Genmab A/S Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: Our total revenue grew by 19% year-over-year and operating profit by 56%, we completed a share buyback in June and ended H1 with approximately $3 billion in cash.
  • Positive Sentiment: The FDA has accepted our sBLA for epcoritamab in second-line follicular lymphoma for priority review (PDUFA 11/30/2025), and the Phase III EPCORE FL-1 trial met its co-primary endpoints of progression-free survival and overall response rate.
  • Positive Sentiment: Phase 1/2 data for single-agent RINA S in heavily pretreated advanced endometrial cancer showed a 50% confirmed ORR and 100% disease control rate, and three Phase III trials are planned by year-end targeting a 2027 launch.
  • Positive Sentiment: Epcoritamab (Epkinley) generated $211 million in H1 sales (+74% YoY) and TIVDAC achieved $78 million (+30% YoY), with independent launches in Japan and Europe boosting commercial momentum.
  • Neutral Sentiment: We continue to prioritize investment in high-impact late-stage programs, discontinuing the Hexabody OX40 asset to focus resources on our core pipeline, while advancing a new Hexabody candidate into the clinic by year-end.
AI Generated. May Contain Errors.
Earnings Conference Call
Genmab A/S Q2 2025
00:00 / 00:00

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Operator

Hello, and welcome to the Genmab First Half twenty twenty five 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.

Operator

Please note that Genna may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van den Winkle. Please go ahead.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Hello, and welcome to our financial results for the 2025. With me today is our Chief Financial Officer, Anthony Pagano our Chief Commercial Officer, Brad Bailey and our Chief Medical Officer, Taya Mahdi. And for the Q and 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 and the sum of our strategic collaborations.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

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 six months, our total revenue grew by 19%, fueled by increased recurring revenue.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

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. 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 $3,000,000,000 in cash.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

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 Akasunamab are all poised to drive significant revenue growth for Genmab by the end of this decade. And all three programs made progress towards this potential over the past few months. Excitingly for Abkinly, in May, we submitted an SBLA to the FDA for epiritamab in second line follicular lymphoma in combination with rituximab and lenalidomide, or R2, based on statistical and clinically significant improvements in overall response rates.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

In July, the FDA accepted this BLA for priority review with a target action date of 11/30/2025. If approved, abpiritamab plus R2 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 Epcurve FL1 study met its dual endpoints of progression free survival and overall response rates in a preplanned interim analysis. These unprecedented positive results will be the basis for global regulatory submissions. And Thij will share some of the details of this promising data with you in just a moment.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

These important Phase III results support our goal to move her kidney 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 epcaritamab development program. This includes 14 abstracts at including two oral presentations and 28 abstracts including one oral at ICML. So Abkindly, with its rapid clinical development and over active for over 40 active clinical trials, remains positioned to become the core therapy in B cell lymphomas, with anticipated peak sales exceeding 3,000,000,000 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 onetwo RAINFALL-one study was unveiled at ASCO.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Today, Thay 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 anticipate that we will have three 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.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

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 $2,000,000,000 We're also launching a Phase II study for Akasundamab as we evaluate its potential in advanced melanoma. As 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 Tai, who will provide a brief review of our recent company announcement on efgartigimod, followed by an overview of the promising RINA S data from ASCO. Tai, the floor is yours.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

Thank you, Jan. We are, of course, extremely pleased to announce the data results of the Phase III Epcor FL1 trial, which met its two primary endpoints of overall response rate and progression free survival, demonstrating statistically significant and remarkably clinical data differences in both endpoints, reducing the risk of disease progression or death by seventy nine percent, 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.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

For both interim analysis, the safety profile of efgartigimod in combination with R2 was consistent with the known safety profile of the individual regimens and no new safety signals have been observed. Patients with relapsed or refractory follicular lymphoma do have therapeutic options available. However, responses become progressively shorter and less doable with each subsequent line of therapy. This is accompanied by an increased risk of transformation into aggressive large cell lymphoma. What the data we shared today for Epiritamab highlights is the potential to completely transform and disrupt this current treatment paradigm.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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 Epkini 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 MENA 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.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

At ASCO, we presented the first results for single agent Vina S in women with advanced endometrial cancer from the dose expansion cohort B2 of the ongoing Phase onetwo RAINFOR-one study. This cohort includes sixty four patients with heavily pretreated endometrial cancer, who were randomized one to one to receive either Arena S at one hundred milligram per meter square, or Arena S at one hundred twenty milligram per meter square. In the efficacy evaluable patients, the confirmed ORR was fifty percent including two complete responses with Rena S one hundred milligram per meter squared, and the disease control rate at that dose was one hundred percent. Antitumor activity was observed regardless of exploratory folate receptor alpha expression levels. In addition to a superior response rate, treatment with MENA S at a hundred milligram per meter square led to deeper and more meaningful tumor size reductions.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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 seven point seven months, eight of the 11 confirmed responses were still ongoing. And shown in the SWIRMA plot, responses with Wiener 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. We now also had a manageable safety profile consistent with previous reports. And the safety profile was broadly similar between the two dose levels.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

The most common treatment emergent AEs were cytopenias and grade one and two 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 folic receptor alpha, supports the important hypothesis that MENA 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 the lines and move VinaS 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.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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. And as Jan mentioned, we are accelerating expanding the development of Vina S into additional trials, which already announced three Phase IIIs to dose their first patient in 2025, one of them already well ongoing. And now I hand it over to Brad for a review of the solid recent commercial performance for F. Kinley and Tiftac.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Hey, thanks, Tide. We delivered strong performance across our commercial business in the 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.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Overall, sales rep Kinley and TIVDAC in the 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 Evcanly and Tibdaq that will be important catalysts for our future growth. Following regulatory approvals for TIVDAC 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 in our work to reach more patients and deliver on Epkinley's growth potential.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

As Jan noted, we presented data at ASCO, EHA, and ICML that together emphasized the strength of the Epkinley clinical development program across histologies and treatment settings. And importantly, as we announced earlier today, we've accelerated our work to move McKinley into earlier lines of therapy with the launch in second line follicular lymphoma expected later this year. Turning now to McKinley's first half performance. McKinley posted $211,000,000 in global sales. This is a 74% year over year increase.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

We're highly encouraged by Epkinley's performance and steady growth across geographies to date, as we work to bring Epkinley to as many appropriate patients as possible. Performance in The US continues to demonstrate the value of Epkinley 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, Epkinley 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.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Across all other markets, through our partner AbbVie, we've also seen solid growth for Epkinley and Tepkinley. This is driven by an increasing number of countries gaining access and reimbursement along with a rapid uptake by physicians following reimbursement decisions. Globally, Epkinley 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, Epkinley is uniquely positioned as the only bispecific approved as an off the shelf dual indication option in DLBCL and FL.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

With encouraging utilization across markets, consistently positive feedback from physicians on Epkinley'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 Epkinley to become the core therapy across B cell lymphomas. Moving now to TIP. TIPDAC 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. In the first half of this year, we built on this progress to bring TIVDAC to more women and deliver on our commitment to contribute to the gynecologic cancer community in a meaningful way.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Global sales for TIVDAC in the 2025 totaled $78,000,000 This is up 30% compared to the same time last year. Of note, commercial sales now reflect our launch of Tivdaq in Japan in May. This was the first medicine launched independently by Genmab and we're seeing encouraging uptake. In The US, 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.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Our teams are ready to launch TIVDAC with the first launch anticipated in Germany soon. Other countries are expected to follow based on regulatory and reimbursement timelines. 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 Epkenly and our emerging Gynoc portfolio.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

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 TIVDAC and Epkenly in the back half of the year. With that, I'll hand the call over to Anthony to discuss our financials.

Anthony Pagano
EVP & CFO at Genmab

Thanks Brad. In the 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 eptinezumab and RENAS. As we're going to see, our financials remain strong. We achieved 19% total revenue growth and 27% recurring revenue growth.

Anthony Pagano
EVP & CFO at Genmab

This was driven by very strong royalties from DARZALEX and Kasimpta. And importantly, this growth was also driven by product sales from McKinley and TIVDAC, 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 $6,800,000,000 for the first half of the year, which translates to over $1,000,000,000 in royalty revenue for us.

Anthony Pagano
EVP & CFO at Genmab

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.

Anthony Pagano
EVP & CFO at Genmab

And this sets us up well, as we prepare for potential expansion into earlier lines for Epkinley, including second line FL, and the potential launch of RENAS in 2027. And we continue to take a disciplined approach to these investments. Total OpEx in the 2025 were slightly less than $1,000,000,000 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.

Anthony Pagano
EVP & CFO at Genmab

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 $119,000,000 Then moving on to tax, we have tax expense of $136,000,000 which equates to an effective tax rate of about 20%. Taken together, our net profit amounts to $531,000,000 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 to $3,700,000,000 delivering a robust 15% growth at the midpoint. And that compares to 12% growth under our previous guidance.

Anthony Pagano
EVP & CFO at Genmab

We're increasing the midpoint of our total revenue guidance by $100,000,000 This is driven by the strong performance of DARZALEX and positive at Kinley sales momentum. And that's partially offset by 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 focused and disciplined approach to our investments, we still expect to be in a range of around $2,100,000,000 to $2,200,000,000 Putting this all together, we're planning for operating profit in a range between around $1,100,000,000 to $1,400,000,000 with the midpoint of guidance amounting to over $1,200,000,000 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.

Anthony Pagano
EVP & CFO at Genmab

Now, finally, to give you just a bit of color on FX. Here, every 10 move in the exchange rate relative to our guidance rate for the dollar to kroner of 7.2 is worth around $5,000,000 in operating profit or loss at the midpoint. In summary, our performance in the 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 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.

Anthony Pagano
EVP & CFO at Genmab

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 van de Winkel
Co-Founder, President & CEO at Genmab

Thank you, Anthony. Let's move on to our final slide. So we have strengthened the foundations of our business in the 2025. We have expanded the reach of both Abkinly and Tivdaq to more patients, and we anticipate even further growth for Abkinli before the end of the year. For RENAS, we have presented additional supportive clinical data showing its potential beyond ovarian cancer.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

And we are prepared to maximize that potential with additional Phase III clinical trials. And we continue to anticipate further Akasunlimab 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 2025, our solid financial performance, including our own products at Kinley and Tiftec, reinforced the strength of our financial foundation. This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in our Hype Impact Phase III programs, allowing us to unleash the full potential of our late stage pipeline, while maximizing the success of our commercialized medicines.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

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

Thank you, you. We are now going to proceed with our first question. And the questions come from the line of Jonathan Chang from Leerink. Please ask your question.

Jonathan Chang
Senior MD & Senior Research Analyst at Leerink Partners

Hi, guys. Thanks for taking my questions. 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? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Jonathan, for the question. Excellent question. I'm going to hand it over to Ty first, and then Brad will certainly add to that. Ty, why don't you start?

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

Yes, Jonathan, thank you for the question. As it relates to the position, 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 three to read now for Epkinley, but there are more to come in the next six to nine 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 one and a half years later.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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 'twenty six. The phase three is both in monotherapy as well as in combination with lenalidomide are also results that we're looking forward. Frontline follicular lymphoma study is going extremely well. And so from a positioning, from a data generation point of view, we feel very strong in the utilization.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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 kidney is also paying off quite well. 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're executing successfully on these studies.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

And that's equally important, not only on the clinical execution, but also on the regulatory execution. So you look at some of the competitive news. Go ahead.

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Yeah, Jonathan, thanks for the question. And just kind of building on what Tai 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 a 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.

Jonathan Chang
Senior MD & Senior Research Analyst at Leerink Partners

Thanks Thanks. For taking the

Jan van de Winkel
Co-Founder, President & CEO at Genmab

And to top it off, we just submitted close to 30 abstracts on efgartigimod for ASH. So there will be a lot of data hopefully at the end of the year. Let us move to the second to the next question, operator.

Operator

Sure. We are now going to take our next question. And the questions come from the line of Asika Goonwadin from Truist. Please ask your question.

Asthika Goonewardene
Asthika Goonewardene
Managing Director, Senior Biotech Analyst at Truist Securities

Hi, guys. Thanks for taking my question. So there is a lot of chaos at the FDA right now or calamity, what do you want to call it? And we think about some of the regulatory filings you have coming up. Want to so I have a two part question on that.

Asthika Goonewardene
Asthika Goonewardene
Managing Director, Senior Biotech Analyst at Truist Securities

One, how confident do you feel that you can file RAINFALL-one Part C, which is a single arm cohort? How confident you can feel you can file that for accelerated approval? And secondly, is there any risk of pushback from the FDA on Epcor FL-one to wait until OS is more mature? Thanks.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Asika, for the questions. I will ask you to start off with the RAINFOL study, and then maybe you can also take the FL-one study units.

Judith Klimovsky
EVP & Chief Development Officer at Genmab

Yes, thank you, Jan, and thank you, Arstica. 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 three well underway. So, at this moment, we don't have, we don't perceive any risk on that.

Judith Klimovsky
EVP & Chief Development Officer at Genmab

And as we committed to launch in 2027, we reinforce our commitment to launch Arena on 2027. And with regard to EPCOR 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, 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.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you, Yurat. Thanks, Astika, for the question.

Operator

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.

Rajan Sharma
Rajan Sharma
Executive Director - Pharma & Biotech Equity Research at Goldman Sachs

Hi. Thanks for taking the question. So firstly on Epkinley, 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 2025 and 2026?

Rajan Sharma
Rajan Sharma
Executive Director - Pharma & Biotech Equity Research at Goldman Sachs

And then just on the label there, do you expect that there'll be no requirement for hospitalization? And then the second question was just on the pipeline. I know you said 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 being progressed this year.

Rajan Sharma
Rajan Sharma
Executive Director - Pharma & Biotech Equity Research at Goldman Sachs

So it would be great to just hear your confidence in that platform. And could that OX40 asset be used in immunology potentially? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Rashaan, for the questions. I will ask first Brad to comment on the Abkinli questions, and then Thay, you can probably speak a bit more on Hexabody OX40. What I can tell you before they start, Rashaan, is that we are very excited about the Hexabody platform. We're actually bringing 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.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

But I will let Thij give you some further color there. But Brad, why don't you start on Abkinly and the launch strategy for in the follicular lymphoma setting?

Brad Bailey
EVP & Chief Commercial Officer at Genmab

Yeah, no, 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 Epkinley to pave the way in this indication, specifically in the second line FL. And in The US, 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
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

And then I'll take the question on OX40. Well, the first thing I would say is that just to correct that text summarization 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 or 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.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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're investing, as you've been hearing for a while now from us, our resources, money where we can see the most return on investment. So that was the oxfordi question. Maybe I'll take the labeling question that we still owe you. The follicular lymphoma label already does not include any hospitalization.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

That's true for monotherapy follicular Epkini and follicular lymphoma in third line, And that's also going to be true in combination with R2.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thij. Let's move on to the next question.

Operator

We are now going to take our next question. And the questions come from the line of Yaron Werber from TD Securities. Please ask your question.

Analyst

Hey, congrats on the quarter and thanks for taking my question. This is Jaina on for Yaron. Now that follicular lymphoma is really a growing part of the conversation for Kinley, how are you thinking about Kinley's opportunity and differentiation versus Luzumio specifically? Thanks so much.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you very much for the question. I am handing it over to you, Tai.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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, you know, dramatic. Epkini has shown better efficacy, higher ORR, higher CR rates both in follicular lymphoma and then definitely also diffuse use of B cells.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

So it's seen more efficacious of the two bispecifics. The subcutaneous administration has been a disadvantage for us and, you know, 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 Mosul. So broadly speaking, we feel now very, very good about our position.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

And, you know, I don't know if Brad has anything to say to that.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Tayo. Is plenty. Yeah. 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. Please ask your question.

Michael Schmidt
Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

Oh, hey, thanks for taking my questions. I had another one on RHYNA 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 yeah, just wondering if you could expand upon that opportunity. Do you have any data in how is Phase I data in how is it supporting this? And what do we know about the folate receptor alpha expression in lung cancer? Thanks so much.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Michael, for the question. I'm going to hand it over to Tai, and he can give you an excellent rationale, Michael.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

All right, 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 Arena 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 photoreceptor 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.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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 full receptor alpha expression, so this is the first case study for us to then explore additional solid tumor indications, not the last but the first, and 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 continue to be encouraging.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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, you know, strategically explore the opportunity for Arena S initially in EGFR muted, but not restricted necessarily to EGFR muted 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.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Di. Thanks, Michael.

Operator

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.

Matt Phipps
Group Head - Biotechnology at William Blair

Thanks for taking my question. Congrats on the strong Epcora SL1 data. Maybe a question for Ty. You mentioned the broad development plan with efgartamab as being a strength. I was wondering what you think about ADC combinations.

Matt Phipps
Group Head - Biotechnology at William Blair

And do you see a role for those longer term in lymphoma? Maybe how you will continue to explore those? And then quickly, axasilamab and melanoma, will that use the same Q6 dosing? Or do you need to explore additional dosing regimens in melanoma? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Matthew. I can take the second question. Akasunamab, we will stick with this every six week dosing because we think it's optimal for that compound. So we don't need to do a further dose frequency combinations, we believe. And I'll let Judith add to that if there are any further things to add.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

But Thij, why don't you start with the Epco development plans in the context of ADC combinations?

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

Yes. Thank you for the question. And maybe the way I start this is like 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, that we were going to enter monotherapy in the relapsedrefractory setting and then very rapidly move down the lines into the frontline, in diffuse large B cell and follicular lymphoma. And these are the studies that are yet to read out. And so that was the development plan.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

And once we had 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 that are being submitted to ASH. There's actually an ISD that's going to open up in commission with Lanka, I which think where you are heading towards to. There are other ADCs that are coming.

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

Merck has one where, you know, the discussion is 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. Do think that with increasing data, what is our ambition, what is also becoming a reality is that bispecifics, in particular, abkini, are going to become a backbone of these novel combinations in the future.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Tay. Especially, combinability seems to be really, really good with efgartigimod. We can combine it with literally all 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 epiritamab. Judith, do you want to add anything more to the akasunamab every six week dosing question?

Judith Klimovsky
EVP & Chief Development Officer at Genmab

No, no, thank you. As you said, we explore every six weeks because it showed the best in terms of efficacy and safety.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Judith. I think that's it, Matthew. Thank you very much for the questions.

Operator

We are now going to proceed with the last question. And the questions come from the line of Kew Steng from Redburn Atlantic. Please ask your question.

Qize Ding
Equity Research Analyst at Rothschild & Co Redburn

Hi, thanks for taking my question. 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 comers? And just a quick follow-up. Is the RINA S going to be test as monotherapy or in combination with other checkpoint inhibitor? Thank you.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thank you for the question. Tai, can you address this one?

Tahamtan Ahmadi
EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab

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 VinaS both in monotherapy and as well as in combination. And if you look a little bit in how our philosophy is on drug development as it played out in kidney or in Vina S in ovarian and 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're going to test and which line of therapy. But clearly, it is going to interrogate mono and combination therapy.

Jan van de Winkel
Co-Founder, President & CEO at Genmab

Thanks, Thay. Very clear. So this is the last question, operator.

Operator

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

Jan van de Winkel
Co-Founder, President & CEO at Genmab

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. Thank you.

Analysts
    • Jan van de Winkel
      Co-Founder, President & CEO at Genmab
    • Tahamtan Ahmadi
      EVP - Chief Medical Officer & Head of Experimental Medicines at Genmab
    • Brad Bailey
      EVP & Chief Commercial Officer at Genmab
    • Anthony Pagano
      EVP & CFO at Genmab
    • Jonathan Chang
      Senior MD & Senior Research Analyst at Leerink Partners
    • Asthika Goonewardene
      Managing Director, Senior Biotech Analyst at Truist Securities
    • Judith Klimovsky
      EVP & Chief Development Officer at Genmab
    • Rajan Sharma
      Executive Director - Pharma & Biotech Equity Research at Goldman Sachs
    • Analyst
    • Michael Schmidt
      Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC
    • Matt Phipps
      Group Head - Biotechnology at William Blair
    • Qize Ding
      Equity Research Analyst at Rothschild & Co Redburn
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