Hello, and welcome to Genmab's Financial Results Conference Call for the First Nine Months of 2024. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that Genmab may hold your personal data, as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. 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 Genmab's conference call to discuss the company's financial results for the period ending September 30, 2024. With me today to present these results is our CFO, Anthony Pagano. And we will also welcome our new Chief Commercial Officer, Brad Bailey. For the Q&A, we will also be joined by our Chief Medical Officer, Tahi Ahmadi, and our Chief Development Officer, Judith Klimovsky. 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. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. At Genmab, we have a history of consistent and exceptional success. Eight products either created by Genmab or via our technology are currently approved and making a difference in the lives of patients. Of all approved bispecific antibodies, two of them were created using our DuoBody technology. This success allows us to continue our focus on transforming our business in a strategic and step-wise manner, with an eye to the future and how we can best serve patients through our innovative antibody medicines. At the beginning of 2024, EPKINLY was the key focus of our late-stage development. Nine months later, we now have two wholly-owned late-stage assets, Rina-S and acasunlimab. Recent events showcase how we are prioritizing the development of these programs. Starting with EPKINLY, we believe that our validated DuoBody technology has given it a best-in-class profile. We are extremely pleased with the launch, especially in Japan, where we have a significant head start over other therapies and, at present, EPKINLY is the only approved CD3, CD20 based bispecific. In fact, since launch, we have consistently outperformed our closest competitors globally. In August, EPKINLY received its second approval in Europe. That makes it the first and only subcutaneous bispecific antibody approved in both the European Union and the U.S. to treat both relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma. This demonstrates the potential of epcoritamab to provide a convenient single treatment option across multiple B-cell malignancies. We received additional support for the potential of EPKINLY in September with the FDA granting a second breakthrough therapy designation for EPKINLY in relapsed/refractory follicular lymphoma, this time in combination with rituximab and lenalidomide. With five Phase 3 clinical trials ongoing and more than 20 abstracts accepted at this year's ASH meeting, including four oral presentations, we and our partner, AbbVie remain committed to exploring the development of epcoritamab as a potential core therapy across B-cell malignancies, as demonstrated through the breadth of data presentations this year across forms of lymphoma and lines of therapy. We have also seen recent progress with Rina-S and acasunlimab, our two wholly-owned programs with the potential to be best-in-class therapies. Both of these programs have now moved toward late-stage development with the recent listing of Phase 3 trials on clinicaltrials.gov. We presented promising dose expansion data in ovarian cancer for Rina-S at ESMO, and we also presented PK/PD data at the World Conference on Lung Cancer for acasunlimab that is supportive of our every six week dosing schedule. We continuously evaluate our clinical pipeline to ensure we are prioritizing our resources in the best and most effective way possible. After careful consideration, we have decided to terminate the early-stage clinical programs, GEN1047, GEN3017 and Gen1056. And we will no longer start Phase 3 development for TIVDAK in second line plus head and neck cancer. What should be clear is that our strategic prioritization means we are very focused on maximizing the potential of our Phase 3 programs, EPKINLY, Rina-S and acasunlimab. The number of patients who may benefit from medicines powered by our innovation continues to expand. In September, Amgen's TEPEZZA was approved in Japan, making it the first and only treatment for active thyroid eye disease in the country. J&J achieved multiple approvals for RYBREVANT across the U.S., Europe, and Japan. And J&J has also expanded DARZALEX FASPRO indications with additional approvals and a regulatory submission. These developments highlight significant advancements in products that fuel our growing recurring revenues. Brad will now provide you with a review of the recent performance for EPKINLY and TIVDAK, both of which have consistent quarter-over-quarter growth. Brad, the floor is yours.

Thank you, Jan. I'm delighted to be joining my first earnings call as Chief Commercial Officer. And over the past several years, we've had a clear focus on building our commercialization capabilities at Genmab. To date, we've been very pleased by the strong performance of our launches in the U.S. and Japan, powered by this strategic investment at work, and this quarter is no different. Specifically, during the third quarter, our commercialization teams executed effectively to deliver our own medicines, EPKINLY and TIVDAK to even more patients worldwide. EPKINLY, which is the first and only bispecific approved for both relapsed/refractory third line plus diffuse large B-cell lymphoma and third line plus follicular lymphoma, closed Q3 with strong performance, reporting 17% growth in the quarter, $82 million in net sales globally and year-to-date sales of $203 million. Overall, we've continued to see robust uptake across key accounts, strong field execution, and positive responses from physicians and patients. What we're seeing in the field is validating EPKINLY's differentiated profile. Most importantly, patients are benefiting from its efficacy, manageable safety, and the seamless experience of subcutaneous administration. In the U.S., EPKINLY continues to assert in-class leadership through competitive differentiation and targeted activation with rapid uptake and adoption by key accounts, including a meaningful acceleration following the FL approval. We attribute this performance to three key factors. First and foremost is EPKINLY's clinically differentiated profile, which addresses a high unmet need across histologies. We've heard positive feedback from physicians regarding the long-term follow-up data presented at ASCO, underscoring the durability of powerful responses with EPKINLY in third line plus DLBCL. And as Jan mentioned, we look forward to building upon this with continued follow-up at ASH in December. Second is broad U.S. market accessibility across payers, institutional formularies, and diverse sites of care. Third is the highly effective and well-coordinated execution across our field-based commercialization teams to deliver optimal customer experiences. As we look ahead, brand execution will focus on accelerating adoption and tailoring the approach to account needs. Moving on to Japan, we continue to be pleased with EPKINLY's performance with growth largely driven through strong field execution and the broadening types of accounts activated. As we move to Q4, we will continue to focus on account openings to assure a broad range and become familiar with EPKINLY ahead of a potential approval in FL. In Europe and rest of the world, through our partner, AbbVie, we also saw strong growth in the third quarter. Turning to TIVDAK. TIVDAK continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and $32 million in sales. The increase in demand is largely driven by the strength and breadth of accounts using TIVDAK. TIVDAK provides unprecedented efficacy where previous options have typically offered low response rates and poor outcomes. And its strong performance with solid year-over-year growth builds a strong foundation to deliver future success in the gyn/onc space. We continue to receive positive feedback from physicians around the results from the innovative 301 confirmatory trial which demonstrated an overall survival benefit for TIVDAK, with most stating that these data establish TIVDAK as the clear standard of care in second line plus recurrent or metastatic cervical cancer globally. As we move ahead, we're focused on capturing more value from our owned commercialized medicines, which represented 35% of Genmab's overall revenue growth this year. Our foundational investments in our commercialization capabilities are fueling our success and will enable us to scale functions across the business to support our long-term growth. We're building on our momentum and expect a successful year-end conclusion. With that, I'll pass it over to Anthony to provide more perspective on our third quarter financials.

Thanks, Brad. We continue to strengthen our foundation throughout the first nine months of the year. We delivered on our goal of multiple successful regulatory approvals and launches for EPKINLY, and we're pleased with how these launches are progressing. We've also significantly enhanced our long-term growth potential with the acquisition of ProfoundBio. And as we'll see, our financials remain strong. Recurring revenues grew by 37%. This was principally driven by strong royalties from DARZALEX, Kesimpta, and other approved medicines as well as strong performance for EPKINLY and TIVDAK. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to strategically prioritize our investment, especially in our Phase 3 programs, EPKINLY, Rina-S, and acasunlimab. Now let's take a look at those revenues in a bit more detail. We grew total revenue to over DKK 15 billion in the first nine months of the year. And as I've already highlighted, that included a 37% increase in our recurring revenue. This strong growth was driven by higher DARZALEX and Kesimpta royalties as well as royalties from other products. Looking at DARZALEX specifically. Overall, net sales grew by 19%. That's net sales of nearly $8.6 billion, which translates to almost DKK 10 billion in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting. And as Brad noted, we're pleased with how EPKINLY and TIVDAK are performing with consistent growth quarter-over-quarter. Now what we're most excited about is that we can see the investments we've made in building out our commercialization teams and capabilities to secure the EPKINLY launch are paying off. And this is reflected in our in-class leadership and the strength of our launch in Japan. Taken together, these two products contributed 35% of our total revenue growth in the first nine months. This really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued focused investment in our priorities, as you can see on the next slide. We continue to take a disciplined approach to our investments with a focus on portfolio prioritization and being efficient. Total operating expenses including ProfoundBio acquisition and integration-related charges were approximately DKK 9.9 billion. As you can see, the majority of the investment or 74% was driven by R&D, and this compares to 71% in the prior year. As you'd expect, given everything we've said about prioritization, we've accelerated investment into advancing our Phase 3 programs, EPKINLY, Rina-S, and acasunlimab. SG&A growth moderated up only 8% year-over-year reflecting our focus on driving SG&A efficiency. 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 15 billion. That's up 29% on last year. Here, I want to highlight the improving quality of our revenue profile. In 2024, recurring revenues represented 92% of total revenue compared to 86% over the same period last year. Total OpEx was around DKK 9.9 billion, up 23%. And even with that increased investment, we're still delivering over DKK 4.5 billion of operating profit, and that's up more than 27%. Moving to our net financial items. Here, we have a net gain of DKK 1 billion. This was driven by net foreign exchange rate gain as well as by an increase in interest income. Then we have tax expense of around DKK 1.6 billion, which equates to an effective tax rate of 28.1%. And here, I'd note, as I did last quarter, that we continue to evaluate the integration of ProfoundBio operations from a tax perspective. So our effective tax rate may experience some volatility as activities progress. We anticipate this will normalize within the next 12 to 18 months. And that brings us to our net profit of almost DKK 4 billion. So as you can see, continued strong underlying financial performance. Now let's take a look at our guidance. Here, based on strong performance in the first nine months, I'm pleased to say that we've been able to narrow our guidance range with our revenue growth outpacing this year's growth and investment. We are raising the lower end of our revenue range, and this increase is driven by higher royalty revenues from DARZALEX. As a result, we now anticipate revenue in the range of DKK 21.1 billion to DKK 21.7 billion, which is a growth of 30% at the midpoint. Importantly, we continue to anticipate strong growth for our own medicines with around DKK 1.4 billion of growth from EPKINLY and TIVDAK. Turning now to our operating expenses. Here, we've lowered the upper end of our OpEx range, anticipating DKK 13.7 billion to DKK 14 billion, excluding acquisition and integration-related charges. This reflects our disciplined approach to investments as well as rigorous portfolio prioritization. So as you can see, we continue to deliver on our guidance and prioritization commitments. Taken together, we are generating significant underlying profitability. We're on track to deliver another year of substantial operating profit of between DKK 6.2 billion to DKK 7.1 billion, excluding acquisition and integration costs. At the midpoint, this represents growth of 25% compared to last year. So in summary, we continue to focus on our priorities while consistently delivering on our financial commitments. Now having covered 2024, let's look ahead a bit to 2025. While guidance will be given in February next year, we are committed to investment in Phase 3 trials for EPKINLY, Rina-S, and acasunlimab. Now as I stand here today, consensus expectations for our investment in 2025 appear to be in a reasonable place, capturing our investment priorities. Now let me wrap up and provide a few closing remarks. In summary, we are advancing our late-stage product portfolio from one to three products while achieving our financial goals through strategically prioritizing our investments. This focused approach enables us to realize our vision and to capitalize on the significant growth opportunities ahead. And with that, I'm going to hand you back over to Jan.

Thank you, Anthony. Let's move now to our final slide. We are very pleased with the progress we have made towards our 2024 goals. Additional approvals have enabled us to expand the reach of EPKINLY and TIVDAK. We've strategically advanced our proprietary product portfolio, including the Phase 3 trials for Rina-S and acasunlimab. And in addition to Rina-S, the acquisition of ProfoundBio gave us next-generation ADC platforms. All of this advanced our evolution into an integrated biotech innovation powerhouse. Finally, for HexaBody CD38, we are in the process of preparing data submissions to J&J. The data package is scheduled to be submitted by the end of December, the opt-in period of 60 days is expected to start in the beginning of January, which means we anticipate a decision from J&J no later than the first quarter of 2025. We will inform the market via press release when J&J has made their decision. This release will include relevant top-line clinical data. To support the integrity of J&J's review process, we will not disclose the information before the official release. Before we move to Q&A, I'm pleased to announce that we will hold our annual R&D updates and our data review event on December 11. To ensure the event is accessible to as many people as possible, this year's presentations will once again be fully virtual. Details will be available on our website, and we look forward to a lively event. That ends our formal presentation. Operator, please open the call for questions now.

Thank you. We will now move to our first question. One moment please. Your first question comes from the line of Jonathan Chang. Please go ahead.

Hi, guys. Thanks for taking the question. First question, just a clarification on the HexaBody-CD38. Did you say that the top line data will be disclosed in the press release when J&J makes a potential opt-in decision or the data package submission press release? And then second question, on Rina-S, can you discuss the rationale behind not having an FR alpha expression requirement in the Phase 3? What's the mechanistic rationale for Rina-S working at low or no FR-alpha expressing patients? Thank you.

Thanks, Jonathan, for the question. For the HexaBody-CD38 top line data, we will announce that once J&J has made the opt-in decision. So we already know the opt-in decision and then we will release the key clinical data, Jonathan. So not at the date of submission, but when the opt-in decision is coming in. Then for Rina-S, I propose to move this question to Judith and Judith can give you further color on the folate receptor alpha expression levels requirements. Judith?

Yes. Thank you. So the data presented at ESMO, we showed activity regardless of the expression, 75% cut off or above, which is the approved cutoff for another folate receptor in the market. In addition, there is a footnote that says that we have seen activity in patients that had folate-receptor below 25%. So based on the data that we have described, the decision was not to preselect for folate receptor alpha expression.

Thanks, Judith. Thanks Jonathan for the questions.

Thank you. Your next question comes from the line of Michael Schmidt. Please go ahead.

Hi, this is Paul on for Michael. Thanks for taking our questions. Maybe just a follow-up on Rina-S. So for the Phase 3 study, the clinical trials listing doesn't seem to have any geographic limitations yet. So can you talk about how you plan to limit perhaps patients who have been treated with mirvetuximab maybe based on your site distribution? And then my second question is just on TIVDAK and what's sort of factored into your decision to discontinue the planned Phase 3 given your enthusiasm earlier this year? And does that have any impact on how you view the potential in other solid tumors? Thank you.

Thanks, Paul, for the questions. I think Judith can actually start with both questions, and maybe Tahi can step in also on the Rina-S. Judith?

Yes. Thank you. So for TIVDAK, as Anthony and Jan alluded, it's a strategic decision based on the prioritization of our pipeline and taking into consideration the totality of the data, external and internal. But basically, it's a strategic decision based on prioritization of our pipeline. And for Rina-S, I will start by saying that the approval of mirvetuximab is rolling. So of course, in some countries where mirvetuximab is not approved, it's not needed, and it's not standard of care. And in those countries where it is approved, it's become standard of care, and we have this into consideration for the Phase 3.

Thanks, Judith. I don't know, Tahi, whether you want to add anything to that or this is okay?

I wanted to add to the previous question that the phenomenon where antibody-drug conjugates with specific payloads show effectiveness in tumors with low or ultra-low expression is not exclusive to Rina-S. It is related to the stability of the linker used in the payload and the ability to accurately detect the expression of a particular target. As Judith mentioned, we see efficacy in low and negative expressions, which also depends on how we assess low-negative folate receptor alpha positive ovarian cancer. I want to emphasize that this phenomenon is not new.

All right. Thanks, Tahi. I think we can go to the next question, operator.

Thank you. Your next question comes from the line of Zain Ebrahim. Please go ahead.

Hello, Zain Ebrahim from JP Morgan. Thank you for taking my questions. I have two for you. My first question is about GEN1042. When can we expect updates regarding the next steps for GEN1042? Is the decision to deprioritize TIVDAK in head and neck treatments related to your plans for GEN1042? My second question pertains to HexaBody-CD38. The timeline you provided is helpful, but how should we evaluate the potential safety profile in the head-to-head trial, considering the safety signals we observed last year based on the baseline characteristics of the recruited patients? Do you believe there is a lower risk of any cardiovascular issues arising in that head-to-head trial? Thank you.

Thank you for the questions. I believe I can address both of them. Regarding 1042, we are still in the process of gathering more data, and we expect to make a decision on the next steps in the coming month. We will review all the data collected, including different doses and dosing frequencies, before determining the next steps for the 1042 bispecific program. As for HexaBody-CD38, we will release data when J&J announces their opt-in decision. At this time, we are not discussing any other data to avoid any bias in the decision-making process. We want to ensure they can make the decision in the best possible manner. I'm closely reviewing all the available data, and you will hear from Brad at the appropriate time.

Great, thanks a lot.

Thanks.

Thank you. Your next question comes from the line of Suzanne van Voorthuizen. Please go ahead.

Hi, team. Thanks for taking my question. First question in relation to EPKINLY and the commercial traction. Can you frame which indications or treatment settings, geographies, or other segments that you're looking at, you expect to be potential major drivers from here for the coming years? And remind us how you think about the peak potential of the drug. And then a tiny follow-up on HexaBody-CD38, very helpful guidance there. But did you also comment on the timeline for the update you have referred to? Should we still continue to expect something this year? Thank you.

Thanks, Suzanne, for the questions. And the first one, I will definitely turn over to Brad and then see whether I can add further perspective after Brad has given you his input on the commercial potential and where to expect that. For HexaBody-CD38, we will actually plan to present the data in Q1, Suzanne. Brad, maybe you can answer the question on EPKINLY commercial potential and the geographies, the countries, etc. Brad, are you there?

Are you still connected, sir?

Brad?

He is now unmuted, sir.

Yes. Thank you, operator. My apologies, unable to get the mute off. So thank you for the question. And yes, from an EPKINLY perspective, obviously, I'm extremely pleased with the work that's been done from a U.S. and Japan perspective and driving over 90% of the revenues at this point in time, certainly rest of world with EPKINLY. We're now in a position as we're expanding from third line plus DLBCL with potential new approvals in FL as well and most recently in Europe and then expected early next year in Japan. So we still see the two major drivers in U.S. and Japan with certainly our partner, AbbVie, as we are in these later lines of therapy that are certainly modest in patient numbers at this point. But certainly, as we continue along the development plan moving into earlier lines of therapy as well as combinations where we see the value to be increased at that point in time. So thank you.

Thanks, Brad, for that color. Hopefully, that helps Suzanne.

Got it. Thank you.

Thank you.

Thank you. We will now take the next question, and the question comes from the line of Xian Deng. Please go ahead.

Thank you very much. Thank you for taking my questions. Two, please. The first one is on 2025 catalyst. I mean I understand this is probably a bit too early to give full details for next year's catalysts. But just wondering, on high level, do you think we could expect the acasunlimab clinical data follow-up next year? Will we also see more clinical data on Rina-S perhaps in combo? That's the first question. And the second one is on sort of TIVDAK and the costs related to that. So just wondering, given now you will not progress with the Phase 3 trial, just wondering how much in terms of R&D savings do you expect to come from that. Or the other way of asking this is, could you remind us roughly how big the size of the trial in relation to the other Phase 3? Thank you very much.

Thanks, Xian, for the questions. And definitely, next year, we will inform you of catalysts, early next year, when we give guidance for the year, Xian. But definitely for acasunlimab, we expect further data on the lung cancer setting, for sure. And for Rina-S, there will surely be data, both updated data, I think, for ovarian carcinoma but also other tumors. So there will definitely be data, and we will let you know early next year what the catalysts are and the approximate timing. And then maybe Anthony Pagano can give you a bit of color on the Phase 3 trial costs for TIVDAK as we anticipated them originally. Anthony?

Yes. Thanks. And I can comment on the investment profile a bit, and then any additional color either Tahi or Judith may provide, they can do after I provide my comments. I think the net here is that we're really focused on prioritizing our portfolio. You heard from Jan today that we've taken four decisions, three on earlier-stage programs and one on a later-stage program, the TIVDAK program, you just noted. This is done with an eye towards really prioritizing our other Phase 3 programs, including EPKINLY, Rina-S, and acasunlimab. And what I'd leave you with here are two thoughts. This prioritization is something we take very, very seriously, and we'll continue to do. And then the impact of that is reflected in the revised 2024 OpEx guidance as well as, and it's probably worth repeating, the comments that I made as it relates to 2025. So again, looking ahead at 2025, again, I'll provide guidance in February. We're committed to investment in Phase 3 trials for EPKINLY, Rina-S, and acasunlimab. Again, as I stand here today, consensus expectations for our investment in 2025 appear to be in a reasonable place, again capturing those investment priorities that I just highlighted. So I'm not really in a position to break out the specifics, again, other than just to highlight for you, really, our laser-sharp focus on directing the lion's share of our capital in terms of R&D investment, particularly the growth, to these Phase 3 programs that I just mentioned. Judith, anything you want to highlight, anything you haven't said already on the TIVDAK program?

No, no, no. I mean you said it, it's a strategic decision. And at that time, when the decision was made, we were in the planning stage. So the Phase II was not fully designed and costed. It was the prioritization of the portfolio that led to the decision.

Thanks, Judith, thanks Anthony. Thank you, Xian for the questions. Let's move on to the next one.

Thank you. Your next question comes from the line of Yaron Werber. Please go ahead.

Thank you for addressing my question. I would like to follow up on GEN1042 regarding CD40x4-1BB. From what I gather, you are still working on dosing in conjunction with the standard of care for the first line, specifically in head and neck cancer. Additionally, there are several other opportunities that you are exploring, including non-small cell lung cancer, pancreatic cancer, and melanoma, with data expected next year. Are you planning to move to Phase 3 and will you provide an update on the trial design? What should we anticipate for next year? Thank you.

Thanks for the question. On GEN1042, we are still collecting data in frontline settings in four different cancers, and we believe that we have all the data in hand in the coming months to make a decision on next steps, and we'll let you know at that time.

Thank you.

Let's move to the next question.

Thank you. Your next question comes from the line of Asthika Goonewardene. Please go ahead.

Hi, guys. Thanks for taking my question. I have a quick one on HexaBody-CD38. Is the final data packages that you will send to J&J going to include any of the preclinical data that you explored in autoimmune diseases? And then on Rina-S, Judith, you mentioned at the presentation at ESMO how that had an indication that patients with FR alpha, less than 25% had clinical activity. Can you tell us if you actually saw clinical responses in those patients? Those are my questions. Thanks so much.

Thanks, Asthika, for the questions. And Judith can definitely take the second one on Rina-S. But for the HexaBody-CD38, the data package will be the clinical head-to-head data, Asthika, in multiple myeloma, which we'll share with J&J in December. And Judith, maybe you can speak a bit about the Rina-S data.

Yes. And Asthika, thank you for the question. And again, I would refer you to a slide that was presented at the oral presentation at ESMO that shows the waterfall plot with 75% above and below. And a footnote that says we saw responses as well in patients below 25%. And we can refer you to the slide number on that oral presentation. So yes, we saw responses.

Thanks Judith, and thanks Asthika for the questions.

Thank you. Your next question comes from the line of Yifeng Liu. Please go ahead.

Hi, thanks for taking my question. I've got one for Rina-S, and obviously, we talked about the FR alpha expression level. My question is, do you see that sort of adaptable into other tumor indication in the sense that you may see responses or signals or early signals that they respond across different level of FR alpha expression levels? And how should we think about the opportunities there? Thanks.

Thanks, Yifeng, for the questions. Why don't you ask, Tahi, to start? And then maybe Judith you can add when you have a few things, angles, to add. Tahi?

There is already data being generated in the protocol, which is publicly disclosed, specifically concerning endometrial cancer and a subset of non-small cell lung cancer that does not express folate receptor alpha. We may have the chance to present this data in the future, but we can't commit to a timeline for when that will happen or when we will have the data available. We are currently in the process of collecting this data. Folate receptor alpha-expressing tumors are being examined at this moment.

Thanks, Tahi. Thanks Yifeng for the question. Let's move to the next one operator.

Thank you. Your next question comes from the line of Matt Phipps. Please go ahead.

Thanks for taking my question. Just one quick follow-up on the TIVDAK decision. Are you still planning to evaluate TIVDAK plus KEYTRUDA in the frontline head-and-neck setting? And then is this part of just a maybe broader shift to incorporate some of the next-gen ADC components from ProfoundBio into programs going forward? Any additional ProfoundBio assets that we should be looking for?

Thanks, Matt, for the questions. Let me ask Judith to comment on the TIVDAK question. And then I can tell you, as it relates profounds, we have now two other programs in the clinic as we speak; and the third one beyond Rina-S, which will go to the clinic, a bispecific HuMax-EGFr ADC program. We are very, very keen on actually moving forward all of these ADC programs. And then at some point, we may actually also begin to combine some of the immune activator programs like the acasunlimab program with ADCs because we think it makes perfect sense conceptually to start combining those. But we are very excited about the pipeline, Matt. We will see a very rapid progress, I think, of the pipeline in the coming time. But in the coming year, we will definitely focus a lot on the late-stage clinical development, Phase 3 program, for a number of antibodies. But let me ask Judith to give color on the KEYTRUDA combinations in frontline.

Yes, thank you. So as you know, I mean, innovaTV 207 run by Pfizer is ongoing and has a cohort that is exploring TIVDAK in combination with pembrolizumab in the first line setting. So you are correct. The cohort is ongoing.

Thanks, Judith, and thanks Matt. Please move to the next question.

Thank you. Your next question comes from the line of Alistair Campbell. Please go ahead.

Thanks, everyone. Thanks for taking the questions. Thanks a ton. Just a quick follow-up on the Rina-S trial, just to be clear, are you going to be testing for folate receptor expression at baseline? And could that be a predefined analysis of the data? Or is this going to be an all-comers trial? And then just noticed your recent collaboration with Revitope. So wondering if you can discuss what's attracting you to that technology. What do you think that could offer just different from your own capabilities in bispecifics?

Thanks for the questions. The first one on the Rina-S trial, I think it's straightforward. Judith can address that. And maybe, Tahi, you can address the second one.

Yes. So for the first one, the study is not preselecting for folate receptor expression. So this is a direct answer. Of course, we are assessing folate receptor expression in every patient, but it's not used to preselect.

Thanks, Judith. And then maybe Tahi on the new deal with the new technology.

Well, generally speaking, we always are looking at outside technologies that complement and enhance our internal capabilities. This is a deal to complement discovery efforts that we're working on to understand how we can expand the opportunity space for T-cell redirection particularly, but not only with respect to that, but particularly also to the solid oncology space where it has, for the most part, been challenging to come up with concepts that are able to replicate the success of T-cell redirection in the hem space, particularly in myeloma and lymphoma. So this is just another component for us to expand our research opportunities, and it works really well and nicely with our CD3 program that we have internally.

Thanks, Tahi. It's actually very complementary and not competitive with our DuoBody technology. We believe that this will actually widen the space where we can use T-cell engagers. Next question please.

Thank you. Your next question comes from the line of Vikram Purohit. Please go ahead.

Hi, good afternoon. Thanks for taking our questions. So we had two, one on the pipeline discontinuations, one on EPKINLY. So apologies if you mentioned this and we missed it, but the discontinuations you mentioned, are they part of a broader pipeline review? And as a result, can we expect more deprioritization from the earlier-stage efforts you have underway in the coming quarters? And then secondly, on EPKINLY, was just curious to get your sense on how the profile of patients with DLBCL that you've been treating has been evolving over the past couple of months as the launch has progressed? Thank you.

Thanks for the questions. So let me address the first one. We have actually now really reprioritized our pipeline. And we actually have no progress of the 1047, 3017 and 1056 programs because these programs simply didn't meet the high bar we have set internally for really having truly differentiated therapeutic candidates. So yes, we have now, I think, gone through a lot of pipeline reprioritization. In the future, you will again see both new programs added to the pipeline. We recently, for example, added a DuoBody-FAPaxDR4 bispecific program with fantastic preclinical data that's called GEN1057 to the pipeline. It started recruiting patients in September. And there will be others starting soon, like the HuMax-EGFr ADC program, which is coming from the ProfoundBio acquisition. And we will also potentially close other programs based on data, but this is the pipeline reprioritization for now. It is actually very rigorous. And we actually intend to focus more and more on the winners and expand the breadth of the winners in the future. Then for EPKINLY, the profile of patients, and maybe Brad is the best person to start, and then maybe Tahi can also add further perspective. Brad?

Yes. Thanks, Jan. Thanks for the question. And we certainly continue to hear from HCPs regarding the types of patients about their positive clinical experiences across both DLBCL and now FL, certainly further validating our differentiated profile, in the subcutaneous administration as well and the ease of administration. But sort of past the initial phase of the launch period, we're now hearing that the types of patients are evolving, instead of multiple later lines of therapy, into the third-line plus setting in DLBCL. And with FL, it's a little too early to accurately assess any type of unique patients at this point but continue to hear favorable responses from our providers.

Thanks, Brad. Tahi, do you want to add anything to that?

Well, I mean, I would just say, generally saying, I think there is continuous evidence that the initial hypothesis around EPKINLY, epcoritamab, that the subcutaneous administration from a patient convenience point of view, but also from a safety point of view, would play out well and would expand access to this modality for patients. I think it's fair to say that this is playing out.

Thanks, Tahi. And what I can also say is that we are seeing really, really good data in broader and broader patient populations also in clinical trials, Vikram. I can tell you that also the CLL data has been selected for the ASH press program on December 8 as one of the very few programs with epcoritamab. So we also see some very good data in CLL. And then when you look at the overall presentations at ASH, you can look at the abstracts for now, we see actually a better and better profile suggesting that epcoritamab is clearly having a best-in-class profile and different B-cell cancer. So we are very excited about the potential that we're going to broaden and maximize the potential of the epcoritamab program together with our partner AbbVie over the coming time. So more to come in early December at ASH. And also, I think one of the highlights is, on December 8, in the ASH press program, which will feature amongst other programs, epcoritamab treatment of patients with CLL.

Got it. Thank you very much. Very helpful.

All right. Thank you for the question.

Thank you. We will now take our final question for today. And your final question comes from the line of Etzer Darout. Please go ahead.

Great, thanks for taking the question. Just given the portfolio review, just wondered if you had any updated thoughts on the platform in autoimmune diseases sort of given what we're hearing about CD38 and OX40 in development, just your kind of overall thoughts given sort of your platform, antibody platform, and some of the enthusiasm around some of these mechanisms in autoimmune. Thanks.

Thanks, Etzer, for the questions. And I will start here, and then Tahi and Judith, don't hesitate to step in then with more perspective. We still have a very active number of programs in preclinical development, Etzer and autoimmune indications, either with ourselves or with ourselves in combination with argenx where we are working on a number of programs in the autoimmune area, also using our next-generation antibody technology platforms. And of course, there is potential to potentially move also with ADC technologies towards autoimmune. And we definitely have a number of preclinical scenarios we're working on, but they are not yet ready for clinical introduction. So the majority of the work at Genmab over the coming years will still be in cancer where we have carved our dominant focus, but we are clearly very interested in exploring innovative ways to move towards autoimmune with the T cell engager program, potentially ADCs, or other next-generation antibody technologies. And this year, we will also see the clinical validation of the HexaBody program via our HexaBody-CD38 approach, but that is right now in multiple myeloma. But that I think has also a potential in autoimmune type settings. But more to come in the future. Tahi, Judith, do you want to add anything to that?

I think you summarized it very well. Thank you.

Thank you, Jan.

All right, Judith, Tahi. So thanks, Etzer, for the questions. And more to come in the future.

Thank you, sir, please proceed.

Yes. Thank you very much, operator. So thank you all for calling in today to discuss Genmab's financial results for the first nine months of 2024. If you have any additional questions, 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 all again soon.

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.