Genmab A/S Q1 2026 Earnings Call Transcript

Quartr
Provided by Quartr
May 7, 2026

Key Takeaways

  • Positive Sentiment: Genmab reported a strong Q1 with total revenue up 25%, proprietary sales of DKK 176m (+43%) and operating profit up 23%, and reiterated 2026 guidance (midpoint ~14% revenue growth) while targeting gross leverage below 3x by end-2027.
  • Positive Sentiment: Rina‑S hit a major milestone as the phase III RAINFOL‑02 trial completed enrollment and the company expects two Rina‑S datasets in H2 2026, is starting two new phase III trials (chemo‑replacement in platinum‑sensitive ovarian cancer and a frontline endometrial trial), and plans for potential 2027 launches.
  • Positive Sentiment: EPKINLY continues strong commercial momentum—global sales growth, approvals in 65+ countries, and a U.S. label change removing the automatic 24‑hour hospitalization recommendation in 3L+ DLBCL—which management expects will broaden outpatient/community use ahead of a frontline DLBCL readout in 2026.
  • Neutral Sentiment: The frontline acoziborole head‑and‑neck study was upsized (500 → 700) to increase probability of success; management says this amendment won’t change previously guided timelines and Merus integration to capture acoziborole is underway.
  • Negative Sentiment: Integration and tax considerations: Genmab reported an effective tax rate of ~28.9% and warned the rate may be volatile while integrating Merus (expected to normalize in 12–18 months), and acquisition‑related costs/amortization are excluded from the presented guidance.
AI Generated. May Contain Errors.
Earnings Conference Call
Genmab A/S Q1 2026
00:00 / 00:00

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Operator

Hello, welcome to the Genmab's First Quarter 2026 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

Operator

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 a 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 like to hand the conference over to our first speaker today, Jan van de Winkel. Please go ahead.

Jan van de Winkel
President, and CEO at Genmab

Hello, welcome to our financial results call for the first quarter of 2026. With me today is our Chief Financial Officer, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind.

Jan van de Winkel
President, and CEO at Genmab

Let's move to the first quarter highlights. In Q1 2026, we continued to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. Importantly, we continue to invest with discipline in our medicines, in our pipeline and in our future growth, fully aligned with our capital allocation priorities. Even with these strategic investments, we grew operating profits.

Jan van de Winkel
President, and CEO at Genmab

The quarter was also marked by progress in our mission to bring innovative medicines to patients. There are a few highlights I would like to mention. EPKINLY continued to build positive momentum. We were very pleased to see the hospitalization recommendation removed from the third line plus relapsed or refractory diffuse large B-cell lymphoma label. We are on track with the integration of Merus. We are approaching this with the same focus and discipline that we brought to ProfoundBio.

Jan van de Winkel
President, and CEO at Genmab

Finally, the breadth, depth and potential of Rina-S continues to increase. The data we presented at SGO in April further support the promise of Rina-S, including in combination with the standard of care therapies such as bevacizumab. We are also making significant progress with our development plan, as you can see on the next slides. We anticipate starting two new phase III trials for Rina-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers.

Jan van de Winkel
President, and CEO at Genmab

These include a phase III chemo replacement trial in platinum-sensitive ovarian cancer and the first frontline trial for Rina-S in endometrial cancer. We continue to explore new opportunities for Rina-S outside gynecological oncology with a phase II signal-seeking basket trial in advanced gastrointestinal cancers. I'm pleased to share an update on the ongoing phase III trial in second-line plus platinum-resistant ovarian cancer on the next slides.

Jan van de Winkel
President, and CEO at Genmab

Recruitment has been much faster than expected, the phase III RAINFOL-02 trial has now completed enrollment. This important milestone brings forward the pivotal phase III data for Rina-S in platinum-resistant cancer into 2026. This reflects strong investigator engagement, the significant unmet medical needs in this indication, and the strength of our execution on one of our highest priority late-stage programs.

Jan van de Winkel
President, and CEO at Genmab

We can now look forward to two data sets in the second half of this year for Rina-S in platinum-resistant ovarian cancer and the opportunity for broader global regulatory filings earlier than anticipated. For both petosemtamab and EPKINLY, we are maintaining our guidance on the timing of data, as you see here.

Jan van de Winkel
President, and CEO at Genmab

The key takeaway is that 2026 continues to be a very catalyst-rich year for Genmab, with readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients. With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK. Brad.

Brad Bailey
Chief Commercial Officer at Genmab

Thanks, Jan. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for TIVDAK and EPKINLY reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake, and ultimately reach more patients.

Brad Bailey
Chief Commercial Officer at Genmab

This performance, combined with our work this year to advance our portfolio and expand our footprint to reach patients in more markets, positions us well to deliver on our growth ambitions in 2026 and beyond. In the quarter, EPKINLY continued to gain notable traction as the only bispecific approved in DLBCL and FL indications. Looking globally, EPKINLY grew 52% year over year, reaching $137 million in sales. In the U.S., EPKINLY continued to expand across both academic and community settings.

Brad Bailey
Chief Commercial Officer at Genmab

This growth reinforces EPKINLY's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems. The recent approval of fixed duration of EPKINLY plus R² in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter.

Brad Bailey
Chief Commercial Officer at Genmab

In the quarter, we're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy and proven safety with seamless subcutaneous administration. Looking ahead, we expect adoption in the community to continue to expand across both FL and DLBCL, bringing EPKINLY-based therapies closer to where patients live.

Brad Bailey
Chief Commercial Officer at Genmab

In March, the FDA revised the label for EPKINLY in third-line plus DLBCL to remove the recommendation for 24-hour hospitalization following the first full dose. Now, the label advises physicians to assess whether outpatient monitoring or hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting. Beyond the U.S., performance remains strong.

Brad Bailey
Chief Commercial Officer at Genmab

In Japan, EPKINLY continues to stand out as the only bispecific approved in both third-line plus LBCL and FL, with continued year-over-year growth. The FL launch is building positively on the brand success in large B-cell lymphoma, supported by strong field execution and ongoing site activation. In other markets, through our partner, AbbVie, EPKINLY continues to grow with approvals in more than 65 countries, which most have dual indications.

Brad Bailey
Chief Commercial Officer at Genmab

For the remainder of 2026, we're focused on maximizing our first-mover advantage in second-line FL in the U.S. while preparing for expected approvals in this setting in Europe and Japan later this year, and in early lines of DLBCL in the future. We look ahead, our priority is to accelerate development, including in combination and across early lines of therapy, to continue to build on the already strong clinical data demonstrating EPKINLY's versatility and ultimately establish EPKINLY as the core therapy in B-cell malignancies.

Brad Bailey
Chief Commercial Officer at Genmab

Turning now to TIVDAK, which is the global standard of care in recurrent or metastatic cervical cancer. TIVDAK grew 18% year-over-year, reaching $39 million in sales in the quarter. This reflects both the significant need for therapies that improve survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets. In the U.S., the brand delivered steady performance and continues to lead the market, a position it has held since launch nearly five years ago.

Brad Bailey
Chief Commercial Officer at Genmab

Outside the U.S., we're seeing encouraging progress in newer launch markets. In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the U.K., TIVDAK launched in February through private prescribing and payer channels. We're actively engaging NICE and SMC to secure broader availability.

Brad Bailey
Chief Commercial Officer at Genmab

At the same time, building upon our work in the U.K. and our established presence in Germany, we're actively preparing for additional launches, with infrastructure and teams being established across key European markets, including France, Italy, and Spain. Given the significant unmet need in advanced cervical cancer, we look forward to the impact TIVDAK can make for more patients as additional markets gain approval and reimbursement.

Brad Bailey
Chief Commercial Officer at Genmab

More broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact over time, particularly with Rina-S in the future. To wrap up, our Q1 performance positions us well to sustain momentum in 2026.

Brad Bailey
Chief Commercial Officer at Genmab

With continued performance and expanding portfolio, we're well-positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including three potential blockbuster assets with EPKINLY, Rina-S, and petosemtamab.

Brad Bailey
Chief Commercial Officer at Genmab

And our proven ability to scale commercialization and successfully launch in markets where we can drive the greatest impact for patients. Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for Genmab. With that, I'll turn it over to Anthony to walk through the financials.

Anthony Pagano
CFO at Genmab

Thanks, Brad. Before diving into the numbers, as we highlighted last quarter, please note that these results and guidance in our remarks exclude the impact of acquisition-related expenses, including amortization. The reconciliation to our reported results is included in the appendix. In Q1 2026, we delivered growth driven by sustained revenues and the solid market performance of our portfolio.

Anthony Pagano
CFO at Genmab

Importantly, this growth was also driven by product sales from our own medicines, especially EPKINLY, continuing to diversify our revenue base. Our investments remained fully in line with our capital allocation priorities, including significant investments for EPKINLY, Rina-S, and petosemtamab. We made these important investments while growing operating profit by 23%. Moving to tax.

Anthony Pagano
CFO at Genmab

As you can see in the appendix of this presentation, we have tax expense of around $21 million, which equates to an effective tax rate of 28.9%. Here, I do want to pause for a moment and note that we are currently evaluating the integration of Merus operations from a tax perspective. Our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12-18 months.

Anthony Pagano
CFO at Genmab

Overall, the first quarter of 2026 demonstrates the continued strength and quality of Genmab's underlying financial performance. With that, let's move to our 2026 financial guidance. We remain on track to achieve our existing financial guidance, with revenue growth that enables strategic investment supporting long-term value creation. At the midpoint, we expect 14% total revenue growth, driven by continued momentum in EPKINLY and our royalty portfolio, further enhancing revenue quality.

Anthony Pagano
CFO at Genmab

For operating expenses, we expect to be in a range of around $2.7 billion-$2.9 billion, reflecting planned investments to advance late-stage development for petosemtamab and Rina-S, as well as launch readiness activities to support multiple potential product launches. Even with the strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026.

Anthony Pagano
CFO at Genmab

In summary, our performance in the first quarter of 2026 underscores our ability to deliver revenue growth, advance key pipeline assets, and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2026, we will continue to build on our momentum through disciplined prioritization of our investments, continued operating discipline, and expansion of market opportunities. This positions us for sustained growth and long-term value creation. On that note, I'm gonna hand you back over to Jan.

Jan van de Winkel
President, and CEO at Genmab

Thank you, Anthony. Let's move on to our final slide. In the first quarter of 2026, our financial performance reinforced the strength of our foundation and the durability of our growth trajectory. That strength supports a disciplined capital allocation strategy focused on the areas with the greatest potential to create long-term value, accelerating our late-stage pipeline, maximizing the success of our commercialized medicines, and ensuring strong launch readiness for future opportunities.

Jan van de Winkel
President, and CEO at Genmab

As we further move into 2026, we also remain focused on integrating Merus so that we can capture the full value of petosemtamab . Lastly, we remain committed to deleveraging, targeting gross leverage below 3x by the end of 2027, while maintaining balance sheet strength and flexibility. Taken together, Genmab is very well positioned. We have a growing and increasingly diversified revenue base, a powerful late-stage pipeline, and multiple catalysts ahead.

Jan van de Winkel
President, and CEO at Genmab

Our focus remains clear, to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable long-term value for shareholders. That ends our formal pre-presentation. Thank you for listening. Operator, please open the call now for questions.

Operator

Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star one and one again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question.

Operator

Please stand by while we compile the Q&A queues. This will take a few moments. Now we're going to take our first question, it comes line of Jonathan Chang from Leerink. Your line is open. Please ask your question.

Jonathan Chang
Jonathan Chang
Analyst at Leerink Partners

Hi, guys. Thanks for taking my question. On the frontline petosemtamab head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes? Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Jonathan, for the question. Tahi, why don't you take the first question by Jonathan?

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. Thank you, Jan, and thank you, Jonathan. Yes, indeed, we increased the size of the frontline study. I think we had in the past indicated that there were thoughts that we had, as it relates to the studies, that we want to ensure that they have the highest probability of success. The details, I don't think are the ones that we want to discuss in a public space, but these trials are being increased based on our insight that we generated during due diligence to ensure that they have the highest probability to our standards.

Tahi Ahmadi
Chief Medical Officer at Genmab

We do not have any anticipation that these changes have any impact on the timelines and on step first stay with our guidance that one or both of the beta studies will read out this year and will provide data this year.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi. Let's move on to the next question.

Operator

Yes, of course. Now we're going to take our next question. It comes line of Zain Ebrahim from JPMorgan. Your line is open. Please ask your question.

Zain Ebrahim
Zain Ebrahim
Analyst at JPMorgan

Thanks a lot. I've got two questions. Zain Ebrahim, JPMorgan. First question is just to follow up on the previous one. It's helpful that you just said you don't expect the increased size of the first line trial to impact the timing. Just to understand in more detail why that is, given that you're increasing the trial from 500 patients to 700 patients. Have you already completed enrollment of the initial patient population that you're looking to enroll, and how is enrollment progressing?

Zain Ebrahim
Zain Ebrahim
Analyst at JPMorgan

I suppose and, I guess tied to that, whether the increases for HPV-negative patients, that will be helpful to understand as well. Second question is just on EPKINLY first-line DLBCL. You've guided for the readout this year and haven't narrowed it up further. Is that the final analysis, or are we still waiting on the interim?

Jan van de Winkel
President, and CEO at Genmab

Thanks, Zain, for the questions. I think, Tahi, you can handle both of them yourself, at least the next question, and then the EPCORE first-line trial.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. Zain, I will have to repeat what I just said, which is, yes, we increased the study from 500 patients to 700 patients. This was indeed to ensure that this trial has the appropriate data that we need for our probability of success, how we feel about the program and what we understand about the program. This will not impact the timelines and what patient populations it does impact or the timing or the status of EPCORE.

Tahi Ahmadi
Chief Medical Officer at Genmab

I hope you will appreciate that in the context of a very competitive landscape, we are trying to be a little bit more disciplined on what we're sharing, when we're sharing it. Two things. It will not change the timelines of what we've guided before, and we continue to stay with the statement that one or both of these studies will read out this year. As it relates to diffuse large B-cell, again, I think there we have also been very disciplined, and I will try to be continuously disciplined today.

Tahi Ahmadi
Chief Medical Officer at Genmab

We've guided that the frontline diffuse large B-cell will read out this year, and we have not comment on interim or final or any of these questions. We stay with the statement that the diffuse large B-cell study will have a readout this year.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Zain.

Zain Ebrahim
Zain Ebrahim
Analyst at JPMorgan

All right. Thanks very much.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Zain. Let's move on.

Operator

Thank you. Now we're going to take our next question, and it comes line of James Gordon from Barclays. Your line is open. Please ask your question.

James Gordon
James Gordon
Director and Head of European Pharma, Biotech, and Life Sciences Equity Research at Barclays

Hello. James Gordon from Barclays. Thanks for taking the question or two quick ones. One was Rina-S. There's one and two coming in H2 this year. Just wanted to confirm, with the two trials reporting so closely together, phase II and a phase III, will you definitely report them as separate results? If the phase II is positive, you'll file it and not wait for the phase III, or have you discussed that plan with FDA? Might they say, "Well, if they're so close together, let's see both."

James Gordon
James Gordon
Director and Head of European Pharma, Biotech, and Life Sciences Equity Research at Barclays

The other one was just more generally that we've seen more data from B7-H4 ADCs in gynecological cancers. How do you think that stacks up versus folate ADCs? There seems to be a few people going for this approach. Is it the different target, Tahi?

Jan van de Winkel
President, and CEO at Genmab

Thanks, James, for the questions. I will ask Judith to address both the phase II and phase III PROC trials, Judith, and then the B7-H4 versus folate receptor alpha ADCs.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Yeah. No, thank you for the question. For the first part, as we highlighted, the phase III accrued ahead of projections, that means that we will have these two datasets this year. Given the change in landscape in PROC, the potential for the phase III submission and approval becomes more relevant. This is the plan. We stay behind our guidance that Rina-S will be launched in PROC in 2027, with these two dataset as supportive, but the main dataset for filing the phase III that will allow for global submissions.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Part one, with regard to the competitive landscape, of course, you know, we are very aware of the B7-H4, the two in investigation, the GSK and petosemtamab . As we said, several times, we know that this is an hypercompetitive space.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

We stand behind the strength of the data of Rina-S in terms of efficacy, safety, durability of the efficacy, and a clinical development plan and speed to market. More competitors makes it, you know, more competitive, but doesn't preclude the fact that we could be not just first in class, but best in class, given the data so far.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Judith. It comes down to effective execution, James. We moved basically two years from zero phase III to now five phase III, with the news of today.

Operator

Thank you. Now we're going to take our next question. The question comes line of Xian Deng from UBS. Your line is open. Please ask your question.

Xian Deng
Xian Deng
Executive Director and Analyst at UBS

Hi, Xian from UBS. Thank you for taking my question. I got a few EPKINLY frontline DLBCL trials, please. Just wondering, given, you know, the typical PFS curve tend to pretty much, you know, almost start to plateau after, let's say, 18 months or so in a typical, let's say, what frontline DLBCL trial like POLARIX. Just purely hypothetically, right? It doesn't have to be, you know, anything to do with EPKINLY.

Xian Deng
Xian Deng
Executive Director and Analyst at UBS

Just purely from a statistical point of view, do you expect a big change in hazard ratio, when, you know, during the last 25% of events, just assuming sort of a typical, let's say, frontline DLBCL trial, you know, PFS curve? That's the first question.

Xian Deng
Xian Deng
Executive Director and Analyst at UBS

The second one is kind of, you know, also on that one, your study is capped at 30% of IPI Stage 2 patients. Just wondering if you could give any colors on whether, you know, you've reached this number or your IPI 2 patients is actually below this. Just wondering what impact could it have in terms of powering and timing or for the primary endpoint. Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thank you, Xian. I was always teach never to answer hypothetical questions. I will see. We'll test out whether Tahi is willing to do that for your first question and then move into the second part as well. Tahi, over to you.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yes, Xian. Thank you. Yeah. What I can say is you're absolutely right. Classical historical diffuse large B-cell, oh, by the way, not only POLARIX. Frontline studies tend to plateau around month 18-20, and I think that's my only comment on that question. Particularly speculating what I expect, I don't think is helpful because I actually don't know how these curves are gonna behave on this trial until we see the data. The cap is also correct. There's a 30% cap.

Tahi Ahmadi
Chief Medical Officer at Genmab

You know, again, I don't think it's appropriate at this point to talk about what the actual demographics of the study are. The only other point that I think is important to understand, the primary endpoint is actually IPI 3-5, and if IPI 3-5 passes, you know, certain statistics, then it will read out 2-5. I think these are my comments on your questions.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Tahi.

Tahi Ahmadi
Chief Medical Officer at Genmab

-very again.

Xian Deng
Xian Deng
Executive Director and Analyst at UBS

Thank you.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Well, I tried.

Operator

Thank you.

Jan van de Winkel
President, and CEO at Genmab

Yes, absolutely. Thank you. On to the next one, operator.

Operator

Yes, of course. Now we're going to take our next question. The question comes then of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Rajan Sharma
Rajan Sharma
Executive Director of Pharma and Biotech Equity Research at Goldman Sachs

Hi. thanks for taking the question. First one on EPKINLY, just kind of following on the theme there, but what do you think is sort of the relevant benchmark for EPCORE DLBCL-4? That's a second-line trial, just in the context of the competitive landscape and some of the potential advantages that EPKINLY has. Secondly, just on the new Rina-S trial that you announced, RAINFOL-08, is that likely to be a KEYTRUDA combination trial? Thanks.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Rajan, for the questions. Tahi, why don't you take the first one, and then maybe Judith can go onto the new Rina-S trial, one of the new Rina-S trials. Tahi.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yes. This is a question about the second-line diffuse large B-cell, right? I think there's a couple of things to be said about the BMC128 study. First, it is again a randomization against our R-GemOx. In the end, that's what the study is gonna be compared, and everything else is then a cross-study comparison. They're obviously a little bit problematic.

Tahi Ahmadi
Chief Medical Officer at Genmab

What is the excitement on our end for this particular regimen is that this is a regimen comprised of oral medication and lenalidomide in a subcutaneous administration that hopefully will show positive data and meaningful positive data for patients. Also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination, so R-GemOx, but also improved in efficacy vis-a-vis monotherapy.

Tahi Ahmadi
Chief Medical Officer at Genmab

It's really perfectly suited for the outpatient setting or the community setting, that's what this trial was intended to do, to generate a regimen that is patient-friendly with increased CR rate, that then is appropriate and suitable for the community setting. We'll see what the data is, but that's the intent of the trial.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi. Maybe Judith on the combination for Rina.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Okay. The question, can you repeat the question? The combination with Bev-

Jan van de Winkel
President, and CEO at Genmab

Yeah

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Did you ask? Oh, yeah.

Rajan Sharma
Rajan Sharma
Executive Director of Pharma and Biotech Equity Research at Goldman Sachs

No.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

The data that we present. In terms of combination, the combination with bevacizumab was presented at SGO. As you can appreciate, if you were there, you know, the safety was a very well tolerated. The study was meant only for safety, but in terms of efficacy, we are very pleased with the median number of cycles of 10. Even the fact that 15 of the patients were refractory, 85% of the patients got more than six cycles.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

This is with bevacizumab. In terms of pembrolizumab, we have two cohorts ongoing in different settings, and we will communicate the data when the data is a little bit mature and enrolled. It's actively enrolling.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Judith. I think that answers your questions, Rajan. Let's move on to the next question.

Operator

Yes, of course. Now we're going to take our next question. The question comes then of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Michael Schmidt
Senior Managing Director at Guggenheim Partners

Hey. Thanks for taking my questions. I had another one on EPCORE DLBCL-2. Maybe just in terms of the enrollment of this study, Tahi, could you just comment on how enrollment has been relative to your expectations when starting the trial? Secondly, I know in the phase II study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed duration treatment in the phase III study. Can you speak to your confidence level that the fixed duration paradigm can replicate the phase II data? Thanks.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Michael. Tahi.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. Generally speaking, I think, true for 1-8, which is the second-line diffuse large B-cell trial. The front-line diffuse large B-cell trials, these trials accrued significantly faster than they were initially projected. I think that's a statement that we've made multiple times. As it relates to the original phase II data in frontline where, we continued epcoritamab monotherapy after R-CHOP for the full year, the design of the trial, the phase III trial, where it's R-CHOP for six cycles, plus EPKINLY, followed by two monotherapy cycles of EPKINLY.

Tahi Ahmadi
Chief Medical Officer at Genmab

You know, when we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to. As we generated the data and had the opportunity to see this and also discuss with health authority, it became very clear, partially also because of the data that was presented by Faucher and MRD negativity, that you don't actually need to expose these patients to continued therapy. Keep in mind, significant of the portion of these patients are cured already with R-CHOP.

Tahi Ahmadi
Chief Medical Officer at Genmab

That's why we ended up with the design. We feel extremely confident that the, if you will, shortened observation of EPKINLY, as you framed it, doesn't have any impact on the ability of this combination regimen to achieve CR and even MRD negativity at really very high rates, as they have been in the public domain and shared.

Tahi Ahmadi
Chief Medical Officer at Genmab

We have a reason, as I've discussed many times, to be confident because we've seen this now in a number of trials with EPKINLY, that the phase III trials tend to mimic the original first two data just because the mechanism is very predictable for EPKINLY.

Michael Schmidt
Senior Managing Director at Guggenheim Partners

Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi. Thanks, Michael.

Operator

Thank you. Now we're going to take our next question. The question comes now of Benjamin Jackson from Jefferies. Your line is open. Please ask your question.

Benjamin Jackson
Benjamin Jackson
VP of Equity Research at Jefferies

Brilliant. Thank you for the question. I guess just another one, thinking about sequencing of drugs through the lines of therapies in DLBCL. We've heard from some docs that perhaps POLIVY is a very strong salvage option. When you're speaking to physicians, are you hearing that there is a preference for bispecifics up front just naturally because of the order that those drugs can come in? Any thoughts that could be a tailwind that would be useful. Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Ben, for the question. Tahi, this one is again for you.

Tahi Ahmadi
Chief Medical Officer at Genmab

Well, I think, yeah, I'll try to answer Benjamin and maybe Brad has to add something. He may add something to do. From the way I think about this, at least, I mean, this is, I think this is also how physicians that we work with and obviously engage think about this. The sequencing of drugs, generally speaking, is a function of efficacy and safety.

Tahi Ahmadi
Chief Medical Officer at Genmab

In particular, in diffuse large B-cell frontline, where R-CHOP cures a decent amount of patients, I think the anticipation just has to be that, you know, this trial, the trial that reads out is going to generate data that is going to have a significant impact on the outcomes for patients.

Tahi Ahmadi
Chief Medical Officer at Genmab

If it does, then that will lead to natural adoption because the obvious goal in diffuse large B-cell is to avoid the relapsed refractory setting where things become, generally speaking, a little bit harder to manage.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi. Brad, do you want to add anything to this, to sequencing of the medicines?

Brad Bailey
Chief Commercial Officer at Genmab

I think maybe the only thing to add, Tahi said it well, is we do hear from physicians that, you know, we've said quite a while or all along that the value of bispecifics are certainly in the earlier lines of therapy where patients are actually treated closer to their home. We're starting to see this really come to fruition with the advent of the second-line FL launch just late last year, and that's been a key growth driver.

Brad Bailey
Chief Commercial Officer at Genmab

The feedback from physicians, hospitals and health systems has been extremely positive with the, not only the unprecedented data, as Tahi referenced, but also the convenience in being able to realize the value closer to the patient's home.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Brad. Ben, we are super excited about the potential to see both the frontline and the second line diffuse large B-cell lymphoma data, pretty soon, for EPKINLY or epcoritamab, so, exciting times.

Operator

Thank you. Now we're going to take our next question. The question comes now of Charlie Haywood from Bank of America. Your line is open. Please ask your question.

Charlie Haywood
Charlie Haywood
Analyst at Bank of America

Hi, Charlie Haywood, Bank of America. Thanks for taking the question. I have two, please. First is on your peto phase II OS rates. Just wondered if you've taken a two-year OS cut, and any directional comment on how that OS curve has trended relative to the first 12-month data that we've seen. Would it be fair to think a similar trajectory to what you've seen at year one, or could you actually see similar to what your competitors saw with faster first 12-month curve decline and then stabilize more thereafter?

Charlie Haywood
Charlie Haywood
Analyst at Bank of America

Will that data be presented any time? Second one is just on Rina-S in second line and endometrial. Could you just remind us on timelines of that data? Frame your excitement in that op relative to, you know, the more imminent second line PROC setting. I think potential smaller patient number there, but possibly higher unmet need given lack of, you know, limited ADC presence to date. Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Charlie, for the questions. Tahi, why don't you take the first one on peto, and then Judith can handle the question on Rena, and then endometrial cancer for second line.

Tahi Ahmadi
Chief Medical Officer at Genmab

If I understood your question correctly, you were asking if we are intending to update the phase II data set for peto in second line or in front line?

Charlie Haywood
Charlie Haywood
Analyst at Bank of America

In front line, yes.

Tahi Ahmadi
Chief Medical Officer at Genmab

Front line. Well, I mean, we'll probably at some point we're going to update that curve presented in the data, but I think the more meaning we got is gonna be the actual study. You know, we said one or two of them will be out this year. That is probably the more meaningful data set, and relevant to the brand and to the company.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Tahi. Judith, maybe the something more on the timeline for second-line plus endometrial and Rina.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Yeah. No, thank you for the question. As you know, the phase III is actively enrolling. We haven't guided the business community about read out, but what I can say is the activation and enrollment is going very well.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Judith.

Judith Klimovsky
Executive Vice President and Chief Development Officer at Genmab

Just something to add to Tahi's first question on the first-line peto-pembro combination. I think that it's very apparent what we already presented with 17 months follow-up, which is not negligible. At this time point, around 30% were censored and alive. This gives you a kind of magnitude of duration. As Tahi alluded, now we are fixated on the phase III, which are much more relevant. I think that the data presented at ASCO is a very good representation of the durability of the effect.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Judith. Thanks, Charlie, for the questions.

Charlie Haywood
Charlie Haywood
Analyst at Bank of America

Thank you.

Jan van de Winkel
President, and CEO at Genmab

Let's move on to the next question.

Operator

Yes, of course. Now we're going to take our next question, it comes from line of Eva Fortea-Verdejo from Wells Fargo. Your line is open. Please ask your question.

Eva Fortea-Verdejo
Eva Fortea-Verdejo
VP and Analyst at Wells Fargo

Hi, team. Thanks for taking our question. A quick one from us on Peto as it relates to CRC development. How should we be thinking about timing for any announcements for this tumor type? Are you exploring other mechanisms that would make sense to combine with beyond chemo? Thanks.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Eva, for the question. I think probably Tahi can handle this one, CRC updates for Peto in the second half.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. Look, we've answered this question a couple of times. We obviously have looked at the CRC data. We have generated more CRC data. We liked what we saw early on in the diligence. We continue to like what we see. We will update you a little bit closer to similar to what we did with Rina, to when these studies then go into the public domain on our next steps. There will be more to come at some point.

Tahi Ahmadi
Chief Medical Officer at Genmab

As it relates to combination with other mechanisms, there's a number of interesting things that are happening in this space in the subset of patients. Obviously, we are aware of that, and there is a good rationale to combine with Peto. More to come on that end as well.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi. We keep the cards close to our chest, Eva, because it's very exciting area and also a very competitive area. We want to be first and hopefully best here.

Eva Fortea-Verdejo
Eva Fortea-Verdejo
VP and Analyst at Wells Fargo

Got it. Thanks.

Operator

Thank you. Now we're going to take our next question. The question comes in of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Matthew Phipps
Matthew Phipps
Partner and Group Head of Biotechnology Equity Research at William Blair

Hello. Thanks for taking my question. I'm going to harp on the peto pace of enrollment as well. You know, there are some rumors on whether or not the increase to 200 patients would focus exclusively on HPV-negative patients. can maybe just remind us on your thought on the breakdown of patients by that baseline characteristic. then has the number of patients needed to conduct the ORR analysis changed, or is this really just patients for the OS analysis? Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Matt, for the question. Tahi, can you address both of these questions and give some perspective?

Tahi Ahmadi
Chief Medical Officer at Genmab

Matt, I'm gonna ask you to answer your questions. Good question. I will not go into the specifics. I will stick with the line that I used before, that, you know, the increase in the N of the study was intended to increase the overall probability of success of the study as we see it, based on what we understood in the diligences were decisions made already back then, and that we continue to understand about pito, and that none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi. Thanks, Matt, for the questions.

Operator

Thank you. Now we're going to take our next question. The next question comes in of Yaron Werber from TD Securities. Your line is open. Please ask your question.

Yaron Werber
Yaron Werber
Managing Director and Analyst at TD Securities

Great. Thank you so much. Tahi, I'm just gonna maybe ask another question on the LiGeR program, maybe a little bit broader. Do you plan on filing with both studies, or would you file presumably on second line, potentially first and then front line? When you do release the data by year-end, do you think it's gonna be, let's assume it's gonna be in second line first because you're not continuing to over-enrolling that study? Would you have, you know, at least the interim OS, and would it even be mature OS at that time? Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Yaron. Tahi, that's another sharp one.

Tahi Ahmadi
Chief Medical Officer at Genmab

A very good question. Unfortunately, my answer will be the same that I did before. Right now, all we guide, and, have been consistently guiding that we indeed expect one or more of these studies to read out this year. I will not comment on which one first or second and together all these permutations that may exist.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Tahi. More to come later, Yaron Werber.

Operator

Thank you. Now we're going to take our next question. Just give us a moment. The question comes to line of Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question.

Romy O’Connor
Analyst at Van Lanschot Kempen

Hi, team. This is Romy on for Suzanne. One on EPKINLY. Looking ahead to the phase III readouts in first line, we recently did a survey which found that doctors are projecting EPKINLY even before seeing this data to be the most dominant first line option. I just want to know your thoughts on what you see as the most important features of EPKINLY specifically that drives this enthusiasm. Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks very much for referring to that very nice survey. We like the data, of course, and then we'll ask Tahi to sum up basically what the key parameters are here before for why EPKINLY is so advantageous in the first line setting according to the survey.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. I mean, this is like, you know, if you step back, this is also something that we talked about from the very beginning, when we engaged on the development program with EPKINLY, that the CD3xCD20 mechanism of action of EPKINLY is a unique and very powerful single-agent mechanism that comes with a safety profile that predominantly is infusion-related reactions and then otherwise it's extremely well-tolerated.

Tahi Ahmadi
Chief Medical Officer at Genmab

Because of subcutaneous administration, also a convenience administration that makes it easy for the patient and also for the providers. If you start combining EPKINLY and CD3xCD20 with chemotherapy, we've already seen this in all kinds of phase II studies or phase III studies, that tends to be a mechanism that is very well combined with chemotherapy and at least additive.

Tahi Ahmadi
Chief Medical Officer at Genmab

That's, I think, what's driving the enthusiasm about frontline in terms of what the expectation is around data. What drives EPKINLY specifically, of course, is then the observation that, A, in very high likelihood will be the first study to read out in frontline diffuse large B-cell with a significant time advantage. B, it is the one that comes with a subcutaneous administration. As Brad was saying earlier, in frontline diffuse large B-cell, the vast majority of these patients are actually treated in the community setting.

Tahi Ahmadi
Chief Medical Officer at Genmab

The fact that there is now a potential readout on a drug that is available for these physicians and these patients in this particular setting, particularly in the U.S. healthcare system, that is labeled, it's the only one that is labeled without restrictions on where it can be provided to the patients. I think that is what driving the entire enthusiasm on that particular study, and I think why we had, I don't know, six or seven questions from you guys on this study.

Romy O’Connor
Analyst at Van Lanschot Kempen

Great. Thank you.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Tahi, for the answer. Let's move on to the next question.

Operator

Yes, of course. Now we're going to take our next question, and it comes to line of Victor Floc'h from BNP Paribas.

Victor Floc'h
Victor Floc'h
Analyst at BNP Paribas

Thanks for taking my question. Just one on EPKINLY. I mean, EPKINLY has reported a decent Q1 performance. I was just wondering whether this is driven by the recent label change in the U.S. I mean, in equal or, I mean, I was just wondering if you've seen like a material uplift in the academic setting and whether you can comment on the key orders that you need to clear to further drive penetration in this setting. Thank you very much.

Jan van de Winkel
President, and CEO at Genmab

Absolutely, Victor. Good question. Brad Bailey, you can handle both of these, huh?

Brad Bailey
Chief Commercial Officer at Genmab

Yeah. No, I think, first of all, thanks for the question and the strong start to the year is certainly evident by the profile being appreciated by physicians as well as health systems. Primarily being, you know, looked at as the only bispecific with the dual indication. The proven efficacy piece is certainly extremely important as well as the subcutaneous administrations, which is what Tahi had mentioned well.

Brad Bailey
Chief Commercial Officer at Genmab

Now, as it relates to moving forward into earlier areas, the ability to again, have all of these ingredients in place, moving quickly into earlier lines, featuring combinations as well as fixed-dose options is extremely important. Also, as you mentioned, as it relates to the performance second-line FL, we're seeing as a key part of this driver performance. The hospital removal of potential hospitalization data has been very well-received.

Brad Bailey
Chief Commercial Officer at Genmab

Again, looking to remove just additional barriers to be able to treat patients closer to where they live in the ways, you know, that you're seeing with this extremely important profile from an efficacy, safety, and deep durable responses along with subcutaneous administration.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Brad. Thanks, Victor, for the question.

Operator

Thank you. Now we're going to take our next question. The question comes line of Kalpit Patel from Wolfe Research. Your line is open. Please ask your question.

Kalpit Patel
Kalpit Patel
Director and Analyst at Wolfe Research

Thanks for taking the question. For EPKINLY, the EPCORE DLBCL-2 trial in frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind POLARIX study? Do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in the first line?

Jan van de Winkel
President, and CEO at Genmab

Thanks for the questions. Tahi, you can address both of these, huh?

Tahi Ahmadi
Chief Medical Officer at Genmab

On this question on like what hazard ratio we are expecting has come up a lot, and essentially it doesn't make much sense to speculate. What we've said is that based on the public data that is available in phase II, there's of course, and you heard this in the other question earlier, expectation and enthusiasm of what the possible readout of that study. Phase IIIs have in the past on EPKINLY tended to mimic close phase II data, as I said, because it's a mechanism of action that's very predictable.

Tahi Ahmadi
Chief Medical Officer at Genmab

We're excitingly, as you, awaiting the readout and of course are very enthusiastic of how positive this trial could be, but we will see what it is when we have it. As it really relates to OS now, we all know from the ODAC that, you know, the FDA will approve frontline diffuse large B-cell regimens even without OS benefit.

Tahi Ahmadi
Chief Medical Officer at Genmab

I've said in the past, the ability of showing an OS benefit, of course, is becoming a little bit more challenging, diffuse large B-cell general because of the increasing available of very effective salvage therapies for particularly the worst patients with primary refractory, they have access to CAR T. The bispecifics that are also now penetrating second line and are already very much available in third line.

Tahi Ahmadi
Chief Medical Officer at Genmab

Having said all of that, it's also a function of the effect size that you have on PFS, meaning the larger the PFS hazard ratio benefit becomes, the larger the opportunity to show an OS benefit. That's kind of like broadly speaking how we think about it.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Tahi. Let's move on to the next question.

Operator

Yes, of course. Now we're going to take our last question for today. It comes line of Judah Frommer from Morgan Stanley. Your line is open. Please ask your question.

Judah Frommer
Judah Frommer
Analyst at Morgan Stanley

Hi, thanks for squeezing us in here. Just to follow up on the pito trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial? Will you be adding any investigation sites? I'm just curious if you are, if any other EGFR bispecifics might be being studied at those sites and what reception might be. Thanks.

Jan van de Winkel
President, and CEO at Genmab

Thanks, Judah, for the question. Tahi, can you address the recruitment and the setting for the pito trial?

Tahi Ahmadi
Chief Medical Officer at Genmab

Yes. What I will answer, Judah, is that this amendment that increases the N had no impact on additional sites or need for any additional sites since the study's enrolling extremely well. That's why it won't have an impact on anything.

Jan van de Winkel
President, and CEO at Genmab

Thanks. Thanks, Tahi. That, I think addresses the last question of today. Thank you all for calling in today. If you have any additional questions, please reach out to the investor relations team of Genmab. We very much look forward to speaking with all of you soon in this super exciting year for the company. Thank you.

Operator

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

Analysts
    • Anthony Pagano
      CFO at Genmab
    • Benjamin Jackson
      VP of Equity Research at Jefferies
    • Brad Bailey
      Chief Commercial Officer at Genmab
    • Charlie Haywood
      Analyst at Bank of America
    • Eva Fortea-Verdejo
      VP and Analyst at Wells Fargo
    • James Gordon
      Director and Head of European Pharma, Biotech, and Life Sciences Equity Research at Barclays
    • Jan van de Winkel
      President, and CEO at Genmab
    • Jonathan Chang
      Analyst at Leerink Partners
    • Judah Frommer
      Analyst at Morgan Stanley
    • Judith Klimovsky
      Executive Vice President and Chief Development Officer at Genmab
    • Kalpit Patel
      Director and Analyst at Wolfe Research
    • Matthew Phipps
      Partner and Group Head of Biotechnology Equity Research at William Blair
    • Michael Schmidt
      Senior Managing Director at Guggenheim Partners
    • Rajan Sharma
      Executive Director of Pharma and Biotech Equity Research at Goldman Sachs
    • Romy O’Connor
      Analyst at Van Lanschot Kempen
    • Tahi Ahmadi
      Chief Medical Officer at Genmab
    • Victor Floc'h
      Analyst at BNP Paribas
    • Xian Deng
      Executive Director and Analyst at UBS
    • Yaron Werber
      Managing Director and Analyst at TD Securities
    • Zain Ebrahim
      Analyst at JPMorgan
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