Good morning, I'm James Gordon, JP Morgan European Pharma and Biotech analyst and today I've got the pleasure of introducing the Genmab presentation and we're gonna hear from Genmab's CEO Jan van de Winkel. Thanks very much for joining us today Jan and look forward to the presentation.
Thanks. James. It's a real pleasure to once again at the JP Morgan conference in 2024 give a presentation on our company. The slides of today's presentation will be available for download on our website immediately after the event, so let's get started. The presentation may contain forward-looking statements and as such may contain certain risks and uncertainties. I'm sure you're all familiar with that. Over more than 20-year history, we have 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 inspirational and ambitious vision for the company.
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 consistent and solid track record of success, as which you can see here on the left. The success is supported by an extremely strong financials that allow us to invest in growth opportunities and taken together, we have built a solid foundation that has supported our evolution into a fully integrated biotech innovation powerhouse. Our successes have been possible because of what makes us unique. We firmly believe in the natural ability of the immune system to fight against disease and we use our deeper understanding of disease mechanisms, targets and antibody biology to invent proprietary technologies.
This in-house expertise is matched with strategic partnerships that help us to take our products further than we can do on our own and give us access to high quality and unique disease targets and additional cutting-edge technologies that can be combined with our own. We leverage a combination of cutting-edge scientific capabilities and innovative scientific approach, our expertise in translational research and strategic partnerships to create a robust pipeline of potentially first-in-class or best-in-class products. H ere is a summary of our innovative clinical pipeline as it exists today. In green, on the top are 9 products or product candidates with at least 50% ownership of Genmab and this number will move to 11 very quickly once our next programs with BioNTech, GEN1059 and GEN1055, enter the clinic in the coming months.
Most programs either are or have the potential to be first-in-class or best-in-class including our two approved medicines, EPKINLY and TIVDAK and I will describe them later. In blue, you will see multiple programs being developed by partners that were either created by Genmab or via our proprietary DuoBody technology. There is no cost for us for these programs and once approved, they provide us with recurring royalty revenue. Thinking about that recurring revenue, let's take a moment to look at the high quality and the power of our discovery engine, which we believe sets us up very well for the long term. First, we have eight approved medicines, as you can see in the box on the righ that are part of our innovation and technology and are currently generating revenue for us. The top three are already blockbusters.
The remaining five have meaningful growth profiles and have the potential to become blockbusters or mega blockbusters. I can say this with confidence because we have the clinical development plans in place and with our partners, we are investing to make this happen. The six royalty-generating products are marketed by pharma and biotech powerhouses, J&J, Novartis and Amgen. Our two proprietary products are co-marketed with AbbVie and Pfizer and they are both considered potential blockbusters. So we are confident that we will realize this potential, especially with AbbVie and Pfizer on our sides. So now let's turn to the power of a highly productive R&D engine. Of around the 40 programs we have moved to the clinic as I noted eight are already approved and 19 are in active clinical development as we speak.
There's a high level of success compared to peers and this is no accident. We understood very early on that the competitive advantage of our deeper antibody science and focused discovery engine could provide. So we have invested more in discovery to increase the number and quality of our product candidates. This includes investment into our proprietary technologies, which we'll discuss on the next slides and we also have access to a suite of other technologies through our partners. This unique position allows us to bring only the products with the best potential through to development. I t's our deep insight into antibodies and our proprietary platforms that has helped us to discover, build or design the eight products that are currently approved.
If all eight approved products would be wholly owned by Genmab, we would have generated estimated revenue in 2023 of around $14 billion and as we move toward a model in the future where we have 100% ownership of our products, we believe that we continue this track record of success and further solidify our position as a biotech innovation powerhouse. So let's now take a look at our technologies. We believe that our diverse technology platforms are the key to our success. Genmab has four proprietary antibody technology platforms, including DuoBody and HexaBody. They allow us to select the most appropriate modality from our toolbox to tackle a specific disease target and of the eight approved medicines that are based on our innovations, half of them are DuoBody-based bispecifics.
One of these bispecifics is epcoritamab, which was approved in 2023 as EPKINLY in the U.S. and Japan and as TEPKINLY in Europe and the U.K. The approval of epcoritamab, which we are co-developing and co-commercializing with AbbVie, was an incredibly important milestone for patients in need of new innovative treatment options administered subcutaneously. As a reminder, Genmab is the commercial lead for EPKINLY in both the U.S. and in Japan, which is a first for our company. We are pleased with how the launch is progressing so far but the current approvals are only the first step to potentially establishing epcoritamab as the core therapy across diffuse large B-cell lymphoma, follicular lymphoma and beyond. In June, we announced positive top-line results from the follicular lymphoma cohort of the Phase 1/2 EPCORE NHL-1 trial.
The data supported 2 exciting regulatory actions last year. The FDA had granted breakthrough therapy designation for epcoritamab for adults with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy. The EMA has validated a Type II variation application for epcoritamab in the same indication. Together with AbbVie, we are advancing a robust clinical development program for epcoritamab across B-cell malignancies. In addition to the data in follicular lymphoma, you can also see this in the multiple Phase III studies currently in the planning and that we anticipate will be initiated in this year. So let's move to the next slide for a brief look at the broad clinical development program for epcoritamab. Together with AbbVie, we have an ambitious vision for development of epcoritamab.
In 2023, we had three ongoing Phase III studies, which you can see here on the slides. For 2024, we aim to potentially double that number with the addition of new trials, uh, that you see here highlighted in purple. These include a new frontline study in Follicular Lymphoma as well as additional Phase III trials in relapsed or refractory Diffuse Large B-Cell lymphoma and the encouraging data we have seen so far, including the data presented at the 2023 ASH Conference in December, further support epcoritamab's combinability and highlight its potential to move into these earlier lines of therapy. The first Genmab medicine on the market was TIVDAK, which we are co-developing and co-commercializing with Pfizer.
The approval of TIVDAK in September 2021 introduced a critically needed treatment option for patients with advanced cervical cancer, with disease progression on or after chemotherapy and it represents a significant scientific advancement as the first and only ADC for treatment of in this patient population that was approved. With the positive results from both the confirmatory innovaTV 301 study in cervical cancer and the data in head and neck cancer from the innovaTV 207 study last year, TIVDAK has cleared a very high bar for continued investment and development and we are very pleased with our plans to actively engage with health authorities on the next step for TIVDAK in both of the of these indications.
T his week, we actually announced that we got priority review for the cervical cancer data released last year. So we are very excited about that with a PDUFA date of May 9th . This was press released yesterday. We are also investigating a number of promising investigational medicines in collaboration with BioNTech. The most advanced of these are the DuoBody-based bispecifics, acasunlimab, previously known as GEN1046 and GEN1042. Both have the potential to be first-in-class in development for the treatment of solid tumors and we are very excited about the data that we have seen so far.
For acasunlimab, we are very pleased to announce—we were very pleased to announce in November last year, that we have actually planned engagement with health authorities on the design of a pivotal trial in second-line non-small cell lung cancer and that we would share the clinical data on which this decision was based on a medical conference in the first half of this year. In addition to maturing this program and also expanding it with a Phase II trial in endometrial cancer, that was initiated last September. For GEN1042, we remain very encouraged by the clinical efficacy data we are seeing in multiple tumor types and we anticipate that we will have the data we need to determine next step for this program this year.
The alliance of Genmab's expertise in antibody biology and development and BioNTech's immuno-oncology know-how creates a very powerful partnership and we look forward to working together to advance other investigational medicines, including GEN1053, which is called HexaBody -CD27 and next in the clinic in the coming time, GEN1059, which is standing for DuoBody-EpCAMx4-1BB, so the third 4-1BB targeted bispecific program and GEN1055 or HexaBody -OX40, another HexaBody-based molecule. But it gets better. There are three additional Genmab owned medicines in the clinic at this moment. First is GEN3014 or HexaBody -CD38, which we are developing in an exclusive worldwide license and option agreement with Janssen.
GEN3014 was recognized at ASH in December last year with a poster presentation on preliminary results from the expansion cohort at the recommended Phase II dose of the ongoing Phase I/II trial. We are actively enrolling now in the head-to-head trial with daratumumab, the gold standard in multiple myeloma and we hope to have the data in the second half of this year and we are very encouraged by what we are seeing. As we have said previously, we anticipate the head-to-head data in the second half of 2024. Looking at some of our earlier-stage programs, the Phase I/II trial of GEN1047 or DuoBody-CD3xB7H4 is currently in the dose expansion Phase an important step in progressing our CD3-based bispecific platform in solid tumors.
GEN3017, or DuoBody-CD3xCD30, which you see here on the right, started recruitment for a first-in-human trial also last year. Our expanding and maturing pipeline is possible because of strategic investments in key areas. One, research. Building on a strong track record, we have actually have a state-of-the-art R&D facilities in both the Netherlands and in u.s and we continue to invest in new antibody technologies and next-generation therapeutic antibody formats, in addition to the four which we already have. Two, development. We are focusing on scaling up so that we can rapidly move from early to late stage clinical development. We see significant potential to drive insights through data sciences, so we are investing very heavily in data sciences and artificial intelligence right now.
I believe that data science and real-time integration of translational research are key to accelerate product development in the future and to ensure the right therapies get to the right patients more effectively and three, commercialization. We have a highly experienced team in place and now two successful launches with the approvals of EPKINLY and TIVDAK. Underpinning all of this is investment in key enabling functions to actually support growth and to manage risk and this investment we can do in part because of our strong recurring revenue streams from the six approved medicines that you see here on this slide. These medicines, which are powered by our technology and innovation, exemplify the commitment to applying the world-class antibody expertise to create truly differentiated antibody therapeutics with the potential to fundamentally improve patients' lives.
The success of approved products also demonstrates the benefit of working collaboratively with strong partners, complementary with Genmab in terms of technologies, capabilities and knowledge across the whole innovation ecosystem of pharma, biotech and other tech and academia. 2024 is anticipated to become our twelfth year of profitability, which is quite unique for a biotech company. The products on the market that we have discussed provide us with significant recurring revenue growth and this growth lets us invest in our pipeline and our organization, allowing us to create significant long-term value and evolve for continued success. So, which gives us a strong backbone of significant underlying profitability. In 2023, Genmab made key strides towards meeting its 2030 vision, making for a transformative year in our company's history and our patients' care.
W e are not resting on our laurels. 2024 is shaping up to be just as momentous, further establishing our independent destiny as a company and giving the people we help new ways to fight disease. So now I will tell you how. We anticipate multiple approvals this year for epcoritamab. This DuoBody-based bispecific co-developed with AbbVie is Genmab's second company-owned product to hit the market and we expect to receive European and U.S. approvals in follicular lymphoma in the second half of 2024. In the meantime, we look to file for approval in Japan in this indication in the first half of 2024. As I already mentioned, we will also start multiple Phase III trials with epcoritamab, with the goal of moving to earlier lines of therapy and that's where we want to be.
TIVDAK, our first company-owned therapy, is ready to file with the regulatory authorities in Europe and Japan for cervical cancer, in addition to the acceptance of the BLA this week in the us and that will happen in the first half of this year, this filing. We are engaging with health authorities on next steps in head and neck cancer, so we will broaden this from cervical cancer into other cancers now in the coming time. Promising data from GEN1046 now known as acasunlimab, is forthcoming in the first half of 2024 while we engage with health authorities planning for Phase III. Not far behind, we are eager to share data also for GEN1042 in 2024, which may include head and neck and squamous and non-squamous non-small cell lung cancer.
As these programs progresses, we will also be pushing forward with other promising programs, including data from gen1047 and you will see that data this year at a conference. Finally, we look forward to the highly anticipated results of the head-to-head trial of GEN3014, which gets a lot of attention right now, versus DARZALEX FASPRO in the second half of this year. In summary, we have a laser-sharp strategy, that will effectively drive us forward towards our 2030 vision. This vision will continue to act as our guiding light, anchored in our core purpose, where our own unstoppable team will improve the lives of patients through innovative and differentiated antibody therapeutics.
Our first two Genmab-owned medicines are now on the market, giving us a strong rationale to make focused investments to to make the most of 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 patients with cancer and other serious diseases. The best is yet to come and now we are ready for Q&A and I hope it will be lively and energizing.
Do you want to bring anyone up with you, or?
Should I sit down?
Do you want to bring any other members of management up with you, or?
Anthony is more than welcome to join.
Great, thanks very much for the presentation and does anyone have a question in the audience they'd like to start with? In that case, I'll start us off, which would be HexaBody -CD38. Just how differentiated do you think this asset is shaping up to be versus DARZALEX? And my question will be on a few parameters. How does it look if we try and compare efficacy? But also, are there any concerns on tolerability? Is there potentially a tolerability challenge here?
HexaBody -CD38 is pre-clinically at least tenfold more active than daratumumab. This is like a miracle. D aratumumab is one of the most active antibody therapeutics I've seen in the last 30 years, which is one of the reasons that it is actually doing so well in multiple myeloma now, James. HexaBody-CD38 pre-clinically is at least tenfold more active, in some cases, many, many-fold more active than daratumumab. That's a completely different mechanism of action, so we're now testing it out basically in patients after an IMiD and after a proteasome inhibitor. It's naïve to CD38 targeting molecules.
What we see actually in the most recent data in 90 evaluable patients, recently at the ASH conference, that basically we see in 6 of the 9, really, really impressive responses. This is roughly double the response rate which we've ever seen with monotherapy of daratumumab. E fficacy-wise, this clearly seems to be shaping up as being differentiated, albeit that this is a very small data set and we need to await the proper head-to-head arms data, which will come this year. Then safety-wise, we believe that this is actually an antibody which we can very safely administer to patients.
T here was actually some turmoil last year about some Grade five events, which we announced in the abstract for that presentation at the ASH. But it was one patient which was diagnosed with COVID and we know that these patients which are COVID infections are infected are very patients with B-cell cancer which which got COVID are really trouble. We know that also from other companies, so that may actually explain that Grade five event. There was another patient with cardio with a cardiac arrest and we also know that basically cardiac complications happen a lot in COVID-infected individuals.
This patient was not tested for COVID, james but it is actually not unlikely because the expansion arm was run during the pandemic, that this patient was also infected with COVID virus and then there was a bit more turbulence about a second patient with a Grade 4 cardiac problem among the expansion cohort patients at the ASH presentation. We are not too worried about that because the patient had a history of cardiac events and plus, the cardiac events actually happened at the cycle 8, so very far during the treatment. That's not logical to link that to the medicine, because then you would expect it to happen much earlier, actually, in the therapy.
Answering your question, you can never exclude that this is a very safe molecule until you have done more data analysis, james but you're not overly worried about the safety pattern of HexaBody-CD38 and we are very impressed by the initial efficacy data, so we are very excited about that data set shaping up in the coming months.
Thank you and when you say shaping up in the current months, so what further data will we see from that study? And then when will we get data from the head-to-head study?
T he data from the head-to-head study will very likely be visible in the second half of this year and it all depends on how quickly we can recruit the two arms in the, in the study and we will give you an update at regular intervals on how far we are with the recruitment. Right now, we are on track to have all the head-to-head data in the second half of this year and we will, of course, also follow the expansion cohort data in time, because what we seem to see with HexaBody-CD38, that actually not only do the patients get into deep responses, the responses get better and better in time and that's exactly what you would expect to happen with a well, a well-working antibody therapeutic.
W e will probably update you also at some medical conference with further data from the expansion cohort in this year. We have not yet decided, James, at what conference that will be.
Will the expansion cohort be just the same number of patients followed for longer, or will there be further patients that we'll actually see any data on?
No, the expansion cohort is only that same number of patients, because we only needed that expansion cohort in order to get the green light to do the head-to-head study. The real value of the comparison will be to compare HexaBody-CD38 with the gold standard, which is Darzalex.
W hen we do get the head-to-head data, how rough, how robust do you think the initial data set is in terms of trying to extrapolate how much better the efficacy is? 'Cause it's than DARZALEX, it's a single arm study.
Would you expect to see the same magnitude of differentiation in the Phase II or is that a bit too ambitious?
I t's very difficult to predict until you have seen the data, james and I haven't seen the data. But what I can tell you is that in the expansion cohort, arm, which is the data we are discussing now from, from ASH last year, patients were very heavily pretreated, much more heavily pretreated than 10 years earlier in the very first monotherapy, data with daratumumab. Don't forget that some of these patients had already seen CAR T, others had seen bispecifics, which were not even existing and usually in cancer, once you actually, get patients in later lines of therapy, which have been more heavily pretreated, they are more difficult to get into a response. Despite that, we saw roughly double the response rate and much deeper responses with HexaBody-CD38. In the new cohort, the head-to-head cohort, they're very precisely stratified.
N ow it's much easier to compare the potency of both therapeutic candidates and actually the expansion cohort data bodes quite well but it's very difficult to predict, James, what will be the response rates there. But I would not be surprised whether it would be even better than what you see in the expansion cohort.
Thank you. With the caveats of cross-trial comparison, the data looks impressive but is there still gonna be a big role for CD38 therapies in the future? I know J&J had an analyst meeting recently and they talked about some new therapies in multiple myeloma, including things like bispecifics, including yours and also CAR T therapy like CARVYKTI. So is there gonna be a big role for CD38s in ten years' time?
Absolutely, if you have listened carefully to J&J's presentation, they also say that, well, in all of the combinations, they use the CD38 targeting as a backbone and no matter whether you're talking bispecific antibodies, next-generation IMiDs, or even CAR Ts, it's going to be combined with a CD38 and to actually have access to a much more potent CD38 next-generation molecule is hugely effective when you realize that the publicly stated ambition for J&J is to actually move towards a curative regimen for multiple myeloma, which is still the third most common blood cancer and still is incurable up to today and don't forget that also, not all patients with multiple myeloma responds to an anti-CD38 antibody like daratumumab and also other patients stop responding to an anti-CD38.
One of the things which HexaBody-CD38 does, it actually can kill tumor targets with lower levels of expression of CD38 than daratumumab can. T his is hugely interesting. The other more interesting question is well, can you even do trials? Because when you look at the recent data from the PERSEUS trial, which is the dara-VRd trial, which came up at ASH in December last year, the data is just phenomenal, like absolutely phenomenal and completely game-changing. The real question is about well, practicability of doing trials, because this already took years to get to the readout point for PERSEUS.
When you have an even more potent combination, you can, in the future, envision trials which would take 10 years or 12 years before they can read out, which is probably impractical and not very good for patients either, because when you let them wait with a working mechanism that long. W hat we need is a proactive action from the regulators to allow companies to actually use molecular endpoints earlier on in these frontline studies and multiple myeloma is probably one of the best possible areas where you can use a molecular endpoint like MRD negativity to the 10^-5 degree.
Because we have shown in multiple daratumumab studies now together with Janssen, that that deep MRD negativity does correlate with both PFS and does correlate with overall survival in a very, very stringent way. I t depends now it's back to the regulators to really dream up for the future with these more and more potent regimens how you can actually basically stimulate companies to do new new combinations and what we should all try to do is actually make better and better, better therapies for patients. I'm super proud that daratumumab is now already benefiting the lives of at least 450,000 patients as of, as per Q3 last year.
I hope that that number goes up steeply over the coming time, because in that way, you really improve the lives of those patients and the families of those family members of those patients and create a better world and that's in the end, the goal for our company: to actually do our work so that we can actually not only give better treatments to patients but also create a happier and better world and a good return on your investments for all the investors who are smiling here now in the room.
If all goes the way you hope it will be the Phase II head-to-head looks good and the FDA is receptive to doing a trial design that you think would be good, roughly what timeline could the product be on the market?
I it's difficult to predict. Let's assume that we have the data this year from the head-to-heads, that Janssen would opt in, because they need another CD38 targeting molecule with better potency than the current gold standard. Let's assume that we see a difference in how the agencies actually deal with frontline combinations.
T here is a lot of discussion on this frontrunner program now, which is contemplated by the FDA, where the FDA would allow a sponsor to use a molecular endpoint, actually to use one trial where you add a new agent to a frontline regimen, which is probably going to be VRd based on the PERSEUS data, which is the most potent and then use a molecular endpoint for the conditional approval. You could potentially see that it will take a few years to recruit this trial because they, the Janssen will very likely power it very sufficiently-
To make the chances optimal that they will actually see a difference in an already very actively active combination of therapy. I t would take at least 3, 4 years before you would but then you could potentially under that assumption, James, you could potentially have it in front line, which is where 50% of the patients are, which could be very impactful there.
I t's a big decision and it would have a significant impact on Genmab. Does J&J's decision to opt in on or not opt in change how you do anything else with the business?
T his is what we are now doing is trying to facilitate that we get the data as quickly as possible and as I just described in my presentation, Genmab has no shortage of programs. W e have an amazing pipeline now of nine proprietary clinical programs. We will soon have eleven programs and the goal for this year is to move a number of those programs into Phase III and we have very good chances that we can do that then and then maximize the potential of those product candidates and potentially stop other programs James or maybe even license them out to partners and we are not interested in upfront money because we are very well capitalized now.
We have north of $3.5 billion, which I showed in my presentation and no debts. So we can actually put significant firepower behind the development of some of these molecules. But we would like a potential partner to invest their monies and their resources into developing product candidates and then give us an option on 50% co-ownership once the molecule works. So what you will see is us focusing on two or three of these programs, which we hope can have determined as winners and then maximize the attention there, because that is the best way to create more value. T hat's what we all learned in biotechnology.
Once you have a winner, you can actually build much easier, big value, like daratumumab shows, by expanding the potential of that winner than to wait on the next winner. So what we are doing now is as rigorously as possible try to zoom in on the winners or on the candidate winners and then expand the program like we're doing with EPKINLY right now, because this is only the beginning. The program we have now shown you today for EPKINLY is only part of the program because we already envisioning other combinations, also novel combinations here in different B-cell cancers, because that's what we want to do. We want to actually really push the treatment of B-cell cancers into a completely new space basically with EPKINLY as the base.
Thank you and we've got Anthony with us as well, so CFO of Genmab. My question for you would be OpEx. So OpEx has grown somewhere between 30%-50% in the last couple of years. There's been quite a lot of investment in all this pipeline Jan's been talking about. Is that set to continue? Is there a lot more you need to invest in this year and in subsequent years? And what are the moving parts around that?
A s we got into 2023 and we gave our guidance in February of, of last year, we were super clear about our investment priorities and really quantified that year-over-year growth. At the same time last February, very carefully articulated what the transition in terms of our investment levels would look like moving forward and particularly, really putting a finer point on the key drivers of investment as we transition from 2023 into 2024 and we've been reiterating those messages consistently throughout the entire year and really went through it again on our Q3 earnings call. But let me just take a minute and unpack that here for, for you and for the audience. As we think about our business and we think about maybe our overall investment, put it into two key categories: R&D and then SG&A.
If we think about R&D and really zooming in on the R or the discovery we looked at that part of our business a couple of years ago and concluded it was an underutilized asset. So we materially scaled up their investment there, in terms of really unleashing the power of that discovery engine. That R part of our business or discovery is now reaching a place where that investment will certainly more significantly moderate here as we move from 2023 into 2024. Now, moving forward, the composition can change but the investment level and the quantum is now getting to a place where we think it's at the right level. On the development side, we've been really clear here the swing factor is gonna be new Phase IIIs. We've been very clear that epcoritamab is absolutely in growth mode here.
We took the opportunity at our post-ASH conference to highlight the 3 new Phase III trials, we now have 6 Phase III trials that are up and running for epcoritamab. Now, beyond that, what we highlighted was that the swing factor for 2024 would be new Phase IIIs. Here on our Q3 earnings call pending regulatory feedback, we announced our intention to start a new Phase III or a first Phase III for 1046 in the post-IO space, second-line lung cancer and also potentially, again, pending regulatory feedback, a Phase III trial in second-line head and neck cancer for TIVDAK. T here moving forward, the point is that incremental investment in R&D is really gonna be focused on potentially revenue-generating Phase IIIs, which is good news for our investors.
Now, if we quickly unpack, SG&A, here, again, you'd look at that as two distinct investments. First, G&A. As Jan highlighted, we scaled up our business and here to give you a proxy for that scale-up was, we had 547 people at the end of 2019. This year, we're gonna exit 2023 with some multiple of that, with somewhere in the mid-2,000s. We had to make important investments in G&A to support the growth and manage risk. I'd say to a large degree, those investments are now in the rearview mirror. W e're really focused on driving that G&A number and keeping it at the level it's at, today or have moderate, very moderate growth. Now to complete the story on the S side selling or commercialization.
Here, we've highlighted two key markets that we wanted to build out as we entered into commercializing our products and here was the United States and Japan and you know what? Thank God, James, we made those investments, 'cause you can see how it's proven out in the performance so far with TIVDAK and here is we've been competing very vigorously with EPKINLY in the marketplace. Now, as we transition to 2024, the driver of the growth is really gonna be the annualization impact of the investments we've made. Now, there you should be thinking about the U.S. launch for EPKINLY being in May, as well as the launch for EPKINLY in Japan coming later in the year, in November, so it'll be a much more significant annualization impact.
But the net is, really, if we step back, that we have a really focused, disciplined, bottom-up approach to investment. We're really now focused on allocating the incremental investment into these potentially revenue-generating, Phase IIIs and we won't shy away from making those investments if it makes sense to do so. Hopefully, that gives you a nice, picture and then the final message just to wrap up this has been entirely consistent. If we zoom back, I said you can go back look at the transcript from last february and I bet it's 95% the same message, so hopefully that helps.
Thank you for the consistent message.
There you go.
We're almost out of time. There's lots of pipeline I could ask about but maybe one earlier project. Jan, you mentioned CD3 B7H4 and that's Phase I data and I don't believe we've seen any data for that before. So what are we gonna see for that? And am I right, that's an unpartnered asset, what might you do with that?
T his is a very exciting T-cell engager for the treatment of solid tumors and that has been very difficult. CAR T or T-cell engagers for solid cancers have not been very successful until now and we are seeing very encouraging signals with the DuoBody in the dose escalation. We've done a mix of different tumors at least 10 different cancers and we have now reached the optimal dose. From that, we can conclude, James, that we have seen signals there during the dose escalation and that it was also safe to give that bispecific T-cell engager and we used a very unique composition of that engager. We have not yet disclosed what uniquenesses of that engager but B7H4 gets more and more popular.
The ADC concepts, the also other T-cell engager concept but this one is doing particularly well. So you will see all the data from the dose escalation. We're right now doing a dose expansion at the optimal dose and we may actually play a bit more about the dose in order to. When we continue to be enthusiastic about the data, what you probably need for in the context of the FDA Optimus program is different dose variations and more data there, so that the FDA is convinced that you've actually given the lowest possible dose, which is active and efficacious to patients, so that you are allowed to move to a pivotal study. So this year you will see the data from the dose escalation study, maybe some initial data from the expansion cohort data.
We have not yet zoomed in on a specific cancer or cancers data to or change to really focus our attention on for future developments. I can tell you there's a lot of interest already from pharma companies and other companies on the Verbatum that we will actually show data this year and we have not yet decided what to do with the program. We could actually hold on to it ourselves but as I said, well, the key strategy for the company is to zoom in on two or three winners and it depends on how the other programs progress within this year. W e have some very good candidates. Our pipeline has a higher quality than we ever had before in our history.
We have one of the best track records in biotech in creating new products. We have described that today, unprecedented track record and we're getting better and better on it. T his is definitely a nice candidate and you will see data this year at a medical conference.
Great. Thank you very much. I can see we're now out of time, so thanks very much.