Genmab A/S (CPH:GMAB)
Denmark flag Denmark · Delayed Price · Currency is DKK
1,707.00
-4.00 (-0.23%)
Apr 27, 2026, 4:59 PM CET
← View all transcripts

Morgan Stanley 23rd Annual Global Healthcare Conference

Sep 9, 2025

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Good morning, everyone. Welcome to this session of the Morgan Stanley Global Healthcare Conference, Day 2. Let me read a quick disclosure before we get started with Genmab here. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. 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 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
Co-Founder, President & CEO, Genmab

Absolutely. In all of our 25-year history, we've focused on differentiated antibody therapeutics that we could track record, as you know, eight of the approved antibody therapeutics that are based on our science on the market. Two of them we commercialize ourselves, Tivdak and EPKINLY. EPKINLY is a late-stage program now in multiple phase III clinical trials. Add to that RINASCE and Akasunimab, which also are moving into more and more late-stage clinical trials. They will actually make sure that we will grow into the future. Of course, we are also trying to look at the external world for opportunities. They are likely to perform to buyer and also from our own pipeline. We actually intend to add more products through it to actually drive sustainable growth for the coming decades.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. Maybe if we start with the ongoing phase III trial for your CD3xCD20 bispecific EPKINLY in first-line DLBCL. How has the trial been progressing? What do you see as the benchmarks or outcomes for a strong commercial launch in the front-line setting in DLBCL?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

The trial is completely recruited, actually very far ahead of schedule, and we expect it to read out the final at the end of next year. Very near-term. 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 markets from line diffuse large B-cell lymphoma, as you now look at the landscape. We're very excited about the potential of that trial to read out quickly. 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 and moving to top-line results. We submitted that data for ASH. I think they're going to give me a new microphone because they're unhappy with my microphone.

I apologize for that. Now, should I start all over again?

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

No, we heard everything you said.

Jan van de Winkel
Co-Founder, President & CEO, Genmab

Second-line follicular lymphoma trial has fantastic data, as you have seen, with a hazard ratio of 0.21. It's a 79% lower risk of disease progression or that that has simply never been seen. EPKINLY is doing really, really well. 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, Judith. We are very excited about the potential of EPKINLY. We are going to further broaden it. We submitted nearly 30 abstracts to ASH this year, including the follicular lymphoma second-line pivotal data.

Many of them are novel combinations, basically either tried by Genmab together with EPKINLY in our collaboration or investigator-initiated studies because one of the real advantages of EPKINLY is it's not only super effective, it has a very clean safety profile. You don't need hospitalization, and it is easily combinable with other medicines. That is exactly what doctors want to see for the next phase of treatment of B-cell cancer. We are very excited about EPKINLY. It's doing actually, it's better than what we anticipated, actually.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

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 we advance into earlier treatment lines? I guess specifically, how does EPKINLY fit within that?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

I mean, EPKINLY is optimally positioned in that it's super, super potent. I mean, it gets better when you combine it with other agents, actually multiple other agents. It is actually not requiring hospitalization, and you can inject it in the one-to-two-second injection, 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. EPKINLY has absolutely the potential to become the backbone therapy for new combinations and for B-cell cancers and potentially beyond, as it moves into other areas.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. Maybe if we move to RINASCE, your ADC, how do you view competitive positioning in platinum-resistant ovarian cancer and endometrial cancer, especially against the ADC competitors that may be further advanced in development? Kind of, you know, I guess RINASCE specifically, but then within the broader ADC landscape.

Jan van de Winkel
Co-Founder, President & CEO, Genmab

I mean, RINASCE has a unique linker technology and a drug-to-antibody ratio of eight, so eight payloads per antibody molecule without changing the PKPD. They're not nothing, but you can actually get very potent killing, yeah, 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'll be another data download at ESMO in October in Berlin of the endometrial cancer second-line plus data. It is differentiated because it actually can hit tumors with very low levels of overexpression of folate receptor alpha for very durable responses. 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. It can broaden the market and move out into other markets.

We believe that this molecule has the potential to be an all-comer type drug for multiple cancers. We're going to move next into non-small cell lung cancer, and we'll do it this year. We've already treated some patients with non-small cell lung cancer in an earlier trial that we took over from Profound Bio. We're very excited about the potential to move into other cancers because that'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 RINASCE as we believe. It's all about differentiation. Not all of these folate receptor alpha targeted ADCs are similar or identical. I think it comes down to differentiation. Judah, it comes down to flawless execution. Remember that we only acquired Profound Bio in May last year.

Now, one and a half years later, we have not only accelerated it from phase one two into one phase three, you will add two more phase threes there between now and the end of the year. We're planning multiple phase threes for the coming year. I think it comes down to a combination of doing the right trials and doing them flawlessly and very rapidly because it's all down to execution in the end.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. Maybe just getting back to platinum-resistant ovarian cancer and endometrial cancer, how can an accelerated pathway come together for RINASCE in those conditions?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

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. We're also running phase III trials. The phase III trial for POC is already running and is expected to complete recruitment in 2027. That's where 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. For endometrial, it's exactly the same, but lagging a little bit behind. The strategy is in place. We got already a breakthrough therapy designation based on the endometrial cancer data. I think we have it all figured out how to optimally position it very rapidly for the market.

We still believe that we can get it on the market in 2027 in the ovarian cancer setting.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. 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 RINASCE be well-suited there?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

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 bevacizumab. It's either bevacizumab plus RINASCE or bevacizumab, or we run it against other patients against observation. We will start a phase III between now and the end of the year that will add, competition-wise, another 25,000 patients potentially at the market for RINASCE. We're very excited about that potential. We are actually planning an additional phase III for next year, also in that setting. 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 a 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 will, I think, drive the success of the company. I think that's what the company is aiming for.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. You touched on with what you're doing in lung, but in terms of expanding RINASCE beyond ovarian and endometrial cancers, lung, I think breast is an indication you've talked about. How are you thinking about expanding into additional indications?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

We are 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. We also test multiple other cohorts. The same holds for other cancers. We would prefer, Judith, to keep the cash storage just for this moment because it's a very competitive area, as you said, because folate receptor alpha is now, I think, a clinically validated target. More and more companies are becoming interested. We all know about innovation in China. This whole 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.

I think we want to keep the cash a bit longer close to our chest for other cancers. We see actually multiple tumors with folate receptor alpha expression levels, which are not 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 than ovarian cancer. We believe that they may actually be optimal for RINASCE to provide help and an opportunity for patients there.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, 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 RINASCE kind of maybe uniquely positioned from a molecule design perspective versus what you think those competing molecules could do?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

I mean, the unique characteristics for RINASCE, as I said, it has a very hydrophilic linker. The nut is that you can attach hydrophobic payloads because that's what you want. You want actually toxic molecules attached to the antibody. You do that with a regular linker, which is not hydrophilic. You change the PKPD characteristics of the antibody. You get very short half-lives. They get very strange clearance characteristics. That is why they become toxic. Also, you cannot dose escalate them fast enough. What happens to be with the linker and payload combination in RINASCE is you get very good bystander killing. You kill other cells with antigen negative, with a folate receptor negative, in a 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. I think it has unique characteristics to be very, very effective. What I can tell you, one of the charms of the Profound Bio acquisition last year, Judah, that was the very first acquisition in 25 years for the company. We brought in technology from another company so that we can actually use their payload and linker technology also for other programs. 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 the end of next year for sure, under our leadership. 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 Akasunimab as a very potent immune activator and also others like 1042, also an immune activator, both targeting CD40. 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.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

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

Jan van de Winkel
Co-Founder, President & CEO, Genmab

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 now of action in different autoimmune disorders. We are discussing a potential use in that direction together with a partner, Epfi, which is, of course, an autoimmune specialized company. We have to balance that with what we can do in the cancer area. I mean, for Genmab, I can tell you, Judith, we have actually a number of INI applications preclinically. Some we are working on with Algenix as our partner, and these are like 50-50 partnerships. Some we are doing 100% ourselves. We are actually experiencing that it takes longer to develop molecules for an INI indication because you need more safety data, more extensive tox data.

We definitely believe that some of these approaches will be valuable in the future for treatment of patients. 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, Judith, that some of our molecules work really, really well. For example, Kesimpta, you're aware of that molecule. It's a CD20 antibody which we originally developed in the early 2000s and part of the GSK in 2006 for the treatment of CLL. It's actually a far better medicine for relapsing MS. I mean, Novartis is doing a fantastic job there. It's the fastest growing drug now for relapsing MS. It actually, in the last quarter, had over $1 billion in sales for Novartis.

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. That molecule was originally developed in a Roche partnership in 2003. I was overseeing the preclinical development at that time for that molecule. It works. I think I can tell you it works actually really well in some cancers. Despite that, Roche deprioritizes it, hands it over to a group of venture capitalists. They do one trial in Graves' eye disease or thyroid eye disease with spectacular data and FDA breakthrough therapy designation in the 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 U.S., a medicine for treatment of thyroid eye disease. Guess what? 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. The next one, they didn't even make that because Amgen then bought Horizon for $28 billion. Yes, we know that our molecules can actually work very, very good in other indications. Realistically, I think Genmab is a company with most of its expertise in oncology. 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 Myn8 for NovoNova for hemophilia.

That is a molecule NovoNova has created with our help and our technology, our dual body technology platform against factor 11 and 12. That is for treatment of hemophilia. They found one molecule out of over 30,000 molecules. It's a 15-fold better than MYLIBRA in their preclinical evaluation. That has been, I think, filed this year also for a regulatory approval. That could be another molecule which is based on the Genmab technology. This could actually work really well for treatment of another disease, which is an important disease, hemophilia.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay. Now that's a good overview of how you're thinking about strategically approaching the market. 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
Co-Founder, President & CEO, Genmab

We are definitely very, very actively interested in moving out from the academic hospitals and from the cancer hospitals into the community healthcare centers because it's such an important area of treatment in this country, which is the biggest market, as you 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. Of course, right now, it's only on the market with third-line plus diffuse large B-cell lymphoma and follicular lymphoma.

It is one molecule for both of these indications, which is a unique positive for smaller healthcare centers because they don't want to think, well, is this patient a follicular lymphoma patient or 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 other contexts. This is much more straightforward. It is a two-second injection under the skin, which patients like, doctors like. I think we get more and more visibility and traction now in the community healthcare centers. Our commercial teams have really set up a very good structure of engaging with these healthcare centers. 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 healthcare centers. It's very early after their diagnosis.

They have a real preference of being treated in their community healthcare center close by their home and not travel like three hours to a cancer hospital with a plane or by car. I think we have a molecule uniquely positioned to do really, really well, especially in earlier lines of treatments. 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 ASHCLARE recruiting as we speak. We cannot give you a time estimate there. 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 developed building up quickly.

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 EPKINLY optimally in the community healthcare center. I think it has all the characteristics that I understand from our commercial team. The feedback is very, very positive and gets more and more momentum. I think upcoming ASH, Judith, will be important because of the nearly 30, I think, abstracts that we have submitted. We have not yet heard back. What we know now for some years is that most of the abstracts submitted based on EPKINLY are selected for presentation by the hematology community. We have good hopes that we actually have a good exposure at ASH this year in December. I think important is that we can actually get a label in the front-line and second-line setting.

Anthony Pagano
EVP & CFO, Genmab

Yeah, maybe just to add on a little bit, as we think about the actual performance we've seen so far, that provides a really strong foundation. I think about $211 million in global sales in H1 competing very effectively against the incumbent. That didn't happen by accident. That was years of planning. That was years of investment. As we thought about approaching the launch of EPKINLY in May of 2023 in the U.S. and then subsequently in Japan, these are the markets where we're leading. We spent a lot of time thinking about this as the first time to really launch Genmab into the marketplace and the chance to launch EPKINLY. As we did that, we had an eye that EPKINLY was not going to always be a late-line product. Ultimately, we get into earlier lines. This could be a multi-billion dollar opportunity. We're competing against fierce competition.

This was resourced accordingly from day one. As you can see, so far, the execution has been rather strong, I would say. I think it provides a really strong platform for additional launches for EPKINLY moving forward. The overall, let's say, commercialization capability of that platform will also serve us very well for RINASCE. Now, very specifically to your question around the community setting, this is more relevant as you get into earlier lines. Just to remind everybody, we did recently announce some data in the outpatient setting, very encouraging data showing that the patients could be treated the first full dose outside of the hospital. I think the results speak for themselves. Importantly, a large part of that trial was actually conducted in the community.

That was another way to sort of demonstrate not only 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. We're very pleased with, let's say, the overall performance so far, but also the prospects moving forward.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. Maybe that's a good way to kind of move into some sort of strategy and capital allocation question. 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 five years ago?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

Our capital allocation strategy is super clear and is 100% aligned with our strategy. Number one is investing back in our business, more specifically prioritizing our late-stage programs, particularly EPKINLY, RINASCE, and Akasunimab. You're all aware of the phase III work ongoing for those programs. If I think about those programs, they also have characteristics where we could potentially do more than the existing phase III work. Certainly, we're looking to do more with those phase III programs. As it relates to R&D, no one should take what I've said that 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. 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 in the not-too-distant future.

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. We're not going to shy away from investments that are going to generate incremental revenue, incremental profit. We'll take it very carefully as the market opportunities expand for EPKINLY. As we bring RINASCE 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. That's in terms of number one, investing back into our business. Number two is looking outside the four walls of Genmab. Here, we've demonstrated that we can do this rather effectively. Post the Profound Bio 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 three ongoing phase IIIs and two registrational phase IIs. Moving forward, of course, you would expect us to continue to look for opportunities. We're doing that. You shouldn't think that we're going to be chasing deals. If the right deal crosses our desk, we'll certainly pursue it. We'll have to kind of wait and see. Last but not least, if once you go through items number one and two, in terms of investing back in our business, considering external opportunities, we can think about potentially returning capital to shareholders. That is number three as we speak here. That's, I think, very clearly a capital allocation strategy, and it sort of aligns with our overall business strategy.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

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

Jan van de Winkel
Co-Founder, President & CEO, Genmab

I think we're focused on looking at the right product where we can be very good evaluators. We can really 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 owners. That's the primary lens. You get into a kind of a value and price discussion. That's a function of the product opportunity, where it is in development, and a cash flow sort of profile. For now, we've not gotten into the discussion around size.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Got it. Okay, super helpful. 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 this story?

Jan van de Winkel
Co-Founder, President & CEO, Genmab

No, I think we covered it quite nicely. I mean, there's a big focus on the commercial programs. Also, what we didn't cover yet is, you know, moving also into Europe with Tivdak. I mean, it has been approved in Japan and in Europe. I can tell you this launch now in both territories, but we do this in a stepwise, gradual way. Also, to make ourselves ready in 2027 for launches of RINASCE and Akasunimab, following very closely the offer. 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, Judith, to really build the company to the next level.

We also hired in Rein Wall 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. We never had to do that because it was always the partner who actually took the heavy lifting, either AbbVie or Pfizer, for the two commercial products. I think they're also building up expertise and stronghold to really be very effective. Of course, the world is changing with a lot of geopolitical dynamics factored in there. I think it's important to have people like Rein on board now to really set us up for success in the future. We're building a stronger and stronger team. Coming back to the Profound Bio acquisition, what Anthony already has summarized really, really nicely.

We are very proud that over 90% of the team members associated with Profound Bio are now integrated in Genmab. We're actually quite good in integrating a new entity into the Genmab team. That also, I think, bodes well for if we would 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.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. I'm going to move now into sort of a mini survey that we're asking all of our management teams. If anyone in the audience has a question, just raise your hand and we'll get you a microphone. Biotech seems to be more exposed to external and macro factors of late. We're asking each of our management teams three 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
Co-Founder, President & CEO, Genmab

No, very clearly, we think that the world is changing. Innovation ecosystems are changing. We are very pleased with having two sites, actually. One is Suzhou and one in Shanghai, which both came in via the acquisition of Profound Bio. We're more or less a foothold in the Chinese innovation landscape. I read, I think, some of your analysts' 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. We're very, very actively watching the field. We will do this in a very careful, strategically sound manner if we would strike. We're also aware that a number of oncology opportunities have been sourced from China.

I think the world is changing, and I think it's good for us to be represented there. We're very excited about our site there, and we believe that this is the right move because the world is actually moving into a new level at this moment.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. 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
Co-Founder, President & CEO, Genmab

I mean, at Genmab, we have a very, very proactive view on AI. We use it in all parts of our business in a very integrated manner. I think we have literally over a thousand ChatGPT company versions. This is a closed version that we are using basically as an extra tool. 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, Judith, 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 and take medicines more rapidly through that development stage to commercial. We're actually combining information sets from different databases in a clever way.

We know exactly in which hospital patients are going to show up, which are eligible to potential treatment with our medicines. We're using AI and digital technology all over. I think it will fundamentally disrupt the way we do business between now and five years from now. Our goal is, Judith, 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 five and a half 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. We think we can speed that up even by using AI technology in a more proactive way in the future.

We've actually hired a very, very senior data science expert from Amgen, again, Hesham Hamadeh, who's overseeing all of our data, digital, and AI work at Genmab. It's a pretty sizable team, I can tell you.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. 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, I met them pricing debates, tariffs, and anything you can think of on the regulatory side.

Jan van de Winkel
Co-Founder, President & CEO, Genmab

None of these are keeping me awake at night luckily. There's not a lot I can tell you that keeps me up at night. We follow the landscape 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. This is a very fluid situation. Nothing is concrete. We think that right now the way we organize, we are not impacted significantly this year for sure by either of these changes. With the new U.S. administration, that may change in the future. 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.

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. I think we are well protected up to now. That may change, for example, with RINASCE. Right now, we have a supply chain from Asia. 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. I think we need to anticipate changes. Up to now, we are relatively relaxed about it.

Vikram Purohit
Executive Director & Equity Analyst, Morgan Stanley

Okay, great. That was a great overview. If there are no questions from the audience, I think we're just about out of time. Thank you again for participating.

Jan van de Winkel
Co-Founder, President & CEO, Genmab

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

Powered by