for an innovative biotech company like Genmab, which is an international company to have a foothold in that ecosystem. So we're very, very actively watching the field. We will do this in a very careful strategically sound manner if we would strike. But we're also aware that a number of oncology opportunities have been sourced from China. So I think the world is changing, and I think we -- it's good for us to be represented there. We're very excited about our side there. And we believe that this is the right move because the world is actually moving into a new level at this moment.

Judah Frommer

Analysts
#30

Okay. And the second theme is AI. How are you currently leveraging AI or thinking about the potential for AI to disrupt the biotech space? Positively or negatively?

Jan van de Winkel

Executives
#31

I mean at Genmab, we have a very, very proactive view on AI, use it in all parts of our business in a very integrated manner. I think we have literally over 1,000 ChatGPT company version, which is a closed version, which we are using basically as an extra tool. But we use it in discovery and development. We actually are working on in silico generation of antibody medicines. It's not ready for prime time, Judah, but we are definitely investing in that quite a lot. We also look at clinical trials. Can we actually do the trials in centers. It's a pre-scheme so that they are actually the heavy recruiting centers so we can actually learn more and may take medicines more rapidly through that development stage. To commercial, we're actually combining information sets from different databases in a clever way. So we know exactly in which hospital patients are going to show up, which are eligible to potential treatment with our medicines. So we're using AI and digital technology all over. I think it will fundamentally disrupt the way we do business between now and 5 years from now. Our goal is Judah, that we actually can bring medicines much more quickly to patients than we can do right now. I think the company is well set up to be quick already. I mean EPKINLY went literally in less than 5.5 years from the first injection in the first patient to a U.S. market approval, which is, I think, a world record for an antibody-based medicine. But we think we can speed that up even by using AI technology in a more proactive way in the future. And we have actually had a very, very senior data science expert from Amgen [indiscernible] who's overseeing all of our data, digital and AI work at Genmab, but it's a pretty sizable team, I can tell you.

Judah Frommer

Analysts
#32

Okay. Great. And the last topic is just the regulatory side of things. I guess, what would you characterize as being most impactful from the regulatory side? And what's keeping you up at night these days, changes at FDA [indiscernible] pricing debates, tariffs, anything you can think about on the regulatory side?

Jan van de Winkel

Executives
#33

I mean none of these are keeping me awake at night luckily, and there's not a lot I can tell you which keep me up at night. But, which we follow the landscape like really, really closely. We have a geopolitical dynamics task force, which meets on a weekly basis. We get updates and the Board gets updates on a weekly basis on what is changing. I mean this is a very fluid situation. I mean nothing is concrete. We think that right now, the way we are organized, Judah, we are not impacted significantly this year for sure, by either of these changes. But with the new U.S. administration, that may change in the future. But then what we need to do as a company is very actively react and proactively react on potential changes in dynamics. Right now, limited impact, I would say, on our business. And also that is also attributable to, for example, EPKINLY that actually the drug is produced in the United States. Right now that is a big market by our partner, AbbVie. And so I think we are well protected up to now, but that may change, for example, with Rina-S. Right now, we have a supply chain from Asia, but we are now, of course, setting up other supply chains as we speak. I already spoke about technical operations because we need that in the future. And I think we need to anticipate, I think, changes. But up to now, we are relatively relaxed about it.

Judah Frommer

Analysts
#34

Okay. Great. That was a great overview. If there are no questions in the audience. I think we're just about of time. So thank you again for participating.

Jan van de Winkel

Executives
#35

Thank you for having us here, and have a good day, everybody.

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