Genmab A/S Q3 2024 Earnings Call Transcript

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

Question: Jonathan Chang - Leerink Partners - Analyst : First question, just a clarification on the HexaBody CD38. Did you say that the top line data will be disclosed in the press release when J&J makes a potential opt-in decision or the data package submission press release? And then second question, on Rina-S, can you discuss the rationale behind not having an FR alpha expression requirement in the Phase 3. What's

Question: Sam Abraham - JPMorgan - Analyst : Sam Abraham, JPMorgan. Just for me, please. So my first question is on GEN1042. So when can we expect to hear from you in terms of next steps before GEN1042? And is the decision to prioritize Tivdak in head and neck related to your potential plans for GEN1042? And then my second question was just on HexaBody CD38 in terms of -- it's quite helpful in the time line that you gave us. But just how should we think about the potential safety profile in the head-to-head trial given the safety signal we saw last year based on the baseline recruitment (inaudible) the patients you recruited, do you think that the lower risk of any cardiovascular signal coming through in that head-to-head trial?

Question: Suzanne van Voorthuizen - Van Lanschot Kempen N.V. - Analyst : First question in relation to up EPKINLY and the commercial traction. Can you frame which indications or treatment settings geographies or other segments that you're looking at, you expect to be potential major drivers from here in the forthcoming years? And remind us how you think about the peak potential of the drug. And then a tiny follow-up on HexaBody CD38, very helpful guidance there. But did you also comment on the time line for the update that you have referred to, should we still continue to expect something this year?

Question: Xian Deng - UBS - Analyst : Thank you very much. Two, please. The first one is on 2025 catalyst. I mean I understand this is probably a bit too early to give full details for next year's catalysts. But just wondering, on high level, do you think we could expect the acasunlimab clinical data follow-up next year but we'll also see more clinical data on Rina-S to have these combo. That's the first question. And the second one is on test and the cost related to that. So just wondering, given now you will not progress with the Phase 3 trial -- just wondering how much in terms of R&D savings do you expect to come from that? Or the other way of asking this is could you remind us roughly how big the size of the trial in relationship to the other Phase 3 ?

Question: Yaron Werber - TD Cowen - Analyst : Great. I just have essentially a follow-up on GEN1042 on the CD40x4-1BB. So it sounds like your -- the way I'm reading you correctly, is you're still doing some work on dosing in combination with standard of care in first line. If I remember correctly, it was head and neck and then you had several other opportunities coming behind like non-small cell pancreatic and melanoma and the data is going to be next year. Like are we -- are you thinking that you're moving to Phase 3 and you'll give us an update on the trial design? Or what should we expect next year?

Question: Asthika Goonewardene - Truist Securities - Analyst : I have a quick one on HexaBody C38. Is the data package that you will -- final data packages will send to J&J going to include any of the preclinical data that you explored in autoimmune diseases? And then on Rina-S, Judith, you mentioned the presentation at ESMO, how that had an indication that patients with FR alpha less than 25% had clinical activity. Can you tell us if you actually saw clinical responses in those patients? That's my question.

Question: Yifeng Liu - HSBC - Analyst : I've got one for Rina-S, and obviously, we talked about the FR alpha expression level. And do you see that -- my question is, do you see that adaptable into other tumor indication in the sense that you see responses or signals or early signals that the response across different level of FR alpha expression levels? And how should we think about the opportunities there?

Question: Matthew Phipps - William Blair & Company - Analyst : Just one quick follow-up on the Tivdak decision. Are you still planning to evaluate Tivdak plus KEYTRUDA in the frontline head and neck setting -- and then is this part of just a maybe broader shift to incorporate some of the next-gen ADC components from ProfoundBio into programs going forward. Any additional ProfoundBio assets that we should be looking for?

Question: Alistair Campbell - RBC Capital Markets - Analyst : Just a quick follow-up on the Rina-S trial. Just to be clear, are you going to be testing for folate receptor expression at this line? And could that be a predefined a predefined analysis of the value? Or is this going to be an all-comers trial. And then just move your recent collaboration with Revitope. So wondering if you discuss what's attractive to that technology. What do you think that could offer this different from your own capabilities and bispecifics.

Question: Vikram Purohit - Morgan Stanley - Analyst : So we had two, one on the pipeline discontinuations, one on the EPKINLY. So apologies if you mentioned this and we missed it, but the discontinuations you mentioned, are they part of a broader pipeline review? And as a result, can we expect more deprioritization from the earlier-stage efforts you have underway in the coming quarters? And then secondly, on EPKINLY, was just curious to get your sense on how the profile of patients with DLBCL that you've been treating has been evolving over the past couple of months as the launch has progressed?

Question: Yaron Werber - TD Cowen - Analyst : Yes. Thanks, Thai -- Thanks, Jan. Thanks for the question. And we certainly continue to hear from HCPs regarding the types of patients about their positive clinical experiences across both DLBCL and now FL, certainly further validating our differentiated profile in the subcu administration as well and the ease of administration. But past the initial phase of the launch period, we're now hearing that the types of patients are evolving into the true and so multiple later lines of therapy into the true third-line plus setting in DLBCL. And with FL, it's a little too early to accurately assess any type of unique patients at this point but continue to hear favorable responses from our providers.

Question: Etzer Darout - BMO Capital Markets - Analyst : Just given the portfolio review, just wondered if you had any updated thoughts on to the platform in autoimmune disease, given what we're hearing about CD38 and 40 in development, just your overall thoughts given your platform, antibody platform and some of the enthusiasm around some of these mechanisms in autoimmune.