Q2 2026 Genmab AS Earnings Call

August 6, 2026

Operator: Hello, welcome to the Genmab H1 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, anticipate, 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. Today's presentation will also include comments on certain non-IFRS financial measures, which management uses to describe the company's baseline performance and which supplement, but do not substitute for, the comparable IFRS measures. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure.

Speaker #1: 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 #1: Unless this is required by law. Today's presentation will also include comments on certain non-IFRS financial measures, which management uses to describe the company's baseline performance, and which supplement but do not substitute for the comparable IFRS measures.

Speaker #1: We encourage you to review our full financial statements and publicly filed reports, and not to rely on any single financial measure. Please also note that at Genmab, we may hold your personal data as indicated by you as a part of our investor relations outreach activities.

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

Speaker #1: In order to update you on Genmab going forward, please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to our first speaker today, Jan van de Winkel.

Speaker #1: Please go ahead.

Speaker #2: Hello, everyone, and welcome to our financial results call for the first half of 2026. With me today is our Chief Financial Officer, Anthony Pagano.

Jan van de Winkel: Hello, everyone, welcome to our financial results call for H1 2026. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahamtan Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As the operator said, we will be making forward-looking statements, so please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do, accelerate our late-stage pipeline, maximize our commercialized medicines, and stay disciplined with our capital. That is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio.

Jan van de Winkel: Hello, everyone, welcome to our financial results call for H1 2026. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahi Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As the operator said, we will be making forward-looking statements, so please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do, accelerate our late-stage pipeline, maximize our commercialized medicines, and stay disciplined with our capital. That is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio.

Speaker #2: Our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahi Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovski.

Speaker #2: As the operator says, we will be making forward-looking statements, so please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place.

Speaker #2: We have been clear about what we set out to do: accelerate our late-stage pipeline, maximize our commercialized medicines, and stay disciplined with our capital.

Speaker #2: And that is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio. Even as we have made focused and strategic investments in our late-stage programs, in launch readiness, and in the integration of Mirros.

Jan van de Winkel: Even as we have made focused and strategic investments in our late-stage programs, in launch readiness, and in the integration of ProfoundBio. We did all this while growing operating profit. To me, that says a lot about the quality of our business. Beyond financial performance, I am enthusiastic about our recent pipeline progress. Let me walk you through the highlights. In June, we announced positive top-line results from the phase III EPCORE DLBCL-4 trial, which shows statistically significant, clinically meaningful improvement in progression-free survival. What is important about these results is what they demonstrate about epcoritamab more broadly. There is growing evidence of the versatility of epcoritamab-based combinations across multiple lines of therapy. This data was followed by the European approval of TEPKINLY plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second-line setting.

Speaker #2: And we did all this while growing operating profit. To me, that says a lot about the quality of our business. And beyond financial performance, I’m enthusiastic about our recent pipeline progress, so let me walk you through the highlights.

Speaker #2: In June, we announced positive top-line results from the Phase 3 EPCOR DLBCL IV trial, which showed statistically significant and clinically meaningful improvement in progression-free survival.

Speaker #2: What is about these results? What is important about these results is what they demonstrate about the algorithm more broadly. It is growing evidence of the versatility of algorithm-based combinations across multiple lines of therapy.

Speaker #2: This data was followed by the European approval of TAPKINLI plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second-line setting. This makes TAPKINLI the first and only bispecific-based therapy approved in Europe for this indication.

Jan van de Winkel: This makes TEPKINLY the first and only bispecific-based therapy approved in Europe for this indication. Our presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. We are looking forward to sharing with you petosemtamab data with updated results in colorectal cancer presented at ESMO in October. Based on this promising data, we are continuing to build momentum for petosemtamab. We are initiating two new phase III studies in colorectal cancer. Tahamtan will share more detail on them in just a moment. Let's turn to the catalysts we continue to look forward to this year on the next slides. As we move into H2 of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts.

Speaker #2: Our presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. And we are looking forward to sharing with you Pitucentumab data with updated results in colorectal cancer presented at ASMO in October.

Speaker #2: Based on this promising data, we are continuing to build momentum for Pitucentumab. We are initiating two new Phase 3 studies in colorectal cancer, and Tahi will share more detail on them in just a moment.

Speaker #2: Now let's turn to the catalysts. We continue to look forward to this year on the next slides. As we move into the second half of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts.

Speaker #2: For RINA-S, we anticipate that both Phase 2 and Phase 3 platinum-resistant ovarian cancer datasets will be available in the fourth quarter. For Pitucentumab, we are eagerly awaiting the readouts for both studies.

Jan van de Winkel: For Rina-S, we anticipate both phase II and phase III platinum-resistant ovarian cancer datasets will be available in Q4. For petosemtamab, we are eagerly awaiting the readouts for both studies. With better visibility, we can now say that the front-line study is expected to read out in Q4, while the second and third-line study is anticipated to read out in Q1 of 2027. Finally, for EPKINLY, we anticipate that top-line data from the frontline EPCORE DLBCL-2 study, which will be based on an interim analysis, will also be available in Q4. What this means is that for each of our late-stage programs, we remain on track for phase III readouts in H2, then potential approvals and launches in 2027. This is what we have been building towards. It reflects our focused execution. Exciting times ahead.

Speaker #2: And with better visibility, we can now say that the front-line study is expected to readout in the fourth quarter, while the second and third-line study is anticipated to readout in the first quarter of 2027.

Speaker #2: Finally, for APKINLI, we anticipate that top-line data from the front-line EPCOR DLBCL II study, based on an interim analysis, will also be available in the fourth quarter.

Speaker #2: What this means is that, for each of our late-stage programs, we remain on track for Phase 3 readouts in the second half, and then potential approvals and launches in 2027.

Speaker #2: This is what we have been building towards, and it reflects our focused execution. So, exciting times ahead. Now, I would like to hand you over to Tahi to walk you through the details of the Phase 3 colorectal studies.

Jan van de Winkel: I would like to hand you over to Tahi to walk you through the details of the phase III colorectal studies. Tahi, the floor is yours.

Speaker #2: Tahi, the floor is yours.

Speaker #3: Thank you, Jan. We are pleased to share our plans for Pitucentumab in colorectal cancer, which build on our ongoing Phase 3 trials in head and neck cancer.

Tahamtan Ahmadi: Thank you, Jan. We are pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing phase III trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. As you know, Pito is a EGFR LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care, and LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RAS/RAF wild-type colorectal cancer. The early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October.

Tahi Ahmadi: Thank you, Jan. We are pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing phase III trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. As you know, Pito is a EGFR LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care, and LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RAS/RAF wild-type colorectal cancer. The early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October.

Speaker #3: As you can see on the slide, there are a significant number of patients impacted by these diseases. And as you know, PITO is an EGFR/LGR5 bispecific antibody.

Speaker #3: The rationale for its development and metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. And LGR5 is a marker of cancer stem cells, in this disease.

Speaker #3: Combination of EGFR and LGR5 targeting has been shown to be more effective than cetuximab in various preclinical models in RAS, RAF wild-type colorectal cancer. The early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October.

Speaker #3: Based on this promising data, we are initiating two Phase 3 studies: one in front-line and one in second-line colorectal cancer. For front-line, we have already initiated a Phase 3 randomized, open-label, global trial that is designed to assess the efficacy and safety of Pitucentumab plus investigator's choice of chemotherapy, either mFOLFOX6 or FOLFIRI.

Tahamtan Ahmadi: Based on this promising data, we are initiating two phase III studies, one in frontline and one in second-line colorectal cancer. For frontline, we have already initiated a phase III randomized trial, open label, a global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator choice chemotherapy of either mFOLFOX6 or FOLFIRI, a first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS/RAF wild-type. It will thus be versus the standard of care, namely cetuximab plus chemotherapy. For the second-line colorectal cancer patients, the phase III trial will be similarly a randomized open label and global trial. This trial is designed to assess the efficacy and safety of petosemtamab plus investigator choice therapy of either modified FOLFOX 6 or FOLFIRI. The second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS/RAF wild-type.

Tahi Ahmadi: Based on this promising data, we are initiating two phase III studies, one in frontline and one in second-line colorectal cancer. For frontline, we have already initiated a phase III randomized trial, open label, a global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator choice chemotherapy of either mFOLFOX6 or FOLFIRI, a first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS/RAF wild-type. It will thus be versus the standard of care, namely cetuximab plus chemotherapy. For the second-line colorectal cancer patients, the phase III trial will be similarly a randomized open label and global trial. This trial is designed to assess the efficacy and safety of petosemtamab plus investigator choice therapy of either modified FOLFOX 6 or FOLFIRI. The second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS/RAF wild-type.

Speaker #3: A first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RASS, RAF, wild-type. It will thus be versus the standard of care, namely Cituximab plus chemotherapy.

Speaker #3: For the second-line colorectal cancer patients, the Phase 3 trial will be similarly a randomized open label and global trial. This trial is designed to assess the efficacy and safety of Pitucentumab plus investigator choice therapy of either modified FOLFIRI 6 or FOLFIRI.

Speaker #3: The second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS, RAF wild-type. And here, the trial will be versus the standard of care, which is cetuximab or panitumumab plus chemotherapy.

Tahamtan Ahmadi: Here the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy. Taken together with our two ongoing phase III trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer and the encouraging data we continue to generate, petosemtamab is rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients. With that, I'm pleased to hand over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

Tahi Ahmadi: Here the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy. Taken together with our two ongoing phase III trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer and the encouraging data we continue to generate, petosemtamab is rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients. With that, I'm pleased to hand over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

Speaker #3: So taken together with our two ongoing Phase 3 trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer, and the encouraging data we continue to generate, Pitucentumab is a rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients.

Speaker #3: And with that, I'm pleased to hand over to Brad for review of the recent commercial performance for APKINLI and TIFDAC.

Speaker #1: Thanks, Tahi. A proprietary portfolio performed incredibly well in the first half of the year. Sales totaled $396 million representing 37% growth compared to the same time last year.

Brad Bailey: Thanks, Tahi. Our proprietary portfolio performed incredibly well in H1 of the year. Sales totaled $396 million, representing 37% growth compared to the same time last year. These results demonstrate the strength of Antibody Sciences, as well as the strong execution by our teams to bring our medicines to patients around the world. The performance we delivered in H1 2026 reflects growth for both EPKINLY and TIVDAK globally. We're very pleased with how EPKINLY is performing. In fact, EPKINLY grew to $312 million in sales for H1 of the year, representing a 48% increase year-over-year and a 28% increase in the quarter. In the US, we delivered accelerated growth with increases in both new patient starts and new site activations.

Speaker #1: These results demonstrate the strength of antibody sciences as well as the strong execution by our teams to bring our medicines to patients around the world.

Speaker #1: The performance we delivered in the first half of 2026 reflects growth for both APKINLI and TIFDAC globally. We're very pleased with how APKINLI is performing.

Speaker #1: In fact, APKINLI grew to $312 million in sales for the first half of the year, representing a 48% year increase year over year, and a 28% increase in the quarter.

Speaker #1: In the US, we delivered accelerated growth with increases in both new patient starts and new site activations. The launch of chemo-free fixed duration APKINLI plus R-squared and second-line FL has been going extremely well with rapid uptake across sites.

Brad Bailey: The launch of chemo-free fixed duration EPKINLY plus R-squared in second-line FL has been going extremely well with rapid uptake across sites. This contributed positively to our growth in H1 of the year and suggests that EPKINLY is becoming a preferred regimen in this setting. We've also seen increasing growth in the community this year, with the majority of new sites activated coming from community practices, and now over 90% of our key customers are ordering for two or more sites. This is driven by EPKINLY's differentiated dual indication label without a recommendation for 24-hour hospitalization and broad adoption of EPKINLY plus R-squared in second-line FL, which is leading more sites to utilize EPKINLY across its approved indications.

Speaker #1: This contributed positively to our growth in the first half of the year and suggests that APKINLI is becoming a preferred regimen in this setting. We've also seen increasing growth in the community this year, with the majority of new sites activated coming from community practices, and now over 90% of our key customers are ordering for two or more sites.

Speaker #1: This is driven by APKINLI's differentiated dual-indication label without a recommendation for 24-hour hospitalization, and broad adoption of APKINLI plus R-squared and second-line FL, which is leading more sites to utilize APKINLI across its approved indications.

Speaker #1: This performance reflects strong execution by our field teams, physician confidence in APKINLI’s differentiated clinical profile, and the value of using a single bispecific option across DLBCL and FL.

Brad Bailey: This performance reflects strong execution by our field teams, physician confidence in EPKINLY's differentiated clinical profile, and the value of using a single bispecific option across DLBCL and FL. The uptake we're seeing in the community, with more physicians gaining experience using EPKINLY at sites of care closer to where patients live, is a positive indicator as we look ahead to potential launches in early lines of DLBCL. Outside the US, performance remains strong. In Japan, EPKINLY continues to build on its compelling position in the market with approvals in both DLBCL and FL. We expect the second-line FL launch, anticipated later this year, will serve as another growth driver for the brand. Through our partner AbbVie, EPKINLY's global footprint continues to expand, including recent approvals for EPKINLY plus R-squared in second-line FL in Europe and China.

Speaker #1: The uptake we're seeing in the community, with more physicians gaining experience using APKINLI and sites of care closer to where patients live, is a positive indicator as we look ahead to potential launches in early lines of DLBCL.

Speaker #1: Outside the US, performance remains strong. In Japan, APKINLI continues to build on its compelling position in the market, with approvals in both DLBCL and FL.

Speaker #1: We expect the second-line FL launch, anticipated later this year, will serve as another growth driver for the brand. Through our partner AVI, APKINLI's global footprint continues to expand, including recent approvals for APKINLI plus R-squared and second-line FL in Europe and China.

Speaker #1: Overall, we're really pleased with APKINLI's growth globally and particularly in the US and Japan where we've booked sales. The momentum we are seeing today reinforces our confidence in APKINLI's long-term growth opportunities, especially its potential in early lines of therapy.

Brad Bailey: Overall, we're really pleased with EPKINLY's growth globally, and particularly in the US and Japan, where we book sales. The momentum we are seeing today reinforces our confidence in EPKINLY's long-term growth opportunities, especially its potential in early lines of therapy. As we look towards the back half of 2026, we're focused on continuing to grow EPKINLY and strengthening our leadership in the market by maximizing our first-mover advantage in second-line FL and preparing for anticipated launches in early lines of DLBCL in the future. Turning briefly to TIVDAK. TIVDAK totaled $84 million in sales during H1 of the year, driven by continued performance in the US, as well as in our launch markets in Japan and Europe. In markets where TIVDAK is available, we saw expanding site activations, underscoring the continued need for treatments that can improve survival for women with advanced cervical cancer.

Speaker #1: As we look towards the back half of 2026, we're focused on continuing to grow APKINLI and strengthening our leadership in the market by maximizing our first-mover advantage and second-line FL, and preparing for anticipated launches in early lines of DLBCL in the future.

Speaker #1: Turning briefly to TIFDAC, TIFDAC totaled $84 million in sales during the first half of the year, driven by continued performance in the US, as well as in our launch markets in Japan and Europe.

Speaker #1: In markets where TIFDAC is available, we saw expanding site activations, underscoring the continued need for treatments that can improve survival for women with advanced cervical cancer.

Speaker #1: As part of our work to bring TIFDAC to more patients, we secured reimbursement for TIFDAC in the UK, and the conversations continue to progress in additional markets.

Brad Bailey: As part of our work to bring TIVDAK to more patients, we secured reimbursement for TIVDAK in the UK, and the conversations continue to progress in additional markets. Looking ahead, we remain focused on continuing to scale our commercialization capabilities to support TIVDAK launches in new markets while building on that foundation to prepare for the anticipated launches of Rina-S and petosemtamab in the future. Heading into H2 of 2026, we're extremely pleased with the performance across our portfolio. Our performance to date, combined with meaningful momentum underway across the business to advance our pipeline and expand our commercialization footprint, positions us well to grow adoption of our approved medicines to benefit more patients and successfully launch additional indications and new medicines as we look towards the end of 2026 and into 2027 and beyond.

Speaker #1: Looking ahead, we remain focused on continuing to scale our commercialization capabilities to support TIFDAC launches in new markets, while building on that foundation to prepare for the anticipated launches of Rina-S and Pitucentumab in the future.

Speaker #1: Heading into the second half of 2026, we're extremely pleased with the performance across our portfolio. Our performance to date combined with meaningful momentum underway across the business to advance our pipeline and expand our commercialization footprint positions us well to grow adoption of our approved medicines to benefit more patients, and successfully launch additional indications and new medicines as we look towards the end of 2026 and end of 2027 and beyond.

Speaker #1: With that, I'll turn it over to Anthony to walk us through the financials.

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

Speaker #2: Thanks, Brad. The first half of 2026 demonstrated the continued strength of our business, with revenue growing 25% year over year. Beyond the headline 25% revenue growth, I'd highlight two characteristics of our performance.

Anthony Pagano: Thanks, Brad. The H1 2026 demonstrated the continued strength of our business, with revenue growing 25% year over year. Beyond the headline 25% revenue growth, I'd highlight two characteristics of our performance. First, high growth, second, broad-based growth. Now, starting with the high growth. DARZALEX increased 21% year over year, while worldwide EPKINLY net product sales increased 48%, reflecting continued commercial momentum and strong execution. Beyond these two brands, the remainder of our portfolio increased 35% year over year. Now turning to broad-based growth. Approximately half of our year-over-year revenue growth came from DARZALEX. Impressively, the other half was generated by EPKINLY and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base.

Speaker #2: First, high growth, and second, broad-based growth. Now, starting with the high growth, Darzalex increased 21% year over year, while worldwide APKINLI net product sales increased 48%, reflecting continued commercial momentum and strong execution.

Speaker #2: Beyond these two brands, the remainder of our portfolio increased 35% year over year, now turning to broad-based growth. Approximately half of our year-over-year revenue growth came from Darzalex.

Speaker #2: Impressively, the other half was generated by APKINLI and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable.

Speaker #2: That evolution continues to strengthen the quality of our revenue base. The strength of our business also provides the financial flexibility to continue investing behind our highest-value growth opportunities, including Epkinly, Rina-S, and pitucentumab.

Anthony Pagano: The strength of our business also provides the financial flexibility to continue investing behind our highest-value growth opportunities, including EPKINLY, Rina-S, and pidocentimab. At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that Genmab can increase investment while continuing to expand profitability. Now, before moving to our updated 2026 guidance, let me briefly comment on tax. Our effective tax rate for the H1 was 3.6%, primarily reflecting the ongoing integration of Merz and related recognition and utilization of deferred tax assets. As shown in the appendix to the presentation, this equates to tax expense of DKK 13 million. Now, as we've discussed previously, we continue to evaluate the integration of Merz from a tax perspective. As a result, our effective tax rate may continue to fluctuate as those integration activities progress.

Speaker #2: At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that GENMAB can increase investment while continuing to expand profitability.

Speaker #2: Now, before moving to our updated 2026 guidance, let me briefly comment on tax. Our effective tax rate for the first half was 3.6%, primarily reflecting the ongoing integration of MERIS and related recognition and utilization of deferred tax assets.

Speaker #2: As shown in the appendix to the presentation, this equates to a tax expense of $13 million. Now, as we've discussed previously, we continue to evaluate the integration of MERIS from a tax perspective.

Speaker #2: As a result, our effective tax rate may continue to fluctuate as those integration activities progress. We expect our effective tax rate will normalize over the next 12 to 18 months.

Anthony Pagano: We expect our effective tax rate will normalize over the next 12 to 18 months. Now, with that, let me turn to our updated 2026 financial guidance. The strength of our business and the financial flexibility it continues to create are reflected in our updated 2026 financial guidance. Compared with our previous guidance, we now expect to deliver 5% higher revenue and 7% higher operating profit while increasing investment by only 2%. This demonstrates the operating leverage inherent in our business. Starting with revenue, we now expect full-year revenue to be in the range of DKK 4.3 to 4.5 billion, representing 19% year-over-year growth at the midpoint. This compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both DARZALEX and EPKINLY, with the DKK 195 million increase at the midpoint being approximately equally split between DARZALEX and EPKINLY. Now turning to operating expenses.

Speaker #2: Now, with that, let me turn to our updated 2026 financial guidance. The strength of our business, and the financial flexibility it continues to create, are reflected in our updated 2026 financial guidance.

Speaker #2: Compared with our previous guidance, we now expect to deliver 5% higher revenue and 7% higher operating profit. While increasing investment, but only 2%. This demonstrates the operating leverage inherent in our business.

Speaker #2: Starting with revenue, we now expect full-year revenue to be in the range of 4.3 to 4.5 billion. Representing 19% year-over-year growth at the midpoint.

Speaker #2: And this compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both DARZALEX and EPKINLY, with the $195 million increase at the midpoint being approximately equally split between DARZALEX and EPKINLY.

Speaker #2: Now, turning to operating expenses, we are continuing to invest behind our highest-value growth opportunities. Our updated operating expense guidance includes additional investment to maximize long-term value of our portfolio.

Anthony Pagano: We are continuing to invest behind our highest value growth opportunities. Our updated operating expense guidance includes additional investment to maximize the long-term value of our portfolio, including the two new phase III petosemtamab studies we announced today. Even with these incremental investments, we are only increasing our OPEX guidance by 2%, resulting in a new midpoint of DKK 2.88 billion. Finally, operating profit is now expected to be in the range of DKK 1.1 to 1.4 billion. Importantly, the majority of our revenue outperformance continues to translate into higher operating profit while preserving our ability to invest behind our highest value growth opportunities. In summary, our H1 performance provides further evidence of the strength of our business. We are delivering high growth, broadening our revenue base, investing behind our highest value opportunities, and continuing to expand profitability. Together, this positions us well to deliver sustained growth and long-term value creation.

Speaker #2: Including the two new phase three Pitucentumab studies we announced today. Even with these incremental investments, we're only increasing our OpEx guidance by 2%, resulting in a new midpoint of 2.88 billion dollars.

Speaker #2: Finally, operating profit is now expected to be in the range of 1.1 to 1.4 billion. Importantly, the majority of our revenue outperformance continues to translate into higher operating profit, while preserving our ability to invest behind our highest-value growth opportunities.

Speaker #2: In summary, our first half performance provides further evidence of the strength of our business. We are delivering high growth, broadening our revenue base, investing behind our highest-value opportunities, and continuing to expand profitability.

Speaker #2: Together, this positions us well to deliver sustained growth and long-term value creation. Now, on that note, I'm going to hand you back over to Jan.

Anthony Pagano: Together, this positions us well to deliver sustained growth and long-term value creation. On that note, I'm going to hand you back over to Jan.

Anthony Pagano: On that note, I'm going to hand you back over to Jan.

Speaker #1: Thank you, Anthony. Let's now move to our final slide. Looking at the first half overall, we have had a strong six months, both scientifically and financially.

Jan van de Winkel: Thank you, Anthony. Let's now move to our final slides. Looking at the H1 overall, we have had a strong six months, both scientifically and financially. Our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long-term value. When I look at where we are, the revenue base we have built, our versatile and promising product pipeline, and what is still to come in the coming months, I'm super excited. That now ends our formal presentation, and thank you for listening. Operator, please open the call for questions.

Speaker #1: And our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long-term value. So when I look at where we are, the revenue base we have built, our versatile and promising product pipeline, and what is still to come in the coming months, I'm super excited.

Speaker #1: That now ends our formal presentation, and thank you for listening. And operator, please open the call for questions.

Speaker #3: Thank you so much, dear participants. As a reminder, if you wish to ask a question, please press star 11 on your telephone keypad, and wait for your name to be announced.

Operator: Thank you so much, dear participants. As a reminder, if you wish to ask a question, please press star 11 on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while I compile the Q&A roster. This will take a few moments. Now we're going to take our first question. It comes line of Zane Abraham.

Speaker #3: To withdraw a question, please press star 1 and 1 again. Please then bow or compile the Q&A roaster; this will take a few moments.

Speaker #3: And now we're going to take our first question. And it comes to line of Zane Abraham. Your line is open. Please ask your question.

[Analyst] (JPMorgan): Hello.

Zain Ebrahim: Hello.

Operator: Your line is open. Please ask your question.

Speaker #4: Hi everyone. Thanks for taking the question. Zane Abraham, JP Morgan. First question is on the Pitucentumab second-line trial which we're now guiding for the readout in Q1 of 2027.

[Analyst] (JPMorgan): Hi, everyone. Thanks for taking the question. Zane Abraham, JPMorgan. First question is on the petosemtamab second line trial, which way you're now guiding for the readout in Q1 in 2027. Just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint, so overall survival, or is it the upsizing of the trial? How is recruitment progressing for the second line trial, relative to your expectations? I think the slide suggests it's still recruiting. Just any updates there would be helpful. My second question is on EPCORE DLBCL-4. Quite a strong PFS outcome, but just any sense of what you've seen so far on overall survival, or was it just too immature to see a trend at this point?

Zain Ebrahim: Hi, everyone. Thanks for taking the question. Zane Abraham, JPMorgan. First question is on the petosemtamab second line trial, which way you're now guiding for the readout in Q1 in 2027. Just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint, so overall survival, or is it the upsizing of the trial? How is recruitment progressing for the second line trial, relative to your expectations? I think the slide suggests it's still recruiting. Just any updates there would be helpful. My second question is on EPCORE DLBCL-4. Quite a strong PFS outcome, but just any sense of what you've seen so far on overall survival, or was it just too immature to see a trend at this point?

Speaker #4: I just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint to overall survival, or is it the upsizing of the trial?

Speaker #4: And how is recruitment progressing for the second-line trial relative to your expectations? I think the slide suggests it's still recruiting. So just any updates there would be helpful.

Speaker #4: And then my second question is on Abcor DLBCL4. It's quite a strong PFS outcome. But just any sense of what you've seen so far on overall survival, or was it just too mature to see a trend at this point?

[Analyst] (JPMorgan): What's the latest feedback you've had from the FDA on whether the second line trial or the first line trial could be used as a confirmatory trial?

Speaker #4: And what's the latest feedback you've had from the FDA on whether the second-line trial or the first-line trial could be used as a confirmatory trial?

Zain Ebrahim: What's the latest feedback you've had from the FDA on whether the second line trial or the first line trial could be used as a confirmatory trial?

Speaker #1: Thank you, Dan, for the questions. And I think I will hand them both over to Tahi. Maybe start, Tahi, with the second-line trial for Pitu and head and neck cancer, and then move on to DLBCL4 to address some of the points raised here.

Jan van de Winkel: Thank you, Dan, for the questions. I think I will hand them both over to Tahi. Maybe start, Tahi, with the second line trial for peto and head and neck cancer, then move on to DLBCL-4 to address some of the points raised here.

Speaker #4: Yeah, thank you for the question. And so let's take the Pitu first. As endpoint is overall survival. So this is an event-driven projection from when we have the data.

Tahamtan Ahmadi: Thank you for the question. Let's take the peto first. As you correctly noted, the endpoint is OS, so this is an event-driven projection for when we have the data, and the trial is fully enrolled. That was to that question. We are just updating based on what we see when we expect to have the top line results, which is now in Q1 of next year. As it relates to the second-line, third-line Len Epco combination, you noted correctly, that this is a very exciting PFS benefit for patients for what is a chemo-free regimen of a pill with a subcutaneous injection, with a really impressive CR rate for patients. That is the most meaningful kind of data point, and we are really excited about the data.

Tahi Ahmadi: Thank you for the question. Let's take the peto first. As you correctly noted, the endpoint is OS, so this is an event-driven projection for when we have the data, and the trial is fully enrolled. That was to that question. We are just updating based on what we see when we expect to have the top line results, which is now in Q1 of next year. As it relates to the second-line, third-line Len Epco combination, you noted correctly, that this is a very exciting PFS benefit for patients for what is a chemo-free regimen of a pill with a subcutaneous injection, with a really impressive CR rate for patients. That is the most meaningful kind of data point, and we are really excited about the data.

Speaker #4: And the trial is fully enrolled. So that was to that question. And so we're just updating based on what we see when we expect to have the top-line results, which is now in the first quarter of next year.

Speaker #4: As it relates to the second-line and third-line Abcor combination, you noted correctly that this is a very exciting PFS benefit for patients for what is a chemo-free regimen of a pill with a subcutaneous injection.

Speaker #4: With a really impressive CR rate for patients that's the most meaningful kind of data point. And we are really excited about the data. The OS, of course, at that point, is totally immature, which is why it's not yet been reported.

Tahamtan Ahmadi: The OS, of course, at that point, is totally immature, which is why it is not yet been reported, and the data will be presented in an upcoming conference, so we will have a chance to look at it in a little bit more granular detail. As it relates to the part of your question for the confirmation of the indication that is already approved, we are, of course, in very active engagement with the agency on all kinds of fronts. Whether the frontline or the second-line trial is going to be the confirmatory trial, I think that is an ongoing discussion right now, to a degree, also depends on how are the results of the frontline trial going to be. This is all there is to say at this point. We have an active process, active engagement, and it will be one of the two.

Tahi Ahmadi: The OS, of course, at that point, is totally immature, which is why it is not yet been reported, and the data will be presented in an upcoming conference, so we will have a chance to look at it in a little bit more granular detail. As it relates to the part of your question for the confirmation of the indication that is already approved, we are, of course, in very active engagement with the agency on all kinds of fronts. Whether the frontline or the second-line trial is going to be the confirmatory trial, I think that is an ongoing discussion right now, to a degree, also depends on how are the results of the frontline trial going to be. This is all there is to say at this point. We have an active process, active engagement, and it will be one of the two.

Speaker #4: And the data will be presented in an upcoming conference. So we'll have a chance to look at it a little bit more granular detail.

Speaker #4: As it relates to the part of your question, for the confirmation of the indication that is already approved, we are, of course, in very active engagement with the agency on all kinds of funds.

Speaker #4: And so, whether the front-line or the second-line trial is going to be the confirmatory trial, I think that's an ongoing discussion right now. To a degree, it also depends on how the results of the front-line trial are going to be.

Speaker #4: And so this is all there is to say at this point. We have an active process, active engagement, and it'll be one of the two.

Speaker #1: Thanks, Tahi. Let's hand it back. The question back to the operator, and then see whether there's another one.

Jan van de Winkel: Thanks, Tahi. Let's hand the question back to the operator, and then see whether there is another one.

Speaker #3: Yes, of course. And now we're going to take our next question. Just give us a moment. And the question comes line of Michael Schmidt from Guggenheim Partners.

Operator: Yes, of course. Now we are going to take our next question. Just give us a moment. The question comes from the line of Michael Schmidt from Guggenheim Securities. Your line is open, please ask your question.

Speaker #3: Your line is open. Please ask your question.

Speaker #5: Hey, thanks for taking my questions. I had one on Abcor DLBCL2, and I'm just trying to wrap my head around the timing of the interim analysis in the fourth quarter this year.

Michael Schmidt: Hey, thanks for taking my questions. I had one on EPCORE DLBCL-2. I'm just trying to wrap my head around the timing of the interim analysis in Q4 this year. Based on our work, we think this should have already occurred at some point last year. How do you explain this one-year delay, essentially, of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

Speaker #5: Based on our work, we think this should have already occurred at some point last year. How do you explain this one-year delay, essentially, of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

Speaker #1: Thanks, Michael, for the question. Tahi, can you address this one?

Jan van de Winkel: Thanks, Michael, for the question. Taya, can you address this one?

Tahamtan Ahmadi: Well, let's start first. We're very excited about the results of this trial, as they are going to read out next quarter. This is the most important study, I think it's fair to say, within the epcoritamab franchise. There's exciting phase II data that is in the public domain. Last year and the year before presented at ASH around the combination of epco with R-CHOP that showed really unprecedented CR rates, which is driving the excitement for the results of this trial. The only other thing to say is that we have been now confirming that this is based on the interim and that it will be top-lined next quarter. I think we should probably leave it at this at this point. Once we have the data in our hands, we can have a good conversation about all of these other questions that may arise.

Tahi Ahmadi: Well, let's start first. We're very excited about the results of this trial, as they are going to read out next quarter. This is the most important study, I think it's fair to say, within the epcoritamab franchise. There's exciting phase II data that is in the public domain. Last year and the year before presented at ASH around the combination of epco with R-CHOP that showed really unprecedented CR rates, which is driving the excitement for the results of this trial. The only other thing to say is that we have been now confirming that this is based on the interim and that it will be top-lined next quarter. I think we should probably leave it at this at this point. Once we have the data in our hands, we can have a good conversation about all of these other questions that may arise.

Speaker #4: Well, let's start first. We're very excited what the results of this trial as they've been going to readout. Next quarter, this is the most important study, I think it's fair to say, within the Abcor readout franchise.

Speaker #4: There's exciting phase two data that is in the public domain. Last year and the year before, presented at ASH, around the combination of Abcor with Artshop, that showed really unprecedented CR rates.

Speaker #4: Which is driving the excitement for the results of this trial. And so the only other thing to say is that we have been now confirming that this is based on the interim and that it will be top-line next quarter.

Speaker #4: And I think we should probably leave it at this at this point. And once we have the data in our hands, we can have a good conversation about all of these other questions that may arise.

Speaker #4: But for now, I'm looking forward to next quarter.

Tahamtan Ahmadi: For now, next quarter, looking forward to it.

Tahi Ahmadi: For now, next quarter, looking forward to it.

Speaker #1: Thanks, Tahi. Thanks, Michael, for the question.

Jan van de Winkel: Thanks, Taya. Thanks, Michael, for the question.

Speaker #3: Thank you. Now we're going to take our next question. And the question comes line of James Gordon from Barclays. 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 James Gordon from Barclays. Your line is open. Please ask your question.

Speaker #6: Hello, James Gordon from Barclays. A question, a couple of clarifications, please. One question was on Pitu. So the the refractory trial, presumably because the first line has an OR primary with interim OS, whereas the refractory trial is more mature OS.

James Gordon: Hello, James Gordon from Barclays. A question, a couple of clarifications, please. One question was on PETE. The first-line trial is now going to report before the refractory trial, presumably because the first line has an ORR primary with interim OS, whereas the refractory trial is more mature OS. For the first line trial that I think we're going to get in Q4, how mature will the interim OS be when you report it that you plan to file? Do you think the first line or refractory is a higher bar in terms of being successful? It was just two clarifications. One was for epcoritamab, where we're going to get the interim in the first-line trial in Q4. If it doesn't work at interim, will you tell us that and say that the trial is going to continue on to the final data?

Speaker #6: So for the first-line trial, I think we're going to get in Q4. How mature will the interim OS be when you report it that you plan to file?

Speaker #6: And do you think that the first-line or refractory is a higher bar in terms of being successful? And then it was just two clarifications.

Speaker #6: One was for Epkinley and where we're going to get the interim and the first-line trial in Q4. So if it doesn't work at interim, will you tell us that and say that the trial is going to continue onto the final data, or it's just we won't hear anything if we don't hear anything by the end of the year, we'll have to assume that it didn't work at interim?

James Gordon: It's just we won't hear anything, and if we don't hear anything by the end of the year, we'll have to assume that it didn't work interim. How that works, please. The other clarification was just for Rina-S and PROC, so the 01 and 02 trials, they're both in Q4, so phase II and a phase III. Are we going to get two different readouts? It's the phase III that's material because that's what you're filing, so we'll just get all the data together.

Speaker #6: How that works, please? And the other clarification was just for Rina S and Proc. So there's the O1 and O2 trials. They're both in Q4.

Speaker #6: So phase two and phase three. Are we going to get two different readouts, or will you just is the phase three that's material because that's what you're filing?

Speaker #6: So we'll just get all the data together.

Speaker #1: Thanks, James, for the questions. And the clarification requests. So the first two I'm going to hand over again to Tahi, and then Judith can deal with the phase two and phase three data for Proc for Rina.

Jan van de Winkel: Thanks, James, for the questions and the clarification requests. The first two, I'm going to hand over again to Taya, and Judith can deal with the phase II and phase III data for PROC for RENA. Taya, why don't you start with PETO and the frontline trial?

Speaker #1: But Tahi, why don't you start with Pitu and the front-line trial?

Speaker #4: So there was actually, I think, like, I don't know. I start counting at three, but okay, I'll try to address all of the points that were made.

Tahamtan Ahmadi: It was actually, I think, I don't know. I stopped counting at three, I'll try to address all of the points that were made and asked. The first thing is, on the PETO trial, we've, in the beginning, stuck to the guidance that had come from here as one or both going to read out this year. Now we are being more precise that we actually will have the top-line results on the frontline indication, which is very exciting because this is obviously the one indication that has a significantly larger impact on patients, larger population, and we believe this is going to be very exciting data when we have it to present and discuss. As it relates to what will be meeting statistical significance, we don't have any visibility to this would be all speculation. I don't think this makes any sense.

Tahi Ahmadi: It was actually, I think, I don't know. I stopped counting at three, I'll try to address all of the points that were made and asked. The first thing is, on the PETO trial, we've, in the beginning, stuck to the guidance that had come from here as one or both going to read out this year. Now we are being more precise that we actually will have the top-line results on the frontline indication, which is very exciting because this is obviously the one indication that has a significantly larger impact on patients, larger population, and we believe this is going to be very exciting data when we have it to present and discuss. As it relates to what will be meeting statistical significance, we don't have any visibility to this would be all speculation. I don't think this makes any sense.

Speaker #4: And ask. So the first thing is, on the Pitu trial, we've, in the beginning, stuck to the guidance that had come from EOS—one or both going to read out this year.

Speaker #4: Now we are being more precise that we actually will have the top-line results on the front-line indication, which is very exciting because this is obviously the one indication that has a significantly larger impact on patients' larger population and we believe this is going to be very exciting data.

Speaker #4: When we have it to present and discuss. As to relates to what will be meeting statistical significance, we don't have any visibility to this.

Speaker #4: So this would be all speculation. So I don't think this makes any sense. But so we'll have that discussion when we have the interim results in our hands.

Tahamtan Ahmadi: We'll have that discussion when we have the interim results in our hands. What we are saying is we will have an interim data that we expect to be the basis for filing in the next quarter on this frontline, PETO trial. I think you asked about whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this, to be honest. I think having an OS benefit is always a high bar, we have a very high confidence in PETO being able to provide an overall survival benefit for patients in frontline and in second line.

Tahi Ahmadi: We'll have that discussion when we have the interim results in our hands. What we are saying is we will have an interim data that we expect to be the basis for filing in the next quarter on this frontline, PETO trial. I think you asked about whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this, to be honest. I think having an OS benefit is always a high bar, we have a very high confidence in PETO being able to provide an overall survival benefit for patients in frontline and in second line.

Speaker #4: But what we are saying is we will have an interim data that we expect to be the basis for filing. In the next quarter on this front-line Pitu trial.

Speaker #4: Then I think you asked about what whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this, to be honest.

Speaker #4: I think having a OS benefit is always a high bar. And then we have a very high confidence in Pitu being able to provide an oversurvival benefit for patients in front-line and in second-line this is underwritten to a degree by these two BTD indications.

Tahamtan Ahmadi: This is underwritten to a degree by these two BTD indications, data sets in a public domain, is, of course, also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients in head and neck in these two studies that are already operationalized. In colorectal, where we are today announcing that we're going to start two phase IIIs and any future trials. It's a very exciting drug. We're really looking forward to the data in frontline, we can have a more detailed discussion on what actually the data will be.

Tahi Ahmadi: This is underwritten to a degree by these two BTD indications, data sets in a public domain, is, of course, also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients in head and neck in these two studies that are already operationalized. In colorectal, where we are today announcing that we're going to start two phase IIIs and any future trials. It's a very exciting drug. We're really looking forward to the data in frontline, we can have a more detailed discussion on what actually the data will be.

Speaker #4: The datasets in the public domain and then this, of course, also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients.

Speaker #4: In head and neck, in these two studies that are already operationalized. In colorectal, where we are today announcing that we're going to start two phase threes and then on your future trials.

Speaker #4: It's a very exciting drug. We really looking forward to the data in front-line and then we can have a more detailed discussion on what actually the data will be.

Speaker #1: And then there was a question, Tahi, on Abcor readout in the front-line study when we wouldn't hit the interim. What would happen then with the Pitu trial?

Jan van de Winkel: There was a question, Taya, on epcoritamab in the frontline study, when we wouldn't hit the interim, what would happen then with the trial?

Speaker #4: I think we should stick with what we just said. We expect to present the interim data next quarter.

Tahamtan Ahmadi: I think we should stick with what we just said, that we expect to present the interim data next quarter.

Tahi Ahmadi: I think we should stick with what we just said, that we expect to present the interim data next quarter.

Speaker #1: All right. Very good. Let's stay with that. And then Judith, maybe the phase two and phase three datasets for Rina and Proc. A bit more color there.

Jan van de Winkel: All right. Very good. Let's stay with that. Judith, maybe the phase II and phase III data sets for RENA and PROC, a bit more color there. Judith, are you there?

Speaker #1: Judith, are you there?

Speaker #4: If she's unmuted, I can take that too.

Tahamtan Ahmadi: If she's unmuted, I can take that too.

Tahi Ahmadi: If she's unmuted, I can take that too.

Jan van de Winkel: Okay. Why don't you take it, Tahi?

Speaker #1: Okay. Why don't you take it, Tahi?

Speaker #4: So there will be, indeed, as you said, a phase two and PROC. And then we already talked about that there's also a phase three.

Tahamtan Ahmadi: There will be indeed, as you said, there's a phase II in PARP, and then, we already talked about that there's also a phase III. Both of these data sets, of course, will be made available at the time that we get them and then have the top-line results.

Tahi Ahmadi: There will be indeed, as you said, there's a phase II in PARP, and then, we already talked about that there's also a phase III. Both of these data sets, of course, will be made available at the time that we get them and then have the top-line results.

Speaker #4: Both of these datasets, of course, will be made available at the time that we get them. And then we'll have the top-line results.

Speaker #1: I think that should do it for now, Tahi. Thanks.

Jan van de Winkel: I think that should do it for now, Tahi. Thanks.

Speaker #6: Thank you.

Tahamtan Ahmadi: Thank you.

James Gordon: Thank you.

Speaker #1: Thanks, James.

Jan van de Winkel: Thanks, James.

Speaker #3: Thank you. Now we're going to take our next question. And the question comes from the line of Gregory Renza from Truist. Your line is open, please.

Operator: Thank you. Now we're going to take our next question. The question comes from the line of Gregory Renza from Truist. Your line is open, please ask.

Speaker #3: Ask.

Speaker #5: Hi, thanks so much for taking our question. This is about Uncle Greg. I have one for Pitu in head and neck. With competitors advancing quickly in the second line and third line setting ahead of your SN2 readout in the first quarter next year, what efficacy and durability profile would Pitu need to show to remain competitive?

Gregory Renza: Hi. Thanks so much for taking our question. This is support one for Greg. I have one for Pito in head and neck. With competitors advancing quickly in the second-line, third-line setting ahead of your action to read out in Q1 of next year, what efficacy and durability profile would Pito need to show to remain competitive? Thanks so much.

[Analyst] (Truist): Hi. Thanks so much for taking our question. This is support one for Greg. I have one for Pito in head and neck. With competitors advancing quickly in the second-line, third-line setting ahead of your action to read out in Q1 of next year, what efficacy and durability profile would Pito need to show to remain competitive? Thanks so much.

Speaker #5: Thanks so much.

Speaker #1: Thanks, Greg, for the question. Tahi, can you take this one?

Jan van de Winkel: Thanks, Greg, for the question. Tahi, can you take this one?

Speaker #4: Sure. I think you're alluding to the J&J filing. I think one thing to say is that we just had a conversation about this, and that the second-line dataset will be a Phase 3 with an overall survival benefit.

Tahamtan Ahmadi: Sure. I think you're alluding to the J&J filing. I think one thing to say is that we just had a conversation about this and that the second-line data set will be a phase III with an overall survival benefit, and that is a, of course, completely significantly different data set as an ORR duration of response data set that may form the basis of accelerated approval, as it is for amivantamab. We remain very steadfast in our statement that we believe petosemtamab is the best-in-class second-generation EGFR bispecific based on all the data that we have seen in head and neck, but also outside of head and neck.

Tahi Ahmadi: Sure. I think you're alluding to the J&J filing. I think one thing to say is that we just had a conversation about this and that the second-line data set will be a phase III with an overall survival benefit, and that is a, of course, completely significantly different data set as an ORR duration of response data set that may form the basis of accelerated approval, as it is for amivantamab. We remain very steadfast in our statement that we believe petosemtamab is the best-in-class second-generation EGFR bispecific based on all the data that we have seen in head and neck, but also outside of head and neck.

Speaker #4: And that is, of course, a completely and significantly different dataset as an ORR duration of response dataset that may form the basis of accelerated approval.

Speaker #4: As it is for Amivantamab. So we remain very steadfast in our statement that we believe Pitu is the best-in-class second-generation eGFR bispecific based on all the data that we have seen in head and neck, but also outside of head and neck.

Speaker #4: And the totality of our data, the fact that we will have a front-line indication with Pembo that we are seeking with the Phase 3 readout next quarter, and then an overall survival Phase 3 readout in the first quarter of next year, I think this is a very compelling and comprehensive dataset across these two studies.

Tahamtan Ahmadi: The totality of our data, the fact that we will have a frontline indication with pembrolizumab that we are seeking with the phase III readout next quarter, and then an overall survival phase III readout in Q1 of next year. I think this is a very compelling and comprehensive data set across these two studies, monotherapy, second-line, third-line, combination with pembrolizumab frontline that is going to really underwrite our ambition in head and neck. We're very comfortable with our position and where we are. The expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Tahi Ahmadi: The totality of our data, the fact that we will have a frontline indication with pembrolizumab that we are seeking with the phase III readout next quarter, and then an overall survival phase III readout in Q1 of next year. I think this is a very compelling and comprehensive data set across these two studies, monotherapy, second-line, third-line, combination with pembrolizumab frontline that is going to really underwrite our ambition in head and neck. We're very comfortable with our position and where we are. The expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Speaker #4: Monotherapy, second line, third line, combination with Pembo front line—that is going to really underwrite our ambition in head and neck. And so we're very comfortable with our position and where we are.

Speaker #4: And the expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Speaker #1: Thank you, Tahi. Thanks, Greg. Let's move on to the next one.

Jan van de Winkel: Thank you, Tahi. Thanks, Greg. Let's move on to the next one.

Speaker #3: Thank you. And the next question comes from Xiang Deng from UBS. Your line is open, please ask your question.

Operator: Thank you. The next question comes line of Xian Deng from UBS. Your line is open. Please ask your question.

Speaker #7: Hi. Thank you for taking my question. So I guess I would just try my luck a little bit on the Abqinli front-line trial. So given the interim still has not passed, this really suggests the events are happening really, really a lot slower than expected.

Xian Deng: Hi. Thank you for taking my question. I guess I'll just try my luck a little bit on the ABPI-005 frontline trial. Given the interim two has not passed, this really suggests that events are happening really a lot slower than expected. Just wondering, is there any reason that you could think of that you can suspect that your R-CHOP arm would perform differently from the one from MONJUVI phase III trial or the POLIVY phase III trial, at least in the IPI 2 to 5 group? That's the first question. The second one, just wondering for PETAL in frontline. Your trial design is chemo-free, it's with pembrolizumab combo only, whereas Revolving is plus pembrolizumab plus chemo. Just wondering if you could elaborate a bit of rationale in that trial design to go without chemo, please. Thank you.

Speaker #7: So just wondering is there any reason that you could think of that you can suspect that the R12 arm would perform your R12 arm would perform differently from the one from Montjuïc phase three trial or the PolyV phase three trial, at least in the IPS three to five group?

Speaker #7: That's the first question. And the second one, just wondering for Pitu in front line. So your trial design is chemo-free. So it's with Pembo combo only, whereas relevant is plus Pembo plus chemo.

Speaker #7: So just wondering if you could elaborate a bit on the rationale in that trial design to go without chemo, please. Thank you.

Speaker #1: Thanks, Xiang. I think I'm going to pass them over again to you, Tahi.

Jan van de Winkel: Thanks, Siyang. I think I'm going to pass them over again to you, Tahi.

Speaker #4: Thank you. So, on the front line, this is such a piece that I think, first things first, it's best if we just stick to a few things.

Tahamtan Ahmadi: Thank you. On the frontline, diffuse large B-cell lymphoma, I think first things first. I think it's best if we just stick to a few things first. We are very excited, and really much looking forward to this trial based on everything we know about how EPKINLY has behaved in the past and how predictive these phase II data sets have been, not only in the second-line follicular lymphoma trial, but also now in the second, third-line, diffuse large B-cell lymphoma trial, in the combination with lenalidomide. The phase III trial is almost point to point replicated what had been described in the phase II data sets. There's a lot of anticipation that we have, and I'm sure you too, for that trial, and there's a lot of excitement about the results that are going to be then reported next quarter.

Tahi Ahmadi: Thank you. On the frontline, diffuse large B-cell lymphoma, I think first things first. I think it's best if we just stick to a few things first. We are very excited, and really much looking forward to this trial based on everything we know about how EPKINLY has behaved in the past and how predictive these phase II data sets have been, not only in the second-line follicular lymphoma trial, but also now in the second, third-line, diffuse large B-cell lymphoma trial, in the combination with lenalidomide. The phase III trial is almost point to point replicated what had been described in the phase II data sets. There's a lot of anticipation that we have, and I'm sure you too, for that trial, and there's a lot of excitement about the results that are going to be then reported next quarter.

Speaker #4: First, we are very excited and really looking forward to this trial. Based on everything we know about how Abqinli has behaved in the past, and how predictive these phase two datasets have been—not only in the second line for the Conformal trial, but also now in the second and third line diffuse HB set trial.

Speaker #4: In the combination with Lenalidomide, the phase three trials almost point to point replicated what had been described in the phase two dataset. And so there's a lot of anticipation that we have, and I'm sure you too, for that trial.

Speaker #4: And there's a lot of excitement about the results that are going to be then reported next quarter. As it relates to the performance of R12, I mean, we have no visibility to how R12 has behaved on that trial.

Tahamtan Ahmadi: As it relates to the performance of R-CHOP, we have no visibility to how R-CHOP has behaved on that trial. We will find out when we get the data. I think it's probably fair to say that R-CHOP in the past, as you pointed out yourself, has had a very robust performance, kind of behaves the way R-CHOP behaves across multiple trials. Generally speaking, cross-trial comparisons on the control arm are always a little bit flawed because they are informed by regions and patients and all of these things. We don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP. On Pito frontline, the question was what the reason was for the combination of pembro. A lot of these discussions happened a long time ago when this was still in the hands of Milos.

Tahi Ahmadi: As it relates to the performance of R-CHOP, we have no visibility to how R-CHOP has behaved on that trial. We will find out when we get the data. I think it's probably fair to say that R-CHOP in the past, as you pointed out yourself, has had a very robust performance, kind of behaves the way R-CHOP behaves across multiple trials. Generally speaking, cross-trial comparisons on the control arm are always a little bit flawed because they are informed by regions and patients and all of these things. We don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP. On Pito frontline, the question was what the reason was for the combination of pembro. A lot of these discussions happened a long time ago when this was still in the hands of Milos.

Speaker #4: We will find out when we get the data. I think it's probably fair to say that R12 in the past, as you pointed out yourself, has had a variable bus performance and kind of behaves the way R12 behaves across multiple trials.

Speaker #4: But generally speaking, cross-trial comparisons on the control arm are always a little bit flawed because they're informed by regions and patients and all of these things.

Speaker #4: So, we don't really have any visibility, but it's probably not unreasonable to assume that R12 behaves like R12. On the Pitu front line, the question was what the reason was for the combination of Pembo, and a lot of these discussions happened a long time ago when this was still in the hands of Meerus.

Speaker #4: But I think, generally speaking, head and neck patients are known to be a fragile population. Locality of the disease and the status of the patient play a significant role in the tolerability of the treatment.

Tahamtan Ahmadi: I think, generally speaking, head and neck patients are known to be a fragile population. Locality of the disease, status of the patient play a significant role in the tolerability of the treatment. Even today, if you look at the paradigm, there are patients who get treated with pembro chemo, and there are patients who get treated only with pembro that is not only a decision made by the CPS score, but it's probably even larger informed by the patient that sits in front of the physician and their status. The data that is out there in the phase II for the combination for pembro-peto though is dramatically different. It's twice the high response rate and durability than has been described even for chemotherapy pembro.

Tahi Ahmadi: I think, generally speaking, head and neck patients are known to be a fragile population. Locality of the disease, status of the patient play a significant role in the tolerability of the treatment. Even today, if you look at the paradigm, there are patients who get treated with pembro chemo, and there are patients who get treated only with pembro that is not only a decision made by the CPS score, but it's probably even larger informed by the patient that sits in front of the physician and their status. The data that is out there in the phase II for the combination for pembro-peto though is dramatically different. It's twice the high response rate and durability than has been described even for chemotherapy pembro.

Speaker #4: And even today, if you look at the paradigm, there are patients who get treated with Pembo chemo, and there are patients who get treated only with Pembo. That is not only a decision made by the CPS score, but it's probably even more largely informed by the patient that sits in front of the physician and their status.

Speaker #4: So the data that is out there in the phase two for the combination for pembo/pitu, though, is like dramatically different. It's like twice as high response rate and durability than has been described even for chemotherapy/pembo.

Speaker #4: So, in that regard, our anticipation is that Pitu Pembo is going to provide a truly very significant and important dataset for patients with head and neck, because it will have, hopefully, if it replicates the data in phase two, a very significant ORR and duration of response improvement, even over chemotherapy combinations which roughly range in the 30% range of response.

Tahamtan Ahmadi: In that regard, our anticipation is that pembro-peto is going to provide a truly very significant and important data set for patients with head and neck because it will have, hopefully, if it replicates the data in the phase II, a very significant ORR and duration of response improvement even over chemotherapy combinations. We've roughly ranged in the 30% range of response. Then we'll have a conversation about the comparison to what the JNJ strategy may or may not be when we have that data in our hands.

Tahi Ahmadi: In that regard, our anticipation is that pembro-peto is going to provide a truly very significant and important data set for patients with head and neck because it will have, hopefully, if it replicates the data in the phase II, a very significant ORR and duration of response improvement even over chemotherapy combinations. We've roughly ranged in the 30% range of response. Then we'll have a conversation about the comparison to what the JNJ strategy may or may not be when we have that data in our hands.

Speaker #4: And then we’ll have a conversation about the comparison to what the J&J strategy may or may not be when we have that data in our hands.

Speaker #1: Thanks, Tahi. I think very clear. Thanks, Xiang, for the questions. Let's move on to the next one.

Jan van de Winkel: Thanks, Taj. I think very clear.

Operator: Thank you.

Jan van de Winkel: Thanks, Jan, for the questions. Let's move on to the next one.

Speaker #3: Yes, of course. And now we're going to take our next question. It comes from the line of Rajan Sharma from Goldman Sachs. Your line is open.

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

Speaker #3: Please ask your question.

Speaker #5: Hi. Thanks for taking my questions. Firstly, just on Abqinli and just on that first-line trial again. So maybe could you just help us understand, was the data that you saw in the second-line trial better than you were actually expecting internally?

Rajan Sharma: Hi, thanks for taking my questions. Firstly, just on EPKINLY and just on that first-line trial again. Maybe could you just help us understand, was the data that you saw in the second-line trial better than you were actually expecting internally? I'm just wondering if, maybe I'm stretching here, but is that giving you increased confidence that the frontline trial could read out at the interim? Then could you maybe just discuss your latest perspectives on the endometrial cancer treatment landscape? Merck have said that they've hit PFS and OS from the interim of their TROP2-ADC trial. Does that, in your mind, when the data come, will that set a bar for Rina-S? Could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and folate receptor alpha in endometrial? Thank you.

Speaker #5: And I'm just wondering, if maybe I'm stretching here, but is that giving you increased confidence that the frontline trial could read out at the interim?

Speaker #5: And then could you maybe just discuss your latest perspectives on the endometrial cancer treatment landscape? Merck have said that they've hit PFS and OS from the interim of their TROP 280C trial.

Speaker #5: Does that, in your mind, when the data come, will that set a bar for RenoS? And could you maybe just talk about areas of differentiation there, and potential relative expression of TROP2 and folate receptor alpha in endometrial?

Speaker #5: Thank you.

Speaker #1: Thanks, Rajan, for the questions. So before Tai starts, I think for the front line study, I can tell you we are super excited based on the phase two studies and the data released last year at us, the year before at us, Rajan.

Jan van de Winkel: Thanks, Rajan, for the questions. Before Taj starts, I think for the frontline study, I could tell you we are super excited based on the phase II studies, the data released last year at ASH, the year before at ASH, Rajan. We believe that this data will be very, very good in the frontline setting. Of course, the second-line data was also fantastic data, but it's unrelated, I feel, to the frontline data because it's in a different setting with different patients with different levels of illness. We are excited about both settings. The frontline setting, I think the enthusiasm comes from rapid recruitment and also running against the gold standard. R-CHOP has been for over 20 years the gold standard in diffuse large B-cell lymphoma.

Speaker #1: So we believe that this data will be very, very good in the front line setting. And of course, the second line data was also fantastic data, but it's unrelated.

Speaker #1: I feel to the front line data, because it's in a different setting with different patients with different levels of illness. But I think we are excited about both settings, but the front line setting, I think the enthusiasm comes from rapid recruitment and also running against the gold standard.

Speaker #1: I mean, R-CHOP has been, for over 20 years, the gold standard in diffuse large B-cell lymphoma. The phase 2 data actually show if that would translate to phase 3, this will be sensational data.

Jan van de Winkel: The phase II data actually show if that would translate to phase III, this will be sensational data. Let's hope for good data in Q4. Taj, you want to add anything to that? Maybe Judith can go into the landscape for endometrial cancer.

Speaker #1: And let's hope for good data in the fourth quarter. Tai want to add anything to that and then maybe Judith can go into the landscape for endometrial cancer.

Tahamtan Ahmadi: Sure. The only thing I would add is I tried to make that point earlier. I think Jan touched on that. This Len Epco phase III actually reported out the way we were anticipating and hoping, this is like a pattern that we've seen. The efficacy and safety of TEPKINLY is very predictable. We have seen now multiple times that phase II combination data approximates very closely to what the phase III describes in the larger data set, this is also just to underscore the point that Jan was making. One of the reasons why we are continuously excited, looking forward to that data next quarter in the front line. Judith can talk about the emerging, never changing, never stopping landscape in endometrial and anywhere else.

Speaker #4: Yeah, sure. The only thing I would add is, I tried to make that point earlier. I think Jan touched on that. The EBCO phase 3 actually reported out the way we were anticipating and hoping.

Tahi Ahmadi: Sure. The only thing I would add is I tried to make that point earlier. I think Jan touched on that. This Len Epco phase III actually reported out the way we were anticipating and hoping, this is like a pattern that we've seen. The efficacy and safety of TEPKINLY is very predictable. We have seen now multiple times that phase II combination data approximates very closely to what the phase III describes in the larger data set, this is also just to underscore the point that Jan was making. One of the reasons why we are continuously excited, looking forward to that data next quarter in the front line. Judith can talk about the emerging, never changing, never stopping landscape in endometrial and anywhere else.

Speaker #4: And this is kind of like a pattern that we've seen. The efficacy and safety of Abqinli is very predictable. And so we have seen now multiple times that phase 2 combination data approximates very closely to what then the phase 3 describes in the larger dataset.

Speaker #4: And this is also just to underscore the point that Jan was making. One of the reasons why we are continuously excited, looking forward to that data next quarter in the front line, and then Judith can talk about the emerging, never-changing, never-stopping landscape in endometrial and anywhere else.

Speaker #1: Thanks, Tai. Judith, are you back online? Apparently not. So maybe Tai, you can dive a bit into the endometrial cancer landscape.

Jan van de Winkel: Thanks, Taj. Judith, are you back online? Apparently not. Maybe, Taj, you can dive a bit into the endometrial cancer landscape.

Speaker #4: Then I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a Topo ADC with the TROP2 target, and that has really very little bearing on our strategy because I think from the very beginning we were aware that this was going to read out before the datasets for Rina are going to be available.

Tahamtan Ahmadi: I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a TOPO1 ADC with a TROP2 target. That has really very little bearing on our strategy because I think from the very beginning, we were aware that this was going to read out before the data sets for Rina-S are going to be available. We continue to be very excited about Rina-S, not only in PROC, where we already guided we're going to have some data this year, but also in endometrial, folate receptor alpha is expressed maybe on a lower level than in PROC, but it is expressed. One of the things that we have routinely and repeatedly described with Rina-S is this phenomenon of efficacy across the spectrum of folate receptor alpha expression. Endometrial is an exciting second indication.

Tahi Ahmadi: I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a TOPO1 ADC with a TROP2 target. That has really very little bearing on our strategy because I think from the very beginning, we were aware that this was going to read out before the data sets for Rina-S are going to be available. We continue to be very excited about Rina-S, not only in PROC, where we already guided we're going to have some data this year, but also in endometrial, folate receptor alpha is expressed maybe on a lower level than in PROC, but it is expressed. One of the things that we have routinely and repeatedly described with Rina-S is this phenomenon of efficacy across the spectrum of folate receptor alpha expression. Endometrial is an exciting second indication.

Speaker #4: We continue to be very excited about Rina, not only in PROC, where we've already got it, and we're going to have some data this year, but also in endometrial, where receptor alpha is expressed—maybe at a lower level than in PROC, but it is expressed. One of the things that we have routinely and repeatedly described with Rina is this phenomenon of efficacy across the spectrum of folate receptor alpha expression.

Speaker #4: So endometrial is an exciting second indication. We really initiated two phase threes in that indication. And so we would look very much forward to have that discussion when we have the data.

Tahamtan Ahmadi: We initiated two phase III in that indication, we will look very much forward to have that discussion when we have the data, I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Tahi Ahmadi: We initiated two phase III in that indication, we will look very much forward to have that discussion when we have the data, I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Speaker #4: And I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Speaker #1: Absolutely. And we have a breakthrough therapy designation, of course, in one of the settings in endometrial cancer. It's super important. Let's move on to the next question.

Jan van de Winkel: Absolutely. We have a breakthrough therapy designation, of course, in one of the settings in endometrial cancer. It's super important. Let's move on to the next question.

Speaker #3: Yes, of course. And now we're going to take our next question. The question comes from the line of Eva Forter. Your line is open.

Operator: Yes, of course. Now we're going to take our next question. The question comes from the line of Eva Forte. Your line is open. Please ask the question.

Speaker #3: Please ask your question.

Speaker #7: Hi, team. Thanks for taking our question. On CRC, as a landscape becomes increasingly crowded with the GFR-based specific, how's your newly disclosed strategy differentiated from the competing assets in the space, particularly compared to Amivantamab?

Eva Forte: Hi, team. Thanks for taking our question. On CRC, as the landscape becomes increasingly crowded with EGFR bispecific, how is your newly disclosed strategy differentiated from the competing assets in the space, particularly compared to amivantamab? If I might just sneak in a follow-up. Given the growing focus on RAS-directed therapies in CRC, would a combination strategy with pitostatin be a viable approach, and what's your current thinking on a potential development path for such a combination? Thanks so much.

Eva Fortea: Hi, team. Thanks for taking our question. On CRC, as the landscape becomes increasingly crowded with EGFR bispecific, how is your newly disclosed strategy differentiated from the competing assets in the space, particularly compared to amivantamab? If I might just sneak in a follow-up. Given the growing focus on RAS-directed therapies in CRC, would a combination strategy with pitostatin be a viable approach, and what's your current thinking on a potential development path for such a combination? Thanks so much.

Speaker #7: And if I may just sneak in a follow-up, given the growing focus on RAS-directed therapies in CRC, would a combination strategy with pirtobrutumab be a viable approach?

Speaker #7: And what's your current thinking on a potential development path for such a combination? Thanks so much.

Speaker #1: Thanks, Eva, for the questions. I really liked those questions because we are super excited about the potential differentiation of pitosentamab, but that will ask Tai to give you a bit more color on why we are so excited.

Jan van de Winkel: Thanks, Ava, for the questions. We like those questions because we are super excited about the potential differentiation of petosemtamab. I will ask Tahi to give you a bit more color on why we are so excited. We will present more data from the phase II setting in colorectal cancer at the ESMO conference. Also, the combinations is also an area we are pursuing. Tahi, why don't you give a bit more color to Ava?

Speaker #1: We will present more data from the phase two setting. And colorectal cancer. At the small conference. And then also the combinations is also an area we are pursuing.

Speaker #1: Tai, why don't you give a bit more color to Eva?

Speaker #4: Yes, please. Thank you. So first things first, I think colorectal as this new indication that we're embarking on with pito, if you recall, even when we started to talk about publicly, the intended acquisition of MIROS, there was already a lot of questions about colorectals.

Tahamtan Ahmadi: Yes, please. Thank you. First things first, I think, colorectal as this new indication that we are embarking on with Pito. If you recall, even when we start to talk about, publicly the intended acquisition of Merus, there was already a lot of questions about colorectal. There was a relatively small data set that had been shared, but that numerically showed very impressive ORR data. Of course, this data set has grown, both in numbers of patients and durability, and Jan already pointed out that we will share that. Our enthusiasm has continuously remained very high for what we see in this data set and underscores our conviction that Pito is not only the really, in every data set, colorectal, head and neck monotherapy, combination, continuously to show that on point estimates and cross-study comparisons are difficult.

Tahi Ahmadi: Yes, please. Thank you. First things first, I think, colorectal as this new indication that we are embarking on with Pito. If you recall, even when we start to talk about, publicly the intended acquisition of Merus, there was already a lot of questions about colorectal. There was a relatively small data set that had been shared, but that numerically showed very impressive ORR data. Of course, this data set has grown, both in numbers of patients and durability, and Jan already pointed out that we will share that. Our enthusiasm has continuously remained very high for what we see in this data set and underscores our conviction that Pito is not only the really, in every data set, colorectal, head and neck monotherapy, combination, continuously to show that on point estimates and cross-study comparisons are difficult.

Speaker #4: There was a relatively small dataset that had been shared, but that numerically showed very impressive ORR data. And of course, this dataset has grown with numbers of patients and durability.

Speaker #4: And Jan already pointed out that we will share that. And so our enthusiasm has continuously remained very high for what we see in this dataset and underscores our conviction that pito is not only the really in every dataset, colorectal, head and neck monotherapy, combination, continuously to show that on point estimates and cross-study comparisons are difficult, it appears to have higher response rate and a better safety profile than, for example, Amivantamab.

Tahamtan Ahmadi: It appears to have higher response rate and a better safety profile than, for example, amivantamab. This is what underscores the conviction that we really, with Pito, have the best-in-class second-generation EGFR bispecific, and that will also translate into meaningful data sets in the phase III settings for both front line and second-line colorectal, which is why we started these 2 trials now, even though, as you kind of like alluded to, JNJ already has started these trials. That's the colorectal part. The RAS field, of course, is super exciting. I think I worked on a RAS inhibitor 12 years ago when it didn't work.

Tahi Ahmadi: It appears to have higher response rate and a better safety profile than, for example, amivantamab. This is what underscores the conviction that we really, with Pito, have the best-in-class second-generation EGFR bispecific, and that will also translate into meaningful data sets in the phase III settings for both front line and second-line colorectal, which is why we started these 2 trials now, even though, as you kind of like alluded to, JNJ already has started these trials. That's the colorectal part. The RAS field, of course, is super exciting. I think I worked on a RAS inhibitor 12 years ago when it didn't work.

Speaker #4: And so this is what underscores the conviction that we really, with pito, have the best-in-class, second-generation EGFR-wise specific, and that will also translate into meaningful datasets in the phase 3 settings for both front-line and second-line colorectal, which is why we started these two trials now, even though, as you kind of alluded to, J&J already has started these trials.

Speaker #4: So that's the colorectal part. And the RAS field, of course, is super exciting. I think I worked on a RAS inhibitor 12 years ago, when it didn't work.

Speaker #4: And so it's a super fascinating field to watch. We are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal.

Tahamtan Ahmadi: It's a super fascinating field to watch, we are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal, we are actively engaging in discussions, to really embark on these novel combinations. There will be more to come in the near future.

Tahi Ahmadi: It's a super fascinating field to watch, we are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal, we are actively engaging in discussions, to really embark on these novel combinations. There will be more to come in the near future.

Speaker #4: And we are actively engaging in discussions to really embark on these novel combinations, and there will be more to come in the near future.

Speaker #1: Thanks, Tai. So, thank you, Eva, again for pointing out this super exciting area. And more to come this year, in the coming months. Let's move to the next question.

Jan van de Winkel: Thanks, Tahi. Thank you, Ava, again for pointing out this super exciting area, and more to come this year, in the coming months. Let's move to the next question.

Speaker #3: Yes, of course. Now we're going to take our next question. The question comes from Suzanne Van Huizen from Van Lanschot Kempen. Your line is open.

Operator: Yes, of course. Now we're going to take our next question. The question comes in of Suzanne van Hooijdonk from Van Lanschot Kempen. Your line is open. Please ask your question.

Speaker #3: Please ask your question.

Speaker #5: Hi, this is Suzanne. Thanks for taking my questions. Also, on PITO, which are competitor or partner, J&J, going for accelerated approval with amivantamab in head and neck?

Suzanne van Hooijdonk: Hi, this is Suzanne. Thanks for taking my questions. Also on Peto, with your competitor or partner, JNJ, going for accelerated approval with amivantamab in head and neck. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with Peto at this point in time. Could you comment on that? Secondly, you mentioned a couple of times the high confidence in the best-in-class profile for Peto compared to Ami. Could you elaborate on what is underpinning that confidence, the high response, better safety in the data sets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action? Thank you.

Suzanne van Voorthuizen: Hi, this is Suzanne. Thanks for taking my questions. Also on Peto, with your competitor or partner, JNJ, going for accelerated approval with amivantamab in head and neck. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with Peto at this point in time. Could you comment on that? Secondly, you mentioned a couple of times the high confidence in the best-in-class profile for Peto compared to Ami. Could you elaborate on what is underpinning that confidence, the high response, better safety in the data sets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action? Thank you.

Speaker #5: Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with pito at this point in time. Could you comment on that?

Speaker #5: And secondly, you mentioned a couple of times the high confidence in the best-in-class profile for pito compared to AMI. Could you elaborate on what is underpinning that confidence, the high response better safety in the datasets?

Speaker #5: What do you believe is driving that differentiation? Is it the molecule, or the mechanism of action? Thank you.

Speaker #1: Suzanne, thank you very much for these questions. I'm going to hand them over in a sec to Tai, but I can tell you that you will definitely have to wait for the ASMO dataset for the Phase 2 data, which will give you a bit of further color on why we are so enthusiastic.

Jan van de Winkel: Suzanne, thank you very much for these questions. I'm going to hand them over in a sec to Tahi, but I can tell you that you will definitely have to wait for the ESMO data set for the phase II data, which will give you a bit of further color why we are so enthusiastic. As it relates to the strategy, we think that we will have a differentiated drug, actually, based on everything we know. I'll pause here and let Tahi give you a bit more color, Suzanne, on the head and neck setting and front line, second line, accelerated approval versus potentially approval based on phase III.

Speaker #1: And as it relates to the strategy, we think that we will have a differentiated drug actually based on everything we know. But a pause here and let Tai give you a bit more colors, Suzanne, on the head and neck setting and front line, second line, accelerated approval versus potentially approval based on phase three.

Speaker #4: Yeah, thank you. And I'm going to reiterate what I tried to point out earlier. I think when we step back on head and neck, where we are, is we're going to have a top-line result in front line, in the next quarter this year.

Tahamtan Ahmadi: Thank you. I'm going to reiterate what I tried to point out earlier. I think if we step back on head and neck, where we are is, we're going to have a top-line result in front line in next quarter this year. Then OS readout for the monotherapy, in Q1 of next year. I think this is a completely different in terms of comprehensiveness, but also by capturing patient population, profile than the accelerated profile now that JNJ is pursuing with amivantamab in head and neck. We feel very comfortable, particularly because the larger population is in front line about our position where we are, and we, of course, doing everything to accelerate these filings and these launches, to the degree that is possible. Nothing changed on our end. We always knew.

Tahi Ahmadi: Thank you. I'm going to reiterate what I tried to point out earlier. I think if we step back on head and neck, where we are is, we're going to have a top-line result in front line in next quarter this year. Then OS readout for the monotherapy, in Q1 of next year. I think this is a completely different in terms of comprehensiveness, but also by capturing patient population, profile than the accelerated profile now that JNJ is pursuing with amivantamab in head and neck. We feel very comfortable, particularly because the larger population is in front line about our position where we are, and we, of course, doing everything to accelerate these filings and these launches, to the degree that is possible. Nothing changed on our end. We always knew.

Speaker #4: And then a OS readout for the monotherapy in the first quarter of next year. I think this is a completely different in terms of comprehensiveness, but also by capturing patient population.

Speaker #4: Profile then the accelerated approval now that J&J is pursuing with amivantamab in head and neck. So we feel very comfortable, particularly because the larger population is in frontline, about our position where we are and, of course, doing everything to accelerate these findings and these launches to the degree that it is possible.

Speaker #4: So nothing changed on our end. We always knew we have, obviously, there's some partnership on amivantamab with J&J, some visibility to their plans. And so this is exciting for patients—more opportunities.

Tahamtan Ahmadi: We have obviously, there's some partnership on amivantamab with JNJ, some visibility to their plans. This is exciting for patients, more opportunities. We are very confident in our head and neck strategy, and there will also be additional studies that we already announced are going to be initiated in the very near future, and may just not be public to discuss because I think we changed a little bit our strategy some time ago, sooner to the colorectal trials to publicly announce these trials more closer to when the first patient is dosed. Your second question was around what again, sorry?

Tahi Ahmadi: We have obviously, there's some partnership on amivantamab with JNJ, some visibility to their plans. This is exciting for patients, more opportunities. We are very confident in our head and neck strategy, and there will also be additional studies that we already announced are going to be initiated in the very near future, and may just not be public to discuss because I think we changed a little bit our strategy some time ago, sooner to the colorectal trials to publicly announce these trials more closer to when the first patient is dosed. Your second question was around what again, sorry?

Speaker #4: But we are very confident in our head and neck strategy, and there will also be additional studies that we have already announced that are going to be initiated in the very near future and may just not be publicly discussed, because I think we changed our strategy a little bit some time ago.

Speaker #4: Similar to the colorectal trials, we plan to publicly announce these trials closer to when the first patient is dosed. And then your second question was around what again?

Speaker #4: Sorry.

Speaker #1: Best-in-class criteria. Why do we say that this is?

Jan van de Winkel: Best-in-class criteria. Why do we say that-

Tahamtan Ahmadi: Why do we say this? Why do we say this? Cross-study comparisons are difficult, but if you just cross-compare monotherapy in second-line head and neck. The small data set that were presented in combination with pembrolizumab in frontline for both trials, for both drugs. The colorectal combination with chemotherapy data sets that exist for both drugs. In all four of these data sets, actually, petosemtamab outperforms amivantamab on the efficacy. In totality, it does have a differentiated safety profile. It doesn't have the same challenges, to the degree at least, with skin-related toxicities. I think it's a little bit speculative to figure out why that is, but they're clearly different antibodies with different secondary arms. It's not unreasonable to speculate that the difference in the second arm may have a biological mechanistic role that differentiates both on efficacy and safety.

Tahi Ahmadi: Why do we say this? Why do we say this? Cross-study comparisons are difficult, but if you just cross-compare monotherapy in second-line head and neck. The small data set that were presented in combination with pembrolizumab in frontline for both trials, for both drugs. The colorectal combination with chemotherapy data sets that exist for both drugs. In all four of these data sets, actually, petosemtamab outperforms amivantamab on the efficacy. In totality, it does have a differentiated safety profile. It doesn't have the same challenges, to the degree at least, with skin-related toxicities. I think it's a little bit speculative to figure out why that is, but they're clearly different antibodies with different secondary arms. It's not unreasonable to speculate that the difference in the second arm may have a biological mechanistic role that differentiates both on efficacy and safety.

Speaker #4: Oh, why do we say this? Yeah, why do we say this? So cross-study comparisons are difficult. But if you just cross-compare monotherapy and second-line head and neck, the small datasets that were presented in combination with Pembro in front-line for both trials, for both drugs, the colorectal combination with chemotherapy datasets that exist for both drugs — in all four of these datasets, actually, Pitu outperforms Amivantamab.

Speaker #4: On the efficacy. And then, in totality, it does have a differentiated safety profile. It doesn't have the same challenges, to the degree at least, with skin-related toxicities.

Speaker #4: I think it's a little bit speculative to figure out why that is, but they're clearly different antibodies with different secondary arms. And it's not unreasonable to speculate that the difference in the second arm may have a biological mechanistic role that differentiates both on efficacy and safety.

Speaker #4: But as is, and I think there's now a larger dataset I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety.

Tahamtan Ahmadi: As is, and I think there's now a larger data set, I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety. This is where we come with this conviction that we have a best-in-class asset in our hands.

Tahi Ahmadi: As is, and I think there's now a larger data set, I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety. This is where we come with this conviction that we have a best-in-class asset in our hands.

Speaker #4: And this is where we come with this conviction that we have a best-in-class asset in our hand.

Speaker #1: Thank you, Tai. Thanks, Suzanne, for the questions. Let's move on.

Jan van de Winkel: Thank you, Taj. Thanks to you all for the questions. Let's move on.

Speaker #3: Thank you. Now we're going to take our next question. And now we're taking the question from Charlie Highwood from Bank of America. Your line is open.

Operator: Thank you. Now we're going to take our next question. Now we're taking the question from Charlie Haywood from Bank of America. Your line is open. Please ask your question.

Speaker #3: Please ask your question.

Speaker #6: Hi, Charlie Highwood, Bank of America. Thanks for taking questions. I have two, please. So this one is just—or both, actually, I'm really aware—so first is on the second-line prop dates about coming in fourth quarter.

Charlie Haywood: Hey, Charlie Haywood, Bank of America. Thanks for taking the questions. I have two, please. The first one is just, or both, actually, on Rina-S. First is on the second-line progression-free survival data you've got coming in Q4. Both phase II, phase IIIs in Q4. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts, anything to consider as we sort of read across between the two? Secondly, we've seen limited phase II PFS data for the folate receptor class in general. Could you frame any target PFS profile or PFS delta versus control arm you'd expect to see to be clinically meaningful for that phase III readout? Thank you.

Speaker #6: So both phase two, phase three is in fourth quarter. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts, anything to consider as we sort of read across between the two?

Speaker #6: And secondly, we've seen limited Phase II PFS data for the folate receptor class in general. So, could you frame any target PFS profile or PFS delta versus the control arm you'd expect to see to be clinically meaningful for that Phase III readout?

Speaker #6: Thank you.

Speaker #1: Thanks, Charlie, for the questions. Tai, can you address both of them? First, the differences between the Phase 2 and Phase 3, and then the profile as it relates to folic receptor alpha expression levels.

Jan van de Winkel: Thanks, Charlie, for the questions. Taj, can you address both of them? Differences between the phase II and phase III, and the profile, as it relates to folate receptor alpha expression levels.

Speaker #4: Yeah. So by inclusion-exclusion criteria, they're very much more or less the same patient population. So there is a readout for sure, based on the phase 2 data to the phase 3 data. And then the only difference is, of course, a phase 2 dataset always has its own dynamics.

Tahamtan Ahmadi: Yeah. By inclusion/exclusion criteria, they're very much more or less the same patient population. There is a readout for sure based on the phase II data to the phase III data, the only difference is, of course, a phase II data set has always its own dynamics, vis-a-vis a phase III trial. There's obviously like a larger footprint for a phase III trial as it relates to a phase II trial, so these are kind of like the where the patients come on and the difference between having a choice or being forced to have a choice versus not having a choice. That's kind of the difference between these two data sets, probably all to say to that. As it relates to speculating on the readout, I don't think I want to do that.

Tahi Ahmadi: Yeah. By inclusion/exclusion criteria, they're very much more or less the same patient population. There is a readout for sure based on the phase II data to the phase III data, the only difference is, of course, a phase II data set has always its own dynamics, vis-a-vis a phase III trial. There's obviously like a larger footprint for a phase III trial as it relates to a phase II trial, so these are kind of like the where the patients come on and the difference between having a choice or being forced to have a choice versus not having a choice. That's kind of the difference between these two data sets, probably all to say to that. As it relates to speculating on the readout, I don't think I want to do that.

Speaker #4: Vis-à-vis a phase three trial. And then there's obviously a larger footprint for a phase three trial as it relates to a phase two trial.

Speaker #4: So these are kind of like where the patients come on, and the difference between having a choice, or being forced to have a choice, versus not having a choice.

Speaker #4: And so that's kind of the difference between these two datasets. I probably ought to say, too, that as it relates to speculating on the readout, I don't think I want to do that.

Tahamtan Ahmadi: All I can say is that we are super excited about this data, that if you look at what is already in the public domain for Rina-S, it shows a very high response rate, 50% plus 50, which is probably even more important, a very long durability of response. This duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AE, so it then allows a long continuation of treatment, which then drives the duration of response. If you put these things together, you can already get a sense of the direction of the PFS, which I think will be without a doubt not only significant but also meaningful for patients. I think that's where we should leave it, we can have this conversation when the data is in the public domain.

Tahi Ahmadi: All I can say is that we are super excited about this data, that if you look at what is already in the public domain for Rina-S, it shows a very high response rate, 50% plus 50, which is probably even more important, a very long durability of response. This duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AE, so it then allows a long continuation of treatment, which then drives the duration of response. If you put these things together, you can already get a sense of the direction of the PFS, which I think will be without a doubt not only significant but also meaningful for patients. I think that's where we should leave it, we can have this conversation when the data is in the public domain.

Speaker #4: All I can say is that we are super excited about this data. If you look at what is already in the public domain for VNIS, it shows a very high response rate—50% plus—with, which is probably even more important, a very long durability of response.

Speaker #4: And the duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AEs. So it then allows a long continuation of treatment, which then drives the duration of response, and if you put these things together, you can already get a sense of the direction of the PFS, which I think will be, without a doubt, not only significant but also meaningful for patients. I think that's where we should leave it, and then we can have this conversation when the data is in the public domain.

Speaker #1: Thanks, Tai. And on top of that, Charlie, you will get that we are, like, a year—one and a half years—ahead of some of the potential competitors.

Jan van de Winkel: Thanks, Taj. On top of that, Charlie, you will get that we are like a year, one and a half years ahead of some of the potential competitors. I think we're in good shape here.

Speaker #1: So I think we're in good shape here.

Speaker #6: Thank you.

Charlie Haywood: Thank you.

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

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

Speaker #3: Yes, of course. Now we're going to take our next question, and the question comes from Yaron Weber from TD Securities. Your line is open.

Operator: Yes, of course. Now we're going to take our next question. This question comes to line of Yaron Werber from TD Cowen. Your line is open. Please ask your question.

Speaker #3: Please ask your question.

Yaron Werber: Great. Thank you so much. Quick question on petosemtamab. For the first-line study, can you just give us a sense when you upsized this study, can you confirm that you didn't change the powering assumption, that you're enrolling the random distribution of HPV negatives and positives that are in the market, you're not enriching specifically for only one subtype? Secondly, you're going to show us the second-line recurrent head and neck data at ESMO, with or without pembrolizumab. Is there a chance that you might want to move to phase III in that study with pembrolizumab to complement your monotherapy second-line data, which is coming Q1 next year? Thank you.

Speaker #5: Great, thank you so much. Quick question, I'm Pito. For the first-line study, can you just give us a sense of when you upsized the study?

Speaker #5: Can you confirm that you didn't change the powering assumption and that you're enrolling the random distribution of HPV-negative and HPV-positive patients that are in the market?

Speaker #5: You're not enriching specifically for only one subtype. And then secondly, you're going to show us the second-line recurrent head and neck data at ESMO.

Speaker #5: With or without Pembro, is there a chance that you might want to move the Phase 3 in that study with Pembro to complement your monotherapy second-line data, which is coming Q1 next year?

Speaker #5: Thank you.

Speaker #1: Thanks, Yaron. Tai, can you address both of the questions?

Jan van de Winkel: Thanks, Yaron. Taj, can you address both of the questions?

Speaker #4: So let's take the first one first. This is, I think, as we've said multiple times, we changed this trial to increase the probability of success.

Tahamtan Ahmadi: Let's take the first one first. This is, I think we said multiple times, we changed this trial to increase the probability of success, and this was not in any particular shape or form driven by anything that really emerged after the acquisition. This was actually a decision that we at Genmab had made during the diligence process, and that got executed immediately. It was one of the first things that we actually executed, and this was purely driven to ensure that we have the proper power for all kinds of subgroup analyses that are going to be important for global filings. I think that's all there is to say about this. The rest is not necessarily part of our thought process or anything that we have spoken about. The second question that you had was around other strategies for PITO, and I would say this.

Tahi Ahmadi: Let's take the first one first. This is, I think we said multiple times, we changed this trial to increase the probability of success, and this was not in any particular shape or form driven by anything that really emerged after the acquisition. This was actually a decision that we at Genmab had made during the diligence process, and that got executed immediately. It was one of the first things that we actually executed, and this was purely driven to ensure that we have the proper power for all kinds of subgroup analyses that are going to be important for global filings. I think that's all there is to say about this. The rest is not necessarily part of our thought process or anything that we have spoken about. The second question that you had was around other strategies for PITO, and I would say this.

Speaker #4: And this was not in any particular shape or form driven by anything that really emerged after the acquisition. This was actually a decision that we at Genmab had made during the diligence process, and that got executed immediately.

Speaker #4: It was one of the first things that we actually executed. This was purely driven to ensure that we have the proper power for all kinds of subgroup analyses.

Speaker #4: Those are going to be important for global filings. So I think that's all there is to say about this. The rest is not necessarily part of our thought process or anything that we have spoken about.

Speaker #4: And then the second question that you had was around other strategies for Pito, and I would say this—we've been very clear. There's going to be more to come on Pito and head and neck.

Tahamtan Ahmadi: We've been very clear. There's going to be more to come on PITO and head and neck. We will present these trials in the granularity and at a time similar to what we just did with colorectal when they are literally dosing patients. In some near future, we will have more conversation about more activities or what trials in head and neck, if that's fair.

Tahi Ahmadi: We've been very clear. There's going to be more to come on PITO and head and neck. We will present these trials in the granularity and at a time similar to what we just did with colorectal when they are literally dosing patients. In some near future, we will have more conversation about more activities or what trials in head and neck, if that's fair.

Speaker #4: And we will present these trials in the granularity and at the time similar to what we just did with colorectal, when they are literally dosing patients.

Speaker #4: And that is so, in the future, we'll have more conversations about more activities, about trials in head and neck, if that's fair.

Speaker #1: Thanks, Tai. I think that's clear. Thanks, Yaron, for the questions. Let's see whether there are further questions.

Jan van de Winkel: Thanks, Tey. I think that's clear. Thanks, Javan, for the question. Let's see whether there are further questions.

Speaker #3: Yes, of course. Now we're going to take our next question. And the question comes from the line of Benjamin Jackson. Your line is open. Please ask your question.

Operator: Yes, of course. Now we're going to take our next question. The question comes line of Benjamin Jackson. Your line is open. Please ask the question.

Speaker #7: Brilliant. Thank you for the question. I've got two pleas. The first one on Rina S. Look, we've seen a couple of other companies make moves into drugs that look to overcome top A1 resistance.

Benjamin Jackson: Brilliant. Thank you for the question. I've got two, please. The first one on Rina-S. Look, we've seen a couple of other companies make moves into drugs that look to overcome TOPO1 resistance. Look, the aim for Rina-S is to come first to market, but are there any implications to this and thinking positively or negatively how this resistance could emerge for when thinking about the Rina-S commercial opportunity once the competition comes to market? Secondly, look, not a focused topic today, lots of other stuff going on, but obviously any updated thoughts on the EPKINLY potential in autoimmune diseases where B-cell pathology is key. There's obviously a few competitors making noises in this area with similar drugs, so it'd be interesting to hear your thoughts there. Thank you.

Speaker #7: So, look, the aim for Rina S is to come first to the market, but are there any implications to this? And, thinking positively or negatively, how could this resistance emerge?

Speaker #7: First, when thinking about the Rina-S commercial opportunity once the competition comes to market. And then secondly—look, not a focused topic today, there's lots of other stuff going on, but obviously, any updated thoughts on the Epkinly potential in IO and eye diseases where B-cell pathology is key?

Speaker #7: There are obviously a few competitors making noise in this area with similar drugs, so it would be interesting to hear your thoughts there. Thank you.

Speaker #1: Thanks, Ben, for the question. So, with Rina, we of course hope to be first to the market, and we are going to read out already a Phase 3 in Q4.

Jan van de Winkel: Thanks, Ben, for the question. With RINA, we of course, hope to be first to the market and we are going to read out already a phase III in Q4. Tey, do you want to comment on TOPO1 resistance and strategy for RINA?

Speaker #1: But with Tai, do you want to comment on top of one resistance and strategy for Rina?

Speaker #4: Well, I mean, you said the first and most important part is there are already three Phase 3s actively enrolling patients in ovarian cancer.

Tahamtan Ahmadi: Well, you said the first one, the most important part is there are already three phase IIIs actively enrolling patients in ovarian cancer, one in PARP and two in PSOC, one maintenance and one in the platinum replacement strategy. We are constantly and actively working on moving essentially the entry point for RINA into earlier lines. We have already talked about that there's more to come also in the ovarian cancer space with RINA. That's basically the reality. You have to develop these drugs and then just try to move into earlier lines as efficiently and as effectively as data allows and operation allows.

Tahi Ahmadi: Well, you said the first one, the most important part is there are already three phase IIIs actively enrolling patients in ovarian cancer, one in PARP and two in PSOC, one maintenance and one in the platinum replacement strategy. We are constantly and actively working on moving essentially the entry point for RINA into earlier lines. We have already talked about that there's more to come also in the ovarian cancer space with RINA. That's basically the reality. You have to develop these drugs and then just try to move into earlier lines as efficiently and as effectively as data allows and operation allows.

Speaker #4: One in PARK and two in PSOC. One in maintenance and one in the platinum replacement strategy. And so we are constantly and actively working on moving, essentially, the entry point for Rina into earlier lines, and we have already talked about that. There's more to come also in the ovarian cancer space with Rina.

Speaker #4: And that's basically the reality: you have to develop these drugs, and then just try to move into earlier lines as efficiently and as effectively as the data allows.

Speaker #4: And operation allows. That's the first part. Also, the only thing to say about this emerging idea of topo resistance because of Rina, which we are very confident will be the first topo payload ADC in PARC, then this is more a post-Rina problem, to be honest.

Tahamtan Ahmadi: That's the first, partly also the only thing to say about this emerging idea of TOPO resistance, because if Rina-S, which we are very confident will be the first TOPO payload ADC in PARP, then this is more a post-Rina-S problem, to be honest.

Tahi Ahmadi: That's the first, partly also the only thing to say about this emerging idea of TOPO resistance, because if Rina-S, which we are very confident will be the first TOPO payload ADC in PARP, then this is more a post-Rina-S problem, to be honest.

Speaker #1: Exactly. And then INI and Epcor—right now, the focus is on cancer, multiple cancers, and we will have exciting data read out in Q4.

Jan van de Winkel: Exactly. Autoimmune and epcoritamab, right now the focus is on cancer, multiple cancers, and we will have exciting data read out in Q4. Let's discuss autoimmune in more detail in the future. Cancer is clearly the priority for us right now. Operator, can we move to the next question?

Speaker #1: And then, let's discuss INI in more detail in the future. But cancer is clearly the priority for us right now. Operator, can we move to the next question?

Speaker #3: Yes, of course. And now we're going to take our next question. The question comes from the line of Judah Fromer from Morgan Stanley. Your line is open.

Operator: Yes, of course. Now we're going to take our next question. The question comes line of Judah Frommer from Morgan Stanley. Your line is open. Please ask the question.

Speaker #3: Please ask your question.

Speaker #6: Yeah, hi. Thanks for taking the question. Maybe just a follow-up on Pito in front line. Can you help us with thoughts on the nature of the update in Q4?

Judah Frommer: Yeah. Hi, thanks for taking the question. Maybe just a follow-up on peto in frontline. Can you help us with thoughts on the nature of the update in Q4? It'll be a top line, but can you give us any direction on whether you'll press release in line with some of the top lines we've seen for EPKINLY? Could we potentially see subgroup data, perhaps by HPV status? If not, do you have a sense for when we would see responses by HPV negative versus positive patients? Thanks.

Speaker #6: So, it'll be a top line, but can you give us any direction on whether you'll issue a press release in line with some of the top lines we've seen for Epkinly, or could we potentially see subgroup data, perhaps by HPV status?

Speaker #6: And if not, do you have a sense for when we would see responses by HPV-negative versus HPV-positive patients? Thanks.

Speaker #1: Thanks, Judah. Tai, can you give a bit of color on the top-line results that we intend to present in the Q4 timeframe?

Jan van de Winkel: Thanks, Judah. Tey, can you give a bit of color on the top-line results that we intend to present in the Q4 timeframe?

Speaker #4: Well, I think the accurate response to that question is that top-line results in Genmab historically focus on the primary endpoint. And I think that's what's going to be happening for Pito as well.

Tahamtan Ahmadi: Well, I think the accurate response to that question is top-line results in general are historically focused on the primary endpoint. I think that's what's going to be happening for petosemtamab as well. Obviously once we have the top-line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data in a public presentation at a conference.

Tahi Ahmadi: Well, I think the accurate response to that question is top-line results in general are historically focused on the primary endpoint. I think that's what's going to be happening for petosemtamab as well. Obviously once we have the top-line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data in a public presentation at a conference.

Speaker #4: And then, obviously, once we have the top-line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data.

Speaker #4: In a public press conference, in a public presentation at a conference.

Speaker #1: Thanks. Thanks, Tai. I think we keep it to that, Judah, this time.

Jan van de Winkel: Thanks. Thanks, Tey. I think we keep it to that, Judah, this time.

Speaker #3: Thank you. Now we're going to take another question. And now we're going to the correction comes to the line of Victor Flock from BNP Paribas.

Operator: Thank you. Now we're going to take another question. The question comes to line of Victor Flock from BNP Paribas. Your line is open. Please ask your question.

Speaker #3: Your line is open. Please ask your question.

Victor Flock: Tey, thanks so much for taking my questions. Actually two questions on EPKINLY. First one, very impressive momentum lately, and obviously you've mentioned the accelerated uptake in the community setting. But just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling the remainder of the year for EPKINLY? My second question, still on EPKINLY, but on IP. There is a report from Bloomberg arguing that EPKINLY's formulation patent family could extend beyond the combination of matter patents and could potentially add five years, potentially in the US, six years in Europe.

Victor Floc'h: Tey, thanks so much for taking my questions. Actually two questions on EPKINLY. First one, very impressive momentum lately, and obviously you've mentioned the accelerated uptake in the community setting. But just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling the remainder of the year for EPKINLY? My second question, still on EPKINLY, but on IP. There is a report from Bloomberg arguing that EPKINLY's formulation patent family could extend beyond the combination of matter patents and could potentially add five years, potentially in the US, six years in Europe.

Speaker #5: Hi, thanks so much for taking my questions. Actually, two questions on Epkinly. First one, very impressive momentum lately. I mean, obviously, you've mentioned the accelerated uptake in the community setting.

Speaker #5: So, just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling the remainder of the year for Epkinly?

Speaker #5: And my second question, still on Epkinly but on IP: there is a report from Bloomberg arguing that Epkinly's formulation patent family could extend beyond the composition of matter patents and could potentially add like five years in the US and six years in Europe.

Speaker #5: So, just wondering whether you can discuss your IP strategy and your current assumptions for Epkinly in terms of IP. Thanks so much.

Victor Flock: Just wondering whether you can discuss your IP strategy and your current assumption for it in the interim of IP. Thanks so much.

Victor Floc'h: Just wondering whether you can discuss your IP strategy and your current assumption for it in the interim of IP. Thanks so much.

Speaker #1: Thanks, Victor, for the question. So, the first one can be handled by Brad. And for the second one, I think I will ask Tai to give some color on the length of time for the patents.

Jan van de Winkel: Thanks, Victor, for the question. The first one can be handled by Brad, and the second one, I think I will ask Tjeerd to give some color on the length of time for the patents. Brad, why don't you start on the stocking question?

Speaker #1: Brad, why don't you start on the stocking question?

Speaker #6: Yeah, no, thank you for the question. And just briefly on the community, we are encouraged, as you mentioned, with the momentum there. And it’s due to the dual indication—the only bispecific with the dual indication—and it’s really been received extremely well by physicians as well as health systems.

Brad Bailey: Yeah, no. Thank you for the question. Just briefly on the community, we are encouraged, as you mentioned, with the momentum there, and it's due to the dual indications, the only bispecific with the dual indications, and it's really been received extremely well by physicians as well as health systems. As it relates specifically to stocking, no stocking issuance or no stocking at this point in time to be discussed.

Speaker #6: But as it relates specifically to stocking, there's no stocking issue, or no stocking at this point in time to be discussed.

Speaker #1: Thanks. Thanks, Brad. And Tai, do you want to add to address the IP and the length of time we have patent protection, or do you not want to do that right now?

Jan van de Winkel: Thanks, Brad. Tjeerd, you want to add to address the IP and the length of time we have patent protection, or don't you want to do that right now?

Speaker #4: Yeah, I would say this: discussing our patent and IP strategy on calls like this, in the nuanced details, is probably not appropriate right now.

Tahamtan Ahmadi: Yeah, I would say this. Discussing our patent and IP strategy on a call like this in the nuance details is probably not appropriate. Right now, I would stick to mid-30s is where we are. Then, of course, there's always an IP strategy to try to generate additional intellectual protection property protection that helpfully extends some of that protection.

Tahi Ahmadi: Yeah, I would say this. Discussing our patent and IP strategy on a call like this in the nuance details is probably not appropriate. Right now, I would stick to mid-30s is where we are. Then, of course, there's always an IP strategy to try to generate additional intellectual protection property protection that helpfully extends some of that protection.

Speaker #4: I would stick to, like, mid-30s is where we are. And then, of course, there's always an IP strategy to try to generate additional intellectual property protection that, hopefully, extends some of that protection.

Speaker #1: Okay. Thanks, Tai. I think, big picture, we keep it to that for now.

Jan van de Winkel: Okay, thanks, Tjeerd. I think, Victor, we keep it to that for now.

Speaker #5: Great. Thank you very much.

Victor Flock: Great. Thank you very much.

Victor Floc'h: Great. Thank you very much.

Speaker #1: Thanks.

Jan van de Winkel: Thanks.

Operator: Thank you.

Speaker #3: Thank you.

Jan van de Winkel: Any further questions?

Speaker #1: Any further questions?

Speaker #3: We have, would you like to take?

Operator: Would you like to take-

Speaker #1: Yes. Why don't we take one or two more, and then we probably have to end the call and follow up one-on-one.

Jan van de Winkel: Yes. Why don't we take one or two more, and then we probably have to end the call and follow it up one-on-one.

Operator: Yes, of course. Of course, not a problem. Now we're going to take our next question then. The question comes from the line of Kalpit Patel. Your line is open. Please ask your question.

Speaker #3: Yes, of course. Of course, not a problem. And now we're going to take our next question, then. The question comes from the line of Kalpit Patel.

Speaker #3: Your line is open. Please ask your question.

Speaker #6: Yeah. Hey, thanks for taking the question. One more on the first-line DLBCL study. I guess, originally, when you guys designed that protocol and had assumptions for that frontline study, is the timing of the readout—fourth quarter—more or less in line with what you guys originally modeled when you first started the study?

Kalpit Patel: Yeah. Hey, thanks for taking the question. One more on the first-line DLBCL study. I guess originally when you guys designed that protocol and had assumptions for that Frontline study, is the timing of the readout Q4 more so in line with what you guys originally modeled when you first started the study? Then when you completed the enrollment, I believe in 2024, did that estimate, the timing estimate of the readout materially shift? The reason I ask is because the start to finish still looks roughly in line between when Frontline and the POLARIX study started and they finished. Any color on your model assumptions would be useful. Thank you.

Speaker #6: And then, when you completed the enrollment, I believe in 2024, did the timing estimate of the readout materially shift? The reason I ask is because the start to finish still looks roughly in line between when FRONTLINE and the POLARIC study started and when they finished.

Speaker #6: So, any color on your model assumptions would be useful. Thank you.

Speaker #1: So, Kalpit, we are super excited about the frontline setting. The readout will be in Q4. We believe that the data will be excellent, based on the Phase 2 data.

Jan van de Winkel: Kalpit, we are super excited about the Frontline setting. The readout will be in Q4. We believe that the data will be excellent based on the phase II data. We're not going to address any further timing and timeline issues here, but look forward to the data.

Speaker #1: We're not going to address any further timing or timeline issues here, but we look forward to the data.

Speaker #3: Thank you. And now we're going to take our final question for today. Just give us a moment. And the question comes from the line of Matthew Phipps from William Blair.

Operator: Thank you. Now we're going to take our final question for today. Just give us a moment. The question comes line of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Speaker #3: Your line is open. Please ask your question.

Speaker #7: Hi, thanks for squeezing me in. Comparing the frontline CRC trial with PITO to the Origami Two trial, they obviously look pretty similar in design except that the PITO trial does include an ORR primary endpoint.

Matthew Phipps: Hi. Thanks for squeezing me in. Comparing the Frontline CRC trial with petosemtamab to the OrigAMI-2 trial, they obviously look pretty similar in design, except for the petosemtamab trial does include an ORR primary endpoint. Is this safe to assume you will try to explore Project Frontrunner in that Frontline trial? Just curious on Rina-S in non-small cell lung cancer. You've had a trial ongoing there this year. Any updated thoughts on the potential there or when we might see some data from that phase II trial? Thank you.

Speaker #7: Is it safe to assume you will try to explore product front-runner in that frontline trial? And then, just curious on Rina-S in non-small cell lung cancer.

Speaker #7: I've had a trial ongoing there this year. Any updated thoughts on the potential there, or when we might see some data from that Phase 2 trial?

Speaker #7: Thank you.

Speaker #1: Thanks, Matt, for the questions. Tai, can you address both the frontline CRC trial and the non-small cell lung cancer trial data for Rina?

Jan van de Winkel: Thanks, Matt, for the question. Tjeerd, can you address both for the Frontline CRC trial and also the non-small cell lung cancer trial data for RINA?

Speaker #6: Sure. Yeah. So it's

Tahamtan Ahmadi: Sure. Yeah. It's fair to assume that we will also explore, if it is opportune, Project Frontrunner opportunities for colorectal for both trials. I think that is a fair assumption. On the lung cancer Rina-S trial, once we have, I think, a data set that allows a robust discussion on what the next steps are going to be, I think it's a proper and opportune time to present that data. I've said this many times. We're working in a super competitive environment. There's multiple folate receptor ADCs from very large competitors that are coming left and right. I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. We will present that data at the time when we also have the next steps ready.

Tahi Ahmadi: Sure. Yeah. It's fair to assume that we will also explore, if it is opportune, Project Frontrunner opportunities for colorectal for both trials. I think that is a fair assumption. On the lung cancer Rina-S trial, once we have, I think, a data set that allows a robust discussion on what the next steps are going to be, I think it's a proper and opportune time to present that data. I've said this many times. We're working in a super competitive environment. There's multiple folate receptor ADCs from very large competitors that are coming left and right. I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. We will present that data at the time when we also have the next steps ready.

Speaker #4: Fair to assume that we will also explore if it is an opportune project for non-opportunities for colorectal for both trials. I think that is a fair assumption.

Speaker #4: And on the lung cancer Rina-S trial, once we have, I think, a data set that allows a robust discussion on what the next steps are going to be, I think it's a proper and opportune time to present that data.

Speaker #4: I've said this many times—we're working in a super competitive environment. There are multiple footed receptor ADCs from very large competitors that are coming left and right.

Speaker #4: And so I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. So we will present that data at the time when we also have the next steps ready.

Speaker #1: Thanks, Tai. Thanks, Matt. So thank you all for joining us today. And thank you for that lively and invigorating Q&A. With three super important phase three studies reading out in the coming months.

Jan van de Winkel: Thanks, Tjeerd. Thanks, Matt. Thank you all for joining us today, and thank you for that lively and invigorating Q&A. With three super important phase III studies reading out in the coming months, we are well on track to deliver sustainable growth well into the next decades. We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. As always, if you have questions for now, please reach out to our IR team.

Speaker #1: We are well on track to deliver sustainable growth well into the next decades. We look forward to sharing more exciting updates with you in the future as we move through the rest of the year.

Speaker #1: And, as always, if you have questions for now, please reach out to our IR team.

Speaker #3: This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

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

Tahamtan Ahmadi: Thank you.

Tahi Ahmadi: Thank you.

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