Jan van de Winkel: Thanks Asthika, for the questions. So the first two, I think I want to hand over to Anthony Mancini and Tahi can address the last one. Anthony?
Anthony Mancini: Yes. Thanks, Asthika, for the question. So I think it’s a great question, academic versus community. I think in the earlier – in the early part of our launch, we really had a focus on new starts that were heavily pretreated patients were being treated. That was really largely academic focused. We’ve started to see in recent months now that there’s been a modest shift beyond the major academic centers. Of course, our key accounts are primarily major research institutions and health systems that have CAR-T capabilities. So we have seen a shift of late beyond major academic centers, and we’re encouraged by our ability to get to broader sites of care. And we’ve now seen large physician group practices starting to use EPKINLY, but it’s at the early stages, Asthika, at this point in the community.
Of course, that’s a U.S. dynamic in Japan. It’s really a hospital-based dynamic overall. But I think this will continue to evolve over time. And as data evolves with outpatient data, as you mentioned and optimization data, both in DLBCL and FL I think we’ll start to see more large physician group practices start to use EPKINLY in a greater way. But again, this is the shift. And with that, maybe I’ll pass it to Tahi to talk about the next 1046 design question.
Tahi Ahmadi: Sure.
Jan van de Winkel: Maybe Tahi can start with the status of the outpatient study, the Phase 2 outpatient study. That’s one of the questions from Asthika. Any update, Tahi, on the status of that Phase 2 study?
Tahi Ahmadi: Well, I mean it’s growing quite well. And I think there are also plans to present some of the data towards the end of the year, but that’s probably all I can say [indiscernible] study, actually.
Jan van de Winkel: All right.
Tahi Ahmadi: So that’s all that. And on 1046, well, the simple question is no – the answer is no. So one dose on schedule regardless of the PD-L1 status, also not entirely issue if I would understand how that would work with the bispecific that once we’re engaged for maybe. But simple answer one dose one schedule.
Jan van de Winkel: All right, thanks. All right, thanks. Thanks for question.
Operator: Thank you. We will take our next question – your next question comes from the line of Emily Field [Barclays]. Please go ahead. Your line is open.
Emily Field: Hi, thanks for taking my question. I’ll just have two quick ones. So the first one for Acasunlimab, are we going to be seeing the data at ASCO in the poster for both cohort A and cohort B. And then a question on DARZALEX and just sort of the multi myeloma competitive environment. Obviously, earlier, we saw the DREAMM-7 data for BLENREP, which would test DARZALEX in the comparator arm? I know this is second line plus and the share numbers you gave earlier in first line are super helpful. But are you seeing that asset reentry into the market based on the data you’ve seen so far as a competitive threat to DARZALEX? Thank you.
Jan van de Winkel: Thanks, Emily for the questions. I think, Tahi, you can probably handle both of the questions. The data at the poster at ASCO for Acasunlimab and then the BLENREP new data from GSK and the impact on the DARZALEX landscape.
Tahi Ahmadi: Well, so the first thing, I’ll take the GEN1046 and I’ll give my question on the BLENREP data and maybe Anthony Mancini may also have his own view on this. But on GEN1046, what you will see is the data that we used to make the decision. And obviously, the decision was twofold: one, what is the appropriate dosing schedule and be overall? Is there a path forward? What’s the proof of concept for this combination. And we’ll see essentially the answer to both of these questions. So that means you will see the relevant data from the arms. On BLENREP, I don’t want to sound this way, but it’s almost – it feels like it’s a little bit, I think, a little bit too late. As the treatment paradigm has changed and daratumumab has moved into earlier lines, I think the study asked the question. That was certainly relevant at a time when it was designed, but may not be necessarily relevant at the time it was answered. I don’t know if Anthony wants to add further to that.
Anthony Mancini: No, I think you covered it.
Jan van de Winkel: All right. I think we need to leave it with that, Emily. I think there’s now probably better BCMA-targeted molecules like bispecifics and teclistamab is doing really well, as you heard from Anthony Mancini.
Emily Field: Great.
Jan van de Winkel: All right. Operator, let’s move to the next question.
Operator: Thank you. Your next question comes from the line of Peter Verdult [Citigroup]. Please go ahead. Your line is open.
Peter Verdult: Thank you. Peter Verdult of Citigroup. Two questions, please. To Jan and Tahi. I – and I ask your patience here, but I just want to ask you sections question differently on this GEN1046 data, we’re going to see why you’ve moved into Phase 3. Can I – rather than trying to be [indiscernible], I mean it’s a big area, huge commercial opportunity but also very competitive. So my simple question is there enough data to materially change consensus applications in this drug? Do you feel that there could be a pivotal moment in terms of how people view GEN1046, given how long we’ve been waiting for this data to come through? So that’s question number one. And then number two, for Anthony Pagano. Just ballpark, when we think about ProFound on an annualized basis, is a good starting point to think a cost base around $100 million, including what might be can you get to prosecute Rina-S?
Just anything you can help us with in terms of a run rate in terms of the ProfoundBio cost base. Thank you.
Jan van de Winkel: Thanks, Peter, for the questions. The first one, I will move on to Tahi, because he is really on top of that data together with unit. And we are very excited to present that. And I think it’s going to be very clear, Peter. And take an underlining decisions we have taken towards pivotal. But, Tahi, maybe you can give a bit more color for Peter.
Tahi Ahmadi: Yes. I was why. It’s not that easy because I don’t necessarily know how you guys are going to react. Because it all depends on like what one has in mind in terms of expectations and reality. The way I look at this and the way I think is the way we think about this and the reason we are excited is go something like this. This is going to be a IO option with the similar benefits that immuno-oncology approaches in the past have shown when they were compared against chemotherapy in our mind in that we would be – what we hope to achieve the study which we hope you will appreciate in the data set is that efficacy is important, durability is probably even more important and overall survival to scenic one on. And so it is indeed a competitive space.
But I think it’s also fair to say that a lot of the approaches have not met the criteria that I just laid out. I’ve met maybe one, but not all of them. And I think this is how we look at it. This is why we are excited about it. It’s, in many ways, also validation of a long effort to validate for BBS mechanism. And that in of itself also has some value for us.
Jan van de Winkel: Thanks, Tahi, I think we should keep it with that. And then finally, also a question for Andre Pagano, I was worried that there wouldn’t be a question for you, Anthony, but now you can go.
Anthony Pagano: I stayed on the line, Jan don’t worry. And thanks, Pete. Yes, maybe to start off with the shorter term, Pete, in terms of our 2024 guidance. And it’s what we indicated as part of announcing the proposed acquisition and I reiterated again today that for 2024, we expect to be at or moderately above the upper end of our current guidance range, which is DKK12.4 million to DKK13.4 billion. And to be clear, as I sort of think about what the upper bound of that could be, it’s certainly going to have a 13 handle on it, meaning our OpEx numbers when I start with the 13. We’re really focused on, as you would expect, continue to manage our overall investments in a focused and disciplined way. As we’ve done historically.
Now if I kind of zoom out a little bit, Pete, as you’d expect, we have to invest to unlock the full potential particularly around Rina-S as well as our existing late-stage programs. So, as I highlighted on our call to announce the proposed acquisition of ProFound, we do expect R&D investments to step up over the near to medium term. What you should be really clear on though is that we fully intend to remain substantially profitable through the – throughout this investment period. So we’re going to manage our expenses accordingly. And that means that moving forward, we’re going to continue to be focused and disciplined in our approach to allocate the capital across these mid- to late-stage R&D programs with the most potential. As we’ve done in the past, we’re not going to shy away from deprioritizing other programs, particularly early-stage programs that won’t meet our high bar for continued development.
