Q1 2026 Genmab AS Earnings Call

May 7, 2026

Operator: Hello and welcome to the Genmab's Q1 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. 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.

Speaker #2: Hello and 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.

Speaker #2: Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results.

Speaker #2: 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.

Speaker #2: 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 Winkel.

Operator: I would like to hand the conference over to our first speaker today, Jan van de Winkel. Please go ahead.

Speaker #2: Please go ahead.

Jan van de Winkel: Hello, welcome to our financial results call for Q1 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, Tahamtan Ahmadi, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. Let's move to the Q1 highlights. In Q1 2026, we continue 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: Hello, welcome to our financial results call for Q1 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. Let's move to the Q1 highlights. In Q1 2026, we continue 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.

Speaker #3: Hello, and 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.

Speaker #3: For the Q&A, we will be joined by our Chief Medical Officer, Tai Yamadi. And our Chief Development Officer, Judith Klimowski. As noted, we will be making forward-looking statements.

Speaker #3: So please keep that in mind. Let's move to the first quarter highlights. In Q1 2026, we continue to deliver strong financial performance. And make focused progress against our strategic priorities.

Speaker #3: We grew total revenue by 25%, reflecting continued momentum across our portfolio. And importantly, we continue to invest with discipline—in our medicines, in our pipeline, and in our future growth.

Speaker #3: Fully in line with our capital allocation priorities. Even with these strategic investments, we grew operating profits. The quarter was also marked by progress in our mission to bring innovative medicines to patients.

Jan van de Winkel: 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, and we are approaching this with the same focus and discipline that we brought to ProfoundBio. 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.

Speaker #3: There are a few highlights I would like to mention. At Kili, we continue to build positive momentum. We were very pleased to see the hospitalization recommendation for a move from the third line plus relapse story refractory diffuse B-cell lymphoma label.

Speaker #3: And we are on track with the integration of Meris. And we are approaching this with the same focus and discipline that we brought to profound bio.

Speaker #3: 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 Beva Cesumab.

Speaker #3: We are also making significant progress with our development plan, as you can see on the next slides. We anticipate starting two new phase three trials for Rina S in the coming months.

Jan van de Winkel: 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. These include a phase III chemo replacement trial in platinum-sensitive ovarian cancer, and the first frontline trial for Rina-S in endometrial cancer. As we continue to explore new opportunities for Rina-S outside gynecological oncology, with a phase II signal-seeking basket trial in advanced gastrointestinal cancers. Finally, 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. Because 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.

Speaker #3: Underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers. These include a phase three chemo replacement trial in platinum sensitive ovarian cancer.

Speaker #3: And the first frontline trial for Rina S in endometrial cancer. And we continue to explore new opportunities for Rina S outside gynecological oncology, with a phase two trial seeking with a phase two signal seeking basket trial in advanced gastrointestinal cancers.

Speaker #3: Finally, I'm pleased to share an update on the ongoing phase 3 trial in second-line plus platinum-resistant ovarian cancer on the next slides.

Speaker #3: Because recruitment has been much faster than expected, the phase 3 RAINFALL O2 trial has now completed enrollment. This important milestone brings forward the pivotal phase 3 data for Rina S in platinum-resistant cancer into 2026.

Speaker #3: This reflects strong investigator engagement, the significant unmet medical need in this indication, and the strength of our execution on one of our highest priority late stage programs.

Jan van de Winkel: 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. We can now look forward to 2 datasets in H2 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. 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?

Speaker #3: So we can now look forward to two data sets in the second half of this year for Rina S in platinum resistant ovarian cancer.

Speaker #3: And the opportunity for broader global regulatory filings earlier than anticipated. For both P2 Centermap and Epikinli, we are maintaining our guidance on the timing of data as you see here.

Speaker #3: So 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.

Speaker #3: With that, I'm very pleased to hand you over to Brad, for a review of the recent commercial performance for Epikinli and Diftec. Brad.

Speaker #4: Thanks, John. 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.

Brad Bailey: Thanks, John. 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. 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.

Speaker #4: Momentum for TVDAC and Epikinli reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake, and ultimately reach more patients.

Speaker #4: 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.

Speaker #4: In the quarter, Epikinli continued to gain notable traction as the only bispecific approved in DOBCL and FL indications. Looking globally, Epikinli grew 52% year over year, reaching $137 million in sales.

Speaker #4: In the US, Epkinly continued to expand across both academic and community settings. And this growth reinforces Epkinly's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems.

Brad Bailey: In the US, EPKINLY continued to expand across both academic and community settings. 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 R-squared in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter. 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.

Speaker #4: The recent approval of fixed-duration Epikinli plus R-square in second-line FL has been a growth driver for the brand and contributed positively to Epikinli's growth in the quarter.

Speaker #4: The recent approval of 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.

Speaker #4: Looking ahead, we expect adoption in the community to continue to expand across both FL and DOBCL, bringing Epikinli-based therapies closer to where patients live.

Speaker #4: And 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.

Brad Bailey: 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 US, performance remains strong. 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's 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.

Speaker #4: 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.

Speaker #4: Beyond the US, performance remains strong. In Japan, Epikinli continues to stand out as the only bispecific approved in both third line plus LBCL and FL.

Speaker #4: With continued year-over-year growth. The FL launch is building positively on the brand's success in large B-cell lymphoma. Supported by strong field execution and ongoing site activation.

Speaker #4: In other markets, through our partner AbbVie, Epikinli continues to grow with approvals in more than 65 countries, which most have dual indications. For the remainder of 2026, we're focused on maximizing our first mover advantage in second line FL in the US, while preparing for expected approvals in this setting in Europe and Japan later this year.

Brad Bailey: For the remainder of 2026, we're focused on maximizing our first-mover advantage in second-line FL in the US while preparing for expected approvals in this setting in Europe and Japan later this year, and in early lines of DLBCL in the future. As 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. 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.

Speaker #4: And in early lines of DOBCL in the future. As 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 Epikinli's versatility and ultimately establish Epikinli as the core therapy in B-cell malignancies.

Speaker #4: Turning now to TVDAC. Which is the global standard of care in recurrent or metastatic cervical cancer. TVDAC grew 18% year over year, reaching $39 million in sales in the quarter.

Speaker #4: 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.

Speaker #4: In the US, the brand delivered steady performance and continues to lead the market, a position it has held since launched nearly five years ago.

Brad Bailey: In the US, the brand delivered steady performance and continues to lead the market, a position that has held since launch nearly 5 years ago. Outside the US, 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 UK, TIVDAK launched in February through private prescribing and payer channels, and we're actively engaging NICE and SMC to secure broader availability. At the same time, building upon our work in the UK 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.

Speaker #4: Outside the US, 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.

Speaker #4: We also made meaningful progress expanding patient access this quarter. In the UK, TVDAC launched in February through private prescribing and payer channels. And we're actively engaging NICE and SMC to secure broader availability.

Speaker #4: At the same time, building upon our work in the UK 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.

Speaker #4: Given the significant unmet need in advanced cervical cancer, we look forward to the impact TVDAC can make for more patients as additional markets gain approval and reimbursement.

Brad Bailey: 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. 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. 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, 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.

Speaker #4: And 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.

Speaker #4: To wrap up, our Q1 performance positions us well to sustain momentum in 2026. 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 Epikinli, Rina S, and Petasymptomab.

Speaker #4: 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.

Speaker #4: With that, I'll turn it over to Anthony to walk through the financials.

Brad Bailey: With that, I'll turn it over to Anthony to walk through the financials.

Speaker #3: 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.

Anthony Pagano: 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. Revenue grew by 25%, driven by strong royalties from DARZALEX and Kesimpta. 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.

Speaker #3: A 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.

Speaker #3: Revenue grew by 25%. Driven by strong royalties from Darzalex and Casimpta, and importantly, this growth was also driven by product sales from our own medicines, especially Epikinli, continuing to diversify our revenue base.

Speaker #3: Our investments remained fully in line with our capital allocation priorities. Including significant investments for Epikinli, Rina S, and Petasymptomab. And we made these important investments while growing operating profit by 23%.

Speaker #3: Moving to tax. 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%.

Anthony Pagano: 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 to 18 months. Overall, Q1 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.

Speaker #3: And here, I do want to pause for a moment and note that we are currently evaluating the integration of Merit's operations from a tax perspective.

Speaker #3: So, 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 to 18 months.

Speaker #3: 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.

Speaker #3: 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 Epikinli and our royalty portfolio, further enhancing revenue quality.

Anthony Pagano: At the midpoint, we expect 14% total revenue growth driven by continued momentum in EPKINLY and our royalty portfolio, further enhancing revenue quality. For operating expenses, we expect to be in a range of around DKK 2.7 to 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. In summary, our performance in Q1 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.

Speaker #3: For operating expenses, we expect to be in a range of around 2.7 to 2.9 billion dollars. Reflecting planned investments to advance late-stage development for Petasymptomab and Rina S, as well as launch readiness activities to support multiple potential product launches.

Speaker #3: And even with the strategic step up, our guidance delivers on our commitment to maintain substantial profitability in 2026. 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.

Speaker #3: 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.

Speaker #3: This positions us for sustained growth and long-term value creation. And on that note, I'm going to hand you back over to Jan.

Anthony Pagano: This positions us for sustained growth and long-term value creation. On that note, I'm gonna hand you back over to Jan.

Speaker #1: Thank you, Anthony. Let's move on to our final slides. In the first quarter of 2026, our financial performance reinforced the strength of our foundation and the durability of our growth trajectory.

Jan van de Winkel: Thank you, Anthony. Let's move on to our final slide. In Q1 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. 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 3 times 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.

Speaker #1: 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.

Speaker #1: And as we further move into 2026, we also remain focused on integrating Merit's so that we can capture the full value of Petasymptomab. Lastly, we remain committed to deleveraging, targeting gross leverage below three times by the end of 2027, while maintaining balance sheet strength and flexibility.

Speaker #1: 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. And our focus remains clear: to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable, long-term value for shareholders.

Jan van de Winkel: 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.

Speaker #1: So that ends our formal presentation. Thank you for listening. Operator, please open the call now for questions.

Speaker #4: Thank you. Dear participants, as a reminder, if you wish to ask a question, please press *11 on your telephone keypad and wait for your name to be announced.

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

Speaker #4: To withdraw a question, please press star 1 and 1 again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question.

Speaker #4: Please stand by. We'll compile the Q&A cue. This will take a few moments. And now we're going to take our first question. And it comes along from Jonathan Chang.

Speaker #4: From Lyric, your line is open. Please ask your question.

Speaker #5: Hi, guys. Thanks for taking my question. On the frontline Petasymptomab head and neck cancer study, it looks like the size of the study has been increased.

Jonathan Chang: 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.

Speaker #5: Can you discuss the rationale behind any changes to the study and the implications of those changes? Thank you.

Jan van de Winkel: Thanks, Jonathan, for the question. Tahi, why don't you take the first question by Jonathan?

Speaker #1: Thanks, Jonathan, for the question. Tai, why don't you take the first question by Jonathan?

Tahamtan Ahmadi: Thank you, Jan, and thank you, Jonathan. 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: Thank you, Jan, and thank you, Jonathan. 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.

Speaker #6: Jonathan. Yes, so 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 wanted 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.

Speaker #6: But these trials are being increased based on our insight that we generated during the diligence to ensure that they have the highest probability to our standards.

Tahamtan Ahmadi: We do not have any anticipation that these changes have any impact on the timelines, and steadfast stay with our guidance that one or both of the pivotal studies will read out this year and will provide data this year.

Speaker #6: We do not have any anticipation that these changes have any impact on the timelines and steadfast stay with our guidance that one or both of the Petas studies will read out this year and will provide data this year.

Tahi Ahmadi: We do not have any anticipation that these changes have any impact on the timelines, and steadfast stay with our guidance that one or both of the pivotal studies will read out this year and will provide data this year.

Speaker #1: Thanks, Tai. Let's move on to the next question.

Jan van de Winkel: Thanks, Tahi. Let's move on to the next question.

Speaker #4: Yes, of course. Now we're going to take our next question. And it comes along from Zayn Abraham from JP Morgan. Your line is open.

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

Speaker #4: Please ask your question.

Speaker #7: Thanks a lot. We've got two questions, Zayn Abraham, JP Morgan. First question is just a follow-up on the previous one. And it's helpful that you just said you don't expect the increased size of the first-line trial to impact the timing.

Zain Ebrahim: Thanks a lot. I've got two questions. Zain Ebrahim, J.P. Morgan. 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. Have you already completed enrollment of the initial patient population that you're looking to enroll, and how is enrollment progressing, I suppose? I guess tied to that, whether the increase is for HPV-negative patients, that'll 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.

Speaker #7: But just to understand in more detail why that is, given that you're increasing the trial from 500 patients to 700. So have you already completed enrollment of the initial patient population that you're looking to enroll?

Speaker #7: And how is enrollment progressing? I suppose, I guess tied to that, whether the increase is for HPV-negative patients—that would be helpful to understand as well.

Speaker #7: Second question is just on Epikinli, first line DLBCL. You've guided for the readout this year and haven't narrowed out further. So is that the final analysis, or are we still waiting on the interim?

Zain Ebrahim: Is that the final analysis, or are we still waiting on the interim?

Speaker #1: Thanks, Zayn, for the questions. I think, Tai, you can handle both of them. Start with the neck question, and then the EPCOT first-line trial.

Jan van de Winkel: Thanks, Zain, for the questions. I think, Tahi, you can handle both of them. Start with the next question and then the A-Epco first-line trial.

Tahamtan Ahmadi: Zain, I'm sorry. I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. 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, and this will not impact the timelines and what patient populations it does impact or the timing or the status of EPCORE. 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.

Speaker #6: Yeah, Zayn, I'm sorry. I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. 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, and this will not impact the timelines and the what patient populations, it does impact on the timing or the status of a core I hope you will appreciate that in the context of a very competitive landscape.

Tahi Ahmadi: Zain, I'm sorry. I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. 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, and this will not impact the timelines and what patient populations it does impact or the timing or the status of EPCORE. 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.

Speaker #6: We are trying to be a little bit more disciplined on what we're sharing. When we're sharing it, so two things. It will not change the timelines of what we have guided before, and we continue to stay with the statement that one or both of these studies will read out this year.

Tahamtan Ahmadi: 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. We've guided that the front-line 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.

Tahi Ahmadi: 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. We've guided that the front-line 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.

Speaker #6: As it relates to diffuse HPV cell, again, I think there we have also been very disciplined, and I will try to be continuously disciplined today.

Speaker #6: We've guided that the frontline diffuse HPV cell will read out this year. And we have not commented on interim or final or any of these.

Speaker #6: Questions? But we stay with the statement that the diffuse HPV cell study will have a readout this year.

Speaker #1: Thanks, Tai.

Jan van de Winkel: Thanks, Tahi.

Tahamtan Ahmadi: Thanks very much.

Zain Ebrahim: Thanks very much.

Speaker #7: Thanks very much.

Speaker #1: Thanks, Zayn. Let's move on.

Jan van de Winkel: Thanks, Tahi. Let's move on.

Speaker #4: Thank you. And now we're going to take our next question. And it comes along from James Gordon from Barclays. Your line is open. Please ask your question.

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: Hello. James Gordon from Barclays. Thanks for taking the question or two quick ones. One was Rina-S. There's 01 and 02 coming in H2 this year. Just wanted to confirm, with the 2 trials reporting so closely together, so 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? Have you discussed that plan with FDA? Might they say, Well, if they're so close together, let's see both. The other one was just more generally that we've seen more data from B7H4 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 as a different target in gyne.

Speaker #8: Hello, James Gordon from Barclays. Thanks for taking the question or two quick ones. One was reinterest. So there's 01 and 02 coming in H2 this year.

Speaker #8: So just wanted to confirm, with the two trials reporting so closely together, so phase two and phase three, would you definitely report them as separate results?

Speaker #8: And if the Phase Two is positive, you'll file it and not wait for the Phase Three? Or have you discussed that plan with the FDA?

Speaker #8: Or might they say, "Well, if they're so close together, let's see both"? And the other one was just more generally that we've seen more data from B7H4 ADCs.

Speaker #8: In gynecological cancers, how do you think that stacks up versus FOLA ADCs? There seems to be a few people going for this approach as it's a different target, guiding.

Speaker #1: Thanks, James, for the questions. I will ask Judith to address both the phase two and phase three POC trials, Judith, and then the B7H4 versus FOLAT receptor alpha ADCs.

Jan van de Winkel: Thanks, James, for the questions. I will ask Judith to address both the phase II and phase III PROC trials, Judith, and then the B7H4 versus folate receptor alpha ADCs.

Speaker #9: Yeah. Thank you for the question. So for the first part, as we highlighted, the phase three accrued ahead of projections. That means that we will have these two data sets this year.

Judith Klimovsky: Yeah. No, thank you for the question. 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. 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. Part one. With regard to the competitive landscape, of course, you know, we are very aware of the B7H4, the two in investigation, the GSK and the.

Speaker #9: Given the change in landscape in PROC, the potential for the phase three submission and approval becomes more relevant. And this is the plan. So we stay behind our guidance that Rina will be launched in PROC in 2027.

Speaker #9: With these two data sets at supportive, but the main data set for filing the phase three that will allow for global submissions. Part one.

Speaker #9: With regard to the competitive landscape, of course, we are very aware of the B7H4, the two in investigation, the GLACs and PROTISAM. As we said several times, we know that this is a hyper-competitive space.

Judith Klimovsky: As we said, several times, we know that this is an hypercompetitive space. We stand behind the strength of the data of Rina 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.

Speaker #9: We stand behind the strength of the data of Rina in terms of efficacy. Safety, durability of the efficacy. And clinical development plan and speed to market.

Speaker #9: So more competitors makes it 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.

Speaker #1: Thanks. Thanks, Judith. So it comes down to effective execution, James. And to remove then basically two years from zero phase threes to now five phase threes with the news of today.

Jan van de Winkel: Thanks. Thanks, Judith. It comes down to effective execution, James. And we moved in, basically 2 years from 0 phase III to now 5 phase III, with the news of today.

Speaker #4: Thank you. Now we're going to take our next question. And the question comes along from Shan Deng from UBS. Your line is open. Please ask your question.

Operator: Thank you. Now we're going to take our next question. The question comes line of Xian Deng from UBS.

Xian Deng: Xian from UBS. Thank you for taking my question. I got a few on afatinib frontline DLBCL trials, please. Just wondering, given the typical PS PFS curve tend to pretty much almost start to plateau after 18 months or so in a typical what frontline DLBCL trial like POLARIX. Just purely hypothetically, right? It doesn't have to be anything to do with afatinib, just purely from a statistical point of view, do you expect a big change in hazard ratio when during the last 25% of events, just assuming sort of a typical frontline DLBCL trial PFS curve? That's the first question.

Speaker #10: Hi. Shan from UBS. Thank you for taking my question. So I got a few Epikinli frontline DLBCL trials, please. Just wondering, given the typical PFS curve, tend to pretty much almost start to plateau after, let's say, 18 months or so, in a typical, let's say, frontline DLBCL trial like PolarX.

Speaker #10: Just purely hypothetically, right, doesn't have to be anything to do with Epikinli. Just purely from a statistical point of view, do you expect a big change in hazard ratio when during the last 25% of events just assuming sort of a typical, let's say, frontline DLBCL trial PFS curve?

Speaker #10: That's the first question. And the second one is kind of also on that one is your study is kept at 30% of IPI stage two patients.

Xian Deng: The second one is kind of, you know, also on that one, is, 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.

Speaker #10: So just wondering if you could give any color on whether you've reached this number or your IPI2 patients is actually below this. And just wondering what impact could it have in terms of powering and timing for the primary endpoint.

Speaker #10: Thank you.

Speaker #1: Thank you, Seon. I was always teased never to answer hypothetical questions, but I will see we'll test out whether Tai is willing to do that.

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

Speaker #1: For your first question and then move into the second part as well, Tai. Over to you.

Tahamtan Ahmadi: Yes. Thank you. What I can say is you're absolutely right. Classically, historically, we've seen such pivotal, by the way, not only POLARIX, frontline studies tend to plateau around month 18 to 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 going to behave on this trial until we see the data. The cap is also correct. There's a 30% cap. 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 to 5.

Tahi Ahmadi: Yes. Thank you. What I can say is you're absolutely right. Classically, historically, we've seen such pivotal, by the way, not only POLARIX, frontline studies tend to plateau around month 18 to 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 going to behave on this trial until we see the data. The cap is also correct. There's a 30% cap. 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 to 5.

Speaker #11: Yes. Yeah. Thank you. So yeah. So what I can say is you're absolutely right. Classical historical diffuse HPV cell all, by the way, not only PolarX.

Speaker #11: Frontline studies tend to plateau around month 18 to 20. And I think that's my only comment on that question. I'm hypothetically speculating what I expect.

Speaker #11: I don't think it's helpful because I actually don't know. How these curves are going to behave on this trial until we see the data.

Speaker #11: The cap is also correct. There is a 30% cap. Again, I don't think it's appropriate at this point to talk about what the actual demographics of the study are.

Speaker #11: And the only other point that I think is important to understand the primary endpoint is actually IPI3 to 5. And if IPI3 to 5 passes a certain statistics, then it will read out 2 to 5.

Tahamtan Ahmadi: If IPI 3 to 5 passes, you know, certain statistics, then it will read out 2 to 5. I think these are my comments on your questions to the degree.

Tahi Ahmadi: If IPI 3 to 5 passes, you know, certain statistics, then it will read out 2 to 5. I think these are my comments on your questions to the degree.

Speaker #11: And so I think these are my comments on your questions. To the degree.

Jan van de Winkel: Thanks. Thanks, Tahi

Speaker #1: Thanks, Tai.

Tahamtan Ahmadi: that I can.

Tahi Ahmadi: that I can.

Speaker #11: That I can.

Speaker #10: Thank you. Well, I tried.

Xian Deng: Thank you. Well, I tried.

Speaker #4: Thank you.

Operator: Thank you.

Jan van de Winkel: Yes, absolutely. Thank you. Onto the next one, operator.

Speaker #1: Yes. Absolutely. Thank you. Next, on to the next one operator.

Speaker #4: Yes, of course. And now we're going to take our next question. And the question comes along from Rajan Sharma from Goldman Sachs. Your line is open.

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

Speaker #4: Please ask your question.

Rajan Sharma: Hi, thanks for taking the question. First one on EPKINLY, just kind of following on the theme there. What do you think is sort of the relevant benchmark for EPCORE DLBCL-4? That's the 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, Rainfall-O eight, is that likely to be a KEYTRUDA combination trial? Thanks.

Speaker #12: Hi. Thanks for taking the question. So, first one on Epikinli, just kind of following on the theme there, but what do you think is sort of the relevant benchmark for Epkinly DLBCL4?

Speaker #12: That's the second-line trial. Just in the context of the competitive landscape and some of the potential advantages that Epikinli has. And then secondly, just on the new RinaRS trial that you announced rainfall 08, is that likely to be a catruder combination trial?

Speaker #12: Thanks.

Speaker #1: Thanks, Rajan, for the questions. Tai, why don't you take the first one, and then maybe Judith can go on to the new RinaS trial, one of the new RinaS trials.

Jan van de Winkel: Thanks, Rajan, for the questions. Tahi, why don't you take the first one, and then maybe Judith can go into the new Rina-S trial, one of the new Rina-S trials. Tahi?

Speaker #1: Tai?

Speaker #11: Yes. So this is a question about the second line diffuse HPV cell, right? And so I think there's a couple of things to be said about the 1 to 8 study.

Tahamtan Ahmadi: 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 128 study. First, it is again a randomization against 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. What is the excitement on our end for this particular regimen is that this is a regimen comprised of a oral medication, lenalidomide, and a subcutaneous administration that hopefully will show positive data, and meaningful positive data for patients, and also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination with GemOx, but also improved in efficacy vis-a-vis monotherapy.

Tahi Ahmadi: 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 128 study. First, it is again a randomization against 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. What is the excitement on our end for this particular regimen is that this is a regimen comprised of a oral medication, lenalidomide, and a subcutaneous administration that hopefully will show positive data, and meaningful positive data for patients, and also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination with GemOx, but also improved in efficacy vis-a-vis monotherapy.

Speaker #11: First, it is, again, a randomization against our Gemmax. So in the end, that's what the study is going to be compared. And everything else is going to cross-study comparison there.

Speaker #11: Obviously, a little bit problematic. But what is exciting on our end for this particular regimen is that this is a regimen comprised of an oral medication and alendamide, and a subcutaneous administration.

Speaker #11: That hopefully will show a positive data. And meaningful positive data for patients. And then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combinations with Gemmax, but also improved in efficacy vis-à-vis monotherapy.

Tahamtan Ahmadi: It's really perfectly suited for the outpatient setting or the community setting, and 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.

Speaker #11: And it's really perfectly suited for the outpatient setting or the community setting. And 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.

Tahi Ahmadi: It's really perfectly suited for the outpatient setting or the community setting, and 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.

Speaker #11: And so we'll see what the data is, but that's the intent of the trial.

Speaker #1: Thanks, Tai. And then maybe Judith on the combination for Rina.

Jan van de Winkel: Thanks, Tahi. Maybe Judith on the combination for Rina.

Judith Klimovsky: Okay. Can you repeat the question?

Speaker #13: The question, can you repeat the question? The combination with Bev, did you ask? Oh, yeah. The data that we present. Okay. So we in terms of combinations, the combination with Bev was presented.

Jan van de Winkel: Yeah

Judith Klimovsky: bevacizumab, did you ask? Oh, yeah.

Rajan Sharma: No.

Judith Klimovsky: The data that we present. Okay. 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 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 6 cycles, this is with bevacizumab. In terms of pembrolizumab, we have 2 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.

Speaker #13: That is GO. And as you can appreciate, if you are there, 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.

Speaker #13: And even the fact that 15 of the patients were refractory 85% of the patients got more than 6 cycles. So this is with Bev.

Speaker #13: In terms of Pembro, we had two cohorts ongoing in different settings. And we will communicate the data when the data is a little bit more mature.

Speaker #13: And enrolled. So it's actively enrolling.

Speaker #1: Thanks, Judith. I think that answered your questions, Rajan. Let's move on to the next question.

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

Speaker #4: Yes, of course. And now we're going to take our next question. And the question comes along from Mikael Schmidt from Guggenheim Partners. Your line is open.

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.

Speaker #4: Please ask your question.

Michael Schmidt: 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.

Speaker #14: Hey. Thanks for taking my questions. I had another one on Epicor DLBCL2. Maybe just in terms of the enrollment of the study, Tai, could you just comment on how enrollment has been relative to your expectations when starting the trial?

Speaker #14: And secondly, I know in the phase two study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed duration treatment in the phase three study.

Speaker #14: And maybe speak to your confidence level that the fixed duration paradigm can replicate the Phase 2 data. Thanks.

Speaker #1: Thanks, Michael. Tai?

Jan van de Winkel: Thanks, Michael. Tahi?

Speaker #15: Yeah. Generally speaking, I think true for 1 to 8, which is the second line diffuse HPV cell trial, as for the frontline diffuse HPV cell trials, that these trials accrued significantly faster than they were initially projected.

Tahamtan Ahmadi: Yeah. Generally speaking, I think, true for 128, which is the second-line diffuse large B-cell trial, as for the front-line diffuse large B-cell trials, that 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, and the design of the trial, the phase III trial, where it's R-CHOP for 6 cycles plus EPKINLY, followed by 2 monotherapy cycles of EPKINLY. You know, when we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to.

Tahi Ahmadi: Yeah. Generally speaking, I think, true for 128, which is the second-line diffuse large B-cell trial, as for the front-line diffuse large B-cell trials, that 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, and the design of the trial, the phase III trial, where it's R-CHOP for 6 cycles plus EPKINLY, followed by 2 monotherapy cycles of EPKINLY. You know, when we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to.

Speaker #15: And I think that's a statement that we've made multiple times. As it relates to the original phase two data in frontline where we continued Epicor monotherapy after RCHOP for the full year and the design of the trial, the phase three trial where it's RCHOP for six cycles, plus Epikinli followed by two monotherapy cycles of Epikinli.

Speaker #15: 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 Fauci on MRD negativity that you don't actually need to expose these patients to continued therapy.

Tahamtan Ahmadi: 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 on 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. 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 in the public domain and shared.

Tahi Ahmadi: 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 on 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. 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 in the public domain and shared.

Speaker #15: Keep in mind, significant portion of these patients are cured already with RCHOP. And so that's why we ended up with the design. If you're extremely confident that if you will shorten observation of Epikinli, 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.

Tahamtan Ahmadi: We have a reason, as I have 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 2 data just because the mechanism is very predictable for EPKINLY. Thank you.

Speaker #15: And 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 3 trials tend to mimic the original first two data just because the mechanism is very predictable for Epkinly.

Tahi Ahmadi: We have a reason, as I have 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 2 data just because the mechanism is very predictable for EPKINLY. Thank you.

Speaker #14: Yeah. Thank you.

Speaker #1: Thanks, Tai. Thanks, Michael.

Jan van de Winkel: Thanks, Tahi. Thanks, Michael.

Speaker #4: Thank you. And now we're going to take our next question. The question comes from Benjamin Jackson from Jefferies. Your line is open.

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

Speaker #4: Please ask your question.

Speaker #1: 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.

Benjamin Jackson: 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 there would be useful. Thank you.

Speaker #1: So when you're speaking to physicians, are you hearing that there is a preference for bispecifics upfront, just naturally because of the order that those drugs can come in?

Speaker #1: So any thoughts that could be a tailwind there would be useful, thank you. Thanks, Ben, for the question. Tai, this one is again for you.

Jan van de Winkel: Thanks, Ben, for the question. Ty, this one is again for you.

Tahamtan Ahmadi: 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, and I think this is also how physicians that we work with and always engage think about this, the sequencing of drugs, generally speaking, is a function of efficacy and safety. And 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: 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, and I think this is also how physicians that we work with and always engage think about this, the sequencing of drugs, generally speaking, is a function of efficacy and safety. And 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.

Speaker #15: Well, I think, yeah, I'll try to answer Benjamin and maybe Brad has to add something he may add something to do. But from the way I think about this, at least, I mean, I think this is also how physicians that we work with and obviously engage think about this.

Speaker #15: The sequencing of drugs generally speaking is a function of efficacy and safety. And in particular, in diffuse HPV cell frontline where RCHOP cures a decent amount of patients, I think the anticipation just has to be that these trial that reads out is going to generate data that is going to have a significant impact on the outcomes for patients.

Tahamtan Ahmadi: If it does, then that will lead to a 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.

Speaker #15: And if it does, then that will need to latch for adoption because the obvious goal in diffuse HPV cell is to avoid the relapse refractory setting where things become generally speaking a little bit harder to manage.

Tahi Ahmadi: If it does, then that will lead to a 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.

Speaker #1: Thanks, Tai. Brad, do you want to add anything to this, to sequencing of the medicines?

Jan van de Winkel: Thanks, Tahi. Brad, do you want to add anything to this, to sequencing of the medicines?

Speaker #16: Yeah. I think maybe the only thing to add, Tai said it well, is we do hear from physicians that and we've said quite a while all along that the value of bispecifics are certainly in earlier lines of therapy where patients are actually treated closer to their home or starting to see this really come to fruition with the advent of the second line FL launch just late last year.

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

Speaker #16: And that's been a key growth driver. The feedback from physicians, hospitals, and hospitals and health systems has been extremely positive, with not only the unprecedented data as Tai referenced, but then also the convenience and being able to realize the value closer to the patient's home, so.

Speaker #1: Thanks. Thanks, Brad. And Ben, we are super excited about the potential to see both the frontline and the second line diffuse HPV cell lymphoma data pretty soon for Epikinli or Epikaritumab.

Jan van de Winkel: Thanks. Thanks, Brad. 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 epcoritamab. Exciting times.

Speaker #1: So we're exciting times.

Speaker #4: Thank you. Now we're going to take our next question, and the question comes along from Charlie Haywood from Bank of America. Your line is open.

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

Speaker #4: Please ask your question.

Charlie Heywood: Hi. Charlie Heywood, Bank of America. Thanks for taking the question. I have two, please. First is on your pivotal phase II OS rates. Just wondered if you've taken a 2-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 1, or could you actually see similar to what your competitors saw with faster first 12-month curve decline and then stabilize more thereafter? Will that data be presented any time? Second one is just on Rina-S in second-line 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.

Charlie Haywood: Hi. Charlie Heywood, Bank of America. Thanks for taking the question. I have two, please. First is on your pivotal phase II OS rates. Just wondered if you've taken a 2-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 1, or could you actually see similar to what your competitors saw with faster first 12-month curve decline and then stabilize more thereafter? Will that data be presented any time? Second one is just on Rina-S in second-line 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.

Speaker #17: Hi, Charlie Haywood, Bank of America. Thanks for taking the question. I have two, please. First is on your PETO phase two 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 months' data that we've seen.

Speaker #17: 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?

Speaker #17: And then, will that data be presented anytime? And then the second one is just on Rina-S in second-line endometrial. Could you just remind us on timelines of that data?

Speaker #17: And then frame your excitement in that up relative to the more imminent second line proc setting. I think potential smaller patient number there, but possibly higher unmet need given lack of limited ADC presence to date.

Charlie Heywood: I think potential smaller patient number there, but possibly higher unmet need given lack of, you know, limited ADC presence to date. Thank you.

Charlie Haywood: I think potential smaller patient number there, but possibly higher unmet need given lack of, you know, limited ADC presence to date. Thank you.

Speaker #17: Thank you.

Speaker #1: Thanks, Charlie, for the question. Tai, why don't you take the first one on peto, and then Judith can handle the question on Rina, and then Mitchell can answer second line.

Jan van de Winkel: Thanks, Charlie, for the questions. Ty, why don't you take the first one on pivotal, and then Judith can handle the question on RINA and then endometrial cancer second line.

Speaker #15: So if I understood your question correctly, you were asking if we are intending to update the phase two dataset for pito in second line?

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

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

Speaker #15: Or in front line?

Charlie Heywood: In front line, yes.

Charlie Haywood: In front line, yes.

Speaker #17: In front line, yes.

Tahamtan Ahmadi: 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 meaningful readout is gonna be the actual study. You know, we said one or two of them will read out this year. That is probably the more meaningful data set, and relevant to the brand and to the company.

Tahi Ahmadi: 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 meaningful readout is gonna be the actual study. You know, we said one or two of them will read out this year. That is probably the more meaningful data set, and relevant to the brand and to the company.

Speaker #15: Front line. Well, I mean, we'll probably at some point go in to update that curve and present it in the data, but I think the more meaning we've got is going to be the actual study.

Speaker #15: So we said one or two of them will read out this year. And so that is probably the more meaningful dataset, and relevant to the brand and to the company.

Jan van de Winkel: Thanks, Tahi. Judith, maybe just something more on the timeline for second line plus endometrial and Rina-S.

Speaker #1: Thanks. Thanks, Tai. And then, Judith, maybe something more on the timeline for second-line plus endometrial and Rina?

Jan van de Winkel: Thanks, Tahi. Judith, maybe just something more on the timeline for second line plus endometrial and Rina-S.

Speaker #2: Yeah. No, thank you for the question. And as you know, the Phase 3 is actively enrolling, with us having guided the investor community about readouts. But what I can say is the activation and enrollment is going very well.

Judith Klimovsky: Yeah. No, thank you for the question. As you know, the phase III is actively enrolling. We haven't guided the business community about readouts. What I can say is the activation and enrollment is going very well.

Speaker #1: Thanks. Thanks, Judith.

Jan van de Winkel: Thanks. Thanks, Judith.

Speaker #2: And just something to add to Tai's first question on the first line, pito Pembro combination, I think that it's a very apparent what we already presented with 17 months follow-up, which is not negligible.

Judith Klimovsky: To add, just something to add to Tahi's first question on the first-line, pivotal pembrolizumab 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.

Speaker #2: And at this time point, around 30% were censored and alive. And this gives you a kind of magnitude of duration and as Tai alluded, now we are fixated on the phase threes which are much more relevant.

Speaker #2: But I think that the data presented at ASCO is a very good representation of the durability of the effect.

Jan van de Winkel: Thanks. Thanks, Jude. Thanks, Charlie, for the questions.

Speaker #1: Thanks. Thanks, Judith. Thanks, Charlie, for the questions. Let's move on to the next question.

Tahamtan Ahmadi: Thank you.

Tahi Ahmadi: Thank you.

Jan van de Winkel: Let's move on to the next question.

Speaker #4: Yes, of course. And now we're going to take our next question. And it comes from Eva Forte from Wells Fargo. Your line is open.

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

Speaker #4: Please ask your question.

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

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

Speaker #18: Hi, team. Thanks for taking our question. A quick one from us on pito, as it relates to CRC development. How should we be thinking about timing for any announcements for this tumor type?

Speaker #18: And are you exploring other mechanisms that would make sense to combine with beyond chemo? Thanks.

Speaker #1: Thanks, Eva, for the question. I think probably Tai can handle this one. CRC updates for pito, and the second half.

Jan van de Winkel: Thanks, Eva, for the question. I think probably Tahi can handle this one, CRC updates for pivotal in the H2.

Speaker #17: Yeah. So look, we've answered this question a couple of times. We obviously have looked at the CRC data. We have generated more CRC data.

Tahamtan Ahmadi: 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 Mina to when these studies then go into the public domain on our next steps. There will be more to come at some point. 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, and obviously, we are aware of that and there is a good rationale to combine with petosemtamab, more to come on that end as well.

Tahi Ahmadi: 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 Mina to when these studies then go into the public domain on our next steps. There will be more to come at some point. 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, and obviously, we are aware of that and there is a good rationale to combine with petosemtamab, more to come on that end as well.

Speaker #17: We liked what we saw. Early on in the diligence, we continue to like what we see. And we will update you a little bit closer to similar to what we did with Rina.

Speaker #17: When these studies then go into the public domain, on our next steps. So there will be more to come at some point. As it relates to combination with other mechanisms, as a number of interesting things are happening in the space in a subset of patients and obviously we are aware of that.

Speaker #17: And there is a good rationale to combine with pito. And so more to come on that end as well.

Jan van de Winkel: Thanks, Taj. 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.

Speaker #1: Okay. Thanks, Tai. So we keep the cards close to our chest, Eva, because it's a very exciting area, and also a very competitive area. So we want to be first and, hopefully, best here.

Eva Forte: Got it. Thanks.

Eva Fortea: Got it. Thanks.

Speaker #18: Got it. Thanks.

Speaker #4: Thank you. Now we're going to take our next question, and the question comes along from Matthew Phipps from William Blair. Your line is open.

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

Speaker #4: Please ask your question.

Matt Phipps: Hello. Thanks for taking my question. I'm going to harp on the petosemtamab 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.

Matthew Phipps: Hello. Thanks for taking my question. I'm going to harp on the petosemtamab 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.

Speaker #19: Hello. Thanks for taking my question. I'm going to harp on the pito symptomatic enrollment as well. There is some rumors on whether or not to increase the tumor patients would focus exclusively on HB negative patients.

Speaker #19: So you can maybe just remind us on your thought on the breakdown of patients by that base on characteristic. And then has the number of patients needed to conduct the ORR analysis changed?

Speaker #19: Or is this really just patients for the OS analysis? Thank you.

Speaker #1: Thanks, Matt, for the questions. Tai, can you address both of these questions and give some perspective?

Jan van de Winkel: Thanks, Matt, for the question. Taj, can you address both of these questions and give some perspective?

Tahamtan Ahmadi: Matt, I'm gonna 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 with decisions made already back then, and that we continue to understand about pivotal, and that none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

Tahi Ahmadi: Matt, I'm gonna 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 with decisions made already back then, and that we continue to understand about pivotal, and that none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

Speaker #15: Matt, I'm going to ask you to answer your our questions. Good question. I will not go into the specifics. I will stick with the line that I used before.

Speaker #15: That the increase in the end 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 diligence.

Speaker #15: These 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.

Speaker #1: Thanks, Tai. Thanks, Matt, for the questions.

Jan van de Winkel: Thanks, Tahi. Thanks, Matthew, for the questions.

Speaker #4: Thank you. And now we're going to take our next question. The next question comes along from Yaron Weber from TD Securities. Your line is open.

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

Speaker #4: Please ask your question.

Yaron Werber: Great. Thank you so much. Taj, I'm just gonna maybe ask another question on the LiGeR program, maybe a little bit broader. Do you, 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 'cause you're not over-enrolling that study. Would you have kind of, you know, at least the interim OS, and would it even be mature OS at that time? Thank you.

Speaker #1: Great, thank you so much. Tai, I'm just going to maybe ask another question, and I'll like your program—maybe a little bit broader. Do you plan on filing with both studies?

Speaker #1: Or would you file presumably on second line potentially first? And then front line? And when you do release the data by year-end, do you think it's going to be let's assume it's going to be in second line first because you're not continuing to you're not over-enrolling that study.

Speaker #1: Would you have kind of at least the interim OS? And would it even be mature OS at that time? Thank you. Thanks, Yaron. Tai, that's another sharp one.

Jan van de Winkel: Thanks, Yaron. Tahi, that's another sharp one.

Tahamtan Ahmadi: A very good question. Unfortunately, my answer will be the same as 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. Sorry, guys.

Tahi Ahmadi: A very good question. Unfortunately, my answer will be the same as 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. Sorry, guys.

Speaker #5: Very good question. Unfortunately, my answer will be the same as before. Right now, all we guide—and have been consistently guiding—is that we indeed expect one or more of these studies to read out this year.

Speaker #5: And I will not comment on which one first or second together. All these permutations that may exist.

Speaker #1: Thanks, Tai. So more to come later, Yaron.

Jan van de Winkel: Thanks. Thanks, Tahi. More to come later, Yaron.

Speaker #4: Thank you. Now we're going to take our next question. Just give us a moment. And the question comes along from Suzanne Van Verhuizen from Van Lan Schotkampen.

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

Speaker #4: Your line is open. Please ask your question.

[Analyst] (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.

Romy O'Connor: 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.

Speaker #20: Hi, team. This is Romy on for Suzanne. One on up Kimberly. So, looking ahead to the phase 3 readouts and first line, we recently did a survey which found that doctors are projecting that Kimberly, even before seeing this data, to be the most dominant first-line option.

Speaker #20: I just want to know your thoughts on what you see as the most important features at Kimberly specifically that drive this enthusiasm. Thank you.

Speaker #1: Thanks very much for referring to that very nice survey. We like the data of course. And then we'll ask Tai to sum up basically what the key parameters are here for why at Kimberly is so advantageous in that first line setting according to the survey.

Jan van de Winkel: Thanks very much for referring to that very nice survey. We like the data, of course. I will 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.

Speaker #5: Yeah. So I mean, this is like if you step back, this is also something that we talked about from the very beginning when we engaged on the development program with Kimberly that the CD3, CD20 mechanism of action of at Kimberly is a unique and very powerful scene agent mechanism that comes with a safety profile that predominantly is infusion-related reactions.

Tahamtan Ahmadi: 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 CD3/CD20 mechanism of action of EPKINLY is a unique and very powerful T-cell engaging mechanism that comes with a safety profile that predominantly is infusion-related reactions and then otherwise is extremely well-tolerated. Because of subcutaneous administration, also convenience administration that makes it easy for the patient and also for the providers. If you start combining EPKINLY and CD3/CD20 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 or make it with chemotherapy and at least additive.

Tahi Ahmadi: 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 CD3/CD20 mechanism of action of EPKINLY is a unique and very powerful T-cell engaging mechanism that comes with a safety profile that predominantly is infusion-related reactions and then otherwise is extremely well-tolerated. Because of subcutaneous administration, also convenience administration that makes it easy for the patient and also for the providers. If you start combining EPKINLY and CD3/CD20 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 or make it with chemotherapy and at least additive.

Speaker #5: And then otherwise, it's extremely well tolerated. And because of its subcutaneous administration, also a convenience administration that makes it easy for the patient and also for the providers.

Speaker #5: And so if you start combining at Kimberly and CD3, CD20 with chemotherapy, we've already seen this in all kinds of phase two studies or phase three to be a mechanism that is very well combinable with chemotherapy.

Speaker #5: And at least additive. And so that's, I think, what's driving the enthusiasm about front line in terms of what the expectation is around data.

Tahamtan Ahmadi: 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 the observation that A, it 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: 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 the observation that A, it 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.

Speaker #5: And then what drives at Kimberly specifically, of course, is then the observation that A, in very high likelihood, will be the first study to read out in front line diffuse HB cell with a significant time advantage.

Speaker #5: And B, it is the one that comes with a subcutaneous administration. And as Brad was saying earlier, in frontline diffuse HB cell, the vast majority of these patients are actually treated in the community setting.

Tahamtan Ahmadi: The fact that there is now a potential readout on a drug that is available for these patients, for these physicians and these patients in this particular setting, particularly in the US 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.

Speaker #5: And so, the fact that there is now a potential readout on a drug that is available for these patients—for these physicians and these patients in this particular setting, particularly in the US healthcare system—that is labeled as the only one that is labeled without restrictions on where it can be provided to the patients, I think that is what's driving the entire enthusiasm on that particular study.

Tahi Ahmadi: The fact that there is now a potential readout on a drug that is available for these patients, for these physicians and these patients in this particular setting, particularly in the US 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.

Speaker #5: And I think, why we had—I don't know what—six or seven questions from you guys on this study.

Speaker #20: Great. Thank you.

[Analyst] (Van Lanschot Kempen): Great. Thank you.

Romy O'Connor: Great. Thank you.

Speaker #1: Thanks, Tai, for the answer. Let's move on to the next question.

Jan van de Winkel: Thanks, Tahi, for the answer. Let's move on to the next question.

Speaker #4: Yes, of course. And now we're going to take our next question, and it comes from the line of Victor Flock from BNP Paribas. Your line is open.

Operator: Yes, of course. Now we're going to take our next question, and it comes to the line of Victor Flack from BNP Paribas. Your line is open. Please ask your question.

Speaker #4: Please ask your question.

Victor Flack: Oh, thanks, Tahi, 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 US. I mean, any color on, 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 hurdles that you need to clear to further drive penetration in this setting. Thank you very much.

Victor Floc'h: Oh, thanks, Tahi, 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 US. I mean, any color on, 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 hurdles that you need to clear to further drive penetration in this setting. Thank you very much.

Speaker #21: Thanks, Seth, for taking my question. Just one on at Kimberly. So I mean, at Kimberly, as we posted a decent Q1 performance, I was just wondering whether this is driven by the recent label change in the US.

Speaker #21: So I mean, in Ecuador, I mean, I was just wondering if you've seen 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.

Speaker #21: Thank you very much.

Jan van de Winkel: Absolutely, Victor. Good question. Brad, you can handle both of these, huh?

Speaker #1: Absolutely, Victor. That's a good question. So, Brad, you can handle both of these, huh?

Speaker #22: 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.

Brad Bailey: 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. Now, as it relates to the moving forward into earlier areas, the ability to again, have all of these ingredients in place, moving quickly into earlier lines, the featuring combinations as well as fixed-dose options is extremely important.

Speaker #22: Primarily, being looked at as the only bispecific of the dual indication, and the proven efficacy piece is certainly extremely important, as well as the subcutaneous administrations, which is what Tai had mentioned as well.

Speaker #22: Now, as it relates to the moving forward into earlier areas, the ability to, again, have all of these ingredients in place moving quickly into earlier lines, the featuring combinations as well as fixed dose options, is extremely important.

Speaker #22: But then also, as you mentioned, as it relates to the performance in second-line FL, we're seeing it as a key part of this driver of performance.

Brad Bailey: 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, the potential hospitalization data has been very well received. 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.

Speaker #22: And then the hospital removal of the potential hospitalization update has been very well received. And again, looking to prove just additional barriers to be able to treat patients closer to where they live, in the ways that you're seeing with this extremely important profile from an efficacy, safety, and deep durable responses along with subcutaneous administration.

Speaker #1: Thanks, Brad. Thanks, Victor, for the question.

Jan van de Winkel: Thanks, Brad.

Brad Bailey: Thank you.

Jan van de Winkel: Thanks, Victor, for the question.

Speaker #4: Thank you. Now we're going to take our next question, and the question comes from Kalpit Patel from Wolfe Research. Your line is open.

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.

Speaker #4: Please ask your question.

Speaker #1: Yeah. Hey, thanks for taking the question. For at Kimberly, the EPCOR DLBCL2 trial in front line setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind polaric study?

Kalpit Patel: Yeah. Hey, 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 first line?

Speaker #1: And then, do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in first line?

Speaker #2: Thanks for the questions, Tai. You can address both of these, huh?

Jan van de Winkel: Thanks for the questions. Tahi, you can address both of these, huh?

Speaker #5: Yeah. So this question, I'm like, what hazard ratio we are expecting has come up a lot in essentially, it doesn't make much sense to speculate.

Tahamtan Ahmadi: 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 is, 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. We're excitedly 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.

Tahi Ahmadi: 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 is, 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. We're excitedly 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.

Speaker #5: What we've said is that, based on the public data that is available in phase two, there is, of course—and you heard this in the other question earlier—expectation and enthusiasm about what the possible readout of that study is.

Speaker #5: So phase three have, in the past, on at Kimberly, tended to mimic close phase two data, as I said, because it's a mechanism of action that's very predictable.

Speaker #5: And so we're excitedly, as you, awaiting the readout and, of course, are very enthusiastic about how positive this trial could be. But we will see what it is when we have it.

Speaker #5: As it relates to OS, now, we all know from the ODAC that the FDA will approve frontline diffuse HB cell regimens even without OS benefit.

Tahamtan Ahmadi: 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. I've said in the past, the ability of showing an OS benefit, of course, is becoming a little bit more challenging in 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, and the bispecifics that are also now penetrating second line and are already very much available in third line. 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.

Tahi Ahmadi: 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. I've said in the past, the ability of showing an OS benefit, of course, is becoming a little bit more challenging in 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, and the bispecifics that are also now penetrating second line and are already very much available in third line. 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.

Speaker #5: As I've said in the past, the ability of showing an OS benefit, of course, is becoming a little bit more challenging in diffuse HB cell in general because of the increasing availability of very effective salvage therapies for particularly worse patients.

Speaker #5: Primary refractory, they have access to cards. And the bispecifics that are also now penetrating second line are now already very much available in third line.

Speaker #5: 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.

Tahamtan Ahmadi: That's kind of like broadly speaking how we think about it.

Speaker #5: That's kind of like broadly speaking how we think about it.

Tahi Ahmadi: That's kind of like broadly speaking how we think about it.

Speaker #1: Thanks. Thanks, Tai. Let's move on to the next question.

Jan van de Winkel: Thanks. Thanks, Tahi. Let's move on to the next question.

Speaker #4: Yes, of course. And now we're going to take our last question for today, and it comes from Judah Frommer from Morgan Stanley. Your line is open.

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.

Speaker #4: Please ask your question.

Speaker #22: Yeah, hi. Thanks for squeezing us in here. Just a follow-up on the PDO trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial?

Judah Frommer: Yeah. Hi, thanks for squeezing us in here. Just to follow up on the pivotal 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.

Speaker #22: Will you be adding any investigation sites? And just curious if you are if any other EGFR bispecifics might be being studied at those sites and what reception might be.

Speaker #22: Thanks.

Speaker #1: Thanks, Judah, for the question. Tai, can you address the recruitment and the setting for the PDO trial?

Jan van de Winkel: Thanks, Judah, for the question. Tahi, can you address the recruitment and the setting for the pivotal trial?

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

Speaker #5: 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 in the studies enrolling extremely well, so that's why it won't have an impact on anything.

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

Speaker #1: Thanks. Thanks, Tai. And that, I think, addresses the last question of today. So thank you all for calling in today. If you have any additional questions, please reach out to the Investor Relations team at Genmab.

Jan van de Winkel: 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.

Speaker #1: 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.