Genmab A/S (NASDAQ:GMAB) Q2 2025 Earnings Call Transcript

Genmab A/S (NASDAQ:GMAB) Q2 2025 Earnings Call Transcript August 7, 2025

Genmab A/S beats earnings expectations. Reported EPS is $0.54, expectations were $0.39.

Operator: 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 believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to the actual results unless this is required by law. Please note that Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would now like to turn the conference over to your first speaker today, Jan de Winkel. Please go ahead.

Jan G.J. van de Winkel: 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; and our Chief Medical Officer, Ta Ahmadi. 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. So please keep that in mind during the call. During today’s presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. 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, 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.

Let’s review how we have delivered on these commitments in the first half. Over the past 6 months, our total revenue grew by 19%, fueled by increased recurring revenue. And we have invested fully in line with our capital allocation priorities, focusing on our high-impact programs. More on that in a moment. Importantly, we have grown operating profit by 56%, even while making these strategic investments. In addition, in June, we completed share buyback, underscoring both our confidence in Genmab’s future and our commitment to delivering value to our shareholders. We ended the first half with around $3 billion in cash. And that 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 as well as a reminder of the overall potential. Epcoritamab, Rina-S and acasunlimab are all poised to drive significant revenue growth for Genmab by the end of this decade. And all 3 programs made progress towards this potential over the past few months. Excitingly for EPKINLY in May, we submitted an sBLA to the FDA for epcoritamab in second-line follicular lymphoma in combination with rituximab and lenalidomide or R-square based on a statistical and clinically significant improvement in overall response rates. In July, the FDA accepted the sBLA for priority review with a target action date of November 30, 2025. If approved, epcoritamab plus R-square has the potential to be the first bispecific antibody combination regimen available as a second-line treatment option for patients with relapsed or refractory follicular lymphoma.

Even more excitingly, today, we announced that the EPCORE FL-1 study met its dual endpoints of progression-free survival and overall response rate in a preplanned interim analysis. These unprecedented positive results will be the basis for global regulatory submissions. And Tahi will share some of the details of this promising data with you in just a moment. These important Phase III results support our goal to move EPKINLY into earlier lines of therapy in order to benefit more cancer patients. Also supporting this goal in recent months, we and AbbVie have presented data highlighting the depth, breadth and strength of the comprehensive epcoritamab development program. This includes 14 abstracts at EHA, including 2 oral presentations and 28 abstracts, including 1 oral at ICML.

Q&A Session

So EPKINLY, with its rapid clinical development and over — over 40 active clinical trials remains positioned to become the core therapy in B-cell lymphomas 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 I/II RAINFOL-01 study was unveiled at ASCO. Today, Tai 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, and we anticipate that we will have 3 Phase III 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 III in endometrial cancer and a Phase III trial in platinum- sensitive ovarian cancer.

Beyond gynecologic cancers, we also announced our intent to begin a Phase II 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. Based on this exceptionally strong execution, we remain on track to bring Rina-S to ovarian cancer patients in 2027. And given its best-in-class profile, we expect to achieve peak sales in ovarian and endometrial cancers exceeding $2 billion. We’re also launching a Phase II study for acasunlimab as we evaluate its potential in advanced melanoma. And we continue to look forward to additional data for this program in non-small cell lung cancer in the second half of the year. Now over to Tahi, who will provide a brief review of our recent company announcement on epcoritamab, followed by an overview of the promising Rina-S data from ASCO.

Tahi, the floor is yours.

Tahamtan Ahmadi: Thank you, Jan. We are, of course, extremely pleased to announce today the results of the Phase III EPCORE-FL1 trial, which met its dual primary endpoints of overall response rate and progression-free survival, demonstrating statistically significant and remarkably clinical data and differences in both endpoints, reducing the risk of disease progression or death by 79%. In other words, a hazard ratio of 0.21. These results, which were derived from a preplanned interim analysis will be submitted for presentation at this year’s ASH meeting, and they will serve as the basis for global regulatory submissions. Now here, 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 in the beginning of this year.

These results also demonstrated comparable consistent statistically significant improvements in ORR and PFS and the details you can see on this slide. For both interim analysis, the safety profile of epcoritamab in combination with R-square was consistent with the known safety profile of the individual regimens and no new safety signals have been observed. Patients with relapsed and refractory follicular lymphoma do have therapeutic options available. However, responses become progressively shorter and less doable with each subsequent line of therapy, and this is accompanied by an increased risk of transformation into large cell — into aggressive large cell lymphoma. What the data we shared today for epcoritamab highlights is the potential to completely transform and disrupt this current treatment paradigm.

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 EPKINLY to patients in need of innovative therapies earlier in their treatment journey where they can have a much larger impact. Now let’s move on to the recent VNA-S data that was shared at ASCO. Previously, we discussed the medical need for patients with ovarian cancer. There’s also continued to be a significant unmet medical need for the treatment of women with endometrial cancer. At ASCO, we presented the first results for single-agent Rina-S in women with advanced endometrial cancer from the dose expansion cohort B2 of the ongoing Phase I/II RAINFOL-01 study.

This cohort included 64 patients with heavily pretreated endometrial cancer who were randomized 1:1 to receive either Rina-S at 100 milligram per meter square or Rina-S at 120 milligram per meter square. In the efficacy evaluable patients, the confirmed ORR was 50%, including 2 complete responses with Rina-S 100 milligram per meter square and the disease control rate at that dose was 100%. Antitumor activity was observed regardless of exploratory folate receptor alpha expression levels. In addition to a superior response rate, treatment with Rina-S at 100 milligram per meter square led to deeper and more meaningful tumor size reductions. At the time of the data cutoff for the presentation, the median duration of response was not yet reached and with a median follow-up of 7.7 months, 8 of the 11 confirmed responses were still ongoing.

And shown in the [ swimmer ] plot, responses with Rina-S were observed early with a median time to response of 6 weeks for both groups, that is de facto at the first response assessment. Rina-S also had a manageable safety profile consistent with the previous reports. And the safety profile was broadly similar between the 2 dose levels. The most common treatment-emergent AEs were cytopenias and Grade 1 and 2 gastrointestinal events. 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, support the important hypothesis that Rina-S potentially works irrespective of the level of folate receptor alpha expression.

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, opening multiple avenues for therapeutic expansion. So our ambition is to expand both within gynecological cancers across lines and move Rina-S into the earlier lines as fast and efficient as possible, but also beyond targeting additional solid tumors such as in a first step, non-small cell lung cancer. To that end, a proof-of-concept Phase II study is in the plan to start dosing patients in the fourth quarter of this year. And as Jan mentioned, we are accelerating and expanding the development of Rina-S into additional trials, which already announced 3 Phase IIIs to dose the first patient in 2025, one of them already well ongoing.

And now I’ll hand it over to Brad for a review of the solid recent commercial performance for EPKINLY and Tivdak.

Brad Bailey: Thanks, Tahi. 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 execution by our field teams. 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. Overall, sales for EPKINLY and Tivdak in the first half of 2025 were up 60% year-over-year. This accounted for 31% of our total revenue growth, 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 EPKINLY and Tivdak that will be important catalysts for our future growth. Following regulatory approvals for Tivdak 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. We also made important progress on our work to reach more patients and deliver on EPKINLY’s growth potential. As Jan noted, we presented data at ASCO, EHA and ICML that together emphasize the strength of the EPKINLY clinical development program across histologies and treatment settings. And importantly, as we announced earlier today, we’ve accelerated our work to move EPKINLY into earlier lines of therapy with the launch in second-line follicular lymphoma expected later this year.

Turning now to EPKINLY’s first half performance. EPKINLY posted $211 million in global sales. This is a 74% year-over-year increase. We’re highly encouraged by EPKINLY’s performance and steady growth across geographies to date as we work to bring EPKINLY to as many appropriate patients as possible. Performance in the U.S. continues to demonstrate the value of EPKINLY as an off-the-shelf dual indication option for both DLBCL and FL as we’re seeing accelerating adoption across sites of care and increases in new patient starts. 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.

In Japan, EPKINLY 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. Across all other markets through our partner, AbbVie, we’ve also seen solid growth for EPKINLY and TEPKINLY. This is driven by an increasing number of countries gaining access and reimbursement along with the rapid uptake by physicians following reimbursement decisions. Globally, EPKINLY 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. Today, EPKINLY 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 EPKINLY’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 EPKINLY to become the core therapy across B-cell lymphomas. Moving now to Tivdak. Tivdak has proven to be a significant advancement for women with recurrent or metastatic cervical cancer in the U.S. It has changed the treatment paradigm serving as a model for a new standard of care around the world. In the first half of this year, we built on this progress to bring Tivdak to more women and deliver on our commitment to contribute to the gynecologic cancer community in a meaningful way. Global sales for Tivdak 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 Tivdak in Japan in May. This was the first medicine launched independently by Genmab, and we’re seeing encouraging uptake. In the U.S., performance continues to 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. Our teams are ready to launch Tivdak with the first launch anticipated in Germany soon. Other countries are expected to follow based on regulatory and reimbursement time lines. 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.

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 EPKINLY and our emerging GynOc portfolio. As we continue executing the next phase of our commercialization strategy, we’re focused on expanding utilization of our medicines and bringing them to as many patients as possible around the world. The work we’ve done to transform our commercialization business and accelerate our pipeline is paying off. As we progress through this new and exciting chapter for Genmab, we look forward to all that is to come for Tivdak and EPKINLY in the back half of the year.

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

Anthony Pagano: Thanks, Brad. In the first half of 2025, we delivered solid revenue growth, driven by sustained recurring revenues and the solid market performance of our products. We’ve also significantly enhanced our long-term growth potential as we continue to gather promising clinical data for both epcoritamab and Rina-S. As we’re going to see, our financials remain strong. We achieved 19% total revenue growth and 27% recurring revenue growth. This was driven by very strong royalties from DARZALEX and Kesimpta. And importantly, this growth was also driven by product sales from EPKINLY and Tivdak, which together represented around 31% 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. 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. In fact, in the first half of this year, recurring revenues represented 97% of our total revenue, and that compares favorably to 90% in the first half of last year. 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 us up well as we prepare for potential expansion into earlier lines for EPKINLY, including second-line FL and the potential launch of Rina-S in 2027.

And we continue to take a disciplined approach to these investments. Total OpEx in the first half of 2025 were slightly less than $1 billion, up 6% over the first half of last year, and that excludes the impact of the ProFound Bio acquisition. And we’re managing our investments strategically, prioritizing our high-impact Phase III programs and focused investments in our commercialization capabilities. 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. Next, looking at our net financial items. Here, we have a net gain of $119 million. Then moving on to tax. We have tax expense of $136 million, which equates to an effective tax rate of about 20%.

Taken together, our net profit amounts to $531 million. So as you can see, continued strong underlying financial performance. With that, let’s move to our 2025 financial guidance. 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. We now expect our revenue to be in the range of around $3.5 billion to $3.7 billion, delivering a robust 15% growth at the midpoint, and that compares to 12% growth under our previous guidance. We’re increasing the midpoint of our total revenue guidance by $100 million. This is driven by the strong performance of DARZALEX and positive EPKINLY sales momentum, 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%, 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 billion to $2.2 billion. Putting this all together, we’re planning for operating profit in a range between around $1.1 billion to $1.4 billion, with the midpoint of guidance amounting to over $1.2 billion of operating profit and strong year-over-year growth of 26%. 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. 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.

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. 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 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.

And on that note, I’m going to hand you back over to Jan.

Jan G.J. van de Winkel: Thank you, Anthony. Let’s move on to our final slide. So we have strengthened the foundations of our business in the first half of 2025. We have expanded the reach of both EPKINLY and Tivdak to more patients, and we anticipate even further growth for EPKINLY before the end of the year. For Rina-S, we have presented additional supportive clinical data showing its potential beyond ovarian cancer. And we are prepared to maximize that potential with additional Phase III clinical trials. And we continue to anticipate further acasunlimab data this year. 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.

In summary, in the first half of 2025, our solid financial performance, including our own products, EPKINLY and Tivdak reinforced the strength of our financial foundation. This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in our hypeimpact Phase III programs, allowing us to unleash the full potential of our late-stage pipeline 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. That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.

Operator: [Operator Instructions] And the questions come from the line of Jonathan Chang from Leerink.

Wei Ji Chang: Congrats on the positive Phase III EPCORE FL1 results. What is your latest thinking on the positioning of epco versus other CD20 bispecifics in the competitive landscape, both in terms of clinical development and your commercial experience?

Jan G.J. van de Winkel: Thanks, Jonathan, for the question. Excellent question. I’m going to hand it over to Tahi first, and then Brad will certainly add to that. Tahi, why don’t you start?

Tahamtan Ahmadi: 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. We have a very broad and aggressive development plan. This is the first Phase III to read out now for EPKINLY, but there are more to come in the next 6 to 9 months. As you just look at the breadth of the 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, even though we started 1.5 years later. We announced that our frontline diffuse large B-cell study is fully accrued a year ahead of initial projections. So we are very anxiously awaiting those results coming.

And we announced that we expect them to come in ’26. The Phase III is both in monotherapy as well as in combination with lenalidomide are also results that we’re looking forward. The frontline diffuse — frontline 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, the fact that we very early on started to generate data that was informing physicians in the outpatient setting how to utilize EPKINLY is also paying off quite well. 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. But broadly speaking, we feel that we have the most broadest, most ambitious program in the bispecific space.

And we’ve also been consistently showing that we are executing successfully on these studies. 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. Brad?

Brad Bailey: Yes, Jonathan, thanks for the question. And just kind of building on what Tahi had said, we’re certainly encouraged by our current leading sales position globally and also being the only off-the-shelf dual indication bispecific. We’re just receiving tremendous feedback from our physicians and customers. And now as we’ve said all along, starting to move into earlier lines of therapy with larger markets. It’s proving beneficial, as mentioned, with the 60-plus countries where we’re approved, 50 within the dual indication. And certainly, this FL — most recent FL data can continue to help us expand into the community where we’ve seen accelerating uptake already. So it has been a differentiator in the marketplace.

Jan G.J. van de Winkel: And to top it off, Jonathan, we just submitted close to 30 abstracts on epcoritamab for ASH. So there will be a lot of data, hopefully, at the end of the year. Let us move to the next question, operator.

Operator: We are now going to take our next question. And the questions come from the line of Asthika Goonewardene from Truist.

Asthika Sarith Goonewardene: So there is a lot of chaos at the FDA right now or calamity, whatever you want to call it. As we think about some of the regulatory filings you have coming up, I want to — so I have a 2-part question on that. One, how confident do you feel that you can file RAINFOL-01 Part C, which is a single-arm cohort? How confident you feel you can file that for accelerated approval? And secondly, is there any risk of pushback from the FDA on EPCORE FL-1 to wait until OX is more mature?

Jan G.J. van de Winkel: Thanks, Asthika, for the questions. I will ask Judith to start off with the RAINFOL study, and then maybe you can also take the FL-1study, Judith.

Judith V. Klimovsky: Yes. Thank you, Jan. Thank you, Asthika. So I’ll start with RAINFOL. The accelerated approval, of course, is predicated on strong data on ORR and duration of response. At this moment, we don’t have any reason to believe that the FDA will have any pushback provided the data supports, and we are aligned with the regulations in terms of the Phase III well underway. So at this moment, we don’t have — we don’t perceive any risk on that. And as we committed to launch in 2027, we reinforce our commitment to launch Rina-S in 2027. And with regard to EPCORE FL-01, 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. So we feel very confident that we have a path forward with ahead of us.

Operator: We are now going to proceed with our next question. The questions come from the line of Rajan Sharma from Goldman Sachs.

Rajan Sharma: So firstly, on EPKINLY, so assuming you get the approval in November, could you just outline your initial launch strategy? Is there a specific patient group that you might be targeting? Or yes, and how should we think about revenue contribution in ’25 and ’26? And then just on the label there, do you expect that there will be no requirement for hospitalization? And then the second question was just on the pipeline. I noticed that the HexaBody-OX40 or GEN1055 has been discontinued in solid tumors. Could you just talk to the rationale here? And I think that’s the second HexaBody asset now that’s not been progressed this year. So it would be great to just hear your confidence in that platform? And could that OX40 asset be used in immunology potentially?

Jan G.J. van de Winkel: Thanks, for the questions. I will ask first Brad to comment on the EPKINLY questions. And then Tahi, you can probably speak a bit more on HexaBody-OX40. What I can tell you before they start, Rajan, is that we are very excited about the HexaBody platform to actually bring a new one into the clinic, we hope between now and the end of the year. So we are certainly very confident in the platform, but we also are rigorous in prioritizing our portfolio, focusing more and more on late-stage programs. And that requires tough decisions. But I will let Tahi give you some further color there. But Brad, why don’t you start on EPKINLY and the launch strategy for in the follicular lymphoma setting?

Brad Bailey: Thank you for the question. And I think as we’ve stated for quite some time, larger opportunity is in these earlier lines of therapy, and we’re certainly pleased with the potential for EPKINLY to pave the way in this indication specifically, in the second-line FL. And in the U.S., as we’ve discussed, FL is a really important opportunity as we expand into the community where we’ve already seen accelerating uptake and see this as a meaningful opportunity for patients, but also for the brand moving forward.

Tahamtan Ahmadi: And then I’ll take the question on OX40. Well, the first thing I would say is that just to correct the impression that hexamerization as it is used for this particular target or also how it was used for CD27 in order to increase outside inside signaling by improving clustering that hypothesis definitely helped through. So the HexaBody-OX40 program did show all the things that we were anticipating and hoping for both in terms of a much, much stronger signal in terms of the biology, but also in terms of overcoming the bell-shaped curve. The decision to discontinue, as 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.

And from a development path vis-a-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 are money where we can see the most return on investment. So that was the OX40 question. Maybe I’ll take the labeling question that we still owe you. The follicular lymphoma label already does not include any hospitalization. That’s true for monotherapy follicular lymphoma — EPKINLY in follicular lymphoma in third line, and that’s also going to be true in combination with elsewhere.

Operator: We are now going to take our next question, and the questions come from the line of Yaron Werber from TD Securities.

Unidentified Analyst: Congrats on the quarter. This is [ Gina ] on for Yaron. Now that follicular lymphoma is really a growing part of the conversation for EPKINLY, how are you thinking about EPKINLY’s opportunity and differentiation versus [ mosunetuzumab ] specifically?

Jan G.J. van de Winkel: Thank you very much for the question. I am handing it over to you, Tahi.

Tahamtan Ahmadi: Well, I mean, thank you for the question. First things first. Well, we have a positive Phase III in second line and they don’t — they don’t yet have reported the results. I think they have publicly said that they expect the results to come in by the end of the year. So that’s the first differentiation. 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, EPKINLY has shown better efficacy, higher CR rates, both in follicular lymphoma and then definitely also diffuse [ large ] B-cells. So it’s the more efficacious of the 2 bispecifics. The subcutaneous administration has been an advantage for us and Roche is trying to bridge towards that, 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 [indiscernible]. So broadly speaking, we feel now very, very good about our position. And I don’t know if Brad has anything to say to that.

Jan G.J. van de Winkel: That is plenty. Let’s move on to the next question.

Operator: We are now going to take our next question. The questions come from the line of Michael Schmidt from Guggenheim Partners.

Michael Werner Schmidt: I had another one on Rina-S and specifically around your plans for development outside ovarian cancer. You did talk about this new Phase II study in non-small cell lung cancer. And yes, just wondering if you could expand upon that opportunity. Do you have any data in-house, Phase I data in-house supporting this? And what do we know about the folate receptor alpha expression in lung cancer?

Jan G.J. van de Winkel: Thanks, Michael, for the question. I’m going to hand it over to Tahi, and he can give you an excellent rationale, Michael.

Tahamtan Ahmadi: Thank you for the question, and I’ll start at the beginning. So yes, I think the way we have been talking about this is as we have increasingly learned that Rina-S is able to generate efficacy even in patients who have lower levels of folate receptor alpha expression, that, of course, then raises interest in disease areas where folate receptor alpha is expressed but at lower levels. And so that was what I was mentioning and referring to. EGFR-mutated non-small cell lung cancer, so that’s the indication we are looking at as the next step is one that slightly different. So adenocarcinoma non-small cell lung cancer is known to have folate receptor alpha expression really broadly, but not as high as it is, for example, in ovarian, but somewhat similar to endometrial actually.

EGFR-mutated non-small lung cancer does actually have an increase in folate receptor alpha expression. And so this is the first case study for us to then explore additional solid tumor indication, not the last, but the first in a sequence that is very much driven by preclinical data and scientific rationale. We do have, as you were pointing to already a small cohort that is very well enrolled now for its size, initially meant to just generate some safety data. And so we do have some signals, and they are continue 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 in EGFR mutant, but not restricted necessarily to EGFR-mutated non-small cell lung cancer.

So very excited about that study, and so we’re going to be very much looking forward to the data the study will generate.

Operator: Are now going to proceed with our next question. The questions come from the line of Matthew Phipps from William Blair.

Matthew Christopher Phipps: Congrats on the strong EPCORE FL-1 data. Maybe a question for Tahi. You mentioned the broad development plan with epcoritamab as being a strength. 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? And then quickly, acasunlimab in melanoma, will that use the same Q 6- week dosing? Or do you need to explore additional dosing regimens in melanoma?

Jan G.J. van de Winkel: Thanks, Matthew. I can take the second question. Acasunlimab, we will stick with this every 6-week dosing because we think it’s optimal for that compound. 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. But Tahi, why don’t you start with the epco development plans in the context of ADC combinations.

Tahamtan Ahmadi: Yes. Thank you for the question. And maybe the way I start is what I laid out was the regulatory strategy that was following a very clear outlined strategy, which we actually really talked about 5 years ago that we were going to enter a monotherapy in the relapsed/ refractory setting and then very rapidly move down the lines into frontline, both in diffuse large B-cell and follicular lymphoma and these other studies are yet to read out. And so that was the development plan. And once we have the development plan, we would then focus on complementary data that would drive or inform how physicians can use the drug in different settings. A combination with an ADC is a very interesting one in that regard, in that place.

Jan already mentioned that there’s a lot of data generation up to a little bit more than 30 abstracts are being submitted to ASH. There’s actually an ISV that’s going to open up in combination with [indiscernible], which is I think where you’re heading towards to. There are other ADCs that are coming, Merck has one where there are discussions ongoing. And so I think ADCs very well will have a role in diffuse large B-cell as well if they are able to improve the outcomes. I do think that with increasing data, what is our ambition, what is also becoming a reality is that bispecifics, in particular, EPKINLY are going to become a backbone of these novel combinations in the future.

Jan G.J. van de Winkel: Thanks, Tahi. Especially combinability seems to be really, really good with epcoritamab. We can combine it with literally all different — all types of different agents, Matthew. And I think that may be a big advantage of the bispecific format like the one we use for epcoritamab. Judith, do you want to add anything more to the acasunlimab every 6-week dosing question?

Judith V. Klimovsky: No, thank you. As you said, we explored every 6 weeks because it showed the best in terms of efficacy and safety.

Operator: We are now going to proceed with the last question. And the questions come from the line of Qize Ding from Redburn Atlantic.

Qize Ding: I just have one follow-up question on the Rina-S in non-small cell lung cancer. Is the Phase II trial going to test Rina-S in patients in the first-line or second-line setting of the non-small cell lung cancer or all comers? And just a quick follow-up. Is the Rina-S going to be tested as monotherapy or in combination with other checkpoint inhibitors?

Jan G.J. van de Winkel: Thank you for the question. Tahi, can you address this one?

Tahamtan Ahmadi: Yes. 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 may not necessarily want to show our hands as we are moving into this field. This study, as I mentioned, is intended to give us the optionality to interrogate Rina-S both in monotherapy and as well as in combination. And if you look a little bit and how our philosophy is on drug development as it played out in EPKINLY or in Rina-S in ovarian and in endometrial, then I think you can get an idea of how this study is going to be set up without going into the details of what combinations we are going to test and which line of therapy. But clearly, it is going to interrogate mono and combination therapy.

Jan G.J. van de Winkel: So this was the last question, operator.

Operator: Yes, this is the last question showing. So I hand back to you for closing remarks. Thank you.

Jan G.J. van de Winkel: So thank you for calling in today. If you have additional questions, please reach out to our Investor Relations team, and we very much look forward to speaking with you again soon.

Operator: This concludes today’s conference call. Thank you all for participating. You may now disconnect your lines.