Genmab (NASDAQ:GMAB), the Denmark-based biotechnology company, reported strong financial results for the third quarter of 2023 in its recent earnings call. The company's net sales grew by 22% in the first nine months of the year, reaching nearly DKK 11.8 billion ($1.8 billion). The robust financial performance was driven by recurring revenues, which also grew by 22%, and the sales of DARZALEX, a key product of Genmab, which saw net sales grow by 22% to nearly $7.2 billion.
Key takeaways from the call:
- Genmab's cancer drug, Epcoritamab, co-developed with AbbVie (NYSE:ABBV), received approvals in Japan, Europe, the US, Canada, and the UK for the treatment of certain types of relapsed or refractory large B-cell lymphoma.
- Other programs in Genmab's pipeline, such as GEN1046 and Tivdak, have shown promising results and are progressing towards regulatory approval.
- Genmab continues to invest in its pipeline and expand its capabilities. Operational expenditure (OpEx) was up 42% in the first nine months of 2023.
- Genmab adjusted its 2023 financial guidance, expecting revenue to be in the range of DKK 15.9 billion to DKK 16.5 billion and OpEx in the range of DKK 10.6 billion to DKK 10.9 billion.
During the call, Genmab executives shared updates on various ongoing studies and programs. They expressed confidence in the market potential of EPKINLY, which saw $22 million in net sales for the quarter and $28 million year-to-date. The potential of GEN1046 in post-checkpoint inhibitor lung cancer and its positive results in non-small cell lung cancer were also discussed. Furthermore, a Phase II study for GEN1046 in endometrial cancer is set to commence.
The company also outlined plans for significant Phase 2 work on CD40/41BB and PD-L1/4-1BB in 2023, and potential late-stage development for these drugs. Genmab plans to continue investing in R&D to maximize the value of their current tech platforms and generate new investigational new drug (IND) candidates. On the sales, general and administrative (SG&A) side, growth is expected to moderate as they approach scale, with some incremental investments anticipated as they potentially expand the EPCO label.
Jan van de Winkel, CEO of Genmab, announced plans to provide more detailed information on the development plan for EPKINLY (epcoritamab) at a post-ASH update. Anthony Pagano, CFO of Genmab, discussed the company's investment strategy, highlighting continued investment in growth opportunities and potential late-stage development for CD40/41BB, PD-L1/4-1BB, and Tivdak. He also confirmed that OpEx levels for 2024 will be guided by the company's investment priorities, with R&D investment expected to increase as Phase 3 trials for EPCORE are initiated, and G&A growth moderating as the company approaches scale.
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In addition, Genmab's stockholders receive high returns on book equity, and the company's cash flows can sufficiently cover interest payments, providing further evidence of its solid financial health. Despite the stock having fared poorly over the last month, the company's strong financials and analysts' positive earnings revisions suggest potential for future growth.
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Full transcript - GMAB Q3 2023:
Operator: Hello, and welcome to Genmab's Third Quarter 2023 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delays or and successful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going. Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.
Jan van de Winkel: Hello, and welcome to Genmab's conference call to discuss our financial results for the period ending September 30, 2023. With me today to present these results is our CFO, Anthony Pagano. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky; our Chief Operating Officer, Anthony Mancini and our Chief Medical Officer, Tahi Ahmadi. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. Genmab's strong foundation is built on our consistent track record of success. As we near the end of the year, it's a good time to reflect on how far we have come as a company even in the last 12 months. We continue to expand our pipeline with new INDs and new product candidates in the clinic. We also matured our pipeline with new clinical trials and positive data readouts. And very excitingly, there are now eight approved medicines that are followed by our innovations, half of which were created with our proprietary DuoBody technology. Epcoritamab which we are codeveloping with AbbVie is also our first medicine to be approved for patients and territories outside the US. These advances are possible because we have a dedicated and unstoppable team at Genmab, an international team that has grown to enable us to continue to evolve into a leading integrated biotech innovation powerhouse. Let's now turn to recent key company events. September was an exciting month for epcoritamab as we and AbbVie received approvals in both Japan as EPKINLY and Europe as TEPKINLY. Like the approval in the US earlier in the year, these approvals were important milestones both for our patients and needs and for Genmab as a company. The approval in Japan is especially significant, as we at Genmab are the commercial lead for EPKINLY there. We began growing our presence in Japan in 2019. So we would be ready for just such an opportunity. So we are very pleased to be launching our own product there, especially as EPKINLY as the first and only bispecific antibody approved in Japan to treat adults with certain types of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. And we are excited to note that in addition to the US, Japan and Europe, epcoritamab has now been approved in Canada and the UK. I'm also happy to announce that once again the broad potential of epcoritamab to become a core therapy for B-cell malignancies will be on display at this year's prestigious ASH Conference at the end of at the beginning of December. We have had 15 total abstracts accepted for presentation at ASH, two of which are oral presentations. Of the accepted abstracts, four will be initial disclosures of clinical data for epcoritamab including an oral presentation of data from the EPCORE NHL-5 trial of epcoritamab in combination with lenalidomide as treatment for patients with relapsed or refractory diffuse large cell B-cell lymphoma. This data is further support for EPCORE's combinability and highlights its potential to move into earlier lines of therapy. HexaBody-CD38 will also be recognized at ASH with a poster presentation on preliminary results from the expansion cohort at the recommended Phase 2 dose of the ongoing Phase 1/2 trial. We are actively enrolling in the head-to-head portion of the trial. We are very encouraged by what we are seeing. And as we said previously, we anticipate to have to have data in 2024. If we look beyond our own pipeline and include all abstracts involving products that are powered by Genmab's innovations, there are nearly 200 total abstracts accepted for presentation at this year's ASH meeting 36 of them oral presentations. Now I want to turn to some additional exciting updates on the progress of our maturing proprietary antibody product pipeline. First, GEN1046. It has cleared to the high bar that we set. We are very pleased to share that we are now engaging with health authorities to determine next steps. Previously, we shared data from an expansion cohort of patients with non-small cell lung cancer who failed prior checkpoint inhibitors. We saw encouraging single-agent activity, but responses are not durable. Based on clinical and strong preclinical data that showed that the combination of GEN1046 plus checkpoint inhibitors resulted in improved efficacy, we embarked on a scientific question, how to most optimally engage 4-1BB activation with checkpoint inhibition? The Phase 2 study of GEN1046 in combination with pembrolizumab in patients with PD-L1 positive non-small cell lung cancer who failed standard of care therapy with an immune checkpoint inhibitor address this question And emerging data from this study has provided us a clear answer. So far the data from this study indicates that we can combine these two mechanisms and that this leads to improved efficacy. Based on this, we believe there is a clear path forward and we are engaging with health authorities to determine next steps. We look forward to sharing the relevant clinical data at a medical conference in the first half of 2024. As a reminder, we are developing GEN1046 with BioNTech (NASDAQ:BNTX). Moving to Tivdak. We were very pleased that we along with our partner Seagen presented the late-breaking results from the innovaTV 301 trial of tisotumab vedotin in recurrence or metastatic cervical cancer during the presidential Symposium of the Asthma Congress in Madrid in October. This follows the announcement by us and Seagen in September that the trial met its primary endpoint of overall survival. As a reminder, the results of this trial are intended to serve as both the pivotal confirmatory trial for Tivdak's accelerated approval in the US as well as to support global regulatory applications. Likewise, Tivdak has also cleared the high bar that we set. We are optimistic about the data, we have seen in head and neck cancer post standard of care. Here, we will actively engage with health authorities on next steps in this indication. Moving to GEN1042. We are also co-developing with BioNTech and we remain very encouraged by the clinical efficacy data that we are seeing across several tumor types. We are currently taking the learning's from GEN1046 on how we can optimally dose and schedule GEN1042. We need more time to do this so we now anticipate that we will have the data we need to determine next steps for this program in the coming months. Looking at some of our earlier stage programs, I have a brief update on GEN1047, our DuoBody CD3B7H4. We have now completed dose escalation in the Phase 1/2 trial and have transitioned to dose expansion. This is an important step in progressing our CD3-based bispecific platform in solid tumors. GEN3017 our DuoBody-CD3xCD30 a program that we announced last quarter has now started recruitment for our first-in-human clinical trial. We're also very pleased to announce another IND submission for 2023 GEN1059, our DuoBody-EpCAMx4-1BB. The first preclinical disclosure for this program which will further leverage our knowledge of 4-1BB also took place at ESMO in October. This bispecific antibody which we are codeveloping with BioNTech has potential in solid tumors. We anticipate that GEN1059 will enter the clinic in 2024. Finally, as we work to progress these new and existing programs we have also made the decision to seize development of GEN3009, our DuoHexaBody-CD37. This decision was made following its strategic evaluation of the program within the context of our entire portfolio and was not based on any safety or regulatory concerns. Our goal of transforming the lives of patients is always at the center of our decisions and we look forward to continuing to create and develop truly differentiated antibody products. The power of our innovation is reflected in programs that apply our DuoBody technology. Two of these products are Janssen's Talvey and Rybrevant. In August Talvey was approved in both the US and Europe for relapsed or refractory multiple myeloma making it the fourth approved DuoBody-based bispecific antibody. Also in August, Janssen submitted an sBLA for Rybrevant followed by a type 2 extension to the EMA in October. Both of these submissions are based on the confirmatory Phase 2 pro longed study. So overall you can see plenty of progress across our business with lots to be excited about as we look forward. And that's a good note on which to hand over to Anthony Pagano and he will take you through our financials. Anthony the floor is yours.
Anthony Pagano: Great. Thanks, Jan. We continue to strengthen our foundation over the first nine months of the year. Of course, top of mind for everyone are the multiple regulatory approvals for EPKINLY. And as we'll see our financials continue to be strong. Recurring revenues grew by 22% on a reported basis and impressively 30% on an operational basis. This was principally driven by strong royalties from DARZALEX, along with significant growth from our other seven approved medicines. Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build the team and capabilities, we need to succeed. So let's look at those revenues in a bit more detail. We continued to see strong performance for DARZALEX, during the first nine months of the year. As you can see in the chart, overall, net sales grew by 22%. That's net sales of nearly $7.2 billion which translates to over DKK 8 billion in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting. So DARZALEX remains a key driver of our revenue. We grew total revenue to almost DKK 11.8 billion in the first nine months of the year. And as I've already highlighted, that included a 22% increase in our recurring revenue. And to be clear, that's on a reported basis. Excluding some FX headwinds, recurring revenues grew by 30% on an operational basis. Last year's results make for a somewhat tough comparator, as we saw pretty significant FX tailwinds, particularly for our royalty revenue. As a reminder, under our DARZALEX agreement, for purposes of calculating our royalties, sales outside the United States are translated to US dollars at a specified annual hedged foreign exchange rate. Operational growth in the first nine months of this year, continued to be strong, driven by higher DARZALEX royalties as well as royalties from our other products, and this really illustrates the power of our recurring revenue. We also recognized the first full quarter of sales for EPKINLY in Q3. And we're very pleased with how the launch is progressing so far, with around $22 million in net sales for the quarter and $28 million year-to-date. Overall, our strong recurring revenue growth enables continued highly focused investment, as you can see on the next slide. Back in February, we were very clear that we would continue to invest to capture the opportunities we see in front of us. And that's exactly what we've done, with total OpEx up 42% in the first nine months of the year. At that time back in February, I outlined our top four investment priorities. First, securing a successful EPKINLY launch by, investing in our two key markets, the United States and Japan. Second, continuing to advance our pipeline. Here the lion's share of our investment is being directed to our most advanced programs including EPKINLY, Tivdak, 1046 and 1042 which are all exciting opportunities for us. Third, investing in our world-class discovery engine, including focused investments to expand our therapeutic focus to include, I&I. And fourth, foundational investments and enabling functions to achieve required scale. As you can see, our investments continue to be fully in line with these priorities. And as always, we continue to focus on long-term value creation. So with that let's now take a look at our financials as a whole. Here you can see our summary P&L. Revenue came in at close to DKK11.8 billion. That's up 26% on last year. As mentioned that's negatively impacted by FX headwinds. Total expenses were around $8 billion with 71% being R&D and 29% SG&A. And even with the increased investment and significant FX headwinds, we're still delivering around DKK3.7 billion of operating profit. Moving now to our net financial items. Here we have a gain of over $1 billion so far in 2023. This is driven by an increase in interest income due to higher effective interest rates, as well as the strengthening of US dollar against the Danish kroner in the first nine months of the year. Then we have tax expense of about $1 billion, which equates to an effective tax rate of 21.2%. And that brings us to our net profit of over DKK3.7 billion. So as you can see continued strong underlying financial performance. With that let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. With the approval of EPKINLY in May and TALVEY in August there are now eight products on the market that are generating recurring revenues for us, and we expect significant cash inflows for the years to come. Moving to the right. We remain focused on our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding EPCORE. But that's just one of the exciting opportunities that provide us with a compelling rationale for increasing our investment. As we've told you before, if we want to seize these meaningful opportunities we've got to invest and that's exactly what we're doing. So with that background, let's take a look at our guidance. As you can see, we are adjusting our 2023 financial guidance. In summary, we are lifting the bottom end of our revenue and OpEx ranges. This is due to current year-to-date performance and the strong US dollar. This, of course, has the effect of tightening the ranges across the board. We now expect our revenue to be in a range of DKK15.9 billion to DKK16.5 billion. One of the drivers of this increase is higher DARZALEX royalties. So we've increased our guidance here to DKK11.3 billion to DKK11.5 billion. Turning to our investments. As always, we remain focused on executing against our strategy and key priorities and at the same time creating long-term value. So we're investing to capture the significant growth opportunities in front of us. And here we're increasing the bottom end of our OpEx guidance, to a range of DKK 10.6 billion to DKK 10.9 billion. This is primarily related to increased and accelerated investment in epcoritamab clinical trials and the progression of other pipeline products including, 1046 and Tivdak. Putting all this together, we're on track to deliver another year of substantial operating profit in a range of DKK 4.8 billion to nearly DKK 5.8 billion. As a reminder, note that these projections are based on an assumed US dollar-Danish kroner exchange rate of 6.8. And finally, to give you a bit more color on FX, every 10 basis point move in the exchange rate relative to our guidance rate, is worth around DKK 80 million in operating income for the balance of the year. Now before I wrap up, I do want to take a moment to zoom out a bit, and take a look at the very high quality of our revenue profile and the power of our discovery engine. We believe this powerful combination sets us up very well for the long term. First, let's think about the eight approved medicines, you can see in the box in the top right-hand side of the page, that are powered by our innovation and technology and that are currently generating significant revenues for us. The top three, are already blockbusters. The remaining five, all have meaningful growth profiles and have the potential to become blockbusters. I can say this with confidence, because we have the clinical development plans and with our partners we're investing to make this happen. The six royalty-generating products are marketed by pharma and biotech powerhouses, J&J, Novartis (LON:0QLR) (SIX:NOVN) and Amgen (NASDAQ:AMGN). And our two proprietary products are co-marketed with AbbVie and Seagen and moving forward we anticipate Pfizer (NYSE:PFE). So, we're confident we will realize their potential. Now, let me turn to the power of our discovery engine. Of around the four programs we've moved into the clinic, eight are already approved and 19 are currently in active clinical development. That's a pretty strong hit rate and it's no accident. We understood very early -- we understood very early on, the competitive advantage that our deep antibody science and focused discovery engine could provide. So, we've invested more in discovery to increase the number and quality of our product candidates. This includes investment into our proprietary technology platforms. We believe that these diverse tech platforms are key to our success. They allow us to select the most appropriate modality from our toolbox, to tackle a specific disease target. We have four proprietary tech platforms including DuoBody and HexaBody 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. It's our deep insight into antibodies and our proprietary platforms that have helped us discover, build or design the eight products that are currently approved. If all eight currently approved products we're wholly owned by Genmab, we would have the potential to generate estimated revenue here in 2023 of over $14 billion. As we move forward to a model in the future where we have 100% ownership of our products we believe we can continue this track record of success and further solidify our position as an innovative biotech powerhouse. Now to really wrap up let me provide a few closing remarks. In summary we've had a solid first nine months of 2023. We've created growing recurring revenue streams including now two of our own products on the market and that gives us a strong backbone of significant underlying profitability. And we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us. And on that note I'm going to hand you back over to Jan.
Jan van de Winkel: Thanks Anthony. We continue to work towards our goal for the year and are especially excited about the multiple approvals for epcoritamab the positive data for tisotumab vedotin and for the next steps in the development of our earlier-stage product pipeline. I'm also pleased to announce that we will hold our annual R&D update and as data review event on December 12. To ensure the event is accessible to as many people as possible this year's presentation will be fully virtual. Details are available on our website and we look forward to a lively event. So that ends our presentation of Genmab financial results for the first nine months of 2023. Operator, please open the call for questions.
Operator: Thank you. [Operator Instructions] We will now take the first question coming from the line of Vikram Purohit from Morgan Stanley (NYSE:MS). Please go ahead.
Vikram Purohit: Great. Thank you for taking our question. We had two. First on GEN3014. So as you mentioned there were some clinical data that was recently featured for this program through abstracts that were posted for ASH. And we were wondering what you think are some of the appropriate benchmarks to compare against here on both efficacy and safety to really frame these initial results? And secondly, just to clarify for the R&D update you'll be hosting alongside ASH. Should we expect to see any updates for GEN1042 or GEN1046 at this event?
Jan van de Winkel: Thanks Vikram for the questions. I will hand over the first to Tahi. He can give you further perspective on the benchmarks which you need to think about for the HexaBody-CD38 program. And then the question on 1042 and 1046 to give a bit more color I will hand it over to Judith. So let's start with Tahi for the GEN3014. Tahi?
Tahi Ahmadi: Yes. Thank you for the question. So yes in principle of course for daratumumab a benchmark would be the 501 study the study and then also for the subcutaneous administration the study. And it gives you a range of efficacy of somewhere between 30% to 40% with 19% data that can follow-up a little bit more about 90% of the patients having VGPR better. But it's also important to understand that this data was generated in a setting with completely different treatment paradigm. And presumably the data in today's world with patients are more heavily treated with other mechanisms may look differently probably less favorable. That's why there is a head-to-head randomized that we are generating. But broadly speaking, that's the efficacy benchmark. And I think it's important, as you think about comparison from an efficacy point of view not only oral but also the depth of response is going to be very important, and certainly for us, as we look at the data that we have on our hands. The same with safety and I think the safety data issue of course is like small data sets in a different environment. There are some factors that are different in today's world. For example, one of the patients that had a great past event for say patient with COVID that was certainly not a virus existing at the time when the reference data sets were generated from eight years ago. So again, there I would say, the comparison will come from the randomized data set, which is why we're doing randomized study.
Jan van de Winkel: Thanks Tahi. And maybe over to Judith, maybe a bit more color on 1042 and 1046, Judith at ASH.
Judith Klimovsky: Yes. Thank you, Jan. So as you alluded Jan, for 1046, we look forward to share the data of study 04 in a Scientific Congress that will -- and we are looking for opportunities within the first quarter, second quarter, next year. So this is why the actual data will be presented. We expect at ASH to give a little bit more color directionally where we are going. But as we’ve discussed several times at CT 2021, we presented interesting data of responders in non-small cell lung cancer after failing the current standard of care, which encompass chemo and immunotherapy. Responses were always not durable. Interestingly, enough when we analyze the clinical data, we saw that this responders were concentrated in the period one positive. And we also saw that these responders, who are mostly in the patients that received a checkpoint inhibitor in the last eight months, based on those data points and the strong preclinical synergy between pembro and 1046 we designed 04 study, which -- those results allow us to discuss in future meetings with head authorities next steps. So we will see where we are but we've directionally plan to present a little bit more color. This is 1046. 1042, we are very encouraged and what we continue to see not just aligned with the four responders that we presented like CT in head and neck but in other tumor types. We're also getting the learnings from 1046 in order to understand better how to dose and schedule 4-1BB engagement. So, we may give more color but we need to understand where we are to see to what degree. And it will be more directionally, because we usually presented in scientific congress before we share with investors and analysts, but we will do our best to directionally give more color.
Jan van de Winkel: Thanks Judith. Vikram, as you can hear, we are literally steaming about all these three programs. So we're very excited and I think we use the coming months to further position the molecules for next steps and more to come from Genmab in the coming months for sure.
Vikram Purohit: Okay. Thank you.
Jan van de Winkel: Thanks, Vikram.
Operator: Thank you. We will now take the next question from the line of Jonathan Chang from Leerink. Please go ahead.
Jonathan Chang: Hi guys. Thanks for taking my question. First question, can you discuss the progress made with the early EPKINLY launch? What gives you confidence that EPKINLY can become the market leader in the CD20xCD30 class? And then second question on GEN1046, what could a path forward in post-IO lung cancer look like? And can you discuss the opportunity for this program in endometrial cancer? Thank you.
Jan van de Winkel: Thanks, Jonathan, two excellent questions. The first one, I will hand over to Anthony Mancini, who will be delighted to speak about the EPKINLY launch and next steps. And then 1046 maybe Judith can give a bit more color on the both checkpoint inhibitor lung cancer landscape and the way to develop a – potentially develop the molecule. Anthony Mancini?
Anthony Mancini: Thanks, Jan and thanks, Jonathan for the question. As was covered earlier, we're seeing a really healthy uptake of EPKINLY and really strong execution of our launch plans in the first quarter. And we're also highly encouraged by the launch momentum and the overall positive feedback that we're getting from our customers that are using EPKINLY the third line plus DLBCL setting. Our go-to-market approach really look to leverage our first-mover advantage. And the strong early uptake really is driven by a couple of factors that I think give me confidence that we can continue that through the life cycle. First, the solid execution and focus on key accounts. And on key customers from our field-based teams across medical affairs, across the sales team, across our alliance with AbbVie and of course the market access team. And that really has yielded strong customer engagement and EPKINLY early uptake. And it's also resulted in rapid access. So what we're seeing Jonathan is 99% of covered medical lives in the United States with functional access to EPKINLY, which is very encouraging. It's also very clear that there's a high unmet need in later line DLBCL and EPKINLY is really filling the void, enabling an off-the-shelf access to T cell engaging innovation across diverse sites of care. We feel very good about being the first FDA-approved T cell engaging bispecific antibody for the treatment of patients with third-line DLBCL but we really understand it's an important starting point to build from to help EPKINLY become the core therapy across B-cell malignancies. So overall, we're highly encouraged by the early response in the market to EPKINLY. And so far uptake has gone better than expected.
Jan van de Winkel: Thanks very much, Anthony. And Jonathan, we intend to actually give further color on the complete development plan this year potentially at the post-ASH event. So we will talk more about how to further build the market and the landscape for use of EPKINLY in the coming years. Now let's move to Judith for giving a bit more color on the importance of the post checkpoint inhibitor, lung cancer market because we feel that that's a very strongly growing market with a need for new medicines. Judith?
Judith Klimovsky: Yes. So as we all know, checkpoint inhibitors moving to the first line, a single agent, if patients have PD-L1 above 50% or in combination with chemo for patients with lower expression of PD-L1. There is a huge unmet medical need for patients that failing pembro checkpoint inhibitors and chemo where the standard of care, unfortunately is paxo [ph] that drive an overall let's say benchmark bar but from 12% to 17%, 18%, 20% at the most and with very prognosis and this segment is growing. As you know, more and more patients received first-line combinatory treatment or even sequential. And it is in this very setting where we conducted the randomized 04 study assessing two different schedules and even 1046 single agent, which gives us a strong foundation for a potential Phase III in this very setting. So we are encouraged about the methodical follow of the science and this is where we are engaging with health authorities in coming weeks to define better and we will share more as we define better those plans.
Jan van de Winkel: Thanks, Judith. So more to come in the coming weeks and months Jonathan for sure.
Jonathan Chang: Understood. Thank you.
Jan van de Winkel: Thank you.
Operator: Thank you. We will now take the next question from the line of Michael Schmidt from Guggenheim Partners. Please go ahead.
Paul Jeng: Hi. This is Paul on for Michael. Thanks for taking our question. First one is on the pivotal data for EFCO in follicular lymphoma at ASH. How are you thinking about the opportunity and differentiation from [indiscernible] based on the emerging clinical profile and your conversations with physicians? How much do you think that the evolving duration of response will possibly factor into how the two drugs are positioned? And then my second question is sort of building off the prior one on GEN1046. Can you sort of just talk a little bit about your decision to initiate that Phase II study for endometrial cancer, whether that was driven by emerging data in Phase I or perhaps the non-small cell lung cancer combo trial? Thank you.
Jan van de Winkel: Thanks, Paul. The first question I think can be handled by Tahi. And then the second one maybe Judith, you can talk a bit about endometrial on the start of that trial and why we are so excited there. Tahi?
Tahi Ahmadi: Yes. Thank you for the question. So, as it relates to the data in follicular lymphoma, there's obviously some public release of our data top lines, but you will see more data. And I think here the most important part will be to pay attention to the optimized schedule that will be presented at ASH and then the safety profile of EPCORE in the optimized setting which will I think very clearly show that EPCORE then has a profile both on efficacy, but also from a safety profile that is extremely competitive with best-in-class safety and best-in-class efficacy even in follicular lymphoma. Duration of response is a tricky one. To some degree, it's a question of follow-up. Obviously mosunetuzumab has significantly longer follow-up and EPCORE because they started about three years before us. And so that is also reflected in the duration of response. And then there's other parts that are kind of like compounders to some degree. The only point base certainly played that. But even with that I think there will be some data in the future and continuously showing that patients who are and that's basically the truism about this mechanism. Patients who achieved a deep response particularly CR are staying very, very long in their in their CR. And in some cases, we will see if that is actually reflection of a big word in cancer about to cure, because we have patients now who are approximating five years in CR. So broadly speaking on EPCORE, I would say pay attention to the disclosure of data where we share at ASH and also the updated data and the optimization data set.
Jan van de Winkel: Thanks, Tahi. Let's move to GEN1046, Judith and maybe talk a bit about rationale for endometrial cancel, why did we start of that study et cetera? : Thank you, so much. So, we started studying endometrial because it's a tumor type where 4-1BB is constitutively over-expressed and is it setting to test an hypothesis different from what we have done in 04, which I already alluded to. So this is the reason total endometrial cancer. Now we understand that endometrial cancer is not a single disease. You have the MSI high and MSI low. We are gathering data as we speak. And based on the data, we plan to daggle these different subtypes and go from there. And so it's very preliminary to say what is the path forward, because we are gathering data in this Phase 2 program to understand the data and where there could be a path forward. As another point to flag is endometrial cancer in the Phase 1, we saw long durable responses with 46 as a single agent, which again prone us to investigate more. So again we expect to have this data in coming months to allow us to make decisions.
Jan van de Winkel: Excellent Judith. Thank you very much. Thanks Paul for your questions.
Operator: Thank you. We will now take the next question from the line of Etzer Darout from BMO. Please go ahead.
Etzer Darout: Great. Thanks for taking the question. The first one on sort of GEN1046 again, you have data next year at a medical meeting. Just how are you thinking about the target relative to other IO agents that we've seen now being combined with PD-1, like, what we're seeing from the TIGIT class just how you see the PD-L1 4-1BB mechanism relative to that? And then maybe quickly on HexaBody-CD38. Just if you could remind us the opt-in rights for J&J with respect to that program, just so we could think a little bit about more or less when that could be triggered potentially by J&J? Thank you.
Jan van de Winkel: Thanks Etzer for the questions. The first one I will hand over to Judith to talk a bit about 4-1BB targeting versus other immune checkpoint targets. And I can take the HexaBody-CD38 question myself. Judith why don't you go ahead?
Judith Klimovsky: Yeah. So I first tried to say that there is no precedent of IO as a single agent provided responses in patients that failed checkpoint inhibition PD1 inhibitors. So if you think about the array of diseases or other targets, the response rate in patients that failed checkpoint inhibitor is zero, or in a handful. So we -- for PD-L1 4-1BB, we showed in the first cohort that there were responses. And there was 17% and we enrolled all comers. Then we presented in Q3 2021, when we segmented this population based on the PD-L1 presence, the response rate was higher albeit durable. However, we had this preclinical day that showed this synergy additivity with pembro, and this is what prone us to do the offer. So to reinforce the fact that high single-agent activity post IR it's almost unheard of but we saw it with 1046 to overcome the durability and strengthened signal the right next step to combine with pembro was the next step and this is what we have done, which results are emerging and we will share. So there is no precedent of IO, IO in a post-IO that PG are all going to first line in PD-L1 high. This is where the data show that there is a stronger activity. So even in the hypothetical case that DGD go to the first line it won't change the huge unmet medical need in a post-IO for non-small cell lung cancer in particular.
Jan van de Winkel: Thank you, Judith. I think that's very clear. Let me take the HexaBody-CD38 opt-in rights for J&J. They have the right to take a decision yes or no for opting in. So after we give them the data from the dose escalation, the dose expansion data which we already have and the head-to-head data against the subcu data, which we are gathering very rapidly. We believe that we have the head of data next year and then basically hand over that data package to J&J. And then they have only a very limited time to say yes or no. And the opt-in they want to develop commit to develop that molecule in any indication they want to, but I think multiple myeloma is now at the number one I think indication for HexaBody-CD38 definitely with the new data now from the expansion cohort. And then we will get a $150 million upfront payment and they pay for all and we get straight 20% royalty rather than a 12% to 20% royalty until some point in 2031 where we go from 13% to 20% in the tiered fashion. So next year will be an important year because then we will hand over the head-to-head data package on top of the dose escalation and the dose expansion cohort data which we already have in our hands. And we keep following the data at ASH, which we will present on a poster will be updated data from the abstract. So please watch out for that and Tahi already gave you some color on what to look for versus years ago daratumumab monotherapy data. But you can hear from the enthusiasm of the team here that we are really -- we can't wait San Diego and can present that data because we believe it's very, very encouraging. I think we should probably leave it to that upsell for the time being.
Etzer Darout: Very good. Thank you. Thank you for the additional color.
Jan van de Winkel: All right. Thank you.
Operator: Thank you. We will now take the next question from the line of Sachin Jain from Bank of America (NYSE:BAC). Please go ahead.
Sachin Jain: Hi, there. Thanks for taking my questions. Just more follow-ons on the same topics if I may. So firstly estate on the CD38 Grade 5 events. Thank you for clarifying. One of the two was COVID. Was that the respiratory event? And any color on the patient characteristics with CV event just to get some color as to whether that was treatment related or not in your mind? And then just a follow-on on the Grade 5s. The abstract was obviously a May cutoff. Have you seen any Grade 5 events since that May cut off? So that's on the CD38. Second topic is the 1046. You said more color at ASH. Just to clarify what you have met with the regulators by then so could you confirm your Phase 3 program at the ASH event? And then a follow-on on your clear efficacy comment, do I infer that as a response rate above the 20% for taxi you referenced? And any color on the duration of response you're seeing? Thank you.
Jan van de Winkel: Thanks Sachin. Let's see what my colleagues are willing to give you this information. Tahi can definitely comment further on the Grade 5 events for HexaBody-CD38 and I will ask Judith to think carefully about how to answer the question on 1046 and the ASH data as it relates to clarity on a potential Phase 3 trial as well as the bar for responses. Tahi maybe you can start.
Tahi Ahmadi: Yes. So I mean as I said I think earlier the one patient was a patient who passed away due to COVID and the other one was cardiac event. Neither of the two events were in our judgment and the judgment of the investigators or in the judgment of the DMC related to that -- sorry in the studies. And if you look at the study that I referenced earlier you'll see there is roughly like a 7% fish rate of Grade 5 events on these trials of patients passing away of all kinds of business not always related to drug. So at this point, we don't really have in the assessment of the DMC safety signal with small patients that in any way or shape or form seems to deviate for what is known for the class of CD38 antibodies. I hope that answers it.
Jan van de Winkel: Thanks Tahi. And then Judith on 1046 and ASH potential updates there or further clarity on the program. .
Judith Klimovsky: Yes. So thank you for the question. I think that we will try directionally to give more color just to share the design we expect to have more certainty on that and this usually happens after discussions with health authorities. So we give as much as we can predicated on where we stand in the process. As related to the benchmark I alluded to the multiple data sets in this setting that unfortunately failed and failed because they haven't done or they didn't do this rigorous scientific approach question by question to connect the dots and have the best potential hypothesis. And this allow us to wait a little bit to have not only but duration which is critical time to event is the right endpoint in a Phase 3 setting. So I mean, I want to reinforce that we will share as much as we can whenever we can. The commitment is there, but we are bound to when these meetings will happen. .
Jan van de Winkel: Thanks Judith and thanks Sachin for the questions.
Sachin Jain: Thank you.
Operator: Thank you. We will now take the next question from the line of Kaveri Pohlman from BTIG. Please go ahead.
Kaveri Pohlman: Yeah. Good afternoon. Thanks for taking my question. My first question is for Jan. Can you provide any insight into your expectations for its efficacy in CD38 pretreated patients given that previous studies have shown that these patients develop resistance via overexpression of complement inhibitory proteins? And my second question is for EPKINLY. Can you provide any color on your plans for follicular lymphoma and any time lines around that? Also for EPKINLY in DLBCL especially from the safety standpoint are you planning to have some real-world data collected that could further differentiated from its competitors?
Jan van de Winkel: Thanks Kaveri for the questions. I think I will hand both over to Tahi. Before Tahi starts, I already stated in an earlier comment we will intend to actually describe the compound development plan for EPKINLY in more detail -- or epcoritamab I should say in more detail at the post-ASH update. But Tahi, maybe you can give us a bit more color on the efficacy of potential efficacy in CD38 pretreated patients.
Tahi Ahmadi: Yeah. Thank you, and you're absolutely right, right? And there was a subgroup analysis worked on the combined data in the cycle one study that actually looked at the impact of -- in those cases, there are tumor treatment on the CD38 expression which actually gets kind of shredded after surface so to speak to the process called cytosis and then the upregulation of complement inhibitory proteins and that's absolutely correct. And so this is why the study that we're conducting is actually in CD38 naive patients with the head-to-head comparison against subcu. We have had some signals of efficacy in daratumumab exposed patients. And the dose escalation there were two patients who had a response. But broadly speaking, that's not where we're focusing right now because the focus is right now as in the original agreement with Janssen to generate data that allows us and Janssen frankly to elucidate whether the single point mutation that is underlying the hexamerization really has the impact that we have pre-clinically seen and that we believe to be seeing in the clinical data so far. And then sorry, the second part of the question was about positioning of EPCORE in follicular lymphoma. So yes, to some degree there is already a Phase 3 in combination with Len and the second line and we have talked about that we are actively working with AbbVie on plans on a frontline study. So there will be some news to come in the near future. That is in follicular lymphoma. And then in Diffuse Large B-cell Lymphoma there are multiple data sets attempted to generate data both to show also the impact of epcoritamab in comparison to CAR T, right? And driving on the point that actually this modality that just bispecific antibody the accessibility of it the ease of the administration and the safety of it compared quite favorably to CAR T therapies in the real-world data. I hope that answered the question.
Jan van de Winkel: Thanks, Tahi. I think that was a good question Kaveri. Thank you very much for the questions.
Kaveri Pohlman: Thank you.
Operator: Thank you. We will now take the next question from the line of Michael Novod from Nordea. Please go ahead.
Michael Novod: Thank you very much. Just a few follow-up questions especially to timing. If we take GEN1042 first, I just need to understand. So I think Judith said some directional guidance also on GEN1042. When do you expect to sort of have more clear data on GEN1042 and also for some of the potentially larger indications. I think we all had expected it would be around ESMO, but is that also sort of then later in 2024? And to HexaBody-CD38, there was a question earlier on relating to the J&J potential opt-in. Timing-wise, is it most realistic that you need to complete the head-to-head which says October 2024 on clinicaltrials.gov? Or could that happen sort of midway in that trial also? Maybe just to clarify. Thank you very much.
Jan van de Winkel: Thanks, Michael for the question. So I will hand over to Judith for 1042 to give you a bit further drilling for the timing when do we have the data in hand, we believe that in some of the tumors we actually have the data in the coming months if not sooner. But Judith can give you a bit further color Michael. Then for HexaBody-CD38 timing of the potential opt-in for J&J, I mean they have the right to wait for all of the data the head-to-head cohorts, Michael, I don't know whether they need to make a long story short because we think the data is shaping up very nicely as you can see from the expansion cohorts, but it's up to them. So, it's very difficult to actually give you an estimate of when J&J would like to obtain because it's basically in their corner. But the full had head-to-head data will likely come in the second half of 2024 not before, but there will be a lot of data already by that time in the first half of whether that's is up to J&J. But maybe I can hand over the 1042 timing question and some of the tumor cohorts to Judith. Judith?
Judith Klimovsky: Yes. Thank you. So, as you know Michael we are collecting data to assess the hypothesis that checkpoint inhibition pembro ads to 142 and this is fiber potentiated by the addition of chemotherapy and the creation of immunogenic cell This is the basic hypothesis that guided us to collect to address in different tumor types. Among them head and neck and non-small cell lung cancer, squamous and non-squamous mainly. This hypothesis is the same. So, the data sets are complementary from one each other. So, the goal is to have a kind of a good number of patients with some level of durability for more than one cohort because this will make the data stronger. So, this is why there is no firm congress to when we are presenting. But I can tell you that enrollment is going very well. So it will be in 2024 depends on when the abstract is close to submission and the data we have in hand to decide the venue. So, I cannot provide you a firm date at this point.
Jan van de Winkel: Thanks Judith.
Michael Novod: Thanks Jan.
Jan van de Winkel: Thanks Michael.
Operator: Thank you. We will now take the last question from the line of Emily Field from Barclays (LON:BARC). Please go ahead.
Emily Field: Great. Thank you so much for fitting me in. I will ask a quick financial question. I believe that for OpEx going into 2024 I think consensus is modeling about half growth rate of OpEx for 2023. Obviously, it's going to be off of a larger base for next year. But maybe Anthony if you have any comments on just how we should think about modeling OpEx going to 2024 before you officially guide for it?
Jan van de Winkel: Thanks Emily for the question. And Anthony will be delighted Anthony Pagano to answer a question on finances. So, Anthony floor is yours.
Anthony Pagano: Yes thanks Emily. Thanks Jan. Yes, you're right Emily, of course, we'll at the appropriate time and end of the year to take the time to really contextualize our overall guidance including our investment levels. I can summarize for you now though really what our message has been consistently throughout 2023 about how we should think about our overall OpEx levels moving forward. So, I'll take the next minute or two to summarize that. As always, given our strong position we're going to continue to invest in the significant growth opportunities in a focused and disciplined way. It's something that we do take very, very seriously. As I think about that investment profile moving forward, particularly as it relates to let's say call it, the transition from 2023 to next year in the mid-term there are three drivers here now particularly as it relates to R&D. First, EPCORE R&D is still in growth mode, so I fully expect EPCORE investment to go up as we add new Phase 3 trials, over the coming years. And here it's really important to remember that this is grounded in our conviction of EPCO's potential to help a large number of people, living with cancer and of course will continue to be data-driven. And here I mean, looking at the clinical data and the landscape, and also resource and sizing our investment, accordingly given this potential very meaningful opportunity. Second, again, still thinking about R&D and this is kind of the swing factor which additional programs will transition to later-stage development. As a reminder, you heard a lot about this today, we're doing some significant, let's call it, Phase 2 work for both CD40/41BB and PD-L1/4-1BB during the course of 2023. And as just announced the emerging data from 1046, leads us to believe there is a path forward here in terms of late-stage development. Also for Tivdak, based on what you've heard today, we also believe that there's a path forward here particularly in terms of expanded development into head and neck also we think warrants further late-stage development. Now with that hopefully will come, larger revenue opportunities in the medium-term. Sticking with R&D and the third factor we're going to continue to invest to maximize the value of our current tech platforms. And here we're going to continue to invest to generate the next wave of IND candidates as well as progress some of our early-stage pipeline. And Jan shared with you some of the exciting progress there. So that takes care of R&D. A let's talk about SG&A and starting on the G&A side. Here we are starting to increasingly approach scale based on our existing footprint. So growth here is already starting to moderate. And we expect it to further moderate here, as we transition from Q4 2023 into 2024. Now if we think about the S part of SG&A, as it relates to EPCO there's a couple of things that you should all be thinking about as you start to model for 2024 and beyond. First, for the US, to be clear the 2023 P&L reflects nearly a full year of costs for the initial indication. There will be some annualization impact next year but, that's going to be more on the moderate side. And here as we potentially build out the EPCO label overtime, of course there's going to be some incremental investments. However, we will be able to leverage existing investments in many cases. Now shifting to our other priority market -- in terms of Japan, the same for what I just went through for the United States also applies. However everything is just pushed out a bit, based on the potential approval or approval that we've now seen with Epcoritamab in Japan is coming at a much later point in the year. So the incremental impact in 2024 will be higher. So, maybe just to wrap-up the comments on, our investment levels, so everything I just covered of course is directional in nature. As always we're going to continue to be very focused and very disciplined in our approach. And we're going to continue to take a detailed bottom-up approach and make sure that we're putting the appropriate amount of resource into our most important priorities. And certainly look forward in February, in conjunction with our full year results we're really sharing what our investment priorities will look like for 2024. But what we heard today hopefully was conveyed a lot of excitement across our entire pipeline.
Jan van de Winkel: Thanks Anthony. Thanks Emily, for the financial question.
Operator: Thank you. I would now like to turn the conference back to Jan van de Winkel for closing remarks.
Jan van de Winkel: So, thank you for calling in today to discuss Genmab's financial results for the first nine months of 2023. If you have additional questions, please reach out to our Investor Relations team. We hope that you all stay safe, keep optimistic and remain healthy and we very much look forward to speaking with you all again soon.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
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