Genmab A/S ($GMAB)

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 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 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 the lines. 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 or removed from the third line plus relapse or refractory diffuse a B-cell lymphoma label. And we are on track with the indication of mirrors. And we are approaching this with the same focus and discipline that we brought to perform bio. 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 renal 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 rent and endometrial cancer. As we continue to explore new opportunities Forina outside canecological oncology, with a Phase II trial seeking 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 RAINFALL 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 to 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 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, John. Our proprietary portfolio is off to a strong start here in 2026. I 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 uptimes 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 R square in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter. The recent approval of in the quarter. We're seeing physicians increasingly use this chemophi 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. And in March, the FDA revised the label for EPKINLY in third line plus neoBCL to remove the recommendation for 24-hour hospitalization following the first full dose. Now the label advises physicians to assess whether outpatient monitoring for hospitalization is appropriate following the first full dose. We do expect this will further broaden news 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 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 which most 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 in across early lines of therapy, to continue to build on the already strong clinical data demonstrating EPKINLY versatility and ultimately establish Epkinly as Vcore therapy and 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 5 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 to 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 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 [indiscernible]. And importantly, this growth was also driven by product sales from our own medicines especially at 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%. And here, 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 oral 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 arenas 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. Advanced 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 loan readiness for future opportunities. And as we further move into 2026, we also remain focused on integrating mirrors 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 I have, 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 answers our formal presentation. Thank you for listening. Operator, please open the call now for questions.

[Operator Instructions]. 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 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 time lines and staffs with our guidance that one or both of the peto 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 in 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.

Thanks, Zain, for the question. I think, Tahi can handle both of the rest next question and then the [indiscernible] 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 time lines and the what patient populations, it does impact the timing or the status of a core. 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 time lines 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 the fee such Visa, again, I think there, we have also been very disciplined, and I will try to be continuously disciplined today. We've guided at the front line, if such [indiscernible] will readouts this year. And we have not commented on interim or final or any of these questions. But we stay with the statement that the fact B-cell study will have a readout this year.

Thanks, Tahi. Let's move on.

And next James Gordon from Barclays.

James Gordon for Barclays. Two quick ones. One was rent. So there's 011 and 02 coming into H2 this year. So I just wanted to confirm, with the two trials reporting so closely together, so Phase II and Phase III. Would 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 so close together, let's see both. And the other 1 was just more girl, we see more data from [indiscernible] in gynecological cancers. How do you think that stacks up versus pro there seems to be a few people go for this approach is a different target in

Thanks, James, for the questions. I will ask Judith to address both the Phase II and Phase III PK trial unit and then the B7-H4 versus 4 receptor for ADCs.

Thanks 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 2 data sets this year given the change in landscape in Prague, the potential for the Phase III submission and approval becomes more relevant. This is the plan. So we stay behind our guidance that Rina-S will be launched in Prague in 2027 with these two data sets a supportive, but the main data set for filing the Phase III that will allow for global submissions. Part one. With regard to the competitive landscape, of course, we are very aware of the B7-H4, the 2 in investigation, the [indiscernible] as we said several times, we know that this is a hypercompetitive space we stand behind the strength of the data offering in terms of efficacy, safety durability of the efficacy and clinical development plan and speed to market. So more competitors makes it more competitive that doesn't preclude the fact that we could be not just first-in-class, but best-in-class given the data so far?

Thanks. Thanks, Judith. So it comes down to effective execution, James. And we moved in basically 2 years from 0 Phase IIIs to now 5 Phase IIIs with the news of today.

And the question comes line of Xian Deng from UBS.

Xian Deng from UBS. So I got a few EPKINLY frontline BCL trials, please. Just wondering, given the typical PFS curve tend to pretty much almost start to plateau after, let's say, 18 months or so in a typical, let's say, frontline DLBCL, like color just purely hypothetically, right doesn't have to be anything to do with aptly. Just purely from a statistical point of view, do you expect a big change in hazard ratio when -- during the last 25% of events, just assuming sort of a typical, let's say, frontline DLBCL trial, PFS curve? That's the first question. And the second one is kind of also on that one is your study is capped at 30% of IPI Stage 2 patients. So just wondering if you could give any color on whether you've reached this number or your IPI II patients is actually below this. I'm just wondering what impact could you have in terms of powering and timing for the primary end point?

Thank you, so I was always teached never to answer hypothetical questions. But we'll see -- we'll test if Tahi is willing to do that. Then move into the second [indiscernible] over to you.

So yes. So what I can say is you're absolutely, right, classical historic of the usage pizza all, by the way, not on Polaris. Frontline studies tend to plateau around month 18 to 20. And I think that's my only comment on that question. I am particularly speculating what I expect. I don't think it's helpful because I actually don't know how these costs are going to behave on this trial until we see the data. The cap is also correct. It'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 the primary endpoint is actually IPI 3 to 5 and IPI 3 to 5 passes certain statistics than able read out 2 to 5. And so I think these are my comments on the questions can.

Yes, absolutely. Thank you. On to the next one, operator.

Yes, of course. And now we're going to take our next question. And the question comes on 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 AC-DC. That's the 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, RAINFALL 08,-- is that likely to be a KEYTRUDA combination trial?

Thanks, for the questions. Tahi, why didn't you take the first one and then maybe Judith can go onto the new Rina-S, one of the new Rina-S.

Yes. So this is a question about the second line is such [indiscernible]? And so I think there's a couple of things to be said about the 128 study. First, it is again a randomization against [indiscernible], that's what the study is going to be compared and everything else is then a cost study comparison. They are obviously a little bit problematic. But what is the excitement on our end for this particular regimen is that this is a regimen comprised of an oral medication analithomide and subcutaneous administration. That hopefully, will show positive data and meaningful positive data for patients and then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination with [indiscernible] but also improved in efficacy vis-a-vis monotherapy and it's really perfectly suited for the outpatient setting or the community setting. And that's what this trial was intended to do to generate a regimen that is patient-friendly with increased CR rates 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.

And then maybe red on the combination for Rina-S?

The question, can you repeat the question, the combination with Bev? Did you ask? Yes. The data that we present. Okay. we -- in terms of combination, the combination with Web was presented at SGO. And as you can appreciate, if you are there, the safety was very well operated this study was meant only for safety. But in terms of efficacy, we are very pleased with the median number of cycles of 10 million and even the fact that 15 of the patients who were refractory, 85% of the patients got more than 6 cycles. So this in terms of November, we had 2 cohorts ongoing in different settings, and we will communicate the date when the data is a little bit mature and enrolled. So it's actively at all.

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

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

I had another one on EPCOR 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 valued, I believe, a continuous treatment paradigm versus the fixed duration treatment in the Phase III study? And maybe speak to your confidence level that the fixed duration paradigm can replicate the Phase II data.

Thanks, Michael.

Yes, generally speaking, I think true for 128, which is the second such BSA trial as for the front anti trials that these trials include significantly faster than they were initially objected. 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 pimontherapy after HP for the full year and the design of the trial, the Phase III trial, where it's [indiscernible] cycles plus pine followed by 2 monotherapy cycles of EPKINLY. When we started to generate this data, cash, in 2020, we were going for the maximum possible exposure, if you wanted to. As we generated the data and had the opportunity to see this as also discussed with health authority became very clear, partially also because of the data that was presented by voucher and MRD negativity that actually need to expose these patients to continue therapy. Keep in mind, significant portion of these patients are cured already with CHOP. And so that's why we ended up with the design. We feel extremely confident that, if you will, shorten observation of EPKINLY, as you framed it doesn't have any impact on the ability of this combination regimen to achieve CR and even MRD negativity at really very high rates in the public domain and [indiscernible] and we have a reason as I've discussed many times, to be confident because we've seen this now in a number of [indiscernible] that the Phase III starts tend to mimic the original first 2 data just because the mechanism is very predictable for PMA.

Thanks, Michael.

And now we're going to take our next question. And the question comes on of Benjamin Jackson from Jefferies.

It guess just another one thinking about sequencing of drugs through the lines of therapies in DLBCL. We've heard from some docs 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. This one is again for you.

Well, I think -- I'll try to answer Benjamin and maybe Brad add something he may add some too. But from the way I think about this, at least means and I think this is also how physicians that we work with and obviously engage. I think about this. The sequencing of drugs generally speaking, is a function of efficacy and safety. And in particular, in the Fuse frontline where use a decent amount of patients. I think the anticipation just has to be that this trial -- the trial that reads out is going to generate data that is going to have a significant impact on the outcomes for patients. And if it does, then we'll need to natural adoption because office goal in diffuse B-cell is to avoid the relapse a factory setting where things would come generally speaking, a little bit higher to merge?

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

I think maybe the only thing to add, to said it well is we do hear from physicians that -- and we've said quite a while all along that the value of bispecifics are certainly in the earlier lines of therapy where patients are actually treated because of their home. We're starting to see this really come to fruition with the advent of the second line launch just late last year, and that's been a key growth driver. The feedback from physicians, hospitals and hospitals and health systems has been extremely positive with not only the unprecedented data as [indiscernible] and 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 online and the second-line diffuse B-cell lymphoma data pretty soon for EPKINLY. So exciting times.

And the question comes down of Charlie Haywood from Bank of America.

Charlie here with Bank of America. I have 2, please. First is on your peto Phase 2 OS 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 1? Or could you actually see similar to what your competitor saw with faster first 12-month curve decline and then stabilize more thereafter? Then will that data be presented any time? And then second one is just on Rina-S second-line endometrial. Could you just remind us on time lines of that data and then frame your excitement in that up relative to the more imminent second-line processing, I think, potential smaller patient number there, but possibly higher unmet need given lack of limited ADC presence to date.

Thanks, Charlie, for the question. Tahi, why don't you take the first one on peto and then Judith can handle the question on Rina and then [indiscernible] second line.

So if I understood your question correctly, you were asking if we are intending to update the Phase II data set for peto in second line? In frontline? Well, I mean, probably at some point going to update that curve presented in the data, but I think the meaning regattas going to be the actual study. So we said 1 or 2 of them will read out this year. And so that is probably the more meaningful data set and relevant to the brand and to the company.

And then did maybe something more on the time line for second line plus endometrial and arena?

Yes. Thank you for the question. And as you know, the Phase III is actively enrolling we haven't guided the [indiscernible] community about readouts. But what I can say is the activation and enrollment is going very well. Just something to add to is first question on the first-line Epitopembro combination. I think that it's very apparent what we already presented with 17 months follow-up, which is not negligible. And at this time point, around 30% was sensor and a live and this gives you a kind of magnitude of duration. And 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 very good representation of the durability of the effect.

And it comes from line of Eva Fortea from Wells Fargo.

One from us on PD as it relates to CRC 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 probably Tahi can handle this one CRC updates for peto in the second half.

Yes. So look, we've answered this question a couple of times. We obviously, if you look at the CLC data, we have generated more CRC data. We liked what we saw early on in the diligence. We continue to like what we see. And we will update you a little bit closer to -- similar to what we did with MENA when these studies then go into the public domain. -- on our next steps. So there will be more to come at some point. As it relates to combination with other mechanisms as a number of interesting things that are happening in this space and the subset of patients and obviously, we are aware of that, and there is a good rationale to combine with peto. So more to come on that end as well.

Thanks, T. So we keep the cards close to our just Eva because it's a very exciting area and also a very competitive area. So we want to be first and hopefully best here.

Thank you. Now we're going to take our next question. And the question comes from 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 to increase the 20 patients would focus exclusively on HD-negative patients. So can you maybe just remind us on your thought on the breakdown of patients by that based on characteristic. And then as 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.

Matt, I'm going to ask answer your questions. Good question. I will not go into the specifics I was stating that I used before, that the increase in the end of the study was intended to increase the overall tolerability of success study as we see it based on what we understood in the diligence with decisions made already back then and that we continue to understand about peto and that none of the things that we're doing right now has any impact on the time lines for the readouts that we anticipate.

Thanks, Matt, for the questions.

And now we're going to take our next question. The next question comes on of Yaron Weber from TD Securities.

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

That's another shot on.

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 that we indeed expect one or more of these studies to read out this year. And I want to comment on which 1 first or second together all these permutations that make is.

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

This is [indiscernible] on for Suzanne. One on EPKINLY. So looking ahead to the Phase III readout in first line, we recently did a survey, which found that doctors are projecting EPKINLY even before same 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 referring to that very nice [indiscernible]. We like the data, of course, and I will ask Tahi to sum up basically what the key parameters are here for why EPKINLY is so in the first-line setting according to the [indiscernible].

Yes. So I mean this is like if you step back, this is also something that we talked a bit from the very beginning when we engaged on the development program with EPKINLY that the CD320 mechanism of action of EPKINLY is a unique and very powerful seen agent mechanism that comes with a safety profile that one is infusion-related reactions. And then otherwise, it's extremely well tolerated. And because of subcutaneous administration also convenience and administration that makes it easy for the patient and also for the for the providers. And so if you start combining EPKINLY in 320 with chemotherapy, we have already seen this in all kinds of Phase II studies or Phase III studies that tends to be a mechanism that is very well combined with chemotherapy and at least additive. And so that's, I think, what's driving the enthusiasm of the front line in terms of what the expectation is around data. And then what drives Kidney specifically, of course, and the observation at a in very high likelihood will be the first study to read out in front line if such we saw at a significant time advantage. And b, it is the one that comes with a subcutaneous administration. And as Brad was saying earlier, in frontline diffuse such cell, the vast majority of these patients are actually treated in the community setting. And so the fact that there is now a potential readout on a drug that is available for these patients -- for these physicians and these patients in this particular setting in the U.S. health care system. That is label, the only one that is labeled without restrictions on where it can be provided to the patients. I think that is what's driving the entire enthusiasm on that particular study. And I think why we had, I don't know questions from you guys on the study.

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

Yes, of course. We're going to take our next question, and it comes from the line of Victor Floch from BNP Pariba.

Just one on EPKINLY. So I mean [indiscernible] reported a decent Q1 performance. I was just wondering whether -- this is driven by the recent label change in the U.S. So I mean, any color on -- I mean, I was just wondering if you've seen a material uplift in the academic setting and whether you can comment on the key orders that you need to clear to further drive penetration in this setting?

Absolutely, Victor. So good question. So Brad, you can handle both of these.

Yes. No, I think -- first of all, thanks for the question, and the strong start to the year is certainly evident by the profile being appreciated by physicians as well as health systems primarily being looked at as the only bispecific of the dual indication and the proven efficacy piece is certainly extremely important as well as the subcutaneous administrations, which is what Tahi mentioned well. Now as it relates to the moving forward into earlier areas, the ability to, again, have all of these ingredients in place, moving quickly into earlier lines, featuring a combination as well as fixed dose options is extremely important. But then also, as you mentioned, as it relates to the performance second line FL we're seeing as a key part of this driver of performance. And then the hospital removal of potential hospitalization data has been very well received. And again, looking to prove just additional barriers to be able to treat patients closer to where they live in the ways that you're seeing with this extremely important profile from an efficacy, safety and feet durable responses along with subcutaneous administration.

Now we're going to take our next question. And the question comes line of Kalpit Patel from Wolf Research.

For EPKINLY, the EPCOR DLBCL 2 trial in frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful especially given the context behind POLARIX study. And then 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 part of these.

Yes. So on this question, unlike what hazard ratio we are expecting has come up a lot. And essentially, it doesn't make me sense to speculate. What we have said is that based on the public data that is available in Phase II, there is, of course -- and you heard this in the other question earlier, expectation and enthusiasm of what the possible read of that study. So Phase III have in the past on a tended to mimic close Phase II data, as I said, it's a mechanism of action that's very predictable. And so we are excitingly as you awaiting the readout and of course, are very enthusiastic of how positive this try would be, but we will see what it is when we have it. As it really relates to OS now, we all know from the order that the FDA will approve frontline diffuse regimens even without was benefit. I said in the past, the ability of showing NS benefit, of course, is becoming a little bit more challenging defies general because of the increasing available or very effective salvage therapies for particularly worse patients refractory FX to cards and the bispecifics that are also now penetrating second line and are already very much available in third line. Having said all of that, it's also a function of the effect size that you have from PFS, meaning the larger the PFS has a ratio benefit becomes the largely the opportunity to show an OS benefit. That's kind of like broadly speaking, how we think about that.

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

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

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

Yes. What I will answer, Judah, is that this amendment that increases trend had no impact on additional sites or a need for any additional sizes. Study is enrolling extremely well. So that's why it won't have an impact on anything.

Thanks, tahi. And that's -- I think address is the last question of today. So thank you all for calling in today. And if you have any additional questions, please reach out to the Investor Relations team of Genmab. We very much look forward to speaking with all of you soon. And it's a 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.