Half Year 2024 Genmab A/S Earnings Call

Hello and welcome to the Genmab First Half 2024 Financial Results Conference Call. As a reminder, this conference call is being recorded.

Unknown Executive: As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expectations. However, actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expects.

Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

Jan van der Winkel: Genmab is not under any obligation to update statements regarding the future or to confirm such statements in relation to actual results, unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would like to hand the conference over to our first speaker today, Jan van der Winkel. Please go ahead.

Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law.

Please also note that Genmab may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy.

Speaker Change: I would like to hand the conference over to our first speaker today, Jan van der Winkel, please go ahead.

Jan van der Winkel: Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending June 30, 2024. With me today to present these results is our CFO, Anthony Pagano, our Chief Operating Officer, Anthony Mancini, and our Chief Medical Officer, Taha Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As I have already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships.

Speaker Change: Hello and welcome to Genmab's conference call to discuss the company's financial results for the period ending June 30, 2024. With me today to present these results is our CFO Anthony Pagano, our Chief Operating Officer Anthony Mancini, and our Chief Medical Officer Tah Yamadi. Welcome to Genmab.

Speaker Change: For the Q&A we will be joined by our Chief Development Officer Judith Klimovsky.

Speaker Change: As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call.

During today's presentation, we will reference products being developed under some of our strategic collaborations.

Speaker Change: This slide acknowledges those relationships.

Jan van der Winkel: We have had a very exciting second quarter. The acquisition of Profound Bio, which was completed in May, was a historic event for Genmab and one that will enhance our long-term growth profile. In just a moment, you will hear from Tahi on some of the exciting next steps that we have planned for Ryanair S, and later, Anthony Pagano will walk you through the financial impact of the acquisition. June was an exceptionally eventful month for Epkinly, which is now the first and only bispecific antibody approved in the US to treat both 3-lapsed-cell refractory follicular lymphoma and 3-lapsed-cell refractory diffuse large B-cell lymphoma.

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Speaker Change: We have had a very exciting second quarter. The acquisition of Profound Bio, which was completed in May, was a historic event for Genmab and one that will enhance our long-term growth profile.

Speaker Change: In just a moment, you will hear from Tahi on some of the exciting next steps that we have planned for Ryanair S and later Anthony Pagano will walk you through the financial impact of the acquisition.

Speaker Change: June was an exceptionally eventful month for Epkinly, which is now the first and only bispecific antibody approved in the U.S. to treat both relapsed-cell refractory follicular lymphoma and relapsed-cell refractory diffuse large B-cell lymphoma.

Jan van der Winkel: In addition to the U.S. approval for relapsed or refractory follicular lymphoma, the CHMP adopted a positive opinion recommending TAP-Kinley, as apgaritumab is called in Europe, for the same indication. Both regulatory actions were supported by data from the APCOR NHL-1 trial, which was also recently published in the Lancet Hematology. We would also like to note the This one is in combination with lenalidomide for transplant-eligible patients with relapsed or refractory diffused large B-cell lymphoma.

Speaker Change: In addition to the U.S. approval in relapsed or refractory follicular lymphoma, the CHMP adopted a positive opinion, recommending TAP-Kinley, as apgaritumab is called in Europe , for the same indication.

Both regulatory actions were supported by data from the APCOR NHL-1 trial, which was also recently published in the Lancet Hematology.

Speaker Change: I would also like to note the potentially imminent start of another Phase III trial for Epco-Ritamol.

Speaker Change: This one in combination with lenalidomide for transplant ineligible patients with relapsed or refractory diffused large B-cell lymphoma.

Jan van der Winkel: Together with our partner AbbVie, we continue to evaluate abgaritumab in multiple patient populations and treatment settings, with the goal of establishing abgaritumab as a core therapy in B-cell malignancy. During our Q1 earnings call, we discussed the FDA approval and Japan NDA submission for TIFTAC, both of which occurred early in the quarter. As a reminder, with its approval in the U.S., TIFTAC became the first ADC with demonstrated overall survival data to be granted full FDA approval for the treatment of patients with recurrence or metastatic cervical cancer who have disease progression on or after chemotherapy.

Speaker Change: Together with our partner AbbVie, we continue to evaluate abgaritumab in multiple patient populations and treatment settings, with the goal of establishing abgaritumab as a core therapy in B-cell malignancies.

Speaker Change: During our Q1 earnings call, we discussed the FDA approval and Japan NDA submission for TIFTEC, both of which occurred early in the quarter.

As a reminder, with its approval in the U.S., TIFTAC became the first ADC with demonstrated overall survival data to be granted full FDA approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Jan van der Winkel: I'm also excited to note that data from the Innovative 301 study, on which the approval was based, was recently published in the prestigious New England Journal of Medicine. But now, we hope that you've all had the chance to listen to our June 3rd call to review some of the exciting data that we presented at ESCO, including for TIFDAQ, AppKindy, and, of course, Akka Sunnimal. I will provide you with a brief reminder of the very promising Akasumi Mob data and our next steps for the program on today's call. But before that, I would like to highlight a key change to the Akasumi MAP program that we announced on Monday. Genmab has now taken full control of the development of Akash Sunnima.

Speaker Change: I am also excited to note that data from the Innovative 301 study, on which the approval was based, was recently published in the prestigious New England Journal of Medicine.

Unknown Executive: Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expect.

Speaker Change: By now we hope that you have all had the chance to listen to our June 3rd call to review some of the exciting data that we presented at ESCO, including for TIFDAC, AppKindy, and of course Akka Sunnimab.

Unknown Executive: Actual results may differ materially, for example, as a result of the late 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.

Speaker Change: Thay will provide you with a brief reminder of the very promising Akersulimab data and our next steps for the program on today's call.

Unknown Executive: Please also note that Genmab may hold your personal data as indicated by your as a part of our investor relations outreach activities, in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy.

Speaker Change: Before this, I would like to highlight a key change to the Akasumi Mob program that we announced on Monday.

Speaker Change: Genmab has now taken full control of the development of Akash Sunnimab. This is a fantastic opportunity for us to own and advance these promising assets.

Jan van der Winkel: This is a fantastic opportunity for us to own and advance this promising asset. Our partner, BioNTech, has opted not to participate in the further development of Akasun Limab, but we understand that this decision was based on their strategic portfolio prioritization and does not reflect the strength or potential of Akasun Limab.

Jan Van Derwinkel: I would like to hand the conference over to first speaker today, Jan Van Derwinkel, please go ahead. Hello and welcome to Genmab's conference call to discuss the company's financial result for the period ending June 30, 2024. With me today, to present these results is a CFO entity Pagano, a chief operating officer entering Monsini and a chief medical officer, Taya Madi.

Speaker Change: Our partner, BioNTech, has opted to not participate in the further development of Akasun Limab. We understand that this decision was based on their strategic portfolio prioritization and does not reflect the strength or potential of Akasun Limab.

Jan van der Winkel: This now becomes our second wholly owned candidate, Madison, entering phase three by the end of this year, underscoring our strong confidence in the clinical promise and commercial potential. We are exceptionally well positioned to maximize the potential of Akasuni Mob, and we are very excited about the future of this program. I would also like to add that even though our partnership is changing on this program, it remains extremely strong and collaborative, and we are committed to continuing to work together to advance innovative antibody treatments for patients.

This now becomes our second wholly owned candidate, Madison, entering phase three by the end of this year.

Jan Van Derwinkel: For the Q&A, we will be joined by our chief development officer, Judith Klimowski. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations.

Speaker Change: underscoring our strong confidence in the clinical promise and commercial potential.

Speaker Change: We are exceptionally well positioned to maximize the potential of Akasundi Mob and we are very excited about the future of this program.

Speaker Change: I would also like to add that even though our partnership is changing on this program, it remains extremely strong and collaborative, and we are committed to continuing to work together to advance innovative antibody treatments for patients.

Jan Van Derwinkel: This slide acknowledges those relationships. We have had a very exciting second quarter. The acquisition of profound bio, which was completed in May, was an historic event for Genmab and one that will enhance our long-term growth profile. In just a moment, you will hear from Tahi on some of the exciting next steps that we have planned for Reiner S and later Anthony Pagano will work through the financial impact of the acquisition. June was an exceptionally event for Monsini, which is now the first and only bi-specific antibody approved in the US to treat both relapsed or refractory follicular lymphoma and three-lapsed or refractory diffuse lab B cell lymphoma.

Jan van der Winkel: Turning to medicines powered by our innovation. Janssen announced that RIPERVAN has now been approved by the European Commission for the first-line treatment of adult patients with advanced non-small cell lung cancer, with activating each of our exon 20 insertion mutations. In addition, they have submitted a BLA for a subcutaneous version of Amivantamop for all currently approved or submitted indications of the IV type of arms in certain patients with non-small cell lung cancer. More recently, in July, Janssen announced approval in the U.S. for Darfalex-Fospro in combination with Bortezomib, lenalidomide, and dexamethasone for the treatment of patients who are newly diagnosed with multiple myeloma and are eligible for an autologous stem cell transplant.

Speaker Change: Finally,

Speaker Change: Turning to medicines powered by our innovation.

Speaker Change: Janssen announced that RIPERVAN has now been approved by the European Commission for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating HFR exon 20 insertion mutations.

Speaker Change: In addition, they have submitted a BLA for a subcutaneous version of Amivantamop for

Speaker Change: For all currently approved or submitted indications of IV type of arms in certain patients with non-small cell lung cancer.

Jan Van Derwinkel: In addition to the US approval and relapsed or refractory follicular lymphoma, the CISMP adopted a positive opinion recommending TAP-KIN-LI, as Abkiritimab is called in Europe, for the same indication. Both regulatory actions were supported by data from the Abkur NHL-1 trial, which was also recently published in the Lancet hematology. We would also like to note the potentially imminent start of another Phase III trial for Abkiritimab. This one in combination with Lena Lidemite for transplant inelensible patients with relapsed or refractory diffuse lab B cell lymphoma.

Speaker Change: More recently, in July , Janssen announced approval in the U.S. for Darfalex Faspro in combination with Bortezomib, linalidomide, and dexamethasone for the treatment of patients who are newly diagnosed with multiple myeloma and are eligible for autologous stem cell transplant.

Jan van der Winkel: This combination, based on data from the Phase III Perseus study, has the potential to improve long-term outcomes for patients newly diagnosed with multiple myeloma and further supports Darcelax as a backbone therapy for this disease. Anthony Mancini will provide you with a review of the recent performance for Darcellex, plus other select royalty medicines, as well as, of course, for Epkinly and Tiftax. First, I'm pleased to hand over now to Tahi, who will provide you with a reminder of the significant progress we are making with our wholly owned late-stage clinical programs, Akka Sunimob and Reiner F. Tahi, the floor is yours.

Speaker Change: This combination, based on data from the Phase III Perseus study, has the potential to improve long-term outcomes for patients newly diagnosed with multiple myeloma, and further supports Danzalax as a backbone therapy for this disease.

Speaker Change: Anthony Mancini will provide you with a review of the recent performance for Darcelax, plus other select royalty medicines, as well as, of course, for Epkinly and TifTac.

Jan Van Derwinkel: Together with a partner Abkiritimab in multiple patient populations and treatment settings, with the goal of establishing Abkiritimab as a core therapy in B cell malignancies. Journal Q1 in running school, we discussed the FDA approval and Japan and the A submission for TIFTAC, both of which occurred early in the quarter. As a reminder, with its approval in the US, TIFTAC became the first ADC with demonstrated overall survival data to be granted full FDA approval for the treatment of patients with recurrence or metastatic cervical cancer with disease progression on or off a chemotherapy.

Speaker Change: First, I'm pleased to hand over now to Tahi, who will provide you with a reminder of the significant progress we are making with our wholly owned late-stage clinical programs Akka Sunimop and Reiner F. Tahi, the floor is yours.

Tahamtan Ahmadi: I'm sure by now you've all seen the phase two, a cancer trial, data in combination with pembrolizumab in second line non-small cell lung cancer that we presented at ASCO. This data is very encouraging, demonstrating significant disease control and overall survival alongside a manageable safety profile. As a reminder, in this CPI-pretreated patient population, we presented an impressive median overall survival of 17.5 months and a 12-month OS rate of 69%. Additional data will be presented at medical conferences, including the World Conference on Lung Cancer in September next month.

Tahi: Thank you, Jan.

Tahi: I'm sure by now you have all seen the Phase II Arthrocytoma data in combination with Pembrolizumab in second line non-small cell lung cancer that we presented at ASCO.

Tahi: This data is very encouraging, demonstrating significant disease control and overall survival alongside a manageable safety profile.

Jan Van Derwinkel: D. I'm also excited to note that data from the Innovative 301 study on which the approval was based was recently published in the prestigious New England Journal of Medicine. But now we hope that you have all had the chance to listen to our June 3rd call to review some of the exciting data that we presented at ASCO, including for TIFFDAC, APKINDI and of course, AKASINNEMOP. TIFFDAC will provide you with a brief reminder of the very promising AKASINNEMOP data and our next steps for the program on today's call.

Tahi: As a reminder, in this CPI pre-treated patient population, we presented an impressive median oversurvival of 17.5 months and a 12-month OS rate of 69%.

Tahi: Additional data will be presented at medical conferences, including the World Conference on Lung Cancer in September next month.

Tahamtan Ahmadi: This will include translational data that should help you better understand our confidence in the Q6 week dosing schedule. And to ensure that there is no confusion, this will not include updated clinical data. We are simply too close to ASCO and therefore limited by a very short follow-up, which really prevents a meaningful impact on time to events analysis. That's all.

Tahi: This will include translational data that should help you better understand our confidence in the Q6 week dosing schedule.

Jan Van Derwinkel: Before this, I would like to highlight the key change to the AKASINNEMOP program that we announced on Monday. Jan Mupp has now taken full control of the development of AKASINNEMOP. This is a fantastic opportunity for us to own and advance these promising assets. Our partner, BioPEC, has opted to not participate in the third of the development of AKASINNEMOP. We understand that this decision was based on their strategic portfolio prioritization and does not reflect the strength or potential of AKASINNEMOP.

Tahi: And to ensure that there is no confusion, this will not include updated clinical data. We are simply too close to ASCO and therefore limited by a very short follow-up.

Tahi: which really prevents a meaningful impact on time-to-events analysis. That's that.

Tahamtan Ahmadi: The encouraging data both on Maskell and the translation data that will be presented at WCLC reinforces our commitment to swiftly progressing the Phase III trial in PDR1-positive patients with non-small lung cancer who progressed on a CPI, either alone or in combination with chemotherapy. We expect to start this study before the end of the year. Given both our proven and extensive clinical development experience and our track record of acceleration, as you've seen with Epkinly, we are confident in our ability to advance our carcinoma through phase three and beyond. Moving now to Vinayesh.

Tahi: The encouraging data, both on Maskell and the translation data that will be presented at WCLC.

Tahi: reinforces our commitment to swiftly progressing the Phase III trial in PDR1-positive patients with non-small lung cancer who progressed on a CPI, either alone or in combination chemotherapy.

Tahi: And we expect to start this study before the end of the year.

Jan Van Derwinkel: This now becomes our second wholly-owned candidate, Madison, entering Phase 3 by the end of this year, underscoring our strong confidence in the clinical promise and commercial potential. We are exceptionally well positioned to maximize the potential of AKASINNEMOP as we are and we are very excited about the future of this program. I would also like to add that even though our partnership is changing on this program, it remains extremely strong in color, and we are committed to continuing to work together to advance innovative antibody treatments for patients.

Tahi: Given both our proven and extensive clinical development experience, and our track record of acceleration, as you've seen with Epkinly, we are confident in our ability to advance our caesarean map through Phase III and beyond.

Speaker Change: Moving now to Rina S.

Tahamtan Ahmadi: As a reminder, this slide summarizes why WINA-S aligns with our vision to transform the lives of patients, and we believe it has the potential to do so. Deepin, and consequently expand activity beyond what has been seen with first-generation 14-receptor alpha proteins, becoming a potential best-in-class treatment for ovarian cancer and other photoreceptor alpha-expressing solid tumors. In addition to the efficacy, it also has a differentiated safety profile, avoiding interstitial lung disease and corneal toxicity seen with other ADC therapies. Dissertation.

Rina S: As a reminder, this slide summarizes why VNIS aligns with our vision to transform the lives of patients.

Speaker Change: We believe it has the potential to broaden

Speaker Change: deepen and consequently expand activity beyond what has been seen with first-generation photoreceptor-alpha approaches.

Jan Van Derwinkel: Finally, turning to medicines powered by our innovation. Johnson announced that RIPROFONS has now been approved by the European Commission for the first line treatment of adult patients with advanced non-small saline cancer with activating each of our Exxon-20 insertion mutations. In addition, they have submitted a BLA for a subcutaneous version of MISANTEMOP for all currently approved or submitted indication of IV RIPROFONS in certain patients with non-small saline cancer. More recently in July, Johnson announced approval in the U.S, for data-select phosphory in combination with bautismate, linalidamide, and dexameterzone for the treatment of patients who are newly diagnosed with multiple myeloma and are eligible for autologous stem cell transplant. This combination, based on the data from the Phase III Persia study, has the potential to improve long-term outcomes for patients newly diagnosed with multiple myeloma and further supports Danselect as a backbone therapy for this disease.

Speaker Change: Becoming a potential best-in-class treatment for ovarian cancer and other photoreceptor alpha-expressing solid tumors.

Speaker Change: In addition to the efficacy, it also has a differentiated safety profile, avoiding interstitial lung disease and corneal toxicity seen with other ADC therapies.

Tahamtan Ahmadi: Both efficacy and safety are a direct result of the novel proprietary hydrophilic linker technology developed by ProfoundBio. We're exceptionally well positioned to maximize the potential of ENA-S. Given both of them clicker development capabilities, the track record of acceleration, and our experience in the Gynox space already with TIFDAI. And as we said before, we anticipate the first potential approval of Arena could be in 2017, and importantly, we anticipate blockbuster peak sales potential.

Speaker Change: This dissertation

Speaker Change: Both inefficacy and safety is a direct result of the novel proprietary hydrophilic linker technology developed by ProfoundBio.

Speaker Change: We're exceptionally well positioned to maximize the potential of VNA-S.

Speaker Change: Given both our Poon Clicker development capabilities, the track record of acceleration, and our experience in the Gynox space already with TIFFDAQ.

Speaker Change: And as we said before, we anticipate the first potential approval for WINAS could be in 2027, and importantly we anticipate Blockbuster peak sales potential.

Tahamtan Ahmadi: This is what we shared with you when we announced the acquisition of ProfoundBio. Now that we are officially responsible for the development of VNAS, let's take a look at our near-term plan. Previously, we told you that we would be providing an update to the initial Encouraging Phase 1 Ovarian Cancer data that was presented at CICI last year. We now confirm that you will see both updated data and additional follow-up at ASML in September.

Speaker Change: Now this is what we shared with you when we announced the acquisition of ProfoundBio.

Speaker Change: Now that we are officially responsible for the development of WINA-S, let's take a look at our near-term plans.

Anthony Mancini: Anthony Montcini will provide you with a review of the recent performance for Danselect plus autoselect royalty medicines, as well as of course for Epkinlian tiftech.

Speaker Change: Previously, we told you that we would be providing an update to the initial Encouraging Phase I Ovarian Cancer data that was presented at CICI last year.

Tahi: First, I'm pleased to like to to hand over now to Tahi, who will provide you with a reminder of the significant progress we are making with our wholly-owned late-stage clinical programs, Akasunimop and Rhino-F. Thank you, Jan. I'm sure by now you've all seen the phase two acasinum of data in combination with pembolism in second line non-small cell lung cancer that we presented at ASCO. This data is very encouraging demonstrating significant disease control and over-survival alongside a manageable safety profile.

Speaker Change: I can now confirm that you will see both updated data and additional follow-up at ASML in September .

Tahamtan Ahmadi: I am also pleased to note that we are on track to deliver on our Accelerated Development Plan. We have a line on the Dulles Foothill Authority and expect to start a phase 3 trial in second line plus platinum resistant ovarian cancer before the end of the year. So, in summary, significant progress for both Akasonymab and Vinayas, and we look forward to sharing more information with you when it becomes available. I will now hand this over to my colleague, Anthony Mancini.

Speaker Change: I'm also pleased to note that we are on track to deliver on our accelerated development plan.

Speaker Change: We have a line on the dose with health authorities.

Speaker Change: and expect to start a phase 3 trial in second line plus platinum resistant ovarian cancer before the end of the year.

Speaker Change: So, in summary, significant progress for both Akasonic MAP and VNAS, and we look forward to sharing more information with you when it becomes available.

Tahi: So, reminder, in this CPI pre-3D patient population, we presented an impressive median over-survival of 17.5 months in a 12-month OS rate of 69%. Additional data will be presented at medical conferences including the World Conference on Lung Cancer in September next month. This will include traditional translational data that should help. You better understand our confidence in the Q6 week dosing schedule. And to ensure that there is no confusion, this will not include updated clinical data.

Speaker Change: I will now hand it over to my colleague Anthony Mancini.

Anthony Mancini: In Q2 and in the first half of 2024, performance across our two key revenue streams, Royalty Medicines and Genmab Commercialized Medicines, continued to demonstrate strong growth. Turning to our Royalty Medicines portfolio on slide 8, Darzalex delivered strong demand growth with $5.57 billion in first half net sales.

Anthony Mancini: Thanks, Todd.

Anthony Mancini: In Q2, and in the first half of 2024,

Anthony Mancini: Performance across our two key revenue streams, Royalty Medicines and Genmab Commercialized Medicines, continued to demonstrate strong growth.

Anthony Mancini: Turning to our Royalty Medicines portfolio on slide 8.

Anthony Mancini: Darzalex delivered strong demand growth with $5.57 billion in first half net sales.

Anthony Mancini: A 19% year-over-year growth driven by market share gains overall and meaningful market share increases in frontline multiple myeloma. As Jan mentioned, on July 30th, FDA approval was received for a new indication for a Darzalex-Faspro-Quad combination based on the Perseus study in newly diagnosed, transplant-eligible multiple myeloma. As J&J mentioned in their earnings, primary endpoints were also met in two additional Darzalec studies in Q2. Cepheus, a Darzalex-based quadregimen and transplant ineligible newly diagnosed multiple myeloma, an aquila in smoldering mildew. Detailed results from these studies will be presented at an upcoming scientific meeting.

Anthony Mancini: A 19% year-over-year growth driven by market share gains overall and meaningful market share increases in frontline multiple myeloma.

Tahi: We are simply too close to ASCO and therefore limited by a very short follow-up, which really prevents a meaningful impact on time to events and analysis. That said, encouraging data both on ASCO and the translation data that will be presented at WCLC reinforces our commitment to swiftly progressing the phase three trial and positive patients with non-small and cancer who progressed on a CPI either alone or in combination chemotherapy. And we expect to start this study before the end of the year. Given both our proven and extensive clinical development experience and our track record of acceleration, as you've seen with Epkinley, we are confident in our ability to advance Akasunim up through phase three and beyond.

Anthony Mancini: As Jan mentioned, on July 30th, FDA approval was received for a new indication for a Darzalex-Faspro quad combination based on the Perseus study in newly diagnosed transplant-eligible multiple myeloma.

Speaker Change: As J&J mentioned in their earnings call,

Speaker Change: Primary endpoints were also met in two additional Darzalex studies in Q2. Cepheus, a Darzalex-based quad regimen and transplant ineligible newly diagnosed multiple myeloma,

Anthony Mancini: An aquila in smoldering myeloma.

Anthony Mancini: Detailed results from these studies will be presented in an upcoming scientific meeting.

Tahi: Moving now to Rina S. As a reminder, this slide summarizes why Rina S aligns with our vision to transform the lives of patients. We believe it has the potential to broaden, deepen and consequently expand activity beyond what has been seen in the first generation folding receptor alpha approaches, becoming a potential best in class treatment for a varying and other folded receptor alpha-expressing solid tumors. In addition to efficacy, it also has a differentiated safety profile avoiding interstitial lung disease and cornea toxicity seen with other ADC therapies.

Anthony Mancini: Combining with the final analysis of Maya, showing a median overall survival of seven and a half years, it's clear that Darzalex is foundational to survival in multiple myeloma and that growth opportunities will continue with Darzalex in early treatment sets. Beyond the early settings, Darzalex is continuing to be a backbone therapy in combination with both newer and older therapies in relapse or refractory multiple myeloma, including with Tecphylae, our CD3-BCMA dual body bispecific, and Talve, our CD3-GPRC5D dual body bispecific, which each delivered solid performance in the first half of 2024. We expect continued growth and continued usage Cosimta achieved continued strong demand performance with over $1.4 billion in the first half, a 64% year-over-year growth.

Speaker Change: Coupled with the final analysis of Maya showing a median overall survival of seven and a half years, it's clear that Darzalex is foundational to survival in multiple myeloma and that growth opportunities will continue with Darzalex in early treatment settings.

Speaker Change: Beyond the early settings, Darzalex is continuing to be a backbone therapy in combination with both newer

Speaker Change: and older therapies in relapse or refractory multiple myeloma, including with Tecphylae, our CD3-BCMA dual-body bispecific, and Talve, our CD3-GPRC5D dual-body bispecific.

Tahi: This differentiation, both in efficacy and safety, is a direct result of the novel proprietary hydrophilic linker technology developed by profound bio. Receptionally well positioned to maximize the potential of Rina S, given both our proven clinical development capabilities, the track record of acceleration, and our experience in the Gynec space already with TIFF DAC. And as we said before, we anticipate the first potential for Rina S could be in 27 and importantly, we anticipate blockbuster peak sales potential.

Speaker Change: which each delivered solid performance in the first half of 2024.

Speaker Change: We expect continued growth and continued usage of Darzalex throughout the multiple myeloma patient journey.

Speaker Change: Kasympta achieved continued strong demand performance with over $1.4 billion in the first half.

Anthony Mancini: Cosimta Performance is not only progressing well in the United States but also outside the United States. It continues to be the new-to-brand prescription share leader in 7 of 10 major markets outside the U.S. Tepesda, the first and only FDA-approved treatment for thyroid eye disease, generated net sales of $479 million in Q2. In addition, with the June 17th FDA submission for the subcutaneous formulation of Riborvan, our EGFR-CMET bi-specific, it's another milestone to help make an even bigger impact on EGFR-mutated non-small-cell lung cancer.

Speaker Change: A 64% year-over-year growth.

Speaker Change: Kasympta performance is not only progressing well in the United States but also outside the United States. It continues to be the new-to-brand prescription share leader in 7 of 10 major markets outside the U.S.

Tahi: Now this is what we shared with you when we announced the acquisition of profound bio. Now that we officially responsible for the development of Rina S, let's take a look at our near-term plans. Previously, we told you that we'd be providing an update to the initial encouraging phase one of our encountered data that was presented at CCLAS. Matthew, we can now confirm that you will see both updated data and additional follow-up at as more in September.

Speaker Change: Tepeza, the first and only FDA-approved treatment for thyroid eye disease generated net sales of $479 million in Q2.

Speaker Change: In addition, with the June 17th FDA submission for the subcutaneous formulation of Riborvan,

Speaker Change: It's another milestone to help make an even bigger impact on EGFR-mutated, non-small-cell lung cancer patients.

Tahi: I'm also pleased to note that we are on track to deliver on our accelerated development plan. We have aligned on the dose with health authorities and expect to start a phase three trial in second line plus platinum resistant ovarian cancer before the end of the year.

Anthony Mancini: In summary, we expect continued strong Genmab revenue growth from our six diverse royalty medicines in the second half of 2024 and beyond. Turning to our Genmab commercialized medicines on slide nine. On June 26th, we received accelerated approval in the U.S. for our second indication for Abkinle, as a monotherapy for patients with relapsed or refractory follicular lymphoma after two more lines of prior therapy. We also received a positive CHMP opinion for this indication on June 27, with an approval decision in Europe expected in Q3. The early response in the U.S. to Epkinly and follicular lymphoma has been very positive.

Speaker Change: In summary, we expect continued strong Genmab revenue growth from our six diverse royalty medicines.

Speaker Change: in the second half of 2024 and beyond.

Tahi: So in summary, significant progress for both Akasunimab and Rinaez, and we look forward to sharing more information with you when it becomes available.

Speaker Change: Turning to our Genmab commercialized medicines on slide 9.

Speaker Change: On June 26th, we received accelerated approval in the U.S. for our second indication for Atkinley.

Anthony Mancini: I will now hand it over to my colleague, Anthony Mancini. Thanks, Todd. In Q2 and in the first half of 2024, performance across are two key revenue streams, royalty medicines, and Genmab commercialized medicines continued to demonstrate strong growth.

Speaker Change: as a monotherapy for patients with relapsed or refractory follicular lymphoma after two more lines of prior therapy.

Speaker Change: We also received a positive CHMP opinion for this indication on June 27th with an approval decision in Europe expected in Q3.

Anthony Mancini: Turning to our royalty medicines portfolio on slide eight, Dar-Zilex delivered strong demand growth with 5.57 billion in first half net sales, a 19% year-over-year growth driven by market sharegames overall and meaningful market share increases in front line multiple myeloma. As Jan mentioned on July 30, FDA approval was received for a new indication for Dar-Zilex spread Dar-Zilex fast grow quad combination based on the Perseus study in newly diagnosed transplant eligible multiple myeloma.

Speaker Change: The early response in the U.S. to Epkinly and follicular lymphoma has been very positive.

Anthony Mancini: We continue to hear encouraging feedback from our customers across diverse sites of care regarding the FL label that does not require hospitalization. This gives us confidence in expanding FKINLI utilization across practice settings as the first and only T cell engaging bi-specific antibody approved for both 3rd line plus DLBCL and 3rd line plus FKINLI. In addition, we presented two and a half year follow-up data at ASCO, demonstrating the long-term durability and powerful responses with Epkinle in third-line DLBC.

Speaker Change: We continue to hear encouraging feedback from our customers across diverse sites of care regarding the FL label that does not require hospitalization.

Speaker Change: This gives us confidence in expanding at Kinley Utilization across practice settings as the first and only T cell engaging bi-specific antibody approved for both 3rd Line Plus DLVCL and 3rd Line Plus FL.

Speaker Change: In addition, we presented two-and-a-half-year follow-up data at ASCO demonstrating the long-term durability and powerful responses with Epkinly in 3rdLinePlus DL-BCL.

Anthony Mancini: As J&J mentioned in the earnings call, primary endpoints were also met into additional Dar-Zilex studies in Q2. Sefius, a Dar-Zilex-based quadregiment in transplant ineligible newly diagnosed multiple myeloma, an aquila in smoldering myeloma. Detailed results from these studies will be presented in an upcoming scientific meeting. Couples with the final analysis of Maya showing a median overall survival of seven and a half years, it's clear that Dar-Zilex is foundational to survival in multiple myeloma and that growth opportunities will continue with Dar-Zilex in early treatment settings.

Anthony Mancini: We're very pleased with Kinley demand performance across our key geographies, with over 90% of net sales coming from the U.S. and Japan. Epkinley delivered $121 million in net sales for the first half, with $70 million in Q2, which includes foreign exchange headwinds in the first half of 2024.

Speaker Change: We're very pleased with that Kinley demand performance across our key geographies with over 90% of net sales coming from the U.S. and Japan.

Speaker Change: Epkinley delivered $121 million in net sales for the first half, with $70 million in Q2, which includes foreign exchange headwinds in the first half of 2024.

Anthony Mancini: In both the U.S. and Japan, Epkinle has seen robust uptake across the account, strong field execution, and positive responses from customers and the patients we serve, really validating Epkinley's differentiated profile that balances powerful efficacy, manageable safety, and a seamless patient experience with subcutaneous administration. Overall, the launch is exceeding our expectations, with our third line plus DLBCO and third line plus FL indications as the first steps towards establishing epkinile as the core therapy across B-cell malignancies. Turning to TIVDAC, our tissue factor-directed ADC, it delivered $60 million in net sales for the first half of 2024. A year-over-year growth of 48% This represents the 11th consecutive quarter of demand growth for TIBDEX.

Speaker Change: In both the U.S. and Japan, Epkinley has seen robust uptake across the account.

Speaker Change: strong field execution and positive responses from customers and the patients we serve, really validating Epkinley's differentiated profile that balances powerful efficacy, manageable safety, and a seamless patient experience with subcutaneous administration.

Anthony Mancini: Beyond the early settings, Dar-Zilex is continuing to be a backbone therapy in combination with both newer and older therapies in relapse or refractory multiple myeloma, including with Tech-Viely, our CD3 BCMA dual-body-by-specific, and Talve, our CD3-GPRC-5D dual-body-by-specific, which each delivered solid performance in the first half of 2024. We expect continued growth and continued usage of Dar-Zilex throughout the multiple myeloma patient journey. Casimta achieved continued strong demand performance with over 1.4 billion in the first half, a 64% year-over-year growth.

Speaker Change: Overall, the launch is exceeding our expectations with our 3rd Line Plus DLBCO and 3rd Line Plus FL indications as the first steps towards establishing FKinley as the core therapy across B-cell malignancies.

Speaker Change: Turning to TIBDAQ, our tissue factor-directed ADC, it delivered $60 million in net sales for the first half of 2024, a year-over-year growth of 48%.

Speaker Change: This represents the 11th consecutive quarter of demand growth.

Anthony Mancini: We're very pleased with the performance, and the recent full approval based on the significant 30% improvement in overall survival in the Innovative 301 study is driving increased breadth and depth of prescribing. Geinank and Medank customers continue to provide positive feedback on the impact TIBDAQ is making on the lives of women with cervical cancer. And we're well on our way to establishing TBAC as a clear standard of care in second line spots for current or metastatic cervical cancer.

Speaker Change: We're very pleased with the performance and the recent full approval based on the significant 30% improvement in overall survival in the Innovative 301 study is driving increased breadth and depth of prescribing.

Anthony Mancini: Casimta performance is not only progressing well in the United States, but also outside the United States, it continues to be the new to brand prescription share leader in seven of 10 major markets outside the Wes, Topesa, the first and only FDA-approved treatment for thyroid eye disease generated net sales of $470.9 million in Q2. In addition, with the June 17th FDA submission for the subcutaneous formulation of RyberVend, our EGFR CMET by specific, it's another milestone to help make an even bigger impact on EGFR mutated non-small cell lung cancer patients.

Speaker Change: Gynonc and MedOnc customers continue to provide positive feedback on the impact TibDAC is making on the lives of women with cervical cancer.

Speaker Change: And we're well on our way to establishing TBAC as a clear standard of care in second line spots for current or metastatic cervical cancer.

Anthony Mancini: The successful building in gynecologic oncology with TIBDAC is an important foundation to prepare for future potential launches such as RENA-S and folate receptor alpha expressing platinum resistant ovarian cancer. As an end-to-end biotech company, we're very pleased at our Genmab commercialized medicines' performance, which represents 31% of Genmab's overall revenue growth in the first half, and look forward I'd like to take a moment to thank our partners and our entire cross-functional Genmab team across commercialization, R&D, and enabling functions for their tireless efforts every day to make a meaningful difference to the patients we serve. With that, I'll hand the call to Anthony Pagano to provide more perspective on both our first half financials and our updated guide.

Speaker Change: The successful building in gynecologic oncology with TIBDAC is an important foundation to prepare for future potential launches such as RENA-S in folate receptor alpha-expressing, platinum-resistant ovarian cancer.

Anthony Mancini: In summary, we expect continued strong Genmab revenue growth from our six diverse royalty medicines in the second half of 2024 and beyond.

Speaker Change: As an end-to-end biotech company, we're very pleased at our Genmab commercialized medicines performance.

Speaker Change: represents 31% of Genmab's overall revenue growth in the first half and look forward to carrying this momentum through the second half of 2024 and beyond.

Anthony Mancini: Turning to our Genmab commercialized medicines on slide 9, on June 26th we received accelerated approval in the US for our second indication for Epkinley as a monotherapy for patients with relapse to refractory follicular lymphoma after two more lines of prior therapy. We also received a positive CHMP opinion for this indication on June 27th with an approval decision in Europe expected in Q3. The early response in the US to Epkinley in follicular lymphoma has been very positive.

Speaker Change: I'd like to take a moment to thank our partners and our entire cross-functional Genmab team across commercialization, R&D, and enabling functions for their tireless efforts every day to make a meaningful difference to the patients we serve.

Anthony Pagano: With that, I'll hand the call to Anthony Pagano to provide more perspective on both our first half financials and our updated guidance.

Anthony Pagano: Yes, great. Thanks, Anthony.

Anthony Pagano: We continue to strengthen our foundation throughout H1. Having delivered on our goal of successful regulatory approvals and launches for Epkinly in the US, Europe, and Japan in 2023, we are pleased with how these launches are progressing, and even more so now, with a second indication in the U.S. and the potential for additional approvals in Europe and Japan for late-line follicular lymphoma. We've also significantly enhanced our long-term growth potential with the completion of the acquisition of ProfoundBio.

Anthony: Yes, great. Thanks, Anthony.

Anthony Pagano: We continue to strengthen our foundation throughout H-1.

Anthony Mancini: We continue to hear encouraging feedback from our customers across diverse sites of care regarding the FL label that does not require hospitalization. This gives us confidence in expanding at Kinley utilization across practice settings as the first and only T-cell engaging bites to the antibody approved for both third line plus DLDCL and third line plus FL. In addition, we presented two and a half year follow-up data at ASCO demonstrating the long-term durability and powerful responses with Epkinley in third line plus DLDCL.

Speaker Change: Having delivered on our goal of successful regulatory approvals and launches for Epkinly in the US, Europe , and Japan in 2023, we are pleased with how these launches are progressing.

Anthony: and even more so now.

Speaker Change: with a second indication in the U.S. and the potential for additional approvals in Europe and Japan for late-line follicular lymphoma.

Speaker Change: We've also significantly enhanced our long-term growth potential with the completion of the acquisition of ProfoundBio.

Anthony Pagano: And as we'll see, our financials remain strong. Recurring revenues grew by 42% in H1. This was principally driven by strong royalties from Darzalex, Cosimta, and other approved medicines, as well as strong performance from both F. Kinley and TIBDAQ. This strong H1 performance is driving an increase to our full year revenue guidance. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business, our pipeline, and our team and capabilities in a very focused and disciplined way.

Anthony Pagano: And, as we'll see, our financials remain strong.

Anthony Mancini: We're very pleased with Epkinley demand performance across our T-geographies with over 90% of net sales coming from the US and Japan. Epkinley delivered 121 million in net sales for the first half with 70 million in Q2 which includes foreign exchange headwinds in the first half of 2024. In both the US and Japan, Epkinley has seen robust uptake across the accounts, strong field execution, and positive responses from customers and the patients we serve, really validating Epkinley's differentiated profile that balances powerful activity, manageable safety, and a seamless patient experience with subcutaneous administration. Overall, the launches exceeding our expectations with our third line plus DLDCL and third line plus FL indications as the first steps toward establishing Epkinley at the core therapy across the sell and the latencies.

Anthony Pagano: Recurring revenues grew by 42% in H1.

Speaker Change: This was principally driven by strong royalties from Darzalex, Kesimpta, and other approved medicines, as well as strong performance from both Epkinley and Tivdak.

Speaker Change: This strong H-1 performance is driving an increase to our full-year revenue guidance.

Speaker Change: Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business, our pipeline, and our team and capabilities in a very focused and disciplined way.

Anthony Pagano: Now, before we take a closer look at the results from H1 and our improved guidance, I'd like to provide you with an overview of some of the details and financial impact of the acquisition of ProfoundBio. Starting on the left.

Speaker Change: Now, before we take a closer look at the results from H1 and our improved guidance, I'd like to provide you with an overview of some of the details and financial impact of the acquisition of ProfoundBio.

Anthony Pagano: We've summarized how the 13.1 billion kroner purchase price has been allocated. First, you can see the largest portion of the purchase price has been allocated to RENA-S, and here, amortization will begin upon regulatory approval, which is estimated to be in 2027. Second, for the ADC tech platform, amortization started at the closing of the transaction and will continue over 15 years. And this is what you can already see impacting the P&L in 2024 with an estimated full year impact of $48 million. We also have goodwill, which isn't amortized and will be tested for impairment every year.

Speaker Change: Starting on the left, we've summarized how the $13.1 billion purchase price has been allocated.

Anthony Mancini: Turning to TIBDAQ, our tissue factor directed ADC it delivered 60 million in net sales for the first half 2024. A year over year growth of 48%. This represents the 11th consecutive quarter of demand growth. For today. Jack, we're very pleased with the performance and the recent full approval based on the significant 30% improvement in overall survival in the Innovative 301 study is driving increased breadth and depth of prescribing. Guinank and Medank customers continue to provide positive feedback on the impact Tivdak is making on the lives of women with cervical cancer and we're well on our way to establishing Tivdak as a clear standard of care and second line spots for current or metastatic cervical cancer. The successful building in gynecologic oncology with Tivdak is an important foundation to prepare for future potential launches such as Rina S, in fully receptor alpha expressing platen-resistant ovarian cancer.

Speaker Change: First, you can see the largest portion of the purchase price has been allocated to RENA-S.

Speaker Change: And here, amortization will begin on regulatory approval, which is estimated to be in 2027.

Speaker Change: Second, for the ADC tech platform, amortization started at the closing of the transaction and will continue over 15 years. And this is what you can already see impacting the P&L in 2024 with an estimated full year impact of $48 million.

Speaker Change: We also have Goodwill, which isn't amortized and will be tested for impairment every year.

Anthony Pagano: And finally, the difference between the purchase price and the total fair value listed here is primarily due to an assumed deferred tax liability of $2.1 billion. This reflects the estimated future tax obligations related to the acquired intangible assets, primarily RENA-S and the ADC tech platform. Now moving to the right.

Speaker Change: And finally, the difference between the purchase price and the total fair value listed here is primarily due to an assumed deferred tax liability of $2.1 billion. This reflects the estimated future tax obligations related to the acquired intangible assets, primarily RENA-S and the ADC tech platform.

Anthony Pagano: You can see that since closing the deal, we've incurred $330 million in costs related to ProfoundBio. And on a four-year basis, we expect costs of around $1.15 billion. As you will see, acquisition and integration-related charges, or deal costs, are a separate line item on our P&L.

Speaker Change: Now moving to the right.

Speaker Change: You can see that since closing the deal, we've incurred $330 million of costs related to ProfoundBio.

Anthony Mancini: As an end-to-end biotech company, we're very pleased that our GenMab commercialized medicines performance represents 31% of GenMab's overall revenue growth in the first half and look forward to carrying this momentum through the second half of 2024 and beyond.

Speaker Change: And on a four-year basis, we expect costs of around $1.15 billion.

Speaker Change: As you will see, acquisition and integration related charges, or deal costs, are a separate line item on our P&L.

Anthony Pagano: Taken together with the ADC amortization expenses, these are expected to be around $400 million for the year. And as a reminder, these costs were excluded from the directional financial guidance I provided when we announced the deal back in April. So with this background, let's take a look at our results for H1, and let's start with our revenues. We grew total revenue to over 9.5 billion kroner in H1. And as I've already highlighted, that included a 42% increase in our recurring revenue. This strong growth was driven by higher Darzalex and Cosimta royalties, as well as royalties from other products. And we're pleased with how Epkinle and Tib Dakker are performing.

Speaker Change: Taken together with the ADC amortization expenses, these are expected to be around $400 million for the year. And as a reminder, these costs were excluded from the directional financial guidance I provided when we announced the deal back in April .

Anthony Mancini: I'd like to take a moment to thank our partners and our entire cross-functional GenMab team across commercialization, R&D, and enabling functions for the tireless efforts every day to make a meaningful difference to the patients we serve.

Anthony Pagano: Taken together, these two products contributed 31% of our total revenue growth in H1. And this really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued highly focused investment, as you can see on the next slide. In line with our significant growth opportunities, total OPEX was approximately 6.7 billion kroner in H1. As you can see, the majority of the growth was driven by R&D investments.

Anthony Pagano: With that, I'll hand the call to Anthony Pugano to provide more perspective on both our first half financials and our updated guide. Yes, great, thanks Anthony. We continue to strengthen our foundation throughout H1. Having delivered on our goal of successful regulatory approvals and launches for Epkinley in the U.S., Europe, and Japan in 2023, we are pleased with how these launches are progressing. And even more so now, with a second indication in the U.S., and the potential for additional approvals in Europe and Japan for a late-line, follicular lymphoma, we've also significantly enhanced our long-term growth potential with the completion of the acquisition of profound bio.

Speaker Change: So, with this background, let's take a look at our results for H1 and let's start with our revenues.

Speaker Change: we grew total revenue to over nine point five billion croner in h one and as i've already highlighted that included a forty-two percent increase in our recurring revenue

Speaker Change: this strong growth was driven by higher d eles and consumpti roalties as well as royalties from other products

Speaker Change: and we're pleased with without epkimlely tiive dacer performing

Speaker Change: Taken together, these two products contributed 31% of our total revenue growth in H1. And this really illustrates the power of our recurring revenue.

Speaker Change: And overall, this strong recurring revenue growth enables our continued highly focused investment as you can see on the next slide.

Anthony Pagano: And, as we'll see, our financials remain strong, recurring revenues grew by 42% in H1. This was principally driven by strong royalties from Darzilex, Kacinta, and other approved medicines, as well as strong performance from both Epkinley and Tibdeck. This strong H1 performance is driving an increase to our full-year revenue guidance. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business, our pipeline, and our team and capabilities in a very focused and disciplined way.

Speaker Change: In line with our significant growth opportunities, total OPEX was approximately 6.7 billion kroner in H1.

Speaker Change: As you can see, the majority of the growth was driven by R&D investments.

Anthony Pagano: Here, we've accelerated our investment in our product portfolio, especially the advancement of our mid to late stage pipeline. Specifically, we're expanding the development of Epkinle, Tivdak, Akasinlimab, and now, of course, Rita S. As you can also see, SG&A growth moderated and was up only 12 percent. And this reflects our continued focus on driving SG&A efficiency. As previously highlighted, we continue to invest to secure a successful AppKinley launch in our two key markets, the US and Japan.

Speaker Change: Here, we've accelerated our investment into our product portfolio, especially the advancement of our mid- to late-stage pipeline.

Speaker Change: Specifically, we're expanding the development for Epkinli, Tivdak, Akkasunilamab, now, of course, Rina S.

Speaker Change: As you can also see, SG&A growth moderated, and was up only 12%, and this reflects our continued focus on driving SG&A efficiency.

Anthony Pagano: Now, before we take a closer look at the results from H1 and our approved guidance, I'd like to provide you with an overview of some of the details and financial impact of the acquisition of profound bio. Starting on the left, we've summarized how the 13.1 billion-croner purchase price has been allocated. First, you can see the largest portion of the purchase price has been allocated to Rina S. And here, amortization will begin on regulatory approval, which is estimated to be in 2027.

Speaker Change: As previously highlighted, we continue to invest to secure a successful AppKinley launch in our two key markets, the US and Japan.

Anthony Pagano: And of course, we've been really focused on the acquisition and integration of profound bio. Now, let's take a look at our financials as a whole. Here you can see our summary P&L. Revenue came in at over $9.5 billion.

Speaker Change: And of course, we've been really focused on the acquisition and integration of profound bio.

Anthony Pagano: That's up 36% on last year. Total OPEX was around $6.7 billion, and here again, most of which was R&D. And even with that increased investment, we're still delivering over $2.4 billion of operating profit, and that's up more than 29%. Moving to our net financial items, here we have a gain of $1.4 billion. This was driven by the strengthening of the dollar against the yen in the first half of the year, as well as by an increase in interest income.

Speaker Change: Now let's take a look at our financials as a whole.

Anthony Pagano: Then we have a tax expense of $1.1 billion, which equates to an effective tax rate of 28.9%. Here, I do want to pause for a moment and note that we are currently evaluating the integration of profound bio operations from a tax perspective. So our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12 to 18 months.

Anthony Pagano: And that brings us to our net profit of over 2.7 billion kroner. So, as you can see, continued strong underlying financial performance. Having now looked at our H1 results, let's take a look at our updated guidance. At a macro level, you'll see we're projecting higher revenues and operating profit even as we take on two wholly owned Phase 3 programs. I've already covered in some detail the impact of the profound bio

Speaker Change: Here you can see our summary P&L.

Speaker Change: Revenue came in at over 9.5 billion kroner. That's up 36% on last year.

Anthony Pagano: Second, for the ADC tech platform, amortization started at the closing of the transaction and will continue over 15 years. And this is what you can already see impacting the P&L in 2024 with an estimated four-year impact of 48 million. We also have Goodwill, which isn't amortized and will be tested for impairment every year. And finally, the difference between the purchase price and the total fair value listed here is primarily due to an assumed deferred tax liability of 2.1 billion.

Speaker Change: Total OPEX was around 6.7 billion and here again most of most of which was R&D.

Speaker Change: And even with that increased investment, we're still delivering over $2.4 billion of operating profit. And that's up more than 29%.

Speaker Change: Moving to our net financial items, here we have a gain of $1.4 billion.

Speaker Change: This game was driven by the strengthening of the dollar against the kroner in the first half of the year, as well as by an increase in interest income.

Anthony Pagano: This reflects the estimated future tax obligations related to the acquired intangible assets, primarily Rina S and the ADC tech platform. Now, moving to the right, you can see that since closing the deal, the Fengkurd 330 million of costs related to profound bio. As on a full-year basis, we expect costs of around 1.15 billion. As you will see, acquisition and integration related charges or deal costs are a separate line item on our P&L.

Speaker Change: Then we have tax expense of 1.1 billion which equates to an effective tax rate of 28.9 percent. And here I do want to pause for a moment and note that we are currently evaluating the integration of profound bio operations from a tax perspective.

Speaker Change: So our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12 to 18 months.

Speaker Change: And that brings us to our net profit of over 2.7 billion kroner.

Anthony Pagano: Taken together with the ADC amortization expenses, these are expected to be around 400 million for the year. And as a reminder, these costs were excluded from the directional financial guidance I provided when we announced the deal back in April.

Speaker Change: So, as you can see, continued strong underlying financial performance.

Speaker Change: Having now looked at our H1 results, let's take a look at our updated guidance.

Speaker Change: At a macro level,

Speaker Change: You'll see we're projecting higher revenues and operating profit even as we take on two wholly owned Phase 3 programs.

Anthony Pagano: So, with this background, let's take a look at our results for H1 and let's start with our revenues. We grew total revenues to over 9.5 billion crooner and H1. And as I've already highlighted, that included a 42% increase in our recurring revenue. This strong growth was driven by higher darsalex and consumer royalties as well as royalties from other products. And we're pleased with how appkinly and tibdack are performing. Taken together, these two products contributed 31% of our total revenue growth in H1.

Speaker Change: I've already covered, in some detail, the impact of the profound bio acquisition.

Anthony Pagano: Now, as far as us taking on full responsibility for Akasunamab, this does have the effect of grossing up both our revenue and our expenses for all products that remain in our collaboration with BioNTech. This results in around 600 million kroner of both higher revenue and higher costs. But really, it's important to note that this classification change in our guidance does not impact our operating profit.

Speaker Change: Now, as far as us taking on full responsibility for Akasunamab, this does have the effect of grossing up both our revenue and our expenses for all products that remain in our collaboration with BioNTech.

Speaker Change: This results in around 600 million kroner of both higher revenue and higher costs.

Speaker Change: But really here it's important to note, this classification change in our guidance does not impact our operating profit.

Anthony Pagano: And this really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued highly focused investment as you can see on the next slide. In line with our significant growth opportunities, total op-ex was approximately 6.7 billion crooner and H1. As you can see, the majority of the growth was driven by R&D investments. Here, we've accelerated our investment into our product portfolio, especially the advancement of our mid to late stage pipeline.

Anthony Pagano: Now, looking at the highlights of our revised guidance, we now expect our revenue at the midpoint to be up 28% over last year and be in the range of 20.5 to 21.7 billion kroner. One of the drivers of this increase is strong net sales of our royalty medicine. We are now anticipating higher Darzalex net sales in the range of $11.4 to $11.8 billion. So, here, we've increased our royalty guidance to 13.3 to 13.8 billion kroner. And that's an increase on both the top and bottom end of the range.

Speaker Change: Now, looking at the highlights of our revised guidance, we now expect our revenue at the midpoint to be up 28% over last year and be in the range of 20.5 to 21.7 billion kroner.

Speaker Change: One of the drivers of this increase is strong net sales of our royalty medicines.

Speaker Change: We are now anticipating higher Darzalex net sales in the range of $11.4 to $11.8 billion.

Speaker Change: So here we've increased our royalty guidance to 13.3 to 13.8 billion kroner, and that's an increase to both the top and bottom end of the range.

Anthony Pagano: Specifically, we're expanding the development for appkinly, tibdack, acasinolimab. Now, of course, Rita S. As you can also see, S-GNA growth moderated and was up only 12%. And this reflects our continued focus on driving S-GNA efficiency. As previously highlighted, we continue to invest to secure a successful at Kinley launch in our two key markets, the US and Japan. And of course, we've been really focused on the acquisition and integration of profound bio.

Anthony Pagano: And importantly, we also anticipate that we're going to have over 1.3 billion kronor of growth from Epkinley and TIVDAC. Now, turning to our op-eds, excluding deal and amortization costs, we are anticipating OPEX to be in the range of $13.7 to $14.3 billion, which includes R&D investment to support the advancement of profound bios clinical programs, primarily RENA-S, and also on Now, I told you when we announced the acquisition of ProfoundBio that, excluding acquisition and integration related charges, we are anticipating OPEX at or moderately above the upper end of our previously disclosed OPEX guidance.

Speaker Change: And importantly, we also anticipate that we're going to have over 1.3 billion kronor of growth from Epkinle and TIBDAC.

Speaker Change: Now, turning to our Op-Ex.

Speaker Change: Excluding deal and amortization costs, we are anticipating OPEX to be in the range of $13.7 to $14.3 billion.

Speaker Change: which includes R&D investment to support the advancement of ProfoundBio's clinical programs, primarily RENA-S.

Speaker Change: and also on our side, Aqa Suleiman.

Anthony Pagano: Now let's take a look at our financials as a whole. Here you can see our summary P&L. Revenue came in at over 9.5 billion owners. That's up 36% on last year. Total op-ex was around 6.7 billion. And here again, most of which was R&D. And even with that increased investment, we're still delivering over 2.4 billion of operating profit. And that's up more than 29%. Moving to our net financial items, here we have a gain of 1.4 billion.

Speaker Change: Now, I told you when we announced the acquisition of ProfoundBio that excluding acquisition and integration related charges, we are anticipating OPEX at or moderately above the upper end of our previously disclosed OPEX guidance.

Anthony Pagano: So, now excluding both the profound bio deal and amortization costs, and this 600 million kroner item that I just described relating to the Biontech collaboration, this classification change, you can see that we're absolutely delivering on that guidance commitment. And note that even with our increased investments, we continue to generate significant underlying profitability, and we're on track to deliver another year of substantial operating profit. In fact, when you exclude the acquisition, integration, and amortization costs for Profound Bio, the midpoint of our current operating profit guidance is now at $6.2 billion, and that compares favorably to our previous guidance of $5.9 billion. And that's up 17% over 2020's rate.

Speaker Change: So, now excluding both the profound bio deal and amortization costs, and this 600 million kroner item that I just described relates to the BioInsect collaboration, this classification change, you can see that we're absolutely delivering on that guidance commitment.

Anthony Pagano: This gain was driven by the strengthening of the dollar against the Corona in the first half of the year, as well as by an increase in interest income. Then we have tax expense of 1.1 billion, which equates to an effective tax rate of 28.9%. And here I do what a pause for a moment and note that we are currently evaluating the integration of profound bio operations from a tax perspective. So our effective tax rate may experience some volatility as integration activities progress.

Speaker Change: And note that even with our increased investments, we continue to generate significant underlying profitability, and we're on track to deliver another year of substantial operating profit.

Speaker Change: In fact, when you exclude the acquisition, integration, and amortization costs for Profound Bio, the midpoint of our current operating profit guidance is now at $6.2 billion, and that compares favorably to our previous guidance of $5.9 billion.

Speaker Change: And that's up 17% over 2023.

Anthony Pagano: Now, before wrapping up, I'm going to spend just a minute to double-click on the changes to our OPEX guidance. As a reminder, at the midpoint, our original OPEX guidance was 12.9 billion kroner. As you can see, the impact of the operational changes for Genmab and ProfoundBio is around $500 million. This includes the $800 million of costs related to ProfoundBio's operations, and this is really driven by the investment in RENA-S that I referenced earlier.

Speaker Change: Now,

Speaker Change: Before wrapping up, I'm going to spend just a minute to double click on the changes to our OPEX guidance.

Anthony Pagano: However, we do anticipate that this is going to normalize within the next 12 to 18 months. And that brings us to our net profit of over 2.7 billion. So as you can see, continued strong underlying financial performance.

Speaker Change: As a reminder, at the midpoint, our original OPEX guidance was 12.9 billion kroner.

Speaker Change: As you can see, the impact of the operational changes for Genmab and ProfoundBio is around $500 million.

Anthony Pagano: Having now looked at our H1 results, let's take a look at our updated guidance. At a macro level, you'll see we're projecting higher revenues in operating profit even as we take on two wholly owned phase 3 programs. I've already covered in some detail the impact of the profound bio acquisition. Now, as far as us taking on full responsibility for Accusinumab, this does have the effect of grossing up both our revenue and our expenses for all products that remain in our collaboration with BioNTech.

Speaker Change: This includes the $800 million of costs related to ProfoundBio's operations, and this is really driven by investment in RENA-S that I referenced earlier.

Anthony Pagano: It also includes a net $300 million reduction related to Genmab, driven by continued prioritization efforts and scale benefits partially offset by Acosimumab development. And that brings us to 13.4 billion kroner, which is fully in line with what we communicated when we announced the acquisition in early April. Then you can see the impact of the classification item or gross up of the expenses for the products remaining in the buy and set collaboration of $600 million. Now, again, to be clear, these higher costs are fully offset by higher revenue and have no impact on operating profits.

Speaker Change: It also includes a net $300 million reduction related to Genmab driven by continued prioritization efforts and scale benefits partially offset by Acosimumab development.

Speaker Change: And that brings us to 13.4 billion kroner, which is fully in line with what we communicated when we announced the acquisition in early April .

Anthony Pagano: This results in around 600 million croner of both higher revenue and higher costs. But really here, it's important to note, this classification change in our guidance does not impact our operating profit. Now, looking at the highlights of our revised guidance, we now expect our revenue at the midpoint to be up 28% over last year and being the range of 20.5 to 21.7 billion croner. One of the drivers of this increase is strong net sales of our royalty medicines.

Speaker Change: Then you can see the impact of the classification item or gross up of the expenses for the products remaining in the buy and set collaboration of $600 million.

Speaker Change: Now again, to be clear, these higher costs are fully offset by higher revenue and have no impact on operating profit.

Speaker Change: And finally, you can see here, and we have the profound bio deal and amortization costs of $400 million.

Anthony Pagano: And finally, you can see here we have the deep bio deal and amortization costs of $400 million. Now, having gone through the H1 numbers, as well as our revised and improved guidance, let me provide a few closing remarks. In summary, we've had a very solid first half of the year. We have growing recurring revenue streams increasingly from our proprietary products. And that gives us a strong backbone of significant underlying profitability, and we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us. And on that note, I'm going to hand you back over.

Speaker Change: Now, having gone through the H-1 numbers, as well as our revised and improved guidance, let me provide a few closing remarks.

Anthony Pagano: We are now anticipating higher-dars-elect net sales in the range of 11.4 to 11.8 billion dollars. So here, we've increased our royalty guidance to 13.3 to 13.8 billion croner. And that's an increase to both the top and bottom end of the range. Rich, and importantly, we also anticipate that we're going to have over 1.3 billion crore of growth from Epkinley and Tivdeck. Now, turning to our op-ex, excluding deal and amortization costs, we are anticipating op-ex to be in the range of 13.7 to 14.3 billion, which includes R&D investment to support the advancement of profound biosclinical programs, primarily Rina F, and also on our side, Akasuna Mab.

Speaker Change: In summary, we've had a very solid first half of the year.

Speaker Change: We have growing recurring revenue streams increasingly from our proprietary products.

Speaker Change: And that gives us a strong backbone of significant underlying profitability. And we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us.

Jan van der Winkel: Thanks, Anthony. Now, let's move to our final slide. During the first half of the year, we have made significant progress towards our 2024 goals. Especially for Epkinly, we have now announced or initiated two new phase 3 trials, and the label has been expanded in the U.S. to include relapsed or refractory follicular lymphoma. And, of course, we are extremely pleased with the full approval for TIBDAC that occurred in April and the encouraging Phase II agarosole map data that has informed the planned Phase III trial.

Speaker Change: And on that note, I'm going to hand you back over to Jan.

Jan: Thanks, Anthony. Let's move to our final slides.

Speaker Change: During the first half of the year we have made significant progress towards our 2024 goals.

Speaker Change: Especially for Epkinly, we have now announced or initiated two new phase 3 trials and the label has been expanded in the US to include relapsed or refractory follicular lymphoma.

Anthony Pagano: Now, I told you when we announced the acquisition of profound bio, that excluding acquisition and integration-related charges, we are anticipating op-ex at or moderately above the upper end of our previously disclosed op-ex guidance. So, now, excluding both the profound bio deal and amortization costs, and the 600 million-coronor item that I just described relates to the bi-insect collaboration, this classification change, you can see that we're absolutely delivering on that guidance commitment. And note that even with our increased investments, we continue to generate significant underlying profitability, and we're on track to deliver another year of substantial operating profit.

Speaker Change: And of course, we are extremely pleased with the full approval for TIBDAC that occurred in April , and the encouraging Phase II acosonium update that has informed the planned Phase III trial.

Jan van der Winkel: And as a reminder, that makes two wholly owned assets, Akwesunimab and Rhineis, that we anticipate will both enter late stage development before the end of this year. As we move into the second half of the year, we continue to have a lot to look forward to. That concludes our presentation of Genmab's financial results for the first half of 2024. Operator, let's go to the questions. Thank you so

Speaker Change: And as a reminder, that makes two wholly owned assets, Akosunimap and Rhinas, that we anticipate will both enter late stage development before the end of this year.

Speaker Change: As we move into the second half of the year, we continue to have a lot to look forward to.

Speaker Change: That ends our presentation of Genmab's financial results for the first half of 2024. Operator, let's go to the questions.

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 11 again. To ensure everyone has the opportunity to ask a question today, please limit yourself to just one question and one follow-up question. Thank you so much. And now we're going to take our first question, and it comes from the line of Emily Field from Barclays. Your line is open; please ask a question.

Speaker Change: 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 11 again.

Anthony Pagano: In fact, when you exclude the acquisition, integration, and amortization costs for profound bio, the midpoint of our current operating profit guidance is now at 6.2 billion, and that compares favorably to our previously-previous guidance of 5.9 billion. And that's up 17% over 2023.

Speaker Change: To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question and one follow-up question. Thank you so much.

Speaker Change: And now we're going to take our first question.

Speaker Change: And it comes from the line of Emily Field from Barclays. Your line is open, please ask a question.

Anthony Pagano: Now, before wrapping up, I'm going to spend just a minute to double-click on the changes to our op-ex guidance. As a reminder, at the midpoint, our original op-ex guidance was 12.9 billion-coronor. As you can see, the impact of the operational changes for gemmap and profound bio is around 500 million. This includes the 800 million of costs related to profound bio's operations, and this is really driven by investment in Rina S that I referenced earlier.

Emily Field: Hi, thanks for taking my question. I just wanted to ask two, and I guess one kind of as a follow-up, just on Acosomomav, when do you expect to start enrolling patients in phase three? Are you expecting that you would use a dosetaxel as a control arm, and just how are you thinking about a potential changing standard of care with the potential approval of Troc2 ADCs? And then secondly, now that you're going to have two wholly owned projects that you're starting, going into phase three, how should we think about Genmab R&D costs in 25 and

Emily Field: Hi, thanks for taking my question.

Emily Field: I just wanted to...

Emily Field: and I guess one kind of as a follow-up. Just on akathomimab, you know, when do you when do you expect you start enrolling patients in the phase three? Are you expecting that you would use docetaxel as a control arm, you know, and just how are you thinking about a potential changing standard of care with what the potential

Speaker Change: of the approval of CHOKE-2 ADCs. And then secondly, just, you know, now that you're going to have two wholly-owned projects that you're starting going into phase three, how should we think about Genmab R&D costs in 25 and 26?

Jan van der Winkel: Thanks, Anthony. Thanks, Emily, for the questions. The first one to tie, you can give a bit more color on the phase 3 trial for Akatsumi Mob, and then Anthony Pagano can undoubtedly give you further color on the R&D costs. Tai, why don't you start? Yeah.

Anthony Pagano: It also includes a net 300 million reduction related to gemmap driven by continued prioritization efforts and scale benefits partially offset by accidentally mapped development. And that brings us to 13.4 billion-coronor, which is fully in line with what we communicated when we announced the acquisition in early April. Then you can see the impact of the classification item or gross-up of the expenses for the products remaining in the bi-inset collaboration of 600 million.

Speaker Change: Thanks.

Speaker Change: Thanks, Anthony. Thanks, Emily, for the questions. Let's get the first one to Tai, who can give a bit more color on the phase three trial for Akatsumi Mob, and then Anthony Pagano can undoubtedly give you a bit of color on the R&D costs, Emily. Tai, why don't you start?

Tahamtan Ahmadi: Yeah, thank you for the question. I mean, as it relates to the control arm, I think I have mentioned this multiple times already. You know, all the relevant health authority interactions and the relevant and only relevant. Paris, and at this point, this is Dr. Um, I think there's a lot of hype and discussion about, um, whether, you know, a subgroup analysis of a Principal Negative can lead to an approval. I think this is a discussion for another company, but all health authorities have been, Christy, on this particular question.

Tai: Yeah, thank you for the question. I mean, as it relates to the control arm, I think we've...

Speaker Change: I've mentioned this multiple times, we had...

Speaker Change: You know, all the relevant health authority interactions and the relevant and the only relevant comparison at this point is Dorsodaxo.

Anthony Pagano: Now, again, to be clear, these higher costs are fully offset by higher revenue and have no impact on operating profit. And finally, you can see here that we have the profound bio-deal and amortization costs of 400 million.

Speaker Change: I think there's a lot of hype and discussion about whether, you know, a subgroup analysis of a

Speaker Change: you just created.

Tahamtan Ahmadi: So it will be Dorsodaxa as the control arm, that's the regulatory-approved control arm, and I think I mentioned this in the prepared remark. We are operationalizing towards having this study up and running by the end of the year.

Tai: Chris is clear on this particular question.

Tai: So it will be Dorsodaxa as the control arm, that's the regulatory approved control arm, and I think I mentioned this in the prepared remark, we are operationalizing towards having this study up and running by the end of the year.

Unknown Executive: Now, having gone through the H1 numbers as well as our revised and improved guidance, let me provide a few closing remarks. X, In summary, we've had a very solid first half of the year. We have growing recurring revenue streams, increasingly from our proprietary products. And that gives us a strong backbone of a significant underlying profitability. And we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us. And on that note, I'm going to head you back over to Young.

Tahamtan Ahmadi: Thanks. Thanks, Ty.

Anthony Pagano: And I think further details will come in the future, Emily. Let's move to Anthony and then have some further color on the R&D expansion. Anthony.

Ty: Thanks, thanks, Ty. And I think further details will come in the future, Emily. Let's move to Anthony and then have a further call on the R&D expansion. Anthony?

Anthony Pagano: Yeah, thanks, Emily. You know, as we think about our investment in R&D, we've been super clear about, you know, our priorities. And I think a good way to sort of frame this out is to break R&D down into two segments. Segment number one being research and discovery, all the way through to early development. And then the second segment being that mid to late stage.

Anthony: Yeah, thanks, Emily. You know, as we think about our investment in R&D, we've been super clear about, you know, our priorities.

Anthony: And I think a good way to sort of frame this out is to, you know, break R&D down into two

Unknown Executive: Thanks Anthony, let's move to our final slides. During the first half of the year, we have made significant progress towards our 2024 goals, especially for Abkinli. We have now announced our initiated two new phase three trials and the labor has been expanded in the US to include relapse or a factory for legal and former. And of course, we are extremely pleased with the full approval for TIFFDAC that occurred in April and the encouraging phase two, Akasunim updated that has informed the plant phase three trial.

Ty: segments.

Speaker Change: Segment number one being research and discovery all the way through to early development, and then the second segment being that mid- to late-stage

Anthony Pagano: As we think about that first segment, being research and discovery through to early stage development, we've talked quite a bit about scaling that up over the last number of years. We've viewed that as an underutilized asset in the company, and we can see that we're now bearing the fruits of that investment in terms of scaling that up in terms of the number and quality of I&Ds we see coming through. We've been very clear now as we've gotten into sort of 2023, 2024; we think that the whole setup and that investment the amount of money we're allocating there is now at the appropriate level, and any investments there will be much more moderate, if any, will be much more moderate in nature. The second segment is that mid to late stage segment.

Speaker Change: segments.

Speaker Change: As we think about that first segment...

Speaker Change: being research and discovery through to early stage development. We've talked quite a bit.

Speaker Change: about us scaling that up over the last number of years.

Ty: We viewed that as an underutilized asset in the company, and we can see that we're now bearing the fruits of that investment in terms of scaling it up, in terms of the number and quality of INDs we see coming through.

Unknown Executive: And as a reminder, that makes two wholly owned assets, Akasunim up and Rynas, that we anticipate the boat and the late states development before the end of this year. As we move into the second half of the year, we continue to have a lot to look forward to.

Ty: We've been very clear now as we've gotten into sort of 2023, 2024, we think that that whole set up and that investment, the amount of money we're allocating there is now at the appropriate level and any investments there will be much more moderate, if any, will be much more moderate in nature.

Unknown Executive: That ends our presentation of General Financial Results for the first half of 2024.

Anthony Pagano: And here, this is where the focus of the organization is. This is our priority. We are prioritizing investments in this area versus investments in other areas. So, clearly, investments in Kinley, TIVDAC, 1046, and now RENA-S will get the lion's share of any growth here moving forward. And I think it's very obvious as to why this is, particularly any registration-type trials, again, we're prioritizing those that are potentially revenue-generating in nature, and that's what we're really focused on doing, Emily.

Ty: The second segment is that mid to late stage segment.

Unknown Executive: Operator, let's go to the questions. Thank you so much, dear participants. As a reminder, if you wish to ask a question, please press star 111 on the telephone keyboard and wait for a name to be announced. To withdraw a question, please press star 11 again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question and one follow-up question. Thank you so much.

Speaker Change: And here, this is where the focus of the organization is. This is our priority. We are prioritizing investments in this area versus investments in other areas. So

Speaker Change: Holtz, clearly investments in it, Kinley, Tivdak.

Speaker Change: 1046

Reena S.: and now Reena S.

Ty: We'll get the lion's share of any growth here moving forward. And I think it's very obvious as to why this is.

Emily Field: And now we're going to take our first question. And it comes to learn of Emily Field from Buckley. So, learn as openly as to questions.

Ty: particularly any registration type trials Again we're prioritizing those are potentially revenue generating in nature and that's what we're really focused on doing, Emily. So you should very much sort of think about R&D along these two segments and any growth moving forward or the majority of the growth moving forward is really going to be from segment number 2 that mid to late stage.

Anthony Pagano: So you should very much sort of think about R&D along these two segments, and any growth moving forward, or the majority of the growth moving forward, is really going to be from segment number two, that mid- to late-stage program, particularly potentially registration-enabling trials.

Emily Field: Hi. Thanks for taking my question. I just wanted to ask one kind of as a follow-up. Just on Akasunimab, when do you expect you start in rolling patients in the phase three? Are you expecting that you would use a dosy taxil as a control arm? And just how are you thinking about a potential changing standard of care with the potential of the approval of TRO2 ADCs? And then secondly, just, you know, now that you're going to have two holy-on-projects that you're starting going into phase three, how should we think about GenMab R&D cost in 25 and 26?

Ty: programs, particularly potentially registration enabling trials.

Jan van der Winkel: Thanks, Anthony. Thanks, Emily, for the questions. Operator, let's move to the next question.

Ty: Thanks, Anthony. Thanks, Emily, for the questions. Operator, let's move to the next questions. Thank you.

Operator: And the next question comes from the line of Xiang Deng from UBS. Your line is open. Please ask your question.

Speaker Change: And the next question comes to the line of Xiang Deng from UBS. Your line is open, please ask your question.

Xian Deng: Hi, thank you for taking my questions. Two, please.

Unknown Executive: Thanks. Thanks, Anthony. Thanks, Emily, for the questions. The first one to tie you can give a bit more color on the phase three trial for Akasunimab.

Xiang Deng: Hi, thank you for taking my questions. Two, please. The first one is on Akatsumi map. You mentioned now you are, this is a wholly owned asset, but just wondering, would you still be open to, for example, new partners here?

Unknown Executive: And then Anthony Pakana can undoubtedly give you a protocol on the R&D cost, Emily.

Tahi: Hi, why don't you start? Thank you for the question. I mean, as it relates to the control arm, I think we've mentioned this multiple times we had, you know, all the relevant health authority interactions and the relevant and the only relevant comparison at this one, the dosy taxil. I think there's a lot of hype and discussion about whether, you know, a subgroup analysis of.., and so on. I think this is a discussion for another company, but all health authorities have been critically on this particular question.

Speaker Change: Or are you committed that this is what will be wholly owned going forward?

Speaker Change: And if you are open to new partners, what sort of things would you be looking for in an ideal partner, please?

Speaker Change: So that's the first question. And the second one is on Akwesasne map data update for World Long.

Tahi: I'm just wondering, maybe for Tahi, so what sort of things can we actually expect? Will we have a bigger patient size for the every-six-week arms, please? Thank you.

Xian Deng: The first one is on the Akasumi Map. You mentioned now that this is a wholly owned asset, but just wondering, would you still be open to, for example, new partners here, or are you committed that this will be wholly owned going forward? And if you are open to new partners, what sort of things would you be looking for in an ideal partner, please?

Jan van der Winkel: So that's the first question. And the second one is on the Akasumi Map data update for World Lung. Just wondering, maybe for Tahi, what sort of things can we actually expect? Will we have a bigger patient size for the every six weeks arm, please? Thank you.

Speaker Change: Thanks, Xian, for the questions. So for AKASUNIMAP, I can tell you that we are very, very, very pleased to have it now wholly owned. So we are not foreseeing that we need to look for a partner. We think this is a fantastic molecule, which can potentially be much broader position than the initial indication. And we intend to hold on to it for the time being, Xian. What we could do in the future is potentially look for a partner and select areas, for example,

Jan van der Winkel: Thanks, Xian, for the questions. So for AKASUNIMAP, I can tell you that we are very, very, very pleased to have it now wholly owned. So we are not foreseeing that we need to look for a partner.

Tahi: So will we dose a doctor as a control arm, that's the regulatory approved control arm, and I think we mentioned this in the in the prepared remark. We are operationalizing towards having this story up and running by the end of the year. Thanks, thanks, Ty, and I think throughout details will come in the future.

Jan van der Winkel: We think this is a fantastic molecule, which could potentially have a much broader indication than the initial indication, and we intend to hold on to it for the time being, Xian. What we could do in the future is potentially look for a partner and select areas, for example, for China, because that sets a different dynamics in the markets right now. As you know, we have a key priority market, the US and Japan; we will likely move into EU5, EU4 plus the UK, also with some of our products in the future, but maybe China is a good territory, we think, to look for a partner.

Anthony Pagano: I'm Emily. Let's move to Anthony, and then have a fuller color on the on the expanded Anthony. Yeah, thanks, Emily. You know, as we think about our investment in in R&D, we've been super clear about, you know, our priorities. And I think the way the good way to sort of frame this out is to, you know, break R&D down into two segments, segment number one being research and discovery all the way through to early development, and then the second segment being that mid to late stage segment.

Speaker Change: As you know, we have key priority markets in Japan. We'll likely move into EU5, EU4 plus UK, also with some of our products in the future. But maybe China is a good territory we think to look for a partner. So maybe a regional partnership.

Jan van der Winkel: So maybe a regional partnership is potentially an option, but we have not decided that. We are just very, very pleased with 100% ownership, and we will progress as aggressively as we can, Xian, to move it towards registration trials and then to the markets. And then maybe, Tai, you can give a bit more color on the type of data at World Learning and other conferences, because there will likely be other conferences in the coming months, Xian, where we will present data. Sure.

Speaker Change: It's potentially an option, but we have not decided that. We are just very, very pleased with the 100% ownership, and we will progress as aggressively as we can to move it towards registration trials and then to the market.

Anthony Pagano: As we think about that, that first segment being research and discovery through to early stage development, we've talked quite a bit about us scaling that up over the last number of years. We viewed that as an underlying underutilized asset in the company, and we can see that we're now bearing the fruits of that investment in terms of scaling that up in terms of the number and quality of I and D's we see coming through.

Tai: Then maybe, Tai, you can give a bit more color on the type of data at WorldLearn and other conferences, because there will likely be other conferences in the coming months, Xian, where we will present data. Tai? Sure. Thank you, Jan. And thank you for the question.

Tahamtan Ahmadi: Sure. Thank you, Jan, and thank you for the question.

Tahamtan Ahmadi: The data that you will see is essentially trying to provide clarity on how a Q6 week schedule changes the biology. So you will see data on T-cell expansion in relevant subgroups of T-cells. You will see data on T-cell exhaustion and relevant T-cell subsets and other pharmacodynamic markers relevant to the mechanism of action, as well as PK data that correlates and explains what the real pharmacokinetic and pharmacodynamic differences are between Q3 and Q6 and why that matters and how that translates into the clinical observations that we observed. So that is the main focus of these data sets to provide additional color on the mechanism, on the biology, and how we concluded the differentiated profile for Q6 weeks.

Tai: The data that you that you will see is essentially trying to provide granularity on how

Anthony Pagano: We've been very clear now as we've gotten into sort of 2020 the rate of 2024, we think that that that whole setup and that investment, the amount of money we're allocating there, is now at the appropriate level and any investments there will be much more moderate. If any will be much more moderate in nature, the second segment is that mid to late stage segment. And here, this is where the focus of the organization is this is our priority.

Speaker Change: A Q6 week schedule changes the biology, so you will see...

Tai: Data on T-cell expansion of relevant subgroups of T-cells, you will see data on T-cell exhaustion and relevant T-cell subsets and other pharmacodynamic markers relevant to the mechanism of action as well as PK data that correlates and explains what really the pharmacokinetic and pharmacodynamic differences are between Q3 and Q6.

Anthony Pagano: We're prioritizing investments in this area versus investments in other areas. So clearly, investments in that Kinley tip deck 1046, and now Reena asks, we'll get the lion share of any growth here moving forward. And I think it's very obvious as to why this is particularly any registration type trials. Again, we're prioritizing those are potentially revenue generating in nature. And that's what we're really focused on doing Emily. So you should very much sort of think about R&D along these two segments and any growth moving forward or the majority of the growth moving forward is really going to be from segment number to that mid to late stage. Program particularly potentially registration enabling trials. Thanks Anthony, thanks Emily for the question. Let's operate on a smooth to the next questions. Thank you.

Tai: and why that matters and how that translates into the clinical observations that we observed. So that is the main focus on these data sets to provide additional color on.

Tai: on the mechanism, on the biology, and how we concluded.

Speaker Change: the differentiated profile for Q6 week scheduling.

Operator: Thanks, Tai. Let's move to other questions, Operator. Thank you. And now we're going to take the question from Jonathan Chang from Lyric.

Speaker Change: Thanks, Tai. Let's move to other questions, Operator. Thank you.

Operator: And now we're going to take the question from Jonathan Chang from Lyric. Your line is open. Please ask your question.

Operator: Your line is open. Please ask your question. Hi guys, thanks for taking my questions. First question: what are your latest thoughts on the next development?

Speaker Change: And now we're going to take the question from Jonathan Chang from Lyric. Your line is open, please ask your question.

Jonathan Chang: Hi guys, thanks for taking my questions.

Jonathan Chang: First question, what are your latest thoughts on the next development steps of renal acid ovarian cancer?

Jonathan Chang: When could we learn the details of the Phase 3 Second Line Plus Platinum Resistive Ovarian Cancer Study, expected to start toward the end of the year?

Speaker Change: And then as a follow-up to that, what is your confidence level and ability of RENAS to address patients across the biomarker spectrum in ovarian, and how important is that to your strategy?

Yaron Werber: And the next question comes to land of Shangden from UBS. Your land is open. Please ask your question. Hi, thank you for taking my questions to please. The first one is on Akasuni map. You mentioned now, you are, this is a holy own asset, but just wondering, would you still be open to, for example, new partners here? Or are you committed that this is what will be holy owned going forward? And if you are open to new partners, what sort of things would you be looking for?

Jonathan Chang: Thanks Jonathan for the questions on Rhino S, another molecule we are super excited about. Let's ask Tai to start and then Judith to step in to provide extra color. Tai, why don't you start with both questions? Sure, I'll...

Yaron Werber: Yeah, I do partner please. So that's a first question and the second one is on Akasuni map data update for work long. Just wondering, maybe for Tahi, so what sort of things can we actually expect? Well, we have a bigger patient size for the every six weeks on, please. Thank you. Thanks, Yaron, for the question. So, for Akassulimab, I can tell you that we are very, very, very pleased to have it now wholly owned.

Tai: Thanks Jonathan for the questions on Rhino-S, another molecule we are super excited about. Let's ask Tai to start and then Judith to step in to provide extra color. Tai, why don't you start with both questions? Sure, I'll take the second one first. I mean, this is from the very beginning, was part of our

Tahamtan Ahmadi: Sure, I'll take the second one first. I mean, this was part of our excitement about amino acids as a molecule and also relates to our excitement in the linker technology that We believe quite firmly, and I think you will then have the opportunity to see the data at ASIMO, that we know ASIMO will have activity, meaningful activity across the spectrum and beyond, of photoreceptor expression in PROC patients.

Tai: Excitement about amino acids as a molecule and also relates to our excitement in the linker technology that

Speaker Change: We believe quite firmly, and I think you will then have the opportunity to see the data at ESMO, that ESMO will have meaningful activity across the spectrum and beyond.

Speaker Change: of photoreceptor expression in PROC patients. So that's the first part. As it relates to the details on to phase three, I mean,

Tahamtan Ahmadi: So that's the first part. As it relates to the details on phase three, I mean, some of this will become public as the study goes into public space and clinical trials of GARF. Very clear what the segment is. I think I have already kind of addressed a sub-question that you may have in your mind around what the population is, and I think the control arm is a hodgepodge of available alternative therapies in this setting in a DELA-CHARLES trial.

Yaron Werber: So, we are not for seeing that we need to look for a partner. We think this is a fantastic molecule, which can potentially be much broader position than the initial indication. And we intend to hold on to it for the time being. We could do with the futures potentially look for a partner and select areas, for example, for China. Now, because that sits a different dynamics in the markets right now, as you know, we have a ski for your tea markets, US and Japan, you'll likely move into a EO5 EO4 plus UK.

Speaker Change: Some of this will become public as the study goes into the public space in clinicaltrials.gov.

Speaker Change: Very clear what the segment is. I think I already kind of addressed a sub-question that you may have in your mind around what the population is and I think the control arm.

Speaker Change: is a hodgepodge of available alternative therapies in this setting in the Adela-Charles trial. And so that will be the first study, not the last one.

Tahamtan Ahmadi: And so that will be the first study, not the last one. I think you will have to wait to some degree. We are in a dynamic where we obviously want to update you, and so we have updated you and informed you that we are very well along in the start of the study already. But we also want to be cognizant of the fact that this is a hyper-competitive environment. You'll see it as it gets executed, but it will get executed quite rapidly and accelerated. I promise you that.

Yaron Werber: Also, it's some of our products in the future, but maybe China is a good territory, we think to look for a partner. So maybe a regional partnership is potentially an option that we have not decided that we have just very, very pleased with the 100% ownership. And we will progress as aggressively as we can. We can move towards registration trials and then to the markets. And then maybe tie you can give a bit more color on the type of data as well.

Speaker Change: I think you will have to wait to some degree. We are in a dynamic where we obviously want to update you. And so we updated you and informed you that we are very well in the start-up of the study already. But we also want to be cognizant of the fact that this is a hyper-competitive environment.

Speaker Change: You'll see it as it gets executed, but it will get executed quite rapidly and accelerated. I promise you that.

Yaron Werber: And other conferences, because there likely be other conferences in the coming months. Let's see how we represent data tie. Sure. Thank you. And thank you for the question. The data that you that you will see is essentially trying to provide community on how a Q6 week schedule changes the biology. So you will see data on tea set expansion of relevant subgroups of tea cells, you will see data on tea set exhaustion relevant.

Jan van der Winkel: Thank you, guys. So, more to come, Jonathan, in the very near future. Very near.

Speaker Change: Thank you, Ty. So more to come, Jonathan, in the very near future, very near.

Operator: Thank you. We're going to take our next question, and the next question comes from Asthika Goonewardene from Twist. Your line is open. Please ask your question.

Yaron Werber: Teaser subsets and other pharmacodynamic markers relevant to the mechanism of action as well as PK data that correlates and explains what really the pharmacokinetic and pharmacodynamic differences are between Q3 and Q6. And why that matters and how that translates into the clinical observations that we observed. So that is the main focus on these data sets to provide additional color on the mechanisms on the biology. And then how we concluded the differentiated profile for Q6 week schedule. Thanks, Tai. Let's move to other questions. Operator. Thank you.

Speaker Change: Thank you. We're going to take our next question.

Speaker Change: And the next question comes from Asthika Goonewardene from Twist. Your line is open, please ask your question.

Asthika Goonewardene: Hi guys, thanks for taking my question and congrats on the progress and impressive outlook that's been laid out so far for the second half of this year and future. I want to go back to 1046 and also tag on 1042. Sahil, you mentioned you were clear on what to expect and what not to expect at World Lungs. I'm curious if there are other conferences later in the year where you could provide an update for 1046, given how exciting the ASCO data was, and we want to see more follow-up.

Asthika Goonewardene: Hi guys, thanks for taking my question and congrats on the progress and impressive outlook that's laid out so far for the second half of this year and future. I want to go back to 1046 and also tag on 1042. Tahi, you mentioned, you were clear on what to expect and what not to expect at World Long.

Speaker Change: I'm curious if there are other conferences later in the year where you could provide an update for 1046 just given how exciting that the ASCO data was and we want to see more follow up.

Asthika Goonewardene: And related to that, on previous calls, I think we've kind of got the feeling that there might be something on 1042, perhaps in head and neck later this year. Just want to check back on that and see if that's still a possibility or what kind of update we can expect on that as well. Thanks.

Speaker Change: And related to that, in previous calls, I think we've kind of got the feeling that there might be something on 1042, perhaps in head and neck later on this year. Just want to check back on that and see if that's still a possibility or what kind of update we can expect on that module as well. Thanks.

Asthika Goonewardene: Thanks, Asthika, for the questions. I think, Ty, you can handle them both.

Jonathan Chang: And now we're going to take the question from Jonathan Chang from Lyric. No, Lan is open. Please ask a question.

Speaker Change: Thanks, Asthika, for the questions. I think, Tai, you can handle them both. Maybe shed a bit of light on other conferences.

Tahamtan Ahmadi: Maybe I can shed a bit of light on other conferences.

Tahamtan Ahmadi: Sure. So let's take 1042 first. I think what I've... We've said multiple times, what we're clear on is there were some observation learnings that I hope will also become a little bit more transparent with the mentioned presentation at World Loan that were at least taken into consideration and are being tested as we speak. And when that data is mature, then we'll present that, and that will then provide, we're quite confident, a very clear answer on 1042.

Jonathan Chang: Hi guys. Thanks for taking my questions. First question. What are your latest thoughts on the next development steps of rena as no varying cancer? When could we learn the details of the phase three second line possible? And we just a varying cancer study expected to start for the end of the year. And then as a follow up to that. What is your constant level in ability of rena as to address patients across the biomarker spectrum in a Marion?

Jonathan Chang: And how important is that to your strategy? Thank you. Thanks for the questions on rena as a normal molecule. We're super excited about sets. I'll try to start and then you did to tear to step in if to provide extra color. I want to start the boat questions. Sure. I'll take the second one first. I mean, this is from the very beginning. It was part of our excitement about me as a molecule and also relates to our excitement in the link the technology that We believe quite firmly, and I think you will then have the opportunity to see the data at SMO that we know S will have activity, meaningful activity across the spectrum and beyond, of our photoreceptor expression in proc patients.

Tai: Sure. So let's take 1042 first. I think what I've...

Jonathan Chang: So that's the first part. As it relates to the details on the phase three, I mean, some of this will become public as the study goes into the public space and clinical trials of golf, where it's here with the segment is, I think I already kind of addressed a sub-question that you may have in your mind. I want what the population is and I think the control on is a archipage of available alternative therapies in this setting and in a deal of choice.

Speaker Change: What we've said multiple times, what we're clear is there were some observation learnings that I hope will also become a little bit more transparent with the mentioned presentation at World Loan that were at least taken into conservation and

Tai: are being tested as we speak. And when that data is mature,

Tai: Then we'll present that and that will then provide, we're quite confident, a very clear answer on 1042. So I'm not going to comment on this any more than that because to some degree we'll just have to wait for data in our hands.

Tahamtan Ahmadi: So I'm not going to comment on this any more than that because, to some degree, we'll just have to wait for the data in our hands. On 1046, I think Jan already mentioned there's going to be additional data at CIDC. This will be a lot around translational data. In terms of clinical data, I think it makes sense to generate a little bit more follow-up and also more patients that have been enrolled in order to... better elucidate the mitigation strategy that we implemented to make it safer. And so that with a time to event readout takes a little bit more time. So we'll bring that into the public domain as soon as it makes sense from the data.

Jan: On 1046, I think Jan already mentioned there's going to be additional data at CIDC. This will be a lot around translational data. In terms of clinical data, I think, you know,

Speaker Change: It makes sense to generate a little bit more follow-up and also more patients that have been enrolled in order to...

Speaker Change: to better

Speaker Change: You know, elucidate the mitigation strategy that we implemented to make it more safe. And so that with a time to event readout takes a little bit more time. So we'll bring that into the public domain as soon as it makes sense from a data set.

Jan van der Winkel: Thanks. Thanks, Tai. And we'll give you extra, Asthika, that also at CIDC, we intend to present some further preclinical data, which will further help you to understand this new biology of activating T-cells and K-cells via 4-1-2-B in specific. So lots of new data supporting, I think, the excitement around Akasunlimab.

Speaker Change: Thanks. Thanks, Tai. And we give you extra, Asthika, that also at CIDC we intend to present some further preclinical data, which will further help you to understand this new biology of activating T-cells and K-cells via 4-1-2-B bispecifics. So lots of new data supporting, I think, the excitement around Akkerson Limon.

Operator: Thank you. Now we're going to take our next question, and the next question comes from the line of Peter Verdult from CTO. Your line is open, please ask your question.

Speaker Change: Thank you. Now we're going to take our next question.

Speaker Change: Thank you.

Speaker Change: And the next question comes from the line of Peter Verdult from Citi. Your line is open, please ask your question.

Jonathan Chang: And so that will be the first study not the last one. And so I think you will have to wait. To some degree, we are in a dynamic where we obviously want to update you. And so we updated you on informing that we very well in the startup of the study already. But we also want to be cognizant of the fact that this is a hyper competitive environment. And so you'll see it as it gets executed but it will get executed quite rapidly and accelerated. I promise you that. Thank you. So more to come Jonathan in the very near future, very near. Thank you.

Peter Verdult: Yeah, thank you, Peter at Old City. Two questions, please. Jan, speaking to the Pfizer oncology team, they've got four head and neck cancer assets that they could go into phase three, but they're saying not all will. So I just wanted to confirm, and apologies if I've missed this, but is the head and neck phase three program for TivDAC confirmed, or do we await confirmation of that? And then for Tahi or for Jan, I'm sorry to test your patience, but what is the latest on antibody timelines in terms of data release and J&J decision, or has it not changed since the last update? Again, apologies for testing your patience.

Unknown Executive: What will you take on our next question?

Peter Verdult: Yeah, thank you Peter at Old City. Two questions please. Jan, speaking to the Pfizer oncology team, they've got...

Speaker Change: Forehead and Neck Cancer Assays

Speaker Change: But they could go into phase three.

Speaker Change: But they're saying not all will, so I just wanted to confirm, and apologies if I've missed this, but is the head and neck phasery program for TIVDAC confirmed or do we await confirmation of that?

Speaker Change: And then, for Tahi or for Yan, I'm sorry to test your patience, but what is the latest on Hexabody timelines in terms of data release and J&J decision, or is it unchanged since the last update? Again, apologies for testing your patience.

Jan van der Winkel: Thanks Peter for the question. So why don't I ask Judith to give a bit of color on the head and neck plans for TIFTAC, but before that, I can probably handle the Hexabody CD38 question Peter. We are progressing really, really rapidly, and we are fully on schedule to present the data and present them to J&J in the second half of this year for Hexabody CD38 versus SubQ DARA, and there will likely be an update from the company also by the end of this year, maybe not at a medical conference, but then in another format. So maybe Judith, you could give a bit of color on head and neck cancer data for

Asthika Goonewardene: And the next question comes to learn of askika goodewardiner from twist. Your line is open. Please ask your question. Hi guys, thanks for taking my question and the rest of the progress in this is absolutely as far as the second half of the year in the future. I wanted to go back to 1046 and also tied on 1042. You mentioned you were clear on what to expect and what not to expect that were long.

Speaker Change: Thanks, Peter, for the question. So why don't I ask Judith to give a bit of color on the head and neck plans for TIFDAG. But before that, I can probably handle the Hexabody CD38 question, Peter. We are progressing really, really rapidly, and we are fully on schedule to present to have the data and present them to J&J in the second half.

Asthika Goonewardene: I'm curious if there are other consequences later in the year where you could provide an update for 1046. Even how exciting that the asko data was and do want to be more follow up and related to that in previous calls. I think we've kind of got to feeling that there might be something on 1042 perhaps in head and nest later on this year. Just want to check back on that and see back to possibility or what kind of update we can expect.

Speaker Change: for Extra Body CD38 versus Sub-Q DARA, and there will likely be an update from the company also by the end of this year, maybe not on a medical conference, but in another format. So maybe Judith, you can give a bit of color on head and neck cancer data for TIFDAC.

Judith Klimovsky: Yeah, so as you know, we presented the encouraging data on orders based on RMC at ASCO. Of course, you know, we are waiting for maturity of this data, and in parallel, we open another cohort with eligibility criteria, and we are assessing this in conjunction with Part E, which is a combination to assess the strategic fit for the company and for PIVDAC and make further decisions by the end of the year. So we are closely monitoring the data.

Judith Klimovsky: Yeah, so, as you know, we presented encouraging data on ORRAR based on RMC.

Judith Klimovsky: at ASCO. Of course, you know, we are waiting for maturity of this data and in parallel.

Judith Klimovsky: We opened another cohort with the eligibility criteria and we are assessing this in conjunction with Part E, which is combination to assess the strategic fit.

Asthika Goonewardene: Thanks. Thanks, askika for the questions. I think you can handle them both. Maybe a little bit of light on other conferences. Sure. So let's take 1042 first. I think whether we've said multiple times over clear is there were some observation learnings that I also become a little bit more transparent with the mentioned presentation. That were at least taken into conservation and being tested as we speak. And when that data is mature, then we'll present that and that will then provide quite confident a very clear answer on 1042.

Judith Klimovsky: for the company and for TIBDAG and make further decisions by the end of the year.

Judith Klimovsky: Yeah. Yeah. Thank you. Just to be clear, sorry, just to be clear, is the phase three program confirmed, or are you awaiting that data? Now, usually, you know, we start with some things at risk, but we jump into the pool when it's the right strategic state, and

Asthika Goonewardene: So we are closely monitoring the data. Yeah. Yeah. Thank you. Just to be clear, sorry, Judith, just to be clear, is our phase three program confirmed or are you awaiting that data first?

Speaker Change: Now usually, you know, we start some things at risk, but we jump into the pool when it's the right strategic fit and we have the right target profile for a particular indication, and this is what we are following the data for.

Asthika Goonewardene: So I'm not going to comment on this any more than that because some degree would just have to. Swet, for data, no hands. On 1046, I think Jan already mentioned there's going to be additional data at SITC, there's going to be a lot of translational data. In terms of clinical data, I think it makes sense to generate a little bit more follow-up and also more patients that have been enrolled in order to better elucidate the mitigation strategies that we implemented.

Speaker Change: Thank you.

Operator: Thank you. Next one, please, Operator. Yes, of course. Now we're going to take our next question, and it comes from Yaron Werber from TD Security. Your line is open; please ask your question. Great. I also made just a quick follow on that. I just want to confirm, so it sounds like phase three is only going to be testing the Q6 week, head-to-head against those attacks, and I don't know if you can comment, would the primary be just PFS, or is that going to be PFS and then OS kind of co-primary? Thank you. Thanks, Yaron, for the questions. Ty, can you give a bit of color on the endpoints for the fake tree? Sure.

Speaker Change: Thank you.

Speaker Change: Yes, of course. Now we're going to take our next question and it comes from Yaron Werber from TD Security. Your line is open, please ask your question.

Yaron Werber: Great. I also made just a quick follow-on. I just want to confirm, so it sounds like the Phase 3 is only going to be testing the Q6 week.

Yaron Werber: Head-to-head against those attacks sold, and I don't know if you can comment, would the primary be just PFS or is that going to be a PFS and an OS kind of core primary? Thank you.

Asthika Goonewardene: To make it more safe. And so that that with the time to event, we don't take a little bit more time. So we'll bring that into the public domain as soon as it makes sense on the data set. Thanks, thanks, Dai. And we get your extra Asthika that also at SITCV and then to present some further preclinical data. It's a further help you to understand this new biology of activating a D1000 in case of fear for one would be by specifics. So lots of new data supporting, I think, the excitement around Akasuni. Thank you.

Peter Valdout: Now we're going to take over next question.

Speaker Change: Thanks Yaron for the questions. Ty, can you give a bit of color on the endpoints for the fake tree?

Yaron Werber: It will be a two-arm study with a control arm and with the Q6 arm of Akasuniyama in combination with PEMBO. This is where we have the signal, this is where the data leads us, and the end point will be over survival.

Ty: Sure. It will be a two-arm study with a control arm and with the Q6 arm of Akasuniov in combination with PEMBO.

Speaker Change: This is where we have the signal, this is where the data leads us, and the end point will be over Survivor.

Speaker Change: Thanks very clearly, Tai. I think that's the answer, Yaron, for your question.

Peter Valdout: And the next question comes to the line of Peter Valdout from CTOLAN. Is open, please ask the question. Yeah, thank you, Peter L.

Speaker Change: Thank you. Let's move to the next one operator. Thank you.

Tahamtan Ahmadi: Thank you very clearly, Tai. I think that's the answer, Yaron, for your question. Thank you. Let's move to the next one, Operator. Thank you. And now we're going to take our next question, and it comes on the line from Matthew Phipps on behalf of William Blair. Your line is open, please ask your question.

Speaker Change: And now we're going to take our next question and it comes from Matthew Phipps from William Blair. Your line is open, please ask your question.

Peter Valdout: City. Two question, please Jan, speaking to the Pfizer oncology team, they've got four head and neck cancer assets that they could go into phase three, but they're saying not all will. So I just wanted to confirm an apologies if I've missed this, but is the head and neck phase sheet program for tip that confirmed all we do we await confirmation of that. And then retire you for Jan, I'm sorry to test your patients, but what is the latest on hexabody time minds in terms of data release and jam data decision or is unchanged since the last update.

Matthew Phipps: You know, you've had a nice launch of UpKinley and Lymphoma so far to date in the GLBCO space.

Matthew Phipps: Wondering how we should think about uptake in follicular lymphoma given already another crew right specifically there and how much that can contribute in the near term. Thank you.

Operator: Thanks, Matthew, for the question. And then Anthony Mancini, I think you can best handle this one, maybe a bit more on color uptake in follicular lymphoma versus diffused B-cell lymphoma.

Speaker Change: Thanks Matthew for the question and then Anthony Mancini I think you can best handle this one maybe a bit more on color uptake in follicular lymphoma versus diffused lymphocytic b-cell lymphoma.

Anthony Mancini: Yeah, thanks, Matt, for the question. We're about six weeks into launch here, but it's going really, really well. We're, again, really encouraged by what we hear in terms of customer reaction to the favorable label without required hospitalization or monitoring. And we think it gives us confidence that we can advance EpKinley use across diverse sites of care. We're starting to see growing EpKinley adoption in many of the, you know, large physician group practices.

Peter Valdout: Again, apologies for testing your patients. Thank you. Thanks Peter for the question. So why don't I ask you to give a bit of color on the head and neck plans for for tip that before that I can probably handle the hexabody city 38 question Peter. We are progressing really, really rapidly and we are fully on schedule to present to have the data and present them to Jane, Jane, the second half. Next up by the city 38 versus sub queue data and the likely be an update from the company also by the end of this year, maybe not on the medical conference, but then another form of so maybe you that you can give a bit of color on the head and neck cancer data for tip that.

Anthony Mancini: Yeah, thanks, Matt, for the question. Look, we're about six weeks into the launch here, but it's going really, really well. We're, again, really encouraged by what we hear in terms of the customer reaction.

Anthony Mancini: to the favorable label without required hospitalization or monitoring.

Anthony Mancini: And we think it gives us confidence that we can advance Epkinle use across diverse sites of care. We're starting to see growing Epkinle adoption in many of the, you know, large physician group practices.

Anthony Mancini: And we believe that the third line plus FL label is going to really enhance our ability to deliver innovation more broadly to patients in need where they want to be treated closer to home. And we think the Kinley profile really enables that. In terms of the size of the population, it's really a modest population size. But because of the differentiation of having one product across both indications, we think reactions have been very favorable so far in the community. So I'll leave it be.

Anthony Mancini: And we believe that the third-line F.L. label is going to really enhance our ability.

Peter Valdout: Yeah, so as you know, we presented encouraging data on order based on RMC at ask of course, you know, we are waiting for maturity of this data and in parallel. We open another cohort with a strict eligibility criteria and we are assessing this in conjunction with part E, which is combination to assess a strategic seat for the company and for tip that make further decision by the end of the year. So we are closing monitoring the data.

Anthony Mancini: to deliver innovation more broadly to patients in need where they want to be treated closer to home. And we think the Kinley profile really enables that. In terms of the size of the population, it's really a modest population size, but because of the differentiation of having one product across both indications, we think it's, the reactions have been very favorable so far in the community. So I'll leave it there.

Jan van der Winkel: Thanks, Anthony. Thanks, Matt, for the question. Let's move on to the next one, operator.

Anthony Mancini: Thanks, Anthony. Thanks, Matt, for the question. Let's move on to the next one, operator.

Operator: And now we're going to take our next question, and it comes from the line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Speaker Change: Yes, of course.

Peter Valdout: Yeah, yeah, thank you. [inaudible] Thank you very much. Thanks, Anthony. Thanks Matt for the question. Let's move on to the next one operator. Yes, of course. And now we're going to take our next question, and it comes to learn of Michael Schmidt from Good and Guy partners. Your line is open, please, after question. Yeah, thanks for taking my questions. I had a commercial question to follow up on that curtain, Marvin. Yeah, just thinking I had one ring, how we should think about this.

Speaker Change: And now we're going to take our next question and it comes from the line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Michael Schmidt: Hey, thanks for taking my questions. I had a commercial question, a follow-up on EPCORIDIMAP, and, yeah, just thinking ahead, wondering how we should think about the launch trajectory, perhaps, in follicular lymphoma relative to the initial launch in DOBCL, given, presumably, there's a fair amount of commercial synergies, you know, with this lip expansion. And in DOBCL, specifically, how much visibility do you have, perhaps, based on claims data and other sources on how the drug is used relative to other treatment options, you know, be it other antibodies or CAR-T cell therapies?

Michael Schmidt: Hey, thanks for taking my questions. I had a commercial question, a follow-up on EPCORIDIMAP and...

Michael Schmidt: Thanks so much.

Michael Schmidt: Yeah, just thinking ahead, wondering how we should think about the launch trajectory perhaps in follicle and fomal relative to the initial launch and DOBCL.

Peter Valdout: The launch trajectory, perhaps in follicle and formal relatives to the initial launch in DLBCL, given presumably there's a fair amount of commercial synergies, you know, in the slave expansion. And in DLBCL specifically, how much visibility do you have perhaps based on claims data and other other sources on how the drug is used relative to others. Treatment options, you know, beat other antibodies or cartoons of that. Thanks so much. Thanks Michael for the questions.

Speaker Change: Given, presumably, there's a fair amount of commercial synergies, you know, with this layup expansion.

Speaker Change: and in DLTCL specifically.

Speaker Change: How much visibility do you have, perhaps based on claims data and other sources, on how the drug is used relative to other treatment options, you know, be it other antibodies or CAR T-cell therapies? Thanks so much.

Anthony Mancini: Thanks, Michael, for the questions. I think Anthony Mancini at this will keep you busy for a few minutes.

Speaker Change: Thanks, Michael, for the questions. I think Anthony Mancini at this will keep you busy for a few minutes.

Anthony Mancini: Thanks. Thanks, Michael, for the question. In terms of the launch trajectory in FL versus DLBCL, to give you a little bit of context, you know, and this is really drug-treated patients, the DLBCL third-line-plus market is about 3,600 patients in the U.S., so it's really quite similar size in Japan. In FL, it's about half of that, so it's about, you know, close to 2,000 patients. We really we with the claims data that we are seeing right now, we, you know, the capture, as you know, is not great. So we're not able to see the great details.

Speaker Change: Thanks. Thanks, Michael, for the question. In terms of the launch trajectory in FL versus DLVCL, to give you a little bit of context, you know, and this is really drug-treated patients,

Speaker Change: The DLBCL third-line plus market is about 3,600 patients in the U.S. It's really actually quite similar size in Japan. In FL, it's about half of that. So it's about, you know, close to 2,000 patients.

Anthony Mancini: But we do a lot of market research, and we do a lot of, so we're able to see where the drugs are used, and in the DLDCL space, where we've had four full quarters in the U.S., we really are starting to see more truly third-line patients. And, again, what we're seeing in the real world is really mirroring what we see in the clinical trials, so very positive customer reactions. And I felt it was too early to tell.

Speaker Change: We really, we, with the claims data that we are seeing right now, we, you know, the capture, as you know, is not great, so we're not able to see the great detail, but we do a lot of market research and we do a lot of

Michael Schmidt: of customer research on a qualitative basis. So we're able to see where the drugs are used. And in a DLDCL space where we've had four full quarters in the US, we really are starting to see now more truly third line patients.

Anthony Mancini: That said, I think that when we ask physicians what they're after, the profile in terms of powerful efficacy, manageable safety, and really seamless and efficient step-up dosing and sub-team administration that's offered with Epkinly is something that's really attractive, particularly across diverse practice settings. So when you think about staff time, chair time, scheduling efficiency, these are things that position us really well. So we're encouraged by these first few steps here to make Epkinly truly the core therapy across B-cell malignancies. And we'll leave it there.

Anthony Mancini: Thank you, Anthony. Thanks for the question, Michael.

Operator: Thank you. 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.

Peter Valdout: I think Anthony Monsini at this will keep you busy for a few minutes. Thanks, thanks Michael for the question. In terms of the launch trajectory in FL versus DLBCL to give you a little bit of context, you know, and this is really drug treated patients. The DLBCL third line plus markets, about 3600 patients in the US are really actually quite similar size in Japan in FL. It's about half of that. So it's about close to 2000 patients.

Peter Valdout: We really, with the claims data that we are seeing right now, we, you know, the capture, as you know, is not great. So we're not able to see the great detail, but we do a lot of market research and we do a lot of customer research on a qualitative basis. So we're able to see where the drugs are used. And in a DLBCL space where we've had four or four quarters in the US, we really are starting to see now more truly third line patients.

Peter Valdout: And again, what we're seeing in the real world is really mirroring what we see in the clinical trial. So very positive customer reactions in FL too early to tell. That said, I think that when we ask physicians what they're after, the profile in terms of powerful efficacy, manageable safety and really seamless and efficient step up dosing and subcube administration that's offered with that canally is something that's really attractive, particularly across diverse practice settings.

Peter Valdout: So when you think about staff time, chair time, scheduling efficiency, these are things that position us really well. So we're encouraged by the, by these first few steps here to make up can lead truly the court therapy across some legacies. And, and we're, you know, we'll leave it there. Thank you Anthony. Thanks for the question Michael. Thank you.

Rajan Sharma: Now we're going to take our next question and it comes in line of Rajan Sharma from Goldman Sachs.

Your line is open piece of.