Genmab A/S (GMAB) Earnings Call Transcript & Summary
September 4, 2024
Earnings Call Speaker Segments
Vikram Purohit
analystOkay, everyone, let's go ahead and get started. Sorry for the slight delay here, but we'll make up for it on the back end. We have the team from Genmab up on stage. Thank you for joining us. I really appreciate your time.
Jan van de Winkel
executiveWe are delighted. Thank you for having us.
Vikram Purohit
analystOf course. Just need to make a mention of disclosure statements. For all important disclosures, please see Morgan -- www.morganstanley.com/researchdisclosures. My name is Vikram Purohit, I'm one of the biotech analyst for the Morgan Stanley research team to cover Genmab. Very happy today to have you both on stage with me to discuss some of the key areas of progress with the business, some of the key upcoming milestones. But before we get into specifics, I would just love to get a quick overview from you on where you've been focused on the business over the past year or so and then we can go from there.
Jan van de Winkel
executiveWell, we are -- we have turned the company from an R&D-focused innovation powerhouse into an end-to-end integrated innovation powerhouse with now leading to 8 products already on the market based on our science. Two of them, we are commercializing and codeveloping with a partner. And we're very excited about. Epkinley and Tivdak are doing well and increasingly do better and better and get very good traction in very small markets, which we are expanding the markets as we speak. And then, of course, we did an acquisition of ProfoundBio, the very first acquisition in 25 years of the company. and brought on board a 100% owned late-stage product candidates Rina-S, which will very soon go into Phase III clinical development. So I think the company is doing really, really well. The pipeline is progressing excellently. So I think exciting times in the coming months, we'll have a lot of data. So we are very, very excited about the company.
Vikram Purohit
analystGreat. I mean, on the topic of developing out the proprietary pipeline, looking forward 5, 10 years from now, what do you hope the revenue mix looks like from a partnership revenue basis and then from your wholly-owned Pipeline basis.
Jan van de Winkel
executiveI will pass it on to Anthony to answer this one.
Anthony Pagano
executiveYes. So as everyone knows, we've been focused on building out our capabilities over the last number of years to increase our percentage of value capture. When the company was founded, we were very much focused on, let's call it, a licensing model, where we take our products or make our technologies available and essentially hand those technologies or products over to larger biotech or larger pharma and collect passive income streams. In 2013, we set out a new strategy for the company, which was to forward integrate and increase the value capture for the business. Now as our pipeline has matured, we've done just that. We've taken together with our partners Epkinley and Tivdak to market, finished development, taking those products to the market, and let's call it a 50-50 type model. The next leg of the story for Genmab is to further increase that value capture and take that percentage up closer to 100%. More recently, we flagged 2 programs where we do own 100%. That's Rina-S and also GEN1046 with the DuoBody PD-L1x4-1BB So moving forward, the base case for us is to take programs further and further and to own closer to that 100%. What this ultimate revenue mix will look like as we exit this decade between royalty 50-50 or 100% owned is probably too early to call. But what we only leave everybody with is that we've made the investments to have the appropriate capabilities to capture more value as we move forward. And I think the zooming in quickly on some of the performance, particularly around Epkinley, we're very pleased with the early returns on the commercial performance of Epkinley in the 2 markets that we've prioritized that being the United States and Japan. And as we move forward and think about progressing to the 100% owned model, that gives us a lot of confidence and our ability to compete and ultimately win as we think about pushing GEN1046 and Rina-S through Phase III development and then pushing those products if successful out towards the market.
Vikram Purohit
analystUnderstood. On Rina-S, when you -- when you were in the marketplace looking for targets, assets that could be interesting, what was your criteria? And how did you come on ProfoundBio and Rina-S as kind of the right asset profile?
Jan van de Winkel
executiveWell, all of our products need to be either having the potential for best-in-class or first-in-class. I mean that is an absolute requirement for all of the molecules to work on. And what happened here is that I think a year ago in April '23, we met with ProfoundBio and we were very impressed by their linker technology because the trick here is a linker. They have a very hydrophilic linker, which allows them to attach a few -- a lot of hydrophobic payloads to the molecule. And by doing that, not to change the half-life and the PK/PD parameters of that molecule. We already work on ADC for a number of years. As you know, we have actually developed codeveloped together with CGEN, Tivdak, which is a small molecule, first-generation ADC. So we were very excited about that concept, but there was no clinical data. Then in November last year, at SITC, at the first clinical data in ovarian cancer and endometrial cancer, we were incredibly impressed by the data and we knew that this was a potential best-in-class technology platform. Then we approached them after JPMorgan. And of course, they didn't pick up my phone call because they wanted to finish the Series B. My initial plan was to go in there before the Series B, actually, but I was respectful of that process. And then immediately afterwards, we actually looked at the complete pipeline. There was not only the lead molecule in the clinic, but there's actually 2 others moving into the clinic, also with their technology and a third one, which will move into the clinic imminently is a bispecific ADC, all that brilliant preclinical data, and we actually realized that having access to this next-generation ADC platform was potentially a very good move for Genmab because it actually could be complementary to our 4 platforms in next-generation antibody technologies. And we were already very, very deeply involved in ADC developments anyhow. So we thought it was a perfect mix and also culturally, there seems to be a very good alignment between the teams. So we moved swiftly and very effectively, I think by -- with the announcement on April 3 of the proposed merger and executed it in May. Right now, we're very busy with the integration. I can also tell you that I got at least 2 e-mails from other CEOs from very prominent companies who, a, congratulated me on the acquisition of ProfoundBio and b, said they're very disappointed because you snapped it away in front of our face basically. So I think more companies were looking at the technology platform and up to now, integration is going really well. Most of the team stays on board. At Genmab, we intend to actually expand rather than swing that, and you will see more and more ADCs coming into our pipeline. Now we have about 16% to 20% ADC products in our pipeline, but that will increase from here. And we think it's a perfect complement. And I think also strategically on a longer-term basis, what we really want to see is combinations of ADCs. It's immunogenic cell that of cancer cells and combine that with immune-activating drugs. And I believe that we are breaking open a completely new area with 4-1BB, agonistic approaches, which are conditional approaches. Acasunlimab will go into Phase III in the coming -- literally in the coming months. But we have also other 4-1BB targeted programs together with BioNTech, and they're still partnered with also where we also expect clinical data for 1042 in the coming months basically to dictate the decision to next step. So ideally, you can actually do mix and match. You can actually start combining ADCs with immune activators. We got not only very rapid shrinkage of tumors but also long-lasting responses. So where you ask me, I've never been more excited about the pipeline. I think this fits like perfect, absolutely perfect with our technology base and we are super excited. I think this will actually open up a completely new era for the company and hopefully for the fields.
Anthony Pagano
executiveGreat. Maybe just to add on in terms of thinking about making this investment decision around ProfoundBio particularly Rina-S and other addition to what Jan said a couple of things that stood out for me was that Rina-S was Phase III ready. So think about allocating the amount of capital we did, there wasn't a lot of additional investment or time that we needed to expand or take to transition this program to Phase III and in conjunction with our Q2 earnings call, we announced that we intend to do just that. We actually brought it forward from 2025 to 2024 in terms of the potential Phase III start for Rina-S. And then secondly, I talked about building our capabilities. Certainly, we can leverage these more broadly. But secondly, we see a lot of benefit and learnings from what we did with Tivdak in the gynecological oncology space. So I think this was 2 additional boxes that we could sort of check as we think about making this investment decision.
Vikram Purohit
analystGot it. Got it. And then when we think about what the real-world differentiation could be from ProfoundBio's linker technology. For Rina-S, how could that differentiate versus competing agents in the field, some of the other ADCs out there, what could that look like from a safety perspective, from an efficacy perspective, what will that mean for patients?
Jan van de Winkel
executiveYes, very good question. I mean in 2 weeks from now at ESMO, we will comment with a fuller data set from the Phase I/II trial, and we already said publicly in April that we have seen more data that there was in the public dominant at SITC last year. What it could mean is that we actually go for a much broader population of patients at much wider range of fully to set off overexpression, like the first generation full interceptor alpha targeted ADCs only work in a very highly expressing tumors with full interceptor alpha. We potentially would like to broaden that not only in ovarian cancer, but also moving into other tumors. And what we already saw in the initial data set and I kind of preempt the data at ESMO, but what you will likely also experience while seeing that data is that what Tahi Ahmadi, our Chief Medical Officer already said as well, it seems that actually patients can stay much longer on this molecule. So much cleaner and more a clean safety profile, which will actually allow patients to benefit much, much longer, much more prominently from this type of ADC. So we hope that we actually get much more long-lasting response to citizens. There are many times the problems with ADC. But ADCs the good thing about developing an ADC of e-commerce, you see rapid shrinkage. You know that you have an active drug there basically. But what we also know from some of the ADCs now in development on the market, but they sometimes very rapidly relapse these tumors and then it's difficult to bring them under control. So when you have a much safer molecule, which you can give over a prolonged period of time, you will definitely get further data on duration of responses, et cetera. So from everything we have seen, we become more and more enthusiastic. We are going to broaden the problem for Rina-S tremendously. We are not only moving into Phase III. But in time, you will see us taking more and more studies to it. And what Genmab will do more broadly in the coming years, we will actually focus on the top 4 of 5 clinical programs, which have created very good data and then broaden those programs and probably at the expense of doing a bit less in the pipeline and a bit more focused work in the pipeline. So we're going to focus to complete more late-stage development from here. And what we did in the last 3 years is we actually expanded to clinical operations and execution teams tremendously. And we kept more or less some of the research and preclinical development teams at Bay because we have a very, very sizable team of scientists already. So we keep on turning out more and more of these IND candidates, but we are probably going to plateau that development in the coming time and then expand at the clinical development and commercial side. So I think super exciting. I mean we're now 25 years young. In February this year, we will celebrate our 25th anniversary and the best is yet to come.
Vikram Purohit
analystGreat. Great. What can you tell us about the Phase III study starting by the end of this year, the first Phase III study for Rina-S. How is that going to be designed? What's the patient population? Any I guess, initial guidance to kind of keep in mind for how to best interpret that program.
Jan van de Winkel
executiveI mean I cannot give you -- I can but I won't give you any details at this point because of the competitive landscape, there's a lot of other companies now with full interceptor alpha-targeted ADC approaches. But I can say very, very soon, I think you will see the program appear on ct.gov. And then I'm more than happy to talk about it openly. We think it's a differentiated protocol, a differentiated population versus some of the competitors, and we want to keep it like that and then do very rapid execution and also move into other trials quite quickly for Rina-S. So more to come in the coming -- potentially for the weeks for you to see.
Vikram Purohit
analystGot it. Got it. Okay. And I know when you announced the transaction, you mentioned blockbuster sales potential for Rina-S. Was that just for the initial Phase III indication you're going into now? Or was that across all the indications you might be or all the studies might end up stacking on top of this one?
Jan van de Winkel
executiveI will ask Anthony to start off and then see whether I can complement that. Anthony?
Anthony Pagano
executiveYes. So we talked about that at least initially when we announced the deal back in April, we're talking about the asset or the program. Certainly, as we move forward, we could consider providing additional guidance. But for now, it's talking about the entire asset, number one. And number two, the other guidance we provided was that we're focused on trying to deliver the first launch in the U.S. in 2027. We also said about starting the first Phase III to repeat what I said earlier, we would start that in 2025, and it's the highlight we've brought that forward to 2024. So we're really focused on putting our foot on the gas pedal here in terms of both speed in terms of going fast, putting the gas pedal. But as Jan highlighted, we think there's a potential to go broad as well and broad here is, I think, broader across ovarian, but potentially in other therapeutic areas as well. We're very excited about this overall opportunity even more so here today than we announced the deal in early April.
Vikram Purohit
analystGot it. Understood. That's great. So then what are the gating items then for additional studies for stacking additional programs on for Rina-S? What are the gating items right now? What are the next steps for kind of expanding?
Jan van de Winkel
executiveI mean we're already planning those studies in different populations of ovarian cancer, tumors and also other tumors and also different combinations. So we are testing out different combinations very, very soon with Rina-S because we believe that there will be synergies with other molecules. And you will see this as a program which we will very rapidly expand and get broader and board. This will actually materialize over the coming months, for sure.
Vikram Purohit
analystOkay. Okay. Understood. So given the integration work you have right now ongoing for ProfoundBio for Rina-S. Is BD a near-term priority? Or are you more focused right now on just integrating the company and kind of operationalizing Rina-S and getting it to kind of more mature state?
Jan van de Winkel
executiveI mean we have a very active BD team that is actually looking at the whole competitive landscape and the treatment landscape very, very proactively. So that will remain a priority because we believe that we can potentially add more complementary platforms to the general pursuit of technologies. And also, we are definitely interested in another late-stage clinical asset when it is an antibody-based medicine, it could actually fit with our portfolio. On a shorter-term basis, we are really super focused on the execution of Rina-S and moving the other 3, not 2, but soon 3, have ADC programs into the clinic and determine the optimal dose and then move further with those problems or stop them, and they are not having good data. But I would say don't be surprised when we would execute again. But the priority right now is integration of ProfoundBio, making that teamwork seamlessly as an integral part of the map. We will keep the Suzhou site near Shanghai, where we do CMC and early-stage clinical development to potentially expand that site because there's an enormous amount of innovation ongoing in China, which I think we can tap in very effectively also by having a foothold there. We also keep the Seattle site. This is a smaller site for the ProfoundBio to give us exposure on the West Coast of the U.S. So I think integration will be one of the top priorities. But we will, at the same time, follow the field and also not be willing to shy away from rapid and very swift movements. I mean we did this very rapidly. As I said, it's all culminated in a matter of one and half months early this year. And then we announced the proposed acquisition with the consent of both boards, and I think that we put very rapidly like 60, 70 employees from Genmab on due diligence as this was our first half of M&A in the history of Genmab, I wanted it to be perfectly well screened and validated before we would actually execute. And I think now having done that and with the feedback we are seeing up to now, I mean this is seen universally as strategically a very clever deal. And I can tell you that also the e-mails from the disappointed CEOs also gave me some further at least realization that we did the right thing here. And then the another nice surprise that I discussed actually a few weeks ago that we had actually an agreement with another company which is working on 1 ADC would actually compare different platforms side by side and they took a license from ProfoundBio before we acquired the company. So Genmab is actually now having a pretty good tap into the future royalty income for that molecule. And this -- they actually showed that the ProfoundBio linker and payroll technology was absolutely superior to some other very prominent technologies. So I think we did the right thing here we can and we would not shy away from doing it another time. But the priority right now is integration of ProfoundBio and really make them feel very, very much integrated with the team and progress Rina-S and the other programs.
Vikram Purohit
analystGreat. Great. Related to that, maybe then a question for Anthony then. With 2 Phase III studies starting by the end of the year and then with indication expansion program expansion for Rina-S, what could the impact data operating expenses for R&D in the near term and then SG&A in the long term as you look to commercialize both therapies?
Anthony Pagano
executiveYes. So we've been super clear about what our capital allocation framework is and turning to the P&L, what our investment priorities are and what the direction of travel is. So let me unpack that for you a little bit. If we think about R&D, over the last number of years, we've materially scaled up research and discovery. Intentionally, we thought that was an underutilized asset or an untapped asset in the company. And as a function of increasing that investment in research and discovery, we can see the number of potential IND candidates have increased over the last number of years. That was an intentional decision we made actually back in 2017, 2018, and we can see now that bearing fruit. Now what that means where we are at today, that number is increasingly at scale. So any incremental investment there is going to be more moderate in nature. We really feel as a company and organization as we sit here today, that overall level of research and discovery investment is in directionally in an okay place. That's now, I think, equally true for, let's call it, our Phase I, Phase II investment. What this all -- the net of this means is that we're really focused now moving forward in terms of our incremental R&D investment really focused on registrational trials or Phase III trials. And these are investments, of course, that if successful, are going to generate revenue for us. These are investments we need to make today to ensure the overall financial profile of the company as we exit the decade. And we won't shy away from making those investments. What we will do is, obviously, very clearly articulate the clinical data supporting those decisions and the rationale for making those Phase III investment decisions like we did for Aca and like we're going to do here for Rina-S with presenting this ESMO -- data ESMO here shortly. So long story short in terms of our R&D, incremental investment will disproportionately be these registration trials or Phase III trials. Now turning to SG&A. Again, we had to make a number of important investments over the last number of years to build out our commercialization capability, particularly in the United States and Japan. We've seen the performance in these 2 markets. particularly around Tivdak and Epkinley and we're pleased with the performance we've seen so far. And these are investments that absolutely we had to make to ensure the performance that we did we have entered a very competitive market environment with Epkinley in the DLBCL space or the FL space. These were investments that we had to make to ensure our competitive positioning not only for today, but over the next number of years as we think about launches into second-line and frontline for Epkinley. Now with those investments that we've made, we feel that we've increasingly at scale in the United States and Japan. So any investment moving forward will be more incremental in nature. Now look, we will have to make investments for Rina-S and for Aca, but this is going to be more, I would say, in the field-facing type direct costs versus the underlying infrastructure we had to build out for Epkinley in particular. Now in terms of G&A, I talked about sales and marketing and G&A. Again, here, this number is increasingly at scale. And again, this was a commitment we made to the market going back to the beginning of 2023 that we are increasingly at scale. We kind of recommitted to that promise as part of our 2024 guidance and then you can see us actually honoring that commitment and looking at the H1 performance on overall SG&A moderated significantly. It was only up 12% and year-over-year. And if you look discretely at Q2, it was up only 8%. So I can leave you with is that across our entire business, we'll continue to take a very focused and disciplined approach and scrutinize all of our investments and make sure we're absolutely driving any efficiencies that we can drive. At the same time, we're not going to shy away from making the investments that we have to make to ensure the long-term health of the business.
Vikram Purohit
analystGot it. Got it. Very clear. Maybe now it's a good time to switch over to acasunlimab. So recently, you announced that you're going to be pursuing that program fully independently. I think there might have been a little bit of confusion around the decision from BioNTech to not progress with you on that molecule. So do you want to just kind of talk us through the decision they came through your understanding of it. And then your subsequent decision to be motivated to progress that program independently and not seek another partner for the time being.
Jan van de Winkel
executiveAbsolutely. I'm delighted to, Vikram. I mean the data is just spectacular. I think the data is really, really good. The ASCO data and of course, it needs to hold up because you're talking about the tail of the curve, and it needs to be holding up, and we will follow that in time. I think we share the enthusiasm both with BioNTech for acasunlimab to be a really, really active immune activate, a new principle, a new concept, a completely new concept. But it was a purely strategic decision. And I mean, you can think -- I think you need to ask Ugur from BioNTech, but what I know is that they have at least 2 competing program for exactly the same patient population. And these are programs where they own 100%. And in this case, they own only 50% of acasunlimab. And Genmab had the dominant commercialization rights in Japan and the U.S., so not that attractive basically from a BioNTech perspective. So I can easily see that they make a decision to focus on 2 rather on 3, because to run 3 Phase IIIs in parallel, competing for the same patient population is probably not the smartest thing on earth for any company, but I think you need to ask BioNTech about the exact motivation. What I can tell you is that what we still share is the enthusiasm for the condition -- the concept of conditional activation of 4-1BB because it has been very challenging, as we know, we targeted antibodies before. They were either very toxic or not very active. And now we have a super active set of molecules, we believe. And we are still partnering 50-50 at 1042 program, which is currently being evaluated together with Pembro and Frontline had a neck cancer, so a completely different patient population. And in the coming months, we will get the data because we're doing different dose iterations and dose frequency operations to actually make a decision on next steps for that program. I'm very confident that we share the excitement with BioNTech for that program, and this is not overlapping with any of the other programs. So I would be surprised if they would make a similar strategic decision. And then there was a third program, it's the brilliant preclinical data that's [indiscernible] 4-1BB the same -- again the same concept of conditional activation of T cells and NK cells CA 4-1BB agonism, which is only triggered once both of the arms of the antibodies are bound and that program is in dose escalation by BioNTech. We own 50% of that program. So we're still very, very actively involved in multiple joint programs. We've had HexaBody OX40 program in the clinic right now in dose escalation, which is a very potent immune activator. And we believe that -- but I think both companies believe that combining ADC concepts with immune activators is probably the way to go to ACAP to completely chemo-free treatment paradigms for patients which not only give rapid debiting of tumors, but also long-lasting responses. So yes, I've never been more excited in my life. And I am following this whole antibody therapeutic field for 30 years now, becoming an old man here, I'm afraid. From the early days of ipilimumab, I still remember the excitement of what we saw there in malignant melanoma but it always puzzled me that you only get a very small -- relatively small percentage of patients benefiting from these immune activators. And this may be a novel concept which let more patients benefit from immune activation. So I think we will open up IO 3.0 here with this type of approaches. And I think we share the enthusiasm with BioNTech. So we keep very, very closely working together. I mean both companies are very much science focused and, I think, rational companies. And this is one of these things that can happen with acasunlimab. But we are delighted about as we come. I was jumping in the sky, and I couldn't believe the market reaction was the day later about the thing which made me so happy at that point.
Vikram Purohit
analystUnderstood. Understood. Okay. Great. We have a little more than 5 minutes left. I think maybe we should pivot over to GEN3014. I know it's a big topic of focus for quite a few people. Starting at the start, I guess, how has GEN3014 been designed to be potentially differentiated versus DARZALEX. Let's start there.
Jan van de Winkel
executiveI mean this is a completely different antibody, this step 1. The CD38 antibody targeting CD38 is very different from the antibody and DARZALEX. The DARZALEX has only a very small ability to block the ecto-enzymatic activity of CD38. CD38 is an ectoenzyme involved in the generation of adenosine. Adenosine is an immunosuppressive molecule the idea is that when you can block the enzymatic activity of CD38, you stimulate the immune system that's more prominently. The antibody in HexaBody CD38 3014, is blocking that for 70%, 80%. So very, very good block of the enzymatic activity. That's one. Then the HexaBody mutation is a single immunoacid mutation. So it's not a heavily mutated antibody, is 1 very precisely chosen mutation. This actually allows for a much more intense clustering of the antibody once it binds to the tumor cells. And in that way, you actually increase complement media, the killing 10 to 100 folds, which is like a miracle, which you can do that because -- but you may remember with daratumumab and we picked up from a panel, I think of over 100 CD38 antibodies, it was the only 1 which gave very good complement activation. And none of the other antibodies had complement activation because of the unique epitope this molecule was targeting and CD38. What we can now do with HexaBody mutation, we can actually do several of the CD38 antibodies into wonderful complement activator. So that's a completely different mechanism of action than daratumumab preclinically, depending on which assay you're looking at is between 10 and 100-fold more potent in killing CD38 positive targets. And that effect, FICO is that you can kill targets with much lower levels of CD38. So I think we do know that once you kill them more effectively, CD38 positive cells, you can get into deeper responses and deeper responses correlated much more long-lasting benefit for patients. So I think that the preclinical data looks brilliant. This is published now also. The early clinical data from the dose escalation, I think is also looking very, very good. Was a little bit of angst last year at ASH about cardiovascular complications, more recently, our Chief Medical Officer, Tahi Ahmadi got a question from some analysts I think our investor whether we have seen problems with cardiovascular events and he said no. And I think for the rest, we need to wait on the data. So I think it is actually a very tolerable molecule with a much more potent efficacy profile. Yes, and I think it has the potential to be clinically differentiated. And the good thing is we will see that in the coming months because we are going to have the complete data set as agreed the J&J to share with them, and we will flag that up to the market for sure. Next year, we will see the detailed clinical data. Maybe we give you some top line data this year. We have not decided that because we don't have the data in hand right now. But I'm very optimistic that this is a very attractive candidate for J&J potentially to opt into. Also in the context of IRA. I mean when you look at the recent CMS list with 2 molecules from Novo insulin or insulin plus B3 seen as 1 molecule. If that is true and CMS has that kind of broad definition. And DARZALEX and DARZALEX FASPRO should also be seen as 1 product potentially. And at least, I think J&J can potentially take all the risk off the table by as soon as possible, biting into a next-generation CD38, which is for sure a different antibody and for sure, a different mechanism of action. So there will be no debate in the future about whether that's the same molecule or not. I think that is probably a very attractive, I think, option. But in the end, J&J needs to decide that if he came. So the good thing is you're now coming closer to the agreed data sets. And yes, I think the data looks brilliant. I mean, where you would have told me 10 years ago that it is possible to make a more positive antibody than daratumumab, I would have laughed at it because I wouldn't have believed it because daratumumab is a unique antibody, is one of the best therapeutic antibodies developed over the last decades. So I think in the industry, 3 years from now, it's going to be 1 of the top 3 biggest cancer drugs on earth. Right now it's the biggest product for J&J and then to have a better one, which is differentiated. I think it's potentially super exciting. So -- and you will get that on top of our own pipeline news, et cetera. This will be extra income. So just think about that. We don't need it, I think, to really have to keep this growth part for the company in the coming years, but this is purely on top of it when our partner would take that over. So I'm very excited about that.
Vikram Purohit
analystGot it. Got it. So it sounds like you were saying top line data to the market maybe this year, but definitely next year.
Jan van de Winkel
executiveDefinitely next year. And this year, we will have to decide, but we will definitely flag up once we share the data set because that starts the clock at a very finite time, J&J can only say, yes or no. And yes, I mean, up to now, everything we have seen looks like it's following the preclinical data, which is very, very nice differentiation.
Vikram Purohit
analystUnderstood. Have you and J&J agreed on a specific threshold for how much of an improvement versus DARZALEX would be meaningful or would make them more inclined to opt in? Or do you have a completely...
Jan van de Winkel
executiveNo. We haven't communicated on that. But I think what is important for J&J potentially, but you need to ask John Reed, one of the colleagues from J&J. I mean they need probably clinical differentiation, which we can explain to doctors and to the markets as being meaningful, otherwise they run the risk that was seen as a trick to propagate the income profile, and it will be very challenging for a company like J&J. So I think they want to see a really clear difference, I think, in clinical efficacy. And very likely, you will find that an adept of responses and the duration of response because that is preclinical data suggests because Dara is already a very good antibody. Actually, it's a fantastic antibody. It's not only very good, it's fantastic. But I think to be that with more durable, long-lasting and deeper responses is probably very important. If you communicate, and that is what J&J is doing that their intention is to actually cure multiple myeloma patients in the future. They don't know what the magical combination is, but they keep saying that as part of that combination is the CD38 antibody, and then to have one with a patent life very far beyond the end of the 2030s, I think could be hugely, hugely attractive for a company like J&J.
Vikram Purohit
analystUnderstood. Assuming the option does happen, what do you think a potentially pivotal program could look like for 3014?
Jan van de Winkel
executiveAsk J&J, but I think what they will likely do is look at the front runner program because for multiple myeloma under the new front runner concept, is that the FDA in the future wants to give conditional approvals based on the molecular end point for all the cancers. I mean, this is almost the clearest for multiple myeloma, where MRD negativity to the 10 minus shift degree. You see it as a very validated endpoint correlating with PFS correlating with survival. So technically, they can do 1 or 2 trials in frontline combination trial of 2 arms, having a poor molecular end point for quick readout and then following the full trial for overall survival of PFS endpoint, and that's when you do that in frontline at 50% of the patients when you also on top of that, add 1 more trial in second line, that's another 30% of the patients, you can actually basically penetrate 80% of the multiple myeloma market, and that's the bulk of the market. The 2 trials, and I think that is a very smart approach. But I would be changed here, I would do that right away. I would not even think about a second, but they have to, of course, make up their mind and they are experts in multiple myeloma. And I think they can figure that out and then they can't figure it out, I'll help them.
Vikram Purohit
analystUnderstood. We're a little bit past time. But maybe just to close out, I know we weren't able to touch on many parts of the business. But any closing thoughts on key milestones for people to look forward to for the assets we discussed and also more broadly for the business?
Jan van de Winkel
executiveI mean data, data, data. I mean as for data in 2 weeks from now, have lung data acasunlimab, explaining why we need this every 6-week timing because the market didn't really understand that well. Now you get the translational data which makes it completely clear that will be reinforced by the SITC data in November, more translational research data. And in the coming months, you will see filing of the package to J&J. You may have top line data there Epkinley. We have got lots of data at ASH because we do multiple combinations. We get more and more trials on board. For Epkinley, the drug is doing really, really well. I can assure you. So a lot of data and I will give you for free also potentially INDs and other entrants into the pipeline. And of course, Rina-S, I forgot probably one of the most impactful ones. I think the acquisition of for Bio at ESMO, you will see the data of the Phase I/II trial and then a more robust data set and also more longer follow on, not only in ovarian cancer but also endometrial cancer, and we're super excited about that data.
Vikram Purohit
analystPerfect. Perfect. Great place to close out. Thank you, everyone, for joining us. Thank you both for being here. Really appreciate your time.
Jan van de Winkel
executiveThank you.
Anthony Pagano
executiveThank you.
Vikram Purohit
analystAll right.
Jan van de Winkel
executiveThank you all.
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