Genmab A/S

CSE:GMAB

Hello, and welcome to the Genmab's Financial Results Conference Call for the First Quarter of 2025. As a reminder, this conference call is being recorded.

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I would now like to hand the conference over to your first speaker today, Jan de Winkel. Please go ahead.

Hello, and welcome to Genmab's conference call to discuss our financial results for the period ending March 31, 2025.

With me today to present these results is our Chief Financial Officer, Anthony Pagano; our Chief Commercial Officer, Brad Bailey; 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, and this slide acknowledges those relationships.

In 2025, we continue to advance towards becoming a fully integrated biotech independently developing and commercializing wholly owned antibody differentiated therapies. Our disciplined capital allocation strategy and sustained execution support -- support our continued growth and long-term value creation.

In the first quarter, we continued to deliver on our strategic priorities. Our total revenue grew by 19%, fueled by the solid performance of EPKINLY and Tivdak and increased recurring revenue. Our investments remain fully in line with our capital allocation priorities, supporting key late-stage pipeline programs and maximizing the success of our commercialized medicines.

And we made these important investments while growing our operating profit by 62%. In addition, in March, we initiated our planned share buyback of up to 2.2 million shares. This share repurchase underscores both our confidence in Genmab's future and our commitment to delivering value to shareholders.

We ended the quarter with over $3 billion in cash, reinforcing the strength of our financial foundation. And this strength gives us the flexibility for continued growth and expansion. We will continue to prioritize our investments with a laser-sharp focus on our late-stage proprietary clinical pipeline, specifically epcoritamab, Rina-S and acasunlimab and [indiscernible].

In February, EPKINLY became the first and only subcutaneous T cell engaging bispecific antibody approved in Japan to treat both relapsed or refractory follicular lymphoma and relapsed or refractory large B-cell lymphoma after 2 or more lines of therapy. In addition, epcoritamab in combination with GemOx was added to the NCCN guidelines for second-line patients with diffuse large B-cell lymphoma who are ineligible for a transplant.

Tivdak expanded its presence with approvals in both Europe and Japan. It's now the first and only ADC approved in both territories for the treatment of recurrent or metastatic cervical cancer after prior therapy. Excitingly, the launches of Tivdak in Japan and Europe will be the first time that Genmab will lead commercialization efforts on our own without a partner. This will bring us closer to achieving our goal of bringing our own medicines to patients and will strengthen our growing leadership in transforming care for patients with gynecological cancers, which also positions us for success for the potential launch of Rina-S.

Our potential for future success is also reflected in the multiple data presentations that either occurred recently or that we anticipate in the coming months. In March, we presented the highly anticipated updated results of Rina-S in advanced ovarian cancer at the 2025 Society of Gynecologic Oncology Annual Meeting on Women's Cancer or SGO in Seattle. Last month, we had data from a variety of programs presented at AACR. This included preclinical data from Rina-S as well as the early-stage bispecifics GEN1057 and GEN1059. And we are now looking forward to ASCO, where we will have multiple presentations, including data for Rina-S in endometrial cancer.

Tahi will now bring you up to date with the status of this program, followed by an overview of the promising Rina-S data from SGO. Tahi, the floor is yours.

Thank you, Jan. If you could make sure that we are now on Slide 8.

We're confident that Rina-S has the potential to become a best-in-class treatment for ovarian cancer, endometrial and other folate receptor alpha expressing solid tumors. This confidence has led us to accelerate the development of Rina-S first into a Phase 3 trial in second-line plus platinum-resistant ovarian cancer. And also, we are now on track to start a Phase 3 study in second-line plus endometrial cancer before the end of the year.

Behind this confidence is encouraging data, including the results we will present at ASCO in endometrial cancer as well as the data that we recently presented at SGO in PROC.

Now let's take a brief look at the SGO data. If you could go to Slide 9, please. We told you in February that we intended to present meaningful follow-up data from the expansion cohort for PROC early in the first half of 2025 and we did just that last month at SGO. The data presentation included updated efficacy and safety data with around 24 weeks of additional follow-up from the data cutoff previously presented at ESMO last year.

As a reminder, these are heavily pretreated ovarian cancer patients. Regardless of folate receptor alpha expression, results showed that Rina-S dosed at 120 milligram per meter square every 3 weeks led to a confirmed objective response rate of 55.6%. And this encouraging antitumor activity was durable. With a median on study follow-up of 48 weeks, the median duration of response was not reached as only 1 of the 10 patients experienced disease progression.

Rina-S was well tolerated and once again, no signs of ocular toxicity or ILD were observed. Altogether, this data reinforces the potential of Rina-S to become a best-in-class treatment for ovarian cancer, benefiting a broader patient population than currently approved therapies with a differentiated efficacy signal across the entire patient population that is with no need for selection based on folate receptor alpha expression, better and differentiated safety profile that is without ocular toxicity or ILD and an unprecedented durability.

Now over to Brad for a review of the solid recent commercial performance for EPKINLY and Tivdak.

Thank you, Tahi. We started the first quarter of 2025 with solid performance from our commercialized medicines, reinforcing our foundation for continued growth and expansion across our portfolio. We've continued to invest strategically in our commercialization capabilities to ensure we are set for long-term success as we enter the exciting next phase of our commercialization strategy with our wholly owned launches initiating in Japan and Europe this year.

Overall, our commercialized medicines contributed positively to our revenue growth in the quarter with combined EPKINLY and Tivdak sales up 56% year-over-year, accounting for 29% of our total revenue growth. As we drive towards our 2030 vision, we see significant opportunity to build on our momentum across the commercialized portfolio, and we expect the contributions of our commercialized medicines to continue to increase. This is driven in large part by the confidence we have in our ability to capitalize on what we expect to be a $6 billion-plus combined market opportunity for EPKINLY, Rina-S, and acasunlimab as the total addressable patient population for these potentially transformative medicines grow significantly. It has become increasingly clear that our investments in our commercialization capabilities are continuing to fuel our success, yielding meaningful results and enabling us to strategically scale to support our long-term growth.

Turning now to EPKINLY. In Q1, EPKINLY posted $90 million in global sales, a 73% year-over-year increase, and we have observed continued growth across geographies with encouraging uptake, strong field execution, and consistent positive feedback from physicians. We continue to make strong progress, bringing EPKINLY to as many patients as possible around the world through our targeted go-to-market commercialization strategy as we address areas of high-end patient need across diverse sites of care.

As Jan touched on earlier, Q1 marked a number of meaningful milestones for our commercialized medicines and for EPKINLY in particular. This includes becoming the first and only bispecific approved with a dual indication in third-line plus DLBCL and follicular lymphoma in the U.S., EU, and now Japan as well. It also includes important progress that reinforces EPKINLY's clinical profile and potential in earlier lines of therapy. We're highly encouraged by EPKINLY's performance to date and its growth potential, particularly as we look ahead to earlier lines of therapy on the horizon, and we're confident that we have the foundation in place for EPKINLY to become the core therapy across B-cell lymphomas.

In the U.S., we have seen increasing uptake across sites of care, which will continue to be an important growth driver as we move forward. This expanded utilization reinforces EPKINLY's uniquely differentiated clinical profile, positive label, and value as the only dual indication bispecific in DLBCL and FL.

In Japan, the launch of EPKINLY in third-line plus relapsed or refractory follicular lymphoma is going extremely well, building on the uptake we've seen in LBCL and driven by national and field-level activities and account activation. Across all other markets, we've experienced growth with EPKINLY through our partner, AbbVie. Globally, EPKINLY has received more regulatory approvals across both DLBCL and FL than any other bispecific, with approvals in more than 50 countries presently. This positions EPKINLY well for continued growth and utilization across markets. As we look ahead, we remain focused on accelerating the adoption of EPKINLY, rapidly identifying patients across diverse sites of care, and advancing our robust development program across histologies and earlier lines of therapy to further establish EPKINLY as the core therapy across B-cell lymphomas.

Next, we'll turn to TIVDAK. Strong and stable performance in the US in Q1 was driven by the depth and breadth of sites of care using TIVDAK. Sales during the quarter were $33 million, which is up 22% over Q1 2024. As we shared during our Q4 earnings call, TIVDAK was updated to a category 1 preferred treatment and obtained a new category 2B designation for its use in combination with Pembro for PD-L1 positive patients, further reinforcing its potential as the clear answer in recurrent and metastatic cervical cancer.

In March, TIVDAK received approvals in both Japan and the EU, where Genmab will lead commercialization independently. Recognizing the significant need facing patients in Japan and Europe, our teams are working closely with health authorities to bring TIVDAK to patients in these regions as quickly as possible. Together, these approvals mark a significant milestone for Genmab, ushering us into the next phase of our commercialization strategy as we bring TIVDAK to more patients around the world and grow our gynec portfolio globally.

With continued solid performance across our commercialized brands and progress expanding our commercial portfolio, we feel confident in how we are positioned to continue executing our growth strategy now and in the future. Looking ahead, we will continue to make the necessary investments in our commercialization capabilities to fuel our success, competitively scale our business and drive strong results. As we build upon the launch success of both EPKINLY and TIVDAK, we are laser focused on expanding utilization of these life-changing treatments and bringing them to as many patients as possible around the world. These efforts mark a meaningful and disciplined shift towards the next phase in our commercialization strategy. Our strategic expansion into new markets will enable us to transform through the paradigms at global scale.

With that, I'll hand the call over to Anthony to discuss our financials further.

Thanks, Brad. In Q1, we delivered solid revenue growth driven by sustained recurring revenues and a solid market performance of our products. We've also significantly enhanced our long-term growth potential as we continue to gather promising data for Rina-S and EPKINLY. And as we'll see, our financials remain strong.

We achieved 19% total revenue growth. And importantly, we grew our recurring revenues by 33%. This was driven by strong royalties from DARZALEX and Kesimpta. And importantly, this growth was also driven by product sales from EPKINLY and TIVDAK, which together represented around 29% of our total revenue growth.

Looking at DARZALEX, where we continue to see strong growth. Overall, net sales drew by around 20%. That's net sales of over $3.2 billion for the quarter, which translates to $450 million in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline settings. So you can see that the quality of our revenue profile continues to improve.

In fact, in Q1 of this year, recurring revenues represented 95% of our total revenues. And that compares to 85% in Q1 last year. So it's really clear that the investments we've made in building out our commercialization teams and capabilities are paying off. And this sets us up well as we prepare for potential expansion into earlier lines for EPKINLY, including second-line FL and the potential launch of Rina-S in 2027. And we continue to take a disciplined approach to these investments.

Total operating expenses in the first quarter were $485 million. And that's up 5% compared to the first quarter of last year. And we managed our investments strategically, prioritizing our high-impact Phase 3 programs and focused investments in our commercialization capabilities. Our operational discipline contributed to our operating profit growth of impressive 62% in the first quarter. So here, you can see that we continue to deliver on our commitments.

Next, looking at our net financial items, here we have a net gain of $56 million. Then moving on to tax, we have tax expense of around $49 million, which equates to an effective tax rate of 20.3%. Taken together, our net profit amounts to $195 million for the quarter. So as you can see, continued strong underlying financial performance.

With that, let's move to our 2025 financial guidance. We remain on track to achieve our existing financial guidance with projected double-digit revenue and profit growth. We expect our revenues to be in the range of around $3.3 billion to $3.7 billion, delivering a robust 12% growth at the midpoint. And this is despite our nonrecurring revenue decreasing by more than $100 million. So it's our recurring revenues from royalty medicines and increasingly from EPKINLY and TIVDAK that's driving the anticipated growth in 2025. In total for the year, we expect our recurring revenues to grow by 18%.



For operating expenses, we expect to be in a range of around $2.1 billion to $2.2 billion. And this reflects our disciplined approach to investments as well as rigorous portfolio prioritization. Putting all this together, we're planning for operating profit in a range between $895 million to nearly $1.4 billion, with the midpoint of guidance amounting to $1.1 billion of operating profit and year-over-year growth of 16%.

Now to give you just a bit of color on FX, every 10-point move in the exchange rate relative to our guidance rate, which was dollar to kroner at 7.2, that's worth around $5 million in operating income or loss at the midpoint. So in summary, our guidance really highlights our continued focused and disciplined approach to our investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value.

Now let me wrap things up. Our performance in the first quarter of 2025 really underscores our ability to deliver solid revenue growth, advance key pipeline assets and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2025, we are building on this momentum by further prioritizing our investments and expanding market opportunities. And we are, of course, monitoring the current geopolitical situation, including tariffs and the potential impact on our -- business.

At this stage, we do not anticipate a significant impact on our 2025 financial guidance. And what's important to note here is that even in these volatile times, our very strong financial foundation, coupled with our continued financial rigor and disciplined capital allocation strategy, enables us to position Genmab for growth and expansion as well as create value for our shareholders and patients.

And on that note, I'm going to hand you back over to Jan.

Thank you, Anthony. Let's move to our final slide.

While we face geopolitical uncertainty, the fundamentals of our business are strong, and our strategic priorities for 2025 and beyond remain unchanged. We expanded the reach of both EPKINLY and TIVDAK with additional regulatory approvals with more to come as we announced our intent to submit another supplemental biologics license application for epcoritamab in the first half of this year. For acasunlimab and Rina-S, we anticipate presenting additional supportive clinical data. Both have the potential to move into broader indications with new clinical trials, including the potential expansion of Rina-S into endometrial cancer. And we will continue to actively look for opportunities to grow our pipeline, both organically and inorganically, positioning us for long-term growth and value creation.

In summary, in the first quarter of 2025, our solid financial performance, including from EPKINLY and TIVDAK reinforced the strength of our financial foundation. This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in our high-impact Phase 3 programs and maximizing the success of our commercialized medicines. Putting together, we are set up for long-term success. Having set the stage for sustained innovation, operational excellence and value creation through the decade and beyond.

So before we move to Q&A, I'm pleased to announce that we will hold a virtual review of the Rina-S data presented at both SGO and ASCO on June 2. Details will be available on our website, and we look forward to a lively and energizing event.

And that ends our formal presentation. Operator, please open the call for questions now.

[Operator Instructions] And now we're going to take our first question for today, and it comes from the line of Jonathan Chang from Leerink.

This is [indiscernible] on for Jonathan. So 2 from us. First one, can you help set expectations for the upcoming Rina-S endometrial cancer data presentation at ASCO? And second, related to that, how should we be thinking about the commercial opportunity of Rina-S in endometrial cancer? And how does that compare to the opportunity in ovarian cancer?

Thanks for the questions. I will handle only on the first one to Tahi. I mean, of course, we are still under embargo. We cannot give you too much information, but he can definitely shed some color on the data to be presented at ASCO. And then Anthony Pagano can definitely say a bit more about the potential -- commercial potential for Rina-S. And if needed, Brad can add to that. Tahi, why don't you start?

Yes. Thank you for the question. So as Jan was saying, we're obviously in embargo. So I cannot give you a detailed preview of the data. But as we said before, the data in our mind is very compelling. I think it underscores the potential for Rina-S to be a best-in-class ADC in endometrial. It's going to be important to understand that the treatment paradigms have shifted in endometrial now.

Most patients are getting a combination of checkpoint and chemotherapy in combination frontline. So we are very excited about the efficacy signal. It's a signal that also underscores a second hypothesis that is very important for Rina-S that is that because of the profile of the drug, it really has an efficacy across the expression of folate receptor alpha-positive tumors. And that in a nutshell, also has a readout to other opportunities in our mind. So that's kind of like how I would frame the data. And then I'll ask Anthony and Brad to comment on the opportunity in endometrial.

Yes. I think it's important to kind of remember the journey we've been on with Rina-S. When we made the acquisition and announced it back in April of last year, so a little over a year ago, we outlined an overall -- our excitement for the program, our excitement around what we can really do with this asset in our hands. And, if you look back at what we said, we said a couple of important things at that point. We said at that stage, this was a $1 billion-plus opportunity and that we could - very excited about really putting our foot on the gas pedal from a development perspective, and that could potentially lead to the first approval in 2027.

Now let's fast forward 13 months and look at what we've accomplished. We provided meaningful data to the market to really reinforce the business case, at least in second-line plus PROC shared last year, reinforced at SGO this year, and we look to further expand that into data represented at ASCO for endometrial cancer.

And what we did earlier this year is we really outlined a framework how this potentially is not only a $1 billion-plus opportunity, but potentially a $2 billion-plus opportunity, and really outlined the building blocks of that $2 billion-plus opportunity, which includes second-line plus PROC, second-line plus endometrial, second-line plus PSOC, and frontline endometrial. And our plan here moving forward is to present more and more data to give you confidence that, that $2 billion-plus target is achieved.

So I think what we can say about this overall is that endometrial looking at the patient numbers does represent a meaningful component of that $2 billion. We've not broken down the specifics other than to give you a sense of the size of the potential patient populations. But overall, we're very happy owners of Rina-S. And since we've owned the program, we've made significant progress in really putting our foot on the gas pedal, both in ovarian as well as endometrial cancer.

Brad, maybe you want to provide a little bit more color here.

Thanks Anthony. I think as has been stated from Tahi and Anthony, certainly Rina-S is a potential primary growth driver for us in the future. We have confidence there, of which both endometrial and ovarian are meaningful to this overall development plan. And so more to come, but certainly encouraged here at this point.

Now we're going to take our next question, and it comes from the line of Yaron Werber from TD Securities.

This is Dinah on for Yaron. Following up with that first question on Rina-S. What do you think is the efficacy bar in endometrial cancer now that you see that the paradigm for treating is shifting to kind of use CPI combination in first line? And then secondly, on acasunlimab, obviously, you're going to have another update on that this year. Can you give us a little more detail on the timing of this presentation since it looks like it's not going to be at ASCO and what we might see? And also, what you would consider a success for acasunlimab?

So Tahi, I think, can handle the efficacy bar question for endometrial cancer. And then Judith, maybe you can give a bit of color on the data, which we intend to present, which we are very excited about this year and timing and what you would consider a success. So maybe, Tahi, you can start.

And as I alluded in my response to the first question, of course, there's also a shift in the patient flow now that patients are actually getting chemotherapy in combination with checkpoint in frontline. But historically, the second-line has been an indication where the response rate to chemotherapies are maybe in the 10% to 15% range. And I want to just reiterate the point that I think we feel very comfortable that the data that is going to be presented in the very near future and publicly available will underscore the point that this is really a best-in-class profile from an efficacy point of view as well as from a durability point of view.

Thanks, Tahi. Maybe Judith on acasunlimab.

Thank you Jan. So, for acasunlimab, we said that it will be H2 2025. And the reason is the longer follow-up, the -- more meaningful will be the data that we will present because, as you know, the primary endpoint in that very setting is overall survival. And for overall survival, the comparator is docetaxel with a median of 11 months. So we want to have the follow-up needing to give us the data to support beating on the primary. So this is the reason and that is H2 2025 to give meaningful follow-up. And I told you already the bar that you need to beat. So this is just to put the study in the right context and the data in the right context.

Thank you, Judith. And what I can add to that is that the Phase 3 is progressing very nicely. So recruiting patients there, and we are continuously excited about what we see.

Now we're going to take the question from Xian Deng from UBS.

Two on EPKINLY, please. The first one, so just wondering, so $9 million sales for this quarter, just wondering if you could give us a sense of a rough split between follicular lymphoma and DLBCL, please? The reason I'm asking is that if I assume sort of $60 million looking at previous quarter for DLBCL, that means $20 million to $30 million or so for follicular lymphoma, that actually looks really good versus what Roche has achieved. So just wondering any color on that and what's the differentiating factor, the physician feedback there, particularly in follicular lymphoma, that would be great.

The second question is on EPKINLY second-line plus follicular lymphoma. Given now you plan to submit in the first half of this year. So just wondering, I appreciate you highlighted that the patient population here is about 9,000 patients. But just wondering what is your expected duration for this cohort, please because 1 year or 2-year usage makes a huge difference in terms of sales.

Thank you, Xian, for these excellent questions. And the first one is going to Brad to give you a bit more color on sales for EPKINLY. And the second one, I will hand over to Tahi to talk a bit more about the very exciting second-line plus follicular lymphoma data as much as we can speak about it at this time because the data are embargo. But Brad, why don't you start with a bit more color on sales?

Thank you for the question. And while really not in a position to size contribution of sales specifically seeing continued robust uptake and strong momentum following the respective FL launches and positive responses from providers, both in the U.S. and Japan as well as Europe.

U.S. specifically contributed to the accelerated growth post-approval FL certainly did across sites of care, most significantly in the community setting, and this was further solidifying the value of the dual indication as well as also from a label perspective, hearing from providers that the clinical profile SubQ as well as the no hospitalization specifically for FL has been a key benefit and certainly seeing some very positive, although early in Japan, very positive responses from providers as well as the market regarding FL there as well.

I'll turn it over to Tahi on the duration.

Thank you for the question. And so there's probably a few things that I would say to that. Number one, the duration of treatment is actually fixed in this particular study, meaning that the regimen is a 12-month duration treatment of lenalidomide, rituximab and then epcoritamab. As Jan said, it's really impossible for us really to preview any of the data. This has, to some degree, something to do with the fact that the study is ongoing still and reading out for its primary PFS endpoint.

This submission, as we alluded in the press release, is based on an interim primarily on overall response. Obviously, the agency had access to all data. And obviously, that was very exciting to us. So, I think one thing to look out as these progresses and we will be able to share with you is the magnitude of the effect size because obviously, this is a somewhat unprecedented regulatory pathway that we're taking, and we're really excited about the opportunity.

Thanks, Tahi. So more to come, very exciting times.

Now we're going to take the question from Michael Schmidt from Guggenheim Partners.

This is Paul on for Michael. I had a couple of follow-ups on Epcore. So first, congrats on the recent top line data with R2 in follicular. Can you just talk a little bit more about your confidence in the regulatory approval based on just the ORR co-primary? Would you expect the agency to factor in or consider the interim PFS as well?

And then just on the landscape, there's a CD19 R2 regimen that's also in review right now. How do you expect Epcore to potentially compete understanding that we haven't seen the full data yet, is there a sort of balance of safety and efficacy that physicians would really consider in the setting?

Thanks, Paul, for the questions. I think I'll hand both of them over to Tahi, and we are very, very confident about the data. But Tahi, why don't you give a bit more color to Paul?

So as much as I can try, what I can tell you is, obviously, starting with the fact that we, at some point, received breakthrough designation for this particular indication that was already based on some Phase 2 data that we had shared with the agency, continuing then that we are now moving forward with the submission in a really unprecedented setting that already should tell you that there's been some data shared with the agency in totality, frankly, that has allowed us to engage and then get positive feedback and such that we are then committing to a submission before the end of the first half.

And so then I would say this is going to be a discussion about how profoundly the treatment paradigms have changed based on the effect size as it relates to the positioning vis-a-vis competition. So more to come, but we are very happy and very excited to share this in the near future.

Maybe a bit more color on the CD19 R2 combination versus the EPCO as clear? Or can't you comment on that, Tahi?

Well, I mean, the data for [Indiscernible] is obviously in the public domain. So it's hard for me to answer this question without getting into some discussion on previewing too much of the data because, as I said before, there is a strong need for us to maintain the integrity of the study as we're reading for the interim PFS. You just mentioned one of the reasons why that is important for us. So I cannot really get too much into it, except that I can share my confidence that this will not be necessarily a topic once the data is publicly available.

And the question comes from the line of Yifeng Liu from HSBC.

I've got 2. One is, I was wondering if you could comment on the sort of environment for BD now given all the macro volatility and unknowns on tariffs and et cetera. Could you maybe provide some update on the BD side? And secondly is on your R&D cost. And obviously, a good result in the first quarter, but you sort of reiterated your guidance. I just wonder, is R&D cost more sort of second half weighted? And how should we think about that?

These are very good questions. So I will definitely hand the second one over to Anthony. I will take the BD environment question myself.

It's actually an excellent environment for BD if you are a company looking for assets which can potentially complement our pipeline because it's actually very challenging times for smaller biotechs, which are innovative, but which are a need for cash and support. I think this is very, very difficult for them. So this to actually then partner a molecule or hand over a molecule to a company with a robust cash position like Genmab and a strong financial foundation is really a very good starting point. And I can assure you that we have a number of very good candidates, either late stage or late-stage ready molecules on the radar screen, which we are discussing. So we believe that this is actually a very good environment for BD if you are on the acquiring side, not when you're on the selling side. I think this puts a bit more pressure on the system. That's where I can probably leave it at this moment. And then hand over to Anthony to talk a bit more about R&D costs. Anthony?

Yes. Thanks, Jan. Look, we've outlined a really clear strategy about how we're going to invest across our business really focusing on the late-stage assets, EPKINLY, Rina-S and acasunlimab as well as focused and disciplined investments in our commercialization capabilities and really building out some of our markets in a really focused way. And Q1 is fully reflective of that.

Now in terms of the expected growth that we're going to expect here in Q2, Q3 and Q4, getting to your question around R&D expenses, it's going to be fully in line with that. Really, there's going to be 3 primary drivers of the growth here for the balance of 2025. The first is going to be the ramp-up of the Phase 3 1046 or acasunlimab trial. That was a trial that was launched last year and will continue to ramp up and scale up during the course of 2025. The same is true for Rina-S and second-line plus PROC. Here, we again started that trial late last year and will be ramping up during the course of 2025.

And then, of course, in the second half of the year, we announced that we expect the Phase 3 second-line plus endometrial trial to really be in launch mode. So those will be the 3 primary drivers. And again, those investments are fully in line with our stated objective of investing and prioritizing investments in our late-stage pipeline.

And now we're going to take our next question from the line of Vikram Purohit from Morgan Stanley.

We had 2. First, on the topic of your work in immunology. I know you have a partnership with argenx focused on some early-stage immunology work. And you've also alluded to previously, I think, the potential for EPKINLY in I&I. So I just wanted to see if there's any updates on your thinking there for future potential efforts in I&I and how much of an internal priority that is for you right now when you look at different opportunities across your pipeline? And then secondly, I was just curious on determining next steps for GEN 1042. I think your milestone calendar mentioned you're going to be deciding on next steps there this year. Just wanted to see how you're thinking about that decision and kind of what determines the go/no-go there.

Thanks, Vikram, for the questions. I can take the first one on immunology, and then I will ask Judith to give a bit more color on 1042 next steps for that bispecific program.

So we are very excited about the potential to use our expertise in I&I. And we actually have a number of programs which we wholly own, and we have also programs where we work together with argenx. They're all preclinical, Vikram, but we are very excited about the potential of some of these programs, but they are at the stage that we are creating the preclinical candidates for selection towards developing them in the clinic. The majority of our activities is still going to be based also in the coming years on oncology. So more than 80% of our efforts is in oncology, but we're getting increasingly interested in also using our expertise that includes the whole breadth of the antibody-based product candidate expertise also in other settings. And I&I is, I think, an excellent one, but it's a bit early stage.

EPKINLY is, I think, probably the most advanced molecule, which we want to move into I&I. We are discussing right now with our partner, AbbVie, how to do that exactly in which indications, et cetera. So more to come in the coming time. Definitely, we -- our portfolio is dominated by oncology opportunities. But as we already have shown both with kesimpta and also TEPEZZA is that, of course, molecules which can originally -- originally developed for oncology indications can be excellent drugs, Vikram, in other indications. And I&I is the area where antibody-based medicines have made an incredible difference to the treatment of patients. So we believe that we can be very strong there, but it's lagging behind the cancer-focused opportunity.

So I will stop there and then ask Judith to give a bit of color on 1042 next steps. Judith?

I don't know whether we have Judith still on board, but 1042...

Judith line is connected.

Disconnected. Okay. Let me answer that question and Vikram. 1042 next steps, we are waiting on duration data, and we will take a decision on the next step for 1042. The CD40 4-1BB antibody. And of course, we're still collecting data, especially in the head and neck cancer setting, the frontline setting. And that decision will be taken in the second half of this year. And we are waiting for more duration data to really get a good feeling for what the strength is of our data versus the evolving landscape in head and neck cancer.

As you know, there's a lot of new developments in head and neck, and we want our candidates or product candidates to be very competitive also in the evolving therapeutic landscape. And in order to do that well and also to rigorously prioritize our attention on the different product candidates, we really need more duration data, duration of response data. And we will get that in the second half of this year. I will leave it with that, Vikram.

Now we're going to take our next question. And the question comes from the line of Asthika Goonewardene from Truist.

So I got a couple, please. So on [ VRS ], I wanted to just close the loop on other tumor types beyond ovarian and endometrial. There were expansion cohorts in lung and other tumor types, which I thought would be fairly mature this year for you to report data on, but you're not talking about them. Is that because they're still ongoing and the data is not ready yet? Or are you deprioritizing development in those other tumor types outside of ovarian and endometrial? If the latter, is it a folate receptor alpha expression issue?

And then second, on COLUMBA, your competitor, COLUMBA, has an ASCO coming up on May 20 to discuss the sBLA for STARGLO. It's a little odd given that STARGLO looks like a pretty successful trial with an OS benefit. So, what do you think is the question that the FDA wants the panel to discuss? And do you anticipate the same might be that EPCO might face the same kind of question as well?

Thanks, Asthika, for the questions. I think I will ask Tahi to initially start with both of these and then see whether we can add further to the second question, maybe for Judith. Tahi, why don't you start with the other tumor types and the level of interest for Rina-S because I can tell you, it's sky high. It's not lowering at all._

Yes. Just thanks for the question, Asthika. Just also to clarify. We obviously inherited a protocol from ProfoundBio, but not all of the things that were initially in there were actually operationalized. We did, and I mentioned this on the call, I think, in response to a question from you previously, opened up a cohort in non-small cell lung cancer and are actively enrolling patients in that study. And there will be more activity on this. I promise you that very soon, we can also share in the public domain.

As Jan was saying, actually, the more data we generate, and the endometrial data to some degree is the additional layer of data that helps us understand the profile of the opportunity for VRS. The more we get convinced that VRS has an opportunity across the spectrum of folate receptor alpha expression. We know that in ovarian and in endometrial patients who have low or even are negative by an assay respond to VRS. And so that actually increases our confidence. We never had any other tumor type open. We have not enrolled any other patients outside of endometrial, ovarian, or lung cancer at this point. But there will also be additional activities before the end of the year. So more to come.

On the ODAC, it's not really appropriate for us to speculate on why or why not the FDA has asked for an ODAC for that study. I think if you look into that study and into the public data, there are some things we could think about as it relates to U.S. patients. But anyway, we are focused on EPKINLY. We are very confident in how we are developing, moving EPKINLY forward in the dual indications. We are very excited, as I mentioned earlier, for the follicular lymphoma data. And we are also anxiously looking forward to have a readout on the frontline diffuse large B-cell study sometime in '26 if the events come in based on the accrual. And that is what we are focused on.

Yes, the only thing to add, if you can hear me now. Yes, can you hear me now?

Yes.

Yes. No, the only thing to add is just what you mentioned, Jan, is that EPCO, in conjunction with GemOx, got NCCN endorsement [indiscernible] which is very encouraging and very good for patients in the U.S.

Thank you, Judith. I think we'll leave it with that, Asthika. Thanks for the question.

Now we will take our next question. And the question comes from the line of Matthew Phipps from William Blair.

Great to see EPKINLY move forward with the project frontrunner here in second-line follicular. Wondering if you all are thinking about or have any agreements to use the project frontrunner and any other ongoing or planned Phase 3 studies. I know the frontline follicular study also has a complete response endpoint. Perhaps that is maybe also designed for a potential project frontrunner path.

Thank you for the question. And I think, Tahi, you can probably address whether we have any discussions with the FDA on other programs like frontline.

Yes. So, thank you. Boardly speaking, conversations about novel approaches are easier if you have compelling data. and are not so straightforward in a theoretical vacuum without any data. So obviously, what we have said before is we continue to explore opportunities to accelerate access for patients, particularly when we feel that the data is profound and meaningful to patients. This was one of the situations where we took an innovative approach. And based on the data, had a positive interaction with the FDA, and that's why we were able to move forward. And we'll continue to do that in whatever study comes out with other data we have, if the data is compelling, and we feel there is an opportunity to bring this to patients earlier.

Now we're going to take our final question for today, and it comes from the line of Rajan Sharma from Goldman Sachs.

Just one from me, and it's maybe a bit of housekeeping. I just noticed on your slide, you're guiding to an EPCORE DLBCL-2 trial readout in 2026, but clinicaltrials.gov still has a primary completion date of mid-'27. Could you just help us reconcile that? Is it just a case of clinicaltrials.gov not being updated?

Thanks, Rajan, for the question. Tahi, can you comment on that?

Yes. Again, thank you for the question. Generally speaking, I wouldn't take clinicaltrials.gov as the most validated resource to figure out when studies are read out. These studies are obviously event-driven. And then they're also depending a little bit on the speed of accrual. I think we had this in multiple of our calls where we pointed out that the accrual of both the second-line follicular lymphoma and the frontline diffuse large B-cell was significantly faster than initially projected, and that always means that you have a compression of patient accrual, but also an opportunity to collect events and get the results maybe at an earlier time point than previously projected.

I think that's very clear, Tahi. Thanks a lot. Thanks, Rajan, for the questions. So thank you all for calling in today to discuss Genmab's financial results for the first quarter of 2025. And if you have any additional questions, please reach out to our Investor Relations team. We very much look forward to speaking with you again soon.

This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice day.