Earnings call transcript: Genmab Q3 2025 sees strong growth, stock dips

Genmab (GMAB) reported its third-quarter earnings for 2025, showcasing significant growth in revenue and operating profit. Despite these strong results, the company’s stock experienced a slight decline, falling by 1.99% to $28.86 in premarket trading. The earnings call highlighted a 21% increase in total revenue year-to-date and a 52% rise in operating profit. However, the market’s reaction was tempered, possibly due to broader market conditions or investor expectations.

Key Takeaways

• Total revenue grew by 21% year-to-date.
• Operating profit increased by 52%.
• Stock price declined by 1.99% in premarket trading.
• Epkinly sales surged by 64% year-over-year.
• Genmab maintains a strong cash position with $3.4 billion.

Company Performance

Genmab demonstrated robust performance in Q3 2025, with significant growth in both revenue and operating profit. The company continues to lead in antibody-based innovation, with a strong pipeline and expanding global market presence. Notably, the sales of Epkinly, a key product, increased by 64% year-over-year, reflecting its growing market acceptance and potential for further growth.

Financial Highlights

• Revenue: $3.5-$3.7 billion projected for 2025, representing 15% growth.
• Operating profit: $1.1-$1.4 billion guidance for 2025.
• Cash position: $3.4 billion at the end of Q3.
• Epkinly sales: $333 million in Q3, a 64% increase year-over-year.
• TIVDAK sales: $120 million year-to-date.

Market Reaction

Despite the positive earnings report, Genmab’s stock fell by 1.99% to $28.86 in premarket trading. This decline could be attributed to investor caution or broader market trends. The stock’s performance is within its 52-week range, which has seen highs of $33.65 and lows of $17.24, indicating a stable but cautious market sentiment.

Outlook & Guidance

Looking ahead, Genmab projects significant profitability in 2026 and meaningful EBITDA growth in 2027. The company is focusing on expanding its European commercial operations and investing in high-impact late-stage pipeline programs. Genmab’s strategic initiatives include a proposed acquisition of Merus and potential launches in second-line follicular lymphoma and endometrial cancer.

Executive Commentary

• "We are confident that Genmab will deliver significant profitability in 2026," stated Anthony Pagano, CFO, emphasizing the company’s strong financial foundation.
• Tahamtan Ahmadi, CMO, remarked, "Petosemtamab has all the attributes of a best-in-class second-generation EGFR bispecific," highlighting the potential of Genmab’s pipeline.
• CEO Jan van de Winkel noted, "Our very strong financial foundation, sustained profitability, and disciplined capital allocation strategy positions Genmab for growth."

Risks and Challenges

• Market competition in the antibody sector could impact future growth.
• Regulatory hurdles for new drug approvals may pose challenges.
• Macroeconomic factors, such as currency fluctuations, could affect financial performance.
• Execution risks in potential acquisitions and expansions.
• Dependence on key products for revenue growth.

Q&A

During the earnings call, analysts inquired about the potential of Petosemtamab in head and neck and colorectal cancer. Genmab expressed confidence in its future, citing positive outlooks for Epkinly’s expansion into earlier line therapies and continued strong performance expected in 2026.

Full transcript - Genmab AS (GMAB) Q3 2025:

Conference Moderator: 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 actual results, unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van de Winkel.

Please go ahead.

Jan van de Winkel, CEO, Genmab: Hello and welcome to our financial results call for the first nine months of 2025. With me today is our Chief Financial Officer, Anthony Pagano. Our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahamtan Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. During today’s presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. As we near the end of 2025, I would like to remind you of the commitments that we made at the beginning of the year. 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.

I’m pleased to say that we are following through on these commitments for supporting our continued growth and long-term value creation. Over the past nine months, our total revenue grew by 21%, fueled by increased recurring revenue. We have invested fully in line with our capital allocation priorities. Importantly, we have grown operating profit by 52%, even while making these strategic investments. We ended the first half with around $3.4 billion in cash. Our strong financial foundation has given us the flexibility for continued growth and expansion through investment in our high-impact late-stage programs. Epkinly and rinatabart sesutecan have both progressed rapidly over the course of this year with extremely encouraging data sets. For rinatabart sesutecan, we have initiated additional phase 3 clinical trials.

As part of our disciplined investment into the highest potential programs, together with BioNTech, we have agreed that the current data in frontline head and neck cancer for GEN 1042 did not meet our high bar for continued development. As part of our capital allocation priorities, was our promise to explore focused M&A opportunities. We have delivered on this commitment with the potentially transformative proposed acquisition of Merus. Let’s briefly review the highlights. The proposed acquisition of Merus is an exceptional opportunity that advances our evolution into a global biotech leader. It accelerates our shift towards a 100% owned model. It expands and diversifies our revenue, and it brings us closer to achieving our 2030 vision to improve the lives of patients. With this proposed acquisition, we will add Petosemtamab, or Peto, to our already compelling portfolio.

High-potential assets like Petosemtamab, which has received two breakthrough therapy designations, are truly rare. The totality of data we have seen for Petosemtamab underscores the potential as a best-in-class EGFR bispecific across head and neck cancer indications, as well as in other EGFR-expressing tumors. With data anticipated in 2026 from one or both of the ongoing phase 3 trials, we expect Petosemtamab will also be first-in-class, with an initial launch expected in 2027. We are confident that our expertise and leadership in antibody-based innovation, as well as our swift and broad clinical development of both Epkinly and rinatabart sesutecan, demonstrate our ability to fully realize Petosemtamab’s potential. We also see real promise for it to join Epkinly and rinatabart sesutecan as a multi-billion dollar program. We expect to close the acquisition by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions.

Combined with our disciplined capital allocation, strong financial foundation, and proven commercial execution, this transaction sets us up for durable long-term growth into the next decade. Now, let’s turn to some of the recent advancements for our late-stage programs. Beginning with Epkinly, we eagerly await its potential approval in second-line follicular lymphoma later this month. In addition to the unprecedented phase 3 second-line follicular lymphoma data we discussed during our second quarter call. Recently, we announced updated results for Epkinly in the outpatient setting. These data evaluated the feasibility of treating and monitoring patients with relapsed or refractory diffuse large B-cell lymphoma in this setting. Data from both the phase 3 second-line and outpatient studies are included in more than 20 Epkinly abstracts that have been accepted for presentation at this year’s ASH meeting. End of the year.

Excitingly, the second-line follicular lymphoma data will be one of seven oral presentations for Epkinly at ASH. These abstracts highlight advances that expand Epkinly’s clinical profile, supporting use in earlier lines of therapy and across additional B-cell malignancies. Now let’s turn to rinatabart sesutecan. Last month at ESMO, we presented an update of the data for single-agent rinatabart sesutecan in patients with advanced endometrial cancer. Today, Tahamtan Ahmadi will provide a brief overview of this data, which further supports the encouraging results that we showed at ASCO. This progress reflects our vision to accelerate our innovative late-stage pipeline and shows additional momentum behind the possibilities of rinatabart sesutecan. Our confidence in the potential of rinatabart sesutecan in endometrial cancer is reinforced by the breakthrough therapy designation granted by the US FDA.

As a reminder, this indicates that the FDA considers rinatabart sesutecan to have the potential to significantly improve patient outcomes compared with existing therapies. The data we have seen and the recognition from the FDA both support our development plans for rinatabart sesutecan. I’m pleased to tell you that we have initiated the phase 3 trial in endometrial cancer. Our rapid development of rinatabart sesutecan continues. We are also preparing for potential commercialization. TIVDAK is now available for prescribing in Germany, our first European markets. The foundation that we are building in the European guideline community with TIVDAK will set us up for future success with rinatabart sesutecan. Now over to Tahamtan Ahmadi and the updated rinatabart sesutecan data from ESMO. Tahamtan, go ahead.

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Thank you, Jan. At ASCO, we presented the first results for single-agent rinatabart sesutecan in patients with advanced endometrial cancer from the ongoing phase 1, 2, RINA 41 study. At ESMO, just a few weeks ago, we provided an update on that data with four additional months of follow-up. What we saw was that at a median follow-up of around a year, rinatabart sesutecan dosed at 100 mg per m² showed deep and durable responses regardless of folate receptor alpha expression. With a disease control rate at that dose continuing to be at 100% and a confirmed ORR remaining at 50%, including two complete responders. With 7 out of the 11 confirmed responses still ongoing at that data cutoff. This compares to the standard of care chemotherapy, which delivers approximately 15% ORR and a limited durability, roughly around six months.

In addition to the durable efficacy, rinatabart sesutecan continues to have a manageable safety profile. There are still no signals of ocular toxicity, interstitial lung disease, or neuropathy across the entire program. In summary, the data we have seen for rinatabart sesutecan, both in endometrial cancer and the data we have presented on platinum-resistant ovarian cancer, reinforce our conviction that rinatabart sesutecan is best-in-class ADC across efficacy, safety, and durability across the entire spectrum of folate receptor alpha expression. We are maximizing its potential with an accelerated and extremely comprehensive development plan that includes now three ongoing phase 3s, if you follow today’s disclosure on clinicaltrials.gov, and two phase 3s that are intended for potential registration under the accelerated approval pathway in the United States, one in platinum-resistant ovarian cancer and one in second-line endometrial cancer.

We expect a first launch in 2027, and we also are generating data beyond guidelines with sequence-seeking phase 2 trial in non-small cell lung cancer. Now over to Brad for a review of the recent commercial performance for Epkinly and TIVDAK.

Brad Bailey, Chief Commercial Officer, Genmab: Yeah, thank you, Tahamtan. Q3 marked another strong quarter for our proprietary portfolio. Our commercialized medicines are contributing positively to our overall revenue growth, driven by the strong performance in our established markets, as well as now the early success in new markets. This gives us further confidence in our growth potential as we advance our portfolio and prepare to bring our medicines to even more patients around the world. Take a closer look now at performance overall. Epkinly and TIVDAK sales through the third quarter of 2025 were up 54% year over year. This accounted for 25% of our total revenue growth. As we have said before, we expect our proprietary portfolio to increasingly contribute to our overall revenue growth over time. During the quarter, we continue to scale our operations across markets in a disciplined fashion, accelerate the adoption of our medicines, and meet patients’ needs.

As you just heard from Jan, the proposed Merus transaction provides us with the unique potential to double down on our shift to a 100% owned model and maximize our long-term growth. With Epkinly, rinatabart sesutecan, acasulumab, and potentially petosemtamab, we have the pieces in place to deliver several multi-billion dollar opportunities in the coming years. Let’s turn now to our Epkinly’s performance. Epkinly posted $333 million through Q3, which represents a 64% year-over-year increase. We’re highly encouraged by Epkinly’s performance and steady growth globally as the clear leader in the third-line setting across diffuse large B-cell lymphoma and follicular lymphoma. In the U.S., performance continues to demonstrate the value of Epkinly as the only dual indication option in DLBCL and FL. We’re seeing increases in adoption across sites of care and new patient starts, reinforcing both the clinical and operational differentiation that Epkinly brings to the market.

Indications, further growing utilization within ordering accounts and expanding more broadly into the community setting. As we prepare to enter earlier lines of therapy with the anticipated launch in second-line FL later this year, we’ll build on this positive momentum to bring Epkinly to even more patients. Now looking in Japan, we’re seeing an encouraging start to Epkinly’s launch in third-line plus follicular lymphoma. Our teams are building on the traction we’ve seen in large B-cell lymphoma and continue to drive account activation while also preparing for future potential launches. To that end, today we filed a supplemental JNDA for Epkinly in second-line FL, marking another important milestone to potentially bring Epkinly to earlier lines of therapy in this priority market.

Across all other markets, through our partner AbbVie, we saw solid sales for Epkinly in the quarter as an increasing number of countries gain access to reimbursement and saw rapid uptake. Globally, Epkinly has received the most regulatory approvals for a bispecific in DLBCL and FL, with approvals in more than 65 countries worldwide, including more than 50 countries now with the dual indication. As we look ahead to the remainder of the year and into 2026, we’re focused on increasing utilization across sites of care and delivering Epkinly to patients in earlier disease settings where we may have the opportunity to transform outcomes. With its strong performance to date and accelerating development program, we’re confident in Epkinly’s growth potential to reach peak sales of more than $3 billion in the future. Now let’s look at TIVDAK.

TIVDAK is well recognized as the global standard of care in recurrent or metastatic cervical cancer. Our year-to-date sales for TIVDAK totaled $120 million, with performance in both new and established markets, highlighting the clear need for women with advanced cervical cancer across geographies. In the U.S., we continue to see strong, stable performance across sites of care. In Japan, we saw continued early launch success, further reinforcing the patient need, the strength of our launch strategy, and impactful execution by our field teams. Broadening our reach across markets, in September, TIVDAK officially launched in Germany. This marks the first medicine we’ve launched in Europe independently. We’ve seen encouraging early uptake in Germany, providing positive momentum as we look ahead to expand to additional countries. With our focus on TIVDAK, we’ve made important progress establishing our operations to support our current and future portfolio in Europe.

This strong foundation will ensure we’re equipped to broaden our impact with the gynecologic cancer community and deliver our medicines to more patients around the world. The work we’ve done to transform our business has positioned us well now for sustained growth and profitability. We remain focused on expanding the utilization of our medicines and bringing them to as many patients as possible. The proposed acquisition of Merus and the potential addition of Petosemtamab could strengthen the opportunities ahead for our proprietary portfolio of antibody-based medicines. We look forward to closing out the fiscal year with continued strong performance. With that, I’ll hand the call over to Anthony to discuss our financials.

Anthony Pagano, Chief Financial Officer, Genmab: Thanks, Brad. We continue to deliver solid revenue growth throughout the first nine months of 2025, driven by sustained recurring revenues and the solid market performance of our products. We’ve also strengthened our long-term growth potential as we continue to generate encouraging clinical data for both Epkinly and rinatabart sesutecan. Our financials remain strong. We grew total revenues by 21%, with recurring revenue up 26%. This was driven by royalties from Darzalex and Kesimpta. Importantly, this growth was also supported by product sales from Epkinly and Tivdak, which together represented 25% of our total revenue growth. Looking at Darzalex, we continue to see extremely strong growth. Overall, net sales grew by nearly 22%. That’s $10.4 billion for the first nine months of the year, which translates to over $1.7 billion in royalty revenue for us.

This growth was driven by continued share gains and solid performance in the front-line setting. You can see that the quality of our revenue profile continues to improve. In fact, in the first nine months of this year, recurring revenues represented 96% of our revenues, and that’s up from 92% in the same period of last year. A clear sign of increasing visibility and durability of our revenues. What is really clear is that the investments we’ve made in building out our commercialization teams and capabilities are paying off. This sets us up well as we prepare for potential expansion into earlier lines for Epkinly, including second-line FL and the anticipated launch of Rinatabart sesutecan, and contingent on the successful close of the transaction, the launch of Petosemtamab. We continue to take a disciplined approach to these investments.

Total OpEx in the first nine months of 2025 was slightly less than $1.5 billion, up 7% over the same period last year, excluding the impact of the ProfoundBio acquisition. We are managing our investments strategically, prioritizing our high-impact phase 3 programs and focused investments in our commercialization capabilities. Our operational discipline contributed to our operating profit growth of an impressive 52% in the first nine months of the year. You can see that we are really continuing to deliver on our commitments. Next, looking at our net financial items. Here, we have a net gain of $142 million. Moving on to tax, we have tax expense of $217 million, which equates to an effective tax rate of 18.9%. Taken together, our net profit amounts to $932 million. You can see continued strong underlying financial performance. With that, let’s move to our 2025 financial guidance.

We remain on track to achieve our existing financial guidance with projected double-digit revenue and double-digit profit growth. We expect our revenue to be in the range of around $3.5 billion-$3.7 billion, delivering a robust 15% growth at the midpoint. It is our recurring revenues from royalty medicines and from Epkinly and TIVDAK that have been driving that growth in 2025. In total for the year, we expect our recurring revenues to grow by 22%. For operating expenses, due to our continued focused and disciplined approach to our investments, we still expect to be in a range of around $2.1 billion-$2.2 billion. Putting all this together, we are planning for operating profit in a range between around $1.1 billion-$1.4 billion. With the midpoint of our guidance amounting to over $1.2 billion of operating profit and strong year-over-year growth of 26%. Our guidance highlights our continued strategic discipline.

Targeted investments, and operational efficiency, all while advancing our pipeline and enhancing shareholder value. Now, to give you just a bit more color on FX. Every 10-point move in the exchange rate relative to our guidance rate of the US dollar to the Danish krone of 7.20 is worth just around $1 million in operating profit or loss at the midpoint. Now, finally, before I conclude, I would like to take a minute to look ahead to 2026. While, of course, our guidance will be given in February next year, as I stand here today, 2026 consensus expectation for Genmab standalone investments appear to be in a reasonable place, capturing our investment priorities. As I take a look at consensus expectations for Merus investments, they also appear to be in a reasonable place.

Importantly, we remain confident that Genmab will deliver significant profitability in 2026 and meaningful EBITDA growth in 2027. Our performance in the first nine months of 2025 underscores our ability to produce solid, high-quality revenue growth, advance key pipeline assets, deliver on our capital allocation commitments with the proposed acquisition of Merus, and maintain strong profitability through disciplined execution. In summary, our very strong financial foundation, sustained profitability, and disciplined capital allocation strategy positions Genmab for growth, creating value for both shareholders and for patients. On that note, I’m going to hand the call back over to Jan.

Jan van de Winkel, CEO, Genmab: Thank you, Anthony. Let’s move on to our final slides. We have strengthened the foundations of our business in the first nine months of 2025. We have expanded the reach of both Epkinly and TIVDAK to more patients. For Rinatabart sesutecan, we have presented additional supportive clinical data, showing its potential beyond ovarian cancer. We are prepared to accelerate and maximize the potential with additional phase 3 clinical trials. We continue to anticipate further acosulimab data this year, and they will be presented at ESMO IO in December in London. Beyond our commitment to our existing pipeline priorities, we further delivered on our capital allocation strategy with the proposed acquisition of Merus, an extraordinary opportunity that will advance our evolution into a global biotech leader and position us for sustainable long-term growth and value creation.

Before we move to the Q&A, I’m pleased to announce that we will hold our annual R&D updates and data review on December the 11th. To ensure that this event is accessible to as many people as possible, this year’s presentation will once again be fully virtual. Details will be available on our website, and we look forward to a lively event. That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.

Conference Moderator: Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We kindly ask analysts to limit themselves to one question per person. We will now take the first question. From the line of Jonathan Chang from Leerink, please go ahead.

Hi guys. Thanks for taking my question. Now, coming out of ESMO, there’s been a lot of discussion around the competitive landscape of Petosemtamab and Rinatabart sesutecan. What are your latest thoughts on how these drugs are positioned in the competitive landscape, and what gives you confidence in the potential for these two programs to be key drivers of growth? Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Jonathan. Very good questions. Let me ask Ty to start off, giving you our thinking on the positioning of Pito as the best and first-in-class molecule, and the same for Rinatabart sesutecan. I am sure that you will then also add to that. Ty, why do you not get going?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Thank you, Jonathan, for the question. Let me start this. There was really nothing that in any shape or form was a surprise to us. Our conviction in Pito and RINA being the best and first-in-class asset in the respective indications of head and neck and gynecologic has not changed. Pito, if you look at the totality of data, Jan said this in a prepared remark, in our mind, has all the attributes of the best-in-class second-generation EGFR bispecific. There are two phase 3s already ongoing in head and neck and second line immunotherapy for which it has a BTD, and in combination with Pembo in front line where it has BTD, so it is also on track to be the first-in-class. Nothing really changed on that. As it relates to RINA, there is, of course, a couple of folate receptor alpha ADCs in development by AstraZeneca and Eli Lilly.

Again, this is not news. We are, generally speaking, operating in a very competitive landscape. None of the data in any way, shape, or form are changing our assumption that rinatabart sesutecan, based on the data in PROC and endometrial. Both in response and long-term follow-up and durability and long-term safety, has the profile to be best in class. I mentioned this in my comments. There are now two phase 2s that are ongoing for some time. We expect a launch, at least one of these indications, in 2027. There are three phase 3s that are actively enrolling. I think we have a good position here also to be the first-in-class topo ADC in gynecologic space, and we are expanding already into other indications. In totality, we feel very comfortable about the profile of the assets.

We feel extremely comfortable about where we are positioned in the competitive landscape, and we feel very confident in our ability to accelerate the development of Petosemtamab once we are having control of this asset, hopefully, and on Rinatabart sesutecan. So there’s more to come on both of these assets. That’s probably all there is to say at this point.

Jan van de Winkel, CEO, Genmab: Thanks, Ty. Judith, do you want to add anything to that?

Conference Moderator: No, beautifully said. Nothing to add. Thank you.

Jan van de Winkel, CEO, Genmab: All right. Thanks, Jonathan, for the question. Let’s go to the next question.

Conference Moderator: Thank you. We will now take the next question from the line of Michael Schmidt from Guggenheim Partners. Please go ahead.

Hey, thanks for taking my question and congrats on all the progress. I had a question on Epkinly. I was just wondering if you could comment on the commercial dynamics. I’m just curious in terms of sales, what are you seeing in terms of use in the approved indications between follicular and DLBCL? How should we think about the near-term growth opportunity in second-line follicular in the U.S. and Japan in your markets? What is the magnitude of that near-term growth opportunity? Thanks so much.

Jan van de Winkel, CEO, Genmab: Thanks, Michael, for the questions. I think these are perfect questions for Brad to handle. Brad?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Thank you for the question. We actually are extremely encouraged and pleased with our progress to date and the performance. We do not actually split out by indication, and that is actually part of the benefit. We are hearing from customers and planning around their feedback that the dual indication from an operationalization perspective is extremely beneficial, along with the seamless subcutaneous administration. As we move into the earlier lines of therapy, this is a tremendous opportunity to bring treatment close to where patients live. This is an opportunity, again, moving forward with where we are. We are extremely encouraged with our performance to date. As we know, the value is in the earlier lines of therapy, and I look forward to seeing that success in the future as well.

Jan van de Winkel, CEO, Genmab: Thanks, Brad. Do you want to say a bit about the size of the market in second-line follicular lymphoma?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Yeah, the second-line follicular lymphoma, as previously stated, we really feel the value of these medicines are much broader and much greater in the earlier lines. Approximately 9,000 patients in second-line FL. It is really our first step into this larger opportunity. We would expect that this enabling treatment in earlier lines will open up additional opportunities for us in the not-too-distant future as well.

Jan van de Winkel, CEO, Genmab: Thanks, Brad. Thanks, Michael, for the question.

Conference Moderator: Thank you. We will now take the next question from the line of Shan, then from UBS. Please go ahead.

Brad Bailey, Chief Commercial Officer, Genmab: Hi, thank you very much. Thank you for taking my questions. Sorry, if I may just say on Epkinly a bit, I wonder if I could maybe push a little bit more. Sort of the near-term performance, I mean, this quarter, we did see kind of a miss in Epkinly. Just wondering, is there anything you would flag in terms of this quarter’s performance? Also just wondering for second-line follicular lymphoma, just wondering, how should we think about the launch trajectory? Do you think this is actually going to be a bit more gradual, I don’t know, follicular lymphoma? Is it mainly community setting, or do you think this actually will be a pretty fast uptake? Thank you very much.

Jan van de Winkel, CEO, Genmab: Thanks, Jan, for the questions. I’m going to hand them over to Brad. Brad, please comment.

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Yeah, we’re actually seeing. Right now, the observed consistent and continued uptake across sites of care in the U.S. We do see, to your latter part of the question, that second-line FL allows this acceleration in the community setting where FL patients are actually treated, as you stated. We do see that as a consistent uptake over time as we continue to get operationalization, if you will, of bispecifics in the community setting. As it relates to the performance, we’re extremely encouraged by what we’re seeing year to date with the performance, both in the U.S. as well as Japan and through our partner AbbVie globally. Again, feel like, as we’ve said all along, the earlier lines of therapy are where the value of Epkinly will be. The second-line FL is really that first step taking us into this next phase.

Hopefully that answered your question.

Jan van de Winkel, CEO, Genmab: Thanks, Brad. Jan, we definitely hope to move forward to front line and second-line. The first-line follicular lymphoma also very rapidly from here with readouts, hopefully soon, of the phase 3 trials. We are very encouraged by Epkinly and really look forward to a very, very good future there. Let us move to the next question.

Conference Moderator: Thank you. We will now take the next question from the line of Qize Ding from Rothschild & Co. Please go ahead.

Hi, thanks for taking my question. One, if I may, can you elaborate a little bit more on your decision to terminate the clinical development of 1042 in first-line head and neck cancer? Also, what is the implication to the future development of this drug in first-line lung cancer and first-line melanoma? Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Kisit, for the question. I think I can start there and then maybe Judith can step in there. What we determined together with our partner, BioNTech, is that basically the data of 1042 in combination with chemo and Pembo in front line head and neck cancer did not meet the high bar we have internally for continued development. We stopped the development there. That is where I want to leave it at. Judith, do you want to add anything there?

Conference Moderator: Yeah, no, I just to add that this was the most relevant data set and the initial proof of concept. Based on that, we decided to stop the development in combination with Pembo and chemo.

Jan van de Winkel, CEO, Genmab: Thanks. Thanks, Judith. Thanks, Kesimpta, for the question.

Conference Moderator: Thank you. We will now take the next question. From the line of Rajan Sharma from Goldman Sachs. Please go ahead.

Brad Bailey, Chief Commercial Officer, Genmab: Hi, thanks for taking my question. I’m just wanting to get your thoughts ahead of the Epkinly PDUFA in November. There’s obviously been a bit more of a focus seemingly on US representation in clinical trials. Just wanted to get your confidence going into that potential approval. If you could just confirm that efficacy in the EPCORE FL-1 trial is consistent across both US and non-US patients. Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Rashawn, for the questions. Ty, can you give some color on the U.S./non-U.S.?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Yeah, I mean, basically, the way I’m going to respond to that without getting into the minutiae of the data is that there’s absolutely nothing at this point that would indicate that it will not be approved in the next few weeks or days in the United States.

Jan van de Winkel, CEO, Genmab: All right, thanks. I think we are highly confident, Rashawn. Let’s wait and see the coming weeks.

Conference Moderator: Thank you.

Jan van de Winkel, CEO, Genmab: Next question.

Conference Moderator: We will now take the next question from the line of Yaron Werber from TD Securities. Please go ahead.

Great. Thanks so much. Anthony, I got a couple of questions for you more about 2026 and then 2027. You mentioned for next year, the numbers, standalone OpEx for Merus and Genmab are reasonable. For Merus, they’re sort of in the 450 range in terms of OpEx, let’s call it. 450, maybe some even have as high as 500. I think we’re imagining there’s going to be some synergies as you bring that company in. I know you can’t give guidance, but can you give us a little bit of a sense? Are we thinking about this correctly? Secondly, when you’re talking about significant profitability next year, there could be as much as $430 million change between interest income net to now interest expense net because of the debt liability. Are we thinking about that correctly? Because it would impact profitability next year.

Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Yaron, for the questions. Anthony, I think it’s good that you also got the chance to answer some questions here. Yaron, thanks for that guidance.

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Thanks. I can really start off by thinking, as you all now know and appreciate, we have a very disciplined and focused approach to our investments. We have outlined for the market, starting at the overall capital allocation framework, a very clear framework of where and how we are going to invest on the one hand. As we do that, we do that in the most prioritized and productive manner as possible. That is how we are able to deliver on our 2024 actual financial results and also what our overall guide was for 2025 and where the year-to-date performance is. Moving forward, that same approach in terms of very clear investment priorities remains, as well as that approach to being super focused and disciplined. Now, to reiterate what I said, as I kind of look at overall standalone consensus for Genmab, that is in a reasonable place.

Likewise, for MIRIS, now here, I’m looking at the consensus number, is in a reasonable place. We also have to appreciate where we are at in the overall process here as it relates to being on track to closing the transaction in early Q1 2026. Today, I thought it was important to provide the market the commentary similar to what I did last year, that I think the overall investments are in a reasonable place. Of course, we will look for opportunities to prioritize, to remain disciplined, and ultimately will provide our guidance when we get to February of 2026. Now, my comment as it relates to significant profitability, just to be super clear, here, I am referring to EBIT. So I’m referring to our EBIT figure, our operating profit, consistent with historical practice. We are guiding on the EBIT line.

Overall, if I think we sort of step back, we think about the overall setup here, what you should expect here on is continued investment in line with our capital allocation framework, lots of focus and discipline by the team, and continue to deliver on our overall commitments, both operationally and financially.

Jan van de Winkel, CEO, Genmab: Thanks, Anthony. Let’s move on to the next question. Thanks, Yaron.

Conference Moderator: Thank you. We will now take the next question from the line of Asthika Goonewardene from Truist. Please go ahead.

Hey, guys. Thanks for taking my questions. I want to also just say congrats on all the growth that you guys have shown this quarter. It’s impressive. Yaron, when the Merus acquisition was announced, you mentioned that head and neck cancer was the main driving factor for that interest there. You said you’ll talk a little bit more about colorectal when that data is presented. The data in CRC at the TRIPLE meeting was, I would say, perhaps a little better than what even Bill telegraphed. How do you view that colorectal opportunity? Importantly, to that, as well as head and neck, do you feel that you need a subcutaneous formulation to be competitive with the emerging competition from Rivalvent? Thanks.

Jan van de Winkel, CEO, Genmab: Thanks very much for the questions. We said that while the study was primarily determined by head and neck, and we want to expand head and neck, Asthika, as you know, into locally advanced and potentially other settings fairly soon. We would say that the data, the early data in colorectal cancer is very exciting, but very early data. We believe that there is potential in all of EGFR-positive tumors also outside of head and neck, but there is simply no limited data there. I will ask Ty to maybe give a bit more color there on our thinking. Ty?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Yeah, thank you, Asthika, and thank you for obviously hard questions. I think, as Jan said, early data, limited data, encouraging. We should leave it at that until we have control of the asset, and it’s really us to speak about the data. I think that’s kind of the top line. Broadly speaking, I think we even talked about this in the prepared remarks when we announced the acquisition. We do think of Petosemtamab as a best-in-class second-generation EGFR bispecific, and that obviously includes also opportunities outside of head and neck. The focus is where it is right now. Two phase 3s ongoing in head and neck. There we have a significant head start over any form of competition. Subcutaneous administration is something that we are very familiar with, that we have some deep understanding of prior past.

It is obviously something that we are looking at as part of a lifecycle management. Our focus right now is execution on the studies that are already ongoing, and then we can talk more about what Genmab is going to plan in due time.

Jan van de Winkel, CEO, Genmab: Thanks, Ty. Confirming that, Asthika, the subQ development is an integral part of our strategy for Petosemtamab, but more to come after the finalization of the transaction. Let’s move on to the next question, operator.

Conference Moderator: Thank you. We will now take the next question from the line of Matthew Phipps from William Blair. Please go ahead.

Hi, thanks for taking my question. I’ve had a lot of investor interest recently on the first-line DLBCL trial with Epkinly reading out next year. I’m wondering if you can give us any sense why you think that’s a first-half or second-half readout. What level of PFS benefit do you think you need to really outcompete the Pola-R-CHP regimen that has gained some traction there? Thanks.

Jan van de Winkel, CEO, Genmab: Thanks, Matthew, for the question. Ty, can you give a bit of color on the front line, the first-line fecal and form trial, and the potential need for the type of data to give us a differentiated angle over other therapies?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Thank you again. I think we have guided that we expect the readouts to happen in 2026, and we should probably leave it at this right now. This is obviously an event-driven study, and we will update in the appropriate setting when we have a bit more clarity. Clearly, the study was more or less fully accrued in the summer of last year. As it relates to what it has to do in order to be competitive in the competitive landscape, we pull the, I don’t know. I don’t think it makes sense to go into some kind of discussion about hazard ratio and what it has to show. I think we are very confident that when the study reads out, there will be a significant improvement over the standard of care and in that regard, also.

Significantly differentiated from the PoliV data, the PoliRx study. That is partially underwritten by the data that’s going to be represented now with a longer follow-up at ASH, where you have a phase two data set that in these high-risk patients, IPI at 3-5, shows an incredible high CR rate with an incredible high durability. What we’ve seen over and over again is that these very robust phase two studies that we ran and then with the data we generated on them more or less one-to-one translates into the phase three. We anticipate the same to be true for the front line diffuse HBCR study.

Jan van de Winkel, CEO, Genmab: Thanks, Ty. In addition to efficacy, also think about the convenience of the subQ dosing and the safety pattern may be very different from other combination therapies, Matthew. We are very excited about the potential to see the readouts, hopefully soon, from the frontline diffuse large B-cell lymphoma form. It’s a potential game changer we feel for Epkinly. Let’s move to the next question.

Conference Moderator: Thank you. The next question comes from the line of Victor Flood from BNP Paribas. Please go ahead.

Yes, thank you for taking my question. Victor Flood from BNP Paribas. Maybe just like an outskipping question on data readout timing. Thanks so much for the comment on the first-line DLBCL. You used to have an anticipated readout column on slide seven. I just wanted to ask you whether you can confirm that all the phase 3 trials that are on that slide, all the timings are consistent with what you’ve discussed last time for the second quarter update. Thanks so much.

Jan van de Winkel, CEO, Genmab: Ty, can you give comments on the timings there?

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Nothing has changed.

Jan van de Winkel, CEO, Genmab: We have confirmed the signal.

Thank you.

Thanks. Let’s move to the next one.

Conference Moderator: Thank you. The next question is from the line of Zain Ebrahim from JP Morgan. Please go ahead.

Hi, everyone. Thanks for taking my question. I’ve got one clarification question for Anthony, just on the OpEx for ’26 in terms of when you say both the standalone investments for MIRIS and for Genmab are at a reasonable place, I think is how you characterized it. Does that include the potential for indication expansion that you outlined for locally advanced head and neck? For Petosemtamab and maybe other indications that we might hear about more in Q1 was my first question. The second question is just on, if you can remind us on the filing strategy for Rinatabart sesutecan in PROC next year. I know you just said everything’s on track, but in terms of recruitment, how that’s progressing for the phase 3 and when we can expect to see more duration and response data from the phase 2 trial. Thanks a lot.

Jan van de Winkel, CEO, Genmab: Thanks, Zain, for the questions. I will leave the first one to Anthony, of course, to give you further clarity there. The second one I can take for Winner S filing strategy. The initial filing will likely be based on the phase two, potentially registration trial for Proc. That trial is completely recruited, and also in parallel, the phase three is recruiting very rapidly. We are fully on track there to have a readout next year and potentially a filing and an approval hopefully in 2027. Anthony, can you give a bit more color on the inclusion of the locally advanced head and neck for the Genmab trials as projected for 2026?

Yes. The short answer is yes. I think about, again, just reiterating, as we think forward to 2026, it was important to condition the market, thinking about overall investment levels. Again, to reiterate, as I look at consensus today for both Genmab standalone as well as Merus, look to be in a reasonable place, also reflective of our investment priorities. Of course, we are going to provide ultimately our guidance to the market in February of 2026. To put a finer point on it, Zain, yes, as I stated today, does include what we think about it from an overall portfolio development, including your specific question around inclusion of investment in the locally advanced.

Thanks. Thanks, Anthony. Thanks, Zain, for the questions. Let’s move on to the next one.

Conference Moderator: Thank you. Next question is from the line of Charlie Haywood from Bank of America. Please go ahead.

Hi, Charlie Haywood, Bank of America. Thanks for taking the questions. The first one was on just how you’re looking at the first-line head and neck cancer landscape, specifically, I guess, the option to have a triplet versus a doublet strategy, how you think those segments of the market differ versus the Keytruda mono or combo arms that you have as part of the trials. The second one being in Winner S, your endometrial data, I think optically looked like better responses in the folate receptor greater than 25% and a bigger delta than you’d seen in Proc. I guess confidence in efficacy across broad folate receptor alpha expressors. Thank you.

Jan van de Winkel, CEO, Genmab: Thanks, Charlie, for the questions. Ty, can you start, and then maybe Judith, you can step in there. Let’s first start with the front line head and neck cancer landscape.

Tahamtan Ahmadi, Chief Medical Officer, Genmab: Sure. I mean, I would say the way I would answer your question is that, broadly speaking, in the current landscape, as you were alluding to, there is a Pembo mono strategy and then a Pembo chemo strategy. At times, physicians make that choice based on maybe a slightly higher response rate for the chemo Pembo combination and a faster time to response. That has a lot to do with location of the tumor and then size of the tumor. That all becomes essentially irrelevant if the data in the phase two with Pitot and Pembo is essentially double, twice the reported response rate for chemo Pembo because at that point, you basically have a higher, twice as high response rate without the significant toxicities of chemotherapy. These patients do not necessarily tolerate chemotherapy too well. This is what we like about the.

Profile of Petosemtamab in particular, also in the data and Pembo Petosemtamab. It really, in the combination, provides an opportunity where you have a high response rate, a rapid time to response without any of the quite significant toxicities that go along with combination chemotherapy in this patient setting. That is the head and neck story. On the EC, on the Rinatabart sesutecan, on the endometrial cancer, I mean, there are nuances here and there. It is not that we have ever said that folate receptor alpha expression is irrelevant to the response. That is not the case. What we said is that Rinatabart sesutecan has a profile that allows us to generate meaningful responses across the entire spectrum of folate receptor alpha expression and thus does not require a biomarker selection. That is a strategy that has allowed us to go into these indications.

Endometrial is generally considered to be a lower folate receptor alpha expressing tumor than Rinatabart sesutecan. It is also what is underlining the confidence in going to other indications such as, for example, EGFR. Non-small cell lung cancer. This is one of the differentiating aspects of Rinatabart sesutecan, that it is able to generate meaningful and stable response rates across the entire spectrum. That does not mean that the higher do not even have higher responses. That just means that even at the low end, the responses are meaningful and durable.

Jan van de Winkel, CEO, Genmab: Thanks. Thanks, Ty. Let’s move on to the next question. Thanks, Charlie.

Conference Moderator: Thank you.

Jan van de Winkel, CEO, Genmab: Next question, please. Yeah.

Conference Moderator: There are no further questions at this time. I would now like to turn the conference back to Jan van de Winkel for closing remarks.

Jan van de Winkel, CEO, Genmab: Thank you for calling in today. If you have additional questions, please reach out to our investor relations team. We very much look forward to speaking with you all again soon.

Conference Moderator: This concludes today’s conference call. Thank you for participating. You may now disconnect.

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