Hello, and welcome to the Genmab Q3 2022 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, anticipate, 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 it is required by law. Please also note that Genmab may hold your personal data as indicated by you as a 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. I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead. Hello, and welcome to the Genmab conference call to discuss our financial results for the first 9 months of 2022. With me today to present these results is our CFO, Anthony Pagano, and then for the Q&A, we will be joined by our Chief Medical Officer, Tahamtan Ahmadi. Let's move to slide 2. 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 3. Genmab has a science-anchored 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 4. When we presented this slide during our Q1 earnings call, we said that we have never been in a better position to achieve our ambitious vision of transforming cancer treatments. We made that assertion on the basis of our consistent track records, our world-class team, and our strong financial foundation. Since Q1, we have strengthened our position. In the first nine months of the year, we increased the number of cumulative INDs, the number of approved medicines powered by Genmab's innovation, and the number of clinical-stage products in our own pipeline. We have also grown and strengthened the team, and our financial foundation is even more robust. We continue to feel really well-positioned for growth moving forward. Excitingly, we have the potential to further increase the number of approved products in the coming year. You can see that on the next slide, which covers our recent key updates. Let's move to slide five. As we announced over the summer, Genmab and our partner AbbVie intended to submit applications for regulatory approval of epcoritimab in the U.S. and Europe during the second half of this year. I'm thrilled to say that these submissions have now occurred, an important step in potentially bringing epcoritimab to people living with certain hematological malignancies who are in need of a new therapeutic option. If approved, epcoritimab would also become our second medicine on the market and the third DuoBody-based therapy to receive regulatory approval. I'm also excited to announce that the broad potential of epcoritimab will be on display at this year's prestigious ASH Annual Meeting in New Orleans. 19 total abstracts showcasing our work in hematological malignancies were accepted, including 10 highlighting data from epcoritimab clinical studies, 4 of which are oral presentations. These presentations include initial data of epcoritimab in patients with Richter syndrome from the EPCORERE CLL-1 trial, and data from 3 arms of the EPCORERE NHL-2 study. Updated data for epcoritimab in patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, as well as initial results in first-line follicular lymphoma. Our earlier stage investigational medicines will be recognized at this year's ASH with a poster presentation on preliminary dose escalation results for HexaBody-CD38 and preclinical data for DuoBody-CD3xCD30. If we look beyond our own pipeline and include all products that are powered by Genmab's innovations, there are more than 50 total abstracts accepted for presentation at this year's ASH, 10 of them oral presentations. In addition to ASH, we are looking forward to preliminary DuoBody-CD40x4-1BB data at ESMO IO in December in Geneva. Later this week, preclinical presentations at SITC for DuoBody-CD3xB7H4 and two of our investigational medicines in development with BioNTech, DuoBody-PD-L1x4-1BB and HexaBody-CD27. For HexaBody-CD27, this will be the first preclinical disclosure. Beyond our own pipeline, Janssen has announced that they received approvals in both Europe and the U.S. for subQ TECVAYLI for the treatment of patients with relapsed or refractory multiple myeloma. TECVAYLI, created and developed by Janssen, is the second approved medicine created using our DuoBody platform. Further support of this innovative bispecific antibody technology came from Novo Nordisk's announcement last week that treatment was initiated in the first Phase III study of Mim8 in hemophilia. We look forward to next steps following the regulatory submissions for epcoritimab. We are optimistic that DuoBody-based medicines will continue to become new treatment options for people with unmet medical needs. Of course, DARZALEX continues to redefine the treatment of multiple myeloma. As you have seen, J&J net sales for Dara are up 35% so far this year, and that's generating more than DKK 7 billion in royalties for us, contributing materially to the robust financials I spoke about earlier. I'm pleased to now turn the call over to Anthony Pagano to take you through our first nine months financial results. Anthony, give it a go. Great. Thanks, Jan. Let's move to slide 6. We continue to strengthen our foundation during the first 9 months of 2022. To start, as Jan just mentioned, together with our partner, AbbVie, we achieved our goal of regulatory submissions for EPCORE in both the U.S. and Europe. As we'll see, our financials are exceptionally strong. We grew operating profit by 67% in the first 9 months of the year. We also increased recurring revenues by 81%. This was driven by strong royalties from DARZALEX and other approved medicines. You'll remember, of course, that we didn't have any TEPEZZA revenues in Q1 of last year. Our strong balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business and our pipeline. We continue to do that in a very focused and disciplined way. Especially in these volatile times, the strength of our financial profile really does stand out. An important part of this has been to continue to build the team and capabilities to enable us to succeed. Let's look at those revenues in a bit more detail on the next slide. We saw continued strong performance for DARZALEX in the first nine months of the year. As you can see in the chart, overall, net sales grew by 35%. That's net sales of $5.89 billion, which translates to over DKK 7 billion in royalty revenue. This exceptional growth was driven by continued strong market shares and continued uptake of the subQ formulation. DARZALEX remains a key driver of our revenue, as you can see on slide eight. We grew total revenue to over DKK 9.3 billion in the first nine months of the year. As I've already highlighted, that included an 81% increase in our recurring revenue. We've already spoken about DARZALEX and the very strong performance there. Turning to Kesimpta and TEPEZZA, we saw an increase of DKK 582 million in royalties compared to last year. In addition to royalties, our recurring revenue also includes collaboration revenue. For Q3 of this year, here we have a one-off payment from Seagen of approximately $15 million. This revenue reflects our 50% share of payments received by Seagen related to the deal with Zai Lab for tisotumab vedotin in China. Now, taken together, this growth really illustrates the power of our recurring revenue. Finally, we are seeing some pretty significant tailwinds, particularly for our royalty revenue, related to some positive foreign exchange rate impacts. I'm gonna come back to that in just a bit. In summary, our revenue profile continues to get stronger, and we're using our strong recurring revenue to continue investing in a highly focused way, as you can see on the next slide. In line with our significant growth opportunities, total operating expenses grew 55% in the first nine months of the year. In R&D, we've accelerated our investment into our product portfolio, especially the advancement of EPCORE and multiple other pipeline projects. We've also further strengthened the Genmab team to support our growth in commercialization and our expanding pipeline. That includes supporting TIVDAK and the filings and potential launch for EPCORE. Finally, we're leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand Epcoritamab. Now, let's take a look at our financials as a whole on slide 10. Here you can see our summary P&L for the first nine months. Revenue came in at over DKK 9.3 billion. That's up 60% on last year. Total expenses were about DKK 5.7 billion, with 69% being R&D and 31% SG&A. That brings us to our very strong operating profit of nearly DKK 3.7 billion. For me, this result continues to be particularly impressive given the context. Why do I say that? Through Q3, we have lower non-recurring revenue this year, and we've also increased our total investment by more than DKK 2 billion. Even considering these items, we still delivered a 67% increase in operating profit. Now, moving to our net financial items. Here we have income of nearly DKK 2.7 billion, which is primarily driven by the same two partially offsetting items that we highlighted in both Q1 and Q2. First, we've got the strengthening of the US dollar against the Danish krone positively impacting the value of our cash and investments. On the other side of the ledger, we have losses on our marketable securities due to rising interest rates and some losses on our public equity investments that we made in conjunction with licensing deals. We have a tax expense of around DKK 1.4 billion, which equates to an effective tax rate of 22.5%. That brings us to our net profit of over DKK 4.9 billion krone. As you can see, extremely strong financial performance. Now, before we take a look at our improved guidance, I want to take a minute to revisit our robust financial framework on the next slide. First off, let's think about our revenue profile, which you can see on the left. At the beginning of 2020, DARZALEX was our only product on the market. Today, we have six, and that provides us with expected recurring revenue growth of 69% in 2022. There's a clear path to potentially expand the number of approved products with the recent submissions for epcoritimab. Taken together, we expect significant cash inflows in the years to come. Moving to the right, we continue to be focused on our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding epcoritimab. Based upon the work that we've done so far and the data we've seen, we're convinced epcoritimab is a drug that has the potential to really make a difference for patients. Epcoritimab is just one of the exciting opportunities that provide us with a compelling rationale for increasing our investment. As we told you before, if we want to seize these meaningful opportunities, we've got to invest, and that's exactly what we're doing. With that background, let's look at our guidance on slide 12. As you will have seen, we raised our 2022 guidance last week. We now expect our revenue to be in a range of DKK 13.5 billion-DKK 14.5 billion, and that's an increase of DKK 1.5 billion to both the bottom and top end of our range. There are four items driving this increase. First, based on the strong performance so far this year, we've increased the bottom end of the range for DARZALEX net sales. Our new range is $8 billion-$8.2 billion. Second, the upper end of our revenue range now assumes an additional milestone. Specifically, we've included a significant milestone associated with the potential acceptance of the epcoritimab BLA for review by the FDA. Third, our revenue continues to be positively impacted by the strong U.S. dollar. Fourth, the largest driver for our increased revenue guidance is related to a significant tailwind for our DARZALEX royalties. Under our DARZALEX agreement, for purposes of calculating our royalties, sales outside of the U.S. are translated to U.S. dollars at a specified annual hedged foreign exchange rate. The positive impact of this has increased throughout the year, and it has become more significant as we've gotten into Q3 and looking ahead to Q4. More specifically, as the U.S. dollar has strengthened materially against most major currencies this year, there could have been an expectation that we would have seen a significant headwind for DARZALEX-reported DARZALEX net sales. However, we've not only maintained our total DARZALEX net sales guidance, we've actually been able to raise our guidance throughout the year. So in many respects, for DARZALEX royalties in 2022, we've been pretty fortunate. I guess you could say we've gotten our cake and eaten it too. That's a pretty unusual situation, so we certainly shouldn't count on it moving forward. To summarize, the main takeaway here for DARZALEX royalties is that in addition to the very strong year-over-year operational growth, we have a significant benefit in 2022 due to this contractual hedge rate. As you think about updating your models for DARZALEX royalties moving forward, you should not use 2022 krone-denominated royalties as a base. Now, one final comment on revenue. Overall, our increase in revenue is approximately 30% operational and 70% FX. Now having covered revenue, let's turn to our investments. We remain focused on executing against our strategy and key priorities and creating long-term value. Here, we are increasing our OpEx guidance to a range of DKK 8 billion-DKK 8.4 billion. This increase is primarily driven by the negative impact of the strong U.S. dollar. Putting all this together, we're planning for substantial operating profit in a range of DKK 5.1 billion-DKK 6.5 billion. Now, as I've already highlighted, we've continued to see a material appreciation of the dollar so far this year. Taking this into account, we've updated our guidance rate for the Danish krone, US dollar from 6.8-7.2. Finally, to give you a bit more color on FX, every 10-point move in the exchange rate relative to our guidance rate is worth around DKK 30 million in operating income for the balance of the year. Now to my final slide, let me provide a few closing remarks. In summary, we've had an exceptional first nine months of 2022. We've created growing recurring revenue streams, and that gives us a strong backbone of significant underlying profitability. 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. On that note, I'm gonna hand you back over to Jan. Thanks, Anthony. Let's move to slide 14. We continue to work towards our goals for the year and are especially excited about the recent advancement for epcoritimab, including the two regulatory submissions, the many abstracts accepted for presentation at ASH, and that an additional Phase III study, EPCORE DLBCL-2, is now listed on ClinicalTrials.gov. The study will evaluate the safety and efficacy of subQ epcoritimab in combination with R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma. Together with AbbVie, we anticipate that this study will start early next year. I'm also excited to announce that we will hold our annual R&D update and ASH data review on December 12, and that the event will once again be in person. Details about the event are available on our website, and we look forward to seeing you all in New Orleans. Let's move to our final slide. That ends our presentation of Genmab's financial results for the first 9 months of 2022. Operator, now please open the call for questions. Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. Please limit yourselves to one question per person. We will now take the first question. One moment, please. It comes from line of Vimal Kapadia from Bernstein. Please go ahead. Your line is open. Oh, great. Thank you very much for taking my question. Could I please just ask a little bit of context on the ASH abstracts? In particular around the competitive data, actually. You know, Roche seem to have quite a credible approach with the fixed dose period for glofitamab. And they're also presenting data on mosunetuzumab in the elderly unfit population given its safety profile. I'm really just curious how you think about that versus epcoritimab, and in particular, any comments around the fixed dosing period for glofitamab? Because that seems like quite an attractive offering. Just curious how you think about that. Thank you very much. Thanks. Thanks, Vimal, for the question. I'm going to hand it over to Tahi, because Tahi is, I think, an expert in this area. Tahi, maybe you can answer that question, which is actually composed of two questions from Vimal. Yes, sure. So the first question is essentially the question around finite versus infinite treatment in a setting where patients are expected to relapse and then succumb to the disease within months prior to the introduction of this novel mechanism. I think the jury frankly is out. I mean, I think this is where everybody has their own biases around this. Very cleerly, Roche made a decision in their development very early to have a fixed duration. We certainly, in the setting where this use as a single agent had the decision to continue on therapy question. If you look a little bit into the CART data and you use that to understand biology, then it becomes apparent that the patients who lose their response to CART are the patients who lose the presence of their CART cells. If you extrapolate from that, there's reason to believe that this maintenance of these CRs, which is what keeps these patients essentially alive, frankly, because when they relapse from epcoritimab or from glofitamab, their survival is very short because there's really no other opportunities available. They are already at the very end of treatment opportunities. There's some reason to believe, I think, and that's at least where we are coming from, that this continuation of treatment may actually have the opportunity to prolong CRs even longer. Really the way it boils down to is the question of a subQ shot versus an IV infusion, which makes it a little bit more easy for us to have a long-term maintenance strategy once a month of subQ shot. I don't think it's that much of a burden on the patient if that gives them a higher chance of staying in CR. The second question was, I guess you were touching on mosunetuzumab in the elderly. You know, I think they have done some interesting work in generating data in this frail patient population that is not eligible for R-CHOP. I would also say very clearly that mosunetuzumab does not have anywhere close to the efficacy signal that epcoritimab has had in diffuse large B-cell lymphoma. The diffuse large B-cell is a disease that patients succumb to if they don't go into CR. I think we're quite comfortable that, you know, generating data in a similar setting, EPCORE will generate significantly more efficacy that is relevant to the patients. A frontline elderly patient that's not eligible for R-CHOP is still a frontline patient that deserves some chance to have a higher rate of CR. Great. Thank you. Thanks. Thanks, Tahi. Thanks, Vimal, for the questions. Very good. Let's move to the next one. Thank you. We will now take the next question. It comes from the line of Jonathan Chang from SVB Securities. Please go ahead. Your line is open. Hi, guys. Thanks for taking my question, and congrats on the progress and delicious cake. My question is, there are other companies that have recently said the FDA is asking for confirmatory studies to be mostly enrolled before granting accelerated approval. Could you provide some insight on where you stand with respect to this on epcoritimab? Thank you. Thanks. Thanks, Jonathan, for the question. I think Tahi is completely up to speed on the confirmatory study. Tahi, maybe you can give some color there. What I won't do is tell you exactly where we are because that's just not the way this works. What I can tell you is that we, you know, started this Phase III that is a confirmatory Phase III for the indication which we're seeking accelerated approval in December of 2020. We would, I would say it's fair to say with some foresight, we're very aggressive in the initiation of the Phase III that was intended to serve the confirmation for the accelerated approval that we are seeking in the indication which is in the relapsed refractory diffuse large B-cell. We are quite confident with where we are. Thanks, Tahamtan Ahmadi. Thanks, Jonathan Chang, for the question. Thank you. Let's move to the next one. Thank you. It comes from the line of Matthew Harrison from Morgan Stanley. Hi, this is Chris Ahn for Matthew. Thank you for taking our questions. For GEN3014, given the encouraging data that you have shown in ASH, any update on the head-to-head study against DARZALEX? Thanks for the question, Chris Ahn. No updates for the head-to-head against subQ DARZALEX. That will start early in the new year. The head-to-head in that study. It's actually a multi-arm study, but the head-to-head will start early next year. Okay, thank you. Thank you. Thank you. We will now take the next question. It comes from the line of Peter Verdult from Citi. Please go ahead. Your line is open. Yeah, thank you. Peter Verdult, Citi. Just one question for Jan or Tahi. Should we take it as read that GEN1042 is going to Phase III, given that you are calling it out or calling the ESMO I-O data presentation out, in your pre-prepared remarks? Jan, I realize you can't go into details or front run the data, but perhaps you could provide some mood music like you did last quarter going into that HexaBody ASH abstract. The question's on GEN1042. Thank you. Thanks. Thanks, Peter, for the question. Unfortunately, the data is under embargo. I think on December 1, you will see the abstract on 1042, and that's preliminary data in a solid cancer. We also, well, this year, we hope to make a decision, Peter, on whether we move 1042 and/or 1046 or both to late stage clinical development. We will update the market once we are ready to do that. We're clearly very excited about presenting the data at ESMO or in Geneva. We're under embargo. We cannot say any further about the data. I think hopefully this warms you up a bit, Peter, for that. Thanks, Jan. All right. Thank you. Let's move to the next analyst. No problem. Thank you. Next one is Michael Schmidt from Guggenheim Partners. Please go ahead. Your line is open. Hi, this is Paul in for Michael. Thanks for taking our question. Just another one on epcoritimab. There was some discussion with AbbVie on their recent earnings call on the requirement for that 24-hour inpatient stay after the first full dose and potential efforts to remove that requirement with subsequent studies. Just wanted to get your comments on current perspectives and go forward plans for that inpatient monitoring and how we should think about sort of plans moving forward. Thanks. Hey, Paul, that's a good question, and I will pass it on to Tahamtan Ahmadi, who's fully up to speed on the efforts to remove that stay in hospital. Tahamtan Ahmadi? All right. Hospitalization. As of now, patients get hospitalized exactly one day. That's when they get the first full dose. We have a study that is active and enrolling that is now testing two things, actually. It is testing whether we can administer epcoritimab's subQ through the learnings that we've had how to manage CRS with fluid management and steroid in an outpatient setting. Then maybe more importantly, actually, it tests whether this can also be done in a non-academic institution setting. These are sites that are specifically chosen in the United States community hospitals. Because fundamentally, what this is all about is, like, how to get to a safe process that allows the administration of EPCORE to patients in the communities where they are being treated and where they're being seen with such disease. We're working on that and generating the data to support that. Now, the Phase IIIs that are actually enrolling don't actually demand hospitalization already. How that's going to play out in the discussions with the FDA, I think is a completely separate topic. I think there's some clues how the agency is thinking about this, that one can draw from the recent label of the CD3xBCMA from Janssen. Thanks, Tai. Thanks, Paul, for the question. Let's move on to the next one. Sure. Thank you. Next one is from the line of Peter Welford from Jefferies. Please go ahead. Your line is open. Oh, hi, thanks for taking my questions. This question back on to the HexaBody-CD38. I appreciate that obviously the ASH abstract is coming. Sorry, the ASH data is coming, and we've only got the abstract. But I wonder if you can just comment a little bit in terms of what we've seen at the moment and what we can all read. Can you just talk a little bit about how you've seen a dose-response across the various doses to the recommended phase 2 dose? Also what would I guess we'll get incremental at ASH because I guess from our point of view and looking at the data, particularly in those patients who have had prior DARZALEX, it looks like the incremental ability to generate a response of HexaBody-CD38 is relatively minimal. I think there were two MRs in the population. Can you just talk a little about how we should, I guess, view this data and consider it when we see the detailed presentation at ASH? Thank you. Thanks. Thanks, Peter. I don't think we can actually give you too much information before the ASH presentation, but I'm handing it over to Tai, who can perhaps provide a bit more color on the dose-response relationship. Tai, are you able to say anything about that? Well, maybe I'll try my best to contextualize the data that was presented. As Jan was saying, we cannot really comment, and, you know, you should also not expect much more than, as you said yourself, incremental data, because this is still ongoing in the data generation. This is how we see the data that is being presented, and this is, I think, may be helpful to you. First of all, we are enrolling a study in relapsed/refractory multiple myeloma, but in a very different time, with very different treatment paradigms and options than the original data or even isatuximab data was generated. The patients on the trial have a median of seven prior lines of therapy. For the most part, they have also exhausted recent BCMA opportunities. It's a completely different patient population. That's the first part to understand. The second part is this discussion about patients who have seen CD38 versus patients who have not seen CD38. We use the term refractory. It's, you know, it really boils down to have you seen or have you not seen a CD38 antibody. There is this phenomenon of trogocytosis, right, that the CD38 antibodies, in simplistic terms, seem to shred off CD38 off the surface. While after a period of time, it does appear to come back at a lower expression level, as these patients continue to relapse or progress, I think it's fair, and it was always clear to us that the main play for a HexaBody or for any improvement on a CD38 antibody is in a population that is sensitive to that mechanism, which is why a priori from the very initiation of the program, we incorporated as a proof of concept, the head-to-head comparison to DARZALEX subQ. As you look at the data, there's some in the abstract, I think it could be quite helpful to look at the PD markers. It could help you to understand the degree of depletion of NK cells, the reduction of the complement. At least these are the things that we looked at as we try to cross-compare to what dara used to do. If you then take into context what I mentioned about a larger tumor burden, more refractory patients, more heavily pre-treated, that's where we are continuously seeing, I think, the evidence that the hexamerization does indeed improve the at least complement-mediated efficacy. That's also somewhat evident by the depth of response. Thanks, Tai. I think, Peter, we cannot give any further color. We have to wait till the ASH presentation, to which we are very much looking forward, and I hope we can speak about it with you too in New Orleans. Great. Thank you. All right. Thanks. Thank you. We will now take the next question. It comes from the line of Emily Field from Barclays. Please go ahead. Your line is open. Hi. Thanks for taking my question. Hopefully I can just squeeze two in. I just wanted to follow up on that last question on HexaBody-CD38. You know, given the end of positioning head to head versus daratumumab, maybe just pivoting to the safety component of the discussion, you know, is it too early to draw any conclusions kinda from the abstract in terms of adverse events relative to the POLLUX study? Would that be the right comparator? Or just any color you can give on what you're seeing on safety early on there. Then just, Anthony, your. That was very helpful in terms of the FX commentary on modeling. But just a question on the exact mechanics because I don't wanna get it wrong. Is it that there's an FX conversion rate for the royalty stream chosen at the beginning of each year that resets, kind of like how the royalty stream itself resets on an annual basis, and so that's why the benefit is increasing throughout the year? Is that the right way to think about it? Thank you. Thanks, Emily, for the two questions. Maybe first asking Tahi to give a bit of color on the safety pattern of HexaBody-CD38 versus Dara perhaps, Tahi, and then Anthony will hopefully give you a bit more technical information on the Hexa and the tailwind, basically. Emily next. Tahi? Sure. Safety. First, if you wanted to compare it, then probably the 501 or SIRIUS study would be the data sets for daratumumab to look at. Now comes the reason why you should look at them. Partially because as I just mentioned, you know, there's a difference in an uncontrolled phase 2 study, or in this case, actually a first in human study, the attribution of an observed AEs is always complicated. We do see a few more AEs related to cytopenias. For the most part, actually, they are related to the disease burden that the patients have at the time, which is slightly different than for 501 series, as I mentioned before. What is interesting, what is different and what also took us a little bit of time, where we're getting a much better handle on, is that the infusion-related reactions are different. For daratumumab, specifically, the infusion-related reactions were a major problem to get through the first infusion, specifically. They were predominantly related to this very unique pattern of upper airway symptoms, laryngeal edema, bronchospasm, in the extreme version, laryngitis, laryngeal edema or rhinitis, almost in every single patient. It was actually thought to be related to the release of C2a-positive basophils, which is why we added at some point inhibition of the leukotriene pathway in the management of these IRs. For HexaBody-CD38, that's actually not at all what we're seeing. We don't see anything remotely like that. It actually behaves from an infusion-related point of view, like any other complement or any other B-cell-targeting antibody previously. It's more the classical rigor, shivering fever kind of symptomatology. That has been much better handled now. We have gotten a much better handle on that as well. It's a very different pattern. It doesn't lead to the Thanks, Tahi. Sorry, just I'd like to conclude. It doesn't lead to these issues that we had at Dara, where you had these extremely long infusion durations in the beginning. Thanks. Thanks, Tahi. That's probably all we can say and more at ASH, Emily. Maybe Anthony, you can give a bit more technical insight into the hedge, et cetera. Sure. Happy to try to help, Emily. I guess to start, the way you're thinking about it is correct. Essentially it does, you know, reset, you know, every year to use your language. Again, just to reiterate what I said on my opening remarks, you know, under the Dara agreement, for purposes of calculating the royalties, sales outside the U.S. are translated to US dollars at a specified annual hedged foreign exchange rate. That mechanism really is a part of the 2012 contract that we had with Janssen. I think if you look at the performance this year, whether it be compared to last year or how we've managed to improve our guidance throughout the year, the hedge here in 2022 has been very significant, and it's been positive. Really in the history of the DARZALEX sales, this is probably by far and away the most significant impact we've ever had. Again, look, this could come around, you know, the other way in future periods, but this year it certainly has, you know, served us very, very well. You know, my advice for everyone out there modeling DARZALEX royalties is really not to extrapolate from 2022 krone-denominated royalties. Really start with the basics in terms of US dollar-denominated sales. Work through our royalty tiers. Remember the contribution to the Halozyme royalties, and then convert that over to kroner at whatever rate you think is best, but closer to spot. Emily, I hope that gives you some additional, you know, insight into the mechanics, but also some additional guidance moving forward. Thank you. Thanks. Thanks, Anthony. Sure. Thanks, Emily, for the questions. Let's move on to the next analyst. Thank you. Next question comes from the line of Elizabeth Walton from Credit Suisse. Please go ahead. Your line is open. Hi. Thank you very much for taking my questions. I have 2 left. The first, Janssen helpfully provided that Faspro has now reached 85% of DARZALEX sales in the US. I'm wondering if you could provide some color on the level of Faspro penetration outside of the US, as you have done in previous quarters. My second question relates to your new phase 3 study in previously untreated DLBCL. You've chosen R-CHOP as your comparator. I'd love a little bit more context on how we should think about your trial design, given the POLARIX data, the European approval of Polivy in this setting, and the ongoing review by regulators in the US. Thank you. Thanks, Elizabeth, for the questions. I'm going to pass the second one on to Tahi to give a bit more context on the R-CHOP as a comparator for EPCORE. Then the question on the Faspro outside the US penetration, I think the latest data we have seen is that it's about 80% in Europe. In some countries, it's close to 100% basically of Faspro use. But overall, I think the average is around 80%, Elizabeth. Maybe Ty you can give a bit of context on why we have chosen R-CHOP. Sure as the control arm. Sure. As you can imagine, this is a big study. It's a large phase three that was just you know made public on the ClinicalTrials.gov. And so we've had of course interactions with relevant health authorities. This is a little bit the difference between what is a regulatory standard of care and what may be or may not be approved. Even though Polivy got an approval in Europe and is in active review with the FDA, it is by and large not available in most jurisdictions in the world. For that simple reason, it's just not the standard of care at this point. R-CHOP is still the standard of care. I mean, as I also would say that the incremental improvement is not necessarily consistent across all subgroups in the product study. R-CHOP is the regulatory standard of care, and that's why it's our control arm. Thanks, Ty. I think that's crystal clear. Elizabeth, hopefully that's. Thank you. Okay with you. Yeah, perfect. Let's move to. Thank you. Thanks, Elizabeth. Let's move to the next question. Thank you. We will now take the next question. It comes from the line of Michael Novod from Nordea. Please go ahead. Yeah, thanks a lot. Just a brief follow-up on HexaBody-CD38. Maybe you could just give us a sort of better understanding of the actual timelines, how long it likely takes on a base case scenario to run the head-to-head for HexaBody-CD38 versus DARZALEX, the structure of the trial, size of the trial. Because I guess inevitably it's gonna be that that sort of decides the final decision from J&J. Just to get a feeling of whether this is something end of 2023-ish or sort of first half of 2024 or second half of 2024, which this is sort of gonna be done and completed. Thanks, Michael, for the question. I don't think we are giving away the exact details of the trial, but I can tell you that it'll probably take between 12 months to 16-17 months to get all the data from the head-to-heads, Michael. End of 2023, first half of 2024 is probably the right denominator here. Okay, great. Thank you. Thank you. Thank you. Let's move to the next one. Yeah. We will now take the next question. It comes in the line of Asthika Goonewardene. Please go ahead. Hey, guys. Thanks for taking my questions. I'm gonna follow through then ask two as well, if you don't mind. One, for EPCORE, is your sales force in place and ready to go? I'm wondering, can you pull off a day one launch, and do you expect a bolus of patients on launch? I'd like to ask on TIVDAK, you have two potential volume growth opportunities in first line cervical and perhaps other indications like head and neck. I'd like to know, I know this is a decision that would also involve your partner, but which of these label expansion opportunities is more real to you? And when do you expect to take next clinical steps in collaboration with your partner to pursue them? Thank you. Thanks, Asthika, for both questions. Epcoritimab, we are getting completely launched already. Everything is ready to go, I think early next year. We believe that we can actually target a pretty good group of patients for the launch, assuming that we get a label as we expect it to be. But we have not given any further color, Asthika, on how many patients and whether it's a bolus, et cetera. I think probably coming closer to the launch, we'll probably give you a bit more color on that. For TIVDAK, we are certainly moving forward to potential combined cervical as well as other tumors, and I think that will probably get clear during the next year. So data, our partner Seagen has already hinted the data in head and neck cancer and potentially other tumors for TIVDAK could come next year. They are running the trials, Astika, so they're determining the phasing. But I think during 2023 it will become very clear which of the studies we are going to initiate. But we are getting more and more excited about how TIVDAK is actually doing in cervical cancer, how enthusiastic doctors and patients are about the medicine. Clearly, we hope to broaden the label beyond the second, third line cervical cancer label in the coming years. Next year it will get clear. Probably mid-next year, I think we should get a sort of a further color on that. Thanks, Jan. Thank you, Asthika. Thank you. Let's move to the next one. No problem. Next one comes from the line of Jaina Han from Cowen. Please go ahead. Your line is open. Hi, this is Jaena Han on for Yaron Werber. Congrats on a solid quarter, and thanks for taking my questions. I have a couple on GEN3014, your HexaBody-CD38. Given that GEN3014 has shown promising data in preclinical models for DLBCL and AML, what are your plans for the drug in these indications as opposed to just multiple myeloma? And also, are you thinking of developing a sub-Q formulation like you did for DARZALEX? Thank you so much. Thanks, Jaina, for the questions. Very strong diffuse large B-cell lymphoma data as well as AML data. Now we know the recommended phase 2 dose, Jaina. We have actually asked in the phase 1/2 study, which is ongoing, where we will hopefully soon in 2023 move to both the diffuse large B-cell lymphoma and in AML in cohort. Hopefully we'll start collecting clinical data next year. To answer your second question, Jaina, we have not yet decided to go for a subQ formulation. We now know the recommended phase 2 dose, but we first want to see how well actually what CD38 is actually doing versus with the data. We believe that in principle, this can be transformed into a subQ formulation, but we haven't made firm plans for development. Let's first look at the clinical data in the different settings. Great. Thank you so much. Thank you. We will now take the next question. It comes from the line of Zoe Karamanoli. Please go ahead. Your line is open. Hi. Thanks for taking my question. This also relates to ASH abstracts. We saw for the first time data in Richter syndrome. I appreciate that this is only from 10 patients, but can you comment on how ORR of 60% compares to other therapies available or in development, that especially since some of your competitors don't seem to have generated this data yet? Thank you. Thank you very much for the question. Sorry, I didn't catch your name, but this is very exciting data. We are really pleased with that data. Not only the 60% ORR, but also the complete response rate of 50% is quite unusual. I will ask Tahi to give a bit of perspective. Maybe, Tahi, you can put it in perspective versus other medicines, basically. Yeah, sure. Thank you for the question, and I would say this. It's actually you will see this at ASH, a hodgepodge of patients who were diagnosed with Richter or who had already failed one line of treatment for Richter. There's really nothing there. I think one of the reasons why this is getting the attention at ASH is because this is. To be careful with this word, but this is without the precedent and the true meaning of the word. There is no data for a single agent in that what is essentially biologically the equivalent of a transformed diffuse large B-cell on top of a background CLL that gets that kind of a disease control. We are very excited. It is, you know, part of when we started off on epcoritimab, we said that the ambition for epcoritimab was to develop it across the entire spectrum of B-cell opportunities. I hope you start to see this as we meant this. We're generating data in a number of subsegments, not only in the main two kind of like large indications. Richter is certainly part of that equation. Okay. Thanks, Tahamtan Ahmadi. Thank you. Thanks for the question. Let's look forward to ASH. This is not the only exciting presentation. Also the diffuse large B-cell lymphoma presentations and the follicular lymphoma presentations, they're all ones you should really focus on because it's very exciting data. We will now take the next question. It comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead. Hi. Just one question about J&J's TECVAYLI. What is the royalty that Genmab is expected to get, and how do you see its impact on DARZALEX? Thank you. TECVAYLI, we got mid-single digit royalties, basically, for TECVAYLI, and we believe that this drug will actually be used in combination with daratumumab. I think there's already a number of phase 3s testing that ongoing by J&J. We believe it will actually broaden the market for daratumumab and not cannibalize it. But I think for further questions you need to ask J&J, 'cause they are developing TECVAYLI. Yeah, today I think another one of the banks came out with a very good report where they did interviews of hematologists basically on the basis of the TECVAYLI data and predicting that basically drugs like TECVAYLI, CD3 T-cell engagers like epcoritimab, like TECVAYLI, could potentially quite easily replace CAR T, which is very exciting. Then I think make it make patients in community healthcare centers available for therapy with these off-the-shelf CD3 T-cell engagers. I think very exciting times. Further questions on how TECVAYLI will be positioned in the multiple myeloma arena I think should go to J&J. Great. Thank you. Thank you. Thank you. I would like to hand back over to Jan for final remarks. All right. Thank you all for calling in today to discuss Genmab's financial results for the first nine months of 2022. If you have any additional questions, don't hesitate to reach out to our investor relations team. We hope that you all stay safe, keep very optimistic, and remain healthy. I'm very much looking forward to speaking with all of you again soon. That does conclude our conference for today. Thank you for participating. You may all disconnect.