Q2 2025 Genmab AS Earnings Call
Speaker #2: Hello and welcome to the GENMAB first half 2025 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 beliefs, anticipates, plans, or expects.
Speaker #2: Actual results may differ materially. For example, as a result of delayed or unsuccessful development projects. GENMAB is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to the actual results unless this is required by law.
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Speaker #2: Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van der Winkel.
Speaker #2: Please go ahead.
Speaker #3: Hello, and welcome to our financial results for the first half of 2025. With me today is our chief financial officer, Anthony Pagano. Our chief commercial officer, Brad Bailey.
Speaker #3: And our chief medical officer, Tanya Madi. And for the Q&A, we will be joined by our chief development officer, Judith Klimovsky. As we have already said, we will be making forward-looking statements.
Speaker #3: So please keep that in mind during the call. During today's presentation, we will reference products being developed, and some of our strategic collaborations. This slide acknowledges those relationships.
Speaker #3: I would like to start with a reminder of our commitments for 2025. In February, we said that we would accelerate the development of our high-impact, late-stage pipeline.
Speaker #3: That we would maximize the potential of our commercialized medicines and that we would deliver on our capital allocation priorities, supporting our continued growth and long-term value creation.
Speaker #3: Let's review how we have delivered on these commitments in the first half. Over the past six months, our total revenue grew by 19%. Fueled by increased recurring revenue.
Speaker #3: And we have invested fully in line with our capital allocation priority. Focusing on our high-impact programs. More on that in a moment. Importantly, we have grown our operating profit by 56%, even while making these strategic investments.
Speaker #3: In addition, in June, we completed a share buyback, underscoring both our confidence in GENMAB's future and our commitment to delivering value to our shareholders. We entered the first half with around $3 billion in cash.
Speaker #3: And note that it not only reinforces the strength of our financial foundation, but importantly, it gives us the flexibility for continued growth and expansion. Now let's turn to some of the recent advancements for our late-stage programs.
Speaker #3: As well as a reminder of the overall potential. At Quritamab, Rina S. and Akasuni Mab are all poised to drive significant revenue growth for Genmab by the end of this decade.
Speaker #3: And all three programs made progress towards this potential over the past few months. Excitingly, for Abkinli in May, we submitted an SBLA to the FDA for AbQuritamab in second line follicular lymphoma, in combination with rituximab and lenalidomides, or R square, based on a statistical and clinically significant improvement in overall response rates.
Speaker #3: In July, the FDA accepted this BLA for priority review, with a target action date of November 30, 2025. If approved, AbQuritamab plus R-squared has the potential to be the first bispecific antibody combination regimen available.
Speaker #3: As a second-line treatment option for patients with relapsed or refractory follicular lymphoma, even more excitingly, today we announced that the AbCoV FL1 study met its dual endpoints.
Speaker #3: Of progression-free survival and overall response rate in a pre-plant interim analysis. These unprecedented positive results will be the basis for global regulatory submissions. And Tanya will share some of the details of this promising data with you in just a moment.
Speaker #3: These important phase three results support our goal to move Abkinli into earlier lines of therapy in order to benefit more cancer patients. Also supporting this goal in recent months, we and Abfi have presented data highlighting the depth, breadth, and strength of the comprehensive AbQuritamab development program.
Speaker #3: This includes 14 abstracts at EHA, including two oral presentations, and 28 abstracts, including one oral, at ICML. So, Abkinli, with its rapid clinical development and over 40 active clinical trials, remains positioned to become the core therapy in B-cell lymphomas.
Speaker #3: With anticipated peak sales exceeding $3 billion, turning to Rina S. The first disclosure for single-agent Rina S., in patients with advanced endometrial cancer, from a dose expansion cohort of the phase 1, 2 rainfall 0, 1 study, was unveiled at ASCO.
Speaker #3: Today, Tanya will provide a brief reminder of this exciting data. During our post-ASCO event, we also announced our plans to broaden the reach of Rina S.
Speaker #3: And we anticipate that we will have three phase three trials underway by the end of the year. In addition to our ongoing trial in platinum-resistant ovarian cancer, we plan to initiate a phase three in endometrial cancer and a phase three trial in platinum-sensitive ovarian cancer.
Speaker #3: Beyond gynecologic cancers, we also announced our intent to begin a Phase 2 trial in non-small cell lung cancer. So you can see our track record of being able to accelerate the clinical development of key programs continues.
Speaker #3: Based on this exceptionally strong execution, we remain on track to bring Rina S. to ovarian cancer patients in 2027. Given its best-in-class profile, we expect to achieve peak sales in ovarian and endometrial cancers exceeding $2 billion.
Speaker #3: We also are launching a Phase 2 study for Akasuni Mab as we evaluate its potential in advanced melanoma. Additionally, we continue to look forward to additional data for this program in non-small cell lung cancer in the second half of the year.
Speaker #3: Now over to Tanya, who will provide a brief review of our recent company announcement on AbQuritamab, followed by an overview of the promising Rina S.
Speaker #3: Data from ASCO. Tanya, the floor is yours.
Speaker #4: Thank you, Jan. We are, of course, extremely pleased to announce the results of the Phase 3 AbCoV FL1 trial, which met its dual primary endpoints of overall response rate and progression-free survival.
Speaker #4: Demonstrating statistically significant and remarkably clinical data in differences in both endpoints, reducing the risk of disease progression or death by 79%. In other words, a hazard ratio of zero point two.
Speaker #4: These results, which were derived from a pre-plant in-treme ysis, will be submitted for presentation at the CSASH meeting and they will serve as the basis for global regulatory submissions.
Speaker #4: Now, I would like to note that the supplemental BLA submission that Jan mentioned earlier with the FDA was actually based on data from an earlier interim analysis at the beginning of this year.
Speaker #4: These results also demonstrated comparable consistent statistically significant improvements in OR and PFS and the details you can see on this slide. For both in-treme analysis, the safety profile of AbQuritamab in combination with R square was consistent with the known safety profile of the individual regimens and no new safety signals have been observed.
Speaker #4: Patients with relapsed and refractory follicular lymphoma do have therapeutic options available. However, responses become progressively shorter and less durable with each subsequent line of therapy.
Speaker #4: And this is accompanied by an increased risk of transformation into large cell aggressive large cell lymphoma. What the data we shared today for AbQuritamab highlights is the potential to completely transform and disrupt this current treatment paradigm.
Speaker #4: And this is really also reflected in the collaboration with the FDA as we were able to accelerate the submission in the United States. Both the recent SBLA submission and these data which will support the planned global regulatory submissions, as mentioned, bring us closer to being able to offer Abkinli to patients in need of innovative therapies earlier in their treatment journey where they can have a much larger impact.
Speaker #4: Now let's move on to the recent Rina S. data that was shared at ASCO. Previously, we discussed the medical need for patients with ovarian cancer.
Speaker #4: There's also continued to be a significant unmet medical need the treatment of women with endometrial cancer. At ASCO, we presented the first results for single-agent Rina S.
Speaker #4: In women with advanced endometrial cancer from the dose expansion cohort B2 of the ongoing Phase 1/2 Rainfall study, this cohort included 64 patients with heavily pretreated endometrial cancer who were randomized one-to-one to receive either Rina S at 100 milligrams per meter square or Rina S at 120 milligrams per meter square.
Speaker #4: In the efficacy evaluation of patients, the confirmed ORR was 50%, including two complete responses with Rina S 100 milligrams per meter square, and the disease control rate at that dose was 100%.
Speaker #4: Anti-tumor activity was observed regardless of exploratory folate receptor alpha expression levels. In addition to a superior response rate, treatment with Rina S at 100 milligrams per meter squared led to deeper and more meaningful tumor size reductions.
Speaker #4: At the time of the data cutoff for the presentation, the median duration of response was not yet reached. With a median follow-up of 7.7 months, eight of the 11 confirmed responses were still ongoing.
Speaker #4: As shown in the swim-up plot, responses with Rina S were observed early, with a median time to response of six weeks for both groups; that is, de facto, at the first response assessment.
Speaker #4: We now also had a manageable safety profile consistent with previous reports. The safety profile was broadly similar between the two dose levels. The most common treatment emergencies were cytopenias and grade 1 and 2 gastrointestinal events.
Speaker #4: Notably, there were no signals of ocular toxicity interstitial lung disease or neuropathy observed in these reported patient cohorts. And the data we've now seen in both ovarian and especially endometrial cancer, which is known to actually have a much lower expression of folate receptor alpha, supports the important hypothesis that Rina S potentially works irrespective of the level of folate receptor alpha expression.
Speaker #4: And, as folate receptor alpha is expressed across a broad range of solid tumors, this, of course, presents an opportunity to broaden the potential across a diverse array of tumor types.
Speaker #4: Opening multiple avenues for therapeutic expansion. Our ambition is to expand both within gynecologic cancers across the lines and move Rina S into the earlier lines as fast and efficiently as possible.
Speaker #4: But also beyond, targeting additional solid tumors, such as in the first step, non-small cell lung cancer. To that end, a proof of concept phase two study is in the plan to start dosing patients in the fourth quarter of this year.
Speaker #4: As Jan mentioned, we are accelerating the development of Rina S into additional trials. We have already announced three Phase III trials, with the first patient expected in 2025, one of which is already ongoing.
Speaker #4: And now I hand it over to Brad for a review of the solid recent commercial performance for Abkinli and TIFDAC.
Speaker #5: Hey, thanks, Tanya. We delivered strong performance across our commercial business in the first half of 2025. This is driven by our innovative antibody science, our proven launch capabilities, and the execution by our field teams.
Speaker #5: We've maintained leading positions for our commercialized brands, and have achieved critical milestones that will support our long-term growth. This performance reinforces the solid foundation we've built as we strategically scale our operations, accelerate adoption of our medicines, and positively impact treatment paradigms for patients around the world.
Speaker #5: Overall, sales for Abkinli and TIFDAC in first half of 2025 were up 60% year over year. This accounted for 31% of our total revenue growth.
Speaker #5: And we expect to see our commercialized medicines increasingly contribute to our overall revenue growth over time. In the second quarter, we achieved significant milestones for Abkinli and Tifdac that will be important catalysts for our future growth.
Speaker #5: Following regulatory approvals for TIFDAC in Japan and Europe last quarter, we've now entered into the next phase of our commercialization strategy focused on long-term value creation through our wholly-owned launches.
Speaker #5: We also made important progress in our work to reach more patients and deliver on Abkinli's growth potential. As Jan noted, we presented data at ASCO, EHA, and ICML that together emphasized the strength of the Abkinli clinical development program across histologies and treatment settings.
Speaker #5: And importantly, as we announced earlier today, we've accelerated our work to move Abkinli into earlier lines of therapy, with the launch in second-line follicular lymphoma expected later this year.
Speaker #5: Turning now to Abkinli's first half performance. Abkinli posted 211 million in global sales. This is a 74% year over year increase. We're highly encouraged by Abkinli's performance and steady growth across geographies to date, as we work to bring Abkinli to as many appropriate patients as possible.
Speaker #5: Performance in US continues to demonstrate the value of Abkinli as an off-the-shelf, dual-indication option for both DLBCL and FL, as we're seeing accelerated adoption across sites of care and increases in new patient starts.
Speaker #5: As we continue executing on our launches and prepare to enter earlier lines of therapy, we remain focused on increasing adoption and rapidly identifying patients particularly in the community setting where most patients seek treatment.
Speaker #5: In Japan, Abkinli launched in third-line plus follicular lymphoma in May. The launch is off to an encouraging start, building on the uptake we've seen in large B-cell lymphoma, and also driven by the national and field-level activities and account activation.
Speaker #5: Across all other markets, through our partner Abby, we've also seen solid growth for Abkinli and Abkinli. This is driven by an increasing number of countries gaining access and reimbursement, along with the rapid uptake by physicians following reimbursement decisions.
Speaker #5: Globally, Abkinli has received the most regulatory approvals for a bispecific in DLBCL and FL, with approvals in more than 60 countries worldwide. This includes nearly 50 countries with approvals in both indications.
Speaker #5: Today, Abkinli is uniquely positioned as the only bispecific approved as an off-the-shelf, dual-indication option in DLBCL and FL. With encouraging utilization across markets, consistently positive feedback from physicians on Abkinli's profile, and our progress moving into earlier lines of therapy, we're confident that we have the commercial and clinical foundation in place for kinli to become the core therapy across B-cell lymphomas.
Speaker #5: Moving now to TIFDAC. TIFDAC has proven to be a significant advancement for women with recurrent or metastatic cervical cancer in the US. It has changed the treatment paradigm, serving as a model for a new standard of care around the world.
Speaker #5: In the first half of this year, we built on this progress to bring TIFDAC to more women and deliver on our commitment to contribute to the gynecologic cancer community in a meaningful way.
Speaker #5: Global sales for TIFDAC in the first half of 2025 totaled $78 million. This is up 30% compared to the same time last year. Of note, commercial sales now reflect our launch of TIFDAC in Japan in May.
Speaker #5: This was the first medicine launched independently by GenMab, and we're eing encouraging uptake. In the US, performance continues be strong and stable across sites of care, and in Europe, we've made important progress, establishing our infrastructure and operations to support commercial markets in the region.
Speaker #5: Our teams are ready to launch TIFDAC with the first launch anticipated in Germany soon. Other countries are expected to follow based on regulatory and reimbursement timelines.
Speaker #5: This progress marks a strong entrance into the next phase of our commercialization strategy as we launch our medicines independently, enter new markets, and broaden our impact for patients in the gynecologic cancer community.
Speaker #5: So with continued solid performance of our commercialized medicines and proven launch execution, we're confident in our path for growth. We believe we have the right pieces in place to drive long-term value creation and maximize our opportunities ahead for Abkinli and our emerging GINOC portfolio.
Speaker #5: As we continue executing the next phase of our commercialization strategy, we're focused expanding utilization of our medicines and bringing them to as many patients as possible around the world.
Speaker #5: The work we've done to transform our commercialization business and accelerate our pipeline is paying . As we progress through this new and exciting chapter for GenMab, we look forward to all that is to come for TIFDAC and Abkinli in the back half of the year.
Speaker #5: With that, I'll hand the call over to Anthony Pagano to discuss our financials.
Speaker #6: Thanks, Brad. In the first half of 2025, we delivered solid revenue growth, driven by sustained recurring revenues and a solid market performance of our products.
Speaker #6: We've also significantly enhanced our long-term growth potential as we continue to gather promising clinical data for both AbQuritamab and Rina S. And as we're going to see, our financials remain strong.
Speaker #6: We achieved 19% total revenue growth and 27% recurring revenue growth. This was driven by very strong royalties from Darzalex and Casimpta. And importantly, this growth was also driven by product sales from Abkinli and TIFDAC, which together represented around 31%.
Speaker #6: Of our total revenue growth, looking at Darzalex, we continue to see strong growth. Overall, net sales grew by nearly 22%. That's $6.8 billion for the first half of the year, which translates to over $1 billion in royalty revenue for us.
Speaker #6: This growth was driven by continued share gains and strong performance in the frontline setting. So you can see that the quality of our revenue profile continues to improve.
Speaker #6: In fact, in the first half of this year, recurring revenues represented 97% of our total revenue. This compares favorably to 90% in the first half of last year.
Speaker #6: Stepping back, what's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off. And this sets up well as we prepare for potential expansion into earlier lines for Abkinli including second-line FL and the potential launch of Rina S in 2027.
Speaker #6: And we continue to take a disciplined approach to these investments. Total OpEx in the first half of 2025 was slightly less than $1 billion, up 6% over the first half of last year.
Speaker #6: And that excludes the impact of the ProfoundBio acquisition. We are managing our investments strategically, prioritizing our high-impact phase three programs and focused investments in our commercialization capabilities.
Speaker #6: Our operational discipline contributed to our operating profit growth of an impressive 56% in the first half. So here, you can see that we're really continuing to deliver on our commitments.
Speaker #6: Next, looking at our net financial items, we have a net gain of $119 million. Then, moving on to tax, we have a tax expense of $136 million, which equates to an effective tax rate of about 20%.
Speaker #6: Taken together, our net profit amounts to $531 million. So, as you can see, there is continued strong underlying financial performance. With that, let's move to our 2025 financial guidance.
Speaker #6: Here, I'm pleased to note that we're improving our guidance based on projected higher revenues and operating profit. Even as we continue to expand the development of our late-stage programs.
Speaker #6: We now expect our revenue to be in the range of around $3.5 to $3.7 billion, delivering a robust 15% growth at the midpoint. This compares to 12% growth under our previous guidance.
Speaker #6: We're increasing the midpoint of our total revenue guidance by $100 million. This is driven by the strong performance of Darzalex and positive Abkinli sales momentum.
Speaker #6: And that's partially offset by a slight impact from lower Tepezza royalties and milestone revenue. So we now anticipate that our recurring revenues for the year will grow 22%.
Speaker #6: And that compares to 18% under our previous guidance. For OpEx, due to our continued focus and disciplined approach to our investments, we still expect to be in a range of around $2.1 to $2.2 billion.
Speaker #6: Putting this all together, we're planning for operating profit in a range between approximately $1.1 billion and $1.4 billion. With the midpoint of guidance amounting to over $1.2 billion in operating profit and strong year-over-year growth of 26%.
Speaker #6: Our improved guidance highlights our continued strategic discipline, targeted investments, and operational efficiency, all while advancing our pipeline. Now, finally, to give you just a bit of color on FX.
Speaker #6: Here, every 10-point move in the exchange rate relative to our guidance rate for the dollar to kroner of 7.2 is worth around $5 million in operating profit or loss at the midpoint.
Speaker #6: In summary, our performance in the first half of 2025 underscores our ability to deliver solid, high-quality revenue growth, advance key pipeline assets, and maintain strong profitability through disciplined execution.
Speaker #6: Looking ahead to the second half of 2025, we will continue to build on this momentum by further prioritizing our investments and expanding market opportunities. Now we are, of course, continuing to monitor the geopolitical situation.
Speaker #6: And the potential impact on our business. At this stage, we do not anticipate a significant impact on our 2025 financial guidance. What's important to note is our very strong financial foundation, sustained profitability, and disciplined capital allocation strategy really enable us to position GenMab for growth and expansion, as well as create value for shareholders and patients.
Speaker #6: And on that note, I'm going to hand you back over to Jan. Thank you, Anthony. Let's move to let's move on to our final slide.
Speaker #6: So we have strengthened the foundations of our business in the first half of 2025. We have expanded the reach of both Abkinli and TIFDAC to more patients.
Speaker #6: And we anticipate even further growth for Abkinli before the end of the year. For Rina S., we have presented additional support of clinical data showing its potential beyond ovarian cancer.
Speaker #6: And we are prepared to maximize the potential of that potential with additional Phase 3 clinical trials. We continue to anticipate further Akasuni Mab data this year.
Speaker #6: In addition to these priorities, we will continue to actively look for opportunities to grow our pipeline both organically and inorganically, positioning us for sustainable long-term growth and value creation.
Speaker #6: In summary, in the first half of 2025, our solid financial performance including our own products, Abkinli and TIFDAC, reinforced the strength of our financial foundation.
Speaker #6: This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in our high-impact Phase 3 programs, allowing us to unleash the full potential of our late-stage pipeline.
Speaker #6: While maximizing the success of our commercialized medicines, together with our demonstrated track record of execution, we are set up for long-term success and continued outperformance through 2030 and beyond.
Speaker #6: That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.
Speaker #2: Thank you, Sal. As a reminder to ask a question, please press star one and one on your telephone and wait for your name to be announced.
Speaker #2: To withdraw your question, please press star one and one again. Once again, please press star one and one on your telephone and wait for your name to be announced.
Speaker #2: To withdraw your question, please press star one and one again. For the benefit of all your participants on the call today, please limit yourself to one question per person.
Speaker #2: If you have any further questions, please rejoin the queue. Thank you. We are now going to proceed with our first question. And the questions come from the line of Jonathan Chang from Lierink.
Speaker #2: Please ask your estion.
Speaker #7: Hi, guys. Thanks for taking my questions. And congrats on the positive Phase 3 AbCoV FL1 results. What is your latest thinking on the positioning of AbCoV versus other C20 bispecifics in the competitive landscape?
Speaker #7: Both in terms of clinical development and your commercial experience. Thank you.
Speaker #6: Thanks, Jonathan, for the question. Excellent question. I'm going to hand it over to Tanya first, and then Brad will certainly add to that. Tanya, why don't you start?
Speaker #8: Yes, Jonathan. Thank you for the question. As it relates to the position, I think we feel—and we've been saying this for a while—very comfortable where we are.
Speaker #8: We have a very broad and aggressive development plan. This is the first Phase 3 to read out now for Abkinli, but there are more to come in the next six to nine months.
Speaker #8: As you just look at the breadth of development, and also the accrual as well as the times when these studies were initiated, I think we have a head start now in second-line follicular lymphoma for sure, right?
Speaker #8: Even though we started one and a half years later, we announced our front-line diffuse HB cell study is fully accrued a year ahead of initial projections.
Speaker #8: So we are very anxiously awaiting those results coming. And we announced that we expect them to come in '26. The phase three is both in monotherapy as well as in combination with lenalidomide.
Speaker #8: Also, results that 're looking ward. The front-line diffuse follicular lymphoma study is accruing extremely well. And so from a positioning, from a data generation point of view, we feel very strong in the utilization, I think Brad can also talk about this.
Speaker #8: The fact that we very early on started to generate data that was informing physicians in the outpatient setting how to utilize Abkinli is also paying off quite well.
Speaker #8: And so, there's more to come on that end as well. As it relates to how the market reacts, I probably should hand this over to Brad.
Speaker #8: But broadly speaking, we feel that we have the broadest and most ambitious program in the bispecific space. We have also been consistently showing that we are executing successfully on these studies.
Speaker #8: And that's equally important, not only on the clinical execution but also on the regulatory execution. If you look at some of the competitive news.
Speaker #8: Brad?
Speaker #3: Yeah. Yeah, Jonathan. Thanks for the question. And just kind of building on what Tanya had said, we're certainly encouraged by our current leading sales position globally.
Speaker #3: And then also being the only off-the-shelf dual-indication bispecific, we're just receiving tremendous feedback from our physicians and customers. Now, as we've said all along, we're starting to move into earlier lines of therapy with larger markets, which is proving beneficial, as mentioned, with the 60-plus countries where we're approved.
Speaker #3: 50 within a dual indication. And certainly, this FL's most recent FL data can continue to help us expand into the community where we've seen accelerating uptake already.
Speaker #3: So, it has been a differentiator in the marketplace.
Speaker #6: Thank you, guys.
Speaker #7: I'll entertain the estion.
Speaker #6: Thanks. And to top it off, Jonathan, we just submitted close to 30 abstracts on AbQuritamab for ASH, so there will be a lot of data, hopefully, at the end of the year.
Speaker #6: Let us move to the second-to-next question, operator.
Speaker #2: Sure. We are now going to take our next question. The questions come from the line of Asica. Morning from Truist. Please ask your question.
Speaker #9: Hi, guys. Thanks for taking my question. So there is a lot of chaos at the FDA right now or calamity, whatever you want to call it.
Speaker #9: And we think about some of the regulatory filings you have coming up. I want to, so I have a two-part question on that. One, how confident do you feel that you can file Rainfall or One-Part C, which is a single-arm cohort? How confident do you feel you can file that for accelerator approval?
Speaker #9: And secondly, is there any risk of pushback from the FDA on AbCoV FL1 to wait until overall survival is more mature? Thanks.
Speaker #6: Thanks, ASICA, for the questions. I will ask you to start off with the rainfall study and then maybe you can also take the FL1 study units.
Speaker #2: Yeah. Thank you, Jan. And thank you, ASICA. So I start with rainfall. The accelerated approval, of course, is predicated on strong data on ORR and duration of response.
Speaker #2: At this moment, we don’t have any reason to believe that the FDA will have any pushback, provided the data supports us and we are aligned with the regulations in terms of the phase three trial, which is well underway.
Speaker #2: So at this moment, we don't perceive any risk on that. As we committed to launch in 2027, we reinforce our commitment to launch Rina in 2027.
Speaker #2: And with regard to AbCoV FL01, as you know, that indication got BTD in September 2024. So we are engaging with the FDA in a very active and positive manner so and as we announced publicly today, we got the SBLA was accepted with the PDUFA date in November.
Speaker #2: This gives us great confidence that we have a path forward ahead of us.
Speaker #6: Thank you, Judith. Thanks, ASICA, for the estion.
Speaker #2: We are now going to proceed with our next question. The questions come from the line of Regent Sharma from Goldman Sachs. Please ask your question.
Speaker #10: Hi. Thanks for taking the question. So firstly, on Abkinli, so as you mean you get the approval in November, could you just outline your initial launch strategy?
Speaker #10: Is there a specific patient group that you might be targeting? Or, yeah, how should we think about revenue contribution in '25 and '26? And then just on the label, there, you expect that there'll be no requirement for hospitalization?
Speaker #10: And then the second question was just on the pipeline. I just indicated that the PEXA body OX40 or Genmab 1055 has been discontinued in solid tumors.
Speaker #10: Could you just talk to the rationale here? And I think that's the second PEXA Ody asset now that's not being progressed this year. So it'd be great to just hear your confidence in that platform.
Speaker #10: And could that OX40 asset be used in immunology, potentially? Thank you.
Speaker #6: Thanks, Jan, for the questions. I will ask first Brad to comment on the Abkinli questions, and then Tanya, you can probably speak a bit more on PEXA and OX40.
Speaker #6: What I can tell you before they start, Rajan, is that we're excited about the PEXA body platform. We're really bringing a new one into the clinic.
Speaker #6: We hope to achieve our goals between now and the end of the year. So, we are certainly very confident in the platform. However, we are also rigorous in prioritizing our portfolio, focusing more and more on late-stage programs.
Speaker #6: And that requires tough decisions. But I will let Tanya give you some further color there. But Brad, why don't you discuss Abkinli and the launch strategy for the follicular lymphoma setting?
Speaker #3: Yeah. No, thank you for the question. And I think, as we've stated for quite some time, the larger opportunity is in these earlier lines of therapy.
Speaker #3: And we're certainly pleased with the potential for Abkinli to pave the way in this indication specifically, in the second-line follicular lymphoma (FL). In the U.S., as we've discussed, FL is a really important opportunity as we expand into the community.
Speaker #3: Where we've already seen accelerating uptake and see this as a meaningful opportunity for patients, but also for the brand moving forward.
Speaker #6: Thanks, Brad.
Speaker #8: And then I'll take the question on OX40. Well, the first thing I would say is like just to correct the impression that PEXA memorization asset is used for this particular target or also how it was used for the CD27 in order to increase outside-inside signaling by improving clustering.
Speaker #8: That hypothesis definitely helped as we anticipated. The PEXA body OX40 program did show all the things that we were anticipating and hoping for, both in terms of a much, much stronger signal regarding the biology and in terms of overcoming the bell-shaped curve.
Speaker #8: The decision to discontinue Jan was already indicating was primarily around the fact that it's from a profile not really differentiated from some of the other assets that we have.
Speaker #8: And from a development path, the path vis-à-vis other opportunities that exist is really not as promising as some of the other opportunities. So we are investing, as you've been hearing for a while now from us, our resources or money where we can see the most return on our investment.
Speaker #8: So that was the OX40 question. Maybe I'll e the labeling question that we still owe you. The follicular ymphoma label already does not include any hospitalization that's true for monotherapy follicular ymphoma Abkinli and follicular lymphoma in third line.
Speaker #8: And that's also going to be true in combination with R square.
Speaker #6: Thanks, Tanya. Let's move on to the next question.
Speaker #2: We are now going to take our next question. The questions come from the line of Yaron Weber from TD Securities. Please answer your question.
Speaker #11: Hi. I'm back on the call. And thanks for your question. This is Jana on for your own. Now that follicular lymphoma is really a growing part of the conversation for Abkinli, how are you thinking about Abkinli's opportunity and differentiation versus Lusumio specifically?
Speaker #11: Thanks so much.
Speaker #6: Thank you very much for the question. I am handing it over to you, Tanya.
Speaker #8: Well, I mean, thank you for the question. First things first, we have a positive Phase 3 and second-line, and they don't yet have a report of the results.
Speaker #8: I think they are publicly said that they expect the results to come in by the end of the year. So that's the first differentiation.
Speaker #8: We will have a significant head start. And I think that has played out well for us. In terms of the signal, consistently, although maybe not as dramatic, Abkinli has shown better efficacy and higher CR rates, both in follicular lymphoma and definitely also in diffuse B cell.
Speaker #8: So it's the more efficacious of the two bispecifics. The subcutaneous administration has been an advantage for us. And, you know, it's trying to bridge towards that.
Speaker #8: But not yet. So that's another differentiation that currently is playing out. And I think in terms of safety, with the subsequent optimization, our CRS rates are as low as they are with MOSO.
Speaker #8: So, broadly speaking, we feel very, very good about our position. And I don't know if Brad has anything to say to that.
Speaker #6: Thanks. Thanks, Tanya. That is plenty. Yeah. Let's move on to the next question.
Speaker #2: We are now going to take our next question. The questions come from the line of Michael Schmidt from Guggenheim Partners. Please ask your question.
Speaker #12: Oh, hey. Thanks for taking my question. I had another one on Rina S., and specifically around your plans for development outside of ovarian cancer.
Speaker #12: You did talk about this new Phase 2 study in non-small cell lung cancer. And yeah, I'm just wondering if you could expand upon that opportunity?
Speaker #12: Do you have any in-house phase one data supporting this? And what do we know about the follicular alpha expression in lung cancer?
Speaker #12: Thanks so much.
Speaker #6: Thanks, Michael, for the question. I'm going to hand it over to Tanya, and he can give you an excellent rationale, Michael.
Speaker #8: All right. Thank you for the question. And I'll start at the beginning. So yes, I think the way we have been talking, this is as we have increasingly learned that Rina S is able to generate efficacy even in patients who have lower levels of follicular receptor alpha expression.
Speaker #8: That, of course, then raises interest in disease areas where follicular receptor alpha is expressed but at lower levels. And so that was what I was mentioning and referring to.
Speaker #8: EGFR-mutated non-small cell lung cancer. So that's the indication we are looking at, as the next step is one that is slightly different. Adenocarcinoma non-small cell lung cancer is known to have follicular receptor alpha expression really broadly, but not as high as it is, for example, in ovarian.
Speaker #8: But somewhat similar to endometrial, actually. EGFR-mutated non-small cell lung cancer does, in fact, have an increase in follicular receptor alpha expression. And so this is the first case study for us to then explore additional solid tumor indications, not the last but the first in a sequence that is very much driven by preclinical data and scientific rationale.
Speaker #8: We do have, as you were pointing to already, a small cohort that is very well involved now for its size. Initially meant to just generate some safety data.
Speaker #8: And so we do have some signals, and they are continuing to be encouraging. So we continue to generate that data. But the intent of this study is really to give us now a dedicated vehicle with multiple different arms, so that we can really strategically explore the opportunity for Rina S initially and EGFR mutated, but not restricted necessarily to EGFR mutated non-small cell lung cancer.
Speaker #8: So very excited about that study, and we are going to be very much looking forward to the data from the study we'll generate.
Speaker #6: Thanks, Tanya. Thanks, Michael.
Speaker #2: We are now going to proceed with our next question. The questions come from the line of Matthew Phipps from William Blair. Please ask your question.
Speaker #12: Thanks for repeating my question. Congrats on the strong AbCoV FL1 data. Maybe a question for Tanya. You mentioned the broad development plan with AbQuritamab as being a strength.
Speaker #12: I was wondering what you think about ADC combinations and do you see a role for those longer-term in lymphoma? Maybe how you will continue to explore those?
Speaker #12: And then quickly, I can send them out in melanoma. Will that use the same Q6 week dosing, or do you need to explore additional dosing regimens in melanoma?
Speaker #12: Thank ou.
Speaker #6: Thanks, Matthew. I can take the second question. Akasuni might be able to stick with this every six-week dosing because we think it's optimal for that compound.
Speaker #6: So we don't need to do further dose frequency combinations, we believe. And I'll let Judith add to that if there are any further things to add.
Speaker #6: But Tanya, why don't you start with the AbCoV development plans in the context of ADC combinations?
Speaker #8: Yeah, thank you for the question. And maybe the way I start this is like, you know, what I laid out was the regulatory strategy that was following a very clear outline strategy, which we actually really talked about five years ago.
Speaker #8: That we were going to enter a monotherapy in the relapse refractory setting and then very rapidly move down the lines with into the line both in diffuse large B-cell lymphoma and follicular lymphoma.
Speaker #8: And these are the studies that are yet to read out. And so that was the development plan. Once we had the plan, we would then focus on complementary data that would drive or inform how physicians can use the drug in different settings.
And, uh, it's just a quick follow-up. Is the arena going to be tested as a monotherapy or in combination with other checkpoint inhibitors? Thank you.
Thank you for the question, Ty. Can you address this one?
Yes. Um, um, I will try to address it, although I do think we are now entering into spaces where we have to be careful because it's a competitive landscape, and we need not necessarily want to.
Um, show our hands as we are moving into this field. This study, as I mentioned, is intended to give us the optionality.
Um, to to to interrogate winner as both in Monett therapy, um, and well, as well as in, um, combination. And if you
Look a little bit in how our philosophy is and talk development, as it played out in a kindly um, or in in a s in ovarian and, and in the mutual. Um, then I think you can get an idea of how the study is going to be set up without going into the details of what combinations, we're going to test in which line of therapy, but clearly, it is going to interrogate more and combination therapy.
Thanks Ty. Very clear.
So, this was the last question, operator. Yes, this is the last question showing. So, I head back to you for closing remarks. Thank you.
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