Genmab A/S Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 8, 2025
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Operator

Hello, and welcome to the Genmab's Financial Results Conference Call for the First Quarter of twenty twenty five. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward looking statements that include words such as beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. 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.

Operator

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 now like to hand the conference over to your first speaker today, Jan van der Winkle. Please go ahead.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Hello, and welcome to Genmab's conference call to discuss our financial results for the period ending 03/31/2025. With me today to present these results is our Chief Financial Officer, Anthony Pagano Chief Commercial Officer, Brad Bailey and our Chief Medical Officer, Taya Mahdi. For the Q and A, we will be joined by our Chief Development Officer, Judith Glimovsky. As already said, we will be making forward looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

In 2025, we continue to advance towards becoming a fully integrated biotech independently developing and commercializing wholly owned antibody differentiated therapies. Our disciplined capital allocation strategy and sustained execution support our continued growth and long term value creation. In the first quarter, we continued to deliver on our strategic priorities. Our total revenue grew by 19%, fueled by the solid performance of Abkinly and Tivtaq increased recurring revenue. Our investments remain fully in line with our capital allocation priorities, supporting key late stage pipeline programs and maximizing the success of our commercialized medicines.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

And we made these important investments while growing our operating profit by 62%. In addition, in March, we initiated our planned share buyback of up to 2,200,000.0 shares. This share repurchase underscores both our confidence in Genmab's future and our commitment to delivering value to shareholders. We ended the quarter with over $3,000,000,000 in cash, reinforcing the strength of our financial foundation. And this strength gives us the flexibility for continued growth and expansion.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

We will continue to prioritize our investments with a laser sharp focus on our late stage proprietary clinical pipeline, specifically abcaritamab, Rina S and akasunlimab, and maximizing the success of our commercialized medicines. Now let's turn and focus for a moment on the overall potential of our promising late stage pipeline where we see multiple billion dollar opportunities. Epculitamab, rhinase and akasunamab are all poised to drive significant revenue growth for Genmab by the end of this decade. Abkindi with its rapid clinical development is positioned to become the core therapy in B cell lymphomas with anticipated peak sales exceeding $3,000,000,000 This will be driven by three expected Phase III readouts. Two of these, including in frontline diffuse large B cell lymphoma, are anticipated by the end of twenty twenty six.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Excitingly, we recently announced our intention to submit a supplemental biologics license application to the FDA for efgartigimod in second line follicular lymphoma. And this decision was supported by positive top line results from the Phase III APCORE FL1 trial. We are pleased with the strength of this initial data, and we plan to submit the full results for presentation at an upcoming medical conference in 2025. Turning to Rhino S, we are exceptionally well positioned to maximize its blockbuster potential. And I say this because we have got a powerful combination of proven clinical development capabilities, a track record of acceleration and deep expertise in the gynaec space with TIVDAC.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Based on the exceptionally strong execution of the team post acquisition of Profound Bio, we remain on track to bring Rhino S to ovarian cancer patients in 2027. And given its best in class profile, we expect to achieve peak sales exceeding $2,000,000,000 There is also a meaningful opportunity for novel treatments like akasunlimab in non driver mutation second line plus non small cell lung cancer to provide both improved response rate and durability of response. So here, we anticipate a peak sales opportunity of $1,000,000,000 And as you know, beyond these programs, we are continuing to actively look for opportunities to further grow our pipeline, both organically and inorganically. Now let's turn to some of our first quarter advancements. Abkindle's robust clinical development and regulatory approvals reinforce its market leading position.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

As I just noted, last week, we announced our intent to seek approval in The U. S. For ebrutinib plus rituximab and selenalidomide in patients with relapsed or refractory follicular lymphoma following at least one prior systemic therapy. We intend to submit this supplemental BLA in the first half of twenty twenty five. And this milestone illustrates our commitment together with AbbVie to the ongoing development of abcaretumab.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

In February, AbKinli became the first and only subcutaneous T cell engaging bispecific antibody approved in Japan to treat both relapsed or refractory follicular lymphoma and relapsed or refractory large P cell lymphomas after two or more lines of therapy. In addition, epiritamab in combination with GemOx was added to the NCCN guidelines for second line patients with diffuse large B cell lymphoma who are ineligible for a transplant. Tivdek expanded its presence with approvals in both Europe and Japan. It's now the first and only ADC approved in both territories for the treatment of recurrent or metastatic cervical cancer after prior therapy. Excitingly, the launches of TIVTech in Japan and Europe will be the first time that Genmab will lead commercialization efforts on our own without a partner.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

This will bring us closer to achieving our goal of bringing our own medicines to patients and will strengthen our growing leadership in transforming care for patients with gynecological cancers, which also positions us for success for the potential launch of Rhino S. Our potential for future potential success is also reflected in the multiple data presentations that either occurred recently or that we anticipate in the coming months. In March, we presented the highly anticipated updated results of Reina S in advanced ovarian cancer at the twenty twenty five Society of Gynecologic Oncology Annual Meeting on Women's Cancer, or SGO, in Seattle. Last month, we had data from a variety of programs presented at AACR. This included preclinical data from Rhino S, as well as the early stage bispecifics GEN-ten 57 and GEN-ten 59.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

And we are now looking forward to ASCO, where we will have multiple presentations, including data for rhino S in endometrial cancer. Thij will now bring you up to date with the status of this program, followed by an overview of the promising rhino S data from SGO. Thij, the floor is yours.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Thank you, Jan. If you could make sure that we're now on slide eight. We're confident that WinAS has the potential to become a best in class treatment for ovarian cancer, endometrial and other folate receptor alpha expressing solid tumors. This confidence has led us to accelerate the development of VNS, first into a Phase III trial in second line plus platinum resistant ovarian cancer. And also, we are now on track to start a Phase III study in second line plus endometrial cancer for the end of the year.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Behind this confidence is encouraging data, including the results we will present at ASCO in endometrial cancer, as well as the data that we recently presented at SGO in Prague. Now let's take a brief look at the SGO data. You could go to slide nine, please. We told you in February that we intended to present meaningful follow-up data from the expansion cohort for Prague early in the first half of twenty twenty five, And we did just that last month at SGO. The data presentation included updated efficacy and safety data with around twenty four weeks of additional follow-up from the data cutoff previously presented at ESMO last year.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

As a reminder, these are heavily pretreated ovarian cancer patients. Regardless of folate receptor alpha expression, results showed that Vina S dosed at one hundred and twenty milligram per meter squared every three weeks led to a confirmed objective response rate of fifty five point six percent. And this encouraging anti tumor activity was durable. With a median on study follow-up of forty eight weeks, the median duration of response was not reached as only one of the ten patients experienced disease progression. Vina S was well tolerated and once again no signs of ocular toxicity or ILD were observed.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Altogether, this data reinforces the potential of Vina S to become a best in class treatment for ovarian cancer, benefiting a broader patient population than currently approved therapies with a differentiated efficacy signal across the entire patient population, that is with no need for selection based on folate receptor alpha expression, better and differentiated safety profile that is without ocular toxicity or ILD and an unprecedented durability. Now over to Brad for a review of the solid recent commercial performance for Epkini and Tiftac.

Brad Bailey
EVP & CCO at Genmab

Thank you, Ty. We started the first quarter of twenty twenty five with solid performance from our commercialized medicines, reinforcing our foundation for continued growth and expansion across our portfolio. We've continued to invest strategically in our commercialization capabilities to ensure we are set for long term success as we enter the exciting next phase of our commercialization strategy with our wholly owned launches initiating in Japan and Europe this year. Overall, our commercialized medicines contributed positively to our revenue growth in the quarter, with combined Epkenly and TIVDAC sales up 56% year over year, accounting for 29 of our total revenue growth. As we drive towards our 02/1930 vision, we see significant opportunity to build on our momentum across the commercialized portfolio, and we expect the contributions of our commercialized medicines to continue to increase.

Brad Bailey
EVP & CCO at Genmab

This is driven in large part by the confidence we have in our ability to capitalize on what we expect to be a $6,000,000,000 plus combined market opportunity for Epkinley, Rina S, and Akasulimab as the total addressable patient population for these potentially transformative medicines grows significantly. It has become increasingly clear that our investments in our commercialization capabilities are continuing to fuel our success, yielding meaningful results and enabling us to strategically scale to support our long term growth. Turning now to Epkenly. In Q1, Epkinley posted $90,000,000 in global sales, a 73% year over year increase, and we have observed continued growth across geographies with encouraging uptake, strong field execution, and consistent positive feedback from physicians. We continue to make strong progress bringing up Kinley to as many patients as possible around the world through our targeted go to market commercialization strategy as we address areas of high unmet patient need across diverse sites of care.

Brad Bailey
EVP & CCO at Genmab

As Jan touched on earlier, Q1 marked a number of meaningful milestones for our commercialized medicines, and for Epkinley in particular. This includes becoming the first and only bispecific approved with a dual indication in third line plus DLBCL and follicular lymphoma in The US, EU, and now Japan as well. It also includes important progress that reinforces Epkinley's clinical profile and potential in earlier lines of therapy. We're highly encouraged by Epkinley's performance to date and its growth potential, particularly as we look ahead to earlier lines of therapy on the horizon. And we're confident that we have the foundation in place for Epkinley to become the core therapy across B cell lymphomas.

Brad Bailey
EVP & CCO at Genmab

In The U. S, we have seen increasing uptake across sites of care, which will continue to be an important growth driver as we move forward. This expanded utilization reinforces Epkinley's uniquely differentiated clinical profile, positive label, and value as the only dual indication bispecific in DLBCL and FL. In Japan, the launch of Epkinley in third line plus relapsed or refractory follicular lymphoma is going extremely well, building on the uptake we've seen in LBCL and driven by national and field level activities and account activation. Across all other markets, we have experienced growth with Epkenly through our partner AbbVie.

Brad Bailey
EVP & CCO at Genmab

Globally, Epkenly has received more regulatory approvals across both DLBCL and FL than any other bispecific, with approvals in more than 50 countries presently. This positions Epkenly well for continued growth and utilization across markets. As we look ahead, we remain focused on accelerating the adoption of Epkenly, rapidly identifying patients across diverse sites of care, and advancing our robust development program across histologies and earlier lines of therapy to further establish Epkinley as the core therapy across B cell lymphomas. Next, we'll turn to TIVDAC. Strong and stable performance in The US in Q1 was driven by the depth and breadth of sites of care using TIVDAC.

Brad Bailey
EVP & CCO at Genmab

Sales during the quarter were $33,000,000 which is up 22% over Q1 twenty twenty four. As we shared during our Q4 earnings call, TIVDAC was updated to a Category one preferred treatment and obtained a new Category 2B designation for its use in combination with pembro for PD L1 positive patients, further reinforcing its potential as the clear answer in recurrent and metastatic cervical cancer. In March, Tibdaq received approvals in both Japan and The EU for gemmab will lead commercialization independently. Recognizing the significant need facing patients in Japan and Europe, our teams are working closely with health authorities to bring Tibdaac to patients in these regions as quickly as possible. Together, these approvals mark a significant milestone for Genmab, ushering us into the next phase of our commercialization strategy as we bring TIVDAC to more patients around the world and grow our Gynoc portfolio globally.

Brad Bailey
EVP & CCO at Genmab

With continued solid performance across our commercialized brands and progress expanding our commercial portfolio, we feel confident in how we are positioned to continue executing our growth strategy now and in the future. Looking ahead, we will continue to make the necessary investments in our commercialization capabilities to fuel our success, competitively scale our business and drive strong results. As we build upon the launch success of both Epkinley and TIVDAC, we are laser focused on expanding utilization of these life changing treatments and bringing them to as many patients as possible around the world. These efforts mark a meaningful and disciplined shift towards the next phase in our commercialization strategy. Our strategic expansion into new markets will enable us to transform treatment paradigms at global scale.

Brad Bailey
EVP & CCO at Genmab

With that, I'll hand the call over to Anthony to discuss our financials further.

Anthony Pagano
Executive VP & CFO at Genmab

Thanks, Brad. In Q1, we delivered solid revenue growth, driven by sustained recurring revenues and a solid market performance of our products. We've also significantly enhanced our long term growth potential as we continue to gather promising data for RHINNA S and up Kinley. And as we'll see, our financials remain strong. We achieved 19% total revenue growth.

Anthony Pagano
Executive VP & CFO at Genmab

And importantly, we grew our recurring revenues by 33%. This was driven by strong royalties from DARZALEX and Kasimpta. And importantly, this growth was also driven by product sales from FKINLEY and TIVDAQ, which together represented around 29% of our total revenue growth. Looking at DARZALEX, where we continue to see strong growth. Overall, sales grew by around 20%.

Anthony Pagano
Executive VP & CFO at Genmab

That's net sales of over $3,200,000,000 for the quarter, which translates to $450,000,000 in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline settings. So, you can see that the quality of our revenue profile continues to improve. In fact, in Q1 of this year, recurring revenues represented 95% of our total revenues, and that compares to 85% in Q1 last year. So it's really clear that the investments we've made in building out our commercialization teams and capabilities are paying off.

Anthony Pagano
Executive VP & CFO at Genmab

And this sets us up well, as we prepare for potential expansion into earlier lines for F. Kinley, including second line FL, and the potential launch of ReDAS in 2027. And we continue to take a disciplined approach to these investments. Total operating expenses in the first quarter were $485,000,000 and that's up 5% compared to the first quarter of last year. And we managed our investments strategically, prioritizing our high impact Phase III programs and focused investments in our commercialization capabilities.

Anthony Pagano
Executive VP & CFO at Genmab

Our operational discipline contributed to our operating profit growth of an impressive 62% in the first quarter. So here, you can see that we continue to deliver on our commitments. Next, looking at our net financial items. Here, we have a net gain of $56,000,000 Then moving on to tax, we have tax expense of around $49,000,000 which equates to an effective tax rate of 20.3%. Taken together, our net profit amounts to $195,000,000 for the quarter.

Anthony Pagano
Executive VP & CFO at Genmab

So as you can see, continued strong underlying financial performance. With that, let's move to our 2025 financial guidance. We remain on track to achieve our existing financial guidance with projected double digit revenue and profit growth. We expect our revenue to be in the range of around $3,300,000,000 to $3,700,000,000 delivering a robust 12% growth at the midpoint. And this is despite our non recurring revenue decreasing by more than $100,000,000 So, it's our recurring revenues from royalty medicines, and increasingly from Epkinley and TIVDAC that's driving the anticipated growth in 2025.

Anthony Pagano
Executive VP & CFO at Genmab

In total for the year, we expect our recurring revenues to grow by 18%. For operating expenses, we expect to be in a range of around $2,100,000,000 to $2,200,000,000 And this reflects our disciplined approach to investments, as well as rigorous portfolio prioritization. Putting all this together, we're planning for operating profit in a range between $895,000,000 to nearly $1,400,000,000 with the midpoint of guidance amounting to $1,100,000,000 of operating profit and year over year growth of 16%. Now to give you just a bit of color on FX, every 10 move in the exchange rate relative to our guidance rate, which was dollar kroner at 7.2, that's worth around $5,000,000 in operating income or loss at the midpoint. So in summary, our guidance really highlights our continued focused and disciplined approach to our investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value.

Anthony Pagano
Executive VP & CFO at Genmab

Now, let me wrap things up. Our performance in the first quarter of twenty twenty five really underscores our ability to deliver solid revenue growth, advance key pipeline assets, and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2025, we're building on this momentum by further prioritizing our investments and expanding market opportunities. And we are, of course, monitoring the current geopolitical situation, including tariffs and the potential impact on our guidance on our business. At this stage, we do not anticipate a significant impact on our 2025 financial guidance.

Anthony Pagano
Executive VP & CFO at Genmab

And what's important to note here is that even in these volatile times, our very strong financial foundation, coupled with our continued financial rigor and disciplined capital allocation strategy enables us to position Genmab for growth and expansion, as well as create value for our shareholders and patients. And on that note, I'm going hand you back over to Jan.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you, Anthony. Let's move to our final slide. While we face geopolitical uncertainty, the fundamentals of our business are strong and our strategic priorities for 2025 and beyond remain unchanged. We expanded the reach of both at Kinley and Tiftec with additional regulatory approvals, with more to come. As we announced our intent to submit another supplemental Biologics License Application for abirritamab in the first half of this year.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

For acasulimab and Rhinase, we anticipate presenting additional supportive clinical data. Both have the potential to move into broader indications with new clinical trials, including the potential expansion of Rhino S into endometrial cancer. And we will continue to actively look for opportunities to grow our pipeline, both organically and inorganically, positioning us for long term growth and value creation. In summary, in the first quarter of twenty twenty five, our solid financial performance, including from Abkinley and Tiftec, reinforced the strength of our financial foundation. This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in our high impact Phase III programs and maximizing the success of our commercialized medicines.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Putting together, we are set up for long term success, having set the stage for sustained innovation, operational excellence and value creation through the decade and beyond. So before we move to Q and A, I'm pleased to announce that we will hold a virtual review of the Rhino S data presented at both SGO and ASCO on June 2. Details will be available on our website, and we look forward to a lively and energizing event. And that ends our formal presentation. Operator, please open the call for questions now.

Operator

Thank you. And now we're going to take our first question for today. And it comes from the line of Jonathan Chang from Leerink. Your line is open. Please ask your question.

Analyst

Is Ewen on for Jonathan. Thanks for taking our questions. So two from us. First one, can you help set expectations for the upcoming renal endometrial cancer data presentation at ASCO? And second, related to that, how should we be thinking about the commercial opportunity of renal S in endometrial cancer?

Analyst

And how does that compare to the opportunity in ovarian cancer? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Albert, for the questions. I will hand on the first one to Thij. And I mean, of course, we're still under embargo. We cannot give you too much information, but he can definitely shed some color on the data to be presented at ASCO. And then Anthony Pagano can definitely say a bit more about the potential commercial potential for RHINAS and if needed, Brad can add to that.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thay, why don't you start?

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yes. Thank you for the question. So as Jan was saying, we're obviously on an embargo, so I cannot give you a detailed preview of the data but as we said before, the data in our mind is very compelling. I think it underscores the potential for Vina S to be a best in class ADC in endometrial. It's going to be important to understand that the treatment paradigms have shifted in endometrial now.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Most patients are getting a combination of checkpoints and chemotherapy in combination frontline. So we're very excited about the efficacy signal. It's a signal that also underscores a second hypothesis that's very important for MENA S that is that because of the profile of the drug, it really has an efficacy across the expression of folate receptor alpha positive tumors, and that in a nutshell also has a readout to other opportunities in our mind. So that's kind of like how I would frame the data. And then I'll ask Anthony and Brad to comment on the opportunity in endometrial.

Anthony Pagano
Executive VP & CFO at Genmab

Yeah, I think it's important to kind of remember the journey we've been on with Rina S. When we made the acquisition and announced it back in April of last year, so a little over a year ago, we outlined an overall, our excitement for the program, our excitement around what we can really do with this asset in our hands. And really, you look back at what we said, we said a couple of important things at that point. We said at that stage, was a billion dollar plus opportunity and that we could very excited about, really putting our foot in the gas pedal from a development perspective. And that could potentially lead to the first approval in 2027.

Anthony Pagano
Executive VP & CFO at Genmab

Now let's fast forward thirteen months and look at what we've accomplished. We provided meaningful data to the market to really reinforce the business case, at least in second line plus a PROC shared last year reinforced at SGO this year. And we look to further expand that into data represented ASCO for endometrial cancer. And what we did earlier this year is we really outlined a framework how this potentially is not only a $1,000,000,000 plus opportunity, but potentially a 2,000,000,000 plus opportunity and really outlined the building blocks of that $2,000,000,000 plus opportunity, which includes second line plus proc, second line plus endometrial, second line plus PSOC and frontline endometrial. And as our plan here moving forward is to present more and more data to give you confidence that that 2,000,000,000 plus target is achieved.

Anthony Pagano
Executive VP & CFO at Genmab

So I think what we can really say about this overall is that endometrial looking at the patient numbers does represent a meaningful component of that $2,000,000,000 We've not broken down the specifics other than to give you a sense of the size of the potential patient populations. But overall, we're very happy owners of Arena S. And since we've owned the program, we've made significant progress in really putting our foot in the gas pedal, both in ovarian as well as endometrial cancer. Brad, maybe you want to provide a little bit more color here.

Brad Bailey
EVP & CCO at Genmab

Yeah, Anthony. I think as has been stated from Diane, Anthony, certainly Green S is a potential primary growth driver for us in the future. We have confidence, there, of which both endometrial and ovarian are meaningful, to this overall development plan. So more to come, but certainly encouraged here at this point.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Brad. Thanks, Ewen, for the question. I think we can move on to the next analyst.

Operator

Thank you. Now we're going to take our next question and it comes from the line of Yaron Weber from TD Securities. Your line is open. Please ask your question.

Analyst

Is Yaron on for Yaron. Following up with that first question on Rina S, what do you think is the efficacy bar in endometrial cancer now that you say that the paradigm for treating it is shifting to kind of use CPI combination in first line? And then secondly on ecoslimab, obviously you're going to have another update on that this year. Can you give us a little more detail on the timing of this presentation since it looks like it's not going to be at ASCO and what we might see? And also what you would consider a success for axosilamab?

Analyst

Thank

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you for the questions. So Thay, I think, can handle the efficacy bar question for endometrial cancer. And then Judith, maybe you can give a bit of color on the data, which we intend to present, which we are very excited about this year and timing and what you would consider a success. So maybe, Thay, you can start.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yeah, thank you again for the question. And as I alluded in my response to the first question, of course, there's also a shift in the patient flow now that patients are actually getting chemotherapy in combination with checkpoints in frontline. But historically the second line has been an indication where the response rates to chemotherapies are maybe in the ten to fifteen percent range and I want to just reiterate the point that I think we feel very comfortable that the data that is going to present in the very near future and publicly available will underscore the point that this is really a best in class profile from an efficacy point of view as well as from a durability point of view.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Thay. Maybe Judith on akasunlimab?

Judith Klimovsky
Executive VP & Chief Development Officer at Genmab

Yeah. Thank you, Jan. So for akasunlimab, we said, you know, that it will be H2 twenty twenty five. And the reason is the longer follow-up, the more meaningful will be the data that would present because as you know, the primary endpoint in that very setting is overall survival and for overall survival, the comparator is docetaxel with a median of eleven months. So we want to have the follow-up meeting to give us the data to support, you know, beating on the primary.

Judith Klimovsky
Executive VP & Chief Development Officer at Genmab

So this is the reason and that is H2 twenty twenty five to give meaningful follow-up. And I told you already the bar that you need to read, so this is the just to put the study in the right context, and the data in the right context.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you, Judith. And what I can add to that is that the Phase III is progressing very nicely, so recruiting patients there, and we are continuously excited about what we see. Let's move on to the next analyst.

Operator

Yes, of course. Now we're going to take the question from Shiang Deng from UBS. Your line is open. Please ask your question.

Xian Deng
Xian Deng
Director - Equity Research at UBS Group

Hi. Thank you for taking my questions. Two on at Kindle, please. First one, just wondering, so 19,000,000 sales for this quarter, just wondering if you could give us a sense of a rough split between follicular lymphoma and DLBCL, please. The reason I'm asking is that if I assume sort of 60,000,000 ACE looking at previous quarter for DLBCL, that means kind of 20 to 30,000,000 or so for follicular lymphoma.

Xian Deng
Xian Deng
Director - Equity Research at UBS Group

That actually looks really good versus what Roche has achieved. So just wondering, you know, any color on that and what's the differentiating factor, physician feedback there, particularly in follicular lymphoma, that would be great. The second question is, at Kingly second line plus follicular lymphoma, given now you plan to submit in the first half of this year. So just wondering, you know, appreciate you highlighted that the patient population here is about 9,000 patients. But just wondering what is your expected duration for this cohort, please?

Xian Deng
Xian Deng
Director - Equity Research at UBS Group

Because, you know, one year or two year usage makes a huge difference in terms of sales. Thank you very much.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you, Sion, for these excellent questions. And the first one is going to Brad to give you a bit more color on sales for Abkinly. And the second one, I will hand over to Thay to talk a bit more about the very exciting second line plus follicular lymphoma data, as much as we can speak about it at this time, because the data are no embargo. But Brad,

Jan van de Winkel
Co-Founder, President & CEO at Genmab

why

Jan van de Winkel
Co-Founder, President & CEO at Genmab

don't you start with a more color on sales?

Brad Bailey
EVP & CCO at Genmab

No, no. Thank you for the question as well. And while really not in a position to size contribution of sales, specifically seeing continued robust uptake and strong momentum following the respective FL launches and positive responses from providers both in The US and Japan as well as Europe. US specifically contributed, to the accelerated growth post approval FL certainly did across sites of care, most significantly in the community setting. This was further solidifying the value of the dual indication, as well as also from a label perspective, hearing from providers that the clinical profile sub q as well as the no hospitalization specifically for FL has been a key benefit.

Brad Bailey
EVP & CCO at Genmab

Certainly seen some very positive, although early in Japan, very positive responses from providers as well as the market regarding FL there as well. I'll turn it over to Tai on the duration.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yeah, thank

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

you for the question. So there's probably a few things that I would say to that. Number one, the duration of treatment is actually fixed in this particular study, meaning that the regimen is a twelve month duration treatment of lenalidomide, rituximab, and then efcoridomide. As Jan said, it's really impossible for us really to preview any of the data. This has to some degree something to do with the fact that the study is ongoing still and reading out for its primary PFS endpoint.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

This submission as we alluded in the press release is based on a interim primarily on overall response. Obviously the agency had access to all data and obviously that was very exciting to us. So I think one thing to look out as this progresses and we will be able to share with you is the magnitude of the effect size because obviously this is a somewhat unprecedented regulatory pathway that we're taking. We're really excited about the opportunity. Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Thay. So more to come, Siyan, very exciting times. Let's move on to the next question, operator.

Operator

Thank you so much. Now we're going to take the question from Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Paul Jeng
Vice President at Guggenheim Partners

Hi, this is Paul on for Michael. Thanks for taking our question. I had a couple of follow ups on Epco. So first, congrats on the recent top line data with R squared and follicular. Can you just talk a little bit more about your confidence in the regulatory approval based on just the or our co primary?

Paul Jeng
Vice President at Guggenheim Partners

Would you expect the agency to factor in or consider the interim PFS as well? And then just on the landscape, there's a CD19 R2 regimen that's also in review right now. How do you expect EFCO to potentially compete? Understanding that we haven't seen the full data yet, is there a sort of balance of safety and efficacy that physicians would really consider in the setting? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Paul, for the questions. I think we'll hand both of them over to Thay, and we are very, very confident about the data. But Thay, why don't you give a bit more color to Paul?

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yeah, so as much as I can try, what I can tell you is obviously starting with the fact that we at some point received breakthrough designation for this particular indication that was already based on some Phase II data that we had shared with the agency continuing then that we are now moving forward with this submission in a really unprecedented setting that already should tell you that there's been some data shared with the agency in totality frankly that has, you know, allowed us to engage and then get positive feedback and such that we are then committing to a submission before the end of the first half. And so then I would say this is going to be a discussion about how profound the treatment paradigms are changed based on the effect size as it relates to the positioning vis a vis competition. So more to come. But we're very happy and very excited to share this in the near future.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Maybe a bit more color on the CD19 R2 combination versus APCO R2, or can't you comment on that, Tai?

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Well, I mean, the data for tafa is obviously in the public domain, So it's hard for me to answer this question without getting into some discussion on previewing too much of the data because as I said before, there is strong need for us to maintain the integrity of the study as we're waiting for the interim PFS. You just mentioned one of the reasons why that is important for us. So I cannot really get too much into it except that I can share my confidence that this will not be necessarily topic once the data is publicly available.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

I think that's good enough, Thay. Thanks a lot. Thanks, Paul, the questions.

Operator

Thank you. Now we're going to take our next question. And the question comes from the line of Yifan Liu from HSBC. Your line is open. Please ask your question.

Yifeng Liu
Yifeng Liu
Analyst at HSBC

Hello. Thanks for taking my questions. I've got two. One is, I was wondering if you could comment on the sort of environment for BD now given all the macro volatility and unknowns on tariffs and etcetera. Could you maybe provide some update on the BD side?

Yifeng Liu
Yifeng Liu
Analyst at HSBC

And secondly is on your R and D cost And obviously, a good result in the first quarter, but you sort of reiterated your guidance. Just wonder, is R and D cost more sort of a second half weighted? And how should we think about that?

Jan van de Winkel
Co-Founder, President & CEO at Genmab

It's a very good question. So I will definitely hand the second one over to Anthony. We'll take the BD environment question myself. It's actually an excellent environment for BD if you are a company looking assets which can potentially complement our pipeline, because it's actually very challenging times for smaller biotechs that are innovative, but with our need for cash and support. I think this is very, very difficult for them.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

So this to actually then partner a molecule or handover molecule to a company with a robust cash position like Genmab, and a strong financial foundation is really a very good starting point. And I can assure you that we have a number of very good candidates, either late stage or late stage ready molecules on the radar screen, which we are discussing. So, we believe that this is actually a very good environment for BD if you are on acquiring sites, not when you're on the selling side. I think this puts a bit more pressure the system. That's where I can probably leave it at this moment and then hand over to Anthony to talk a bit more about R and D costs.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Anthony?

Anthony Pagano
Executive VP & CFO at Genmab

Yes. Thanks, Jan. Look, we've outlined a really clear strategy about how we're going to invest across our business, really focusing on the late stage assets at Kinley, Rina S and Akasunamab, as well as focus and disciplined investments in our commercialization capabilities and really building out some of our markets in a really focused way. And Q1 is fully reflective of that. Now, in terms of the expected growth that we're going to expect here in Q2, Q3 and Q4, getting to your question around R and D expenses, it's going to be fully in line with that.

Anthony Pagano
Executive VP & CFO at Genmab

Really, there's going to be three primary drivers of the growth here for the balance of 2025. The first is going to be the ramp up of the Phase three ten forty six or axosilomib trial. That was a trial that was launched last year, and will continue to ramp up and scale up during the course of 2025. The same is true for RENA S and second line plus PROC. Here, we again started that trial late last year, and we'll be ramping up during the course of 2025.

Anthony Pagano
Executive VP & CFO at Genmab

And then of course, in the second half of the year, we announced that we expect the Phase three second line plus endometrial trial to really be in launch mode. So those will be the three primary drivers. And again, those investments are fully in line with our state of objective investing and prioritizing investments in our late stage pipeline.

Yifeng Liu
Yifeng Liu
Analyst at HSBC

Thanks very much.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Anthony. Thanks. Let's move on to the next question, please.

Operator

Yes, of course. And now we're going to take our next question from the line of Vikram Purohit from Morgan Stanley. Your line is open. Please ask your question.

Vikram Purohit
Vikram Purohit
Analyst at Morgan Stanley

Great. Good afternoon. Thank you for taking our questions. We had two. First, on the topic of your work in immunology.

Vikram Purohit
Vikram Purohit
Analyst at Morgan Stanley

I know you have a partnership with Argenx focused on some early stage immunology work and you've also alluded to previously, I think, the potential for Epkinley in INI. So I just wanted to see if there's any updates on your thinking there for future potential efforts in I and I and how much of an internal priority that is for you right now when you look at different opportunities across your pipeline. And then secondly, I was just curious on determining next steps for GEN-ten '40 '2. I think your milestone calendar mentions you're going to be deciding on next steps there this year. Just wanted to see how you're thinking about that decision and kind of what determines the gono go there.

Vikram Purohit
Vikram Purohit
Analyst at Morgan Stanley

Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Vikram, for the questions. I can take the first one on immunology, and then I will ask Jule to give a bit more color on ten forty two next steps for that bispecific program. So we are very excited about the potential to use our expertise in INI. And we actually have a number of programs which we wholly own, and we have also programs where we work together with Algenx. They're all preclinical, VCOM, but we are very excited about the potential of some of these programs.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

But they are at the stage that we are creating the preclinical candidates for selection towards developing them in the clinic. The majority of our activities is still going to be based also the coming years on oncology. So more than 80% of our efforts is in oncology, but we're getting increasingly interested in also using our expertise that includes the whole breadth of the antibody based product candidate expertise also in other settings. And INI is, I think, an excellent one. But it's a bit early stage.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Abkindi is, I think, probably the most advanced molecule, which we want to move into INI. We are discussing right now with our partner, AbbVie, how to do that exactly and with indications, etcetera. So more to come in the coming time. Definitely, we have our portfolio is dominated by oncology opportunities. But as we already have shown, both at Kesimpta and also TEPEZZA is that, of course, molecules that can originally we saw originally developed for oncology indications can be excellent drugs, Vikram, and other indications.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

And INI is the area where antibody based medicines have made an incredible difference to the treatment of patients. So we believe that we can be very strong there, but it's lagging behind the cancer focused opportunity. So I will stop there, and then I'll ask Jure to give a bit of color on ten forty two next steps. Juren?

Jan van de Winkel
Co-Founder, President & CEO at Genmab

I don't know whether we

Jan van de Winkel
Co-Founder, President & CEO at Genmab

have Judith still on on on board, but +1 042

Operator

line is connected.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Oh, disconnected. Oh, okay. So so then let me do that. You did? All right.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Let me answer that question, Vikram, ten forty two next steps. We are waiting on duration data, and we will take a decision on next step for ten forty two, the CD441b antibody. And of course, we're still collecting data, especially in the head and neck cancer setting, frontline setting. And so that decision will be taken in the second half of this year. And we are waiting for more duration data to really get a good feeling for what the strength is of our data versus the evolving landscape in head and neck cancer.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

As we know, there's a lot of new developments in head and neck, and we want all of our candidates or product candidates to be very competitive also in the evolving therapeutic landscape. And in order to do that well and also to rigorously prioritize our attention on the different product candidates. We really need more of a duration data duration of response data. And we will get that in the second half of this year. I will leave it with that, Vikram.

Vikram Purohit
Vikram Purohit
Analyst at Morgan Stanley

Thank you.

Operator

Thank you. Now we're going to take our next question. And the question comes from the line of Asika Gunubarden from Truist. Your line is open. Please ask your question.

Asthika Goonewardene
Asthika Goonewardene
Analyst at Truist Securities

Hi, guys. Thanks for taking the questions. So I

Asthika Goonewardene
Asthika Goonewardene
Analyst at Truist Securities

got a couple please. So on VIA S, I want to just

Asthika Goonewardene
Asthika Goonewardene
Analyst at Truist Securities

close the loop on other tumor types beyond ovarian and endometrial. There were expansion cohorts in lung and other tumor types, which I thought would be fairly mature this year for you to report data on, but you're not talking about them. Is that because they're still ongoing and the data is not ready yet? Or are you deprioritizing development in those other tumor types outside of ovarian endometrial? If the latter, is it a full receptor alpha expression issue?

Asthika Goonewardene
Asthika Goonewardene
Analyst at Truist Securities

And then second, on Columbia, your competitor Columbia has an AdCom coming up May 20 to discuss the SPLA for StarGlob. It's a little odd given that StarGlob looks like a pretty successful trial with an OS benefit. So, what do you think is the question that the FDA wants to panel to discuss? And do you anticipate the same might be that Echo might face the same kind of question as well? Thanks.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Rastika, for the questions. I think I will ask Tay to initially start with both of these and then see whether we can add further to the second question, maybe via Judith. Tay, why don't you start with the other tumor types the level of interest for Ryanair, because I tell you, I think it's sky high. It's not lowering at all.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yeah, just thanks for the question, I think, just also to clarify. You know, we obviously inherited a protocol from profound bio but not all the things that were initially in there were actually operationalized. We did mention this on the call I think in response to a question from you previously, opened up a cohort in non small cell lung cancer and are actively enrolling patients in that study and there will be more activity on this, I promise you very soon that we can also share in the public domain. As Jan was saying, actually the more data we generate and the endometrial data to some degree is the additional layer of data that helps us understand the profile, the opportunity for VNRS, the more we get convinced that VNRS has an opportunity across the spectrum of folate receptor alpha expression. We know that in ovarian and in endometrial patients who have low or even are negative by an assay respond to tubulin assay and so that actually increases our confidence.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

We never had any other tumor type open, we have not enrolled any other patients outside of endometrial, ovarian or lung cancer at this point, but there also will be additional activities before the end of the year. So more to come. On the ODAC, it's not really appropriate for us to speculate on why or why not the FDA has asked for an ODAC for that study. I think if you look into that study and into the public data, there are some things one could, you know, think about as it relates to U. Patients.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

But anyway, we are focused on APKINI. We're very confident in how we are developing moving APKINI forward in the dual indications. We're very excited as I mentioned earlier for the follicular lymphoma data and we're also anxiously looking forward to have a readout on the front line diffuse large B cell study sometime in '26 if the events come in based on the accrual. And that is what we are focused on.

Judith Klimovsky
Executive VP & Chief Development Officer at Genmab

Thanks, And

Judith Klimovsky
Executive VP & Chief Development Officer at Genmab

the only thing to the only thing to add, if you can hear me now. Yeah. Can you hear me now?

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Yes.

Judith Klimovsky
Executive VP & Chief Development Officer at Genmab

Yes.

Judith Klimovsky
Executive VP & Chief Development Officer at Genmab

No, the only thing to add is just you mentioned, Jan, is that Epco, in conjunction with Jamox, got NCCN endorsement, which is very encouraging and very good for patients in The U. S.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you, Juret. I think we'll leave it with that, Ashtika. But thanks for the questions.

Operator

You. Now we're going to take our next question. And the question comes from line of Matthew Sipps from William Blair. Your line is open. Please ask your question.

Matthew Phipps
Equity Research Analyst at William Blair

Thanks. Thanks for taking my question. Great to see Kimley move forward with the project front runner here in second line follicular. Wondering if you all are thinking about or have any agreements to use the Project Front Runner and any other ongoing or planned Phase III studies. I know the Front Line follicular study also has a complete response endpoint.

Matthew Phipps
Equity Research Analyst at William Blair

Perhaps that is maybe designed also for a potential Project FRONTROUND or PATCH? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you for the question. And I think, Tai, you can probably address whether we have any discussions with the FDA on other programs like FRONTROUND.

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yeah, so I think broadly speaking, conversations about novel approaches are easier if you have compelling data and are not so straightforward in a theoretical vacuum without any data. So obviously what we've said before is we continue to explore opportunities to accelerate access for patients, particularly when we feel that the data is profound and meaningful to patients. This was one of the situations where we took an innovative approach and based on the data had a positive interaction with the FDA and that's why we were able to move forward and we'll continue to do that and whatever study comes out with other data we have, if the data is compelling and we feel there is an opportunity to bring this to patients earlier.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Tay. Let's move on.

Operator

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

Rajan Sharma
Rajan Sharma
Executive Director at Goldman Sachs

Hi. Thanks for taking the question. Just one from me, and it's maybe a bit of housekeeping. I just noticed on your, slides you're guiding to a core DLBCL two trial readout in 2026, but ClinicalTrials.gov still has a primary completion date of mid-twenty seven. Could you just help us reconcile that?

Rajan Sharma
Rajan Sharma
Executive Director at Goldman Sachs

Is it just a case of ClinicalTrials.gov not being updated?

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Rachan, for the question. Tai, can you comment on that?

Tahamtan Ahmadi
Executive VP, Chief Medical Officer & Head of Experimental Medicines at Genmab

Yeah. Again, thank you for the question. Generally speaking, I wouldn't take clinicaltrials.gov as the most validated resource to figure out when studies read out. These studies are obviously events driven and then they're also depending a little bit on the speed of accrual. I think we had this in multiple of our calls where we pointed out that the accrual of both the second line follicular lymphoma and the front line diffuse large B cell was significantly faster than initially projected and that then always means that you have a compression of a patient accrual, but also an opportunity to collect events and get the results maybe at an earlier time point than previously projected.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

I think that's very clear, Thay. Thanks a lot. Thanks, Rajan, for the questions. So thank you all for calling in today to discuss Genmab's financial results for the first quarter of twenty twenty five. And if you have any additional questions, please reach out to our Investor Relations team.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

We very much look forward to speaking with you again soon.

Operator

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

Analysts
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Key Takeaways

  • Strong Q1 results: total revenue grew 19%, operating profit rose 62%, a 2.2M share buyback plan was initiated, and cash reserves exceeded $3 billion.
  • Emphasis on late‐stage pipeline assets—Abkinly, Epculitamab, RhinoS, Akasunlimab—with forecasted peak sales of over $3 billion, $2 billion, and $1 billion for Abkinly, RhinoS, and Akasunlimab, respectively.
  • Regulatory progress for Abkinly: submission of a supplemental BLA in second‐line follicular lymphoma based on Phase III APCORE FL1 data, approval as Japan’s only subcutaneous bispecific, and epiritamab’s inclusion in NCCN guidelines.
  • RhinoS demonstrated a 55.6% objective response rate and durable anti‐tumor activity in heavily pretreated ovarian cancer without ocular toxicity or ILD, advancing to Phase III trials in ovarian and endometrial indications.
  • Commercial momentum continues with $90 million in Epkinly sales and $33 million for TIVDAC, alongside upcoming self‐led launches in Japan and Europe.
A.I. generated. May contain errors.
Earnings Conference Call
Genmab A/S Q1 2025
00:00 / 00:00

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