Hello, and welcome to the Genmab Q3 2021 conference call. Throughout the call, all participants will be in a listen-only mode, and afterwards, there will be a question and answer session. Just to remind you, 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 delayed or unsuccessful 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 forward. Please refer to our website for more information on Genmab and our privacy policy. Today, I'm pleased to present Jan van de Winkel. Please go ahead with your meeting. Hello and welcome to the Genmab conference call to discuss the company's financial results for the first nine months of 2021. 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, and our Chief Operating Officer, Anthony Mancini. Let's move to slide two. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. Let's move to slide three. Genmab has a science-focused and innovation-based culture, and collaborations and partnerships have always been part of our DNA. During today's presentation, we will reference some of the products being developed under these strategic collaborations, and this slide acknowledges those relationships. Let's move to slide four. Genmab has never been in a better position to achieve our ambitious vision of transforming cancer treatment. The solid foundation we have built is supporting our evolution into a fully integrated biotech innovation powerhouse. We achieved a major milestone in this evolution during the third quarter with the FDA approval of tisotumab vedotin as TIVDAK. Let's move to slide five. Throughout Genmab's history, we have been focused on using our deep antibody expertise to create and develop antibody products that have the potential to improve patients' lives. There are now five products on the market that incorporate our innovation, and for the first time, we, in collaboration with our partner, Seagen, on TIVDAK, are in a position to bring our own medicine to patients. In September, approximately three weeks before the PDUFA date, the FDA granted accelerated approval for TIVDAK for recurrent or metastatic cervical cancer, with disease progression on or after chemotherapy. As the first and only ADC approved in this indication, TIVDAK may provide a much-needed new treatment option for patients. This incredible achievement was only possible because of the efforts of our dedicated and talented team, the excellent collaboration with Seagen, and the patients, families, and caregivers, as well as the nurses, physicians, and study teams who participated in our clinical trials. TIVDAK was available for qualifying patients 48 hours following approval, and Genmab and Seagen are co-promoting TIVDAK in the USA. We look forward to providing you with further updates on the launch of TIVDAK in due course. Now let's look at slide six and look at some of the other recent achievements in our pipeline and beyond. In addition to the exciting approval in collaboration with Seagen, we also have a broad clinical development program in place for tisotumab vedotin. Notably, data from the InnovaTIV 2 of 5 study, which combines tisotumab vedotin with other therapies and in earlier lines of cervical cancer, was presented during an oral session at ESMO in September. Also in September, those escalation data from the EPCORE NHL-1 study of epcoritamab, a product in development with AbbVie, was published in The Lancet. More recently, ASH announced abstracts accepted for presentation. We are very pleased that there will be multiple presentations of epcoritamab data, including preliminary results at CLL, as well as data for epcoritamab in combination with R-CHOP and in combination with REVLIMID and Rituxan. Some of our other DuoBody programs will be featured later this week at the SITC conference. Presentations during this event include the first preclinical presentation of a new DuoBody program, DuoBody-CD3xB7H4. For the products we are developing with BioNTech, there will be a rapid oral on dose escalation data for GEN1042, and a poster presentation on the expansion cohort data for GEN1046. Excitingly, there are also pipeline updates for both of these programs. A phase II study of GEN1046 as monotherapy and in combination with pembrolizumab in patients with recurrent or refractory metastatic non-small cell lung cancer is anticipated to start before the end of this year. In addition, the ongoing phase I/II study of GEN1042 was recently updated to include multiple expansion cohorts in combination and in additional indications. These include GEN1042 in combination with pembrolizumab in first-line non-small cell lung cancer, in first-line head and neck squamous cell carcinoma, and in first-line melanoma. In combination with pembrolizumab and chemotherapy in first-line head and neck squamous cell carcinoma and in first-line pancreatic ductal adenocarcinoma. At this time, I would also like to inform you about some further changes to our pipeline. Following the recommendation of our portfolio boards, we have decided that we will not advance the development of HexaBody-DR5/DR5 and in agreement with our partner AbbVie, DuoBody-CD3x5T4. As I stated previously, at Genmab we have very high efficacy standards for our clinical pipeline, and we are rigorous in our decision-making. All decisions are driven by data, and initial results for both programs showed that they were insufficiently competitive compared to other product candidates in our robust next generation antibody product pipeline. With our goal of transforming the lives of patients in mind, we look forward to continuing to progress our strong clinical candidates and to bringing additional candidates into our pipeline as we continue to create and develop truly differentiated antibody products. In this context, I'm pleased to inform you that we expect to dose the first patient with DuoBody-CD3xB7H4 imminently. The power of Genmab's innovation is also reflected in products being developed by other companies. Just last month, Janssen received a positive opinion from the CHMP, recommending conditional approval. Conditional marketing authorization in the EU for amivantamab for the treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. If approved by the European community, it will be the first approval in the European Union for a therapy created using our proprietary DuoBody technology. Further validation for the DuoBody technology is reflected in two other areas. First, multiple DuoBody products in development with our collaboration partners are anticipated to enter phase III development. These include Janssen's teclistamab and Novo Nordisk's Mim8, which were both published on clinicaltrials.gov. Second, as you may have recently seen, there will be data from Janssen's teclistamab and talquetamab at ASH, including in combination with daratumumab. We are very encouraged to see progress in various DuoBody programs and look forward to seeing data from products leveraging our world-class DuoBody technology at ASH in December. DARZALEX continues to evolve and subcutaneous daratumumab is now the only approved therapy for AL amyloidosis in China and Japan. Sales in the first nine months of the year were also strong, and J&J reported $4,378 million in net sales, an increase of 49% over the first nine months of 2020, resulting in DKK 4,167 million in royalties to Genmab. I will now turn the call over to Anthony, who will discuss our revenue in more detail. Anthony, the floor is yours. Great. Thanks, Jan. Let's move to slide seven. As I've done in the past, I'll start with an overview of our financial framework and the related key drivers. First off, let's think about our revenue profile. At the beginning of 2020, we had just one product on the market, which was DARZALEX. Today we have five. For me, that's just remarkable to go from one to five products in less than 24 months. Now, on the left, you can see our recurring revenue streams. That's TIVDAK, DARZALEX, Kesimpta, TEPEZZA, and RYBREVANT. Taken together, we expect them to generate significant cash flows for us in the years to come. Moving to the right-hand side of the page, as always, we continue to be focused in our investments. In particular, we're accelerating and expanding the potential winners in our pipeline. We're also investing in our commercialization capabilities for TIVDAK and ensuring we are ready to launch should epcoritamab be approved. With that background, let's jump into our Q3 numbers and take a look at DARZALEX sales on slide eight. We saw continued strong performance for DARZALEX in the first nine months of the year. You can see that in the chart on the left. Overall, DARZALEX sales grew by 49%. That's net sales of approximately $4.4 billion, which translates to DKK 4.2 billion in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the subQ formulation. DARZALEX remains a key driver of our revenue, as you can see on slide nine. Our recurring revenues grew by 52% in the first nine months of the year, primarily due to higher DARZALEX royalties. We've already spoken about DARZALEX and the very strong performance there. Moving to Kesimpta, we're encouraged by the nice quarter-over-quarter growth seen in the first nine months of the year. Here, sales grew by 64% in Q3 versus Q2. As you know, we didn't record any royalties for TEPEZZA in the first quarter due to the supply chain disruption. Horizon recommenced supply in April and recorded strong sales in the second and third quarters. Here, sales grew by 36% in Q3 versus Q2. Taken together, Kesimpta and TEPEZZA generated DKK 524 million of royalties for the nine months ended 2021, compared to DKK 179 million for the same period last year. That's growth of DKK 345 million, and this really illustrates the power of our recurring revenues. We're also enthusiastic about the approvals of RYBREVANT and TIVDAK, and look forward to seeing how sales progress for both of these. Our revenue profile continues to get stronger, with increases both in recurring and non-recurring revenue after excluding, of course, the one-time upfront payment from AbbVie in 2020. We're taking our strong recurring revenues and investing in a highly focused way, as you can see on the next slide. Total operating expenses grew 38% in the first nine months of the year, and here you can see where we invested. We continue to accelerate our investment in our product portfolio, especially the expansion of both Epco and DuoBody PD-L1x4-1BB. We've also continued to invest strategically on expanding our team, hiring key team members to support our growing product pipeline. We've continued to build our commercialization and broader organizational capabilities to support our expanding pipeline and increasing capabilities for our own commercial products. Finally, we're leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs. Now let's take a look at our financials as a whole on slide 11. Here you can see our summary P&L. For the first nine months of the year, revenue came in at approximately DKK 5.9 billion. That's up 60% on last year if we exclude the one-off payment from AbbVie in 2020. Total expenses were about DKK 3.7 billion, with 79% being R&D and 21% G&A. Our operating income came in at a very strong DKK 2.2 billion. Our net financial items amounts to income of DKK 808 million, which was primarily driven by the strengthening of the US dollar against the Danish kroner on our US dollar-denominated cash and investments. We have our tax expense of DKK 725 million, which equates to an effective tax rate of 24%. That brings us to our net income of around DKK 2.3 billion. As you can see, extremely strong financial performance for the first nine months of the year. Now, let's take a look at our guidance on slide 12. Given the continued strong numbers in the last quarter, we once again improved our 2021 guidance. We now expect our revenue to be in the range of DKK 7.9 billion-DKK 8.5 billion, driven primarily by the continued strong growth of DARZALEX. Our OpEx guidance is now in a range of DKK 5.3 billion-DKK 5.6 billion, a decrease compared to the previous guidance, driven primarily by the timing of some of our investments in R&D activities and organizational capability build. We anticipate that we'll continue to step up our investments in Q4 and the following quarters in line with our overall strategy and key priorities. Putting this all together, we're planning for substantial operating income in 2021 in a range of DKK 2.3 billion-DKK 3.2 billion. Now, for my final slide, let me provide a few closing remarks. In summary, we've had a very strong first nine months. We've created growing recurring revenue streams based on products with exceptional growth profiles. That gives us a backbone of significant underlying profitability. We're investing those revenues in a highly focused way to realize our vision and capitalize on the significant growth opportunities in front of us. On that note, I'll hand you back to Jan to discuss our key priorities. Thanks, Anthony. Let's move to slide 14. As you can see, due to events in the third quarter, we met a number of our 2021 key priorities, and we anticipate meeting more of these very soon with the presentation of first-in-class bispecific next generation checkpoint immunotherapy data at SITC. We're also looking forward to ASH this year. We will hold a virtual 2021 R&D update and ASH data review event following ASH on December 14. Details about this event will be available on our website in the coming days. Over the past nine months, we have made great strides in our evolution into a leading, fully integrated biotech innovation powerhouse. We are looking forward to the rest of what has already been an extremely strong year. Let's move to our final slide. That ends our presentation of Genmab's financial results for the first nine months of 2021. Operator, please open the call for questions. Our first question comes from the line of Wimal Kapadia from Bernstein. Please go ahead. Well, great. Thank you very much for taking my question. Could I just first ask, I know there's a lot of attention at SITC on 1042, but I'm actually just curious more on the B7-H4 target. First time I was unaware of it, so we're seeing some preclinical data. I'm just curious to hear more given that, you know, the expression of B7-H4 is believed to be inversely correlated to PD-L1. And given that combined with the interest in preclinical data, how should we really think about this target, and how you think it stacks up with the rest of your pipeline? Then, my second question is just on talquetamab, the GPRC5D CD3 bispecific. The ASH abstracts look quite compelling, particularly in combination with Dara. I'm just thinking about how, you know, how should we think about the profile of this molecule and how it stacks up versus some of the other BCMA bispecifics in development. Thank you. Thanks, Vimal, for the questions. I will park the first one because I will hand that over to Judith Klimovsky. Then let me address briefly talquetamab. I mean, talquetamab is an antibody from Janssen. They are just using our DuoBody technology platform to actually target the GPRC5D molecule that seems to be very efficacious. I think it's up to Janssen to actually provide further perspective, Vimal, on how this one stacks up against the BCMA and against other targets. It's probably not good for me to do that, but I will refer to Janssen to give more perspective, and they will certainly do that, I think at ASH, because they are very excited about that program, I know. The data, as she's already flagged up together with daratumumab, look really encouraging, the first data. I think they have to position this one versus talquetamab. It's just gotten to phase III, I think, last week, recruiting the first patient, so that one is moving ahead very rapidly as well. Let me pause there, Wimal, and hand the first question over to Judith. Maybe Judith, you can give a bit more perspective on the CD3 B7-H4 program. We will have preclinical data, Wimal, also at SITC, which is upcoming. Judith? Judith, are you there? Maybe there's a connection problem, Wimal. Let me address that one then myself. Hear me? Oh, yes. Now we can hear. Can you hear me now? Yes. Yes. Okay. Please go ahead, Judith. I think we cannot hear you now. I think there's a connection issue, Judith. Should I answer this question then? B7-H4, Vimal, is expressed actually very nicely on a number of solid cancers, and also at expression levels, which make it a very good target for a CD3 bispecific retargeting approach. We have some very exciting preclinical data. Some of that data will be shared with all of you at SITC. We believe it stacks up very nicely versus some other targets we are working on with CD3 retargeting approaches in our preclinical pipeline. We are very excited to actually start dosing the first patient almost imminently in the coming days or weeks, for sure. And then we will do dose escalation and see how the safety profile looks like in our hands. I think there will be a lot more detail at SITC in the coming days. Maybe handing it back to the operator. Thanks very much. The next question comes from the line of James Gordon from JP Morgan. Please go ahead. Hello. James Gordon for JP Morgan. Thanks for taking the questions. One was also about SITC and the abstracts that are now out for GEN1042 and GEN1046. I guess, starting with GEN1042, I know that there's been quite a lot of excitement about this product, but if I read the abstract right, it looked like there were two out of 49 patients had a response. So it didn't look like a very high ORR so far. But what is it then that's driven the excitement? Is it that there's a certain dose or tumor type or some other way of dissecting the data that looks a lot more exciting? For GEN1046, the lung data looks good, but I know there were these other nine cohorts. Have you now seen data for other cohorts that do look promising for GEN1046? Or should we really think about this as a drug that is for high PD-L1 expression lung cancer, but probably not for other areas? Just based on that, I haven't seen anything else in this whole month since the last SITC. Two other quick questions, really just timing. For epcoritamab, the EPCORE looked very good, but any update on what you're thinking on timing for potentially the earliest you could file it? Could epcoritamab still be potentially a 2022 filing? J&J arbitration, could that still be maybe H1 next year we might hear anything? What's the latest thinking on timing for that and why that's taking longer? Thanks, James, for sneaking in four questions, actually. You're allowed only one, but we will answer them all four, I can assure you. The first two, I will probably hand over to Judith Klimovsky if we can get her back. Forwarded to an automated voice messaging system. Online. Eight six two two one zero. I think we have a real connection problem there. The Epco, let me start with the Epco question, James. We definitely are on schedule and will aim for potential filing in 2022 for in at least one indication. We are very much, I think, aligned with AbbVie and the teams to allow us to do that. That next year will be very exciting for epcoritamab. I think the abstract data looks good, and I think the actual data at ASH, which will be presented, will be an update to the data in the abstracts, James. We very much look forward to the ASH conference this year. The final question, the J&J arbitration. I cannot really provide any further comments on timing because this is up to the arbitrators. What I can tell you is that the process is in full swing. I think it's going well from a technical side, and we very much hope that we will soon hear from the arbitrators on a potential binding verdict there to remove this potential overhang on the company as soon as possible. We definitely look forward to that. Let's see whether I can bring Judith online here for GEN1042- Yeah. 6. Judith? Thank you. Can you hear me now? Yes, perfect. Okay. I'm sorry for the problem with the connection. I will start by CD3, B7-H4. As we know bispecific have been successful in hematologic malignancies, not so in solid tumors. We think that our technologies and knowledge of the target put us in a better position to try to tap this holy grail of oncology. In essence, B7-H4 is a great target because it's expressed in tumor cells, but it's not expressed in normal tissue. It's expressed as we alluded in the abstract, and we'll see more data in a very common tumor type that unfortunately is not well served today, particularly breast cancer, ovarian cancer, lung cancer, and is inversely related, as you said, with the expression of PD-L1, preclinically. We are ready to move this to the clinic in the near future. We just want to test because as we know, I mean, it's cool that cell therapies or bispecifics have been able to modify the treatment paradigm of solid tumors. These are the tumors that we will study initially, if you know, we study dose escalation and we see a signal. This is with regard to CD3xB7-H4. With regard to the second question, which was on GEN1042, correct? Yeah. The question was basically why are we so excited with only two out of 49 responders? That is what James asked. Okay. What drives the enthusiasm? Maybe a bit more color on 1042, Judith. Oh, yeah. Thank you. As you said, you know, we have two confirmed PRs, one in melanoma, one in lung NET, but we are all overall enthusiastic about the 51% disease control rate, which is not to be disregarded, particularly taking into account the patient population which exhausted every prior line of therapy. As you know, with immunotherapy, ORR is only one part of the story, but the way that immunotherapy works is usually modifying the time to event curve, not so much on ORR. We are excited because, you know, given the patient population and given the CD40 target plus 4-1BB, we really expected limited activity in terms of tumor shrinkage. But you know, the DCR, disease control rate, is relevant in this tumor population. Yeah. I don't know if there were more questions when I was disconnected. I'm sorry again. No, just one more question on GEN1046. We basically have good data and lung data which will be described of course at SITC. The question is, did we also see data in other cancers to drive our enthusiasm, or is this a lung cancer only type program? You will see more data in the poster soon, which is on November 12. The setup of the phase I with expansion was to learn on the biology of this asset, which is so novel, particularly for 4-1BB, to guide us next step. The totality of the data, including in other tumor types, speak to the same fact that we have seen in non-small cell lung cancer. The totality of the data is robust enough to guide us on next step, lung and not lung. Thank you, Judith. James, hopefully that pleases you and then more to come at SITC in a few days. Back to the operator. Thanks, Judith. The next question comes from the line of Kennen MacKay from RBC. Please go ahead. Hi. Thanks for taking the question and congrats on the commercial progress here. Maybe two questions, if I may as well. For Judith, relating to GEN1046, I wonder if you can talk a little bit more about the rationale behind the dose decision there. You'd mentioned this is a little bit of sort of a Goldilocks drug, where just treating to the absolute max tolerable dose potentially isn't the right way to go here. Just again, wanted to understand the rationale behind the dose decision there. Maybe for Jan, as you're narrowing the pipeline here, I'm always curious what in the early stage pipeline you're most excited about next. Thanks so much. Thanks. Thanks, Kennen. I will let you think about the GEN1046 question. I can tell you that we are rigorous in our decision-taking, Kennen, as it relates to the pipeline. We stopped two programs, as I said in my introductory remarks, the DR5 program and the 5T4 program. I can tell you that the early-stage pipeline is very exciting. We are very excited about the DuoHexaBody-CD37 program, and we'll probably come with a short update this year and then more data kind of next year when we can show the whole dose escalation data. The HexaBody-CD38 program is very high interest, and it's moving ahead nicely. There, you will get this year a short status update from us, and then more on the dose escalation data next year in the new year when we have all that data present. Then we will also plan to move at least two, perhaps even more, new products into the clinical pipeline in the new year, in 2022. 2022 will be a very exciting year for the company, I think, not only with the potential initial filing for Epco, but also with hopefully moving one or two programs to the late-stage clinical development. That can also include programs like GEN1042, GEN1046, which are now on the radar screen basically of everybody. We are very excited about the pipeline, Keenan. I think it has never been a stronger pipeline than it is right now. We will continuously have to weed through and identify the real winner, potential winners, and then stop the other programs, because I think focus is very important. That has brought Genmab to where we are right now, focusing on the right molecules, on the right technologies to create differentiated antibody medicines. I think we're getting better and better in that. I think the quality of the pipeline is increasing, and not everything will work, but not necessarily because molecules are not active, but they are simply not competitive enough for our internal high standards as it relates to novel products. We believe that we need to focus all of our attention and efforts, Kennen, in molecules that can be transformational. We believe that epcoritamab will be transformational for B-cell cancers. I think the data will show that, which you will see hopefully also, again reconfirmed at ASH. We are now putting a very large military machine with epcoritamab behind that program. I think the pipeline is in very good shape, and we are very pleased with that. Let me hand over to Judith to speak a bit more about the dose, the exact choosing of the doses for GEN1046. Judith? Yes. Thank you. We are presenting a poster at CT as well on a semi-mechanistic PK/PD model where we put a lot of preclinical and clinical data. Because as you alluded, there is this Goldilocks effect or bell-shaped curve, and allow us to choose the dose of 100 milligrams as it's the perfect dose for trimer formation. That means the trimer between PD-L1, the bispecific, and 4-1BB. This is why it was chosen. Interestingly enough, when we fed the model, even with translational data, everything was very, very strong that 100 milligrams is the dose where we optimize the trimer formation and the agonistic effect for 4-1BB. We are very confident with the dose that was selected based on multiple data points that we put in the model. Thanks. Thanks, Judith. Hopefully, Kennen, that is okay for you. Otherwise you will get back to us separately in a call. Operator, maybe we can move to the next question. Sure, yeah. The next question comes from the line of Jonathan Chang from SVB Leerink. Please go ahead. Hi, guys. Thanks for taking the questions and congrats on all the progress. First question on the epcoritamab ASH abstract in relapsed refractory CLL. I'm curious to get your thoughts on what the appropriate benchmarks are in this late line CLL setting. What kind of data would you need in this later line study to support development in earlier line CLL settings? Thanks, Jonathan, for the question. I will hand it over to Judith. Maybe, Judith, you can give some perspective on benchmarks for the very heavily pretreated CLL population which we included in the first Epco study. Yeah. Yeah. Thank you for the question. It depends not only on the prior lines of therapy, but the categories of agents that patients got, and particularly whether they exhausted BTK inhibitors and VENCLEXTA or not. The population that we enrolled was heavily pretreated, and most of them got BTK inhibitors. Furthermore, most of them have a very bad biological prognostic characteristics at 17p deletion. There the bar is low, unfortunately for those patients. It's getting some level of remission and the durability is important as well. It's not a single factor. As you know, these patients are very beaten up because they are down the road, so it's a response, it's durability of response and tolerability. Thank you, Judith. Thanks. Thanks, Jonathan. Got it. Thank you. Let's move to the next question. The next question comes from the line of Michael Schmidt from Guggenheim Securities. Please go ahead. Hey, guys. Thanks for taking my questions. I had two questions. Another one on GEN1046. I think I heard you say that you're planning a phase II study in combination with Pembro in relapsed refractory non-small cell lung cancer patients. I'm just trying to understand the rationale, given that the bispecific antibody probably already blocks the PD-1 interaction. I'm just curious how much added or synergistic efficacy one would expect there and why. The second question was on epcoritamab. I know you have the R-CHOP combo phase I data at ASH. I'm just curious how you think the Roche POLARIX result may potentially affect your plans to move Epco into first-line DLBCL down the road. Thanks so much. Thanks, Michael, for the questions. I think I will hand them over to Judith and then see whether I can add further perspective there. Maybe, Judith, you can address both. Yes. the 1046 question and the epcoritamab R-CHOP question. Yes. Thank you. Let's start with GEN1046. As you have seen in the abstract, there are very important biological observations. In 26 patients that had tumor samples to assess PD-L1 presence, those that were PD-L1 positive, that were only 10 tumor samples from 10 patients, seven had a tumor shrinkage. On the converse, you know, 16 patients or tumor samples belonging to patients that were PD-L1 negative, most of them, like 12 out of 16, had no tumor shrinkage. There is a clear association between PD-L1 presence and the activity of this compound. We also showed in the PK/PD model that the receptor occupancy for PD-L1 is not optimal, which is 100%. With PD-L1 4-1BB, because as said before, the dose was selected to optimize the agonistic effect, we leave PD-L1 30% without inhibition. We know from other PD-1, PD-L1 inhibitors in the market that for them to be fully active, you need, like, 100% receptor occupancy. This, plus the fact that as we show in the abstract, the activity what we saw in the expansion is much more higher for those patients that were treated with a PD-1, PD-L1 inhibitor in the last eight months, and the receptor occupancy is still there than the patients that didn't. It makes gives us the rationale that combining with a PD-1 inhibitor is the right next step to optimize the potential benefit of 1046. Maybe the epcoritamab question about how Yes. The POLARIX data could impact the first-line bispecific and from a frontline development strategy standpoint. Yes. Yes. Thank you. We will hear more details on the POLARIX data at ASH. We only hear what everybody knows, like the high level results. Based on the actual data, we will assess whether expanding more our clinical development plan or amending is necessary, and we will react accordingly. We are waiting for more results to understand how this could impact our clinical development plan. Thanks. Thanks, Judith. Thanks, Michael. The next question comes from the line of Sachin Jain from Bank of America. Please go ahead. Hi there. Thanks. Take my questions. I've got a couple on GEN1042 and GEN1046, if I may. On GEN1042, Jan, I think you at the introduction listed a bunch of combination studies with KEYTRUDA or KEYTRUDA chemo combination. If I heard you correctly, the line was a bit tough. I just wondered what combination data you have that is supporting those combination studies versus the mono data we've seen in the abstracts. The second question is, you very clearly commented on the ORR and, you know, why we should focus on the disease control rate. I wonder if you'd comment on the second aspect where there's been investor focus, which is the one grade four liver event, and how you think about that, and any further data you've got on liver tox there. The second question was on GEN1046. You referenced further development. I think your partner, BioNTech, said that the phase II study was gonna start in Q4 2022 next year. Just wondering what's taking so long for that study start. I had a clarification question on what's coming at SITC. It seemed from Judith's answer that we will be getting updated lung data and updated data on other cohorts rather than just markers of response in lung, as we saw in the abstract. I just wanted to clarify that. Thank you. Thanks, Sachin. GEN1042 and GEN1046 are very popular, for sure. That keeps, I think, Judith quite busy. I will hand over both questions to you, Judith, and then see where I can add. Maybe- Yeah. Start with GEN1042 and the combo data. What evidence we have preclinically, I think is probably the right angle here. Thank you, Jan. As Jan said, we have very compelling preclinical data of the synergy additivity of GEN1042+ pembrolizumab. The cohort of combinations of GEN1042+ pembro are in clinicaltrials.gov. I am pleased to tell you that we are actively enrolling. We expect to have actual clinical data of the combination in coming months. It's moving nicely. This is for GEN1042. The other question on GEN1042 was the liver tox or the tox in general. In general, GEN1042 is very well tolerated with most of the safety events grade one or grade two. We have seen 10% increase in 10% of the patients increase of AST/ALT elevation grade three or above only 6%. That means two patients. We are following, but so far it seems manageable and the percentages are what we consider a very well-tolerated range. This is for GEN1042. Any other question on GEN1042 I am missing? No, I think you can move to GEN1046 and the timing of the phase II. I think that caused some confusion. Yes. I think caused by our friends at BioNTech. Yeah. We are expecting to finalize the randomized phase II to assess more data. We have some expansions ongoing in different combinations or in different settings that will guide us on the next steps on the randomized phase II. Everything is linked. We are waiting for data sets coming from the current expansions to guide us on the activation on the randomized phase II, which will occur next year. Thanks, Judith. Then maybe some comments on this data from other cancers with GEN1046 at SITC, maybe a bit on what type of data, basically. Yeah. Thank you. I alluded to that before. The data that you will find in the poster is aligned in the other solid tumors, aligned with the biological signals that we found for non-small cell lung cancer in terms of the PD-L1 expression, and in terms of finding the biological rationale to guide us on next steps. This include a non-small cell lung cancer and other tumor types. Very clear. Thanks. Can I just take one follow on the GEN1042 Pembro combo data you referenced is coming in the next months. Could you be more specific on that? Just chance my arm there. Thank you. Oh, yeah. Judith? Yeah. Thank you. Yes. Can you hear me? Yes. Yes. We amended the protocol and it's updated in clinicaltrials.gov, that we added cohorts of combinations with pembrolizumab in head and neck, in non-small cell lung cancer and in melanoma. Those data sets will guide us on next decisions, and we expect to have this data in next month. Thanks, Judith. Thank you. These cohorts are recruiting very quickly here, Sachin. I think that is a reflection of how enthusiastic doctors are about GEN1042 as well. I think more to come at SITC and then certainly more to come next year. Thank you. Thanks, Sachin. The next question. Maybe next question. Yep. Yeah. It comes from the line of Matt Weston from Credit Suisse. Please go ahead. Thank you. Can I ask a costs question, please? Obviously a key element of the guidance raise for this year was the change in the cadence of spending. I'm very interested in how the change in cadence of spending is then gonna run into 2022. Jan, you've outlined a raft of new trials which are starting. Clearly, you have a lot of commercial opportunity in terms of setting the scene for your early portfolio and the launch. Any comment on how we should anticipate the cadence of costs going into 2022 would be very helpful. Thank you. Okay. Thanks, Matt, for the question. I will hand it over to Anthony Pagano. As you know, we will give guidance in February next year, but maybe let's see whether Anthony can provide a bit more color for you, Matt. Anthony, please go ahead. Yeah. Thanks. Thanks, Jan. Thanks, Matt. First of all, you're right. With the expense run rate for the first nine months, costs were a bit on the low side relative to our previous full year guidance. Our revised guidance in the range of DKK 5.3 million-DKK 5.6 million in OpEx, you know, as you're kind of pointing out, is due really to timing of our investments for certain R&D activities and overall our organizational capability build. The R&D expenses were impacted really around phasing of costs related to various pipeline programs. For me, it's really a matter of timing, and we expect costs related to our R&D activities to ramp up in the coming quarters. It's important to understand this is really in line with our overall strategy and our key priorities, and we'll continue to be focused and disciplined as we move forward. As a reminder, and Jan alluded to this, for Epco, together with AbbVie, we are planning to start a number of late-stage trials in the coming quarters. On SG&A, our focus in the short term is really on the launch of TIVDAK and also preparing for potential Epco launch. It's important here to highlight that this will also entail additional investments in building the commercialization infrastructure and pre-launch activities. Overall, the revised 2021 guidance on OpEx primarily reflects shift or phasing. I think, Matt, the key takeaways is that, look, we have a wonderful business, solid set of technologies, exciting pipeline, and we're evolving to become this fully integrated biotech. We're starting off with TIVDAK. We're super excited about the opportunity there. You know, more moving forward, we have all eyes, and we'll be super focused on epcoritamab as we move forward, both from a development as well as a commercialization readiness perspective. More to come in terms of our exact business plan activities and our guidance ultimately here for 2022 as we move forward, particularly around our 2021 earnings release in February. Thanks, Anthony. Thanks, Matt, for the question. Thank you. Let's move to the next one, operator. Next question comes from the line of Peter Welford from Jefferies. Please go ahead. Hi. Thanks. Yeah. I've got just two left. Firstly, just on ten forty-two, wonder if you could just talk a little bit about the selection of the dose for that molecule. You talked a bit about ten forty-six. Ten forty-two, are you also looking to optimize the trimer formation and also the agonistic effect of the 4-1BB? Or are there other factors to bear in mind for this? Can you just talk a little bit about how you got to the recommended base dose for the expansion cohorts? Secondly, just in regards to the J&J DuoBody, it might just be an omission and for simplistic sake, but it looks as though according to your pipeline chart, as though other than Teclistamab and Talquetamab, if I said this right, some of the other programs like the CD3, CD123, CD33, PSMA are now omitted but are in the clinic. Is that just simplicity or has J&J decided to focus its DuoBody collaboration now on Teclistamab and Talquetamab in the remaining programs? Thank you. Thanks. Thanks, Peter. I hand over both questions actually to Judith, and then see where I can add on the J&J question. Judith, maybe on 1042, a bit more color on the dose selection and the dose finding. Yes. Thank you. In case of CD40 and 4-1BB, both are agonistic targets, and both have what we call the Goldilocks effect. We did a very thorough assessment based on PD, and the dose of 100 milligrams is the dose that optimize the trimer formations for both targets, CD40 and 4-1BB. We are very confident that this is the dose. This is why we didn't even escalate till MTD, because we had the optimal biological dose at 100 milligrams. We feel very confident with the dose. The second question was with regard to the J&J DuoBody platform. This was a question on other assets. Exactly. They have seven basically in the clinic. Peter asked, Well, why are we focusing on amivantamab, teclistamab, and talquetamab? What about the others, basically? Yeah. I mean, what we know is what is in the public domain and the assets that have data in the public domain that make us excited about for sure amivantamab, teclistamab and talquetamab. The others are early on, and there is not too much in the public domain for us to be excited about. Exactly, Peter. They are still in the clinical development. Some of them have post-recruiting. Others are basically recruiting as we understand it, but we actually decided to focus on the more interesting, exciting ones with either moving into phase III, like teclistamab or are already on the market like amivantamab, and also in phase III. Talquetamab is triggering a lot of enthusiasm right now. It's in phase II and probably also will move to further lines of clinical development soon. Then there is still, I think, potential for one or two of the others, Peter, to also move forward, but we decided to put less emphasis on that. That's it. Thank you. Thank you. Operator, maybe we can move to the next question. Yes. Our last question comes from the line of Asthika Goonewardene from Truist Securities. Please go ahead. Hey, guys. Thanks for taking my question. I'd like to start off, maybe one to Judith. On GEN1042, two-part question here. Is there any rationale for this drug in the monotherapy setting, or is this only gonna be a combination? And then also on GEN1042, will you be looking at serial biopsies, and what do you expect to see, in terms of, you know, T-cell infiltration into the tumor microenvironment? And I got a couple of follow-ups. Thanks, Asthika, for the questions. Judith, I think I will keep you busy today, so this will both be for you. Yeah. Thank you for the question. We think that GEN1042 should be developed in combination because of the biology of CD40 and 4-1BB. This is why, you know, we started the combinations early on. As I said, you know, we are already enrolling GEN1042+ pembro, and there are two other cohorts in clinicaltrials.gov in combination with chemo plus minus pembro. It's clearly the biology of these compounds needs something else, and this is we are adding to. This is the combination. Your second question is a great question, and one of the cohorts in GEN1042 is a melanoma cohort with a very heavy translational research component. Part of it is paired biopsies that will allow us to understand in depth the infiltration of the tumor with lymphocytes and other pharmacodynamic markers of activity, which are really relevant because of the novelty of the target. As we put in the poster and put in the abstract, and you will see more data in the phase I, we were able to modulate a target, which is very important because that means that this compound is really targeting CD40 and activated dendritic cells, which is what we want from GEN1042. More to come as we gather more data, but the biological rationale and premise behind the compound is being shown in the phase I and with the pharmacodynamic markers, and we are including this in the abstract, and you will see more in the poster. Thanks. Thanks for that. Great. Thank you. Asthika, any follow-up? Yes, Jan, I think around this time last year, when asked the question what are your top three priorities for 2021, I think you kind of articulated 1046, 1042 and EPCO. If we ask you that same question for 2022, what would you say? Yeah, these are still the top three priorities, but we'll add actually a number of other to that. The company gets, I think, broader and I think also, I think, increasingly professionally organized. I think we will actually broaden our pipeline, Asthika. As I already alluded to, in an earlier question, is we are very excited about some of the early-stage clinical programs. We believe that, some of them have the potential to move to late stage. We will still keep these three as our top priorities, Asthika, but we'll probably add CD37 and CD38 to those priorities for 2022. Great. Thanks for taking my question, guys. Thank you. Thanks for that. Operator, are there any further questions? There are no further audio questions. I'm handing back to you. All right, thank you for calling in today to discuss Genmab's financial results for the first nine months of 2021. If you have any additional questions, which later come up, please reach out to our investor relations team. We hope that you all stay safe and remain healthy and optimistic, and very much look forward to speaking with you again soon. This concludes our conference call. Thank you all for attending. You may now disconnect your lines. Thank you.