Genmab A/S Corporate Call On HexaBody CD38 (GEN3014) Transcript

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

Question: James Gordon - JPMorgan - Analyst : The question, if I look at slide 5, which hopefully lays out the key late stage pipeline news flow, it's notable that there isn't anything listed for this year. So is that definitely the case, or say for EPKINLY in the first line trial, is there any chance that there could be an interim that means we could get some data ahead of next year, or is it definitely nothing until next year? And then the other part of the question would be would it -- if there isn't anything happening on the readout front, I know that doesn't mean there's not lots going on for you to be doing. With clarity on HexaBody now, could that mean there is a bit more urgency to do some more M&A, get some more late stage pipeline, because now you definitely do have a '29, '30 erosion to address or absolutely no change and it's fine that there is no readouts in the next 12 months?

Question: Yen-Der Li - LeeRink Partners - Analyst : This is Yen-Der Li on for Jonathan Chang. So we have a question about looking at the head to head data, there seem to be a higher adverse event and discontinuation for GEN3014 compared to DARZALEX. Could you share your take on why this is the case and can you discuss the potential implication of this data to the other HexaBody programs such as GEN1055?

Question: Xian Deng - UBS - Analyst : So two, please. Maybe the first one just to follow up on the previous questions. Other than the IV versus sub-Q difference, do you think this kind of tells you much about the HexaBody technology? Just wondering, do you think the fact that you have higher AEs, but then the ORR seem to be broadly comparable. Do you think that might, by any chance signals, I don't know, maybe higher potency, by any chance or any follow up HexaBody program needs to be extremely clean in terms of the targets? So any insights, that would be great. That's the first question. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 10, 2025 / 4:00PM, GMAB.CO - Genmab A/S Corporate Call On HexaBody CD38 (GEN3014) Second question is, just wondering, looking at your major Phase 3 trials, acasunlimab in second lung cancer, EPKINLY frontline DLBCL, and Rina-S in second line ovarian cancers. Just wondering if I were to ask you to force rank those three trials in terms of probability of success, just wondering, how do you view that?

Question: Asthika Goonewardene - Truist Securities - Analyst : Can I ask, will you provide -- did J&J provide any feedback on the reason for opting out? I mean when you look at the data that's presented, certainly the depth of response seemed to be favored in the GEN3014 arm. Was it more to do with overall response rate or was it the toxicity profile that made them want to back out? And then, Tahi, it sounds like from your comments that maybe the IV formulation may made it a little bit harder to balance the AEs or made it a little bit more pronounced. So does a subcutaneous version of the HexaBody product make sense? And then lastly, when do you plan on actually providing us with the data from this head to head study?

Question: Yifeng Liu - HSBC Bank Plc - Analyst : Just one clarification question. Since that I'm assuming that your agreement with J&J on HexaBody-CD38 is terminated, any chance you can -- this asset is still transferable? If that's the case and whether there's any sort of restriction being -- could be applied potentially coming from your agreement with J&J?

Question: Yifeng Liu - HSBC Bank Plc - Analyst : Just to clarify that, thanks very much, first of all. Even if you were to transfer it to licensing out, that sort of restrictions still apply. Am I correct in understanding that?

Question: Vikram Purohit - Morgan Stanley & Co. LLC - Analyst : So first on HexaBody-CD38, we were just curious. When you all made the decision to kind of cease internal development here, did that take into consideration the potential for the molecule and autoimmune conditions? And kind of when you think about the future for autoimmune development in your pipeline, is HexaBody-CD38 something that could resurface? And then secondly, we had a housekeeping question. Just wanted to make sure on timelines that acasunlimab Phase 2 data updated second line NSCLC that's still on track for this year. And then actually a final housekeeping question. I know that you mentioned that for 2025 guidance, there's no changes, but is there anything we should keep in mind on the OpEx side now that HexaBody-CD38 is being rolled back either for 2025 or 2026, anything that we should be mindful of?

Question: Matt Phipps - William Blair - Analyst : I realize you're not going to pursue these, but just wondering if you have data from the AML or DLBCL arms of the trial. And how that might -- if that looked in kind of differentiated versus any data that you had from? That's like historically. And then thinking about this program for the OX40 target, I'm just wondering, I guess you get clustering of the OX40 receptor, but do you not get depletion of OX40 positive T-cells from the enhanced complement pathway activation?

Question: Yaron Werber - Cowen - Analyst : I have a question actually on EPKINLY. So EPCORE DLBCL-1 has a primary survival and the EPCORE DLBCL-2 has primary of PFS, and it sounds like we're going to get data from both of them next year. So I guess my question, do you think we're going to have PFS data from both studies or for DLBCL-1, do you think you're going to hit survival already next year? And then for DLBCL-2, would you also have some survival data when you read out the PFS next year?

Question: Suzanne van Voorthuizen - Kempen & Co - Analyst : I was wondering, looking ahead into the 2030s. Can you elaborate how confident you are that your current assets and pipeline as is can make up for the DARZALEX cliff? And considering the different profit splits here and there, which assets do you see as the most valuable for Genmab by that time? And allow me also a follow-up for EPKINLY specifically. For the frontline and relapsed/refractory studies in DLBCL, how do you foresee the data from the Phase 3 trials to position EPKINLY in those treatment paradigms and to help further adoption there?

Question: Alistair Campbell - RBC Capital Markets, LLC - Analyst : Just a very brief follow-up, actually, just thinking about the HexaBody platform. So not just -- not CD38, but outside of CD38. I mean given the data you've seen from this trial, which is sort of indicates very good target engagement but a step-up in side effect as well. If you think about HexaBody as a platform outside of oncology, so in I&I, does this give you pause for thought or do you think it's actually simply about choosing the right target at the right dose?

Question: Qize Ding - Redburn Atlantic - Analyst : I only have one. So following today's news, am I right to assume that your level of confidence in your HexaBody technology platform remains unchanged going forward, right? And also what have you learned from the HexaBody-CD38 for the future development of other HexaBody pipeline assets?

Question: Rajan Sharma - Goldman Sachs International - Analyst : Just noting in the kind of the comments that you've made on the high bar set by dara in multiple myeloma. Could you just kind of talk to what this means for your future R&D focus outside of HexaBody-CD38? Is it fair to assume that myeloma may not be an area of focus for you going forward? Whether that's through the internal pipeline or external? If it's not -- that the case, what do you need to see in early stage trials to give you confidence that there is a benefit beyond dara and other current therapy? And then just a follow-up on acasunlimab, could you just remind us on what gives you confidence that the 4-1BB part of the mechanism is actually adding anything on top of just additional PD-L1 activity?

Question: Yaron Werber - Cowen - Analyst : So Tahi, just for you, I wanted to follow up on your comment earlier about CD38 is a target for I&I. I think you mentioned that there is a requirement to show long-term survival in preclinical animal models, and that makes it a challenge for I&I studies. Can you just maybe highlight that again and maybe share a little bit more information?