Genmab Q3 2026 Earnings Call Transcript

Genmab (NASDAQ:GMAB) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Genmab’s total revenue increased by 22% year-over-year, driven by strong performances from its portfolio, notably a 47% increase in Epkinly sales.

The company experienced significant product development milestones with positive Phase 3 readouts for Rina S, pituzentamab, and Epkinly, reinforcing its leadership in oncology.

Genmab maintained its 2026 financial guidance, expecting revenue between $4.325 billion and $4.525 billion, with expectations to end the year in the upper part of this range.

Strategic focus remains on maximizing late-stage assets, with attention to commercialization readiness for new launches, particularly in gynecological and colorectal cancer spaces.

Management emphasized their confidence in achieving multibillion-dollar peak sales for its leading products and highlighted ongoing efforts to leverage their commercialization capabilities.

Full Transcript

OPERATOR

Hello and welcome to the Genmab Third Quarter 2026 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference you may be presented with forward-looking statements that include words such as believes, anticipates, plans, or expects. Actual results may differ materially, for example as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results unless this is required by law.

Today’s presentation will also include comments on certain non-IFRS financial measures which management uses to describe the company’s baseline performance and which supplement but do not substitute for the comparable IFRS measures. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure. Please also note that Genmab may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on Genmab going forward.

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

Jan G. J. van de Winkel (President & Chief Executive Officer)

Good to have you all with us and welcome to Genmab’s results call for the first nine months of 2026. Joining me are our Chief Financial Officer Anthony Pagano, our Chief Commercial Officer Brad Bailey, our Chief Medical Officer Tahamtan Ahmadi, and Chief Development Officer Judith Klimovsky. They will join us for the Q&A. As the operator said, we will be making forward-looking statements, so please keep that in mind during the call. This has been a long, max stretch for Genmab and I’m delighted to share it with you. Let’s start with the numbers. Our total revenue is up 22% with growth coming from across our portfolio. We have continued to manage our investments thoughtfully and strategically, allowing us to grow our adjusted operating profit by 9%. Growth and profitability together are certainly a sign of a healthy, high-quality business, but the product development news is what has me most energized.

October was a truly unprecedented month in our history with three milestone Phase 3 readouts, all with the potential to change how patients are treated. Three strengths stand behind these results: our expertise in antibody science and oncology, our ability to evaluate innovation, and our speed of execution. You can see all three in these programs. We acquired Rina S in May 2024 when it was a single Phase 1/2 trial. Two and a half years later it has a positive Phase 3 and a broad Phase 3 program across ovarian and endometrial cancers. We acquired pituzentamab last December and less than 11 months after closing, it too has a positive Phase 3 and a growing Phase 3 program. Epkinly, an antibody created by Genmab co-developed with AbbVie, has delivered three Phase 3 readouts this year.

We said these therapies had substantial promise and the Phase 3 data have now confirmed it. And in each case, the Phase 3 result is consistent with the Phase 2 data that led us there. Let me turn to the next slide to remind you of this remarkable Phase 3 data and what it means for us going forward. Last week we held a call summarizing the important Phase 3 data sets that we announced in October. You can listen to a replay of that call on our website, so I will keep this brief and focus on what it means for us. First, Epkinly: the DLBCL2 trial, which met its progression-free survival endpoint with a hazard ratio of 0.49, demonstrated that Epkinly has the potential to change how frontline diffuse large B-cell lymphoma is treated after more than two decades of R-CHOP as the standard.

Expanding into frontline supports Epkinly’s potential to become the core therapy in B-cell malignancies. Second, Rina S: our ambition is for Rina S to be the best, first, and broadest in class. The Rainfall-02 trial, which met both its primary endpoint of progression-free survival with a hazard ratio of 0.5 in the intent-to-treat population and the key secondary endpoint of overall survival, supports that ambition with efficacy irrespective of folate receptor alpha expression level or previous therapy. Platinum-resistant ovarian cancer is just our first potential launch.

With our established global presence in recurrent or metastatic cervical cancer, the breadth of our Rina S program across ovarian and endometrial cancers positions us well to lead innovation in the gyneco-oncology section. And third, pituzentamab: the Liger HN1 trial, which met its dual endpoints of overall survival with a hazard ratio of 0.5 as well as objective response rate, anchors the program in first-line head and neck cancer. This will be followed by our next milestone, the Liger HN2 trial in the second- and third-line setting, which we expect in the first quarter of 2027. And with two Phase 3 trials underway, we are already expanding into colorectal cancer, which is another area of significant unmet need.

Given the global capabilities that we have built, I have no doubt that we are well prepared to continue to maximize the potential of all three of these programs with successful commercialization, if approved. Now let me pass on to Brad to talk more about this and how our currently commercialized medicines like Epkinly and Tivdak are doing in the market. Brad, the floor is yours.

Bradley Bailey (Executive Vice President & Chief Commercial Officer)

Thanks, Jan. Our proprietary medicines continue to perform extremely well, with Epkinly and Tivdak reaching more patients around the world. These results reflect the strength of our antibody science and effective execution by our teams to increase treatment adoption, broaden access, and expand to new markets. Together with the late-stage progress Jan shared earlier, this performance puts us in a strong position to close out 2026 and deliver on our next phase of growth.

Epkinly is the most prescribed bispecific antibody in lymphoma globally, and we’re building on that leadership. Sales grew to $491 million in the first nine months, representing a 47% increase year over year. In the U.S., Epkinly continues to grow across indications and sites of care, particularly in the community where its differentiated dual-indication profile is resonating with physicians. During the quarter we increased the number of sites ordering Epkinly and expanded adoption among existing accounts, with more than 97% of key customers now ordering from two or more sites.

We’re especially pleased with the uptake of chemo-free, fixed-duration Epkinly plus R-squared in second-line FL, which is now considered the standard of care in this setting. This uptake is broadening physician experience with Epkinly, driving increased utilization across both FL and DLBCL and bringing bispecific-based treatment to sites closer to where patients live. Outside the U.S., Epkinly continues to perform very well in Japan. The launch of Epkinly plus R-squared in second-line FL is off to an encouraging start, building on Epkinly’s established presence in the market through our partner AbbVie. This combination is also approved in more than 40 countries, creating opportunities to reach more eligible patients. For the rest of this year, our focus is on maximizing these opportunities, particularly in the U.S. and Japan where we book sales, while preparing for anticipated launches in early lines of DLBCL as soon as next year.

Moving to Tivdak, sales totaled $131 million in the first nine months, which is an increase of 9% year over year. This reflects strong, stable performance in the U.S. and continued growth in our launch markets in Japan and Europe, driven by effective field execution and expanding site activation. Tivdak is now approved and reimbursed in multiple countries, with additional reimbursement discussions underway. This expansion is bringing Tivdak to more patients while strengthening the local market knowledge, customer relationships, and access capabilities that will help drive our success with Rina S and pituzentamab in the future.

Looking ahead, our focus is on translating progress in our late-stage portfolio into well-executed launches and access for patients. For Epkinly first line, DLBCL represents a substantial opportunity to reach patients at the start of treatment and potentially advance the standard of care. The broad physician network and treatment experience we’re building today in Epkinly’s approved indications across sites of care serve as strong foundations as we prepare to expand into earlier lines of DLBCL.

If approved, Epkinly plus R-CHOP would significantly expand Epkinly’s role in lymphoma treatment and move us closer to our ambition of establishing Epkinly as the core therapy in B-cell malignancies. For Rina S, the positive Rainfall-02 results represent an important step forward for patients with platinum-resistant ovarian cancer, who face limited options and poor outcomes. If approved, Rina S would become our second medicine in gynecologic cancer and advance our ambition to become the recognized leader in this space. Our proven experience with Tivdak gives us an established understanding of gynecologic cancer care and longstanding relationships with physicians and care teams to set a strong foundation for our work with Rina S in the future.

Lastly, as Jan shared, Liger HN1 was the first positive Phase 3 trial in first-line head and neck cancer in nearly a decade. If approved, pituzentamab will broaden our solid tumor portfolio and could offer an important new treatment option for patients in a setting where progress has been long overdue. Over the last several years, we’ve built a commercialization engine across key markets designed to scale with our portfolio and support the growth ahead.

We’re pairing deep antibody and oncology expertise with local market insights and data to differentiate our medicines, secure broad access, and drive successful launches. Our field teams bring these capabilities together with a highly coordinated and seamless engagement plan for care teams and customers, supporting broad uptake and utilization. As we close out 2026 and look towards 2027, we’re in a strong position: driving growth from our approved medicines, advancing readiness for anticipated launches next year, and turning the strength of our science into sustained growth and meaningful impact for more patients. With that, I’ll turn it over to Anthony to walk you through the financials.

Anthony Pagano (Chief Financial Officer)

Thanks, Brad. The first nine months of 2026 demonstrated the continued strength of our business with revenue growing 22% year over year. And I highlight two characteristics of our performance: first, the high level of the growth, and second, the broad-based nature of that growth. Starting with the high growth, Darzalex increased 19% year over year, while worldwide Epkinly net product sales increased 47%, reflecting continued commercial momentum and strong execution. Beyond these two brands, the remainder of our portfolio increased 30% year over year.

Turning to broad-based growth, approximately half of our year-over-year revenue growth came from Darzalex. Impressively, the other half was generated by Epkinly and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base and this strength provides us with the financial flexibility to continue investing behind our highest value growth opportunities. This includes launch readiness for Epkinly, Rina-S and pitosentamab as well as the ability to broaden the development for both of our wholly owned programs.

As you know, we currently have nine ongoing Phase 3 trials for Rina-S and pitosentamab with more announced or in development. And even with this investment we grew adjusted operating profit by 9%. So together our results demonstrate that Genmab can increase investment while continuing to expand profitability. Now let me briefly comment on tax. Our effective tax rate for the first nine months was 3.4%, primarily reflecting the ongoing integration of MERIS and related recognition and utilization of deferred tax assets. As we previously discussed, our effective tax rate may continue to fluctuate as those integration activities progress. We expect our effective tax rate will normalize over the next 12 to 18 months.

With that, let me turn to our 2026 financial guidance. We remain on track to achieve our 2026 guidance which we are maintaining with strong revenue growth and strong profitability. We expect our revenue to be in the range of around 4.325 billion to 4.525 billion, delivering a robust 19% growth at the midpoint and it’s Epkinly and the continued momentum in our royalty portfolio that’s driving that growth. Given our performance through the first nine months, we now expect revenue to be in the upper part of that range.

For operating expenses, our full year investment plan has not changed, so we still expect to be in a range around 2.81 billion to 2.95 billion and we expect to be around that midpoint of 2.88 billion. We expect Q4 OpEx to step up significantly because we have substantial activity planned in the fourth quarter including manufacturing, clinical development and launch readiness for Rina-S and pitosentamab. So I would caution against taking down your 2026 OpEx figures as a result of our first nine months.

Putting all this together, we’re planning for adjusted operating profit in a range between 1.065 billion to 1.35 billion, with the midpoint of our guidance amounting to over 1.2 billion. With revenue in the upper part of the range and OpEx around the midpoint, we expect our operating profit to end above that midpoint. Our guidance highlights our continued strategic discipline with revenue growth funding targeted investments in pitosentamab, Rina-S and launch readiness, all while maintaining strong profitability.

Now finally, before I conclude, I’d like to take a minute to look ahead to 2027. While of course our guidance will be given in February next year, as I stand here today, 2027 consensus expectations for OpEx on Bloomberg and FactSet appear to be in a reasonable place capturing our investment priorities. Importantly, we remain confident that Genmab will deliver strong profitability both in 2026 and continued growth in 2027. So in summary, our performance in the first nine months of 2026 underscores our ability to produce high quality revenue growth, advance our late stage pipeline and maintain strong profitability through disciplined execution.

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

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thank you Anthony. This brings us to our final slide. It has already been a remarkable year for Genmab both for our science and our financials. I can summarize this with three themes. The first is our sustained financial growth based on revenue from our portfolio including significant contributions from Epkinly. The second is a high potential late stage pipeline where we have had unprecedented Phase 3 readouts across Epkinly, Rina-S and pitosentamab setting up potential launches in 2027 and multibillion dollar peak sales potential and finally our disciplined capital allocation.

We are investing in our high impact late stage programs with broad clinical development and launch readiness, all while sticking to our goal of gross leverage below three times by the end of next year. In short, we have three high quality late stage programs, a broadening revenue base and more catalysts still to come. All of this gives us real momentum as we head into the next decades. So as we move forward to the end of the year, I could not be more energized about our future both in 2027 and beyond.

That concludes our prepared remarks. Before we move to Q and A, I’m pleased to announce that we will hold our annual virtual R and D update and ASH data review event on December 16th. Details will be available on our website and with over 20 accepted abstracts, including six oral presentations, we look forward to a lively event. With that, thank you for listening. Operator, we are now ready for questions.

OPERATOR

Thank you. Dear participants, as a reminder, if you wish to ask a question, please press 11 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star one and one again, please. Then we will compile the Q and A roster. This will take a few moments and now we’re going to take our first question and it comes from the line of Benjamin Jackson from Jefferies. Your line is open. Please ask your question.

Benjamin Jackson (Analyst at Jefferies)

Brilliant. Thank you for the question. Guys, can I just start on the ASH abstract for DLBCL4, please? Just interested if there’s any colour you can add around what you’re seeing or thinking about with regards to that OS hazard ratio that obviously shows no detriment to the patients. But is this something similar to what we saw in and around the DLBCL1 trial where we need to adjust for any COVID related deaths or subsequent therapies? And how do you see this reading across to the first line trial?

Is it just a factor of the short or very short follow up compared to the other trials that we see in the space? And is this something that ultimately you will need to show a statistically significant OS benefit in one of these two trials to be confirmatory across the board? So any thoughts in and around the OS side of that as well? And then also just as a follow up on the safety side, slight increase in that trial in and around grade five events. Is there any colour you can add here? Is this COVID related again or is something else at play? Thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks Ben. You very cleverly, I think, put three questions under the first one, that is the ASH abstracts, and then the safety one is an extra question. So we’ll ask Tahamtan to start and then Judith can chip in where you can add further color. Tahamtan?

Tahamtan Ahmadi (CMO EVP Head of Experimental Medicine)

Yeah, thank you Jan and thank you Benjamin. There are probably five questions in there, so I’m going to take them one at a time. As it relates to the OS for the 04 trial, I think you already alluded to a median follow up on that trial driven by the impressive hazard ratio on the PFS side that triggered the readout was 10 months. And if you just think about the comparison to 05 or the glofitamab study, the follow up there was more like towards 28 to 30 months.

And so from that you can just already appreciate that this is totally immature, very few events. As it relates to COVID, COVID is not necessarily an issue anymore. These trials were run post the COVID phase but of course the availability of bispecifics and CAR-Ts, so the next available lymphoma treatment, does to a degree play a role. We’re still very confident that this hazard ratio will continue to actually improve and actually show a benefit for Epkinly. So we’ll have to just wait for that follow up.

As it relates to confirmatory trial, I think fair to say at this point that the frontline diffuse large B-cell Phase 3 with an overwhelming positive PFS will function from a regulatory point as the confirmatory trial. That was the second question that you had. And the third one was on safety. You correctly noted that there were a few death events on the Epkinly arm, also on the control arm. But there’s really no isolated signal. This is really multifactorial and it’s a relatively small number of patients. So there are all kinds of different factors that play a role there. So we stand behind the conclusion that really the trial didn’t show any new safety signals. And I think it will be better appreciated when the data is actually presented in its totality.

I hope I touched on all of the questions.

Benjamin Jackson (Analyst at Jefferies)

Yes, that’s brilliant. Thank you very much.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks Tahamtan. Thanks Ben for the question. Let’s move to the next question.

OPERATOR

Yes, of course. And now we’re going to take the question from the line of Charlie Heywood from Bank of America. Your line is open. Please ask your question.

Charlie Heyward (Analyst at Bank of America)

Charlie Heyward, Bank of America. Thanks for taking the question. I have two please. So the first one is just looking ahead to potential launches for these assets and how on PITO specifically I think your prior commentary was a billion dollar sales by 29. And so just wondering, obviously you’ve hit OS at interim, which I imagine was more of an upside scenario. So how has that informed confidence to reach that status by 29? And then the second question, just on your two Phase 3 readouts or your fileable readouts coming next year. So Pito second third line, head and neck and then Rina-S second line endometrial. I guess both optically smaller ops than the recent anchor readouts you’ve had, but both broader halo potential for the assets you’ve got. So you know OS benefit for Pito across potentially first line, second line and third line and then Rina-S, ovarian and endometrial.

So how would you view the commercial importance and the potential halo effect of those two indications? Thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Bradley Bailey (Executive Vice President & Chief Commercial Officer)

Thanks Jan and thank you for the question. And as we look ahead, obviously oncology in general is a data driven market and very competitive market, but also extremely data driven. And we’re confident in the data that we’ve seen to date for all the assets as you mentioned across your questions and you know, we’re confident also in the capabilities we’ve built at this point to bring our medicines to market. We really built our commercialization capabilities with all of this in mind over the last few years and certainly with this level of growth and expansion, looking to differentiate in these spaces, we evaluate the markets with multiple sources overall and feel confident in the guidance we’ve provided thus far. And as we get into the data further with the presentations, as we’ve stated at an upcoming medical congress next year, we’ll be able to provide further color on that as we move forward.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Anthony Pagano (Chief Financial Officer)

Yeah, thanks Charlie. Look, we’ve been super clear. We had high conviction, zooming in on pitosentamab. We had high conviction in pitosentamab in October. We backed it up with the really super strong Phase 3 results including the OS that you referenced. So we stand fully behind the peak year sales estimate for pitosentamab at multibillion and we stand fully behind that $1 billion number for 2029. So I really feel like on the heels of this data, Charlie, we’re well positioned here moving forward.

Charlie Heyward (Analyst at Bank of America)

Great, thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks Charlie.

OPERATOR

Now we’re going to take our next question and the question comes from the line of Zain Abraham from JP Morgan. Your line is open. Please ask your question.

Zain Abraham (Analyst at JP Morgan)

Hello, thanks for taking the question. Zain Abraham, Jason Morgan here from me as well. First question is on PITO and just how we should think about the duration of treatment that you’re expecting to see from a modeling perspective. I think in the phase two you showed median progression-free survival of about nine months, but based on the phase three results, you’re actually doubling overall survival. So could we see potentially longer duration of therapy than that progression-free survival nine-month point?

And my second question is on Epkinly and how we should think about the pace of the rollout in first-line DLBCL and second-line DLBCL pending approval next year. Given the strength of the data, particularly in first line, could you see blockbuster sales for Epkinly next year?

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Tahamtan Ahmadi (CMO EVP Head of Experimental Medicine)

Yeah, thank you, Jan, and thank you, Zain, for the question. Now, of course, as I’m sure you understand, we’re not going to be able to get at this point into a nuanced discussion around duration of treatment and any kind of detailed discussion on the data until we have it in the public domain. I think it’s important to step back though, as you also were alluding to in a question, to remind ourselves that, you know, from a pure odds ratio on response and then particularly on the OS hazard ratio, what we’re looking at is really like a transformative study, and we’re really excited to show the totality of the data in the context of the patients that were enrolled, and then we can have these nuanced discussions around modeling duration of treatment and these things.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Ty. And Brad, maybe a bit on the rollout of Epkinly in the different settings.

Bradley Bailey (Executive Vice President & Chief Commercial Officer)

You know, thanks. Thank you for the question. And, you know, we’ve said for quite some time the largest opportunity is obviously as we move into earlier lines of therapy, specifically in frontline, and where the majority of the patients we know are treated in the community and intent of treatment is curative. The market’s already moving, I think, as we know, from R-CHOP to these R-CHOP combinations, and also long stated that we believe bispecifics can really build on this R-CHOP and emerge as the new standard.

The top-line data at this point validate this position and the role that Epkinly plus R-CHOP could play, and we feel extremely confident again in the data for Epkinly. We’ve built the capabilities all along to prepare for earlier lines of therapy as it relates to our infrastructure, and we expect strong uptake at launch, primarily with academics and then certainly moving into the community as more sites gain experience, as we’re already seeing, and a bit of a proof point with the second-line FL launch from around the same time last year that’s driven the primary part of our uptake thus far. So we expect strong uptake and look forward to sharing more as we move further.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Zain Abraham (Analyst at JP Morgan)

Thanks a lot.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Let’s move to the next question. Operator.

OPERATOR

Yes, of course. And the question comes from Romy Corner from Van Lanschot Kempen. Your line is open. Please ask your question.

Romy Corner (Analyst at Van Lanschot Kempen)

Hi, this is Romy. Thank you for taking my questions. Maybe just following on to the previous one: so with the potential long treatment duration that we might see with Pita centamab, just wondering how you’re thinking of the subcutaneous formulation and how advanced along is that? And looking at the frontline DLBCL space, so following the positive data that we saw, how should we be thinking about the positioning of Epkinly and R-CHOP against, for example, Pola-R-CHP?

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

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Romy. The first question can be on the subcutaneous. Maybe Ty can start with that and then also handle the second question on the competition and the positioning versus Pola-R-CHP in frontline diffuse large B-cell lymphoma. Ty, maybe you can start.

Tahamtan Ahmadi (CMO EVP Head of Experimental Medicine)

Yeah. So on the PITO questions first, we obviously started—I think the deal with Halozyme was announced in the midst of the closure period of the acquisition of Magenta—so we’ve been working on subcutaneous. We have always understood subcutaneous to be an important lifecycle management component, and that’s probably where we have to leave it at this point for a variety of reasons. On the Epkinly question, this question comes up a lot and I think it’s good to step back for a moment. So first off, R-CHOP plus Epkinly hazard ratio 0.49—this word “unprecedented” gets sometimes overused, but this is literally a trial at a scale of positivity that has not been seen in the rituximab-based standard for a quarter of a century. So what that also means, even without having a discussion on the nuanced data, is that when you have an effect size of that scale that it probably will have an impact on a number of populations.

So where you can tell the difference between hazard ratio between 3 to 5 to 2 to 5 was non-existent, which basically means that the hazard ratio of two mimics the hazard ratio of the 3 to 5 population. That in and of itself is already a significant differentiator. And then there are other subgroup populations that you could think about as it relates to the original Pola-R-CHP data set from POLARIX that led to the approval. So I think that’s the first differentiator that’s important. The second part that is important is while we’re here today and we have a phase three, the glofitamab Pola-R-CHP study is going to read out sometime in the future—I think Roche has got it towards the end of next year—so there is a significant time advantage and that’s an important one. I think the third part that sometimes also doesn’t get really appreciated is that from the beginning, and what we discussed and Brad touched on this, the vast majority of these patients get treated in the community, and in the community R-CHOP is the standard of care.

That’s something that physicians in the community are comfortable with for 25 years plus. The subcutaneous administration is a differentiator for the community. Dual indication is a differentiator in the community. And so these things all are important aspects. Not to have two marketed products within a regimen plays a role in certain cost-conscious markets. And then the last point is if you actually look at the most recent ASH abstract that just got released by Roche—as something that we also talked many, many years ago already—there might be actually a ceiling that is determined by CD3/CD20 that is then determining how high you can go in the efficacy in terms of CR, because there is really no difference between R-CHOP glofitamab and R-CHP glofitamab. So I think that kind of summarizes how we think about it.

We feel very comfortable with the positioning of where we are. We’re super excited to share this data as soon as we get the opportunity to, and then we’ll have more detailed conversations.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thank you. Thanks, Romy.

OPERATOR

Thank you. Now we’re going to take our next question, and the question comes from Astika Gunobardene from Leerink. Your line is open. Please ask your question.

Karina

Hi everyone, this is Karina for Astika. I had a question for RINA. So sacituzumab, their phase 3 data in endometrial showed meaningful PFS and OS benefit, but they also had 35% response rate and considerable stomatitis. So with sacituzumab filed now, does RINA still have a shot at accelerated approval? And I have a follow-up.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Judith Klimovsky (EVP & Chief Development Officer)

Yes, thank you for the question. So, as you know, for RINA in endometrial we have a dual strategy. We started with a single-arm and in parallel we opened a phase three randomized study, so basically aligned with what we did with PDOC. So the more likely scenario now is that the filing will be based on the phase three result.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Judith. That’s very clear. Thanks for RINA.

Karina

And I have a follow-up for RINA. As the ovarian cancer data you guys showed a strong OS hazard ratio and there has been like a lot of buzz generated as well. Are you seeing any preliminary impact on patient recruitment to the other ongoing phase three studies and also basket studies?

Jan G. J. van de Winkel (President & Chief Executive Officer)

Judith, can you handle this one as well?

Judith Klimovsky (EVP & Chief Development Officer)

Thank you for the question. As you can appreciate, the unprecedented results of RINA in PROC are creating what we call a halo effect. So we expect recruitment on the other studies to be even more encouraged by these results being already made public.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Judith. Thanks, Karina. We move on to the next question. Thanks.

OPERATOR

Thank you. And now we’re going to take our next question, and it comes from the line of Gregory Ranza from Truist Securities. Your line is open. Please ask your question.

Subbu

Hi, thanks so much for taking our question. This is Subbu on for Greg. Another one on RINA: on the greater than $2 billion peak sales, how does that number split across platinum-resistant, platinum-sensitive, and endometrial cancers? What setting drives most of the value? Thanks so much.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Gregory, for the question. Anthony, you can handle this one.

Anthony Pagano (Chief Financial Officer)

Yeah, and thanks, Greg. Really, I come back to the high conviction we’ve had in RINA-S, and again now we’ve backed this up with the phase three data that was released in October and really showing that strong OS data, so really our conviction is really backed up now based upon this data. So again, we stand fully behind that peak-year sales estimate, and just remind everybody for RINA-S that’s greater than $2 billion. That conviction comes from the data, but also comes from the capabilities we’ve deliberately built—how we develop the medicines, how we commercialize them—and you’ve seen, again, remind everybody, that strong execution with Tivdak and Epkinly, and that same engine is already doing the appropriate prelaunch work, particularly now zooming in on RINA-S and really leveraging all of the capabilities we’ve also built out in the gynecological oncology space.

I think we’re very, very well positioned to deliver against that greater than $2 billion estimate for RINA-S. Gregory, at this stage we’re not breaking it down any further than that in terms of further breaking down ovarian or endometrial to split. Really, I just have you focused on the capabilities in place and the data in place for us to now deliver against that greater than $2 billion target for RINA-S.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Anthony. And as a reminder, Gregory, we also have trials in lung cancer as well as in the gastrointestinal cancers with RINA-S. So it may have far broader potential than just ovarian and endometrial. Let’s move to the next question. Operator.

OPERATOR

Yes, of course. Now we’re going to take the question from Rajan Sharma from Goldman Sachs. Your line is open. Please ask a question.

Rajan Sharma (Analyst at Goldman Sachs)

Hi, thanks for taking my questions. I’ve got two as well. First one just on Epkinly dynamics. It looks like sequential growth between 2Q and Q3 was relatively flat, so could you just maybe talk about what you’re seeing there and is that sort of the run rate we should be expecting until the frontline approval comes through? And then secondly, maybe just following up on a question from the call last week, just now that you have the data in hand, how are you thinking about the shape of the top line and the bottom line of the company through the Darzalex royalty expiration? Are you confident that there’s ability to grow through that or at least be flat? Thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Bradley Bailey (Executive Vice President & Chief Commercial Officer)

Yeah, thank you for the question. And we certainly continue to see, kind of post the second-line FL launch as well as removal of hospitalization, strong growth specifically in the U.S. with Epkinly, and as we look globally, expecting as mentioned, we just launched in Japan with second-line FL as well. And so I think you’ll see that continue to, you know, we expect continued growth there also. But we said all along, you know, the earlier lines of therapy is where the value is, and as we have just seen the data with frontline, looking to continue to build on this strength that we have with our infrastructure.

Both our field teams, our market access, patient service teams in the field are ready to deliver from that perspective as well. So I’ll leave it there.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Anthony Pagano (Chief Financial Officer)

Yeah, happy to do so. And really it’s going to be reiterating some key messages we’ve been sharing with the markets here now for really the last year. It really starts with the strength, the quality, and the high conviction that we had and continue to have really across Epkinly, Rena S, and piocentamab. Again, now we backed this up with this Phase 3 data here during the course of October, and again we stand fully behind the peak sales estimates that we’ve previously communicated.

Just to remind everybody, that’s greater than 3 billion for Epkinly, greater than 2 billion for Rena S, and multi-billion for piocentamab. I would also then look to something we highlighted during our call today when I talked about the characteristics of the growth that we’re seeing. Ex-Darzalex, Epkinly up 47% compared to last year. The rest of the portfolio up 30%. So putting that all together from a revenue perspective, we absolutely have the building blocks in place to see an overall very nice revenue growth trajectory here moving forward.

And then, sort of thinking about the investment and ultimately the bottom line, Rajan, I would really anchor you back to the important financial commitments that we’ve made to the market most recently when we acquired Maris in Q4 of last year, or late Q3, and really three things that we said to you all. We said number one, we would deliver strong operating profit in 2026. Here we’re up year-to-date 9% on adjusted operating profit. We also said when we thought about 2027 we committed to deliver operating profit growth and to delever to below three times gross leverage.

And based upon the strong performance of our brands, coupled with focused and disciplined investment, we are very well positioned to deliver these important 2027 financial commitments. So if you sort of zoom out, Rajan, it’s really thinking we have it from a revenue perspective, the building blocks in place, very high-quality data we’ve seen here in October, and that real focus in leveraging that revenue to the extent possible to drive profits for Genmab. So we’re not in a position today to give you any real specific medium-term guidance, but you really should take away from this that the building blocks are really in place here at Genmab from both a product perspective as well as a capability perspective.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

OPERATOR

Thank you. Now we’re going to take our next question, and the question comes from the line of Shan Deng from UBS. Your line is open. Please ask the question.

Shan Deng (Analyst at UBS)

Hi, thank you very much for taking my questions, two please. One on piocentamab in colorectal. So just looking at the ESMO data you presented. So just wondering, the ORR of course looks very high, but the current standard of care in the frontline setting also looks pretty high. And my understanding is the duration is what really matters. So just wondering, given the public data we’ve seen is relatively early stage and you’ve already started Phase 3, what are your thoughts in terms of duration?

And especially considering amivantamab is actually a lot ahead in terms of timeline. So just wondering your confidence on duration, especially also versus amivantamab on that. So that’s the first question. Second one is on Rena S. So you are announcing the Phase 3 trial in frontline pMMR endometrial. So just wondering if that’s trying to replace chemo induction, or more to add during maintenance. And sorry, this is a long second question. So it’s kind of a broader one on Rena S in that you are also starting Phase 3 on maintenance in PSOC as well as induction in PROC. So historically the maintenance in those settings, whether it’s endometrial or ovarian, it tends to be monotherapy and no chemo.

Just wondering, given the toxicity of chemo, but then of course this is an ADC, what are your overall thoughts on potentially using ADCs in the maintenance setting? I’m asking because whether you can use it in maintenance setting actually matters a lot in peak sales. So thank you very much.

Jan G. J. van de Winkel (President & Chief Executive Officer)

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

Tahamtan Ahmadi (CMO EVP Head of Experimental Medicine)

Yeah, let me start with the PLATO question, and then between Judith and me, we can certainly also answer the Rena questions. Let’s start with the colorectal. Yeah, so I mean you’re absolutely right that the follow-up for the frontline data set that we presented was relatively short. I think it was five months. But in the end there are two data sets. There’s also a second-line data set with a slightly longer follow-up, which is the same combination with chemotherapy, FOLFIRI.

And so you can, to a degree, extrapolate from the second-line durability that is already, I think, better appreciated to the frontline durability. In the end, durability is a function of the mechanism, of course the safety profile and the treatment duration, and of course the sensitivity of the disease. And so this is at least how we think about it. So we look at these data sets not in complete isolation. They also inform each other. And if you take them in totality, both with point estimates, higher response rate that have been described than any data set that has been described before—response rate in that data set in frontline, obviously on the left side, and then in the second line in the totality of patients—these data points give us confidence, and then the durability that we see on the second line confirms that conviction.

And then of course, by now I think we have, broadly speaking, a pretty robust understanding of the safety of piocentamab. And that’s particularly relevant also as you start getting into these thought exercises and comparing it to amivantamab. And I think we’ve talked about this also in the last call. There is a very clear distinction in the safety profile and the tolerability of piocentamab versus amivantamab. In terms of the system organ class, obviously as an EGFR class there are skin-related toxicities, but the numerical degree is greatly higher and the complexity and even the locality of the affected skin areas is drastically different between these two assets.

And so if you then compare the safety that we have generated now repeatedly—and it also is in the Phase 3, obviously—to the available data sets with amivantamab, and then you know that amivantamab achieves that safety profile with a very complex and involved mitigation strategy, then I think it’s pretty obvious that there’s a massive differentiation on safety, and that definitely in our mind translates into our building. So I think that’s my answer on the colorectal.

We feel super excited about colorectal, and I think the data that we presented just at ESMO underwrites that excitement that of course already had motivated us to start these two Phase 3s. And then I would say this would not be the first Phase 3 that we have started after the competition that read out before the competition.

Judith Klimovsky (EVP & Chief Development Officer)

Yeah, so thank you for your question. So for Rena S, the endometrial cancer study that is in the public domain is the Phase 3 in the second/third line. The first line is—so we haven’t provided specifics about the design or comparator, but as you well alluded to, the standard of care is induction chemo plus IO followed by maintenance IO. So we haven’t shared the specifics of the trial, but stay tuned; it will be shortly posted. With regard to PSOC, we have a dual strategy—in fact, like triple strategy. So in PSOC second/third line, we have two studies, Study 04 and 07. One is maintenance post doublet chemo plus/minus BEV, and the other one is what we call replacement strategy. And we have the first-line PSOC posted recently in clinicaltrials.gov, which is not PSOC at first-line maintenance, which is doublet chemo followed by BEV versus, you know, doublet chemo followed by BEV plus Rena.

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

Tahamtan Ahmadi (CMO EVP Head of Experimental Medicine)

Well, the only other thing is, like in your question you alluded to the idea of whether or not an ADC at all is a maintenance drug. And I think there again nuances matter. I think we have talked a lot about what we consider to be differentiation for Rena S, and that is that it is mainly heme toxicity. They are mainly restricted to the first or second cycle, and then thereafter it is actually a very well tolerated drug with an extremely low discontinuation rate.

And then if you have a drug that has a safety profile that is truly tolerable, meaning it doesn’t have this discontinuation due to high toxicity—neurotoxicity, interstitial lung disease, or any other form of cumulative toxicity—then it is actually indeed a very good maintenance drug. And we presented data on Rena plus BEV last year about the good tolerability in terms of patients staying on both drugs, BEV and Rena, for a long period of time.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thank you. Thank you, Judith and Tahy. That I think is really, really a very good, very good response to the question from Shan.

Shan Deng (Analyst at UBS)

Thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Let’s move to the next question. Operator.

OPERATOR

Yes, of course. And the next question comes from Jaron Weber from TD Securities. Your line is open. Please ask a question.

Jaron Weber (Analyst at TD Securities)

Great. Thank you so much. So I have a couple of questions. The first one is on piocentamab. Would you file based on the first-line survival data that you just got, or would you wait to file and include the second-line survival data, which we’re expecting early next year? And then secondly, and I think it’s maybe a nuanced question relative to what was asked before. I think when many of us look at the guidance now—3 billion and higher for Epkinly, 2 for Rena S, and billions for piocentamab—they all look fairly conservative.

What would it take to update them? Thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Jaron, for the question. So the first one, Judith and Tahy can take that one—maybe Judith—and then Anthony, you can give more perspective on the guidance.

Judith Klimovsky (EVP & Chief Development Officer)

Yeah. So as we guided the Street when we shared the top-line results of LEDGER-01, we are actively planning and engaging with health authorities for the potential filing based on the results that we already communicated.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Judith. Anthony?

Anthony Pagano (Chief Financial Officer)

Yeah, at this stage we’re going to stand fully behind the previous peak-year sales estimates for the three brands. Again, reminder, it’s greater than 3 billion for Epkinly, greater than 2 billion for Rena S, and just want to clarify, I think you said a billion for pitocinamab. For pitocinamab it’s multibillion. We had strong conviction in these estimates coming into the readouts that we saw in October and we continue to have that high conviction.

And that’s where I’m going to leave it for now.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Anthony. Thanks, Jam, for the two questions.

OPERATOR

Thank you. Now we’re going to take our next question. And it comes from the line of Victor Flock from BNP Paribas. Your line is open. Please ask a question.

Victor Flock (Analyst at BNP Paribas)

Hi, thanks so much for taking my question. Maybe just first one, a quick follow-up on the subcutaneous formulation. I noticed that you’ve added a new cohort to the phase 2 colorectal study. Just wondering whether this would be enough to support a substitute finding across indication or would you still need a dedicated bridging study? And the follow-up is on the commercial opportunity for pito. I was wondering whether the substitute could become as important as a driver for pito than it has been for Darzalex, and whether the substitute launch is already factored in your ambition to reach at least 1 billion in sales by 2029. And finally, more broadly, how does Keytruda expected loss of exclusivity towards the end of the decade shape your long-term expectation for pito? Thank you very much.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, Victor, for the questions. Maybe Judith, you can actually take the pito subQ question.

Judith Klimovsky (EVP & Chief Development Officer)

Thank you. So I would echo Ty, and with regard to the pito subcutaneous, you know we already mentioned the partnership with Halozyme to start the development of the subcutaneous. It’s part of our life cycle management. So it’s premature to highlight details of the specific plans that we will follow.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks. Thank you, Judith. Maybe the subQ as a driver, like Darzalex subQ was driving the Darzalex sales. Maybe you can give a bit of perspective there.

Bradley Bailey (Executive Vice President & Chief Commercial Officer)

Yeah, no, thank you for the question. And as already mentioned, the Liger HN1 data show the potential for pitocinamab to be both first and best in class in frontline head and neck, and we’re confident in this potentially practice-changing data that we’ve just looked into and shared, and, you know, any innovations certainly or updates would be assessed in the future and we’ll, you know, simply update those as we move forward. But again, an area of high unmet need right now, and very confident in the data we presented at this point.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks. Thanks, Baret. Thanks, Victor, for the questions. Let’s move on to the next one.

OPERATOR

Yes, of course. And now we’re going to take our final question for today. Just give us a moment. And it comes from the line of Sean Lahmann from Morgan Stanley. Your line is open. Please ask a question.

Sean Lahmann (Analyst at Morgan Stanley)

Hello everyone. Congrats on the results. Thanks for taking my number and hope everyone’s well. Two quick ones. First of all, strategic, given the significant strengthening you’ve observed of late-stage pipeline, has your appetite for external business development changed or is execution on internal assets now the highest return use of capital is the first one? And the second one is just on the two CRC programs. What milestones should we expect over, say, next 12 to 24 months?

And given where you could position this in CRC, particularly with the differentiated safety profile you’re pointing to, could the opportunity outsize what you observe or expect in head and neck? Thank you.

Jan G. J. van de Winkel (President & Chief Executive Officer)

Thanks, John. I will take the first one myself, then the CRC questions Judith can handle. So BD, we are very active, Shaun, and looking at interactions with other companies for potential combinations of our drugs. We already announced the Insight partnership recently. There will be more to come, but we are currently f