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 on successful 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 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 G.J. de Winkel. Please go ahead.

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 8 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 deliver — 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 take — let’s look forward, starting with our pipeline. We currently have 12 products or product candidates in 30 clinical trials either ongoing or recruiting. This includes 7 Phase III trials between EPKINLY, Rina-S and acasunlimab. And based on the strong emerging data, we expect more to come. Because these 3 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 diffuse large B-cell lymphoma and follicular lymphoma. Three of 5 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 3 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, 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 that 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. And — with its best-in-class profile expected to achieve peak sales exceeding $2 billion. And with the 2 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 assets. Non-driver mutated second-line non-small cell lung cancer continue to be an area of significant needs. Given the worsening of performance status as patients progress, through lines of therapy, physicians are interested in more tolerable chemo-free regimens.

Yet that many novel treatments failing in Phase III trials, docetaxel continues to be the current standard of care. By identifying potential synergies of IO 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 the investment in these areas today — that will position us well at the end of the decade.

I will now 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.

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 2 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 3 months, Tivdak and EPKINLY have collectively received 3 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 PDL1-positive disease.

And earlier this month, of 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 3-year long-term data from our EPCORE 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 maintain the response for more than 3 years with no new safety signals identified. These results represent the longest duration of CRs reported by a bispecific 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 continues to perform exceptionally well since its initial launch in 2023. We — 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 bispecific approved with a dual indication in third line plus DLBCL and follicular lymphoma. Throughout 2024, we continue 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 and positive physician feedback highlighting the value of EPKINLY’s dual indication, it’s uniquely differentiated clinical profile and seamless administration. Moving forward, we will continue to focus on accelerating adoption across broad sites of care.

In Japan, EPKINLY is the only approved CD3, CD20 bispecific and 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 bispecific approved in Japan with a dual indication in LBCL and FL.

In the rest of the world, we’re seeing increased utilization of EPKINLY 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. We — 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 ZiLab, 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.

Thanks, Brad. We continue 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. And importantly, we grew our recurring revenues by 35%. And — 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 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 DKK 14 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 DKK 13.8 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 overdelivered on our financial commitments made at the time of the 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 $1.3 billion, which equates to an effective tax rate of 14.4%. The — 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 DKK 7.8 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 Krone 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 Krone to dollars using an exchange rate of $6.89, 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 billion to $3.7 billion, delivering robust growth of 12% at the midpoint. And this is despite our nonrecurring 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. We — 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 2 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.

I — looking beyond 2025, for EPKINLY, we anticipate 3 potentially significant pivotal readouts by the end of 2026, including frontline and second-line DLBCL and 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 million 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% or 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 — 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, and — 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 and accelerating the development of our high-impact late-stage programs at 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 and 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, advanced 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.

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 package 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 includes top line clinical data. Regardless of J&J’s decision, Genmab’s strategic priorities in 2025 and beyond remain unchanged. Looking beyond these events, this year, we are anticipating additional regulatory decisions for both at 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.

[Operator Instructions]. And now we’re going to take our first question. And it comes to line of Jonathan Chang from Leerink.

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 year-end.

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.

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 then 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 at chemotherapy and checkpoint inhibition. And so we are very excited about that data. We think it’s going to be a robust data. It will be very well appreciated by investigators and investors win it is public, and that’s driving our excitement to move forward aggressively with the Phase III.

Thanks, Tahi, Thanks, Jonathan, for a very good question. Let’s move on to the next analyst.

And the next question comes from the line of Michael Schmidt from Guggenheim Partners.

This is Paul on for Michael. Just for EPCORE and the DLBCL landscape, there’s a competing CD25 specific that could potentially have combo data approved this year for the transplant in eligible second-line plus setting. What do you have to show to be competitive here for EPCORE 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 CD25 specifics for DLBCL?

Thanks very much, Paul, for the questions. I’ll let Tahi address those for epcoritamab. Tahi?

So the second line the first part, of course, we just really a couple of days ago, got the good news that the NCCN has included our data with GemOx and EPCORE 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 like capture both opportunities, the debulking with chemotherapy for in conjunction with the CD3, CD20 bispecific GMO strategy as well as the more outpatient-oriented oral medication plus a subcutaneous administration enhancing T cell function strategy, and these 2 things are going to play out.

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

Thanks, Tahi. Let’s give the floor back to the operator. .

And now when we take a next question. And it comes line of Asthika Goonewardene from Truist.

Just very quick to follow up on EPKINLY, $281 million in the first full year of launch is very commendable. Just want to jump into the market dynamics in the second half. I wanted to see if there was 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, over 136,000 potential treatable patients with acasunlimab the $1 billion in peak sales teams a little bit light compared to the others that you provided. Can you tell us a little bit about what goes into as mentioned, is that something to do with the longer treatment interval for 6 weeks versus 3 weeks? Or is there something else that you’re anticipating with acasunlimab.

Thanks, Asthika, for the questions. I will ask Brad to comment on the first 2 and then maybe Judith can step in also on the estimate for acasunlimab Brad, why don’t you start with EPCORE.

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

Then maybe the market size for acasunlimab, as we estimated at around $1 billion for 136,000 patients. Do you want to add anything to that, Brad?

Yes. No, for ACA, certainly a competitive space that we see, particularly in this Post-I/O setting a significant opportunity, as you showed on your slide earlier. And — but nothing really further to comment on that from a size perspective at this point. .

All right. Thanks, Brad. Judith, any color from the clinical side on acasunlimab and the estimated markets?

Yes. 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. .

Thanks, Judith. I hope that’s clear, Asthika. Let’s give the floor back to the operator.

And now we’re going to take our next question, and it comes from line of Yifeng Liu from HSBC. .

Maybe I have 1 follow-up on acasunlimab. So in 2095 the Phase II data update, what are we expecting to see in the data in the presentation? And then what sort of roughly the timing of that presentation?

And secondly, on EPKINLY second line and transplant eligible. 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 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?

Yes. So thank you for the question. As you know, we presented the first couple of Meyer’s curve on overall survival last year at ASCO we saw very interesting durability. elevate the curves were not with enough maturity or with more maturity, we expect to stay the same stream and this is what we will present later this year. So basically, durability of the time to event endpoint, mainly or .

Thanks, Judith, Tahi maybe a comment on the second line plus question for EPCORE.

And maybe I use as an opportunity to more broadly lay out our diffuse such B cell strategy as it relates to a 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 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 a opportunity of choices for investigators to treat their patients respected of the need either somebody who needs more debulking or maybe somebody is a little bit more frail.

Really, the main focus is actually frontline. This is — I think we spoke about this, and we also put this on the slide. The study is fully culled to anticipate the 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 be that 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.

Thanks, Tahi. I think it’s very clear. Let’s move on to the next question.

Now we’re going to take our next question. It comes from the line of Xian Deng from UBS.

Just one on time, please. Just wondering, you mentioned the frontline DLBCL trial could be — 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 2-year or 3-year follow-up at that time — and that time — that follow-up time frame, do you think that’s actually enough to allow FDA to give a decision without being out for longer follow-up just considering the previous precedent?

Thanks, Xian, for the question. Very exciting one, so I’ll let Tahi address that. Tahi?

Yes, sure. I mean so first things first, the study was fully good in 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 2 IPI or higher, but there’s also a subgroup analysis for 3 IPI and 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 1 I was seen in POLARIX. And so we don’t anticipate that it’s going to be an issue for us.

Thanks, Tahi Let’s move on to the next question.

And the next question comes from the line of Yaron Werber from TD Securities.

Great. So maybe just, Tahi, just a follow-up. The — should we assume that the second line follicular and second-line DLBCL, that data by year-end 26, is that filable, assuming positive as well, so you can follow both 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 how do we — is there a royalty, I assume, back to Pfizer? And congrats on getting that.

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?

We, just to clarify what Jan also said at the beginning in his prepared remarks, there are 3 of the 5 ongoing Phase IIIs that are fully accrued and awaiting a readout based on events, say, in third line, diffuse large B-cell in second-line follicular lymphoma, which is in combination with R2 and in frontline diffuse large B-cell and we were talking about the frontline diffuse large B cell study that finished a call 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 is projected and thus because it’s event-driven studies, we anticipate a readout earlier than initially projected. .

Thanks, Tahi. And then maybe move on to Brad for the exact commercial formulation of the contract for Tivdak. Brad?

Yes. 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 lead party in both of those areas as we’re still promoting here in the U.S. and in Europe. — and rest of 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, U.S. and China remain the same. .

Thanks, Brad. Very clear. Thanks, Yaron, for the questions. Let’s move on to the next question.

Thank you, and now we are going to take our next question. It comes from the line of Matthew Phipps from William Blair.

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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, maybe a little more on 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? .

Thanks, Matt, for the questions. And I think Tahi you can address both folate receptor alpha question for endometrial and then also the EPCORE question.

All right. First things first. So this question has come up a couple of times, so I’ll try to be very clear. So firstly 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 the data on degree also in the ASO presentation already disclosed, but there’s obviously more data that we have in today 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.

And I spoke to that before, this is to be 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 receptor alpha expression. Now we do stratify in the Phase III by the various cutoffs, which is 125 and 75%, and that’s just good purpose.

And EPKINLY, sorry. On EPKINLY, the question was whether the lack of hospitalization is going to help us expand into areas outside of the the larger academic institutions. And I think that is certainly a general part of our strategy with piney,and that’s my understanding is 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.

Brad. Do you want to comment on this

Yes. Thanks, Tahi. I agree with what you said. I think it’s just another validation of physicians reported a 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, that — across broad and diverse sites of care as well. So it’s just reinforcing that from the physician standpoint. .

Thanks, Brad. I’m add to top it off. As a reminder, there’s 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.

The next question comes from the line of Qize Ding from Redburn Atlantic.

Just one quick question on the Rina-S because you just mentioned about your clinical development plan in ovarian cancer, endometrial cancer. I’m just wondering — what is your clinical development plan for other solid tumor indications such as lung and breast.

Very good question, Qize, and we will let Tahi comment on that, Tahi excitement all on other tumors.

Yes. So, there is, indeed, as you were alluding to folate receptor alpha expression in non-month 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 their cohort.

And so hopefully, we’ll get validation of what we all believe, which is that this — this asset will also have efficacy in these 2 indications, and then we’re going to inform you about the next steps quite timely. .

Thanks Tahi, Thanks, Qize, for the question. Let’s move on to the next question.

And now I’ll go in to take our next question. And it comes from line of Justin Smith from Bernstein.

I’ve got 2. 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 I’m not waiting until after the HexaBody decision from J&J? Just — is it a case of interesting assets out there? Or just any thoughts on why the buyback timing now? .

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 anyway I will 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, I 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. .

Yes. I will hesitate to comment and so 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. .

All right. I agree with that. So as J&J is the feedback, Justin. And then for Anthony, maybe a more rationale on the buyback right now?

Yes, 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 priorities I highlighted is really accelerating the development of our late-stage pipeline and maximizing the success of our commercialized medicines, as I highlighted.

Second priority is pursuing focused BD and M&A. And after we evaluate these opportunities from these first 2 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 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 stepped through that in a fair amount of detail and very clearly outline these priorities and also demonstrated how we’ve executed against that framework in 2024, and — and how we’re set up very well to continue to execute against that in 2025.

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

And the question comes from line of Vikram Purohit from Morgan Stanley.

Great. 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 2025 is a heavy execution year for the pipeline. I just wanted to see how strong of the priority external BD and M&A could be for the year?

And if you decided 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.

Thanks, Vikram, for the questions. Let me address the BD one, and then Anthony can do the guidance question. So the BD is very, very important to us, Vikram we want to organically and inorganically strengthen the pipeline, accelerated. What we will do focus on antibody-based medicine because that is our field of expertise.

We did it very well last year with ProfoundBio. I can tell you that we did this not 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. We said what basically congratulations on the ProfoundBio deal and we just snapped the way in front of our face because we are 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 products or Phase III-ready programs ideally for Genmab. And that is to complement our own pipeline. We’re also filling our own pipeline.

We are bringing more and more new molecules in the pipeline ourselves from our own platforms. We have several platforms, now ADC platforms, which are responsible for 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 announced in 2 Phase III or potentially others to come. in other tumors. I think it’s really long — it’s fitting very well with our expertise as a developer of differentiated antibody medicines. I think I believe it with that, Vikram. So we will have to see how effectively we can execute, but 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 on the guidance.

Yes. 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 $100 million plus nonrecurring revenue headwind looking at the improving quality of our revenue profile, recurring revenue is now at 95%.

If we look at then the performance 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 at 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 3 investment priorities and where these exactly will land and let us do with the expansion and acceleration of EPCORE clinical development with the 5 Phase III trials ongoing and expansion of EPCORE in our key markets.

Then we have Rina-S with the start of 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 [indiscernible] with the Phase III — Phase II start in another indication and also progressing the Phase III, Vikram.

So it’s really going to be these 3 programs, I would say, that are largely driving the variability in OpEx. Again, if we sort of if I finished 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 — or more than $1.1 billion.

All right. Thanks, Vikram, for the questions. Let’s move on to the next one.

And now we’ll going to take our last question for today. And it comes the line of Rajan Sharma from Goldman Sachs.

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 1042 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.

Thanks, Rajan for the questions. So I will ask Judith to comment on the timing for 1042. And Anthony, for the what is the plans for 1042 in development.

Let me start with the I&I question. What we already said, right, John, is that EPKINLY, we believe, is an excellent candidate for development also in select I&I indications, and 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 I&I area, but we also have collaboration with Argenx, which is preclinical. and a number of internal 100% owned program for Genmab.

So we continue to be very focused on creating next-generation differentiated antibody-based medicine candidates for I&I. And then 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?

Yes. So as we put in the slide by 2025, I cannot be more precise at this point because, as you know, durability is key for IO and we need to assess durability in 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. .

Thanks, Judith. And then Anthony, what is in the budget of the guidance for 2025 for 1042.

Yes. Well, look, Rajan, thanks, and good to hear from you. I think as we sort of think about 1042 has the, of course, the ongoing work that Judith has just alluded to. And I’d say the future work was really just not really material 1 way or the other this year. That’s primarily based and is a function of timing.

Then finally, to top it off, Rajan, I can tell you that not only lead, but also a part of Biotech is very excited about what we have seen up to now withy 1042. We need more data, as Judith already alluded to. But we also think there was a great potential for combining 1042 with different ADCs and other concepts which both companies are working on.

So I think exciting times we will 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 are 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.

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