Good afternoon. I'm James Gordon, J.P. Morgan European Pharma and Biotech Analyst, and it's my pleasure to introduce the Genmab presentation this afternoon, and we're going to hear from Genmab CEO Jan van de Winkel. Thank you very much for joining us today. Look forward to the presentation and the Q&A.
Thank you, James. It's a pleasure to join you once again at the J.P. Morgan Healthcare Conference as we kick off 2025. The slides from today's presentation will be available for download on our website immediately after the event, so let's get started, and this presentation may contain forward-looking statements, and the research may contain certain risks and uncertainties. Over our more than 25-year history, we've had a laser-sharp focus on harnessing the power of human antibodies to develop differentiated antibody therapeutics. Behind that focus is an unstoppable team and a core purpose which guides our work: an extremely successful strategy and an ambitious vision for the company, and now, we are five years away from this vision. We are entering a new phase in our evolution to become a fully integrated biotech innovation powerhouse.
Following the approval of our second product in 2023, we have never been in a better position to achieve our inspirational vision. We have a strong and consistent track record of success, as you see here on the left. And this success has resulted in extremely strong financials that allow us to invest in growth opportunities, including the acquisition of Profound Bio in 2024, that unlock new opportunities as we strengthen our oncology portfolio and generate and develop new medicines with the potential to transform the treatment of cancer. Taken together, we have built a solid foundation that has supported our evolution into a fully integrated biotech innovation powerhouse. So now, let's take a look at the innovative clinical pipeline as it exists today. In green, at the top, we have 12 products or product candidates where we own at least 50% of them.
Most of these programs either are or have the potential to be first or best in class. That includes two approved medicines, Epkinly and Tivdak, and our two late-stage programs, Rina-S and Acasunlimab. We are utilizing our DuoBody proprietary technologies to create a differentiated pipeline that will set us up for future success. Then in blue, at the bottom, you see the multiple programs being developed by partners that were either created by Genmab or via our proprietary DuoBody bispecific technology. There is no cost for us for these programs, and once approved, they provide us with growing, recurring royalty revenue. The second Genmab medicine on the market was Epkinly, which we are co-developing and co-commercializing with AbbVie. Epkinly has a differentiated clinical profile, delivering deep and durable responses, manageable safety, and seamless subcutaneous administration.
As a reminder, Genmab is the commercialization lead for Epkinly in both the U.S. and Japan, which is a first for our company, and it's clear that our commercialization strategy with Epkinly is working. Today, nearly 90% of the global revenues are from the U.S. and Japan, the two primary markets that we defined as Genmab-led. Epkinly has already achieved a significant milestone as the first bispecific antibody approved for both third-line plus diffuse large B-cell lymphoma and follicular lymphoma in both the U.S. and in Europe. We anticipate a dual indication in Japan as well. The multiple approvals for Epkinly allow us to address critical needs in these patient populations, particularly those who have exhausted other treatment options, while at the same time providing a single option for providers, especially those in the community setting.
We are pleased by the ongoing launch, which has demonstrated five consecutive quarters of growth, and together with AbbVie, we are advancing an ambitious clinical development program for epcoritamab across B-cell malignancies, which includes five phase III trials ongoing, with more in the planning. This work will build upon our initial opportunity in later line disease by significantly expanding our addressable patient population in earlier lines of therapy across diffuse large B-cell lymphoma and follicular lymphoma. Our commitment to advancing Epkinly across various indications in B-cell cancers is a testament to its potential as a best-in-class treatment. Turning specifically to the market opportunity for Epkinly, we are extremely encouraged by our launch performance to date. We hear from physicians that Epkinly's clinical differentiated profile and subcutaneous administration have together been very positively received.
We view these factors as key drivers for our opportunity to expand and differentiate across histologies and in earlier line settings, potentially establishing epcoritamab as the core therapy across diffuse large B-cell lymphoma, follicular lymphoma, and beyond. The first Genmab-owned medicine on the market was Tivdak, which we are co-developing and co-commercializing with Pfizer. The approval of Tivdak was the first advance in second-line plus cervical cancer in more than 20 years, consistent with our approach to focus on the best and first-in-class medicines in areas of high clinical needs. This will continue to be a key focus as we strengthen our commitment to transforming the treatment of gynecological cancers as we grow our portfolio.
With Tivdak, we are continuing to build on our successful launch, which has generated 12 consecutive quarters of demand growth to contribute to the global needs for innovative treatments in this disease stage with an anticipated approval in Japan in the first half of this year. Taken together, the success we have seen in advanced cervical cancer and the strong presence we have built within this community and with physicians set a strong foundation to catalyze the growth of our gynecological oncology portfolio. With the acquisition of Profound Bio last year, we capitalized on this foundation with the ownership of Rina-S. Based on the encouraging data that we have seen, we are confident that Rina-S has the potential to become a best-in-class treatment for ovarian cancer and other folate receptor alpha-expressing solid tumors.
We believe it has the potential to benefit a broader patient population than currently approved therapies, with anti-tumor activity seen across the full spectrum of folate receptor alpha expression, as well as in patients with prior exposure to Elahere. In addition to efficacy, it has also a differentiated safety profile, avoiding interstitial lung disease, or ILD, and corneal toxicities, which is seen with other ADC therapies. This differentiation, both in efficacy and in safety, is a direct result of the novel proprietary hydrophilic linker technology developed by Profound Bio. Here I present our near-term vision for Rina-S, focusing on its development in ovarian and endometrial cancer. I'm pleased to note that we now have initiated the first phase III trial for Rina-S in second-line PROC.
This is important to reiterate here, is that this is a trial including all comers, regardless of folate receptor alpha expression, as well as patients with prior exposure to Elahere. This trial design will allow Rina-S to meet the significant needs of patients who either cannot be treated with Elahere or who progressed after it. In 2025, we will continue to explore combinations to expand the potential of Rina-S beyond PROC. Our investment in expanded development for Rina-S aligns with our commitment to deliver innovative and truly differentiated therapies for patients. Current standard of care in folate receptor alpha-plus ovarian cancer is for patients with folate receptor alpha expression levels larger than 75% or high expression. This is estimated to be about 30% of the platinum-resistant ovarian cancer patient population.
With Rina-S, Rina-S's differentiated profile has the potential to address a broader patient population, including low to medium expression, which is about 85% of platinum-resistant ovarian patient population. We anticipate the first potential approval for Rina-S could be in 2027 in second-line plus platinum-resistant ovarian cancer. Importantly, we anticipate at least blockbuster sales potential supported by expansion into other indications in ovarian and endometrial, as you see on this slide. We are exceptionally well-positioned to maximize the potential of Rina-S, given both our proven clinical development capabilities, track record of acceleration, and our experience in the guideline space with Tivdak. In 2024, Genmab took full control of the Acasunlimab program. Assuming sole responsibility for the continued development of Acasunlimab offers Genmab a remarkable opportunity to fully own and advance this promising asset.
The phase II data for Acasunlimab has been very encouraging, demonstrating significant disease control and overall survival alongside a manageable safety profile. This encouraging data supports a first-in-class opportunity for non-small cell lung cancer patients following treatment with a checkpoint inhibitor. We look forward to providing an update to this data later in the year, and the positive data we have seen so far reinforce our firm commitment to swiftly progress to phase III, and we are pleased that at the end of last year, Acasunlimab became our second wholly owned asset in late-stage development, underscoring our confidence in its clinical promise and commercial potential. We are progressing a strategic development program to explore Acasunlimab's full potential across solid tumors, and we will announce additional trials as appropriate.
We are exceptionally well-positioned to maximize the potential of Acasunlimab, given our proven clinical development capabilities and track record of acceleration and commercialization. Non-driver-mutated second-line non-small cell lung cancer continues to be an area of significant needs. With many novel treatments failing in phase III trials, docetaxel continues to be the current standard of care. Patients who either progress or are refractory to immunotherapy need treatment options that deliver a durable survival benefit without significant safety concerns. By identifying potential synergies of IO therapies, we have the potential to unlock clinical benefits that were not possible with monotherapy alone, and there is a meaningful opportunity for novel treatments in the second-line plus setting to provide not just improved response rate, but durability of response.
Given the worsening of performance status as patients progress through lines of therapy, physicians are interested in more tolerable, chemo-free regimens in their second-line plus patients. Investment in our late-stage priorities is possible in part because of the growing recurring revenue streams from six approved partnered medicines that you see here on this slide. These medicines, which are powered by our technology and innovation, exemplify our commitment to applying world-class antibody expertise to create truly differentiated antibody therapeutics with the potential to fundamentally improve patient lives. Our six royalty medicines, together with two Genmab-owned medicines on the market, are driving significant revenue growth. Importantly, all eight medicines are projected to grow significantly, with our two own medicines increasingly contributing to that growth. We have scaled our investment with the majority in R&D, where we have prioritized investments in our mid and late-stage pipeline.
We are currently having seven active phase III trials with more phase III trials to come, which are anticipated to drive most of our investment growth. And we are substantially profitable and anticipate to continue to be so as we continue to invest in programs that have the potential to be revenue-generating in the near to midterm. Genmab has an established track record of being able to select and develop innovative and differentiated therapies. We are able to do this because we are a company deeply rooted in science, and we follow the data derived from our clinical programs. And here you can see some of the key pipeline events we are anticipating as part of our continued development. So let's now start with HexaBody-CD38. Here I will reiterate what I said during our third quarter results call in November.
We have submitted the data package to J&J, and we anticipate a decision from them no later than in the first quarter of this year. We will inform the market via press release when J&J has made their decision, and this release will include relevant clinical data. To support the integrity of J&J's review process, we will not disclose this information before the official release. Looking beyond this event, this year we are anticipating additional regulatory decisions for both Epkinly and Tivdak, as well as additional data for both Acasunlimab and Rina-S. For Rina-S specifically, the expansion data in endometrial cancer will also inform next steps for that indication. Finally, for GEN1042, I look forward to providing you with an update on our next step for the program in frontline head and neck cancer.
In 2024, Genmab made significant strides by investing in our pipeline and technologies with a strong focus on prioritizing late-stage development and expansion for Epkinly, Rina-S, and Acasunlimab. As we prioritize investments in these key programs, 2025 will serve as a key stepping stone on our path forward toward our 2030 vision of fundamentally transforming the lives of people with cancer and other serious diseases. Our strategic focus ensures that our pipeline remains robust, impactful, and aligned with our long-term goals. In summary, our laser-sharp strategy will effectively drive us toward our 2030 vision. This vision will continue to act as a guiding light, anchored in our core purpose where our unstoppable team will improve the lives of patients through innovative and differentiated antibody therapeutics.
Two Genmab-owned medicines are now on the market, together with six royalty medicines, which provide solid financial growth, giving us strong rationale to invest in our two wholly owned assets, Rina-S and Acasunlimab, as well as our proprietary pipeline, to make the most of the opportunities ahead of us. And we will continue to be disciplined in our approach to this investment. We are confident that as we look to the future, we will see the realization of our continued evolution into a fully integrated biotech innovation powerhouse. We have never been in a better position to achieve our vision of transforming the lives of people with cancer and other serious diseases. Thank you all. I think we now go into a lively Q&A. Thank you.
As usual for the Q&A, I don't know if there's microphones on, but you can raise your hand if you have a question, or in theory, you can use this app. But I think raising your hand may work better. Does anyone have a question they'd like to start with? Maybe I'll start with a question, which would just be so HexaBody-CD38. So can you confirm the data has now gone to J&J? The clock has already started. Is that where we are?
Absolutely. J&J has access to all the data in the data room. We loaded it up in different batches, but it's all there. Clock has started, and the decision as per the contract, James, must come by Q1 at the latest.
And in terms of the different scenarios there, so J&J could opt in or not opt in, but if they were not to opt in, could you potentially still develop the asset in some areas yourself? And could you even renegotiate with them to have more freedom to where you develop the asset as well?
I mean, as per the contract, yes, we can develop the molecule ourselves if J&J would decide not to opt in, but not in the indications where daratumumab is on the market or where it's in late-stage clinical development. That means other indications in multiple myeloma. There are still some areas left where daratumumab doesn't work or stopped working. We can potentially think about other cancers like AML, diffuse large B-cell lymphoma, where we have seen some very good preclinical data with this molecule.
Another potential is solid tumors, and the reason that I mentioned that, James, is that the antibody, which is part of HexaBody-CD38, is a very good blocker of the ectoenzymatic activity of the CD38 molecule, which is involved in the creation of adenosine. Adenosine is an immunosuppressive molecule. So potentially, this antibody is a much better immune activator than daratumumab, which could be a key reason to use it in combination with checkpoint-targeted molecules based on preclinical data. Finally, this could be a molecule which is of importance for treatment of I&I, of autoimmune diseases and inflammatory diseases, because of the fact that daratumumab is known to be actually pretty active in some of the inflammatory diseases. But this is all speculation. Let's first wait on the J&J opt-in decision.
We believe that all the data is there, and we have presented that also to them already last year, I can tell you, at the end of last year. So I think they are now doing the number crunching and looking at all the patients individually and then hopefully make an informed decision.
And could it potentially be attractive to, if they were not to opt in, to try and renegotiate so that you could try and develop the drug for the same place and for some of the places where Darzalex has been approved?
Absolutely, yes. And we have renegotiated contracts before, like the GSK contract. That was one of the first things I did when I became the CEO of the company in 2010.
Within a week, I renegotiated together with Anthony and David Eatwell at that time the contract with GSK, and I think it really stabilized the company overnight. At that time, that was for Arzerra for ofatumumab. But I think there is a possibility always, of course, to do a contract negotiation, but let's first wait on the opt-in decision. I think that's the next step.
Maybe just a final one on that theme, which would be some of the other areas that could be interesting. Would you be in a position to say, "Right, we're really taking this into clinical development," or would it more be we now need to do some very early exploratory trials because you just don't know that much yet about how well it would work, say, outside the Darzalex indications?
You definitely need to look at safety, and you probably need a subcutaneous formulation, I think, for many of these indications, because what you see, the trend is with antibody medicines that more and more of them are formulated as subq formulations, and definitely in multiple myeloma, that is the situation, but also, of course, in autoimmune diseases. I mean, and that needs to be a next step, I think, once you decide on developing that program, and for Genmab, James, to be very honest, we need to, I think, under that scenario, I would say, let's park it for now, but under that scenario, we would have to balance that with other programs we have in our own pipeline, which we already own 100%, and we need to balance that.
What you will see from Genmab over the coming years, and that will become clear on the 12th of February when we give financial guidance, is we actually are going to grow our operating expenses within a very focused manner, actually focusing on late-stage clinical development, mid to late-stage clinical development, and be very rigorous in the pipeline, actually not shying away from killing programs where, despite sometimes showing activity in the clinical setting, but simply not being super competitive in the evolving landscape. I mean, we have several programs now, which we have decided to stop over the last several months, not because they are not active, but we think that in the evolving landscape, they're not going to be differentiated molecules.
Because what the reality, I think, is dictating right now is that in oncology, more and more competition is going to become available for different areas of cancer, and these markets will be sliced up. So what we want to do is focus on parts of the market where we actually can have a really differentiated molecule, also in the evolving landscape, which is changing the whole time. So I think the dynamics is going to change. So we have to balance that in a very careful way.
And you've driven some internal programs, I think partly because you acquired Rina-S and some funds are going into that. Is that a shape of how things might evolve, that Genmab might develop a few less drugs that are internal or might be more mixed in terms of internal drugs versus actually bringing in innovation as well?
I mean, we definitely started that trend in 2024. I mean, for the very first time in 25 years, we have actually done an acquisition, adding complementary ADC technologies and skills to a set of proprietary antibody platforms, which really broadened our suite of technologies in a very, very elegant way. And right now, I think 40% of all the total programs, clinical and preclinical, 40% is ADCs, over 50% is based on the DuoBody technology, and roughly 10% is based on the HexaBody technology. So we have a truly innovative set of technologies creating next-generation antibody medicines, but we also brought on board not only Rina-S, which I described in my presentation, which is now in phase III clinical development based on very, very good data in PROC. And this year, you will see also data in endometrial cancer.
We already know from the ESMO presentation that endometrial cancers also respond really, really well to Rina-S, but it also brought in three other clinical stage programs, which are now all in the clinic. It's a PTK7 ADC, a CD70 ADC, and a bispecific c-MET EGFR ADC, all with very, very good preclinical data. They all three are now in dose escalation, and so we will see actually a mix of internally generated molecules and externally sourced molecules. And I think that could actually be the right thing for the company to move forward and actually accelerate its revenue stream going forward, but we wouldn't focus on very early-stage molecules, James, but we are clearly scanning the market, I think, for late-stage molecules, perhaps even early commercial molecules, because we now have a very solid commercial presence in both the U.S. and Japan.
We are going to prepare to become broader commercially active in the coming time, also in the context of Rina-S, because that can potentially already be launched in 2027, as I said in my presentation. Genmab will become more and more an integrated end-to-end biotech company. I think to accelerate growth and accelerate revenue streams by sourcing external innovation is something which I think fits very well with our profile, but it's definitely a relatively new trend. Yeah.
Maybe another trend is you're fully owning an asset yourself rather than being partners. Rina-S, you're going to own it all. Is that the sign of everything to come now? You won't do partnering. You're going to be all you want to fully own everything you work on?
I think it will be a mix, James. We will do 50% ownership as the minimum.
You will not see us doing single-digit for sure or low double-digit type partnering like we did in the early days of the company now roughly 20 years ago, then we moved to a 50/50 era, which is basically a decade old now with initially Seagen, now Pfizer, and then in 2020, the corona year with AbbVie for Epkinly, which we are pretty happy with, but it will be a mix between 50/50 and I think 100% owned molecules, and you will see the direction of more and more 100% owned molecules in our pipeline because simply the impact on our business model will be much more strong and much more impactful than with products where you actually own a smaller part of the ownership from, so the trend will be to move more and more towards 100% owned.
Are you still in digest mode on Rina-S or if there was something else to kind of beyond all these exciting meetings, there's a BD that goes on in the background and you meeting new friends as well?
We have actually, I think, two or three teams of BD colleagues here now in San Francisco now walking through the sunny streets of San Francisco to really see whether they can actually interact with smaller biotech companies and also other companies to really look for complementarity, look for programs where we can work together. I think we have in our DNA that we are working really, really well with other companies. We have over 25 partners as we speak, I think seven or eight pharma companies and then most of the other companies, biotech companies or tech companies.
I think that is very much close to our DNA as a company. We will also in the future be very, very open to partnerships. One of the types of partnerships we are actually actively looking at is potential partnering in China for Rina-S and Acasunlimab because we think China is a fantastic market. It's a growing market. It's a market we don't want to ignore. We have a foothold in China now because we have a Suzhou-based CMC early R&D facility which we brought into the company last year because of the Profound Bio acquisition. We can actually tap into this wonderful innovation which is happening right now in China. We believe that it's a complex market. Definitely commercially, it's a very, very complex market with very different dynamics than the Japanese and the U.S. markets.
So we clearly are speaking with candidate partners for a partnership in China for those two molecules because we are going to be responsible for them as 100% owners of these molecules. And you will see us potentially getting broader also pretty soon in order to prepare for Rina-S launches in the 2027 timeframe. So you will see partnering as an integral component also in the future of Genmab. That very much belongs to how we shape the company over 25 years. And we like to, I think, tap into new pools of innovation to look at new areas of innovation. We are spending a lot of energy right now and also capital on AI and digital technologies. We actually are using that in many, many parts of our business, and that will get more impactful.
And also there, you're looking for partnerships basically to actually try to innovate and accelerate innovation in our company. And I think there's a lot of opportunities there. So you will see that partnering component as an integral component for sure. So that explains why we have so many people on the boots on the ground here in San Francisco at this moment.
And I think maybe just to add on to that, as it relates to the integration of Profound Bio and particularly Rina-S, one thing I do want to highlight, when we announced the deal in early April, we provided a lot of forward guidance. Among that forward guidance that we provided was at that time that the first phase 3 for Rina-S would start in 2025.
Based upon the clinical data and the integration, we were actually able to bring forward the start of the first phase III into 2024, so I think overall, the integration of Profound Bio and particularly us being able to put our foot on the gas pedal for Rina-S has gone very, very well, and remind everyone of the other forward guidance that we provided at the time of acquisition was that the potential first commercial launch could come as early as 2027 and that this is a greater than $1 billion peak sales opportunity. You can see today in Jan's presentation that we stand firmly behind that forward guidance. I think also to add on as it relates to thinking about opportunities outside the four walls of Genmab, as Jan highlighted, we've built out our capabilities both from an R&D late-stage development perspective as well as a commercialization.
I think that lays out a really strong foundation and framework to think about later-stage opportunities moving forward. We're certainly not going to chase deals, but the right deal does cross our desk. We certainly won't shy away from it.
When you are looking at deals, what year are you most focused on? So are you focused on which markets on here? Does it matter if maybe there is an earnings split in 2029-30 when DARZALEX royalty cease, and then you might get a bit smaller and then a bit bigger? Or is the plan to try and find a way to cushion or offset the DARZALEX blow?
I think obviously we don't want to, as I just highlighted, chase a deal to solve for a specific time point.
We want to have the right product where we can obviously be very, very good evaluators of what we're potentially bringing in. And this could also be an internal opportunity and then be very good owners of it. And this is going to be really leveraging the expertise and capabilities that we've built out. And as you know, timelines can shift. Sometimes they can get pushed out. Sometimes they can get brought in. As I just highlighted with Rina-S, right, initially we thought the first phase III could start in 2025. We've been able to bring that forward. So I think really it's going to depend on the particular product opportunity.
Certainly, as I think about it, broadly speaking, we're focused on this sort of end of decade to make sure that what our revenue profile, revenue growth opportunities look like, coupled with what our overall late-stage pipeline looks like as we exit the decade. It'll be a mix of all of these factors.
In terms of products that you have already gotten out, so Acasunlimab or GEN1046, that is going forward. It has gone forward. But GEN1042, you haven't yet announced a decision. That's taken a while to make the decision. I saw in your slide you said a decision will be made in 2025. What do you still need to see for GEN1042? What's the missing data point? What do you need that to show to say, "Right, we're going for that"?
The data we are waiting for is duration.
Duration of responses, and that takes time. Unfortunately, that takes time. And actually, the more time it takes, probably the better it is. But we also want to say that the market is restless. And we also partnered with BioNTech because we're both fully invested in that molecule. We're very excited about that molecule, James. And we fully believe that we will continue with working on that molecule. But we have to evaluate right now. I think I spoke about frontline head and neck cancer because that's where we have most of the data, but we also have data in other cancers. And we think that that's a fantastic immune activator also to use potentially in combination with ADCs. And both companies have different ADC programs right now. I just told you that 40% of the programs are ADC programs now.
And this could be the fantastic molecule just boosting immunity because many of these ADCs cause what is called immunogenic cell deaths. And this could be a super synergistic molecule there. So I think we need to, I think, wait on that duration data and take a decision on head and neck cancer and then also describe to you all how we move forward to that molecule. But we actually are very enthusiastic about the potential of the molecule. And did it take longer? Yes. That is one of the differences, James, between ADCs and immuno-oncology molecules. IO molecules, we now know, take a long time and are very complex. The biology is very complex. We know of a lot of failures. I mean, a lot of programs have been pulled recently also by other companies. And look at Acasunlimab or 1046. It took us a long time.
First, we saw that we needed to combine it with a PD-1 axis blocker. We know that Acasunlimab actually is a PD-L1, 4-1BB antibody that can actually block the PD-1, PD-L1 axis, but not at the dose we were using to fully activate, optimally activate the T cells because these are bell-shaped curves, and then we realized that we only blocked the PD-1 axis for 70%, whereas you probably need complete blockade to get sustainable activation of T cells, so first, we actually discovered that we needed to combine it with a PD-1 blocker, so we took the one which is most commonly used, pembrolizumab, and that is now also going to be tested in the phase III trial, and then we tested different dosing frequencies because basically when you overstimulate the immune system via 4-1BB, this is unique biology for 4-1BB.
You get actually less activity than you actually have less frequent stimulation of the system. And this is just inherent to the biology of that system. And it takes a long time. And then on top of that, bispecific antibodies like these have bell-shaped curves, so very complex kinetics. So it takes a lot more time than ADC. And an ADC molecule is either toxic or safe. And you see also whether it shrinks tumors or not. And when it shrinks tumors and it's not toxic, you can use it for a very long time, like Rina-S, because patients don't have to be taken off the molecule. So I think the mix is actually quite ideal when you have both access to immuno-oncology molecules and to different types of ADCs.
You can actually come to combination regimens which are completely chemo-free and potentially much better treatments for different types of cancer. So what we intend to do is to actually explore them broadly. We have also other immuno-oncology antibodies right now. We have an HexaBody-OX40 in dose escalation with fantastic preclinical data. So you'll probably see going forward a mix of immune checkpoint targeted molecules together with ADCs and likely combinations also in clinical trials. And I believe the biotech needs to speak for themselves, but I think they're thinking exactly the same, that this is the right approach going forward in order to progress therapy of cancer from very toxic types of therapy to much more benign therapies which are giving you more long-lasting positive effects on the lives of cancer patients. And that is, I think, the Holy Grail.
I mean, right now, we've made a lot of progress as an industry in the hematology field over the last years. And we have been, I think, very active together with J&J in multiple myeloma, essentially turning that deadly, incurable cancer into a cancer you can actually live with for many, many years with very good quality of life. But the reality is that in solid tumors, this is actually much more difficult. And I think with these new approaches, and I think you need courageous, innovative companies to actually take those approaches and test those approaches despite investors and analysts becoming restless at some point because it's not going quick enough for them. I see a number of them in the room now smiling. But I think we now have solid financials. We are very, very profitable. We intend to stay profitable.
We're going to bite in deep and actually hold on like a pit bull until we actually crack that.
It is a big component exactly what you just said of being an impatient analyst. But for 1042, when do you think you'll have enough duration to?
In the coming months. We think it's a matter of months, not years. So it's 25. Yeah.
And are you already testing it as an ADC combo? Is that something you still need to start doing?
No, I think the next step will be preclinical work, I think. We have numerous ADC programs now active. This is actually 40% of our pipeline right now. We have different categories of ADCs. We have ADCs where we actually combine it via the linker technology from Profound Bio with toxic payloads like topoisomerase inhibitors, modified tubulin blockers. But we also have immune activatory payloads.
Again, we look for synergies with immuno-oncology approaches like TLR7, TLR8, agonists. So we are now doing a lot of preclinical work, James. But I think once it's ready for prime time, we'll definitely flag that up at the market. But there's a lot of activity right now. But in the coming years, we want to actually focus in on the mid-stage and late-stage programs and actually do a lot more preclinically in the models, I think, before testing it at the clinic because it's far less costly and probably more efficient for the company.
I don't want Anthony to fill it out. I haven't asked him a question about spend.
So when you guide people, I'm not asking what the guidance will be, but will you guide, assuming that you don't have to pay for 1042 and that you're not having to spend extra money on anything with J&J in terms of renegotiating, and then we just see what happens after that? So I think you've, to some extent, said the 25 numbers now did make some sense in terms of how the market was thinking about spend, I think you said on the Q3 call. But under what assumption should that be that we're doing our modeling?
Yeah. So as we sort of think about 2025 investment levels, you're right, James. On the Q3 earnings call, I did indicate that I felt that the analyst consensus of around $2.4 billion is in a reasonable place.
Of course, we're going to provide our formal guidance on February 12th in conjunction with our Q4 earnings. There'll be lots of puts and takes and pluses and minuses, and I think what I said would take into account the scenarios around 1042 and/or HexaBody-CD38. I don't think that's going to necessarily drive the numbers too significantly one way or the other in 2025, so I think it can encompass all of those scenarios now. That's probably where I would leave it for now.
Maybe what I would highlight to build on the theme that Jan started to introduce is this concept of prioritization, where you're going to see increasingly not only the growth that we'll see next year in investment levels, but also the composition of our investment levels be more geared towards phase two registration trials and phase three registration trials, again, towards what's going to drive revenue as we exit this decade.
Makes sense. I think unless there's any very quick final questions, we've got to wrap up there. Great. Thank you very much.
Thank you.