GENMAB A/S (GMAB) Q1 2026 Earnings Call Transcript

Hello, and welcome to the Genmab First Quarter 2026 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 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 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 our financial results call for the first quarter of 2026. With me today is our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. Let's move to the first quarter highlights. In Q1 2026, we continue to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. And importantly, we continue to invest with discipline in our medicines, in our pipeline and on our future growth, fully aligned with our capital allocation priorities. Even with these strategic investments, we grew operating profits. The quarter was also marked by progress in our mission to bring innovative medicines to patients.

There are a few highlights I would like to mention. EPKINLY continued to build positive momentum. We were very pleased to see the hospitalization recommendation removed from the third line plus relapsed or refractory diffuse large B-cell lymphoma label. And we are on track with the integration of Merus. We are approaching this with the same focus and discipline that we brought to ProfoundBio. Finally, the breadth, depth and potential of Rina-S continues to increase. The data we presented at SGO in April further support the promise of Rina-S, including in combination with the standard of care therapies such as bevacizumab. We are also making significant progress with our development plan, as you can see on the next slide. We anticipate starting two new Phase III trials for Rina-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers.

This includes a Phase III chemo-replacement trial in platinum-sensitive ovarian cancer and the first frontline trial for Rina-S in endometrial cancer. As we continue to explore new opportunities for Rina-S outside gynecological oncology, we plan a Phase II signal-seeking basket trial in advanced gastrointestinal cancers. Finally, I'm pleased to share an update on the ongoing Phase III trial in second line plus platinum-resistant ovarian cancer on the next slide: because recruitment has been much faster than expected, the Phase III RAINFOL-02 trial has now completed enrollment. This important milestone brings forward the pivotal Phase III data for Rina-S in platinum-resistant cancer into 2026. This reflects strong investigator engagement, significant unmet medical needs in this indication and the strength of our execution on one of our highest priority late-stage programs. So we can now look forward to two data sets in the second half of this year for Rina-S in platinum-resistant ovarian cancer and the opportunity for broader global regulatory filings earlier than anticipated.

For both petosemtamab and EPKINLY, we are maintaining our guidance on the timing of data as you see here. So the key takeaway is that 2026 continues to be a very catalyst-rich year for Genmab, with readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients. With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for EPKINLY and Tivdak. Brad?

Thanks, Jan. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for Tivdak and EPKINLY reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake and ultimately reach more patients. This performance combined with our work this year to advance our portfolio and expand our footprint to reach patients in more markets positions us well to deliver on our growth ambitions in 2026 and beyond. In the quarter, EPKINLY continued to gain notable traction as the only bispecific approved in DLBCL and FL indications. Looking globally, EPKINLY grew 52% year-over-year, reaching $137 million in sales. In the U.S., EPKINLY continued to expand across both academic and community settings, and this growth reinforces EPKINLY's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems.

The recent approval of fixed duration EPKINLY plus R2 in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter. We're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy and proven safety with seamless subcutaneous administration. Looking ahead, we expect adoption in the community to continue to expand across both FL and DLBCL, bringing EPKINLY-based therapies closer to where patients live. In March, the FDA revised the label for EPKINLY in third line plus DLBCL to remove the recommendation for 24-hour hospitalization following the first full dose. Now the label advises physicians to assess whether outpatient monitoring or hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting.

Beyond the U.S., performance remains strong. In Japan, EPKINLY continues to stand out as the only bispecific approved in both third line plus LBCL and FL with continued year-over-year growth. The FL launch is building positively on the brand success in large B-cell lymphoma, supported by strong field execution and ongoing site activation. In other markets through our partner, AbbVie, EPKINLY continues to grow with approvals in more than 65 countries, most of which have dual indications. For the remainder of 2026, we're focused on maximizing our first-mover advantage in second line FL in the U.S., while preparing for expected approval in this setting in Europe and Japan later this year, and in early lines of DLBCL in the future. As we look ahead, our priority is to accelerate development, including in combination across early lines of therapy, to continue to build on the already strong clinical data demonstrating EPKINLY's versatility and ultimately establish EPKINLY as the core therapy in B-cell malignancies.

Turning now to Tivdak, which is the global standard of care in recurrent or metastatic cervical cancer. Tivdak grew 18% year-over-year, reaching $39 million in sales in the quarter. This reflects both the significant need for therapies that improve survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets. In the U.S., the brand delivered steady performance and continues to lead the market, a position that has held since launch nearly five years ago. Outside the U.S., we're seeing encouraging progress in newer launch markets. In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the U.K., Tivdak launched in February through private prescribing and payer channels, and we're actively engaging NICE and SMC to secure broader availability.

At the same time, building upon our work in the U.K. and our established presence in Germany, we're actively preparing for additional launches with infrastructure and teams being established across key European markets, including France, Italy and Spain. Given the significant unmet need in advanced cervical cancer, we look forward to the impact Tivdak can make for more patients as additional markets gain approval and reimbursement. And more broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact over time, particularly with Rina-S in the future. To wrap up, our Q1 performance positions us well to sustain momentum in 2026. With continued performance and an expanding portfolio, we're well positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including three potential blockbuster assets with EPKINLY, Rina-S and petosemtamab and our proven ability to scale commercialization and successfully launch in market, we can drive the greatest impact for patients. Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for Genmab. With that, I'll turn it over to Anthony to walk through the financials.

Thanks, Brad. Before diving into the numbers, as we highlighted last quarter, please note that these results and guidance and our remarks exclude the impact of acquisition-related expenses, including amortization. A reconciliation to our reported results is included in the appendix. In Q1 2026, we delivered growth driven by sustained revenues and the solid market performance of our portfolio. Revenue grew by 25%, driven by strong royalties from DARZALEX and Kesimpta. And importantly, this growth was also driven by product sales from our own medicines especially EPKINLY, continuing to diversify our revenue base. Our investments remain fully in line with our capital allocation priorities, including significant investments for EPKINLY, Rina-S and petosemtamab. And we made these important investments while growing operating profit by 23%. Moving to tax. As you can see in the appendix of this presentation, we have tax expense of around $21 million, which equates to an effective tax rate of 28.9%.

I do want to pause for a moment and note that we are currently evaluating the integration of Merus operations from a tax perspective. So our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12 to 18 months. Overall, the first quarter of 2026 demonstrates the continued strength and quality of Genmab's underlying financial performance. With that, let's move to our 2026 financial guidance. We remain on track to achieve our existing financial guidance with revenue growth that enables strategic investment supporting long-term value creation. At the midpoint, we expect 14% total revenue growth driven by continued momentum in EPKINLY, and our royalty portfolio, further enhancing revenue quality. For operating expenses, we expect to be in a range of around $2.7 billion to $2.9 billion, reflecting planned investments to advance late-stage development for petosemtamab and Rina-S as well as launch readiness activities to support multiple potential product launches.

And even with the strategic step up, our guidance delivers on our commitment to maintain substantial profitability in 2026. In summary, our performance in the first quarter of 2026 underscores our ability to deliver revenue growth, advance key pipeline assets and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2026, we will continue to build on our momentum through disciplined prioritization of our investments, continued operating discipline and expansion of market opportunities. This positions us for sustained growth and long-term value creation. And on that note, I'm going to hand you back over to Jan.

Thank you, Anthony. Let's move on to our final slide. In the first quarter of 2026, our financial performance reinforced the strength of our foundation and the durability of our growth trajectory. That strength supports a disciplined capital allocation strategy focused on the areas with the greatest potential to create long-term value, accelerating our late-stage pipeline, maximizing the success of our commercialized medicines and ensuring strong launch readiness for future opportunities. As we further move into 2026, we also remain focused on integrating Merus so that we can capture the full value of petosemtamab. Lastly, we remain committed to deleveraging targeting gross leverage below 3x by the end of 2027, while maintaining balance sheet strength and flexibility. Taken together, Genmab is very well positioned. We have a growing and increasingly diversified revenue base, a powerful late-stage pipeline and multiple catalysts ahead, and our focus remains clear to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable long-term value for shareholders. So that ends our formal presentation. Thank you for listening. Operator, please open the call now for questions.

Operator Instructions were provided. And now we're going to take our first question. And it comes from the line of Jonathan Chang from Leerink.

On the frontline petosemtamab head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes?

Thanks, Jonathan, for the question. Tahi, why don't you take the first question by Jonathan?

Thank you, Jan. Thank you, Jonathan. Yes, so indeed, we increased the size of the frontline study. I think we had in the past indicated that there were thoughts that we had as it relates to the studies that we want to ensure that they have the highest probability of success. Details, I don't think are the ones that we want to discuss in the public space. But these trials are being increased based on our insight that we generated during due diligence to ensure that they have the highest probability to our standards. We do not have any anticipation that these changes have any impact on the timelines and we steadfastly stay with our guidance that one or both of the petosemtamab studies will read out this year, and we'll provide data this year.

Thanks, Tahi. Let's move on to the next question.

Yes, of course. Now we're going to take our next question. It comes from the line of Zain Ebrahim from JPMorgan.

We've got two questions. Zain Ebrahim, JPMorgan. First question is just a follow-up on the previous one. And it's helpful that you just said you don't expect the increased size of the first-line trial to impact the timing. But just to understand in more detail why that is given that you're increasing the trial from 500 patients to 700. So have you already completed enrollment of the initial patient population that you're looking to enroll? And how is enrollment progressing? I suppose? And I guess, tied to that, whether the increases for HPV-negative patients that will be helpful to understand as well. Second question is just on EPKINLY first-line DLBCL. You've guided for the readout this year and haven't narrowed out further. So is that the final analysis? Or are we still waiting on the interim?

Thanks, Zain, for the question. I think, Tahi can handle both of the rest next question and then the EPCORE first-line trial.

Yes, Zain, sorry, I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. This was indeed to ensure that this trial has the appropriate data that we need for our probability of success, how we feel about the program and what we understand about the program, and this will not impact the timelines or the status of accrual. I hope you will appreciate that in the context of a very competitive landscape, we are trying to be a little bit more disciplined on what we're sharing when we're sharing it. So two things: it will not change the timelines of what we have guided before, and we continue to stay with the statement that one or both of these studies will read out this year. As it relates to diffuse large B-cell, again, I think there we have also been very disciplined, and I will try to be continuously disciplined today. We have guided that the frontline diffuse large B-cell will read out this year. And we have not commented on interim or final or any of these questions. But we stay with the statement that the diffuse large B-cell study will have a readout this year.

And now we're going to take our next question, and it comes from the line of James Gordon from Barclays.

James Gordon from Barclays. Two quick ones. One was Rina-S. There's 01 and 02 coming in H2 this year. So, I just wanted to confirm with the two trials reporting so closely together, so Phase II and the Phase III, will you definitely report them as separate results? And if the Phase II is positive, you'll file it and not wait for the Phase III? Or have you discussed that plan with FDA? Or might they say, 'Well, if they're so close together, let's see both.' And the other one was just more generally, we've seen more data from B7-H4 ADCs in gynecological cancers. How do you think that stacks up versus folate ADCs? There seems to be a few people going for this approach. Is it a different target in gynecologic oncology?

Thanks, James, for the questions. I will ask Judith to address both the Phase II and Phase III PROC trials, Judith, and then the B7-H4 versus folate receptor alpha ADCs.

Yes. Thank you for the question. So for the first part, as we highlighted the Phase III accrued ahead of projections. That means that we will have these two datasets this year. Given the change in landscape in PROC, the potential for the Phase III submission and approval becomes more relevant, and this is the plan. So we stay behind our guidance that Rina-S will be launched in PROC in 2027, with these two datasets being supportive, but the main dataset for filing will be the Phase III that will allow for global submissions. Part two, with regard to the competitive landscape, of course, we are very aware of the B7-H4 programs in investigation, including those from other companies. As we said several times, we know that this is a hypercompetitive space. We stand behind the strength of the data of Rina-S in terms of efficacy, safety, durability of the efficacy and clinical development plan and speed to market. So, more competitors makes it more competitive, but doesn't preclude the fact that we could be not just first-in-class, but best-in-class given the data so far.

Thanks, Judith. So, it comes down to effective execution, James. And we moved in basically two years from zero Phase IIIs to now five Phase IIIs with the news of today.

And the question comes from the line of Xian Deng from UBS.

Xian from UBS. So I got a few on EPKINLY frontline DLBCL trials, please. Just wondering, given the typical PFS curves tend to pretty much almost start to plateau after, let's say, 18 months or so in a typical frontline DLBCL trial like POLARIX, purely hypothetically, do you expect a big change in hazard ratio during the last 25% of events, just assuming a typical frontline DLBCL trial, PFS curve? That's the first question. And the second one is on that trial, it's capped at 30% of IPI Stage 2 patients. So, could you give any color on whether you reached this number or your IPI2 patients is actually below this? And what impact could it have in terms of powering and timing for the primary endpoint?

Thank you, Xian. I was always taught never to answer hypothetical questions, but I will see. We will test whether Tahi is willing to do that for your first question and then move to the second part as well. Tahi, over to you.

Yes, thank you. So, you're absolutely right: classical historical frontline diffuse large B-cell trials, not only POLARIX, tend to plateau around month 18 to 20. That is my only comment on that first question. Particularly speculating what I expect, I don't think it's helpful because I actually don't know how these curves are going to behave on this trial until we see the data. The cap is also correct: there's a 30% cap. Again, I don't think it's appropriate at this point to talk about what the actual demographics of the study are. The only other point that I think is important to understand is the primary endpoint is actually IPI 3 to 5 and if the IPI 3 to 5 passes certain statistics then readout will go to IPI 2 to 5. And so I think these are my comments on the questions.

And now we're going to take our next question. And the question comes from the line of Rajan Sharma from Goldman Sachs.

So first one on EPKINLY, just kind of following on the theme there. But what do you think is sort of the relevant benchmark for the EPCORE DLBCL-4? That's a second-line trial just in the context of the competitive landscape and some of the potential advantages that EPKINLY has? And then secondly, just on the new Rina-S trial that you announced, RAINFOL-08, is that likely to be a KEYTRUDA combination trial?

Thanks, Raj, for the question. Tahi, why don't you take the first one and then maybe Judith can go into the new Rina-S trial, one of the new Rina-S trials. Tahi?

Yes. So this is a question about the second-line diffuse large B-cell, right? And so I think there's a couple of things to be said about the BMC128 study. First, it is randomized against R-GemOx. So in the end, that's what the study is going to be compared to and everything else is then a cross-study comparison, which is always somewhat problematic. But what is the excitement on our end for this particular regimen is that this is a regimen comprised of an oral medication, lenalidomide, and a subcutaneous administration that hopefully will show positive and meaningful data for patients and then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination with R-GemOx, while also improved in efficacy versus monotherapy. It's really perfectly suited for the outpatient setting or the community setting. And so, that's what this trial was intended to do: to generate a regimen that is patient-friendly with increased CR rate that then is appropriate and suitable for the community setting. And so, we'll see what the data is, but that's the intent of the trial.

Thanks, Tahi. And then maybe Judith, on the combination for Rina-S?

Okay. The question, can you repeat the question, the combination with bevacizumab was presented at SGO. The combination with bevacizumab was presented at SGO, and as you can appreciate, the safety was very well tolerated. This study was meant primarily for safety. But in terms of efficacy, we are very pleased with the median number of cycles of 10 and even the fact that 15% of the patients were refractory; 85% of the patients got more than six cycles. So, this is with bevacizumab. In terms of pembrolizumab, we have two cohorts ongoing in different settings, and we will communicate the data when the data is a little more mature and enrolled. So, it's actively enrolling.

Thanks, Judith. I think that answers your questions, Rajan. Let's move on to the next question.

And the question comes from the line of Michael Schmidt from Guggenheim Partners.

I had another one on EPCORE DLBCL-2. Maybe just in terms of the enrollment of the study, Tahi, could you just comment on how enrollment has been relative to your expectations when starting the trial? And secondly, I know in the Phase II study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed duration treatment in the Phase III study. Maybe speak to your confidence level that the fixed duration paradigm can replicate the Phase II data.

Thanks, Michael. Tahi.

Yes, generally speaking, this is true for BMC128, which is the second-line diffuse large B-cell trial, as for the frontline diffuse large B-cell trials: these trials accrued significantly faster than they were initially projected. And I think that's a statement that we've made multiple times. As it relates to the original Phase II data in frontline where we continued epcoritamab monotherapy after R-CHOP for the full year and the design of the Phase III trial, where it's R-CHOP for six cycles plus EPKINLY followed by two monotherapy cycles of EPKINLY. When we started to generate this data, back in 2020, we were considering the maximum possible exposure. As we generated the data and had the opportunity to see this and also discussed with health authorities, it became very clear, partially also because of the data that was presented on MRD negativity, that you don't actually need to expose these patients to continue therapy.

Keep in mind, a significant portion of these patients are cured already with R-CHOP. And so that's why we ended up with the design. We feel extremely confident that shortening the duration of EPKINLY doesn't have any impact on the ability of this combination regimen to achieve CR and even MRD negativity at very high rates as have been seen in the public domain and shared. We have reason, as I've discussed many times, to be confident because you've seen us now in a number of trials with EPKINLY, that the Phase III trials tend to mimic the original Phase II data because the mechanism is very predictable for EPKINLY.

And now we take our next question. And the question comes from the line of Benjamin Jackson from Jefferies.

I guess just another one, thinking about sequencing of drugs through the lines of therapies in DLBCL. We've heard from some doctors that perhaps POLIVY is a very strong salvage option. So, when you're speaking to physicians, are you hearing that there is a preference for bispecifics upfront just naturally because of the order that those drugs can come in? So any thoughts that could be a tailwind there would be useful.

Thanks, Ben, for the question. Tahi, this one is again for you.

Well, I think, yes, I'll try to answer Benjamin and maybe Brad can add something. The way I think about this, and I think this is also how the physicians that we work with think about this, the sequencing of drugs is generally a function of efficacy and safety. In frontline diffuse large B-cell, where R-CHOP cures a decent amount of patients, the anticipation has to be that a positive trial readout could generate data that has a significant impact on outcomes for patients. If it does, that will lead to natural adoption because the objective in diffuse large B-cell is to avoid the relapsed/refractory setting where things become generally harder to manage.

Thanks, Tahi. Brad, do you want to add anything to this, the sequencing of the medicines?

I think maybe the only thing to add: Tahi said it well. We do hear from physicians that the value of bispecifics is certainly in earlier lines of therapy where patients are treated closer to their home. We're starting to see this really come to fruition with the advent of the second-line FL launch just late last year, and that's been a key growth driver. The feedback from physicians, hospitals and health systems has been extremely positive with not only the unprecedented data, as Tahi referenced, but also the convenience and being able to realize the value closer to the patient's home.

Thanks, Brad. And then we are super excited about the potential to see both the frontline and the second-line diffuse large B-cell lymphoma data, pretty soon, for EPKINLY. So, exciting times.

Now we take our next question and the question comes from the line of Charlie Haywood from Bank of America.

Charlie here with Bank of America. I have two, please. First is on your petosemtamab Phase II overall survival rates. Just wondered if you've taken a 2-year OS cut and any directional comment on how that OS curve has trended relative to the first 12-month data that we've seen? Would it be fair to think a similar trajectory to what you've seen at year one, or could you actually see similar to what your competitors saw with faster first 12-month curve decline and then stabilize more thereafter? And then will that data be presented any time? And second, on Rina-S in second-line endometrial, could you remind us on timelines of that data? And then frame your excitement in that relative to the more imminent second-line PROC setting, potentially smaller patient number there, but possibly higher unmet need given limited ADC presence to date?

Thanks, Charlie, for the questions. Tahi, why don't you take the first one on petosemtamab and then Judith can handle the question on Rina-S and endometrial cancer second line.

So if I understood your question correctly, you were asking if we are intending to update the Phase II dataset for petosemtamab in frontline? We will follow up at some point and we want to update that curve and present the data, but I think the more meaningful readout is going to be the actual study. We said one or two of them will read out this year, and so that is probably the more meaningful dataset and relevant to the brand and to the company.

Thanks, Tahi. And then Judith, maybe something more on the timeline for second line plus endometrial and Rina-S.

Yes. As you know, the Phase III is actively enrolling. We haven't guided the investor community about readout timing. But what I can say is the activation and enrollment is going very well. Just something to add to Tahi's first point on the first-line petosemtamab-pembrolizumab combination: it's very apparent from the data we presented with 17 months follow-up, which is not negligible, that at this time point around 30% was censored and alive, and this gives you a magnitude of duration. As Tahi alluded, now we are fixated on the Phase III which are much more relevant. But I think that the data presented at ASCO is a good representation of the durability of the effect.

Thanks, Judith. Thanks, Charlie. Let's move on to the next question.

And now we're going to take our next question. And it comes from the line of Eva Fortea-Verdejo from Wells Fargo.

A quick one from us on petosemtamab as it relates to colorectal cancer development. How should we be thinking about timing for any announcements for this tumor type? And are you exploring other mechanisms that would make sense to combine with beyond chemo?

Thanks, Eva, for the question. I think Tahi can handle this one, CRC updates for petosemtamab in the second half.

Yes. We've answered this question a couple of times. We have looked at the CRC data and have generated more CRC data. We liked what we saw early on in due diligence and continue to like what we see. We will update you a little closer to the time, similar to what we did with Rina-S, when these studies go into the public domain on our next steps. So, there will be more to come. As it relates to combination with other mechanisms, there are a number of interesting things happening in this space in subsets of patients, and there is a good rationale to combine with petosemtamab. So more to come on that as well.

Thanks, Tahi. We keep the cards close to our chest, Eva, because it's a very exciting and competitive area. We want to be first and hopefully best here.

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

I'm going to harp on the petosemtamab enrollment as well. There are some rumors on whether or not the increase to 200 patients would focus exclusively on HPV-negative patients. Maybe just remind us your thoughts on the breakdown of patients by that baseline characteristic? And has the number of patients needed to conduct the ORR analysis changed? Or is this really just patients for the OS analysis?

Thanks, Matt, for the questions. Tahi, can you address both of these questions and give some perspective?

Good question. I will not go into the specifics. I will stick with the line I used before: the increase in the N was intended to increase the overall probability of success of the study as we see it based on what we understood in due diligence. These were decisions made already back then and that we continue to understand about petosemtamab and none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

The next question comes from line of Yaron Werber from TD Securities.

Tahi, I'm going to ask another question on the LiGeR program, maybe a bit broader. Do you plan on filing with both studies? Or would you file presumably in second-line potentially first and then frontline? When you release the data by year-end, do you think it's going to be in second-line first because you're not continuing to over-enroll that study? Would you have at least interim OS, and would it even be mature OS at that time?

Thanks, Yaron. Tahi, that's another sharp one.

A very good question. Unfortunately, my answer will be the same as I did before. Right now, all we guide and have been consistently guiding is that we indeed expect one or more of these studies to read out this year. I will not comment on which one first or second or together—all these permutations exist but we are staying with the guidance that readouts will occur this year.

So more to come later, Yaron.

And the question comes from the line of Suzanne van Voorthuizen from Van Lanschot Kempen.

This is Romy on for Susanna. One on EPKINLY. Looking ahead to the Phase III readout in first line, we recently did a survey which found that doctors are projecting EPKINLY even before seeing this data to be the most dominant first-line option. I just want to know your thoughts on what you see as the most important features of EPKINLY specifically that drives this enthusiasm.

Thanks very much for that question and reference to the survey. Tahi, can you sum up the key parameters for why EPKINLY is so advantageous in the first-line setting according to the survey?

If you step back, this is something we talked about from the beginning when we engaged on the development program with EPKINLY: the CD3xCD20 mechanism of action of EPKINLY is unique and very powerful as a single-agent mechanism that comes with a safety profile that predominantly includes infusion-related reactions and otherwise it's extremely well tolerated. Because of subcutaneous administration, it provides convenience that makes it easy for the patient and for providers. When you start combining EPKINLY with chemotherapy, we have already seen in various Phase II and Phase III studies that it tends to be a mechanism that is very well combined with chemotherapy and is at least additive. That's what's driving enthusiasm about frontline expectations. And what drives EPKINLY specifically is the observation that it is very likely to be the first study to read out in frontline diffuse large B-cell with a significant time advantage. It also comes with subcutaneous administration. As Brad noted earlier, the vast majority of frontline DLBCL patients are treated in the community, so the potential readout on a drug that can be provided in that setting is particularly impactful in the U.S. health care system. I think that's driving the interest in that study.

And now we're going to take our next question. It comes from the line of Victor Floch from BNP Paribas.

Just one on EPKINLY. EPKINLY reported a decent Q1 performance. I was wondering whether this is driven by the recent label change in the U.S. Have you seen a material uplift in the academic setting and can you comment on the key hurdles you need to clear to further drive penetration in this setting?

Absolutely, Victor. Brad, you can handle both of these.

Thanks. The strong start to the year is evident and the profile is being appreciated by physicians and health systems, primarily because it is the only bispecific with dual indications and proven efficacy, as well as subcutaneous administration, which Tahi mentioned. Moving into earlier areas, the ability to offer combinations, fixed-duration options and to move quickly into earlier lines is important. The performance in second-line FL has been a key driver. The removal of the hospitalization recommendation has been very well received and removes barriers to treat patients closer to where they live. Overall, efficacy, safety, convenience and demonstrated uptake in second-line FL are all contributing to the momentum.

And the question comes from the line of Kalpit Patel from Wolfe Research.

For EPKINLY, the EPCORE DLBCL-2 trial in the frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind POLARIX? And do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in the first line?

Thanks for the questions. Tahi, you can address both of these.

Questions about expected hazard ratios have come up a lot and it's not appropriate to speculate. Based on the public Phase II data, there is enthusiasm about the possible readout. Historically, our Phase III trials have tended to mimic the Phase II results for EPKINLY because of the predictability of the mechanism. Regarding OS, we know from precedent that regulators have approved frontline DLBCL regimens without OS benefit. Demonstrating an OS benefit is becoming more challenging in DLBCL because of the increasing availability of effective salvage therapies such as CAR T-cell therapy and bispecifics in later lines. That said, the larger the PFS effect size, the larger the opportunity to show an OS benefit. Broadly, that is how we think about it.

Yes, of course. And now we're going to take our last question for today. It comes from the line of Judah Frommer from Morgan Stanley.

Just a follow-up on the petosemtamab trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial? Will you be adding any investigational sites? I'm just curious if you are adding sites and whether any other EGFR bispecifics might be studied at those sites and what the reception might be?

Thanks, Judah, for the question. Tahi, can you address the recruitment and the setting for the petosemtamab trial?

Yes. What I will answer, Judah, is that this amendment that increases the N had no impact on additional sites or need for any additional sites. The study is enrolling extremely well. So that's why it won't have an impact on additional sites.

Thanks, Tahi. And that, I think, addresses the last question of today. So thank you all for calling in today. If you have any additional questions, please reach out to the Investor Relations team at Genmab. We very much look forward to speaking with all of you soon in this super exciting year for the company. Thank you.

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