Genmab A/S (NASDAQ:GMAB) Q4 2024 Earnings Call Transcript

Genmab A/S (NASDAQ:GMAB) Q4 2024 Earnings Call Transcript February 14, 2025

Operator: Hello, and welcome to the Genmab Full Year 2024 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. 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 our first speaker today, Jan van de Winkel. Please go ahead.

Jan van de Winkel: Hello, and welcome to Genmab’s conference call to discuss our financial results for the period ending December 31, 2024. With me today to present these results is our CFO, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi, and our Chief Development Officer, Judith Klimovsky. 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. 2024 was marked by significant milestones towards our mission to deliver innovative medicines to patients.

We made strategic investments to both accelerate the development of late-stage programs with the potential to generate meaningful revenue by the end of the decade, and to maximizing the success of our commercialized medicines. So we delivered on our capital allocation priorities in 2024, and as Anthony will describe later, we will do so again in 2025. Overall, our financial performance in 2024 was exceptionally strong, and we have further solidified our foundation for sustainable future success. Let’s take a look at this in more detail. 2024 was a year of strong execution and disciplined investments, driving 31% total revenue growth, fueled by the success of our eight commercialized medicines, including EPKINLY and TIVDAK. Our investments are fully aligned with our strategic priorities, supporting key late-stage pipeline programs and commercial expansion, allowing us to grow operating profit by an impressive 26%, demonstrating the strength of our business.

Despite significant investments, including the $1.8 billion acquisition of ProfoundBio and a $500 million share buyback, we ended the year with nearly $3 billion in cash, reinforcing our financial strength. This exceptionally strong financial position gives us the flexibility to continue investing in innovation while delivering long-term value to shareholders. Taken together, our financial results for 2024 exemplify our ability to deliver strong revenue growth while simultaneously advancing high-potential programs. Now let’s look forward, starting with our pipelines. We currently have 12 products or product candidates in 30 clinical trials, either ongoing or recruiting. This includes seven Phase III trials between EPKINLY, Rina-S, and Acasunlimab.

And based on the strong emerging data, we expect more to come. Because these three programs are poised to drive significant revenue growth for Genmab by the end of this decade, we have prioritized investments for 2025 and purposely reallocated our R&D dollars to these programs. Now let’s take a deeper look at why we are confident in their significant potential. Starting with EPKINLY. Together with AbbVie, we continue to advance an ambitious clinical development program for epcoritamab across B-cell malignancies, including frontline studies in diffused large B-cell lymphoma and follicular lymphoma. Three of five ongoing Phase III studies have been fully recruited well ahead of schedule. And in addition to confirmatory data, based on accelerated enrollment, we now anticipate three potentially significant pivotal readouts by the end of 2026.

Second line plus follicular lymphoma, frontline diffuse large B-cell lymphoma, and in second line plus diffuse large B-cell lymphoma for transplant ineligible patients. If successful, this could lead to significant market expansion, especially as frontline diffuse large B-cell lymphoma represents the single largest indication, as you can see this on the next slide, where we summarize the significant market opportunity for EPKINLY. We have successfully obtained multiple regulatory approvals for EPKINLY, making this therapy accessible to a broader patient population. And thanks to our exceptionally strong performance in key markets like the U.S. and Japan, we are confident in our ability to expand EPKINLY’s reach even further. In fact, our commitment to advancing EPKINLY across multiple indications in B-cell cancers underscores its potential as a best-in-class treatment with a peak sales opportunity exceeding $3 billion.

Let’s now turn to Rina-S. As we have shared previously, we have now initiated the first Phase III trial for Rina-S in second line plus platinum-resistant ovarian cancer. This trial is designed to address all comers, regardless of folate receptor alpha expression, expanding its potential reach to a broader patient population. We intend to present meaningful follow-up data from the expansion cohort with PROC early in the first half of 2025. Additionally, we are actively generating combination data to inform next steps in platinum-sensitive ovarian cancer. Beyond development in ovarian cancer, we are also planning to present data in endometrial cancer in the first half of this year. And based on the strong signals we are seeing, we plan to start a Phase III study in second line plus endometrial cancer by the end of the year.

All this adds up to a significant market opportunity for Rina-S, which you can see on the next slide. Rina-S’ differentiated profile has the potential to address a broader patient population than is served by current standard of care, including low to medium folate receptor alpha expression, targeting about 85% of the platinum-resistant ovarian patient population. We are exceptionally well-positioned to maximize the potential of Rina-S, given our proven clinical development capabilities, track record of acceleration, and our experience in the Gyn/Onc space with TIVDAK. Based on the exceptionally strong execution of the team post-acquisition, we remain on track to bring Rina-S to patients by 2027. With its best-in-class profile, expected to achieve peak sales exceeding $2 billion, and with the two Phase IIIs we plan to have underway by year’s end, we are well on track to putting in place the building blocks to achieve this target.

Finally, let’s take a look at the market opportunity for Acasunlimab. In 2024, Genmab took full control of the Acasunlimab program, providing us with a remarkable opportunity to fully own and advance this promising asset. Non-driver-mutated, second-line, non-small-cell lung cancer continues to be an area of significant need. Given the worsening of performance status as patients’ progress through lines of therapy, physicians are interested in more tolerable, chemo-free regimens. Yet with many novel treatments failing in Phase III trials, Docetaxel continues to be the current standard of care. By identifying potential synergies of IL therapies, we have the potential to unlock clinical benefits that were not possible with monotherapy alone. So there is meaningful opportunity for novel treatments like Acasunlimab in the second-line plus setting to provide not just improved response rates, but durability of response.

And we are progressing a strategic development program to explore Acasunlimab’s full potential across solid tumors. So in summary, in 2025, we will be in execution mode. We will continue to deliver on our financial commitments through focused investments in our high-priority, late-stage, and commercial programs, because it is the investment in these areas today that will position us well at the end of the decades. I want to hand over the presentation to Brad, who will provide you with a review of the recent performance for TIVDAK and EPKINLY, both of which have seen growth in 2024. Brad, the floor is yours.

Brad Bailey: Thank you, Jan. Over the course of 2024, our commercialization teams executed effectively to bring EPKINLY and TIVDAK to an increasing number of patients around the world. Overall, EPKINLY and TIVDAK ended the year in a strong position, demonstrating the strength of our commercialization strategy and the performance of our field teams. We also achieved critical milestones, including two new regulatory approvals in the U.S. and continued our work to rapidly progress our development program to fuel our future growth. Through these efforts, our commercialized medicines contributed 29% of our revenue growth for the year. Moving to highlights from our commercialized portfolio, we achieved meaningful milestones with both medicines that contributed to their overall growth.

Over the past three months, TIVDAK and EPKINLY have collectively received three new or updated NCCN guidelines designations. First, in December, TIVDAK monotherapy was upgraded from Category 2a to Category 1 designation for the treatment of recurrent or metastatic cervical cancer, further validating its clinical benefit for these patients. TIVDAK, in combination with pembrolizumab, was also added as a Category 2b designation for patients with PD-L1 positive disease. And earlier this month, EPKINLY, in combination with GemOx, received a Category 2a designation for the treatment of diffuse large B-cell lymphoma in the relapsed refractory setting. This is especially notable as we look to bring the potential of EPKINLY into earlier lines of therapy in the future.

Lastly, for EPKINLY at ASH, we presented a three-year long-term data from our EPCOR NHL-1 study, which evaluated EPKINLY in patients with third-line or later relapsed or refractory DLBCL. These data showed that over half of patients who achieved a complete response in the trial maintained their response for more than three years with no new safety signals identified. These results represent the longest duration of CRs reported by a bi-specific in this setting, further reinforcing EPKINLY’s clinically differentiated profile and potential to deliver deep, durable responses. Now let’s turn to performance, beginning with EPKINLY. EPKINLY has continued to perform exceptionally well since its initial launch in 2023. It closed 2024 in a position of strength, achieving $78 million in sales in the quarter and $281 million in sales for the year.

This growth was driven primarily by sales in the United States and Japan. In the U.S., EPKINLY remains the first and only bi-specific approved with a dual indication in third-line plus DLBCL and follicular lymphoma. Throughout 2024, we continued to see sustained uptake across sites of care driven by targeted field execution and the successful FL launch in June. Since the FL launch, we have observed accelerated growth in positive physician feedback, highlighting the value of EPKINLY’s dual indication, its uniquely differentiated clinical profile, and seamless administration. Moving forward, we will continue to focus on accelerated adoption across broad sites of care. In Japan, EPKINLY is the only approved CD3, CD20 bi-specific in third-line plus relapsed or refractory large B-cell lymphoma, and we continue to see strong, stable performance, largely driven by field execution and account activation.

We are well positioned to build on this leadership position in Japan with the anticipated approval for third-line plus relapsed or refractory follicular lymphoma in early 2025. With this indication, EPKINLY will become the first and only bi-specific approved in Japan with a dual indication in LBCL and FL. In the rest of the world, we’re seeing increased utilization of EPKINLY through our partner, AbbVie and achieved approvals in more than 50 countries worldwide by the end of 2024. We look forward to this trajectory continuing in 2025 and beyond. Looking ahead, our teams remain focused on driving adoption in priority markets while accelerating our robust development program to establish EPKINLY as the core therapy in B-cell lymphomas, including in earlier lines of therapy.

As we continue to target areas of high unmet need, our commercialization teams remain focused on creating optimal customer experiences through the disciplined execution of our targeted go-to-market strategy that has consistently driven our success to-date. Turning now to TIVDAK. As the only ADC with a proven survival benefit in advanced cervical cancer, TIVDAK has continued to achieve solid growth since its launch in 2021 and is regarded by physicians as the global standard of care and the clear answer in second-line plus recurrent or metastatic cervical cancer. TIVDAK produced $131 million in sales during the year, including $38 million in the fourth quarter, driven by depth and breadth of ordering accounts. With strong utilization rates in this setting, we anticipate modest growth in the U.S. in 2025.

Looking ahead, we see opportunities to expand the potential of TIVDAK in advanced cervical cancer to new markets where patients’ needs remain high. We expect approval in Japan early this year, where Genmab will lead full commercialization responsibilities, and in Europe later this year following a positive CHMP opinion issued in January. Importantly, the anticipated launch in Europe provides a catalyst to enter the next phase of our commercialization strategy as we expand our work to new markets. As of January 1, Genmab and Pfizer have agreed to transition full commercialization responsibilities for TIVDAK in second-line plus recurrent or metastatic cervical cancer to Genmab for all countries outside the U.S. and China, where Pfizer will continue to partner with Genmab and Zai Lab, respectively.

We’re pleased with the terms of this updated agreement as it optimally positions us to expand our commercialization capabilities first to Europe in a strategic and financially disciplined manner, just as we have successfully done in the U.S. and Japan to date. We’re confident that with this approach, we can optimize the launch opportunity for TIVDAK and also build a strong foundation for the potential launches of Rina-S and Acasunlimab in the future. We are extremely pleased by the performance of our commercialized brands in 2024, validating our strategic approach and investments to-date. As we look toward 2025 and beyond, our focus remains on building upon the strong foundation we’ve established in the U.S. and Japan to capture more value from our commercialized medicines, increasing utilization of EPKINLY and TIVDAK across regions, and strategically entering new markets to prepare for the launches of our wholly-owned medicines to reach even more patients in the future.

With that, I’ll hand the call to Anthony to provide more perspective on our financials.

Anthony Pagano: Thanks, Brad. We continued to strengthen our foundation throughout the year. We delivered on our goal of multiple successful regulatory approvals and launches for EPKINLY, and we’re pleased with how these launches are progressing. We’ve also significantly enhanced our long-term growth potential with the addition of Rina-S to our late-stage pipeline as part of the acquisition of ProfoundBio. And as we’ll see, our financials remain exceptionally strong. We achieved 31% total revenue growth. Importantly, we grew our recurring revenues by 35%. This was driven by strong royalties from DARZALEX and Kesimpta and from product sales from EPKINLY and TIVDAK. This growth reflects sustained recurring revenue expansion and robust execution across markets.

We can see that the investments we’ve made in building out our commercialization teams and capabilities are paying off. And this sets us up well as we prepare for potential expansion into earlier lines for EPKINLY and the potential launch of Rina-S in 2027. Stepping back and looking at our revenues, what really stands out for me is the improving quality of our revenue profile. In 2024, recurring revenues rose to represent 91% of total revenue, and that’s compared to 88% in 2023. Finally, looking at DARZALEX specifically. Overall, net sales grew by almost 20%. That’s net sales of nearly $11.7 billion for the year, which translates to almost DKK14 billion in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting.

Turning to our investments, where we continue to take a disciplined approach. Total operating expenses in 2024 were DKK13.8 billion. As you can see, the majority of the investment, over 70%, was driven by R&D, reflecting our focus on late-stage priority programs at EPKINLY, Rina-S and Acasunlimab. Our investment in SG&A was focused to put us in a strong position for key market launches in the U.S. and Japan. So if we step back and think about our investment levels for 2024, we over delivered on our financial commitments made at a time of ProfoundBio acquisition. This was achieved through the balance of disciplined investing, in line with our capital allocation framework and a continued and increased focus on productivity and prioritization efforts.

And in a minute, you’re going to see how this has been effectively carried through to 2025. Pulling this all together, our operating profit for 2024 grew 26%. So we delivered exceptionally strong profitability while investing to advance those programs with the highest potential for long-term growth. Then moving on to tax. As you can see in the appendix of this presentation, we have tax expense of around DKK1.3 billion, which equates to an effective tax rate of 14.4%. The decrease compared to last year’s rate of 22.8% was primarily due to our ability to recognize deferred tax assets that were not previously recognized. Moving forward, we anticipate that our effective tax rate should be closer to the Danish statutory rate of 22%. Taken together, our net profit amounts to nearly DKK7.8 billion.

So as you can see, continued strong underlying financial performance. With that, let’s move to our 2025 financial guidance. To start, the guidance we’re providing today is in dollars. That’s because as of January 1, our functional currency changed from kroner to dollars due to the growing number and significance of our U.S. dollar-denominated transactions. For comparison, we’ve converted our 2024 results from kroner to dollars using an exchange rate of DKK6.89, representing the average rate during the year. With that background, now let’s take a look at our 2025 guidance. We expect our revenue to be in the range of around $3.3 to $3.7 billion, delivering robust growth of 12% at the midpoint. And this is despite our non-recurring revenue decreasing by more than $100 million.

So it’s our recurring revenues from royalty medicines and revenues from EPKINLY and TIVDAK that’s driving our anticipated growth in 2025. For operating expenses, as I highlighted for you at Q3 last year, expectations were in a reasonable place. For 2025, we expect to be in a range of around $2.1 billion to $2.2 billion. So as you can see, we not only delivered but over delivered on the commitment we made at Q3. 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 million to nearly $1.4 billion, with the midpoint of guidance amounting to more than $1.1 billion of operating profit and year-over-year growth of 16%.

Now, let’s take a look at the components of our guidance. Building on the exceptional growth in 2024, we expect recurring revenues to grow 18% in 2025, driven by DARZALEX and Kesimpta, and this increasingly includes contributions from EPKINLY and TIVDAK. Taken together, these two products contribute 34% of our total projected revenue growth. This really highlights the continually improving quality of our revenue profile. Notably, our recurring revenue represents 95% of our total projected revenue in 2025. Looking beyond 2025, for EPKINLY, we anticipate three potentially significant pivotal readouts by the end of 2026, including frontline and second-line DLBCL and second-line FL that could support regulatory filings and subsequently additional meaningful revenue growth.

Finally, coming back to DARZALEX, we anticipate that DARZALEX sales will continue to ramp up and be in the range of $12.6 to $13.4 billion. Turning now to OpEx. We’ve purposely reallocated our R&D investments in 2025 and are focused on advancing our high-impact, late-stage programs, EPKINLY, Rina-S, and Acasunlimab. So here, we are prioritizing late-stage assets with strong commercial potential while also applying a balanced approach to our investments in our early pipeline. As a result, our investment in these late-stage programs increases from 45% of total R&D spending in 2024 to more than 55% in 2025. Our sales and marketing investments are focused on launch readiness in key markets, most notably for Rina-S, with a disciplined approach that balances growth and efficiency.

These investments are aligned to drive both immediate launches and long-term revenue. For G&A, I am pleased to note that spend is broadly flat between 2024 and 2025. And here, our G&A capabilities are increasingly at scale, so we expect minimal growth. If you add it all together, you can see the power of our growing recurring revenues and underlying profitability. In 2025, we’ll make significant investments in late-stage R&D and launch preparations. At the same time, we plan to deliver 16% operating profit growth at the midpoint. This reflects our ability to scale efficiently and control costs, supporting both near-term launches and long-term value creation. So when you look at our 2025 guidance as well as our 2024 results, you can see that we continue to deliver on our financial commitments.

Having covered our results for 2024 and our guidance for 2025, let me outline our capital allocation strategy aimed at fueling revenue growth by the end of the decade and enhancing shareholder value. First, we will continue to invest in accelerating the development of our high-impact, late-stage programs, EPKINLY, Rina-S, and Acasunlimab, with investment into Phase III clinical trials. We will also continue to maximize the success of our commercialized medicines because it’s our investment in these programs now that will potentially generate meaningful revenue for us by the end of the decade. Second, we will continue to seek out business development and M&A opportunities that fit within our core focus areas. As you know, we executed on our acquisition of ProfoundBio last year.

Here, I’d like to highlight how quickly and successfully we were able to integrate ProfoundBio into our business, as evidenced by our ability to progress Rina-S so significantly. We not only brought forward the start of the first Phase III trial for Rina-S, but today we announced a second Phase III trial in an additional indication. Now, having built out our development and commercialization capabilities, we’re well positioned to continue to consider both mid to late-stage development to commercial-stage product opportunities. And finally, today we’re announcing our plan to repurchase an additional approximate 1.9 million shares, which is equivalent to around $370 million at our current stock price. This underscores our confidence in Genmab’s future and our commitment to delivering value to our shareholders, both in the short and long term.

In summary, our performance in 2024 underscores our ability to deliver exceptional revenue growth, advance key pipeline assets and maintain strong profitability through disciplined execution. Looking ahead to 2025, we are building on this momentum by further prioritizing our investments and expanding market opportunities, positioning us for sustained growth and long-term value creation for our shareholders. And on that note, I’m going to hand you back over to Jan.

Jan van de Winkel: Thank you, Anthony. Let’s move on to our final slides. Now with this strong foundation supporting us, we are looking ahead to an energizing 2025. Starting with HexaBody CD38, we submitted the data packets to J&J, and we anticipate a decision from them no later than the first quarter of this year. At that time, we will press release the decision and include top-line clinical data. Regardless of J&J’s decision, Genmab’s strategic priorities in 2025 and beyond remain unchanged. Looking beyond this event, this year we are anticipating additional regulatory decisions for both EPKINLY and TIVDAK, including the potential approval of TIVDAK in Europe, following a positive opinion from the CHMP in January. For both Acasunlimab and Rina-S, we anticipate presenting additional supportive clinical data, and both have the potential to move into broader indications with new clinical trials.

And we will continue to actively look for opportunities to grow our pipeline, both organically and inorganically, positioning us for sustained growth and long-term value creation for our shareholders. In summary, in 2024, we further solidified our already very strong foundation and delivered on our commitments. And in 2025, we will continue our laser-sharp focus on an investment in our late-stage product pipeline and commercial execution. That ends our formal presentation. Operator, please open the call for questions.

Q&A Session

Operator: Thank you [Operator Instructions]. And now we’re going to take our first question. And it comes from the line of Jonathan Chang from Leerink. Your line is open. Please ask your question.

Jonathan Chang: Hi, guys. Thanks for taking my questions. Can you discuss your reasons for confidence in the endometrial cancer opportunity for Rina-S and for committing to a Phase III, second line plus endometrial cancer study by yearend? Thank you.

Jan van de Winkel: Thanks, Jonathan for the question. I will let Tahi dive into this. Tahi, can you talk about the endometrial cancer data and the commitment to go into a Phase III?

Tahamtan Ahmadi: Sure. Jonathan, thank you for the question. I think you heard from Jan earlier that we will present data in endometrial, so we have the data. It’s been submitted and it will be publicly available in the end of this first half. That data in our mind is highly competitive. It is the most robust efficacy signal that is currently being generated in that new population that you described, patients with endometrial cancer who had chemotherapy and checkpoint inhibition. And so we are very excited about that data. We think it’s going to be robust data. It will be very well appreciated by investigators and investors when it is public. And that’s driving our excitement to move forward aggressively with the Phase III.

Jan van de Winkel: Thanks, Tahi. Thanks, Jonathan, for a very good question. Let’s move on to the next analyst.

Operator: Thank you. And the next question comes from the line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Paul Jeng: Hi, this is Paul on for Michael. Thanks for taking our question. Just for EPCO and the DLBCL landscape, there’s a competing CD20 bispecific that could potentially have combo data approved this year for the transplant and eligible second line plus setting. What do you have to show to be competitive here for EPCO monotherapy? And can you provide any updates on the status of your efforts there with GemOx? And as a follow-up, how are physicians currently thinking about the potential to sequence multiple CD20 bispecifics for DLBCL? Thank you.

Jan van de Winkel: Thanks very much, Paul, for the questions. I will let Tahi address those for epcoritamab, Tahi?

Tahamtan Ahmadi: Yeah, thank you again for the question. So the second line in the first part, of course, we just a couple of days ago got the good news that the NCCN has included our data with GemOx and EPCO in second line patients who are ineligible for transplant with a Type 2a recommendation. So that’s very exciting. And then there’s, of course, the Phase III ongoing in combination with lenalidomide. So from our end, we kind of capture both opportunities, the debarking with chemotherapy followed in conjunction with the CD3, CD20 bispecific GemOx strategy, as well as the more outpatient-oriented oral medication plus a subcutaneous administration enhancing T cell function strategy. And these two things are going to play out.

I think, as we have said many, many times, the opportunity in the relapsed refractory setting for diffuse B-cell is really in expanding access to this novel mechanism. And we think that from the whole target product profile for the subcutaneous administration, the fact that it is the only one that is approved in both indications, it is extremely well positioned to enter the community space and provide access to patients in those settings.

Jan van de Winkel: Thanks. Thanks, Tahi. Let’s give the floor back to the operator.

Operator: Thank you. And now I’m going to take our next question. And it comes from the line of Asthika Goonewardene from Truist. Your line is open. Please ask your question.

Asthika Goonewardene : Hi, guys. Just very quick to follow up on EPKINLY. $281 million in the first full year of launch is very commendable. Just wanted to delve into the market dynamics in the second half. Wanted to see if there’s something funky about Q4, given that it was kind of flat on Q3, if there’s anything unusual you’d point to. And then if I can ask, on Acasunlimab, I like that you’re putting peak sales number here for the key pipeline assets. With 136,000 potential treatable patients for Acasun, $1 billion in peak sales seems a little light compared to the others that you provided. Can you tell us a little bit about what goes into this? Just to make sure, is that something to do with the longer treatment interval, the six weeks versus three weeks? Or is there something else that you’re anticipating with Acasun? Thanks.

Jan van de Winkel: Thanks, Asthika, for the questions. I will ask Brad to comment on the first two. And then maybe Judith can step in also on the estimates for Acasunlimab. Brad, why don’t you start with EPCO?

Brad Bailey: Thank you very much for the question. And we remain very confident, actually, in the core markets with the U.S. and Japan, with EPKINLY’s performance with the growth that we’re seeing there. We did have a one-time accounting adjustment for sales in Europe, France, specifically, that impacted the Q4 numbers specifically. Otherwise, again, feel very confident with our growth trajectory at this point.

Jan van de Winkel: Then maybe the market size for Acasunlimab, as we estimated it, around $1 billion for 136,000 patients. Do you want to add anything to that, Brad?

Brad Bailey: Yeah, no, for Acasun, it’s certainly a competitive space that we see, particularly in this post-IL [ph] setting, a significant opportunity, as you showed on your slide earlier. But nothing really further to comment on that from a size perspective at this point.

Jan van de Winkel: All right, thanks. Thanks, Brad. Judith, any color from the clinical side on Acasunlimab and the estimated markets?

Judith Klimovsky: Yeah, the only thing to add is, as you know, we preselect for PD-L1 positive. So this came into account on the assessment of the market opportunity.

Jan van de Winkel: Thanks. Thanks, Judith. Hope that’s clear, Asthika. Let’s give the floor back to the operator.

Operator: Thank you. And now we’re going to take our next question. And it comes from the line of Yifeng Liu from HSBC. Your line is open. Please ask your question.

Yifeng Liu: Thanks for taking my question. I have one follow-up on Acasunlimab. So in 2025, the Phase II data updates, what are we expecting to see in the data in the presentation? And then what’s roughly the timing of that presentation? And then secondly, on EPKINLY, second line, and transplant ineligible. So you’ve launched a DLBCL-4 trial last year. And could you maybe talk a little bit about the proposition for that setting against the DLBCL-1? Thanks.

Jan van de Winkel: Thanks for both questions. Judith, why don’t you talk a bit more about the Acasunlimab data, which we are very excited about to present this year, and a bit more on timing? And then Tahi can address the epcoritamab question in the second line plus DLBCL setting after that. Judith?

Judith Klimovsky: Yeah, so thank you for the question. As you know, we presented the first Kaplan-Meier curves on overall survival last year at ASCO. We show very interesting durability. Albeit, the curves were not with enough maturity, or with more maturity. We expect to see the same string signal. And this is what we will present later this year. So basically, durability of the time to event endpoints, mainly OS.

Jan van de Winkel: Thanks. Thanks, Judith. And Tahi, maybe a comment on the second line plus question for EPCO?

Tahamtan Ahmadi: Yeah, thank you. And then maybe I use it as an opportunity to more broadly lay out our diffuse large B-cell strategy as it relates to EPKINLY. So initial launch, as you know, as a single agent in third line plus, going really well. Then the next extension of data was in combination, getting data in our hands and providing confidence to physicians and patients that this is a safe and an efficient way of administering this new mechanism. The GemOx data now recognized with a 2a classification by the NCCN, meaning this is something that, in the judgment of the NCCN, is providing benefits to patients. And then we have this Phase III that is ongoing with lenalidomide. These are complementary in our minds and give an opportunity of choices for investigators to treat their patients respective of their needs, either somebody who needs more debarking or maybe somebody who’s a little bit more fair.

Really, the main focus is actually frontline. This is saying, I think we spoke about this, and we also put this on the slide. The study is fully equipped and we anticipate a readout in 2026. And a lot of the data that we’re generating now is in anticipation of that data set and to really supplement a very robust complementary data set in frontline, such that when this indication hopefully is going to read out positive, we’ll have, again, a very complementary data set to provide physicians with all opportunities to treat their patients. That’s essentially broadly, the strategy. And this is why also in the second line, we have a chemo and a non-chemo combination strategy, if that makes sense.

Jan van de Winkel: Thanks, Tahi. I think it’s very clear. Let’s move on to the next question.

Operator: Thank you. And now we’re going to take our next question. It comes from the line of Xian Deng from UBS. Your line is open. Please ask your question.

Xian Deng: Hey, thank you very much for taking my question. Just one, EPKINLY please. I’m just wondering, as you mentioned, the frontline DLBCL trial could have readout by the end of 2026. Just wondering, if you have a readout by end of 2026, do you think you will have two-year or three-year follow-up at that time? And that follow-up time frame, do you think that’s actually enough to allow FDA to give a decision without being asked for longer follow-up, just considering the previous precedent? Thank you very much.

Jan van de Winkel: Thanks, Xian, for the question. Very exciting one. So I’ll let Tahi address that. Tahi?

Tahamtan Ahmadi: Yeah, sure. I mean, so first things first. So the study was fully recruited in the summer of last year. And so then there is an event-driven endpoint, PFS. That is the accepted endpoint. And the population in the study is two IPI or higher. But there’s also a subgroup analysis for three IPI or higher. These events play out, and we anticipate they play out in 2026. That would mean that the study would meet its statistical-defined primary endpoint. I think what you’re referring to is the challenge that the FDA had with a lack of over-survival benefit initially, as it relates to the POLARIX study. And so obviously, it will be whatever the data will be. But based on the Phase II data set that we have generated, a pretty robust Phase II data set, we are quite optimistic, actually, that the signal in the experimental arm will be significantly stronger than the one that was seen in POLARIX. And so we don’t anticipate that it’s going to be an issue for us.

Jan van de Winkel: Thanks, Tahi. Let’s move on to the next question. Thank you, Xian.

Operator: Thank you. And the next question comes from Yaron Werber from TD Security. Your line is open. Please ask your question.

Yaron Werber: Great. Thank you so much. So maybe just to follow up, should we assume that the second-line follicular and second-line DLBCL data by year 2026, is that fileable, assuming positive, as well? So you can file both for first and second line? Or do you need more data from second line? And then just, secondly, on TIVDAK, so it sounds like from now on, you’re going to be the lead commercialization party, and you will book sales in the U.S., Europe, and Japan. And how do we model that? Like is there a royalty, I assume, back to Pfizer? And congrats on getting that. Thank you.

Jan van de Winkel: Thanks, Yaron, for the question. So Tahi, you can address the question on the very exciting developments with epcoritamab. And then Brad, why don’t you explain the exact contract on TIVDAK and commercialization to Yaron after Tahi. Tahi?

Tahamtan Ahmadi: Well, just to clarify what Jan also said at the beginning in his prepared remarks, there are three of the five ongoing Phase IIIs that are fully recruited and awaiting a readout based on events. This is in third line diffused large B-cell. In second line, follicular lymphoma, which is in combination with R-squared, and in front line, diffuse large B-cell. And we were talking about the front line, diffuse large B-cell study that finished its accrual last year and where we anticipate a readout by events earlier than it was initially prognosticated. And that’s also true for the second line, follicular lymphoma Phase III, which also accrued significantly faster than initially projected. And thus, because this are event-driven studies, we anticipate a readout earlier than initially projected.

Jan van de Winkel: Thanks, Tahi. And then maybe we move on to Brad for the exact commercial formulation of the contract for TIVDAK. Tahi — Brad?

Brad Bailey: Yeah, no, just thank you. And again, we are excited about the opportunity as it provides us the opportunity to expand our commercialization footprint. But the terms of the agreement, as mentioned earlier, remain that U.S. and China are as is, where Pfizer is actually still a lead party in both of those areas, as we’re still co-promoting here in the U.S. and in Europe. And rest of the world, including Japan we will be the lead party at that point. And there will be a low double-digit royalties involved as per the contract that we’ve already set up. But it’s just as a reminder, the U.S. and China remain the same.

Jan van de Winkel: Thanks, thanks, Brad. Very clear. Thanks, Yaron for the questions. Let’s move on to the next question.

Operator: Thank you, Jan. And now we’re going to take our next question. It from the line of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Matthew Phipps: Well, thanks for taking my questions. Are you guys able to disclose if you’re going to use a folate receptor alpha expression cutoff for the endometrial cancer Phase III? And then on EPKINLY, given, I don’t know, maybe half a year of launch, you’re a little more in that in follicular lymphoma at this point. Do you see any broader utilization in follicular given no need for hospitalization? Just wondering if that is helping get into community settings and if you think that will be a continuing trend. Thank you.

Jan van de Winkel: Thanks, Matt for the questions, and I think Tahi, you can address both, both the folate receptor alpha, the question for endometrial, and then also the EPCO question.

Tahamtan Ahmadi: All right. First things first. So this question has come up a couple of times, so I’ll try to be very clear. So first folate receptor alpha is a validated target in ovarian. In PROC, essentially, all patients have some degree of folate receptor alpha expression. Second, and this is partially related to the antibody that is the component of Rina-S and the internalization rate and partially related to the linker and the stability that comes to the hydrophilic linker. The profile of Rina-S is that it has generated, and we have this data, and we, to a degree, also in the asthma presentation already disclosed it, but there’s obviously more data that we have internally that we’re not able to disclose yet, has generated robust data across the entire spectrum of folate receptor alpha expression, including patients who are, by the technicality of the assay, called negative.

I spoke to that before. This is, to a degree, also a function of the sensitivity. So to be clear, our strategy in the Phase II and our strategy in the Phase III is to not select folate alpha receptor expression. Now, we do stratify in the Phase III by the various cutoffs, which is 125 and 75, and that’s just good practice. And EPKINLY, sorry. On EPKINLY, the question was whether the lack of hospitalization is going to help us expand into areas outside of the larger academic institutions. And I think that is certainly a general part of our strategy with EPKINLY, and that’s my understanding also playing out already, that the utilization of EPKINLY in follicular lymphoma is helping us to get access into institutions that originally were not open to using EPKINLY in the diffuse large B-cell setting, and that’s also how the community is getting more comfortable.

And that leads also to the discussion on our active efforts to remove hospitalization from the diffuse large B-cell label. But I would actually ask Brad to maybe add from his point of view to this.

Jan van de Winkel: Brad, do you want to comment on this?

Brad Bailey: Yeah, thanks, Tahi, and I agree with what you said. I think it’s just another validation of physicians reported really strong response to our favorable clinical profile, the dual indication, as well as the positive label without hospitalization that’s required or not required in FL. So we do feel confident that this FL approval has and will continue to help us deliver innovative bispecifics across multiple histologies across broad and diverse sites of care as well. So it’s just reinforcing that from the physician standpoint.

Jan van de Winkel: Thanks, Brad, and Matt, to top it off, as a reminder, there is no requirement for any hospitalization in any of the ongoing Phase III trials. So I think that should clarify that. Let’s move to the next question.

Operator: Thank you. The next question comes of Qize Ding from Redburn Atlantic. Qize, your line is open. Please ask your question.

Qize Ding: Hi, just one quick question on the Rina-S. Because you just mentioned about your clinical development plan in ovarian cancer and endometrial cancer, I just wonder, what is your clinical development plan for other solid tumor indications such as lung and breast? Thank you.

Jan van de Winkel: Very good question, Qize, and we will let Tahi comment on that. Tahi, are you excited about other tumors?

Tahamtan Ahmadi: Yes. So there is indeed, as you were alluding to, folate receptor alpha expression in non-small cell lung cancer, particularly in patients who have EGFR mutation, but not only restricted to that, and in triple negative breast. And we already spoke about that. There will be activities in that range. We already have a cohort in non-small cell lung cancer with patients who have EGFR mutations in second line open and are enrolling patients in that cohort. And so hopefully we’ll get validation of what we all believe, which is that this asset will also have efficacy in these two indications, and then we’re going to inform you about next steps quite timely.

Jan van de Winkel: Thanks, Tahi. Thanks, Qize for the question. Let’s move on to the next question.

Operator: Thank you. And now we’re going to take our next question, and it comes to line of Justin Smith from Bernstein. Your line is open. Please ask your question.

Justin Smith: Yeah, thanks very much. I’ve got two. First one, just on dara, if you wanted to possibly share any thoughts about the potential impact from the potential relaunch of Blenrep this year. And then the second one, just on the buyback, I’m sorry if I’m thinking about things the wrong way, but just trying to understand why you’ve announced that now and not waiting till after the HexaBody decision from J&J. Is it a case of just aren’t interesting assets out there, or just any thoughts on why the buyback timing now? Thank you.

Jan van de Winkel: Thanks, Justin, for the question. So I think the Dara question is definitely more a question for J&J because they are developing daratumumab, but I will anyway ask Tahi to give his perspective because he’s an expert in multiple myeloma. Maybe you can say some general things there on the landscape, Tahi. And then Anthony can absolutely give you more rationale and thinking behind the buyback which we just announced today, Justin. Tahi, maybe some further color on Blenrep and the landscape in multiple myeloma?

Tahamtan Ahmadi: Yeah. I would hesitate to comment on another company’s assets. So broadly speaking, it’s always good for patients that there are a lot of opportunities, and I think we should leave it at that.

Jan van de Winkel: All right, I agree with that, Tahi. So ask J&J is the feedback, Justin. And then for Anthony, maybe more rationale on the buyback right now?

Anthony Pagano: Yeah, happy to give you a little bit more context here. Look, our capital allocation priorities are super clear and are aligned with fueling revenue growth and enhancing shareholder value. Our first priority, as I highlighted, is really accelerating the development of our late-stage pipeline and maximizing the success of our commercialized medicine, as I highlighted. Second priority is pursuing focused BD and M&A. And after we’ve evaluated these opportunities from these first two priorities, we can consider our third priority, which your question is about, which is return of capital. As a reminder, here in 2024, we executed an approximate $500 million buyback of 1.8 million shares. And for 2025, having carefully considered this, looking at all factors, we announced today our plans to buy back an additional 1.9 million shares.

And we really think this strikes the right balance of fueling the revenue growth and enhancing shareholder value. So I think this is the appropriate time to really outline for all of our stakeholders, our shareholders, our capital allocation framework and priorities. And I think we’ve stepped through that in a fair amount of detail and very clearly outlined these priorities and also demonstrated how we’ve executed against that framework in 2024 and how we’re set up very well to continue to execute against that in 2025.

Jan van de Winkel: Thanks, Anthony. I think it’s crystal clear. Thanks, Justin, for the questions. Let’s move on to the next analyst.

Operator: Thank you. And the question comes from Vikram Purohit from Morgan Stanley. Your line is open. Please ask your question.

Vikram Purohit: Great. Thanks for taking our questions. We had one on BD as a follow-up to the last question, and then one on guidance. So on BD, I mean, given you noted that 2025 is a heavy execution year for the pipeline, I just wanted to see how strong of a priority external BD and M&A could be for the year. And if you decide to go that route, what is the profile of the assets you’d find most interesting and attractive to kind of bring into the pipeline where it stands now? And then secondly, on guidance, I was just wondering if you could provide a bit more color about what the drivers are for the bookends for the revenue, gross profit, and OpEx guidance that you outlined for the year. Thank you.

Jan van de Winkel: Thanks, Vikram for the questions. Let me address the BD one and then Anthony can do the guidance question. So BD is very, very important for us. Vikram, we want to organically and inorganically strengthen the pipeline, accelerate it. What we will do is focus on antibody-based medicines because that is our field of expertise. We did it very well last year with ProfoundBio. I can tell you that we did this, closed this acquisition in record time and actually run into the Chief Medical Officer of a very large pharma and the Head of Oncology of a very large biotech we all know who said, well, basically congratulations on the ProfoundBio deal. And you snapped it away in front of our face because you were simply much quicker than other companies.

And what we are looking for, Vikram, is antibody-based medicines which are totally differentiated. We can use our expertise in this field for over 25 years now to really zoom into the right opportunities. And that should be Phase III programs or Phase III ready programs ideally for Genmab. And that is to complement our own pipeline. We are also filling our own pipeline. We are bringing more and more new molecules into the pipeline ourselves from our own platforms. We have several platforms now, ADC platforms, which are responsible for over 50% of our pipeline right now. Then we have — sorry, 40% of our pipeline and the 50% is about bispecifics at this moment and the rest is HexaBody. So we have molecules from our own pipeline but we also look very actively at companies having interesting assets which we can then accelerate like we did for Rina-S as we described today in the call.

I mean, within the year of the acquisition already announcing two Phase IIIs and potentially others to come in other tumors, I think it’s really belonging — it’s fitting very well with our expertise as a developer of differentiated antibody medicines. I think I will leave it with that, Vikram. So we’ll have to see how effectively we can execute that we are looking at multiple opportunities as we speak. So we are very busy with that. And let’s now move to Anthony to give a bit more color of the guidance.

Anthony Pagano: Yeah, Vikram, I think the starting point I would really just highlight for you to really kind of frame this out. And hopefully this is super clear for both 2024 and 2025. From my perspective, we absolutely delivered on our financial commitments. If we zoom in on 2025 and just look at the — really the quality of the guidance we put forward total revenue growth, all my comments will be at the midpoint. Total revenue growth at 12%, recurring revenue growth of 18%. We had a $100 million plus non-recurring revenue headwind. Looking at the improving quality of our revenue profile, recurring revenues now at 95%. If we look at then the performance of EPKINLY and TIVDAK, we can really see the investments we’ve made, really focused investments we’ve made over the last couple of years and building out our commercialization capabilities really paying off.

You can look at the net product sales collaboration revenue line where we see growth for that line really driven by again, EPKINLY and TIVDAK. Primarily EPKINLY to be clear, projected growth of around 39%, nearly 40% at the midpoint. So it gives you a sense of the quality of the revenue profile. Of course, a big driver of our revenue continues to be DARZALEX. And here we provided our range of $12.6 billion to $13.4 billion, 13 billion at the midpoint. So I would say this is probably the primary driver here of the revenue guidance range. In terms of our investments, again, we’ve really delivered on our commitments here, really purposefully reallocating our investments to the late stage pipeline and really investing in a smart way in sales and marketing to really deliver on today’s launches, but to continue to build that foundation and platform for upcoming future launches.

And again, delivering on our commitments. In terms of the OpEx range, around $2.1 billion to $2.2 billion. This is really driven by the three investment priorities and where these exactly will land. It really has to do with the expansion and acceleration of EPCOR clinical development with the five Phase III trials ongoing and expansion of EPCOR in our key markets. Then we have Rina-S with the start of the Phase III and second line plus endometrial cancer, as well as the overall trajectory of the Phase III trial in PROC. And of course, we have the ongoing work with GEN1046 or Acasunlimab with the Phase II start and another indication and also progressing to Phase III. So it’s really going to be these three programs, I would say, that are largely driving the variability of OpEx. But again, if we sort of, if I finish my comments where I started, really we continue to deliver on our financial commitments, very strong recurring revenue growth and seeing that come through to the bottom line in terms of the 16% operating profit growth at the midpoint, we’re projecting for more than $1.1 billion.

Vikram Purohit: Thanks, again. Very helpful.

Jan van de Winkel: All right, thanks Vikram for the questions. Let’s move on to the next one.

Operator: Thank you. And now we’re going to take our last 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: Hi, thanks for taking my question. So I was just wondering if we could get an update on GEN1042. I know this slide said that there’s going to be a decision in 2025, but it’s obviously been a decision that’s been pending for some time. So just interested in understanding what you’re still trying to establish here. And if we could just get a little bit more clarity on the timing. Is that likely to be first half or second half of the year? And just one for Anthony on clarification on the guidance. Is there anything assumed in guidance for GEN1042 development? And then a very quick one to wrap up. You previously talked about potential developments in immunology and inflammatory disease either through your own internal pipeline or through external sources. Could you just kind of talk to your latest thoughts there and appetite both from an internal and external perspective? Thank you.

Jan van de Winkel: Thanks, Rajan for the questions. I will ask Judith to comment on the timing for 1042 and Anthony for what is in the plans for GEN1042 and development. Let me start with the INI [ph] question. What we already said, Rajan, is that EPKINLY, we believe, is an excellent candidate for development also in select INI indications. So we are in discussions now with AbbVie to actually plan and discuss next steps for EPKINLY. We think it’s an excellent molecule which will likely work really, really well in the INI area. But we also have collaboration with argenx, which is preclinical, and a number of internal 100%-owned programs for Genmab. So we continue to be very focused on creating next-generation differentiated antibody-based medicine candidates for INI. And we will update you once we are closer to the clinic. But the most advanced candidate is EPKINLY. Then let’s move on to Judith to speak a bit about timing for 1042. Judith?

Judith Klimovsky: Yes, thank you. And thank you for the question. So as we put in the slide, it’s by 2025. I cannot be more precise at this point because, as you know, durability is key for IL. And we need to assess durability on first line and then, undergo the prioritization within our own pipeline. And head and neck externally is moving as well. And we will come with all these data sets more likely by the second half of the year.

Jan van de Winkel: Thanks, Judith. And then, Anthony, what is in the budget of the guidance for 2025 for 1042?

Anthony Pagano: Yeah, well, Rajan, thanks. And, you know, good to hear from you. I think as we sort of think about 1042, it has, of course, the ongoing work that Judith just alluded to. And I would say, the future work is really just not really material one way or the other this year. That’s primarily based in the function of timing.

Jan van de Winkel: Then finally, to top it off, Rajan, I can tell you that not only we, but also a part of BioNTech is very excited about what we have seen up to now with 1042. We need more data, as Judith already alluded to. But we also think there is a great potential for combining 1042 with different ADCs and other concepts that both companies are working on. So I think exciting times. We’ll need a bit more data to get more, a better feeling for durability, but a high level of excitement. All right, operator, this was the last question. So thank you all for calling in today to discuss Genmab’s financial results for 2024. If you have additional questions, please reach out to our investor relations team. They’re ready to answer your questions and then we hope that you all stay safe, keep optimistic and we very much look forward to speaking with you all again soon.

Operator: This concludes today’s conference call. Thank you for participating. You may now all disconnect. Have a nice day.