Q3 2025 Genmab AS Earnings Call
Speaker #2: Hello and welcome to the GENMAB A/S first half 2025 Financial Results conference call . As a reminder , this conference call is being recorded .
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Speaker #2: Going forward . Please refer to our website for more information on Genmab and our Privacy Policy . I will now like to hand the conference over to your first speaker today , Jan van der Winkel .
Speaker #2: Please go ahead .
Speaker #3: Hello and welcome to our financial results call . For the first nine months of 2025 . With me today is our chief Financial Officer , Anthony Pagano , our chief commercial officer , Brad Bailey .
Speaker #3: And our Chief medical officer , Diarmaid . And for the Q&A , we will be joined by our Chief Development Officer , Judith Klimowski .
Speaker #3: As noted , we will be making forward looking statements . So please keep that in mind during today's presentation . We will reference products being developed under some of our strategic collaborations and this slide acknowledges those relationships .
Speaker #3: As we near the end of 2025 , I would like to remind you of the commitments that we made at the beginning of the year .
Speaker #3: We said that we would accelerate the development of our high impact , late stage pipeline , that we would maximize the potential of our commercialized medicines , and that we would deliver on our capital allocation priorities .
Speaker #3: I'm pleased to say that we are following through on these commitments , supporting our continued growth and long term value creation . Over the past nine months , our total revenue grew by 21% , fueled by increased recurring revenue , and we have invested fully in line with our capital allocation priorities .
Speaker #3: Importantly, we have grown operating profit by 52% even while making these strategic investments. We ended the first half with around $3.4 billion in cash.
Speaker #3: Or strong financial foundation has given us the flexibility for continued growth and expansion through investment in our high impact , late stage programs .
Speaker #3: Epkinly and Renesas have both progressed rapidly over the course of this year , with extremely encouraging data sets . And for us , we have initiated additional phase three clinical trials as part of our disciplined investment into the highest potential programs , together with BioNTech , we have agreed that the current data in frontline head and neck cancer for Jan 1042 did not meet our high bar for continued development as part of our capital allocation priorities was our promise to explore focused M&A opportunities .
Speaker #3: We have delivered on this commitment with the potentially transformative proposed acquisition of Merus . So let's briefly review the highlights . The proposed acquisition of Merus is an exceptional opportunity that advances our evolution into a global biotech leader .
Speaker #3: It accelerates our shift towards a 100% owned model. It expands and diversifies our revenue, and it brings us closer to achieving our 2030 vision to improve the lives of patients.
Speaker #3: With this proposed acquisition , we will add pay to or pato to our already compelling portfolio hypertension , assets like Pato , which has received two Breakthrough Therapy designation , are truly rare .
Speaker #3: The totality of data we have seen for Pato underscores the potential as a best in class EGFR bispecific across head and neck cancer indications , as well as in other EGFR expressing tumors and with data anticipated in 2026 from one or both of the ongoing phase three trials , we expect Pato will also be first in class with an initial launch expected in 2027 .
Speaker #3: We are confident that our expertise and leadership and antibody based innovation , as well as our swift and broad clinical development of both Epkinly and Trina as demonstrate our ability to fully realize Petros potential .
Speaker #3: We will also see real promise for it to join Epkinly and Rhenus as multibillion dollar program . We expect to close the the acquisition by early in the first quarter of 2026 , subject to the satisfaction of customary closing conditions and combined with our disciplined capital allocation , strong financial foundation and proven commercial execution , this transaction sets us up for durable , long term growth into the next decade .
Speaker #3: Now , let's turn to some of the recent advancements . Advancements for late stage programs , beginning with Akinleye . We eagerly await the potential of its potential approval in second line follicular lymphoma later this month .
Speaker #3: In addition to the unprecedented phase three second line follicular lymphoma data , we discussed during our second quarter call recently , we announced updated results for Epcoritamab in the outpatient setting .
Speaker #3: These data evaluated the feasibility of treating and monitoring patients with relapsed or refractory diffuse large B-cell lymphoma . In this setting , data from both the phase three second line and outpatient studies are included in more than 20 abstracts that have been accepted for presentation at this year's meeting .
Speaker #3: End of the year . Excitingly , the second line follicular lymphoma data will be one of seven oral presentations for Apco at Ash .
Speaker #3: These abstracts highlight advances that expand algorithms clinical profile , supporting use in earlier lines of therapy and across additional B-cell malignancies . So now let's turn to Rina's .
Speaker #3: Last month at Asmo we presented an update of the data for single agent Rina As in patients with advanced endometrial cancer today , Tai will provide a brief overview of this data which further supports the encouraging results that we showed at Asco .
Speaker #3: This progress reflects our vision to accelerate our innovative late stage pipeline and shows additional momentum behind the possibilities of Rina as or confidence in the potential of Rina as an endometrial cancer is reinforced by the breakthrough Therapy designation granted by the US , FDA .
Speaker #3: As a reminder , this indicates that the FDA considers Rina as to have the potential to significantly improve patient outcomes compared with existing therapies .
Speaker #3: The data we have seen and the recognition from the FDA both support our development plans for Rina . As , and I am pleased to tell you that we have initiated a phase three trial in endometrial cancer .
Speaker #3: So our rapid development of Rina as continuous and we are also preparing for potential commercialization . Tivdak is now available for prescribing in Germany or First European markets .
Speaker #3: And the foundation that we are building in the European Community with Tivdak will set us up for future success with Rina as now over today and the updated Rina as data from Asmo .
Speaker #3: Go ahead .
Speaker #4: Thank you Janne at Asco , we presented the first results for single agent Venus in patients with advanced endometrial cancer from the ongoing phase one two rainfall or one study .
Speaker #4: And at asmo just a few weeks ago , we provide an update on that data with four additional months of follow up . What we saw was that at a median follow up of around a year , Rina asked those at 100mg/m .
Speaker #4: Square showed deep and durable responses regardless of folate receptor alpha expression . The disease control rate at that dose continuing to be at 100% , and a confirmed RR remaining at 50% , including two complete responders and with seven out of the 11 confirmed responses still ongoing at that data cutoff .
Speaker #4: This compares to the standard of care chemotherapy, which delivers a 15% response rate (RR) with limited durability, roughly around six months.
Speaker #4: In addition to the durable efficacy we know, it continues to have a manageable safety profile. There are still no signals of ocular toxicity.
Speaker #4: Interstitial lung disease , or neuropathy across the entire program . So in summary , the data we have seen for Venus , both in endometrial cancer and the data we've presented on proc , reinforce our conviction that Venus is best in class ADC across efficacy , safety and durability across the entire spectrum of folate receptor alpha expression .
Speaker #4: And we are maximizing its potential with an accelerated and extremely comprehensive development plan that includes now three ongoing Phase 3 studies. If you follow today's disclosure on ClinicalTrials.gov, there are two Phase 3 studies that are intended for potential registration under the accelerated approval pathway in the United States: one in Prague and one in second-line endometrial cancer.
Speaker #4: And we expect a first launch in 2027 . And we also are generating data beyond Nunc with signal seeking phase two trial in non-small cell lung cancer .
Speaker #4: And now over to Brett for a review of the recent commercial performance for Epkinly and Tivdak .
Speaker #5: Yeah , thank you , Tony Q3 marked another strong quarter proprietary portfolio . Our commercialized medicines are contributing positively to our overall revenue growth , driven by the strong performance in our established markets , as well as now , the early success of new markets .
Speaker #5: This gives us further confidence in our growth potential as we advance our portfolio and prepare to bring our medicines to even more patients around the world .
Speaker #5: Take a closer look now at performance overall , Epkinly and Tivdak sales through the third quarter of 2025 were up 54% year over year for our .
Speaker #5: This accounted for 25% of our total revenue growth. And as we've said before, we expect our proprietary portfolio to increasingly contribute to our overall revenue growth over time.
Speaker #5: During the quarter , we continued to scale our operations across markets in a disciplined fashion , accelerate the medicines and meet patients needs .
Speaker #5: And as you just heard from John , the proposed merits transaction provides us with the unique potential to double down on our shift to a 100% owned model and maximize our long term growth with Epkinly Reena S and potentially Mab , we have the pieces in place to deliver several multibillion dollar adoption of our the coming years .
Speaker #5: Let's turn now to our Epkinly . Epkinly posted $333 million through Q3 , which represents a 64% year over year increase . We're highly encouraged by Epkinly performance and steady growth globally as the clear leader in the third line setting across diffuse large B-cell lymphoma and follicular lymphoma in the US , performance continues to demonstrate the value of Epkinly as the only dual indication option in DLBCL and FL , we're seeing increases in adoption across sites of care and new patient performance the clinical and operational differentiation that Epkinly brings to the market .
Speaker #5: Dedications . Further growing utilization within ordering accounts and expanding more broadly into the community setting . As we prepare to enter earlier lines of therapy with the anticipated launch in Second Line , FL later this year , we'll build on this positive momentum to bring Epkinly to even more patients .
Speaker #5: Now, looking in Japan, we're seeing an encouraging start to the epkinly launch in third line plus follicular lymphoma. Our teams are building on the traction we've seen in large B-cell lymphoma and continue to drive account activation, while also preparing for future potential launches.
Speaker #5: To that end , today we filed a supplemental Genda for Epkinly in second line FL , marking another important milestone to potentially bring Epkinly to earlier lines of therapy .
Speaker #5: In this priority market across all other markets . Through our partner AbbVie , we saw solid sales for Epkinly in the quarter as an increasing number of countries gain access and reimbursement , and saw rapid uptake globally .
Speaker #5: Epkinly has received the most regulatory approvals for a bispecific and DLBCL , and FL , with approvals in more than 65 countries worldwide , including more than 50 countries .
Speaker #5: Now , with the dual indication , as we look ahead to the remainder of the year and into 2026 , we're focused on increasing utilization across sites of care and delivering epkinly to patients in earlier disease settings , where we may have the opportunity to transform outcomes .
Speaker #5: With its strong performance to date and accelerating development program , we're confident in Kinley's growth potential to reach peak sales of more than $3 billion in the future .
Speaker #5: Now , let's look at Tivdak . Tivdak is well recognized as the global standard of care in recurrent or metastatic cervical cancer . Our year to date sales for Tivdak totaled $120 million , with performance in both new and established markets , highlighting the clear need for women with advanced cervical cancer across geographies in the US , we continue to see strong , stable performance across sites of care , and in Japan , we saw continued early launch success , further reinforcing the patient need , the strength of our launch strategy and impactful execution by our field teams , broadening our reach across markets .
Speaker #5: In September , Tivdak officially launched in Germany . This marks the first medicine we've launched in Europe independently . Weve seen encouraging early uptake in Germany , providing positive momentum as we look ahead to expand to additional countries with our focus on Tivdak , we've made important progress establishing our operations to support our current and future portfolio in Europe .
Speaker #5: This strong foundation will ensure we're equipped to broaden our impact with the gynecologic cancer community and deliver our medicines to more patients around the world .
Speaker #5: The work we've done to transform our business has positioned us well now for sustained growth in profitability . We remain focused on expanding utilization of our medicines and bringing them to as many patients as possible .
Speaker #5: The proposed acquisition of Maris and the potential addition of pitocin could strengthen the opportunities ahead for our proprietary portfolio of antibody based medicines .
Speaker #5: We look forward to closing out the fiscal year with continued strong performance. With that, I'll hand the call over to Anthony to discuss our financials.
Speaker #6: Thanks , Brad . We continue to deliver solid revenue growth throughout the first nine months of 2025 , driven by sustained recurring revenues and a solid market performance of our products .
Speaker #6: We've also strengthened our long-term growth potential as we continue to generate encouraging clinical data for both Epcoritamab and arenas, and our financials remain strong.
Speaker #6: We grew total revenues by 21% , with recurring revenue up 26% . This was driven by royalties from Darzalex and Kesimpta , and importantly , this growth was also supported by product sales from Epkinly and Tivdak , which together represented 25% of our total revenue growth .
Speaker #6: Looking at Darzalex , we continue to see extremely strong growth . Overall , net sales grew by nearly 22% . That's $10.4 billion for the first nine months of the year , which translates to over $1.7 billion in royalty revenue for US , this growth was driven by continued share gains and solid performance in the frontline setting .
Speaker #6: So you can see that the quality of our revenue profile continues to improve . In fact , in the first nine months of this year , recurring revenues represented 96% of our revenues , and that's up from 92% in the same period of last year .
Speaker #6: A clear sign of increasing visibility and durability of our revenues . What's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off .
Speaker #6: This sets us up well as we prepare for potential expansion into earlier lines for Epkinly , including second line FL and the anticipated launch of Rena s and contingent on the successful close of the transaction , the launch of Pito and we continue to take a disciplined approach to these investments .
Speaker #6: Total OPEX in the first nine months of 2025 was slightly less than $1.5 billion, up 7% over the same period last year.
Speaker #6: Excluding the impact of the profound Bio acquisition, we are managing our investments strategically, prioritizing our high-impact Phase 3 programs and focused investments in our commercialization capabilities.
Speaker #6: Our operational discipline contributed to our operating profit growth of an impressive 52% in the first nine months of the year . So here you can see that we're really continuing to deliver on our commitments next .
Speaker #6: Looking at our net financial items here , we have a net gain of 142 million . Then moving on to tax . We have tax expense of 217 million , which equates to an effective tax rate of 18.9% .
Speaker #6: Taken together , our net profit amounts to $932 million . So as you can see . Continued strong underlying financial performance . With that , let's move to our 2025 financial guidance .
Speaker #6: We remain on track to achieve our existing financial guidance with projected double digit revenue and double digit profit growth . We expect our revenue to be in the range of around 3.5 to $3.7 billion , delivering a robust 15% growth at the midpoint .
Speaker #6: And it's our recurring revenues from royalty , medicines and from Epkinly and Tivdak . That's been driving that growth in 2025 . In total for the year , we expect our recurring revenues to grow by 22% .
Speaker #6: For operating expenses due to our continued focused and disciplined approach to our investments . We still expect to be in a range of around 2.1 to $2.2 billion , putting all this together , we're planning for operating profit in a range between around 1.1 to $1.4 billion , with the midpoint of our guidance amounting to over 1.2 billion of operating profit and strong year over year growth of 26% .
Speaker #6: Our guidance highlights our continued strategic discipline , targeted investments and operational efficiency , all while advancing our pipeline and enhancing shareholder value . Now , to give you just a bit more color on FX , every ten point move in the exchange rate relative to our guidance rate of the US dollar to the Danish kroner of 7.20 is worth just around $1 million in operating profit or loss at the midpoint .
Speaker #6: Now , finally , before I conclude , I would like to take a minute to look ahead to 2026 , while of course , our guidance will be given in February next year .
Speaker #6: As I stand here today . 2026 consensus expectation for Genmab standalone investments appear to be in a reasonable place . Capturing our investment priorities .
Speaker #6: And as I take a look at consensus expectations for Maris Investments , they also appear to be in a reasonable place . Importantly , we remain confident that Genmab will deliver significant profitability in 2026 and meaningful EBITDA growth in 2027 .
Speaker #6: Our performance in the first nine months of 2025 underscores our ability to produce solid , high quality revenue growth , advance key pipeline assets , deliver on our capital allocation commitments with the proposed acquisition of Maris and maintain strong profitability through disciplined execution .
Speaker #6: So , in summary , our very strong financial foundation sustained profitability and disciplined capital allocation strategy positions , Genmab for growth , creating value for both shareholders and for patients .
Speaker #6: And on that note, I'm going to hand the call back over to Jan.
Speaker #3: Thank you Anthony . Let's move . Let's move on to our final slides . We have strengthened the foundations of our business . And the first nine months of 2025 , we have expanded the reach of both Epkinly and Tivdak to more patients for Rena , as we have presented additional supportive clinical data showing its potential beyond ovarian cancer , and we are prepared to accelerate and maximize the potential with additional phase three clinical trials .
Speaker #3: And we continue to anticipate a further occasion this year . And they will be presented at Asco , IO in December in London .
Speaker #3: Beyond our commitment to our existing pipeline priorities , we further delivered on our capital allocation strategy with the proposed acquisition of Merus , an extraordinary opportunity that will advance our evolution into a global biotech leader and position us for sustainable , long term growth and value creation .
Speaker #3: Before we move to the Q&A , I'm pleased to announce that we will hold our annual R&D updates and as as data review on December the 11th , and to ensure that this event is accessible to as many people as possible .
Speaker #3: This year's presentation will once again be fully virtual . Details will be available on our website and we look forward to a lively event that ends our formal presentation .
Speaker #3: Thank you for listening . Operator . Please open the call for questions .
Speaker #2: Thank you . To ask a question , please press star one . One on your telephone and wait for your name to be announced .
Speaker #2: To withdraw your question, please press star one on one. Again, we kindly ask analysts to limit themselves to one question per person.
Speaker #2: We will now take the first question . From the line of Jonathan Chung from Leerink . Please go ahead .
Speaker #7: Hi , guys . Thanks for taking my question . Now , coming out of Ismo , there's been a lot of discussion around the competitive landscape of Pito and Rena's .
Speaker #7: What are your latest thoughts on how these drugs are positioned in the competitive landscape ? And what gives you confidence in the potential for these two programs to be key drivers of growth ?
Speaker #7: Thank you .
Speaker #3: Thanks , Jonathan . A very good questions . So let me ask tie to start off giving you our thinking on the positioning of Pato as the best and first in class molecule in the same arena as and I'm sure that you will then also add to that tie .
Speaker #3: Why don't you get going ?
Speaker #4: Well , thank you , Jonathan , for the question . And so let me start with this . There was really nothing that I , in any shape or form , was a surprise to us .
Speaker #4: Our conviction in Pito and Vena being the best and first-in-class assets in the respective indications of head and neck and Ganong has not changed.
Speaker #4: Pito , if you look at the totality of data that is in the prepared remarks in our mind has all the attributes of the best in class .
Speaker #4: Second-generation EGFR bispecific. There are two Phase 3 trials already ongoing: one in head and neck cancer in the second line of immunotherapy, for which it has a Breakthrough Therapy Designation (BTD), and one in combination with Pembrolizumab (Pembro) in the front line.
Speaker #4: So it's also on track to be the first in class. Nothing really changed on that as it relates to Vena. There are, of course, a couple of fully receptor alpha ADCs in development by Azzi and Eli Lilly.
Speaker #4: Again , this is not news . We are generally speaking , operating in a very competitive landscape . None of the data in any way , shape or form are changing .
Speaker #4: Our assumption that vena as based on the data in proc and endometrial , both in response and long term follow up and durability , and long term safety as the profile to be best in class .
Speaker #4: I mentioned this in my comments . There are now two phase twos that are ongoing for some time , and we expect a launch .
Speaker #4: At least one of these indications, 27, and three Phase Threes that are actively enrolling. So I think we have a good position here.
Speaker #4: Also to be the first in class topo ADC in space . And we're expanding already into other indications . So in totality we feel very comfortable about the profile of the assets .
Speaker #4: We feel extremely comfortable with where we are positioned in the competitive landscape, and we feel very confident in our ability to accelerate the development of Pito.
Speaker #4: Once we are having control of this asset, hopefully, and on Vena. And so, there's more to come on both of these assets.
Speaker #4: That's probably all there is to say at this point .
Speaker #3: Thanks , Tai . Do you want to add anything to that ?
Speaker #8: No , you said nothing to add .
Speaker #3: Thank you . All right . Thanks . Thanks , Jonathan , for the question . Let's go to the next question .
Speaker #2: Thank you. We will now take the next question from the line of Michael Smith from Guggenheim Partners. Please, go ahead.
Speaker #9: Hey, thanks for taking my questions. And congrats on all the progress. I had a question on Epkinly, and I was just wondering if you could comment on the commercial dynamics.
Speaker #9: You know , I'm just curious in terms of sales , what you're seeing in terms of use in , in the approved indications between follicular and DLBCL .
Speaker #9: And then how should we think about the near-term growth opportunity in second-line follicular in the US and Japan? In your markets?
Speaker #9: What is the magnitude of that near-term growth opportunity ? Thanks so much .
Speaker #3: Thanks , Michael , for the questions . And I think these are perfect questions for Brad to handle . Brad .
Speaker #5: You know , thank you for the question . We actually are extremely encouraged and pleased with our progress to date in the performance .
Speaker #5: We don't actually split out by indication . And that's actually part of the the benefit . And we're hearing from customers and planning around their their feedback that the dual indication from an operational perspective is extremely beneficial , along with the seamless subcu administration .
Speaker #5: And as we move into the earlier lines of therapy , see , this is a tremendous opportunity to bring treatment closer to where patients live and see this as an opportunity again , moving forward with where we are so extremely encouraged with our performance to date .
Speaker #5: And as we we know the value is in earlier lines of therapy . And I look forward to seeing that success in the future as well .
Speaker #3: Thanks , Brad . Do you want to say a bit about the size of the market and second line of lymphoma ?
Speaker #5: Yeah , the second line , follicular lymphoma is precipitated . We really feel the value of these medicines are much broader and much greater in the earlier lines , approximately 9000 patients in second line FL and it's really our first step into this , this larger opportunity .
Speaker #5: And so we would expect that this , you know , enabling treatment in earlier lines will open up additional opportunities for us in the not too distant future as well .
Speaker #3: Thanks . Thanks , Brad . Thanks , Michael , for the question .
Speaker #2: Thank you . We will now take the next question from the line of Xiang Deng from UBS . Please go ahead .
Speaker #10: Hi . Thank you very much . Thank you for taking my questions . Sorry . If I may just stay on a bit .
Speaker #10: I wonder if I could maybe push a little bit more sort of the near-term performance , giving . I mean , this quarter we did see kind of a miss in Epkinly just wondering , is there anything , you know , you would flag in terms of this , this quarter's performance and also just wondering for second line follicular lymphoma , just wondering , how should we think about the launch trajectory , do you think this is actually going to be a bit more gradual , giving ?
Speaker #10: I don't know , follicular lymphoma . Is it mainly community setting or do you think this actually will be a pretty fast uptake ?
Speaker #10: Thank you very much .
Speaker #3: Thanks for the questions . I'm going to hand them over to Brad . Brad , please comment .
Speaker #5: Yeah , we're actually seeing right now the observed consistent and and continued uptake across sites of care in the US . And we do see to your latter part of the question that second line FL allows this acceleration to community setting where patients are actually treated , as you stated .
Speaker #5: And we do see that as a consistent uptake over time as we continue to get operationalization , if you will , of bispecifics in the community setting as it relates to the performance .
Speaker #5: We're extremely encouraged by what we're seeing year to date with the performance , both in the US as well as Japan and through our partner AbbVie .
Speaker #5: Globally . And again , feel like , as we've said all along , the earlier lines of therapy are where the value of our epkinly will be .
Speaker #5: And the second line , FL , is really that first step . Taking us into this next phase . So hopefully that answered your question .
Speaker #3: Thanks . Thanks , Brad , and definitely see . And we definitely hope to move forward to to front line and second line .
Speaker #3: Diffuse large B-cell lymphoma . Also very rapidly from here with readouts hopefully soon of the phase three trials . So we're very encouraged by Epkinly and really look forward to very , very good future .
Speaker #3: There . Let us move to the next question .
Speaker #2: Thank you . We will now take the next question from the line of Keith Dean from Rothschild and Co . Please go ahead .
Speaker #11: Hi . Thanks for taking my question . One , if I may . So can you elaborate a little bit more on your decision to terminate the clinical development of 1042 in first line anticancer and also what is the implication to the future development of this drug in first line lung cancer and first line melanoma ?
Speaker #11: Thank you .
Speaker #3: Thanks for the question. I think I can start there, and then maybe you can step in. So what we determined together with our part of BioNTech is that basically the data of 1,042, in combination with chemo and pembro in frontline, had an answer.
Speaker #3: Didn't meet the high bar . Of internally for continued development . So we stopped the development there . And that's where what we leave it at .
Speaker #3: Do you want to add anything there ?
Speaker #8: Yeah . No , I just to add that this was the most relevant data set and the initial proof of concept , and based on that , we decided to stop the development in combination with pembro and chemo .
Speaker #3: Thanks. Thanks. Thanks for the question.
Speaker #2: Thank you. We will now take the next question from the line of Rajan Sharma from Goldman Sachs. Please, go ahead.
Speaker #12: Hi. Thanks for taking my question. I just wanted to get your thoughts ahead of the Epkinly PDUFA in November. There's obviously been a bit more of a focus, seemingly, on U.S. representation in clinical trials.
Speaker #12: So, I just wanted to get your confidence going into that potential approval. And if you could just confirm that efficacy in the Epcor FL1 trial is consistent across both U.S. and non-U.S. patients.
Speaker #12: Thank you .
Speaker #3: Thanks for the questions . Ty . Can you give some color on the US non US ?
Speaker #4: Yeah , I mean , basically the way I'm going to respond to that without getting into the minutia of the data , is that there's absolutely nothing at this point that would indicate that it will not be approved in the next few weeks or days in the United States .
Speaker #3: All right . Thanks . Thanks . I think so . We're highly confident . Rajan . So let's wait and see . The coming weeks .
Speaker #2: Thank you .
Speaker #3: Next .
Speaker #13: Question .
Speaker #2: We will now take the next question from the line of Yaron Werber from TD securities . Please go ahead .
Speaker #14: Great . Thanks so much , Anthony . I got a couple of questions for you . More about 2026 . And then 27 .
Speaker #14: So you mentioned for next year the numbers standalone up from mirrors and Genmab are reasonable for mirrors . There are sort of in the 450 range in terms of , you know , opex .
Speaker #14: Let's call it , you know , 450 , maybe some even have as high as 500 . I think we're imagining there's going to be some synergies as you bring that company in .
Speaker #14: And I know you're not you can't give guidance . But can you give us any a little bit of a sense how we're thinking about this correctly .
Speaker #14: And then secondly , when you're talking about significant profitability next year , there could be as much as 430 million change between interest income , net to now , interest expense net .
Speaker #14: You know, because of the debt liability, we are thinking about that correctly, because it would impact profitability next year. Thank you.
Speaker #3: Thanks for the questions, Anthony. I think it's good that you also got the chance to answer some questions here. Thank you.
Speaker #3: Thanks for that guidance .
Speaker #6: Thanks . So you know , I can really start off by thinking , as you all now know and appreciate , we have a very disciplined and focused approach to our investments .
Speaker #6: We've outlined for the market , starting with the overall capital allocation framework . A very clear framework of where and how we're going to invest .
Speaker #6: On the one hand , and as we do that , through that in the most prioritized and productive manner , as possible , that's how we're able to deliver on our 2024 actual financial results .
Speaker #6: And also , you know what our overall guide was for 2025 and where the year to date performance is moving forward . That same approach in terms of very clear investment priorities remains , as well as that approach to being super focused and disciplined .
Speaker #6: Now, to reiterate what I said, as I kind of look at the overall standalone consensus for Genmab, that is in a reasonable place.
Speaker #6: Likewise , for now , here I'm looking at the consensus number is in a reasonable place . We also have to appreciate where we are at in the overall process here .
Speaker #6: As it relates to being on track to closing the transaction in early Q1 2026 . Today , I thought it was important to provide that market , the market , the commentary similar to I did last year , that I think the overall investments are in a reasonable place .
Speaker #6: Of course , we will for opportunities to prioritize , to remain disciplined and and ultimately we'll provide our guidance when we get to February of 2026 .
Speaker #6: Now , my comment as it relates to significant profitability , just to be super clear here I am referring to Ebit . So I'm referring to our Ebit figure , our operating profit consistent with historical practice .
Speaker #6: We are guiding on Ebit line . So overall , I think we sort of step back . We think about the overall setup here .
Speaker #6: What you should expect here on is continued investment in line with our capital allocation framework . Lots of focus , focus and discipline by the team and continuing to deliver on our overall commitments , both operationally and financially .
Speaker #3: Thanks , look Anthony . Let's move on to the next question . Thanks , Yaron .
Speaker #2: Thank you . We will now take the next question from the line of Ashtekar Kunwar from Truist . Please go ahead .
Speaker #15: Hey guys . Thanks for taking my questions . One also to say congrats on all the growth that you guys have shown this quarter .
Speaker #15: Impressive , John . When the acquisition was announced , you mentioned that head and neck cancer was the main driving factor for that .
Speaker #15: For your interest there. And you said you would talk a little bit more about colorectal when that data is presented. The data in CRC at the triple meeting was, I would say, perhaps a little better than what even Bill telegraphed.
Speaker #15: So how do you view that colorectal opportunity and then importantly to that as well as head , neck . Do you feel that you need a subcutaneous formulation to be competitive with their emerging competition from Rybrevant ?
Speaker #15: Thanks .
Speaker #3: Thanks very much for the for the questions . And we said that , well , the value was primarily determined by head and neck .
Speaker #3: And we want to expand head and neck . As you know , into locally advanced and potentially other settings . Fairly soon . And we would say that the data , the early data in colorectal cancer is very exciting , but very early data and , and we believe that the is potential in other EGFR positive tumors also outside of head and neck .
Speaker #3: But there is simply no or limited limited data . There . I will ask Ty to maybe give a bit more color there on our thinking .
Speaker #4: Ty . Yeah , thank you and thank you for all the hard questions . So I try to manage this . I think , as Yan said , early data , limited data , encouraging and we should leave it at that until we have control of of the asset .
Speaker #4: And it's really up to us to speak about the data. But I think that's kind of the top line, and broadly speaking, I think we even talked about this in the prepared remarks when we announced the acquisition.
Speaker #4: We do think of Pito as a best in class , second generation EGFR bispecific , and that obviously includes also opportunities outside of head and neck .
Speaker #4: But the focus is where it is right now . Two phase three is ongoing in head and neck , and there we have a significant head start over any form of competition .
Speaker #4: Subcutaneous administration is something that we are very familiar with, that we have, you know, some deep understanding of in the past and is obviously something that we are looking at as part of a lifecycle management.
Speaker #4: But our focus right now is execution on the studies that are already ongoing . And then and we can talk more about what Genmab is going to plan in due time .
Speaker #3: Thanks . Thanks , Ty . So , so confirming that the Subcu development is an integral part of our strategy for Pito . But more to come after the finalization of the transaction .
Speaker #3: Let's move on to the next question . Operator .
Speaker #2: Thank you . We will now take the next question from the line of Matthew Phipps from William Blair . Please go ahead .
Speaker #16: Hi . Thanks for taking my question . I've had a lot of investor interest recently on the first line , DLBCL trial with Epkinly reading out next year .
Speaker #16: I'm wondering you can give us any sense of what you think . That's a first half or second half readout . And then what level of PFS benefit do you think you need to really outcompete the R-chop regimen that has gained some traction there ?
Speaker #16: Thanks .
Speaker #3: Thanks , Matthew , for the question . Can you give a bit of color on the on the frontline , the large B-cell lymphoma trial and the potential need for for the type of data to to give us a angle , a differentiated angle over other other therapies ?
Speaker #4: Well, I'll take it. I think we have guided that we expect the readout to happen in 2026, and we should probably leave it at this right now.
Speaker #4: This is obviously an event driven study , and we will update in the appropriate setting when we have a little bit more clarity .
Speaker #4: But clearly the study was more or less fully accrued in in the summer of last year . So as it relates to to what it has to do in order to be competitive in the in the competitive landscape vis a vis polivy , I don't know , I don't think it makes sense to go into some kind of discussion about hazard ratio and what it has to show .
Speaker #4: I think we are very confident that if the study , when the study reads out that it will be a significant improvement over the standard of care and in that regard , also significantly differentiated from the Polivy data , the Polak study .
Speaker #4: That is partially underwritten by the data that is going to be represented now with a longer follow up at ash , where you have a phase two data set that in these high risk patients , IP3 five shows a .
Speaker #4: Incredible high CR rate with an incredible high durability . And on what we've seen over and over again is that these very robust phase two studies that we ran and then the data we generated on on them , more or less 1 to 1 , translates into the phase three .
Speaker #4: And so we anticipate the same to be true for the frontline diffuse large B-cell study .
Speaker #3: Thanks . So so in addition to efficacy also think about the convenience of the subcu dosing and the safety pattern may be very different from other other combination therapies .
Speaker #3: Matthew . So we are very excited about the potential to see the readout . Hopefully soon from the frontline . The large B-cell lymphoma , as a potential game changer .
Speaker #3: We feel for Epkinly . Let's move to the next question .
Speaker #2: Thank you . The next question comes from the line of Victor Flock from BNP Paribas . Please go ahead .
Speaker #17: Yes . Thank you for taking my question . Maybe just a small housekeeping skipping question on on data readout timing . So thanks so much for the comment on the .
Speaker #17: First line , DLBCL . But you used to have an anticipated readout column on the slide seven . So I just wanted to ask you whether you can confirm that all the phase three trials that are , you know , on the on the slides , all the all the timings are consistent with what we what you've discussed last time for the for the third quarter .
Speaker #17: Second quarter update . Thanks so much .
Speaker #3: Thank you . Comments on the on the timings there .
Speaker #4: Nothing has changed .
Speaker #3: So we have confirmed .
Speaker #13: That Victor .
Speaker #17: Thank you .
Speaker #3: Thanks . Let's move to the next one .
Speaker #2: Thank you . The next question is from the line of Zion Ibrahim from JPMorgan . Please go ahead .
Speaker #18: Hi . Thanks for taking my question . Got one clarification question for Anthony just on the opex for 26 , in terms of when you say both the standalone investments for mirrors and for Genmab are at a reasonable place , I think I think is how you characterized it .
Speaker #18: Does that include the potential for indication expansion that you outlined for locally advanced head and neck for Pepto , and maybe , maybe other other indications that we might hear about more in Q1 was my first question .
Speaker #18: And the second question is just on if you can remind us on the filing strategy for for RNAs in Proc next year , is are you just said everything's on track ?
Speaker #18: But in terms of recruitment , how that's progressing for the phase three and when we can expect to see more duration of response data from the phase two trial .
Speaker #18: Thanks a lot .
Speaker #3: Thanks for the questions . I will leave the first one to Anthony , of course , to give you further clarity there . The second one I can take for Rena as a filing strategy .
Speaker #3: The initial filing will likely be based on the Phase 2 potentially registrational trial for Proc. That trial is completely recruited and also in parallel.
Speaker #3: The Phase Three is recruiting very rapidly, so we are fully on track there to have a readout next year, potentially of filing and an approval, hopefully in 2027.
Speaker #3: Anthony , can you give a bit more color on the inclusion of the locally advanced head and neck for the Genmab trials as projected for 2026 ?
Speaker #6: Yes . The short answer is yes . So I think about , again , just reiterating as we think about forward to 2026 , it was important to condition the market thinking about overall investment levels .
Speaker #6: Again , to reiterate , expect as a look at consensus today for both Genmab standalone as well as , you know , look to be in a reasonable place .
Speaker #6: Also reflective of our investment priorities . Of course , we're going to provide ultimately our guidance to the market . In February of 26 , but to put a finer point on it , Zain .
Speaker #6: Yes , as I sit here today , does include what we think about it from an overall , you know , portfolio development , including your specific question around inclusion of investment in the locally advanced .
Speaker #3: Thanks . Thanks , Anthony . So thanks for the questions . Let's move on to the next one .
Speaker #2: Thank you . Next question is from the line of Shirley Haywood from Bank of America . Please go ahead .
Speaker #19: Hi , Charlie Hayward , Bank of America . Thanks for taking the questions . First one was on just how to look , how you're looking at the first line , head and neck cancer landscape specifically .
Speaker #19: I guess the the option to have a triplet versus a doublet strategy . How you think those segments of the markets differ versus , you know , the Keytruda mono or combo arms that you have as part of the trials and then the second one being in Rena s your endometrial data , I think , optically looked like better responses in the folate receptor , greater than 25% .
Speaker #19: And a bigger delta than you'd seen in proc . So I guess confidence in efficacy across broad folate receptor alpha expresses . Thank you .
Speaker #3: Thanks , Charlie , for the questions . Can you start and then maybe you can step in there . Let's first start with the frontline head and neck cancer landscape .
Speaker #4: Sure . I mean I would say the way I would answer your question is that , broadly speaking , in the current landscape , as you were alluding to there , there is a pinball mono strategy and then a pembro chemo strategy .
Speaker #4: And at times physicians make that choice based on maybe a slightly higher response rate for the chemo pembro combination . In a faster time to response .
Speaker #4: And that's a lot to do with the location of the tumor and the size of the tumor. That all becomes essentially irrelevant if the data in the Phase 2 with Pato and Pembro is essentially double the reported response rates for Chemo-Pembro. Because at that point, you basically have a response rate that is twice as high, without the significant toxicities of chemotherapy.
Speaker #4: And these patients don't necessarily tolerate chemotherapy too well . So this is what we like about the the profile of Pato in particular .
Speaker #4: Also in the data . And really in the combination provides an opportunity where you have a high response rate , a rapid time to response without any of the quite significant toxicities that go along with combination chemotherapy in these patient setting .
Speaker #4: That's the head and neck . Sorry . On the on the EC on the Venus and the cancer . I mean there are nuances here and there .
Speaker #4: It's not that we have ever said that folate receptor alpha expression is irrelevant to the response; that's not the case. What we said is that Venus has a profile that allows us to generate meaningful responses across the entire spectrum of folate receptor alpha expression, and thus does not require a biomarker selection.
Speaker #4: And that's a strategy that has allowed us to go into these indications that are generally considered to be a lower folate receptor alpha-expressing tumor than Proc.
Speaker #4: And it's also what is underlying the confidence in going into other indications , such as , for example , EGFR non-small cell lung cancer .
Speaker #4: And so this is one of the differentiating aspects of Venus, that it is able to generate meaningful and stable response rates across the entire spectrum.
Speaker #4: That doesn't mean that the higher don't even have higher responses . That just means that even at the low end , the responses are meaningful and durable .
Speaker #3: Thanks . Thanks , Ty . Let's go on .
Speaker #13: To the next question .
Speaker #3: Thanks , Charlie .
Speaker #13: Thank you . Please .
Speaker #2: There are no further questions at this time . I would now like to turn the conference back to Jan Van Winkle for closing remarks .
Speaker #3: So thank you for calling . And today , if you have additional questions , please reach out to our Investor Relations team . We very much look forward to speaking with you all again soon .