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, 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.

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.

We did all this while growing operating profit. To me, that says a lot about the quality of our business.

Beyond financial performance, I'm enthusiastic about our recent pipeline progress. Let me walk you through the highlights.

In June, we announced positive top-line results from the Phase 3 EPCORE DLBCL-4 trial, which showed statistically significant, clinically meaningful improvement in progression-free survival. What is important about these results is what they demonstrate about epcoritamab more broadly.

It is growing evidence of the versatility of epcoritamab-based combinations across multiple lines of therapy. This data was followed by the European approval of Tepkinly plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second-line setting.

This makes Tepkinly the first and only bispecific-based therapy approved in Europe for this indication. Our presentations at medical conferences throughout 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 3 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 2 and Phase 3 platinum-resistant ovarian cancer data sets will be available in the fourth quarter. For petosemtamab, we are eagerly awaiting the readouts for both studies.

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 Tepkinly, 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 3 readouts in the second half, and then potential approvals and launches in 2027. This is what we have been building towards, and it reflects our focused execution.

Exciting times ahead. Now I would like to hand you over to Tahi to walk you through the details of the Phase 3 colorectal studies.

Tahi, the floor is yours.

Thank you, Jan. We're pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing Phase 3 trials in head and neck cancer.

As you can see on the slide, there are a significant number of patients impacted by these diseases. As 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. 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 3 studies, one in frontline and one in second-line colorectal cancer. For frontline, we have already initiated a Phase 3 randomized trial, open-label, a global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator's 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.

Will thus be versus the standard of care, namely cetuximab plus chemotherapy. For second-line colorectal cancer patients, the Phase 3 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's choice therapy of either modified FOLFOX6 or FOLFIRI as a second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS/RAF wild-type. Here, the trial will be versus standard of care, which is cetuximab or bevacizumab plus chemotherapy.

Taken together with our two ongoing Phase 3 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 a rapidly emerging as a genuinely multi-indication asset with the potential to reach a significant number of patients. With that, I'm pleased to hand over to Brad for a review of the recent commercial performance for Tepkinly 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 our 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 growth for both Tepkinly and Tivdak globally. We're very pleased with how Tepkinly is performing.

In fact, Tepkinly grew to $312 million in sales for the first half of the year, representing a 48% year increase year-over-year and a 28% increase in the quarter. In the US, we delivered accelerated growth, with increases in both new patient starts and new site activations.

The launch of chemo-free, fixed-duration Tepkinly plus R squared in 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 suggests that Tepkinly 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. Now over 90% of our key customers are ordering for two or more sites.

This is driven by Tepkinly's differentiated dual-indication label, without a recommendation for 24-hour hospitalization, and broad adoption of Tepkinly plus R squared in second-line FL, which is leading more sites to utilize Tepkinly across its approved indications. This performance reflects strong execution by our field teams, physician confidence in Tepkinly'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 Tepkinly 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 US, performance remained strong.

In Japan, Tepkinly 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, Tepkinly's global footprint continues to expand, including recent approvals for Tepkinly plus R squared in second-line FL in Europe and China. Overall, we're really pleased with Tepkinly's growth globally, and particularly in the US and Japan, where we book sales.

The momentum we're seeing today reinforces our confidence in Tepkinly'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 Tepkinly 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 US, 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 UK, 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 Tepkinly 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 Tepkinly 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 Tepkinly, 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've 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 to $4.5 billion, representing 19% year-over-year growth at the midpoint. This compares with 14% under our previous guidance.

This improved outlook reflects the continued strong performance of both DARZALEX and Tepkinly, with the $195 million increase at the midpoint being approximately equally split between DARZALEX and Tepkinly. 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 3 petosemtamab studies we announced today.

Even with these incremental investments, we're 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 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.

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 six months, both scientifically and financially. Our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long-term value.

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.

Operator, please open the call for questions.

Hi, everyone. Thanks for taking the questions.

Zain Ebrahim, J.P. Morgan.

First question is on the petosemtamab second-line trial, where you're now guiding for the 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 to overall survival, or is it the upsizing of the trial? How is recruitment progressing for the second-line trial relative to your expectations?

I think the slides suggested it's still recruiting, just any updates there would be helpful. Then my second question is on EPCORE DLBCL-4.

It's quite a strong PFS outcome, but just any sense of what you've seen so far in overall survival, or is it just too immature to see a trend at this point? 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, Zain, for the questions, and I think I will hand them both over to Tahi. Maybe start, Tahi, with the second-line trial for peto in head and neck cancer, and then move on to DLBCL-4 to address some of the points raised here.

Thank you for the question. Let's take the peto first.

As you correctly noted, the endpoint is overall survival, this is an event-driven projection for when we have the data, and the trial is fully enrolled. That was to that question.

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 epco combination, oh yeah, 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're 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, 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. 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 also depends on how the results of the frontline trial are going to be.

This is all there is to say at this point. We have an active process, active engagement, and it'll be one of the two.

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

Hey, thanks for taking my questions. 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 one-year delay essentially of the interim efficacy analysis, especially given that this study enrolled faster than expected, I believe?

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

Let's start first. We are very excited about the results of this trial as they be 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 2 data that is in the public domain last year and the year before presented at ASH on the combination of epco with R-CHOP that showed really unprecedented CR rates, which is driving the excitement for the results of this trial.

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-lined next quarter, and I think we should probably leave it at this point. Once we have the data in our hands, we can have a good conversation about all of these other questions that may arise.

For now, next quarter, looking forward to it.

Thanks, Tahi. Thanks, Michael, for the question.

Hello, James Gordon from Barclays. A question and a couple of clarifications, please.

One question was on peto, the first-line trial is now going to report before the refractory trial, presumably because the first-line has an ORR primary with interim OS, whereas the refractory trial is more mature OS. For the first-line trial, that I think we're going to get in Q4, how mature will the interim OS be when you report it?

Do you plan to file? Do you think that first-line or refractory is a higher bar in terms of being successful?

Then there's just two clarifications. One was for Tepkinly, and when we're going to get the interim in the first-line trial in Q4.

If it doesn't work at interim, will you tell us that and say that the trial is going to continue on to the final data, or is it just 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 at interim? How that works, please.

Then the other clarification was just for Rina-S in PROC. There's the 01 and 02 trials, they're both in Q4, Phase 2 and a Phase 3.

Are we going to get two different readouts or is the Phase 3 that's material because that's what you're filing? Will we just get all the data together?

Thanks, James, for the questions and the clarification requests. For the first two, I'm going to hand over again to Tahi, and then Judith can deal with the Phase 2 and Phase 3 data for PROC for Rina.

Tahi, why don't you start with peto and the frontline trial?

There was actually I think I don't know, I stopped counting at three, but okay, I'll try to address all of the points that were made and asked. The first thing is on the peto trial, right, we've from the beginning stuck to the guidance that had come from Merus, one or both are going to read out this year.

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, meaning statistical significance, we don't have any visibility to this, this would be all speculations, I don't think this makes any sense.

We'll have that discussion when we have the interim results in our hands. 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 whether we believe that OS in one indication or the other is a higher bar. I don't really know how to answer this, to be honest.

I think having a 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 indications, the data sets in the public domain, and then 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 3s, and then in future trials.

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.

Then

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

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

All right, very good. Let's stay with that.

Then Judith, maybe the Phase 2 and Phase 3 data sets for Rina in PROC, a bit more color there. Judith, are you there?

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

Why don't you take it, Tahi?

There will be indeed, as you said, there's a Phase 2 in PROC and then we already talked about that there's also a Phase 3. Both of these data sets, of course, will be made available at the time that we get them and then have the top-line results.

I think that should do it for now, Tahi. Thanks.

Thank you.

Thanks, James.

Hi. Thanks so much for taking our question.

This is Sepehr on for Greg. I have one for peto in head and neck.

With competitors advancing quickly in the second-line, third-line setting ahead of your HN2 readout in the first quarter next year, what efficacy and durability profile would peto need to show to remain competitive? Thanks so much.

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

Sure. I think you're alluding to the J&J filing.

I think one thing to say is that we just had a conversation about this, that the second-line data set will be a Phase 3 with an overall survival benefit. That is a, of course, completely significantly different data set as a ORR duration of response data set that may form the basis of accelerated approval as it is for amivantamab.

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. The totality of our data, the fact that we will have a frontline indication with pembro that we are seeking with the Phase 3 readout next quarter, and then a overall survival Phase 3 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, and so we are very comfortable with our position and where we are. The expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Thank you, Tahi. Thanks, Greg.

Let's move on to the next one.

Hi. Thank you for taking my questions.

I guess I would just try my luck a little bit on the Tepkinly frontline trial. Given the interim still has not passed, this really suggests the events are happening really really a lot slower than expected.

Just wondering, is there any reason that you could think of that you can suspect that your R-CHOP arm would perform differently from the one from Mondello Phase 3 trial or the POLARIX Phase 3 trial, at least in the IPI 3 to 5 group? That's the first question.

The second one, just wondering for peto in frontline. Your trial design is chemo-free, it's with pembro combo only, whereas relevant is plus pembro plus chemo.

Just wondering if you could elaborate a bit of rationale in that trial design to go without chemo, please. Thank you.

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

Thank you. On the frontline DLBCL, 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 Tepkinly has behaved in the past and how predictive these Phase 2 data sets have been, not only in the second-line follicular lymphoma trial, but also now in the second-, third-line DLBCL trial in combination with lenalidomide.

The Phase 3 trials almost point-to-point replicated what had been described in the Phase 2 data sets. 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, 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. It kind of behaves the way R-CHOP behaves across multiple trials.

Generally speaking, cross-trial comparisons on the control arm are obviously a bit flawed because they're informed by regions and patients and all of these things. We don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP.

On peto frontline, the question was what the reason was for the combination of pembro. A lot of these discussions happened a long time ago when this was still in the hands of Merus.

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.

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 score, but it's probably even larger informed by the patient that sits in front of the physician and their status.

The data that is out there in the Phase 2 for the combination of pembro-peto, though, is dramatically different. It's twice as high response rate and durability than has been described even for chemotherapy-pembro.

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 2, a very significant ORR and duration of response improvement even over chemotherapy combinations with roughly range in the 30% range of response. Then we'll have a conversation about the comparison to what the J&J strategy may or may not be when we have that data in our hands.

Thanks, Tahi. I think very clear.

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

Hi. Thanks for taking my questions.

Firstly, just on Tepkinly and just on that first-line trial again. 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?

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? 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 their TROP2 ADC trial. Does that, in your mind, when the data come, will that set a bar for Rina-S?

Could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and folate receptor alpha in endometrial? Thank you.

Thanks, Rajan, for the questions. Before Tahi starts, I think for the frontline study, I can tell you we are super excited based on the Phase 2 studies and the data released last year at ASH, the year before at ASH, Rajan.

We believe that this data will be very, very good in the frontline setting. 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.

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. R-CHOP has been for over 20 years the gold standard in diffuse large B-cell lymphoma.

The Phase 2 data actually show, if that would translate to Phase 3, 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?

Then maybe Judith can go into the landscape for endometrial cancer.

Sure. The only thing I would add is I tried to make that point earlier, I think Jan touched on that.

The len-epco Phase 3 actually reported out the way we were anticipating and hoping. This is kind of a pattern that we've seen.

The efficacy and safety of Tepkinly is very predictable, and so we have seen now multiple times that Phase 2 combination data approximates very closely to what then the Phase 3 describes in a larger data set. 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 frontline.

Then Judith can talk about the emerging, never-changing, never-stopping landscape in endometrial and everywhere else.

Thanks, Tahi. Judith, are you back online?

Apparently not, maybe, Tahi, you can dive a bit into the endometrial cancer landscape. Then

I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a Trop2 ADC 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 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.

One of the things that we have routinely and repeatedly described with Rina is this phenomenon of efficacy across a spectrum of folate receptor alpha expression. Endometrial is an exciting second indication.

We already initiated two Phase 3s in that indication, and so we 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, which is super important. Let's move on to the next question.

Hi, team. Thanks for taking our question.

On CRC, as the landscape becomes increasingly crowded with EGFR bispecific, how's your newly disclosed strategy differentiated from the competing assets in the space, particularly compared to amivantamab? If I might 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 so much.

Thanks, Eva, for the questions, and we like those questions because we are super excited about the potential differentiation of petosemtamab. 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 2 setting in colorectal cancer at the ESMO conference. 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.

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.

Of course, this data set has grown, both numbers of patients and durability. Jan already pointed out that we will share that.

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 only 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. This is what underscores the conviction that we really with peto have the best-in-class second-generation EGFR bispecific and that will also translate into meaningful data sets in the Phase 3 settings for both frontline and second-line colorectal, which is why we started these two trials now, even though, as you kind of alluded to, J&J already has started these trials.

That's the colorectal part. The RAS field, of course, is super exciting.

I worked on RAS inhibitor 12 years ago when it didn't work. 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. Thank you, Eva, again for pointing out this super exciting area, and more to come this year in the coming months.

Let's move to the next question.

Hi, this is Suzanne. Thanks for taking my questions.

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?

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 high response, better safety in the data sets?

What do you believe is driving that differentiation? Is it the molecule or the mechanism of action?

Thank you.

Suzanne, thank you very much for these questions. I'm going to hand them over in a sec to Tahi, but I can tell you that you will definitely have to wait for the ESMO data set for the Phase 2 data, which will give you a bit of further color why we are so enthusiastic.

As it relates to the strategy, we think that we will have a differentiated drug actually based on everything we know. I'll pause here and let Tahi give you a bit more color, Suzanne, on the head and neck setting and frontline, second-line, accelerated approval versus potentially approval based on Phase 3.

Thank you. I'm going to reiterate what I tried to point out earlier.

I think if you step back on head and neck, where we are is we're going to have a top-line results in frontline in next quarter 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.

We feel very comfortable, particularly because the larger population is in frontline, about our position, where we are. We're, of course, doing everything to accelerate these filings and these launches to the degree that is possible.

Nothing changed on our end. We always knew, and we have obviously there's some partnership on amivantamab with J&J, some visibility to their plans.

This is exciting for patients, more opportunities, but we are very confident in our head and neck strategy. 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 sometime ago, similar to the colorectal trials, to publicly announce these trials more closer to when the first patient is dosed.

Then your second question was around what again, sorry?

Best-in-class criteria, why do we say that? Oh,

why do we say this? Why do we say this?

Look, 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 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. 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're clearly different antibodies with different secondary arms.

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. As is, and I think there's now a larger data set, I think, yeah, all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety.

This is where we come with this conviction that we have a best-in-class asset in our hand.

Thank you, Tahi. Thanks, Suzanne, for the questions.

Let's move on.

Hi, Charlie Haywood, Bank of America. Thanks for taking my questions.

I have two, please. Both actually on Rina-S.

The first is on the second-line PROC data you've got coming in fourth quarter. Both Phase 2, Phase 3 is 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? Secondly, we've seen limited Phase 2 PFS data for the folate receptor class in general.

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 3 readout? Thank you.

Thanks, Charlie, for the questions. Tahi, can you address both of them?

Differences between the Phase 2 and Phase 3, and then the profile as relates to folate receptor alpha expression levels.

Yeah. By inclusion, exclusion criteria, they're really much more or less the same patient population.

There is a readout for sure based on the Phase 2 data to the Phase 3 data, and then the only difference is, of course, a Phase 2 data set has always its own dynamics vis-a-vis a Phase 3 trial. Then there's always a larger footprint for a Phase 3 trial as it relates to Phase 2 trials.

These are kind of like the where do patients come on and the difference between having a choice or being forced to have a choice versus not having a choice. That's kind of the difference between these two data sets probably ought 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.

This duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AEs, it then allows a long continuation of treatment, which then drives the duration of response. If you put these things together, you can already get a sense of 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. On top of that, Charlie, you will get that we are like a year, one and a half years ahead of some of the potential competitors.

I think we're in good shape here.

Thank you.

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

Great. Thank you so much.

Quick question on peto. For the first-line study, can you just give us a sense, when you upsized 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 they're in the market, you're not enriching specifically for only one subtype?

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 3 in that study with pembro to complement your monotherapy second-line data, which is coming Q1 next year?

Thank you.

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

Let's take the first one first. This is, I think we've said multiple times, we changed this trial to increase the probability of success.

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, and 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. I think that's all there is to say about this.

The rest is not necessarily part of our thought process or anything that we have spoken about. 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 in head and neck. We will present these trials in the granularity and at a time similar to what we've just did with colorectal, when they are literally dosing patients.

That is, in some near future, we will have more conversations about 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.

Brilliant. Thank you for the question.

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. Look, the aim for Rina-S is to come first to market, but are there any implications to this and thinking positively or negatively, how this resistance could emerge for when thinking about the Rina-S commercial opportunity once the competition comes to market?

Then secondly, look, not a focus topic today, lots of other stuff going on, but obviously any updated thoughts on the Tepkinly 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, it'd be interesting to hear your thoughts there.

Thank you.

Thanks, Ben, for the questions. With Rina, we, of course, hope to be first to the market, and we're going to read out already a Phase 3 in Q4.

Tahi, do you want to comment on Topo1 resistance and strategy for Rina?

You said the first and the most important part is they are already three Phase 3s actively enrolling patients in ovarian cancer: one in PROC and two in PSOC, one in maintenance and one in the platinum replacement strategy. We are constantly and actively working on moving essentially the entry point for Rina into earlier lines.

We've already talked about that there's more to come also in the ovarian cancer space with Rina. That's basically the reality.

You have to 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.

Practically also the only thing to say about this emergent idea of Topo resistance, because if Rina, which we have very confidence, will be the first Topo payload ADC in PROC, then this is more a post-Rina problem, to be honest.

Exactly. Then I&I and epcoritamab, right now the focus plan is on cancer, multiple cancers, and we will have exciting data readouts in Q4.

Then let's discuss I&I in more detail in the future, but cancer is clearly the priority for us right now. Operator, can we move to the next question?

Hi. Thanks for taking the question.

Maybe just a follow-up on peto in frontline. Can you help us with thoughts on the nature of the update in Q4?

It'll 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 Tepkinly, or could we potentially see subgroup data perhaps by HPV status? If not, do you have a sense for when we would see responses by HPV-negative versus positive patients?

Thanks.

Thanks, Judah. Tahi, can you give a bit of color on the top-line results which we intend to present in the Q4 timeframe?

I think the accurate response to that question is top-line results in Genmab historically focus on the primary endpoint. I think that's what's going to be happening for peto as well.

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, this time.

Hi. Thanks so much for taking my questions.

Actually, two questions on Tepkinly. First one, very impressive momentum lately.

Obviously, you've mentioned the acceleration of uptake in the community setting. Just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling the remainder of the year for Tepkinly?

My second question, still on Tepkinly, but on IP. There is a report from Bloomberg arguing that Tepkinly's formulation patent family could extend beyond the combination of matter patents and could potentially add like five years potentially in the US, six years in Europe.

Just wondering whether you can discuss your IP strategy and your current assumption for Tepkinly in terms of IP. Thanks so much.

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?

No, thank you for the question. 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 indications, and it's really been perceived extremely well by physicians as well as health systems.

As it relates specifically to stocking, no stocking issue or no stocking at this point in time to be discussed.

Thanks, Brad. 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?

I would say this. Discussing our patent and IP strategy on calls like this in the nuance details is probably not appropriate.

Right now, I would stick to mid-30s is where we are, and then, of course, there's always an IP strategy to try to generate additional intellectual property protection that helpfully extend some of that protection.

Thanks, Tahi. I think, Victor, we keep it to that for now.

Great, thank you very much.

Thanks. Any further questions?

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.

Hey. Thanks for taking the question.

One more on the first-line 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?

Then when you completed the enrollment, I believe in 2024, did the timing estimate of the readout materially shift? 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.

Any color on your model assumptions would be useful. Thank you.

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 2 data. We're not going to address any further timing and timeline issues here, but look forward to the data.

Hi, thanks for squeezing me in. 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 Project FrontRunner in that frontline trial? Then just curious on Rina-S in non-small cell lung cancer, you've had a trial ongoing there this year.

Any updated thoughts on the potential there, when we might see some data from that Phase 2 trial? Thank you.

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

Sure. 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. 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.

I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. We will present that data at the time when we also have the next steps ready.

Thanks, Tahi. Thanks, Matt.

Thank you all for joining us today, and thank you for that lively and invigorating Q&A. With three super important Phase 3 studies reading out in the coming months, we are well on track to deliver sustainable growth well into the next decades.

We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. As always, if you have questions for now, please reach out to our IR team.

Thank you.