Genmab - ADR Aktie

Hello, and welcome to the Genmab Third Quarter 2026 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference 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 on the successful 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.

Today's presentation will also include comments on certain non-IFRS financial measures, which management uses to describe the company's baseline performance. and which supplements but do not substitute for the comparable IFRS measures.

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Please refer to our website for more information on Genmab and our price policy. I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

Good to have you all with us, and welcome to Genmab's Results Call for the first 9 months of 2026. Joining me are our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. And our Chief Medical Officer, Tahi Ahmadi, and Chief Development Officer, Judith Klimovsky, you will both join us for the Q&A. p.

S the operator said, we will be making forward-looking statements so please keep that in mind during the call. This has been a long lag stretch for Genmab, and I'm delighted to share it with you that start with the numbers. Our total revenue was up 22% with growth coming from across our portfolio, we have continued to manage our investments thoughtfully and strategically, allowing us to grow our adjusted operating profit by 9%.

Growth and profitability together are certainly a sign of a healthy, high-quality business. But the product development news is what we got this is what has me most energized. October was a truly unprecedented month in our history with 3 milestone Phase III readouts all with the potential to change how patients are treated.

The strengths stand behind these results. Our expertise in antibody science and oncology, our ability to evaluate innovation and our speed of execution. You can see all 3 in these programs. We acquired Arenas in May 2024 when it was a single Phase I/II trial, 2.5 years later, that's a positive Phase III and a broad Phase III program across the ovarian and endometrial cancers.

We acquired [ petasantimab ] last December and less than 11 months after closing, it too has a positive history and a growing Phase III program. And at EPKINLY, an antibody created by Genmab and co-developed with AbbVie has delivered 3 Phase III readouts this year. We said these therapies had substantial promise and the Phase III data have now confirmed that.

And in each case, the Phase III result is consistent with the Phase II data that led us there. Let me turn to the next slide to remind you of this remarkable Phase III data and what it means for us going forward. Last week, we held a goal summarizing the important Phase III data sets that we announced in October.

You can listen to a replay of that call to our websites. So we'll keep this brief and focus on what it means for us. First, at EPKINLY, the [ APCO DLBCL ] 2 trial, which not its progression-free survival and [indiscernible] with a hazard ratio of 0.49 and demonstrated that has the potential to change our frontline diffuse last B-cell lymphoma is treated after more than 2 decades of our job as the standards.

And expanding into online supports EPKINLY's potential to become core therapy and B-cell malignancies. Second, [indiscernible] has to be the best first and broadest in class, the RAINFALL 02 trial, which met both its primary endpoint of progressive-free survival with a hashed ratio of 0.2 million in the intent-to-treat population and the key secondary endpoint of overall survival supports that ambition and efficacy irrespective of fully receptor other expression level or previous nivetuximab.

And platinum-resistant ovarian cancer is just our first potential launch. With our established global presence and recurrent or metastatic [indiscernible] cancer, the breadth of arenas program across ovarian endometrial cancers positions us well to lead innovation in the Cano oncology section.

And third to petosemtamab. The [indiscernible] trial, which met its dual endpoints of overall survival with a hazard ratio of 0.5 as well as objective response rates, anchor program in first-line head and neck cancer. This will be followed by our next milestone, the [indiscernible] trial in the second and third line setting, which we expect in the first quarter of 2027.

And with 2 Phase III trials underway, we are already expanding into colorectal cancer, which is another area of significant unmet needs. And given the global capabilities that we have built, I have no doubt that we are well prepared to continue to maximize the potential of all 3 of these programs with successful commercialization if approved.

Now let me pass on to Brad to talk more about this and how we currently commercialize medicines that Genmab and [indiscernible] are doing in the markets. Perhaps the floor is yours.

Our proprietary medicines continue to perform extremely well with [indiscernible] reaching more patients around the world. These results reflect the strength of our antibody science and effect execution by our teams to increase treatment adoption broaden access and expand the new markets.

Together with the late-stage progress Jan shared earlier, this performance puts us in a strong position to close out 2026 and deliver on our next phase of growth. EPKINLY is the most prescribed bispecific antibody in lymphoma globally, and we're building on that leadership.

Sales grew to $491 million in the first 9 months representing a 47% increase year-over-year. In the U.S., EPKINLY continues to grow across indications and sites of care, particularly in the community for its differentiated dual indication profile is resonating with physicians. During the quarter, we increased the number of sites ordering at EPKINLY and expanded adoption among existing accounts with more than 97% of key customers now ordering from 2 or more sites.

We're especially pleased with the uptake of chemo-free, fixed duration of EPKINLY plus R-squared in second-line FL, which is now considered the standard of care in this setting. This uptake is broadening physician experience with EPKINLY driving increased utilization across both FL and DLBCL and bringing bispecific based treatment to sites closer to where patients live.

Outside the U.S., EPKINLY continues to perform very well. In Japan, the launch of EPKINLY plus R2 second-line FL is off to an encouraging start, building on EPKINLY established presence in the market. Through our partner AbbVie, this combination has also approved in more than 40 countries creating opportunities to reach more eligible patients.

For the rest of this year, our focus is on maximizing these opportunities, particularly in the U.S. and Japan, where we book sales while preparing for anticipated launches in early lines of DLBCL as soon as next year. Moving to Tivdak Sales totaled $131 million in the first 9 months, which is an increase of 9% year-over-year.

This reflects strong, stable performance in the U.S. and continued growth in our launch markets in Japan and Europe, driven by effective field execution and expanding site activation. Tivdak is now approved and reimbursed in multiple countries with additional reimbursement discussions underway.

This expansion is bringing TIVDAK to more patients while strengthening the local market knowledge, customer relationships, and access capabilities that will help drive our success with Rena S and petosemtamab in the future. Looking ahead, our focus is on translating progress in our late-stage portfolio into well-executed launches and access for patients.

For EPKINLY, first-line DLBCL represents a substantial opportunity to reach patients at the start of treatment and potentially advance the standard of care. The broad physician network and treatment experience we're building today and EPKINLY's approved indications across sites of care serves as a strong foundation as we prepare to expand into earlier lines of the DLBCL. If approved, EPKINLY would significantly expand EPKINLY's role in lymphoma treatment and move us closer to our ambition of establishing EPKINLY as the core therapy in B-cell malignancies.

Rena S, The positive RAINFALL 02 results represent an important step forward for patients with platinum-resistant ovarian cancer who face limited options and poor outcomes. If approved, Rena S would become our second medicine in gynecologic cancer and advanced our ambition to become the recognized leader in this space.

Our proven experience with TIVDAK gives us an established understanding of gynecologic cancer care and long-standing relationships with physicians and care teams have set a strong foundation for our work with Rena S in the future.

Lastly, as John shared, Lager HN1 was the first positive Phase III trial in first-line head and neck cancer in nearly a decade. If approved, petosemtamab will broaden our solid tumor portfolio, and could offer an important new treatment option for patients in a setting where progress has been long overdue.

Over the last several years, we built a commercialization engine across key markets designed to scale with our portfolio and support the growth ahead. We're pairing deep antibody and oncology expertise with local market insights and data to different general medicines, secure broad access and drive successful launches.

Our field teams bring these capabilities together with a highly coordinated and seamless engagement plan for care teams and customers supporting broad uptake and utilization.

As we close out 2026 and look towards 2027, we're in a strong position, driving growth from our approved medicines, advancing readiness for anticipated launches next year and turning the strength of our science into sustained growth and meaningful impact for more patients.

With that, I'll turn it over to Anthony to walk you through the financials.

Thanks, Brad. The first 9 months of 2026 demonstrated the continued strength of our business. with revenue growing 22% year-over-year. And I'd highlight 2 characteristics of our performance. First, the high level of the growth; and second, the broad-based nature of that growth. Starting with the high growth. DARZALEX increased 19% year-over-year while worldwide EPKINLY net product sales increased 47%, reflecting continued commercial momentum and strong execution. .

Beyond these 2 brands, the remainder of our portfolio increased 30% year-over-year. Turning to broad-based growth. Approximately half of our year-over-year revenue growth came from DARZALEX. Impressively, the other half was generated by EPKINLY and the remainder of our portfolio.

Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base. And this strength provides us with the financial flexibility to continue investing behind our highest value growth opportunities.

This includes launch readiness for EPKINLY, Rena-S and postman as well as the ability to broaden the development for both of our wholly owned programs. As you know, we currently have 9 ongoing Phase III trials for Rena S and petosemtamab with more announced or in development.

And even with this investment, we grew adjusted operating profit by 9%. So together, our results demonstrate that Genmab can increase investment while continuing to expand profitability. Now let me briefly comment on tax. Our effective tax rate for the first 9 months was 3.4%, primarily reflecting the ongoing integration of Merus and related recognition and utilization of deferred tax assets.

As we've previously discussed, our effective tax rate may continue to fluctuate as those integration activities progress. We expect our effective tax rate will normalize over the next 12 to 18 months. With that, let me turn to our 2026 financial guidance. We remain on track to achieve our 2026 guidance, which we are maintaining with strong revenue growth and strong profitability.

We expect our revenue to be in the range of around $4.325 billion to $4.525 billion delivering a robust 19% growth at the midpoint. And it's EPKINLY and the continued momentum in our royalty portfolio that's driving that growth. Given our performance through the first 9 months, we now expect revenue to be in the upper part of that range.

For operating expenses, our full year investment plan has not changed. So we still expect to be in a range of around $2.1 billion to $2.95 billion and we expect to be around that midpoint of $2.88 billion. We expect Q4 OpEx to step up significantly because we have substantial activity planned in the fourth quarter including manufacturing, clinical development and launch readiness for Rena S and petosemtamab.

So I would caution against taking down your 2026 OpEx figures as a result of our first 9 months. Putting all this together, we're planning for adjusted operating profit in a range between $1.065 billion to $1.35 billion, with the midpoint of our guidance amounting to over $1.2 billion.

With revenue in the upper part of the range and OpEx around the midpoint, we expect our operating profit to end above that midpoint. Our guidance highlights our continued strategic discipline with revenue growth, funding targeted investments in petosemtamab, Rena S, and launch readiness, all while maintaining strong profitability.

Now finally, before I conclude, I'd like to take a minute to look ahead to 2027. While of course, our guidance will be given in February next year. As I stand here today, 2027 consensus expectations for OpEx on Bloomberg and FactSet appear to be in a reasonable place, capturing our investment priorities. Importantly, we remain confident that Genmab will deliver strong profitability both in 2026 and continued growth in 2027.

So in summary, our performance in the first 9 months of 2026 underscores our ability to produce high-quality revenue growth, advance our late-stage pipeline and maintain strong profitability through disciplined execution.

Together, this positions us well to deliver sustained growth and long-term value creation. Jan, back over to you.

Thank you, Anthony. This brings us to our final slides. It has already been a remarkable year for Genmab, both for our science and our financials. I can summarize this with 3 themes. The first is our sustained financial growth based on revenue from our portfolio, including significant contributions from EPKINLY.

The second is a high-potential late-stage pipeline where we have to have unprecedented Phase III readouts across EPKINLY, Rena S and petosemtamab, setting up potential launches in 2027 and multibillion-dollar peak sales potential. And finally, our disciplined capital allocation. We are investing in our high-impact late-stage programs with broad clinical development and launch readiness.

All while sticking to our goal of gross leverage below 3x by the end of next year. In short, we have 3 high-quality late-stage programs, a broadening revenue base and more catalysts still to come. All of this gives us real momentum as we head into the next decade.

So as we move forward to the end of the year, I could not be more energized about our future, both in 2027 and beyond. That concludes our prepared remarks. Before we move to Q&A, I'm pleased to announce that we will hold our annual virtual R&D update and as data review event on December 16.

Details will be available on our website and with over 20 accepted abstracts, including 6 oral presentations, we look forward to a lively event. With that, thank you for listening. Operator, we are now ready for questions.

[Operator Instructions] And it comes the line of Benjamin Jackson from Jefferies.

Can I just start on the asset abstract for DLBCL, please? Just interested if there's any color you can add around what you're seeing or thinking about with regards to that OS favored ratio that obviously shows no detriment to the patients.

But is this something similar to what we saw in and around the DLBCL 1 trial, where we need to adjust for any come related deaths or so therapies. And how do you see this reading across to the first-line trial? Is it just a factor of the short or very short follow-up compared to the other trials that we see in the space and is this something that ultimately you will need to show a statistically significant OS benefit in 1 of these 2 trials to be confirmatory across the board.

So any thoughts around the OS side of that as well? And also just as a follow-up on the safety side, slight increase in that trial in and around great events? Is there any color you can add here? Is this correlated again? Or is something else at play?

Thanks, Ben. Very cleverly, I think, put 3 questions under the first one. The abstracts and then the safety 1 is an extra question. So I'll ask Tahi to start and then unit ship in you can add further color. Tahi?

Yes. Thank you, Jan. Thank you, Vindi. There are probably 5 questions in there. So let me take them 1 at a time. As it relates to the U.S. for the -- or [indiscernible] I think you already alluded to a median follow-up on that trial driven by the impressive else ratio on the PFS side, that triggers the readout was 10 months.

If you just think about the cost comparison to '05 or the GOP [indiscernible] the follow-up there was more like towards to months. And so from that, you can just already appreciate that this is totally immature, so very few events.

As it relates to Cobios not necessary an issue anymore. These trials were on post the covert phase. But of course, the availability of bispecifics and cards. So the next available lymphoma treatment, thus to degree play a role.

We're still very confident that the hesitation will continue to actually improve and actually show a benefit for kidney. So we'll have to just wait for that follow-up. As it relates to confirmatory trial, I think it's fair to say at this point. at the front line is a bisaPhase II with an overwhelming positive PFS will function as our regulatory -- from a regulatory point also confirmatory trial.

That was the second question that you had. And the third one was on safety. You correctly noted that there were a few debt events on the Kenyan also on the control arm. But in the now isolated signal that is really motor factorial and it's a relatively small number of patients.

So there are all kinds of different factors that play a role there. So we stand behind the conclusion that really trying to show any new safety signals. And I think we will be better appreciated when the data is actually presented in its totality at ASH. I hope I touched on all of the questions.

Yes, of course. And we're going to take the question from the line of Charlie Haywood from Bank of America.

Charlie Haywood Bank of America. I have 2, please. So the first 1 is just looking ahead to potential launches for these assets and how on Peto specifically, I think your prior commentary was $1 billion sales by 29%. And so I just wondered.

Obviously, you've hit OS at Interim, which I imagine was more of an upside scenario. So how has that informed confidence to reach that status by '29 and then the second question, just on your 2 Phase III readout your filable readouts coming next year. So Peto second, third line head and neck and then Rene second-line endometrial I guess, both optically smaller ops than the recent anchor readouts you've had, but both broader halo potential for the assets you've got, so OS benefit for Peto across potentially first line, second line and third line and then [indiscernible] and endometrial. So how do you view the commercial importance and the potential halo effect of those 2 indications?

Thanks, Charlie. Brad, can you start off with both questions and then Anthony can potential chip and also as it relates to the sales in 29 to provide further color, if needed. Bart, maybe you can start .

Thanks, John, and thank you for the question. And as we look ahead, obviously, the oncology in general is a data-driven market and a very competitive market, but also extremely data-driven, and we're confident in the data that we've seen to date for all the assets, as you mentioned, across this -- your questions.

And we're confident also on the capabilities we've built at this point to bring our medicines to market. We really built our commercialization capabilities with all of this in mind over the last few years and certainly with this level of growth and expansion, looking to differentiate in these spaces.

We evaluate the markets with multiple sources overall and feel confident in the guidance we've provided thus far. And as we get into the data further with the presentations, as we've stated, upcoming medical congress next year, we provide further color on that as we move forward.

Thanks, Grant. Anthony, you want to give further color?

Yes. Yes. Thanks, Charlie. Look, we've been super clear. We had high conviction. I was resuming on Petosemtamab. We had high conviction in petosemtamab in October, we backed it up with the really super strong Phase III results, including the OS that you referenced.

So we stand fully behind the peak year sales estimate for petosemtemab at multibillion, and we stand fully behind that $1 billion number for 2029. So I really feel like on the heels of this data, Charlie, we're well positioned here moving forward.

And the question comes from the line of Zain Ebrahim from JPMorgan.

First question is on peto and just how we should think about the duration of treatment that you're expecting to see from a modeling perspective. I think in the Phase II, you showed median progression-free survival of about 9 months. But based on the Phase III results, you're basically your factory doubling overall survival.

So could we see potentially longer duration of therapy than that progression-free survival 9-month point? And my second question is on EPKINLY and how we should think about the pace of the rollout in first-line DLBCL and second WCL pending approval next year. Given the rent of the data, particularly in first line, could you see blockbuster sales for come next year?

Thanks, Zain, for the question. So maybe, Tahi, you can start with the Peto duration of response question. I don't know how much detail we can give here. But you can potentially give some perspective. And then Brad, maybe you can talk about the launches and the rollout of ATCO in frontline DLBCL and further.

Yes. Thank you, Jan, and thank you, , for the question. Now of course, as I'm sure you all understand, we're not going to be able to get at this point into a nuance discussion around duration of treatment and any kind of like detailed discussion on the data until we have it in the public domain.

I think it's important to step back, though, as you also alluding to any questions to remind ourselves that from a pure out ratio on response and then particularly on the OS hazard ratio.

What we're looking at is really like a transformative study, and we're really excited to show the totality of the data in the context of the patients that were involved, and then we can have these nuanced discussions around modeling duration of treatment in these things. .

And Brad, maybe a bit on the rollout of EPKINLY in the different settings.

Thank you for the question. And we've said for quite some time, the largest opportunities, obviously, as we move into earlier lines of therapy, specifically in frontline. And where the majority of the patients we know are treated in the community and intentive treatment is curative. .

The market is already moving, I think as we know, from our CHOP to these R-CHOP combinations and also long stated that we believe bispecifics can really build on this RO and emerge as the new standard.

The top line data at this point, validate this position and the roll up EPKINLY plus R-CHOP can play, and we feel extremely confident again in the data prep EPKINLY. We've built the capabilities all along to prepare for earlier lines of therapy as it relates to our infrastructure.

And we expect strong uptake at launch primarily with academics and then certainly moving into the community as more sites gain experience as we're already seeing and a bit of a proof point with a second-line FL launch from around the same time last year. That's driven the primary part of our uptake thus far. So we expect strong uptake and look forward to sharing more as we move further .

Thank you, Brad. And as you said before, data is the currency in oncology sign. And what we hope is that we can actually present the data of the frontline study with epcoritamab quite quickly. and show how fantastic that data is so that, that launch will be even quicker once it's on the market. Let's move to the next question, operator.

Yes, of course. And the question comes from line of Romy O'Connor from Van Lanschot.

This is Romy. Maybe just following on to the previous one. So with the potential long treatment duration that we might see with petosemtamab. Just wondering how you're thinking of the subcutaneous formulation. And how advance along is that? And looking at the frontline DLBCL space following the positive data that we saw -- how should we be thinking about the positioning of kinin RCHOP against, for example, Polar chip?

So do you anticipate more of a broad adoption or could treatment decisions be dependent on risk characteristics, for example?

Thanks, Romy. The first question can be on the subcu, maybe a can start with that and then also handle the second question on the competition and the positioning versus Polachi and online diffuse at bisylyphoma. Tahi, maybe you can start.

Yes. So on the Peter questions first, we obviously started -- I think the deal with [indiscernible] was announced in middle in the midst of the closure period of the acquisition of MiR. So we've been working on secure.

We have always understood subcu to be an important life cycle management component. And that's probably where we go to leave it at this point for a variety of reasons. On the pinna question, this question comes up a lot, and I think that good to step back for a moment. So first off, spine has a patio 0.49. This was unprecedented that gets sometimes overused, but this is literally the trial at a scale of positivity that has not been seen in the fish business for quarter for Century.

What that also means, even without having a discussion on the nuanced data that when you have an effect size of that scale that probably will have an impact on a number of populations.

So we can tell the difference in hesitation between 5 to 2 to 5 was nonexistent, which basically means that the has a ratio of mimics has a pasture of the 3 to 5 population. That in of itself is already a significant differentiator. And then there are other subgroup populations that you could think about. As it relates to the original Polar CHP data set, from Polarix on that late approval. So I think that's the first differentiator that's important. The second point that is important is when we're here today when we have a Phase II the [ GlofipolaCHP ] study is going to read out sometime in the future. I think washes got it towards the end of next year. So there is a significant time advantage.

That's an important point. I think the third part that sometimes gets also not really appreciated is that from the beginning, what we discussed and Brad touched on this, last majority of these patients get treated in the community.

And in the community on top is the standard of care. That's something that physicians in the community are comfortable with for 25 years plus. The subcu administration is a differentiator for the community. Dual indication is a differentiator in the community.

And so these things all are important aspects, not to have 2 marketed products within a regimen payable in certain costs conscious markets. And then the last point is, if you actually look at the most recent ASH aside that just got released by [indiscernible] that we also talked many, many years ago already, there might be actually seeing that is determined for CD3/CD20 that is then determining how high you can go in the efficacy in terms of because there is really no difference between our shop, [indiscernible] going. So I think that kind of examines how we think about it. We feel very comfortable with the positioning of where we are. We're super excited to share this data as soon as we get the opportunity to, and then we'll have more detailed conversations.

Now we're going to take our next question. And the question comes line of Asian from Leerink.

This is Carina for Asthika congressional data. I had a question for Rene. So facts, Phase III data in endometrial showed a meaningful PFS and OS benefit, but they also had 35% response rate on visable was acting to file now does Venti have a accelerated approval? And I have a follow-up.

Thank you, Karina. Judith, can you take that question?

Yes. So thank you for the question. So as you know, for Rena S, we have a well strategy. We started with a single arm. And in parallel, we opened a Phase III randomized are -- so basically aligned with what we did with PRO. So the more likely scenario now is that the filing will be based on the Phase III as a.

Thanks. That's very clear. .

SP594907783 And I have a follow-up. For Rena as the ovarian cancer data, they had -- you guys showed a strong OS ASD ratio and there has been like a lot of buzz generated at ESMO. Are you seeing like any preliminary impact on patient recruitment to the other ongoing Phase III studies and also basket studies.

Judith, can you handle this one as well?

And thank you for the question. As you can appreciate the unprecedented results of Rina in Pro are creating what we call inhale effect. So we expect recruitment on the other studies to be even more encouraged by these results being already making public. .

And now we're going to take our next question, and it comes from Gregory Renza.

Another one on [indiscernible] on the greater than $2 billion peak sales, how does that -- how does that number split across 5 resistant, pain sensitive and endometrial cancers. What setting drives most of the value?

Thanks, [indiscernible] for the question. Anthony, you can handle this one for sure.

Yes. Thanks, Greg. Really, I'll come back to the high conviction we've had in Rena S and again, now we back this up with the Phase III data that was released in October and really showing that strong OS data. So really, our convection is really backed up now in based upon this data.

So again, we stand fully behind that peak year sales estimate. And just to remind everybody for Renas, that's greater than $2 billion. That conviction comes from the data, but it also comes from the capabilities we've deliberately built get how we develop the medicines, how we commercialize them.

And you've seen, again, remind everybody that strong execution with Tivdak and EPKINLY, and that same engine is already doing the appropriate prelaunch work particularly now zooming in on green as and really leveraging all of the capabilities we've also built in the gynecological oncology space.

So I think we're very, very well positioned to deliver against that greater than $2 billion estimate for Rena S. Gregory at this stage, we're not breaking it down any further than that in terms of further breaking down ovarian or endometrial to split?

Really, I just have you focused on the capabilities in place the data in place for us to now deliver against that greater than $2 billion target for Rena S.

Thanks, Anthony. And as a reminder correctly, we also have trials in lung cancer colon intestinal cancers to arena. So it may have a far broader potential than just ovarian and then the endometrial. Let's move to the next question, operator.

And now we're going to take the question from Rajan Sharma from Goldman Sachs.

I've got 2 as well. First one, just on kite dynamics. It looks like sequential growth between 2Q and Q3 was relatively flat. So could you just maybe talk about what you're seeing there?

And is that sort of the run rate we should be expecting until the frontline approval comes through? And then secondly, maybe just following up on a question from the call last week.

Just now that you have the data in hand, how are you thinking about the shape of the top line and the bottom line of the company through the patent exploration -- or sorry, your royalty exploration. Are you confident that the ability to grow through that or at least be flat?

Thanks, Jason. Very good questions. Brad, can you handle the first one. EPKINLY grow dynamics. And how to think of that going forward? And then Anthony, maybe you can start on the top line versus bottom line, and I can potentially jump in there as on pat?

Yes, thank you for the question. And we certainly continue to see kind of post the second line FL launch as well as removal of hospitalization, strong growth, specifically in the U.S. with EPKINLY. And we look globally expecting, as mentioned, we just launched in Japan with second-line FL as well.

And so I think you'll see that continue to -- we expect continued growth there also, but we said all along the earlier lines of therapy is where the value is and as we have just seen the data with frontline, looking to continue to build on the strength that we have with our infrastructure, both our field teams, our market access, patient service teams in the fields are ready to deliver from that perspective as well. So I'll leave it there.

Thanks, Brad. And maybe, Anthony, on the top line versus bottom line going forward?

Yes, happy to do so. And really, it's going to be reiterating some key messages we've been sharing with the markets here now for really the last year, it really starts with the strength, the quality and the high conviction that we had and continue to have really across EPKINLY, Rena S and petosemtamab again. Now we back this up with this Phase III data here during the course of October.

And again, we stand fully behind the peak sales estimates that we've previously communicated. Just remind everybody, that's greater than $3 billion for EPKINLY, greater than $2 billion for RNAs and multibillion for petosemtamab. I would also then look to something we highlighted during our call today when I talked about the characteristics of the growth that we're seeing DARZALEX at EPKINLY up 47% compared to last year.

The rest of the portfolio up 30% so putting that all together from a revenue perspective, we absolutely have the building blocks in place to see an overall very nice revenue growth trajectory here moving forward.

And then sort of thinking about the investment and ultimately, the bottom line, Rajan, I would really anchor you back to the important financial commitments that we've made to the market, most recently when we acquired Merus in Q4 of last year or right like Q3.

And really 3 things that we've said to you all. We said, number one, we would deliver strong operating profit in 2026. Here, we're up year-to-date 9% on adjusted operating profit. We also said when we thought about 2027 we committed to deliver operating profit growth and to delever to below 3x gross leverage.

And based upon the strong performance of our brands, coupled with focused and disciplined investment, we are very well positioned to deliver these important 2027 financial commitments.

So if you sort of zoom out, Rajan, is really thinking we have it from a revenue perspective, the building blocks in place, very high-quality data we've seen here in October. And that real focus in leveraging that revenue to the extent possible to drive profits for Genmab.

So we're not in a position today to give you any real specific medium-term guidance, but you really should take away from this that the building blocks are really in place in the Genmab from both a product perspective as well as a capability perspective.

Thanks, Anthony. I think very little to add. It comes down to execution, execution, execution here, Rajan that's what we're pretty good at.

Now we're going to take our next question. And the question comes from of Xian Deng from UBS.

Two, please. One on petosemtamab in colorectal. So just looking at the ATM data. you presented. So just wondering, the OR, of course, looks very high, but the current standard of care in this particular. Sorry, in the frontline setting also looks pretty high. And my understanding is the duration is what really matters.

So just wondering, given the public data we see is relatively early stage, and you've already started Phase I. So just wondering what are your thoughts in terms of duration and especially considering amibantumab, it's actually a lot ahead in terms of time line.

So just wondering your confidence on duration, especially also versus recent on that? So that's the first question. Second one is on winner. So you are announcing the Phase III trial in frontline PMR, endometrial so just wondering is that trying to replace chemo induction or more sort of to add during maintenance. And sorry, this is a long second question. So it's kind of a broader one on Rena S is that you're also starting Phase III on maintenance and on PFO as well as reduction in [indiscernible]

So historically, the maintenance in those settings, whether it's endometrial or ovarian, it tends to be monotherapy and no chemo. Just wondering, given the toxicity of chemo but then, of course, this is this is ADC.

So just wondering what are your overall thoughts on potentially using ADC the maintenance setting. I'm asking because whether you can use a initiating actually a matter of a lot in Q2.

Thanks, Xian. Very good questions. The first one, I think can be handled by Tahi. And then Judith, you can take the Rena S question, and then Tahi can potentially step in there as well.

Yes. Let me just start with the plate question and then between June we can certainly also answer the wine questions. Let's start with the colorectal. Yes. So I mean you're absolutely right that the follow-up for the frontline data set that we presented was relatively short.

I think it was 5 months. But in the end, there are 2 data sets, there's also second-line data set with a slightly longer follow-up which is the same combination with chemotherapy or [ FOX or FOLFIRI. ] And so you can, to a degree, extrapolate from the second line durability that is already, I think, better appreciated to the front line variability.

And in the end, the ability is a function of the mechanism, of course, the safety profile and the treatment duration. And then of course, the sensitivity of the disease.

And so this is at least how we think about it. So we look at these data sets, not in complete isolation. They also inform each other.

And if you take them in totality, both with point estimates higher response rates that have been described than any data set that has described before, response rate in that data set in frontline obviously, on the left side.

And then in the second line in the totality of patients these data points give us confidence and then the durability that we've seen on the second line emerge confirms that conviction.

And then, of course, right now, I think we are broadly speaking, a pretty robust understanding of the safety of item. And that's particularly relevant also as you start getting into the thought exercise and comparing it to [ amivantamab. ] And I think we've talked about this also in the last call, there is a very clear distinction in the safety profile and the tolerability of peto versus [indiscernible] it's in terms in the system organ class, obviously, as an EGFR class, there are skin-related toxicities, but the numerical degree great higher and the complexity and even like the locality of the affected skin areas is drastically different between these 2 assets.

And so if you then compare the safety that we have generated now repeatedly and that also is in the Phase III, obviously, to the available data sets with Amy and then you know that amivantamab achieves that safety profile where they're very complex and involved mitigation strategy, then I think it's pretty obvious that there's a massive differentiation on safety and that definitely, in our mind, translates into ability.

So I think that's my answer on the collector. So we feel super excited about correct. And I think the data that we presented just at ESMO underwrites the excitement that, of course, already had motivated us to these 2 Phase IIIs. And then I would say this, Rena S, this would not be the first Phase III that we have started after the competition that read out before the competition. And then I'll give it to Judith for the Rena questions.

Yes. So thank you for your questions. For Rena, the endometrial cancer study that is in the public domain is the Phase III in the second third line -- the first line is planned. So we haven't provided specifics about the design or comparator. But as you well alluded to -- the standard of care is indexing chemo plus IO followed by maintenance IO. .

So we haven't shared the specifics of the trial, but stay tuned with the shortly positive. With regard to [indiscernible] have a well strategy, in fact, a trip strategy. So in [indiscernible] second, third line, we have 2 studies, 304 and 07, One is maintenance post doublet chemo plus/minus 1 and the other one is what we call replacement strategy.

And we have the first line piece posted recently in clinicaltrial.gov, which is not this of a first line maintenance which is double chemo followed by BEV versus double chemo followed by the plus arena.

So basically, what we are doing is covering all the aspects to potentially unleash the full potential of REN in the whole spectrum of the disease. Do you want to add anything?

Well the only other thing is on in your question, you alluded to the idea of whether or not an ADC at all is a maintenance drug. And I think there, again, nuance this matter. I think we have talked a lot about what we consider to be a differentiation for Rena S that is that it is mainly heme toxicity. They are mainly restricted to the first or second cycle.

And then thereafter, it is actually a very well-tolerated drug with an extremely low discontinuation rate. And then if you have a drug that has a safety profile that is truly tolerable, meaning it doesn't have this discontinuation due to [indiscernible] neurotoxicity industrial lung disease or any other form of cumulative toxicity, then it is actually indeed, a very good maintenance store.

And we presented data on Rena Bev last year that speaks about that, the good tolerability in terms of patients staying on both drugs Bev and Rena for a long period of time.

Thank you, Judith and Tahi. I think is really, really a very good response to the question from Tahi. Let's move to the next question, operator.

Yes, of course. And the next question comes from line of Yaron Werber from TD Securities.

Great. So I have a couple of questions. The first 1 is on Fido. Would you file based on the first-line survival data that you just got -- or would you wait to file and include the second-line survival data, which we're expecting early next year?

And then secondly, and I think it's maybe a nuance question relative to what was asked before, I think when many of us look at the guidance now, $3 billion and higher for EPKINLY to Farina and billions for peto, they all look fairly conservative. What would it take to update them?

Thanks, Yaron, for the question. So the first one, Judith and Tahi can take that one. maybe you that. And then, Anthony, you can give more perspective on the guidance.

Yes. So as we guided the Street when we share the top line results of a [indiscernible] we are actively planning engaging with health authorities for the potential filing based on the results that we already communicated.

Thanks, Judith. Anthony?

Yes, sort of just at this stage, we're going to stand fully behind the previous peak year sales estimates for the 3 brands. Again, reminder, it's greater than $3 billion for EPKINLY greater than $2 billion for Renasant I just want to clarify, I think you said $1 billion for petosemtamab. For petosemtamab, it's multibillion. We had strong conviction in these estimates coming into the readouts that we saw in October, and we continue to have that high conviction, and that's where I'm going to leave it for now.

Thanks, Anthony. Thanks, Yaron, for the 2 questions.

Now we're going to take our next question comes from Victor Floch from BNP Paribas

Maybe just first one, a quick follow-up on the Subcu combination. I noticed that you've added a new cohort to the Phase II colorectal study. Just wondering whether this would be -- whether it would be enough to support a subcu finding a co-syndication or would you still need a dedicated bridging study?

And the follow-up is on the commercial opportunity for peto. I was wondering whether the subcu could become as important as a driver for peto that it has been for DARZALEX and whether the subcu launch is already factored in your ambition to reach at least billion in sales by 2029.

And finally, more broadly, how does KEYTRUDA expected loss of exclusivity towards the end of the decade shape you a long-term expectation for it.

Thanks, Victor, for the questions. Maybe Judith you can actually take the peto subcu question?

Yes yes. I would echo Tahi answer with regard to the [indiscernible] We already mentioned the partnership with [indiscernible] to start the development of the subcutaneous. It's part of our life cycle management. So it's premature to highlight details of the specific plans that we will follow.

And Brad, maybe the subcu is a driver like [indiscernible] driving the DARZALEX sales, maybe you can say a bit give a bit of perspective there.

Yes, thank you for the question. And as already mentioned, the Lager H1 data show the potential for petosemtamab to be both first and best-in-class in frontline head and neck, and we're confident in this potentially practice-changing data that we've just looked into and shared.

And any innovation certainly or updates would be assessed in the future, and we'll certainly update those as we move forward. But again, an extremely area of high unmet need right now and very confident in the data we presented at this.

Thanks, Pat. Thanks, Victor, for the questions. Let's move on to the next one.

Yes, of course. And now we're going to take our final question for today. And it comes to line of Sean Laaman from Morgan Stanley.

2 quick ones. First of all, strategic, given the significant strengthening you've observed as late-stage pipeline, has your appetite for external business development changed? Or is execution on internal assets now the highest return use of capital is the first one.

And the second one is just on the 2 CRC programs. What milestone should we expect over, say, next 12 to 24 months? And given where you could position this in CRC, particularly with the differentiated safety profile you're pointing to, could the opportunity outside what you're observing or expect in head and neck?

Thanks, Sean. I will take the first one myself. So then the CMC questions Judith can handle. So BD, we are very active, Sean, and looking at interactions with other companies for potential combinations of our drugs. We already announced the insights insight partnership recently, there will be more to come.

But we are currently focusing on really maximizing the potential of our late-stage programs. 2 of the 3 have been taken in via BD by acquisitions. But we also are working very strongly on our organic pipeline. We don't talk a lot about it because we want you to focus on the late stages programs.

But this year, we moved already 4 new programs, antibody-based programs into the clinic from our own pipeline, 2 bispecifics, 2 ADCs and at least 2 more programs will be moved into the clinic between now and the end of the year. So we are very actively working on our organic pipeline, but it will be balanced.

But right now, the focus is clearly on maximizing the potential of the late stage, what I call winning programs son. And also, we have, of course, a commitment in addition to this expansion of the programs to also lower the leverage basically by end of next year to less than threefold growth leverage, which we have focused on.

But we have a very active BD team to really bring the outside landscape into a great perspective for us so that we can strike again if needed in the future. And then maybe Judith, you can talk about the colorectal cancer setting. .

Yes. So thank you unfortunately, CMC is a high unmet medical need and a larger opportunity potentially commercially than head and neck. So in first-line care as while the treatment paradigm is an EGFR antibody, usually [indiscernible] plus FOLFOX, or FOLFIRI. .

Unfortunately, the median PFS is only 12 months and median overall survival around 2 years. In the second line, the unmet medical need is even more comparing with best treatment in [indiscernible] with cetuximab, panitumumab or any other EGFR plus chemo, the response rate is only 30%, 40% median PFS 6 months and median survival of one year. So compelling unmet medical need, where as we highlighted as I highlighted in ESMO we showed very strong, encouraging, although still early preliminary data.

So we expect to have longer follow-up of these data sets which is pretty good for a Phase II proof of concept, and we will communicate this when the data is more mature.

Thank you, Judith. Thank you. I think this will end our Q&A. So thank you all for your questions and for being with us today. And as always, if you have additional questions, please reach out to our Investor Relations team.

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

Hello, and welcome to Genmab's Investor Event. [Operator Instructions] As a reminder, this conference is being recorded today. If you have any objections, please disconnect at this time. I would now like to pass the call to Jan van de Winkel, Genmab's CEO. Please proceed.

Hello, everyone, and welcome to our investor event. I can tell you this has been a really exciting month for Genmab and more importantly, for patients. We delivered 3 positive Phase III clinical readouts in 3 different cancers, diffuse large B-cell lymphoma, platinum-resistant ovarian cancer, and head and neck cancer. And at ESMO, new data that support taking petosemtamab further into colorectal cancer.

There are 3 things I want you to take away today. First, we believe the 3 Phase III readouts have the potential to change how patients are treated. Second, data at ESMO on petosemtamab support expansion into colorectal cancer. And third, what this means for Genmab? Multiple potential launches starting in 2027 and a growth trajectory increasingly driven by our own medicines. So with me today, is our Chief Medical Officer, Tahi Ahmadi, who will walk you through the data. And for our Q&A, we will be joined by our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. Next slide.

As always, we will be making forward-looking statements, so please keep that in mind during the call. Actual results may differ materially. And please refer to the statement on this slide and to our filings. As we are in a quiet period, today's discussion is limited to information already in the public domain. We will cover the broader business on our Q3 call on November 5. Next slide.

At JPMorgan in January, I said 2026 would be a defining year for Genmab. We have been clear about what we set out to do. We told you that EPKINLY, Rina-S, and petosemtamab, were on track to Phase III readouts. In the second half of this year, setting up potential approvals and launches in 2027, and that is exactly what we have done. And on unprecedented month for Genmab, we've reported 3 Phase III data sets that each have the potential to establish a new standard in their respective indications. EPKINLY plus R-CHOP versus R-CHOP in first-line diffuse large B-cell lymphoma, reducing the risk of progression or death by 51%. Rina-S in platinum-resistant ovarian cancer demonstrated a 71% reduction in the risk of disease progression and a 67% reduction in the risk of death in the ITT population.

Petosemtamab plus pembrolizumab in first-line head and neck cancer showed both a statistically significant improvement in response rate and an overall survival. Each is in a setting where patients need better options, and each has the potential to change the standard of care. And the Phase II data at ESMO showed that petosemtamab can go further into colorectal cancer. Next slide.

This slide shows how we got there. Over the past 10 months, we had 3 Phase III readouts for EPKINLY in January, June, and October, both Phase II and Phase III data for Rina-S and the first Phase III readout for petosemtamab, each on the time line we guided. And there is more to come but the Phase III LiGeR-HN2 readout in previously treated head and neck cancer are expected in the first quarter of 2027. Together, these data support potential approvals and launches beginning in 2027. And this is what we have been building towards that reflects our focused execution and strategic choices we made for Rina-S and petosemtamab. In January, I told you that we deliver on our promises. This month, we have shown it. And what sets Genmab apart is not just our great science with our consistent ability to execute with speed, agility, and a focus on patients. Tahi the floor is yours now.

If we can go to the next slide. Thank you, Jan. Let me start with EPKINLY in first-line diffuse large B-cell lymphoma, the largest opportunity in B-cell lymphoma and in a setting where R-CHOP has been the gold standard for more than a decade and with way too many patients still relapse after frontline therapy. If you can go to the next slide.

EPCORE diffuse large B-cell 2 is the first Phase III trial to show that adding a bispecific antibody to frontline chemoimmunotherapy significantly improves progression-free survival in diffuse large B-cell lymphoma. In patients with an IPI score of 2 to 5, EPKINLY plus R-CHOP reduced the risk of progression or death by 51%, a hazard ratio of 0.49 with a p-value below 0.0001. To put that into context, the landmark trial that established R-CHOP as a standard of care was almost 25 years ago. And in a disease where a segment of patients is cured, the addition of rituximab to R-CHOP with a hazard ratio of around 0.58 back then was considered to be the ceiling of what one could reasonably expect. Cost-trial comparisons always have their limits.

But even with the most recent positive Phase III trials, a hazard ratio of 0.49 speaks for itself. It did so over a fixed duration subcutaneous regimen and with the safety consistent with the known profiles of epcoritamab and R-CHOP. And this is a pattern we've now seen multiple times with EPKINLY. Efficacy and safety are very predictable. The Phase II combination data are highly consistent with the larger Phase III data sets. We saw that in the combination with enzalutamide in June, and we see it here again.

In our view, these results have the potential to change frontline practice in the diffuse large B-cell lymphoma, and we look very much forward to presenting the full data in the future medical meeting, together with AbbVie, we will engage with the global health authorities. Next slide, please.

Now here is why this matters. Today, EPKINLY's approved indications, third line plus diffuse large B-cell and follicular lymphoma and more recently, second line plus follicular lymphoma addressed around 27,000 patients, with potential 2027 launches in second line plus and first-line diffuse large B-cell lymphoma and first-line follicular lymphoma to follow soon.

EPKINLY can address around 146,000 patients across the U.S., EU5, and Japan, more than 5x where we are today. Firstline diffuse large B-cell alone represents around 70,000 of these patients by far, the largest population where we can have the greatest impact for these patients. And we have prepared for this moment, frontline patients are primarily treated close to home in the community. Our work to date at EPKINLY has built strong momentum among community sites with broadening treatment experience across both diffuse large B-cell lymphoma and follicular lymphoma. And this will be important as we look ahead to a potential launch in frontline diffuse large B-cell lymphoma. In fact, we shared during our last earnings call that the majority of new adoption for EPKINLY in the U.S. came from community centers, exactly where these first-line patients are treated.

If we can go to the next slide, please. The Phase III readouts this year put EPKINLY on a path to expand diffuse large B-cell lymphoma from first-line onwards with data in first-line follicular lymphoma still to come in the future. With a differentiated dual indication profile and demonstrated versatility across lines of therapy and histologies as a monotherapy or in the various combinations, EPKINLY has the potential to become the core therapy in B-cell malignancies. And we see a peak sales opportunity of more than $3 billion for this program. And with the front-line data in hand, we believe we are around 1 to 1.5 years ahead of the main competitors in this setting.

Now let's turn to Rina-S. Next slide, please. Rina-S is the first of our 2 wholly-owned late-stage medicines we will talk about today. And we have 2 data sets to cover here. The positive Phase III RAINFOL-02 top line and the Phase II RAINFOL-01 data presented at IGCS.

Next slide, please. The Phase II data at IGCS show why we had such high conviction going into the Phase III readout. In heavily pretreated patients, Rina-S delivered a confirmed response rate of 45.9% and a median duration of response of 12.1 months. And these responses were seen across the folate receptor alpha expression levels. The safety profile supports long-term use. There are no ocular events, neuropathy, and no ILD signal. And only 1.8% of patients discontinued due to treatment-related adverse events.

As I said on our call in the second quarter in August. Put these together, and you could already get a sense of the direction of the PFS and what RAINFOL-02 has now shown.

Next slide, please. RAINFOL-02 marks a significant milestone for Genmab and for women with platinum-resistant ovarian cancer who today have limited treatment options. The study met its primary endpoint of progression-free survival versus investigator choice therapy in both populations we analyzed. In the intent-to-treat population, which comprised of all randomized patients with PROC regardless of the folate receptor alpha expression, Rina-S demonstrated a 71% reduction in the risk of progression or death with a unprecedented hazard ratio of 0.29.

In the primary analysis, which mandated that patients with a folate receptor alpha expression above 75% PS2 positivity had to be treated with mirvetuximab, Rina-S demonstrated a 67% reduction in the risk of progression or death with a hazard ratio of 0.33. Importantly, RAINFOL-02 also met its key secondary endpoint of over survival in both populations. Safety was consistent with what we have seen before with no new safety signal. And these results support the phenomenon we have routinely described with Rina-S that is the efficacy irrespective of folate receptor alpha expression level or prior treatment with mirvetuximab. And this gives Rina-S the potential to reach a much broader group of patients. Our ambition for Rina-S has been from the beginning to be the best first and broadest in class, and we plan to file as soon as possible with a potential launch in 2027, and we will present the full data at a future medical meeting. If we now go to the next slide, please.

When we acquired ProfoundBio in May 2024, there was one Phase I/II trial ongoing. Today, there are 6 Phase III trials that have been announced and initiated across ovarian and endometrial cancers, addressing around 79,000 patients. PROC is the first potential launch. With possibility of endometrial and platinum-sensitive disease in the future, we are building a franchise we own entirely with a peak sales opportunity of more than $2 billion.

With the Phase III data now in our hands, Rina-S has the potential to become best-in-class ADC. Combined with our established global presence in recurrent or metastatic cervical cancer, the breadth of our programs in ovarian and endometrial cancer positions us well to lead innovation in the gynecological cancer space. Next slide.

Now finally, let's move on to petosemtamab, our second wholly-owned late-stage medicine that we believe has the potential to redefine how epithelial cancers are treated. I'll offer 3 updates here. The Phase III LiGeR-HN1 top line in first-line head and neck cancer and the updated Phase II data at ESMO in both head and neck and in colorectal data.

If we go to the next slide, please. In August, we said ESMO would show why we are so enthusiastic about petosemtamab. First, let's focus on head and neck cancer. In first-line head and neck, the Phase II data that underpinned LiGeR-HN1 have held up with a longer follow-up, a 63% confirmed response rate and a median overall survival of 28.2 months. This data supported the Phase III data we announced just this morning, as you will see on the next slide.

LiGeR-HN1 enrolled around 700 patients with first-line PD-L1 positive recurrent or metastatic head and neck cancer, comparing petosemtamab plus pembrolizumab with pembrolizumab alone with a dual primary endpoint of response rate and overall survival. At the first interim analysis conducted by an independent data monitoring committee, the combination delivered a statistically significant and clinically meaningful improvement in response rate regardless of HPV status. It also significantly improved overall survival, reducing the risk of death by 50%, meeting both primary endpoints. Petosemtamab was generally well tolerated with no new safety signals.

Let me put this into context. Today, patients with first-line head and neck cancer face some of the most dismal outcomes of any front-line cancer. Pembrolizumab alone delivers response rate in the high teens to low 20s and an overall survival of roughly a year. When you combine pembrolizumab with chemo, the results aren't much better. The overall response rate increases to approximately 36% with a moderate improvement in over survival to 13 months. Going back to what I said that if the Phase III came anywhere in the ballpark of our Phase II data, there would be no question this would be the new standard.

This makes petosemtamab the first bispecific antibody with positive Phase III data in first-line head and neck cancer, the largest population in this disease and in a setting where currently pembrolizumab alone or in combination with chemo is the standard of care. And we believe this has the potential to change that standard, bringing us closer to potentially delivering the first EGFR targeting bispecific antibody approved for first-line head and neck cancer. And this reinforces our conviction that petosemtamab is not only potentially the first, but also the best-in-class second-generation bispecific as an EGFR LGR5 bispecific antibody. And we will present the full data at a future meeting and engage with regulatory authorities on a potential filing here as well. Next slide.

Also at ESMO, we presented updated data in colorectal cancer. Colorectal cancer gives petosemtamab a second path for growth beyond head and neck cancer. And so here, petosemtamab plus chemotherapy delivered response rates of 81% in left-sided first-line tumors and 67% in second-line, disease control in both above 90% with no new safety signals. And these data supported 2 Phase III trials in colorectal, addressing a patient population around 3x the size of head and neck. If you go to the next slide.

When we acquired Merus, we said we would pursue a broad focused development. Today, we have a positive Phase III in first-line head and neck LiGeR-HN2, we'll read out in Q1 2027 and 2 Phase III trials in colorectal cancer, a program addressing already around 315,000 patients with multibillion-dollar peak sales potential.

So to sum it all up, 3 Phase III trials, 3 positive results in 3 cancers where patients need better options. And in each case, the Phase III results are consistent with the Phase II data that led us here.

With that, I'll give it back to you, Jan.

Thank you, Tahi. Very clear. Let me bring it all together. Next slide, please. Over the past decade, we have taken Genmab from a royalty-based company to a fully integrated biotech with its own medicines and a powerful late-stage pipeline. This month is the proof point for that strategy. So what does this all mean for Genmab? To me, it comes down to 3 things.

First, 3 positive Phase III readouts in first-line diffuse large B-cell lymphoma, platinum-resistant ovarian cancer, and first-line head and neck cancer, each with the potential to change clinical practice. Second, new data at ESMO on petosemtamab that support expansion beyond head and neck into colorectal cancer. And third, a development plan and clinical evidence that combined support, supports a growth trajectory you can now see very clearly, multiple potential launches beginning in 2027 with peak sales potential of more than $3 billion for EPKINLY, more than $2 billion for Rina-S, and multibillion dollars for petosemtamab. And 2 of these 3 medicines are wholly owned.

Together, these 3 programs carry 5 FDA breakthrough therapy designations and with 6 new Phase III trials launch this year, each one is still expanding. In August, at our Q2 call, I said that with 3 super important Phase III studies reading out, we are well on track to deliver sustainable growth well into the next decade. Together, today, with 3 positive results in hand, I can say with great confidence that growth will increasingly be driven by our own medicines.

None of this would be possible without the patients and caregivers who take part in our trials, the investigators and our talented and passionate colleagues across Genmab. Thank you. Our purpose is to transform lives with pioneering antibody science. And this month brought us closer to doing that for many more cancer patients. Next slide.

That now ends our formal presentation. Operator, please open the call for questions, and thank you.

[Operator Instructions] Our first question will come from the line of Yaron Werber with TD Cowen.

Terrific. Congrats on really landmark results. Really great to see this. So I guess the big question is, it looks like this data is relatively immature for the HPV-positive population. Would you agree with that? And should we assume that roughly 20% of patients were HPV positive, in which case most of the effect was -- must have been driven a lot of it by the HPV-negative population?

Thanks, Yaron, for the question. I will hand it over to Tahi to give potentially more color there. Tahi?

Thank you Yaron for the question. So first thing I would say this, the study population, broadly speaking, and that's not only true for HPV positive, but for local regional versus metastatic and for the various subtypes of head and neck is almost on point reflective of the epidemiology of the disease. That's the first point.

The second point is, I'm not sure where this idea comes from that there is a difference between the subgroups in terms of maturity. The data met its statistical significance because the hazard ratio is so profound. That's just the way statistics work. Obviously, there is a follow-up, but it already tells you a little bit what the scale of the OS difference was with that follow-up. Just to basically get to the point, broadly speaking, regardless of HPV positive or negativity or any of the subgroups, I think it's fair to say that all subgroups in one way or the other had a positive outcome on this trial and benefited from the combination.

Thanks, Tahi. I think we should leave it with this, Yaron, and then we will give further color at a medical conference, hopefully soon.

Your next question will come from the line of Xian Deng with UBS.

Really, really congratulations for your really extraordinary data and all of them. So maybe if I could ask a maybe bigger picture question, please. Just looking at your peak sales guidance, you still kept your $3 billion for EPKINLY, $2 billion for Rina-S, even including frontline endometrial, right? I mean now you have your own Phase III data, and you've probably also seen the latest updates from the ESMO from your competitors. So just wondering, I mean, I would say your peak sales guidance are probably vastly, vastly below what the Street is actually expecting now. I'm just wondering how do you think about this guidance? And yes, any color on the thoughts behind, please?

Thanks, Xian, for the compliments. And I hand this question over to Anthony, who can give you a bit further color on the thinking on peak sales guidance. Anthony?

Yes. Thanks, Xian. Look, I think as a starting point, and you all know this, we had high conviction around our 3 very strong products. Of course, that's EPKINLY, Rina-S, and petosemtamab. And now what you've seen here during the month of October is that we've backed up that high conviction with these very strong Phase III data sets across all 3 products, and Tahi has done a wonderful job really elucidating that point. And then that takes us to the next point. And that gives us high conviction in the peak year sales estimates that we've previously communicated, again, across EPKINLY, Rina-S, and petosemtamab. And I think here's an important point, and we stand fully behind those estimates.

This conviction not only comes from that strong data that we presented, but it also comes from the very strong capabilities that we've intentionally built out here at Genmab over the last number of years. That's the capabilities to develop these products. It's also the very strong commercialization capabilities and the strong performance we've seen for Tivdak and EPKINLY. And of course, in addition to that, all of the prelaunch work that we've done across all 3 brands here moving forward.

So Xian, what I want to leave you with is that we stand fully behind the estimates that we've previously provided and are super excited about the data we've been able to present here and deliver to the market during the course of October.

Next question will come from Michael Schmidt with Guggenheim.

Congrats on this amazing execution on these Phase III studies and also very smart business development. Any comments on how the pembrolizumab control arm performed in the head and neck cancer study relative to historic studies? Just curious. And then as you have this very impressive data now in hand that clearly derisks petosemtamab as a product candidate. How do you think about expanding that opportunity into other cancer types? I did see you had the collaboration announcement with Incyte recently, obviously, on the KRAS inhibitor, but I'm curious if there are other opportunities that you could now evaluate with this validation in hand?

Michael, thanks very much for the compliments. And then I hand this over again to Tahi, control arm, Tahi and then the expansion plan for petosemtamab because we are super excited, as you can imagine, Michael, about what you are seeing here. Tahi?

Yes. Look, without getting into a nuanced discussion on the data of the trial, which I think you will appreciate will probably more appropriately happen in the context of a medical conference. I think it's probably fair to say that the pembro arm behaved exactly the way a pembro arm has behaved in the past.

On future plans, I think we have been very clear in our ambition, I think, from the day when we announced our intent to acquire Merus that we're going to anchor petosemtamab in head and neck and really think of it as the best-in-class bispecific -- EGFR bispecific in the entire space.

And now recently also have put a little bit more emphasis on the very exciting opportunity in colorectal cancer. As it goes to the concrete studies that we're going to initiate, I think we're going to stick to what we've been practicing now for, I think, the last 12 months or so, where we are going to be very disciplined in announcing new trials right around the time when they are actually open. I keep saying this it's a very competitive field, everybody is watching. But if you followed how this has translated for Rina-S, I hope you have to trust in us that we are going to expand this program appropriately with all the conviction that we have in petosemtamab as a drug to bring this innovation, which we really think is a transformative innovation to as many patients with head and neck as possible.

Thanks, Tahi. Michael, it comes down to execution, execution, execution from here, I think, on multiple fronts, both in the clinical trials as well as in the filing and bringing it to the market for Rina and for petosemtamab. So we're very focused on execution in the coming time.

Next up will be James Gordon with Barclays.

James Gordon from Barclays. My question is on regulatory and commercial. So planned time lines for global filings, not just the U.S., but Europe, Japan, and China. Can you get all 3 of these done, say, in the next 6 months? Or are any further things needed you need more mature data in other places?

And the commercial part of that, does it now make sense for Genmab to build a truly global sales force in, say, head and neck and gynae? Or could we actually see some partnering announcements in some regions, maybe outside the West? Is there a reason a larger company could make even more of these products or help to make even more of these products, which look like very, very strong clinical data?

Thanks, James, for the questions. I will ask Tahi on the first one, the regulatory process in the different territories. And then Brad can comment on the expansive commercialization plans we are putting into gear at this moment. Maybe Tahi, you can start on the sequence of the regulatory filings and the timing roughly.

Sure, James. And unfortunately, I won't do that. So I will just say that with the profound OS benefits, I think it's very clear that we will engage globally with all the relevant health authorities in the most expeditious time possible.

Thanks, Tahi. And Brad, a bit of color on the commercialization.

Yes. Thanks for the question. And as we know, oncology is an extremely competitive and data-driven market, and this data gives us extreme confidence. As you've mentioned, as we've said all along, we've built our capabilities from a commercialization perspective with this level of growth and portfolio expansion in mind. And the differentiated focus that we've currently brought, both U.S., Japan and now in Europe around scientific engagement, customer engagement as well as our market access and patient support services really puts us in a position to be extremely confident to execute moving forward, and we can certainly update more as we move along the progress here.

Your next question will come from the line of Benjamin Jackson with Jefferies.

Just quick ones from my side. The first is on Rina-S, I think it's becoming clear in the PROC space that a big driver of the efficacy or the clinical efficacy that we're seeing is actually the duration of response. Are you able to comment or give any color in and around how duration of response varies between the folate receptor alpha different subgroups given that could be a better predictor of the actual clinical efficacy we're seeing between those groups?

And then secondly, just interested to hear your thoughts going forward in and around EPKINLY combinations in the earlier line of cancer. So specifically around DLBCL here. You've obviously shown previously early-stage data in and around the combination with Polivy. Is this something that you could pursue? And how would you pursue that? Do they need full-blown Phase III randomized controlled trials? Or could you do it in a simpler and quicker fashion to enhance the label out there?

Thanks, Ben, for the questions. I think they both go to Tahi first on the Rina-S PROC and duration of response. And then EPKINLY, we think that EPKINLY is very, very good for combinations with different other medicines as we already have shown now with several combination partners. Maybe Tahi can give a bit of color on that as well on the plans for EPKINLY together with AbbVie. But Tahi, why don't you start with Rina?

Sure. Thank you for the question. Now let's start in the beginning. I mean, I think we said this for a while, and you touched on this, that one of the many differentiating aspects about Rina-S, its safety profile, its tolerability, its lack of neurotoxicity or IL toxicity or for that matter of interstitial lung disease. And this tolerability with a very, very low rate of discontinuation due to AEs mainly related to neutropenia that's really almost restricted to the first cycle is leading to long duration of treatment, and that is beyond the overall response that's driving the duration of response.

Now I'm not going to get into a discussion on how these different subgroups behave specifically because I think you will appreciate like to the answer I gave to the peto question, that this is probably best done in the context of a full disclosure of the data and the whole demographics and all of this.

But I would say with a hazard ratio of 0.29 on the PFS, it's really not that hard to imagine that essentially, which whatever way you were going to look at the data, slice or dice, there was an unprecedented benefit for patients. On the EPKINLY question frontline, you're right. We also generated data with our HPV poly in combination with EPKINLY and had an opportunity to present that in the future, and then we'll have a conversation about that. Look, given the fact that we have such a profound positive trial with R-CHOP, I think our focus is on R-CHOP.

Globally, it is still for the totality of patients, the standard of care. [ R-CHOP ] poly has made some inroads, I think, predominantly for patients with ABC, if you really look into it. Now with a completely new standard of care, the way we think, I think a lot of this is going to fall into the hands of EPKINLY-R-CHOP, which really honestly with an unprecedented hazard ratio for diffuse large B-cell, I think what reasonably could have been expected before the emergence of bispecifics. I think that's where the focus is. This data is, of course, important. That's why we're generating it, and we will continue to engage with the respective ways of engaging with health authorities or other methods of making this combination also available for patients.

But I don't foresee us having another Phase III of that scale and size. That's probably not the best resource spend for us. The focus is on the transformative data that we have generated and the significant time advantage that we have over Roche.

Your next question will come from the line of Victor Floch with BNP Paribas.

First, congrats on all the fantastic data, incredible job across the board. Maybe first question on peto [indiscernible]. Any chance you could share a bit more on how consistent the OS benefit was across the different PD-L1 CPS subgroups? And do you believe peto could become a new standard of care across the entire PD-L1 positive population? And a quick follow-up on locally advanced head and neck cancer. To what extent do you think these results have further derisked the opportunity in that setting? Does the magnitude of the survival benefit give you greater confidence in moving into earlier stage of the disease?

Thanks, Victor. And both questions go to Tahi again. Tahi, why don't you kick it off?

Yes. Thank you for the question. I will answer the same way that I answered the earlier question, which is whichever you slice and dice it, patients benefited on the LiGeR-HN2 trial, and that's in response and OS. I think that probably should suffice for today in terms of detailed subgroup discussions. Of course, you're absolutely 100% right. If you have such a profound impact on overall survival and also on response, that has an impact on how you view the probability of success of the local regional setting, particularly when you know that roughly 1/3 of the patients who are enrolled in the trial actually, they had their first emergence of the disease was actually local regional. So I think there's a lot of readouts that are important and that have an impact on how we think about the local regional space. So more to come on that end.

Your next question will come from the line of Gregory Renza with Truist Securities. [Operator Instructions]

That's great. And congratulations, Genmab team for the monumental data points today and over this last stretch. Jan, maybe just a question for you and maybe allow me to ask you to reflect a little bit on really what the significance is of these 3 to 3 late-stage programs hitting over the course of the month. So could you just add some color on what that means for you as you've reflected over your career on something as significant as this. And you certainly mentioned execution as maybe one of the secret ingredients. As you think back to the ProfoundBio acquisition and of course, more recently, Merus, maybe just touch on what you were seeing there that certainly pulled through to the success today and how that carries forward. Congrats again.

Thanks, Gregory, for the compliments. And I would be happy to speculate here and give you a bit of color. And I can talk the whole hour, I think, on this. But let me condense that what we are, I think, very good at as a company is understanding of these diseases. We can completely understand and actually target well for antibody-based medicines. And also, we are very focused on the mechanism of action of these molecules. So I think we have a better understanding of how these actually work these antibody-based medicines than other companies. So that makes us a very good candidate, I think, to also look outside for innovation, what we have done twice now, once with ProfoundBio in May '24 and once in December last year, only very recently with Merus. Because we actually could understand the mechanism of action of these antibody-based medicines better, I think, than other parties.

And in that way, we could focus very much on execution and actually very rapidly move them to the clinic and very rapidly expand them and then actually basically in settings that we could understand and actually then very effectively move to Phase III data. And that is what all culminated in the last 3 weeks, Gregory, that basically one organically created molecule epcoritamab and 2 inorganic molecules were hitting actually truly unprecedented data in different clinical settings but that comes very much down to the experience we built up in the company over the last 27 years. So it gives you a very good feeling today. It's definitely a day, Gregory, I will never forget, I can tell you.

This is quite amazing data, and I saw the emotions on one of the oncologists who was presenting the data just before you saw them today to our portfolio Board, which I chair in Genmab. And the profound emotion I saw on my colleagues face when she described the detailed data, you've only seen the headline data from petosemtamab in head and neck cancer front-line made it completely clear to me that we're actually doing something really, really good for patients and their families in the coming years. And that is in the end what drives me and all the team members at Genmab to actually make this world a better world by providing better treatments for cancer patients. And this is all coming together now in a very short time frame. And from here on, bring the antibodies to the market and then helping more patients as soon as we can get there. I think I should leave it with that, Gregory for now.

Your next question will come from the line of Qize Ding with Rothschild & Co. Redburn.

Qize Ding From Rothschild & Co Redburn. Congrats on the success for -- across the board. I just have one quick question for Anthony. So given now you have plans for new clinical studies, so how should we really think about -- I mean, you haven't provided any guidance on OpEx, right? But how should we really think about the R&D expenses? And also you talked about the potential commercial launch. So how should we think about SG&A expenses next year? Any color would be great.

Yes. Thanks for the question. I just want to remind everybody on the call that we are in a quiet period. So we do have our Q3 earnings call on November 5. What I can sort of offer for you, though, to let you -- provide some more color about how we think about this, and it's going back to what we've said, we've been very clear both from an operational and business perspective, but also a financial perspective, what our commitments are. We've told you what we're going to do, and we've done it. Now we've just delivered here on very -- really just tremendous Phase III data across all 3 brands. We've delivered on these commitments in terms of backing up that high conviction around these 3 assets. Likewise, together with the rest of the management team, we've been very clear with the capital markets what our financial commitments are.

We've told you on the other side of the Merus acquisition that despite the significant investments in petosemtamab and Rina-S, we would drive significant EBIT in 2026. We've told you we'd be very focused and disciplined in our investments. And we've talked a little bit about the forward trajectory. So what I would say for now is look at all of the commitments that we've made also from a financial perspective, and we'll continue to operate our business with that same focus and discipline from an operational perspective as well as a financial perspective. It will be that same thought process and mentality moving forward. That's probably where I need to leave it for now, just recognizing that we are in a quiet period.

Next question will come from the line of [ Nicole Berritto ] with Wolfe Research.

On for Kalpit. Congrats on the recent data. You mentioned that the addressable patient population for Rina-S across various indications. We were wondering about the 1L ovarian cancer maintenance trial and how that could expand the total addressable market for Rina-S as well the time lines for the study. And then we also wanted to ask about how you view Gilead's NaPi2b drug and the competitive landscape for PROC. Any comments on pluses or minuses versus Rina-S for cross-trial comparison?

Thanks, Nicole, for the questions. Tahi, can you take these 2?

Yes. So I have to say again, that I understood the question about PROC, but there was a question before that was breaking out of my line a little bit. So if you want to just repeat that first part of your question? Oh, NaPi2b, that's what it was?

Yes.

Okay. So broadly speaking, the same question. Let me do this way. Look, when we acquired ProfoundBio, we were very clear. We thought, a, folate receptor alpha was the best target in the GYN, OC space; but b, that Rina-S was the best folate receptor alpha ADC. And we made that point back then based on the specifics of sesutecan, which is some -- and the linker -- the hydrophilicity of the linker and the totality of the antibody construct and how that was differentiated from some of the other TOPO ADCs and why that on the safety side will matter and why we believe that we would have results across the entire spectrum.

And so here we are now the first Phase III to read out in the PROC space Rina-S with these unprecedented results. And you have some visibility to the profile of the drug, of course, through the Phase II data that was also presented at IGCS with the most Phase IIIs of any TOPO right now active in the setup of enrolling patients across GYN, OC and endometrial.

And so I think broadly speaking, we feel very strongly that Rina-S will be -- is on its path to being the best-in-class ADC regardless of target because it has the efficacy regardless of folate receptor alpha expression, broadly speaking, that means any woman with ovarian cancer. And because of its safety profile, which just to repeat myself, then leads to this long durability and duration of response. It's a first-in-class, and it's also on its way to become the broadest in class. And I think that's how we see this and everything else -- is everything else.

Thanks, Tahi. And then again, Nicole, it comes down to execution, do these trials effectively and rapidly and then try to be ahead of the competition because that's important in the future because of the class effect of these topoisomerase inhibitor-based ADCs. I think it's important to be first on the market.

Next question will come from the line of Matthew Phipps with William Blair.

Let me offer my congrats on transformational data. Another competitive question. Obviously, at ESMO, we saw the Sac-TMT TroFuse-005 study in endometrial. It looked like the benefit there was mainly driven in the moderate to high TROP2 expressing patients. How do you maybe see that landscape playing out where you won't be first to market? Do you think there will be maybe subgrouping based on expression levels?

Thanks, Matthew. Tahi, can you handle this one?

Yes, sure. And you said it, so I won't repeat it because I don't usually like necessary to talk about other companies' drugs. First of all, congratulations. This is a Phase III results for these patients with endometrial cancer in the second line. But as you said, it looks to be driven by the moderate to high class significantly here. I think it's also then fair to say if you look at the safety profile that there are some safety liabilities. And so we see an opportunity space for Rina-S in that space. We are very confident in our endometrial signal. We are running these trials. We'll obviously have to see what the results are. But all things being equal, we don't see these results in any way as changing our conviction and our commitment to endometrial, if that makes sense.

Thanks, Tahi. And on top of that, Matthew, we have a breakthrough therapy designation from the FDA also in endometrial. So we are quite enthusiastic about what we can do there.

Next question will come from the line of Rajan Sharma with Goldman Sachs.

Firstly, I just wanted to clarify, I'm not sure if you answered it earlier or addressed it, but do you expect to get priority review on all or any of the 3 data sets, the Phase IIIs that you've read out recently? I realize it's a little bit early, particularly for peto, but any color there would be helpful. And then just maybe thinking about sort of launch ramp for these assets now that you have the Phase III data in hand, can you maybe just help us understand how you think about that? Are these likely to be kind of relatively rapid launches given the fact that you're potentially changing standard of care? And then more specifically, how do you think about timing of the profit contributions for each of these launches, particularly in the context of the expiration of your DARZALEX royalty stream?

Thanks, Rajan. These are 3 sharp questions. The first on priority review, I think it's too early because we are engaging with the regulatory authorities for all 3 very soon, not having the data. So -- but it's too early, I think, to actually discuss priority review or not. Let's wait -- await the outcome of the interactions with the regulators on that. Then the launch ramp, let me move that over to Brad. Maybe you can give some color there, Brad.

Thank you for the question. And as kind of mentioned earlier, still extremely confident. We've been building for this for quite some time. We have some pretty good success here with both Tivdak and EPKINLY. And oncology is a data-driven market. And so as Jan mentioned, with regards to the regulators and the review and all that's taking place, what we do know is we're confident in our abilities to date and feel very confident that we'll get more into the ramp into the future, maybe as soon as earnings next week and/or even earlier next year.

Next question will come from Zain Ebrahim with JPMorgan.

So 2 questions from my side. One on peto, so just can you talk through to what extent this -- the data in head and neck gives you more confidence in colorectal cancer where I think the data that we saw at ESMO was quite strong. you highlighted in terms of the ORR holding up in left side of colorectal. And when is the earliest that we can see the colorectal data? Because I think we weren't really -- I'm not sure we were really expecting OS today, so that's obviously interim. Do you have a similar sort of interim in the colorectal Phase III?

And just tied to that, the KRAS G12D combination that you announced with Incyte, when is the earliest we can see some data from that? And what would you say is the key data point that underpinned the confidence from them to sign the collaboration? Is it that Phase II colorectal data? And why did you choose the KRAS G12D?

Thanks, Zain, for the questions. I will hand them over to Tahi. And Tahi, maybe you can give more color on our level of confidence for colorectal cancer with peto and the combination with KRAS inhibitor from Incyte.

Yes, sure. Thank you for the question. And maybe this is a good moment to step back. I mean Jan touched on this. When you think about at least that's how we do it at Genmab, a drug and its potential, you think about what you know about the disease, about the patients, about the heterogeneity of the disease, what do you understand about the target, what do you understand about the mechanism of action. And then increasingly also what you understand about the safety. And so without a doubt, having the data now in our hands here on head and neck gives us a better or higher confidence in the mechanism of action and a deeper understanding of the safety of the drug.

And so I touched on this in the prepared remarks where I said consistently now, we've seen this with these drugs that the Phase IIs that we are generating the data are a pretty good indicator. They're not perfect, of course, because they're Phase IIs, but they are a pretty robust indicator of how the Phase IIIs behave, at least how we interpret them and then what drives our conviction to the Phase IIIs. And so just by that readout, of course, our conviction in colorectal has already increased, and that is, of course, then underpinned by the fact that with more patients and more longer follow-up, the colorectal data in frontline and second line continues to get better and more robust.

And so we feel very strong about the colorectal space now. Even more so than before as a second anchor for peto because in the end, and this goes to your second question, we believe it's the best-in-class EGFR bispecific. And this is why Incyte was interested in partnering with us. And we were interested in partnering with them because we think their KRAS also has equally the potential. And so I think that's why we had the opportunity to come together as 2 companies to do something really innovative for patients. As to when we get the data, I don't think there's any place to speculate on this.

We'll obviously, like we have always done, generate data as expeditiously as possible and then more importantly, go to next steps. And equally, I would not speculate on what we're doing on colorectal. All I can say is that we're generally speaking, not only pay a high amount of attention to science but I think there's equally a lot of pride in Genmab in the execution and the operationalization of trials. So I think we have now shown repeatedly. All that is to say.

Thanks, Tahi. To top it off, Zain, I mean, originally, Merus made the screening for petosemtamab, which led to the drug being selected for development on colon cancer organoids because of the LGR5 expression on colorectal cancer cells, stem cell-like cells. And we think that actually there is a very good rationale and very good data, preclinical data now supported by clinical data that colorectal cancer is a very, very good indication for petosemtamab. And then by adding other drugs with other mechanisms of actions like the KRAS G12D inhibitor from Incyte to petosemtamab, that could give very potent novel combinations for therapy in the future.

So we are super interested in that. And you will see more examples of novel combinations from us in the coming time, but always really focused on our anchor positions in certain diseases like I already explained earlier to -- in my answer to one of the other analysts from Truist. So I think we'll leave it to that and see and look whether there's any further questions.

That will conclude today's Q&A. I will now hand the call back to Jan for any closing remarks.

So thank you all for joining us today, and thank you for a very lively Q&A. The 3 positive Phase III readouts, new data supporting expansion, and a clear path to launch starting in 2027. We very much look forward to speaking with you all on our Q3 call on November 5. So -- and as always, please don't hesitate to reach out to our Investor Relations team with any further questions.

Thank you for joining Genmab's investor event. This concludes today's conference call. You may now disconnect.

[Audio Gap] Charlie Haywood from Bank of America [indiscernible] Andrew Carlsen, Head of Investor Relations at Genmab with us today. Welcome. Thank you for joining us. We're starting, obviously, lots of interest, people thoughts are coming up. So just remind us [indiscernible] coming up that we'll be focusing on.

Sure. Maybe taking a step back and then looking at 2026, so far, so good, a strong first half, as you saw at our Q2 results, both operationally and financially, where we upped our guidance, especially the top line where it was driven primarily by DARZALEX, but importantly also by EPKINLY. And getting to your question, we also provided, you could say, more specific guidance as to these important readouts that everyone has been waiting for to take place in 2026. The first one being the EPKINLY frontline study in DLBCL, where we combine EPKINLY with R-CHOP versus R-CHOP, where we guided that the readout will be in Q4, and it's based on a prespecified interim.

Then we also made it clear that we're going to have the Rina-S Phase III trial readout in Q4, which is Rina-S in second-line plus platinum-resistant ovarian cancer. And this is actually also very exciting in a sense that it's a Phase III trial that has been brought forward. So reading out now in Q4 this year and which, of course, puts us in a position to potentially become first-in-class among the next-generation folate receptor alpha ADCs in ovarian cancer. So that's why that's very important. And then finally, we have the frontline metastatic head and neck cancer opportunity with petosemtamab plus Keytruda versus Keytruda, where we will have this readout guide for it to come out in Q4.

So across all 3 late-stage assets, we actually have the potential to be first-in-class meaning that we will be the first bispecific in frontline DLBCL reading out Phase III compared to our competitors. The same goes for the next-generation folate receptor alpha ADCs with Rina-S and for petosemtamab also in frontline head and neck cancer.

Got it. That's very clear. And obviously, peto and Rina-S both acquired through acquisition recently. I think both got broader programs. Remind us where we are on the broader programs for that, any sort of rough time lines on data for that and when we -- if we can expect more Phase III starts this year for both.

So starting with Rina-S, this came through the acquisition of ProfoundBio in 2024 and to provide context as to how you say, rapid development and broad development program is. We are now up at 5 active Phase IIIs with the first reading out as guided here in Q4. Again, this speaks to the breadth and the depth of the program. We've guided for the second line-plus PROC opportunities to read out in Q4. But remember, we also have second-line endometrial cancer Phase III well underway. We have platinum-sensitive maintenance Phase III well underway. And then we announced a platinum-sensitive replacement Phase III this year. And we also announced the frontline endometrial cancer Phase III this year.

So 5 Phase IIIs with the potential to be first in second-line PROC in Q4 with Rina-S. So a broad and aggressive development plan also showing our confidence in the value proposition for Rina-S in the GynOc space. But in addition to that, we've also gone beyond that and started some signal seeking studies in lung cancer. So we've started a Phase II signal seeking trial with Rina-S as well as we've gone into GI solid tumors with Rina-S also signal seeking. So a lot going on with Rina-S since we acquired it in 2024.

Going over to petosemtamab, where we completed the acquisition of Merus in December 2025. There, we inherited 2 Phase III trials, one in the frontline metastatic head and neck cancer and the second line metastatic head and neck cancer. Since then -- or maybe taking a step back, while doing the due diligence and the acquisition we decided to amend the trial designs, not the trial design, but the size of the trials by adding an additional 200 patients to the frontline Phase III trial and add an additional 100 patients to the second-line Phase III trial. We kept the co-primary endpoints unchanged for the frontline head and neck Phase III trial, while in the second-line head and neck trial we made it to a sole primary endpoint of overall survival.

So those were changes that we decided and made during the due diligence of Merus and the acquisition of petosemtamab. And in addition to that, we just recently announced here at Q2 that we are starting 2 Phase III trials in colorectal cancer in frontline colorectal cancer and in second-line colorectal cancer. So again, as you can hear from this, a lot going on, the colorectal cancer trials are something that I just recently announced, but a somewhat ahead of what we initially guided for because when we did the acquisition, we guided for the fact that we would pursue Phase IIIs in locally advanced head and neck and we're still committed to that. But we felt that the -- you say underlying data in CRC was compelling to start these 2 Phase III trials as well.

Got it. Very clear. And then I think worth jumping into fourth quarter, what we've got coming up. I think you've got your second Phase II, Phase III, peto first-line EPKINLY frontline and then some ESMO data. So is there any -- have you given any comment on the sort of sequence of the trials that we're coming reading out in terms of histories or sort of what we could expect first or any?

No. So we haven't provided any sequence or timing with regards to any of these important readouts, we, of course, appreciate the question and I want to understand that. But what we've confirmed is that we're going to have the petosemtamab data in colorectal cancer at ESMO. So that's, of course, something to look forward to. Essentially, you will see the data that has been part of the -- that has kind of informed the decision to start the Phase III trials, both in frontline and second-line colorectal cancer that we have provided you -- that will take place in October 23 to October 27. But other than that, you kind of have to wait for Q4 to figure out whether you will get the Phase III data in Rina-S, Phase III in EPKINLY and as well as Phase III in petosemtamab.

Very clear. And then on the peto frontline, I think, for us and for any people, this is obviously an anchor asset for you, given the size of the deal, the data to date looks very impressive. So remind me, what will we get in fourth quarter and sort of filing strategy time line that I think you could potentially launch by 2027. So what are we getting? And what's the sort of path post that as you get that?

So for petosemtamab, the way the trial is designed, and this was something that Merus has agreed upon with the FDA is that there are 2 co-primary endpoints with an interim look, one being ORR and duration of response and then the other co-primary endpoint is OS. What we are guiding for to read out in Q4 is going to be ORR. And remember, petosemtamab plus pembrolizumab versus pembrolizumab and that's essentially what you should anticipate will be top lining in a press release. We get a lot of questions as to what will this press release contain and I sit here and preempt that.

But if you look at how we've been disclosing our previous Phase III trials, across EPKINLY, it's been anchored around the primary endpoint and only that, whereas all other secondary endpoints or data will be disseminated preferably at a medical conference.

Very clear. Just a reminder, if there are any questions, feel free to raise your hand. I'd say the biggest question I get in on peto is obviously, you're now 6 to 9 months ahead of potential competitor data coming out soon. So your Phase II looks fairly differentiated in terms of response rate data. How do you compare the 2? Like do you think is there a risk of a large dilution in terms of overall efficacy? Is there anything on safety you'd flag as we look to your data, and then we'll look ahead to the competitor coming, I think, mid-'27?

No. But broadly speaking, we are rather confident in the strength of the data on petosemtamab. Remember, we have done a thorough diligence during -- since we initiated the proposal to acquire Merus starting. I think it goes back to September last year. And then, of course, as we now formally took over the asset and the development starting in December, we have become more familiar with the data. And irrespective of how you kind of cut or compare the data to competition, whether it's Bicara's asset or whether it's J&J asset, which is RYBREVANT. We feel rather confident in the profile of petosemtamab and how it performed across this heterogeneous patient population that head and neck cancer is.

And with all the inherent flaws of doing cross-trial comparisons, we feel that petosemtamab, whether you look at efficacy or across safety compares favorably across our competitors.

Got it. And then I guess another big question is the HPV positives and negatives in your trial. I know some of the others are just going for a negative. So actually, you can obviously potentially address both straight up, but the risk is that -- I guess, the patient numbers seem to date in HPV positive as obviously as robust as the negative. So is there confident -- enough confidence that you've got enough patients, a, both in the trial and b, you can show sort of consistent efficacy across the 2?

Again, based to the data that's based -- that's in the public domain, and this is more specifically the Phase II that was presented at ASCO last year, where we saw -- yes, it was a smaller number compared to the HPV negatives. But we did see highly encouraging signal activity, more specifically 50% ORR. We believe that still is rather robust. So we remain confident in the potential to address both HPV negative and positive. And then remember that the trial design, and this is to address also a question we've been getting a lot as some potential imbalances and dilution that you're referring to, the trial design designed to take into account or to reflect the real world of graphics of head and neck cancer, metastatic and cancer patients.

So that, of course, you can all do your literature search kind of inform you as to what proportion of patients will be HPV positive versus negative and the various types of tumor types that exist within head and neck cancer.

That's very clear. And then on your second and third line strategy, obviously, J&J out earlier this year that they have filed on their data, I think, sort of not what everyone had expected. So ahead in terms of timing on the front line, how do you feel about second line? You've got your data coming, I think 1Q next year. So what's your relative position? How can you compete there?

With regards to the second-line opportunity, here, we are also in a rather good position in the sense that we will have a formal Phase III readout based on a hard endpoint, which is overall survival in Q1 next year. We are fully aware that J&J has pursued an accelerated approval path in the U.S. based on overall response rate and duration of response. That data was presented at ASCO. It looked highly encouraging. We also acknowledge that.

But when you compare the data, again, with the data that we presented in that same opportunity, taking into account of patient demographics, which could be, for example, the proportion of patients that are Asian, the proportion of where the primary tumor was located, prior lines of therapy, accounting for all that, we still feel that petosemtamab in that opportunity competes fairly. And to your point, Charlie, we will have a formal global randomized Phase III with a hard endpoint in OS reading out essentially 3 months after they have a potential readout that we still feel that petosemtamab will be competitive compared to that asset of RYBREVANT more specifically in the second-line opportunity.

Got it. That's clear. And then on your colorectal opportunity, I think, obviously, at the time of the deal, it was a reasonable focus of how much of your deal value was having the colorectal anything else. You've obviously seen enough data to gate a Phase III start you're presenting at ESMO. What can we -- is this further patients longer duration? What can we expect at ESMO? And I guess, within that your time lines are behind J&J versus many other indications. So clearly, I think to gate your Phase III, is it fair to assume competitive versus what we've seen from their data to date?

Yes. And to provide some context, when we did the acquisition, Merus did have some early data in colorectal cancer. We were -- we had the opportunity to go through that data as part of our due diligence. That data was later presented at a medical conference in November. And as most of you also concluded, it looked encouraging, but it was rather limited, so it was a small patient number as well as it was a very short follow-up. What has changed since then is that we have followed, of course, these patients, and we've added more patients. So we now have a, you would say, larger data set with longer follow-up. And while we've been following this data, what you can infer, given the fact that we've made this is an important decision to pursue Phase IIIs in frontline and second line, seems to indicate that we continue to be encouraged about the signal we saw -- the early signal we saw in last year in November.

Got it. And then the last of the ones, the locally advanced, I think I would view it as a very significant up, but a lot of assets have failed in the space, and you don't necessarily have the locally advanced data. So confidence to go into a Phase III there. Is that just which could be huge, but risky? Or is there enough confidence that a decent probability of that trial being successful?

The confidence remains unchanged with regards to locally advanced head and neck. And taking a step back to your previous question where when we announced the deal, we came out and said that we see petosemtamab as a next-generation EGFR bispecific that is going to be anchored in head and neck. And by that, we meant first of all, in metastatic frontline and second-line head and neck but also in locally advanced head and neck where you have the resectable and unresectable. So already back in December when -- or September when we announced the deal, we already provided guidance as to -- you can say our appetite to pursue late-stage development in locally advanced head and neck and essentially guided that we would start a Phase III trial in locally advanced head and neck before end of this year.

And that confidence remains unchanged. And that's also still something we'll pursue. It's based, of course, on -- you could say, the early clinical data we've seen in frontline head and neck which we believe in some way or manner should translate to something meaningful for patients in locally advanced head and neck.

Got it. And then on, I guess, peto financials, if you look on risk-adjusted, do you have a rough reckon sizing of the potential peto ops that you've announced so far, could go into say first line, second, third line colorectal

locally advances?

So we've provided kind of the addressable patient population sizes in our materials. And I think what you can see from the announcement of the colorectal cancer trials that we did in Q2, where we also provided updated numbers is that the colorectal cancer patient opportunity is a significant opportunity. So taking a step back, locally advanced as the locally advanced head and neck opportunities as big as frontline and second line head and neck put together. So it's essentially a doubling. So the metastatic head and neck cancer opportunities around 60,000 to 70,000 and then you essentially double it by going into locally advanced.

And then by the announcement we made in Q2 by pursuing colorectal cancer, we're, of course, adding to that. And that is a significant addition of patients essentially larger than head and neck put together.

Got it. And then I think you currently guide to multibillion peak sales consensus at $3.5 billion. Is there any sort of appetite to update that to give more concrete numbers if we see positive data coming up, could we see sort of further incrementals?

So for now, we are comfortable with the multibillion dollar peak sales potential. We think it's appropriate. And it appropriately reflects the opportunity set, which initially was metastatic frontline and second-line head and neck. Now we have adjusted the colorectal cancer opportunity, but you have yet to see any clinical evidence or late-stage evidence for that. So to your point, Charlie, once we have, you could say, more data to inform and also provide a credible set of underlying assumptions, we'll be more comfortable to update it.

But I think the multibillion peak sales potential is appropriate, given we provided the patient populations. We have Phase IIIs in metastatic frontline and second-line head and neck that will read out Q4 and Q1. And then it will take some time before the colorectal cancer opportunity read out. It will also take some time before the locally advance will read out. So before we have that clinical data, you just have to kind of patiently wait to figure out what these multibillion means.

Very clear. Any questions on peto before I move on to Rina-S? Also got -- well, Phase II and Phase III data coming up fourth quarter, I think it's not that we see a sort of fairly underappreciated, I think, always given the deal size, but it could be very significant to you. So again, same set up, remind us what we've got coming, Phase II, Phase III, will you -- how much for you will the Phase II derisk your Phase III in terms of data coming? And what should we expect coming in the fourth quarter?

Yes. So for fourth quarter and Rina-S, we've guided that we will have the Phase II data from the [ RMC ] expansion cohort, which is 100 patients Rina-S in second line plus platinum-resistant ovarian cancer. And as I said, what is, of course, increasingly positive is that the Phase III was brought forward also to read out in Q4, where the Phase III is a formal global study with a primary endpoint of PFS that will allow us to engage with global health authorities. And hence, that has become, you could say, the most important data set.

So from a -- how we're going to disseminate the data, you should assume that the Phase III data readout will be top line and press release, whereas the Phase II data, which is now more -- you can view this as a more robust Phase II data set will ideally be presented at a medical conference or potentially a press release, but that is still to be determined. But what you can rest assured is that we provided guidance as to you will have some insights into these 2 data sets in Q4 this year.

Okay. And on the -- in terms of still to be determined for the Phase II, what will dictate whether you press release it, whether you look to present at the conference because I guess, if it's at a conference after your Phase III, it wouldn't be seen as that material for Genmab as a whole. So I guess how are you feeling about the phasing of that?

Look, I think -- so within oncology or drug development data is currency. So I wouldn't entirely dismiss the Phase II data being irrelevant after the Phase III reads out. So to put it in perspective, you will only get the top line results from the Phase III data. And then we would prefer to present the underlying data at a medical conference. So I think there are a lot of physicians and prescribers, but also investors who would like to see some more granular data as to how in a larger data set as to how Rina-S performs in that setting, and that's where the Phase II data becomes highly relevant because that -- so far, you've seen highly encouraging Phase II data in second-line PROC, but it has been around -- in a patient population of around 20 patients. And now you have the opportunity to actually look at it at a more robust data set of 100 patients.

So it's more figuring out how can we get the most out of this data, this Phase II data. And yes, as I said, that's still to be determined when or where or how it's going to be disseminated. But the Phase III should be clear, that will be press released in a top line manner and then Phase II

[indiscernible].

Got it. And then confidence, obviously, this is -- we know ELAHERE is on the market. This is a folate receptor agnostic trial, I guess, confidence in showing efficacy across the broad expression in your Phase -- sorry, your Phase I/II, you've obviously presented data by some expressions, but I know some competitors have given broader efficacy by expression. Do you think you're in line with that? How do you feel you sit versus those and confidence in the broader label or broader opportunity?

Yes. So referring back to the Phase II data that was presented at SGO. So it's a while ago. But nevertheless, that we showed by expression cutoff above 75 and below 75. And what you can infer from the data that looking at the overall response rate, which was above 56% more precisely and -- but also taking into account that this is only 20 patients. From what you can infer is that yes, there is encouraging overall response rate across folate receptor alpha expression, but it doesn't vary.

You could do -- you could sit and do the math and count the bars in the waterfall plot, which also shows that we also had responses in patients who are post ELAHERE. So that's also another point to remember. But what we want to make clear is that we're not sitting here claiming that it works, you could say, equally well across folate receptor alpha expression, but more that it works well in the sense that high expressions will potentially have high responses, whereas if you have low expressions, the responses will be equivalently lower, but it's better than what you can say the alternative today, which is chemo if you're below 75% expression or ELAHERE if you're above 75% expression.

However, getting back to your question, given that the limited size of the patient, we chose to disclose it above 75% and below 75% because that's also where the cutoff is based on ELAHERE. Whether we will have the opportunity to disseminate the data that's the way you want it, which is, of course, according to these buckets, time will tell. But confidence with regards to working across folate receptor alpha expression remains unchanged.

Got it. That's very clear. And I think the main debate we get in terms of the opportunity in second line PROC and endometrial obviously is getting competitive. You've got 2 folate receptor alpha competitors, B7H4, Gilead has now got an asset in the space. So how do you frame the competitive market since you've done the deal evolved sort of somewhat material or how do you view sort of the competitive risk coming into the space and your sort of competitive [indiscernible]?

We fully acknowledge that the space has become highly competitive, but we have also ensured that we remain competitive. We continue to firmly believe that Rina-S has the potential to become a first-in-class. So think about it. We acquired Rina-S, or ProfoundBio in 2024. Fast forward, we have 5 active Phase IIIs. The first reading out in Q4. Putting that into context versus our competitors, whether it be Eli Lilly, AstraZeneca, GSK, Gilead, they're all just recently entering the market. What I'm trying to get at is that given that we already have the first Phase III reading out, that should also tell you that we are on the way with some of the other Phase IIIs.

And we also have the broadest development program compared to our competitors. Not all of our competitors are, for example, pursuing endometrial cancer, which is also a differentiating factor. And remember, the thesis of the value proposition is that we want to establish Rina-S within the GynOc space across ovarian cancer, whether it's PROC or PSOC as well as endometrial cancer frontline and second line. And we are well on track to delivering that shortly after you will say an acquisition made in 2024, whereas our competitors, they're essentially just getting into the market late last year or this year.

Very clear. And do you see more sort of hypothetically over time, I don't believe folate receptor alpha expression is sort of correlated with some of the other mechanisms of B7H4 with [indiscernible]. Is there a chance that you actually can have better penetration of the highs versus competitors that might look to come into your folate receptor low population because they're not quite as biomarker correlated to those? Or is that not a scenario you see playing out?

No. I think in simple terms, I think what we're seeing right now is more as to who can come in first and go broadest. And the reason for that is that across all those -- at least those from big pharma that you mentioned there, we're using essentially the same Topo1 payload. And then the question is, of course, is there a risk or a potential of patients becoming resistant or refractory to this payload. So here, that's why it's critically important for us to have this all these Phase IIIs up and running well ahead of our competitors to potentially be in the GynOc space first and broadest in the event that this should be a situation that plays out where there will be patients that essentially become refractory to the payload rather necessarily the target.

Got it. And then last one on Rina-S for me. In terms of potential, obviously, assuming positive data, assuming you're launching. Our KOL feedback is because ELAHERE has formed the market very nicely, but you have potential to come in with better data, broader label that this could be a really strong launch. And I know peto, you framed $1 billion by '29, you can have 2 potentially very fast launching oncology assets. Is that sort of how you look at it internally as well in terms of launch trajectory sort of excitement from physicians around this stage as well?

Yes. And I think it goes across our 3 assets, EPKINLY, there, we're just taking them one by one. EPKINLY, what we're looking into is the frontline opportunity, which is essentially half of the addressable patient population. There assuming we have positive data in Q4, that will also allow for launch next year, together with, to your point, Rina-S in second-line PROC as well as frontline petosemtamab where that being the only asset where we've provided kind of a stick as to how the uptake or the launch should look like. And it correctly remember that we -- greater than $1 billion by 2029.

So that essentially gives you an opportunity to draw a line from launch in late 2027 up to 2029. Whereas for EPKINLY or Rina-S, we haven't provided specific guidance to how the uptick is. But however, what I'm trying to get at is that all 3 put together puts us in a really good position with where we're going into meaningful opportunities and with hopefully strong clinical data will allow us to successfully launch these medicines and bring to as many patients as possible. But it's all about what will the data look like in Q4?

Very clear. And then you've alluded to it already. Obviously, EPKINLY, you're getting the first-line data, but starting on your second line DLBCL combo, which was a very strong PFS ratio. I guess what's your confidence in that data? And then how I know you've talked with the other assets. You've done a lot of internal modeling expectations. How did that 0.4 hazard ratio look relative to what you've modeled internally?

Yes. I think what has been positive so far with EPKINLY is that -- and also why we've been somewhat consistent in our way of guiding is that -- if you take a step back and look at the Phase III readouts with the exception of one, they have essentially 1:1 mirrored the Phase II data. So if we go back to the Phase III readout in second line follicular lymphoma last year, in combination with R2, where we had a hazard ratio of 0.21. That highly encouraging data, when we now retrospectively look at it somewhat mirrors actually the Phase II data that we've been presenting at ASH a couple of years ago. The same can be set for this second-line DLBCL readout that we had earlier this year in combination with lenalidomide, where essentially this hazard ratio of 0.4 or 0.44 resembles the Phase II data that we have been presenting at ASH.

Now when we've then been asked, so what are your expectations for the frontline based on what does good look like? Again, we're not in a position to guide on hazard ratios or what the bar is, but we have been pointing back to the R-CHOP in the Phase II data that we just recently at ASH presented where we even showed you the -- and this was a 36 months follow-up, you have the PFS curves and you have even the response rates across cell of origin and even risk type, whether the IP -- sorry, IPI status. And that has kind of been informing our, you can say, excitement or conviction into these readouts. So to -- back to your original question, we would say that the Phase II data and second-line DLBCL read out as expected based on that hypothesis that we put out there.

Very clear. And then going to the frontline trial, obviously, it's a partnered asset, but I guess just reframe your confidence on that trial prior looking at the control arm prior data should have suggested, and I think many investors were expecting it to come earlier. At some point earlier this year, it's later than expected, but you've confirmed it's the interim coming in the fourth quarter. So what's your read of sort of the delay based on anything you can see from the AbbVie side, et cetera, any sort of blinded curves, et cetera, and confidence?

Look, our confidence is unchanged high with regard to this readout. What we've been guiding and reiterating is that we're going to have this readout in 2026. And what has essentially changed is that now we've been more specific when in 2026 is going to take place, where we said it's going to take place in Q4, and that is based on a prespecified interim. Other than that, nothing has really changed. We gave this guidance many months ago. And as everyone is aware in the room, Phase III trials, event driven and all that comes with these blinded trials. We have now increased our conviction and confidence as to timing, and that has been narrowed down to Q4. So unchanged, exciting and looking forward to the data readout in Q4.

Got it. And do you expect to present data for the IPI 3 to 5 and 2 to 5?

So again, the premise and the framework is that we top line result only based on the primary endpoint. And the primary endpoint is IPI 3 to 5. The 2 to 5 is a secondary endpoint.

Right. And then any more on EPKINLY or Rina-S? You sort of alluded to it already, but obviously, wrapping this all together, I think the big picture story for Genmab DARZALEX LOE. These are really sort of gating opportunity, but both with Rina-S, peto, EPKINLY, but both with much broader Phase III. So how -- from where you sit today, if we come out of fourth quarter with positive data, how do you feel about the shape of your sales, margin curves like through the DARZALEX LOE, just remind us how that looks and how you feel about growth through that?

Sure. So rather than sit here and try to do DARZALEX replacement math, I'd rather frame or the value proposition that you should think about is that we're essentially building a stand-alone growth oncology franchise with these 3 late-stage assets, while at the same time, we'll retain our royalty portfolio. So we have this -- we're in a unique position where we've been privileged to have a really strong royalty portfolio that has got us this far. And now we have within a very short time frame, establish a proprietary oncology portfolio that will hopefully read out positively in Q4 this year and allow us to launch in 2027 and put us in a place where we say have -- you can say a business within the business where you still have revenue coming in from the royalty business.

And then you have this wonderful growth business consisting of 3 highly differentiated, potentially best and first-in-class assets that will ensure that Genmab will continue to be this growth and profitable growth business well into the next decade. That's kind of how I see it. Also, given we say our second lever around Rina-S and petosemtamab, where we have the potential to go broader than just the initial indication. So that's highly promising for the future ahead. And then at the same time, we also shouldn't dismiss our early innovation, which is still going on, but it's more, you can say, from a disclosure perspective or how much we talk about it has been put to kind of work in silence, in secrecy.

And then as that matures and becomes more tangible, well, then we will start unlocking what that could potentially bring for the future. But for now, it's all focused about this late-stage portfolio in that business in itself together with the royalty business. And then later on, we will hopefully also have our own proprietary pipeline become sufficiently mature that I also add on top of the growth.

Got it. And then one of the questions I get is, obviously, you've been a larger royalty revenue business data at EPKINLY, you're sort of a bit more in the middle, but your confidence and ability to commercialize your wholly owned assets, what steps do you need to take? What have you got so far already in place? How is launch progress, et cetera, for all of these?

Yes. And we've gone really far with regards to forward integrating and becoming this mature established business. It's been a stepwise approach, where I think we tend to kind of forget the journey of Genmab that it all started with essentially us commercializing Tivdak, which is a tissue factor ADC for the treatment of late-stage cervical cancer. We started that journey with Seagen now Pfizer. We built upon that with EPKINLY together with AbbVie. But where the difference was that we retained more rights or more responsibility from a commercial perspective. So we were -- or we are a commercial lead in the U.S. and Japan.

And that, of course, entails more investments and more investment in capabilities and function, which essentially has put us in a place that we're now ready for the 100% wholly owned proprietary medicines, which is Rina-S, and petosemtamab for launching these next year. Part of the journey that we've also been sharing with you is that, for example, we've been utilizing Tivdak, acquiring back the rights for Tivdak in Europe and Japan to establish, you could say, a launch platform for eventually for when Rina-S comes to market. So that's another good example as to how we are thinking and how strategic we are thinking. And the same you should also think about petosemtamab going into next year. So we feel that we are ready. Of course, there's still some additional investments that need to be put in place next year, but that are already also put in place at this year.

Got it. And then Rina-S and peto, I guess somewhat in launch time lines, you've suggested can happen in '27. Is that -- will that be with extra any sort of price review, et cetera? Or how have you sort of frame the potential to launch those by the end of '27?

So we've left it at that we anticipate to launch all 3 into 2027. And then depending on -- if it's hard right now without having the data as to how quickly the reviews and approvals can come. But I think we remain rather confident that we will be able to launch at some point in 2027 across all 3 assets.

Got it. That's clear. And then one I was going to ask, but in terms of consensus, 2027. Wonder if it's something you've looked at, obviously, lots going on in terms of cost lines, bits on the tax side of things, like have you -- anything you'd comment on in terms of the '27 building blocks, I guess, underlying royalties going well, costs well reflected? How are you feeling about current consensus as we sit?

Look, I feel like it's kind of the same grind every year. I have to remind people as to what we're doing. And the reason why I say it that way is, of course, that it is a rapidly evolving business in the sense that we are investing in growth. So to put it in perspective, this year, we've added 2 more new Phase III trials, which were kind of not guided or reflected to the market in addition to trials that have yet to start, for example, in locally advanced head and neck. So what I'm trying to get at is that it's more about having consensus catch up on that fact that -- remember that we just added 2 CRC trials on top of the already guided locally advanced trials. And this is something that, of course, consensus has to adjust to and appropriately reflect going into next year.

So that is one example from an R&D perspective. And then with regards to SG&A, there, we've been rather explicit that, yes, there are some additional investments that have to be made with regards to as we get closer to launch. And that is more about fine-tuning. But I think the delta or where the catching up still remains is around the fact that we are continuing to broaden the development for both petosemtamab and Rina-S and remembering to carry that to next year's estimates, essentially.

Got it. One very last final one. Deal amortization. You think that's being well reflected yet?

No. And that is something that will be particularly clearly soon. That is something that the market and consensus has to take into account as soon as we hopefully launch or get approvals on these medicines, we will start amortizing essentially the close to $7 billion on peto and 1-point-something billion on Rina-S. And it's a straight-line amortization journey. So it's simple math, but people haven't yet started doing that, and that's something that we'll continue to remind them. And now I said it here, so everyone in this room knows that.

Perfect. Well, we are slightly over time. But very much appreciate the time. Thank you for joining us today, Andrew Carlsen, Genmab.

Thank you for having us.

This session at the Morgan Stanley Global Healthcare Conference. We're very excited to have the team from Genmab, Jan and Tahi with us. Let me just get through a quick disclosure.

For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. I'm Judah Frommer, one of the SMID biotech analysts here at Morgan Stanley. Like I said, very excited to have Genmab here for this session.

So I thought we could start out with key updates since we saw you here last year. Merus is, of course, the biggest, but how have the other aspects of your business evolved over the past year from a high level?

Thank you, Judah. We are delighted to be here, and I'm delighted to update you all on the progress of the company, because we have made a lot of progress. We have now 9 medicines that we generate revenue from. We have 3 late-stage assets, which are all expanding their reach, for the coming time. So we have actually announced 6 new Phase III trials this year and more to come.

And also, we will have a lot of data in Q4. Essentially, all of the 3 lead programs will generate Phase III data in Q4. So we're very excited. And then of course, the financials look very solid. We increased the revenue by 25% in the first half and operating profit by 18%. So very solid financials. This will allow us to invest actually in further expanding the late-stage programs and also preparing for commercial launches, multiple launches next year, assuming the data will be very good and follow the Phase II data.

So we have made a lot of progress and delighted to be back in New York here.

Great. So maybe starting with Merus and petosemtamab, what drew you to the asset? How is it differentiated from other EGFR bispecifics in recurrent metastatic head and neck cancer and CRC? Maybe just initially kind of what drew you to that acquisition?

Yes, I can start off and then I'll let Tahi fill in a bit more of the differentiation part. But petosemtamab is a truly differentiated next-generation EGFR targeting antibody with great preclinical data, very, very good early clinical data in head and neck cancer, 2 breakthrough therapy designations, 2 Phase IIIs.

One of them will read out in Q4, and then the other one, the second line -- second, third line head and neck cancer, will read out in Q1. Immediately thereafter, so very well progressing. Data are really, really good on a numerical basis, really outperform potential competitors there. And also colorectal cancer, we've now announced on August 6, 2 new Phase III trials, one in frontline and second-line colorectal cancer.

You will hear the reasons why at ESMO end of the October time frame, where we will actually describe the Phase II data from -- which were originally from Merus.

Right.

Probably more or less, more than doubled the number of patients, and then also follow them up for a much longer period of time. But I will let Tahi speak a bit more on differentiation versus other EGFR-targeting antibodies. So pause here. Tahi?

Yes. I think this goes back to the thesis that we were formulating when we actually announced that we were going after Merus. As Jan was saying, petosemtamab is a second-generation EGFR bispecific. Second arm is against LGR5.

And what we saw, and I think what continuously to play out, was very early on, which is what triggered our interest that it appear to have a differentiation on the efficacy. It's like -- and cross-study comparisons are always hyper-problematic.

But in every data set that is in the public domain, in monotherapy, in combination with pembro in the head and neck space, in combination with FOLFIRI or FOLFOX in front line or second line, there's always like a numerically higher response rate, vis-a-vis, for example, amivantamab. And on the other hand, and that's probably equally important, it also seems to be differentiated on the safety side. So it doesn't have the degree of skin problems.

It doesn't have the scalp skin issues that amivantamab is dealing with, which then is managed with the whole COCOON regimen. It doesn't seem to have the degree of stomatitis and all of these things. And they, in totality then, and this is kind of like a theme in Genmab, they help patients stay on drug and duration of treatment eventually then also becomes duration of response.

And these things together, higher efficacy, longer duration treatment, they tend to drive then this package that we're looking for that really is then differentiated for the patients. That's what we saw, and this is what's playing out right now in the long-term follow-up data sets, some of which are going to be presented at ESMO.

And so we are really excited about it. We're really excited about the readout that we announced that's going to happen in this quarter. And so we all look forward to having a conversation about that.

Great. And maybe just -- we get the question from time to time, was LGR5 on your radar as a target, or was it really the clinical data that stood out and kind of introduced you to the target?

The question whether we went after an EGFR bispecific?

LGR5.

Oh, LGR5.

Yes.

No. I think like the story of LGR5 is obviously an interesting scientific story. It came out of the Hubrecht Institute. It was an observation that this is a stem cell target.

If you really dig into the history of peto, it was screened in organoid model. Scientifically, this is super intriguing. And then in the end, both Jan and me came out of the lab. We are scientists. But ultimately, it is actual clinical data. And so it becomes very difficult to attribute whatever profile you see.

But in totality, as it is, as a bispecific with these 2 targets, it has a certain clinical behavior. And that's what we were attracted for, that's what we were doing the diligence on, and that was what drove the enthusiasm to do really a major transformational step for Genmab. And this is why we're so excitedly waiting about the first readout, the confirmation of our excitement.

Yes. Okay. Great. And like you said, Jan, we'll get the frontline data in the fourth quarter of this year, that's the LiGeR-HN1 trial. So that will be a top line. I guess, what can you tell us in terms of data communication? What should we expect to be in that press release? You tend to focus and correct me if I'm wrong, on primary endpoint and safety, but how are you thinking about the communication around those data?

Yes, that definitely. As we do with other Phase III. So there will be multiple Phase IIIs, hopefully reading out in the coming time.

Right.

Top line results and also a statement on safety because that's, of course, the second parameter, which is really important for new candidate medicines is that they are not only efficacious, but also have a good safety profile, because that in combination will actually predict how successful they can be as a new treatment option.

So that is what you can expect for the frontline head and neck cancer data for petosemtamab.

Okay.

And then further details will then be presented at a medical conference, hopefully soon thereafter, Judah.

Okay.

With more color, of course, on subsets of patients and another parameter, secondary readouts, et cetera.

Okay. Great. And maybe just remind us of the timing of the decision to increase enrollment in those LiGeR trials, right? Any detail you can share around drivers of that decision? I think, like we've talked before, the timing of when you made that decision is important for investors around the world.

I can refer to Tahi for sure because we already made that decision in the summer last year before we actually approached Merus. But Tahi, you can give it a bit more color.

Yes. I think that decision, and that has gotten a lot of press over this week so to speak, was one of the first things that we talked about when we were looking in the diligence that we want to increase the sample size for both line just to basically capture sufficient number of patients in this, what is in the end, a heterogeneous disease. And it's, by the way, not only heterogeneous by HPV positivity, but it's also locality.

And so we did that. And then I think there was a debate whether this would have a timing impact on enrollment. And yes, so they both, and we said from the beginning, it won't have an impact on the enrollment. It didn't. And so I don't think getting into the details of why we make these decision is.

Yes.

I mean, a little bit too much.

Maybe just on that point, maybe help us with unmet need in head and neck, kind of what response rates and OS look like if pembrolizumab's the right benchmark currently, and maybe how that helped in.

Well, so if you look at the current standard, right, essentially, you are faced with 2 choices. You have pembrolizumab monotherapy or pembrolizumab chemotherapy. Neither of which is really attractive. Pembro has like a 19%, depending on what study, somewhere between high teens to low 20% response rate. The PFS then is automatically driven by the nonresponders and the OS is driven by the responders and it's roughly about a year.

Chemotherapy doesn't really actually change much on these dynamics. It is just an option that then gets taken if a patient has a tumor that is in a certain locality that requires a more immediate intervention. Broadly speaking, that is the response rates are slightly higher.

The overall survival is exactly the same. So they are both, to be honest, some of the most dismal outcomes in any frontline indication in cancer, if you really think about this and put this into context, how much progress we have made in other disease areas.

So the promise of the peto-pembro combination is if you take the Phase II data set that you roughly would triple the response rate. You roughly triple the PFS rate, and then that has a significant impact on the overall survival. And you essentially now have a regimen that would not have the toxicities of chemotherapy.

Right.

And these patients are really frail. They're beaten up. Their locality is problematic. They are more often also in a bad stage because of the risk factors that lead to the disease. Having essentially a nontoxic or outside of the IRR, relatively well-tolerated regimen that has such a magnitude of improvement in efficacy, disease control, and then durability. I think one could argue that if that would actually play out in the Phase III, that that would be transformational.

Right.

And so that's what we're looking for.

Okay. That's helpful. So like you said, the Phase II sort of set a high bar for peto, right? Objective response rate, 63%. I think it was a 9-month median PFS and 79% 12-month OS, right? But I guess, like you said, given the background you mentioned on standard of care, where do ORR and OS need to be to be kind of commercially meaningful as the potential first mover of the next-gen bispecifics? I guess, what has physician reaction been in terms of could we see data maybe come down a little bit from the Phase II?

So look, I mean, if it is going to be in the ballpark what the Phase II, is.

Yes.

It is going to -- to be careful with the words one uses prior to having the data, whether it's going to have a transformational impact on the care of patients with metastatic local recurrent head and neck. That's without a doubt.

If you look at the speed by which these trials enrolled, that gives you a hint. If you see the sense that is building in the community around waiting for this data, that gives you a hint. I think there's a significant amount of anticipation for this data, including in Genmab.

And if it is going to be somewhere in the ballpark, which we are very confident it will be, then I think -- there is no question. This is the new standard.

Yes. I guess in our KOL conversations in the ballpark is great, but that ballpark is so far away from what standard of care is getting these days that it's one of these instances where like investors and doctors maybe have different views on what's good data, but that's good to know.

Yes, we have to believe it, right? We have to see it. But we are pretty excited about getting the data in our hands.

Okay. Great. And then you mentioned just kind of HPV being a driver of some subset of head and neck. Is the goal to be an HPV-agnostic asset? Could we potentially see messaging around efficacy in HPV-negative disease in particular, at some point? I guess, kind of what's the approach here in terms of HPV status and...

Yes. So I think 2 things can be true at the same time. When we say agnostic, by the way, this is also true for Rina-S. We are not meaning that it behaves exactly the same way.

What we are saying is the combination of peto-pembro in our mind, based on what we know so far, will have a meaningful differentiated impact on the standard of care regardless of which of these 2 buckets you fall in, because these 2 buckets behave also differently to pembro.

And so that's what we are saying. And so the idea is to provide this medicine, this new innovation, if you will, with that hopefully repeated magnitude of efficacy to all patients. Now, there is a difference between HPV positive and HPV negative in terms of how they respond to EGFR. That's not only true for peto, it's true for every EGFR antibody.

And there is a biological reason for all of that. Actually more around select the oropharyngeal subtype that seems to then coexist with HPV negativity. But particularly in the frontline, I think we're very comfortable with the idea that the data that we're going to generate, the data that we have so far generated or that Mayo has generated and that we inherited, points very clearly to the fact that regardless of HPV positivity, negativity, there is a differentiation impact.

Okay. Great. And like you said, we're going to get LiGeR-HN2 data first quarter of next year. I guess, how should we think about level of OS benefit and kind of meaningfulness there? And will having OS data on hand support positioning versus maybe in amivantamab or other competition?

Well, the sequence of events is going to be first things first, right? So we're going to have, hopefully, a positive readout on the frontline study, which I think have settled a lot of questions in the investor community, but also in the Genmab minds around the place and the role that peto will play in head and neck because that's just the dramatically larger space in terms of patients and opportunities and improve outcomes.

The second-line monotherapy OS study, well, first of all, it is an OS study, right? What Janssen has is an accelerated pool based on response. It's a little bit tricklier here to benchmark OS, to be honest, because there's a lot of different data sets that are sometimes conflicting, so which is why it's good to have this in a randomized trial to actually control for that.

We are very positive that this trial will also be positive on OS. And then you would have in the totality of benefits, a very, in our mind, comprehensive picture about the role of peto in head and neck that is frankly, not comparable to like a Phase II as good as it looked like.

And then Janssen's strategy is actually going combination with chemotherapy, which is also completely different. So we feel very good about the program that we inherited on these 2 studies.

We feel very good about the data that we have so far seen, and we are very excited about these 2 readouts which are going to underwrite what we said from the beginning, a position for peto to be the best-in-class, also first-in-class really in frontline EGFR, second-generation EGFR bispecific.

Okay. Great. And maybe just before we wrap up the head and neck conversation, competition in the space and additional assets kind of coming down development pipelines is great for patients. But maybe just remind folks how many centers peto has been investigated in, kind of level of familiarity for head and neck specialists with peto at this point in time?

So how many sites have been.

Yes.

Part of these 2 trials. I think there are some overlaps, but it's a number that's north of 300 sites.

Right.

I think like essentially every major network in head and neck, every major investigator in head and neck across the mostly Western world, in one way or the other, is part of the peto program. And so kudos to those collaborations to actually drive this program where it is now.

Yes. Okay. Great. And then maybe we spend a few minutes on CRC, right? I think when you bought Merus, you indicated head and neck was really the focus for the return on that investment, but you're clearly making progress in colorectal as well.

So maybe just briefly describe the planned frontline and second-line plus studies, trial design, arms of those trials? And is there inherent differentiation in design versus competitors' CRC trials?

You want to take that question again?

I think so. I will take over pretty soon.

Okay, good. Well, first things first, right? So we started 2 Phase IIIs in frontline and second-line colorectal, as you were pointing out. In frontline, as I said, RAS wild-type, roughly 900-patient study against FOLFOX or FOLFIRI in combination with cetuximab.

In second line, and that's already where there's a little bit of a differentiation, same population, slightly smaller study, FOLFOX, FOLFIRI combined with cetuximab or bevacizumab. So that's one part, slightly broader in it's intended population label.

And while we, at the time, said that the deal was underwritten, I think that's what the wording was. The deal was underwritten by the head and neck data. We had looked at every single colorectal patient, and it had, of course, been part of our fantasy in our imagination.

And then the only way you actually get an active study enrolling patients in September when you closed the deal in January is that you actually started to work on this already while you were in diligence. So it's okay. So we have been from the beginning, but we're having our eyes very closely on this data. There's going to be more data coming up sometime soon to also drive this enthusiasm for everybody to see.

As I said many times, these are small Phase II data sets. One has to be careful. But numerically, they look incredibly good in our minds. They look very promising and also in comparison -- cost comparison to ami.

And again, it's not about only efficacy, it's also about safety and tolerability. So we're really excited about this colorectal space now that's opening up. And so we're going to run these studies as fast as we have run other studies. And hopefully, we'll then be able to catch up on some creative regulatory pathways that exist, but let's get the data first.

And conceptually, of course, it is very logical to go for colorectal cancer because LGR5 was originally described as part of the Wnt signaling pathway, and the bispecific by Merus was screened on organoids from colorectal cancer.

And that is what this one really differentiated versus hundreds of other bispecifics. So I think conceptually, it really makes a lot of sense to go for colorectal cancer. And yes, we were a lot more enthusiastic Judah, than we actually displayed publicly because I was worried actually that our deal will be threatened between September last year and December with the party being too enthusiastic about colorectal.

Because when you think it through, potential market size of colorectal is like 3x bigger than head and neck cancer. So this could make this a very sweet deal for Genmab. So I'm happy that we've now executed the deal on December 12, and we're now progressing with 2 Phase III trials with colorectal cancer. And that's not all.

I can tell you that we will further expand the peto program, and we will further expand the Rina-S program pretty quickly. That is what we're focusing on right now. So super enthusiastic.

Great. And what should we think about in terms of efficacy benchmarks in frontline and second-line plus CRC for clinical?

Well, again, this is a little bit of a tricky population now because a lot of the older trials, they have some of the patients in there that are now taking out for biomarker-driven approaches.

So it is a little bit tricky to estimate this. But if you just think about, I think, like the overall response rate right now for peto in combination with chemotherapy is in the high 80s. There's a lot of space in there between what is currently standard of care with cetuximab, and then what would be the combination data.

So we feel very comfortable about that. In second line, it's even wider. And that also then tells you a story to a degree, what's true in second line is also true in front line, it's the same biology.

And in second line, we're running like a high 60-ish, 70-ish percent response rate with a margin of like 30%, 40%, almost 50%, right?

So again, we feel very excited about these trials. I forgot to mention this, but it is good that you reminded us. It was actually a drug that was selected to be a colorectal cancer drug because of the biology of the Wnt pathway.

And so the data will be presented, and as you get to see it a little bit more with a little bit more follow-up, has at every step kind of like reconfirmed this initial enthusiasm. Maybe another anecdote on all of this, the first document that left the house after the deal was signed 24 hours after the deal was signed was the request for an IND.

Got it. Great. Maybe we'll move over to EPKINLY. Maybe just talk about the current growth that's coming from second-line follicular lymphoma versus third-line plus DLBCL. What's the biggest barrier to broader community adoption currently, even though you're making progress there?

We're making significant progress there with a lot of adoption in the community setting. And that is driven by the second-line follicular lymphoma. It's also driven by the fact that this is one T-cell engager targeting both diffuse large B-cell lymphoma and follicular lymphoma, which is much more straightforward for community health care centers.

A very good safety profile. It's easy to give. It's like a 2-second injection under the skin. Remember that in frontline and second-line B-cell cancers, these patients want to be treated close to their homes and not in a cancer hospital 4 hours flying from their home or a university hospital.

So we see a lot of traction right now, and in fact, most of the adoption is now coming from the community centers. So very encouraged by that. Looking forward to the frontline readouts, of course, in Q4 because that is basically the largest part of the market. It's essentially half of the potential target market for EPKINLY.

So super enthusiastic, but we also see traction now in other territories. The second-line follicular lymphoma setting was approved last year in November in the U.S., and this year in China and Europe.

Japan is around the corner, literally. So we are going to expand also in other settings there. And also, we have, of course, now also the positive data on the second-line diffuse large B-cell lymphoma, combination with lenalidomide. There we're also speaking with multiple regulators at different parts of the world right now.

So I think there's a good momentum now, and you've seen it. I mean, 48% growth year-over-year. I already said it in my introductory remarks, 28% quarter-over-quarter, going from first quarter to second quarter, beating competitors quarter after quarter after quarter. With T-cell engagers targeting CD20, I think we're in good shape and actually the best shape possible because we are going to have the frontline data, probably a year to 1.5 years sooner than some of the main competitors.

And I want to remind everybody that in the original third-line plus label in diffuse large B-cell lymphoma, Judah, we had like a 29-day difference between us and the competitor, and we have beaten them quarter-by-quarter every quarter since.

So I think time really helps. And that is what you should all be aware of for Genmab. Genmab is a new company now, but we are focusing on really truly differentiated molecules and very good execution because execution is what matters. What we see not only for EPKINLY, where we knew that we already had a number of competitors.

We see that petosemtamab, we just spoke about that, at least 2 key competitors now moving in. Rina-S, where we hopefully will also spend some time on today because it's such an exciting molecule where we see the big ones, the AstraZeneca, the Lilly, and other companies coming in, and also with next-generation folate receptor alpha ADC. So what it comes down to is very good execution. And we have now set up the organization. We can do this in a very effective way.

And I think the acceleration of the Rina-S Phase III shows it for this year, the very rapid coming to the frontline data in head and neck cancer with the petosemtamab asset. And then we're also super excited about having the frontline diffuse large B-cell lymphoma combination trial with R-CHOP, which is the gold standard already for 24 years. And we can beat that. I think we have a good presence also in B-cell cancer. So I think that all in all, brings a very, very exciting I think, picture for the company.

Definitely. So maybe just on that frontline DLBCL trial that we'll also get a data card flip in Q4. In terms of a PFS hazard ratio, we're not looking to pin you down on a number, but I guess, also a ballpark that experts are thinking about that could really transition EPKINLY to standard of care in frontline.

Tahi?

The ice is cracking under my feet, so I am going to walk very slowly. First off, first, let's stay with what we communicated.

So we're going to have a readout this year, and that is very exciting, and then it is going to be based on the interim. And we are very confident about that, to be able to present that. And so there's a lot of mathematical models out there. A lot of the questions that I have in the past have received as R-CHOP. Does R-CHOP behaves the way that R-CHOP behaves? All things are being true and equal. POLARIX, frontline, even other studies, it tends to behave a certain way in a very narrow band.

We are looking with excitement at this data. And then once we have the data, I think we can have a conversation about what it means for the community. One other point, maybe to like also sort of go back a little bit to the first question.

The reason that we were really intensely focused on working with the agencies, particularly the FDA on getting the hospitalization requirement out of the label. And there was a significant effort. There was a separate study that was done in the community to show that it can actually be done in at least within the U.S. health care system, where you -- the community often is also a term that describes distance to tertiary access.

And then with the regimen -- the steroid regimens that control the CRS, all of this was done in preview and in anticipation and preplanned to be in place by the time we will get the frontline data because there, as Jan was saying, these patients are actually in the community, and that's where they are going to get treated.

And so you're going to not have an impact on the disease unless you have a regimen that is -- can be administered by label restriction or regardless of label restriction, but just the practicality of how it has been administered in the community.

And so the whole story about EPKINLY was always about that. So the subcu administration, the ease of route, the control of the CRS and so in totality, you see this now playing out.

I think the current indications, also with [indiscernible] follicular lymphoma, have allowed us to penetrate the community in the U.S. significantly. And this is creating now confidence and experience in preview of hopefully, what will be exciting data on the future, as we said.

I think it doesn't really make sense to speculate where the PFS. I mean, the only thing I will say is this, it's a disease where a segment of patients get cured. And so one has to take that into mind when one starts to think about PFS. The most positive -- if you look at the rituximab study, I think that's maybe like the ceiling if you think about it. The rituximab study had a hazard ratio of 0.55.

Right. Right. Okay. That's helpful. And maybe just last one here. Just the need or the potential to show benefit in both GCB and ABC patients, how are you thinking about that?

With the cell of origin?

Yes.

I don't think there's really a reason to believe and we've never seen anything like that, the cell of origin matters for T-cell redirection.

This comes a little bit, I think, partially driven by the POLARIX data set.

Right.

I'm, without getting too scientific, right, the assay that you use is probably equally important to the determination of a cell of origin in the actual data. It's a very subjective determination, actually, if you look behind it. At the fringes it is not, but at the overlap.

So it was never prespecified, so I don't really know what it means.

We don't have a reason to believe that it behaves differently in any of these subtypes. No data that I've seen neither from what Roche has ever put out in the public domain from their trials, nor what we've seen with the EPKINLY, I don't know, thousands treated. Doesn't seem, neither do actually other historical prognostic factors.

So to the degree, when you have a new mechanism, sometimes what happens is like you reset the whole discussion about risk factors. And quite certainly, we will, in the end, hopefully, when this trial is positive, have a discussion about completely different physical or clinical attributes that describe a subset of patients that may not necessarily benefit as much from T-cell redirection and others. So that's a discussion for tomorrow.

Okay. And I want to make sure we touch on Rina-S, like you said. So we'll get a Phase III readout there in PROC Q4 as well.

I guess how are you thinking about differentiation versus mirvetuximab specifically? And then given activity across folate receptor alpha expression levels, could you avoid a companion diagnostic with Rina-S?

Yes. So I want to be polite to my friends at AbbVie, but I don't think mirvetuximab is part of this conversation. I honestly don't. I think when the data will come out, I mean, we'll have the Phase II data, and then we'll have the Phase III data, we'll end up having a conversation about a completely different treatment paradigm in part. What we've seen so far, of course, like the initial strategy is in mirv exposed for those who are 75 and above, and that's a regulatory strategy because it's the easier path.

What we've seen so far is that Rina-S has a very high response rate, somewhere around 50% in totality, not always the same by these subgroups. And again, the same story that I've repeated this many times. When we say it has a meaningful impact across the spectrum of folate receptor alpha expression, we're not saying that it's equal in each one of them. It's not -- but it has a meaningful and by the way, the inequality comes less through the response, but more duration. That's, by the way, true for mirv too.

If you look at the old mirv trials, the response rate was not necessarily much lower. They have like a 30% response rate in 75% and above.

And then they had like a high 20% response rate and below. It was the duration of response, which basically made it impossible because they actually had a failed Phase III and then they went back really, really, really go back in history a long time ago.

So for Rina-S, what we have seen and what we continuously communicate because this is what we believe, this is what we have in our hands, is that folate receptor alpha expression, the way it is determined, again, what happens is actually as for polymorphisms on folate receptor alpha, you only measure one with the assay.

The way it is determined does not really identify a population that would not benefit. So we have a benefit across the entire spectrum of folate receptor alpha expression from negative all the way to the very high. We believe the data is going to be transformational.

It is incredibly well-tolerated. It doesn't have high toxicity. It doesn't have neurotoxicity. The duration of treatment is extremely long.

In the Phase II data set, we were talking about a duration of response that in aggregate was exceeding 12 months across the entire spectrum. So there's like different segments. The discontinuation rate due to AEs was in the low percentage, single percentage, 3%, 4% maybe. It's the same story all over.

Once you get control over the neutropenia and you settle on your dose, there's really no reason why patients discontinue it. And so we are very excited about this study. I think it will be a very important study for Genmab, but also for [indiscernible] And I don't really think mirvetuximab is part of the conversation anymore.

Okay. Great. I think we will -- probably we could keep going, but I think we'll pause it there for time. Thank you very much for being here. We appreciate it.

Thank you.

Ready for our next panel. I have here with me today, Judith, CDO of Genmab. Thanks so much for joining us.

Thank you for having me.

Perfect. So maybe we can start with kind of introductory question, give us the lay of the land, how is Genmab past 12 months, next 6 to 12 months? Obviously, it's a huge year for the pipeline.

Yes. So we are in a great point in our journey with a very nice full development pipeline encompassed with our 3 major Phase III assets, epcoritamab, Rina-S, petosemtamab. And we are very excited because we just guided in Q2 that 3 big Phase IIIs will be disclosed in next quarter. So super excited.

Great. So maybe we can -- lots to discuss today. Maybe we can start with epcoritamab. We got -- in the past few months, we got the EPCOR DLBCL-4 data, so reduced risk of progression by 60%, death by 56% versus R-GemOx. So what does this data mean for EPCOR's market opportunity? And is there any read-through to the upcoming EPCOR DLBCL-2 readout?

And this is a great question. So as you said, DLBCL4 tested EPCOR versus R-GemOx in the relapsed/refractory second-line plus setting. And the study, we disclosed great PFS 0.40 or 0.44. Now what I would say is talk about the versatility of epco in terms of being able to combine with len. Now DLBCL-2 is a different hypothesis, a different combination and a different line. So basically, there is not a read-through, but the fact that all over and over again, we saw -- because the DLBCL-4 is based on NHL-5 Arm 1. So we see how the Phase II translates into solid Phase III behavior. We expect the same for NHL-2 Arm 1[indiscernible] With DLBCL02, but there are separate designs, hypothesis and to be treated independently.

Got it. And in terms of market opportunity, how does this fit to EPCOR's potential?

Yes. So the potential -- the big potential is for the first-line opportunity in combination with R-CHOP, the study that will be read. We have the approval on DLBCL in Phase III plus. So again, everything adds on, but the big commercial opportunity is DLBCLO2.

Got it. So let's talk about this first-line study that's going to read out in the fourth quarter, as you mentioned. So the primary analysis is conducted for the IPI 3 to 5 population, but you do include about, what, 30% of patients that are IPI 2. And so what's the benchmark for these different patient populations? And how should we be thinking about this readout?

Yes. So the primary is for the 3 to 5 INS hierarchical testing. So if we pass the boundary for the 3 to 5, then we will test 2 to 5. So the study has statistical assumptions. So to be positive, it has to cross the boundary for efficacy as the statistical assumptions. Now if you ask me what is the hazard ratio to be an option chosen by physicians or patients, this is a different story, and it's a more nuance because it's not just a hazard ratio, but how the subsets will behave or what convenience means to patients in terms of subcutaneous or -- so it's -- I cannot establish a threshold. But what I would say that if the study is positive and based on what we know from the Phase II, it will be able to offer a tangible benefit for patients and physicians to consider as a good option.

Got it. And the primary endpoint is for PFS, and it's unlikely for us to see mature OS anytime soon. So I guess like -- is PFS alone sufficient to drive meaningful adoption in the first line? Or from your diligence, does it feel like physicians want to see survival benefit?

Yes. So from a regulatory perspective, PFS is an endpoint validated for first-line DLBCL. We know from POLARIX, we know from frontMIND as well that were approved based on PFS with POLARIX 5 years OS is still 0.89 or from minus 0.85, but it's immature. So PFS is a regulatory endpoint. From a clinical perspective, it's the totality of the data, and we will see what is the maturity of OS, but it's not expected to be mature enough to be statistically significant with this short-term follow-up.

Got it. Just to give us a sense, what's the median OS expected for the control arm?

So for the control arm, what we know is that the PFS, 2 years PFS is around 65%, give or take. And for OS, I would say at 2 years would be like 70%, 75%...

Very helpful. And maybe just a little bit on the treatment duration and cycles. It seems like the Phase III has -- it employs a shorter like treatment duration for EPKINLY than what we saw with the Phase II. Do you foresee any impact?

So thank you for the question. And we were asked this question before. So the Phase II has 12 cycles of epco. When we discussed the design with the health authorities in order to mimic the duration on both arms, we were asked to limit to 8 cycles. We don't think that this will have any meaningful impact on efficacy because from the Phase II data, we know that responses comes early and MRD negativity come early. And it's pretty standard in aggressive diseases that you treat short and hard. So we don't expect any efficacy compromise.

Got it. And how important are complete responses and MRD activity?

It's very important because there is a correlation between CR and duration. So patients who are in CR are more likely to have sustained and non progress than patients that are on PR. Although PR is still relevant, CR has a better correlation with duration.

Got it. Very helpful. Maybe in terms of -- have you disclosed whether the planned analysis for this first-line pivotal study will be interim? Or is it the final readout?

What -- can you repeat that?

Can you discuss if this analysis is an interim analysis or it's the final?

It's interim analysis.

Got it. Okay. And maybe just following the March label update, eliminating the 25-hour mandatory hospitalization in the third line, what impact have you seen in the community uptake? And do you expect this impact to continue?

Yes. So we have seen an acceleration on the uptake on the community side, given by the removal of the hospitalization as well as the approval of the FL, too, second-line FL. We -- Brad mentioned at Q2 that most of the new sites are community sites and 91% of our key customers and 2-plus sites which are the big conglomerate sites. So we are very happy that epco different than others,[indiscernible] It doesn't need hospitalization because it makes much more easier on patients and the health system.

Got it. And you mentioned this second quarter growth was both because of the label FL.

Correct.

So would you say that it's been mostly the FL inclusion or it's been more of the [indiscernible]

I think that it's very hard to quantify is a combination of everything. And even it's very hard on these later stages to dissect the particular indication. So we see that both DLBCL are contributing, and we see a cross-pollination. So new sites that start prescribing on FL, then they go to LBCL and the other way around. This is a very important strategic value of having the double indication.

Got it. Very helpful. Maybe just moving on to petosemtamab. You have the first-line readout in the fourth quarter this year. Maybe just -- we've discussed before how you increased the enrollment in the first-line study, right, to improve the probability of success. Given the studies were already well powered for response rate, is this more of an OS kind of play? And how should we be thinking about the heterogeneity expected for the control arm?

Yes. So we increased the enrollment to ensure that we have robustness of different subsets prespecified in the study and because enrollment was so ahead of schedule that putting more patients didn't impact time lines on the contrary, accelerated the potential to have OS sooner because the curve is like this. So if we enroll more, we get more events, okay? So in terms of the control arm, so the primary is dual. The interim will be based on ORR and duration of response.

So what is expected for the control is 19% ORR with 12 months median overall survival. This is based on pembro alone, KEYNOTE-048. As you well know, in the Phase II proof of concept, Petopembro led to 63% ORR tripling and 12 months 79% OS, where pembro alone is 51% OS. So it's major difference from the Phase II comparing to benchmark and control.

Got it. And last year, from our conversations on petosemtamab, it seemed like for a project frontrunner, it seemed like just doubling the response rate from pembro was enough. Is that still your understanding with regulators for Project Frontrunner? Or are there any changes in the way you view the requirements there?

Yes. So the plan is we will have the results next quarter, we will disclose. We will engage with the health authorities, and we will align on the strategy for filing and submission, including frontrunner.

Got it. And in terms of the patient population, enrolled in the study. I mean you included both HPV-positive patients and HPV negative. Is there any cap to the HPV-positive patients? And can you remind us of the efficacy we've seen for the peto/pembro combination there? And mechanistically, why would it make sense to include this patient population?

So we didn't cap. What we do is we stratify for HPV to ensure that we have balance between the 2 arms. And the reason is more than one. So biologically, there is no reason for pembro IO to work on HPV positive or negative. So KEYNOTE didn't differentiate HPV positive or HPV negative, neither EXTREME. So the study that led to cetuximab approval showed benefit of cetuximab, which is an EGFR in HPV positive and HPV negative. This is external data. Most importantly, in peto-pembro, 8% -- 8 patients, not 8%, 8 patients, which is around 20% of 43 were HPV positive, and the response there was 50%, 5-0, which is much more better than 19. So there was no reason for us to exclude those patients that can derive benefit, but we are stratifying to ensure balance. And given the sample size, 700 patients, we expect the percentage of HPV positive to align with the epidemiology of the disease, which is around 20%, 25%.

Got it. Very helpful. Maybe just touching upon the Phase II data that you showed for this first-line opportunity. And it's been a while, right? But there -- the overall survival was still in progress. There were -- we didn't have enough data. Are you planning on sharing any of this data before the Phase III? And how should we be thinking about this?

Yes. So for that study, we will share like more translational data at ESMO. But the reason we think that 12 months is a very good indicator is because of the IO curve, where after 12 months, for example, for 048, the OS at 12 months is 51%. At 3 years is 25%. At 5 years is 18%. And this is the tail effect. So 12 months, 79%, we are very confident that it will be carried to provide potentially a very sustained overall survival benefit long term because IO is in both arms. So we expect the shape of the curve to be an IO curve.

So this is why -- and because the Phase III will come imminently, there is no reason. But again, the 79% 12 months overall survival first is best-in-class, above FICERA, above amivantamab, and it's a very, very good predictor of long-term survival benefit.

Got it. And maybe for the first -- the second-line opportunity, I mean you also recently changed the study now primary endpoint is overall survival. Can you just like remind us, does that mean you're not pursuing accelerated approval and you're just going to pursue a full approval there? And how does -- how do you envision peto's market opportunity in first line versus the second line?

Yes. So you just hit the nail on the head. We -- when we assessed the time advantage of filing frontrunner for second line vis-a-vis OS, there was minimal or no time advantage. So there was no reason to have 2 filings 1 month apart. So we decided to allocate all the alpha to OS and have a study that can support full approval in a global manner rather than do 2 cuts to gain 3 weeks didn't make any difference. And of course, the huge unmet medical need and the larger opportunity is the first line. The second line commercially is a much earliest opportunity.

Still we could benefit patients and the data is strong. But we -- the data from the Phase II of peto-pembro could transform -- the landscape of head and neck treatment.

Got it. Very helpful. Maybe just in terms of how are we going to see this data? And how should we be thinking about the top line readout for the first line, more importantly, but also the second line? Should we expect any patient subpopulation information? Or is it more going to be like, oh, the study is positive primary endpoint and that's that?

So we will operate according to standard in industry, which is we will have the data we will share with -- because it's material top line data, we will engage with health authorities. And in parallel, we will plan for a full disclosure at a medical congress. And this is pretty standard.

Got it. Should we be expecting the full disclosure before the overall survival?

We haven't guided yet on when overall survival could come because we don't have these projections firm enough to communicate. So as soon as we have this, we will communicate. So I cannot say because we don't have a firm projections.

Got it. Maybe just touching upon the locally advanced opportunity. I mean, how do you see that opportunity for peto in head and neck? And how does it compare given competitive landscape?

In head and neck?

Head and neck.

So we think that PO will have not only time advantage in being first in line for the first line, but has the opportunity will be best-in-class as well. So based on, again, cross-study comparison are never very clean. But when we see the data of peto-pembro versus ami-pembro or Fizera-pembro in terms of efficacy, overall survival, safety, convenience, we see as a very, very attractive value proposition potentially for first-line patients with head and neck.

Got it. Maybe just touching upon the competitive landscape. Does the potential approval of amivantamab in later-stage head and neck impact your strategy for peto at all?

On the contrary, I think that -- so we know that J&J filed and will get priority review, but this will be accelerated approval on the second line plus second, third line, whether the Phase III for the first line will provide the approval on the first line. So it's something will strengthen the hypothesis of EGFR bispecifics, but they are not in direct competition. And we have a very important time advantage vis-a-vis OrigAMI-5, which could potentially will lead to the approval of Ami in first line. In addition, it's a separate strategy. We chose to go with a chemo-free because of the depth of response and the superiority of this combination vis-a-vis chemo or chemo pembro. So it's different, and we will be like 2 years ahead, which is massive.

Got it. And maybe just based on your diligence with physicians, what percentage of patients get treated with -- right now in first line with like pembro alone versus pembro and chemo? Is there any specific patient population that benefits?

Yes. It's a great question. So we -- there is a Flatiron real-world evidence published around 3 years ago, and this is after KEYNOTE-048, both arms were approved 6 years ago that showed 2:1 pembro alone to pembro versus pembro chemo. Of course, this is published 3 years ago based on the U.S. Flatiron data. But when we talk to sites or investigators, it's very individualized based on CPS, frailty or comorbidities of the patients, tumor size or speed of tumor growth. And for example, if the patient is CPS above 20, more likely pembro alone than pembro chemo.

If the patient is frail or elderly, more likely, many patients are tobacco consumers or alcohol that have more comorbidities. So for those patients, same thing, more likely, they won't get exposed to chemo, although if the patient is young and has rapidly proliferative, we will take pembro chemo, but it's a very individualized patient and physician decision.

Got it. Do you feel like the due diligence give similar data or provide similar data in the U.S. versus the EU in this sense?

For -- I think I haven't seen the data for the EU. But when we talk with sites, they all say the same is individualized. And just remember, the chemo in combination with pembro is Carbo/5FU. 5FU is IV weekly, it's not very friendly on patients. So there is -- yes, it's an individualized patient by patient. But as per published data is 2: 1 pembro single agent versus pembro chemo.

Got it. Very helpful. Maybe just moving on to CRC. We're going to see some data at ESMO, and you presented also some data towards the end of last year. Can you just remind us what's peto's opportunity there and how you're thinking about the development strategy given that amivantamab is ahead?

Yes. So we think it's the data that showed in the EORTC-NCI meeting is very strong with an ORR of 80% in first line, independent validating by an ORR of 62% in the second line, which is unprecedented and doubles everything published and with a very solid biological foundation. peto was discovered through a library of colorectal organoids and shown in every preclinical model to overcome -- to be superior than cetuximab. So very strong data. Amivantamab is earlier, but we will present more data at ESMO that position the peto combination as potentially best-in-class, not just in terms of efficacy, but also safety.

Got it. And you just initiated the Phase III.

Two Phase III.

Two Phase IIIs. Can you just remind us which patient populations are you targeting?

So for the first line, we are combining with FOLFOX or FOLFIRI in the KRAS, BRAF wild left side patients. And for second line, same thing, KRAS, BRAF wild, both sites in combination with FOLFOX and FOLFIRI. But the comparator will be bevacizumab plus FOLFOX or FOLFIRI or cetuximab plus FOLFOX or FOLFIRI.

Got it. And in terms of the LGR5 part of peto, I guess like what's the rationale in CRC? I mean this is where, as you mentioned, the molecule was discovered, right, for this indication. What gets you confident that this is not only like a cetuximab molecule?

No. I mean -- so if you look at this paper from Eduard Batlle, it's clear that LGR5 plays a central role. So mechanistically, I mean, 2 very important things. First, the binding to LGR promotes internalization and degradation of EGFR. And in addition, in the context of treatment with peto, LGR is overexpressed and the binding of the bispecifics on LGR strengthens the ADCC and ADCP properties. And so beautifully demonstrated on those paper where in organoids, when they treat the organoids, patient-derived organoids from colorectal cancer with peto, more organoids are stopped because so the LGR is related to stem cells like.

So it stopped growth and metastasis. So very strong preclinical and biological foundation that LGR is key for the activity of peto. Now the problem with LGR is that it's the plasticity. So only a few labs can measure it accurately, but it's no question that LGR and peto was discovered among 500 other bispecifics that were tested same organoids panel of colorectal cancer versus normal cells and peto was the winner, killing 100 more times tumor cells than normal cells, 100. So it's clear that LGR is the one to drive. Again, the problem with LGR is that not every lab can measure because of the plasticity of the cells.

Got it. Maybe just last question on CRC. How are you thinking about the commercial opportunity relative to head and neck?

It's much more bigger. So in terms of population, and I don't know on the top of my head, but I would say it's at least double the commercial opportunity than head and neck.

Got it. Okay. That makes sense. Maybe just with the last few minutes, just switching gears to your folate receptor alpha ADC, Rina-S. I mean you are going to read out the Phase III in the fourth quarter. I guess maybe to start, just -- we've seen a little bit of data in the Phase II, not a lot in terms of follow-up. I mean how should we be thinking -- are we just going to get the Phase III, also the Phase II? How are we going to see this readout? And how much information are we going to get?

Yes. So what we message is that we will have both Arm C, which is the Phase II with around 100 patients and the Phase III in Q4 this year. So a lot of data sets coming like pump and pump. But again, we are very confident on the data that Dr. Lee presented in terms of ORR duration, safety, convenience. So we are looking forward and very enthusiastic about the potential of Rina and PROC. And there is a time advantage because potentially Rina-S will become the first second-generation ADC to show positive data for patients with PROC.

Got it. And maybe just touching upon the study design. I mean, based on our calculations, it seems like the -- like the study is well powered to detect like around 1.5 months and PFS. If we assume control arm around 4 months, that would put it on par with ELAHERE. However, in your view, how much better than ELAHERE would Rina-S need to be?

So when you design a study or your powered, you establish your hazard ratio based on the control. Now it doesn't mean that the data will behave that way, but you need to power to be statistically positive. We know based on the data from Dr. Lee by 12 months, a single patient progress that we expect to be much more better than the minimal assumptions. But again, statistically and the clinical -- the actual data we expect that we will be -- the data will be better than ELAHERE in terms of PFS, duration of response, differentiation on safety with no ocular toxicity or the burden on patients to have this visual test and potentially the double indication in the future for endometrial and nonselective for folate receptor. So we expect to be really differentiated and superior.

Got it. And in terms of like the folate receptor high versus low patients, based on the data we have so far, are there any signs of difference in efficacy?

So what we showed is that in the 20 patients for ovarian in the high, the response rate was 5 out of 6 versus 5 out of 10 in the low. But still, 50% is very good with consistent durability across the board. So this is why we don't believe there is a need to enrich or to have a test that both another burden on patients. So the strategy is in all comers because the efficacy that support it.

Got it. And given that ELAHERE is approaching blockbuster status, how should we be thinking about Rina-S' commercial opportunity given we've seen so much better efficacy in the Phase II?

So thank you, Eva, for the question. So today, our estimate for Rina-S is 2 billion peak sales and the $2 billion include all the [indiscernible] Opportunities, PROC, PSOC and endometrial. So -- but we expect to serve a very -- so today, it's like 27,000 patients in the U.S. with PROC. But again, and this is the number that we estimate for now.

Got it. And based on the early data you have in endometrial and what we've seen for other -- for the receptor alpha ADC in PSOC, like how should we be thinking about indication expansion and Rina-S' progression once we get the PROC?

Yes. So I think that the breadth of the clinical development plan is -- so we started with PROC and endometrial 03, which is after PD-1 and chemo failure. We expanded to PSOC in second-line maintenance and replacement, and we plan to expand even further in both indications, ovarian and endometrial to cover every setting where Rina can help and to position as the ADC of choice.

Excellent. Well, this was incredibly helpful. Thanks so much for joining us today.

Thank you, Eva. Thank you.

Hello, and welcome to the Genmab First Half 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.

Today's presentation will also include comments on certain non-IFRS financial measures, which management uses to describe the company's baseline performance and which supplement but do not substitute for the comparable IFRS measures. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure.

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

Hello, everyone, and welcome to our financial results call for the first half of 2026. With me today 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 the operator said, we will be making forward-looking statements, so please keep that in mind during the call.

As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do, accelerate our late-stage pipeline, maximize our commercialized medicines and stay disciplined with our capital, and that is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio, even as we have made focused and strategic investments in our late-stage programs in launch, readiness, and in the integration of Merus. And we did all this while growing operating profits. To me, that says a lot about the quality of our business.

And beyond financial performance, I'm enthusiastic about our recent pipeline progress. So let me walk you through the highlights.

In June, we announced positive top line results from the Phase III EPCORE DLBCL-4 trial, which showed statistically significant, clinically meaningful improvement in progression-free survival.

What is about these results -- What is important about these results is what they demonstrate about epcoritamab more broadly. There is growing evidence of the versatility of epcoritamab-based combinations across multiple lines of therapy. This data was followed by the European approval of EPKINLY plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second-line setting. This makes EPKINLY the first and only bispecific-based therapy approved in Europe for this indication.

All presentations at medical conferences through the quarter have highlighted the strength of our portfolio. And we are looking forward to sharing with you petosemtamab data with updated results in colorectal cancer presented at ESMO in October. Based on this promising data, we are continuing to build momentum for petosemtamab. We are initiating two new Phase III studies in colorectal cancer, and Tahi will share more detail on them in just a moment.

Now let's turn to the catalysts we continue to look forward to this year, on the next slide. As we move into the second half of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts. For Rina-S, we anticipate both Phase II and Phase III platinum-resistant ovarian cancer data sets will be available in the fourth quarter. For petosemtamab, we are eagerly awaiting the readouts for both studies. And with better visibility, we can now say that the frontline study is expected to read out in the fourth quarter, while the second and third-line study is anticipated to read out in the first quarter of 2027.

Finally, for EPKINLY, we anticipate that top line data from the frontline EPCORE DLBCL-2 study, which will be based on an interim analysis, will also be available in the fourth quarter. What this means is that for each of our late-stage programs, we remain on track for Phase III readouts in the second half and then potential approvals and launches in 2027. This is what we have been building towards and that reflects our focused execution. So exciting times ahead.

Now I would like to hand you over to Tahi to walk you through the details of the Phase III colorectal studies. Tahi, the floor is yours.

Thank you, Jan. We are pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing Phase III trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. And as you know, peto is a EGFR, LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care, and LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RAS/RAF wild-type colorectal cancer. And the early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October.

Based on this promising data, we are initiating two Phase III studies, one in frontline and in second-line colorectal cancer. For frontline, we have already initiated a Phase III randomized trial, open label, a global trial that is designed to assess the efficacy and safety of petosemtamab, plus investigator choice chemotherapy of either mFOLFOX6 or FOLFIRI, a first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS/RAF wild-type. That will thus be versus the standard of care, namely, cetuximab plus chemotherapy.

For the second-line colorectal cancer patients, the Phase III trial will be similarly a randomized open-label and global trial. This trial is designed to assess the efficacy and safety of petosemtamab plus investigator choice therapy of either modified FOLFOX6 or FOLFIRI, the second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS/RAF wild-type. And here, the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy.

So taken together, with our two ongoing Phase III trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer and the encouraging data we continue to generate, petosemtamab is rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients.

And with that, I'm pleased to hand over to Brad for a review of the recent commercial performance for EPKINLY and Tivdak.

Thanks, Tahi. Our proprietary portfolio performed incredibly well in the first half of the year. Sales totaled $396 million, representing 37% growth compared to the same time last year. These results demonstrate the strength of antibody sciences as well as the strong execution by our teams to bring our medicines to patients around the world.

The performance we delivered in the first half of 2026 reflects the growth for both EPKINLY and Tivdak globally. We're very pleased with how EPKINLY is performing. In fact, EPKINLY grew to $312 million in sales for the first half of the year, representing a 48% increase year-over-year and a 28% increase in the quarter. In the U.S., we delivered accelerated growth with increases in both new patient starts and new site activations.

The launch of chemo-free, fixed duration EPKINLY plus R2 and second-line FL, has been going extremely well with rapid uptake across sites. This contributed positively to our growth in the first half of the year and suggested that EPKINLY is becoming a preferred regimen in this setting. We've also seen increasing growth in the community this year with the majority of new sites activated coming from community practices and now over 90% of our key customers are ordering for two or more sites. This is driven by EPKINLY's differentiated dual indication label without a recommendation for 24-hour hospitalization and broad adoption of EPKINLY plus R2 in second-line FL, which is leading more sites to utilize EPKINLY across its approved indications.

This performance reflects strong execution by our field teams, physician confidence in EPKINLY's differentiated clinical profile and the value of using a single bispecific option across DLBCL and FL. The uptake we're seeing in the community with more physicians gaining experience using EPKINLY at sites of care closer to where patients live, is a positive indicator as we look ahead to potential launches in early lines of DLBCL.

Outside the U.S., performance remains strong. In Japan, EPKINLY continues to build on its compelling position in the market with approvals in both DLBCL and FL. We expect the second-line FL launch anticipated later this year will serve as another growth driver for the brand. Through our partner, AbbVie, EPKINLY's global footprint continues to expand, including recent approvals for EPKINLY plus R2 in second-line FL in Europe and China. Overall, we're really pleased with EPKINLY's growth globally and particularly in the U.S. and Japan, where we book sales.

The momentum we are seeing today reinforces our confidence in EPKINLY's long-term growth opportunities, especially its potential in early lines of therapy. As we look towards the back half of 2026, we're focused on continuing to grow EPKINLY and strengthening our leadership in the market by maximizing our first-mover advantage in second-line FL and preparing for anticipated launches in early lines of DLBCL in the future.

Turning briefly to Tivdak. Tivdak totaled $84 million in sales during the first half of the year, driven by continued performance in the U.S. as well as in our launch markets in Japan and Europe. In markets where Tivdak is available, we saw expanding site activations, underscoring the continued need for treatments that can improve survival for women with advanced cervical cancer. As part of our work to bring Tivdak to more patients, we secured reimbursement for Tivdak in the U.K. and the conversations continue to progress in additional markets. Looking ahead, we remain focused on continuing to scale our commercialization capabilities to support Tivdak launches in new markets, while building on that foundation to prepare for the anticipated launches of Rina-S and petosemtamab in the future.

Heading into the second half of 2026, we're extremely pleased with the performance across our portfolio. Our performance to date, combined with meaningful momentum underway across the business to advance our pipeline and expand our commercialization footprint, positions us well to grow adoption of our approved medicines to benefit more patients and successfully launch additional indications and new medicines as we look towards the end of 2026 and into 2027 and beyond.

With that, I'll turn it over to Anthony to walk us through the financials.

Thanks, Brad. The first half of 2026 demonstrated the continued strength of our business with revenue growing 25% year-over-year. Beyond the headline 25% revenue growth, I'd highlight two characteristics of our performance: first, high growth; and second, broad-based growth. Now starting with the high growth. DARZALEX increased 21% year-over-year, while worldwide EPKINLY net product sales increased 48%, reflecting continued commercial momentum and strong execution. Beyond these two brands, the remainder of our portfolio increased 35% year-over-year.

Now turning to broad-based growth. Approximately half of our year-over-year revenue growth came from DARZALEX. Impressively, the other half was generated by EPKINLY and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base. The strength of our business also provides the financial flexibility to continue investing behind our highest value growth opportunities, including EPKINLY, Rina-S and petosemtamab. At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that Genmab can increase investment while continuing to expand profitability.

Now, before moving to our updated 2026 guidance, let me briefly comment on tax. Our effective tax rate for the first half was 3.6%, primarily reflecting the ongoing integration of Merus and related recognition and utilization of deferred tax assets. As shown in the appendix to the presentation, this equates to tax expense of $13 million.

Now as we discussed previously, we continue to evaluate the integration of Merus from a tax perspective. As a result, our effective tax rate may continue to fluctuate as those integration activities progress. We expect our effective tax rate will normalize over the next 12 to 18 months.

Now with that, let me turn to our updated 2026 financial guidance. The strength of our business and the financial flexibility it continues to create, are reflected in our updated 2026 financial guidance. Compared with our previous guidance, we now expect to deliver 5% higher revenue and 7% higher operating profit, while increasing investment by only 2%. This demonstrates the operating leverage inherent in our business.

Starting with revenue, we now expect full year revenue to be in the range of $4.3 billion to $4.5 billion, representing 19% year-over-year growth at the midpoint, and this compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both DARZALEX and EPKINLY, with the $195 million increase at the midpoint being approximately equally split between DARZALEX and EPKINLY.

Now turning to operating expenses. We are continuing to invest behind our highest value growth opportunities. Our updated operating expense guidance includes additional investment to maximize the long-term value of our portfolio, including the two new Phase III petosemtamab studies we announced today. Even with these incremental investments, we are only increasing our OpEx guidance by 2%, resulting in a new midpoint of $2.88 billion. Finally, operating profit is now expected to be in the range of $1.1 billion to $1.4 billion.

Importantly, the majority of our revenue outperformance continues to translate into higher operating profit, while preserving our ability to invest behind our highest value growth opportunities.

In summary, our first half performance provides further evidence of the strength of our business. We are delivering high growth, broadening our revenue base, investing behind our highest value opportunities and continuing to expand profitability. Together, this positions us well to deliver 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 now move to our final slide. Looking at the first half overall, we have had a strong 6 months, both scientifically and financially. And our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long-term value. So when I look at where we are, the revenue base we have built, our versatile and promising product pipeline and what is still to come in the coming months, I'm super excited.

That now ends our formal presentation, and thank you for listening. And operator, please open the call for questions.

[Operator Instructions] First question, and it comes from the line of Zain Ebrahim.

Zain Ebrahim from JPMorgan. First question is on the petosemtamab second-line trial, which you're now guiding for a readout in Q1 of 2027. Just wanted to understand what's driving the slight delay to the readout in Q1? Is it the change in the primary endpoint overall survival? Or is it the upsizing of the trial? And how is recruitment progressing for the second-line trial relative to your expectations? I think the slide suggests it's still recruiting. So just any updates there would be helpful. And then my second question is on EPCORE DLBCL-4. So quite a strong PFS outcome. But just any sense of what you've seen so far in overall survival? Or was it just too mature to see a trend at this point? And what's the latest feedback you've had from the FDA on whether the second-line trial or the first-line trial could be used as a confirmatory trial?

Thank you, Dan, for the questions. And I think I will hand them both over to Tahi. Maybe start Tahi with the second-line trial for peto and head and neck cancer and then move on to DLBCL-4 to address some of the points raised here.

Yes. Thank you for the question. And so let's take the peto first. As you correctly noted, the endpoint is overall survival. So this is an event-driven projection when we have the data and the trial is fully enrolled. So that was to that question. And so we're just updating based on what we see when we expect to have the top line results, which is now in the first quarter of next year. As it relates to the second line, third-line, len/EPCORE combination, earlier you noted correctly that this is a very exciting PFS benefit for patients for what is a chemo-free regimen of a pill with a subcutaneous injection, with a really impressive CR rate for patients. That's the most meaningful kind of data point. And we are really excited about the data the OS, of course, at that point is totally immature, which is why it's not yet been reported and the data will be presented in upcoming conference. So we'll have a chance to look at it in a little bit more granular detail.

As it relates to the part of your question for the confirmation of the indication that is already approved, we are, of course, in very active engagement with the agency on all kinds of fronts. And so whether the frontline or the second-line trial is going to be the confirmatory trial, I think that's an ongoing discussion right now to a degree. It also depends on how the results of the frontline trial are going to be. And so this is all that is to say at this point. We have an active process, active engagement, and it will be one of the two.

Thanks, Tahi. Let's hand it back to the -- the question back to the operator and then see whether there's another one.

Yes, of course. And now we're going to take our next question. And the question comes from the line of Michael Schmidt from Guggenheim Partners.

I had one on EPCORE DLBCL-2. And I'm just trying to wrap my head around the timing of the interim analysis in the fourth quarter this year. Based on our work, we think this should have already occurred at some point last year. How do you explain this 1-year delay essentially of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

Thanks, Michael, for the question. Tahi, can you address this one?

Well, let's start first. We are very excited about the results of this trial as they're going to read out next quarter. This is the most important study, I think it's fair to say, within the epcoritamab franchise. There's exciting Phase II data that is in the public domain last year and the year before presented at ASH on the combination of EPCORE with R-CHOP that showed really unprecedented CR rates, which is driving the excitement for the results of this trial.

And so the only other thing to say is that we have been now confirming that this is based on the interim and that it will be top line next quarter. And I think we should probably leave it at this, at this point. And once we have the data in our hands, we can have a conversation about all of these other questions that may arise. But for now, next quarter, looking forward to it.

Thanks Tahi. Thanks, Michael, for the question.

Now we're going to take our next question. And the question comes from the line of James Gordon from Barclays.

James Gordon from Barclays. A question, a couple of clarifications, please. One question was on peto. So the first-line trial is now going to report before the refractory trial, presumably because the first line has an OR primary with interim OS, whereas the refractory trial is more mature OS.

So for the first-line trial, I think we're going to get in Q4, how mature will the interim OS be when you report it, that you plan to file? And do you think the first line or refractory is a higher bar in terms of being successful? And then was just two clarifications. One was for EPKINLY and where we're going to get the interim in the first-line trial in Q4? So if it doesn't work in interim, will you tell us that and say that the trial is going to continue on to the final data? Or it's just that we won't hear anything. And if we don't hear anything by the end of the year, we'll have to assume that it didn't work interim. How that works, please? And the other clarification was just for Rina-S and PROC, so the 01 and 02 trials, they're both in Q4, so Phase II and Phase III. Are we going to get two different readouts? Or will you just -- it's the Phase III that's material because that's what you're filing, so we'll just get all the data together?

Thanks, James, for the questions and the clarification requests. So the first two, I'm going to hand over again to Tahi and then Judith can deal with the Phase II and Phase III data for PROC, for Rina. But Tahi, why don't you start with peto and the frontline trial?

So it was actually, I think, like, I don't know, I stopped counting at 3, but okay, I'll try to address all of the points that were made and asked. So the first thing is on the peto trial, right, we've -- beginning, stuck to the guidance that had come from EOS 1 or both going to read out this year. And now we are being more precise that we actually will have the top line results on the frontline indication, which is very exciting because this is obviously the one indication that has a significantly larger impact on patients, larger population, and we believe this is going to be very exciting data when we have it to present and discuss.

As it relates to what will be meeting statistical significance, we don't have any visibility to this, so this would be all speculation. So I don't think this makes any sense. But -- so we'll have that discussion when we have the interim results in our hands. But what we are saying is we will have an interim data that we expect to be the basis for filing in the next quarter on this frontline peto trial.

Then I think you asked about what -- whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this, to be honest. I think having an OS benefit is always a high bar, and we have a very high confidence in peto being able to provide an overall survival benefit for patients in frontline and in second line. This is underwritten to a degree by these two BTD indication in data sets in the public domain, and that is, of course, also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients.

In head and neck, in these two studies that are already operationalized in colorectal, where we are today announcing that we're going to start two Phase IIIs and then in future trials. So it's a very exciting drug. We're really looking forward to the data in frontline, and then we can have a more detailed discussion on what actually the data will be.

And then there was a question, Tahi, on epcoritamab in the frontline study, when we wouldn't hit the interim, what will happen then with the trial?

I think we should stick with what we just said, that we expect to present the interim data next quarter.

All right. Very good. Let's stay with that. And then Judith, maybe the Phase II and Phase III data sets for Rina in PROC, a bit more color there. Judith, are you there? Judith, are you there?

Yes, she's on mute. I can take that too.

Okay. [indiscernible]

So we -- there will be indeed -- as you said, there's a Phase II in PROC. And then we already talked about that there's also a Phase III. Both of these data sets, of course, will be made available at the time that we get them and have the top line results.

And the question comes from the line of Gregory Renza from Truist.

This is [indiscernible] on for Greg. I have one for peto in head and neck. With competitors advancing quickly in the second line, and third line setting ahead of your action to readout in the first quarter of next year, what efficacy and durability profile would peto need to show to remain competitive?

Thanks, Greg, for the question. Tahi, can you take this one?

Sure. I think you're alluding to the J&J filing. I think like one thing to say is that we just had a conversation about this, that the second line data set will be a Phase III with an overall survival benefit and that is, of course, completely significantly different data set as a OR duration of response data set that may form the basis of accelerated approval as it is for amivantamab.

So, we remain very steadfast in our statement that we believe peto is the best-in-class second-generation EGFR bispecific based on all the data that we have seen in head and neck, but also outside of head and neck. And the totality of our data, the fact that we will have a frontline indication with pembro that we are seeking with the Phase III readout next quarter and then a over survival Phase III readout in the first quarter of next year. I think this is a very compelling and comprehensive data set across these two studies, monotherapy, second line, third line, combination with pembro frontline, that is going to really underwrite our ambition in head and neck.

So we are very comfortable with our position and where we are. And the -- our expectation is that these trials are going to provide significant data that will hopefully have a significant impact for patients with head and neck.

Thank you, Tahi. Thanks. Let's move on to the next one.

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

So I guess I'll just try my luck a little bit on the EPKINLY frontline trial. So given the interim still has not passed, this really suggests the events are happening really, really a lot slower than expected. So just wondering, is there any reason that you could think of that you can suspect that the R-CHOP arm would perform -- your R-CHOP arm would perform differently from the one from Monjuvi Phase III trial or the POLARIX III trial at least in the IPI-325 group? That's the first question.

And the second one, just wondering for peto in frontline. So your trial design is chemo-free, so it's with pembro combo only, whereas RYBREVANT is plus -- pembro plus chemo. So just wondering if you could elaborate a bit of rationale in that trial design to go without chemo, please?

Thanks, Xian. I think I'm going to pass them over again to you, Tahi.

Thank you. So on the frontline diffuse large B-cell, I think first things first, I think it's best if we just stick to a few things. First, we are very excited and really much looking forward to this trial based on everything we know about how EPKINLY has behaved in the past and how predictive these Phase II data sets have been not only in the second-line follicular lymphoma trial, but also now in the second, third-line diffuse large B-cell trial in the combination with lenalidomide. Phase III trials almost point-to-point replicated what had been described in the Phase II data set. And so there's a lot of anticipation that we have, and I'm sure you too, for that trial, and there's a lot of excitement about the results that are going to be then reported next quarter.

As it relates to the performance of R-CHOP, I mean, we have no visibility to how R-CHOP has behaved on that trial. We will find out when we get the data. I think it's probably fair to say that R-CHOP in the past, as you pointed out yourself, has had a very robust performance, kind of behaves the way R-CHOP behaves in -- across multiple trials. But generally speaking, cross-trial comparisons on the control arm are always a little bit flat because they are informed by regions and patients and all of these things. So we don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP.

On the frontline, the question was what the reason was for the combination of pembro and like a lot of these discussions happened a long time ago when this was still in the hands of Merus. But I think, generally speaking, head and neck patients are known to be a fragile population. Locality of the disease, status of the patient play a significant role in the tolerability of the treatment. And even today, if you look at the paradigm, there are patients who get treated with pembro chemo and there are patients who get treated only with pembro. That is not only a decision made by the CPS [indiscernible], but it's probably even larger informed by the patient that sits in front of the physician and their status.

So the data that is out there in the Phase II for the combination of pembro/peto though is like dramatically different. It's like twice a high response rate and durability than has been described even for chemotherapy pembro. So in that regard, our anticipation is that peto/pembro is going to provide a truly, very significant and important data set for patients with head and neck because it will have, hopefully, if it replicates the data in Phase II, a very significant ORR and duration of response improvement even over chemotherapy combinations, we roughly range in the 30% range of response. And then we'll have a conversation about the comparison to what the J&J strategy may or may not be when we have the data in our hands.

Thanks, Tahi. I think very clear. Thanks, Xian for the questions. Let's move on to the next one.

We're going to take our next question, and it comes from the line of Rajan Sharma from Goldman Sachs.

Firstly, just on EPKINLY and just on that first-line trial again. So maybe could you just help us understand, was the data that you saw in the second-line trial better than you were actually expecting internally? And I'm just wondering if, maybe I'm stretching here, but is that giving you increased confidence that the frontline trial could read out at the interim? And then could you maybe just discuss your latest perspectives on the endometrial cancer treatment landscape? Merck have said that they've hit PFS and OS from the interim of the TROP2 ADC trial. Does that -- in your mind, when the data come, will that set a bar for Rina-S? And could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and folate receptor alpha in endometrial?

Thanks, Rajan, for the questions. So before Tahi starts, I think for the frontline study, I can tell you we are super excited based on the Phase II studies, the data released last year at AST, the year before -- at ASH here Rajan. So we believe that this data will be very, very good in the frontline setting. And of course, the second-line data was also fantastic data, but it's unrelated, I feel to the frontline data because it's in a different setting with different patients with different levels of illness. But I think we are excited about both settings. But the frontline setting, I think the enthusiasm comes from rapid recruitment and also running against the gold standard. I mean, R-CHOP has been for over 20 years the gold standard in diffuse large B-cell lymphoma.

The Phase II data actually show if that would translate to Phase III, this will be sensational data, and let's hope for good data in the fourth quarter. Tahi, do you want to add anything to that? And then maybe Judith can go into the landscape for endometrial cancer.

Yes, sure. The only thing I would add is like I tried to make that point earlier. I think Jan touched on that. The len EPCORE Phase III actually reported out the way we were anticipating and hoping, and this is kind of like a pattern that we've seen. The efficacy and safety of EPKINLY is very predictable. And so we have seen now multiple times that Phase II combination data approximates very closely to what then the Phase III describes in the larger data set. And this is also just to underscore the point that Jan was making, one of the reasons why we are continuously excited and looking forward to that data next quarter in the front line and then Judith can talk about the emerging, never-changing, never stopping landscape in endometrial anywhere else.

Thanks, Tahi. Judith, are you back online? [Audio Gap] Apparently not. So maybe, Tahi, you can dive a bit into endometrial cancer landscape.

Then I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a TOPO ADC for -- with a TROP2 target. And that has really very little bearing on our strategy because I think from the very beginning, we were aware that this was going to read out before the data sets for Rina are going to be available. We continue to be very excited about Rina, not only in PROC, where we already guided we're going to have some data this year, but also in endometrial, folate receptor alpha is expressed, maybe on a lower level than in PROC, but it is expressed.

And one of the things that we have repeatedly described with Rina is this phenomenon of efficacy across the spectrum of folate receptor alpha expression. So endometrial is an exciting second indication. We really initiated two Phase IIIs in that indication. And so -- we will look very much forward to have that discussion when we have the data, and I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Absolutely. And we have a breakthrough therapy designation, of course, in one of the settings in endometrial cancer. It's super important. Let's move on to the next question.

And now we take our next question. Andd the question comes from the line of Eva Fortea.

On CRC, as the landscape becomes increasingly crowded with EGFR bispecific, how is your newly disclosed strategy differentiated from the competing assets in the space, particularly compared to amivantamab? And if I may just sneak in a follow-up. Given the growing focus on RAS-directed therapies in CRC, would a combination strategy with petosemtamab be a viable approach? And what's your current thinking on a potential development path for such a combination?

Thanks, Eva, for the questions, and we like those questions because we are super excited about the potential differentiation of petosemtamab. But I will ask Tahi to give you a bit more color on why we are so excited. We will present more data from the Phase II setting in colorectal cancer at the ESMO conference. And then also the combinations is also an area we are pursuing. Tahi, why don't you give a bit more color to Eva?

Yes, please. Thank you. So first things first, I think colorectal as this new indication that we're embarking on with peto. If you recall, even when we started to talk about publicly the intended acquisition of Merus, there was already a lot of questions about colorectal. There was a relatively small data set that had been shared, but that numerically showed very impressive ORR data.

And of course, this data set has grown with numbers of patients and durability, and Jan already pointed out that we will share that. And so our enthusiasm has continuously remained very high for what we see in this data set and underscores our conviction that peto is not only the -- really in every data set, colorectal head and neck monotherapy combination continuously to show that on point estimates and cross-study comparisons are difficult, it appears to have higher response rate and a better safety profile than, for example, amivantamab. And so this is what underscores the conviction that we really aim to have the best-in-class second-generation EGFR bispecific, and that will also translate into meaningful data sets in the Phase III setting for both frontline and second-line colorectal, which is why we started these two trials now, even though, as you kind of like alluded to, J&J already has started these trials. So that's the colorectal part. And the last field, of course, is like super exciting if you worked on RAS inhibitor 12 years ago when it didn't work.

And so it's a super fascinating field to watch. And so we are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal, and we are actively engaging in discussions to really embark on these novel combinations, and there will be more to come in the near future.

Thanks, Tahi. So thank you, Eva, again, for pointing on this super exciting area and more to come this year in the coming months. Let's move to the next question.

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

This is Suzanne. Also on peto, with your competitor or partner J&J going for accelerated approval with amivantamab in head and neck. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with peto at this point in time? Could you comment on that? And secondly, you mentioned a couple of times the high confidence in the best-in-class profile for peto compared to ami. Could you elaborate on what is underpinning that confidence, the higher response, better safety in the data sets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action?

Suzanne, thank you very much for these questions. I'm going to hand them over in a second to Tahi, but I can tell you that you'll definitely have to wait for the ESMO data set for the Phase II data, which will give you a bit of further color why we are so enthusiastic. And as it relates to the strategy, we think that we will have a differentiated drug actually based on everything we know. But I'll pause here and let Tahi give you a bit more color on the head and neck setting and frontline, second line accelerated approval versus potentially approval based on Phase III.

Yes. Thank you. And I'm going to reiterate what I tried to point out earlier. I think that when we step back on head and neck, where we are is we're going to have a top line result in frontline in next quarter of this year and then a OS readout for the monotherapy in the first quarter of next year. I think this is a completely different in terms of comprehensiveness, but also by capturing patient population profile than the accelerated approval now that J&J is pursuing with amivantamab in head and neck. So we feel very comfortable, particularly because the larger population is in frontline about our position where we are and of course, we're doing everything to accelerate these filings and these launches to the degree that, that is possible.

So nothing changed on our end. We always knew we havev-- obviously, there's some partnership on amivantamab with J&J, some visibility to their plans. And so this is exciting for patients, more opportunities, but we are very confident in our head and neck strategy, and there will also be additional studies that we already announced are going to be initiated in the very near future and may just not be publicly discussed because I think we changed a little bit our strategy some time ago, similar to the colorectal trials to publicly announce these trials, more closer to when the first patient is dosed.

And then your second question was around what, again, sorry?

Best-in-class criteria, why do we say that this...

Why do we say this? So cross-study comparisons are difficult. But if you just cross compare monotherapy in second-line head and neck, the small data set that were presented in combination with pembro in frontline, so both trials for both drugs. The colorectal combination with chemotherapy data sets that exist for both drugs in all four of these data sets actually peto outperforms amivantamab on the efficacy. And then in totality, it does have a differentiated safety profile. It doesn't have the same challenges to the degree at least with skin-related toxicities. I think it's a little bit speculative to figure out why that is, but they are clearly different antibodies with different secondary arms.

And it's not unreasonable to speculate that the difference in the second arm may have a biological or mechanistic role that differentiates both on efficacy and safety. But as is, and I think there's now a larger data set, I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety. And this is where we come with this conviction that we have a best-in-class asset in our hands.

Thank you Tahi. Thanks Suzanne for the questions. Lets move on.

And now we are taking the question from Charlie Haywood from Bank of America.

Charlie Haywood, Bank of America. I have two, please. So the first one is just -- or both actually Rina-S. The first is on the second-line PROC data coming in fourth quarter. So both Phase II, Phase IIIs in fourth quarter. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts? Anything to consider as we sort of read across between the two? And secondly, we've seen limited Phase II PFS data for the folate receptor class in general.

So could you frame any target PFS profile or PFS delta versus control arm you'd expect to see to be clinically meaningful for that Phase III readout?

Thanks, Charlie, for the question. So Tahi, can you address both of them, differences between the Phase II and Phase III and then the profile as it relates to sort of set of expression levels.

Yes. So by inclusion/exclusion criteria, they're very much more or less the same patient population. So there is a readout for sure based on the Phase II data to the Phase III data. And then the only difference is, of course, a Phase II data set has always its own dynamics vis-a-vis a Phase III trial. And then there's obviously like a larger footprint for Phase III trial as it relates to the Phase II trial. So these are kind of like the -- where the patients come on and the difference between having a choice or being forced to have a choice versus not having a choice. And so that's kind of the difference between these two data sets, probably all to say to that. As it relates to speculating on the readout, I don't think I want to do that. All I can say is that we are super excited about this data that if you look at what is already in the public domain for Rina-S, it shows a very high response rate, 50%, plus 50%, which is probably even more important, a very long durability of response.

And this duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AE. So it then allows a long continuation of treatment, which then drives the duration of response. And if you put these things together, you can already get a sense of like the direction of the PFS, which I think will be, without a doubt, not only significant, but also meaningful for patients. I think that's where we should leave it and then we can have this conversation when the data is in the public domain.

Thanks, Tahi. And on top of that, Charlie, you will get that we are like a year, 1.5 years ahead of some of the potential competitors. So I think we're in good shape here.

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

Great. Quick question on peto. For the first-line study, can you just give us a sense when you upsize the study, can you confirm that you didn't change the powering assumption and that you're enrolling the random distribution of HPV negative and positives that are in the market, you're not enriching specifically for only one subtype? And then secondly, you're going to show us the second-line recurrent head and neck data at ESMO with or without pembro? Is there a chance that you might want to move to Phase III in that study with pembro to complement your monotherapy second-line data, which is coming Q1 next year?

Thanks, Yaron. Tahi, can you address both of the questions?

So, let's take the first one first. This is -- I think we said multiple times, we changed this trial to increase the probability of success. And this was not in any particular shape or form driven by anything that really emerged after the acquisition. This was actually a decision that we at Genmab had made during the diligence process and that got executed immediately. It was one of the first things that we actually executed. This was purely driven to ensure that we have the proper power for all kinds of subgroup analyses that are going to be important for global filings.

So I think that's all that is to say about this progress. not necessarily part of our thought process or anything that we have spoken about. And then the second question that you had was around other strategies for peto. And I would say this, we've been very clear. There's going to be more to come on peto and head and neck. And we will present these trials in the granularity at a time similar to what we just did with colorectal when they are literally dosing patients. And that is -- so in some near future, we'll have more conversation with more activities about trials in head and neck, if that's fair.

Thanks, Tahi. I think that's clear. Thanks, Yaron, for the questions. Let's see whether there are further questions.

The question comes from the line of Benjamin Jackson.

I've got two, please. The first one on Rina-S. Look, we've seen a couple of other companies make moves into drugs that look to overcome TOPO1 resistance. So look, the aim for Rina-S is to come first to market, but are there any implications to this and thinking positively or negative to how this resistance could emerge for, when thinking about the Rina-S commercial opportunity once the competition comes to market?

And then secondly, look, not a focus topic today, lots of other stuff going on, but obviously, any updated thoughts on the EPKINLY potential in I&I diseases where B-cell pathology is key? There's obviously a few competitors making noises in this area with similar drugs. So it would be interesting to hear your thoughts there.

Thanks, Ben, for the question. So with Rina, we, of course, hope to be first to the market, and we are going to read out already a Phase III in Q4. But to Tahi, do you want to comment on TOPO1 resistance and strategy for Rina?

Well, I mean, you said the first one. The most important part is there are already three Phase IIIs actively enrolling patients in ovarian cancer, one in PARP and two in PSOC maintenance and one in the platinum replacement strategy. And so we are constantly and actively working on moving essentially the entry point for Rina into earlier lines. And we have already talked about that there's more to come also in the ovarian cancer space with Rina. And that's basically the reality you have to like develop these drugs and then just try to move into earlier lines as efficiently and as effectively as data allows and operation allows.

That's the first part of the -- also the only thing to say about this emerging idea of TOPO resistance because if Rina, which we are very confident, will be the first TOPO payload ADC in PARP, then this is more a post-Rina problem, to be honest.

Exactly. And then INI and epcoritamab, right now, the focus then is on cancer, multiple cancers, and we will have exciting data readout in Q4. And then let's discuss INI in more detail in the future. But cancer is clearly the priority for us right now.

And our next question -- and the question comes from the line of Judah Frommer from Morgan Stanley.

Maybe just a follow-up on peto in frontline. Can you help us with thoughts on the nature of the update in Q4? So it will be a top line, but can you give us any direction on whether you'll kind of press release in line with some of the top lines we've seen for EPKINLY? Or could we potentially see subgroup data perhaps by HPV status? And if not, do you have a sense for when we would see responses by HPV-negative versus positive patients? Thanks.

Thanks Judah. Tai, can you give a bit of color on the top line results that we intend to present in the Q4 time frame.

Well, so I think the accurate response to that question is top line results in Genmab historically focus on the primary endpoint. And I think that's what's going to be happening for peto as well. And then obviously, once we have the top line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data, in a public presentation at a conference.

Thanks Tahi, I think we keep it to that, Judah, at this time.

Now we're going to take another question. And the question comes from the line of Victor Floch from BNP Paribas.

Actually, two questions on EPKINLY. First one, very impressive momentum lately. And I mean, obviously, you've mentioned the accelerated uptake in the community setting. So just like from a modeling perspective, is there any stocking we should be aware of when it comes to like the remainder of the year for EPKINLY? And my second question still on EPKINLY, but on IP, there is a report from Bloomberg arguing that EPKINLY's formulation patent family could extend beyond the combination of mature patents and could potentially add like 5 years potentially in the U.S., 6 years in Europe. So just wondering whether you can discuss your IP strategy and your current assumption for EPKINLY in terms of IP?

Thanks, Victor, for the questions. The first one can be handled by Brad. And the second one, I think I will ask Tahi to give some color on the length of time for the patents. Brad, why don't you start on the stocking question?

Yes. No, thank you for the question. And just briefly on the community, we are encouraged, as you mentioned, with the momentum there. And it's due to the dual indications, the only bispecific with the dual indication then it's really been received extremely well by physicians as well as health systems. But as it relates specifically to stocking, no stocking issue or no stocking at this point in time to be discussed.

Thanks, Brad. And Tahi, do you want to add to address the IP and the length of time we have patent protection? Or don't you want to do that right now?

Yes. I would say this like discussing our patent and IP strategy on calls like this in the nuance details is probably not appropriate. Right now, I would stick to like mid-30s is where we are. And then, of course, there's always an IP strategy to try to generate additional intellectual protection, property protection that hopefully extend some of that protection.

Thanks. I think big figure, we keep it at that for now. Any further questions?

We have. Would you like to take?

Yes. Why don't we take one or two more and then we probably have to end the call and follow it up one-on-one.

And our next question -- and the question comes from the line of Kalpit Patel.

One more on the first-line DLBL -- DLBCL study. I guess, originally, when you guys designed that protocol and had assumptions for that frontline study, is the timing of the readout fourth quarter more so in line with what you guys originally modeled when you first started the study? And then when you completed the enrollment, I believe, in 2024, did that estimate -- the timing estimate of the readout materially shift. And the reason I ask is because the start to finish still looks roughly in line between when frontline and the POLARIX study started and they finished. So any color on your model assumptions would be useful.

Look, Kalpit, we are super excited about the frontline setting. The readout will be in Q4. We believe that the data will be excellent based on the Phase II data. We're not going to address any further timing and timeline issues here, but look forward to the data.

And now we're going to take our final question for today. And the question comes from the line of Matthew Phipps from William Blair.

Comparing the frontline CRC trial with peto to the OrigAMI-2 trial, they obviously look pretty similar in design, except for the peto trial does include an ORR primary endpoint. Is this safe to assume you will try to explore product Frontrunner in that frontline trial? And then just curious on Rina-S in non-small cell lung cancer had a trial ongoing this year. Any updated thoughts on the potential there when we might see some data from that Phase II trial?

Thanks, Matt, for the question. Tahi, can you address both, for the frontline CRC trial and also the non-small cell lung cancer trial data for Rina?

Sure. Yes. So it's fair to assume that we will also explore if it is opportune -- project frontrunner opportunities for colorectal for both trials. I think that is a fair assumption. And on the lung cancer Rina-S trial, once we have, I think, a data set that allows a robust discussion on what the next steps are going to be, I think it's a proper and opportune time to present that data. I've said this many times, we're working in a super competitive environment. There's multiple folate receptor ADCs from very large competitors that are coming left and right. And so I think presenting data without having already actioned on it may not necessarily be the smartest thing for us to do. So we will present that data at the time when we also have the next steps ready.

Thanks, Tahi. Thanks, Matt. So thank you all for joining us today, and thank you for that lively and invigorating Q&A. With three super important Phase III studies reading out in the coming months, we are well on track to deliver sustainable growth well into the next decade. We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. And as always, if you have questions for now, please reach out to our IR team.

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

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.

Good afternoon, everyone. Thanks for joining. I'm James Gordon, Barclay's European pharma and biotech analyst. And it's my pleasure this afternoon to host a fireside with Genmab and we've got two for the price of one because we've got Anthony Pagano, who is the Chief Financial Officer; and Brad Bailey, who's the Chief Commercial Officer. And we've got a little over 20 minutes, so we're going to discuss some of the exciting pipeline, readouts that come out this year. Maybe a bit on the longer-term outlook and maybe hopefully when these work, what's the commercial outlook for these products as well, that would be interesting as well.

So thanks a lot, both of you for joining. And well, maybe just to start off, so it's a big year of readouts. What is it that's coming out this year? And how excited about them are you? And where should we focus, do you think? What should investors be looking at?

Yes. Well, first of all, James, thank you so much for having us, seeing you back here this year. Pleasure to be here with you. You're right, 2026 is really set up to be a very important year for Genmab and our late-stage pipeline. And really, it's about the collection of the three brands EPKINLY, Rina-S and petosemtamab. And what's really appealing for me is you look across these 3 brands, each of them have FDA breakthrough therapy designation. Each of them had in 2025, meaningful data that served to increase our conviction in the prospects of these assets moving forward. I'll bring it specifically to your question, each of them in 2026 have at least one potentially registrational readout. In the case of EPKINLY, this could represent material line extensions into earlier line DLBCL. And then both for petosemtamab as well as Rina-S the chance to have the first potential registrational data leading to a launch of these brands in 2027. So I think individually, each of them are important but really looking at the collection of the data we're going to see during the course of 2026 to increase our conviction into sort of the shorter term, medium term and even longer-term prospects for these brands though I'm sure we'll dive into the specifics of each of them, but a lot to be excited about during the course of 2026.

Great. That's a lovely intro. If we could start with EPKINLY. So I believe we've got two things coming out this year. We've got data that, in the first half, that could convert your current conditional approval in refractory DLBCL into a full approval. And then we've also, at some point this year, got a frontline DLBCL readout. If we could start with second-line. So you had one trial, which was a mono trial that wasn't successful in terms of fitting its primary endpoint on overall survival. Does that have any read to the other second-line trial we're going to get this year? How confident are you in that other trial we've still got to read out?

So as a starting point, our confidence in these two additional readouts during the course of 2026 remains very high and unchanged. We see absolutely no read across from the monotherapy trial that you're speaking about. I think it's important to highlight that, that monotherapy trial in second-line plus DLBCL it was monotherapy. It did hit on PFS. As you noted, it did not reach the endpoint and overall survival and as we highlighted at the time of the announcement, that OS outcome was confounded by really two factors, one being, the impact of COVID, particularly on the EPKINLY arm; and then secondly, the impact of crossover to novel therapies in the control arm.

So if we kind of step back here, the point is it did hit on PFS as well as we see zero read across to the other two trials. And that's really a function of the totality of the data that we see in EPKINLY in combination with other therapies in particular, the Phase II data that we've seen EPKINLY plus R-CHOP in frontline and EPKINLY plus len in second-line plus DLBCL. We have been engaging with some thought leaders in this area post the readout of that trial.

Maybe Brad, do you want to add some of that feedback we've had?

Yes. No. Especially in this type of a patient population at the timing, the thought leaders, both academic as well as out in the community and some of the top global thought leaders in this space actually were quite impressed with the PFS in general is monotherapy. And I think that's the -- to keep that in mind. And then also just looking ahead with the breadth of the readouts that are coming this year feel like encouraged by this initial feedback, and that was also on the heels of having second-line FL approval in combination for the first time and where we had unprecedented hazard ratio and incredible data. So it's exciting moving forward.

And in the trials you're going to report this year for EPKINLY, do you need to show overall survival benefits in there? I don't believe that's the primary endpoint. What do you need to show for these two trials to be successful?

Yes. So the primary endpoint, as you just highlighted, for each of the trials is PFS. That is agreed regulatory endpoint, agreed with the regulators. And -- but of course, when you submit the data, the regulators will look at the totality of the data, but we believe the PFS is the regular -- I'm sorry, the important endpoint here for each of these trials.

Makes sense. And then for first-line, so whereas for the second-line trial, you said we're going to get a readout in the first half. For the first-line trial, it's uncertain when it is this year. Why is that? Because I think there is a paper that says that there's an interim setup at [ 0.75 ] as in 3/4 of the way through, there's an interim. So what do we know about that? Could there already been an interim? Or is that something that might still happen? So tomorrow morning, we could get an update or could it be any time?

So I think the -- you're correct, just to restate what you said. We are expecting the second-line DLBCL trial readout in the first half of the year. the Epco frontline, Epco plus R-CHOP and DLBCL is for 2026. This is an event-driven trial. And our view is that we're going to have data during the course of 2026, that should be registrational in nature.

So if I [indiscernible] which is understandable. You haven't said yet whether an interim has or hasn't happened. There could be one, but it's also the timing is a bit uncertain. because it depends how quickly the events occur?

Yes. I think our keeping to 2026 is primarily a function of just seeing the events occur.

And if this trial does work, what does this mean for the commercial potential of EPKINLY?

Yes. It further states kind of what we've been very consistent all along in saying that the value, specifically the value of EPKINLY is -- as we move into earlier lines of therapy. And this does a couple of things. One, it brings the medicine into the community setting more closer where the patients live; and two, obviously, the patient population numbers. You're looking between second-line and frontline DLBCL as we've talked about with readouts this year and follow on hopefully with approval upwards of around 90,000 to 100,000 more patients than what we have today.

And so if we price that up at where EPKINLY is, what sort of multiplier is that is the frontline opportunity versus the refractory one?

Yes. Frontline is about half the value of the brand.

And I think just maybe on that trial. I mean, we're really excited about the data that we've seen so far in the Phase II setting. Really looking forward to seeing these frontline readouts. And I think Brad started to touch on it, the importance of the second-line follicular lymphoma readout we saw last year, very strong data getting that approved in Q4 of last year. As a reminder, that's a smaller opportunity in terms of the patients, but it has been an important vehicle, if you like, to start talking about EPKINLY in combination therapy. Of course, in this case, second-line FL in combination with R2, but also importantly, starting to get outside those pure academic centers.

And maybe Brad, [indiscernible] we can add on a little bit more color?

Yes. No, the initial phase, and this has been basically all bispecifics, not just in lymphoma, bispecifics, the challenge of being sort of stuck in these major academic centers. And we're starting to see, as Anthony just mentioned, with the second-line FL, broader use in sites of care that are outside of sort of the mothership of these centers. And as a matter fact, out of our key accounts that we had set up where almost 80% of our total business was there, the one site ordering was where we were getting the business now multiple sites are ordering at least two, most of them have three sites, which means that the medicine is being administered close to where the patients live.

A final one on EPKINLY would be in first-line, what does a good result look like? Do you just need to be [indiscernible] just, but just clinically meaningful and statistically significant? Or do you need to be like very, very clinically meaningful because there could be some other things coming on in the future? So for instance, combining, say, Polivy with CD3, CD20 that Roche are doing, do you need to be much more than just like the minimum clinically meaningful to be confident it's going to be an attractive therapy for many years to come, seeing is there some other therapies coming along as well?

I'll start, Brad, and then you can add on. Let's start with the -- again, the Phase II data that we've seen adding EPKINLY to R-CHOP. We feel that, that combination, what we've seen in that Phase II setting is very strong regardless of the competition. In addition, we know the experience over the last several decades, two decades in this setting is R-CHOP. We know that, that is also used very heavily and is the standard of care and is using very predominantly in the community setting where the vast majority of these patients are. So we feel that adding on a very convenient subcutaneous EPKINLY on top of a widely used and accepted over multiple decades, therapy like R-CHOP is the right approach in this frontline setting.

Yes. No, I agree. And moving earlier combination in certain cases, chemo-free is what the market's asking for out of bispecifics and specifically with EPKINLY, we feel like we're well positioned there as well.

Thank you. I could ask a lot more on EPKINLY but I'm going to move on to the other pipeline because I know there's a lot going on this year. So we've also got for Rina-S, so your folate-targeting ADC the RAINFOL-01 study data, so that's second-line plus ovarian cancer. And so in the second half, we're going to get the readout there?

Correct.

So what do you need to show there? Because this is -- we've already got some ORR data, as in overall response rate data. It was more than 50% before. Do you just need to do that again? And is there any reason you wouldn't do that again? Is there something different about the population at all that you're looking at now versus what you've already reported that looks so good?

So first of all, we're very encouraged with the data that we've seen with Rina-S in platinum-resistant ovarian cancer. And again, we remind everyone, we've seen robust efficacy in terms of response rate and duration of response regardless of expression level of this target. Again, we've seen this in platinum-resistant ovarian cancer. We've also seen it in endometrial cancer, second-line plus endometrial cancer, which, in general, has a lower expression level. So looking at the totality of that data, we have a lot of confidence going into this Phase II potentially registrational readout.

Now similar to my comments for EPKINLY, I would say, really be focused on what we've shown so far in that sort of proof-of-concept setting. And we think that this next-generation full receptor alpha ADC is really a step change in the treatment of gynecological oncology indications. Again, here I remind everybody, we have the second-line plus product readout this year in H2. We have the companion, if you like, Phase III trial that has been now recruited, fully recruited, and we're following the same strategy in endometrial cancer and having that essentially accelerated to market Phase II and the companion Phase III and both of these are also well underway.

I think it's really exciting times to see what we can do with Rina-S. And really, again, bridging to broad a little bit, having a potential single option across these two indications could be important as we go to market.

I think opportunity-wise, you're talking between the two ovarian and endometrial, around 120,000 patients roughly split 55, 45 or so, ovarian endometrial. And we've learned this through EPKINLY as we were indicated for both DLBCL and FL as you're operationalizing the new modality outside of the key academic centers, it's a big convenience factor. The feedback from thought leaders and physicians has been very positive being able to operationalize one, and we're seeing this as well. As you see ovarian and endometrial competitive landscapes are a little bit different. And so we like the opportunity there as well with the dual indication.

And is it all or nothing, either works in everyone across all folate expression levels? Or could there be a scenario where actually, you look at a subpopulation. When we find out -- when we see the headlines in the details, is that going to be important how it works in different subpopulations?

So as we think about potential top line results. I mean, we've not yet decided what that will look like. But I would imagine it's going to be top line results. We're not going to get into too much subgroup analysis now both the Phase II and the Phase III. Obviously, there are post-hoc analysis, in some cases, prespecified analyses looking at various cuts of the data. But generally speaking, top line results is kind of focused on the top line.

And I've also been asked about competition because you're not the only company with a folate receptor targeting ADC, [ does it look ] like a promising approach? One thing is time to market. But there are some other companies who are also going across folate expression levels. What do you see is the key differentiation for your assets?

When I think about evaluating any asset, I guess here, we're referring to Rina-S, there's kind of three parts of the framework. One is, what is your product profile? Can it be best-in-class? Second element is looking at it, can it be first in class? And then what does the CDP look like, i.e., Can it be broadest in class? As I think about Rina-S, it checks all of those boxes. Looking at the clinical profile, I think at this stage, we have the most amount of data, particularly when you look at it across indications, we have a chance to be at or above, I think, the majority of the competition first-in-class. We kind of talked about where we're at in terms of having the potential first pivotal readout in the second half of this year and having the Phase III in that [ prox ] setting already fully recruited. We talked about where we're at with endometrial.

And then we're not stopping there. We also started the Phase III in platinum sensitive ovarian cancer, and we're not going to stop there. That speaks to the breadth of the CDP. So we're looking to compete against all of these dimensions best first and broadest because this is the reality in oncology, there is going to be big competition.

Interest of time, I should move on to another -- the third interesting late-stage readout this year, which will be peto, so your bispecific EGFR and LGR5. And so my understanding is we're going to get data from one or even two head and neck cancer trials this year. So what do we actually need to see in there? What's the cutoff for the threshold? I believe again, we're talking about overall response rate data. What does a good result look like?

Yes, you're right, James. So again, just to confirm for everybody, this is unchanged. We're expecting one or both of the ongoing Phase IIIs to read out in the second half of the year. As a reminder, we have a frontline trial, frontline head and neck cancer. It is petosemtamab plus pembro in that frontline setting. And then we have the second-line plus head and neck cancer trial.

Again, I'd point back to the data that we saw during 2025. Now it was part of my opening remarks for each of the brands, including petosemtamab, we saw significant data that increased our conviction during 2025.

Now for petosemtamab to put a finer point on that. What we saw in the data that was presented at ASCO last year in that frontline setting, an overall response rate of around 63% in the combination, pembro plus petosemtamab that compares favorably to monotherapy pembro of around 19%. We see it nearly tripling when you add on petosemtamab, which, to me, is very significant. Also, if you look there at the overall survival data, the 12-month overall survival data, peto plus pembro came in at about 79% at 12 months which compares very favorably, in fact, to historical pembro controls. So we think that setup is very nice if we were to see that replicated as we move into the potential readout here in the second half of the year for one or both of the Phase IIIs. So it's really looking at the totality of the data.

The other thing that stands out for petosemtamab, if you look at the data is the rapidity of the response. You see the vast majority of the responders already responding at the first scan which I think is another important attribute as you think back about going into even earlier lines which we have firm plans to do. And here, we're going to start the first Phase III in locally advanced head and neck cancer by the end of this year.

But going back to my framework of first -- or sorry, best first and broadest, we're applying that same methodology, that same thought process to petosemtamab as well.

Makes sense. And a fireside I was just hosting, the company talked about the phenomenon where when you go from Phase I to Phase II to Phase III, you often get a bit less efficacy because you don't enroll the patients quite as tightly. Then this isn't exactly a Phase II to a Phase III, it is a Phase II. Would you expect any dilution because you're looking at more patients? Or is there any other reason to be a bit cautious?

Well I think what we look at the totality of the data for petosemtamab, we're very encouraged with what we saw in Phase II. I'm certainly not going to use a crystal ball and predict about what the Phase III is going to do. But based upon everything we've seen, we're not expecting in advance any kind of dilution to the effect. I mean, we're very encouraged with this product concept the modality. In our view, this is the best-in-class next-generation eGFR-based bispecific.

Thank you. So we've talked about three drugs. We've talked about EPKINLY, Rina-S and peto, and it's going to be a big year for readouts. But if they all readout, maybe a question for Brad, how do you go about maximizing the value for those because Genmab is doing some distribution of products at the moment, EPKINLY and Tivdak and some partnerships as well. But are you going to build a global distribution network for all of these? And would that be a huge OpEx? How are you thinking about that already now?

Yes. We'll take the OpEx questions towards the end, but we've been quite busy in the last several years putting building businesses for both EPKINLY and Tivdak in partnership. But just as a quick level set in U.S. and Japan, we built the full complement of the business running the business booking sales, market access, everything, pricing reimbursement as well. And so feel very strongly in those two markets where the majority of the revenue comes from with both brands. We've now moved into with Tivdak as we've taken over the market authorization ownership rights from Pfizer for rest of world outside of China, where we're building our European business. So we have a launch in Germany that just took place. So we're showing success in scaling our business and opportunities also in U.K. and France and soon to be Italy and Spain. And so in these select key markets, we will certainly independently go to market. And then in the other markets, we'll look at either distributor ships or some type of partnership.

Because if you see -- I think Anthony mentioned upfront with EPKINLY, we've stated $3 billion plus, Rina-S, $2 billion. And then with petosemtamab in the multibillion range, it will using our proven launch engine, EPKINLY is now well on its way to become into core therapy in B-cell lymphomas, and Tivdak is the global standard of care in cervical. We really do like this [indiscernible] oncology space as it moves -- as we move from Tivdak as our foothold, if you will, into Rina-S. It's been very beneficial for us from both a development perspective. as. Well as we're bringing our medicines to patients ourselves. And from an OpEx perspective, everything that we've stated at this point from a guidance perspective is exactly what it is and feel confident that that's where we'll be.

Well we've got two minutes left, although I've been asking R&D questions, you are the CFO. So maybe I need to ask you a slightly more numbers-y question to me if I'm doing my job properly. So if everything works this year, if all the readouts work, what is the financial outlook for the company? You've also got the royalties from J&J on DARZALEX around the end of the decade go away. But is the company then positioned for growth even through that? What's the overall growth outlook if everything works?

The growth outlook for Genmab is very strong. Brad has articulated the peak year sales estimates for the three brands. That's EPKINLY, $3 billion plus, Rina-S, $2 billion plus and then petosemtamab as multibillion dollars. Just think about that, what that looks like as a stand-alone oncology business, very, very strong.

Importantly, what's underpinning those peak year sales estimates is, for the most part, particularly zooming in on EPKINLY and Rina-S is the known clinical development plans. Of course, both for Rina-S as well as petosemtamab, there are potential expansion opportunities. And those -- we're in the process of doing some early clinical proof-of-concept work.

And then let's not forget our proven research and discovery engine. I can't tell you which product, James, but I'm fully confident as we get into '27, '28, and '29, there should be an internal program that should move from early to late-stage development. That's just based upon our true proven track record. So you have that strong foundation of the royalty business. Of course, as you're right, DARZALEX will go away, but the rest of that portfolio of royalty products as a portfolio has nice growth prospects through that DARZALEX loss of royalty, then you think about stacking on the proprietary business, EPKINLY, Rina-S, petosemtamab expansion opportunities there, plus again, as I mentioned, a pretty good probability on other product from our early stage pipeline to flow through. So overall, the growth prospects, particularly when you get into the 2030s are very strong here at Genmab.

Great. Well, with that, we're out of time. So thank you very much for joining us today.

Yes. Absolutely. Our pleasure. Thank you.

Thanks for joining us. My name is Jonathan Chang. I'm part of the Leerink Partners Equity Research team. It's my pleasure to host the management team of Genmab. We have with us today, CFO, Anthony Pagano; and Chief Commercial Officer, Brad Bailey. Thank you guys very much for joining us today.

Yes, it's a pleasure to be here, Jonathan. Thank you so much for having us.

Would you like to take a few minutes to briefly introduce the company?

Sure. I can kick things off, and then we can dive into your questions. So 2025 for Genmab was another very strong year, and that's both from a financial perspective as well as the progress we've made with our late-stage pipeline. Financially, we saw another year of very strong revenue growth, disciplined OpEx management and really having that profit flow through to the bottom line. As we exit 2025 from a pipeline perspective, what's important to highlight is we have 3 late-stage programs, EPKINLY, Rina-S and petosemtamab. And in 2025, for each of these programs, we saw meaningful clinical data that served to increase our conviction around the prospects and growth opportunities for these programs. And these 2 key themes that I just highlighted in 2025 in terms of the strong financials and the clinical progress carry over into 2026.

For each of these programs, both EPKINLY, Rina-S and petosemtamab, we expect registrational trial readouts during the course of the year, which could carry forward in terms of the potential launches in 2027. So really, what you have here at Genmab is a very strong foundation across the entire business, the financials, the technologies and now most importantly, these 3 late-stage programs with the meaningful data in 2026, leading to potential launches in 2027, which really set us up very well as we get into the back part of this decade, Jonathan. So with that, maybe we should dive into your questions.

Sure. So of course, you mentioned 2026 is an important year for Genmab, where there are several key readouts expected across the late-stage pipeline, including from EPKINLY, Rina-S, petosemtamab. How do you view the commercial opportunities for each of these programs?

Sure. I don't know, Brad, did you want to sort of maybe kick things off?

I'll kick it off. And then we view -- certainly, as we've said quite a bit with EPKINLY, we view this as a blockbuster medicine with the $3 billion-plus potential. And we've also said all along the value proposition of EPKINLY is one that is extremely well suited as we move into earlier lines of therapy. And I think that's critical. We're very encouraged at this point with our performance to date and have made meaningful progress launching second-line FL most recently and starting to see not only our core sites where uptake has been robust in the initial phase in the later lines of therapy in DLBCL and second-line FL where patients are treated a little bit more closely to where they live, the value proposition of EPKINLY with both durable efficacy, but most importantly, that dual indication operationalizing a bispecific in the community is becoming meaningful. And so overall, moving into these earlier lines of therapy, we feel we're very well positioned from an EPKINLY perspective.

Yes. Maybe in terms of bringing the asset that fits into the kind of set the stage. Rina-S, think about the progress we've made in the last 18 months from a pre-proof-of-concept asset to exiting 2025 with 3 ongoing Phase III trials going to have the first potential registrational readout here in 2026 in the second-line plus PROC setting. Here, what really is encouraged with Rina-S is the overall profile of the asset in terms of its differentiated efficacy, we think differentiated safety, ultimately leading to very long potentially duration of therapy or duration of response.

Here, Jonathan, for Rina-S, we've pegged the peak opportunity of being $2 billion plus. And this is really underwritten by 4, let's call it, subsegments of the GYN/ONC space. Of course, we have the second line plus PROC. You also have platinum-sensitive ovarian cancer and then frontline and second-line endometrial cancer. And the good news is that out of those 4 sort of subsegments, the Phase III trials are already well underway. So it's really the combination of the product profile in terms of potential to be best-in-class, first-in-class and it's also broadest in class gives us confidence in that $2 billion-plus number for Rina-S.

Then in terms of petosemtamab, again, here to remind you, this is a program that we acquired at the end of 2025. It has two breakthrough therapy designations, two ongoing Phase III trials, one in frontline head and neck cancer, the other in second-line plus head and neck cancer. These Phase III trials are underway. And here, we expect one or both of these Phase III trials to read out during the course of 2026. Here for petosemtamab, we've pegged the peak opportunity as a multibillion-dollar opportunity. As I mentioned, we have the 2 ongoing Phase IIIs. We have very clear plans to start a next Phase III in the earlier line of head and neck, locally advanced head and neck cancer during the course of 2026.

And ultimately, if you sort of then think about Rina-S and petosemtamab that kind of round out the conversation, there are these, let's call it, initial core indications, Gyn/Onc for Rina-S, and head and neck cancer petosemtamab, for each of these programs, we have earlier-stage clinical work ongoing to potentially expand the clinical reach of these 2 programs. So a lot to be excited about. Obviously, the end-market performance for EPKINLY, the expansion opportunities there, but also what I just covered for Rina-S and petosemtamab. So really exciting time here at Genmab.

Great. Thank you. So we discussed what the peak numbers might look like. Can you help us understand what the time lines of these programs and commercial launch plans look like relative to the DARZALEX royalty stream.

Maybe I can kick start. I think if we take it program by program, we can obviously do that, Jonathan. But maybe the place to start is just look at the totality of what we just explained. Obviously, we're all aware of DARZALEX. I'm not going to get into the DARZALEX math here and trying to get into the replace -- exact precise replacement math. But look at the totality of what we just talked about, EPKINLY at $3 billion plus, Rina-S at $2 billion plus and then petosemtamab is a multibillion-dollar opportunity.

And again, think about the expansion opportunities for both Rina-S and petosemtamab. And let's not forget the robustness of our earlier-stage pipeline and our research and discovery engine. So there is a very strong stand-alone oncology business apart from DARZALEX and our other royalty streams.

Now let's go through product by product. EPKINLY, as we know, is competing very well in the third line plus settings where we're approved today in DLBCL and follicular lymphoma. We have this next expansion opportunity into second-line follicular lymphoma that came online last year. Just to remind ourselves, this is a smaller opportunity in terms of patient size initially, where it's approved in the United States, maybe around 4,000 patients. Brad may comment in a few minutes about why that's important, not only financially, but maybe more operationally, so we can come back to that.

But the real trajectory, Jonathan, towards that $3 billion-plus number for EPKINLY is going to come from getting into earlier lines initially here into DLBCL. Here, again, we have readouts for EPKINLY, both in frontline DLBCL and second-line DLBCL during the course of 2026. So that is going to be really the springboard to start seeing on that trajectory towards that $3 billion-plus number. As a reminder, we also still have for EPKINLY, the frontline follicular lymphoma trial, which will read out here. We've not yet provided guidance on timing. So it's really going to be these 2 trials, seeing that data during the course of 2026, go through the regulatory process back half of '26 into '27 to sort of drive us towards that $3 billion-plus number.

For Rina-S, it's earlier days, of course, this product is not yet on the market. Here, we have the $2 billion-plus number. Initially, it's going into second-line PROC, which will have that data here in '26 and a launch into 2027. We've not yet broken down that number, but those 4 sub-indications that I went through earlier that are driving that $2 billion-plus number. We look -- we're very excited about what we're seeing in terms of the differentiated efficacy, differentiated safety profile, which ultimately together lead to a very robust duration of response, particularly in platinum-resistant ovarian cancer.

And then maybe last but not least, petosemtamab here, again, we're expecting data in '26, potential launch in '27. Here, we have been a little bit more granular. We said that based upon the robust clinical profile, we're expecting petosemtamab to do $1 billion by 2029, ultimately driving us towards that multibillion-dollar plus potential. So a lot to unpack there, Jonathan. We can happy to maybe dive into anywhere you'd like to go from here.

Great. Thank you. From a commercial standpoint, can you talk about your ability to market Rina-S and petosemtamab yourselves?

Yes. No, it's a great question. Thank you. And we're very encouraged to date, and we've been sort of building for this for the last several years actually, and very strategic and deliberate in our footprint, building businesses in both the U.S. and Japan, where we're booking sales and now also building businesses in Europe, where we're launching TIVDAK on our own as well independently, just like we did in Japan.

And I think it's a very important point to make, launching TIVDAK globally puts us in a position from a Gyn/Onc perspective to be uniquely qualified and excited around the potential opportunity for the launch of Rina-S. So we have the infrastructure in place. It's building -- being built, especially based on the core markets where we know we will need to succeed and do well. And we're feeling very confident as it relates to the Rina-S launch opportunity.

And petosemtamab?

Yes. And petosemtamab, likewise, you're putting the synergies between building businesses in both U.S., Japan and now in Europe. You have all of your core capabilities that you need from the launch perspective, and then we'll build certainly our build teams as we get close to launch, which we have a little more time outside of U.S. and Japan, but U.S. and Japan, we're extremely confident as well.

I think here, what's important to highlight under Brad's leadership, really, we've -- he and the team have started to build out and have built out really strong road maps and playbooks in advance of the launch. We've done it with TIVDAK initially, done it rather successfully with EPKINLY, both in the U.S. and Japan. And these same playbooks are now being applied to the potential launches for both Rina-S and petosemtamab in 2027. We talked a lot about the investments that we've been making over, let's call it, the last 4 or 5 years in terms of this commercialization readiness and capabilities. This is why we've done it. We knew eventually we would get into earlier lines for EPKINLY, and we knew that we have additional launch opportunities.

I didn't know the time it was going to be for Rina-S and petosemtamab, but this is why we've made the very strategic forward-thinking investments we've been making over the last a number of years. So the team is really looking forward over the next 12 months or so to get ready for these launches and then post approval to really hit the ground running.

And maybe just to add one other topic on that. The track record of success of sort of U.S. and Japan, now also in launching TIVDAK in Europe has been very strong, and we're very encouraged by what's been delivered to date. And these are -- now TIVDAK is the standard of care in second-line cervical cancer globally. EPKINLY is leading globally and this, as we know, is a highly competitive marketplace. And so we're, again, very encouraged with the past performance, dictating the future success as well.

Great. So let's double-click on exactly that for EPKINLY. What are the reasons for confidence in the ability to maximize the commercial opportunity for EPKINLY? So of course, this includes being able to penetrate earlier lines of treatment, get more adoption in community settings and take share versus other CD20 bispecific players?

Yes. Great question, and I'll try to take that holistically and then drill into each one of those. And back to the comment around the success and how we've been encouraged to date with our success. This starts really with the value proposition of the product profile. The efficacy, both in DLBCL and FL, I mean the hazard ratio of second-line FL is unprecedented. And you have a dual indication and operationalizing bispecifics in the community is a topic across the industry, how to really do this well. And we feel uniquely positioned and it's starting to show out with the second-line FL launch uniquely positioned to bring EPKINLY closer to patients in the community.

We have out of our core sites, the key sites that have been ordering EPKINLY from the very beginning, which, for the most part, began with all the CD3, CD20s in these CAR-T centers, if we call them. Each of those key accounts with where we were focused initially, over -- just over 80% of those key accounts have now put themselves in a position where they have at least 3 sites ordering, not just at the main hub. And so you're seeing the operationalization of bispecifics become more relevant. And certainly, with the dual indication, the safety profile, the subcutaneous -- seamless subcutaneous administration at this point for DLBCL and FL, again, putting us in a position to not only perform in these key academic centers, but also in the community.

Got it. How should we be thinking about the impact of the results of the Phase III EPCORE DLBCL-1 study of EPKINLY monotherapy?

Yes. So this is the trial that read out earlier this year. This is the Phase III monotherapy trial you're referring to. Here, we had, obviously, the positive signal and positive readout in progression-free survival and really not the same case for overall survival. As we sit here today, we're obviously further analyzing the results. We believe the results were confounded due to COVID, as we highlighted, also confounded due to use of novel therapies subsequently in the control arm.

We look forward to presenting and going through that data in more detail in the future. Again, the highlight here is that a monotherapy EPKINLY versus the control arm, which was multiple products, including novel therapies, did beat on PFS. We think that is clinically relevant. And also as we sort of think about moving forward, 0 read across to the ongoing combination trials, EPCORE plus R-CHOP in frontline DLBCL and EPCORE plus lenalidomide in second-line DLBCL. So 0 read across there.

And here, we're very -- our confidence remains strong because of what we've seen EPKINLY can do in combination more broadly, but also the Phase II trial results that we've been publishing at ASH and other conferences at the last number of years in the same exact combos, same exact setting. So it's something that we have to work through. But as we sit here today, it's something we're just going to work through and haven't seen any significant impact to commercial performance as a result of this.

And maybe just to add on that, too quickly, from a thought leader perspective, given the circumstances, obviously, the timing of the trial with COVID, but also back to Anthony's point on the monotherapy, encouraged actually, and it was much more as expected as opposed to not.

Got it. Maybe switching over to RINA-S. What do you see as the key areas of differentiation versus approved FR alpha Elahere and also the growing list of ADCs in development in the ovarian cancer landscape.

So Brad, I'll start. It goes back to this framework, Jonathan, maybe it's too simple for some. I think about best-in-class, first-in-class, broadest in class. Against existing competition, what we're seeing from Rina-S is efficacy across the full spectrum of folate receptor alpha expression levels. We've seen this not only in platinum-resistant ovarian cancer, but also in endometrial cancer, where we're seeing robust activity, again, regardless of expression level.

We're also seeing in terms of that best-in-class profile relative to existing competition, potentially differentiated safety profile, which again means that patients can stay on drug longer, which then drives that duration of response. So we're seeing differentiated response rates across that expression level, differentiated safety, but ultimately better outcomes for patients because they stay on drug longer. So that duration of response is longer. So that's in terms of best-in-class. That's really relative to existing competition. Now relative to future competition, that's where first-in-class and broadest in-class comes into play. I mentioned the progress and highlight the progress we've made since acquiring the program, the robustness of our clinical development program, we're really looking to own the gynecological oncology space. So we have thought about the existing Phase IIIs.

I can't highlight today what else is to come, but there is definitely more to come in terms of Phase III development for Rina-S and Gyn/Onc. Really then leveraging that first-in-class position as well as being broadest in class. So we like where we're at relative to existing competition and really going to keep our foot on the gas pedal to really try to distance ourselves from future competition. And that's also then where the handover to commercialization is super important. It's not just about the clinical development, it's making sure that if and when the product is approved, our commercialization teams are going to be in place to really then effectuate a very strong launch.

How much of a time line advantage do you think Rina-S has over other ADCs in looking to address this all-comers population in platinum-resistant ovarian cancer?

So I think it's probably not helpful for me to speculate. I know what we can do. I know what our time lines are. Again, we're going to have our data in second-line PROC, the Phase II trial this year has been also communicated, the Phase III kind of confirmatory trial in a similar patient setting is also now fully recruited. We also have the second-line endometrial Phase II and Phase III, also very well underway. So we are focused on what we can do and control as it relates to the conduct of our trials and then regulatory readiness and launch readiness. We're doing everything we can every single day to maintain that leading position. We're, of course, very mindful of the competition. That's why we want to keep our foot again on that gas pedal.

Understood. And how do you guys see the endometrial opportunity relative to ovarian cancer?

Yes. It's -- if you look at the patient populations, looking at frontline and second line, you start to see comparable numbers of patients. And so we see this as -- Anthony started with the 4, sort of 4 components in both PROC BSOC and with endometrial. I think it's a very equitable opportunity, if you will, overall.

How about from a competitive landscape consideration? How do you see endometrial comparing to ovarian?

Yes. I think in general, certainly some different players there. And -- but back to Anthony's point on where we are with endometrial and the development perspective, but then also the agnostic with the FR alpha expression, we feel confident there as well.

Yes. I think this kind of brings back to some maybe similarities in terms of the approach and the mindset going back to EPKINLY, having a single option across follicular lymphoma and diffuse large B-cell lymphoma, similar principle here, same physicians are treating not only cervical cancer with TIVDAK, but here for Rina-S both ovarian cancer and endometrial cancer, having a single option, we think is also going to potentially be a really key differentiator when we go to market. So we're really focused on having these 2 options or the single option for these 2 indications available as quickly as possible for patients.

Got it. Maybe we will switch over to petosemtamab. How do you guys see this program positioned in the head and neck cancer landscape?

I can start. And the starting point really is looking at the clinical data that we've seen so far. As a reminder, both in frontline as well as second-line plus head and neck cancer, petosemtamab has been awarded FDA breakthrough therapy designation, really keying in on that frontline data that was released last year for petosemtamab, thinking about the additive benefit on top of pembro where you saw nearly a -- or more than a tripling of the response rate.

So we're seeing very strong response rate. We're also seeing a rather quick clinical response. A lot of the response is coming at the first scan. So not only a robust signal, but a very fast signal as well. And the collection of those 2 is carrying through to what we've seen in terms of the 12-month progression-free survival or overall survival, excuse me, in the high 70%, I think, 79%. So the overall profile of petosemtamab, particularly in combination with pembro is rather strong, which then gives us the confidence to go into the earlier lines locally advanced here with the first Phase III slated to start in 2029 -- I'm sorry, at the end of 2026.

Again, here, there's going to be competition in oncology is a given. So we're really focused on maximizing that clinical profile, go broad and go fast. This is really the principle, particularly as it relates to being first. We think, again, here relative to other eGFR-based bispecifics, we have the chance to be first in head and neck cancer, clear line of sight actually to doing that. So we're super focused on really seeing the first trial readout here in 2026 and get the market in '27.

Got it. And what can we expect in the top line second half '26 disclosure or disclosures from the 2 Phase III studies? There's the frontline study and then there's the second and third-line study.

Yes. So again, to remind everybody, there are 2 ongoing Phase IIIs, one in frontline and one in second line plus head and neck cancer. What we said is that one or both of the trials will read out this year. And that's probably where we have to leave it. Jonathan, if I start kind of telling you what the data endpoints could be that we're looking forward to, then you start by trying to guess or infer which of the trials are going to read out. I think what's important to note is that the clinical profile that we were able to highlight last year at medical conferences is super strong.

We remain convinced that this has best-in-class properties in terms of next-generation eGFR-based bispecifics. And this is only the beginning of the development of this product. So I'd say stay tuned to seeing the top line readouts in the back half of '26.

Got it. How about opportunities beyond head and neck cancer for this program? What's your latest thinking on that?

Yes. Obviously, this has been a topic of conversation. It goes back to that really profile of the program in terms of petosemtamab. And as you all know, in the back half of '25, we released some early but very encouraging data in colorectal cancer. We're in the process of collecting some more data in this indication and look forward to sharing some incremental data in colorectal cancer in the back half of 2026.

Also, you would have seen we have started a proof-of-concept trial in non-small cell lung cancer, unsurprisingly, perhaps for petosemtamab. So I'd say, right now, really focused on this lead core indication of head and neck cancer and then looking really thoughtfully at potential expansion opportunities.

Understood. Let me just check and see if there are any questions from the audience. Is it fair to assume that Genmab at this point is done with -- for the time being on the M&A front?

So for a capital allocation perspective, right now, we're focused on investing back in the business along our strategic and investment priorities, which is really around both R&D and commercialization launch preparedness and execution across these 3 brands. That's absolutely the focus from a financial perspective, but also from an operational perspective, given the very significant opportunities that are right in front of us.

From then further from a capital allocation perspective, we're focused on deleveraging. In terms of acquiring Merus, we took on $5.5 billion of debt. And we said we want to get at or below 3x gross leverage by the end of 2027. So excess capital really will be deployed in that deleveraging plan between now and the end of 2027. Beyond that, let's just see where we're at, at that point in time. It doesn't mean we're not going to do smaller technology deals, really tool and component type deals to plug into our research and discovery engine, but these will be rather small by definition.

Understood. Maybe just in our last minute here, can you just remind us what the milestones and catalysts for the company are for 2026?

No, absolutely. I mean -- and this is really where I think we're really excited and all of you should be equally excited. For EPKINLY, we have the 2 Phase III readouts in frontline and second-line DLBCL. Second-line DLBCL will be in H1 and then the frontline trial will be during the course of 2026. And in particular, the frontline DLBCL is around half of the total addressable patient population for EPKINLY.

Then we have the second line plus PROC data. First, registrational data we'll see for Rina-S, fueling the launch of the brand, hopefully in 2027. And then the same for petosemtamab, where we're going to have the first registrational data here in 2026 in the back half of the year, leading to the potential launch of that brand as well in 2027. So if you think about it, really having material significant line extension opportunities for EPKINLY and then launching 2 blockbuster brands in Rina-S and petosemtamab in terms of the clinical data in 2026 and then the launch opportunity in 2027.

Great. Thank you very much for taking the time.

Thank you.

Hello, and welcome to the Genmab Full Year 2025 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, 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 2025. 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. As we reflect on 2025, I would like to remind you of the commitments that we made at the beginning of the year. We said that we would accelerate the development of our high-impact late-stage pipeline, that we would maximize the potential of our commercialized medicines and that we would deliver on our capital allocation priorities. I'm pleased to say that we have delivered on these commitments. And we begin 2026 with a diversified, high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the 2030s.

In 2025, we grew total revenue by 19%, fueled by both our royalty portfolio and sales from our own medicines. And we also invested fully [ in line ] with our capital allocation priorities. Importantly, we have also grown operating profit even while making these strategic investments. 2025 was marked by some significant milestones in our mission to deliver innovative medicines to patients.

Highlights include positive momentum for EPKINLY as it continues to demonstrate the potential to become a core therapy in B-cell lymphomas, its FDA approval in second-line follicular lymphoma in combination with R2 as well as the unprecedented data in this indication are key milestones. Taken together, these move treatment into earlier lines of therapy and expand our impact for people living with follicular lymphoma. We also built on our commitment to the GynOc community. In addition to the availability of TIVDAK in both Japan and Europe, we expanded the development of Rina-S, ending the year with 3 Phase III trials across PROC, endometrial cancer and PSOC.

Finally, a pivotal step on our journey to sustainable diversified growth was our acquisition of Merus, which enhanced our late-stage portfolio with petosemtamab. Petosemtamab -- with petosemtamab joining EPKINLY and Rina-S, we have a strong pipeline of late-stage assets that will provide us with multiple value-creating catalysts in 2026 and in the future. Now let's take a look at the strength of these 3 programs on the next slide.

With the 5 combined breakthrough therapy designations, these 3 programs have multibillion-dollar potential, and they firmly underpin our long-term growth. EPKINLY is currently the only bispecific antibody with a dual indication across B-cell malignancies in the U.S., Europe and Japan. And following unprecedented data, EPKINLY plus R2 is well positioned to become a best-in-class option in second-line plus follicular lymphoma. Rina-S is a folate receptor alpha targeted ADC designed to broaden eligibility beyond high expressers.

Based on current expression distributions, this could expand the addressable population by as much as 3x versus approved medicines that are restricted to high folate receptor alpha expression. And finally, petosemtamab, a potentially transformative EGFR LGR5 bispecific antibody with compelling data in both first-line and later-line recurrent and metastatic head and neck cancer. As a reminder, in the first-line setting, petosemtamab in combination with pembro achieved a 63% response rate, and that is more than 3x higher than the 19% that has been observed with the standard of care.

2026 will be a defining year for all 3 of these programs, as we will see on the next slide. We expect up to 6 potential -- potentially registrational data readouts that could set the stage for multiple important product launches and line extensions in 2027.

In the second half of the year, we expect Phase II data for Rina-S in platinum-resistant ovarian cancer. We also anticipate that one or both Phase III trials for petosemtamab in first and second line or third line head and neck cancer will deliver top line data in the second half. And while we anticipate around 25,000 potential patients for later lines of therapy in first-line head and neck cancer, this increases to an additional 41,000 patients. For EPKINLY, we anticipate data from 2 Phase III trials in diffuse large B-cell lymphoma. The indication with the largest addressable patient population, around 70,000 people is, of course, frontline diffuse large B-cell lymphoma, and we are looking forward to data in this indication in combination with R-CHOP this year.

We are also looking forward to data in the first half of the year in second-line plus diffuse large B-cell lymphoma in combination with lenalidomide. Now as you are aware, in January, we announced top line results from the Phase III EPCORE DLBCL-1 trial of EPKINLY monotherapy. The results showed an improvement in progression-free survival as well as improvements in complete response rates, duration of response and time to next treatment. And in fact, this is the first Phase III study to demonstrate an improvement in progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma who are treated with the CD3/CD20 T-cell engaging bispecific monotherapy.

Overall survival did not reach statistical significance and further analysis of the data is ongoing, including the potential impact of a variety of factors, including COVID-19 and the increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting, and we will engage with global regulatory authorities on next steps.

The monotherapy results do not change our expectations for our other Phase III trials. And we are very confident that these studies continue to have the potential to move EPKINLY earlier in the treatment paradigm and significantly increase its addressable population from approximately 27,000 patients today to almost 150,000 patients by early in the next decade. The data presented across EPKINLY, Rina-S and petosemtamab in 2025 strengthened our conviction in these programs. Now in 2026, it is the meaningful registrational readouts that will be the catalysts that allow us to potentially bring these antibodies to patients in 2027. I'm pleased to now hand you over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

Thanks, Jan. 2025 marked another successful year for our commercialization team. We maintained leading positions for our proprietary brands globally, and we made important progress evolving into a wholly owned model, fueling our long-term growth engine. In the past year, we successfully executed 4 key launches across our portfolio, 2 of which were led entirely by Genmab, demonstrating the strength of the commercialization model we've built in the U.S., Japan and now in Europe.

We expanded our footprint to 3 additional markets, opening business operations in Germany, the U.K. and France, and we delivered on our commitment to bringing our antibody-based medicines to patients in an area of high need. To this end, TIVDAK became the first ADC approved in recurrent or metastatic cervical cancer in the EU, U.K. and Japan, providing a much needed option for patients whose disease progresses after initial therapy and where outcomes have historically been poor. Additionally, when its approval in the U.S. -- with its approval in the U.S. in relapsed or refractory follicular lymphoma, EPKINLY became the first bispecific antibody approved in any form of non-Hodgkin's lymphoma in the second-line setting and the first bispecific combination therapy approved in the lymphoma space.

These milestones represent progress for patients, and they set the foundation for our growth trajectory in gynecologic cancers, along with Rina-S in the future and further into B-cell malignancies. Through our efforts in 2025, sales of our proprietary medicines totaled $632 million. This is up 54% year-over-year and accounting for approximately 28% of our total revenue growth. We expect this growth trajectory to continue in 2026, grounded in the strong foundation we've built as we deliver our own medicines to an increasing number of patients around the world. Now let's take a closer look at EPKINLY. We closed out 2025 with solid performance, achieving $468 million in sales for the year, which represents a 67% year-over-year increase. This performance was driven by continued growth for the brand across geographies as the first and only bispecific with approved dual indication in diffuse large B-cell lymphoma and FL in Europe, Japan and the U.S.

In fact, EPKINLY closed 2025 with regulatory approvals in more than 65 countries, nearly all of which feature the dual indication. We continue to be encouraged by EPKINLY's strong momentum and the positive feedback we hear from physicians across geographies regarding EPKINLY's differentiated clinical profile, powerful efficacy and proven safety and the value of having a single dual indication option across DLBCL and FL. In the U.S., this momentum translated to continued growth for EPKINLY across sites of care with an acceleration in new sites ordering, including in the community and the majority of health systems now ordering from multiple sites.

As expected, following the launch of EPKINLY in second-line FL in November, we're seeing increased uptake suggesting that this approval will be a growth driver for the brand. In Japan, we continue to see EPKINLY's launch in third line plus FL build on the brand's success in large B-cell lymphoma. This is driven in large part by EPKINLY's dual indication differentiation and execution by our field teams to activate sites. Across all other markets, we continue to increase our presence through our partner, AbbVie, and its global footprint. We closed out the year with yet another quarter of solid sales for EPKINLY in these markets as we continue to see rapid uptake in countries gaining access and reimbursement.

Looking ahead, 2026 will be a pivotal year for EPKINLY as we advance our position in early lines of therapy and anticipate key data readouts supporting EPKINLY's versatility and status as the core therapy in B-cell malignancies. Our focus is on delivering EPKINLY to as many patients as possible, particularly in early lines of therapy where we see the market opportunity and critically where we may have the opportunity to truly transform the trajectory of these diseases for patients. To that end, we're maximizing our first-mover advantage in second-line FL in the U.S., and we expect to build on this opportunity across markets with anticipated approvals in this setting in Europe and Japan later this year.

With this traction in earlier lines of FL, we're looking towards key readouts in 2026 in first- and second-line DLBCL with fixed duration EPKINLY combination therapies to further strengthen EPKINLY's position in DLBCL. Together with a robust development program for EPKINLY and strong execution by our teams, we see a clear opportunity for EPKINLY to achieve blockbuster status over the next few years. Moving now to TIVDAK. TIVDAK continues to be recognized as the global standard of care in recurrent or metastatic cervical cancer. In 2025, TIVDAK generated $164 million in sales, representing a 26% year-over-year increase. TIVDAK continues to perform well across both new and established markets, highlighting the clear need for treatments that improve survival for women with advanced cervical cancer across geographies.

In the U.S., notably, TIVDAK posted its fourth consecutive year-over-year growth, underscoring its continued market leadership. This strong stable performance continues to be driven by the depth and breadth of sites of care using TIVDAK. In Japan, TIVDAK demonstrated another strong quarter of continued performance, underscoring the traction it's gaining in the second-line setting and the high patient need in recurrent and metastatic cervical cancer in the country. This trend continued in Europe where the launch in Germany continues to be off to an encouraging start with strong consistent uptake and positive physician feedback.

As the first medicine we've launched in Europe independently, our efforts in recent months have demonstrated our ability to strategically build infrastructure and scale in new markets. We received MHRA approval in December in the U.K. and are now working towards reimbursement to bring TIVDAK to more patients as soon as possible. As we look ahead to the new fiscal year, we have the foundation in place to continue this momentum and bring TIVDAK to additional markets. Infrastructure and operations are well underway in new markets with our teams executing in preparation for exciting launches on the horizon.

We expect to see continued positive performance across markets as we strengthen and scale our presence and broaden our impact within the gynecologic cancer community. Wrapping up, 2025 was a critical year in our company's evolution. We built on our proven launch expertise and scientific strength and achieved key milestones to solidify our commercialization model and business operations that will unlock our ability to deliver on the significant growth opportunities ahead of us.

Our proven ability to evolve our model in the U.S. and Japan, coupled with the early traction we are seeing in Europe, gives us the confidence that we have the pieces in place today to drive future growth and expansion. With this strong foundation, 2026 is shaping up to be another meaningful year for Genmab. We will grow the impact of our proprietary portfolio, expand our footprint and sharpen our capabilities as we look toward entering new and larger market opportunities and delivering on the blockbuster potential of EPKINLY, Rina-S and petosemtamab in the coming years. With that, I'll hand the call over to Anthony to discuss our financials.

Thanks, Brad. 2025 was a year of strong execution for Genmab with solid revenue growth, expanding profitability and disciplined investment. Looking ahead, our 2026 guidance reflects the same framework we outlined at Q3 and at the time of the Merus acquisition. And it also reflects our continued commitment to funding growth while maintaining substantial profitability. Now before diving into the numbers, please note that the results and guidance I will review exclude the impact of acquisition-related expenses, including amortization.

A reconciliation to our reported results is included in the appendix. In 2025, total revenue increased 19% to $3.7 billion, reflecting strong execution across our royalty portfolio as well as continued progress for our commercialized medicines. We also continue to improve the quality of our revenue profile with a higher contribution from our own medicines, especially EPKINLY, further diversifying our revenue base. In addition, we strengthened our long-term growth potential with the addition of petosemtamab to our late-stage pipeline.

Alongside the Merus acquisition, we made targeted strategic investments during the year with operating expenses up 13%. The investments we've made in building our commercialization capabilities are already delivering for us today. And importantly, they are positioning us to support expansion into earlier lines for EPKINLY and the potential launches of Rina-S and petosemtamab in 2027.

And even with these investments, we expanded operating profit to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales. Overall, 2025 demonstrates the strength and quality of Genmab's underlying financial performance. Turning to our 2026 guidance. Our framework is straightforward. Revenue growth enables strategic investment, which supports 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.

More specifically, we expect DARZALEX net sales in the range of $15.6 billion to $16.4 billion. As discussed previously, expectations for operating expenses were in a reasonable place. For 2026, the increase in operating expenses reflects planned investments to advance late-stage development for petosemtamab and Rina-S as well as launch readiness activities to support multiple potential product launches.

Even with the strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026. With that, now I would like to provide some context for how revenue growth supports a deliberate increase in investments while delivering $1.15 billion of operating profit at the midpoint for 2026. And you can see this on the chart on the right. What really stands out is the strength of our underlying business, demonstrated by strong organic operating profit growth before our planned investments in petosemtamab. Here, we are choosing to reinvest part of the operating leverage now to strengthen future growth drivers while continuing to manage costs actively and maintain profitability discipline.

This balance, reinvesting to support growth while driving substantial profitability is a core feature of our operating model. Taken together, our 2025 results and 2026 guidance demonstrate consistent delivery against our financial commitments. Our capital allocation framework remains fully aligned with our strategy to drive sustainable growth well into the 2030s. First, we will continue to invest to accelerate our late-stage pipeline and maximize the success of our commercialized medicines, including launch readiness.

These investments are intended to generate meaningful revenue for us in the future. Second, we will continue the rapid integration of Merus to accelerate value capture while maintaining focus and prioritization. And third, we remain committed to deleveraging, targeting gross leverage below 3x by the end of 2027, maintaining balance sheet strength and flexibility. In summary, our performance in 2025 underscores our ability to deliver revenue growth, our ability to advance key pipeline assets and our ability to maintain strong profitability through disciplined execution.

Looking ahead to 2026, we are building on this 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. Our confidence in our ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 come from our track record. We have proven that we are excellent evaluators of innovation and that we deliver on our promises. We have also proven that we are disciplined in our execution against our capital allocation framework and in the prioritization of our investments, and we are committed to delivering profitable growth. Genmab is a scaled oncology biotech business with strong momentum, an increasingly diversified growth profile and multiple catalysts ahead.

As we begin 2026, our focus remains on translating our antibody science and development expertise into meaningful breakthroughs for patients and long-term value for shareholders. That ends our formal presentation. Thank you for listening. Operator, please open the call 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.

Can you discuss what the next steps are for EPKINLY following the results of the EPCORE DLBCL-1 study? Can you still get the second line plus label with the EPCORE DLBCL-4 combination study? And what was the rationale, I guess, behind using the monotherapy DLBCL-1 study as the confirmatory study in the first place?

Thanks, Jonathan, for the questions. I will hand it over to Tahi to explain in further detail what the next steps are for the regulatory part for [ 05 ] Tahi?

Yes. Thank you, Jan, and thank you, Jonathan, for the question. Yes, as we already indicated in the press release, I mean, the [ 05 ] study is positive by PFS as a single agent beating a chemo-immuno regimen on progression-free survival, but it missed the overall survival confounded by key aspects that are already discussed in the community. One is being COVID. The study was involved heavily during the Omicron wave. And the other one is the emergence of access to bispecifics, which we are an important part as well. So we will have this discussion with the agencies. They are prespecified analysis in the protocol that were already agreed prior to the readout on these 2 major biases.

And so we'll have this conversation both with the FDA and of course, with the European health authorities and global health authorities on the data set. And we're also going to have this conversation with you guys once it is in the public domain. As it relates on the rationale for -- which was your third question on the rationale for why this is the confirmatory study, it's important to put yourself back into the situation where we were -- when this [ kidney ] program started. This was the first Phase III to be initiated. And hence, it was a confirmatory study because the requirement for an accelerated approval is that you have a confirmatory study initiated and really actually well on enrolled by the time you file for the accelerated approval, which is why this was initially -- it was for a long time, the only diffuse large B-cell study, the confirmatory study.

Discussions are ongoing with the agencies about all the other Phase III studies that we have ongoing to specifically for which we both already guided that we will have a readout this year. There is absolutely from our end and no indication from any of the health authority interactions, any readout to the fail ability of the other study that is being conducted and that we already guided will read out in the first half of this year, which is the combination with [ EPCORE ] in second line, third line. This is a separate study that was set up separately. This was started and initiated after the Omicron wave. It is testing a combination regimen with lenalidomide with a fixed duration, as Brad was alluding to earlier. So it's a different study with different opportunities.

And we will be looking forward to have this data in our hand and to also like communicate them to the community and then to engage with health authorities as appropriate.

Thanks Tahi. Jonathan, I think that answered your question?

Understood. Thank you very much.

The next question comes from the line of Asthika Goonewardene from Truist.

So you presented EPCORE outpatient data late last year. I just want to get an update from you on how this data has been adapted to change in the practice in the U.S. I guess given maybe you can give us an idea of what proportion of community clinics that are still sending patients to DLBCL patients to a large center to get that step-up dose monitoring.

And then just maybe to tag on to Jonathan's question, could you put us at ease and just tell us what you think is the likelihood that you'll be able to convince the regulatory agencies to consider one of the many other EPCORE Phase III study readouts that are coming this year as the confirmatory study?

Thanks, Asthika, for the questions. I will first hand it over to Tahi and then also Brad will definitely be able to comment on the community center use of EPCORE, I believe. But Tahi, why don't you start with the first question?

Yes. I mean thank you, Asthika, for this question. So I'm going to reiterate the green, but reaffirm what I said earlier. We have, at this point, 3 Phase IIIs in diffuse large B-cell, one that we already announced the results and then 2 that we already announced we're going to have the results this year, one in the first half at least, and the other one we have not committed to when. So we are extremely comfortable to a degree also by the precedent already set on the [ glofi ] program, but also generally speaking, that this is really not a concern on our end in terms of the confirmation trial.

We have 2 major Phase IIIs that are reading out in addition to a study that was positive on PFS, but confounded on OS. So this is -- I can -- as much as I can say at this point, we are not concerned about this and don't see a reason to be concerned also if you look at the precedent that was set by [ Russia ]. On the outpatient, I'll leave it to Brad to talk about the pattern of prescription. But what I would say to the outpatient study is that, that was an important strategy for a variety of reasons. One is, of course, what Brad talk about practice patterns in the community, but it's also an incredibly important component for our overall regulatory strategy to modify the label and to have label language that then also facilitates administration of EPKINLY in the community. And Brad, you can take it from here.

Yes. No, Tahi, just dovetailing off that, you're absolutely correct. And we do see this as certainly an enabler, if you will. And as we continue to evolve and receive physician feedback, specifically moving into even earlier -- more early lines of therapy, see this as a potential great opportunity for us.

Now we're going to take our next question. And it comes from the line of Xian Deng from UBS.

So I have one on Rina-S, please. So given the pivotal Phase II that's due to come out this year, and given this is kind of pivotal Phase II and there -- it's not a formal Phase III. So just wondering what determines when you can decide you are going to have a readout? What is the definition of this? Because I guess here, you don't have to have the formal PFS here and it's an open-label trial.

So that's the first question. And then sorry, the second one, sorry, just a very quick yes and no question, please. So for EPKINLY frontline DLBCL trial, just wondering, can you confirm whether you have passed the interim, please?

Thanks, Xian, for the questions. The first one, I will ask Judith to address and then Tahi can give a very short answer on the second question. Judith, why don't you start on the Phase II data for Rina?

Yes. Thank you for the question. So the study was designed or the pivotal arm with a potential outcome of being supportive of accelerated approval and accelerated approval is a path that the FDA has for drugs when the results support with the substantial benefit over current standard of care with endpoints that can predict substantial benefit.

So the way the Phase II design is, is for ORR and duration of response, which is our validated endpoint to [ slate ] for clinical benefit. Now the accelerated approval is also dependent on having Phase IIIs with clinical endpoint. As you know, we have [ O2 ] study ongoing, which is a Phase III with PFS as a primary endpoint.

Thank you, Judith. And then maybe Tahi, can you give some color on the frontline diffuse large B-cell lymphoma study?

Thank you for the question, and I appreciate the attempt of yes, no question. But we're just going to reiterate what we've been saying publicly since JPMorgan that we expect the readout for the study to happen in '26.

Now we are going to take our next question and the question comes from the line of Rajan Sharma from Goldman Sachs.

So just same with EPKINLY. Could you just discuss your expectations into the EPCORE DLBCL-4 trial? What do you think is a clinically meaningful outcome here, especially relative to LUNSUMIO and POLIVY?