Genmab A/S (GNMSF) Q2 2026 Earnings Call Transcript

Hello and welcome to the GenMap 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 beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GenMap 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-IFIS financial measures which management uses to describe the company's baseline performance and which supplement but do not substitute for the comparable IFIS measures. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure. Please also note that GenMap may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on GenMap going forward. Please refer to our website for more information on GenMap and our privacy policy. I would like to hand the conference over to our first speaker today, Jan van der 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, Taya Mahdi. 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 Mirrors. 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 APCOR 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 the apcoritumab more broadly. It is growing evidence of the versatility of apcoritumab-based combinations across multiple lines of therapy. This data was followed by the European approval of TAP-Kinley plus linalidamide and rituximab for the treatment of follicular lymphoma in the second-line setting. This makes TAP-Kinley 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 Pitocentumab data with updated results in colorectal cancer presented at ESMO in October. Based on this promising data, we are continuing to build momentum for Pitocentumab. We are initiating two new phase 3 studies in colorectal cancer, and Ty 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 slides. 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 P2-centromop, we are eagerly awaiting the readouts for both studies. And with better visibility, we can now say that the frontline study is expected to readout in the fourth quarter, while the second and third line study is anticipated to readouts in the first quarter of 2027. Finally, for AppKinley, we anticipate that top-line data from the front-line AppCore DLBCL2 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. So exciting times ahead. Now I would like to hand you over to Thay to walk you through the details of the Phase 3 colorectal studies. Thay, the floor is yours.

Thank you, Jan. We are pleased to share our plans for pitocitumab in colorectal cancer, which built 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 RASRAF 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 one 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 pitoxentamab plus investigator-choice chemotherapy of either M-Folfox-6 or Folfuri, a first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS-RAF wild type. It will thus be versus the standard of care named Cetuximab plus chemotherapy. For the second-line colorectal cancer patients, the phase three trial will be similarly a randomized open-label and global trial. This trial is designed to assess the efficacy and safety of pietrozentomar plus investigator choice therapy of either modified Folfox-6 or 4-fury. 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 Cetoximab or Befacizumab plus chemotherapy. So 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, Pitoxemplamab is rapidly emerging as a generally multi-indication acid 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 App Kinley and Tifta.

Thanks, Ty. 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 growth for both Epkinley and TIBDAC globally. We're very pleased with how Epkinley is performing. In fact, Epkinley 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, Epkinley plus R-squared, 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 Epkinley 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 percent of our key customers are ordering for two or more sites this is driven by epkinley's differentiated dual indication label without a recommendation for 24-hour hospitalization and broad adoption of epkinley plus r-squared and second line fl which is leading more sites to utilize epkinley across its approved indications. This performance reflects strong execution by our field teams, physician confidence in Epkinle'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 Epkinle and 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, Epkinlee 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, Epkinlee's global footprint continues to expand, including recent approvals for Epkinlee plus R-squared and Second Line FL in Europe and China. Overall, we're really pleased with Epkinley'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 Epkinley'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 up Kinley 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 TIBDAC, TIBDAC 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 TIBDAC 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 TIBDAC to more patients, we secured reimbursement for TIBDAC 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 TIBDAC launches in new markets while building on that foundation to prepare for the anticipated launches of RINA-S and Pitocintumab 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 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 Epkidalee 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 Darzilex. 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 Pitocentumab. At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that GemMap 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 merits 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 Marist 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, but 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. And this compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both Darzelex and Epkinle. with the $195 million increase at the midpoint being approximately equally split between Darzilex 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 pedocentumab 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. Now, on that note, I'm going to hand you back over to Jan.

Thank you, Anthony. Let's now move to our final slides. Looking at the first half overall, we've had a strong six 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 thank you so much dear participants as a reminder if you wish to ask a question please press star 1 1 on your telephone keypad and wait for your name to be announced to withdraw a question please press star 1 and 1 again please stand by or compare the Q&A Roster this will take a few moments and now we're going to take our first question

and it comes to the line of Zane Abraham Hello. Your line is open. Please ask a question.

Thanks for taking the question. Zane, Abraham, Jacob, and Morgan. First question is on the PETO-Sensumab second-line trial, which we're now guiding for the readout in Q1 in 2027. Just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint survival, or is it the upsizing of the trial, and how 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 EPCOR-DLBCL4. It's quite a strong PFS outcome, but just any sense of what you've seen so far on overall survival, or was it just too immature to see a trend at this point? And what's the latest feedback you've had from the FDA on whether the second-line trouble, the fast line trial could be used as a contaminated trial.

Thank you, Dan, for the questions. And I think I will hand them both over to Tai. Maybe start Tai with the second line trial for PETO and had a neck cancer and then move on to DLBCL4 to address some of the points raised here.

Yeah, thank you for the question. And so let's take the PETO first. As you correctly noted, the endpoint is over survival. So this is an event-driven projection from 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, LYN-EPCO combination, 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 an 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 it's 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 there is to say at this point. We have an active process, active engagement, and it'll be one of the two.

Thanks, Thay. Let's hand 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. Just give us a moment. And the question comes line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Hey, thanks for taking my questions. I had one on EPCOR DLBCL2 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 the study enrolled faster than expected, I believe?

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

Well, let's start first. We're very excited what the results of this trial, as they'll be going to read out next quarter. This is the most important study, I think it's fair to say, within the Epco Ritimab franchise. There's exciting phase two data that is in the public domain. Last year and the year before presented at ASH around the combination of Epco with ARCHOP that showed really unpercentred 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 Ty thanks Michael for the question thank you now we're going to take our next question and the question comes line of James Gordon from Barclays.

Your line is open. Please ask a question.

Hello, James Gordon from Barclays. A question and 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 uh and then it was just two clarifications one was for epkinley and where we're going to get the interim in the first line trial in q4 so if it doesn't work at interim will you tell us that and say that the trial is going to continue onto the final data or it's 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 interim how that works please and the other the other clarification was just um for arena s and proc so there's the o1 and o2 trials they're both in q4 so phase two and a phase three are we going

to get two different readouts or will you just it's the the phase three that's material because that's what you're filing so we'll just get all the data together thanks jane for the questions and the clarification requests so the first two i'm going to hand over again to tie and then you that can deal with the phase two and phase three data for PROC for RINA. But Ty, why don't you start with PITO and the frontline trial?

So it was actually, I think, like, I don't know. I stopped counting at three, but okay, I'll try to address all of the points that were made and ask. So the first thing is, on the PITO trial, we've, in the beginning, stuck to the guidance that had come from here as one or both I'm going to read out this year. Now we are being more precise that we actually will have the top-line results. On the front-line 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. 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 beta trial. Then I think you asked about 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 over-survival benefit for patients in front line and in second line. This is underwritten to a degree by these two BTD indications, datasets in the public domain, and then it's, 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 in any future trials. It's a very exciting drug. We're really looking forward to the data in the front line and then we can have a more detailed discussion on what actually the data will be.

And then there was a question, Tai, on Apgaritimab 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. And then Judith, maybe the phase two and phase three data sets for RINA in PROC, a bit more color there. Judith, are you there?

If she's unmuted, I can take that too.

Okay, why don't you take a tie?

So there will be, indeed, as you said, there's a phase two in PROC. And then we already talked about that there's also a phase three. 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, Ty. Thank you. Thanks, James.

Thank you.

Now we're going to take our next question.

The question comes from the line of Gregory Renza from TrueEast. Your line is open. Please ask.

Hi. Thanks so much for taking our question. This is a one for Greg.

I have one for Pito in Head & Neck. With competitors advancing quickly in the second line deadline, setting ahead of your action to read out in the first quarter of next year, what efficacy and durability profile would Pito need to show to remain competitive? it. Thanks so much.

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

Sure. I think you were 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 three with an over-survival benefit, and that is a, of course, completely significantly different data set as a OR duration of response data set that may form the basis of accelerator approval as it is for Amivantamab. So we remain very steadfast in our statement that we believe PITO is the best-in-class second-generation EGFR by specific based on all the data that we have seen in head and neck, but also outside of head and neck. And the totality of all data, the fact that we will have a frontline indication with PEMBO that we are seeking with the phase three readout next quarter, and then a over-survival phase three 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 PEMBO frontline, that is going to really underwrite our ambition in head and neck. And so we're very comfortable with our position and where we are. And 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, Tai. Thanks, Greg. Let's move on to the next one.

Thank you. And the next question comes line of Shian Deng from UBS. Your line is open. Please ask a question.

Hi, thank you for taking my question. So I guess I'll just try my luck a little bit on the Appinley frontline trial. So given the interim still has not passed, this really suggests that events are happening, you know, really, really a lot slower than expected. So just wondering, is there any reason that you could think of that, you know, you can suspect that the ARTROP arm would perform, your ARTROP arm would perform differently from, you know, the one from Montjuvi-facery trial or the poly-facery 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, you know, chemo-free, so it's with Pembrol combo only, whereas Revolent is plus Pembrol plus chemo. So just wondering if you could elaborate a bit of, you know, rationale in that trial design to go without chemo, please.

Thanks, Siong. I think I'm going to pass them over again to you, Ty.

Thank you. So on the front line, 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 App Clinic has behaved in the past and how predictive these phase two data sets have been, not only in the second line for the conformer trial, but also now in the second, third line Diffuse HB-cell trial, in combination with lenalidomide, the phase three trials almost point to point replicated what had been described in the phase two 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 ARCHOP, I mean, we have no visibility to how ARCHOP has behaved on that trial we will find out when we get the data I think it's probably fair to say that our job in the past as you pointed out yourself has had a very robust performance kind of behaves the way our shop behaves in across multiple trials but generally speaking cross-tar comparisons on the control arm are always a little bit flawed 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 our shop behaves like R-Chunk. On Peter's front line, the question was what the reason was for the combination of PEMRO. A lot of these discussions happened a long time ago when this was still in the hands of meals. 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 PEMBO chemo and there are patients who get treated only with PEMBO that is not only a decision made by the CPS score but it's probably even larger in front 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 PEMBO-PETO is like dramatically different it's like twice a high response rate and durability than has been described even for chemotherapy PEMBO. So in that regard, our anticipation is that PETO-PEMBO 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 applicates the data in a phase two, a very significant ORR and duration of response improvement even over chemotherapy combinations We roughly range in the 30% range of response. And then, you know, 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, Tai. I think very clear. Thanks, Sian, for the questions. Let's move on to the next one.

Yes, of course. And now we're going to take our next question. and it comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Hi, thanks for taking my questions. Firstly, just on Kinley 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 front line 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 their TROP2 ADC trial. Does that, in your mind, when the data come, will that set a bar for RENORS? And could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and photoreceptor alpha in endometrial.

Thanks, Rajan, for the questions. So before Thay starts, I think for the frontline study, I can tell you we are super excited based on the phase two studies, the data released last year at ASH, the year before at ASH, 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, our job has been for over 20 years, the gold standard in diffuse last B-cell lymphoma. The phase two data actually show if that would translate to phase three, this will be sensational data. And let's hope for good data in the fourth quarter. Ty, do you want to add anything to that? And then maybe you can go into the landscape for endometrial cancer.

Yeah, sure. The only thing I would add is like, you know, I tried to make that point earlier. I think I'm touched on that. And the LEN-EPCO Phase 3 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 Eptimely 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 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, 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 the mid-run anywhere else.

Thanks, Ty. Judith, are you back online? Apparently not, so maybe you can dive a bit into the mid-run landscape.

Then I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a topo ADC with the top two 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 be out before the data sets for ARENA are going to be available. We continue to be very excited about ARENA, not only in PROC, where we already got it, we're going to have some data this year, but also in endometrial, fluid receptor alpha is expressed maybe on a lower level than in PROC, but it is expressed in one of the things that we have routinely, repeatedly described with Wiener is this phenomenon of efficacy across the spectrum of Fourier result to alpha expression. So endometria is an exciting second indication. We initiated two phase threes 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 We are executing our strategy and sticking to our plans.

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

Yes, of course. And now we're going to take our next question. And the question comes from the line of Ewa Forte. Your line is open. Please ask your question.

Hi, James. Thanks for taking our question. On CRC, as the landscape becomes increasingly crowded with EGFR by specific, how's your newly-disclosed strategy differentiated from the competing assets in the space, particularly compared to amivantamab? And if I might just sneak in a follow-up, given the growing focus on RAS-directed therapies in CRC, would a combination strategy with pitocentamab 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. We like those questions because we are super excited about the potential differentiation of P2 centenum. But I will ask Tai to give you a bit more color on why we are so excited. We will present more data from the phase two setting in colorectal cancer at the SMO conference. And then also the combinations is also an area we are pursuing. Tai, why don't you give a bit more color to Eva?

Yes, please. So first things first, I think, you know, Now, colorectal as this new indication that we're embarking on with PITO, if you recall, even when we start to talk about publicly the intended acquisition of MIROS, there was already a lot of questions about colorectals. 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 PITO is not only the BD 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 with peto have the best in class second generation egfr y specific and that will also translate into meaningful data sets in the phase three settings for both front line 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. So that's the colorectal part. And the RAS field, of course, is super exciting. I worked on a 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 um to to really embark on these novel combinations um and there will be more to come in the near future thanks thai so thank you eva again for pointing out this super exciting area and more to come this year the coming months let's move to the next question yes of course now we're going to take our next question and the question comes down of suzanne van huysen from one last shot campaign your line is open please ask your question hi this is suzanne thanks for

taking my questions. Also on PITO, with your competitor or partner, Jane Yegong, for Accelerated Approval with Amit Fondamop and Head & Neck. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with PITO 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 PITO compared to Ami. Could you elaborate on what is 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? Thank you.

Suzanne, thank you very much for these questions. I'm going to hand them over in a sec to Tai, but I can tell you that you will definitely have to wait for the ESMO data set for the phase two 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 Ty 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 three.

Yeah, thank you. And I'm going to reiterate what I tried to point out earlier. I think if 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 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 we're capturing patient population profile than the accelerated profile now that J&J is pursuing So we feel very comfortable, particularly because the larger population is in front line about our position where we are, and we're, of course, doing everything to accelerate these findings and these launches to the degree that it is possible. So nothing changed on our end. We always knew. We have obviously, there's some partnership on AMI-1, which changes 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 public to discuss because I think we changed a little bit our strategy some time ago, sooner to the colorectal trials, to publicly announce these trials more closer to when the first patient is dozed. And then your second question was around what again?

Best-in-class criteria, why do we say this?

Oh, why do we say this? Yeah, 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 PEMBO 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, beta outperforms amirantamab 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're 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 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 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 hands.

Thank you, Tai. Thanks, Susan, for the questions. Let's move on.

Thank you. Now we're going to take our next question. And now we're taking the question from Charlie Haywood from Bank of America. Your line is open. Please ask your question.

Hey, Charlie Haywood, Bank of America. Thanks for taking questions. I have two, please. So this one is just, or both that's from RENA-S. So first is on the second line prop data we've got coming in fourth quarter. So both phase two, phase three is in fourth quarter. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts, anything together as we sort of read across between the two? And secondly, we've seen limited phase two PFS data for the folio 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 three readout?

Thanks, Charlie, for the questions. Ty, can you address both of them? Differences between the phase two and phase three, and then the profile as it relates to for the receptor of expression levels.

Yeah. Yeah, so by inclusion-exclusion criteria, they're really much more or less the same patient population. So there is a readout for sure based on the phase two data to the phase three data. And then the only difference is, of course, a phase two data set has always its own dynamics vis-a-vis a phase three trial. And then there's always like a larger footprint for a phase three trial as it relates to phase two trials. So these are kind of like 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 radar, 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 Wien-IS, 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 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, that we can have this conversation when the data is in the public domain.

Thanks, Ty. And 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. So I think we're in good shape here.

Thank you.

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

Yes, of course. Now we're going to take our next question. And the question comes to the line of Yarong Bebe from TD Securities. Your line is open. Please ask your question.

Great. Thank you so much. Quick question on Pito. 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 negatives 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 three in that study with PEMBRO to complement your monotherapy second-line data, which is coming Q1 next year?

Thank you. thanks Jaron Ty can you address both of the questions so let's take the first one first 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 JMRM 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 findings. So 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. And then the second question that you had was around other strategies for PITO, and I would say this, we've been very clear, there's going to be more to come on PITO and HEDNIC, and we will present these trials in the granularity and 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. So what trials in the head make, if that's fair.

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

Yes, of course. Now we're going to take our next question. And the question comes from Benjamin Jackson. Your line is open. Please ask the question.

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 top-01 resistance. So, look, the aim for Rina-S is to come first to market, but are there any implications to this and thinking, you know, positively or negative 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 focused topic today lots of other stuff going on but obviously any updated thoughts on the epkingley potential in ini diseases where b cell pathology is key there's obviously a few competitors making noises in this area with similar drugs so it'd be interesting to hear your thoughts there thank you thanks ben for the question so with rena we of course hope to be first to the markets and and we are going to read out already a phase three in q4 but with tai do

Do you want to comment on top of one resistance and strategy for RINA?

Well, I mean, you said the first one. The most important part is there are already three phase 3s actively involving patients in ovarian cancer. One in PROC and two in PSOC, one in maintenance, one in the platinum replacement strategy. And so we are constantly and actively working on moving essentially the entry point for rena into earlier lines and we have already talked about that there's more to come also in the ovarian cancer space with rena um 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 um allows um that's the first probably also the only thing to say about this emergent idea of topo resistance. Because if RENA, which we have very confidence will be the first topo payload ADC in Prague, then this is more a post-RENA problem, to be honest.

Exactly. And then INI and Abco Ritimop, right now the focus plan is on cancel, multiple cancels, and we will have exciting data laid out in Q4. and then let's discuss INI in more detail in the future. But cancer is clearly the priority for us right now. Operator, can we move to the next question?

Yes, of course. And now we're going to take our next question. And the question comes to the line of Judith Frommer from Morgan Stanley. Your line is open. Please ask a question.

Yeah, 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? So 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 Epkinlee, or can 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, Judah. But Ty, can you give a bit of color on the top-line results that we intend to present in the Q4 timeframe?

Well, so I think the accurate response to that question is top-line results in general 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 press conference in a public um presentation at a conference thanks thanks thai i think we we keep it to that judah at this time thank you now we're going to take another question and now we're going to uh the question comes to learn of victor flock from bmp bariba your land is open please ask your question Hi.

Thanks so much for taking my questions. Actually, two questions on Ed Kinley. First one, very impressive momentum lately. And I mean, obviously, you've mentioned the accelerated uptake in the community setting. So just like from like a modeling perspective, is there any stocking we should be aware of when it comes to like modeling the remainder of the year for Ed Kinley. And my second question still on Ed Kinley but on IP. There is a report from Bloomberg arguing that Ed Kinley's formulation patent 70 could extend beyond the composition of matter patents and could potentially add like five years potential in the U.S. six years in Europe. So just wondering whether you can you know discuss your IP strategy and your current assumption for APK&E 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 Ty to give some color on the length of time for the patents. Brad, why don't you start on the stocking question?

Yeah, 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. only by specific with the dual indications and it's really been received extremely well by physicians as well as health systems but there's a rate specifically to stocking no stocking issue or no stocking at this point in time to be discussed.

Thanks Brad and Ty 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?

Yeah I would say this like you know like discussing our patent and IP strategy on calls like this in the nuanced 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 protection that helpfully extends some of that protection.

Thanks, Dai. I think, big figure, we keep it to that for now. Great. Thank you very much. Thanks.

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 yes of course of course not a problem and now we're going to take our next question then and the question comes from land of calpit patel your line is open please ask your question yeah hey uh thanks for taking the question um 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, you know, 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 um the start to finish still looks roughly in line between when uh when frontline and the polaric study started and and they finished so any color on on your uh model assumptions would be useful thank you so culprit uh 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 two data we're not going to address any further timing and timeline issues here but

but look forward to the data thank you and now we're going to take our final question for today just give us a moment and the question comes line of matthew phipps from william blair your line is open please ask your question all right thanks for squeezing me in comparing the the frontline crc trial pedo to the origami 2 trial they obviously look pretty similar in design except for the PO trial does include an ORR primary endpoint. Is this safe to assume you will try to explore Project Frontrunner in that frontline trial? I'm just curious on RENA-S in non-small cell lung cancer. I've had a trial ongoing there this year. Any updated thoughts on the potential there when we might see some data from that Phase II trial?

Thanks, Matt, for the questions. Ty, can you address both for the frontline CLC trial and also the non-small cell lung cancer trial data for RENA?

Sure. Yeah. So it's fair to assume that we will also explore if it is opportune project for opportunities for colorectal for both trials. I think that is a fair assumption. And on the lung cancer arena, once we have, I think, a beta 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 fuller receptor ADCs from very large competitors that are coming left and right. And so I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. So we will present that data at a time when we also have the next steps ready.

Thanks, Tai. 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 three 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. 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. I'll all disconnect. Have a nice day.