Genmab A/S Price & Performance (GMAB)

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 and A, we will be joined by our Chief Medical Medical Officer, Tairi Amari and our Chief Development Officer, Yudit 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 [indiscernible] 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 $180,000,000,0.0 acquisition of Perform Bio, and a $500,000,000 share buyback, we ended the year with nearly $3,000,000,000 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 take a 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 3 trials between Abkinli, RHINO S and arcosunimab. 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 Now let's take a deeper look at why we are confident in their significant potential. Starting with Abkenzi, Together with AbbVie, we continue to advance an ambitious clinical development program for AbbVie abcaritumab across B cell malignancies, including frontline studies diffuse large B cell lymphoma and follicular lymphoma. 3 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 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 Abkendi.

We have successfully obtained multiple regulatory approvals for Arapkinli, 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 Abginley's reach even further.

In fact, our commitment to advancing Abkenley across multiple indications in B cell cancers underscores its potential as a best in class treatment with a peak sales opportunity exceeding $3,000,000,000 Let's now turn to Rainer S. As we have shared previously, we have now initiated the first Phase 3 trial for rhino acid 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 cohorts with PROC early in the 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 3 study in second line plus endometrial cancer by the end of the year. All this adds up to a significant market opportunity for Rainer Ash Reina Assisted 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 eighty five percent of the platinum resistant ovarian patient population. We are exceptionally well positioned to maximize the potential of Genmab S given our proven clinical development capabilities, track record of acceleration and our experience in the Gynong space with TivTAC, Based on the exceptionally strong execution of the team, post acquisition, we remain on track to bring With its best in class profile expected to achieve peak sales exceeding $2,000,000,000 and with the 2 Phase 3s we plan to have underway by year end, we are well on track to putting in place the building blocks to a Finally, let's take a look at the market opportunity for AKASUNIMOP, In 2024, Telmab took full control of the AKASUNIMab 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 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 at many novel treatments failing in Phase 3 trials, doseditaxel continues to be the current standard of care. By identifying potential synergies of IO therapies, we have the potential to unlock clinical benefits that are not possible with monotherapy alone.

So there is meaningful opportunity for novel treatments like alcasunimab 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 AKOSULIMAB'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 of this the investment in these areas today, that will position us well at the end of the decades. I will now hand over the presentation to Brad, who will provide you with a review of the recent performance for TivTek and Abkenley 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 Aptinli and TivDAC to an increasing number of patients around the world.

Overall, Abkinley and Tivdac ended the year in a strong position demonstrating the strength of our commercialization strategy 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. Achieved meaningful milestones with both medicines that contributed to their overall growth. Over the past three months, TivDAC and UPKimley collectively received 3 new or updated NCCN guidelines designations. First, in Dec. 0, TYMLAQ monotherapy was upgraded from Category IIa to Category I designation for the treatment of recurrent or metastatic cervical cancer.

Validating its clinical benefit for these patients. TIVDAC in combination with pembrolizumab was also added as Category 2b designation for patients with PD L1 positive disease. And earlier this month, Abkinley in combination with Jimox received a Category 2a designation for the treatment of diffuse large B cell lymphoma in the relapsedrefractory setting. This is especially notable as we look to bring the potential of that kinley into earlier lines of therapy in the future.

Lastly, Brett Tinley at ASH we presented a three year long term data from our EPCOR NHL-one study which evaluated EPCORL in patients with third line or later relapse 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 bispecific in this setting further reinforcing up Kinley's clinically differentiated profile and potential to deliver deep durable responses Now let's turn to performance, beginning with Eptimally. Eptinley has continued to perform exceptionally well since its initial launch in 2023. It closed 2024 in a position of strength achieving $78,000,000 in sales in the quarter and $2.81,000,000 dollars in sales for the year. This growth was driven primarily by sales in The United States and Japan. In The U. S, Abkimly 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 Since the FL launch, we have observed accelerated growth and positive physician feedback highlighting the value of Abkinley'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, Ebakenli is the only approved CD3CD20 bispecific 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 approval for third line plus relapsed or refractory flicker lymphoma With this indication, Epictinley 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 EvKendly through our partner AbbVie and achieved approvals in more than 50 countries worldwide by the 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 Kinley 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 TIBS. As the only ADC with a proven survival benefit in advanced cervical cancer, TYMDAC 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. TypDAC produced $131,000,000 in sales during the year including $38,000,000 in the driven by depth and breadth of order in 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 TIVDAC in advanced cervical cancer to new markets where patients' needs remain high. We expect approval in Japan early this year where GenmaV will lead full commercialization responsibilities and in Europe, later this year following a positive CHMP opinion issued in Jan. 0. 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 Tevdac in second line plus recurrent or metastatic cervical cancer 2 GENMAD for all countries outside The U. S. And China where Pfizer will continue to partner with Genmab and Xi 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 TIVDAC and also build a strong foundation for the potential launches of Arena S and aclosunumab in the future.

We are extremely pleased by the performance of our commercialized brands in 2024 validated 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 Evkinli and TypDAC across regions, and strategically entering new markets to prepare for the launches of our Holy Omedicines 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 Evkinley. And we're pleased with how these launches are progressing.

We've also significantly enhanced our long term growth potential with the addition of RENA S to our late stage pipeline as part of the acquisition of Profound Bio, As we'll see, our financials remain exceptionally strong. We achieved 31% total revenue growth.

And importantly, we grew our recurring revenues by 35% This was driven by strong royalties from DARZALEX Casimpta, and from product sales from EPKINDLY and TIVDAC. 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 EvKimley and the potential launch of VrENA 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 $1,170,000,000,0.0 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 DKK 1,380,000,000,0.0, As you can see, the majority of the investment over 70%, was driven by R and D. Reflecting our focus on late stage priority programs at Kinley, RENA S and Akasumumab, Our investment in SG and 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, think about our investment levels for 2024, we over delivered on our financial commitments made at the time of the ProFound Bio acquisition.

This was achieved through the balance of disciplined investing 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 a 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, have tax expense of around $130,000,000,0.0 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 The first 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 780,000,000,0.0, 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 converted our 2024 results from kroner 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 We expect our revenue to be in the range of around $330,000,000,0.0 to $370,000,000,0.0 delivering robust growth of 12% At the midpoint, And this is despite our non recurring revenue decreasing by more than $100,000,000 So it's our recurring revenues from royalty medicines and revenues from AdKimley and Tivdac that's driving our anticipated growth in 2025. For operating expenses, as I highlighted for you at expectations were in a reasonable place.

For 2025, we expect to be in a range of around 2.1 to $220,000,000,0.0 So as you can see, not only delivered over delivered on the commitment we made This reflects our disciplined approach to investments as well as rigorous portfolio prioritization. Putting all this together, planning for operating profit in a range between $8.95,000,000 Nearly $140,000,000,0.0 With the midpoint of guidance amounting to more than 110,000,000,0.0 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 Kasympta, and this increasingly includes contributions from Ed Kinley, and Tivdec.

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. Looking beyond 2025, for Eptinley, we anticipate 3 potentially significant pivotal readouts by the 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 1,2.6 to $1,340,000,000,0.0 Turning now to OpEx.

We've purposely reallocated our R and D investments in 2025 and are focused on advancing our high impact late stage programs [indiscernible] [indiscernible] So here, we are prioritizing late stage assets with strong commercial potential, while also applying a balanced approach As a result, our investment in these late stage programs increases from 45% of total R and 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 RENA S, which a disciplined approach that balances growth, and efficiency. These investments are aligned to drive both immediate launches and long term [indiscernible] For G and A, I am pleased to note that spend is broadly flat between 2024 and 2025. And here, our G and 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 In 2025, we'll make significant investments in late stage R and D and launch preparations. At the same time, we plan to deliver 16% operating profit growth 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, the end of the decade enhancing shareholder value. First, we will continue to invest in accelerating the development of our high impact late stage programs.

At Kinley, RENA S and Acasumumab, with investment into Phase 3 clinical trials. We will also continue to maximize the success because it's our investment in these programs now that will by the end of the decade. Second, we will continue to seek out business development and M and A opportunities that fit within our core focus areas. As you know, we executed on our acquisition of Profound Bio last year. Here, I'd like to highlight how quickly and successfully we were able to integrate Profound Bio into our business. As evidenced by our ability to progress Arena S so significantly. We not only brought forward the start of the first Phase 3 trial for Arena S, today we announced a second Phase 3 trial in an additional [indiscernible] 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, we're announcing our plan to repurchase an additional approximate 190,000,0.0 shares. Equivalent to around $3.70,000,000 dollars 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 [indiscernible] 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 for our shareholders.

And on that note, I'm going to head you back over Tian, Thank you, Anthony. Let's move on to our final slides. Now with this strong foundation supporting us, we are looking ahead to an an energizing 2025, starting with Hex Body CD38, we submitted the data packets to J and J and we anticipate a decision from them no later than the At that time, we will press release the decision and include top clinical data.

Regardless of J and J's decision, Genlock's strategic priorities in 2025 and beyond remain unchanged. Looking beyond these events, this year we are anticipating additional regulatory decisions for both Kinley and Tiv DAC. Including the potential approval of TivDAC in Europe, following a positive opinion from the CHMP in Jan. 0.

For both AKASUNLIMAP and TRINAR S, we anticipate presenting additional supporting 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 and investment in our late stage product pipeline and commercial execution. Tedenza, our formal presentation operator, please open the call for questions.

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 the question.

Hi, guys. Thanks for taking my questions. Can you discuss your reasons for confidence in the endometrial cancer opportunity for RENA S?

And for committing to a Phase three second line plus endometrial cancer study by year end.

Thank you.

Thanks, Jonathan, for the question. I will let Ty dive into this. Ty, can you talk about the endometrial cancer data and the commitment to go into a Phase 3. 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 most robust efficacy signal that that is currently being generated in that new population that you described, patients with intermediate cancer who 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 by investigators and investors when it is public and that's driving our excitement to move forward aggressively with the Phase 3.

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

Thank you. And the next question comes from the line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask [indiscernible] 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 the transplant ineligible 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 potential to sequence multiple CD20 bispecifics for DLBCL?

Thanks very much, Paul, for the questions. I will let Tahi address those for apocalicomap, Taehy.

Yes.

Thank you again for the question. So the second line in the first part, of course, we just early couple of days ago got the good news that the NCCN has included our data with Gemma ox and EPCO in second line patients who are ineligible for transplant with a type today recommendation. So that's very exciting. And then there's, of course, the Phase 3 ongoing in combination with linulinimide. So from our end, we kind of capture both opportunities. The debarking with chemotherapy more outpatient oriented [indiscernible] all medication plus a subcutaneous administration enhancing T cell function strategy and these 2 things are going to play out I think we have said many, many times, the opportunity in the relapse refractory setting for diffuse is really in expanding access to this novel mechanism. And we think that from the whole target product profile for AbbVie the saponinib administration. The fact that it is a the only 1 that is approved in both indication, it is extremely well positioned to enter the community space and provide access to patients in those settings. Thanks, Thijs. Let's give the floor back to the operator.

Thank you. And now when we take our next question, And it comes from the line of [indiscernible] Twist. Your line is open. Please ask a question.

Hi, guys. Just very quick to follow-up on McKinley. Dollars $3.81,000,000 in the first full year of launch, very commendable. So I want to delve into the market dynamics in the second half.

Flat on if there's anything unusual you point to. And then if I can ask, [indiscernible] acasaloneam, I like that you're putting peak sales number here for the key pipeline assets. Over 136000 potential treatable patients, Baxacin $1,000,000,000 in peak sales team is a little light compared to the others that you provided.

Can you tell us a little bit about what goes into this estimate? Is that something to do with the longer treatment interval? To six weeks versus three weeks or is there something else that you're anticipating with Akashan? Thanks, Astika, for the questions. I will ask Brad. To comment on the first 2, and then maybe Judith can step in also also on the estimates for acaclonimab. Brad, why don't you start with EPCO?

Thank you very much for the question. And we remain very confident actually in the core markets with U. S. And Japan with F. Kinley's performance with the growth we're seeing there. We did have a 1 time accounting adjustment for sales in Europe. France specifically that impacted the numbers specifically. Otherwise, again, feel very confident with our growth trajectory at this point.

Maybe the market size for AKASULIMAP as we estimated it over around 1000436000 patients you want to anything to that, Brad? [indiscernible] a competitive space that we see, particularly in this post to Iowa setting, significant opportunity, as you showed on your slide earlier. 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 site on AKASULIMA up in the estimated markets?

Yes. The only thing to add is, as you know, we pre select for PDL-one positive. So this came into account on the assessment of the market opportunity.

Thanks. Thanks, Judith. Hope that's clear, Ostika. Let's Let's give the floor back to the operator.

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

Thanks for taking my question.

Maybe 1 on follow-up on a casunimab. So in 2019, the Phase 2 data updates, what are we expecting to see in the data in the presentation? And then what sort of roughly the timing of that presentation? And then secondly, on Abkidney second line, and transplant ineligible. So you've launched a DLBCL4 trial last year. And could you maybe talk a little bit about the proposition for that setting against the DLBCL-one Thanks for both questions. Juris, why don't you talk a bit more about the Akersulin update, which we're very excited about to present this year and a bit more on timing and then Ty can address the apkoritumab question in the second line plus DLBCL setting after that. Judith?

Yes. So thank you for the question. As you know, we presented the best the first couple of biomarkers 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 stay 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?

Thanks, Judet. And Ty, maybe comment on the SecondLine Plus question for APCO.

Yes. Thank you. And then maybe I'll use this as an opportunity to more broadly layout our diffuse such piece of strategy as it relates to Abkindy. So initial launch as you know as a single agent in [indiscernible] 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 JEMARX data now recognized with 2A classification by the NCCN, meaning This is something that in the adjustment of the NCCN is providing benefits to patients. And then we have the Phase 3, is ongoing with lenalidomide. These are complementary in our minds and give a opportunity of choices for investigators to treat their patients, respected of their needs. Either somebody who needs more debauking or maybe somebody who's a little bit more fair. Really, the main focus is actually frontline. Is I think we spoke about this and we also put this on the slide. The study is fully good and it's paid a readout in 02/76. 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 [indiscernible] such that when this indication hopefully is going to be the positive, we will have again, a very complementary data set to provide physicians with all opportunities to treat their patients.

That's essentially broadly the strategy.

This is why also in the second line, we have a chemo a non chemo combination strategy, if that makes sense.

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

Thank you. Now we'll go and take our next question. It comes from the line of Shandong from UBS. Your line is open. Please ask your question. Hey, thank you very much for taking my question. Just 1 on Aptime, please. Just wondering, you mentioned the frontline DLBCL trial could be could have readouts by the Just wondering you have a readout by do you think you will have two year or three 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 asked for longer follow-up? Just considering the previous [indiscernible] Thanks, Dion, for the question. Very exciting 1. So I'll let Ty address that. [indiscernible] Sure.

I mean, so first things first, so the study was fully good. The 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 subgroup analysis for 3 IPI and higher. 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 our survival benefit. Initially, as it relates to the Polavix study. And so obviously, it will be whatever the data will be, but based on the Phase 2 data set that we have generated, pretty robust Phase 2 data set, We are quite optimistic actually that the signal in the experimental arm will be significantly stronger than the 1 I was seeing in Prolorex? And so we don't anticipate that it's going to be an issue for us. Thanks, Thij. Let's move on to the next question. Thank you, Sion.

Thank you.

And the next question comes from the line of Yaron Werber from TD Securities. Your line is open. Please ask your question.

Great. Thank you so much. So maybe just Tavy, just a follow-up the should we assume that the second line follicular and second line DLBCL that data by year end 2026, is that fileable assuming positive as well, so you can file both first and second line?

Do you need more data from second line And then just secondly on TivDAC, 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 world I assume, back to Pfizer and congrats on getting that.

Thanks, Sharon, for the question. So, Thij, you can address question on the very exciting developments with abcaritumab and then Brad why don't you explain the exact contract on TivTek and commercialization to Yaron after after Thai. Why? Just to clarify, Jan also said at the beginning in his prepared remarks, there are 3 of the 5 ongoing Phase IIs that are fully accrued awaiting a readout based on events, this is in third line diffuse HB cel. In second line follicular lymphoma, which is in combination with R square, and in frontline diffuse bispecific. And we were talking about the frontline diffuse HBISA study that finished its core 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 three, which also accrued significantly faster than initially projected and thus because this is event driven studies, we anticipate a readout earlier than initially projected.

Thanks, Ty. And then maybe move on to Brad for the exact commercial formulation of the contract for TivTAC. [indiscernible] Yes.

No, just thank you. And again, we are excited about the opportunity as it provides us the opportunity to expand our commercialization footprint. But Terms of the agreements 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 promoting here in U. S. And then 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, The U. S. And China remain the same.

Thanks. Thanks, Brad. Very clear.

Thanks, Jaron, for the questions. Let's move on to the next question. And now we're going to take our next question at comes from the line of Matthew Phipps.

From William Blair. Your line is open. Please ask your question.

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 3 And then on Akimli, 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? Thank you.

Thanks, Matt, for the questions. And I think Ty, you can address both. Both of the late receptor alpha question for endometrial and then also the APCO question.

First things first. So question has come up. A couple of times, so I'll try to be very clear. So first, polytoseptal alpha is a validated target in ovarian. In PROC, essentially all patients have some degree of 42 self alpha expression. Second, and this is partially related to the antibody that is the component of VNS and the internalization rate and partially related to linker and the stability that comes to the hydrophilic linker. The profile of Vina S is that it has generated and we have the state on the degree Also in the ESMO presentation, I already disclosed it, but there's obviously more data that we have internally that we're able to disclose yet, has generated robust data across the entire spectrum. Of 42 receptor alpha expression including patients who are by the technicality of the assay called negative. And I spoke to that before. This is to a degree also a function of the sensitive So to be clear, our strategy in the Phase 2 And our strategy in the Phase 3 is to not select [indiscernible] receptor expression. Now we do stratify in the Phase 3. By the various cutoffs, which is one hundred and twenty five and seventy five.

And that's just good practice.

On Abkeny, the question was whether the lack of hospitalization is going to help us expand into areas outside of the of the larger academic institutions and And I think that is certainly a general part of our strategy with APINI. And that's my understanding also playing out already that the utilization of Abkinde in follicular lymphoma is helping us to get access into institutions that originally were not open to using Abkini in diffuse bispecific setting and that's also how community is getting more comfortable on and that leads also to the discussion on our active efforts to remove hospitalization from the diffuse such visa label, but I would actually ask Brad to maybe add from his point of view to this.

Fernando, do you want to comment on this?

Yes. Thanks, Ty. And I agree with what you said. I think it's just [indiscernible] 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.

Thanks, Brad. And Matt, to top it off, as a reminder, there is no requirement for any hospitalization I think that should clarify then. Let's move to the next question.

Thank you. The next question comes from the line of Ki Zadeem from Redburn Hi. Just 1 quick question on the RENA S. Because you just mentioned about your clinical development plan in ovarian cancer and cancer. I'm just wondering what is your clinical development plan for other solid tumor indications such as lung and breast? Thank you. Very good question, Chris. And we will add Ty comment on that. Ty, [indiscernible] Yes. So There is indeed as you were alluding to for the subdirect expression in non small lung cancer, particularly in patients who have AGOR 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 each of our 2 indications and then we're going to inform you about next steps quite timely.

Thanks, Ty. Thanks, Keisa, for the question. Let's move on to the next question.

Thank you. And now we're going to take our next question. And it comes from the line of Justin Smith from Bernstein. Your line is open. Please ask a question.

Yes, thanks very much. I've got two First 1 just on Dara, if you wanted to possibly share any thoughts about the impact from the potential relaunch of Blendrep this year. And then the second 1, just on the buyback. I'm sorry if I'm thinking about things the wrong way. Just trying to understand why you've announced that now and not waiting to after the Hexabody decision from J and J. I'm just is it a case of if there's aren't interesting assets out there or just any thoughts on why that the buyback timing now?

Thanks, Justin, for the question. So I think Dara question is definitely more a question for J and J because they are developing Dara tumor. But I will ask Ty to give his perspective because he's an expert in multiple myeloma. Maybe you can say some general things there. On the landscape Ty, and then Anthony can absolutely give you more rationale and thinking behind the buyback. Which we just announced today, Justin. Ty, maybe some further color on brand rep and the landscape in multiple myeloma? [indiscernible] I would hesitate to comment. And so on another company's assets, so broadly speaking, it's always good for patients that they are that there are a lot of opportunities and I think we should leave it at that.

All right. I agree with that, Ty. So as J and 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 enhancing shareholder value. Our first priorities I highlighted really accelerating the development of our late stage pipeline and maximizing the success of our commercial medicines, as I highlighted. Second priority is pursuing focused BD and M and A. After we've evaluated 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 $500,000,000 buyback of 180,000,0.0 shares. And for 2025, having carefully considered this, looking at all factors, we announced today our plans to buy back an additional 190,000,0.0 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 outlined these priorities and also demonstrated how we executed against that framework in 2024. And how we're set up very well to continue to execute against that in 2025.

Thanks, Anthony. I think it's Chris for clear. Justin for the questions. Let's move on to the next [indiscernible] Thank you. And the question comes from the line of Vikram Puro Purohit from Morgan Stanley. Your line is open. Please ask your question.

Great.

Thanks.

For taking our questions. We had 1 on BD as a follow-up to the last question and then 1 on guidance.

On BD, I mean, given you noted 2025 is a heavy execution year for the pipeline. I just wanted to see how strong of a priority external BD and M and 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.

Thanks Vikram for the questions. Let me address the BD 1 and then Anthony do the guidance question. So BD is very, very organically and inorganically strengthen the pipeline accelerate it. What we will do is focus on antibody based medicine because that is our field of expert it very well last year with Performbio.

I can tell you that we did this not this acquisition in 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. And we said to basically congratulations on the Prophound Bio deal and we you snapped it away in front of our face because we are simply much quicker than other companies. And what we are looking for of e comm is antibody based medicines, which are truly differentiated We can use our expertise in this field for over twenty five 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 a complement of own pipe We're also filling our own pipeline. We are bringing more and more new molecules into 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 Rainer assets we described today in the call. I mean, within the year of the acquisition already announcing 2 Phase 3 and potentially others to come in other tumors. I think it's really blocking is fitting very well with our expertise as they develop of differentiated antibody medicines I think I believe 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 on the guidance.

Yes. Vikram, I think a starting point I would really just highlight for you 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 and all my comments will be at the midpoint. Total revenue growth at 12% recurring revenue growth of 18%, $100,000,000 plus non recurring revenue headwind looking at the improving quality of our revenue profile, recurring revenue is now at 95% If we look at then the performance of Abkinley and Tivjac, we can really see the investments we've made really focused investments we've made over the last couple of years building out our commercial commercialization capabilities really paying off can look at the net product sales collaboration revenue line where we see growth for that line really driven by again, Abkinley and Tibbdac primarily EfKinley 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 $1,260,000,000,0.0 thirteen billion dollars 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, again, delivering on our commitments. In terms of the OpEx range $210,000,000,0.0 to $220,000,000,0.0 this is really driven by the 3 investment priorities and where these exactly will land. It really has to do with the expansion and acceleration of 3 trials ongoing.

And expansion of EPCOR in our key markets. Then we have RENA S, with the start of Phase three and second line plus endometrial cancer in as well as the overall trajectory of the Phase 3 trial in PROC. And of course, we have ongoing work with Genmab acasumab with the Phase 3 Phase 2 start in another indication and also progressing Phase III VICTIMS. So it's really going to be these 3 programs I would say, that are largely driving the variability in OpEx. But again, if we sort of 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 or more than $110,000,000,0.0 All right. Thanks, Vikram, for the questions. Let's move on to the next 1.

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 [indiscernible] Hi. Thanks for taking my question. 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 it's obviously been a decision that's been pending for some time. So just interested in under [indiscernible] clarity on the timing, is that likely to be first half or second half of the year? And just 1 for Anthony on clarification on the guidance. Is there anything assumed in guidance for 10/42 development? And then a very quick 1 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 and appetite both from an internal and external perspective?

Thanks, Grajel, for the questions. So I will ask Judith to comment on timing for 042 and Anthony for the and the plans for 10/42 in development. Let me start with the INI question. What we already said, Rajon, is that Abkily, we believe, is an excellent candidate for development also in select I and I indications. We are in discussions now with Fee to actually plan and discuss next steps for Kinley. We think it's an excellent molecule. 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 program for Janmox. So we continue to be very focused [indiscernible] antibody based medicine candidates for INI and then we will update you once we are close to the clinic. But the most advanced candidate is Abkenli. Then let's move on to Judith to speak a bit timing for ten forty two.

Yes. Thank you, Jan. 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 IO.

And we need to assess durability in first line and then undergo the prioritization within our own pipeline and head and neck external is moving as well and we will come with all these data set more likely by the second half of the year.

Thanks, Jirrit. And then, Anthony, what is in the budget of the guidance for 2025 for 10/42? [indiscernible] and good to hear from you. I think as we sort of think about 10/42, Hazle, course the ongoing work that Judah just alluded to. I would say the future work is 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, Rayon, I can tell you that not only we, but also our partner BioNTech is very excited about what you seen up to now with 10/42. We need more data as Judith already alluded to.

But we also think there was a great potential for combining ten forty two with different ADCs and all of our concepts, which both companies are working on. 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 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. [indiscernible]