Hello, and welcome to the Genmab First Half 2024 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 beliefs, 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 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 our first speaker today, Jan van de Winkel. Please go ahead. Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending June 30, 2024. With me today to present these results is our CFO, Anthony Pagano, our Chief Operating Officer, Anthony Mancini, and our Chief Medical Officer, Tahi Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. 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. We have had a very exciting second quarter. The acquisition of ProfoundBio, which was completed in May, was an historic event for Genmab, and one that will enhance our long-term growth profile. In just a moment, you will hear from Tahi on some of the exciting next steps that we have planned for Rina-S, and later, Anthony Pagano will walk you through the financial impact of the acquisition. June was an exceptionally eventful month for Epkinly, which is now the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B-cell lymphoma. In addition to the U.S. approval in relapsed or refractory follicular lymphoma, the CHMP adopted a positive opinion recommending Epkinly, as epcoritamab is called in Europe, for the same indication. Both regulatory actions were supported by data from the EPCORE NHL-1 trial, which was also recently published in the Lancet Hematology. We'd also like to note the potentially imminent start of another phase 3 trial for epcoritamab. This one in combination with lenalidomide for transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma. Together with our partner, AbbVie, we continue to evaluate epcoritamab in multiple patient populations and treatment settings, with the goal of establishing epcoritamab as a core therapy in B-cell malignancies. During our Q1 earnings call, we discussed the FDA approval and Japan NDA submission for Tivdak, both of which occurred early in the quarter. As a reminder, with its approval in the U.S., Tivdak became the first ADC with demonstrated overall survival data to be granted full FDA approval for the treatment of patients with recurrent or metastatic cervical cancer, with disease progression on or after chemotherapy. I'm also excited to note that data from the innovaTV 301 study, on which the approval was based, was recently published in the prestigious New England Journal of Medicine. By now, we hope that you've all had the chance to listen to our June third call to review some of the exciting data that we presented at ASCO, including for Tivdak, Epkinly, and of course, acasunlimab. Tahi will provide you with a brief reminder of the very promising acasunlimab data and our next steps for the program on today's call. Before this, I would like to highlight the key changes to the acasunlimab program that we announced on Monday. Genmab has now taken full control of the development of acasunlimab. This is a fantastic opportunity for us to own and advance this promising asset. Our partner, BioNTech, has opted to not participate in the further development of acasunlimab, and we understand that this decision was based on their strategic portfolio prioritization and does not reflect the strength or potential of acasunlimab. This now becomes our second wholly owned candidate medicine, entering phase 3 by the end of this year, underscoring our strong confidence in the clinical promise and commercial potential. We are exceptionally well positioned to maximize the potential of acasunlimab, as we are, and we are very excited about the future of this program. I would also like to add that even though our partnership is changing on this program, it remains extremely strong and collaborative, and we are committed to continuing to work together to advance innovative antibody treatments for patients. Finally, turning to medicines powered by our innovation. Janssen announced that Rybrevant has now been approved by the European Commission for the first-line treatment of adult patients with advanced non-small cell lung cancer, with activating EGFR exon 20 insertion mutations. In addition, they have submitted a BLA for a subcutaneous version of amivantamab for all currently approved or submitted indication of IV RYBREVANT in certain patients with non-small cell lung cancer. More recently, in July, Janssen announced approval in the U.S. for DARZALEX Faspro in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of patients who are newly diagnosed with multiple myeloma and are eligible for autologous stem cell transplant. This combination, based on the data from the phase 3 PERSEUS study, has the potential to improve long-term outcomes for patients newly diagnosed with multiple myeloma, and further supports DARZALEX as a backbone therapy for this disease. Anthony Mancini will provide you with a review of the recent performance for DARZALEX, plus other select royalty medicines, as well as, of course, for Epkinly and Tivdak. First, I'm pleased to like hand over now to Tahi, who will provide you with a reminder of the significant progress we are making with our wholly owned late-stage clinical programs, acasunlimab and Rina-S. Tahi, the floor is yours. Thank you, Jan. I'm sure by now you've all seen the phase 2 acasunlimab data in combination with pembrolizumab in second-line non-small cell lung cancer that we presented at ASCO. This data is very encouraging, demonstrating significant disease control and overall survival, alongside a manageable safety profile. As a reminder, in this CPI pre-treated patient population, we presented an impressive median overall survival of 17.5 months and a 12-month OS rate of 69%. Additional data will be presented at medical conferences, including the World Conference on Lung Cancer in September, next month. This will include traditional translational data that should help you better understand our confidence in the Q6-week dosing schedule. And to ensure that there is no confusion, this will not include updated clinical data. We are simply too close to ASCO, and therefore limited by a very short follow-up, which really prevents a meaningful impact on time to events analysis. That said, the encouraging data, both from ASCO and the translation data that will be presented at WCLC, reinforces our commitment to swiftly progressing the phase 3 trial in PD-L1-positive patients with non-small cell lung cancer, who progressed on a CPI, either alone or in combination with chemotherapy. And we expect to start this study before the end of the year. Given both our proven and extensive clinical development experience and our track record of acceleration, as you've seen with Epkinly, we are confident in our ability to advance acasunlimab through phase 3 and beyond. Moving now to Rina-S. As a reminder, this slide summarizes why Rina-S aligns with our vision to transform the lives of patients. We believe it has the potential to broaden, deepen, and consequently expand activity beyond what has been seen with first-generation folate receptor alpha approaches, becoming a potential best-in-class treatment for ovarian cancer and other folate receptor alpha-expressing solid tumors. In addition to the efficacy, it also has a differentiated safety profile, avoiding interstitial lung disease and corneal toxicity seen with other ADC therapies. This differentiation, both in efficacy and safety, is a direct result of the novel proprietary hydrophilic linker technology developed by ProfoundBio. We're exceptionally well positioned to maximize the potential of Rina-S, given both our full clinical development capabilities, the track record of acceleration, and our experience in the gynecology space already with Tivdak. As we said before, we anticipate the first potential approval for Rina-S could be in 2027, and importantly, we anticipate blockbuster peak sales potential. Now, this is what we shared with you when we announced the acquisition of ProfoundBio. Now that we are officially responsible for the development of Rina-S, let's take a look at our near-term plans. Previously, we told you that we'd be providing an update to the initial encouraging phase 1 ovarian cancer data that was presented at SITC last year. We can now confirm that you will see both updated data and additional follow-up at ESMO in September. I'm also pleased to note that we are on track to deliver on our accelerated development plan. We have aligned on the dose with health authorities and expect to start a phase 3 trial in second-line, plus platinum-resistant ovarian cancer before the end of the year. So in summary, significant progress for both acasunlimab and Rina-S, and we look forward to sharing more information with you when it becomes available. I will now hand it over to my colleague, Anthony Mancini. Thanks, Tahi. In Q2, and in the first half of 2024, performance across our two key revenue streams, royalty medicines and Genmab commercialized medicines, continued to demonstrate strong growth. Turning to our royalty medicines portfolio on slide eight, DARZALEX delivered strong demand growth with $5.57 billion in first-half net sales, a 19% year-over-year growth, driven by market share gains overall and meaningful market share increases in frontline multiple myeloma. As Jan mentioned, on July 30, FDA approval was received for a new indication for DARZALEX- for a DARZALEX Faspro quad combination based on the Perseus study in newly diagnosed transplant-eligible multiple myeloma. As J&J mentioned in their earnings call, primary endpoints were also met in two additional DARZALEX studies in Q2. CEPHEUS, a DARZALEX-based quad regimen in transplant-ineligible, newly diagnosed multiple myeloma, and AQUILA in smoldering myeloma. Detailed results from these studies will be presented in an upcoming scientific meeting. Coupled with the final analysis of MAIA, showing a median overall survival of 7.5 years, it's clear that DARZALEX is foundational to survival in multiple myeloma, and that growth opportunities will continue with DARZALEX in early treatment settings. Beyond the early settings, DARZALEX is continuing to be a backbone therapy in combination with both newer and older therapies in relapse or refractory multiple myeloma, including with TECVAYLI, our CD3 BCMA DuoBody bispecific, and TALVEY, our CD3 GPRC5D DuoBody bispecific, which each delivered solid performance in the first half of 2024. We expect continued growth and continued usage of DARZALEX throughout the multiple myeloma patient journey. Kesimpta achieved continued strong demand performance with over $1.4 billion in the first half, a 64% year-over-year growth. Kesimpta performance is not only progressing well in the United States, but also outside the United States, it continues to be the new-to-brand prescription share leader in 7 of 10 major markets outside the U.S. Tepezza, the first and only FDA-approved treatment for thyroid eye disease, generated net sales of $479 million in Q2. In addition, with the June seventeenth FDA submission for the subcutaneous formulation of Rybrevant, our EGFR c-Met bispecific, it's another milestone to help make an even bigger impact on EGFR-mutated non-small cell lung cancer patients. In summary, we expect continued strong Genmab revenue growth from our six diverse royalty medicines in the second half of 2024 and beyond. Turning to our Genmab commercialized medicines on slide nine. On June 26th, we received accelerated approval in the U.S. for our second indication for Epkinly as a monotherapy for patients with relapsed or refractory follicular lymphoma after two more lines of prior therapy. We also received a positive CHMP opinion for this indication on June 27th, with an approval decision in Europe expected in Q3. The early response in the U.S. to Epkinly in follicular lymphoma has been very positive. We continue to hear encouraging feedback from our customers across diverse sites of care regarding the FL label that does not require hospitalization. This gives us confidence in expanding Epkinly utilization across practice settings as the first and only T-cell-engaging bispecific antibody approved for both third-line plus DLBCL and third-line plus FL. In addition, we presented 2.5-year follow-up data at ASCO, demonstrating the long-term durability and powerful responses with Epkinly in third-line plus DLBCL. We're very pleased with Epkinly demand performance across our key geographies, with over 90% of net sales coming from the U.S. and Japan. Epkinly delivered DKK 121 million in net sales for the first half, with DKK 70 million in Q2, which includes foreign exchange headwinds in the first half of 2024. In both the U.S. and Japan, Epkinly has seen robust uptake across key accounts, strong field execution, and positive responses from customers and the patients we serve, really validating Epkinly's differentiated profile that balances powerful efficacy, manageable safety, and a seamless patient experience with subcutaneous administration. Overall, the launch is exceeding our expectations with our third-line plus DLBCL and third-line plus FL indications as the first steps towards establishing Epkinly as the core therapy across these cell malignancies. Turning to Tivdak, our tissue factor-directed ADC, it delivered DKK 60 million in net sales for the first half of 2024, a year-over-year growth of 48%. This represents the 11th consecutive quarter of demand growth for Tivdak. We're very pleased with the performance, and the recent full approval, based on the significant 30% improvement in overall survival in the innovaTV 301 study, is driving increased breadth and depth of prescribing. Gyn Onc and Med Onc customers continue to provide positive feedback on the impact Tivdak is making on the lives of women with cervical cancer, and we're well on our way to establishing Tivdak as a clear standard of care in second-line plus recurrent or metastatic cervical cancer. The successful building in gynecologic oncology with Tivdak is an important foundation to prepare for future potential launches, such as Rina-S, in folate receptor alpha expressing platinum-resistant ovarian cancer. As an end-to-end biotech company, we're very pleased that our Genmab commercialized medicines performance represents 31% of Genmab's overall revenue growth in the first half, and look forward to carrying this momentum through the second half of 2024 and beyond. I'd like to take a moment to thank our partners and our entire cross-functional Genmab team across commercialization, R&D, and enabling functions, for their tireless efforts every day to make a meaningful difference to the patients we serve. With that, I'll hand the call to Anthony Pagano to provide more perspective on both our first half financials and our updated guidance. Yeah, great. Thanks, Anthony. We continued to strengthen our foundation throughout H1, having delivered on our goal of successful regulatory approvals and launches for Epkinly in the U.S., Europe, and Japan in 2023. We are pleased with how these launches are progressing, and even more so now, with a second indication in the U.S. and the potential for additional approvals in Europe and Japan for late-line follicular lymphoma. We've also significantly enhanced our long-term growth potential with the completion of the acquisition of ProfoundBio. And as we'll see, our financials remain strong. Recurring revenues grew by 42% in H1. This was principally driven by strong royalties from DARZALEX, Kesimpta, and other approved medicines, as well as strong performance from both Epkinly and Tivdak. This strong H1 performance is driving an increase to our full-year revenue guidance. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business, our pipeline, and our team and capabilities in a very focused and disciplined way. Now, before we take a closer look at the results from H1 and our improved guidance, I'd like to provide you with an overview of some of the details and financial impact of the acquisition of ProfoundBio. Starting on the left, we've summarized how the DKK 13.1 billion kroner purchase price has been allocated. First, you can see the largest portion of the purchase price has been allocated to Rina-S. And here, amortization will begin on regulatory approval, which is estimated to be in 2027. Second, for the ADC tech platform, amortization started at the closing of the transaction and will continue over 15 years. This is what you can already see impacting the P&L in 2024, with an estimated full-year impact of $48 million. We also have goodwill, which isn't amortized and will be tested for impairment every year. Finally, the difference between the purchase price and the total fair value listed here is primarily due to an assumed deferred tax liability of $2.1 billion. This reflects the estimated future tax obligations related to the acquired intangible assets, primarily Rina-S and the ADC tech platform. Now, moving to the right, you can see that since closing the deal, we've incurred $330 million of costs related to ProfoundBio. On a full year basis, we expect costs of around $1.15 billion. As you will see, acquisition and integration-related charges or deal costs are a separate line item on our P&L. Taken together with the ADC amortization expenses, these are expected to be around DKK 400 million for the year. And as a reminder, these costs were excluded from the directional financial guidance I provided when we announced the deal back in April. So with this background, let's take a look at our results for H1, and let's start with our revenues. We grew total revenue to over DKK 9.5 billion in H1, and as I've already highlighted, that included a 42% increase in our recurring revenue. This strong growth was driven by higher DARZALEX and Kesimpta royalties, as well as royalties from other products. And we're pleased with how Epkinly and Tivdak are performing. Taken together, these two products contributed 31% of our total revenue growth in H1, and this really illustrates the power of our recurring revenue. Overall, this strong recurring revenue growth enables our continued highly focused investment, as you can see on the next slide. In line with our significant growth opportunities, total OpEx was approximately DKK 6.7 billion in H1. As you can see, the majority of the growth was driven by R&D investments. Here, we've accelerated our investment into our product portfolio, especially the advancement of our mid- to late-stage pipeline. Specifically, we're expanding the development for Epkinly, Tivdak, acasunlimab, now, of course, Rina-S. As you can also see, SG&A growth moderated and was up only 12%, and this reflects our continued focus on driving SG&A efficiency. As previously highlighted, we continue to invest to secure a successful Epkinly launch in our two key markets, the U.S. and Japan. Of course, we've been really focused on the acquisition and integration of ProfoundBio. Now, let's take a look at our financials as a whole. Here, you can see our summary P&L. Revenue came in at over DKK 9.5 billion. That's up 36% on last year. Total OpEx was around DKK 6.7 billion, and here again, most of, most of which was R&D. And even with that increased investment, we're still delivering over DKK 2.4 billion of operating profit, and that's up more than 29%. Moving to our net financial items, here we have a gain of DKK 1.4 billion. This gain was driven by the strengthening of the dollar against the kroner in the first half of the year, as well as by an increase in interest income. Then we have tax expense of DKK 1.1 billion, which equates to an effective tax rate of 28.9%. Here I do want to pause for a moment and note that we are currently evaluating the integration of ProfoundBio operations from a tax perspective. Our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is gonna normalize within the next 12 to 18 months. And that brings us to our net profit of over DKK 2.7 billion. So as you can see, continued strong underlying financial performance. Having now looked at our H1 results, let's take a look at our updated guidance. At a macro level, you'll see we're projecting higher revenues and operating profit even as we take on two wholly owned phase 3 programs. I've already covered, in some detail, the impact of the ProfoundBio acquisition. Now, as far as us taking on full responsibility for acasunlimab, this does have the effect of grossing up both our revenue and our expenses for all products that remained in our collaboration with BioNTech. This results in around DKK 600 million of both higher revenue and higher costs. But really here, it's important to note, this classification change in our guidance does not impact our operating profit. Now, looking at the highlights of our revised guidance, we now expect our revenue at the midpoint to be up 28% over last year and be in the range of DKK 20.5 billion-DKK 21.7 billion. One of the drivers of this increase is strong net sales of our royalty medicines. We are now anticipating higher DARZALEX net sales in the range of $11.4 billion-$11.8 billion. So here we've increased our royalty guidance to DKK 13.3 billion-DKK 13.8 billion, and that's an increase to both the top and bottom end of the range. Importantly, we also anticipate that we're gonna have over DKK 1.3 billion of growth from Epkinly and Tivdak. Now, turning to our OpEx. Excluding deal and amortization costs, we are anticipating OpEx to be in the range of DKK 13.7 billion-DKK 14.3 billion, which includes R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Rina-S, and also on our side, acasunlimab. Now, I told you when we announced the acquisition of ProfoundBio, that excluding acquisition and integration-related charges, we are anticipating OpEx at or moderately above the upper end of our previously disclosed OpEx guidance. So now excluding both the ProfoundBio deal and amortization costs, and this 600 million DKK item that I just described relates to the BioNTech collaboration, this classification change, you can see that we're absolutely delivering on that guidance commitment. And note that even with our increased investments, we continue to generate significant underlying profitability, and we're on track to deliver another year of substantial operating profit. In fact, when you exclude the acquisition, integration, and amortization costs for ProfoundBio, the midpoint of our current operating profit guidance is now at DKK 6.2 billion, and that compares favorably to our previous guidance of DKK 5.9 billion, and that's up 17% over 2023. Now, before wrapping up, I'm gonna spend just a minute to double-click on the changes to our OpEx guidance. As a reminder, at the midpoint, our original OpEx guidance was DKK 12.9 billion. As you can see, the impact of the operational changes for Genmab and ProfoundBio is around DKK 500 million. This includes the DKK 800 million of costs related to ProfoundBio's operations, and this is really driven by investment in Rina-S that I referenced earlier. It also includes a net DKK 300 million reduction related to Genmab, driven by continued prioritization efforts and scale benefits, partially offset by acasunlimab development. And that brings us to DKK 13.4 billion, which is fully in line with what we communicated when we announced the acquisition in early April. Then you can see the impact of the classification item or gross up of the expenses for the products remaining in the BioNTech collaboration of DKK 600 million. Now, again, to be clear, these higher costs are fully offset by higher revenue and have no impact on operating profit. Finally, you can see here, and we have the ProfoundBio deal and amortization costs of $400 million. Now, having gone through the H1 numbers as well as our revised and improved guidance, let me provide a few closing remarks. In summary, we've had a very solid first half of the year. We have growing recurring revenue streams, increasingly from our proprietary products, 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 going to hand you back over to Jan. Thanks, Anthony. Let's move to our final slides. During the first half of the year, we have made significant progress towards our 2024 goals. Especially for Epkinly, we have now announced or initiated two new phase 3 trials, and the label has been expanded in the U.S. to include relapsed or refractory follicular lymphoma. Of course, we are extremely pleased with the full approval for Tivdak that occurred in April, and the encouraging phase 2 acasunlimab data that has informed the planned phase 3 trial. As a reminder, that makes two wholly owned assets, acasunlimab and Rina-S, that we anticipate will both enter late stage development before the end of this year. As we move into the second half of the year, we continue to have a lot to look forward to. That ends our presentation of Genmab's financial results for the first half of 2024. Operator, let's go to the questions. Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one one again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question and one follow-up question. Thank you so much. And now we're going to take our first question. And it comes from the line of Emily Field from Barclays. Your line is open. Please ask your question. Hi, thanks for taking my question. I'll ask two, and I guess one kind of as a follow-up. Just on acasunlimab, you know, when do you expect to start enrolling patients in the phase three? Are you expecting that you would use docetaxel as a control arm? You know, and just how are you thinking about a potential changing standard of care, with the potential approval of TROP2 ADCs? And then secondly, just, you know, now that you're going to have two wholly owned projects that you're starting going into phase three, how should we think about Genmab R&D cost in 2025 and 2026? Thanks. Thanks, Anthony. Thanks, Emily, for the questions. The first one to Tahi, you can give a bit more color on the phase 3 trial for acasunlimab, and then Anthony Pagano can undoubtedly give you further color on the R&D costs, Emily. Tahi, why don't you start? Yeah. Thank you for the question. I mean, as it relates to the control arm, I think we've mentioned this multiple times, we had, you know, all the relevant health authority interactions and the relevant, and the only relevant comparison at this point is docetaxel. I think there's a lot of heightened discussion about whether, you know, a subgroup analysis of a principle negative trial can lead to an approval. I think this is a discussion for another company, but all health authorities have been crystal clear on this particular question. So it will be docetaxel as the control arm. That's the regulatory approved control arm, and I think we mentioned this in the prepared remark. We are operationalizing towards having this study up and running by the end of the year. Thanks. Thanks, Tahi, and I think further details will come in the future, Emily. Let's move to Anthony and then have a further color on the R&D expenses. Anthony? Yeah, thanks, Emily. You know, as we think about our investment in R&D, we've been super clear about, you know, our priorities. I think the way to- a good way to sort of frame this out is to, you know, break R&D down into two segments. Segment number one being research and discovery, all the way through to early development, and then the second segment being that mid to late stage segment. As we think about that, that first segment being research and discovery through to early stage development, we've talked quite a bit about us scaling that up over the last number of years. We viewed that as an underutilized asset in the company, and we can see that we're now bearing the fruits of that investment in terms of scaling that up, in terms of the number and quality of INDs we see coming through. We've been very clear now as we've gotten into sort of 2023, 2024, we think that that whole setup and that investment, the amount of money we're allocating there, is now at the appropriate level, and any investments there will be much more moderate, if any, will be much more moderate in nature. The second segment is that mid to late stage segment. And here, this is where the focus of the organization is. This is our priority. We are prioritizing investments in this area versus investments in other areas. So. Clearly investments in Epkinly, Tivdak, 10-46, and now Rina-S will get the lion's share of any growth here moving forward. And I think it, it's very obvious as to why this is, in particular any registration-type trials, again, we're prioritizing those, are potentially revenue-generating in nature, and that's what we're really focused on doing, Emily. So you should very much sort of think about R&D along these two segments and any growth moving forward, or the majority of the growth moving forward, is really gonna be from segment number two, that mid- to late-stage programs, particularly potentially registration-enabling trials. Thanks, Anthony. Thanks, Emily, for the questions, huh? Operator, let's move to the next questions. Thank you. And the next question comes from the line of Xian Deng from UBS. Your line is open, please ask your question. Hi, thank you for taking my questions. Two, please. The first one is on acasunlimab. You mentioned now, you are, this is a wholly owned asset, but just wondering, would you still be open to, for example, new partners here? Or are you committed that this is will be wholly owned, going forward? And if you are open to new partners, what sort of things would you be looking for in an ideal partner, please? So that's the first question. And the second one is, on acasunlimab data update, for World Lung. Just wondering, maybe for Tahi, so what sort of things can we actually expect? Will we have a bigger patient size for the every six-week arm, please? Thank you. Thanks, Jan, for the question. So for acasunlimab, I can tell you that we are very, very, very pleased to have it now wholly owned. So we are not foreseeing that we need to look for a partner. We think this is a fantastic molecule, which could potentially be much broader position than the initial indication, and we intend to hold on to it for the time being, see how what we could do in the future is potentially look for a partner in select areas, for example, for China, because that's such a different dynamics in the markets right now. As you know, we have as key priority markets, U.S. and Japan. We'll likely move into EU5, EU4 plus U.K., also with some of our products in the future. But maybe China is a good territory, we think, to look for a partner. So maybe a regional partnership is potentially an option, but we have not decided that. We are just very, very pleased with the 100% ownership, and we'll progress as aggressively as we can soon to move it towards registration trials and then to the markets. And then maybe, Tahi, you can give a bit more color on the type of data as well, lung and other conferences, because there will likely be other conferences in the coming months soon where we will present data. Tahi? Sure. Thank you, Jan, and thank you for the question. The data that you will see is essentially trying to provide clarity on how a Q6 week schedule changes the biology. So you will see data on T-cell expansion of relevant subgroups of T-cells. You will see data on T-cell exhaustion and relevant T-cell subsets and other pharmacodynamic markers relevant to the mechanism of action, as well as PK data that correlates and explains what really the pharmacokinetic and pharmacodynamic differences are between Q3 and Q6, and why that matters, and how that translates into the clinical observations that we observed. So that is the main focus on these data sets to provide additional color on the mechanism, on the biology, and how we concluded the differentiated profile for Q6 week scheduling. Okay. Thanks, Ty. Let's move to other questions. Operator? Thank you. Now we're going to take the question from Jonathan Chang from Leerink. Your line is open, please ask your question. Hi, guys. Thanks for taking my questions. First question, what are your latest thoughts on the next development steps of Rina-S and ovarian cancer? When could we learn the details of the phase 3 second-line plus platinum-resistant ovarian cancer study, expected to start before the end of the year? And then as a follow-up to that, what is your confidence level in the ability of Rina-S to address patients across the biomarker spectrum in ovarian, and how important is that to your strategy? Thank you. Thanks, Jonathan, for the questions on Rina-S, another molecule we are super excited about. Let's ask Ty to start and then Judith to step in if to provide extra color. Ty, why don't you start with both questions? Sure, I'll take the second one first. I mean, this is from the very beginning was part of our excitement about Rina-S as a molecule and also relates to our excitement in the linker technology that we believe quite firmly, and I think you will then have the opportunity to see the data at ESMO, that Rina-S will have activity, meaningful activity across the spectrum and beyond of folate receptor expression in FRα-positive patients. So that's the first part. As it relates to the details on the phase 3, I mean, some of this will become public as the study goes into the public space and ClinicalTrials.gov, we you know very clear what the segment is. I think I already kind of addressed a sub-question that you may have in your mind about what the population is, and I think the control arm is a hodgepodge of available alternative therapies in this setting, in a physician's choice trial. And so that will be the first study, not the last one. And so I think you will have to wait. To some degree, we are in a dynamic where we obviously want to update you, and so we updated you on informing you that we are very well in the startup of the study already. But we also want to be cognizant of the fact that this is a hyper-competitive environment, and so, you'll see it as it gets executed, but it will get executed quite rapidly and accelerated, I promise you that. Thank you, Tai. So more to come, Jonathan, in the very near future, very near. Thank you. Now we will take on our next question. The next question comes from the line of Asthika Goonewardene from Truist. Your line is open. Please ask your question. Hi, guys. Thanks for taking my question and congrats on the progress and the impressive outlook that's laid out so far for the second half of this year and future. Wanted to go back to GEN1046 and also tag on GEN1042. Tahi, you mentioned you were clear on what to expect and what not to expect at World Lung. I'm curious if there are other conferences later in the year where you could provide an update for GEN1046, just given how exciting the ASCO data was, and we want to see more follow-up. Related to that, in previous calls, I think we've kind of got the feeling that there might be something on GEN1042, perhaps in Head and Neck later on this year. Just want to check back on that and see if that's still a possibility or what kind of update we can expect on that module as well? Thanks. Thanks, Asthika, for the questions. I think, Tahi, you can handle them both, maybe, shed a bit of light on other conferences. Sure. So let's take 1042 first. I think what I've- what we've said multiple times, so we're clear, is there were some observation learnings that I hope will also become a little bit more transparent with the mentioned presentation at WCLC, that were at least taken into consideration and are being tested as we speak. And when that data is mature, then we'll present that, and that will then provide, we're quite confident, a very clear answer on 1042. So I'm not gonna comment on this any more than that, because to some degree, we'll just have to wait for data in our hands. On 1046, I think Jan already mentioned there's gonna be additional data at SITC. This will be a lot around translational data. In terms of clinical data, I think, you know, it makes sense to generate a little bit more follow-up and on also more patients that have been enrolled in order to better, you know, elucidate the mitigation strategies that we implemented to make it more safe. And so that with the time to event readout takes a little bit more time. So, we'll bring that into the public domain as soon as it makes sense from a data set. Thanks. Thanks, Tahi, and we give you extra, Asthika, that also at SITC, we intend to present some further preclinical data, which will further help you to understand this new biology of activating T-cells and the K-cells via 4-1BB bispecific. So, lots of new data supporting, I think, the excitement around acasunlimab. Thank you. Now we'll go and take our next question. The next question comes from the line of Peter Verdult from Citi. Your line is open. Please ask your question. Yeah, thank you, Peter Verdult, Citi. Two questions, please. Jan, speaking to the Pfizer oncology team, they've got four head and neck cancer assets that they could go into phase three, but they're saying not all will. So I just wanted to confirm, and apologies if I've missed this, but is the head and neck phase three program for Tivdak confirmed, or we, do we await confirmation of that? And then for Tai or for Jan, I'm sorry to test your patience, but what is the latest on HexaBody timelines in terms of data release and J&J decision, or is it unchanged since the last update? Again, apologies for testing your patience. Thank you. Thanks, Peter, for the question. So, why don't I ask Judith to give a bit of color on the head and neck plans for Tivdak? But before that, I can probably handle the HexaBody-CD38 question, Peter. We are progressing really, really rapidly, and we are fully on schedule to present, to have the data and present them to J&J in the second half. For HexaBody-CD38 versus subQ Dara, and there will likely be an update from the company also by the end of this year. Maybe not at a medical conference, but then another format. So maybe, Judith, you can give a bit of color on the head and neck cancer data for Tivdak. Yeah. So as you know, we presented encouraging data on ORR b ased on IRC at ASCO. Of course, you know, we are waiting for maturity of this data, and in parallel, we open another cohort with a stricter eligibility criteria, and we are assessing this in conjunction with part A, which is combination to assess the strategic fit for the company and for Tivdak, and make further decisions by the end of the year. So we are- Thanks. closely monitoring the data. Yeah, yeah. Thank you. Just to be clear, sorry, Judith, just to be clear, is our phase, is the phase 3 program confirmed, or are you awaiting that data first? Not usually, you know. We start some things at risk, but we jump into the pool when it's the right strategic fit and we have the right target profile for a particular indication, and this is what we are following the data for. Thank you. Thanks, Peter. Thank you. Next one, please, operator. Yes, of course. Now we're going to take our next question, and it comes from line of Yaron Werber from TD Cowen. Your line is open. Please ask your question. Great, I also maybe just a quick follow-on on acasunlimab, ma'am. I just wanna confirm. So it sounds like the phase 3 is only going to be testing the Q6 week head-to-head against docetaxel. Can you—I don't know if you can comment, would the primary be just PFS, or is it going to be PFS and then OS kind of co-primary? Thank you. Thanks, Yaron, for the question. Tahi, can you give a bit of color on the endpoints for the phase 3? Sure. It will be a two-arm study with a control arm and with the Q6 arm of acasunlimab in combination with pembro. This is where we have the signal. This is where the data leads us, and the endpoint will be overall survival. Thanks, very clear, Tahi. I think that's the answer, Yaron, for your question. Thank you. Let's move to the next one, operator. Thank you. Now we're going to take our next question, and it comes to the line of Matthew Phipps from William Blair. Your line is open. Please ask your question. Hi, there. Apologies for background noise. Just my question. You know, you've had a nice launch of Epkinly and lymphoma so far to date in the DLBCL space. Just wondering how we should think about uptake and follicular lymphoma, given there's already another approved bispecific there and how much that can contribute mid-term. Thank you. Thanks, Matthew, for the question. And then, Anthony Mancini, I think you can best handle this one. Maybe a bit more on color, uptake in follicular lymphoma versus diffuse large B-cell lymphoma. Yeah. Thanks, Matt, for the question. Look, we're about six weeks into the launch here, but it's going really, really well. We're again really encouraged by what we hear in terms of the customer reaction to the favorable label without required hospitalization or monitoring. And we think it gives us confidence that we can advance Epkinly use across diverse sites of care. We're starting to see growing Epkinly adoption in many of the you know large physician group practices. And we believe that the third line plus FL label is going to really enhance our ability to deliver innovation more broadly to patients in need, where they want to be treated closer to home. And we think the Epkinly profile really enables that. In terms of the size of the population, it's really a modest population size, but because of the differentiation of having one product across both indications, we think it's the reactions have been very favorable so far in the community. So I'll leave it there. Thanks, Anthony. Thanks, Matt, for the question. Let's move on to the next one, operator. Yes, of course. And now we're going to take our next question, and it comes from line of Michael Schmidt from Guggenheim Securities. Your line is open. Please ask your question. Hey, thanks for taking my questions. I had a commercial question, a follow-up on epcoritamab, and yeah, just thinking ahead, wondering how we should think about the launch trajectory, perhaps in follicular lymphoma relative to the initial launch in DLBCL, given, presumably there is a fair amount of commercial synergies, you know, in with this label expansion. And, in DLBCL specifically, how much visibility do you have, perhaps, based on claims data and other sources on how the drug is used, relative to other treatment options, you know, be it other antibodies or CAR T-cell therapies? Thanks so much. Thanks, Michael, for the questions. I think Anthony Mancini, this will keep you busy for a few minutes. Thanks. Thanks, Michael, for the question. In terms of the launch trajectory in FL versus DLBCL, to give you a little bit of context, you know, and this is really drug-treated patients. The DLBCL third line plus market's about 3,600 patients in the U.S. They're really actually quite similar size in Japan. In FL, it's about half of that. So it's about, you know, close to 2,000 patients. We really, with the claims data that we are seeing right now, you know, the capture, as you know, is not great, so we're not able to see the great detail. But we do a lot of market research, and we do a lot of customer research on a qualitative basis. So we're able to see where the drugs are used. In a DLBCL space, where we've had four full quarters in the U.S., we really are starting to see now more truly third-line patients. What we're seeing in the real world is really mirroring what we see in the clinical trials, so very positive customer reactions. In FL, it's really too early to tell. That said, I think that when we ask physicians what they're after, the profile in terms of powerful efficacy, manageable safety, and really seamless and efficient step-up dosing and subq administration that's offered with Epkinly is something that's really attractive, particularly across diverse practice settings. So when you think about staff time, chair time, scheduling efficiency, these are things that position us really well. So we're encouraged by these first few steps here to make Epkinly truly the core therapy across B-cell malignancies. And we're, you know, we'll leave it there. Thank you, Anthony. Thanks for the question, Michael. Thank you. Now we're going to take our next question, and it comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question. Hi, thanks for taking my question. Just one follow-up on Epkinly, actually, and Anthony Mancini, that is. You made a comment in the prepared remarks that the launch is exceeding your expectations. So just be interested in what's driving that. Is that better uptake than you were initially expecting, or is it actually potentially a larger market in third line DLBCL than you were initially expecting? Then secondly, actually, on Epkinly again. In the past, you've talked to potential of removing the need for hospitalization from the DLBCL label. Could you just provide an update on progress there and when it could actually be reflected in the label? Thank you. All right. Thanks, Rajan, for the questions. Anthony Mancini, why don't you try the first one, and then, maybe, Tahi on the next one, for the second question? So thanks for the question, Rajan. Yeah, we really are seeing, you know, execution of our launch plans exceeding our expectations. We continue to be the in-class market leader, and I think it's really driven by a couple of different things. First thing is strong execution across our field-based teams. That's the medical affairs team, the sales team, the market access and patient services team, really with a focus on where we think the key business segments are, the key accounts are. And that's not just in the U.S., that's actually in Japan as well. So we've really seen strong customer engagement and over 85% of our key accounts ordering in the U.S. to date, and over 80% also in Japan. Of course, we have had no barriers from an access perspective, with 99% of covered medical lives in the U.S. with functional access to Epkinly. So again, that's what I mean in terms of the rationale for exceeding expectations, and I think for removing hospitalization from the DLBCL label, Tahi? Well, sure. I mean, we're obviously actively working on this. There are essentially two data sets that will inform and provide the relevant data to approach the health authorities with the change in the label. One is similar to what happened on follicular lymphoma, although with a different strategy. We had a so-called optimization cohort for diffuse large B-cell, where with a more tighter prescription on steroids and fluids, we were able to reduce the CRS rate, particularly reduce Grade 3 and higher. Actually, didn't have any Grade 3 and higher anymore, and then the Grade 2 rate. And then the second data package, which is probably more relevant because it's also practice informing, is a study conducted by our collaborator, AbbVie. Really conducted in the outpatient setting, really conducted in the community hospital setting, and for the first time, really generating clinical data in these practices with their own setup, their own challenges and opportunities to provide comfort and guidance to prescribers who operate in these settings, on the safe administration of Epkinly in the setting for diffuse large B-cell. And this is all going to be compiled and discussed with the authorities in the near future. Thanks, Tahi Thank you, Rajan, for the questions, huh? Thank you. Now we're going to take our next question. The question comes from the line of Yifeng Liu from HSBC. Your line is open. Please ask your question. Hi, thanks for taking my question. Got one on acasunlimab. And just based on the phase 2 data, so obviously, for the 6-week dosing regimen, how do you think about incorporating those responders in your phase 3 design? And then secondly, on also on acasunlimab, I guess, on the BioNTech breakup cost, is there anything that being taken into account in your 2025, or is everything sort of taken account already in 2024 guidance? And thirdly, maybe could you give an update on the EPCORE DLBCL phase 3 trial, EPCORE DLBCL-1 phase 3 trial, the second-line treatment in R/R and DLBCL? Thanks. Thanks, Yifeng, for the questions. The first one, I think is one for Tahi again, the second one, Anthony Pagano, and the third one, on the diffuse large B-cell lymphoma trial. Maybe, Tahi, you can start with the acasunlimab question on the Q6-week dosing and phase 3 design. Yeah, thank you. If I understood you correctly, I, it wasn't really totally clear. You, you're asking whether we would consider some response adaptive approach? That wasn't really clear. So, just maybe I can make myself quite clear. Yeah. Just because I think in the phase 2 results the overall survival benefit is predominantly driven by the responders. Just wonder how you're taking that thinking into a phase 3 design in terms of maybe opportunities of recruiting more potentially that patient can respond better. Yeah. Yeah. So, okay, now I understand a little bit better. I'm not 100% sure whether it's only the responders. I would say it's probably a subset of patients that have also significant stabilization. It's not only purely responsive, and I think this is one of the hallmarks of immunology, that response doesn't A to A translate into the population that benefits for event-driven outcomes, particularly survival. But of course, and we have, and this is probably arguably the largest randomized phase 2 study conducted preceding a phase 3 in that setting, as far as I can tell. We're taking all the data that we have and trying to interrogate and better understand if there are ways to hone on the specific patients that benefit the most. And some of this is already reflected, of course, in the inclusion/exclusion of the phase 3. That's good practice. Thanks, Tahi. Thank you. Let's move over to Anthony Pagano for the second question on the BioNTech, the guidance basically for 2024, 2025. Yeah, thanks. I'll step through this rather carefully in detail. Now I'm gonna start with maybe the economics, right? The economics are effectively not impacted by this gross up, right? To be very clear, this is a classification matter. The impact to operating profit, which is ultimately what matters, is zero. But now let's step through it. We provided our original guidance for 2024. I was really clear that we were looking for an opportunity to transition to net expense accounting in our P&L for 2024, i.e., that we would not have to gross up our P&L for the expenses with, you know, the higher expenses and then offset by revenue. That's what was assumed in our original guidance for 2024. Now, as we got to where we got to, we arrived with BioNTech and their decision to opt out of the, the, GEN1046 program. In conjunction with that, we concluded that we would not be able to move forward with that net accounting moving forward. And that resulted in what I explained today in some level of detail, for programs remaining in the BioNTech collaboration, you know, again, not GEN1046. For all the other programs remaining in the collaboration, we will have to go with this grossed up, classification, if you like it, where we're gonna have, a larger, cost, if you like, but that will be fully offset by the higher cost reimbursement revenue. As I sit here today, that is what we should assume for 2025, and moving forward. If there's an opportunity to further align this accounting and classification with our other agreements, like we have with AbbVie, we'll certainly look for that opportunity, but I, I don't want to bank on that right now. Just to conclude, I do wanna finish where I started: that this classification item and matter does not in any way, shape, or form impact our, our operating profit. This is simply a grossing up, if you like, in plain terms of our, our, our P&L. I, I trust that's clear. Yeah. Thank you. That's really helpful. Thank you very much. Thanks, Anthony. Thank you. Last question for Judith. An update on the status of the DLBCL-1 study. Judith Klimovsky? Yeah, no. So, I don't know which one you allude to. We have 3 studies, phase 3 in DLBCL. So, which one are you particularly asking about? Yifeng? Yifeng, which one? Yeah. So I can give you a summary. So we have a study, which is EPCORE in comparison with standard of care for FL, which we are. It's a time to event study, so we are following up events to get the study to completion. There is a study in the first line, DLBCL, which is EPCORE plus R-CHOP, which is actively recruiting. I would say that this is going very, very well in terms of recruitment. And there is a new study posted, which is in relapsed refractory, a phase 3 with EPCORE Len, which, you know, will start recruiting very soon. So these are the three studies and the status. Thanks. Thanks, Judith. I think that should, that should help Yifeng with the modeling. Let's go for the next question, maybe the last one. Yes, of course. Operator? Yes, of course. Now we're going to take our next question. Yeah, give me a moment. Now we're going to take our next question, and it comes from the line of Mattias Häggblom, from Handelsbanken. Please ask your question. Thank you so much. Mattias Häggblom, Handelsbanken. I'll keep it to one. So BioNTech phrased the decision to opt out from acasunlimab on the earnings call as we are ordered to have critical mass in non-small cell lung cancer. So judging from the market reaction on the day news were announced, investors were obviously disappointed by the change. So where in particular do you think Genmab and BioNTech value the asset differently? I guess I'm trying to better understand, given what you described as across unprecedented over the data, if you think there is something in particular with the asset data generated so far, or profile with the molecule that you perhaps appreciated more than your partner did. Thanks so much. I think I can handle that question. Thanks, thanks for the question. This was purely a strategic priority driven decision. There was no data analysis involved in that. We got feedback from BioNTech on that. I think ask BioNTech about the prioritization of some of the other problems in lung cancer, and you will find the answer. This was a strategic prioritization which led to that opt out of BioNTech, so no other factors were involved at all. Operator, maybe on to the next one. Dear participants, thank you for all your questions for today, and I would now like to hand the conference over to Jan van de Winkel for any closing remarks. Thank you for calling in today to discuss Genmab's financial results for the first half of 2024. If you have additional questions, please, please reach out to our Investor Relations team. We hope that you all stay safe and keep optimistic, and we very much look forward to speaking with you again soon. This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.