Genmab A/S Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jonathan Chang - Leerink Partners - Analyst : Can you discuss your reasons for confidence in the endometrial cancer opportunity for Rina-S and for committing to a Phase III second line plus endometrial cancer study by year-end.

Question: Asthika Goonewardene - Truist Securities - Analyst : Just very quick to follow up on EPKINLY, $281 million in the first full year of launch is very commendable. Just want to jump into the market dynamics in the second half. I wanted to see if there was something funky about Q4, given that it was kind of flat on Q3, if there's anything unusual you'd point to? And then if I can ask, on acasunlimab, I like that you're putting peak sales number here for the key pipeline assets, over 136,000 potential treatable patients with acasunlimab the $1 billion in peak sales teams a little bit light compared to the others that you provided. Can you tell us a little bit about what goes into as mentioned, is that something to do with the longer treatment interval for six weeks versus three weeks? Or is there something else that you're anticipating with acasunlimab.

Question: Asthika Goonewardene - Truist Securities - Analyst : Yeah. The only thing to add is, as you know, we preselect for PD-L1 positive. So this came into account on the assessment of the market opportunity.

Question: Yifeng Liu - HSBC - Analyst : Maybe I have one follow-up on acasunlimab. So in 2095 the Phase II data update, what are we expecting to see in the data in the presentation? And then what sort of roughly the timing of that presentation? And secondly, on EPKINLY second line and transplant eligible. So you've launched a DLBCL 4 trial last year. And could you maybe talk a little bit about the proposition for that setting against the DLBCL 1?

Question: Yifeng Liu - HSBC - Analyst : Yes. So thank you for the question. As you know, we presented the first couple of Meyer's curve on overall survival last year at ASCO we saw very interesting durability. elevate the curves were not with enough maturity or with more maturity, we expect to stay the same stream and this is what we will present later this year. So basically, durability of the time to event endpoint, mainly or ¡

Question: Xian Deng - UBS - Analyst : Just one on time, please. Just wondering, you mentioned the frontline DLBCL trial could be -- could have readout by the end of 2026. Just wondering if you have a readout by end of 2026, do you think you will have two year or three year follow-up at that time -- and that time -- that follow-up time frame, do you think that's actually enough to allow FDA to give a decision without being out for longer follow-up just considering the previous precedent?

Question: Yaron Werber - TD Cowen - Analyst : Great. So maybe just, Tahi, just a follow-up. The -- should we assume that the second line follicular and second-line DLBCL, that data by year-end '26, is that filable, assuming positive as well, so you can follow both first and second line? Or do you need more data from second line? And then just secondly, on Tivdak. So it sounds like from now on, you're going to be the lead commercialization party and you will book sales in the US, Europe and Japan? And how do we model that? Like how do we -- is there a royalty, I assume, back to Pfizer? And congrats on getting that.

Question: Yaron Werber - TD Cowen - Analyst : Yeah. Just -- thank you. And again, we are excited about the opportunity as it provides us the opportunity to expand our commercialization footprint. But the terms of the agreement, as mentioned earlier, remain that US and China are as is where Pfizer is actually still lead party in both of those areas as we're still promoting here in the US. and in Europe. -- and rest of world, including Japan, we will be the lead party at that point, and there will be a low double-digit royalties involved as per the contract that we've already set up. But it's -- just as a reminder, US and China remain the same.

Question: Matthew Phipps - William Blair & Company - Analyst : Are you guys able to disclose if you're going to use a folate receptor alpha expression cutoff for the endometrial cancer Phase III? And then on EPKINLY, given, I don't know, maybe half a year of launch, maybe a little more on that in follicular lymphoma at this point. Do you see any broader utilization in follicular, given no need for hospitalization. Just wondering if that is helping get into community settings and if you think that will be a continuing trend?

Question: Qize Ding - Redburn Atlantic - Analyst : Just one quick question on the Rina-S because you just mentioned about your clinical development plan in ovarian cancer, endometrial cancer. I'm just wondering -- what is your clinical development plan for other solid tumor indications such as lung and breast.

Question: Justin Smith - Bernstein - Analyst : I've got two. First one, just on Dara, if you wanted to possibly share any thoughts about the potential impact from the potential relaunch of Blenrep this year? And then the second one, just on the buyback, I'm sorry if I'm thinking about things the wrong way. But just trying to understand why you've announced that now I'm not waiting until after the HexaBody decision from J&J? Just -- is it a case of interesting assets out there? Or just any thoughts on why the buyback timing now?

Question: Vikram Purohit - Morgan Stanley - Analyst : Great. We had one on BD as a follow-up to the last question and then one on guidance. So on BD, I mean, given you noted 2025 is a heavy execution year for the pipeline. I just wanted to see how strong of the priority external BD and M&A could be for the year? And if you decided to go that route, what is the profile of the assets you'd find most interesting and attractive to kind of bring into the pipeline where it stands now? And then secondly, on guidance. I was just wondering if you could provide a bit more color about what the drivers are for the bookends for the revenue, gross profit and OpEx guidance that you outlined for the year.

Question: Rajan Sharma - Goldman Sachs - Analyst : So I was just wondering if we could get an update on GEN1042, I know this slide said that there's going to be a decision in 2025. but it's obviously been a decision that's been pending for some time. So just interested in understanding what you're still trying to establish here. And if we could just get a little bit more clarity on the timing? Is that likely to be first half or second half of the year? And just one for Anthony on clarification on the guidance. Is there anything assumed in guidance for 1042 development? And then a very quick one to wrap up. You previously talked about potential developments in immunology and inflammatory disease either through your own internal pipeline or through external sources. Could you just kind of talk to your latest thoughts there and appetite both from an internal and external perspective.